PDF version

Editorial

John N Lavis,¹ Mehrnaz Kheirandish,² Lubna Al-Ansary,³ Huda Basaleem,4 Rana Hajjeh,⁵ Ahmed Al-Mandhari ⁶ and Arash Rashidian ⁷

¹ Director, McMaster Health Forum, and Professor, Department of Health Research Methods, Evidence and Impact, McMaster University, Ontario, Canada. ²Regional Adviser, Evidence to Policy, Department of Science, Information and Dissemination, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. ³Professor, Department of Family and Community Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia. ⁴Assistant Vice president for Academic Affairs, University of AdenUniversity of Aden Faculty of Medicine and Health Science, Aden, Yemen. ⁵Director of Programme Management, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. 6Regional Director, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. ⁷Director of Science, Information and Dissemination, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. (Correspondence to Arash Rashidian: This email address is being protected from spambots. You need JavaScript enabled to view it.).

Citation: Lavis JN, Kheirandish M, Al-Ansary L, Basaleem H, Hajjeh R, Al-Mandhari A, Rashidian A. Next generation support and stronger institutions for evidence-informed policy-making. East Mediterr Health J. 2023;29(7):495–497. https://doi.org/10.26719/2023.29.7.495 

Copyright: © Authors; Licensee: World Health Organization. EMHJ is an open access journal. All papers published in EMHJ are available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Evidence-informed policy-making benefitted from much-needed attention and resources during the COVID-19 pandemic (1). As a result, 3 key movements and innovations are now making it possible to provide better evidence support (higher quality and more aligned to the speed of advisory and decision-making) for policy-making than ever:

1. The expansion and streamlining of “living evidence” and “living guidance” approaches. These were used by WHO and other multicountry or national agencies, and included rapid evidence-to-recommendation processes (i.e. living guidelines) (2-4), and rapid evidence provision and synthesis for decision-making (5).
2. Enhanced use of digital technologies for rapid contextualized evidence syntheses. These approaches include upgraded evidence portals and artificial intelligence (AI)-powered evidence syntheses (6). Such innovations were also used in combination with other traditional approaches used for “living evidence”.
3. Expanded use of a ‘general contractor’ model of evidence support that leverages the use of existing expertise through agreements that enable the provision of the relevant evidence from research and data needed in response to urgent needs. While such approaches are not new (7), their use was amplified and extended beyond the existing centres of excellence.

Now is the time to examine further and expand these innovative approaches in countries and settings where they have not been used before, and to formalize and institutionalize the national evidence support system (8). Before COVID-19, ‘rapid’ evidence syntheses were often prepared in weeks and months, however, during the pandemic “policy support” teams began to respond to policymakers’ questions within 2–3 business days. As an example, evidence portals like the COVID-END Inventory, which was tagged the ‘best’ evidence syntheses for any given question based on three criteria: (1) quality of the evidence synthesis; (2) up-to-dateness of the search; and (3) availability of a GRADE evidence profile. It also provided an inventory of decision-relevant evidence syntheses. These enhanced features are now being added to existing evidence portals such as Health Systems Evidence and Social Systems Evidence, to facilitate the identification of the evidence syntheses from which context-appropriate insights can be drawn.

AI-powered living evidence syntheses have begun to emerge across a range of sectors, including in challenging and fast-moving policy areas like climate and health, in which AI is used to automate the processes and reduce the timeline for the development of updated evidence syntheses (9). Being able to download single studies using existing tags aligned to the local context meant that a new synthesis can be prepared remarkably quickly. AI-powered software can dramatically reduce the labour involved in assessing studies for possible inclusion in an evidence synthesis and in keeping these syntheses ‘living,’ which means regularly updated as the context, issue and/or evidence evolve.

Before COVID-19, evidence support for policymakers was often provided in a chaotic way. Data analysts and experts conducted evaluations or evidence syntheses and provided ‘their’ evidence separately. The burden then fell on policymakers to make sense of the disparate inputs.

The WHO Regional Office for the Eastern Mediterranean (WHO/EMRO) and its counterpart, WHO Regional Office for the Americas (PAHO), were unique in calling for a more joint approach that matched the right form of evidence with the right question. WHO/EMRO proposed the “integrated multi-concept” approach (Figure 1) aimed at enhancing evidence-informed policy-making via establishing structural and programmatic linkages between different streams of evidence support mechanisms while avoiding inefficiencies and inconsistencies (10). The approach was used as a critical lens in documenting the experiences of countries assessing the use of evidence for COVID-19 response (5) and now being implemented in 3 pioneering countries of the region, which will provide prototypes for adaptation to other countries (11). Several countries in the region are affected by acute or protracted emergencies, hence the lessons learnt are of immediate value for implementation.

During the pandemic we began to see the expansion of the ‘general contractor’ model, like what happens with home renovations. Rather than having to hire an electrician, plumber, tiler, and other trades, homeowners (in our case policymakers) can turn to a general contractor who can bring in the right collection of evidence at the right time. The contractor may draw on multiple forms of domestic (national or sub-national) evidence, global evidence syntheses, and other types of information (Figure 2).

Rapid contextualized evidence syntheses and the general contractor model can be piloted by members of WHO/EMRO’s Network of Institutions for Evidence and Data to Policy (NEDtP), and such pilots should be seen as part of a broader effort to strengthen national evidence support systems (12). This means enhancements in at least 4 areas:

1. Working with policymakers (on the evidence-demand side) to (a) incorporate evidence use into routine advisory and decision-making processes (which we call ‘enablers’); (b) build and sustain an evidence culture; and (c) strengthen capacity for evidence use.
2. National commitment towards the integrated multiconcept approach for evidence-informed policy-making through linking the main technical programmes and sources of evidence and data at national level.
3. Establishment of rapid evidence for policy agreements with NEDtP member institutions, to elicit and prioritize questions from policymakers and coordinate responses to the questions.
4. Identification and working with timely, demand-driven evidence-support units that can provide different forms of domestic evidence, and leverage living evidence syntheses and other parts of the global evidence architecture.

Noting the attention given to the WHO programme for enhancing evidence-informed policy-making in the region in recent years, and its inclusion in the WHO/EMRO’s Vision 2023, the Eastern Mediterranean Region is uniquely positioned to be at the vanguard of such efforts globally (10,13,14).

References

1. Kuchenmu¨ller T, Lavis J, Kheirandish M, Reveiz L, Reinap M, Okeibunor J, et al. (2022) Time for a new global roadmap for supporting evidence into action. PLOS Glob Public Health 2(6): e0000677. https://doi.org/10.1371/journal.pgph.0000677.
2. Vogel JP, Dowswell T, Lewin S, Bonet M, Hampson L, Kellie F, et al. Developing and applying a 'living guidelines' approach to WHO recommendations on maternal and perinatal health. BMJ Glob Health. 2019;4(4):e001683. 10.1136/bmjgh-2019-001683.
3. El Mikati IK, Khabsa J, Harb T, Khamis M, Agarwal A, Pardo-Hernandez H, et al. A framework for the development of living practice guidelines in health care. Ann Intern Med. 2022;175(8):1154-1160. 10.7326/M22-0514.
4. Millard T, Elliott JH, Green S, Tendal B, Vogel JP, Norris S, Tate R, Turner T. National COVID-19 clinical evidence taskforce. Awareness, value and use of the Australian living guidelines for the clinical care of people with COVID-19: an impact evaluation. J Clin Epidemiol. 2022;143:11-21. 10.1016/j.jclinepi.2021.11.035.
5. Rashidian A, Wu K, Al Ariqi L, Aly E, Mandil A, Barakat A et al. WHO's support for COVID-19 research and knowledge management in the Eastern Mediterranean Region. BMJ Glob Health. 2022;7(Suppl 3):e008737. 10.1136/bmjgh-2022-008737.
6. Cowie K, Rahmatullah A, Hardy N, Holub K, Kallmes K. Web-based software tools for systematic literature review in medicine: systematic search and feature analysis. JMIR Med Inform 2022;10(5):e33219. doi: 10.2196/33219.
7. Booth A, Wright K, Outhwaite H. Centre for reviews and dissemination databases: value, content, and developments. Inter J Tech Assess Health Care 2010;26(4):470-472. 10.1017/S0266462310000978.
8. Global Commission on Evidence to Address Societal Challenges. The Evidence Commission report update 2023: A wake-up call and path forward for decision-makers, evidence intermediaries, and impact-oriented evidence producers Strengthening domestic evidence-support systems, enhancing the global evidence architecture, and putting evidence at the centre of everyday life. Hamilton: McMaster Health Forum, 2023. https://www.mcmasterforum.org/networks/evidence-commission/report/english.
9. Berrang-Ford L, Sietsma AJ, Callaghan M, Minx JC, Scheelbeek PFD, Haddaway NR, et al. Systematic mapping of global research on climate and health: a machine learning review. Lancet Planet Health 2021;5:e514–25. https://doi.org/10.1016/ S2542-5196(21)00179-0.
10. World Health Organization. Developing national institutional capacity for evidence-informed policy-making for health. Cairo: WHO Regional Office for the Eastern Mediterranean, 2019. https://applications.emro.who.int/docs/RC_Technical_Papers_2019_6_en.pdf?ua=1.
11. World Health Organization. Regional action plan for the implementation of the framework for action to improve national institutional capacity for the use of evidence in health policy-making in the Eastern Mediterranean Region. Cairo: WHO Regional Office for the Eastern Mediterranean, 2021. https://applications.emro.who.int/docs/9789290229124-eng.pdf?ua=1.
12. World Health Organization. Summary report on the first formal meeting of the Regional Network of Institutions for Evidence and Data to Policy (NEDtP) to enhance national capacity for evidenceinformed policy-making. Cairo: WHO Regional Office for the Eastern Mediterranean, 2022. https://applications.emro.who.int/docs/WHOEMEDP003E-eng.pdf?ua=1
13. Rashidian A, Mandil A, Mahjour J. Improving evidence informed policy-making for health in the Eastern Mediterranean Region. East Mediterr Health J 2017;23(12):793-794. 10.26719/2017.23.10.793.
14. World Health Organization. WHO’s strategy for the Eastern Mediterranean Region, 2020–2023: Turning Vision 2023 into action. Cairo: WHO Regional Office for the Eastern Mediterranean, 2019. https://apps.who.int/iris/handle/10665/348102.

PDF version

Commentary

Mehrnaz Kheirandish,¹ Tanja Kuchenmuller,² Ludovic Reveiz,³ Marge Reinap,⁴ Joseph Okeibunor,⁵ John Reeder ⁶ and Arash Rashidian ¹

¹Department of Science, Information and Dissemination, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. ²Department of Research for Health, World Health Organization, Geneve, Switzerland. ³Department of Evidence and Intelligence for Action in Health and Incident Management System for COVID-19, WHO Regional Office for the Americas/Pan American Health Organization, Washington, District of Columbia, USA. ⁴Division of Country Health Policies and Systems, World Health Organization Regional Office for Europe, Copenhagen, Denmark. ⁵Emergency Preparedness and Response Programme, World Health Organization Regional Office for Africa, Brazzaville, Congo. ⁶Department of Research for Health, World Health Organization, Geneva, Switzerland. (Correspondence to Arash Rashidian: This email address is being protected from spambots. You need JavaScript enabled to view it.).

Keywords: evidence, policy-making, health systems, research, data, EVIPNet

Citation: Kheirandish M, Kuchenmuller T, Reveiz L, Reinap M, Okeibunor J, Reeder J, Rashidian A. Institutionalizing evidence-informed policy-making in the post-pandemic era. East Mediterr Health J. 2023;29(7):498–499. https://doi.org/10.26719/emhj.23.101

Copyright: © Authors; Licensee: World Health Organization. EMHJ is an open access journal. All papers published in EMHJ are available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).

¹ Evidence-informed Policy Network (EVIPNet) that includes the regional networks of: EVIPNet Africa (WHO African Region), EVIPNet Americas (WHO American Region), EVIPNet Europe (WHO European Region) and the Regional Network of Institutions for Evidence and Data to Policy (NEDtP) in the WHO Eastern Mediterranean Region.

The COVID-19 pandemic caused unprecedented misery and death across the globe (1), highlighting the importance of reliable health information systems and local research data and evidence to guide policies (2-4). Currently, most countries are harnessing public trust for the rebuilding, and sometimes rethinking, of the health systems (5). One remains optimistic that in all these efforts the key lessons from the pandemic will not be forgotten and investing in data systems and processes for evidence-informed policy-making will be prioritized. Such hopes are not always realized after crises, and in this commentary, we highlight a few key actions that require careful attention to catalyze change.

At the end of 2021, in the midst of the COVID-19 emergency, a Call for Action (6) was developed by EVIPNet  and its partners to chart the way forward for evidence-informed decision-making, for future health emergencies and for more routine societal and environmental challenges, in view of building a more resilient, equitable and sustainable world. This call for action was based on taking stock of lessons learnt during the COVID-19 pandemic, as well as from regional and global WHO resolutions and action plans in support of evidence-informed policies for health (7-9).

Three key aspects differentiate the call for action and more recent WHO initiatives from previous efforts. First, there was a clear and increasing emphasis on institutionalizing evidence-informed policy-making at country level, complemented by the need to move away from project- or issue-focused approaches and toward programmatic, integrated and system-focused approaches. From the WHO point of view, institutionalization of evidence-informed policy-making is defined as “process and outcome of (re-)creating, maintaining and reinforcing norms, regulations, and standard practices that, based on collective meaning and values, actions, as well as endowment of resources, allow evidence to become – over time – a legitimate and taken-for-granted part of policy-making” (10,11). Policymakers should ensure the use of research and data evidence as an integral part of decision-making processes.

Second, there is a growing recognition of the importance of the broader evidence system and its diverse actors in shaping decision-making at country level. Efforts should focus on collaborative, synergistic and integrative approaches to resource use, avoiding duplication of efforts and reducing potential confusion arising from conflicting decisions in policy and health system (11,12).

Third, enhancing the use of data and research evidence in health policies requires addressing the rapid growth of misinformation (the infodemic), and eliminating poor practices in research, which together have contributed to the erosion of trust in health systems and in governments in general (13). Although WHO has developed frameworks that can help countries in addressing infodemics (14), building trust and confidence in science requires improved research governance at all levels, including reinforcing good principles and standards that strengthen the transparency, accountability and societal value of the routine use of evidence in policy.

Initiatives such as EVIPNet are actively committed to creating conditions that increase and improve the engagement of citizens in decision-making. This is achieved through bottom-up approaches such as levering real-life experience and building a shared understanding of evidence-informed policy-making processes. On the other hand, the urgent need for evidence, highlighted during the pandemic, in some instances resulted in overlooking basic principles of good research practice. Academic institutions and academic journals should take more responsibility in this regard, so that the race for evidence to answer questions in emergency situations will be better prioritized and governed to avoid waste of resources.

To build on the current momentum and accelerate global action, WHO is convening a virtual global evidence-to-policy summit with the theme “Evidence as a catalyst for policy and societal change: building trust and bridging the gap” in August 2023. The key objective of this event is to bring together researchers and policymakers from WHO, international institutions, Member States, universities, research institutes, and other partners, to take stock of the progress on implementing the Call for Action, identify common challenges, share innovations and lessons learned, and provide recommendations for the next steps.

We call for the enhancement of interagency collaborative initiatives on evidence-informed policy-making. The United Nations, as well as the multilateral, regional and national partners should work together to streamline and strengthen their support to countries in this regard. There is also a need to increase the number of academic institutions working more closely with WHO (e.g. as collaborating centers) in support of evidence-informed policy-making. WHO is keen to enhance and expand existing capacity and partnerships for research evidence in healthcare (15).

References

1. World Health Organization. 14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021. Geneva: World Health Organization. https://www.who.int/news/item/05-05-2022-14.9-million-excess-deaths-were-associated-with-the-covid-19-pandemic-in-2020-and-2021.
2. Schmidt AE, Abboud LA, Bogaert P. Making the case for strong health information systems during a pandemic and beyond. Arch Public Health 2021;79(13). https://doi.org/10.1186/s13690-021-00531-5.
3. World Health Organization. Evidence, policy, impact. WHO guide for evidence-informed decision-making. Geneva: World Health Organization, 2021. https://www.who.int/publications-detail-redirect/9789240039872.
4. Kuchenmüller T, Reeder JC, Reveiz L, Tomson G, El-Jardali F, Lavis JN, et al. COVID-19: investing in country capacity to bridge science, policy and action. BMJ Global Health 2021;6(2):e005012. http://dx.doi.org/10.1136/bmjgh-2021-005012.
5. Sagan A, Thomas S, McKee M, Karanikolos M, Azzopardi-Muscat N, de la Mata I, et al. COVID-19 and health systems resilience: lessons going forwards. Eurohealth 2020;26(2):20-4. https://apps.who.int/iris/handle/10665/336290.
6. World Health Organization. Together on the road to evidence-informed decision-making for health in the post-pandemic era: a call for action. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/WHO-SCI-RFH-2021.08.
7. World Health Organization. Action plan to strengthen the use of evidence, information and research for policy-making in the WHO European Region. Copenhagen: World Health Organization Regional Office for Europe, 2016. https://apps.who.int/iris/handle/10665/338122
8. World Health Organization. Developing national institutional capacity for evidence-informed policy-making for health. East Mediterr Health J. 2021;27(3):314–315. https://doi.org/10.26719/2021.27.3.314.
9. World Health Organization. Framework for strengthening the use of evidence, information and research for policy-making in the African Region. Brazzaville: WHO Regional Office for Africa, July 2021. https://apps.who.int/iris/handle/10665/345395.
10. World Health Organization. Supporting the routine use of evidence during the policy-making process: a WHO Checklist. Geneva: World Health Organization, 2023. https://www.who.int/publications/i/item/9789240056145.
11. World Health Organization. Evidence, policy, impact. WHO guide for evidence-informed decision-making. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/9789240039872.
12. World Health Organization. A guide for evidence-informed decision-making, including in health emergencies. Washington DC: World Health Organization Pan American Health Organization, 2022. https://iris.paho.org/bitstream/handle/10665.2/55828/PAHOEIHKTCOVID1921038_eng.pdf
13. Van Noorden R. How many clinical trials can’t be trusted? Nature 2023;619: 455-458. https://www.nature.com/articles/d41586-023-02299-w.pdf.
14. World Health Organization. WHO competency framework: building a response workforce to manage infodemics. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/9789240035287.
15. World Health Organization. Together on the road to evidence-informed decision-making for health in the post-pandemic era: a call for action. Geneva: World Health Organization, 2022. https://www.who.int/news/item/30-12-2021-together-on-the-road-to-evidence-informed-decision-making-for-health-in-the-post-pandemic-era-new-evipnet-call-for-action.

PDF version

Aamir Jafarey,¹ Sualeha Shekhani,¹ Faiz Raza ² and Sumera Naz ³

¹Centre for Biomedical Ethics and Culture, Sindh Institute of Urology and Transplantation, Karachi, Pakistan (Correspondence to A.M. Jafarey: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²National Institutes of Health, Health Research Institute, TB Research Centre, King Edward Medical University, Lahore, Pakistan. ³Health Research Institute, Islamabad, Pakistan.

Abstract

Background: Mapping of ethical governance structures is very useful in identifying strengths and weaknesses in order to uphold integrity and ensure standardization. However, reliable countrywide data about ethical review committees (ERCs) is unavailable in Pakistan.

Aims: To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan. 

Methods: This pilot mapping exercise used a mixed-methods approach, involving a cross-sectional survey of 19 key healthcare research institutions, and structured in-depth interviews with the chairs of the National Bioethics Committee and the Drug Regulatory Authority of Pakistan. 

Results: Eighteen institutions responded to the ethics mapping survey. Twelve public sector ERCs had a permanent structure and 17 had formal terms of reference. Seven ERCs claimed accreditation, although no central accreditation agency exists in Pakistan. Eight ERCs were chaired by the heads of the institutions. There was no fixed tenure for the heads in 13 committees, and 14 committees allowed multiple terms. Six ERCs had follow-up mechanisms for ethical approvals, and 6 took punitive actions in response to any deviation from an approved protocol, or to a scientific misconduct. Two respondents recalled situations where applicants pressured committee members for favourable approvals. Survey respondents mentioned the lack of central research ethics guidelines as a weakness of the national governance system. Structured interviews revealed the need for formal training of committee members and capacity strengthening, particularly for administrative staff.

Conclusion: There is a need to develop guidelines for local ethics governance in Pakistan, and ensure accreditation of ERCs through the National Bioethics Committee to uphold the integrity of the ethics governance structure.

Keywords: bioethics, research ethics, guidelines, review committee, research protocols, accreditation, Pakistan

Citation: Jafarey A, Shekhani S, Raza F, Naz S. Situation analysis of research ethics governance in Pakistan. East Mediterr Health J. 2023;29(7):500–507. https://doi.org/10.26719/emhj.23.069 Received: 07/08/21; Accepted: 21/11/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Low- and middle-income countries often have compromised health systems and therefore require effective research ethics governance to ensure robust and ethically sound research (1,2). Pakistan is a lower-middle-income country within the Eastern Mediterranean Region and has a developing health sector with limited research output (3). Pakistan operates a 2-tier ethics review mechanism at institutional and national levels. However, the quality of institutional review may vary significantly. Over the years, the number of institutional ethical review committees (ERCs) has increased to meet requirements for funding, collaboration, and publications (4). There are no verifiable data from Pakistan indicating the exact number, nature, and capacity of ERCs, and there is no accreditation process to ensure standardization. At the national level, 2 organizations are involved in ethical scrutiny of some categories of health research: the National Bioethics Committee Research Ethics Committee (NBC-REC), operational since 2004, and the Drug Regulatory Authority of Pakistan Clinical Studies Committee (DRAP-CSC), established in November 2019. The latter reviews only clinical trials, but the former provides ethical review for a wider spectrum of human research. ERC mapping exercises are useful to identify strengths and weaknesses of ethics governance systems (5–7). In Pakistan, such attempts have been sporadic and restricted to particular institutions or provinces, providing limited information (8,9).

This study used a mixed-methods design to conduct a systematic investigation of research governance mechanisms at key public and private research institutions in Pakistan. It provides the first insight into national level mechanisms, examining NBC-REC and DRAP-CSC processes for their strengths, weaknesses, and overlaps. To the best of our knowledge, such an exercise has not been performed in Pakistan. This study is intended to serve as a pilot towards a nationwide mapping exercise.

Methods

Study design

This mapping exercise used a mixed-methods approach, involving a cross-sectional survey of key healthcare research institutions in Pakistan, and structured in-depth interviews with the chairs of two national regulatory institutions.

Mapping survey

A survey was developed specifically for the purpose of key institutional mapping, with 62 closed-ended questions, in 5 broad areas: (1) general information; (2) membership; (3) training for members; (4) procedure for review of proposals; and (5) challenges to review systems. Open-ended questions exploring the challenges to research ethics governance were also included. The tool was piloted on ERC members (not included in the current survey) to ensure face validity, which resulted in refinement of some questions.

The survey was administered to selected public and private sector institutes using purposive sampling. Twelve public sector institutes managed by the autonomous Pakistan Health Research Council (now known as Health Research Institute) were identified (9). One focal person from each centre was invited to participate. Three additional key public sector institutions other than the Pakistan Health Research Council were also included. Nonprobability purposive sampling was used to select 4 private sector institutions from 3 major cities because, based on our knowledge (10), these institutions produced a high volume of research papers, and were more suitable to provide the relevant information. Data collection took place in December 2020 and January 2021.

Structured interviews

Structured telephone interviews were conducted with the heads of NBC-REC and CSC-DRAP to better understand how these organizations operate (11). After obtaining verbal informed consent, the interviews were audio-recorded and transcribed verbatim.

Data analysis

Data obtained from the survey were collated through surveymonkey.com. Results generated included descriptive statistics such as frequencies and percentages. Questions were grouped under themes and subthemes. Data from the survey and interviews were merged to provide an overall picture of ethical governance. Ethical approval was obtained from NBC-REC.

Results

Mapping survey

Nineteen institutions received and completed the survey, giving a 100% response. One institution reported a nonfunctioning ERC; therefore, the data from 18 institutions with functioning ERCs were used: 14 from the public sector and 4 from the private sector (Table 1).

Characteristics of committees

All but 2 committees in the public sector were permanent, and 17 had formal terms of reference (publicly accessible in 10 cases). Fifteen committees conducted only ethical reviews, whereas 2 also provided scientific reviews. All committees reviewed research by staff and faculties, and 16 also reviewed student research. Nine committees accepted projects from other institutions.

Information regarding ERC procedures was available on institutional websites for 9 committees, although 17 respondents believed that this information was widely known across their institutions.

Seven respondents (5 public and 2 private) declared that their committees were accredited, although none identified an actual accreditation agency. Twelve ERCs reported following published research ethical guidelines (Table 1). Nine committees (7 public and 2 private) had designated budgets and 16 had secretarial support; of which, 13 had designated secretaries and 3 had no designated staff or budget.

Leadership of ERCs

Eight ERCs (all public) were chaired by the heads of the institutions, 4 were headed by individuals from outside the institution, and 4 had institutional members as heads. The chairs of 17 committees were appointed by the institutions, and had no fixed tenure in 13 committees (10 public and 3 private). The chairs of 14 committees could serve multiple terms, with 8 serving their second term, and 2 their third and fourth terms. The other respondents either did not respond or were unaware of the term limits for their committees.

Membership composition

On average, committees had 11 members (range 3–21); 13 had 6–15 members, 3 had > 16 members, and 2 had 2–5 members. Committee membership comprised medical doctors (n = 18); researchers or members from outside the institution (n = 15 each); social scientists (n = 8); lay persons (n = 6); ethicists (n = 5); and nurses, religious scholars, or lawyers (n = 4 each). All committee members were nominated by institutions. In 11 committees (9 public and 2 private), there was no fixed tenure, 4 had up to 3 years, and 3 had > 3 years. Fourteen committees had provision for multiple tenures, whereas 2 reported limiting membership to only 1 term. All committees had mechanisms to co-opt additional reviewers.

Training of members

Fourteen committees had no training prerequisite for members; 9 provided training opportunities, and in 7, prior training was not mandatory. Only 2 committees (private) that required mandatory training also funded it. Training was equally likely to be provided at the institution itself, at another institution, or online.

Process of review

The review process in different ERCs is presented in Table 2. Respondents were asked about deviation from the usual review process. Four respondents (3 public and 1 private) believed that 2–20% of research projects from their institutions bypassed their ERC. Four believed it was because of lack of awareness of ethical requirements; 1 believed researchers wanted to cut corners, and another said researchers considered their projects free of ethical concerns. One also said researchers bypassed the ERC because they were submitting to a journal that did not require ethical clearance. Provision for exemption from review was available for 12 committees. Fifteen ERCs had rejected proposals in the past, 1 had never rejected any proposal, and 2 respondents did not know if they rejected a proposal. Fourteen respondents could not recall external pressure on their committees to obtain approval for a research proposal. Two recalled such pressure, with 1 mentioning that the institutional head pushed for approval for a pharma-funded project.

Respondents had diverse understanding of the mandate of NBC-REC (Table 3).

Follow-up of research proposals

All the committees had record-keeping and archiving mechanisms, but only 6 (4 public and 2 private) had post-approval follow-up systems. Six respondents (3 public and 3 private) recalled punitive actions taken in response to deviation from protocols, or for ethical misconduct, with 8 reporting no actions. In 1 case, the penalty was retraction of the published work by the journal concerned.

Structured interviews with heads of national regulatory institutions

NBC-REC and DRAP-CSC are permanent institutions with secretarial structures. The NBC-REC secretariat was housed at the Pakistan Health Research Council, and DRAP-CSC at the Division of Pharmacy Services. The main role of the NBC secretariat was to receive proposals, forward complete proposals to the REC chair, receive the decisions from the chair, and forward them to the applicants. The secretariat also maintained the NBC website. Except for a short period during the peak of the COVID-19 pandemic, members of the secretariat were not involved in the actual review discussions. Another role played by the secretariat was coordinating with the Ministry of National Health Services Regulations and Coordination and government officials.

Membership of both committees was mostly restricted to those with a medical background, primarily physicians, although NBC-REC had elected members; all but 1 with formal qualifications in bioethics. All members of DRAP-CSC were nominated and had experience mostly in biomedical research. NBC-REC had a mechanism for providing training to its members, but there was no such provision at DRAP-CSC.

Approved proposals required a more stringent follow-up by DRAP-CSC because it was within their mandate to halt ongoing clinical trials or disallow research at a particular site if there are ethical concerns. That committee received its legal regulatory powers through laws governing DRAP. NBC-REC required researchers to submit progress reports during predetermined interviews, primarily for archiving purposes. Prior to the COVID-19 pandemic, NBC-REC reviewed proposals asynchronously via email. The rapid turnaround review for COVID-19-related proposals that required a 72-hour turnaround was implemented in April 2020. Meetings were moved online and scheduled as and when proposals arrived, which necessitated several meetings a month during the first wave of the pandemic. The system worked efficiently and therefore a decision was made to review non-COVID-19, regular proposals during virtual meetings. DRAP-CSC had monthly physical meetings but within 3 months of the onset of the pandemic, they also transitioned to online meetings, being held as and when required.

Challenges to research ethics governance

At the institutional level, most respondents identified deficiency of member training as a challenge to research ethics governance. Two respondents considered lack of resources for post-approval monitoring, and 1 respondent each identified conflict of interest, pressures for approval from within the institution, and negative perception of researchers about the review process. One respondent stated that the added responsibility of reviews was burdensome on the committee members and the chair.

Survey respondents were asked to share perspectives regarding challenges to research ethics governance at the national level. Overall apathy towards research ethics and absence of local guidelines contributed to weak governance structures. One respondent believed that the two national level review steps were an unnecessary duplication of effort, and the required fee payments added a financial burden. Another respondent mentioned that there was a lack of coordination between institutional ERCs and national regulatory institutions. Lack of national ERC accreditation was also highlighted.

During the structured interviews, the NBC-REC chair reported that limited secretariat support was a significant challenge to the functioning of the committee. NBC-REC relied primarily on a single-person secretariat and adequate follow-up of proposals was a particular challenge. In contrast, the DRAP-CSC chair identified no such issues.

Discussion

This study provided a systematic, albeit limited, mapping of research ethics governance systems in Pakistan. Previous mapping attempts conducted in Pakistan have cited poor response rates (12). The 100% response rate in this survey can be attributed to the smaller sample size and the use of personal contacts to engage respondents. This was the first formal account of the review role of DRAP-CSC. A previous study exploring national ethics committees in the Eastern Mediterranean Region included NBC-REC (13), while another study provided an in-depth analysis of NBC-REC during the COVID-19 pandemic (14).

The presence of functional national regulatory institutions is promising. NBC-REC, formally notified in 2004, started with sporadic reviews in the initial years, but has since increased its review portfolio several folds. However, it has its challenges, including limited administrative and secretarial support. The secretariat has mostly not been involved in actual meetings, leaving tasks such as minute taking to the chair.

Duplication of ethical review by NBC-REC and DRAP-CSC of proposals already reviewed within institutional committees was identified as a cause of delays. However, given the nascent field of ethics governance in Pakistan, and variability of review capacity at institutional levels, it is important that NBC-REC continues to play a central review role. The current process ensures uniformity and quality control in governance that may not otherwise have been possible in Pakistan because of the lack of accreditation and regulation of ERCs.

The absence of national guidelines governing research ethics was highlighted as a deficiency. Locally adapted guidelines play a vital role in informing context-dependent governance (15). Twelve of our respondents reported following guidelines from various sources, including NBC and the Higher Education Commission. However, these institutions had no actual guidelines, which highlighted the unfamiliarity with the review processes among institutions expected to be more knowledgeable about these matters. Another important challenge identified at the national level was that while ERCs knew about NBC-REC, their responses reflected a lack of clarity regarding its mandate. If study participants occupying prominent roles in research institutions were confused, then a significantly wider lack of awareness can be assumed, which paves the way for systems to be bypassed. There is anecdotal evidence of foreign-funded studies requiring NBC-REC review being published without ever reaching the committee.

CSC-DRAP is a new development in research ethics governance, providing an enforcement arm to the regulatory framework. Its mandate is limited to reviewing and regulating clinical trials, and it has reviewed and permitted 22 mostly COVID-19-related clinical trials between November 2019 and January 2021. Some of the work of DRAP-CSC is a duplication of that of NBC-REC, but it also provides accreditation to clinical sites, contract research organizations, and physical inspections of trial sites. DRAP authorization is a prerequisite for importing and marketing of drugs in Pakistan; therefore, the institution can prevent a clinical trial from starting, or halt it in case of concerns. With barely 1 year of experience, it is too soon to infer the long-term impact of this institution.

The number of ERCs has increased over the years in Pakistan. In our study, all participating institutes except 1 had a functional committee. Nonexistence of an ERC within the Pakistan Health Research Council umbrella is a matter of concern, reflecting a possible lack of research at that institution. The institution is located in an underdeveloped province with poor health indicators and low research output.

The trend towards an increase in the number of institutional ERCs reflected heightened awareness for such a need. However, these committees often only exist on paper, and may not conduct rigorous review of research projects (16, 17). The increasing number of ERCs could be in response to the request by regulators such as Higher Education Commission, College of Physicians and Surgeons Pakistan, and Pakistan Medical Commission requiring physicians to publish research so they can qualify for fellowships or secure promotions, rather than a desire to observe ethical norms during research (18, 19).

Institutional commitment to ethical review governance is critical for successful functioning of committees, and is reflected in the support provided through budgets, secretarial assistance, and training opportunities. In this survey, while most committees had some secretarial support, only 9 had budgetary allocations. A well-functioning secretariat assists in the organization of meetings and ensures steady communication with applicants and proper post-approval follow-up, and requires funding (20). ERCs now require members to obtain formal certification in research ethics (21, 22). However, only 2 ERCs in this study had any training requirements. This is concerning because most committee members had no such training in their professional education.

Our survey illustrated diversity of membership in most committees. It was unsurprising that most committees primarily had physicians as members because the survey covered only medical institutions; however, it was encouraging to note that most committees also had external representation. This added diversity and led to unrestricted discussions, with external members generally being more forthcoming with critical comments (23). Only 4 committees had nurses, which, while expected because of their marginalized status in the medical hierarchy, was disappointing because their exclusion resulted in the loss of important perspectives (24). Although lay person and community representation on committees is recommended, only 6 committees in our survey had such representation. This can be explained by the exclusionary culture associated with medical practice in Pakistan. An encouraging finding was the inclusion of social sciences representation on 9 committees. This reflected a move of committees beyond their traditional comfort zone of reviewing biomedical research, and an enhanced ability to review public health and social sciences research. It was noteworthy that 5 committees had ethicists as members, implying that few committee members may have received formal bioethics training.

Type and length of tenure for members and chairs emerged as a concern. Membership and chairpersonship were entirely by nomination, which may have limited committee membership to older people, given the hierarchical culture in Pakistan. The lack of fixed tenure indicated potential stagnation. The ERC being chaired by the head of the same institution reflected a potential conflict of interest. While this was an accepted trend noted in an unpublished study in 2010, this survey showed that 8 of the 18 committees were chaired by their institutional heads (25, 26). Our sample was limited, but it was alarming to see that institutions were unaware of or were ignoring this potential conflict of interest.

Our effort to present a realistic snapshot of research ethics governance in Pakistan had some limitations. The survey covered only selected institutions, and the interviews only captured the perceptions of the chairs of the 2 national committees, and not the members, whose views could add valuable insight.

Conclusion

Our survey indicated variation in the type and quality of review at the institutional level, which was a reflection of the operations of the ERCs. Accreditation of all ERCs through the NBC could ensure uniformity, quality control, and stronger cohesion between national and institutional ethics governance systems. This study highlights the need to have a comprehensive, countrywide mapping of research and ethics regulatory capacity in Pakistan, and the need for national research ethics guidelines. A local, relevant guidance document would be important to provide a framework for ethical conduct, especially with the growth of research in Pakistan.

Funding: This study was funded by WHO/EMRO.

Competing interests: None declared.

Analyse de la situation de la gouvernance de l'éthique de la recherche au Pakistan

Résumé

Contexte : La cartographie des structures de gouvernance de l'éthique est très utile pour en identifier les points forts et les faiblesses en vue de maintenir leur intégrité et d'assurer leur normalisation. Cependant, il n'existe pas de données fiables à l'échelle nationale sur les comités d'évaluation éthique au Pakistan.

Objectif : Évaluer les mécanismes de gouvernance de l'éthique de la recherche au niveau national et dans les principaux établissements de santé au Pakistan. 

Méthodes : Cet exercice pilote de cartographie a utilisé une approche mixte, impliquant une enquête transversale auprès de 19 établissements clés de recherche en santé, et des entretiens structurés approfondis avec les présidents du Comité national de bioéthique et de l'Autorité de réglementation pharmaceutique du Pakistan. 

Résultats : Dix-huit établissements ont répondu à l'enquête de cartographie éthique. Douze comités d'évaluation éthique du secteur public possédaient une structure permanente et 17 avaient un mandat officiel. Sept comités ont demandé une accréditation, bien qu'il n'existe aucun organisme d'accréditation central au Pakistan. Huit comités d'évaluation éthique étaient présidés par les responsables des établissements. Treize comités étaient sans mandat fixe pour les responsables, tandis que 14 autorisaient les mandats multiples. Six comités disposaient de mécanismes de suivi pour les approbations éthiques, et six avaient pris des mesures de sanction en réponse à tout écart par rapport à un protocole approuvé ou à une faute scientifique grave. Deux répondants ont évoqué des situations où les demandeurs avaient fait pression sur les membres du comité pour obtenir des approbations favorables. Les personnes interrogées ont pointé l'absence de lignes directrices centralisées sur l'éthique de la recherche en tant que faiblesse du système national de gouvernance. Des entretiens structurés ont révélé la nécessité de soumettre les membres du comité à une formation officielle et de renforcer les capacités, notamment en ce qui concerne le personnel administratif.

Conclusion : Il est nécessaire d'élaborer des lignes directrices pour la gouvernance locale de l'éthique au Pakistan et d'assurer l'accréditation des comités d'évaluation éthique par l'intermédiaire du Comité national de bioéthique afin de maintenir l'intégrité de la structure de gouvernance de l'éthique.

تحليل وضع حوكمة أخلاقيات البحوث في باكستان

عامر جعفري، صالحة شيخاني، فيض رضا، سميرا ناز

الخلاصة

الخلفية: يُعد توصیف هياكل الحوكمة الأخلاقية مفيدًا للغاية في تحديد مواطن القوة والضعف من أجل الحفاظ على النزاهة وضمان توحيد المقاييس. ومع ذلك، لا تتوافر في باكستان بيانات موثوق بها على مستوى البلد عن لجان المراجعة الأخلاقية.

الأهداف: هدفت هذه الدراسة الى تقييم آليات حوكمة أخلاقيات البحوث على المستوى الوطني وفي مؤسسات الرعاية الصحية الرئيسية في باكستان. 

طرق البحث: استخدمت عملية التوصيف التجريبي نهجًا ذا طرق بحثٍ متعددة، تضمَّن مسحًا مقطعيًّا شمل 19 مؤسسةً بحثيةً رئيسيةً في مجال الرعاية الصحية، ومقابلات منظمة متعمقة مع رئيسي اللجنة الوطنية لأخلاقيات البيولوجيا وسلطة التنظيم الدوائي في باكستان. 

النتائج: أجابت ثماني عشرة مؤسسةً عن مسح توصيف الأخلاقيات. وكان لدى اثنتا عشرة لجنةً من لجان المراجعة الأخلاقية في القطاع العام هيكل دائم، وكان لدى 17 لجنةً اختصاصات رسمية. وزعمت سبعٌ من لجان المراجعة الأخلاقية أنها مُعتمَدة على الرغم من عدم وجود وكالة مركزية للاعتماد في باكستان. وكان رؤساء المؤسسات يرأسون ثماني لجان من لجان مراجعة الأخلاقيات، مع عدم وجود مدة ولاية محددة للرؤساء في 13 لجنةً، وسمحت 14 لجنةً بتعدد فترات الولاية. وكان لدى ستٍّ من لجان المراجعة الأخلاقية آليات متابعة للموافقات الأخلاقية، واتخذت 6 منها إجراءات تأديبية للتصدي لأي انحرافٍ عن بروتوكول مُعتمد، أو لأي سوء سلوك علمي. وذكرت اثنتان من المؤسسات المستجيبة بعض المواقف التي ضغط فيها مقدمو الطلبات على أعضاء اللجنة للحصول على موافقات مواتية. وأشارت المؤسسات المستجيبة للمسح إلى أن عدم وجود مبادئ توجيهية مركزية بشأن أخلاقيات البحوث يُعدُّ نقطة ضعف في النظام الوطني للحوكمة. وكشفت المقابلات المنظَّمة عن الحاجة إلى تدريب رسمي لأعضاء اللجان، بالإضافة إلى تعزيز القدرات، ولا سيما فيما يتعلق بالموظفين الإداريين.

الاستنتاجات: هناك حاجة إلى وضع مبادئ توجيهية للحوكمة المحلية للأخلاقيات في باكستان، وضمان اعتماد لجان المراجعة الأخلاقية من خلال اللجنة الوطنية لأخلاقيات البيولوجيا للحفاظ على توحيد هيكل حوكَمَة الأخلاقيات.

References

1. Kebede D, Zielinski C, Mbondji PE, Sanou I, Kouvividila W, Lusamba-Dikassa PS. Research and its governance in health research institutions in sub-Saharan African countries: results of a questionnaire-based survey. J R Soc Med. 2014 May; 107(1_suppl):55–69. https//doi.10.1177/0141076814531751 PMID:24914129
2. Akhtar T, Khan J. Health research capacity in Pakistan. Pakistan: Council on Health Research for Development; 2000 (http://www.cohred.org/downloads/681.pdf, accessed 13 March 2023).
3. Jafarey AM, Iqbal SP, Hassan M. Ethical review in Pakistan: the credibility gap. J Pak Med Assoc. 2012 Dec; 62(12);1354–7. PMID: 23866494
4. Hofman KJ, Kanyengo CW, Rapp BA, Kotzin S. Mapping the health research landscape in Sub-Saharan Africa: a study of trends in biomedical publications. J Med Libr Assoc. 2009 Jan; 97(1):41–4. http://doi.org/10.3163/1536-5050.97.1.007 PMID:19158994
5. Dobrow MJ, Costa S, Israr S, Chafe R. Mapping health services and policy research settings in Canada: following the money, the publications and the interest. Healthc Policy. 2010 Nov; 6(2):84. PMID:22043225
6. Clarke A, Gatineau M, Grimaud O, Royer-Devaux S, Wyn-Roberts N, Le Bis I, et al. A bibliometric overview of public health research in Europe. Eur J Public Health. 2007 Jan 1; 17(Suppl 1):43-9. https://doi.org/10.1093/eurpub/ckm063 PMID:17666422
7. Abrar S, Ronis KA, Khan S, Siraj S, Safdar W, Khalid Y et al. Status of ethical review boards at all medical colleges of Khyber Pakhtunkhwa. J Ayub Med Coll Abbottabad. 2015 Jun 20; 27(2):411–4. PMID:26411130
8. Ahsin S, Saeed GN. Self-evaluation of ethical review committee’s functioning at Foundation University Medical College (FUMC) through structured constitution-practice outcome (CPO) assessment model. J Pak Med Assoc. 2017 Jan 1; 67:42. PMID:28065953
9. Health Research Institute. HRI Research Institute. Available at: https://hri.nih.org.pk/research-centres.html
10. Etikan I, Musa SA, Alkassim RS. Comparison of convenience sampling and purposive sampling. Am J Theoret Appl Stat. 2016 Jan 5;5(1):1–4. https://doi.org/10.11648/j.ajtas.20160501.11
11. Lindlof TR, Taylor TR. Qualitative communication research methods, 2nd edition. Thousand Oaks: Sage; 2002.
12. Salim M, Hamid S. Independent review of research proposals from ethical point of view in Pakistan. J Ayub Med Coll Abbottabad. 2018 Oct 1;30(4):588-91. PMID: 30632343
13. Abou-Zeid A, Afzal M, Silverman HJ. Capacity mapping of national ethics committees in the Eastern Mediterranean Region. BMC Med Ethics. 2009 Dec;10(1):1–7. https://doi.org/10.1186/1472-6939-10-8 PMID:19575813
14. Shekhani SS, Iqbal SP, Jafarey AM. Adapting the ethical review process for COVID-19 research: reviewers’ perspectives from Pakistan. East Mediterr Health J. 2021 Dec 1;27(11):1045–51. https://doi.org/10.26719/emhj.21.053 PMID:34927707
15. Kumar NK. Bioethics activities in India. East Mediterr Health J. 2006;12(Suppl 1):S56–65. PMID:17037690
16. Gilman RH, Garcia HH. Ethics review procedures for research in developing countries: a basic presumption of guilt. CMAJ. 2004 Aug 3;171(3):248–9. https://doi.org/10.1503/cmaj.1031121 PMID:15289424
17. Moazam F. Research and developing countries: hopes and hypes. East Mediterr Health J. 2006; 12 (Suppl 1):S30–6. PMID:17037686
18. HEC to facilitate university faculty only under rules, regulations: chief. Daily Times. 21 October 2020. (https://dailytimes.com.pk/680039/hec-to-facilitate-university-faculty-only-under-rules-regulations-chief/, accessed 13 March 2023).
19. Memon AR. Research publications and education in Pakistani medical universities: Avoiding predatory journals and improving the quality of research. J Pak Med Assoc. 2017 Jun 1; 67(6):830–3. PMID:28585576
20. Peteris Z. Bioethics networks: collaborating across national boundaries. Bioethics and shared values of Europe. In: National bioethics committees in action. Paris: United Nations Educational, Scientific and Cultural Organization; 2010:105–7.
21. The WHO strategy on research for health. Geneva: World Health Organization; 2012 (https://www.afro.who.int/sites/default/files/2020-11/WHO_Strategy_on_research_for_health.pdf, accessed 13 March 2023).
22. Davies H, Wells F, Druml C. How can we provide effective training for research ethics committee members? A European assessment. J Med Ethics. 2008 Apr 1;34(4):301–2. http://dx.doi.org/10.1136/jme.2007.021485 PMID:18375685
23. Research ethics committees: basic concepts for capacity-building. Geneva: World Health Organization; 2009 (https://apps.who.int/iris/handle/10665/44108, accessed 13 March 2023).
24. Savage TA. The nurse’s role on ethics committees and as an ethics consultant. Semin Nurse Manage 1994 Mar 1;2(1):41–7. PMID:7922649
25. Jafarey AM. Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective. Sci Eng Ethics. 2002 Sep;8(3):353–62. https://doi.org/10.1007/s11948-002-0055-9 PMID:12353363
26. Sheikh AL. Pharmaceutical research: paradox, challenge or dilemma? East Mediterr Health J. 2006; 12(Suppl 1):S42–9. PMID:17037688

PDF version

Abdulla Bin Ghouth¹ and Nuha Mahmoud²

¹Department of Community Medicine, Hadhramaut University, Al Mukalla, Yemen (Correspondence to A.S. Bin Ghouth: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²Area Coordinator (Aden), World Health Organization Regional Office for the Eastern Mediterranean, Aden, Yemen

Abstract

Background: The health authorities in Hadhramaut Valley and Desert responded to the COVID-19 pandemic differently from other areas in Yemen.

Aims: To document the response of the local authority and Ministry of Health in Hadhramaut to COVID-19.

Methods: The local authority in Syoun (Hadhramaut Valley) convened a meeting of all key players from the health and related sectors in February 2020 where a decision was made to establish a committee to evaluate the health situation and assess the needs. Based on the results of these assessments, a plan was designed to respond to the pandemic. We reviewed available documents on the COVID-19 response in Hadhramaut, interviewed the main stakeholders, and conducted site visits to the COVID-19 response centres.

Results: There was evidence of the crucial role played by the local authority in response to COVID-19. They established 3 well-equipped isolation centres with a total of 142 beds, a stock of 2250 oxygen cylinders, 2 new polymerase chain reaction units, a simplified referral system, and an effective patient follow-up and oxygen home therapy strategy.

Conclusion: Political commitment at the local level is crucial to bridge the gap between policy and implementation, especially during infectious disease outbreaks. It is important to train public health leaders on how to effectively assess local health needs and develop effective and efficient response strategy. Lessons from this study in Hadhramaut provide evidence on how local authorities can coordinate response to emerging health needs and update their strategies.

Keywords: local authority, COVID-19, evidence-informed policymaking, pandemic response, Yemen

Citation: Bin Ghouth A, Mahmoud N. Responding to COVID-19 pandemic at the local level: lessons from Yemen. East Mediterr Health J. 2023;29(7):508−514. https://doi.org/10.26719/emhj.23.036 Received: 10/03/22; Accepted: 05/10/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Hadhramaut Governorate is the largest area in eastern Yemen with a population of about 1 651 000 according to the 2021 projection (1). It is divided administratively into 2 parts: the coastal area with Mukalla City at its centre, and the valley and desert area where Syoun City is the centre. In Hadhramaut Valley and Desert, there are 16 districts with a population of 734 529 inhabitants in 2021 (2). The health services in Hadhramaut are supervised by the Ministry of Public Health and Population based in Syoun City. There is 1 public referral hospital (Syoun Hospital), 2 general hospitals, 5 district hospitals, 37 primary healthcare centres, and 136 health units besides the private hospitals and clinics.

The first confirmed case of COVID-19 was reported in Yemen on 10 April 2020 in Hadhramaut. Up until September 2021, Yemen faced 3 waves of the pandemic. At the beginning of the pandemic there was no polymerase chain reaction (PCR) unit to diagnose the disease in Hadhramaut; therefore, the ministry sent the laboratory samples to Mukalla Central Public Health Laboratory (300 km to the south). There were only 10 available intensive care unit (ICU) beds; 6 in Syoun Hospital and 2 each in Al-Qaten and Tareem Hospitals. In February 2020, there was no isolation centre or ICU beds for COVID-19 in Yemen, due to a shortage of supplies.

To respond to the emerging pandemic, the local authority in Syoun (Hadhramaut Valley) invited all the key stakeholders in the health and other related sectors to a meeting in February 2020. At this meeting, a decision was made to establish a committee to evaluate the health situation and assess local needs, and a plan was devised to respond to COVID-19. The local authority used its experience in responding to previous health crises, such as various dengue outbreaks, and the Chapala cyclone that hit Hadhramaut in 2008. This response was based on the ability of the local authority to mobilize resources from nongovernmental organizations (NGOs), businesses, and oil companies.

The aim of this study was to describe the design, implementation, and evaluation of the response of the local authority and ministry to the COVID-19 pandemic in Hadhramaut, Yemen, and to show how the evidence from local data and knowledge was used in decision-making.

Methods

Study setting and design

The study was conducted in Syoun, the main city in Hadhramaut Valley, Yemen (Figure 1). The investigators used a combination of quantitative and qualitative methods.

Data collection

Quantitative data were collected from the COVID-19 Surveillance System in Syoun. This included the number of cases reported and admitted to the COVID-19 isolation centres, and the incidence per 100 000 population was calculated. Qualitative data were collected through face-to-face interview with main stakeholders and direct observation. Data from needs assessment was analysed. An Excel sheet was developed for data entry and analysis.

Data collection for the needs assessment checklist was undertaken in 2 phases. Phase 1: August–September 2020; the principal investigator assessed through direct observation the isolation centres in Hadhramaut as part of the World Health Organization (WHO) assessment of COVID-19 centres. Phase 2: September 2021; the investigators visited Syoun and interviewed the main stakeholders, including the Assistant Governor, Ministry of Public Health and Population General Director, and the surveillance team and staff in the 3 isolation centres. The semistructured interview included the following questions: (1) How was the decision to build a long-term response plan made when there was no clarity on the timelines for COVID-19? (2) How were decisions regarding responses made? (3) What were the main interventions of the local authority in response to the COVID-19 pandemic? (4) What was the role of other stakeholders and how was coordination with them organized? (5) What were the main challenges faced? (6) How did you deal with the problem of oxygen shortage? (7) What were the priorities in your further planning based on the experience of the COVID-19 pandemic?

In Phase 1, data were collected using the WHO checklist (3). In Phase 2, data were collected through semistructured interviews and these were complemented with a review of available reports, including ministry documents from the Surveillance and Medical Supply Departments, and hospital data. During Phase 2, data on infrastructure and equipment, oxygen supply, and human resources, and surveillance and hospital data were collected. Data collected from the needs assessment were communicated to decision-makers through face-to-face meetings, telephone, and WhatsApp.

The intended use of these data for policymaking was envisioned at different levels: (1) at a local level to encourage commitment towards the health system; (2) to other governorates to present them with a role model of local authority response; and (3) to the Ministry and international organizations to document this approach as an innovative health policy.

Results

Local authority interventions in early response to COVID-19 pandemic

The following interventions were undertaken, based on the needs assessment. Risk stratification created 3 sectors: Syoun in the centre of Hadhramaut Valley covered 3 districts, Al-Qaten in the west, covered 8 districts, and Tareem in the east covered 5 districts. At the local authority meeting, all stakeholders agreed with this stratification based on geographical, environmental, and accessibility considerations. This stratification was used to establish 3 COVID-19 isolation centres in Syoun, Al-Qaten, and Tareem, to facilitate patients’ access to health services, organize referral procedures, and reduce overload on the bed capacity of the main referral hospital in Syoun.

A committee from the Ministry of Public Health and Population office in Syoun and staff from different hospitals visited all hospitals. The committee assessed the healthcare needs based on the available resources. The committee recommended that the local authority establish 3 COVID-19 isolation centres in Syoun, Al-Qaten, and Traeem, with appropriate equipment, oxygen supply, electricity, staff requirements, and other medical and nonmedical logistics. This approach proved to be important in avoiding pressure on hospitals, and allowed policymakers and health officials to monitor potential healthcare demand, to tackle the enormous logistic challenges and to re-allocate resources at the local level.

NGOs, oil companies, and business owners all participated in the COVID-19 response, by paying for oxygen cylinders, food and drugs for patients, and cleaning materials for the new isolation centres. To do this, the local authority called all NGOs in Hadhramaut to a meeting at which the importance of their role in the COVID-19 response was explained and they were briefed about the results of the needs assessment. Oil companies and business owners were contacted directly.

The local authority and Ministry of Public Health and Population coordinated with other regional and international agencies such as the King Salman for Aid and Humanitarian Work, WHO, and Kuwait Red Crescent. Their input facilitated the preparedness of the isolation centre in Syoun (2020), PCR units in Syoun and Al-Wadeeah, and Tareem Field Hospital (2021). WHO trained the physicians, health workers, and surveillance teams.

Outcomes of the intervention

Establishing the COVID-19 isolation centres

The needs assessment conducted by the Syoun Office of the Ministry of Public Health and Population recommended establishment of 3 COVID-19 isolation centres according to the recommended geographical stratification in Syoun, Al-Qaten and Tareem. This was supported by the local authority. Two COVID-19 isolation centres were established in March–April 2020 in Syoun (25 beds) (4) and in Al-Hayat Hospital in Al-Qaten (53 beds) in early 2021 (5), and Tareem Field Hospital (60 beds) was also established in early 2021. Three new COVID-19 isolation centres were established in 16 districts of Hadhramaut Valley and Desert, with a total of 142 beds, including 16 ICU beds and 14 ventilators for treatment of 734 529 patients. Two PCR units were also established in Syoun and Al-Wadeeah, at the border with Saudi Arabia.

Establishing a strategic store for oxygen supply

The oxygen storage strategy resulted from continuous monitoring and follow-up by the local authority, and the Ministry of Public Health and Population supported the decision to implement this strategy. A total of 2050 oxygen cylinders of 40 l were provided by the local authority, 200 by the Ministry, and 300 by other hospitals. During the site visit to the oxygen store, there were 1300 full cylinders, while the remaining 1250 cylinders were in use or away for filling. The ministry office in Syoun coordinated home oxygen therapy.

According to a doctor on duty at Tareem Field Hospital: “All patients initially attend the triage unit in the COVID-19 centre for investigation and diagnosis, and to determine whether their clinical status is suitable for home oxygen therapy. The doctor on duty gives permission to supply the patient with an oxygen cylinder at home and the patient is followed up by the centre every 2–3 days to check if their condition has deteriorated”. A Ministry official stated that “this approach is used in all the COVID-19 centres in Syoun, Al-Qaten, and Tareem, and every patient treated at home by oxygen is registered and followed up by the centre”.

Key achievements in response to COVID-19 pandemic

The key achievements in response to the COVID-19 pandemic were: (1) 3 well-equipped COVID-19 isolation centres were established, with 142 beds; (2) a stock of 2250 oxygen cylinders was provided to resolve the problem of oxygen shortage (Table 1); (3) 2 new PCR units were established; (4) a straightforward referral system was established; (5) an effective follow-up and oxygen home therapy strategy was developed; (6) a well-coordinated response led by the local authority; and (7) a sustainable capacity to respond to any new epidemics was developed.

Analysis of the COVID-19 surveillance data

The number of confirmed cases of COVID-19 increased from 428 in 2020 to 962 in 2021 (+124%) (Table 2). The number of cases admitted to the isolation centres increased by 17% from 264 in 2020 to 310 in 2021. It was clear that the centres in Al-Qaten and Traeem relieved overstretching of the capacity of the Syoun centre. These findings justified the decision of the local health authority to establish these COVID-19 isolation centres.

Discussion

This study described the response of the local authority in Hadhramaut Valley in Yemen to the COVID-19 pandemic. The main interventions undertaken by the local authority and Ministry of Public Health and Population were coordination with all stakeholders, geographic stratification, and rapid health needs assessment. These interventions led to establishment of 3 new COVID-19 isolation centres, 2 PCR units, secure oxygen supply, and an improved referral system and home therapy.

Systematic reviews are the best method to search for evidence in public health practice for decision-making but they take longer than the limited time available to take decisions during crises like the COVID-19 pandemic (6). Some organizations used rapid review methods to answer urgent questions during the pandemic (7). Hamel et al. in 2020 defined rapid review as “a form of knowledge synthesis that accelerates the process of conducting a traditional systematic review through streamlining or omitting a variety of methods to produce evidence in a resource-efficient manner” (8). In the Islamic Republic of Iran, a rapid qualitative study among 30 stakeholders provided evidence to policymakers about which messages were needed in the COVID-19 pandemic, through developing knowledge translation exchange tools (9). All countries face challenges in performing evidence-informed decision-making. In a study of 11 countries in 2022, Vickery et al. concluded that there was an urgent need for evidence-informed decision-making that countries could adapt for local decisions as well as coordinated global responses to future pandemics (10).

Yemen has faced an exceptional emergency situation since 2015, and the pandemic has overstretched the capacity of its already weak health system, which resulted in every local authority making its own response. In Hadhramaut Governorate during February–March 2020, there were many challenges and the local authority sought evidence for informed decision-making in responding to the COVID-19 pandemic, and this was achieved through rapid needs assessment.

During a pandemic, it is critical to prepare appropriate infrastructure and capacity to make an emergency response. Adequate hospital bed capacity is one of the most critical issues during the heath service response to epidemics (11). Even countries with strong health systems, such as Saudi Arabia (12), United States of America (13), and Italy (11), had limited hospital bed capacity and needed additional beds. In Hadhramaut Valley, the local authority took the lead instead of central government in the early response to COVID-19, and a local committee was established to assess the needs of the health sector. The committee recommended that the local authority should establish 3 COVID-19 isolation centres in 3 sectors (Syoun, Al-Qaten, and Traeem) with adequate equipment and oxygen supply, electricity, required staffing levels, and other medical and nonmedical logistics. This approach proved to be important in avoiding pressure on hospitals, and allowed policymakers and health officials to monitor the potential healthcare demand, to tackle the enormous logistical challenges and re-allocate resources at a local level. This approach was also used in England (14).

The local health authority in Hadhramaut responded to the community demand for home treatment of COVID-19, but at that time, there was no clear national recommendation for home treatment of patients who needed oxygen therapy. In Hadhramaut Valley, the Ministry of Public Health and Population developed a policy for home oxygen therapy and a clear follow-up strategy. Home oxygen therapy is a form of community-based care that is recommended to address patient care and healthcare resource limitations (15). The eligibility criteria for referral to the home oxygen therapy team for short-term administration have been extrapolated from existing long-term oxygen therapy regimens (16).

The lessons learned from this study provide evidence of the critical role of the local authority in Hadhramaut in responding to the COVID-19 pandemic through guiding coordination with all stakeholders and updating the national strategies to bridge the gap between policy and implementation. Evidence from Syoun suggests that local authority investment in the health sector should be focused on proper coordination with all stakeholders and early needs assessment. This approach has built a high degree of trust and cooperation among local partners, and facilitated effective implementation of the COVID-19 response. These observations can serve as a foundation for future studies on how existing institutional arrangements can form part of a successful pandemic response. If similar policies based on local needs assessment were to become standardized, it would help with the preparedness of any governorate or country for future pandemics or other health emergencies. This approach is supported by evidence from other studies and countries (17), which emphasized that local governance was important in bridging the gap between policy and the local situation for better coordination of the response to COVID-19.

There were some limitations to this study. The research was focused on Hadhramaut Valley but did not extend to the coastal region or other governorates in Yemen to compare the response of the local authorities in different places. Another limitation was that the needs assessment tool was locally developed and focused on urgent care needs of patients with COVID-19 and did not cover all the essential health services.

Conclusions

Seeking political commitment at the local level is a priority approach to bridging the gap between policy and implementation during infectious disease outbreaks. The capacity to carry out health needs assessment is important. It is clear that evidence from needs assessment can inform local authorities to take decisions and mobilize local resources to respond to outbreaks. This approach may be appropriate in other countries that share the same situation as Yemen. We hope that central authorities, international organizations, and donor countries will work with local authorities because the latter have sufficient local experience and creativity in health and related fields.

Acknowledgement

We thank Dr. Hani Khaled Al-Amoudi, General Director of the office of the Ministry of Public Health and Population in Hadhramaut Valley and Desert, and Dr. Ghazi Bashamakah, Assistant Director of Primary Health Care in Hadramout Valley and Desert (Ministry of Public Health and Population) for administrative support and study participation. Our thanks extend to Assam Al-Katheri, previous Assistant Governor for Hadhramaut Valley and Desert (the local authority) for his participation and provision of valuable data during the interviews; Dr. Arash Rashidian, Director of Science, Information and Dissemination at the WHO Regional Office for the Eastern Mediterranean Region (EMRO); Dr. Mehrnaz Kheirandish, Regional Advisor for Evidence and Data to Policy at EMRO); and Ms. Sumithra Krishnamurthy Reddiar, Technical Officer, Evidence and Data to Policy at EMRO for technical advice and support through all stages of the study; and Ms. Hala Hamada, Programme Assistant, Evidence and Data to Policy at WHO EMRO for administrative support.

Funding: This study was part of project No. SGS08/6 that received technical and financial support from WHO Eastern Mediterranean Region/Department of Science, Information and Dissemination/Evidence and Data to Policy Program. The project was an output of the WHO/EMRO initiative of the Regional Network of Institutions for Evidence and Data to Policy.

Competing interests: None declared.

Riposte à la pandémie de COVID-19 au niveau local : enseignements tirés du Yémen

Résumé

Contexte : Les autorités sanitaires de la vallée et du désert de l'Hadramaout ont riposté différemment des autres régions du Yémen face à la pandémie de COVID-19.

Objectif : Documenter la réponse des autorités locales et du ministère de la Santé face à la COVID-19 dans l'Hadramaout.

Méthodes : Les autorités locales de Say'un (vallée de l'Hadramaout) ont organisé une réunion de tous les acteurs clés du secteur de la santé et des secteurs connexes en février 2020. Au cours de cette réunion, il a été décidé de créer une commission chargée d'évaluer la situation sanitaire et les besoins afférents. Sur la base des résultats de ces évaluations, un plan a été élaboré pour faire face à la pandémie. Nous avons examiné les documents disponibles sur la riposte à la COVID-19 dans l'Hadramaout, interrogé les principales parties prenantes et effectué des visites sur place dans les centres responsables de la riposte à la COVID-19.

Résultats : Il existe des preuves du rôle crucial joué par les autorités locales dans la riposte à la COVID-19. Elles ont mis en place trois centres d'isolement bien équipés disposant d'un total de 142 lits, un stock de 2 250 bouteilles d'oxygène, deux nouvelles unités d'amplification en chaîne par polymérase, un système simplifié d'orientation-recours et une stratégie efficace de suivi des patients et d'oxygénothérapie à domicile.

Conclusion : L'engagement politique au niveau local est essentiel pour combler le fossé entre les politiques et leur mise en œuvre, en particulier lors des flambées épidémiques de maladies infectieuses. Il est important de former les responsables de la santé publique à l'évaluation efficace des besoins locaux en matière de santé et à l'élaboration d'une stratégie de riposte efficace et efficiente. Les enseignements tirés de cette étude menée dans l'Hadramaout fournissent des données probantes sur la manière dont les autorités locales peuvent coordonner la réponse aux besoins sanitaires émergents et mettre à jour leurs stratégies.

الاستجابة لجائحة كوفيد-19 على المستوى المحلي: دروس مستفادة من اليمن

عبد الله بن غوث، نهى محمود

الخلاصة

الخلفية: كانت استجابة السلطات الصحية في وادي وصحراء حضرموت لجائحة كوفيد-19 مختلفةً عن المناطق الأخرى في اليمن. ففي فبراير/ شباط 2020، عقدت السلطة المحلية في سيئون (وادي حضرموت) اجتماعًا ضم جميع الأطراف الفاعلة الرئيسية من قطاع الصحة والقطاعات الأخرى ذات الصلة، واتُخذ قرارٌ بإنشاء لجنة لتقييم الوضع الصحي وتقدير الاحتياجات. وبناءً على نتائج هذه التقييمات، صُممت خطة للاستجابة للجائحة.

الأهداف: هدفت هذه الدراسة الى توثيق استجابة السلطة المحلية ووزارة الصحة لجائحة كوفيد-19 في حضرموت.

طرق البحث: استعرضنا المستندات المتاحة بشأن الاستجابة لجائحة كوفيد-19 في حضرموت، وعقدنا مقابلات مع أصحاب المصلحة الرئيسيين، وأجرينا زيارات ميدانية لمراكز الاستجابة لكوفيد-19.

النتائج: كانت هناك دلائل على الدور الحيوي الذي أدته السلطة المحلية استجابةً لكوفيد-19. فقد أنشأت 3 مراكز عزل مُجهزة تجهيزًا جيدًا بإجمالي 142 سريرًا، و2250 أسطوانة أكسجين، ووحدتين جديدتين لتفاعل البوليميراز المتسلسل، ونظام إحالة مُبسط، واستراتيجية فعالة لمتابعة المرضى وتقديم العلاج بالأكسجين لهم في المنزل.

الاستنتاجات: للالتزام السياسي على المستوى المحلي أهميةٌ كبرى لسد الفجوة بين السياسات والتنفيذ، خاصةً أثناء فاشيات الأمراض المُعْدية. ومن المهم تدريب قادة الصحة العامة على كيفية تقدير الاحتياجات الصحية المحلية بفعالية، ووضع استراتيجية للاستجابة تتسم بالفعالية والكفاءة. وتُقدم الدروس المستفادة من هذه الدراسة في حضرموت دلائل على أن السلطات المحلية باستطاعتها تنسيق الاستجابة للاحتياجات الصحية المستجدة وتحديث استراتيجياتها وفقًا لذلك.

References

1. Population projections (2005–2025). Sana’a: Central Statistical Organisation (http://www.cso-yemen.com/content.php?lng=arabic&id=553, accessed 14 December 2022).

2. Population of Hadramout Valley by district 2021. Ministry of Public Health and Population, Hadhramaut Valley and Desert Office (unpublished report).

3. Yemen COVID-19 treatment centers (isolation units) operational capacity assessment tool. World Health Organization Regional Office for the Eastern Mediterranean; 2020 (unpublished report).

4. Bin-Ghouth A. Site visit to Syoun Isolation Center in Hadramout on Wednesday 12 August 2020. World Health Organization Regional Office for the Eastern Mediterranean; 2020 (unpublished report).

5. Bin-Ghouth A. Site visit to Al-Qaten Isolation Center in Hadramout on Thursday 13 August 2020. World Health Organization Regional Office for the Eastern Mediterranean; 2020 (unpublished report).

6. Borah R, Brown AW, Capers PL, Kaiser KA. Analysis of the time and workers needed to conduct systematic reviews of medical interventions using data from the PROSPERO registry. BMJ Open. 2017;7(2):e012545. https://doi.org/10.1136/bmjopen-2016- 012545

7. Neil-Sztramko SE, Belita E, Traynor RL, Hagerman L, Dobbins M.  Methods to support evidence-informed decision-making in the midst of COVID-19: creation and evolution of a rapid review service from the National Collaborating Centre for Methods and Tools. BMC Med Res Methodol. 2021 Oct 27;21(1):231. https://doi.org/10.1186/s12874-021-01436-1 PMID: 3470667

8. Hamel C, Michaud A, Thuku M, Skidmore B, Stevens A, Nussbaumer-Streit B, et al. Defining rapid reviews: a systematic scoping review and thematic analysis of definitions and defining characteristics of rapid reviews. J Clin Epidemiol. 2020 Jan;129:74–85. https://doi.org/10.1016/j.jclinepi.2020.09.041 PMID:33038541

9. Bastani P, Bahmaei J, Kharazinejad E, Samadbeik M, Liang Z, Schneide CH. How COVID-19 affects the use of evidence informed policymaking among iranian health policymakers and managers. Arch Public Health. 2022 Jan 5;80(1):16. https://doi.org/10.1186/s13690-021-00757-3 PMID: 34983653

10. Vickery J, Atkinson P, Lin L, Rubin O, Upshur R, Yeoh E-K, et al. Challenges to evidence-informed decision-making in the context of pandemics: qualitative study of COVID-19 policy advisor perspectives. BMJ Global Health. 2022 Apr;7(4):e008268. https://doi.org/10.1136/bmjgh-2021-008268 PMID:35450862

11. Cavallo JJ, Donoho DA, Forman HP. Hospital capacity and operations in the coronavirus disease 2019 (COVID-19) pandemic—planning for the nth patient. JAMA Health Forum. 2020 Mar 2;1(3):e200345. https://doi.org/10.1001/jamahealthforum.2020.0345 PMID:36218595

12. Alqahtani F , Khan A, Alowais J, Alaama T, Jokhdar H. Bed surge capacity in Saudi hospitals during the COVID-19 pandemic. Disaster Med Public Health Prep. 2021 Apr 19;1–7. https://doi.org/10.1017/dmp.2021.117 PMID:33866983

13. Douin DJ, Ward MJ, Lindsell CJ, Howell MP, Hough CL, Exline MC et al. ICU bed utilization during the coronavirus disease 2019 pandemic in a multistate analysis—March to June 2020. Crit Care Explor. 2021 Mar 12;3(3):e0361 https://doi.org/10.1097/CCE.0000000000000361 PMID: 3378643

14. Verhagen MD, Brazel DM, Dowd JB, Kashnitsky I, Mills MC. Forecasting spatial, socioeconomic and demographic variation in COVID-19 health care demand in England and Wales. BMC Med. 2020;18:Article number 203 (2020). https://doi.org/10.1186/s12916-020-01646-2

15. Sardesai I, Grover J, Garg M, et al. Short term home oxygen therapy for COVID-19 patients: the COVID-HOT algorithm. J Family Med Prim Care. 2020 Jul 30;9(7):3209–19. https://doi.org/10.4103/jfmpc.jfmpc_1044_20 PMID:33102272

16. Hardinge M, Annandale J, Bourne S, Cooper B, Evans A, Freeman D, et al. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015;70:i1–43. http://dx.doi.org/10.1136/thoraxjnl-2015-206865

17. Talabis S, Babierra DA, Buhat CAH, Lutero DS, Quindala 3rd KM, Rabajante JF. Local government responses for COVID-19 management in the Philippines. BMC Public Health. 2021 Sep;21(1):1711. https://doi.org/10.1186/s12889-021-11746-0 PMID:34544423

PDF version

Short research communication

Messis Abdelaziz,^1,2 Adjebli Ahmed,³ Ayeche Riad,⁴ Ghidouche Abderrezak ² and Ait-Ali Djida ²

¹Université de Bordj Bou Arréridj, El-Anasser, Bordj Bou Arréridj, Algérie; ²Laboratoire de Génie Biologique des Cancers, Université de Bejaia, Bejaia, Algérie; ³Laboratoire d’Ecologie Microbienne, faculté des sciences de la nature et de la vie, université de Bejaia, Bejaia, Algérie; ⁴Laboratoire Caractérisation et Valorisation des Ressources Naturelles, Université de Bordj Bou Arreridj, El-Anasser, Bordj Bou Arréridj, Algérie. (Correspondence to M. Abdelaziz: This email address is being protected from spambots. You need JavaScript enabled to view it.)

ABSTRACT

Background: COVID-19 has become a threat worldwide, affecting every country.

Aims: This study aimed to identify COVID-19 cases in Algeria using times series models for forecasting the disease.

Methods: Confirmed COVID-19 daily cases data were obtained from 21 March 2020 to 26 November 2020 from the Algerian Ministry of Health. Forecasting was done using the Autoregressive Integrated Moving Average (ARIMA) models (0,1,1) with Minitab 17 software.

Results: Observed cases during the forecast period were accurately predicted and placed within prediction intervals generated by ARIMA. Forecasted values of COVID-19 positive cases, recoveries and deaths showed an accurate trend, which corresponded to actual cases reported during 252, 253 and 254 days. Results were strengthened by variations of less than 5% between forecast and observed cases in 100% of forecasted data.

Conclusion: ARIMA models with optimally selected covariates are useful tools for predicting COVID-19 cases in Algeria.

Keywords: COVID-19, time series, double exponential smoothing, ARIMA, forecast, Algeria

Citation: Abdelaziz M, Ahmed A, Riad A, Abderrezak G, Djida A. Forecasting daily confirmed COVID-19 cases in Algeria using ARIMA models. East Mediterr Health J. 2023;29(7):515–519. https://doi.org/10.26719/emhj.23.054 Received: 13/03/21; Accepted: 08/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

On 11 March 2020, the World Health Organization (WHO) declared COVID-19 as a pandemic. The pandemic had spread from mainland China to other countries and territories, disrupting socioeconomic activities. As of 26 November 2020, COVID-19 had infected more than 60 776 978 people globally, killed more than 1 428 228, and resulted in a lockdown that forced people to stay in their homes (1).

Algeria reported its first COVID-19 case on 25 February 2020. By 26 November, it had reported 79 110 confirmed cases, 51 334 recoveries and 2352 deaths (2).

SARS-CoV-2, the COVID-19 virus is very infectious, and many people were not following the non-pharmaceutical public health prevention measures recommended by the Algerian government and other governments to control the pandemic, thus increasing the risks of transmission (2,3).

Accurate forecasting of COVID-19 case trends was essential for preparedness by health authorities to manage the pandemic and resource planning. Time series models such as ARIMA have been widely used to statistically model and forecast infectious disease trends (4). ARIMA models are preferred in this context because they are suitable for investigating short-term effects of acute infectious diseases and are flexible and appropriate for several trajectories (4,5). ARIMA models have been used in several studies to forecast COVID-19 outbreak trends (6-9).

In this study, we developed ARIMA models using daily COVID-19 confirmed and active cases in Algeria to identify the best fitting model of COVID-19 cases from 21 March 2020 to 26 November 2020.

Materials and methods

Data source

Data for this study included confirmed COVID-19 daily cases data obtained from 21 March 2020 to 26 November 2020 from the Algerian Ministry of Health (10).

Methods

The following equation highlights the exponential smoothing method and the ARIMA processes (11):

Determine the first smoothing value and the parameter α

St'=αX+ (1−α)St−1' (1)

Determine the second smoothing value

St" = αSt' + (1 − α)St−1" (2)

ARIMA model for time series sata ARIMA model is stated as follows:

Φ(B)(1 − B)dXt = θ(B)Zt (3)

Where:

Φ(Β) is an autoregressive operator

Ө(Β) is a moving average operator

(1 − Β)d is a differencing operator. It is the expression of dth consecutive differencing so as to make the series stationary

Zt is a Gaussian white noise series with mean zero and variance (σ2z).

ARIMA forecast is based on previous values and portrayed by 3 terms – p, d, q. Where p is the order for the auto regressive expression (AR), q is the order for the moving average expression (MA) and d is the number of differencing required making the time arrangement fixed.

The experiment was carried out using Minitab 17 programming software (12). In general, the equation can be approached using a regression model:

Yt = α + β1Yt−1 + ... + βpyt−p + Φ1 et −1 + ... + Φqet−q + εt (4)

εt = errors from the accompanying conditions.

Results

Using the time-series model approach, the pattern of COVID-19 data distribution in Algeria showed an exponential distribution pattern, where the addition of positive cases increased significantly everyday of the pandemic. The distribution pattern was the same for the number of people who recovered and died (Figure 1). For the positive COVID-19 cases, the mean absolute percentage error (MAPE) value was smaller than the error rate at 10% (Table 1). The increase in the number of people who were positive for COVID-19 directly affected the prediction model for patients who recovered and died (Figure 1). For recovered cases, MAPE value was smaller than the error value set at 10% error rate (Table 1). The recovery rate for COVID-19 patients increased simultaneously with the number of positive cases because of the non-pharmaceutical public health measures taken by the government from 21 March 2020. For deaths due to COVID- 19, the MAPE value was greater than the error value set at 10% (Table 1). The increase in mortality was possibly due to the extent of infection and the medical history of the patients.

In the time series model with 5% error probability (α), the graph followed the ARIMA process (0,1,1), with the P value MA 1 (0.0%) smaller than α.

Estimated results of parameters model for COVID-19 positive data using ARIMA models

Referring to equation (4), mathematically, the ARIMA model (0,1,1) can be stated using the following coefficients: Yt = 317.65 − 0.879et−1

Same as COVID-19 positive data, in the time series model with 5% error probability (α), the graph followed the ARIMA process (0,1,1) with the P value MA 1 (0,0%) smaller than α.

Estimated parameters for COVID-19 Recovery data results using ARIMA model

Referring to equation (4), mathematically the ARIMA model (0,1,1) can be stated as follows: Yt = 205.53 − 0.30et−1

After the positive and recovery data were analysed in time series model with the 5% error probability (α), the graph followed the ARIMA process (0,1,1) with the P value MA 1 (0.00%) smaller than α.

All estimated parameter results of the ARIMA model

Referring to equation (4), mathematically, the ARIMA model (0,1,1) can be stated.

The results of predictions of COVID-19 cases in Algeria (positive, recovered and deaths) showed a gap in the resulting distribution patterns, where the increase in the number of positive cases was not offset by an increase in the number of patients who recovered and a decrease in the number of patients who died. This indicates that public behaviour did not comply with the rules set by the government (physical distancing, large-scale social restrictions, washing of hands, and mask use).

Discussion

From the time WHO declared COVID-19 a pandemic on 11 March 2020, several countries experienced an exponential increase in COVID-19 cases (3), which put a lot of pressure on most healthcare systems worldwide. In response, health authorities attempted to forecast the trend of the pandemic, but this proved difficult because COVID-19 is a novel disease with limited data and knowledge about its trends and dynamics (2). Our forecast showed an accurate trend, which corresponded to the number of positive cases observed and reported by the Ministry of Health in Algeria during 3 days (252,253 and 254). The same situation was observed for forecasted recoveries and deaths.

This finding was strengthened by variations of less than 5% between the forecast and observed cases in 100% of the forecasted data points (Table 2). Similar studies conducted in South Korea, Iran and Italy predicted similar case trends using ARIMA models (6-8).

The strengths of this study include: firstly, this is the first paper to report the use of ARIMA models to forecast COVID-19 cases and trends in Algeria. Secondly, this was the first attempt to use smoothen case data to improve accuracy as compared to similar studies on ARIMA models for COVID-19 conducted in other countries (6-7). Thirdly, we used several independent covariates, which provided more accurate signals to develop short-term model predictions for immediate outbreak response. Finally, we optimized the model training and validation period to provide the highest number of data points to generate the best fit model.

Conclusion

This study demonstrates the effectiveness of ARIMA models as an early warning strategy that can provide accurate COVID-19 forecasts on larger data points (251 days). Forecasted values of COVID-19 positives, recoveries and deaths showed an accurate trend which corresponded to the actual cases observed and reported by the Ministry of Health in Algeria during 3 days (252, 253 and 254). We are confident that the ARIMA model can be used to generate accurate and reliable forecasts of daily COVID-19 cases and similar pandemics, with the addition of new data points and independent covariates.

Acknowledgement

The authors would like to thank the Ministry of Health, Population and Hospital Reform of Algeria and the Johns Hopkins University for publicly releasing the updated COVID-19 datasets.

Funding: None

Competing interests: None declared.

Prévision des cas de COVID-19 confirmés quotidiennement en Algérie à l'aide des modèles ARIMA

Résumé

Contexte : La COVID-19 est devenue une menace à l'échelle mondiale, touchant tous les pays.

Objectif : La présente étude visait à identifier les cas de COVID-19 en Algérie à l'aide de modèles de séries chronologiques pour la prévision de la maladie.

Méthodes : Les données sur les cas de COVID-19 confirmés quotidiennement ont été obtenues du 21 mars au 26 novembre 2020 auprès du ministère algérien de la Santé. Les prévisions ont été effectuées à l'aide de modèles autorégressifs à moyennes mobiles intégrées (Autoregressive Integrated Moving Average, ARIMA) (0,1,1) en recourant au logiciel Minitab 17.

Résultats : Les cas observés pendant la période de prévision ont été prédits avec précision et se situaient dans les intervalles de prédiction générés par les modèles ARIMA. Les valeurs de prévision pour les cas positifs de COVID-19, les guérisons et les décès liés à la maladie ont montré une tendance précise, qui correspondait aux cas réels signalés pendant 252, 253 et 254 jours. Les résultats ont été renforcés par des variations de moins de 5 % entre les cas prédits et ceux observés dans 100 % des données de prévision.

Conclusion : Les modèles ARIMA dotés de covariables sélectionnées de manière optimale sont des outils utiles pour prédire les cas de COVID-19 en Algérie.

التنبؤ بحالات كوفيد-19 المؤكدة يوميًا في الجزائر باستخدام نماذج متوسط الانحدار الذاتي المتكامل (أريما)

مسيس عبد العزيز، أدجيلي أحمد، عياش رياض، غيدوش عبد الرزاق، أيت علي دجيدة

الخلاصة

الخلفية: مثلت جائحة كوفيد-19 تهديدًا في جميع أنحاء العالم، إذ امتد أثرها إلى كل بلدٍ.

الأهداف: هدفت هذه الدراسة إلى تحديد حالات كوفيد-19 في الجزائر باستخدام نماذج السلسلة الزمنية للتنبؤ بالمرض.

طرق البحث: تم الحصول على البيانات اليومية الخاصة بحالات كوفيد-19 المؤكدة من وزارة الصحة الجزائرية، عن الفترة من 21 مارس/ آذار 2020 إلى 26 نوفمبر/ تشرين  الثاني 2020. ونُفذ التنبؤ باستخدام نماذج متوسط الانحدار الذاتي المتكامل (أريما) (0،1،1) مع برنامج Minitab 17.

النتائج: جرى التنبؤ بدقة بالحالات المرصودة خلال فترة التنبؤ، ووُضِعت في حدود فترات التنبؤ التي حددها متوسط الانحدار الذاتي المتكامل (أريما). وأظهرت القيم المتوقعة لحالات كوفيد-19 الإيجابية، وحالات التعافي والوفاة اتجاهًا دقيقًا، وهو ما توافق مع الحالات الفعلية المُبلغ بها خلال 252، و253، و254 يومًا. وعُززت النتائج باختلافات تقل عن 5% بين التنبؤ والحالات المرصودة في 100% من البيانات المتوقعة.

الاستنتاجات: تُعدُّ نماذج متوسط الانحدار الذاتي المتكامل (أريما) مع المتغيرات المشاركة المختارة على النحو الأمثل أدوات مفيدة للتنبؤ بحالات كوفيد-19 في الجزائر.

References

1. Drummond MF, Schwartz JS, Jönsson B, Luce BR, Neumann PJ, Siebert U, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24(3):244–58. doi:10.1017/S0266462308080343
2. Learmonth M, Harding N. Evidence-based management: the very idea. Public Administration. 2006;84(2):245–66. doi:10.1111/j.1467-9299.2006.00001.x
3. Ciani O, Tarricone R, Torbica A. Diffusion and use of health technology assessment in policy making: what lessons for decentralised healthcare systems? Health Policy. 2012 Dec;108(2–3):194–202. doi:10.1016/j.healthpol.2012.09.017
4. Velasco-Garrido M, Gerhardus A, Røttingen J-A, Busse R. Developing Health Technology Assessment to address health care system needs. Health Policy. 2010 Mar;94(3):196–202. doi:10.1016/j.healthpol.2009.10.002
5. Payam MM, Sari AA, Ay MR, Mobinizadeh MR, Maanavi S. Safety and diagnostic performance of dual-source ct scan in comparison with single source ct scan and conventional angiography in coronary heart diseases. J Hospital. 2010;9(1–2):25–32.
6. Garrido MV, Kristensen FB, Busse R, Nielsen C. Health technology assessment and health policy-making in Europe: current status, challenges and potential: Copenhagen: World Health Organization Regional Office for Europe, European Observatory on Health Systems and Policies, EuropeanNetwork for HTA; 2008 (Observatory Studies Series No 14; https://apps.who.int/iris/handle/10665/107911, accessed 27 October 2021).
7. 7Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004 Sep;8(36):iii–iv, ix–xi, 1–158. doi:10.3310/hta8360
8. Sacchini D, Virdis A, Refolo P, Pennacchini M, De Paula IC. Health technology assessment (HTA): ethical aspects. Med Health Care Philos. 2009 Nov;12(4):453–7. doi:10.1007/s11019-009-9206-y
9. Banta D, Jonsson E. History of HTA: Introduction. Int J Technol Assess Health Care. 2009 Jul;25 Suppl 1:1–6. doi:10.1017/S0266462309090321
10. Angelis A, Kanavos P. Multiple criteria decision analysis (MCDA) for evaluating new medicines in health technology assessment and beyond: the advance value framework. Soc Sci Med. 2017 Sep;188:137–156. doi:10.1016/j.socscimed.2017.06.024
11. A checklist for health technology assessment reports. Southampton: INAHTA Secretariat; 2007 (https://www.inahta.org/wp-content/uploads/2014/04/INAHTA_HTA_Checklist_English.pdf, accessed 27 October 2021).
12. Allen L. Non-communicable disease funding. Lancet Diabetes Endocrinol. 2017 Feb;5(2):92. doi:10.1016/S2213-8587(16)30420-X
13. Vo TQ. Health technology assessment in developing countries: a brief introduction for vietnamese health-care policymakers. Asian J Pharm. 2018;12(01). https://dx.doi.org/10.22377/ajp.v12i01.2340
14. Hailey D, Babidge W, Cameron A, Davignon L-A. HTA agencies and decision makers. An INAHTA guidance document. Stockholm: INAHTA; 2010 (http://pds20.egloos.com/pds/201009/07/46/HTA__Decision_Makers.pdf, accessed 27 October 2021).
15. Tarn T, Smith MD. Pharmacoeconomic guidelines around the world. ISPOR Connections. 2004;10(4):5–15.
16. Banta D. The development of health technology assessment. Health Policy. 2003 Feb;63(2):121–32. doi:10.1016/s0168-8510(02)00059-3
17. Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value in Health. 2012;15(8):1172–81. doi:10.1016/j.jval.2012.06.015
18. Facey K, Boivin A, Gracia J, Hansen HP, Scalzo AL, Mossman J, et al. Patients' perspectives in health technology assessment: a route to robust evidence and fair deliberation. Int J Technol Assess Health Care. 2010;26(3):334–40. doi:10.1017/S0266462310000395
19. Verguet S, Kim JJ, Jamison DT. Extended cost-effectiveness analysis for health policy assessment: a tutorial. Pharmacoeconomics. 2016 Sep;34(9):913-23. doi:10.1007/s40273-016-0414-z
20. Raftery J. Review of NICE's recommendations, 1999-2005. Bmj. BMJ. 2006 May 27;332(7552):1266–8. doi:10.1136/bmj.332.7552.1266
21. Tosh JC, Longworth LJ, George E. Utility values in National Institute for Health and Clinical Excellence (NICE) Technology Appraisals. Value in Health. 2011;14(1):102–9. doi:10.1016/j.jval.2010.10.015
22. Wonderling D, Sawyer L, Fenu E, Lovibond K, Laramée P. National clinical guideline centre cost-effectiveness assessment for the national institute for health and clinical excellence. Ann Intern Med. 2011 Jun 7;154(11):758–65. doi:10.7326/0003-4819-154-11-201106070-0000
23. Koch K, Lange S. Response to the expertise: procedures and methods of benefit assessments for medicines in Germany, by Geertruida E. Bekkering and Jos Kleijnen. Eur J Health Econ. 2009 May;10(2):233–6. doi:10.1007/s10198-008-0142-1
24. Herpers M, Dintsios C-M. Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany. Eur J Health Econ. 2019 Feb;20(1):45–57. doi:10.1007/s10198-018-0981-3
25. Mitton C, Seixas BV, Peacock S, Burgess M, Bryan S. Health technology assessment as part of a broader process for priority setting and resource allocation. Appl Health Econ Health Policy. 2019 Oct;17(5):573–6. doi:10.1007/s40258-019-00488-1
26. Bullement A, Podkonjak T, Robinson MJ, Benson E, Selby R, Hatswell AJ, et al. Real-world evidence use in assessments of cancer drugs by NICE. Int J Technol Assess Health Care. 2020 Jul 10:1–7. doi:10.1017/S026646232000043
27. International Working Group for HTA Advancement, Neumann PJ, Drummond MF, Jönsson B, Luce BR, Schwartz JS, Siebert U, et al. Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations? Int J Technol Assess Health Care. 2010;26(1): 71–8. doi:10.1017/S0266462309990833

PDF version

Short research communication

Sultana Al Sabahi,¹ Kamila Al-Alawi,² Alaa Hashish ² and Jean Jabbour ²

¹Centre of Studies and Research, Ministry of Health, Muscat, Oman (Correspondence to S. Al Sabahi: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²WHO Country Office, Muscat, Oman.

Abstract

Background: In addition to the general question about what works, policymakers consider whether health interventions will work in their context, and consider the social values such as affordability, acceptability, equity, equality, and human rights.

Aims: To highlight the importance of having and using an evidence governance system to inform health policymaking in Oman.

Methods: We reviewed the literature and analysed local documents on evidence governance systems in Oman.

Results: The Government of Oman has shown increasing interest in research and innovation in the past few decades. This interest was reinforced through the announcement in November 2021 of the intention to establish a decision-making support unit. Oman’s strategies for evidence-informed policymaking provide direct and well-integrated channels for expert advice, however, the capacity for implementation remains challenging, and there is a lack of clarity in the evidence use mandate. It is not clear how evidence was selected, synthesized and used to inform some of the government policies on health. This can limit the scope of operation and subsequent achievements.

Conclusion: Efforts to strengthen evidence-informed policymaking should focus on building a system for good governance of evidence to ensure that rigorous, systematic, and technically valid evidence is used for policymaking.

Keywords: evidence, decision-making, policymaking, governance, Oman

Citation: Al Sabahi S, Al-Alawi K, Hashish A, Jabbour J. The evidence governance system in Oman. East Mediterr Health J. 2023;29(7):520–523.

https://doi.org/10.26719/emhj.23.081 Received: 28/09/22; Accepted: 22/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

It is recognized that for any action and decision, information is needed to determine whether the stated goals have been achieved or to guide the selection of potential options to achieve those goals. Evidence is what provides this information. Evidence-informed policymaking refers to the use of best-available evidence to inform policies systematically and transparently (1). Despite the vast amount of evidence, which varies between personal experience, tacit knowledge, and the more systematic findings from organized professional research, advocates of evidence-informed policymaking have only promoted scientific evidence as the form best suited to guiding policymaking (2). However, the concept of evidence-informed policymaking has evolved to better address the political aspects associated with decision-making (e.g. interest groups, public opinion, economic situation, and the role of institutions). This article aims to: (1) clarify the difference between evidence-based medicine and evidence-informed policymaking; (2) explain the importance of systems to govern evidence to inform policies; and (3) reflect on the efforts of the system in Oman to support evidence-informed policymaking. This is crucial to countries in the process of bringing evidence-informed policymaking into operation, and it is timely for Oman as the government announced on 13 November 2022 establishment of a decision-making support unit under the General Secretary of the Council of Ministers (3).

Evidence-based medicine versus evidence-informed policymaking

Evidence-based medicine focuses on research to evaluate the effectiveness of interventions (4). There is a hierarchy of research evidence, with meta-analyses and randomized controlled trials considered to be the gold standard (5). The value placed on evidence-based medicine and its perceived success have provoked the application of its basic principles to policy development (4), and there have been increased calls to use scientific evidence in ppolicymaking (6).

Policymakers need to consider whether their policies will work in their particular context (7). Various social factors may not be feasible for experimentation; for example, affordability, acceptability, equity, equality, and human rights (8). While good evidence in medicine is judged by its hierarchy, good evidence for policymaking is judged by its relevance to the issue at stake and then by its methodological quality (9). This is because evidence hierarchies were originally designed to judge the effectiveness of interventions rather than reflecting policy importance or relevance (8). Despite the difference in the approach to selecting what is considered good evidence for medicine and policymaking, evidence-based medicine and evidence-informed policymaking emphasize the importance of selecting, assessing, and synthesizing evidence systematically and transparently (10).

A system to govern the use of evidence in policymaking

To understand the need for a system to govern the use of evidence in policymaking, we need to first understand the political nature of policymaking. Politics is about who gets what, when, and how (11). Allocating scarce resources and setting priorities are the main concerns with policymaking (12). Hence, policymaking involves trade-offs between multiple, potentially competing social values, and it is considered to be a political process (12). This feature differentiates policy decisions from technical exercises, which have, in most circumstances, a single agreed outcome. In contrast, society has no consensus about which social outcomes are paramount or how to judge their particular value. The lack of agreement in the desired outcomes creates the potential for misuse or bias in using evidence to inform policies. The political bias in using evidence may occur during: (1) evidence creation (e.g. manipulation of studies, or strategic design to achieve a desired outcome, even if the research is conducted in rigorous and valid ways, bias may occur in selecting which issues to research, how to study them, and what questions to ask within a study) (13); (2) evidence selection (e.g. ‘cherry-picking’ and strategic review of data to justify a predetermined position) (14); or (3) evidence interpretation (e.g. interpreting methodological rigour as an indication of policy relevance, or judging the quality of evidence based on the method alone) (15).

Evidence-informed policymaking should not focus on merely acquiring more evidence. Instead, it should focus on building a system to enhance the governance of evidence to inform the policymaking process in a systematic, rigorous, and technically valid way (8). These processes should be inclusive of, representative of, and accountable to the multiple social interests of the population served (8). Institutionalization of evidence-informed policymaking through a governance system is important to ensure system-wide and deeply rooted change in evidence use. The processes should also avoid limitations associated with strategies that focus on individuals (e.g. connecting policymakers and researchers, providing decision-makers with evidence, or providing training to individuals to broker knowledge) who may, over time, change roles or leave their positions (16).

In many countries, such a system has been created through building organizations that work to enhance the use of evidence in policymaking. These organizations can exist in different settings (e.g. as independent organizations, within universities, and as part of government departments) and have been called different names (think tanks, government-support organizations, and research centres) (15). It is important to note that institutions are no longer limited to simply being the administrative bodies or physical structures within a system. Currently, institutions are presented in the practices they embark upon, the rules by which they function, and the discursive narratives by which their work is comprehended (17). Therefore, creating a system to improve evidence use could be through establishment or changing the existing structures that use evidence, or by introducing changes to the principles by which those institutions function (8).

Components of evidence governance system in Oman

In Oman, the government has shown increasing interest in research and innovation in the last few decades. Several health centres in the health and non-health sectors have been established (e.g. Centre for Studies and Research at the Ministry of Health and the Medical Research Centre at Sultan Qaboos University). The Research Council (which is currently under the Ministry of Higher Education Research and Innovation) was established to fund research and innovation. The government has expressed interest in using research findings through the Oman 2040 Vision, which emphasizes the importance of achieving their goals through sound and positive guidance and systematic evidence-based planning, and the importance of a knowledge-based economy (18). The Ministry of Higher Education Research and Innovation announced for 2022 a research funding programme that will target priority areas at the Ministry of Health and Ministry of Agriculture, Fisheries, Water, and Water Resources. This programme mandates the involvement of policymakers in selecting priority research to be funded, and developing a plan to implement the research findings. The Government of Oman has reinforced its interest in evidence-informed policymaking through its intention to establish a unit to support decision-making (announced 9 November 2021 and officially established on 13 November 2022) (3).

Oman has some institutional structures to support the utilization of evidence. For instance, the Ministry of Health has tasked its policy advice officers and technical advisors with planning, providing policy options, or commenting on proposed policies. These strategies may provide direct and well-integrated channels for expert advice, yet the appropriate capacity and capability remain challenging for such bodies. Another challenge is the lack of clarity in the mandate for utilizing evidence and limiting the scope of subjects for which such bodies can function. On other occasions, the Government convenes expert panels or technical working groups (e.g. Supreme COVID-19 Committee and Oman 2040 Vision Committee) to inform specific decisions, giving such groups different levels of autonomy.

There is evidence that policymakers recognized the importance of evidence and used it to inform policies (19). However, it was not clear how evidence was selected and synthesized, and in what way it informed policies. It is unclear which social values guided the policy decisions and whose voices were heard. These rules, norms, and procedures are important to achieve the core principle of evidence-informed policymaking (i.e. transparent and systematic use of evidence to serve the social values of the population). By institutionalization of the practice of evidence-informed policymaking in such approaches, we can envision how systems would mature and how evidence use would improve.

Conclusion

Evidence-informed policymaking is the practice of informing policies with the best available evidence in a systematic and transparent manner. Policymaking is a struggle over different ideas and social values; therefore, scientific evidence and social values have to be considered. Unlike evidence-based medicine, scientific evidence cannot be merely judged by its rigorous methods to inform policymaking. Instead, relevance is more important. As a result of the political nature of policymaking, bias in creating, selecting, or interpreting evidence can occur and affect achievement of the intended social goal. Therefore, efforts to support evidence-informed policymaking should be transitioned from focusing on individuals to institutions. The institutions should consider the physical structure as well as the rules, norms, and regulations that mandate the good use of evidence in policymaking. Oman has shown interest in using evidence to support policymaking. Different institutions have been working on different rules to support evidence-informed policymaking; however, the Government of Oman needs to create the mandates, rules, and regulations that ensure the institutionalization of good practice in using evidence in policymaking. Besides establishing formal structures, the Government of Oman should focus on creating procedures, norms, rules, or even laws that reduce bias or improve reasonable scientific practice in policymaking. If the Government of Oman takes into consideration the points raised in this article when establishing a decision-making support unit, it will help it take robust steps towards achieving its goal of informing public policies with the best-available evidence.

Funding: None.

Competing interests: None declared.

Le système de gouvernance des données probantes à Oman

Résumé

Contexte : En plus de se pencher sur la question générale concernant l'applicabilité, les responsables de l'élaboration des politiques se demandent si les interventions sanitaires fonctionneront dans leur contexte et tiendront compte de valeurs sociales telles que l'accessibilité économique, l'acceptabilité, l'équité, l'égalité et les droits humains.

Objectif : Souligner l'importance de disposer d'un système de gouvernance des données probantes et de l'utiliser pour éclairer l'élaboration des politiques de santé à Oman.

Méthodes : Nous avons examiné la littérature et analysé les documents locaux relatifs aux systèmes de gouvernance des données probantes à Oman.

Résultats : Le Gouvernement d'Oman a manifesté un intérêt croissant pour la recherche et l'innovation au cours des dernières décennies. Cet intérêt a été renforcé par l'annonce en novembre 2021 de l'intention de créer une unité d'appui à la prise de décision. Les stratégies d'Oman en matière d'élaboration de politiques fondées sur des données probantes fournissent des canaux directs et bien intégrés pour les conseils d'experts. Cependant, la capacité de mise en œuvre demeure difficile et il existe un manque de clarté dans le mandat d'utilisation des données probantes. La manière dont ces données ont été sélectionnées, synthétisées et utilisées pour éclairer certaines des politiques gouvernementales en matière de santé n'est pas claire non plus. Cela risque de limiter le champ d'application et les réalisations ultérieures.

Conclusion : Les efforts visant à renforcer l'élaboration de politiques reposant sur des bases factuelles doivent se concentrer sur la mise en place d'un système de bonne gouvernance des données probantes afin de garantir l'utilisation de données rigoureuses, systématiques et techniquement valables pour l'élaboration des politiques.

نظام حوكمة الدلائل في عُمان

سلطانة الصباحي، كاميلا العلوي، علاء حشيش، جون جبور

الخلاصة

الخلفية: بالإضافة إلى السؤال العام عمَّا هو صالح للتطبيق، ينظر واضعو السياسات فيما إذا كانت التدخلات الصحية صالحة للتطبيق في سياقها أم لا، وينظرون أيضًا في القيم الاجتماعية مثل، القدرة على تحمُّل التكاليف، والمقبولية، والإنصاف، والمساواة، وحقوق الإنسان.

الأهداف: هدفت هذه الدراسة الى تسليط الضوء على أهمية وجود نظام لحوكمة الدلائل واستخدامه في توجيه عملية وضع السياسات في عُمان.

طرق البحث: راجعنا المؤلفات وحللنا الوثائق المحلية بشأن نُظم حوكمة الدلائل في عُمان.

النتائج: وضع السياسات عمليةٌ سياسية، وتُقيَّم الدلائل الموثوق بها المتعلقة بالسياسات في أغلب الأحيان حسب صلتها بمسألة السياسات التي تكون على المحك.

الاستنتاجات: ينبغي أن تركز الجهود الرامية إلى تعزيز وضع السياسات المسترشدة بالدلائل على بناء نظام للحوكمة الرشيدة للبيِّنات، لضمان استخدام دلائل دقيقة ومنهجية وسليمة من الناحية التقنية في وضع السياسات.

References

1. Annual Report 2017. EVIPNet Europe. Towards a world in which the best available research evidence informs policy-making (http://www.euro.who.int/__data/assets/pdf_file/0004/368833/Annual-report-2017-for-EVIPNet-Europe.pdf?ua=1, accessed 28 March 2023).

2. Iphofen R, O’Mathúna D. Ethical evidence and policymaking: interdisciplinary and international research. Bristol: Policy Press; 2022.

3. To amend the organizational structure of the General Secretariat of the Council of Ministers 2022. Oman: Ministry of Justice and Legal Affairs; 2023 (https://www.mjla.gov.om/legislation/gazettes/details.aspx?Id=626&type=G, accessed 20 March 2023).

4. Sheldrick RC, Hyde J, Leslie LK, Mackie T. The debate over rational decision making in evidence-based medicine: implications for evidence-informed policy. Evid Policy. 2021;17(1):147–59. https://doi.org/10.1332/174426419X15677739896923

5. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet. 2017 Jul 22;390(10092):415–23. https://doi.org/10.1016/S0140-6736(16)31592-6 PMID:28215660

6. Godziewski C. Evidence and power in EU governance of health promotion: discursive obstacles to a “health in all policies” approach. J Common Market Stud. 2020 Sep;58(5):1307–24. https://doi.org/10.1111/jcms.13042

7. Cairney, P., & Oliver, K. (2017). Evidence-based policymaking is not like evidence-based medicine, so how far should you go to bridge the divide between evidence and policy?. Health research policy and systems, 15(1), 1-11.

8. Parkhurst J. The politics of evidence: from evidence-based policy to the good governance of evidence. Routledge; 2017.

9. Parkhurst JO, Abeysinghe S. What constitutes “good” evidence for public health and social policy-making? From hierarchies to appropriateness. Soc Epistemol. 2016;30(5–6):665–79. https://doi.org/10.1080/02691728.2016.1172365

10. Shaw L, Nunns M, Briscoe S, Anderson R, Thompson Coon J. A “Rapid Best‐Fit” model for framework synthesis: using research objectives to structure analysis within a rapid review of qualitative evidence. Res Synth Meth. 2020 May;12(3):368–83. https://doi.org/10.1002/jrsm.1462 PMID:33006277

11. Bhan T. Deserving poor in public sanitation: tracing the policymaking processes of who gets what, when, how, and why in Delhi. Environ Plan B Urban Analyt City Sci. 2022;49(8):2151–67. https://doi.org/10.1177/23998083221089325

12. Woods B, Rothery C, Revill P, Hallett TB, Phillips AN, Claxton K, editors. Setting research priorities in Global Health: Appraising the value of evidence generation activities to support decision-making in health care. York: Centre for Health Economics; 2018.

13. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2017 Feb 16;2(2):MR000033. https://doi.org/10.1002/14651858.MR000033.pub3 PMID:28207928

14. Schoofs EL, Fode M, Capogrosso P, Albersen M, Group ftEAoUYA. Current guideline recommendations and analysis of evidence quality on low-intensity shockwave therapy for erectile dysfunction. Int J Impot Res. 2019 May;31(3):209–17. https://doi.org/10.1038/s41443-019-0132-0 PMID:30911110

15. Al Sabahi S, Wilson MG, Lavis JN, El-Jardali F, Moat K. Examining and contextualizing approaches to establish policy support organizations – a mixed method study. International J Health Policy Manag. 2021 Aug 7;11(9):1788–800. https://doi.org/10.34172/ijhpm.2021.86 PMID:34380206

16. Al Sabahi S, Wilson MG, Lavis JN, El-Jardali F, Moat K, Vélez M. Examining and contextualizing approaches to establish policy support organizations – a critical interpretive synthesis. Int J Health Policy Manag. 2022 May 1;11(5):551–66. https://doi.org/10.34172/ijhpm.2020.181 PMID:33008260

17. Lowndes V, Roberts M. Why institutions matter. The new institutionalism in political science. Bloomsbury; 2013.

18. Oman Vision 2040. Moving forward with confidence. Oman: Ministry of Finance; 2020 (https://www.mof.gov.om/pdf/Vision_Documents_En.pdf, accessed 20 March 2023).

19. Al Sabahi S, Wilson MG, Lavis JN, El-Jardali F, Moat K. Insights from system leaders about operationalising a knowledge translation department in the Oman Ministry of Health. Evid Policy J Res Debate Pract. 2021;18(1):85–107. https://doi.org/10.1332/174426421X16123709152129

PDF version

Short research communication

Vahid Yazdi-Feyzabadi ¹ and Salman Bashzar ²

¹Student Research Committee, Faculty of Management and Medical Information Sciences, Kerman University of Medical Sciences, Kerman, Islamic Republic of Iran. ²Health Services Management Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Islamc Republic of Iran. (Correspondence to Salman Bashzar: This email address is being protected from spambots. You need JavaScript enabled to view it.).

Abstract

Background: Health technology assessment (HTA) is a conventional method for evaluating reasonable use of health technologies in many countries.

Aims: To investigate the ethical soundness of HTA studies in Islamic Republic of Iran.

Methods: All HTA reports published by the HTA office until 2020 were reviewed using the HTA Core Model and the Q-SEA questionnaires.

Results: We evaluated 91 reports for ethical soundness. The research question, literature search and inclusion/exclusion criteria were included in 91.2%, 83.5% and 82.4% of the HTA reports, respectively. Only 13.2% of the reports explicitly stated the objective of the analysis and 6.6% stated the ethics framework. Only 2.2%, 4.4%, 9.9%, 9.9%, 14.3%, and 2.2%, respectively, of the reports, complied with the completeness, bias, policy implications, other implications, conceptual clarification, and conflicting values.

Conclusions: HTA reports in the Islamic Republic of Iran require coordinated and integrated framework acceptable to all stakeholders to ensure their compliance with sound ethical requirements.

Keywords: health technology assessment, medical ethics, quality, Iran

Citation: Yazdi-Feyzabadi V, Bashzar S. Ethical soundness of health technology assessment reports in Islamic Republic of Iran. East Mediterr Health J. 2023;29(7):524–529. https://doi.org/10.26719/emhj.23.039 Received: 16/06/22; Accepted: 18/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Concerns about unassessed benefits and the high cost of healthcare interventions have led to the establishment of health technology assessment (HTA), a policy-oriented interdisciplinary process to inform decision-making (1–3). Similar schemes have been devised throughout the world by establishing agencies or HTA units in health systems (1,4–6). The focus of HTA has been on the medical, economic, social and ethical outcomes; development; distribution; and use of health technologies (4–11), and most national and international HTA organizations have emphasized these aspects. The ethical aspect is, however, often less developed and less considered than other aspects such as clinical characteristics and economic effectiveness (8,12–15).

In the HTA process, ethical analysis can be considered an assessment of ethical issues caused by technology or related to the HTA process (16–21). Health technologies incorporate ethical values and properties that can affect moral values on a personal or society level (22). Ethical analysis can be used as basis for public participation and research on the values and preferences of stakeholders (11,23–27).

Although almost all HTA experts have reached consensus on conducting ethical analysis, the methods proposed for addressing ethical issues differ markedly in terms of philosophical approach, structure and comprehensiveness. However, a “one size fits all” approach is probably not the best option for evaluating ethical considerations about healthcare technologies (12,28). Examining ethical considerations in HTA reports may help improve the quality of reports.

In the Islamic Republic of Iran, HTA is not very old, it was introduced in the late 1990s. HTA activities began in 2007 in the Department of Health Economics at the Center for Network Development and Health Promotion within the Ministry of Health and Medical Education. In 2010, changes in the structure of the Ministry of Health and Medical Education led to the separation of the deputies of hygiene and curative affairs. At the same time, the HTA office began its activities in the Health Technology Assessment, Standardization, and Tariffs Office under the supervision of the Deputy of Curative Affairs and with a new structure. The vision of the HTA office was to establish HTA within the health system, and thus, all forthcoming decisions and policies would be based on scientific evidence obtained from HTA reports (29–31).

Since, as a developing country, the Islamic Republic of Iran is exposed to modern healthcare technologies, this study examined the quality of ethical analyses of all HTA reports in the country.

Methods

This study is a type of grey literature review of HTA reports. All the reports from the Iranian HTA office up to 2020 were retrieved from the Iranian government website (http://ihta.behdasht.gov.ir). We used 2 assessment tools, the HTA Core Model questionnaire (32) and the Q-SEA questionnaire (8), to examine the quality of ethical analyses of all the reports. Two appraisers carried out the assessment and rating at the same time; in case of any disagreement, discussion continued until a consensus agreement was reached on the rating.

The HTA Core Model questionnaire contains 6 domains and 12 issues, including principal questions about the ethical aspects of technology, autonomy, human dignity, human integrity, beneficence/non-maleficence and justice/equity. We used the HTA Core Model for ethical analysis of HTA reports because most Iranian HTA researchers use this model for their assessments. The second tool used, the Q-SEA questionnaire, has 2 domains, the process domain and the outputs domain. The process domain has 5 elements: research questions, literature search, inclusion and exclusion criteria, perspective and the ethics framework. The outputs domain also has 5 elements: completeness, bias, implications, conceptual clarification and conflicting values (8).

Ethical clearance was obtained from the ethics board of Kerman University of Medical Sciences (ethics clearance certificate number IR.KMU.REC.1397.381).

Results

A total of 101 Iranian HTA reports were retrieved. One report was excluded because it was a duplicate, another 3 were excluded because they were not HTA reports, and 6 were excluded due to the lack of access to their full text. Therefore, 91 reports were included in the final ethical analyses.

Regarding the ethical aspect of the HTA reports based on the Q-SEA tool, in the process aspect, 91.2% of the reports included the research question, 83.5% included the text search and 82.4% included the inclusion/exclusion criteria. The analysis perspective was only explicitly mentioned in 13.2% of the reports, and only 6.6% included an ethics framework in their analysis. Maximum compliance was poor, with completeness considered in 2.2% of the reports, bias in 4.4%, policy implications in 9.9%, implications differentiated by stakeholder in 9.9%, conceptual clarification in 14.3% and conflicting values in 2.2%. A description of items included in the HTA reports based on the Q-SEA tool is presented in Table 1.

Using the HTA Core Model questionnaire (Table 2), we found that 80.2% of the reports noted that this was a modern technology in the health field for the Islamic Republic of Iran, adding to, or replacing, the existing health standards. The relationship between the evaluated technology and the religious and cultural beliefs of some groups was only noted in 4.4% of the reports and just over 60% mentioned the hidden or unintended consequences of technology.

The impact of technology on patients’ autonomy was considered in 9.9% of the reports; 5.5% mentioned the impact of the studied technologies on human dignity and 3.3% mentioned integrity. The consequences of implementing/not implementing the technology on justice in the healthcare system were mentioned in only 4.4% of the reports. A description of the items included in the HTA reports from the Islamic Republic of Iran based on the HTA Core Model are presented in Table 2.

Discussion

In reviewing the development of the Iranian HTA reports using the Q-SEA tool, the focus has been on evaluating the quality of the process regarding ethical analysis, and this study shows that 100% of the HTA reports included ethics in their systematic review. However, they did not respond to ethics in the patient, intervention, comparison, outcome (PICO) format as a systematic review of clinical evidence, as suggested by McCullough et al. (33).

Our review of the clinical aspects and effectiveness of the Iranian HTA reports used a search strategy to choose the appropriate information sources. However, none of the reports reviewed mentioned the search for content related to the philosophical and ethical issues of technology. The inclusion and exclusion criteria were clearly stated in 82.4% of the reports and ethical issues were noted in the inclusion criteria.

Because most researchers working on HTA projects believed that other aspects of HTA cover the ethical aspect, they did not conduct a separate ethical analysis. Therefore, in terms of inclusion and exclusion criteria, they also referred to studies on technology-related ethical issues and noted the study of such issues as inclusion criteria.

Less than 15% of the HTA reports we studied clearly stated that their analysis and assessment were unbiased. It should be noted that, when investigating the ethical aspect of technology, certain other methods are commonly used, for example convening an expert panel or focus group discussions that include clinical experts and decision-makers in the relevant field.

A wide range of ethics frameworks, such as the Socratic approach, fundamentalism, coherence analysis or participatory HTA approaches, have been used to analyse the ethical aspects of HTA based on the HTA Core Model (34). In contrast, we found that only some reports noted that the technologies were investigated using the HTA Core Model. There was no transparency in this regard, and stakeholders perceptions of the studied technologies were not examined .

Results relating to the output domain of the tool, which evaluated the quality of the output components, (i.e. the ethical analysis as the outcome of the process) showed that only 2.2% of all reports acknowledged ethical gaps. This finding is significant, indicating the absence of the approaches that many researchers use to ensure the completeness of any ethical analysis (8,19,35,36).

Brief reference to any possible biases during the ethical analysis was made in only 4.4% of the reports, and the policy- and other stakeholder-related implications were discussed in less than 10%. Therefore, from this point of view, Iranian HTA reports were not found to be of good quality, did not explicitly identify various ethical issues and offered no suggestions for stakeholders.

In terms of conceptual clarification, the reports were poorly presented. Although the systematic review does not provide any transparent assessment of conceptual topics, the authors of those reports implicitly proposed several explanations, such as: "it has no effect on human dignity", "it does not affect patient autonomy", or "the studied technology enhances justice in access".

An interesting point about the reports that referred to ethical issues is the use of concepts such as benefits and loss balance, autonomy and human dignity, indicating that these are the most important ethical issues that could present a risk for health technology. This was also noted by Bellemare et al. in a systematic review (14) and Strech and Sofaer in an ethical analysis of 7 reports on the European HTA Network (37).

The issues of justice, safety, human integrity, human dignity and free choice were discussed in only a few Iranian HTA reports. None of the issues discussed around ethics were based on ethical studies; they were based on the opinions of experts and specialists in the technology field.

Although most reports used the HTA Core Model, the lack of a standard model in HTA in the Islamic Republic of Iran can be seen in the ethical analysis of technology-related issues, which has also been highlighted in previous research (14). Most of the reported Iranian HTAs were conducted by only 1 or 2 people; in none of them was a medical ethics expert involved, although this was not mentioned in the reports. This shows the significant weakness of knowledge related to complex philosophical theories, ethical arguments and a lack of expertise in ethical justification methods for HTA studies. The technology-related ethical goals were discussed in only a few reports; these were not transparent and did not use any of the various approaches to ethical analysis.

Over more than a decade since the establishment of the HTA office in the Islamic Republic of Iran, many activities have been carried out to promote HTA, an indication of the serious determination to develop a dynamic and active HTA system. However, our findings show that, although an appropriate structure has been prepared for HTA, there are systematic weaknesses for an integrated and coherent HTA system, especially for the ethical aspect. This issue highlights the need for a standard model for ethical analysis of technology-related issues, training of ethics experts in the field of health, and enhancing the knowledge of experts in ethical theories.

Conclusion

In this study, we used 2 important tools to check the quality of Iranian HTA reports. The results show that the ethical dimension of health technologies, one of the most important aspects of an HTA, has not been properly investigated in HTA studies in the Islamic Republic of Iran, and that there is a huge gap between what is and what can be. We believe, therefore, that a critical appraisal of the ethical dimension of HTA reports is necessary to eliminate the existing gaps.

Acknowledgements

This study is based on a research study entitled “A study on challenges and quality assessment of ethical analyses aspect in health technology assessment in Iran”, approved on 24 December 2018 by the Deputy for Research and Technology of Kerman University of Medical Sciences (code:97000508) and registered with the Ethics Committee (IR.KMU.REC.1397.381). The researchers are grateful to the Deputy for Research and Technology at Kerman University of Medical Sciences.

Funding: This research was funded by the Student Research Committee of Kerman University of Medical Sciences.

Competing interests: None declared.

Validité éthique des rapports d'évaluation des technologies de la santé en République islamique d'Iran

Résumé

Contexte : L'évaluation des technologies de la santé (ETS) est une méthode conventionnelle permettant d'évaluer l'utilisation raisonnable des technologies de la santé dans de nombreux pays.

Objectif : Examiner la validité éthique des études ETS en République islamique d'Iran.

Méthodes : Tous les rapports d'évaluation des technologies de la santé (ETS) publiés jusqu'en 2020 par le bureau chargé de ces évaluations ont été examinés à l'aide du modèle ETS principal et des questionnaires Q-SEA.

Résultats : Nous avons évalué la validité éthique de 91 rapports. La question de recherche, la recherche dans la littérature et les critères d'inclusion et d'exclusion étaient inclus dans 91,2 %, 83,5 % et 82,4 % des rapports ETS, respectivement. Seuls 13,2 % des rapports mentionnaient explicitement l'objectif de l'analyse et 6,6 % en indiquaient le cadre éthique. Parmi les rapports, seuls 2,2 %, 4,4 %, 9,9 %, 9,9 %, 14,3 % et 2,2 %, respectivement, étaient conformes aux exigences en matière d'exhaustivité, d'impartialité, d'implications par rapport aux politiques ou autres, de clarification conceptuelle et de valeurs conflictuelles.

Conclusion : Les rapports ETS en République islamique d'Iran nécessitent un cadre coordonné et intégré qui soit acceptable pour toutes les parties prenantes, afin de garantir leur conformité avec des exigences éthiques bien fondées.

السلامة الأخلاقية لتقارير تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية

وحید یزدی- فیض آبادی، سلمان باش زر

الخلاصة

الخلفية: يُعدُّ تقييم التكنولوجيات الصحية من الطرق التقليدية لتقييم الاستخدام المعقول للتكنولوجيات الصحية في العديد من البلدان.

الأهداف: هدفت هذه الدراسة الى استقصاء السلامة الأخلاقية لدراسات تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية.

طرق البحث: استعرض المكتب المعني بتقييم التكنولوجيات الصحية جميع تقارير تقييم التكنولوجيات الصحية حتى عام 2020 باستخدام النموذج الأساسي لتقييم التكنولوجيات الصحية واستبيانات Q-SEA.

النتائج: قيِّمنا 91 تقريرًا عن السلامة الأخلاقية. وأُدرج سؤال البحث، والبحث في المؤلفات، ومعايير الإدراج/ الاستبعاد في 91.2%، و83.5%، و82.4% من تقارير تقييم التكنولوجيات  الصحية، على التوالي. وأوضحت 13.2% فقط من التقارير صراحةً هدف التحليل، وذكرت 6.6% منها إطار الأخلاقيات. وقد امتثل فقط 2.2%، و4.4%، و9.9%، و9.9%، و14.3%، و2.2% من التقارير، على التوالي، للاكتمال، والتحيز، والآثار المترتبة على السياسات، والآثار الأخرى، والإيضاحات المفاهيمية، والقيم المتضاربة.

الاستنتاجات: تتطلب تقارير تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية إطارًا منسقًا ومتكاملًا، ويكون مقبولًا من جميع أصحاب المصلحة لضمان امتثالهم للمتطلبات الأخلاقية السليمة.

References

1. Lafortune L, Farand L, Mondou I, Sicotte C, Battista R. Assessing the performance of health technology assessment organizations: a framework. Int J Technol Assess Health Care. 2008 Winter;24(1):76–86. doi:10.1017/S0266462307080105
2. Banta D, Oortwijn W. Health technology assessment and health care in the European Union. Int J Technol Assess Health Care. 2000 Spring;16(2):626–35. PMID:10932427
3. Henshall C, Oortwijn W, Stevens A, Granados A, Banta D. Priority setting for health technology assessment. Theoretical considerations and practical approaches. Priority setting Subgroup of the EUR-ASSESS Project. Int J Technol Assess Health Care. 1997 Spring;13(2):144–85. doi:10.1017/s0266462300010357
4. Velasco-Garrido M, Busse R. Health technology assessment: an introduction to objectives, role of evidence, and structure in Europe. Copenhagen: World Health Organization Regional Office for Europe, European Observatory on Health Policies; 2005.
5. Hanney SR, Gonzalez-Block MA, Buxton MJ, Kogan M. The utilisation of health research in policy-making: concepts, examples and methods of assessment. Health Res Policy Syst. 2003 Jan 13;1(1):2. doi:10.1186/1478-4505-1-2
6. Drummond M, Banta D. Health technology assessment in the United Kingdom. Int J Technol Assess Health Care. 2009 Jul;25(Suppl. 1):178–81. doi:10.1017/S0266462309090618
7. Banta D. What is technology assessment? Int J Technol Assess Health Care. 2009 Jul;25(Suppl. 1):7–9. doi:10.1017/S0266462309090333
8. Scott AM, Hofmann B, Gutiérrez-Ibarluzea I, Lysdahl KB, Sandman L, Bombard Y. Q-SEA–a tool for quality assessment of ethics analyses conducted as part of health technology assessments. GMS Health Technol Assess. 2017;13:Doc02. doi:10.3205/hta000128
9. EUnetHTA, Mäkelä M. HTA Core Model® for Medical and Surgical Interventions 1.0 R. Copenhagen: European Network for Health Technology Assessment (EUnetHTA); 2008 (https://corehta.info/model/HTA%20Core%20Model%20for%20Medical%20and%20Surgical%20Interventions%201.0r.pdf, accessed 15 February 2023).
10. Goodman CS. HTA 101: introduction to health technology assessment. Bethesda: National Library of Medicine; 2014 (https://www.nlm.nih.gov/nichsr/hta101/HTA_101_FINAL_7-23-14.pdf, accessed 15 February 2023).
11. NaserHamzeKhanloo M, Bazyar M. Role and necessity of health technology assessment (HTA) in health system. J Health. 2010;1(2):59–68 (https://healthjournal.arums.ac.ir/browse.php?a_id=143&sid=1&slc_lang=en, accessed 15 February 2023).
12. Hofmann BM. Why ethics should be part of health technology assessment. Int J Technol Assess Health Care. 2008 Fall;24(4):423–9. doi:10.1017/S0266462308080550
13. Leys M. Health care policy: qualitative evidence and health technology assessment. Health Policy. 2003;65(3):217–26. doi:10.1016/s0168-8510(02)00209-9
14. Bellemare CA, Dagenais P, Suzanne K, Béland J-P, Bernier L, Daniel C-É, et al. Ethics in health technology assessment: a systematic review. Int J Technol Assess Health Care. 2018 Jan;34(5):447–57. doi:10.1017/S0266462318000508
15. Weinstein BD. What is an expert? Theor Med. 1993 Mar;14(1):57–73. doi:10.1007/BF00993988
16. Clausen C, Yoshinaka Y. Social shaping of technology in TA and HTA. Poiesis & Praxis. 2004;2(2–3):221–46. doi:10.1007/s10202-003-0046-1
17. Hofmann B. The technological invention of disease. Med Humanit. 2001 Jun;27(1):10–9. doi:10.1136/mh.27.1.10
18. Reuzel RP, van der Wilt GJ, ten Have HA, de Vries Robbé PF. Interactive technology assessment and wide reflective equilibrium. J Med Philos. 2001 Jun;26(3):245–61. doi:10.1076/jmep.26.3.245.3015
19. Popay J, Rogers A, Williams G. Rationale and standards for the systematic review of qualitative literature in health services research. Qual Health Res. 1998 May;8(3):341–51. doi:10.1177/104973239800800305
20. ten Have H. Ethical perspectives on health technology assessment. Int J Technol Assess Health Care. 2004 Winter;20(1):71–6. doi:10.1017/s0266462304000819
21. Reuzel R, Oortwijn W, Decker M, Clausen C, Gallo P, Grin J, et al. Ethics and HTA: some lessons and challenges for the future. Poiesis & Praxis. 2004;2(2–3):247–56. doi:10.1007/s10202-003-0054-1
22. Hofmann B. On value-judgements and ethics in health technology assessment. Poiesis & Praxis. 2005;3(4):277–95. doi:10.1007/s10202-005-0073-1
23. Hutton J, McGrath C, Frybourg J-M, Tremblay M, Bramley-Harker E, Henshall C. Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). Int J Technol Assess Health Care. 2006 Winter;22(1):10–8. doi:10.1017/s0266462306050781
24. Braunack-Mayer AJ. Ethics and health technology assessment: handmaiden and/or critic? Int J Technol Assess Health Care. 2006 Summer;22(3):307–12. doi:10.1017/s0266462306051191
25. Gauvin FP, Abelson J, Giacomini M, Eyles J, Lavis JN. “It all depends”: conceptualizing public involvement in the context of health technology assessment agencies. Soc Sci Med. 2010 May;70(10):1518–26. doi:10.1016/j.socscimed.2010.01.036
26. Daniels N, Sabin J. The ethics of accountability in managed care reform: recent efforts at reforming managed care practices have one thing in common: a call for accountability to consumers. Health Aff (Millwood). 1998 Sep–Oct;17(5):50–64. doi:10.1377/hlthaff.17.5.50
27. Hofmann B, Cleemput I, Bond K, Krones T, Droste S, Sacchini D, et al. Revealing and acknowledging value judgments in health technology assessment. Int J Technol Assess Health Care. 2014 Dec;30(6):579–86. doi:10.1017/S0266462314000671
28. Scott AM, Bond K, Gutiérrez-Ibarluzea I, Hofmann B, Sandman L. Quality assessment of ethics analyses for health technology asssessment. Int J Technol Assess Health Care. 2014 Dec;30(6):579–86. doi:10.1017/S0266462314000671
29. Arab-Zozani M, Sokhanvar M, Kakemam E, Didehban T, Hassanipour S. History of health technology assessment in Iran. Int J Technol Assess Health Care. 2020;36(1):34–39. doi:10.1017/S0266462319003489
30. Yazdizadeh B, Mohtasham F, Velayati A. Impact assessment of Iran’s health technology assessment programme. Health Res Policy Syst. 2018 Sep 7;16(1):89. PMID:29471838
31. Mohtasham F, Yazdizadeh B, Zali Z, Majdzadeh R, Nedjat S. Health technology assessment in Iran: Barriers and solutions. Med J Islam Repub Iran. 2016 Jan 26;30:321
32. EUnetHTA. HTA core model version 3.0 for the assessment of diagnostic technologies, medical and surgical interventions, pharmaceuticals and screening technologies. Copenhagen: European Network for Health Technology Assessment (EUnetHTA); 2016 (https://www.eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, accessed 15 February 2023).
33. McCullough LB, Coverdale JH, Chervenak FA. Constructing a systematic review for argument-based clinical ethics literature: the example of concealed medications. J Med Philos. 2007 Jan–Feb;32(1):65–76. doi:10.1080/03605310601152206
34. Anttila H, Jacobsen CB, Koivisto J, Mortensen BB, Wiuff MB, Reiman-Möttönen P, et al. Social aspects. HTA core model for medical and surgical interventions 1.0 R: Copenhagen: European Network for Health Technology Assessment (EUnetHTA), FinOHTA; 2008:128–41 (https://corehta.info/model/HTA%20Core%20Model%20for%20Medical%20and%20Surgical%20Interventions%201.0r.pdf, accessed 15 February 2023).
35. Dixon-Woods M, Agarwal S, Jones D, Young B, Sutton A. Synthesising qualitative and quantitative evidence: a review of possible methods. J Health Serv Res Policy. 2005 Jan;10(1):45–53. doi:10.1177/135581960501000110
36. Strech D, Sofaer N. How to write a systematic review of reasons. J Med Ethics. 2012 Feb;38(2):121–6. doi:10.1136/medethics-2011-100096
37. Ekmekci PE, Güner MD. Evaluation of ethical analyses in seven reports from the European Network for Health Technology Assessment. Int J Technol Assess Health Care. 2019;35(4):273–9. doi:10.1017/S0266462319000485

PDF version

Razyeh Bajoulvand,¹ Mohammad Ramezanlou,² Naser Derakhshani,¹ Salime Goharinezhad,^1,3 Mohammad Gholami,² Fatemeh Toranjizadeh² and Nadia Saniee³

¹Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran (Correspondence to S. Goharinezhad: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²School of Medicine, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. ³Preventive Medicine and Public Health Research Center, Psychosocial Health Research Institute, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. ⁴Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Islamic Republic of Iran.

Abstract

Background: Affordability, accessibility and quality of services provided by a primary healthcare system can contribute significantly to the mitigation and management of a pandemic or disease outbreak. A strong primary healthcare system will mitigate the pressure on health systems during crises.

Aims: We aimed to identify the specific capabilities required to establish a resilient primary healthcare system that could respond effectively to a health crisis, and highlight any research gaps.

Methods: A bibliographic search was conducted on PubMed, Scopus, Web of Science, and ProQuest from 2000 to 2021. Using extracted data, we mapped the studies and categorized published research into a framework of 6 building blocks. A graphical and tabular representation of the data was then provided.

Results: A total of 4276 studies were retrieved, out of which 28 met the inclusion criteria for the systematic review. Data extraction was based on the study design, year of publication, country, type of communicable disease, and main interventions used for building resilient primary healthcare systems. Most of the studies were conducted in 2020 and 2021 during the COVID-19 pandemic and many of them emphasized digital health.

Conclusion: This review summarizes more than 20 years of research on how primary healthcare systems responded to public health emergencies. It provides a broad overview of the subject matter and existing research gaps for intervention planning and policymaking.

Keywords: primary healthcare, crisis, disaster, resilience, pandemic, mapping review, Iran

Citation: Bajoulvand R, Ramezanlou M, Derakhshani N, Goharinezhad S, Gholami M, et al. Strengthening primary health care for effective response to pandemics: a systematic review. East Mediterr Health J. 2023;29(7):530–539. https://doi.org/10.26719/emhj.23.080 Received: 12/6/22; Accepted: 08/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Over the next 50 years, the number of disasters is expected to multiply 5-fold (1). WHO defines a disaster as serious disruption of the function of a community or society, which causes widespread human, social, economic, or ecological losses that cannot be resolved (2,3). Disasters are divided into 3 broad groups: natural, human-made, and pandemic (4).

The global population is currently in the midst of the COVID-19 pandemic, which has spread rapidly across the world (5). On 22 February 2021, according to Johns Hopkins University, the global death toll from COVID-19 was ~2 500 000, making it the second most devastating event in a century and one of the 15 deadliest pandemics in history (6). Infectious disease epidemics are so widespread and complicated that health systems must have effective programmes to deal with them, otherwise, they will place a lot of pressure on the health systems (7–10). Most of the efforts to control COVID-19 have focused on laboratories and hospitals, and the role of primary health care in mitigation, preparedness, response, and recovery has been ignored. The concept of primary health care means making essential health care available to the community at large in a way that is acceptable to them, with their full participation, and at an affordable cost.

Globally, primary health care is recognized as a foundation for health systems due to its unique ability to deliver accessible, cost-effective, and equitable care. During the COVID-19 pandemic, health systems have faced extreme levels of morbidity and mortality, and primary health care has been pivotal in reducing hospital burden, screening, and monitoring. There is no single way to create a resilient primary healthcare system; it depends on the background and context of each country. Some systems have been able to deal with crises more effectively, and along with controlling the pandemic, they have relieved the pressure on hospitals. A pandemic is a major health crisis that occurs over a large geographical area, crosses international borders, and affects large numbers of people. There is no doubt that the COVID-19 pandemic is a public health crisis and a social, economic, and political crisis affecting all areas of health and human life.

This review aimed to identify strategies to strengthen the primary healthcare system during disasters by reviewing previous literature and empirical evidence, and to provide guidance to policymakers in designing a more resilient system. By taking into account the literature and new research related to the ongoing COVID-19 pandemic, strategies for strengthening resilience in primary health care were identified and mapped according to 6 building blocks of leadership and governance; health workforce; medical products, vaccines, and technologies; service delivery; health information systems; and health financing.

Methods

Study design

We conducted a systematic mapping review of studies that reported interventions to improve primary health care during health crises, especially pandemics. The review visually summarized evidence production and publication patterns, trends, and themes by categorizing, classifying, and describing the data. Mapping reviews can be helpful especially when there is an abundance of literature. Standard methodology was followed for screening, data extraction, data analysis, and visualizing the findings in systematic mapping. Two main themes were explored in this mapping review: interventions proposed for strengthening primary health care, and research gaps that need to be addressed.

Search strategy

We searched PubMed, Web of Science, Scopus and ProQuest for English-language articles published between 1 January 2000 and 11 July 2021. The search strategy was developed in consultation with a medical librarian (Table 1). The keywords were: primary health care, communicable diseases, epidemic, pandemic, SARS-CoV, MERS-CoV, SARS-CoV-2, disaster, resilience, risk reduction, response, model, best practice, and policy. Additional searches were performed on the WHO website and in Google Scholar. A review of the final list of articles for inclusion in the study was done manually.

Inclusion and exclusion criteria

We included studies that investigated primary health care, disasters (particularly communicable disease epidemics), risk management, and best practices. The following types of study design were included: reviews, reports, perspectives, qualitative, descriptive, mixed-method studies, case studies, and commentaries. Studies that examined similar cases in health sectors other than primary health care, studies published in languages other than English, and conference abstracts were excluded. We only included papers published after 2000 because of the greater diversity of epidemics and pandemics of communicable diseases in the current century.

Study selection process

Two of the authors screened all the retrieved articles. After elimination of duplicate studies, the titles and abstracts were reviewed and articles that were not consistent with the objectives of the study were excluded. Full texts of the articles were reviewed, and those that did not meet the inclusion criteria or were not related to the study objectives were excluded. A third author appraised the final summary. Endnote X9 reference management software was used to organize the documents.

Data extraction

To identify any flaws in the data extraction form and reach a finalized version, a pilot study was conducted on 5 studies. The final data extraction form included: title, author, country, year, study type, aim of study, type of disaster, disaster management cycle, intervention/experience, barriers/challenges, facilitators, and results. Two reviewers entered the data in Microsoft Excel and resolved any disagreement, with the help of a third author if needed.

Data analysis

The extracted information was analysed using framework analysis, which is a hierarchical approach used to categorize data based on key themes and concepts (11,12). We used the 6 building blocks of a health system framework for strengthening health systems (13). The components of this framework were: (1) service delivery: access and barriers to health services; (2) health human resources: availability, gender, and attitude of health workers; (3) medical supplies: availability and stock of selected medical supplies; (4) governance: accountability and community participation; (5) health information: information flow from health facility to the community; and (6) finance: user fees and indirect payments. The data coding process followed predetermined themes according to the 6 building blocks. These formed the basis for broader themes that were subcategorized to increase the explanatory ability of the data (14,15) using the following steps: (1) familiarization with the data; (2) coding the data to systematically identify and document similarities, differences, and patterns; (3) collecting the coded data and organizing them into a thematic framework by developing a matrix, chart, or table; (4) analysing the data by comparing and contrasting, summarizing, and synthesizing the key issues and themes, and exploring the relationships between them; and (5) drawing conclusions and validating the findings.

Results

Search results

We extracted 4276 articles from the database searches, and reviewed 28 that were relevant to primary health care resilience against communicable disease pandemics (16–43) (Figure 1). During the screening process, 1280 articles were removed because of duplication. In the next phase of screening, the articles were reviewed by title and abstract and 2940 were removed. Finally, during full-text review, 28 articles were excluded because of insufficient information and lack of relevance. Twenty-two studies were conducted in 2020 or 2021 during the COVID-19 pandemic and the remainder in 2010–2019. Most of the studies (75%) of communicable diseases were related to COVID-19, and other diseases were measles, Ebola, cholera, and H1N1 influenza.

Disaster risk management cycle

Only 7 studies were related to the prevention/mitigation phase of disaster management, and 13 to the preparedness phase (Figure 2). All 28 studies addressed the response phase but only 2 mentioned the recovery phase.

Country of study

Oman, Liberia, America, South Korea, Qatar, Germany, Sweden, Greece, Papua New Guinea, Singapore, and Islamic Republic of Iran had 1 study each. India, England, Australia, New Zealand, and Brazil had 2 studies each. There were 3 studies in China. There was 1 study from the WHO South-East Asia Region; 1 collaborative study in Australia and Canada; 1 joint study in Australia, Canada, England, and United States of America (USA); and 1 joint study in Guinea, Sierra Leone, and Liberia.

Interventions, challenges, and facilitators identified

In the studies of interventions for strengthening primary health care against epidemics and pandemics, 10 themes were identified: digital health, clinical interventions, vaccination, strengthening health workers (e.g. skills, knowledge, motivation, and capacity to deliver quality health services), continuity of care, policymaking, guidelines, equipment availability, appropriate infrastructure, and education. We classified these into 6 main categories based on the WHO building blocks framework. For each intervention, some challenges and facilitators were identified (Table 2). A list of essential considerations for health policymakers is shown in Table 3.

Discussion

This study was conducted to identify the best practices and interventions made by countries to establish strong and resilient primary health care to tackle communicable disease pandemics and health emergencies. In this systematic mapping review, 28 articles from 20 countries were identified and reviewed. The WHO 6 building blocks framework was used to classify the identified categories. Ten subcategories were identified to strengthen primary health care against epidemics and pandemics: digital health, clinical interventions, vaccination, strengthening health workers' capacity, continuity of care, policymaking, guidelines, equipment availability, appropriate infrastructure, and education.

The use of teleconsultation reduces crowding and infection risk in primary health care facilities, especially for high-risk populations (16,17,19,25,28) . Epidemics and pandemics present many challenges to provision of primary health care. One of the innovative solutions for population health coverage is the use of technological advances and digital health (44,45). Digital health is one of the most effective and important interventions during epidemics to reduce transmission, especially in quarantine conditions (47,46). Many high-income countries, such as Australia and the USA have digital health systems (48).

Continuity of healthcare, equipment availability, and education were identified as important strategies in strong primary healthcare systems. These can reduce treatment costs, improve community health, increase patient satisfaction, and reduce unnecessary hospitalization, especially during pandemic and epidemic situations (49,51). Screening and follow-up are widely used for diseases in primary health care and can meet the needs of patients with multiple morbidities (52).

Another strategy identified in our study was strengthening health workers' skills, knowledge, motivation, and capacity to deliver quality health services. Proactive training of community health workers is necessary to maximize the effectiveness of interventions during a crisis, as well as strengthening the supply chain management of drugs and finding suitable methods of providing supportive supervision when movements are restricted (23,53,54). The most important factors in emergency and disaster planning are encouraging healthcare personnel to provide effective services, and enhancing motivation of the workforce (10).

In epidemic and pandemic situations, primary health care centres and hospitals have to provide services for a large number of patients. The continuity of these services requires meticulous planning by officials, formulation of guidelines, and policymaking (10,55). Decision-making during epidemics and pandemics is not easy. When an infectious disease emerges, policymakers take early actions to control transmission of the disease. However, decision-making in these situations brings many problems that must be investigated and resolved (56). Countries need to develop rapid and comprehensive research and strengthen strategies for evidence-based policymaking that can handle uncertainty (54, 57, 58).

Medical emergencies pose significant challenges to health systems because of heavy workloads, labour shortages, and reduced willingness of health workers to participate (10, 59). Volunteers can assist health workers in a variety of roles, including patient triage, treatment, and rehabilitation, and can carry out primary health care activities if they receive proper training (59). Other necessities during epidemics and pandemics are comprehensive individual and family support programmes, attention to the needs of health workers, involvement of community members in addressing challenges, and the design and implementation of preventive planning, according to the number of employees in the primary healthcare system (10).

The COVID-19 pandemic disrupted routine primary care for various reasons, including fear of infection, travel restrictions, lack of monitoring systems, repurposing of facilities, personal decisions, and restriction of movement (60). This disruption will have negative consequences for the health system in the future. Recurrence of some diseases has resulted due to delays in routine vaccination of children under the age of 5 years. It is essential to distribute vaccines and drugs according to the needs of each region and to establish acute care centres rapidly in areas where hospitals are unable to provide adequate care for patients with infection (60).

Effective leadership and good governance are key factors in strengthening the health system during epidemics and pandemics, so that it can respond in various ways, including intersectoral cooperation and construction of appropriate infrastructure. To achieve inter- and intrasectoral cooperation, we have to go beyond isolated thinking. Adoption of a social participation approach to improving health is one aspect of strengthening governance and leadership (61).

The health system needs to establish clear mechanisms to promote better coordination and cooperation among its different components. This can be achieved by fostering a trusting environment and strengthening information management. Another recommendation to improve collaboration across sectors is to adopt the health in all policies approach, which involves assessing the potential impact on health of every policy before it is implemented, and making it a standard institutional practice (62).

Globally, pandemics and health emergencies have become a major burden on health systems, affecting other health services as well. Countries have adjusted their primary healthcare systems in response to crises and in proportion to their needs and capabilities. Several of these measures indicate the effectiveness of policies and in some cases the need to implement compensatory policies.

This review had some limitations. First, only English-language studies were included; therefore, other important studies in other languages were not retrieved. Second, potentially important studies published before 2000 were not included. Third, there was limited access to Embase and the full text of some studies in our region.

Conclusion

There has been little research showing how to build resilient primary healthcare systems. Digital health infrastructure needs to be strengthened because the COVID-19 pandemic is ongoing, and there may be other pandemics in the future that will require people to stay at home or avoid visiting health care facilities. To improve primary health care, the workforce plays a vital role; therefore, it is important to address the challenges they face such as heavy workload, lack of protective equipment, and mental and emotional issues. Continuity of routine care during disasters promotes a more resilient public health system; however, this is challenged by an inefficient surveillance system, which can be mitigated with electronic health records. Primary health care becomes more resilient when there is community involvement and intersectoral collaboration. Finally, this review highlights that more research into primary health care resilience is needed to inform future plans and policy recommendations for the response to a global pandemic.

Acknowledgements

We would like to thank the Student Centre at Iran University of Medical Sciences for its support. We acknowledge the assistance of the anonymous reviewers which led to an improved version of the paper.

Funding: None

Competing interests: None declared.

Renforcement des soins de santé primaires pour une riposte efficace aux pandémies : analyse systématique

Résumé

Contexte : L'accessibilité physique et économique ainsi que la qualité des services fournis par un système de soins de santé primaires peuvent contribuer de manière significative à l'atténuation et à la gestion d'une pandémie ou d'une flambée épidémique. Un système de soins de santé primaires solide permet d'atténuer la pression exercée sur les systèmes de santé en temps de crise.

Objectif : Identifier les capacités spécifiques requises pour mettre en place un système de soins de santé primaires résilient, capable de répondre efficacement à une crise sanitaire, et à mettre en évidence les éventuelles lacunes en matière de recherche.

Méthodes : Une recherche bibliographique a été effectuée sur PubMed, Scopus, Web of Science et ProQuest de 2000 à 2021. À l'aide des données extraites, nous avons cartographié les études et classé les recherches publiées selon un cadre formé de six blocs constitutifs. Une représentation graphique des données sous forme de tableau a ensuite été produite.

Résultats : Au total, 4 276 études ont été extraites, dont 28 répondaient aux critères d'inclusion pour l'analyse systématique. L'extraction des données a eu lieu sur la base du plan de l'étude, de l'année de publication, du pays, du type de maladie transmissible et des principales interventions utilisées pour édifier des systèmes de soins de santé primaires résilients. La plupart de ces études ont été menées en 2020 et 2021 pendant la pandémie de COVID-19 et bon nombre d'entre elles mettaient l'accent sur la télésanté.

Conclusion : Cette analyse résume plus de 20 années de recherche sur la réaction des systèmes de soins de santé primaires face aux situations d'urgence de santé publique. Elle donne un aperçu général du sujet traité et des lacunes existantes en matière de recherche pour la planification des interventions et l'élaboration des politiques.

تعزيز الرعاية الصحية الأولية من أجل الاستجابة الفعالة للجوائح: استعراض منهجي

راضية بجولفاند، محمد رامزانلو، ناصر درخشاني، سالم جوهرينجاد، محمد غلامي، فاطمة تورانجيزاده، نادية صنيعي

الخلاصة

الخلفية: يمكن أن تُسهم القدرة على تحمُّل تكاليف الخدمات التي يقدمها نظام الرعاية الصحية الأولية وإتاحتها وجودتها إسهامًا كبيرًا في التخفيف من وطأة الجائحة أو فاشية المرض وإدارتها. ومن شأن نظام الرعاية الصحية الأولية القوي أن يخفف وطأةَ الضغط على النظم الصحية أثناء الأزمات.

الأهداف: هدفت هذه الدراسة الى تحديد القدرات المحددة اللازمة لإنشاء نظام رعاية صحية أولية قادر على الصمود، ويمكنه الاستجابة بفعالية لأي أزمة صحية، وتسليط الضوء على أي فجوات بحثية.

طرق البحث: أُجري بحثٌ ببليوجرافي على كلٍ من PubMed، وScopus، وWeb of Science، وProQuest في المدة من عام 2000 إلى عام 2021. وباستخدام البيانات المُستخرجة، حددنا الدراسات وصنفنا الأبحاث المنشورة إلى إطار يتألف من 6 ركائز. ثم قُدم تمثيلٌ بيانيٌّ وجدوليٌّ للبيانات.

النتائج: تم الحصول على ما مجموعه 4276 دراسةً، استوفت 28 منها معايير الإدراج النهائي للاستعراض المنهجي. واعتمد استخراج البيانات على تصميم الدراسة، وسنة النشر، والبلد، ونوع المرض الساري، والتدخلات الرئيسية المُستخدمة لبناء نُظم قادرة على الصمود للرعاية الصحية الأولية. وأُجريت معظم الدراسات في عامي 2020 و2021 خلال جائحة كوفيد-19 وشدد كثيرٌ منها على أهمية توفير الخدمات الصحية عن بُعد.

الاستنتاجات: يُلخص الاستعراض أكثر من 20 عامًا من البحوث عن كيفية استجابة نظم الرعاية الصحية الأولية لطوارئ الصحة العامة. وهو يُقدم نظرةً عامةً واسعة النطاق على الموضوع والفجوات البحثية القائمة لتخطيط التدخلات ورسم السياسات.

References

1. Shi P. Disaster risk science: Springer Singapore; 2019.

2. Yew YY, Delgado RC, Heslop DJ, González PA. The Yew Disaster Severity Index: a new tool in disaster metrics. Prehosp Disaster Med. 2019 Feb;34(1):8–19. https://doi.org/10.1017/S1049023X18001115 PMID:30600793

3. Garrido J, Saunders W, editors. Disaster risk reduction and land use planning: Opportunities to improve practice. IAEG/AEG Annual Meeting Proceedings, San Francisco, California, 2018. Volume 5; Springer; 2019.

4. Willson K, Lim D. Disaster management in rural and remote primary healthcare settings: a scoping review protocol. JBI Evid Synth. 2020 Jan;18(1):81–6. https://doi.org/10.11124/JBISRIR-D-19-00029 PMID:31343495

5. Cabarkapa S, Nadjidai SE, Murgier J, Ng CH. The psychological impact of COVID-19 and other viral epidemics on frontline healthcare workers and ways to address it: a rapid systematic review. Brain Behav Immun Health. 2020 Oct;8:100144. https://doi.org/10.1016/j.bbih.2020.100144 PMID:32959031

6. Jordà Ò, Singh SR, Taylor AM. Longer-run economic consequences of pandemics? Cambridge, MA: National Bureau of Economic Research; 2020 (working paper 26934; http://www.nber.org/papers/w26934, accessed 8 April 2023).

7. Meskarpour-Amiri M, Shams L, Nasiri T. Identifying and categorizing the dimensions of Iran's health system response to the Covid-19 pandemic. J Military Med. 2020;22(2):108–14.

8. Derakhshani N, Doshmangir L, Ahmadi A, Fakhri A, Sadeghi-Bazargani H, Gordeev VS. Monitoring process barriers and enablers towards universal health coverage within the sustainable development goals: a systematic review and content analysis. Clinicoeconom Outcomes Res. 2020 Aug 25;12:459–72. https://doi.org/10.2147/CEOR.S254946. PMID:32922051

9. Nafar H, Aghdam ET, Derakhshani N, Sani’ee N, Sharifian S, Goharinezhad S. A systematic mapping review of factors associated with willingness to work under emergency condition. Human Resour Health. 2021;19(1):1–10. https://doi.org/10.1186/s12960-021-00622-y

10. Derakhshani N, Maleki M, Pourasghari H, Azami-Aghdash S. The influential factors for achieving universal health coverage in Iran: a multimethod study. BMC Health Serv Res. 2021 Jul 22;21(1):1–13. https://doi.org/10.1186/s12913-021-06673-0 PMID:34294100

11. Furber C. Framework analysis: a method for analysing qualitative data. Afr J Midwifery Womens Health. 2010;4(2):97–100. https://doi.org/10.12968/ajmw.2010.4.2.47612

12. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013 Sep 18;13(1):1–8. https://doi.org/10.1186/1471-2288-13-117 PMID:24047204

13. Organization, WHO. (2007). "Strengthening health systems to improve health outcomes: WHO’s framework for action." Geneva: WHO.

14. Mutale W, Bond V, Mwanamwenge MT, Mlewa S, Balabanova D, Spicer N, et al. Systems thinking in practice: the current status of the six WHO building blocks for health system strengthening in three BHOMA intervention districts of Zambia: a baseline qualitative study. BMC Health Serv Res. 2013 Aug 1;13(1):1–9. https://doi.org/10.1186/1472-6963-13-291 PMID:23902601

15. Zeng W, Li G, Ahn H, Nguyen HTH, Shepard DS, Nair D. Cost-Effectiveness of health systems strengthening interventions in improving maternal and child health in low-and middle-income countries: a systematic review. Health Policy Plan. 2018 Mar 1;33(2):283–97. https://doi.org/10.1093/heapol/czx172 PMID:29253136

16. Al Hasani S, Al Ghafri T, Al Lawati H, Mohammed J, Al Mukhainai A, Al Ajmi F, et al. The Use of Telephone Consultation in Primary Health Care During COVID-19 Pandemic, Oman: Perceptions from Physicians. J Prim Care Community Health. 2020 Jan–Dec;11: 2150132720976480. https://doi.org/10.1177/2150132720976480 PMID:33307943 PMCID: PMC7739075

17. Bassi A, Arfin S, John O, Jha V. An overview of mobile applications (apps) to support the coronavirus disease 2019 response in India. Indian J Med Res. 2020 May;151(5):468–73. https://doi.org/10.4103/ijmr.IJMR_1200_20 PMID:32474557

18. Bell S, Saliba V, Ramsay M, Mounier-Jack S. What have we learnt from measles outbreaks in 3 English cities? A qualitative exploration of factors influencing vaccination uptake in Romanian and Roma Romanian communities. BMC Public Health. 2020 Mar 23;20(1):381. https://doi.org/10.1186/s12889-020-8454-x PMID:32293379

19. Desborough J, Hall Dykgraaf S, Davis S, Kidd M. Reflecting on Australia's five principles for pandemic response in primary care through the lens of early international experiences of COVID-19. Aust J Gen Pract. 2021 Feb 5;50. https://doi.org/10.31128/AJGP-COVID-46 PMID:33543152

20. Kinder K, Bazemore A, Taylor M, Mannie C, Strydom S, George J, et al. Integrating primary care and public health to enhance response to a pandemic. Prim Health Care Res Dev. 2021 Jun 10;22:e27. https://doi.org/10.1017/S1463423621000311 PMID:34109936

21. Miller NP, Milsom P, Johnson G, Bedford J, Kapeu AS, Diallo AO, et al. Community health workers during the Ebola outbreak in Guinea, Liberia, and Sierra Leone. J Glob Health. 2018 Dec;8(2):020601. https://doi.org/10.7189/jogh.08.020601 PMID:30023054

22. Subba SH, Pradhan SK, Sahoo BK. Empowering primary healthcare institutions against COVID-19 pandemic: a health system-based approach. J Fam Med Prim Care. 2021 Feb;10(2):589–94. https://doi.org/10.4103/jfmpc.jfmpc_1416_20 PMID:34041046

23. Siekmans K, Sohani S, Boima T, Koffa F, Basil L, Laaziz S. Community-based health care is an essential component of a resilient health system: evidence from Ebola outbreak in Liberia. BMC Public Health. 2017 Jan 17;17(1):84. https://doi.org/10.1186/s12889-016-4012-y PMID:28095824

24. Pan Z, Yang T, Chi C, Wang C. The role of CARDPC in response to COVID-19 in primary care in China. NPJ Prim Care Respir Med. 2020;30:41. https://doi.org/10.1038/s41533-020-00199-4

25. Rawaf S, Allen LN, Stigler FL, Kringos D, Quezada Yamamoto H, van Weel C, et al. Lessons on the COVID-19 pandemic, for and by primary care professionals worldwide. Eur J Gen Pract. 2020 Dec;26(1):129–33. https://doi.org/10.1080/13814788.2020.1820479 PMID:32985278

26. Prado N, Rossi TRA, Chaves SCL, de Barros SG, Magno L, dos Santos H, et al. The international response of primary health care to COVID-19: document analysis in selected countries. Cad Saude Publica. 2020 Nov 20;36(12):e00183820. https://doi.org/10.1590/0102-311X00183820: PMID:33237251

27. Schmidt ME, von Fricken ME, Wofford RN, Libby RC, Maddox PJ. Access to care during a pandemic: improving planning efforts to incorporate community primary care practices and public health stakeholders. World Med Health Policy. 2020 Sep;12(3):274–81. https://doi.org/10.1002/wmh3.369

28. Javanparast S, Roeger L, Kwok Y, Reed RL. The experience of Australian general practice patients at high risk of poor health outcomes with telehealth during the COVID-19 pandemic: a qualitative study. BMC Fam Pract. 2021 Apr 8;22(1):69. https://doi.org/10.1186/s12875-021-01408-w PMID:33832422

29. O’Sullivan B, Leader J, Couch D, Purnell J. Rural pandemic preparedness: the risk, resilience and response required of primary healthcare. Risk Manage Healthc Policy. 2020 Aug 17;13:1187–94. https://doi.org/10.2147/RMHP.S265610 PMID:32904086

30. Gong FF, Hu GY, Lin HQ, Sun XZ, Wang WX. Integrated healthcare systems response strategies based on the Luohu Model during the COVID-19 epidemic in Shenzhen, China. International Journal of Integrated Care. 2021 Feb 2;21(1):1. https://doi.org/10.5334/ijic.5628 PMID:33597832

31. Ku SS, Choe YJ. A public-private partnership model to build a triage system in response to a COVID-19 outbreak in Hanam City, South Korea. Osong Public Health

Res Perspect. 2020 Oct;11(5):339–42. https://doi.org/10.24171/j.phrp.2020.11.5.11 PMID:33117640

32. Al-Zaidan M, Mohamed Ibrahim MI, Mohamed Ghaith A-K, Azza Mustafa M, Mansoor Nawaz M, Samya Al A. Qatar’s Primary Health Care Medication Home Delivery Service: A Response Toward COVID-19. J Multidiscip Healthc. 2021 Mar 17;14:651–7. https://doi.org/10.2147/JMDH.S282079 PMID:33762825

33. Gudi N, Konapur R, John O, Sarbadhikari S, Landry M. Telemedicine supported strengthening of primary care in WHO South East Asia region: Lessons from the COVID-19 pandemic experiences. BMJ Innov. 2021;7(3):580–5. http://dx.doi.org/10.1136/bmjinnov-2021-000699

34. Jin H, Lu L, Liu J, Cui M. COVID-19 emergencies around the globe: China’s experience in controlling COVID-19 and lessons learned. Int J Qual Health Care. 2021 Feb 20;33(1): mzaa143. https://doi.org/10.1093/intqhc/mzaa143 PMID:33320189

35. Liaw ST, Kuziemsky C, Schreiber R, Jonnagaddala J, Liyanage H, Chittalia A, et al. Primary care informatics response to Covid-19 pandemic: adaptation, progress, and lessons from four countries with high ICT development. Yearb Med Inform. 2021 Aug;30:44–55. https://doi.org/10.1055/s-0041-1726489 PMID:33882603

36. Rosewell A, Bieb S, Clark G, Miller G, MacIntyre R, Zwi A. Human resources for health: lessons from the cholera outbreak in Papua New Guinea. Western Pac Surveill Response J. 2013 Jul 3;4(3):9–13. https://doi.org/10.5365/WPSAR.2013.4.2.006 PMID:24319607

37. Pingel ES, Llovet A, Cosentino F, Lesser J. Committing to continuity: primary care practices during COVID-19 in an urban Brazilian neighborhood. Health Educ Behav. 2021 Feb;48(1):29–33. https://doi.org/10.1177/1090198120979609 PMID:33322924

38. Williams D, Dilcher M, Dong HF, Lester B, Marshall K, Pink R, et al. Lessons from a system-wide response to a measles outbreak, Canterbury, February-April 2019. N Z Med J. 2020 Sep 25;133(1522):71–83. PMID:32994618

39. Eisele M, Pohontsch NJ, Scherer M. Strategies in primary care to face the SARS-CoV-2 / COVID-19 pandemic: an online survey. Front Med. 2021 Jun 2;8: 613537. https://doi.org/10.3389/fmed.2021.613537 PMID:34150788

40. Ohrling M, Øvretveit J, Lockowandt U, Brommels M, Sparring V. Management of the emergency response to the SARS-CoV-2 (COVID-19) outbreak in Stockholm, Sweden, and winter preparations. J Prim Health Care. 2020 Sep;12(3):207–14. https://doi.org/10.1071/HC20082 PMID:32988442

41. Stikova E, Gjorgjev D, Karadzovski Z. Strengthening the early-warning function of the surveillance system: the macedonian experience. NATO Science for Peace and Security Series A: Chemistry and Biology. Springer; 2010:45–58.

42. Goei A. Community care facility-a novel concept to deal with the COVID-19 pandemic: a Singaporean institution’s experience. J Public Health Manag Pract. 2020 Jan/Feb;26(6):613–21. https://doi.org/10.1097/PHH.0000000000001306 PMID:33239528

43. Joulaei H, Honarvar B, Zamiri N, Moghadami M, Lankarani KB. Introduction of a pyramidal model based on primary health care: a paradigm for management of 2009 H1N1 flu pandemic. Iran Red Crescent Med J. 2010;12(3):224–30. https://archive.ircmj.com/article/12/3/70846-pdf.pdf

44. Chauhan V, Galwankar S, Arquilla B, Garg M, Di Somma S, El-Menyar A, et al. Novel coronavirus (COVID-19): Leveraging telemedicine to optimize care while minimizing

exposures and viral transmission. J Emerg Trauma Shock. 2020 Jan–Mar;13(1):20–4. https://doi.org/10.4103/JETS.JETS_32_20 PMID:32308272

45. Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anaesth. 2020 May;67(5):568–76. https://doi.org/10.1007/s12630-020-01591-x PMID:32052373

46. Papadimos TJ, Marcolini EG, Hadian M, Hardart GE, Ward N, Levy MM, et al. Ethics of outbreaks position statement. Part 2: family-centered care. Crit Care Med. 2018 Nov;46(11):1856–60. https://doi.org/10.1097/CCM.0000000000003363 PMID:30312225

47. Monaghesh E, Hajizadeh A. The role of telehealth during COVID-19 outbreak: a systematic review based on current evidence. BMC Public Health. 2020 Aug 1;20(1):1193. https://doi.org/10.1186/s12889-020-09301-4 PMID:32738884

48. Current health expenditure per capita, PPP (current international $) [website]. World Bank; 2021 (https://data.worldbank.org/indicator/SH.XPD.CHEX.PP.CD, accessed 8 April 2023).

49. Starfield B, Shi L, Macinko J. Contribution of primary care to health systems and health. Milbank Q. 2005;83(3):457-502. https://doi.org/10.1111/j.1468-0009.2005.00409.x PMID:16202000

50. Macinko J, Starfield B, Shi L. The contribution of primary care systems to health outcomes within Organization for Economic Cooperation and Development (OECD) countries, 1970–1998. Health Serv Res. 2003 Jun;38(3):831–65. https://doi.org/10.1111/1475-6773.00149 PMID:12822915

51. Rezapour R, Dorosti AA, Farahbakhsh M, Azami-aghdash S, Iranzad I. The impact of the Covid-19 pandemic on primary health care utilization: an experience from Iran. BMC Health Serv Res. 2022;22:404. https://doi.org/10.1186/s12913-022-07753-5

52. Stange KC, Ferrer RL. The paradox of primary care. Annals Family Med; 2009 Jul–Aug;7(4):293–9. https://doi.org/10.1370/afm.1023 PMID:19597165

53. Rezapour R, Letaief M, Khosravi A, Farahbakhsh M, Ahmadnezhad E, Azami S, et al. Primary health care quality assessment frameworks: state of the art review. Health Scope. 2022;11(3):e126407. https://doi.org/10.5812/jhealthscope-126407..

54. Moosavi A, Sadeghpour A, Azami-Aghdash S, Derakhshani N, Mohseni M, Jafarzadeh D, et al. Evidence-based medicine among health-care workers in hospitals in Iran: a nationwide survey. J Educ Health Promot. 2020 Dec;9:365. https://doi.org/10.4103/jehp.jehp_335_20 PMID:33575401

55. Koohpayezadeh J, Azami-Aghdash S, Derakhshani N, Rezapour A, Alaei Kalajahi R, Sajjadi Khasraghi J, et al. Best practices in achieving universal health coverage: a scoping review. Med J Islam Repub Iran. 2021 Dec 30;35:191. https://doi.org/10.47176/mjiri.35.191 PMID:36042832

56. Berger L, Berger N, Bosetti V, Gilboa I, Hansen LP, Jarvis C, et al. Rational policymaking during a pandemic. Proc Natl Acad Sci US A.. 2021 Jan 26;118(4):e2012704118. https://doi.org/10.1073/pnas.2012704118 PMID:33472971

57. Sharp A, Jain V, Alimi Y, Bausch DG. Policy and planning for large epidemics and pandemics - challenges and lessons learned from COVID-19. Curr Opin iInfect Dis. 2021 Oct 1;34(5):393–400. https://doi.org/10.1097/QCO.0000000000000778 PMID:34342301

58. Naghibi D, Mohammadzadeh S, Azami-Aghdash S. Barriers to evidence-based practice in health system: a systematic review. Evidence Based Care. 2021 Dec;11(2):74–82. https://doi.org/10.1111/jep.12222 PMID:25130323

59. Karimi Dehkordi N, Abbasi AF, Radmard Lord M, Soleimanpour S, Goharinezhad S. Interventions to improve the willingness to work among health care professionals in times of disaster: a scoping review. Inquiry. 2021 Jan–Dec;58:469580211059959. https://doi.org/10.1177/00469580211059959 PMID:34903077

60. Medina MG, Giovanella L, Bousquat A, Mendonça MHMd, Aquino R. Primary healthcare in times of COVID-19: what to do? Cad Saude Publica. 2020;36:e00149720. https://doi.org/10.1590/0102-311x00149720 PMID:32813791

61. Thomas S, Sagan A, Larkin J, Cylus J, Figueras J, Karanikolos M. Strengthening health systems resilience: key concepts and strategies. Geneva: World Health Organization; 2020 (Health systems and policy analysis; policy brief 36; https://apps.who.int/iris/handle/10665/332441, accessed 8 April 2023).

62. Ardalan A, Rajaei MH, Masoumi G, Azin A, Zonoobi V, Sarvar M, et al. 2012-2025 roadmap of IR Iran’s disaster health management. PLoS Curr. 2012 Jul 16;4: e4f93005fbcb34. https://doi.org/10.1371/4f93005fbcb34 PMID:22953239

PDF version

Abrar Alshehri,^1,2 Saja Almazrou ³ and Yasser Amer ^2,4-7

¹Clinical Pharmacy Department, Umm Al-Qura University College of Pharmacy, Makkah, Saudi Arabia. ²Adaptation Working Group, Guidelines International Network, Perth, Scotland, UK. ³Clinical Pharmacy Department, King Saud University College of Pharmacy, Riyadh, Saudi Arabia. ⁴Pediatrics Department, King Saud University Medical City, Riyadh, Saudi Arabia (Correspondence to Y. Amer: This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.). ⁵Clinical Practice Guidelines and Quality Research Unit, Quality Management Department, King Saud University Medical City, Riyadh, Saudi Arabia. ⁶Research Chair for Evidence-Based Health Care and Knowledge Translation, Family and Community Medicine Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia. ⁷Alexandria Center for Evidence-Based Clinical Practice Guidelines, Alexandria University, Alexandria, Egypt.

Abstract

Background: Adapted clinical practice guidelines (CPGs) are based on existing recommendations from other developers.

Aims: To produce a mapping summary of the methods used for adaptation of CPGs in the Eastern Mediterranean Region (EMR).

Methods: We conducted a literature review of studies describing adaptation of CPGs in the EMR. Databases and official websites were searched for studies published between 2006 and 2022. We excluded de novo development of CPGs and adaptation of other types of guidelines such as public health guidelines.

Results: As an overview of the current situation of CPG adaptation in the EMR, we identified the 2 main categories: informal and formal adaptation. Six formal adaptation frameworks were used in the EMR: ADAPTE, Adapted-ADAPTE, GRADE-ADOLOPMENT, RAPADAPTE, CAN-IMPLEMENT, and KSU-Modified-ADAPTE. The validation of adapted CPGs to the local context is not well defined in the literature.

Conclusion: Despite the successful use of CPG formal adaptation frameworks, there is no international standardized guidance to identify which framework is most suitable for specific healthcare contexts in the EMR. Each institution has adapted its CPGs differently. A standardized selection tool is needed to enhance the appropriate selection of the adaptation method that fits the local resources and context. We encourage EMR countries and organizations to register their old and new CPG adaptation projects to avoid duplication in guideline synthesis.

Keywords: clinical practice guidelines, guideline adaptation, adaptation methodologies, Eastern Mediterranean adaptation frameworks, Eastern Mediterranean Region

Citation: Alshehri A, Almazrou S, Amer Y. Methodological frameworks for adapting global practice guidelines to national context in the Eastern Mediterranean Region. East Mediterr Health J. 2023;29(7):540–553. https://doi.org/10.26719/emhj.23.070  Received: 14/01/22; Accepted: 23/11/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Guidelines adaptation is a systematic approach to using or modifying guidelines produced in a particular cultural and organizational setting for application in a different setting. It is a valid alternative to de novo guidelines development (1–4). Relevant concepts for adaptation include adoption and contextualization. De novo guidelines development is the process of establishing new clinical practice guidelines (CPGs) from primary or secondary literature. Adoption means implementation of guidelines recommendations in their entirety, without modification or caveat, in a new healthcare context. In guidelines contextualization, additional considerations are required for guidelines implementation (e.g. local workforce, training, health systems, equipment, and accessibility) (1–7).

Adaptation of CPGs was not widespread until the ADAPTE Collaboration published its framework in 2006. Guidelines adaptation may involve additional work to search for local research, or obtain local consensus, regarding how best to make changes to recommendations so that care is relevant to the local context (1–3,5).

Healthcare institutions have a strong interest in obtaining quality evidence to create new CPGs for patient care. However, de novo guidelines development is often costly, time-consuming, and requires a highly experienced team who can review and critique published research (3,5,6,8). Healthcare institutions find adapting CPGs to local practice practical and feasible, and it helps reduce costs for low-income countries, reduces duplication of efforts, and enhances the effectiveness of high-quality guidelines recommendations (3,5,9,10).

Formal guidelines adaptation frameworks provide a systematic approach and increase methodological rigor and quality of CPGs (10). From 2006, apart from ADAPTE, several frameworks have been established to provide an evidence-based approach to guidelines adaptation [e.g. Adapted-ADAPTE, Alberta-Ambassador-Program-Adaptation-Phase, GRADE-ADOLOPMENT, MAGIC (Making GRADE the Irresistible Choice) (or SNAP-IT), RAPADAPTE, Royal College of Nursing, Systematic Guideline Review, Adopt–Contextualize–Adapt Framework, DELBI, KSU-Modified ADAPTE, and PAGE] (5,11–21,22).

Four reasons have been identified for guidelines adaptation: (1) developing CPGs from 1 or more source guidelines that are then contextualized to intended healthcare settings; (2) implementing, endorsing, or adopting source guidelines; (3) updating existing guidelines; or (4) analysing conflicting recommendations (16).

The ADAPTE Collaboration performed a systematic review of guidelines adaptation and proposed a stepwise structured framework (1,2,21). The development process took place between 2005 and 2007 and was refined in 2009 with an updated version of its Guideline Adaptation Manual and Resource Toolkit (1). ADAPTE has been used by many organizations to develop high-quality CPGs through 3 phases (set-up, adaptation, and finalization), 9 modules, and 24 steps (Table 1) (1).

In 2010, after evaluating its manual and resource toolkit, the ADAPTE Collaboration dissolved and transferred its resources to the Guidelines International Network (GIN) to make them available to the international community (1,5,6). The GIN Adaptation Working Group aims to provide methods, resources, and training to standardize and improve guidelines adaptation (1,23). Among the 111 member organizations and 240 individual members from 61 countries in the GIN, there are 6 organizational members from 4 EMR countries: Think Pink: Bahrain Breast Cancer Society; Ministry of Public Health and Primary Health Care Corporation (Qatar); National Center for Evidence-Based Medicine, Saudi Health Council (Saudi Arabia); King Saud University Medical City (Saudi Arabia); and National Authority for Assessment and Accreditation in Healthcare (Tunisia). GIN established 7 regional communities, including an Arab Regional Community, that aimed to support increasing regional interest in evidence-based healthcare and CPGs (24,25).

In 2015, Adapted-ADAPTE was published by the Alexandria Center for Evidence-Based Clinical Practice Guidelines (launched in 2008) to support more clarity, simplicity, and practicality, and to reduce the resources and time needed for guidelines adaptation projects (18,19). In 2018, the Egyptian Pediatric Clinical Practice Guidelines Committee was established as a national initiative by faculty staff in the paediatrics departments of 15 Egyptian universities and the Supreme Council of Egyptian University Hospitals. The Committee used Adapted-ADAPTE to adapt 32 national CPGs (26–29).

In 2014, the first adapted CPG published by King Saud University and King Saud University Medical City was followed by guidelines adaptation projects that were published as articles and presented at scientific conferences. The 2009 stakeholder expert collaboration between the Quality Management Department and Research Chair for Evidence-Based Health Care and Knowledge Translation in Riyadh led to formation of an organization-wide CPG steering committee and departmental committees that functioned as a CPG programme (30). King Saud University and King Saud University Medical City continue to support guidelines adaptation projects at the local (n = 42) and national (n = 8) levels using KSU-Modified-ADAPTE, which was based on Adapted-ADAPTE and the original ADAPTE, with addition of new tools and modification of others, and a proposed section for guidelines implementation tools and strategies (5,31–34).

In 2017, the GRADE-ADOLOPMENT framework was developed (20). It was the first framework to address CPG adaptation, adoption, and de novo guidelines development processes (hence the new acronym ADOLOPMENT). It aimed to develop high-quality guidelines recommendations for local use within a short period. The ADOLOPMENT process consisted of 3 stages (Table 2) (20,33,34). GRADE-ADOLOPMENT was developed as part of a collaborative national CPG initiative between the Saudi Ministry of Health and McMaster University, Canada (20,35,36). The GRADE-ADOLOPMENT and KSU-Modified-ADAPTE frameworks did not benefit from each other, probably because the 2 initiatives were ongoing at the same time, and each had a different scope and purpose. The former was based on GRADE and was part of a national initiative, while the latter was based on ADAPTE and was part of an institutional initiative (16).

RAPADAPTE was used successfully in the EMR. It benefited from ADAPTE and GRADE methods by extending guideline adaptation to evidence database adaptation, through simplifying mapping of DynaMed evidence ratings to GRADE ratings. RAPADAPTE was used to produce the first national evidence-based CPG for breast cancer in Bahrain (39,40).

Some limitations of guidelines adaptation frameworks were identified: (1) most were developed and used in high-income settings; (2) many lacked

formal evaluation of their impact on patient outcomes; (3) many were resource and time consuming; and (4) most often did not describe in detail how to implement adapted guidelines recommendations (10,16).

Wang et al. explored the range of experiences with guidelines adaptation from the perspectives of WHO regional and country offices, and identified 2 dominant models (41): (1) a pragmatic approach to copying or customizing WHO guidelines to suit local needs; and (2) building local capacity for evidence synthesis and guideline adaptation frameworks to support local development of national CPGs informed by international CPGs. Their findings could help improve adaptability of WHO CPGs. They also suggested clarifications to the process of guidelines adaptation in WHO and academic literature, to help adaptors and implementers of CPGs decide on the appropriate course of action according to their specific circumstances (41,42).

The aim of this study was to produce a mapping summary of the methods used for guidelines adaptation in the EMR.

Methods

Sources and methods of selection

We conducted a literature review of studies describing CPG adaptation in the EMR. Databases (including Springer link, EBSCO, ProQuest, and PubMed) and governmental or institutional official websites (e.g. GIN) were searched for studies published between 2006 and 2022. For PubMed, the MeSH terms included (Eastern Mediterranean Region[Title/Abstract]) OR (“Middle East and North Africa*”[Title/Abstract]) OR (“Gulf Cooperation Council”[Title/Abstract]) AND (“guideline adaptation”[Title/Abstract] OR “adapt*”[Title/Abstract]) AND (“clinical practice guideline*”[Title/Abstract]). We included studies, adapted CPG documents, methodology manuals that addressed adaptation (e.g. WHO Handbook), and reviews that described CPG adaptation in the EMR. We excluded de novo guidelines development and adaptation of guidelines other than CPGs, such as public health or social care guidelines. Any studies that focused on subjects other than CPG adaptation (e.g. adaptation of tools and other healthcare quality improvement interventions) were excluded. The search was updated before final submission.

Results and Discussion

Compilation and interpretation of data

The WHO EMR comprises 21 Member States and the occupied Palestinian territory (including East Jerusalem), with a population of nearly 679 million people (43). Table 3 shows a sample of recently adapted CPGs in the EMR. WHO has focused on adapting and implementing CPGs for low-income EMR countries. In November 2015, the WHO Regional Office for the Eastern Mediterranean organized an expert consultation on evidence-based de novo guidelines development and guidelines adaptation, which included experts from Egypt, France, Lebanon, Norway, and Saudi Arabia, as well as WHO staff. Several challenges to producing high-quality CPGs were identified (8).

The first attempt to adapt published CPGs in the EMR was when a panel of 7 committees of oncologists and experts reviewed the 2009 National Comprehensive Cancer Network (NCCN) CPGs (11–14). NCCN published their first CPGs adapted for the EMR in 2014 (12), with an update in 2019 to improve regional recommendations and facilitate access to high-quality evidence (13,14). NCCN guidelines adaptation aimed to develop high-quality standard practice accepted by healthcare practitioners in the EMR. However, the CPGs identified a large gap in knowledge and limited evidence relevant to the CPG health topics in the EMR. These limitations reduced the practical utility and efficiency of the CPGs. The wide range of areas covered by the guidelines was another limitation. The diversity of healthcare services provided in different countries made it difficult to provide standardized guidance throughout the EMR. The socioeconomic situation, limited resources, and infrastructure were other challenges identified (13).

Kidney Disease: Improving Global Outcomes adapted their CPGs to the EMR in 2014, using a nephrology expert group from the region (9 stakeholders) along with an international nephrology expert. The CPGs did not include a clear description about how they were adapted methodologically and how the CPG group managed the conflicts of interest (15).

In 2017, a collaboration between Weill Cornell Medical College – Qatar Rheumatoid Arthritis Consortium and American University of Beirut GRADE Center in Lebanon resulted in a Middle Eastern adaptation of the American College of Rheumatology guidelines for treatment of rheumatoid arthritis, using GRADE-ADOLOPMENT. The panel searched for local research and modified the guidelines recommendations based on cost, health equity, benefits and harms, and acceptability (35).

The Alexandria Center for Evidence-Based Clinical Practice Guidelines finalized 11 guidelines adaptation projects between 2010 and 2015 with additional CPG projects in progress. They used Adapted-ADAPTE as a formal guidelines adaptation framework, including the AGREE II instrument, to assess CPG quality. Evidence-based guidelines recommendation and implementation tools were included in the Adapted-ADAPTE CPGs (18,27–29). This methodology was used for the guidelines adaptation projects of the Egyptian Pediatric Clinical Practice Guidelines Committee (27–29).

In 2013, there was a collaboration between the Saudi Center for Evidence-Based Health Care, a former department of the Ministry of Health, and the GRADE Working Group at McMaster University. This collaboration was initiated to develop Saudi CPGs based on GRADE and the GRADE Evidence to Decision framework, which led to development of GRADE-ADOLOPMENT and 20 national CPGs (20,36,44).

In Tunisia, The National Authority for Assessment and Accreditation in Health Care was established in 2012 as an independent public authority supervised by the Ministry of Health, and launched several national projects for health technology assessments, clinical pathways, and CPGs. The CPG projects were generated using GRADE-ADOLOPMENT with methodological support from the American University of Beirut GRADE Center (e.g. breast cancer screening) (45).

In Bahrain, the first national evidence-based CPG for breast cancer was generated in 2019 using RAPADAPTE through a collaboration between Think Pink: Bahrain Breast Cancer Society, National Health Regulatory Authority, Supreme Council of Health, and the former Bahrain Branch of the UK Cochrane Centre. Formulation of the CPG involved an international advisory board and review panel of guideline methodologists, a multidisciplinary expert group of clinicians, and a range of GI tools (39,40).

In Qatar, SA Qader (graduate nursing student, Hamad Medical Corporation, Doha) and ML King (Faculty of Nursing at University of Calgary in Qatar) led a CPG project for ostomy nursing care, using the AGREE II Instrument and CAN-IMPLEMENT. The latter was originally based on the knowledge-to-action process with an increased focus on guidelines implementation (46,47).

In the United Arab Emirates, a 2020 CPG for type 2 diabetes was adapted by the Emirates Diabetes Society using an informal approach (48).

In the Islamic Republic of Iran, several guidelines adaptation projects were conducted. Zadegan et al. were supported by Tehran University of Medical Sciences and the Ministry of Health and Medical Education to adapt a CPG for traumatic brain injury from 2 source guidelines, guided by the AGREE II assessment (16,49). Another research group adapted CPGs for end-of-life care for patients with cancer, using a modified ADAPTE process in addition to a qualitative study and consensus ratings by a multidisciplinary panel of experts based on local healthcare needs (50).

An early initiative was the Sudan Evidence-Based Medicine Association, which was launched in 2006 to establish infrastructure in health services and medical education for implementing evidence-based healthcare, with a focus on clinical pathways and other guidelines implementation tools and interventions. This association was 1 of the early GIN members in the EMR. Later, the association founders established a new body, Altababa Advanced Training Center, which continued to provide evidence-based healthcare education and training (51,52). Other Sudanese professional societies have produced CPGs (e.g. for systemic hypertension in adults) using an informal guidelines adaptation or adoption approach (53,54).

A systematic review found that, despite improvements in CPGs over the last 2 decades, the quality remained moderate to low when evaluated by AGREE II (55–57). Another recent AGREE II assessment showed that the number of published CPGs was limited, considering the large geographical area of the EMR. The main AGREE II domains that had high scores were clarity of presentation, scope, and purpose, whereas rigor of development and applicability had low scores. The authors recommended that policymakers identify areas for improvement of CPGs, such as training of individuals and recruitment of international experts (56).

A systematic review of 24 CPGs published in Gulf Cooperation Council countries found that 32.78% of all articles were published in Saudi Arabia. The data showed poor adherence to CPGs by healthcare professionals, lack of clear guidelines implementation strategies, lack of awareness of CPGs, and poor access to evidence (58).

The WHO Regional Office for the Eastern Mediterranean and GIN encouraged and facilitated collaboration and networking on capacity building for guidelines adaptation through recognized experts in the region. Collaborators included King Saud University/King Saud University Medical City CPG Programme, American University of Beirut GRADE Center, and National Authority for Assessment and Accreditation in Healthcare and WHO Country Office in Tunisia (5, 8, 45).

The use of formal guidelines adaptation methods for production of organizational or national CPGs is 1 of the proposed solutions to address the knowledge gaps in the adaptation process (6,10).

Evidence-based gap analysis in the EMR is at its initial stage; however, Egypt, Islamic Republic of Iran, Bahrain, Saudi Arabia Tunisia, Qatar, and United Arab Emirates, have already begun adapting CPGs at institutional and national levels using 6 of the formal methods and frameworks. Transparent descriptions of the guidelines adaptation processes and high-quality recommendations are the cornerstone for implementing these adapted guidelines. Multidisciplinary teams of local and national stakeholders should be involved in evaluating evidence-based guidelines recommendations and their applicability to local settings (8,10,59,60).

Implementation of evidence-based guidelines recommendations is the main goal of establishing the CPGs, and the absence of a clear plan for guidelines implementation renders any guidelines useless. Guidelines implementation tools and strategies, such as failure modes and effects analysis and clinical algorithms, were reported for some of the KSU-Modified-ADAPTE CPGs e.g. venous thromboembolism prophylaxis, glaucoma, antiemetics for chemotherapy, surgical antimicrobial prophylaxis, and paediatric status epilepticus (5,32,61–64). Other adapted CPGs in the EMR did not report guidelines implementation projects (e.g. NCCN, Middle East Rheumatoid Arthritis Consortium, Ostomy Care, and Kidney Disease: Improving Global Outcomes) (12,15,34,45).

Currently, validation and applicability of adapted CPGs to the local context are not well defined in the literature. Some CPGs in healthcare lack information about the adaptation processes and outcomes (8–10). Without a clear understanding of how much time and resources are saved by guidelines adaptation, CPG developers or adapters cannot be sure that it is worthwhile. There is no global standardized tool to assess methods for adapting CPGs. However, 2 studies used AGREE II or AGREE Reporting Checklist to assess the adaptation process and quality of CPGs, although AGREE II was designed to assess quality of de novo guidelines development rather than adaptation (38,47). An international expert collaborative panel developed an extension of the RIGHT statement, the RIGHT-Ad@pt Checklist, which was designed specifically for reporting adapted CPGs (65). Another extension of AGREE II that informed adaptation of surgical CPGs (AGREE-S appraisal instrument) was recently published (66). Abdul–Khalek and her colleagues showed that only 40% of adapted CPGs reported using a published method or framework for adaptation, and compliance with ADAPTE varied. The mean score for AGREE II assessment of adapted CPGs was lowest for the rigour of development (56.79%), applicability (50.14%), and editorial independence (42.54%) (67). Apart from the published review that reported an AGREE II assessment of CPGs in the EMR, clinical validity of the current adapted CPGs was not evaluated (56). Future studies should focus on the usability and health impact of adapted CPGs (31,61–64).

Formal guidelines adaptation frameworks provide clearly defined steps toward achieving adapted evidence-based recommendations, and increased transparency for future groups to understand, evaluate, or imitate the process (6,58). To date, there is no evidence supporting the efficiency of 1 guideline adaptation framework over another. However, the Adapted-ADAPTE, CAN-IMPLEMENT, GRADE-ADOLOPMENT, KSU-Modified-ADAPTE, and RAPADAPTE frameworks have been updated from the original ADAPTE, and include additional tools, resources, and templates, and input from many experts. These adaptation methods used in the EMR were based on the original ADAPTE (Adapted-ADAPTE, CAN-IMPLEMENT, and KSU-Modified-ADAPTE) or GRADE (GRADE-ADOLOPMENT) methods, or both (RAPADAPTE) (10,16,19).

Early identification of potential barriers and challenges to processes of guidelines adaptation and implementation should be incorporated during the planning stage of adaptation projects. Previous studies have suggested possible solutions to address these challenges (16,61).

The recent wave of published CPGs of varied quality in response to the COVID-19 pandemic has encouraged the international CPG research community to work on novel evidence-based methodologies for rapid production of guidelines that can address such global public health crises. One suggested solution was the use of formal guidelines adaptation processes (68).

There are significant knowledge gaps and many barriers to the development or adaptation of CPGs in the EMR. Future research with high-quality standards should focus on answering the questions raised in this specific population. Adapted guidelines should be evaluated to improve their applicability and clinical validity for local use. They should have a clear plan for reviewing and updating, and simple enough for further adaptation.

Recommendations to improve collaboration, share and standardize existing CPGs in the EMR

In 2019, Resolution RC66/R.5 of the WHO/EMRO endorsed a regional action plan to increase capacity for evidence-informed policymaking for health. The Regional Network of Institutions for Evidence and Data to Policy highlighted the importance of: (1) developing and regularly updating the priority list for guidelines adaptation and development and health technology assessments; (2) establishing evidence-informed decision-making programmes (e.g. national health technology assessment and guidelines adaptation and development in collaboration with large academic organizations); and (3) supporting policy development and adaptation of WHO guidelines for national priorities by Member States (68–72).

We add our voice to the call in the 2016 WHO report on developing and adapting evidence-based CPGs in the EMR for actions by academic and healthcare delivery organizations and the WHO/EMRO (8). This includes but is not limited to: (1) increased number of academic staff, healthcare providers, and professionals specializing in clinical epidemiology and guidelines methodology; (2) formulation of a regional guidelines advisory committee in the WHO/EMRO that will coordinate with the WHO collaborating centres and centres of excellence in evidence-based healthcare and CPGs; (3) encouragement of research in evidence-based healthcare and CPGs; (4) networking with experts and stakeholders on evidence-based healthcare and CPGs, and collaboration with CPG global organizations like GIN, AGREE Enterprise, GRADE working group, networks, centres, MAGIC Foundation, and RIGHT Working Group; and (5) identifying different formal adaptation frameworks and methodologies in EMR countries and organizations, and the feasibility and sustainability of each framework (22).

Future coordination and integration is recommended in CPG projects, especially those with a national scope. Registration of CPG projects is a global recommendation to avoid duplication of efforts. Two existing international registries are available: GIN International Guideline Library and Registry (https://g-i-n.net/international-guidelines-library/), and PREPARE (Practice guideline REgistration for trancPAREncy) that is hosted by the Evidence-Based Medicine Center, University of Lanzhou, China (http://www.guidelines-registry.org/) (37,38). We recommend that CPG groups in the EMR should register their finalized and in-progress work to establish a regional database and encourage more networking and collaboration.

Conclusions

Despite the successful use of formal guidelines adaptation frameworks, there is no international standardized guidance for identifying which is most suitable for specific healthcare contexts in the EMR. Each institution is adapting its CPGs differently. Several national CPG projects are using different methods within the same countries. A standardized selection tool is needed to enhance appropriate selection of the adaptation method that fits the local resources and contexts. We encourage EMR countries and organizations to register their old and new guidelines adaptation projects to avoid duplication in CPG formation, especially within the same country, and collaborate with global CPG networks and reference organizations.

Acknowledgement

This study was supported by the Research Chair for Evidence-Based Health Care and Knowledge Translation, Family and Community Medicine Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia. We would like to thank Professor Lubna Al-Ansary, Professor Hayfaa Wahabi, Professor Elie Akl, Professor Zbys Fedorowicz, Professor Mazen Ferwana, Dr. Imad Hassan, Dr. Mohammed Ben Hamouda, Ms. Hella Ouertatani, Dr. Asma Ben Brahem, Ms. Elaine Harrow, and Ms. Alice Bird for their useful advice during the writing of this manuscript. This work was initiated as part of A.F. Alshehri’s Master’s degree, College of Pharmacy, King Saud University. Our results were presented at the 16th GIN 2021 Online Conference (74).

Funding: None

Competing interests: None declared.

Cadres méthodologiques pour l'adaptation des lignes directrices mondiales de pratique clinique au contexte national dans la Région de la Méditerranée orientale

Résumé

Contexte : Les lignes directrices de pratique clinique adaptées sont basées sur les recommandations existantes de développeurs tiers.

Objectif : Fournir un résumé cartographique des méthodes utilisées pour adapter les lignes directrices de pratique clinique dans la Région de la Méditerranée orientale.

Méthodes : Nous avons mené un examen de la littérature portant sur les études décrivant l'adaptation des lignes directrices de pratique clinique dans la Région. Les études publiées entre 2006 et 2022 ont été recherchées dans des bases de données et sur des sites Web officiels. Nous avons exclu la littérature sur l'élaboration de novo de ces lignes directrices et l'adaptation d'autres types de lignes directrices, telles que celles utilisées en santé publique.

Résultats : À titre d'aperçu de la situation actuelle de l'adaptation des lignes directrices de pratique clinique dans la Région de la Méditerranée orientale, nous avons identifié deux catégories d'adaptation principales : les modèles informel et formel. Six cadres d'adaptation formelle y ont été utilisés : ADAPTE, Adapted-ADAPTE, GRADE-ADOLOPMENT, RAPADAPTE, CAN-IMPLEMENT et KSU-Modified-ADAPTE. La validation des lignes directrices de pratique clinique adaptées au contexte local n'est pas bien définie dans la littérature.

Conclusion : Malgré l'utilisation réussie de cadres d'adaptation formelle pour les lignes directrices de pratique clinique, il n'existe pas d'orientations normalisées au niveau international pour identifier le cadre le plus adapté aux contextes spécifiques des soins de santé dans la Région. Chaque établissement a adapté ses lignes directrices différemment. Un outil de sélection normalisé est nécessaire pour améliorer l'adéquation des méthodes d'adaptation aux ressources et au contexte locaux. Nous encourageons les pays de la Région de la Méditerranée orientale et les organisations à enregistrer leurs anciens et nouveaux projets d'adaptation des lignes directrices de pratique clinique afin d'éviter les doublons dans la synthèse de ces lignes directrices.

الأطر المنهجية لتكييف المبادئ التوجيهية للممارسات العالمية مع السياق الوطني في إقليم شرق المتوسط

أبرار الشهري، سجى المزروع، ياسر عامر

الخلاصة

الخلفية: تُعدُّ المبادئ التوجيهية للممارسات السريرية مهمةً للغاية لتحسين النتائج الخاصة بالمرضى، ويعتمد تكييفها في أغلب الأحيان على توصيات من مطورين آخرين.

الأهداف: هدفت هذه الدراسة الى تقديم ملخص لطرق البحث المستخدمة لتكييف المبادئ التوجيهية للممارسات السريرية في إقليم شرق المتوسط.

طرق البحث: أجرينا استعراضًا سرديًّا لمؤلفات الدراسات التي تصف تكييف المبادئ التوجيهية للممارسات السريرية في إقليم شرق المتوسط. وبُحث في قواعد البيانات والمواقع الإلكترونية الرسمية عن الدراسات المنشورة في المدة بين عامَي 2006 و2022. واستبعدنا المؤلفات التي تتناول استحداث مبادئ توجيهية للممارسات السريرية، وتكييف أنواعٍ أخرى من المبادئ التوجيهية مثل، المبادئ التوجيهية للصحة العامة.

النتائج: حددنا فئتين رئيسيتين للتكيُّف في إقليم شرق المتوسط، ألا وهما: التكيُّف الرسمي، والتكيُّف غير الرسمي. واستُخدمت ستة أُطر رسمية للتكيُّف: ADAPTE، Adapted-ADAPTE، GRADE-ADOLOPMENT، RAPADAPTE، CAN-IMPLEMENT، KSU-Modified-ADAPTE. ولم يُحدد جيدًا في المؤلفات التحقق من فعالية المبادئ التوجيهية للممارسات السريرية التي كُيفت مع السياق المحلي.

الاستنتاجات: على الرغم من الاستخدام الناجح لأطر التكيُّف الرسمية للمبادئ التوجيهية للممارسات السريرية، فإنه لا توجد إرشادات موحدة دوليًّا لتحديد الإطار الأنسب لسياقات مُحددة للرعاية الصحية في إقليم شرق المتوسط. وقد اختلفت طريقة تكيُّف المبادئ التوجيهية للممارسات السريرية من مؤسسة إلى أخرى. وهناك حاجة إلى وجود أداة اختيار موحدة لتحسين مدى ملاءمة طرق التكيُّف التي تناسب السياق المحلي. ونحث بلدان إقليم شرق المتوسط وشركاءها على تسجيل مشروعاتها القديمة والجديدة الخاصة بتكيُّف المبادئ التوجيهية للممارسات السريرية تفاديًا للازدواجية في توليف المبادئ التوجيهية.

References

1. The ADAPTE Collaboration (2009). The ADAPTE Process: resource toolkit for guideline adaptation. version 2.0. resources – GIN [website]. Guidelines International Network; 2021 ( https://g-i-n.net/get-involved/resources/, accessed 10 March 2023).
2. Fervers B, Burgers JS, Haugh MC, Latreille J, Mlika-Cabanne N, Paquet L, et al. Adaptation of clinical guidelines: literature review and proposition for a framework and procedure. Int J Qual Health Care. 2006 Jun;18(3):167–76. https//doi.org/10.1093/intqhc/mzi108 PMID: 16766601
3. Fervers B, Burgers JS, Voellinger R, Brouwers M, Browman GP, Graham ID, et al. Guideline adaptation: an approach to enhance efficiency in guideline development and improve utilisation. BMJ Qual; Saf. 2011 Mar 1;20(3):228–36. https//doi.org/10.1136/bmjqs.2010.043257 PMID: 21209134
4. Cuello-Garcia C. The movement for adopting or adapting clinical guidelines and recommendations. J Clin Epidemiol. 2021 Mar;131:166–7. https//doi.org/10.1016/j.jclinepi.2020.12.025 DOI: 10.1016/j.jclinepi.2020.12.025 PMID: 33359985
5. Amer YS, Wahabi HA, Abou Elkheir MM, Bawazeer GA, Iqbal SM, Titi MA, et al. Adapting evidence-based clinical practice guidelines at university teaching hospitals: a model for the Eastern Mediterranean Region. J Eval Clin Pract. 2019 Aug;25(4):550–60. https//doi.org/10.1111/jep.12927. PMID: 29691950.
6. Dizon JM, Machingaidze S, Grimmer K. To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development. BMC Res Notes. 2016 Sep 13;9(1):1–8. https//doi.org/10.1186/s13104-016-2244-7 PMID: 27623764
7. Birbeck GL, Wiysonge CS, Mills EJ, Frenk JJ, Zhou XN, Jha P. Global health: the importance of evidence-based medicine. BMC medicine. 2013;11(1):1–9. https://doi.org/10.1186/1741-7015-11-223
8. Developing/adapting evidence-based guidelines in the Eastern Mediterranean Region. East Mediterr Health J. 22(4):286–7. http://www.emro.who.int/emhj-volume-22-2016/volume-22-issue-4/developingadapting-evidence-based-guidelines-in-the-eastern-mediterranean-region.html
9. Grimshaw, J., M. Eccles, and I. Russell, Developing clinically valid practice guidelines. J Eval Clin Pract. 1995 Sep.1(1):37–48. https//doi.org/10.1111/j.1365-2753.1995.tb00006.x PMID: 9238556
10. Wang Z, Norris SL, Bero L. The advantages and limitations of guideline adaptation frameworks. Implement Sci. 2018 May 29;13(1):72. https://doi.org/10.1186/s13012-018-0763-4
11. Coordinating office established to advance MENA/NCCN collaboration. Business Wire, 2010 Summer (http://search.ebscohost.com.sdl.idm.oclc.org/login.aspx?direct=true&db=rps&AN=bizwire.c30894883&site=eds-live, accessed 15 August 2022).
12. Jazieh AR. Adaptation of NCCN Guidelines to the Middle East and North Africa Region. J Natl Compr Canc Netw. 2014 Jul 1;12(7):961–2. https://doi.org/10.6004/jnccn.2014.0091
13. Jazieh AR, Azim HA, McClure J, Jahanzeb M. The process of NCCN guidelines adaptation to the Middle East and North Africa Region. J Natl Compr Canc Netw. 2010 Jul 1;8(Suppl_3):S5–7. https//doi.org/10.6004/jnccn.2010.0125 PMID: 20697132
14. Middle East & North Africa (MENA) editions of NCCN guidelines [website]. National Comprehensive Cancer Network (https://www.nccn.org/global/what-we-do/regions/middle-east-north-africa, accessed 10 March 2023).
15. Al Rukhaimi M, Al Sahow A, Boobes Y, Goldsmith D, Khabouth J, El Baz T. et al. Adaptation and implementation of the" Kidney Disease: Improving Global Outcomes (KDIGO)" guidelines for evaluation and management of mineral and bone disorders in chronic kidney disease for practice in the Middle East countries. Saudi J Kidney Dis Transpl. 2014 Jan;25(1):133–48. https//doi.org/10.4103/1319-2442.124536 PMID: 24434398
16. Song Y, Ballesteros M, Li J, García LM, de Guzmán EN, Vernooij RW et al. Current practices and challenges in adaptation of clinical guidelines: a qualitative study based on semistructured interviews. BMJ Open. 2021 Dec 2;11(12):e053587. https//doi.org/10.1136/bmjopen-2021-053587 PMID: 34857574
17. Annual report 2013. Guidelines International Network; 2014 (http://www.g-i-n.net/document-store/annual-reports/g-i-n-annual-report-2013.pdf, accessed 15 August 2022).
18. Amer YS, Elzalabany MM, Omar TE, Ibrahim AG, Dowidar NL. The ‘Adapted ADAPTE’: an approach to improve utilization of the ADAPTE guideline adaptation resource toolkit in the Alexandria Center for Evidence‐Based Clinical Practice Guidelines. J Eval Clin Pract. 2015 Dec;21(6):1095–106. https//doi.org/10.1111/jep.12479 PMID: 26662728
19. Darzi A, Abou-Jaoude EA, Agarwal A, Lakis C, Wiercioch W, Santesso N et al., A methodological survey identified eight proposed frameworks for the adaptation of health related guidelines. J Clin Epidemiol. 2017 Jun;86:3–10. https//doi.org/10.1016/j.jclinepi.2017.01.016 PMID: 28412463
20. Schünemann HJ, Wiecioch W, Brozek J, Etxeandia-Ikobaltzeta I, Mustafa RA, Manja V et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: GRADE-ADOLOPMENT. J Clin Epidemiol. 2017 Jan;81:101–10. https//doi.org/10.1016/j.jclinepi.2016.09.009 PMID: 27713072
21. Palda VA, Graham I, Davis D, Burgers J, Brouwers M, Cluzeau F et al. Guideline adaptation: an appealing alternative to de novo guideline development. Ann Intern Med. 2008 Apr 1;148(7):564. https//doi.org/10.7326/0003-4819-148-7-200804010-00022 PMID: 18378957
22. Yao X, Xia J, Jin Y, Shen Q, Wang Q, Zhu Y et al. Methodological approaches for developing, reporting, and assessing evidence-based clinical practice guidelines: a systematic survey. J Clin Epidemiol. 2022 Jun;146:77–85. https//doi.org/10.1016/j.jclinepi.2022.02.015 PMID: 35271968
23. Working groups [website]. GIN Guidelines International Network; 2022 (https://g-i-n.net/get-involved/working-groups/, accessed 15 August 2022).
24. Regional communities [website]. Guidelines International Network; 2022 (https://g-i-n.net/get-involved/regional-communities/, accessed 15 August 2022).
25. GIN Connect (membership software by Very Connect) [website]. Guidelines International Network (https://connect.g-i-n.net/members/addressbook?roles=Associate%20Member&roles=Consumer%20Organisation&roles=Lower%20Middle%20Income%20Organisation&roles=Partner%20contact&roles=Honorary%20Patron&roles=Individual%20membership&roles=Lower%20middle%20income%20countries%20individual&roles=Organisational%20Member&roles=Patient%20Representative&roles=Student%20membership&signedupfilter=true>, accessed 15 August 2022).
26. Abdel Baky A, Omar T, Amer Y. 2021. Towards evidence-based pediatrics: a national clinical practice guidelines program in Egypt on behalf of the Egyptian Pediatric Clinical Practice Guidelines Committee (EPG). 16th Guidelines International Network Conference 2021 Online [website]. Guidelines International Network; 2021. (https://g-i-n.net/wp-content/uploads/2021/10/GIN-Conference-2021-Abstract-Book.pdf, accessed 10 March 2023).
27. Egyptian Pediatric Clinical Practice Guidelines Committee [website] (http://epg.edu.eg/, accessed 10 March 2023).
28. Moustafa BH, Rabie MM, El Hakim IZ, Badr A, El Balshy M, Kamal NM et al. Egyptian pediatric clinical practice guidelines for urinary tract infections in infants and children (evidence based). Egypt Pediatric Association Gaz 69, 43 (2021). https://doi.org/10.1186/s43054-021-00073-z
29. Abdel Baky A, Fouda EM, Hussein SM, Sobeih AA, Abd Al Razek AA, Hassanain AI, et al. Bronchiolitis diagnosis, treatment, and prevention in children: An evidence-based clinical practice guideline adapted for the use in Egypt based on the 'Adapted ADAPTE' methodology. Egypt Pediatric Association Gaz 2022;70:article number 1. https://doi.org/10.1186/s43054-021-00094-8
30. Wahabi HA, Alansary LA. Great expectations from the chair of evidence-based health care and knowledge translation. Saudi Med J. 2009 Aug;30(8):989–90. PMID: 19668876
31. Ciocson M, Hernandez M, Atallah M, Amer Y. Central vascular access device: an adapted evidence-based clinical practice guideline. J Assoc Vasc Access. 2014;19(4):221–37. https://doi.org/10.1016/j.java.2014.09.002
32. Titi MA, Alotair HA, Fayed A, Baksh M, Alsaif FAA, Almomani Z, et al. Effects of computerised clinical decision support on adherence to VTE prophylaxis clinical practice guidelines among hospitalised patients. Int J Qual Health Care. 2021 Mar 22;33(1):mzab034. https://doi.org/10.1093/intqhc/mzab034
33. Bashiri FA, Albatti TH, Hamad MH, Al-Joudi HF, Daghash HF, Al-Salehi SM et al. Adapting evidence-based clinical practice guidelines for people with attention deficit hyperactivity disorder in Saudi Arabia: process and outputs of a national initiative. Child Adolesc Psychiatry Ment Health 2021 Feb 8;15(1):6. https://doi.org/10.1186/s13034-020-00351-5 PMID: 33557914
34. Alhabib S, Almadani WH, Owaidah T, Al Khadra A, Amr A, Bakhsh E et al. Evidence-based clinical practice guideline: screening, prophylaxis and management of venous thromboembolism (VTE). Saudi Health Council, National Center for Evidence-Based Medicine; 2021 (https://shc.gov.sa/Arabic/Documents/CPG%20Screening.pdf, accessed 10 March 2023).
35. Darzi A, Harfouche M, Arayssi T, Alemadi S, Alnaqbi KA, Badsha H et al. Adaptation of the 2015 American College of Rheumatology treatment guideline for rheumatoid arthritis for the Eastern Mediterranean Region: an exemplar of the GRADE ADOLOPMENT Health Qual Life Outcomes, 2017 Sep 21;15(1):183. https//doi.org/10.1186/s12955-017-0754-1 PMID: 28934978
36. Saudi Arabian handbook for healthcare guideline development. Riyadh: Ministry of Health; 2014 (https://www.moh.gov.sa/en/Ministry/Structure/Programs/TCP/Documents/Saudi%20Arabian%20Handbook%20for%20Healthcare%20Guideine%20Development-updated16-7.pdf, accessed 10 March 2023)
37. Chen Y, Guyatt GH, Munn Z, Florez ID, Marušić A, Norris SL, et al. Clinical Practice Guidelines Registry: toward reducing duplication, improving collaboration, and increasing transparency. Ann Intern Med. 2021 May;174(5):705–7. https//doi.org/10.7326/M20-7884 PMID: 33721516
38. Harrow E, Twaddle S, Service D, Kopp IB, Alonso-Coello P, Leng G. Clinical Practice Guidelines Registry. Ann Intern Med. 2021 May;174(9):1346–7. https//doi.org/10.7326/L21-0492 PMID: 34543600
39. Alper BS, Tristan M, Ramirez-Morera A, Vreugdenhil MM, Van Zuuren EJ, Fedorowicz Z. RAPADAPTE for rapid guideline development: high-quality clinical guidelines can be rapidly developed with limited resources. Int J Qual Health Care. 2016 Jun 1;28(3):268–74. https//doi.org/10.1093/intqhc/mzw044 PMID: 27097885
40. Sprakel, J, Carrara, H, Manzer, BM, Fedorowicz, Z. A mapping study and recommendations for a joint NGO (Think Pink) and Bahrain Government Breast Cancer project. J Evid Based Med. 2019 Aug;12(3):209–17. https://doi.org/10.1111/jebm.12357 PMID: 31441238
41. Wang Z, Grundy, , Parker, L, Bero L. Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines. BMC Public Health 2020 Nov 23;20(1):1758. https://doi.org/10.1186/s12889-020-09812-0 PMID: 33228608
42. WHO handbook for guideline development. 2nd ed. Geneva: World Health Organization; 2014 (https://www.who.int/publications/i/item/9789241548960, accessed 10 March 2023).
43. World Health Organization Regional Office for the Eastern Mediterranean [website] (http://www.emro.who.int/countries.html, accessed 10 March 2023).
44. Al-Hameed FM, Al-Dorzi HM, Abdelaal MA, Alaklabi A, Bakhsh E, Alomi YA, et al. The Saudi clinical practice guideline for the prophylaxis of venous thromboembolism in medical and critically ill patients. Saudi Med J. 2016 Nov;37(11):1279–93. https//doi.org/10.15537/smj.2016.11.15268 PMID: 27761572
45. Kahale L, Ouertatani H, Brahem A, Grati H, Hamouda M, Saz-Parkinson Z et al. Contextual differences considered in the Tunisian ADOLOPMENT of the European Guidelines on Breast Cancer Screening. Health Res Policy Syst. 2021 May 13;19(1):80. https//doi.org/10.1186/s12961-021-00731-z PMID: 33985535
46. Qader SAA, King ML. Transcultural adaptation of best practice guidelines for ostomy care : pointers and pitfalls. Middle East J of Nurs. 2015 Apr;9(2):3–12. http://www.me-jn.com/April2015/Ostomy.pdf
47. Harrison MB, Graham ID, Van Den Hoek J, Dogherty EJ, Carley ME, Angus V. Guideline adaptation and implementation planning: a prospective observational study. Implement Sci. 2013 May 8;8:49. https//doi.org/10.1186/1748-5908-8-49 PMID: 23656884
48. Alawadi F, Abusnana S, Afandi B, Aldahmani KM, Alhajeri O, Aljaberi K et al. Emirates diabetes society consensus guidelines for the management of type 2 diabetes mellitus – 2020. Dubai Diabetes Endocrinol J. 2020;26:1–20. https://doi.org/10.1159/000506508
49. Zadegan SA, Ghodsi SM, Arabkheradmand J, Amirjamshidi A, Sheikhrezaei A, Khadivi M et al. Adaptation of traumatic brain injury guidelines in Iran. Trauma Mon. 2016 Mar 20;21(2):e28012. https//doi.org/10.5812/traumamon.28012 PMID: 27626012
50. Irajpour A, Hashemi M, Taleghani F. Clinical practice guideline for end-of-life care in patients with cancer: a modified ADAPTE process. Support Care Cancer 2022 Mar;30(3):2497–505. https://doi.org/10.1007/s00520-021-06558-2 PMID: 34786639
51. Wahabi HA. Rapid response: Health in the Middle East. BMJ 2006;333:815. https://www.bmj.com/rapid-response/2011/10/31/evidence-based-health-care-sudan
52. Sharif A. Share experience: AlTababa group advocacy for evidence based healthcare through empowerment and competency-focused training, Khartoum, Sudan. In: 7th Annual Conference International Society of Evidence Based Healthcare [website]. Ajman: Gulf Medical University; 2016 (https://gmu.ac.ae/evidence-based-healthcare/program-outline.php, accessed 10 March 2023).
53. Abdelgadir HS, Elfadul MM, Hamid NH, Noma M. Adherence of doctors to hypertension clinical guidelines in academy charity teaching hospital, Khartoum, Sudan. BMC Health Services Res. 2019 May 14;19(1):309. https//doi.org/10.1186/s12913-019-4140-z PMID: 31088467
54. Sudan guidelines for the management of systemic hypertension in adults, 2nd ed. Sudan Society of Hypertentsion and Non communicable Diseases Directorate; 2014 (http://ssh-sd.org/guidelines/, accessed 15 August 2022).
55. Alonso-Coello P, Irfan, Solà I, Gich I, Delgado-Noguera M, Rigau D et al., The quality of clinical practice guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care, 2010 Dec.19(6):e58. https//doi.org/10.1136/qshc.2010.042077 PMID: 21127089
56. Almazrou SH, Alsubki LA, Alsaigh NA, Aldhubaib WH, Ghazwani SM. Assessing the quality of clinical practice guidelines in the Middle East and North Africa (MENA) Region: a systematic review. J Multidiscip Healthc. 2021 Feb 9;14:297-309. https//doi.org/10.2147/JMDH.S284689 PMID: 33603389
57. Brouwers M, Spithoff K, Lavis J, Kho M, Makarski J, Florez I. What to do with all the AGREEs? The AGREE portfolio of tools to support the guideline enterprise. J Clin Epidemiol. 2020 Sep;125:191–7. https//doi.org/10.1016/j.jclinepi.2020.05.025 PMID: 32473992
58. Koornneef E, Robben P, Hajat C, Ali A. The development, implementation and evaluation of clinical practice guidelines in Gulf Cooperation Council (GCC) countries: a systematic review of literature. J Eval Clin Pract. 2015 Dec;21(6):1006–13. https//doi.org/10.1111/jep.12337 PMID: 25756849
59. Penney GC. Adopting and adapting clinical guidelines for local use. Obstetrician Gynaecologist 2007 Jan;9(1):48–52. https://doi.org/10.1576/toag.9.1.048.27296
60. Wang Z, Norris SL, Bero L. Implementation plans included in World Health Organisation guidelines. Implement Sci. 2015;11:76. https://doi.org/10.1186/s13012-016-0440-4
61. Babiker, A, Amer, YS, Osman, ME, Al-Eyadhy A, Fatani S, Mohamed S et al. Failure Mode and Effect Analysis (FMEA) may enhance implementation of clinical practice guidelines: An experience from the Middle East. J Eval Clin Pract. 2018; 24: 206– 211. https//doi.org/10.1111/jep.12873 PMID: 29285849
62. Alshowaeir D, Almasoud N, Aldossari S, Alsirhy EY, Osman E, Turjoman A et al. Primary open angle glaucoma management in a tertiary eye care center in Saudi Arabia: a best practice implementation pilot project. JBI Evid Implement. 2020 Dec 5;19(2):208–16. https//doi.org/10.1097/XEB.0000000000000257 PMID: 34061052
63. Al-Salloum HF, Amer YS, Alsaleh KA. Monitoring the adherence to an adapted evidence-based clinical practice guideline on antiemetics in 669 patients with cancer receiving 1451 chemotherapy doses at a University oncology center in Saudi Arabia. J Nature Sci Med. 2021;4(1):33. https//doi.org/10.4103/JNSM.JNSM_10_20
64. AlMohaimeed B, Hundallah K, Bashiri F, AlMohaimeed S, Tabarki B. Evaluation of adherence to pediatric status epilepticus management guidelines in Saudi Arabia. Neurosciences. 2020 Jul;25(3):182–7. https//doi.org/10.17712/nsj.2020.3.20190106 PMID: 32683397
65. Song Y, Alonso-Coello P, Ballesteros M, Cluzeau F, Vernooij RW, Arayssi T et al. A reporting tool for adapted guidelines in health care: the RIGHT-Ad@ pt Checklist. Annals of Internal Medicine. 2022 May;175(5):710–9. https://doi.org/10.7326/M21-4352 PMID: 35286143
66. Antoniou SA, Florez ID, Markar S, Logullo P, López-Cano M, Silecchia G et al. AGREE-S: AGREE II extension for surgical interventions: appraisal instrument. Surg Endosc. 2022 Aug;36(8):5547–58. https//doi.org/10.1007/s00464-022-09354-z PMID: 35705753
67. Abdul–Khalek RA, Darzi AJ, Godah MW, Kilzar L, Lakis C, Agarwal A et al. Methods used in adaptation of health–related guidelines: a systematic survey. J Glob Health, 2017 Dec;7(2):020412. https//doi.org/10.7189/jogh.07.020412 PMID: 29302318
68. Munn Z, Twaddle S, Service D, Harrow E, Okwen PM, Schünemann H, et al. Developing guidelines before, during, and after the COVID-19 pandemic. Ann Intern Med. 2020 Dec 15;173(12):1012–4. https//doi.org/10.7326/M20-4907 PMID: 32931327
69. Developing national institutional capacity for evidence-informed policy-making for health. East Mediterr Health J. 2021;27(3):314–5. https://doi.org/10.26719/2021.27.3.3141 PMID: 33788222
70. Summary report on the first formal meeting of the regional Network of Institutions for Evidence and Data to Policy (NEDtP) to enhance national capacity for evidence-informed policy-making, virtual meeting 30 March 2021. Cairo: World Health Organization Regional Office for the Eastern Mediterranean; 2022 (https://apps.who.int/iris/handle/10665/352578, accessed 10 March 2023).
71. Framework for action to improve national institutional capacity for the use of evidence in health policy-making in the Eastern Mediterranean Region [website]. Cairo: World Health Organization Regional Office for the Eastern Mediterranean (http://www.emro.who.int/health-topics/health-information-systems/framework-for-action-to-improve-national-institutional-capacity-for-the-use-of-evidence-in-health-policy-making-in-the-region.html, accessed 10 March 2023).
72. Regional action plan for the implementation of the framework for action to improve national institutional capacity for the use of evidence in health policy-making in the Eastern Mediterranean Region (2020–2024). Cairo: World Health Organization Regional Office for the Eastern Mediterranean; 2021 (https://applications.emro.who.int/docs/9789290229124-eng.pdf?ua=1, accessed 10 March 2023).
73. Alshehri A, Almazrou S, Amer Y. Adaptation of clinical practice guidelines in the Middle East and North African (MENA) Countries. In: GIN Conference 2021 Online. [website]. Guidelines International Network; 2021 (https://g-i-n.net/wp-content/uploads/2021/10/GIN-Conference-2021-Abstract-Book.pdf, accessed 15 August 2022).

PDF version

Asma Sabermahani,¹ Vahid Yazdi-Feyzabadi ² and Salman Bashzar ¹

¹Student Research Committee, Faculty of Management and Medical Information Sciences, Kerman University of Medical Sciences, Kerman, Islamic Republic of Iran. ²Health Services Management Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Islamic Republic of Iran. (Correspondence to Salman Bashzar: This email address is being protected from spambots. You need JavaScript enabled to view it.).

Abstract

Background: No single method of health technology assessment (HTA) can meet all the policy- and decision-making needs in a country. However, there should be minimum criteria for performing HTA worldwide, and many HTA agencies have reached a consensus on this.

Aim: This study aimed to assess the quality of HTA reports in the Islamic Republic of Iran.

Method: We examined all the HTA research reports published by the Iranian HTA office up to 2020, using the International Network of Agencies for Health Technology Assessment checklist for quality assessment.

Results: A total of 97 reports were examined, of which only 10.0% provided complete and appropriate contact details for further information and 5.6% clearly stated a conflict of interest. In 87.78% of the reports, the scope of assessment was clearly determined. The quality of the reports was relatively appropriate as well as details of the sources of information and text search strategies. Some 7.8%, 74.4%, 11.1%, 8.9%, and 4.4%, respectively, of the reports considered legal aspects, economic analysis, ethical implications, social implications, and other stakeholder perspectives.

Conclusion: We recommend that minimum standards be established for the HTA process so that healthcare policy- and decision-makers can make reliable decisions on the basis of the HTA reports.

Keywords: health technology assessment, quality assessment, health policy, Iran

Citation: Sabermahani A, Yazdi-Feyzabadi V, Bashzar S. Evaluating the quality of health technology assessment reports in a developing country. East Mediterr Health J. 2023;29(7):554–561. https://doi.org/10.26719/emhj.22.017 Received: 09/08/21; accepted: 24/10/21

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Growing concerns about reducing health care costs while maintaining and strengthening access to high quality medical care have aroused interest in the better use of medical interventions (1). Discussions about the use of scientific evidence in decision-making have been revolutionized over time and, at present, evidence-based methods are the mainstream approach in many public sectors (2,3). In the healthcare domain, the evidence-based medical principles for clinical measures have expanded in the context of healthcare management and policymaking, and the number of experimental studies for raising the awareness of decision-makers is rising (4).

Moreover, advances in technology in recent years have brought about considerable change in medical care and treatment such that, annually, global medical equipment technology presents thousands of products to the market (5). Policymakers cannot estimate the values and consequences of technologies based merely on complex technical data, and for reasonable decision-making, they need to understand the vast economic, social, ethical and legal effects. Since issues relating to health technologies pose constant challenges to healthcare systems, health technology must be accurately evaluated and efficiently and effectively used in health care. For optimal use of the existing resources, the most effective technologies should be promoted and used in light of organizational, social, ethical and economic issues (6).

Owing to the scarcity of resources for health care, decisions should be evidence-based, especially when selecting expensive technologies (16). This has made many countries develop mechanisms for the introduction and reasonable use of such technologies. This will help control and prevent costs from increasing inordinately, optimally allocate these costs, and prevent the entry of technologies with poor safety and effectiveness records (6,8).

The most salient example of scientific research conducted to provide input to healthcare policymaking is, doubtless, found under the health technology assessment (HTA) model (4). This is a multi-disciplinary context of policy analysis research into the economic, ethical, social and medical outcomes, as well as the development, propagation and use of health technologies (3). It emerged as a result of increasing concerns about the wide-ranging spread of medical equipment in the 1970s and the funding ability of insurance companies (9). The use of HTA for the evaluation and estimation of the value of medical technologies has remarkably increased in the last 2 decades (10).

Historically, most HTA agencies have emphasized the development of high-quality evaluation reports which can be used by a wide range of decision-makers, e.g. the Canadian Agency for Drugs and Technologies in Health, the Swedish Council for Health Technology Assessment, the German Agency of Health Technology Assessment at the German Institute for Medical Documentation and Information and agencies in many other European countries (1). Organizations are increasingly launching HTA for making certain decisions about resource allocation. For example, the National Institute for Health and Clinical Excellence in the United Kingdom uses HTAs for developing guidelines on the use of health technologies in the National Health Service in England and Wales. In Germany, the Institute for Quality and Efficiency in Health Care receives HTA requests from the Federal Joint Committee to make recommendations based on which the pricing and reimbursement for technologies are made (1).

In the Islamic Republic of Iran, HTA was launched in the form of an HTA secretariat at the Health Economy Department of the Network Development and Health Promotion Center in October 2007. The initial stages of its formation were performed with the cooperation and support of professors and researchers for receiving HTA orders and, eventually, receiving HTA reports. The overall project was approved in April 2008 at the Deputy for Coordination, Ministry of Health and Medical Education. During the next stage, the objectives, responsibilities, method of establishment and general structure of the Iranian HTA system were discussed and approved in the policymaking council at the Ministry of Health and Medical Education, supervised by the Deputy for Coordination. Joint expert teams were then formed, and with the consultation of foreign experts, 6 HTA projects were developed and their results were simultaneously presented at the executive meetings to facilitate decision-making. Since March 2010 and following the change in the structure of the Ministry of Health and Medical Education, the deputies for health and treatment were split, and the HTA department at the Technology Evaluation Office started its standard development and healthcare price-setting activities under the supervision of the Deputy for Treatment with a new structure. Since then, it has published many reports on health technologies.

There is no single method for performing HTA which can meet the needs of all decision-makers, stakeholders, and societies (1): HTA agencies have their own guidelines for the performance and presentation of reports, e.g. the guidelines by the International Network of Agencies for Health Technology Assessment (INAHTA). In the Islamic Republic of Iran, the Ministry of Health and Medical Education, which is the health care service provider and funder of HTA studies, is in charge of performing HTA. Therefore, this study aimed to assess the quality of Iranian HTA reports from the foundation of HTA until 19 March 2020.

Methods

This descriptive cross-sectional study was conducted in 2020. All the reports from the HTA office in the Islamic Republic of Iran presented under the title of HTA projects, were retrieved from the website of the Department of Health Technology Assessment in the Ministry of Health and Medical Education (http://ihta.behdasht.gov.ir). The inclusion criteria for the reports were: HTA reports, theses, and dissertations compatible with the priorities of the HTA office or available in the office’s list of reports. Then, these reports were evaluated based on a checklist developed by the INAHTA (11). The checklist has 6 domains and a total of 31 items, including preliminary information (5 items), why the assessment was undertaken (4 items), how the assessment was undertaken (10 items), results of the evaluation and interpretation of the selected data and information (4 items), context (5 items), and post-evaluation events (3 items). It assesses the HTA reports on three levels (yes, partly, no) and was first translated into Farsi by 2 HTA researchers and health policymakers, and then examined by 7 HTA experts. After expert approval, the checklist was back-translated into English to ensure its reliability and validity. The reports were evaluated by 2 researchers independently, and cases of disagreement were discussed with a third researcher to reach a consensus. The data were extracted and entered into a researcher-made form in Excel, and then described and analysed using descriptive statistics.

Ethics clearance was obtained from the Kerman University of Medical Sciences ethics board (ethics clearance certificate number IR.KMU.REC.1398.894).

Results

A total of 101 reports were found on the Iranian HTA office website. We excluded 1 duplicate report and 3 non-evaluation reports. We then assessed 97 reports for general features and 90 reports based on the checklist. Of the 97 reports examined, in terms of the type of technology investigated, the majority focused on therapeutic technologies (equipment) (47.4%), followed by diagnostic and pharmaceutical technologies (both 22.7%) (Table 1).

A number of technologies investigated in the 97 reports dealt with neoplasms (18.6%), followed by health-related equipment and devices (13.4%), diseases of the nervous system (12.37%) and factors affecting health status or contacting health services (10.3%)(Table 2).

In 61 reports there was 1 first author, 6 reports had 2 first authors, and the authors of 30 reports (31.0%) were unknown. Some 34.0% of the HTA studies were conducted by only 9 researchers, each working with their own team; in fact, 11 reports were written by a single researcher, 6 were written by a different researcher, and 6 authors conducted 2 studies each.

The greatest cooperation in performing HTA was reported by the National Institute for Health Research and the centres affiliated with Tehran University of Medical Sciences and the HTA office of the Ministry of Health and Medical Education (52.58%), the Evidence-Based Medical Research Center at Tabriz University of Medical Sciences (9.27%), and the Health Management and Economy Research Center of Isfahan University of Medical Sciences (2.1%). In 30.9% of cases, the researchers’ organizational affiliations were unknown.

For the first item on the checklist, preliminary information, only 10% of the reports provided complete and appropriate contact details for obtaining further information, while 42.2% of the reports lacked such information. The authors were identified in 8 reports (8.9%), and 5.6% transparently stated their conflicts of interest. In 98.9% of the reports there was no statement about external review. A short summary in a non-technical language was presented in only 46.7% (Table 3).

Concerning making reference to the policy question, in 57.8% of the reports this was adhered to completely, and partly stated in 31 reports (34.4%). In 74.4% of the reports, reference was made to the research question(s); in 87.8%, the scope of assessment was clearly determined; and in 82.2% there was a proper description of the health technology that was assessed (Table 3). For the sources of information and text search strategy, the Iranian HTA reports presented precise details about a complete reference list of the included studies (97.8%), databases (86.7%), search strategy (85.6%), and years covered (84.4%). A list of excluded studies was missing in 78.9% of reports.

The findings show that the data extraction method was clearly stated in 68.8% of the reports, and a critical appraisal method was presented in 61.1%. Also, the reports presented appropriate and sufficient information about the data analysis method (61.1%) and the assessment results (78.9%). In terms of the context of the reports, 74.4% considered the economic analysis; only 11.1% considered the ethical implication and only 7.8% the legal implications. In terms of discussing the findings of the assessment, 84.4% did this properly, 67.8% clearly stated the conclusions from the assessment and only 16.7% made recommendations for further action (Table 3).

Discussion

The majority of technologies evaluated in the Islamic Republic of Iran were therapeutic, diagnostic and medical; most of them dealt with noncommunicable diseases or their risk factors. This shows that the epidemiological change from communicable to noncommunicable diseases greatly affected the technologies required and constituted > 60% of the disability-adjusted life years (DALYs) and 70% of global deaths (12). In this regard, the continuous growth of technologies related to these diseases should be taken into account (5).

Our findings indicate that a limited number of researchers conducted the HTA studies: 34.0% were conducted by only 9 researchers. The majority of these researchers possessed the experience and skills to conduct HTA. Therefore, to properly conduct HTA projects, a sufficient number of HTA experts possessing the required skills should be trained and involved, and this is an important measure to be taken before establishing official HTA agencies (13). The strong point of Iranian HTAs is the good organizational relationship between most of the researchers and the healthcare legislator.

Having proper contact details, stating the conflict of interest, and stating whether the HTA report was reviewed are essential for assuring transparency (11). However, our findings revealed that only 10% of the Iranian HTA reports presented complete and proper contact details, and 42.2% of the reports lacked any such information. Only 5.6% clearly stated the conflict of interest, and 1.1% had statement about external review. The presentation of a short non-technical summary enhances understanding of HTA reports and less than half of the reports included this (11).

In this study, the scope of assessment was clearly determined in 87.8% of the HTA reports. Drummond et al. explained 15 key principles for improving HTAs (1). The first states that the HTA objectives and scope should be explicit and compatible with its use. Based on this principle, questions which are to be answered should be stated with maximum precision in the form of specific objectives, and, if possible, testable hypotheses should be formed. In HTA, the answers to the main questions should be presented so that the outcome of the assessment can be stated with a shared understanding of the objective and all the evidence required for answering the questions (1). In terms of answering the policy question, > 70% of the Iranian reports made reference to the questions that were addressed. However, in terms of the policy question, only 57.8% of the reports completely adhered to this principle.

Since HTA aims to provide information for decision-making for policy and action (14), it should adopt appropriate methods for cost–benefit analysis (1,15) and take into account a wide range of evidence and outcomes (1). As for the sources of information and text search strategy, more than 50% of the Iranian HTA reports presented precise details; 22.2% listed the exclusion criteria. Evidently, the researchers who conducted HTA in the Islamic Republic of Iran actively searched maximum data as recommended by the HTA guidelines.

The HTA process is multi-disciplinary; it examines legal aspects, economic analysis, ethical and social implications, and other stakeholder perspectives (16–18). However, most of the Iranian HTA reports failed to consider these factors; most of them only discussed economic aspects. Economic assessment of healthcare interventions, especially new medications and technologies, is often performed to identify the best purchases. Eventually, policymakers and state institutions may fund a package that offers general benefits (19); thus, the other aspects related to technologies should also be examined.

HTAs should meet the national, regional and local needs (1). However, many Iranian HTAs were developed in the form of safety assessment or cost–effectiveness assessment studies that failed to attend to other aspects of an HTA study.

An important principle proposed by Drummond et al. is the active consultation with all the key stakeholders by HTA performers (1), but no record of this was found in the Iranian HTA reports. Although the HTA structure in the Islamic Republic of Iran is similar to the European HTA core model, there were clear differences between the Iranian HTA structure and those of other countries, such as the United Kingdom (20–22) and Germany (23,24).

To create an appropriate input for determining the priorities, resource allocation, and decision- and policy-making in technology-related spheres, HTA reports should accurately evaluate their findings, clearly report their conclusions, and make recommendations for further action. And to comply with a major principle of HTA, a clear distinction should be made between assessment and decision-making (10,25); in other words, since HTA results may not be precisely adopted by decision-makers, clear conclusions should be stated in the report. We found that 84.4% of the reports properly discussed the assessment findings, but only 67.8% clearly expressed conclusions from the assessment. Recommendations for further action were made only in 16.7% of the reports. No similar study has examined the HTA reports of a country; consequently, no comparison can be made between the status of HTA studies in the Islamic Republic of Iran and other countries. However, in comparison with one available study (26), we can conclude that the Iranian studies had major problems.

According to a study by Newman et al. of 14 selected HTA organizations around the world, there is widespread support for some principles, such as determining the objectives and scope of HTA, using a wide range of evidence, as well as impartiality and transparency (27), out of the 15 principles proposed by Drummond et al. for developing an ideal HTA (1). Less support has been provided for some other principles, e.g. generalizability and transferability, transparency in linking HTA results to decision-making processes, adopting a comprehensive social perspective and monitoring the implementation of HTA results.

This study has limitations in that many HTA performers were not identified; thus, lack of access to many researchers led to loss of information about HTA reports, including the method of implementation, and the factors that motivated the researchers to develop such reports.

Conclusion

No single recommendation can be made for HTA studies around the world. However, in its simplest form, an HTA report should possess certain components so that it can provide adequate information for policy- and decision-making. Our study discussed the strong and weak points of Iranian HTA reports and showed that there is a need for the advancement of HTA implementation and the establishment of international standards. The Iranian HTA system has greatly progressed and has great potential for improvements if an appropriate structure is created and local guidelines for HTA are developed and adopted.

Acknowledgment

This study is based on a health policymaking PhD thesis entitled “The Health Technology Assessment System analysis in the Islamic Republic of Iran and the Presentation of Policy Option”, approved on 10 February 2020 at the Deputy for Research and Technology of Kerman University of Medical Sciences (code: 98000894) and registered at the Ethics Committee (IR.KMU.REC.1398.644). The researchers are grateful to the Deputy for Research and Technology at Kerman University of Medical Sciences.

Funding: This research was funded by the Deputy for Research and Technology at Kerman University of Medical Sciences.

Competing interests: None declared.

Examen de la qualité des rapports d'évaluation des technologies de la santé dans un pays en développement

Résumé

Contexte : Aucune méthode d'évaluation des technologies de la santé (ETS) ne peut à elle seule répondre à tous les besoins en matière d'élaboration de politiques et de prise de décisions dans un pays. Cependant, il devrait y avoir des critères minimaux pour encadrer l'utilisation de l'ETS à l'échelle mondiale. De nombreux organismes œuvrant dans ce domaine sont parvenus à un consensus à ce sujet.

Objectif : La présente étude visait à évaluer la qualité des rapports ETS en République islamique d'Iran.

Méthode : Nous avons examiné tous les rapports de recherche ETS publiés jusqu'en 2020 par le bureau iranien chargé de ces évaluations. Nous avons utilisé la liste de contrôle du réseau INAHTA (International Network of Agencies for Health Technology Assessment – Réseau international des organismes d'évaluation des technologies de la santé) pour l'évaluation de la qualité.

Résultats : Au total, 97 rapports ont été examinés, dont 10,0 % seulement fournissaient des coordonnées complètes et appropriées permettant d'obtenir des informations complémentaires, et 5,6 % indiquaient explicitement un conflit d'intérêts. Dans 87,78 % des rapports, la portée de l'évaluation était clairement déterminée. La qualité des rapports était relativement adéquate ainsi que les détails des sources d'information et des stratégies de recherche de textes. Parmi les rapports, 7,8 %, 74,4 %, 11,1 %, 8,9 % et 4,4 %, respectivement, prenaient en compte les aspects juridiques, les analyses économiques, les implications éthiques et sociales ainsi que les autres perspectives des parties prenantes.

Conclusion : Nous recommandons la définition de normes minimales pour encadrer le processus ETS, afin que les responsables de l'élaboration des politiques de santé et les décideurs du domaine puissent s'appuyer sur les rapports ETS pour prendre des décisions fiables.

تقييم جودة تقارير تقييم التكنولوجيات الصحية في أحد البلدان النامية

اسماء صابر ماهانی، وحید یزدی-فیض آبادی، سلمان باش زر

الخلاصة

الخلفية: لا يمكن لطريقة واحدة فقط لتقييم التكنولوجيات الصحية أن تلبي جميع الاحتياجات اللازمة لوضع السياسات واتخاذ القرارات في أي بلد. ومع ذلك، يجب أن يكون هناك حد أدنى من المعايير لتنفيذ تقييم التكنولوجيات الصحية على مستوى العالم، وقد توصلت وكالات عديدة معنية بتقييم التكنولوجيات الصحية إلى توافق في الآراء في هذا الشأن.

الأهداف: هدفت هذه الدراسة إلى تقييم جودة تقارير تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية.

طرق البحث: فحصنا جميع تقارير بحوث تقييم التكنولوجيات الصحية التي نشرها المكتب الإيراني المعني بتقييم التكنولوجيات الصحية حتى عام 2020. واستخدمنا القائمة المرجعية للشبكة الدولية للوكالات المعنية بتقييم التكنولوجيات الصحية بقصد تقييم الجودة.

النتائج: تم فحص ما مجموعه 97 تقريرًا: قدم 10.0% منها فقط بيانات اتصال وافية ومناسبة للحصول على مزيد من المعلومات، بينما أظهر 5.6% منها تضاربًا واضحًا في المصالح. وفي 87.78% من التقارير، حُدد نطاق التقييم بوضوح. وكانت جودة التقارير ملائمة نسبيًّا وكذلك التفاصيل عن مصادر المعلومات واستراتيجيات البحث عن النصوص. وروعيت الجوانب القانونية، والتحليل الاقتصادي، والآثار الأخلاقية، والآثار الاجتماعية وغيرها من وجهات نظر أصحاب المصلحة في 7.8%، و74.4%، و11.1%، و8.9%، و4.4% من التقارير، على التوالي.

الاستنتاجات: أوصينا بوضع الحد الأدنى من المعايير الخاصة بعملية تقييم التكنولوجيات الصحية، حتى يتمكن واضعو السياسات ومتخذو القرارات في مجال الرعاية الصحية من اتخاذ قرارات موثوق بها، استنادًا إلى تقارير تقييم التكنولوجيات الصحية.

References

1. Drummond MF, Schwartz JS, Jönsson B, Luce BR, Neumann PJ, Siebert U, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008;24(3):244–58. doi:10.1017/S0266462308080343
2. Learmonth M, Harding N. Evidence-based management: the very idea. Public Administration. 2006;84(2):245–66. doi:10.1111/j.1467-9299.2006.00001.x
3. Ciani O, Tarricone R, Torbica A. Diffusion and use of health technology assessment in policy making: what lessons for decentralised healthcare systems? Health Policy. 2012 Dec;108(2–3):194–202. doi:10.1016/j.healthpol.2012.09.017
4. Velasco-Garrido M, Gerhardus A, Røttingen J-A, Busse R. Developing Health Technology Assessment to address health care system needs. Health Policy. 2010 Mar;94(3):196–202. doi:10.1016/j.healthpol.2009.10.002
5. Payam MM, Sari AA, Ay MR, Mobinizadeh MR, Maanavi S. Safety and diagnostic performance of dual-source ct scan in comparison with single source ct scan and conventional angiography in coronary heart diseases. J Hospital. 2010;9(1–2):25–32.
6. Garrido MV, Kristensen FB, Busse R, Nielsen C. Health technology assessment and health policy-making in Europe: current status, challenges and potential: Copenhagen: World Health Organization Regional Office for Europe, European Observatory on Health Systems and Policies, EuropeanNetwork for HTA; 2008 (Observatory Studies Series No 14; https://apps.who.int/iris/handle/10665/107911, accessed 27 October 2021).
7. 7Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004 Sep;8(36):iii–iv, ix–xi, 1–158. doi:10.3310/hta8360
8. Sacchini D, Virdis A, Refolo P, Pennacchini M, De Paula IC. Health technology assessment (HTA): ethical aspects. Med Health Care Philos. 2009 Nov;12(4):453–7. doi:10.1007/s11019-009-9206-y
9. Banta D, Jonsson E. History of HTA: Introduction. Int J Technol Assess Health Care. 2009 Jul;25 Suppl 1:1–6. doi:10.1017/S0266462309090321
10. Angelis A, Kanavos P. Multiple criteria decision analysis (MCDA) for evaluating new medicines in health technology assessment and beyond: the advance value framework. Soc Sci Med. 2017 Sep;188:137–156. doi:10.1016/j.socscimed.2017.06.024
11. A checklist for health technology assessment reports. Southampton: INAHTA Secretariat; 2007 (https://www.inahta.org/wp-content/uploads/2014/04/INAHTA_HTA_Checklist_English.pdf, accessed 27 October 2021).
12. Allen L. Non-communicable disease funding. Lancet Diabetes Endocrinol. 2017 Feb;5(2):92. doi:10.1016/S2213-8587(16)30420-X
13. Vo TQ. Health technology assessment in developing countries: a brief introduction for vietnamese health-care policymakers. Asian J Pharm. 2018;12(01). https://dx.doi.org/10.22377/ajp.v12i01.2340
14. Hailey D, Babidge W, Cameron A, Davignon L-A. HTA agencies and decision makers. An INAHTA guidance document. Stockholm: INAHTA; 2010 (http://pds20.egloos.com/pds/201009/07/46/HTA__Decision_Makers.pdf, accessed 27 October 2021).
15. Tarn T, Smith MD. Pharmacoeconomic guidelines around the world. ISPOR Connections. 2004;10(4):5–15.
16. Banta D. The development of health technology assessment. Health Policy. 2003 Feb;63(2):121–32. doi:10.1016/s0168-8510(02)00059-3
17. Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value in Health. 2012;15(8):1172–81. doi:10.1016/j.jval.2012.06.015
18. Facey K, Boivin A, Gracia J, Hansen HP, Scalzo AL, Mossman J, et al. Patients' perspectives in health technology assessment: a route to robust evidence and fair deliberation. Int J Technol Assess Health Care. 2010;26(3):334–40. doi:10.1017/S0266462310000395
19. Verguet S, Kim JJ, Jamison DT. Extended cost-effectiveness analysis for health policy assessment: a tutorial. Pharmacoeconomics. 2016 Sep;34(9):913-23. doi:10.1007/s40273-016-0414-z
20. Raftery J. Review of NICE's recommendations, 1999-2005. Bmj. BMJ. 2006 May 27;332(7552):1266–8. doi:10.1136/bmj.332.7552.1266
21. Tosh JC, Longworth LJ, George E. Utility values in National Institute for Health and Clinical Excellence (NICE) Technology Appraisals. Value in Health. 2011;14(1):102–9. doi:10.1016/j.jval.2010.10.015
22. Wonderling D, Sawyer L, Fenu E, Lovibond K, Laramée P. National clinical guideline centre cost-effectiveness assessment for the national institute for health and clinical excellence. Ann Intern Med. 2011 Jun 7;154(11):758–65. doi:10.7326/0003-4819-154-11-201106070-0000
23. Koch K, Lange S. Response to the expertise: procedures and methods of benefit assessments for medicines in Germany, by Geertruida E. Bekkering and Jos Kleijnen. Eur J Health Econ. 2009 May;10(2):233–6. doi:10.1007/s10198-008-0142-1
24. Herpers M, Dintsios C-M. Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany. Eur J Health Econ. 2019 Feb;20(1):45–57. doi:10.1007/s10198-018-0981-3
25. Mitton C, Seixas BV, Peacock S, Burgess M, Bryan S. Health technology assessment as part of a broader process for priority setting and resource allocation. Appl Health Econ Health Policy. 2019 Oct;17(5):573–6. doi:10.1007/s40258-019-00488-1
26. Bullement A, Podkonjak T, Robinson MJ, Benson E, Selby R, Hatswell AJ, et al. Real-world evidence use in assessments of cancer drugs by NICE. Int J Technol Assess Health Care. 2020 Jul 10:1–7. doi:10.1017/S026646232000043
27. International Working Group for HTA Advancement, Neumann PJ, Drummond MF, Jönsson B, Luce BR, Schwartz JS, Siebert U, et al. Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations? Int J Technol Assess Health Care. 2010;26(1): 71–8. doi:10.1017/S0266462309990833

PDF version

Mehrnaz Kheirandish,¹ Zahra Karimian,^1,2 Kamal Fahmy,³ Arash Rashidian ¹ and Rana Hajjeh ⁴

¹Division of Science, Information and Dissemination, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt. ²Heidelberg Institute of Global Health, Heidelberg University Hospital, Heidelberg, Germany. ³Division of Communicable Diseases, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt. ⁴Directorate of Program Management, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt. (Correspondence to A. Rashidian: This email address is being protected from spambots. You need JavaScript enabled to view it.)

Abstract

Background: Vaccine effectiveness studies provide evidence on the effects of vaccines for preventing disease and the adverse outcomes following a vaccination rollout programme in a country or a specific population.

Aims: To document the technical and capacity-building support provided by WHO to countries in the Eastern Mediterranean Region to conduct COVID-19 vaccine effectiveness studies.

Methods: WHO implemented interventions to enhance the capacity of EMR countries to conduct COVID-19 vaccine effectiveness and similar epidemiological studies. The intervention consisted of several components, including methodological and technical support as well as data and project management at national and regional levels. Two WHO generic protocols were adopted: cohort study among healthcare workers and test-negative design in severe acute respiratory infections surveillance sites.

Results: Egypt, Islamic Republic of Iran, Jordan, and Pakistan participated in the programme. The research protocols were adjusted to country context and settings. WHO provided technical, financial and infrastructure support, including the establishment of quality assessment approaches, study conduct, data management, report development, statistical data analysis, and experience-sharing between the countries. Technical capacity-building was also offered to other countries not involved in the vaccine effectiveness studies.

Conclusion: COVID-19 pandemic provided an opportunity to enhance the research capacities of EMR countries for the conduct of vaccine effectiveness studies. The WHO consolidated efforts and its collaboration with countries resulted in enhancement of capacity and research infrastructure, especially in the 4 countries that were supported by this programme. The capacities acquired through the programme would be very useful for other vaccine-preventable communicable diseases, thus better informing national immunization programmes and policies in EMR countries.

Keywords: vaccine effectiveness, capacity-building, COVID-19, vaccination, vaccine-preventable diseases, immunization, Eastern Mediterranean

Citation: Kheirandish M, Karimian Z, Fahmy K, Rashidian A, Hajjeh R. Capacity-building for conducting COVID-19 vaccine effectiveness studies to enhance evidence-informed vaccination policymaking in the Eastern Mediterranean Region. East Mediterr Health J. 2023;29(7):562–569. https://doi.org/10.26719/emhj.23.094  Received: 25/12/22; Accepted: 09/07/23

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Background

While randomized controlled trials (RCTs) provide the evidence required for assessing efficacy of vaccines against comparator groups (e.g. placebo or other vaccines) in a study setting, vaccine effectiveness studies provide evidence on the effects of vaccines in preventing disease and the adverse outcomes following the rollout of vaccination programmes in countries or specific populations. Significant technical expertise and resources are needed to conduct vaccine-related RCTs and vaccine effectiveness studies. Such studies were rarely being conducted in the Eastern Mediterranean Region (EMR) countries due to a combination of factors such as the lack of technical expertise, limited research infrastructure, limited financial resources, and a lack of policy interests. As a result of the urgent needs for such studies due to COVID-19 pandemic, the World Health Organization Regional Office for the EMR (WHO/EMRO) embarked on a programme to enhance the capacity of EMR countries to conduct vaccine effectiveness studies. The programme enhanced technical expertise and strengthened research infrastructure, leveraging existing respiratory disease surveillance systems.

Since being declared a Pandemic by the WHO on 11 March 2020, COVID-19 became a global health priority (1). The EMR includes 22 countries that have variable healthcare and health research capacities and infrastructure (2–4). The COVID-19 pandemic was a major public health challenge to the Region, in addition to the existing risks that negatively affected health and health outcomes in Member States (5,6).

As of March 2023, the WHO/EMRO media centre had reported at least 350 000 deaths due to COVID-19 in the EMR (7,8), while COVID-19 vaccination coverage remained lower than expected in most countries of the Region (9). Excess COVID-19 deaths in Eastern European countries had been shown to be associated with weaker implementation of COVID-19 regulations and lower vaccine coverage (8).

WHO and its partners have been committed to supporting countries in accessing COVID-19 vaccines by addressing delivery and storage challenges (10), while working closely with ministries of health to ensure that vaccine hesitancy among populations is addressed through the dispelling of misinformation.

While RCTs have demonstrated adequate efficacy of a few COVID-19 vaccines in controlled settings, it is worth noting that many factors, including differences in country demographics and disease profiles, suboptimal cold chain capacity, variation in dose intervals, interchangeability of different vaccine products, off-schedule and incomplete delivery of doses, could affect vaccine effectiveness in the field (11). These factors can cause differences in vaccine effectiveness when compared to vaccine efficacy results from the controlled conditions of RCTs.

Vaccine effectiveness studies provide opportunities to assess the durability of vaccine-mediated immunity over longer periods, their effectiveness in sub-groups of the population not adequately represented in RCTs, as well as any side-effects and potential risks.

The frequent emergence of SARS-CoV-2 variants of concern require ongoing monitoring of vaccine effectiveness against such variants (11,12). Thus, studies are needed to measure vaccine effectiveness against serious outcomes such as long-term protection against serious disease, hospitalization or deaths at population level as well as within different risk groups (e.g. the elderly and those with comorbidities) and for different vaccine products. These studies will also monitor potential side-effects and harms over time and, hence, alleviate public concerns about such risks. Sustainable vaccine effectiveness platforms provide ongoing assessment and long-term monitoring of vaccines, which will in turn provide manufacturers, national health authorities and regulators with essential data to understand vaccine impact and better inform national immunization policies.

As of September 2022 there were at least 172 COVID-19 vaccine candidates undergoing clinical trials worldwide, with 199 candidates in pre-clinical development stages (13). A variety of COVID-19 vaccines, mostly inactivated and protein products, were being produced by or being used in EMR countries (e.g. Sinopharm, Covaxin, Spikogen, Barekat, etc.), for which vaccine effectiveness data was limited compared to other vaccines (e.g. Pfizer-BioNTech, Moderna and Oxford-AstraZeneca,) which had been more widely researched (14,15).

The importance of context-specific vaccine-effectiveness data, as well as the complexity of impact assessment for novel vaccines, created an urgent need for vaccine effectiveness studies by countries in the Region; the proper design and implementation of which warranted careful epidemiological considerations that required technical support and capacity-building in countries for conducting such studies (16).

There is limited evidence of vaccine effectiveness studies (e.g. for flu vaccines) being conducted in the Region prior to the COVID-19 pandemic. As a result, subsequent to the pandemic, the leadership of WHO/EMRO raised the issue within its incident management support team, following which it was collectively decided for the research and knowledge management pillar and the vaccine pillar to lead and support an initiative to enhance the conduct of COVID-19 vaccine effectiveness studies in the EMR (17). Alongside the WHO efforts, certain research teams also conducted key vaccine effectiveness studies, which informed national and global policies (18–21).

The design and implementation of the vaccine effectiveness studies required enhancing the research infrastructure and the technical capacity of ministries of health and investigators, as well as strengthening existing surveillance systems, such as sentinel surveillance sites for other respiratory infectious diseases in the countries. These would in turn facilitate evaluation of COVID-19 vaccine effectiveness and generate valid evidence for policymaking in national and regional immunization programmes.

This paper presents a brief description of the technical and capacity-building support provided by WHO to EMR countries to conduct the vaccine effectiveness studies.

Methods

Since 2020, WHO has adopted the following interventions to enhance the capacity of EMR countries to evaluate COVID-19 vaccine effectiveness and to conduct similar epidemiological studies:

1- Enhancing processes and structures in the Region

   a. Establishment of the multidisciplinary regional COVID-19 vaccine effectiveness technical team

An interdisciplinary technical team of WHO experts from various backgrounds including epidemiology, medicine, pharmacy, laboratory science, health management, economics and health policy developed a roadmap for the selection and support for the conduct of the studies. The team served as the coordination hub, providing institutional direction and insight to the national research teams. External consultants with expertise in epidemiology, statistics and data management, and extensive experience in conducting vaccine effectiveness studies were commissioned to provide further technical support.

   b. Development of the COVID-19 vaccine effectiveness studies dashboard for EMR

A COVID-19 vaccine effectiveness studies dashboard was developed to serve two purposes: (i) enable WHO to keep track of all proposals received from countries seeking WHO support for conducting national COVID-19 vaccine effectiveness studies, and (ii) track other COVID-19 vaccine effectiveness studies conducted and published by EMR countries. The dashboard included data related to the country of study, study design, sample specifications, vaccines under the study, and the dominant variants of SARS-CoV-2 virus during the study.

   c. Standardization of study design and data analysis

WHO developed guidance documents outlining the requirements for conducting COVID-19 vaccine effectives studies by countries using two main methods: cohort study design among healthcare workers (22), and test-negative case-control design in severe acute respiratory infections (SARI) surveillance sites (23). These protocols had advantages. They could be adapted to local settings and capacities in each country and they allowed researchers to engage in a multinational study. Subsequently, standardization was done to harmonize study procedures (designs and methods) among the various proposals received from different institutions, and standardized code books were developed to collect comparable data. This in turn allowed pooling of results across national studies and reporting regional COVID-19 vaccine effectiveness estimates.

   d. Issuance of regional ethical clearance

A regional ethical clearance was obtained through the Eastern Mediterranean Research Ethics Review Committee for the duration of the study. National studies were required to obtain national research ethics clearance as well as the regional clearance.

   e. Development of the regional data entry platform

A central data entry platform was established within Research Electronic Data Capture (REDCap) to collect anonymized disaggregated data from national studies. REDCap is a web-based application designed to support data capture for research studies while providing: (a) an intuitive interface for validated data entry, (b) audit trails for tracking data manipulation and export procedures, (c) automated export procedures for seamless data downloads using common statistical programs, and (d) procedures for importing data from external sources (24).

2- Building national technical capacities in countries

Four region-wide capacity-building workshops and two country-specific interactive training sessions were held virtually from September 2021 through December 2022. The first series of region-wide capacity-building workshops were held in December 2021. It focused on the WHO-approved protocols (study designs/methods) and required criteria for conducting COVID-19 vaccine effectiveness research. The second series of region-wide workshops were held in November 2022 and were dedicated to important considerations for investigators in conducting COVID-19 vaccine effectiveness research given the updates in WHO guidance on the evaluation of COVID-19 vaccine effectiveness and study results worldwide. Two country-specific workshops were held in March 2022, which were tailored to train the research teams from participating countries in the Region on the use of REDCap for data management of their respective study results.

In addition to the region-wide workshops, the regional COVID-19 vaccine effectiveness technical team held interactive meetings and individual consultation sessions with investigators of participating countries. The meetings were tailored to their respective needs and specific requests and the goal was to address any challenges in designing and conducting COVID-19 vaccine effectiveness studies, either during proposal development or study implementation.

Results

Overall, 93 participants from Bahrain, Egypt, Islamic Republic of Iran, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Sudan, Syria, and the United Arab Emirate attended the region-wide workshops, as well as Ethiopia from the WHO/AFRO Region. Following the workshops and a call for proposals for COVID-19 vaccine effectiveness research, the technical team received 12 expressions of interest from the countries. After several rounds of technical evaluation and feedback from the team, proposals from 4 countries were selected for inclusion in the regional study. The investigators of the studies attended country-specific workshops in Egypt, Jordan, Islamic Republic of Iran, and Pakistan (Table 1).

Four country-specific questionnaires were adapted based on the generic WHO vaccine effectiveness protocols and the specific needs of each country, and these were uploaded to the regional data entry platform. Authorized investigators from participating countries were given access to the platform for data entry and trained for regular assessment and quality check of their respective study inputs and data. The use of REDCap provided the opportunity for secure and timely assessment of the data entry processes and helped in addressing technical issues encountered by the countries. The platform facilitated pooling of study results across countries for statistical data analysis and reporting on vaccine effectiveness. Table 2 summarizes key planning and operational challenges observed during the conduct of the studies at different stages.

Discussion

Towards the end of 2022, some 20 COVID-19 vaccine effectiveness studies had been published by EMR countries, 17 (85.0%) of which were from 3 high-income countries (Kuwait, Qatar and UAE), while the remaining were from Egypt, Lebanon, Morocco, and Tunisia (25). This shows that far less COVID-19 vaccine effectiveness data is being generated from low- and middle-income countries (LMICs) in EMR, underscoring the importance of WHO’s support for robust vaccine effectiveness studies in the Region, especially because 16 of the 22 EMR Member States are LMICs (26).

Of the 20 published studies, the authors or collaborators of 14 (70.0%) were affiliated with the ministries of health or other government health institutions of their respective countries. This indicates that the results of these studies are more likely to influence national immunization policies and programmes (27). Therefore, capacity-building for conducting vaccine effectiveness studies and establishing a sustainable network of investigators and decision-makers in the Region is anticipated to help generate long-term quality results that could ultimately be used for evidence-informed policymaking (28). This highlights the need to ensure that investigators conducting national COVID-19 vaccine effectiveness studies receive pertinent technical support and training as part of capacity-building programmes.

Apart from the many advantages of the regional study, we encountered several technical and operational challenges in the process of designing and implementing this multinational COVID-19 vaccine effectiveness study. Some of these were due to the emerging nature of the disease and the study designs (29), while others were due to coordination issues across the region or countries (Table 2). WHO supported countries in addressing and overcoming these challenges, although quality assurance of the study processes continues to be challenging.

There have been different approaches to the response to the COVID-19 pandemic, including enhancing capacity for policy-oriented research (17). Countries need to further invest in vaccine effectiveness studies and ensure that it becomes a part of the routine assessment for current and emerging vaccines.

WHO adapted the guidance for global influenza surveillance and response system for the purpose of integrated sentinel surveillance of influenza and SARS-CoV-2 (as well as other respiratory viruses with epidemic and pandemic potential) (30). Currently, the influenza surveillance network leveraged for COVID-19 surveillance is active in 19 out of 22 EMR countries, which provides further opportunity for vaccine effectiveness studies, noting the enhanced technical and infrastructure capacities in the Region. The SARI surveillance network for influenza in the Region contributes to the establishment of a sustainable platform for monitoring and evaluating COVID-19 vaccine effectiveness; a capacity that is amplified by the infrastructure and technical expertise developed for the regional COVID-19 vaccine effectiveness studies.

Vaccine effectiveness studies are a key source of evidence for national vaccination-related decisions. Hence, the investigators and research teams should strengthen their links with policymakers to identify the key policy questions that need to be answered by research, as well as the timely and effective presentation of the results to the relevant national bodies.

Acknowledgement

We acknowledge the following colleagues and collaborators for their technical and operational support to the regional COVID-19 vaccine effectiveness study: Yvan Hutin, Quamrul Hassan, Osama Mohammed Mere, Kaiyue Wu, Amal Barakat (WHO/EMRO); Stefano Tempia, Isabel Bergeri (WHO/HQ); Marta Valenciano, Sandra Cohuet, Jihane Ben-Farhat, Anthony Nardone, Madelyn Rojas, Jenny Howard (Epiconcept); and Shadrokh Sirous, Saverio Bellizzi, Amira Ahmed, Michael Lukwiya (WHO country offices).

Funding: None.

Competing interest: None declared.

Renforcement des capacités pour la réalisation d'études sur l'efficacité des vaccins contre la COVID-19 afin d'améliorer l'élaboration de politiques reposant sur des bases factuelles dans la Région de la Méditerranée orientale

Résumé

Contexte : Les études sur l'efficacité des vaccins fournissent des données probantes concernant les effets des vaccins sur la prévention des maladies et les résultats indésirables à la suite d'un programme de déploiement de la vaccination dans un pays ou dans une population spécifique.

Objectif : Documenter l'appui technique et le soutien au renforcement des capacités fournis par l'OMS aux pays de la Région de la Méditerranée orientale pour la réalisation d'études sur l'efficacité des vaccins contre la COVID-19.

Méthodes : L'OMS a mis en œuvre des interventions visant à renforcer la capacité des pays de la Région de la Méditerranée orientale à mener des études sur l'efficacité des vaccins contre la COVID-19 et des études épidémiologiques similaires. L'intervention comprenait plusieurs composantes, notamment l'appui méthodologique et technique ainsi que la gestion de données et de projets aux niveaux national et régional. Deux protocoles génériques de l'OMS ont été adoptés : une étude de cohorte auprès des agents de santé et une méthodologie de test négatif dans les sites de surveillance des infections respiratoires aiguës sévères.

Résultats : L'Égypte, la République islamique d'Iran, la Jordanie et le Pakistan ont participé au programme. Les protocoles de recherche ont été adaptés à la situation et aux contextes des pays. L'OMS a apporté un appui technique, financier et infrastructurel, notamment pour la mise en place d'approches d'évaluation de la qualité, la réalisation d'études, la gestion des données, l'élaboration de rapports, l'analyse des données statistiques et l'échange de données d'expérience entre les pays. Des activités de renforcement des capacités techniques ont également été proposées à d'autres pays qui n'ont pas participé aux études sur l'efficacité des vaccins.

Conclusion : La pandémie de COVID-19 a permis de renforcer les capacités de recherche des pays de la Région de la Méditerranée orientale pour la conduite d'études sur l'efficacité des vaccins. Les efforts consolidés de l'OMS ainsi que sa collaboration avec les pays ont permis de renforcer les capacités et les infrastructures de recherche, en particulier dans les quatre pays qui ont bénéficié du soutien de ce programme. Les capacités acquises par le biais du programme pourraient être très utiles dans le cadre d'autres maladies transmissibles évitables par la vaccination, ce qui permettrait de mieux informer les programmes et politiques de vaccination au niveau national dans les pays de la Région.

بناء القدرات لإجراء دراسات عن فعالية لقاحات كوفيد-19 لتعزيز وضع سياسات مسترشدة بالدلائل في إقليم شرق المتوسط

مهرناز خيراندش، زهرا كريميان، كمال فهمي، آرش رشيديان، رنا حاجة

الخلاصة

الخلفية: توفر دراسات فعالية اللقاحات دلائل عن آثار اللقاحات على الوقاية من الأمراض والمخرجات العكسية التي تعقب أحد برامج نشر التطعيم في بلد أو فئة سكانية محددة.

الأهداف: هدفت هذه الدراسة إلي توثيق الدعم التقني ودعم بناء القدرات الذي قدمته المنظمة إلى بلدان إقليم شرق المتوسط لإجراء دراسات عن فعالية لقاحات كوفيد-19.

طرق البحث: نفذّت المنظمة تدخلات لتعزيز قدرة بلدان إقليم شرق المتوسط على إجراء دراسات عن فعالية لقاحات كوفيد-19 ودراسات وبائية أخرى مشابهة. وتألف التدخل من عدة عناصر، شملت الدعم المنهجي والتقني، فضلاً عن إدارة البيانات والمشروعات على الصعيدين الوطني والإقليمي. واتُبع بروتوكولان عامان من بروتوكولات المنظمة: دراسة أترابية بين العاملين الصحيين، وتصميم يتضمن استخدام مجموعة ضابطة نتائجها سلبية لاختبار كوفيد-19 في مواقع ترصد العدوى التنفسية الحادة الوخيمة.

النتائج: شارك في البرنامج مصر، وجمهورية إيران الإسلامية، والأردن، وباكستان، وعُدِّلت بروتوكولات البحث بما يتماشى مع ظروف كل بلد ومكان إجراء البحث. وقدَّمت المنظمة الدعم التقني والمالي ودعم البنية الأساسية، وتضمن ذلك وضع نُهُج لتقييم الجودة، وإجراء الدراسات، وإدارة البيانات، وإعداد التقارير، والتحليل الإحصائي للبيانات، وتبادل الخبرات بين البلدان. كما قُدمت مساعدات لبناء القدرات التقنية في بلدان أخرى لم تشارك في دراسات فعالية اللقاحات.

الاستنتاجات: مثَّلت جائحة كوفيد-19 فرصة لتعزيز قدرات بلدان إقليم شرق المتوسط البحثية اللازمة لإجراء دراسات عن فعالية اللقاحات. وقد عززت المنظمة جهودها وتعاونها مع البلدان، ونتج عن هذا تحسين القدرات البحثية والبنية الأساسية البحثية، لا سيّما في البلدان الأربعة التي دعمها هذا البرنامج. والقدرات المكتسبة من خلال البرنامج مفيدة جدًا للتعامل مع لأمراض السارية الأخرى التي يمكن الوقاية منها باللقاحات، وستوفر دلائل أفضل لتوجيه برامج وسياسات التطعيم الوطنية في بلدان إقليم شرق المتوسط.

References

1. World Health Organization. WHO Director-General’s opening remarks at the media briefing on COVID-19. Geneva: World Health Organization, 11 March 2020. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.

2. World Health Organization. Progress on the health-related Sustainable Development Goals and targets in the Eastern Mediterranean Region. Cairo: World Health Organization Regional Office for the Eastern Mediterranean, 2020:124 p. https://apps.who.int/iris/handle/10665/361800.

3. World Health Organization. Health and well-being profile of the Eastern Mediterranean Region: an overview of the health situation in the Region and its countries in 2019. Cairo: World Health Organization Regional Office for the Eastern Mediterranean, 2020. https://applications.emro.who.int/docs/9789290223399-eng.pdf.

4. Tadmouri GO, Mandil A, Rashidian A. Biomedical and health research geography in the Eastern Mediterranean Region. East Mediterr Health J. 2019;25(10):728–743. DOI: https://doi.org/10.26719/emhj.19.082.

5. Mokdad AH, Forouzanfar MH, Daoud F, El Bcheraoui C, Moradi-Lakeh M, Khalil I, et al. Health in times of uncertainty in the eastern Mediterranean region, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. The Lancet Global Health 2016;4(10):e704–13. DOI: https://doi.org/10.1016/S2214-109X(16)30168-1.

6. Memish ZA, Brennan RJ, Rashidian A, Abubakar A, Khan W, Ghaffar A. COVID-19 pandemic response in one of the world’s most complex and vulnerable settings. BMJ Global Health 2022;7(Suppl 3):e009911. DOI: http://dx.doi.org/10.1136/bmjgh-2022-009911.

7. World Health Organization. WHO Regional Director’s statement on COVID-19. World Health Organization Regional Office for the Eastern Mediterranean, 2022. http://www.emro.who.int/health-topics/corona-virus/index.html.

8. Ylli A, Burazeri G, Wu YY, Sentell T. COVID-19 excess deaths in Eastern European countries associated with weaker regulation implementation and lower vaccination coverage. East Mediterr Health J 2022;28(10):776–780. DOI: https://doi.org/10.26719/emhj.22.074.

9. Hasan Q, Elfakki E, Fahmy K, Mere O, Ghoniem A, Langar H, et al. Inequities in the deployment of COVID-19 vaccine in the WHO Eastern Mediterranean Region, 2020–2021. BMJ Glob Health 2022;7(Suppl 4):e008139. DOI: http://dx.doi.org/10.1136/bmjgh-2021-008139.

10. World Health Organization. Inequitable COVID-19 vaccination coverage in the Eastern Mediterranean Region is a missed opportunity to protect people from severe disease and death. World Health Organization Regional Office for the Eastern Mediterranean, 2021. http://www.emro.who.int/media/news/inequitable-covid-19-vaccination-coverage-in-the-eastern-mediterranean-region-is-a-missed-opportunity-to-protect-people-from-severe-disease-and-death.html.

11. World Health Organization. Evaluation of COVID-19 vaccine effectiveness - Interim Guidance (17 March 2021). Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccine_effectiveness-measurement-2021.1.

12. World Health Organization. Guidance on conducting vaccine effectiveness evaluations in the setting of new SARS-CoV-2 variants: Interim guidance. Geneva: World Health Organization, 2021. https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccine_effectiveness-variants-2021.1.

13. World Health Organization. The COVID-19 vaccine tracker. Geneva: World Health Organization, 2022. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.

14. World Health Organization. Status of COVID-19 vaccines within WHO EUL/PQ evaluation process. Geneva: World Health Organization, 2022. https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_26May2022.pdf.

15. Kudlay D, Svistunov A. COVID-19 vaccines: an overview of different platforms. Bioengineering. 2022;9(2):72. DOI: https://doi.org/10.3390/bioengineering9020072.

16. Teerawattananon Y, Anothaisintawee T, Pheerapanyawaranun C, Botwright S, Akksilp K, Sirichumroonwit N, et al. A systematic review of methodological approaches for evaluating real-world effectiveness of COVID-19 vaccines: advising resource-constrained settings. PLoS ONE. 2022;17(1):e0261930. DOI: https://doi.org/10.1371/journal.pone.0261930.

17. Rashidian A, Wu K, Al Ariqi L, Aly E, Mandil A, Barakat A, et al. WHO’s support for COVID-19 research and knowledge management in the Eastern Mediterranean Region. BMJ Glob Health 2022;7(Suppl 3):e008737. DOI: http://dx.doi.org/10.1136/bmjgh-2022-008737.

18. Heidarzadeh A, Moridani MA, Khoshmanesh S, Kazemi S, Hajiaghabozorgi M, Karami M. Effectiveness of COVID-19 vaccines on hospitalization and death in Guilan, Iran: a test-negative case-control study. International Journal of Infectious Diseases 2023;128:212–222. DOI: https://doi.org/10.1016/j.ijid.2022.12.024.

19. Alali WQ, Ali LA, AlSeaidan M, Al-Rashidi M. Effectiveness of BNT162b2 and ChAdOx1 vaccines against symptomatic COVID-19 among healthcare workers in Kuwait: a retrospective cohort study. Healthcare 2021;9(12):1692. DOI: https://doi.org/10.3390/healthcare9121692.

20. Al Kaabi N, Oulhaj A, Ganesan S, Al Hosani FI, Najim O, Ibrahim H, et al. Effectiveness of BBIBP-CorV vaccine against severe outcomes of COVID-19 in Abu Dhabi, United Arab Emirates. Nat Commun 2022;13(1):3215. DOI: https://doi.org/10.1038/s41467-022-30835-1.

21. Belayachi J, Obtel M, Razine R, Abouqal R. Long term effectiveness of inactivated vaccine BBIBP-CorV (Vero Cells) against COVID-19 associated severe and critical hospitalization in Morocco. PLoS One 2022;17(12):e0278546. DOI: 10.1371/journal.pone.0278546.

22. World Health Organization. Cohort study to measure COVID-19 vaccine effectiveness among health workers in the WHO European Region: guidance document. World Health Organization Regional Office for Europe, 2021. https://apps.who.int/iris/handle/10665/340217.

23. World Health Organization. Estimating COVID-19 vaccine effectiveness against severe acute respiratory infections (‎SARI)‎ hospitalisations associated with laboratory-confirmed SARS-CoV-2: an evaluation using the test-negative design (TND): guidance document World Health Organization Regional Office for Europe, 2021. https://apps.who.int/iris/handle/10665/341111.

24. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: Building an international community of software platform partners. Journal of Biomedical Informatics 2019;95:103208. DOI: https://doi.org/10.1016/j.jbi.2019.103208.

25. VIEW-hub by IVAC. Vaccine Product (current/planned). VIEW-hub by IVAC, 2022. https://view-hub.org/covid-19/?set=vaccine-product-current-planned&group=vaccine-introduction&category=covid.

26. The World Bank.The World by Income and Region. World Development Indicators, 2022. Washington DC: The World Bank. https://datatopics.worldbank.org/world-development-indicators/the-world-by-income-and-region.html.

27. International Vaccine Access Center (IVAC). Vaccine effectiveness studies - Eastern Mediterranean Region. Baltimore: Johns Hopkins Bloomberg School of Public Health, 2022. https://view-hub.org/covid-19/effectiveness-studies?field_region=eastern-mediterranean.

28. Steffen CA, Henaff L, Durupt A, Omeiri NE, Ndiaye S, Batmunkh N, et al. Evidence-informed vaccination decision-making in countries: Progress, challenges and opportunities. Vaccine 2021;39(15):2146–2152. DOI: https://doi.org/10.1016/j.vaccine.2021.02.055.

29. Shi X, Li KQ, Mukherjee B. Current challenges with the use of test-negative designs for modeling COVID-19 vaccination and outcomes. American Journal of Epidemiology 2023;192(3):328–333. DOI: https://doi.org/10.1093/aje/kwac203.

30. World Health Organization. Maintaining surveillance of influenza and monitoring SARS-CoV-2 - Interim Guidance. Geneva: World Health Organization, 2020. https://apps.who.int/iris/rest/bitstreams/1316069/retrieve.

PDF version

Ali Akbari-Sari,¹ Elham Ahmadnezhad,² Zhaleh Abdi,³ Sahand Riazi-Isfahani ² and Sara Saffarpour ²

¹Department of Health Economics, School of Public Health and National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran. ²Health Observatory Secretariate, National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran (Correspondence to E. Ahmadnezhad: This email address is being protected from spambots. You need JavaScript enabled to view it.). ³Department of Research and Education, National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran.

Abstract

Background: The COVID-19 pandemic has increased awareness of the need for high-quality and timely evidence to support policy- and decision-making in emergency situations.

Aims: To describe the experiences of the National Institute of Health Research (NIHR), Islamic Republic of Iran, in adopting evidence-informed policymaking during the COVID-19 pandemic.

Methods: During the COVID-19 pandemic, NIHR institutionalized a rapid response system that was backed up by evidence-informed policy- and decision-making. Activities included establishment of a preparedness and response management committee, gathering and providing timely pandemic information to policymakers, establishing a timeline of actions and activities, and a feedback system for policy responses and queries.

Results: The COVID-19 rapid response committee addressed the questions of 40 policymakers by synthesizing and analysing evidence and making it available to relevant stakeholders. It developed and disseminated knowledge products to provide relevant information. We identified the need for more timely data and more reliable research evidence for pandemic management.

Conclusion: National institutions responding to health emergencies need to take responsibility for establishing and managing a robust rapid response systems that can provide valid and timely evidence to policymakers. Over time, their capacity should be monitored, evaluated and strengthened to adapt and respond appropriately to pandemics, outbreaks and epidemics.

Keywords: COVID-19, evidence, policymaking, Islamic Republic of Iran, rapid response, UHC, pandemic

Citation: Akbari-Sari A, Ahmadnezhad E, Abdi Z, Riazi-Isfahani S, Saffarpour S. Relevance of the COVID-19 rapid response system to public health policymaking in Islamic Republic of Iran. East Mediterr Health J. 2023;29(7):570–574. https://doi.org/10.26719/emhj.23.079

Received: 01/08/22; Accepted: 08/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

There is a growing global interest in achieving Universal Health Coverage (UHC) by strengthening health systems following the introduction of the United Nations Sustainable Development Goals (1). Decisions to achieve these goals need to be informed by evidence. Evidence-informed policymaking is a complex process, and the time required to generate evidence usually exceeds the time that policymakers are willing to wait (2–4). The COVID-19 pandemic forced decision-makers to make rapid decisions under time pressure and situations of scientific uncertainty, which highlighted the need for adaptation of evidence-informed policymaking to changing circumstances. Some solutions have been proposed, and 1 of the most important is the establishment of a rapid response system (5). According to the Evidence-informed Policy Network, rapid synthesis of the best available research evidence on pressing health issues can provide policymakers with a sound basis on which to inform their decisions, and this highlights the importance of establishing a mechanism for generating and disseminating evidence in a timely manner (6, 7). An example of this can be seen in Canada, where a rapid response programme was developed to serve as a key mechanism for facilitating user-pull (8). Evidence-informed policymaking

is now inevitable, and each country must implement its own plan and adapt it to situations that require a rapid response system.

Immediately after detecting the first case of COVID-19 in the Islamic Republic of Iran, the authorities moved quickly to respond through a whole-of-government and whole-of-society approach (9), which committed all sectors to respond to the pandemic. Numerous national committees were formed and policies were formulated and implemented (10). In this regard, the National Institute for Health Research (NIHR) tried to fulfil its mission by taking an active role in tackling COVID-19. NIHR as a national body has 2 main functions of health observation and rapid response. To realize the latter, NIHR addresses the knowledge gap in situations where health system decision-makers need support through access to and synthesis of optimally packaged, relevant, and high-quality research evidence. The aim of this study was to describe the process and establishment of the rapid response system to support evidence-informed policymaking during the COVID-19 pandemic in the Islamic Republic of Iran.

Institutionalization of the COVID-19 rapid response system in the NIHR

The specific intervention was the establishment of a national rapid response system against the COVID-19 pandemic in the Islamic Republic of Iran, which provided relevant research evidence that addressed urgent questions raised by policymakers. Senior policymakers at the Ministry of Health and Medical Education were identified as the primary stakeholders, and the key players were COVID-19 experts, researchers, and academics.

The NIHR has a rapid response system, and the new intervention was an adaptation of the current structure to the COVID-19 pandemic situation. The NIHR established a committee for evidence-informed policymaking, with the following subcommittees: (1) The steering committee determined the work plan, priorities, and general scope of activity; estimated the budget; reviewed the proceedings; oversaw, planned, and organized meetings; coordinated and communicated updates with policymakers; informed the technical committee; and made decisions about allocation of resources. (2) The advisory committee had an arbitration role, providing expert advice and guidance on matters within their fields of expertise. The committee’s critical role was to review and approve materials for publication. Their expertise enabled them to provide valuable feedback on content, accuracy, and relevance. They carefully scrutinized products to ensure that they met quality standards. After the review, they granted permission for publication . This ensured that published materials were reliable resources for policymakers. (3) The technical committee was in charge of developing all products.

The managers and senior policymakers of the Ministry of Health and Medical Education were informed of the COVID-19 rapid response system. The system established specific timelines for different stages of the process, with the initial stage taking 3 business days, the subsequent stage 7 business days, and the final stage 30 business days. These timelines allowed for identification and summary of relevant systematic reviews, which were delivered in a timely and efficient manner to decision-makers.

To facilitate the process of receiving and responding to queries from policymakers and senior health managers, a specific form was developed. This query form included various elements, such as the names of the policymakers submitting the query; a well-defined question formulated as a query; information on the intended use of the response (e.g. for macro or micro-level policymaking, mass media, etc.); and the timeframe within which the response to the query was required. These elements helped streamline the process of receiving and responding to queries in a timely and effective manner. The response form used in the rapid response system was comprehensive and included a range of information such as the name and affiliation of the applicant, as well as the question that had been answered and the deadline for the response. The form also included key findings, review methods, results, and conclusions. It had a section for references, allowing for transparency and accountability in the sourcing of information.

Evidence preparation

The NIHR COVID-19 rapid response system included: finding the best and most relevant evidence; synthesis of the evidence and production of rapid reviews; and generation of meta-analyses in response to user-defined queries.

The evidence was synthesized using the following steps: (1) searching databases such as the Cochrane Library and PubMed; (2) determining the appropriate inclusion and exclusion criteria for extracting evidence; (3) extracting data from final studies; and (4) analysing the data. Different types of evidence were used, especially systematic reviews, meta-analyses of randomized controlled trials, and evidence-based clinical practice guidelines based on systematic reviews of at least 3 randomized controlled trials, which were the first choice. All products were indexed on the NIHR website and delivered to policymakers through official correspondence. They were also presented to them in a series of meetings.

Main outcomes of COVID-19 rapid response system

The committee answered > 40 important questions up to the time of writing this paper. The following topics were covered: (1) Rules for holding mass gatherings, including religious meetings and sports (the evidence led to closure of mosques). (2) School reopening (the evidence led to a halt in reopening). (3) Rate of reinfection and antibody persistence, which led to the formation of a serosurveillance system in the Islamic Republic of Iran. It was hypothesized that herd immunity may lead to disease control and that no vaccine would be needed. This led to the refusal of some individuals and even policymakers to take the vaccine. The seroepidemiological studies conducted through the serosurveillance system showed that reinfection was possible and antibodies were not persistent. This prompted policymakers to put vaccination on the agenda (11). (4) Administration of the first vaccination booster for specific groups (evidence showed that booster doses were effective). (5) The effectiveness of oral and injected antiviral drugs. A rapid review of chloroquine, favipravir, remdesivir, monolopiravir, and some other drugs was carried out. Remdesivir has been widely used in the Islamic Republic of Iran, and the Annual Pharma Statistics Report of the Iranian Federal Drug Administration (2020) mentioned remdesivir as the most widely used drug. Evidence showed that remdesivir was not effective.

As an additional outcome, by creating a COVID-19 information platform and the associated website, the evidence was available for public use and was widely disseminated. This information was also used by the media and some of the questions made headlines in the official media (NIHR; https://nih.tums.ac.ir/En).

Key challenges and related strategies

The important challenges are as follows: (1) Limited human resources posed a challenge to providing prompt responses to queries. This challenge was compounded by difficulties in managing time constraints. In order to overcome these challenges, teams were formed to provide answers to queries instead of relying on individual efforts. This team-based approach expedited the response process, enabling more timely and efficient delivery of responses to policymakers and senior health managers. (2) Lack of technical expertise. Given the variety of the questions, it was a challenge to ensure the required technical expertise within teams. The challenge remains, and the committee has worked to expand the range of expertise. (3) Finding appropriate evidence to address knowledge gaps due to the novelty of COVID-19. To address this issue, relevant sources were regularly monitored and primary data were generated. (4) The current mode of knowledge-sharing in the NIHR is based on a pull platform, which involves policymakers and senior health managers sending their queries to the committee. However, it has been recognized that this approach has limitations and there is a need for a more collaborative exchange platform. To address this challenge, a national framework was developed for consideration by the Ministry of Health and Medical Education. The framework aims to facilitate the exchange of knowledge and expertise between stakeholders through the establishment of a collaborative platform. The proposed exchange platform will enable stakeholders to share information and best practices, engage in discussions and debates, and collaborate on research projects. By moving from a pull to an exchange platform, the NIHR aims to create a more collaborative and inclusive environment for knowledge sharing, which will facilitate the implementation of evidence-based policies and practices. This shift will also help overcome the limitations of resources and expertise, by enabling stakeholders to work together towards a common goal. Overall, the proposed exchange platform has the potential to enhance the quality and relevance of research and policymaking in the field of health.

Key lessons learned

The most important lessons learned were as follows: (1) A national body should take responsibility for management of the COVID-19 rapid response system in order to provide timely evidence. Consideration should be given to strengthening the capacity of its potential members under various situations. (2) Development of a structured format for receiving queries will facilitate the process by streamlining the flow of information. A format tailored to the needs of knowledge users will prevent dispersion of queries and ensure a clear and concise understanding of the information sought. (3) To consider the dissemination of responses in the form of policy briefs or factsheets. The use of mass media will make rapid response efforts more visible. (4) Policy dialogue is recommended to foster mutual understanding between policymakers and respondents and to close any knowledge gaps. This will involve exchanging information, perspectives, and experiences among stakeholders to promote a more informed approach to policymaking. It will also enable stakeholders to collaborate, identify common goals and challenges, and develop potential solutions and strategies. (5) Establishment of the COVID-19 rapid response system could be promoted at subnational levels to enhance the culture of evidence-informed policymaking.

Conclusion

We aimed to explain the process involved in the institutionalization of a national COVID-19 rapid response system in the Islamic republic of Iran. The timely response to the questions of policymakers was challenged by the rapid spread of COVID-19. The establishment of a national system that is supported by senior health policymakers is indispensable. It is imperative to develop the capacity to generate and synthesize reliable evidence in a timely manner to ensure its effective utilization. In order to maintain the effectiveness of the COVID-19 rapid response system, periodic evaluations should be conducted to assess its structural and functional capabilities and make necessary modifications.

Acknowledgement

The authors would like to acknowledge the contribution of all committee members.

Funding: None.

Conflict of interest: None declared.

Pertinence du système de riposte rapide à la COVID-19 pour l'élaboration des politiques de santé publique en République islamique d'Iran

Résumé

Contexte : La pandémie de COVID-19 a renforcé la prise de conscience de la nécessité de disposer de bases factuelles de qualité et produites en temps utile pour soutenir l'élaboration des politiques et la prise de décisions dans les situations d'urgence.

Objectif : Décrire l'expérience de l'Institut national de recherche en santé (NIHR) de la République islamique d'Iran en matière d'élaboration de politiques reposant sur des bases factuelles pendant la pandémie de COVID-19.

Méthodes : Durant cette pandémie, le NIHR a institutionnalisé un système de riposte rapide appuyé par une élaboration des politiques et une prise de décisions fondées sur des bases factuelles. Les activités mises en œuvre comprenaient la création d'un comité de gestion de la préparation et de la riposte, la collecte et la fourniture en temps utile d'informations sur la pandémie aux responsables de l'élaboration des politiques, l'établissement d'un calendrier des actions et des activités, et l'utilisation d'un système de rétroinformation pour gérer les réponses et les demandes liées aux politiques.

Résultats : Le comité chargé d'organiser la riposte rapide à la COVID-19 a répondu aux questions de 40 responsables de l'élaboration des politiques en synthétisant et en analysant les données factuelles et en les mettant à la disposition des parties prenantes concernées. Il a élaboré et diffusé des supports de connaissances afin de fournir des informations pertinentes. Pour gérer la pandémie, nous avons constaté qu'il fallait disposer de données plus opportunes ainsi que de données de recherche plus fiables.

Conclusion : Les institutions nationales qui répondent à des situations d'urgence sanitaire doivent assumer la responsabilité de la mise en place et de la gestion d'un système de riposte rapide robuste, capable de fournir des données factuelles valides et opportunes aux responsables de l'élaboration des politiques. Au fil du temps, leurs capacités devraient être suivies, évaluées et renforcées en vue de s'adapter et de riposter convenablement aux pandémies, flambées et épidémies.

أهمية نظام الاستجابة السريعة لكوفيد-19 في رسم سياسات الصحة العامة في جمهورية إيران الإسلامية

علي أكبري-ساري، إلهام احمدنيجاد، زاله عبدي، سهند رياضي-إصفهاني، سارة صافاربور

الخلاصة

الخلفية: ساهمت جائحة كوفيد-19 في زيادة الوعيَ بالحاجة إلى دلائل عالية الجودة، وتتاح في الوقت المناسب لدعم رسم السياسات واتخاذ القرارات في حالات الطوارئ.

الأهداف: هدفت هذه الدراسة الى وصف تجارب المعهد الوطني للبحوث الصحية، جمهورية إيران الإسلامية، في اعتماد عمليات رسم السياسات المسترشدة بالدلائل خلال جائحة كوفيد-19.

طرق البحث: خلال جائحة كوفيد-19، أضفى المعهد الوطني للبحوث الصحية الطابع المؤسسي على نظام الاستجابة السريعة الذي تدعمه عمليات رسم السياسات واتخاذ القرارات المسترشدة بالدلائل . وشملت الأنشطة إنشاء لجنة لإدارة التأهب والاستجابة، وجمع المعلومات عن الجائحة وتقديمها في الوقت المناسب إلى راسمي السياسات، ووضع جدول زمني للإجراءات والأنشطة، وإنشاء نظام للمعلومات الارتجاعية بشأن استجابات السياسات والاستفسارات المتعلقة بها.

النتائج: تناولت لجنة الاستجابة السريعة لجائحة كوفيد-19 أسئلة 40 من راسمي السياسات من خلال توليف الدلائل وتحليلها وإتاحتها لأصحاب المصلحة المعنيين. وطورت منتجات معرفية ونشرتها لتوفير المعلومات ذات الصلة. وقد حددنا الحاجة إلى ضرورة توافر البيانات في الوقت المناسب على نحو أكبر، بالإضافة إلى دلائل بحثية أكثر موثوقية لإدارة الجوائح.

الاستنتاجات: تحتاج المؤسسات الوطنية التي تستجيب للطوارئ الصحية إلى الاضطلاع بمسؤولية إنشاء نظام قوي للاستجابة السريعة قادر على تقديم دلائل صحيحة وفي الوقت المناسب إلى راسمي السياسات. وبمرور الوقت، ينبغي رصد قدراتها وتقييمها وتعزيزها للتكيف مع الجوائح والفاشيات والأوبئة والاستجابة لها على النحو المناسب.

References

1. Kieny M, Bekedam H, Dovlo D, Fitzgerald J, Habicht J, Harrison G, et al. Strengthening health systems for universal health coverage and sustainable development. Bull World Health Organ. 2017 Jul 1;95(7):537–9. https://doi.org/10.2471/BLT.16.187476 PMID:28670019
2. Head BW. Toward more “evidence-informed” policy making? Public Admin Rev. 2016 May/Jun;76(3):472–84 https://doi.org/10.1111/puar.1247
3. Oxman AD, Lavis JN, Fretheim A. Use of evidence in WHO recommendations. Lancet (London, England). 2007 Jun 2;369(9576):1883–9. https://doi.org/10.1016/S0140-6736(07)60675-8 PMID:17493676
4. Developing national institutional capacity for evidence-informed policy-making for health. Cairo: World Health Organization Regional Office for the Eastern Mediterranean; 2019 (EM/RC66/R.5; https://applications.emro.who.int/docs/RC66-R5-eng.pdf?ua=, accessed 221 March 2023).
5. Kuchenmüller T, Lavis J, Kheirandish M, Reveiz L, Reinap M, Okeibunor J, et al. Time for a new global roadmap for supporting evidence into action. PLOS Glob Public Health. 2(6):e0000677. https://doi.org/10.1371/journal.pgph.0000677
6. Lester L, Haby MM, Chapman E, Kuchenmüller T. Evaluation of the performance and achievements of the WHO Evidence-informed Policy Network (EVIPNet) Europe. Health Res Policy Syst. 2020 Sep 24;18(1):109. https://doi.org/10.1186/s12961-020-00612-x PMID:32972421
7. Using research evidence for policy-making: evidence briefs for policy. Virtual meeting for countries from Eastern Europe and Central Asia: report of the introductory session, 6 October 2020. Copenhagen: World Health Organization Regional Office for Europe; 2021 (WHO/EURO: 2021-2017-41772-57224; https://apps.who.int/iris/handle/10665/339783, accessed 21 March 2023).
8. Wilson MG LJ, Gauvin F-P. Issue Brief: developing a ‘rapid-response’ program for health system decision-makers in Canada. Hamilton: McMaster Health Forum, 7 March 2014. https://macsphere.mcmaster.ca/handle/11375/14877
9. COVID-19 strategic preparedness and response plan (SPRP 2021). Geneva: World Health Organization; 2021 (https://www.who.int/publications-detail-redirect/WHO-WHE-2021.02, accessed 15 April 2023).
10. Preparedness and response for the control of COVID-19 in the Islamic Republic of Iran. Tehran: Ministry of Health and Medical Education; 2020.
11. Khalagi K, Gharibzadeh S, Khalili D, Mansournia MA, Mirab Samiee S, Aghamohamadi S, et al. Prevalence of COVID-19 in Iran: results of the first survey of the Iranian COVID-19 Serological Surveillance programme. Clin Microbiol Infect. 2021 Nov;27(11):1666–71. https://doi.org/10.1016/j.cmi.2021.06.002 PMID:34111585

PDF version

Report

Saverio Bellizzi,¹ Humayun Asghar ² and Khalif Bile ³

¹Jordan Country Office, World Health Organization, Amman, Jordan (Correspondence to Saverio Bellizzi: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²Polio Eradication Programme, World Health Organization Regional Office for the Eastern Mediterranean, Cairo, Egypt. ³Health Systems and Policy, Somali and Swedish Researchers’ Association, Vällingby, Sweden.

Abstract

Background: The WHO Regional Office for the Eastern Mediterranean and the United Nations System Staff College (UNSSC) implemented a leadership programme on epidemic and pandemic preparedness and response, specific to the COVID-19 pandemic, during the second half of 2021.

Aims: To highlight the leadership role played by the WHO Jordan Country Office during the COVID-19 pandemic in collaboration with UNSSC.

Programme: The WHO Jordan country office successfully leveraged the expertise of UNSSC to implement a leadership training to prepare key stakeholders in Jordan for the response to COVID-19 and similar pandemics or outbreaks. The training curriculum included several modules such as leadership in times of crisis, strategic thinking and planning, emotional resilience, preparedness, adopting a system approach to response, and multisectoral partnership-building for pandemic response. The training helped strengthen the generation of evidence for policymaking and promotion of equitable access to health during the COVID-19 pandemic.

Conclusion: Leadership capacity strengthening of national counterparts by WHO and partners can help advance efforts at national level to increase the use of evidence for policymaking and response to pandemics and disease outbreaks.

Keywords: leadership programme, preparedness and response, COVID-19, Jordan

Citation: Bellizzi S, Asghar H, Bile K. Supportive public health leadership for COVID-19 response in Jordan. East Mediterr Health J. 2023;29(7):575–579. https://doi.org/10.26719/emhj.23.035 Received: 07/03/22; Accepted: 19/10/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

Jordan was particularly successful in flattening the epidemiological curve during the first months of the COVID-19 pandemic, up to April 2020, due to the implementation of strict nonpharmaceutical interventions (1). However, the progressive easing of restrictions resulted in an exponential increase in cases. The significant upsurge in cases in mid-January 2022, mainly because of the emergence of the Omicron variant was of concern and prompted the Government of Jordan and its national and international partners to consider additional preparedness and response actions.

The World Health Organization (WHO) Jordan Country Office has been a key actor and a primary supporter of the Jordanian Government, including the Ministry of Health, in the response to the COVID-19 pandemic. To further support, strengthen and sustain the leadership capacity of the WHO country offices and their collaborating ministries of health, the WHO Regional Office for the Eastern Mediterranean (WHO/EMRO) and the United Nations System Staff College (UNSSC) launched the Leadership Programme on Epidemic and Pandemic Preparedness and Response during the second half (July–November) of 2021 (2).

Leadership is essential in coordinating a response to public health emergencies, and weak leadership may result in worsening of the effects (3). The expected role of leadership entails establishing and fostering effective partnership that is flexible and adaptable to changes. This specifically entails evidence-based decision-making with attention to health equity and continuous monitoring and evaluation of preparedness and response (3). This report highlights the critical leadership roles and actions played by the WHO Jordan Country Office from the onset of the COVID-19 pandemic to date, including staff well-being, in collaboration with UNSSC.

WHO/EMRO–UNSSC Leadership Programme on Epidemic and Pandemic Preparedness and Response – COVID-19 pandemic cohort

The programme included openly accessible leadership lecture recordings and resources. The exclusive element for the programme participants comprised individual coaching and mentoring by globally recognized champions such as high-profile former WHO staff involved in emergency response. Subjects discussed included leadership in times of crisis, strategic thinking and planning, emotional resilience, preparedness, adopting a system approach and multisectoral partnership building (2).

Decisive, committed and responsible leadership has emerged as a key factor in determining success during the response to the COVID-19 pandemic (4), and a recognized characteristic of decisive leadership is rapid and accurate response, founded on an evidence-based understanding of the threat posed by COVID-19. Effective leaders ensure good coordination between stakeholders, given the political, socioeconomic and health dimensions of the pandemic. Being a leader also necessitates engaging with stakeholders, advocating to strengthen health systems and prioritizing investment in government-funded public health functions and programmes.

WHO Jordan Country Office leadership

From the onset of the COVID-19 pandemic, the WHO country office in Jordan Jordan has engaged with the National Epidemiology Committee (5). The committee includes representatives of several governmental and nongovernmental sectors and, at the request of the relevant authorities within the Ministry of Health, is tasked with providing appropriate technical advice on the management of COVID-19.

The country office was a partner in the development of the COVID-19 preparedness and response plan in March 2020; this was updated regularly through active collaboration between the country office, other stakeholders and Ministry of Health pillar focal points. The office continued playing a prominent role as leader in health and in the United Nations Country Team through technical support, awareness and advocacy. Within the activities of the office of the United Nations Resident Coordinator, WHO staff featured in United Nations town hall meetings, presenting epidemiological updates, and promoting the public health social measures and vaccination. They provided guidance on healthcare under the United Nations Country Team First Line of Defence initiative.

The concerted effort of the WHO, UNICEF, UNESCO and the World Bank was of great importance in averting the reversal of years of progress in education by continuing to promote the “safe reopening framework”, which sought to keep in-person learning at schools available for the majority of students in Jordan (6).

Science and evidence

Generation of evidence has been one of the core activities of the WHO in Jordan. Four rounds of the SARS-CoV-2 epidemiological survey were conducted in addition to risk factor assessment for COVID-19 infection among health workers and the continuing participation in the global initiative to collect clinical data from several hospitals.

The survey results (7) guided various operational aspects such as planning the COVID-19 vaccination campaign and introducing the COVID-19 forecasting model run jointly with the WHO/EMRO (8). This model helped formulate targeted policy recommendations during the pandemic in Jordan.

The study among health workers confirmed that infection, prevention and control standard precautions represent a significant protective factor, and that hand hygiene, both before and after procedures, is a key protective measure. The results were used to tailor infection control and prevention (as well as capacity building) through the Ministry of Health–WHO joint activities in all health care facilities. 

In consideration of the consequences of COVID-19 on other aspects related to health and well-being, the WHO country office engaged in additional research activities. A short situational review aimed to highlight how the national mental health system is an integral part of health system management and sustainability. Specifically, the COVID-19 pandemic offers a unique opportunity to elevate the WHO supported National Mental Health and Substance Use Action Plan 2018–2021 (9).

Similarly, a report was developed on the milestone experience of the Jordanian Ministry of Health, with the support of the WHO country office, which issued a decision to ban all forms of smoking and vaping to ensure 100% smoke-free indoor public places during COVID-19 and beyond (10).

In collaboration with the Jordanian Ministry of Health, the country office was instrumental to the establishment of the first COVID-19 clinical management online training course through WHO/EMRO (11).

Promotion of equitable access to health

The Jordan country office, in close coordination with the Ministry of Health, integrated equity to health services into the COVID-19 preparedness and response plan. The same principle was adopted when developing the national deployment and vaccination plan (12). This whole-of-society approach was of fundamental importance to Jordan, which hosted, at the time, 658 000 registered Syrian refugees (the total estimate was around 1.3 million) and more than 2 million registered Palestinian refugees (12). The whole-of-society approach translated into prompt vaccination coverage and uptake in special contexts such as prisons and other environments that particularly make people vulnerable from a public health perspective (13).

Jordan paved the way for inclusion of refugees and migrants in access to health care services in support of the goals of Universal Health Coverage (UHC). Such an outstanding approach has been highlighted in the WHO Global School on Refugee and Migrant Health (14).

Staff well-being

The WHO Amman Hub comprises the country office, the Regional Centre for Environmental Health Action, the Regional Office for Polio, the Yemen sub-office, and the Common Services Unit. The heads of offices of the WHO Amman Hub merged their efforts in 2020 by creating a pool of technical and administrative COVID-19 focal points, all working closely with the WHO Amman Hub COVID-19 coordinator and the WHO country office emergency team lead. This structure led to streamlined coordination in creating and updating standard operating procedures within the office as well as for the management of staff and their dependants who had tested positive for COVID-19.

Conclusion

The Leadership Programme on Epidemic and Pandemic Preparedness and Response, established by the WHO/EMRO and the UNSSC, has been addressed in various sections of this report.

The first key message is that the WHO country office must be well-positioned during a public health crisis to provide guidance and ensure: proper coordination and communication at all levels; establishment of an emergency response team with clear roles and responsibilities and accountability; monitoring and evaluation of the evolving situation and the response; adoption of an inclusive approach to involve all stakeholders; and equity in access to health services. Although it may prove difficult to ensure the sustainability of the leadership role of WHO at country level throughout the various phases of a crisis, it is critical that strategic decisions are taken (and re-taken) by highlighting the comparative advantage of WHO as a leader in health while creating models of multisectoral and intersectoral partnerships across the health system. These aspects have been highlighted by Pereira Bajard et al., who indicated the importance of strengthening and enabling WHO country offices to enhance resilience at country level for future emergencies (15). In this regard, the authors specifically alluded to the technical and leadership role of country teams within preparedness and response actions.

The continuous participation in the generation, compilation and dissemination of evidence is a clear WHO role and this is critical in building trust, influencing policymakers and ensuring the best public health preparedness, readiness and response (15). This represents the second key message of the leadership programme.

The third key message is the need to use crises like the COVID-19 pandemic as an opportunity to promote innovative approaches that may be of benefit to health and the health system. Such an opportunity has been emphasized by the WHO Director-General, in his call for action on building health system resilience. The 7 recommendations of the related position paper specifically address pre-existing inequities of public health response to emergencies among marginalized and vulnerable populations (16).

The final message is pivotal to the ability of WHO to continue to deliver and operate efficiently during public health crises. Staff well-being is an undeniable aspect in ensuring business continuity and efficient incident management systems. Clear standard operating procedures are critical to streamline actions, especially in complex settings like the WHO Amman Hub where a diversity of offices and staff operate. In the context of changes and crises, leadership plays a crucial role in optimizing interventions and helping staff to cope with overwhelming work situations (17).

The information provided in this report may present useful lessons for dealing with the COVID-19 or a similar pandemic by other WHO country offices and in advancing leadership development in collaboration with national counterparts and partners.

Acknowledgement

We wish to express our gratitude to Agnes Cserhati, whose coaching and mentoring during the WHO/EMRO-UNSSC leadership programme was instrumental in developing this report.

Funding: None.

Competing interests: None declared.

Leadership de soutien en santé publique pour la riposte à la COVID-19 en Jordanie

Résumé

Contexte : Le Bureau régional de l'OMS pour la Méditerranée orientale et l'École des cadres du système des Nations Unies (UNSSC) ont mis en œuvre un programme de leadership sur la préparation et la riposte aux épidémies et aux pandémies, spécifique à la pandémie de COVID-19, au cours du second semestre 2021.

Objectif : Mettre en avant le rôle en matière de leadership joué par le Bureau de pays de l'OMS en Jordanie pendant la pandémie de COVID-19 en collaboration avec l'UNSSC.

Programme : Le Bureau de pays de l'OMS en Jordanie a mis à profit l'expertise de l'UNSSC pour mettre en œuvre une formation au leadership visant à préparer les principales parties prenantes de Jordanie à la riposte à la COVID-19 et à des pandémies ou des flambées épidémiques similaires. Le programme de formation comprenait plusieurs modules tels que le leadership en temps de crise, la réflexion et la planification stratégiques, la résilience émotionnelle, la préparation, l'adoption d'une approche systémique de la riposte et l'établissement de partenariats multisectoriels pour la riposte à la pandémie. Cette formation a contribué à renforcer la production de données probantes pour l'élaboration des politiques et la promotion d'un accès équitable à la santé pendant la pandémie de COVID-19.

Conclusion : Le renforcement des capacités de leadership des homologues nationaux par l'OMS et ses partenaires peut contribuer à faire progresser les efforts au niveau national pour accroître l'utilisation des données probantes dans l'élaboration des politiques et la riposte aux pandémies et aux flambées épidémiques.

قيادة الصحة العامة الداعمة للاستجابة لكوفيد-19 في الأردن

سافيريو بيليزي، همايون أصغر، خليف بيلي

الخلاصة

الخلفية: نفَّذ كلٌّ من المكتب الإقليمي لمنظمة الصحة العالمية لشرق المتوسط وكلية موظفي منظومة الأمم المتحدة برنامجًا للقيادة بشأن التأهب للأوبئة والجوائح ومواجهتها، لا سيما جائحة كوفيد-19، خلال النصف الثاني من عام 2021.

الأهداف: هدفت هذه الدراسة الى تسليط الضوء على دور القيادة الذي اضطلع به المكتب القُطري للمنظمة في الأردن خلال جائحة كوفيد-19 بالتعاون مع كلية موظفي منظومة الأمم المتحدة.

البرنامج: نجح المكتب القُطري للمنظمة في الأردن في الاستفادة من خبرة كلية موظفي منظومة الأمم المتحدة في تنفيذ تدريب على القيادة لإعداد أصحاب المصلحة الرئيسيين في الأردن للاستجابة لكوفيد-19 والجوائح أو الفاشيات المماثلة. واشتمل منهج التدريب على عدة وحدات تدريبية مثل، القيادة في أوقات الأزمات، والتفكير والتخطيط الاستراتيجيين، والقدرة على الصمود العاطفي، والتأهب، واعتماد نهج قائم على النظام في الاستجابة، وبناء شراكات متعددة القطاعات للاستجابة للجوائح. وقد ساعد التدريب على تعزيز إعداد الدلائل اللازمة لرسم السياسات وتعزيز إتاحة الخدمات الصحية بإنصاف خلال جائحة كوفيد-19.

الاستنتاجات: من شأن تعزيز المنظمة والشركاء لقدرات القيادة للجهات النظيرة الوطنية أن يساعد على النهوض بالجهود المبذولة على المستوى الوطني لزيادة استخدام الدلائل في رسم السياسات والاستجابة للجوائح وفاشيات الأمراض.

References

1. Kheirallah KA, Alsinglawi B, Alzoubi A, Saidan MN, Mubin O, Alorjani MS, et al. The effect of strict state measures on the epidemiologic curve of covid-19 infection in the context of a developing country: a simulation from Jordan. Int J Environ Res Public Health. 2020;17:1–11. doi:10.3390/ijerph17186530
2. WHO EMRO/UNSSC Leadership Programme on Epidemic and Pandemic Preparedness and Response – COVID-19 Pandemic Cohort. Geneva: World Health Organization; 2021 (https://openwho.org/courses/leadership-programme-EMRO-UNSSC, accessed 1 November 2022).
3. Fos PJ, Honoré PA, Honoré RL. Coordination of public health response: the role of leadership in responding to public health emergencies. In: Guerrero E, ed. Science-based approaches to effectively respond to public health emergencies. London: IntechOpen; 2021. doi:10.5772/intechopen.96304.
4. Al Saidi AMO, Nur FA, Al-Mandhari AS, El Rabbat M, Hafeez A, Abubakar A. Decisive leadership is a necessity in the COVID-19 response. Lancet. 2020 Aug 1;396(10247):295–8. doi:10.1016/S0140-6736(20)31493-8.
5. Ben Mimoune N. Policy and institutional responses to COVID-19 in the Middle East and North Africa: Jordan. Washington DC: Brookings; 2020 (https://www.brookings.edu/research/policy-and-institutional-responses-to-covid-19-in-the-middle-east-and-north-africa-jordan/, accessed 1 November 2022).
6. Schools should be “last to close, first to open”. Amman: UNICEF Jordan; 2022 (https://www.unicef.org/jordan/press-releases/schools-should-be-last-close-first-open, accessed 1 November 2022).
7. Bellizzi S, Alsawalha L, Sheikh Ali S, Sharkas G, Muthu N, Ghazo M, et al. A three-phase population based sero-epidemiological study: assessing the trend in prevalence of SARS-CoV-2 during COVID-19 pandemic in Jordan. One Health. 2021 Jul 10;13:100292. doi:10.1016/j.onehlt.2021.100292
8. WHO supports generating evidence for decision-making in Jordan during COVID-19. Geneva: World Health Organization; 2021 (https://www.who.int/about/accountability/results/who-results-report-2020-mtr/country-story/2020/jordan, accessed 1 November 2022).
9. Bellizzi S, Alsawalha L, Samawi L, Al-Shaikh A, Alfar H, Muthu N, Profili MC. The impact of the SARS-CoV-2 pandemic on mental health in vulnerable population settings: the case of Jordan. Front Psychiatry. 2021 Jul 22;12:692541. doi:10.3389/fpsyt.2021.692541
10. Bellizzi S, AlResheidat Z, Boukerdenna H. COVID-19 as a game changer for national tobacco policies: the experience of Jordan. Nicotine Tob Res. 2022 Jul 13;24(8):1319–20. doi:10.1093/ntr/ntac022
11. WHO launches COVID-19 clinical management online training. Cairo: World Health Organization Regional Office for the Eastern Mediterranean; 2020 (http://www.emro.who.int/jor/jordan-news/who-launches-covid-19-clinical-management-online-training.html, accessed 1 March 2022).
12. Bellizzi S, Aidyralieva C, Alsawhala L, Al-Shaikh A, Santoro A, Profili MC. Vaccination for SARS-CoV-2 of migrants and refugees, Jordan. Bull World Health Organ. 2021 Sep 1;99(9):611. doi:10.2471/BLT.21.285591
13. Bellizzi S, Aidyralieva C, Al-Shaikh A, Muthu N, Al-Sadder A, Al-Raiby J. Inclusiveness of prisons in COVID-19 vaccination deployment: evidence from Jordan. Vaccine. 2022 Jan 3;40(1):1–2. doi:10.1016/j.vaccine.2021.11.022
14. WHO Global School on Refugee and Migrant Health. Geneva: World Health Organization; 2021 (https://www.who.int/news-room/events/detail/2021/10/25/default-calendar/who-global-school-on-refugee-and-migrant-health, accessed 1 November 2022).
15. Pereira Bajard M, Stephens N, Eidman J, Warren KT, Molinaro P, McDonough-Thayer C, et al. Serving the vulnerable: the World Health Organization’s scaled support to countries during the first year of the COVID-19 pandemic. Front Public Health. 2022 Mar 10;10:837504. doi:10.3389/fpubh.2022.837504
16. Ghebreyesus TA, Jakab Z, Ryan MJ, Mahjour J, Dalil S, Chungong S, et al. WHO recommendations for resilient health systems. Bull World Health Organ. 2022 Apr 1;100(4):240–240A. doi:10.2471/BLT.22.287843
17. Spagnoli P, Molino M, Molinaro D, Giancaspro ML, Manuti A, Ghislieri C. Workaholism and technostress during the COVID-19 emergency: the crucial role of the leaders on remote working. Front Psychol. 2020 Dec 23;11:620310. doi:10.3389/fpsyg.2020.620310

PDF version

Report

Duaa Alammari,^1,2 Hanan Al-Kadri,^1-3 Mansour Al-Qurashi,^2,4,5 Majid Alshamrani,^2,6,7 Fayssal Farahat,^1,2,8 Aiman Altamimi ⁹ and Anmar Najjar ⁴ 

¹College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia (Correspondence to D. Alammari: This email address is being protected from spambots. You need JavaScript enabled to view it.). ²King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. ³Obstetrics and Gynecology Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. ⁴College of Medicine–Jeddah, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. ⁵Pediatric and Neonatal Department, King Abdul-Aziz Medical City, Jeddah, Saudi Arabia.College of Medicine, King Saud Bin Abdulaziz University for Health Sciences Riyadh, Saudi Arabia. ⁷Departments of Internal Medicine and Infectious Diseases, King Abdulaziz Medical City, Riyadh, Saudi Arabia. ⁸Department of Public Health and Community Medicine, King Abdulaziz Medical City, Riyadh, Saudi Arabia. ⁹University Relations and Media Affairs Department, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.

Abstract  

Background: Rejection, hesitancy and low uptake of the COVID-19 vaccine are major public health challenges in Saudi Arabia.

Aims: To address COVID-19 vaccine hesitancy and rejection at the King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS) using evidence-based strategies.

Methods: A questionnaire was administered electronically to participants at KSAU-HS to understand the reasons for vaccine hesitancy or rejection and develop an evidence-informed vaccination plan. Initial results from March 2021 showed that only 60% of respondents had taken at least 1 COVID-19 vaccine dose. Based on the results of the survey, KSAU-HS designed a 6-month vaccination campaign to raise awareness about the vaccine and its importance and increase acceptability rates. Mass media, social media, and direct messaging as reminders were used to address the barriers identified and to help the university community overcome fears and misconceptions about the COVID-19 vaccine. 

Results: The evidence-based interventions helped achieve a significantly high vaccination rate in the university community, with 99.7% of individuals vaccinated by October 2021; one of the highest vaccination rates among public universities in Saudi Arabia. 

Conclusion: Evidence-based interventions targeted at specific populations can help address prevailing concerns about the COVID-19 vaccine and other similar public health issues.

Keywords: vaccine, vaccination, COVID-19, vaccine hesitancy, university, Saudi Arabia

Citation: Alammari D, Al-Kadri H, Al-Qurashi M, Alshamrani M, Farahat F, et al. Improving COVID-19 vaccine uptake: lessons from an academic institution in Saudi Arabia. East Mediterr Health J. 2023;29(7):580–586. https://doi.org/10.26719/emhj.23.034 Received: 18/07/22; Accepted: 08/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

Introduction

COVID-19 has had a profound impact on public health locally and globally. A report by the Saudi Ministry of Health on 9 February 2021 showed that there were 362 368 cases of COVID-19 and 6415 deaths in the country (1) (Figure 1).

King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS) is a government university that was founded on 6 March 2005 (2). As of early 2020, KSAU-HS had 14 922 affiliates: 777 faculty members, 2979 administrative staff, and 11 166 students (2). Shortly after the first case of COVID-19 was diagnosed in Saudi Arabia, academic institutions were advised to take precautions to contain the spread of the disease. 

Vaccination during a pandemic is among the most effective strategies for containment of the situation (3,4). Therefore, the Saudi Government and Ministry of

Health developed a risk management plan to mitigate the impact of COVID-19 and reduce the rate of infection. Widespread vaccination was one of the recommended strategies, especially in high-risk facilities like universities. In mid-December 2020, Pfizer-BioNtech was the first vaccine against COVID-19 approved in Saudi Arabia, with 500 000 doses delivered (5). However, COVID-19 vaccine hesitancy contributed significantly to the slow vaccination coverage throughout Saudi Arabia.  

KSAU-HS is under the umbrella of the Ministry of National Guard Health Affairs, which had extensive experience with infection control and prevention following the MERS-CoV outbreak at the facility in 2015. At that time, emergency preparedness and infection prevention practices were revised to contain the spread of the disease. As a result, plans for future crisis management were developed and made available at the facility to deal with similar situations (6). Management of the MERS-CoV outbreak was enhanced with the involvement of staff members in sharing experiences and relevant knowledge, developing trust and teamwork, and promoting collective leadership. Recommendations were made to improve crisis management strategies, manage the media, and take proactive actions in advising and supporting staff (6).

In light of the precedent set by the Ministry of National Guard Health Affairs, the KSAU-HS COVID-19 Crises Management Committee was formed in February 2020 with the goal of implementing health protection and disease prevention programmes and policies across all its 3 campuses. The KSAU-HS COVID-19 Infection Prevention and Control Advisory Subcommittee was also formed. Shortly after that, all Saudi universities were instructed to establish committees to combat the spread of COVID-19. Vaccination planning was delegated to the Infection Prevention and Control Advisory Subcommittee, which met with stakeholders to discuss plans and implementation strategies. The preliminary vaccination plans included the establishment of vaccination centres on campuses to facilitate vaccination in the university communities. The subcommittee sought to collect accurate data on vaccination history and hesitancy in the university so they could propose an evidence-based vaccination plan that would meet the needs of the university and the urgency of the pandemic.

The aim was to vaccinate all KSAU-HS affiliates within a limited time using evidence-based strategies to address COVID-19 vaccine hesitancy. All university residents were required to be vaccinated with 2 doses by 1 August 2021, otherwise they would not be allowed on university premises as per the government regulations.

Methods

KSAU-HS developed a comprehensive plan to improve COVID-19 vaccine uptake, which consisted of 3 phases: (1) situation analysis (baseline assessment); (2) stakeholder engagement (streamlining current and accurate data); and (3) community engagement through social and traditional media (awareness programme).

Phase 1: Situational analysis (baseline assessment)

To obtain accurate data that would inform future decisions, the COVID-19 Infection Prevention and Control Advisory Subcommittee created a standard form and distributed it to colleges and deanships to collect data about vaccination rates among their communities, with weekly follow-up. They then worked with the Saudi Ministry of Education to update the vaccination data based on national sources (such as Tawaklna). Throughout the process, college deans and directors were actively involved and provided timely reports to the subcommittee. As a result of the baseline and situational assessment, current and accurate vaccination rates were available at KSAU-HS. This phase helped decision-makers understand the situation and prepared them to support the development of plans, policies, and strategies for vaccination management.

Phase 2: Stakeholder engagement (streamlining current and accurate data)

After the initial phase of data collection, the COVID-19 Infection Prevention and Control Advisory Subcommittee planned conducted an in-house survey to gather more information about vaccine uptake rates and reasons for hesitancy . The survey questionnaire was distributed between March and May 2021 via email through the University Message Center with a link to the web survey. It included demographic information, vaccination data, and reasons for vaccine hesitancy. A total of 7167 (48%) participants completed the survey. Results were reported periodically to relevant decision-makers and COVID-19 committees. A live dashboard was created to provide timely updates to senior leadership (Figure 2). The dashboard displayed various data in charts, including the reasons given by KSAU-HS affiliates for not vaccinating, such as safety concerns, appointment availability, efficacy, past COVID-19 infection, preference for a particular vaccine that was not available, and pregnancy or breastfeeding (Figure 2 and Table 1). The survey results were used to develop an evidence-based vaccination plan to achieve the target vaccination rates.

Drawing on the university’s experience with the MERS-CoV outbreak, it was critical to reach out to different stakeholders, such as affiliates and management, to increase their involvement in the decision-making process and successfully control the spread of COVID-19 at the institution. This strategy yielded positive results in the past and fostered shared leadership and accountability (6).

Phase 3: Community engagement through social and traditional media (awareness programme)

The COVID-19 Infection Prevention and Control Advisory Subcommittee developed a COVID-19 vaccination awareness programme using the results of the survey, which used social media as one of the main distribution channels. The Saudi population is one of the largest internet users globally, with nearly 96% of people using the internet and 80% using social media in 2021 (7). A review of scientific evidence suggested the positive impact of using social media to raise awareness and change health behaviour by disseminating brief messages to the target population (3,4). Social media is a fast and efficient way to communicate with the general public and health professionals to promote infection prevention strategies and community engagement, especially during outbreaks (3,4). Therefore, the internet and social media were used extensively for the awareness programme (intervention) implemented by KSAU-HS (Tables 1 and 2).

Intervention

The COVID-19 committees launched a COVID-19 vaccine hesitancy and awareness programme aimed at highlighting the importance of vaccination for the prevention and control of COVID-19 pandemic. The plan was to increase vaccination rates and address reasons for vaccine hesitancy. The programme was developed in collaboration with the Department of University Relations and Media Affairs at KSAU-HS and relied on multiple sources, including survey results and national (Ministry of Health) and global (World Health Organization; WHO) data. The survey results were used to identify the target audiences and to create targeted messages that addressed reasons for vaccine hesitancy (Table 1). It was critical to address vaccine-specific issues, risks, and benefits, and to highlight issues related to newly approved vaccines. It was also critical to establish active and accessible vaccination centres on university campuses, as non-availability of vaccination centres was among the reasons for vaccine hesitancy. The programme was launched on 6 June 2021 and designed to encourage individuals and social groups to get vaccinated. This was accomplished by disseminating key facts and sharing personal experiences. The Department of University Relations and Media Affairs was responsible for disseminating regular awareness messages and social media posts. This also included university-owned communication channels, such as social media, SMS, and message center. Initiatives also included educational media, announcements, workshops, seminars, and consultations. A list of the interventions is outlined in Table 2.

Results 

Uptake of the first dose of COVID-19 vaccine increased significantly from 63% to 87%  between May and July 2021 (Figure 3). The progress made by KSAU-HS was achieved prior to the COVID-19 vaccination mandate, which took effect on 1 August 2021. The mandatory national vaccination was a Saudi Government decision, and universities were instructed to adhere to the deadlines set by the Ministry of Education and Ministry of Health. Following the mandate, vaccination rates for the first and second doses increased to 99.7% and 99.3%, respectively in October (Figure 3). By the end of October 2021, KSAU-HS had the highest rate of COVID-19 vaccination among the 27 public universities in Saudi Arabia.

Key challenges in implementing the vaccine uptake programme

The presence of outdated or miscommunication of data regarding university community members presented a challenge to collecting accurate data and analysing the situation. A designated team had to manually filter and update the data to eliminate discrepancies.

Vaccine availability was limited between June and August 2021 because of high demand locally and globally, which impacted adherence to vaccination requirements and guidelines.

Survey distribution via email did not produce a high response rate when used as a stand-alone data collection method.

Conclusion

Evidence-based strategies can yield the desired results within a short period, especially for time-sensitive issues. Fear and uncertainty hampered COVID-19 vaccine acceptance. Social media is a powerful tool for reaching a large audience in a timely and cost-effective manner, particularly in critical situations like pandemics. It boosts public awareness and encourages acceptance of new regulations and policies. One key factor to note is that the commitment of the Saudi Government to increasing the uptake of COVID-19 vaccine nationwide may have also contributed to the overall increase in vaccine coverage at KSAU-HS.

Acknowledgement

We would like to acknowledge the contribution of Dr. Arash Rashidian, Director of Science, Information and Dissemination at WHO Regional Office for the Eastern Mediterranean (EMRO); Dr. Mehrnaz Kheirandish, Regional Advisor for Evidence and Data to Policy at EMRO; and Ms. Sumithra Krishnamurthy Reddiar, Technical Officer, Evidence and Data to Policy at EMRO for their technical advice and support through all stages of the development of the case study. We thank Ms. Hala Hamada, Programme Assistant, Evidence and Data to Policy at EMRO for administrative support. We acknowledge the Division of Science, Information and Dissemination/Evidence and Data to Policy Unit at EMRO for funding development of the case study.

Funding: None.

Competing interests: None declared.

Amélioration de l'adoption du vaccin anti-COVID-19 : enseignements tirés d'un établissement universitaire en Arabie saoudite 

Résumé  

Contexte : Le rejet, la faible adoption du vaccin anti-COVID-19 et la réticence face à ce vaccin constituent des défis de santé publique majeurs en Arabie saoudite.

Objectif : Faire face au rejet du vaccin anti-COVID-19 et à la réticence concernant ce vaccin à l'Université King Saud Bin Abdulaziz des sciences de la santé (KSAU-HS) en utilisant des stratégies fondées sur des données probantes.

Méthodes : Un questionnaire a été distribué par voie électronique aux participants de l'Université afin de comprendre les raisons motivant le rejet face à la vaccination et la réticence exprimée à cet égard et d'élaborer un plan de vaccination fondé sur des données probantes. Les premiers résultats de mars 2021 ont montré que 60 % des personnes interrogées seulement avaient reçu au moins une dose de vaccin anti-COVID-19. Sur la base des résultats de l'enquête, l'université susmentionnée a conçu une campagne de vaccination de six mois visant à sensibiliser au vaccin et à son importance, ainsi qu'à accroître les taux d'acceptation. Les médias de masse, les réseaux sociaux et la messagerie directe pour diffuser des rappels ont été utilisés afin de lever les obstacles identifiés et d'aider la communauté universitaire à surmonter les craintes et les idées fausses au sujet du vaccin anti-COVID-19. 

Résultats : Les interventions fondées sur des données probantes ont permis d'atteindre un taux de vaccination considérable dans la communauté universitaire, avec 99,7 % de personnes vaccinées en octobre 2021, soit l'un des taux de vaccination les plus élevés parmi les universités publiques d'Arabie saoudite. 

Conclusion : Des interventions fondées sur des données probantes ciblant des populations spécifiques peuvent aider à répondre aux préoccupations prédominantes concernant le vaccin anti-COVID-19 et d'autres questions de santé publique similaires.

تحسين الحصول على لقاح كوفيد-19: الدروس المستفادة من إحدى المؤسسات الأكاديمية في المملكة العربية السعودية

دعاء العماري ، حنان القدري، منصور القرشي، ماجد الشمراني، فيصل فرحات، أيمن التميمي، أنمار نجار 

الخلاصة  

الخلفية: يُشكل رفض لقاح كوفيد-19، والتردد في أخذه وانخفاض الإقبال عليه تحديات رئيسية في مجال الصحة العامة في المملكة العربية السعودية.

الأهداف: هدفت هذه الدراسة الى معالجة التردد في أخذ لقاح كوفيد-19 ورفضه في "جامعة الملك سعود بن عبد العزيز للعلوم الصحية"، باستخدام استراتيجيات مسترشدة بالدلائل .

طرق البحث: أُرسل استبيان إلكتروني إلى المشاركين في "جامعة الملك سعود بن عبد العزيز للعلوم الصحية"، لفهم أسباب التردد في أخذ اللقاح أو رفضه، ووضْعِ خطة للتطعيم مسترشدة بالدلائل . وأظهرت النتائج الأولية من مارس/ آذار 2021 أن 60% من المستجيبين تناولوا جرعة واحدة على الأقل من لقاح كوفيد-19. واستنادًا إلى نتائج المسح، صممت "جامعة الملك سعود بن عبد العزيز للعلوم الصحية" حملة تطعيم مدتها 6 أشهر لإذكاء الوعي بشأن اللقاح وأهميته، وزيادة معدلات قبوله. واستُخدمت وسائل الإعلام الجماهيرية ووسائل التواصل الاجتماعي والرسائل المباشرة على سبيل التذكير للتغلب على العقبات التي حُددت، ولمساعدة مجتمع الجامعة في التغلب على المخاوف والمفاهيم الخاطئة بشأن لقاح كوفيد-19. 

النتائج: ساعدت التدخلات المسترشدة بالدلائل على تحقيق معدل تطعيم مرتفع إلى حد كبير في مجتمع الجامعة، إذ حصل 99.7% من الأفراد على التطعيم بحلول أكتوبر/ تشرين الأول 2021؛ وهو أحد أعلى معدلات التطعيم بين الجامعات العامة في المملكة العربية السعودية. 

الاستنتاجات: من شأن التدخلات المسترشدة بالدلائل التي تستهدف فئات سكانية مُحددة أن تساعد في معالجة المخاوف السائدة بشأن لقاح كوفيد-19 وغيره من قضايا الصحة العامة المماثلة.

Reference

1. Saudi Arabia Coronavirus disease (COVID-19) situation [website]. KAPSARC Data Portal: 2021 (https://datasource.kapsarc.org/explore/dataset/saudi-arabia-coronavirus-disease-covid-19-situation/information/?disjunctive.daily_cumulative&disjunctive.indicator&disjunctive.event&disjunctive.city_en&disjunctive.region_en, accessed 14 January 2023).

2. About us [website]. King Saud bin Abdulaziz University for Health Sciences; 2021 (https://www.ksau-hs.edu.sa/English/aboutus/pages/about.aspx, accessed 14 January 2023).

3. Al-Dmour H, Salman A, Abuhashesh M, Al-Dmour R. Influence of social media platforms on public health protection against the COVID-19 pandemic via the mediating effects of public health awareness and behavioral changes: integrated model. J Med Internet Res. 2020 Aug 19;22(8):e19996. https://doi.org/10.2196/19996 PMID:32750004

4. Mohammed W, Alanzi T, Alanezi F, Alhodaib H, AlShammari M. Usage of social media for health awareness purposes among health educators and students in Saudi Arabia. Inform Med Unlocked. 2021;23:100553. https://doi.org/10.1016/j.imu.2021.100553

5. Assiri A, Al-Tawfiq JA, Alkhalifa M, Al Duhailan H, Al Qahtani S, Dawas RA, et al. Launching COVID-19 vaccination in Saudi Arabia: lessons learned, and the way forward. Travel Med Infect Dis. 2021 Sep–Oct;43:102119. https://doi.org/10.1016/j.tmaid.2021.102119 PMID:34133965

6. Al Knawy BA, Al-Kadri HM, Elbarbary M, Arabi Y, Balkhy HH, Clark A. Perceptions of postoutbreak management by management and healthcare workers of a Middle East respiratory syndrome outbreak in a tertiary care hospital: a qualitative study. BMJ Open. 2019 May 5;9(5):e017476. https://doi.org/10.1136/bmjopen-2017-017476 PMID:31061009

7. Kemp S. Digital 2021: Saudi Arabia [website]. DATAREPORTAL; 2021 (https://datareportal.com/reports/digital-2021-saudi-arabia, accessed 14 January 2023).

PDF version

Reports

Fatemeh Bahmani,¹ Alireza Parsapour,² Nasrin Abbasi,³ Seyyed Zahraei,⁴ Nader Tavakoli⁵ and Ehsan Shamsi-Gooshki²

¹Department of Medical Ethics, School of Medicine; ⁵Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. 2Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran (Correspondence to: Shamsi G. Ehsan: This email address is being protected from spambots. You need JavaScript enabled to view it.). ³Medical Ethics Department, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran. ⁴Center for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran.

Abstract

Background: Priority-setting for early access to vaccines during a pandemic optimizes the impact of vaccine rollout, however, low- and middle-income countries (LMICs) have little experience in policymaking on this. In the Islamic Republic of Iran, the national clinical ethics committee developed a policy for early access to COVID-19 vaccines with support from the national committee on COVID-19 vaccine.

Aims: This paper reports the process and results of a national COVID-19 vaccine priority-setting in the Islamic Republic of Iran and discusses its ethical and cultural aspects.

Methods: A multidisciplinary team of experts planned and developed a national guideline following an extensive literature review and face-to-face consultations.

Results: We present the list of priority groups and subgroups, tiered through a 4-phase process, as well as the ethical values and sociocultural issues underpinning COVID-19 vaccine prioritization in the Islamic Republic of Iran.

Conclusions: Our experience shows that a transparent and well-reasoned policymaking process can inform fair priority-setting for pandemic vaccines, especially in LMICs.

Keywords: priority-setting, vaccine, vaccination, COVID-19, prioritization, health policy, ethics, Iran

Citation: Bahmani F, Parsapour A, Abbasi N, Zahraei S, Tavakoli N, Shamsi-Gooshki E. Priority-setting for early access to COVID-19 vaccines in Islamic Republic of Iran. East Mediterr Health J. 2023;29(7):587–598. https://doi.org/10.26719/emhj.23.040 
Received: 22/07/22; Accepted: 08/12/22

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo).

Introduction

The COVID-19 pandemic has negatively changed the world and caused great harm, including direct damage to global health, with 534 439 577 confirmed cases and 6 307 218 confirmed deaths worldwide as of 10 June 2022 (1). The pandemic has caused indirect harm by diminishing healthcare delivery to patients with noncommunicable diseases (2); negative consequences for the mental health of the world population (3); and devastating economic losses in low-, middle- and even high-income countries (4,5). The Islamic Republic of Iran documented a surge of COVID-19 cases shortly after the official announcement of the first deaths due to SARS-CoV-2 on 19 February, and as of 10 June 2022, 7 233 472 confirmed COVID-19 cases and 141 343 deaths had been reported (1).

Vaccination is essential to mitigate the harms caused by infectious disease outbreaks, and priority-setting for access to vaccines optimizes the impact of vaccine rollout (6). Inequitable access to safe and effective vaccinaton demands fairness and justice-driven debate around priority-setting for access (7). Prioritization of access to the SARS-CoV-2 vaccine was essential and challenging because supplies were predicted to be critically low in the early phase of vaccine release.

Priority-setting involves processes to decide on the allocation of resources among competing programmes or groups of people (8). There is an increasing demand for explicit, evidence-based prioritization (8) as this can help policymakers better accept their responsibility by increasing public awareness vis-à-vis healthcare decision-making (9).

Hence, in the middle of the COVID-19 pandemic, when the vaccine manufacturers were fighting hard to deliver their first batches, the Strategic Advisory Group of Experts on Immunization of the World Health Organization (WHO) guided countries toward vaccination programmes based on transparent and fair prioritization plans. The WHO provided ethical guidance by publishing a values framework for prioritizing access to the COVID-19 vaccine (10), followed by a prioritization roadmap (6). Health ethics experts and policymakers also made efforts to guide vaccine allocation policies ethically. For example, in the United States of America, in August 2020, the Center for Health Security at Johns Hopkins University published an interim framework for COVID-19 vaccine allocation (11). In September 2020, the Advisory Committee on Immunization Practices proposed 5 ethical principles for distributing the vaccine (12). In October 2020, the final report of a robust study on COVID-19 vaccine allocation by The National Academies of Sciences, Engineering, and Medicine was published (13).

These documents exemplified a rich body of bioethical academic reflection on pandemic vaccine priority-setting in developed countries. Less attention has been paid to addressing the practical application of the proposed frameworks across low- and middle-income countries (LMICs) (14). Although LMICs have little experience in policymaking on priority-setting in general, and for pandemic vaccines in particular (15), research shows that in these countries, priority-setting is commonly based on disorganized reasoning, which arises through ad hoc or implicit processes and lacks reliable evidence, leading to poor health policymaking (15). Indeed, countries in the Middle East are vulnerable to pandemics because of their specific cultural, political and economic context (16).

The Iranian National Clinical Ethics Committee has been established as a policymaking, supervisory and decision-making body in the Ministry of Health and Medical Education since 2018. It is responsible for developing national guidelines on clinical and public health ethics. With support from the national committee on the COVID-19 vaccine, the National Clinical Ethics Committee developed a guideline for early access to COVID-19 vaccines. This study reports the process and results of the collaborative efforts of the National Clinical Ethics Committee and the National Immunization Technical Advisory Group, known as the COVID-19 Vaccine Technical Committee, in determining priority groups for access to the COVID-19 vaccine, and discusses the cultural aspects of policymaking on vaccine prioritization in the Islamic Republic of Iran.

Methods

Planning

The secretariat of the National Clinical Ethics Committee developed and approved a planning proposal, which defined the scope of the guideline, including its overall purposes, target users, necessary implementation activities, main outcomes, resources and timing

(Figure 1). Accordingly, in November 2020 a working group was formed, comprising experts in public health, epidemiology, patient rights and medical ethics along with medical professionals involved in managing the response to the COVID-19 pandemic (Table 1). All invited experts declared that they had no conflict of interest regarding the subject of the guideline and its publication.

Guideline development process

Review of existing guidelines and country priority lists

We conducted 2 nonsystematic literature reviews in November and December 2020 to answer the review questions below.

Which ethical principles and values play a role in early pandemic vaccine allocation and how do they manifest this?

What are the priorities for access to COVID-19 vaccine in different countries?

The key search terms were “vaccine prioritization”, “vaccine allocation” and “vaccination ethics”. We searched the MEDLINE database via PubMed and Google Scholar for articles published between January 2019 and 31 December 2020. Key bioethics databases and recently developed guidelines for COVID-19 vaccine allocation were also searched. We manually included COVID-19 vaccine priority lists of countries and institutes from national and international websites. No geographical limitations were applied, however, we limited the search languages to English and French.

Articles were included if they contained the primary search terms “vaccine”, “allocation” and “prioritization”. A total of 217 records were identified, and after removing duplicates, editorials and commentary articles, and articles discussing global vaccine allocation or mathematical and computer simulation models, 14 papers and 10 guidelines were included for review.

Generation of a comparative list of priority groups and subgroups

We generated a comparative list of priority groups and subgroups by organizing the data extracted from the literature review into a table in which the rows represented the priority population groups and subgroups, the columns represented each country or guideline, and the cell entries specified the rank of that population group or subgroup in the priority list for different countries or guidelines (Table 2).

Development of value framework, identification of prioritization objectives and drafting the guideline

By conducting review sessions and through reflection and prudent debate about the existing literature on ethics and vaccine allocation during pandemics, we sketched a value framework for prioritizing the COVID-19 vaccine (Table 3). We proposed a preliminary priority list according to the average ranking of each population group on the comparative list (Table 2) and the value framework. The value framework and the priority list were sent electronically to 2 qualified external experts for peer review and impartial evaluation and revised accordingly, which yielded a first draft of the guideline.

Developing consensus

Given the time-sensitive nature of the guideline, we employed a face-to-face consensus meeting. The panel included expert members of the National Immunization Technical Advisory Group (Table 1) and the lead author, an expert in medical ethics.

To shorten consensus-making timeframes, the lead author circulated the draft to all members, gathered and qualitatively analysed the comments, and prepared a summary report. After that, all priority groups were openly discussed in several meetings at the Ministry of Health and Medical Education and a consensus of > 70% was achieved for all priorities.

Review and approval

The National Vaccine Committee approved the prioritization list. Subsequently, a joint meeting of the Supreme Council of Medical Ethics (the highest bioethics body in the country, a part of the policy approval framework in the Ministry of Health and Medical Education) and the National Clinical Ethics Committee recognized the guideline in line with the Iranian constitution and upstream laws, and issued the final approval for the Ministry of Health and Medical Education.

National endorsement and dissemination

On 10 January 2021, the National Headquarters for COVID-19 Control, the first body established in the Presidential Institution to manage the response to COVID-19, endorsed the guideline officially and released it to local media as Chapter 4 of the “COVID-19 National Deployment and Vaccination Plan”.

Results

The expert groups involved in the various decision-making stages represented a diverse range of expertise, age, sex and academic roles. For details of the groups, see Table 1.

The 2 fundamental values of maximizing benefit and justice and the 2 operational concepts of utility and equity were recognized as culturally appropriate to ethically guide the prioritization of access to the COVID-19 vaccine (Table 3). The guideline recommended a 4-phase process for vaccine allocation; each phase was split into subphases, including tiered population groups (Table 4).

Discussion

Overview

This study describes the consultative process that resulted in the urgent development of an ethical guideline for prioritizing access to COVID-19 vaccines in the Islamic Republic of Iran between November 2020 and January 2021. Here we discuss the cultural aspects which informed our decision-making.

Starting vaccine rollout with healthcare workers: truthful risk communication and maintaining public trust

The value “maximizing benefits and minimizing harms” is central to public health policymaking. The objective is to determine which policy is the best to protect people from hospitalization and death because of COVID-19, and implies that older adults, who bear the highest rate of hospitalization and death (17), have priority access to vaccine. However, we recommended prioritizing front-line healthcare workers over those individuals at a very high risk of getting sick and dying from COVID-19 in the first phase. This decision is in agreement with the recommendations of WHO (6) and National Academies of Sciences, Engineering, and Medicine guidelines (13), but is at variance with the Advisory Committee on Immunization Practices report, which places healthcare workers and elderly residents in long-time care facilities in the first phase, without specifying the priority group (18).

Besides the ethical justification commonly buoying the placing of healthcare workers as the top priority for vaccination, our decision was based on trust and the imperative to increase public confidence in the COVID-19 vaccine.

Trustworthiness is a virtue, and building a climate of trust is vital for the healthcare setting (19). People demand trust through the honest and transparent communication from governments in response to the COVID-19 pandemic (20). Vaccine confidence has been a challenging issue for a long time, and is closely related to public trust in the broader healthcare system (21). Although the COVID-19 vaccines have been proved safe and efficient by scientific evidence, the issue of building trust constitutes an essential aspect of COVID-19 vaccine uptake due to the expediency of the vaccine development and the emergency use authorization by the food and drug regulatory systems around the world (22).

However, there are specific issues that may impinge on public trust regarding COVID-19 vaccines in the Islamic Republic of Iran. First, the younger and healthier population of healthcare workers was given priority because there was great uncertainty about which vaccines would be available in the early stages and the side-effects and safety of the available vaccines. Second, COVID-19 mortality rates are typically higher among frail elderly persons and those with severe underlying conditions than among healthcare workers. For example, in the first month of the COVID-19 vaccine rollout, 113 deaths were reported after vaccination, of which 78 (65%) occurred among residents of long-term care facilities without any detected causal relationship (23).

Given that vaccine confidence depends on the perceived risk of the vaccine causing harm rather than benefit (24), the risk of people attributing nonrelated deaths to vaccines in the early stages of vaccine rollout is serious. It was more feasible to follow-up and monitor adverse vaccine events among the healthcare workers group.

Prioritizing individuals above 65 years over those with high-risk comorbidities: utility and fairness considerations

Deciding between prioritizing individuals aged over 65 years and those with high-risk comorbidities was challenging as both population groups have been shown to be at higher risk for COVID-19 hospitalization and death in Iran than in other countries (25,26). However, the current guideline assigned vaccine priority to individuals over 65 years. This agrees with the recommendations of the Advisory Committee on Immunization Practices and the WHO guideline. However, in the National Academies of Sciences, Engineering, and Medicine guideline, population groups with underlying problems take precedence over age groups.

The first justification was the higher case fatality and hospitalization rates resulting from the SARS-CoV-2-virus among populations aged 65–70 years or over than among any other population (27–29). According to official reports, 70% of Iranian COVID-19-related deaths occurred among people over 60 years (30). Epidemiological studies show that those aged 65+ years had the highest cumulative risk of death among hospitalized patients with confirmed COVID-19 and that among patients with comorbidities or a high body mass index, there was a greater risk of mortality and hospitalization than among the normal population (31,32).

Second, aging is associated with a higher prevalence of comorbidities. Comorbid conditions are more common (33,34) and more severe (35) among adults over 65 years. Therefore, prioritizing the older age groups also addresses several COVID-19 risk factors, including hypertension, diabetes and cardiovascular disease (35,36).

Third, there is the greater feasibility of providing fair access to all members of an eligible group. Although the Iranian healthcare infrastructure is adequate considering the nature of the risk factors and the vast geographical area of the country, the government cannot afford equal recalling of all eligible individuals in all the aforementioned COVID-19 risk groups.

There is a normative justification to avoid encouraging people to commit fraud, such as faking medical record indicating their comorbid condition.

Including marginalized populations and those who may experience discrimination due to unequal power relationships in the priority list: equity considerations

To avoid discrimination, we explicitly included all eligible population subgroups, and addressed individuals at higher risk of inequitable distribution of vaccines due to unequal power relationships such as medical students and funeral staff in cemeteries, and marginalized populations like prisoners and immigrants. The Islamic Republic of Iran has been host to nearly 3 million Afghan refugees for over 4 decades (37). Afghans are more prone to social inequalities, leading to a higher risk of infectious diseases (38). Unregistered migrant populations are also assigned priority despite the logistic difficulties.

Responsiveness for silent guideline situations: accountability considerations

There are instances when the guideline is silent about which subpopulation in a priority group has priority to access the vaccines and how to fairly distribute vaccines in a subpopulation. Accountable policymaking for pandemic vaccine rollout should include clearly defined roles and responsibilities for these situations.

We recommended involving regional (or university) and local (or hospital) clinical ethics committees to further prioritize vaccine access at the centres within their regions or among the staff at their centres by using the ethical framework of our guideline. It may be regarded as an innovation in that our study predicted the severe shortages that occurred during the early months of the vaccine rollout due to the low pace of the vaccine supply chain in the Islamic Republic of Iran. The experts decided not to wait for enough vaccines to completely immunize all eligible individuals within a hospital or a healthcare centre, and distributed the available doses as early and evenly as possible among a population tier. Therefore, it was predicted that a few doses of vaccines would be delivered to hospitals at each stage; for example, less than 10 shots may be delivered to the staff of a small hospital located in areas far from the provincial capitals. Hence, it suggested that hospital ethics committee prioritize between members of an eligible population group in such situations.

Feasibility considerations

The primary healthcare facility network in the Islamic Republic of Iran has become highly organized (39) and accessible, especially among rural populations (40). An online registration system established for COVID-19 vaccination by the Ministry of Health and Medical Education may increase the feasibility of the guideline. Also, the registration of all patients suffering from chronic disease (e.g. chronic renal failure, diabetes) in a nongovernmental foundation that organizes and promotes care delivery facilitates the implementation of Phase 2 of the recommended vaccination programme.

Study limitations

The most important limitation of this study was the lack of sufficient public engagement in the decision-making process due to time pressures. However, the director of a national nongovernmental organization, Patients’ Rights Watch, was present for the approval process as a National Clinical Ethics Committee member. He also supported efforts to informally seek public opinion by providing feedback and comments from the board of trustees of their organization. Besides, the comments of the clergy, lawyers, and nonmedical experts in the various decision-making stages made possible indirect, timely and informed communication with people from diverse backgrounds.

Despite low public participation in the guideline development, the feedback obtained from lay and society professionals after its publication and dissemination is proof of its acceptability and legitimacy. The guideline developed and disseminated as the “National Document” usually appears to be the reference document for resolving conflicts about the priority population, and deviations from it are addressed. In one example, the Medical Council suggested prioritizing artists for access to vaccines, a suggestion which faced solid public reaction citing the national prioritization plan. However, to promote fairness and participation in the same guidelines in future pandemic planning, much more effort must be made to seek public opinion and involve stakeholders.

Conclusions

The need for public health decision-making based on scientific evidence, ethical principles (13) and sociocultural issues (41) is widely acknowledged. Our experience

shows the administrative possibility and public acceptability of implementing explicit and value-based priority-setting in a developing country. Further evaluation of the reported process and its outcome may improve decision-making practices on resource

allocation. In conclusion, we can recommend further research aimed at assessing the application of this guideline, including qualitative research for documentating the experiences of stakeholders and quantitative analysis exploring the compatibility of the allocation of vaccines with the proposed allocation guideline.

Another conclusion of this work was the successful approach to ethics experts as the “ethicist as an insider”. Cooperation between a professional ethicist and experts from the National Immunization Technical Advisory Group could inform constructive integration of the National Clinical Ethics Committee with the policymaking bodies of the healthcare system.

The most critical shortcomings of the proposed priority-setting policy were the failure to include medical risks and the low participation of the public. Our experience showed that striving to ensure greater communication with and involvement of people in health governance processes increases the legitimacy of public health interventions.

Funding: None.

Competing interests: At the time of the study, Fatemeh Bahmani was a member of the National Clinical Ethics Committee; Alireza Parsapour was secretary of the Supreme Council of Medical Ethics and the National Clinical Ethics Committee; Nasrin Abbasi was the technical officer at the National Clinical Ethics Committee secretariat; Seyyed Mohsen Zahraee was the director of the vaccine-preventable diseases department in the Center for Communicable Disease Control, and a member of the National Committee on the COVID-19 Vaccine and the National Immunization Technical Advisory Group; Nader Tavakkoli was deputy clinical head of the Tehran Coronavirus Taskforce; Ehsan Shamsi-Gooshki was secretary of the National Committee for Ethics in Biomedical Research, Member of the National Clinical Ethics Committee, National Immunization Technical Advisory Group and National Committee on the COVID-19 vaccine.

Définition des priorités pour l'accès rapide aux vaccins contre la COVID-19 en République islamique d’Iran

Résumé

Contexte : La définition des priorités pour l'accès rapide aux vaccins pendant une pandémie optimise l'impact du déploiement des vaccins, mais les pays à revenu faible ou intermédiaire ont peu d'expérience dans l'élaboration de politiques à ce sujet. En République islamique d'Iran, le comité national d'éthique clinique a mis au point une politique pour l'accès rapide aux vaccins contre la COVID-19 avec l'appui du comité national sur le vaccin contre cette maladie.

Objectif : Le présent article rend compte du processus et des résultats de l'établissement des priorités nationales en matière de vaccination contre la COVID-19 en République islamique d'Iran et aborde ses aspects éthiques et culturels.

Méthodes : Une équipe multidisciplinaire d'experts a planifié et élaboré des lignes directrices nationales à la suite d'une analyse documentaire approfondie et de consultations en personne.

Résultats : Nous présentons la liste des groupes et sous-groupes prioritaires, hiérarchisés selon un processus en quatre phases, ainsi que les valeurs éthiques et les questions socioculturelles qui sous-tendent la priorisation du vaccin contre la COVID-19 en République islamique d'Iran.

Conclusion : Notre expérience montre qu'un processus d'élaboration de politiques transparent et bien raisonné permet d'éclairer la définition de priorités équitables pour les vaccins pandémiques, en particulier dans les pays à revenu faible et intermédiaire.

تحديد أولويات الحصول المبكر على لقاحات كوفيد-19 في جمهورية إيران الإسلامية

فاطمة بهماني، علي رضا بارسابور، نسرين عباسي، سيد زهرائي، نادر توکلی، إحسان-شمسي جوشكي

الخلاصة

الخلفية: إن تحديد أولويات الحصول المبكر على اللقاحات أثناء الجائحة يُحسِّن من أثر نشر اللقاحات، غير أن البلدان ذات الدخل المنخفض والمتوسط ليس لديها سوى قدر ضئيل من الخبرة في رسم السياسات المتعلقة بهذا الشأن. وفي جمهورية إيران الإسلامية، وضعت اللجنة الوطنية المعنية بالأخلاقيات السريرية سياسة بشأن الإتاحة المبكرة للقاحات كوفيد-19 بدعم من اللجنة الوطنية المعنية بلقاحات كوفيد-19.

الأهداف: هدفت هذه الدراسة إلى تحديد الأولويات الوطنية للقاحات كوفيد-19 ونتائجها في جمهورية إيران الإسلامية، ويناقش جوانبها الأخلاقية والثقافية.

طرق البحث: اضطلع فريق من الخبراء المتعددي التخصصات بالتخطيط لوضع مبادئ توجيهية وطنية، وأعدَّ هذه المبادئ التوجيهية عقب إجراء استعراض موسَّع للمصنفات، وعقد مشاورات وجهًا لوجه.

النتائج: عُرْضت قائمة الفئات والفئات الفرعية ذات الأولوية في صورة متدرجة، وذلك عبر عملية تتألف من 4 مراحل، بالإضافة إلى القيم الأخلاقية والقضايا الاجتماعية الثقافية التي يستند إليها تحديد أولويات لقاحات كوفيد-19 في جمهورية إيران الإسلامية.

الاستنتاجات: أظهرت التجربة أن عملية رسم السياسات الشفافة والمنطقية يمكن الاسترشاد بها في تحديد أولويات اللقاحات بإنصاف أثناء الجائحة، لا سيَّما في البلدان ذات الدخل المنخفض والمتوسط.

References

1. Tracking. Coronavirus resource center. Baltimore: Johns Hopkins University of Medicine; 2020 (https//coronavirus jhu edu/data. 2020, accessed 10 June 2022).
2. Richards M, Anderson M, Carter P, Ebert BL, Mossialos E. The impact of the COVID-19 pandemic on cancer care. Nat Cancer. 2020;1(6):565–7. doi:10.1038/s43018-020-0074-y
3. Pedrosa AL, Bitencourt L, Fróes ACF, Cazumbá MLB, Campos RGB, de Brito SBCS, et al. Emotional, behavioral, and psychological impact of the COVID-19 pandemic. Front Psychol. 2020 Oct 2;11:566212. doi:10.3389/fpsyg.2020.566212
4. Wilensky GR. Policy lessons from our Covid experience. N Engl J Med. 2020;383(17):e96. doi:10.1056/NEJMp2023204
5. Ataguba JE. COVID-19 pandemic, a war to be won: understanding its economic implications for Africa. Appl Health Econ Health Policy. 2020 Jun;18(3):325–8. doi:10.1007/s40258-020-00580-x
6. WHO SAGE roadmap for prioritizing uses of COVID-19 vaccines in the context of limited supply: an approach to inform planning and subsequent recommendations based on epidemiological setting and vaccine supply scenarios. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccines-SAGE-Prioritization-2022.1, accessed 12 February 2023).
7. Jecker NS, Wightman AG, Diekema DS. Vaccine ethics: an ethical framework for global distribution of COVID-19 vaccines. J Med Ethics. 2021;47(5):308–17.
8. Martin D, Singer P. A strategy to improve priority setting in health care institutions. Heal Care Anal. 2003;11(1):59–68. doi:10.1023/A:1025338013629
9. Ham C, Coulter A. Explicit and implicit rationing: taking responsibility and avoiding blame for health care choices. J Health Serv Res Policy. 2001;6(3):163–9. doi:10.1258/1355819011927422
10. WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020. Geneva: World Health Organization; 2020 (https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-covid-19-vaccination, accessed 12 February 2023).
11. Toner E, Barnill A, Krubiner C, Bernstein J, Privor-Dumm L, Watson M, et al. Interim framework for COVID-19 vaccine allocation and distribution in the United States. Baltimore: Johns Hopkins Cent Heal Secur; 2020 (https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2020/200819-vaccine-allocation.pdf, accessed 12 February 2023).
12. Oliver SE. Overview of vaccine equity and prioritization frameworks. ACIP meeting, 22 September 2020. Atlanta: Centers for Disease Control and Prevention; 2020 (https://stacks.cdc.gov/view/cdc/94844, accessed 12 February 2023).
13. National Academies of Sciences and Medicine E. Framework for equitable allocation of COVID-19 vaccine. Washington DC: National Academies Press; 2020. PMID:33026758
14. Ethics and COVID-19: resource allocation and priority-setting. Geneva: World Health Organization; 2020:5 (https://www.who.int/docs/default-source/blue-print/ethics-and-covid-19-resource-allocation-and-priority-setting.pdf?sfvrsn=4c14e95c_1, accessed 12 February 2023).
15. Kaur G, Prinja S, Lakshmi PVM, Downey L, Sharma D, Teerawattananon Y. Criteria used for priority-setting for public health resource allocation in low-and middle-income countries: a systematic review. Int J Technol Assess Health Care. 2019;35(6):474–83. doi:10.1017/S0266462319000473
16. Sawaya T, Ballouz T, Zaraket H, Rizk N. Coronavirus disease (COVID-19) in the Middle East: a call for a unified response. Front public Heal. 2020;8:209. doi:10.3389/fpubh.2020.00209
17. D'ascanio M, Innammorato M, Pasquariello L, Pizzirusso D, Guerrieri G, Castelli S, et al. Age is not the only risk factor in COVID-19: the role of comorbidities and of long staying in residential care homes. BMC Geriatr. 2021;21(1):1–10. doi:10.1186/s12877-021-02013-3
18. McClung N, Chamberland M, Kinlaw K, Matthew DB, Wallace M, Bell BP, et al. The Advisory Committee on Immunization Practices' ethical principles for allocating initial supplies of COVID-19 vaccine—United States, 2020. Morb Mortal Wkly Rep. 2020;69 (47):1782–6. doi:10.15585/mmwr.mm6947e3
19. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 2001.
20. Zarei L, Shahabi S, Sadati AK, Tabrizi R, Heydari ST, Lankarani KB. Expectations of citizens from the government in response to COVID-19 pandemic: a cross-sectional study in Iran. BMC Public Health. 2021;21 (1):686. doi:10.1186/s12889-021-10722-y
21. Miller DG, Pierson L, Doernberg S. The role of medical students during the COVID-19 pandemic. Ann Intern Med. 2020 Jul 21;173(2):145–6. doi:10.7326/M20-1281
22. Ojikutu BO, Stephenson KE, Mayer KH, Emmons KM. Building trust in COVID-19 vaccines and beyond through authentic community investment. Am J Public Health. 2021 Mar;111(3):366–8. doi:10.2105/AJPH.2020.306087
23. Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, et al. First month of COVID-19 vaccine safety monitoring—United States, December 14, 2020–January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70(8):283–88. doi:10.15585/mmwr.mm7008e3
24. Gille F, Smith S, Mays N. Why public trust in health care systems matters and deserves greater research attention. J Health Serv Res Policy. 2015;20(1):62–4. doi:10.1177/1355819614543161
25. Nikpouraghdam M, Farahani AJ, Alishiri G, Heydari S, Ebrahimnia M, Samadinia H, et al. Epidemiological characteristics of coronavirus disease 2019 (COVID-19) patients in Iran: a single center study. J Clin Virol. 2020;127:104378. doi:10.1016/j.jcv.2020.104378
26. Zheng Z, Peng F, Xu B, Zhao J, Liu H, Peng J, et al. Risk factors of critical & mortal COVID-19 cases: a systematic literature review and meta-analysis. J Infect. 2020;81(2):e16–25. doi:10.1016/j.jinf.2020.04.021
27. Li X, Xu S, Yu M, Wang K, Tao Y, Zhou Y, et al. Risk factors for severity and mortality in adult COVID-19 inpatients in Wuhan. J Allergy Clin Immunol. 2020;146(1):110–8. doi:10.1016/j.jaci.2020.04.006
28. Hoffmann C, Wolf E. Older age groups and country-specific case fatality rates of COVID-19 in Europe, USA and Canada. Infection. 2021;49(1):111–6. doi:10.1007/s15010-020-01538-w
29. Yanez ND, Weiss NS, Romand J-A, Treggiari MM. COVID-19 mortality risk for older men and women. BMC Public Health. 2020;20(1):1–7. doi:10.1186/s12889-020-09826-8
30. Aledavoud SJ. [The COVID-19 hospitalizations of Tehran province reached the limit of four thousand people] (in Farsi). Tehran: Islamic Republic News Agency; 2022 (https://www.irna.ir/news/84282504, accessed 10 June 2022).
31. Alamdari NM, Afaghi S, Rahimi FS, Tarki FE, Tavana S, Zali A, et al. Mortality risk factors among hospitalized COVID-19 patients in a major referral center in Iran. Tohoku J Exp Med. 2020;252(1):73–84. doi:10.1620/tjem.252.73
32. Jalili M, Payandemehr P, Saghaei A, Sari HN, Safikhani H, Kolivand P. Characteristics and mortality of hospitalized patients with COVID-19 in Iran: a national retrospective cohort study. Ann Intern Med. 2021;174(1):125–7. doi:10.7326/M20-2911
33. Williams GR, Mackenzie A, Magnuson A, Olin R, Chapman A, Mohile S, et al. Comorbidity in older adults with cancer. J Geriatr Oncol. 2016;7(4):249–57. doi:10.1016/j.jgo.2015.12.002
34. Van Leersum NJ, Janssen‐Heijnen MLG, Wouters M, Rutten HJT, Coebergh JW, Tollenaar R, et al. Increasing prevalence of comorbidity in patients with colorectal cancer in the South of the Netherlands 1995–2010. Int J cancer. 2013;132(9):2157–63. doi:10.1002/ijc.27871
35. Piccirillo JF, Vlahiotis A, Barrett LB, Flood KL, Spitznagel EL, Steyerberg EW. The changing prevalence of comorbidity across the age spectrum. Crit Rev Oncol Hematol. 2008;67(2):124–32. doi:10.1016/j.critrevonc.2008.01.013
36. Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi:10.18632/aging.103000
37. Refugees in Iran. Tehran: UNHCR; 2021 (https://www.unhcr.org/ir/refugees-in-iran/#:~:text=In, accessed 12 February 2023).
38. Gooshki ES, Rezaei R, Wild V. Migrants' health in Iran from the perspective of social justice: a systematic literature review. Arch Iran Med. 2016;19 (10):735–40. PMID:27743440
39. Asadi-Lari M, Sayyari AA, Akbari ME, Gray D. Public health improvement in Iran—lessons from the last 20 years. Public Health. 2004;118(6):395–402. doi:10.1016/j.puhe.2004.05.011
40. Nasseri K, Sadrizadeh B, Malek-Afzali H, Mohammad K, Chamsa M, Cheraghchi-Bashi M-T, et al. Primary health care and immunisation in Iran. Public Health. 1991 May;105(3):229–38. doi:10.1016/s0033-3506(05)80112-x
41. Childress JF, Faden RR, Gaare RD, Gostin LO, Kahn J, Bonnie RJ, et al. Public health ethics: mapping the terrain. J Law, Med Ethics. 2002;30(2):170–8. doi:10.1111/j.1748-720x.2002.tb00384.x

PDF version

Citation: World Health Organization. Case studies on evidence-informed policymaking: experiences and success stories during the COVID-19 pandemic. East Mediterr Health J. 2023;29(7):599–600. https://doi.org/10.26719/2023.29.7.598 

Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 

¹Summary report of the Seminar on case studies on evidence- informed policy-making: experiences and success stories during the COVID- 19 pandemic. https://applications.emro.who.int/docs/WHOEMEDP005E-eng.pdf. 

Introduction

Appropriate, effective health policies based on sound evidence and data, with a good cost–benefit ratio, represent keys to achieving the health-related Sustainable Development Goals and implementing Universal Health Coverage. In October 2019, the 66th Session of the WHO Regional Committee for the Eastern Mediterranean on Institutionalization of Evidence for Policymaking endorsed the “Framework for Action to Improve National Institutional Capacity for the Use of Evidence in Health Policymaking in the Eastern Mediterranean Region (EMR)” (1-3). This landmark resolution was followed by the establishment of the “Regional Network of Institutions for Evidence and Data to Policy (NEDtP)” (4). With its 33 member institutions from 21 countries and 13 supporting institutions, the network currently supports implementation of the regional framework and promotes collaboration among institutions in the region for sharing knowledge and expertise in evidence-informed policymaking.

Timely and high-quality evidence is crucial for informing health decision-making especially during health emergencies such as the COVID-19 pandemic. In 2021–2022, WHO facilitated the development of 15 case studies highlighting experiences of the use of global, regional and national data and evidence to respond to COVID-19 from 11 institutions and the ministries of health. The case studies covered a wide selection of settings, structures and scenarios, and provided valuable lessons. The studies showed how data and evidence were used to inform the development of national and local policies, including vaccine deployment plans, implementation of public health and social measures, management of infodemics, and delivery of routine services.

In October 2022, WHO/EMRO held a meeting to share experiences and lessons from the case studies and enhance the capacities of EMR countries to use evidence and data in policy decision-making.

Summary of discussions

The COVID-19 pandemic has increased the demand for data and evidence for health decision-making and provided a golden opportunity to enhance the institutionalization of evidence-informed policymaking globally and in the EMR.

At the global level, WHO held the Global Evidence to Policy Summit in 2021 to promote the systematic use of evidence for health decision-making. A call for action (5) and a roadmap for global, regional and country interventions were published following the summit. In the EMR, WHO support for the implementation of a multi-concept approach to integrated use of evidence and data to inform policymaking is helping to integrate different programmes with technical expertise for the generation of relevant data and evidence. Achievements at country level include such initiatives as the establishment of health policy units in the ministries of health.

Jordan, the Occupied Palestinian Territory, Syrian Arab Republic, and Yemen have used data to address a diverse range of policy questions, such as increasing the uptake of COVID-19 vaccines, ensuring adherence to public health measures, enhancing health information system infrastructure, and increasing hospital capacities. Lessons learnt from these studies show that context-specific approaches that use local data, whenever possible, are more effective for reaching the desired outcomes.

Afghanistan, Oman, Pakistan, and Saudi Arabia have used surveys to inform the management of misinformation, development of social and behavioural policies, and vaccine deployment plans. The use of social media to reach a wider audience, and the engagement of communities have been key elements for success.

Islamic Republic of Iran, Libya, Morocco, Somalia, Sudan, and Yemen have used various knowledge translation processes for enhanced policy impact, including the creation of rapid response systems to address policymakers’ questions in a timely manner, and the establishment of an evidence-based governance model to respond to the COVID-19 pandemic. Adopting a multisectoral approach at government level was key to success.

To tackle the complexities of the evidence system and enhance the robustness of evidence-informed health decision-making, it is essential to establish partnerships between all individuals and institutions providing complementary evidence.

Certain shortcomings have caused non-compliance with the national COVID-19 treatment guidelines by healthcare practitioners (6). These include inadequate updating of recommendations; failure to provide essential safety and efficacy information to healthcare providers; use of noncredible references in developing guidelines; discrepancies between pharmacotherapy recommendations and WHO guidelines; inconsistency in the use of terminologies, definitions and classifications; and shortcomings in the assessment of availability, accessibility and affordability of recommended medicines. To mitigate such shortcomings, it is important to foster partnerships between individuals and institutions involved in health decision-making, analyse issues affecting implementation when developing or adapting guidelines, secure political commitment, ensure that rules and regulations are supportive, secure sustainable funding, invest in regular capacity-building programmes, and develop efficient implementation and monitoring plans.

Recommendations

WHO was requested to facilitate dissemination of knowledge products, such as publication of case studies and lessons learnt from programme implementation; support prioritization of a multi-concept approach to evidence and data generation; support countries in the creation of national plans for guideline adaptation and development; and facilitate expansion of NEDtP membership.

References

1. World Health Organization. Developing national institutional capacity for evidence-informed policy-making for health. East Mediterr Health J. 2021;27(3):314–315 https://doi.org/10.26719/2021.27.3.314.
2. World Health Organization. Framework for action to improve national institutional capacity for the use of evidence in health policy-making in the Eastern Mediterranean Region. Cairo: WHO Regional Office for the Eastern Mediterranean, 2019. https://applications.emro.who.int/docs/EMSID001E.pdf.
3. World Health Organization. Regional plan for the implementation of the framework for action to improve national institutional capacity for the use of evidence in health policy-making in the Eastern Mediterranean Region. Cairo: WHO Regional Office for the Eastern Mediterranean, 2021. https://applications.emro.who.int/docs/9789290229124-eng.pdf.
4. World Health Organization. Network of institutions for evidence and data to policy (NEDtP) in the Eastern Mediterranean Region. Cairo: WHO Regional Office for the Eastern Mediterranean, 2023. /evidence-data-to-policy/network-of-institutions/index.html.
5. World Health Organization. Together on the road to evidence-informed decision-making for health in the post-pandemic era: publication of a new call for action. Geneva: World Health Organization, 2021. https://apps.who.int/iris/handle/10665/350883.
6. Al-Mandhari AS, Brennan RJ, Abubakar A, Hajjeh R. Tackling COVID-19 in the Eastern Mediterranean Region. Lancet. 2020; 396(10265):1786–1788. DOI: 10.1016/S0140-6736(20)32349–7.

Next generation support and stronger institutions for evidence-informed policy-making

Institutionalizing evidence-informed policy-making in the postpandemic era

Situation analysis of research ethics governance in Pakistan

Forecasting daily confirmed COVID-19 cases in Algeria using ARIMA models

The evidence governance system in Oman

Ethical soundness of health technology assessment reports in Islamic Republic of Iran

Strengthening primary health care for effective response to pandemics: a systematic review

Methodological frameworks for adapting global practice guidelines to national context in the Eastern Mediterranean Region

Evaluating the quality of health technology assessment reports in a developing country

Capacity-building for conducting COVID-19 vaccine effectiveness studies to enhance evidence-informed vaccination policymaking in the Eastern Mediterranean Region

Relevance of the COVID-19 rapid response system to public health policymaking in Islamic Republic of Iran

Supportive public health leadership for COVID-19 response in Jordan

Improving COVID-19 vaccine uptake: lessons from an academic institution in Saudi Arabia

Priority-setting for early access to COVID-19 vaccines in Islamic Republic of Iran

Case studies on evidence-informed policymaking: experiences and success stories during the COVID-19 pandemic