Study of epidemiological features, antimicrobial resistance profile and clinical outcomes of healthcare-associated infections in intensive care units by Iranian Nosocomial Infection Surveillance System
Shahnaz Rimaz1,*, Parastoo Tajzadeh2,*, Milad Bahrami3,4.*, Mehdi Nooghabi5, Babak Eshrati6, Sohrab Effati7, Maryam Yaghoobi8,9
1 Radiation Biology Research Center, Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. 2Department of Medical Laboratory Sciences, School of Nursing, Kashmar, Mashhad University of Medical Sciences, Mashhad, Islamic Republic of Iran. 3Department of Laboratory Sciences, Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Islamic Republic of Iran. 4Student Research Committee, Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Islamic Republic of Iran. 5Department of Statistics, Ferdowsi University of Mashhad, Mashhad, Islamic Republic of Iran. 6Preventive Medicine and Public Health Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic of Iran. 7Department of Mathematics, Ferdowsi University of Mashhad, Mashhad, Islamic Republic of Iran. 8Department of Epidemiology, Faculty of Public Health, Iran University of Medical Sciences, Tehran, Iran (Correspondence: M. Yaghoobi:
*These authors contributed equally to this work.
Abstract
Background: Healthcare-associated infections are a major cause of mortality worldwide, especially in intensive care units (ICUs) where severely ill patients are in a limited physical space.
Aims: To investigate the incidence rate, microbial etiology, antimicrobial resistance profile, and mortality rate of healthcare-associated infections in ICUs.
Methods: This observational study retrospectively reviewed the medical records of 1722 ICU patients with confirmed healthcare-associated infections at hospitals affiliated with Mashhad University of Medical Sciences in 2017–2019. The patient data collected included age, sex, comorbidities, device use, causative agents, infection type, antimicrobial resistance profile, length of stay, and mortality.
Results: In total, 4077 pathogens were isolated, yielding a healthcare-associated infection incidence rate of 22.1%. The most common microorganisms were Acinetobacter spp. (25.0%), Klebsiella spp. (15.1%), Staphylococcus spp. (14.0%), and Candida spp.(12.3%). Ventilator-associated events (39.5%), urinary tract infections (22.7%), and bloodstream infections (14.8%) were the main types of infection. Comorbidities, skin and soft tissue infections, and infections with Acinetobacter spp., Klebsiella spp., Pseudomonas spp., and Candida spp. were significantly associated with higher mortality among ICU patients. Gram-positive bacteria were most resistant to ciprofloxacin (49.2%), clindamycin (38.0%), and erythromycin (37.1%). Gram-negative bacteria were most resistant to ceftazidime (71.0%), ciprofloxacin (65.2%), and cefotaxime (60.5%). The overall mortality rate was 45.2%.
Conclusion: Healthcare-associated infections in nearly half of ICU patients were fatal, especially when caused by Acinetobacter spp., Klebsiella spp., Pseudomonas spp., or Candida spp. Therefore, effective strategies must be implemented to combat antibiotic-resistant bacteria, along with stricter adherence to infection control programmes.
Keywords: healthcare-associated infection, intensive care unit, incidence, risk factor, drug resistance
Citation: Rimaz S, Tajzadeh P, Bahrami M, Nooghabi MJ, Eshrati B, Effati S et al. Study of epidemiological features, antimicrobial resistance profile and clinical outcomes of healthcare-associated infections in intensive care units by Iranian Nosocomial Infection Surveillance System. East Mediterr Health J. 2023;29(5):xxx-xxx http://doi.org/10.26719/emhj.23.043
Received: 05/08/22; accepted: 22/12/22
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).
Introduction
Healthcare-associated infections arise 48 hours after hospital admission, and are a major cause of morbidity and mortality worldwide, accounting for ~2 million infections and 100 000 deaths annually (1, 2). In addition to prolonging hospital stay, healthcare-associated infections carry a huge financial burden, estimated at US$4.5 billion annually(3, 4). According to a World Health Organization (WHO) report, out of every 100 patients, 7 in high-income countries and 15 in low- and middle-income countries develop healthcare-associated infections during their stay at acute-care hospitals (5). The intensive care units (ICUs), in particular, are hotbeds for developing infections (5). Even though they account for < 10% of all hospital beds, 20–50% of all healthcare-associated infections are contracted in ICUs (6). Immunocompromise, use of invasive devices, severe underlying illnesses, and indiscriminate use of antibiotics are all factors that place ICU patients at increased risk of healthcare-associated infections (7). Therefore, managing infection risk in ICUs should be a priority for all health care professionals.
The prevention of healthcare-associated infections in ICUs requires rigorous control measures. To achieve infection control, WHO recommends a multimodal hand hygiene improvement strategy consisting of 5 critical elements: (1) providing clinical staff with the materials and equipment they need to perform hand hygiene at the point of care, such as alcohol-based hand rub, clean water, soap, and single-use towels; (2) training and education of health workers, patients, and visitors about the importance of hand hygiene; (3) regular evaluation of hand hygiene infrastructure, and monitoring compliance with hand hygiene programmes; (4) continually reminding health workers about the importance of maintaining hand hygiene, verbally or by visual prompts such as posters, stickers, or banners; and (5) prioritizing compliance with hand hygiene at institutional and individual levels to achieve patient and health worker safety (8). The WHO multimodal hand hygiene improvement strategy promises to prevent up to 50% of healthcare-associated infections and save 16 times the cost of implementation (8).
Even though many healthcare-associated infections can be avoided with proper infection control, it is impossible to eradicate them entirely, and antibiotics are still frequently prescribed for ICU patients (9). With abundant use of antibiotics in a limited space, ICUs are the ideal setting for the emergence and transmission of antibiotic-resistant bacteria (10). In this situation, clinicians may face a lack of effective treatment options as bacteria withstand the effects of antibiotics, leading to the emergence of multidrug-resistant, extensively drug-resistant, and pandrug-resistant strains (11). In 2019, antimicrobial resistance was estimated to be responsible for 1.27 million deaths worldwide (12). If we do not take prompt action now, antimicrobial resistance is estimated to cause 10 million deaths annually by 2050 (13).
The distribution of nosocomial infections and antibiotic resistance patterns vary geographically; therefore, each medical centre should devise its own specific antimicrobial treatment policy (14). This is the only way to reduce the incidence, mortality rate, and treatment cost of healthcare-associated infections. In this study, we attempted to investigate the incidence, microbial etiology, antimicrobial resistance profile, and clinical outcomes of healthcare-associated infections in ICUs in north-eastern Islamic Republic of Iran.
Methods
Study design
This observational study retrospectively reviewed the medical records of patients who acquired healthcare-associated infections in ICUs at 4 hospitals affiliated with Mashhad University of Medical Sciences, Islamic Republic of Iran between April 2017 and September 2019. Inclusion was restricted to patients who had been in an ICU for ≥ 48 hours and had developed healthcare-associated infections. Those with incomplete medical records were excluded from the data analysis. The infections were diagnosed according to criteria established by the US Centers for Disease Control and Prevention and the Iranian National Nosocomial Infections Surveillance Guideline (15, 16). Apart from clinical manifestations and physical examination, microbiological tests were undertaken to confirm the diagnosis of healthcare-associated infections. Antibiotic therapy was initiated in all patients after the antimicrobial sensitivity of bacterial isolates was determined.
Definitions
Healthcare-associated infection was defined as an adverse reaction to an infectious agent or its toxins 48 hours after hospital admission. Bloodstream infection was diagnosed if a pathogen was identified in 1 or more blood culture samples from a patient who had accompanying symptoms such as fever, chills, or hypotension. Pneumonia was diagnosed when a patient showed newly developed or progressive infiltrates, cavitation, consolidation, or pleural effusion; had new onset of purulent sputum or a change in the character of the sputum; or a pathogen was cultured from blood, tracheal aspirate, bronchoalveolar lavage, bronchial brushing, or biopsy. If pneumonia was caused by mechanical ventilation, the patient was diagnosed with ventilator-associated infection. Skin and soft tissue infection was defined as purulent pustules, vesicles, or boils, or having at least 2 of the following symptoms with no other recognized cause: pain or tenderness, localized swelling, redness, or heat. Surgical site infection was defined as an infection arising 30 days after surgery, from which a microorganism was isolated, or the site had a purulent discharge. Urinary tract infection was diagnosed when a patient had a urinary catheter placed for ≥ 2 consecutive days and showed ≥ 1 of the following symptoms: fever, urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain/tenderness.
Data collection
We obtained details of hospitalization of patients with healthcare-associated infection from their medical records in the Iranian Nosocomial Infection Surveillance System. The data collected included age, sex, comorbidities, invasive device use, type of infection, causative agents, antimicrobial resistance profile, length of stay, and mortality. Patients who experienced multiple healthcare-associated infections during their stay in hospital were counted separately for analysis of the type of microorganisms and site of infection.
Ethical considerations
The protocol complied with the ethical principles specified in the 1964 Helsinki Declaration and was approved by the Ethics Committee of Mashhad University of Medical Sciences (registration number IR.MUMS.REC.1399.331)and Iran University of Medical Sciences (registration number IR.IUMS.REC.1398.1219)
Statistical analysis
SPSS for Windows version 11 (SPSS Inc., Chicago, IL, USA) was used for data analysis. The categorical variables were described using frequency and percentage, whereas continuous variables were defined by mean (standard deviation) with 95% confidence interval (CI) for precision. Logistic regression analysis using the stepwise forward method was applied to estimate crude odds ratio (OR) and adjusted OR (AOR) with 95% CI, and to identify univariate and multivariate predictors of healthcare-associated infection mortality. All statistics were subjected to an effect size analysis. Statistical significance was defined as P < 0.05.
Results
Clinical and demographic characteristics
Over the course of the study,18 382 patients were admitted to ICUs and 1722 contracted healthcare-associated infections: 901 male (52.3%) and 821 female (47.7%), with a mean age of 57.30 (24.24) years (Table 1). Most (55.2%) patients with healthcare-associated infections were aged > 60 years. Children aged < 2 years (4.8%) and adults aged 40–59 years (22.1%) had the highest rate of healthcare-associated infections. While most patients had no underlying medical condition (30.8%), cardiac (17.5%) and respiratory (12.5%) diseases accounted for most comorbidity at the time of ICU admission. The incidence of healthcare-associated infections in ICU patients steadily increased over a 2-year period, starting from 49 cases in April 2017 to a peak of 269 in September 2019 (Figure 1). The median length of hospital stay was 20 days (interquartile range, 11–33 days). During their stay, patients developed healthcare-associated infections at a median of 5 days from admission to the first episode of infection (interquartile range, 2–12 days). Unfortunately, 45.2% of patients eventually died from infections acquired in the ICU (Table 1).
Device use, infection sites and nosocomial pathogens
During the study period, 4077 pathogens were isolated from 1722 patients: 981 (24.0%) Gram-positive bacteria, 2591 (63.6%) Gram-negative bacteria, and 505 (12.4%) fungi, yielding a healthcare-associated infection incidence rate of 22.1% (Table 2). The most common microorganisms were Acinetobacter spp. (25.0%), Klebsiella spp. (15.1%), Staphylococcus spp. (14.0%), and Candida spp. (12.3%). Among Gram-negative strains, Acinetobacter spp. (39.3%) were the most frequently isolated, followed by Klebsiella spp. (23.9%), Pseudomonas spp. (15.5%), and Escherichia coli (14.1%). Among Gram-positive strains, Staphylococcus spp. (58.4%), especially Staphylococcus aureus (25.0%), and Enterococcus spp. (32.8%) were responsible for most healthcare-associated infections in ICU patients. Endotracheal tubes (39.5%), urinary catheters (19.9%), central venous catheters (12.9%), and arterial catheters (0.3%) were the invasive devices mostly associated with healthcare-associated infections, and other devices were responsible for 31.0%. Ventilator-associated infection (39.5%), urinary tract infection (22.7%), and bloodstream infection (14.8%)were the 3 main types of infection in ICU patients (Table 2).
Independent predictors for mortality
Multivariate logistic regression analysis identified 6 independent predictors of mortality among ICU patients (Table 3). Patients with comorbidity had a significantly increased risk of death (P < 0.001, AOR: 1.46, 95% CI: 1.28–1.65). Acinetobacter spp. (P = 0.039, AOR: 1.40, 95% CI: 1.01–1.93), Klebsiella spp. (P = 0.013, AOR: 1.53, 95% CI: 1.09–2.15), Pseudomonas spp. (P < 0.0001, AOR: 1.93, 95% CI: 1.34–2.78), and Candida spp. (P < 0.0001, AOR: 1.99, 95% CI: 1.37–2.89) were independently associated with higher in-hospital mortality among ICU patients. Mortality associated with the isolated pathogens was: Pseudomonas spp. 59.9%, Candida spp. 59.5%, Klebsiella spp. 58.3%, Acinetobacter spp. 55.0%, E. coli 47.9%, Staphylococcus spp. (34.7%), Enterococcus spp. 47.8%, and Streptococcus spp. 38.4%. Among infection types, only skin and soft tissue infection had a significant mortality risk of 53.4% (P = 0.0391, AOR: 1.40, 95% CI: 1.01–1.93). Even though death from ventilator-associated, urinary tract, and bloodstream infections occurred in 57.2% (AOR: 0.75, 95% CI: 0.38–1.48), 51.6% (AOR: 0.48, 95% CI: 0.29–0.82), and 49.8% (AOR: 0.86, 95% CI: 0.56–1.31) of patients, respectively, logistic regression analysis did not establish a significant association with mortality. Death eventually occurred in 36.1% of patients with surgical site infection and 43.9% of those with pneumonia.
Antimicrobial resistance profile
Gram-positive and Gram-negative bacteria demonstrated varying levels of antimicrobial resistance. Gram-positive bacteria were most resistant to ciprofloxacin (49.2%), clindamycin (38.0%), erythromycin (37.1%), and cefoxitin (27.1%) (Table 4). S. aureus, Staphylococcus epidermidis, and other coagulase-negative staphylococci exhibited considerable resistance to ciprofloxacin (44.4%, 37.0%, and 50.2%), clindamycin (52.8%, 62.0%, and 56.8%), erythromycin (51.2%, 62.0%, and 53.3%), and cefoxitin (41.4%, 52.0%, and 42.2%). Enterococcus spp. were also highly resistant to ciprofloxacin (63.0%), vancomycin (63.0%), and ampicillin (47.2%). However, Streptococcus spp. were susceptible to most antibiotics, except for erythromycin and clindamycin, which recorded resistance of 36.9% and 30.7%, respectively.
<body>Gram-negative bacteria exhibited strong resistance to ceftazidime (71.0%), ciprofloxacin (65.2%), cefotaxime (60.5%), gentamicin (55.2%), trimethoprim–sulfamethoxazole (51.2%), amikacin (46.6%), and imipenem (35.2%). Infections with Acinetobacter spp., Klebsiella spp., and Pseudomonas spp. were best treated with amoxicillin/clavulanic acid (99.4%, 99.4%, and 99.6% susceptibility), ampicillin (98.0%, 96.4%, and 97.1% susceptibility), levofloxacin (96.8%, 98.3%, and 98.6% susceptibility), and cefepime (81.7%, 81.7%, and 80.7% susceptibility). However, treatment with ceftazidime and ciprofloxacin was relatively ineffective because Acinetobacter spp., Klebsiella spp., and Pseudomonas spp. were resistant to ceftazidime (74.9%, 79.8%, and 62.0%) and ciprofloxacin (70.1%, 61.4%, and 69.6%). E. coli also demonstrated resistance to ceftazidime (50.1%), ciprofloxacin (47.9%), cefotaxime (43.8%), and trimethoprim–sulfamethoxazole (36.7%), although to a lesser extent than the other Gram-negative bacteria.
Discussion
In this study, we found a high incidence (22.1%) of healthcare-associated infections in ICUs in north-eastern Islamic Republic of Iran. The most commonly isolated microorganisms were Acinetobacter spp., Klebsiella spp., Staphylococcus spp., and Candida spp. The main types of infection were ventilator-associated, urinary tract, and bloodstream infections. Comorbidities, skin and soft tissue infections, and infections with Acinetobacter spp., Klebsiella spp., Pseudomonas spp., and Candida spp. were associated with higher mortality among ICU patients. Gram-positive bacteria exhibited the strongest resistance to ciprofloxacin, clindamycin, and erythromycin, and Gram-negative bacteria were most resistant to ceftazidime, ciprofloxacin, and cefotaxime.
ICUs are breeding grounds for healthcare-associated infections (5). In ICUs, physicians and nurses can act as vehicles for transferring resident pathogens between wards (17). ICU patients undergo invasive medical procedures and are in a debilitated condition; therefore, they have a 5–10 times higher risk of developing healthcare-associated infections than patients in general medical wards (18). This is why despite representing < 10% of hospital beds, ICUs account for 20–50% of all healthcare-associated infections (6). In 2017, the global incidence of healthcare-associated infections in ICUs was as high as 54% (19), whereas in Europe, the incidence was only 8.3% (20). In our study, healthcare-associated infections occurred in 22.1% of the study population, which was higher than the 9.6–12% documented in previous studies (21, 22).This rate is of concern because it has been steadily increasing from 2017 to 2019. A study in northern Islamic Republic of Iran revealed that compliance with WHO hand hygiene guidelines was as low as 43.4% (23). More disturbingly, another study found that only 56.6% of health care workers had good knowledge of hand hygiene (24). It is now evident that serious action is required to lower the incidence of healthcare-associated infections in Iranian hospitals. We hope to take a critical step toward helping hospitals optimize their infection control programmes and minimize cross-infection risk by identifying the root causes of healthcare-associated infections as well as their microbial etiology and patterns of antimicrobial resistance.
The present study indicated that Acinetobacter spp. (25.0%), Klebsiella spp. (15.1%), Staphylococcus spp.(14.0%), and Candida spp. (12.3%) were the most common microorganisms responsible for healthcare-associated infections in ICUs in northeast Islamic Republic of Iran. Infections with Acinetobacter spp., Klebsiella spp., Pseudomonas spp., and Candida spp. were independently associated with higher in-hospital mortality among ICU patients. In a national study with a similar design, Etemad et al. discovered that Acinetobacter spp. (16.52%), E. coli (12.01%), and Klebsiella spp. (9.93%) were the major microorganisms isolated from ICU patients in the Islamic Republic of Iran. They also found that Acinetobacter spp., Enterococcus spp., Enterobacter spp., and Candida spp. were associated with an increased risk of in-hospital mortality (25). Similarly, in a multicentre study by Jahani-Sherafat et al., Acinetobacter baumannii (33.3%), S. aureus (14.4%), and Pseudomonas aeruginosa (14.4%) were the most prevalent pathogens causing healthcare-associated infections in ICUs, followed by Klebsiella pneumoniae (10.9%) and Enterococcus spp. (8.7%) (26). The prevalence and distribution of microorganisms that cause healthcare-associated infections vary by hospital, geographic area, and patient status (27). It is, therefore, reasonable to expect differences from previous studies regarding microbial etiology.
In our study, endotracheal tubes, urinary catheters, and central venous catheters were the invasive devices most frequently associated with healthcare-associated infections. As demonstrated by the US National Nosocomial Infection Surveillance System, mechanical ventilators, urinary catheters, and central venous catheters contributed to 83% of nosocomial pneumonia, 97% of urinary tract infections, and 87% of bloodstream infections in ICUs (28). The most common types of infection among our ICU patients were ventilator-associated, urinary tract, and bloodstream infections, in accordance with previous regional studies (29, 30). However, none of these infections were associated with an increased risk of death, as also found by Boncagni et al. (31). The only type of infection that was independently associated with increased mortality risk was skin and soft tissue infection. In contrast, Rosenthal et al. conducted a multicentre cohort study of 786 ICUs worldwide and found that ventilator-associated, urinary tract, and bloodstream infections were independent risk factors for mortality (32). This was supported by Bonnet et al. who reported that lung, urinary tract, and bloodstream infections were the most prevalent among ICU patients and were all closely associated with higher mortality (33). The currently available data are inconclusive; therefore, this issue warrants further research.
In our study, treatment of ICU patients was largely interrupted because the bacteria were resistant to the antibiotics. Ceftazidime, cefotaxime, and ciprofloxacin achieved little clinical success against Acinetobacter spp., Klebsiella spp., and Pseudomonas spp. Isolates of Staphylococcus spp. showed resistance to ciprofloxacin, clindamycin, and erythromycin, and Enterococcus spp. were resistant to ciprofloxacin, vancomycin, and ampicillin. Similar patterns of resistance were observed in ICUs in Tehran, where Amimi et al. reported high resistance to ciprofloxacin, cefotaxime, ceftazidime, and ampicillin among A. baumannii, E. coli, P. aeruginosa, and K. pneumoniae isolates (34). Likewise, in Qazvin, Bagherian et al. demonstrated that most strains of Acinetobacter spp., Klebsiella spp., and Pseudomonas spp. Were markedly resistant to most prescribed antibiotics, especially ciprofloxacin, ceftazidime, cefotaxime, cefepime, and piperacillin (35). With such high resistance to a variety of antibiotics, infections that were once curable with a short course of antibiotics could become incurable. In that case, it is reasonable to propose that the high mortality rate of 45.2% observed in our study could have been caused by antibiotic resistance. Hence, it becomes even more important for hospitals to prioritize the rational prescription of antibiotics in their infection control plans.
Our study had a few limitations. The Iranian Nosocomial Infections Surveillance System does not cover different scoring systems that can predict mortality in patients with critical conditions based on clinical and laboratory findings, such as acute physiology and chronic health evaluation (APACHE), sequential organ failure assessment (SOFA), and mortality in emergency department sepsis (MEDS) scores. Thus, we were unable to evaluate the impact of such variables on mortality at ICU admission. The system does not record the hospitalization data of patients who did not contract healthcare-associated infections in ICUs. Therefore, we could not perform further analysis to identify the risk factors for healthcare-associated infections. Taking these factors into account, we strongly recommend conducting a prospective study, possibly with a larger sample size, to capture as much information as possible at ICU admission. Regardless of its limitations, our study offers valuable insight into the epidemiology and etiology of healthcare-associated infections in ICUs in northeast Islamic Republic of Iran.
Conclusion
We documented a high incidence of healthcare-associated infection in ICUs in north-east Islamic Republic of Iran. Because of the emergence of resistant microorganisms in ICUs, healthcare-associated infections in nearly half of ICU patients eventually lead to death, especially when caused by Acinetobacter spp., Klebsiella spp., or Pseudomonas spp. The use of endotracheal tubes and urinary catheters may further expose patients to the risk of healthcare-associated infection. Therefore, to reduce these infections, effective strategies to combat antibiotic-resistant bacteria must be implemented, along with stricter adherence to infection control programmes and enhancement of infection control using feasible and affordable tools and resources. Our findings could be used by policy-makers to develop more practical protocols for hand hygiene, reducing contact with patients, and using invasive devices. Staff training programmes, along with continuous supervision and monitoring, are also essential to prevent the spread of infection.
Acknowledgements
We would like to thank the Vice Chancellors for Research Affairs of Mashhad University of Medical Sciences and Iran University of Medical Sciences (IUMS) for financial support.
Conflict of interest: None declared.
Funding: This work was supported by Mashhad University of Medical Sciences and Iran University of Medical Sciences (Grant numbers 981547 and 16229).
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Responding to COVID-19: lessons learnt from Hadhramaut
Abdulla Bin Ghouth1, Nuha Mahmoud2
1Department of Community Medicine, Hadhramaut University, Al Mukalla, Yemen (Correspondence to: A.S. Bin Ghouth:
Abstract
Background: The health system in Hadhramaut Valley and Desert responded to the COVID-19 pandemic differently from other areas in Yemen. The local authority in Syoun (Hadhramaut Valley) called all key players from the health and related sectors to a meeting in February 2020. They decided 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 responded to COVID-19.
Aims: To document the response of the local authority and Ministry of Health in Hadhramaut to COVID-19.
Methods: We reviewed the available documents, interviewed the main stakeholders, and conducted site visits.
Results: There was evidence of the crucial role played by the local authority in response to COVID-19. The main achievements were establishing 3 well-equipped isolation centres with a total of 142 beds, a stock of 2250 oxygen cylinders, 2 new polymerase chain reaction units, a straightforward referral system, and an effective follow-up and oxygen home therapy strategy.
Conclusion: Political commitment at the local level is a priority approach to bridging the gap between policy and implementation, especially in infectious disease outbreak crises. It is important to train public health leaders for assessment of local health needs. The lessons learned from this study provide evidence of how local authorities can respond to emerging needs through guiding the coordination and updating the national strategies.
Keywords: local authority, COVID-19, evidence-informed policy-making, pandemic response, Yemen
Citation: Bin Ghouth A, Mahmoud N. Responding to COVID-19: lessons learnt from Hadhramaut . East Mediterr Health J. 2023;29(5):xxx-xxx https://doi.org/10.26719/emhj.23.036
Received: 10/03/22; accepted: 05/10/22
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).
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 to September 2021, Yemen has 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, compounded by a shortage of supplies.
To respond to the emerging pandemic, the local authority in Syoun (Hadhramaut Valley) called 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), trades people, 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 of 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 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 also collected. Data collected from the needs assessment were communicated to decision-makers through face-to-face meetings, and telephone, and WhatsApp.
The intended use of these data for policy-making 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 policy-makers and health officials to monitor potential healthcare demand, to tackle the enormous logistical challenges and to re-allocate resources at a local level.
NGOs, oil companies, and tradespeople 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 tradespeople 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 also participated in increasing the capacity of 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 entry point to 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 pursue 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 oversaw and 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 put in place.
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 vindicated 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 policy-makers 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 policy-makers 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 in 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.
Conflict of interest: The authors certify that they have no affiliations with or involvement in any organization, or entity with any financial gains or interest, or nonfinancial interests in the subject matter or materials discussed in this study. The authors certify that the development of the study did not involve financial or professional benefit. The authors certify that the study was developed in coordination and collaboration with staff from WHO and the Ministry of Public Health and Population office in Hadhramaut, who were involved in the response to COVID-19.
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. This project was an output of the WHO/EMRO initiative of the Regional Network of Institutions for Evidence and Data to Policy.
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Lessons learned from an academic institution for improving COVID-19 vaccine uptake in Saudi Arabia
Duaa Alammari1,2, Hanan Al-Kadri1,2,3, Mansour Al-Qurashi2,4,5, Majid Alshamrani2,6,7, Fayssal Farahat1,2,8, Aiman Altamimi9, Anmar Najjar4
1College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia (Correspondence: D. Alammari:
Abstract
Background: COVID-19 vaccine acceptance and uptake are major public health challenges in Saudi Arabia.
Aims: To vaccinate all affiliates of King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS) within a limited time period using evidence-based strategies to address COVID-19 vaccine hesitancy.
Methods: A survey was distributed electronically to develop an evidence-informed vaccination plan to address hesitancy factors. Initial survey results from March 2021 showed that only 60% of affiliates had taken at least 1 COVID-19 vaccine dose. KSAU-HS designed a 6-month vaccination campaign to raise awareness and increase compliance. Barriers and hesitancy to vaccination were managed through mass media, social media, and reminders to achieve high vaccination rates by overcoming fear and misconceptions.
Results: The evidence-based planning resulted in a significantly high vaccination rate, with 99.7% of affiliates vaccinated by October 2021; one of the highest vaccination rates among public universities in Saudi Arabia.
Conclusion: The implementation of evidence-based campaigns through social media can help address prevailing public health concerns, as well as COVID-19.
Keywords: vaccination, COVID-19, public education, evidence-based, evidence-informed policy-making
Citation: Alammari D; Al-Kadri H; Al-Qurashi M; Alshamrani M; Farahat F; Altamimi A; et al. Lessons learned from an academic institution for improving COVID-19 vaccine uptake in Saudi Arabia. East Mediterr Health J. 2023;29(5):xxx-xxx https://doi.org/10.26719/emhj.23.034
Received: 18/07/22; accepted: 08/12/22
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).
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 governmental university that was founded on 6 March 2005 (2). In 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 urged to take precautions to contain the spread of the disease. KSAU-HS reported 121 cases in April 2021, but no deaths were recorded at that time.
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). During the MERS-CoV outbreak, management was aided by involving all staff in sharing experiences and relevant knowledge, developing trust and teamwork, and promoting collective leadership. Recommendations were also made to improve crisis management strategies, coordinate media management, and take a proactive stance in advising and supporting staff (6).
In light of the precedent set by 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 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 plan formulation and implementation. The preliminary vaccination plans included the establishment of vaccination centres on campuses to facilitate vaccination among university affiliates. The Subcommittee sought to collect accurate data on vaccination history and hesitancy among affiliates to propose an evidence-based vaccination plan that met the needs of the university and the urgency of the pandemic. To this end, the Subcommittee used evidence-based strategies to address vaccine hesitancy.
The aim was to vaccinate all KSAU-HS affiliates within a limited time period using evidence-based strategies to address COVID-19 vaccine hesitancy. All affiliates 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 that consisted of 3 phases: (1) situational analysis (baseline assessment); (2) stakeholders’ engagement (streamlining current and accurate data); and (3) community engagement through social and traditional media (awareness programme).
Phase 1: situational analysis (baseline assessment)
On 17 March 2021, the COVID-19 Infection Prevention and Control Advisory Subcommittee needed accurate data to inform future decisions. The first step was to create a standard form and distribute it to colleges and deanships to collect data about vaccination rates among affiliates, with weekly follow-up. The second step included working with the Saudi Ministry of Education to update 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 at KSAU-HS. As a result of baseline and situational assessment, current and accurate vaccination rates were available at KSAU-HS. This phase helped decision-makers understand the situation to support the development of plans, policies, and strategies for vaccination management.
Phase 2: stakeholders’ engagement (streamlining current and accurate data)
After the initial phase of data collection, the COVID-19 Infection Prevention and Control Advisory Subcommittee planned to gather more information about vaccine uptake rates and reasons for hesitancy, and an in-house survey was developed. On 23 March 2021, the first survey was distributed between March and May 2021 via email through the University Message Center with a link to the web survey. The survey 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 graphs, 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 past 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 utilizing 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 also a fast and efficient way to communicate with the general public and health professionals to implement infection prevention strategies and community engagement, especially during outbreaks (3, 4). Therefore, the Internet and social media were used extensively in 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 to prevent and control the COVID-19 pandemic. The plan was to accomplish this goal by increasing vaccination rates and addressing 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 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, and the establishment of active and accessible vaccination centres on university campuses, as these were among the reasons for vaccine hesitancy. The programme was launched on 6 June 2021. The content of the programme was designed to encourage individuals and social groups (university affiliate groups) through contextual influence. This was accomplished by disseminating key facts and sharing affiliates’ 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 for implementing the vaccine uptake programme
The presence of outdated or miscommunication of data regarding university affiliates presented a challenge to collecting accurate data and determining situational analysis. 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 restricted 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 of time, especially for time-sensitive issues. Fear and uncertainty hampered COVID-19 vaccine acceptance among health science affiliates as well as the general public. 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 also contributes to 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.
References
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- 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).
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- Kemp S. Digital 2021: Saudi Arabia [website]. DATAREPORTAL; 2021 (https://datareportal.com/reports/digital-2021-saudi-arabia, accessed 14 January 2023).
Acknowledgements
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.
Conflict of interest: We certify that: (1) we have no affiliations with or involvement in any organization or entity with any financial gains or interest, or nonfinancial interests in the subject matter or materials discussed in the case study; (2) the case study was developed in coordination and collaboration with staff from WHO, who were involved in the response to COVID-19; (3) given the involvement in the COVID-19 response, the principle of objectivity has led the development of the case study; and (4) the development of the case study did not involve financial or professional benefit and served to share our experiences.
Palliative care strategies of Iranian nurses during children’s death from cancer: a qualitative study
Zahra Ebadinejad1, Ali Fakhr-Movahedi2
1Student Research Committee, Paediatric and Neonatal Nursing Department, School of Nursing, Semnan University of Medical Sciences, Semnan, Islamic Republic of Iran. 2Nursing Care Research Centre, Paediatric and Neonatal Nursing Department, School of Nursing, Semnan University of Medical Science, Semnan, Islamic Republic of Iran (Correspondence: A. Fakhr-Movahedi:
Abstract
Background: Children with cancer who are at the end of life and facing death need access to palliative care services. Nurses play an important role in providing palliative care for children with cancer, especially in the end-of-life stages.
Aims: To explore the palliative care strategies of Iranian nurses during children’s death from cancer.
Methods: This was a qualitative research study with conventional content analysis. Participants were 8 nurses, 1 social worker, 1 psychologist, 2 children and 4 mothers from the Paediatric Oncology Unit in Semnan, Islamic Republic of Iran, who had experience in relation to the study aim. Data were collected by individual, in-depth unstructured and semistructured interviews and analysed using the Graneheim and Lundman approach. Data rigor increased with credibility, dependability, transferability and confirmability criteria.
Results: Data analysis led to emergence of the concept of “perceived compassion”. This means when nurses realized that children’s death from cancer was imminent, they implemented strategies based on a sense of compassion and their own desire. This theme was derived from the 2 main categories of “feeling the shadow of death on the child” and “comforting accompaniment”. Feeling the shadow of death on the child included the subcategories of “predeath arrangements” and “an opportunity to continue interactions”. Comforting accompaniment was derived from 3 subcategories: “preparing to announce the child’s death”, “extra-role sympathy” and “postdeath interactions”.
Conclusion: Perceived compassion was the main strategy deployed by Iranian nurses to provide palliative care to children during death from cancer.
Keywords: nursing strategies during death, paediatric palliative care, paediatric cancer, conventional content analysis, Islam Republic of Iran
Citation: Ebadinejad Z, Fakhr-Movahedi A. Palliative care strategies of Iranian nurses during children’s death from cancer: a qualitative study. East Mediterr Health J. 2022;28(7):xxx-xxx https://doi.org/10.26719/emhj.22.047
Received: 10/9/2021, Accepted: 9/5/2022
Copyright © World Health Organization (WHO) 2022. Open Access. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO license (https://creativecommons.org/licenses/by-nc-sa/3.0/igo)
Introduction
Palliative care for children is a comprehensive approach that begins with the diagnosis of life-threatening illness and continues even after the children die, with providing appropriate care to families (1, 2). Children with cancer as recipients of palliative care services suffer adverse consequences such as psychological problems. Paediatric nurses in the palliative care team have multiple responsibilities, such as identifying the psycho-oncology-related symptoms, supporting children and families, strengthening the sense of hope in families, and preparing for the prognosis and challenging treatment trajectory that can lead to the child’s death. Nurses should also consider their personal and professional responses to the death of a child, and the family’s mourning as the basis for optimal care (3–5).
Paediatric nurses should provide information to families about their children’s end-of-life situation to help them to deal with it calmly (6). Nurses in paediatric palliative care have a specific role in providing care for children who suffer from life-threatening conditions such as cancer (7). Nikfarid et al. found that the mothers of children with cancer had experiences such as chronic suffering, health issues, maladaptive coping, and lack of skills due to their children’s disease (8).
The death of a child due to a life-threatening disease such as cancer is a tragedy for parents and other family members (9) that disrupts the social integrity of the family (10). Paying attention to the family at the time of their mourning is a standard part of palliative care (2). Funes et al. concluded that nurses used a variety of strategies such as end-of-life care, providing comfort, and respect for dying patients with cancer (11). October et al. emphasized supporting parents when their child is admitted to the intensive care unit or at the time of death (12). Haylett et al. found that the parents’ deep desire after their child’s death is that others come alongside them by validating their emotions and experience, providing opportunities for family renewal (13). Dong et al. found that nurses are more concerned about the physical comfort of dying patients and fulfil their wishes (14).
Nurses’ actions in palliative care for children with cancer are effective when they are appropriate to the sociocultural context of each country (15). Therefore, identifying and strengthening nursing strategies for dying children and their families before and after death are useful (16). Nursing strategies for children dying of cancer are complex phenomena that depend on the unique context and circumstances surrounding the content of their care. Exploration of this content is required to select a rigorous research methodology, and qualitative research approaches are appropriate. These approaches reveal the hidden aspects of human behaviour and answer questions with human interpretations and mindsets (17, 18). Due to the absence of a localized tool to identify and explain these strategies, this study explored the content of nursing strategies in confronting children’s death from cancer with a qualitative content analysis approach.
Methods
Study design and participants
This study used a conventional qualitative content analysis approach to explore explicit and latent contents in the data. The latent content is expressed as themes (17). The study was performed in the paediatric cancer ward of a reference hospital in Semnan, Islamic Republic of Iran. The inclusion criteria were willingness to participate in the study, to speak in Persian, and nursing experience of caring for a child with cancer for ≥ 6 months. Sudden withdrawal from the study was considered an exclusion criterion. Initially, participants were nurses who had experience of caring for children with cancer and their families. Nurses with the longest experience in paediatric oncology were selected as the key informants. Individual interviews were conducted with mothers and their children as well as other healthcare providers based on the data obtained from the analysis and their confirmation.
To explain nursing strategies in paediatric palliative care, we considered the maximum diversity in terms of characteristics like age, years of work experience and the length of time that the children had cancer. Sampling was performed until data saturation in relation to the study content. Saturation is when no new data of importance for the study emerge and the elements of all categories are accounted (19). We used strategies such as asking questions of the data and constantly comparing coded data and categories throughout the analysis to increase the sensitivity of the data. We explored possible properties of any categories and we did not find that further data pertinent to the categories emerged during data collection. In Interviews 15 and 16, the participants expressed the same ideas. Finally, sampling was completed with 16 participants (including 8 nurses, 1 social worker, 1 psychologist, 2 children and 4 mothers).
Data collection
The aim of this study was to gain understanding of nursing strategies for palliative care of children with cancer, and the possible emergence of a wide range of basic social processes; therefore, we decided to use interviews to gather information. Data were collected by the first author of this study through in-depth and individual interviews. Initially, the interviews were unstructured and started with an open-ended question and continued based on the participants’ conversations. Then, they were based on the progress of data analysis and extraction of new concepts, using semistructured interviews. The researcher explained the purpose of the study to the participants. The time of each interview was determined according to the participant’s preference. The interviews were conducted in agreement with the participants at their work or home. Data collection continued from 20 December 2019 to 18 April 2021. The interviews lasted between 47 and 68 minutes. Initially, face-to-face interviews were conducted, and then following limitations due to the COVID-19 pandemic, interviews were done online. The interviews with nurses began with demographic and open-ended questions about the experience of caring for a child with cancer, which gradually focused on the actions and care of the child in life-threatening and dying conditions. Questions from participants who were not nurses were designed in relation to the data obtained from interviews with nurses to confirm and make the care content more transparent. The interviews continued until the data were saturated. The researcher tried to be minimally involved in the interviews, so that most of the time was spent by the participants. Wherever the participants’ statements were ambiguous, the researcher asked them to explain more about their experiences in order to gain deeper understanding of the participants’ experiences. The researcher also paid attention to changes in the tone of voice and facial cues of the participants. The interviews were recorded using a digital voice recorder and transcript for analysis.
Data analysis and trustworthiness
The Graneheim and Lundman approach was used for data analysis. This approach proposes systematic steps for a conventional qualitative content analysis (17). Based on this approach, the following steps were performed. First, the interviews were transcribed, then the parts of the interview that were to be analysed were considered as the unit of analysis. The words, sentences and paragraphs that were related to each other in terms of content were analysed as meaning units. These units were placed next to each other according to their hidden content and were considered as a code at abstract level. The codes were compared with each other based on their similarities and differences and placed in more abstract categories. Finally, with deep reflection and continuous comparison of categories that had similar characteristics, they were introduced at a higher level of abstraction as the theme of the study. Also, the MAXQDA, 2018 software was used for data analysis and management.
According to Graneheim and Lundman, the criteria of credibility, dependability and transferability were used to increase the trustworthiness of the data (17). Data credibility increased with memo writing and the researcher’s long-term interaction with the data, and peer and participant review. Also, 2 qualitative and expert researchers in palliative care examined the codes and categories in terms of appropriateness and readability. Participants’ points of view were used to assess dependability. In this way, parts of text of the interview with the open codes were sent to participants to compare the appropriateness and homogeneity of the results with their own views, opinions and experiences. Transferability was achieved by accurately describing information that allows readers to evaluate the accuracy of the research and to match the results with their context. Also the external check method was used for confirmability. This means that parts of the text of the interviews along with the codes and categories were sent to 4 external observers and they commented on the accuracy of the findings.
Ethical considerations
This study was approved by the Ethics Committee of Semnan University of Medical Sciences with the number IR.SEMUMS.REC.1398.224. The researchers observed ethical considerations by taking actions such as stating the purpose of the research to the participants, voluntary participation in the research, obtaining informed consent from the participants, ensuring anonymity and preserving their audio files.
Results
Data analysis led to the concept of “perceived compassion”. This was derived from the main categories of “feeling the shadow of death on the child” and “comforting accompaniment”. Perceived compassion was the main strategy for nurses during children’s death and their families. The imminent death of children with cancer was a phenomenon that was unavoidable and beyond the control of nurses. While the nurses had a duty to prepare the children and their families for imminent death, they also took a comforting approach to the situation of the parents after their child’s death. Due to the chronic nature of cancer, communication between children, parents and nurses became close and intimate. Therefore, the conditions at the end of the children’s life caused resentment and sadness in the nurses. While the nurses were feeling and controlling this grief, they were trying to prepare the children and their families to face death. In general, the following strategies were performed by nurses during children’s death from cancer.
Feeling the shadow of death on children
During palliative care, due to the chronic condition and multiple follow-up treatments, nurses had more contact with children with cancer and easily understood the clinical course of the disease. They knew that the children were not recovering and would eventually die. Therefore, their action was focused on creating opportunities for more interaction between parents and children and helping them face death. This category consisted of 2 subcategories: “predeath arrangements” and “an opportunity to continue interactions”.
Predeath arrangements
For predeath arrangements, nurses considered strategies such as informing parents of the probable time of death of their children and separating dying children from other children. The nurses believed that it was the parents’ right to know about their child’s condition and imminent death. Parents were informed of their child’s condition and that nothing could be done. Children facing imminent death may have conditions or needs that are different from those of other hospitalized children. The death of children in front of other hospitalized children may lead to adverse emotional reactions. To this end, nurses transferred dying children to the intensive care unit (ICU) as soon as possible. “When a child is next to die, we do not keep him/her in the ward, in order not to affect the spirt of others. We do not even let other children know that this child has died” (Nurse).
An opportunity to continue interactions
This subcategory included strategies to facilitate parents’ constant presence with their child and to reduce visiting restrictions for other relatives. When the children were in the ICU, despite the special conditions and rules of attending the ward, nurses facilitated the constant presence of parents and other relatives with their child. “In the last moments of life of children in the ICU, mothers were not separated from their children” (Nurse). “We reduced meeting restrictions. Some families were extrovert and liked to communicate more with relatives. We eased some of the visiting restrictions for grandparents and other relatives” (Nurse).
Comforting accompaniment
The nurses prepared parents to hear about their child’s death by providing consolation and an opportunity for them to see their child for the last time. They also maintained interaction with parents after the child died. Implementing these strategies enabled nurses to act as comforting companions for families.
Preparing to announce the child’s death
When the nurses wanted to give news of a child’s death, they took the parents to a quiet environment, where the illness and condition of the child were explained again, assuring the parents that the care team had done their best for the child. The parents were given the opportunity to say goodbye to their child’s body. To allow parents to express their feelings when their child’s death was announced, the nurses moved them away from the stressful environment to a calm environment. “We take the family to a room where the others are unaware. We keep them in a quiet environment and we do not inform them in a crowded ward or in the patient’s room” (Nurse). After that, the nurses considered it was the parents’ right to review the status and progress of their child’s illness. In order that the parents do not feel blame, nurses reassured them that their child’s illness was progressive and that they did everything they could for their child, but unfortunately their child died due to worsening of the illness. The nurses felt that if they allowed the parents to say goodbye to their child before transferring the body to the mortuary, they would be able to deal with the mourning process better.
Extra-role sympathy
Extra-role sympathy included self-sacrificial actions of nurses to offer sympathy and emotional accompaniment to parents beyond the call of duty. The nurses may have been in a bad mood, but when they felt that the parents of the deceased child needed their attention, they accepted the hardship wholeheartedly and tried to comfort them. “After the child’s death, although I was not in a good mood; at the request of the mother of the child, who was deeply saddened, I went to her house and stayed with her for hours until she calmed down” (Head Nurse). “I took her mother to the hospital, with her father. I was with him and no one came with us. After giving a sedative I took her home” (Head Nurse).
Postdeath interactions
Due to the chronic nature of paediatric cancer, friendly relationships were established between the nurses and the children’s families, and these continued after the children’s death, such as attending funerals and keeping in contact with the parents. According to the nurses, the children’s families were considered as part of their own families. Therefore, in this study, many years after the children’s deaths, we still witnessed the interaction of nurses with the children’s families by telephone and in person.
Discussion
The aim of this study was to explore the palliative care strategies of Iranian nurses during children’s death from cancer. The concept of perceived compassion emerged from data analysis. This concept, reflect the nurses’ strategies for dealing with children with cancer at the end-of-life stage. As the children approached the end of life and imminent death, the nurses did their best to provide comfort for the children and their families. Seig et al. found that parents were comforted by receiving friendly care from providers of palliative care (20). Kohi et al. mentioned that children with cancer need compassionate and loving care from nurses and doctors; also that children expect healthcare providers to be close to them if necessary, listen to their needs, and help immediately (21).
When nurses become aware of the imminent death of a child, they perform steps such as keeping that child away from other children and informing the child’s parents. They also permit more interaction between the child and their parents and other relatives. In the final days of a child’s life, Lockwood and Humphrey described impactful interventions, including assisting the family transition toward acceptance of a child pending death, using prognostication as a tool in emotional preparedness, and educating the family about the expected conditions to increase their resilience (22). Kars et al. identified 4 stages in caring at home for parents of children with cancer at the end of life: becoming aware of the unavoidable death; making the child’s life pleasurable; managing the deterioration; and preserving the parent–dying child relationship (23). Johnston et al. found that bereaved parents preferred that their child died at home, and that barriers to being with their child in hospital were reduced (24). According to Malcolm and Knighting, parents of children with cancer expressed that preparing the place for their child’s death, compassionate death, bereavement care, and providing a child and family-centred approach were effective aspects of end-of-life care (25).
Providing comfort for children and parents was another nursing strategy in end-of-life care. Nurses tried to help parents to endure the situation by taking actions such as considering giving bad news to parents, empathizing beyond their duty with parents, and even continuing to communicate with them after their child’s death. Lima et al. showed that telling bad news to parents in the palliative care unit was performed by professionals in a specific room, and then they reviewed what happened (26). Similarly, October et al. concluded that planning a meeting between staff and parents after a child’s death can enhance supportive care for bereaved parents (12).
In this study, extra-role sympathy referred to actions beyond the call of duty taken by nurses during parents’ bereavement for their child. McNeil et al. noted that bereavement support for parents after the death of their child was an essential component of quality palliative care (27). Also, Koch and Jones found that quality palliative care addresses the mourning needs and emotional support of parents (28). We found that nurses continued their relationship with bereaved parents after their children’s deaths. In particular, they communicated with mothers by telephone or face-to-face interaction. Similar continued communication was mentioned in other studies. Van der Geest et al. reported that continued communication and care by healthcare professionals with parents who had lost their children to cancer were associated with lower levels of long-term grief (29). Lichtenthal et al. demonstrated that contact of the healthcare team with bereaved parents after their children’s death improved poor bereavement outcomes (30).
Conclusion
Perceived compassion was the main strategy of nurses in palliative care for children facing death from cancer. In perceived compassion, the nurses’ whole effort was to prepare children and families to better face death; however, sometimes it was difficult for nurses to implement these strategies.
Acknowledgements
This research is part of a doctoral dissertation. The authors thank the participants in the research.
Conflicts of interest: There are no conflicts of interest.
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Evaluating the quality of health technology assessment research reports until 2020: the experience of a developing country, Islamic Republic of Iran
Asma Sabermahani,1,3 Vahid Yazdi-Feyzabadi2,3 and Salman Bashzar1
1Student Research Committee, School of Health Management and Information Sciences; 2Health Services Management Research Centre, Institute for Futures Studies in Health; 3Department of Health Management, Policy and Economics, Faculty of Management and Medical Information Sciences, Kerman University of Medical Sciences, Kerman, Islamic Republic of Iran (Correspondence to Salman Bashzar:
Abstract
Background: There is no single method for health technology assessment (HTA) which can be used in all countries to meet all the needs of the health care system policy- and decision-makers. Still, some minimum criteria for performing HTA should be in place in all the HTA structures worldwide, and many HTA agencies have reached a consensus in this regard.
Aim: This study aimed to assess the quality of Iranian HTA reports.
Method: Were examined all the HTA research reports published by the Iranian HTA office up to 2020. The International Network of Agencies for Health Technology Assessment checklist was employed for quality assessment.
Results: A total of 97 reports were examined: only 10.0% had presented complete and appropriate contact details for obtaining further information, and 5.6% clearly stated a conflict of interests. In 87.78% of the reports, the scope of assessment was clearly determined. The quality of the reports was relatively appropriate as well as the details of the sources of information and text search strategies. Legal aspects, economic analysis, ethical implications, social implications and other stakeholder perspectives were taken into account in 7.8%, 74.4%, 11.1%, 8.9%, and 4.4% of the reports, respectively.
Conclusion: As Iranian HTA reports are not of suitable quality, it is recommended that minimum standard criteria be revised and modified in the HTA process so that large-scale health care policy- and decision-makers can make reliable decisions on the basis of the results.
Keywords: health technology assessment, quality assessment, health policy, Iran
Citation: Sabermahani A, Yazdi-Feyzabadi V, Bashzar S. Evaluating the quality of health technology assessment research reports until 2020: the experience of a developing country, Islamic Republic of Iran. East Mediterr Health J. 2022;28(5):xxx–xxx. https://doi.org/10.26719/emhj.22.017
Received: 09/08/21; accepted: 24/10/21
Copyright © World Health Organization (WHO) 2020. Open Access. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO license (https://creativecommons.org/licenses/by-nc-sa/3.0/igo).
Introduction
Growing concerns about limiting the increase in 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 health care domain, the evidence-based medical principles for clinical measures have expanded in the context of health care management and policy-making, 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). Policy-makers cannot judge 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 health care systems, it must be guaranteed that health technology is accurately evaluated and efficiently and effectively used in health care. For optimal exploitation of the existing resources, the most effective technologies should be propagated and used in light of organizational, social, ethical and economic issues (6).
Owing to the scarcity of resources in 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 in order to control the costs and prevent them from increasing inordinately, optimally allocate these costs, and prevent the entry of technologies with low safety and effectiveness (6,8).
The most salient example of scientific research conducted to provide input in health care policy-making is, doubtless, found under the health technology assessment (HTA) model (4). This is a multi-disciplinary context of policy analysis research into 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 has remarkably expanded in the last 2 decades; it is currently used for the evaluation and estimation of the value of medical technologies (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). Still, organizations are increasingly performing or launching HTA for making certain decisions about resource allocation. For example, the National Institute for Health and Clinical Excellence in the United Kingdom utilizes 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. In the next stage, the objectives, responsibilities, method of establishment and general structure of the Iranian HTA system were discussed and approved in the policy-making 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 health care 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, the present 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 office 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 on this office’s list of reports. Then, these reports were evaluated based on a checklist developed by the INAHTA (11). This checklist encompasses 6 domains and has a total of 31 items, including preliminary information (5 items), why the assessment has been undertaken (4 items), how the assessment has been undertaken (10 items), information based on the evaluation and interpretation of the selected data and information (4 items), context (5 items), and post-evaluation events (3 items). This checklist assesses the HTA reports on three levels (yes, partly, no). The checklist was first translated into Farsi by 2 HTA researchers and health policy-makers, 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 reported to the third researcher to reach a consensus. The data were extracted, input to 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 eliminated 1 report due to being a duplicate, and 3 due to being non-evaluation reports. Finally, 97 reports were assessed in terms of general features, and 90 reports could be assessed based on the checklist. Of the 97 4eports 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 technologies dealing with health-related equipment and devices (13.4%), diseases of the nervous system (12.37%), factors affecting health status or contacting health services (10.3%); a full list of distribution according to condition is given in 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. Meanwhile, 34.0% of the HTA studies were conducted by only 9 researchers, each working with his/her 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 exhibited 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 affiliation was 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 conflict of interests. In 98.9% of the reports there was no statement on being externally reviewed. 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 is clearly determined; and in 82.2% there is a proper description of the health technology that has been 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 in terms of the description of the method of data synthesis (61.1%) and clear presentation of assessment results (78.9%). Furthermore, 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 suggestions for further action (Table 3).
Discussion
The majority of technologies evaluated in the Islamic Republic of Iran are therapeutic, diagnostic and medical; most of them deal with noncommunicable diseases or their risk factors. This shows that the epidemiological movement of diseases from communicable to noncommunicable has greatly affected the technologies required by these diseases, which constitute > 60% of the disability-adjusted life years (DALYs) and 70% of global deaths (12). In this regard, the ever-increasing growth of technologies related to these diseases should be taken into account (5).
Our findings indicate that a limited number of researchers conduct the HTA studies: 34.0% had been conducted by only 9 researchers. The majority of these researchers possessed the experience and skills of performing HTA in the Islamic Republic of Iran. Therefore, to properly conduct HTA projects, a sufficient number of HTA experts possessing the required skills should be trained and involved in conducting such projects, 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 these researchers and the health care legislator.
Having proper contact details, stating the conflict of interests, and stating whether the HTA report has been reviewed are essential items for ensuring transparency (11). However, our findings revealed that only 10% of the Iranian HTA reports presented complete and proper contact details for obtaining further information, and 42.2% of the reports lacked any such information. Only 5.6% clearly stated the conflict of interests, and 1.1% had any statement about being externally reviewed. The presentation of a short non-technical summary to be understood by a wider audience is optimal (11) and enhances the impartiality and transparency of HTA activity. This summary was included in less than half the reports.
In this study, the scope of assessment was clearly determined in 87.8% of the HTA reports. Drummond et al. explain 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 to be addressed. Nevertheless, 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 of the Iranian HTA reports presented precise details; the exception was listing excluded studies (22.2% of reports). Evidently, those who perform HTA in the Islamic Republic of Iran have actively searched maximum data based on HTA guidelines.
The HTA process is multi-disciplinary; it examines legal aspects, economic analysis, ethical implications, social implications, and other stakeholder perspectives (16–18). However, the Iranian HTA reports were not outstanding, and most of them failed to consider these factors; most of the reports only discussed economic aspects. It should be kept in mind that the economic assessment of health care interventions, especially new medications and technologies, is often performed to identify the best purchases. Eventually, policy-makers and state institutions may fund a package of general benefits (19); thus, the other aspects related to technologies should also be examined. It is important that HTAs should meet the national, regional and local needs (1). Nevertheless, 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 cooperation of all the key stakeholders with HTA performers (1), but no trace of this principle is found in Iranian HTA reports. Although the HTA structure in the Islamic Republic of Iran is similar to the European HTA core model, there are clear differences between the Iranian HTA structure and that of other organizations, such as those in the United Kingdom (20–22) and Germany (23,24).
Thus, 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 suggestions about further action. Moreover, 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 in decision-making, 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. Furthermore, suggestions 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, on comparison with one available study (26), we can conclude that the Iranian studies have from major problems.
According to a study by Newman et al. on 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, and HTA 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 connecting HTA results to decision-making processes, adopting a comprehensive social perspective and monitoring the implementation of HTA results.
This study is limited in that many HTA performers were not identified; thus, lack of access to many researchers led to loss of information on 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. Still, in its simplest form, an HTA should possess certain components so that an appropriate input can be offered for policy- and decision-making at the desired levels. Our study discussed the strong and weak points of Iranian HTA reports and showed that there is a considerable space for the advancement of the HTA system in HTA project implementation at the level of international standards. Despite this, the Iranian HTA system has greatly progressed and can have a promising future if an appropriate structure is created and local guidelines for HTA are developed and presented to decision- and policy-makers.
Acknowledgments
This study is based on a health policy-making 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: 980000894) 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: The authors declare that they have no competing interests.
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