Quality of ethical analyses in health technology assessment reports up to 2020: the experience of a developing country

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Vahid Yazdi-Feyzabadi1,2 and Salman Bashzar1

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

Abstract

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

Aims: To investigate the ethical dimension as an inseparable aspect of HTA studies in Iranian HTA reports.

Methods: For quality assessment of ethical analysis, all HTA reports published by the HTA Office up to 2020 were reviewed using 2 valid assessment tools, the HTA Core Model and the Q-SEA questionnaires.

Results: We evaluated 91 reports for quality of ethical analyses. In the process dimension, the research question, literature search and inclusion/exclusion criteria were included in 91.2%, 83.5% and 82.4% of the HTA reports, respectively. The perspective of the analysis was explicitly stated in only 13.2% of the reports and the ethics framework in 6.6%. Maximum compliance with completeness, bias, policy implications, other implications, conceptual clarification and conflicting values was considered in only 2.2%, 4.4%, 9.9%, 9.9%, 14.3% and 2.2% respectively of all reports.

Conclusions: Iranian HTA reports require a coordinated and integrated framework acceptable to all stakeholders.

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

Citation: Yazdi-Feyzabadi V, Bashzar S. Quality of ethical analyses in health technology assessment reports up to 2020: the experience of a developing country. East Mediterr Health J. 2023;29(5):xxx–xxx. https://doi.org/10.26719/emhj.23.039

Received: 16/06/22; accepted: 18/12/22

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

Introduction

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

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

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

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

Since, as a developing country, the Islamic Republic of Iran is exposed to modern health care technologies, this study aimed to examine and evaluate the quality of ethical analyses of all HTA reports.

Methods

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

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

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

Results

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

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

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

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

Discussion

In reviewing the process aspect of the Iranian HTA reports using the Q-SEA tool, the focus has been on evaluating the quality of the elements of that process in achieving ethical analysis, and this study showed that 100% of the HTA reports included the ethical aspect as a part of their systematic review. However, the ethical aspect was not responded to in the PICO format as a systematic review of clinical evidence, as suggested by McCullough et al. (33).

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

Because most researchers working on HTA projects believed that other aspects of HTA cover the ethical aspect, they refused to conduct a separate study for ethical analysis. Therefore, in terms of inclusion and exclusion criteria, they also referred to studies on technology-related ethical issues and have noted the study of such issues as inclusion criteria.

The fact that the analysis and assessment were conducted from an impartial perspective was only clearly defined in less than 15% of the HTA reports we studied. It should be noted that, when investigating the ethical aspect of technology, certain other methods are commonly utilized, for example convening an expert panel or focus group discussions, where clinical experts and decision-makers in the relevant field are included.

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

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

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

In terms of conceptual clarification, the reports were poorly presented. Although the systematic review does not provide any transparent assessment of conceptual topics, the authors of those reports implicitly proposed several explanations, such as: it does not affect human dignity, it does not damage patient autonomy, or the studied technology leads to justice in access.

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

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

Although most reports use the HTA Core Model, the lack of a standard model in HTA in the Islamic Republic of Iran can be seen in the ethical analysis of technology-related issues, which has also been highlighted in previous research (14). Most of the reported Iranian HTAs were conducted by only 1 or 2 people; in none of them was a medical ethics expert involved, but this was not mentioned in the reports. This issue shows the significant weakness of knowledge related to complex philosophical theories, ethical arguments and lack of expertise in the perception of ethical justification methods in HTA studies. The technology-related ethical goals have been discussed in only a small number of reports; these were not very transparent and nor did they use any of the various approaches to ethical analysis.

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

Conclusion

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

Acknowledgement

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

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

Competing interests: The authors declare that they have no competing interests.

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