Dataset Information

Why not integrate ethics in HTA: identification and assessment of the reasons.

ABSTRACT: From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work? This is the key question of this article and several reasons why ethics is not a part of HTA are identified. A) Ethicists are professional strangers in HTA. B) A common agreed methodology for integrating ethics is lacking. Ethics methodology appears to be C) deficient, D) insufficient, or E) unsuitable. F) Integrating ethics in HTA is neither efficient nor needed for successful HTA. G) Most moral issues are general, and are not specific to a given technology. H) All relevant ethical issues can be handled within other frameworks, e.g., within economics. I) Ethics can undermine or burst the foundation of HTA. Hence, there are many reasons why ethics is not an integrated part of HTA so many years after identifying ethics as constitutive to HTA. These reasons may all explain why it is so, but on closer scrutiny, they do not work as compelling arguments for not addressing ethical issues in HTA. Hence, the identified reasons may work well as explanations, but not as justifications. In order to move on from a situation of failure we can: Exclude ethics from definitions of HTA, and as a consequence, establish a separate kind of evaluation (Health Technology Evaluation - HTE). Take the existing definition seriously and actually integrate ethics in the performance of HTA practice. Amend, expand or change HTA so that ethics is more genuinely incorporated. Which of these options to choose is open for discussion, but we need to move away from a situation where we have a definition of HTA which does not correspond with HTA practice.

SUBMITTER: Hofmann B

PROVIDER: S-EPMC4260057 | biostudies-other | 2014

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Why not integrate ethics in HTA: identification and assessment of the reasons.

Hofmann Bjørn B

GMS health technology assessment 20141126

From the conception of HTA in the 1970s it has been argued that addressing ethical issues is an element of HTA, and many methods for integrating ethics in HTA have become available. However, despite almost 40 years with repeated intentions, only few HTA reports include ethical analysis. Why is this so? How come, ethics is a constituent part of HTA, there are many methods available, but ethics is rarely part of practical HTA work? This is the key question of this article and several reasons why e ...[more]

PMID: 25493101

Similar Datasets

Project description:Study questionWhat are the reasons for or against the future clinical application of germline genome modification (GGM)?Summary answerA total of 169 reasons were identified, including 90 reasons for and 79 reasons against future clinical application of GGM.What is known alreadyGGM is still unsafe and insufficiently effective for clinical purposes. However, the progress made using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR-associated system (Cas) has led scientists to expect to overcome the technical hurdles in the foreseeable future. This has invited a debate on the socio-ethical and legal implications and acceptability of clinical applications of GGM. However, an overview of the reasons presented in this debate is missing.Study design, size, durationMEDLINE was systematically searched for articles published between January 2011 and June 2016. Articles covering reasons for or against clinical application of intentional modification of the nuclear DNA of the germline were included.Participants/materials, setting, methodsTwo researchers independently extracted the reported reasons from the articles and grouped them into categories through content analysis.Main results and the role of chanceThe systematic search yielded 1179 articles and 180 articles were included. Most papers were written by professionals in ethics, (science) journalism and biomedical sciences. Overall, 169 reasons were identified, including 90 reasons for, and 79 reasons against future clinical application of GGM. None of the included articles mentioned more than 60/169 reasons. The reasons could be categorized into: (i) quality of life of affected individuals; (ii) safety; (iii) effectiveness; (iv) existence of a clinical need or alternative; (v) costs; (vi) homo sapiens as a species (i.e. relating to effects on our species); (vii) social justice; (viii) potential for misuse; (ix) special interests exercising influence; (x) parental rights and duties; (xi) comparability to acceptable processes; (xii) rights of the unborn child; and (xiii) human life and dignity. Considerations relating to the implementation processes and regulation were reported.Limitations, reasons for cautionWe cannot ensure completeness as reasons may have been omitted in the reviewed literature and our search was limited to MEDLINE and a 5-year time period.Wider implications of the findingsBesides needing (pre)clinical studies on safety and effectiveness, authors call for a sound pre-implementation process. This overview of reasons may assist a thorough evaluation of the responsible introduction of GGM.Study funding/competing interest(s)University of Amsterdam, Alliance Grant of the Amsterdam Reproduction and Development Research Institute (I.D.), and Clinical Center, Department of Bioethics, National Institutes of Health Intramural Research Program (S.H.). There are no competing interests.

Project description:ObjectiveWe aim to develop a comprehensive checklist for evaluating Health Technology Assessment (HTA) studies commissioned in India. The primary objective of this work is to capture all vital aspects of an HTA study in terms of conduct, reporting and quality.MethodologyThe development of a quality appraisal checklist included 3 steps. First, a targeted review of the literature was done to gather information on existing HTA checklists. After reviewing these checklists, an initial draft of the HTA quality appraisal checklist (HTA-QAC) for India was prepared with discussion amongst the authors. Second, the draft checklist was reviewed by the members of the Technical Appraisal Committee (TAC) and their feedback was incorporated. Subsequently, the revised checklist was presented at a virtual meeting of the TAC. Finally, a pilot phase was undertaken to apply HTA-QAC for the approved HTA study reports. Three rounds of virtual discussions were held with the researchers who were involved in the conduct of these HTA studies to resolve any discordance in opinion or develop solutions for the problems in the use of the HTA-QAC followed by a further revision of the checklist.ResultsThe HTA-QAC is divided into two parts: a self-reporting section to be completed by the author, and the other to be completed by the reviewer. The reviewer checklist has two sections: one to review the report and the other to review the model. The author section is in a self-reporting format, which includes details of basic study information, the rationale for the study, policy relevance, study description, study methods, reporting of model parameters, and results. The reviewer section of the checklist focuses on the quality aspect of the conducted study. The domains included in the report review include details on study methodology, results, discussion, and conclusion. The second part of the reviewer section of HTA-QAC constitutes a review of the model in terms of model assumptions, functionality, model inputs, calculations, uncertainty analysis, model output, and model validation.ConclusionWe recommend a standardised process of quality appraisal to ensure the high quality of HTA evidence for policy use in the Indian context. The proposed HTA-QAC will help authors to ensure standardised reporting, as well as allow reviewers to assess the quality of analysis.

Project description:BackgroundHealth technology assessment (HTA) is increasingly performed at the local or hospital level where the costs, impacts, and benefits of health technologies can be directly assessed. Although local/hospital-based HTA has been implemented for more than two decades in some jurisdictions, little is known about its effects and impact on hospital budget, clinical practices, and patient outcomes. We conducted a mixed-methods systematic review that aimed to synthesize current evidence regarding the effects and impact of local/hospital-based HTA.MethodsWe identified articles through PubMed and Embase and by citation tracking of included studies. We selected qualitative, quantitative, or mixed-methods studies with empirical data about the effects or impact of local/hospital-based HTA on decision-making, budget, or perceptions of stakeholders. We extracted the following information from included studies: country, methodological approach, and use of conceptual framework; local/hospital HTA approach and activities described; reported effects and impacts of local/hospital-based HTA; factors facilitating/hampering the use of hospital-based HTA recommendations; and perceptions of stakeholders concerning local/hospital HTA. Due to the great heterogeneity among studies, we conducted a narrative synthesis of their results.ResultsA total of 18 studies met the inclusion criteria. We reported the results according to the four approaches for performing HTA proposed by the Hospital Based HTA Interest Sub-Group: ambassador model, mini-HTA, internal committee, and HTA unit. Results showed that each of these approaches for performing HTA corresponds to specific needs and structures and has its strengths and limitations. Overall, studies showed positive impacts related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians.ConclusionsLocal/hospital-based HTA could influence decision-making on several aspects. It is difficult to evaluate the real impacts of local HTA at the different levels of health care given the relatively small number of evaluations with quantitative data and the lack of clear comparators. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can impact hospital policies, clinical decisions, and quality of care and optimize the use of scarce resources.

Project description:BackgroundIndia recently launched the largest universal health coverage scheme in the world to address the gaps in providing healthcare to its population. Health technology assessment (HTA) has been recognised as a tool for setting priorities as the government seeks to increase public health expenditure. This study aims to understand the current situation for healthcare decision-making in India and deliberate on the opportunities for introducing HTA in the country.MethodsA paper-based questionnaire, adapted from a survey developed by the International Decision Support Initiative (iDSI), was administered on the second day of the Topic Selection Workshop that was conducted as part of the HTA Awareness Raising Workshop held in New Delhi on 25-27 July, 2016. Participants were invited to respond to questions covering the need, demand and supply for HTA in their context as well as the role of their organisation vis-à-vis HTA. The response rate for the survey was about 68% with 41 participants having completed the survey.ResultsThree quarters of the respondents (71%) stated that the government allocated healthcare resources on the basis of expert opinion. Most respondents indicated reimbursement of individual health technologies and designing a basic health benefit package (93% each) were important health policy areas while medical devices and screening programmes were cited as important technologies (98% and 92%, respectively). More than half of the respondents noted that relevant local data was either not available or was limited. Finally, technical capacity was seen as a strength and a constraint facing organisations.ConclusionThe findings from this study shed light on the current situation, the opportunities, including potential topics, and challenges in conducting HTA in India. There are limitations to the study and further studies may need to be conducted to inform the role that HTA will play in the design or implementation of universal health coverage in India.

Dataset Information

Why not integrate ethics in HTA: identification and assessment of the reasons.

Publications

Why not integrate ethics in HTA: identification and assessment of the reasons.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets