ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: A SYSTEMATIC REVIEW

2018 ◽  
Vol 34 (5) ◽  
pp. 447-457 ◽  
Author(s):  
Christian A. Bellemare ◽  
Pierre Dagenais ◽  
Suzanne K.-Bédard ◽  
Jean-Pierre Béland ◽  
Louise Bernier ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Decision ◽  
Health Technology ◽  
Ethical Analysis ◽  
Social Needs ◽  
Inductive Method ◽  
Value Judgments ◽  
Ethical Evaluation

Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

VP138 Integration Of Ethics In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 212-213
Author(s):  
Christian Bellemare ◽  
Suzanne Kocsis Bédard ◽  
Pierre Dagenais ◽  
Jean-Pierre Béland ◽  
Louise Bernier ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Decision ◽  
Practical Method ◽  
Health Technology ◽  
Social Needs ◽  
Operational Method ◽  
Ethics Assessment ◽  
Integrating Ethics

INTRODUCTION:The objective was to identify the conceptual and methodological issues surrounding integration of ethics in Health Technology Assessment (HTA). We conducted a systematic review examining: (i) social needs, (ii) methodological and procedural barriers, (iii) concepts or processes of ethics assessment used and (iv) results of experimentations for integrating ethics in HTA.METHODS:Search criteria included ‘ethic’, ‘technology assessment’ and ‘HTA’. The literature search was done up to 21 November 2016 in Medline/Ovid, SCOPUS, CINAHL, PsycINFO and international HTA Database. Screening of citations, screening of full-text and data extraction were performed by two subgroups of two independent reviewers. The first group was constituted of HTA experts, and the second of ethics and philosophy experts. Data extracted from articles were regrouped in categories for each objective.RESULTS:A list of 2,420 citations was obtained while 1,646 remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. Eight categories were identified within the social needs. The mostly evoked were ‘Informed policy decision making’ (n = 16) and 'Informed public/patient decision making’ (n = 12). Ten categories of methodological and procedural barriers were identified. The most mentioned were 'Lack of standardized and recognized proceedings for ethical analysis’ (n = 28) and ‘Lack of shared consensus on the role of ethical theory and ethical expertise’ (n = 17). Within the concepts or processes of ethics assessment, thirteen categories were identified. The most mentioned were ‘Fairness and Equity’ (n = 12), ‘Beneficence and Non-maleficence’ (n = 10) and, ‘Autonomy’ (n = 10). Within results of experimentations, five categories were identified. The most mentioned was ‘Usefulness of ethics for identifying relevant problems’ (n = 3). While few experimentations were identified, no clear operational method was found in our research.CONCLUSIONS:This study confirms the necessity to design an operational method integrating ethics and addressing social needs of HTA. Our results constitute the basis for developing a new theoretical and practical method.

scholarly journals MENTORING A HEALTH TECHNOLOGY ASSESSMENT INITIATIVE IN KAZAKHSTAN

2014 ◽  
Vol 30 (2) ◽  
pp. 147-152 ◽  
Author(s):  
Sergei Muratov ◽  
David Hailey ◽  
Vicki Foerster ◽  
Bruce Brady ◽  
Don Juzwishin ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Policy Decision ◽  
Health Technology ◽  
Organization Culture ◽  
Train The Trainer ◽  
Staff Members ◽  
Health Policy Decision ◽  
The Republic

Objectives: The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of KazakhstanMethods: Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project.Results: Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work.Conclusions: The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.

scholarly journals History of health technology assessment: Spain

2009 ◽  
Vol 25 (S1) ◽  
pp. 163-173 ◽  
Author(s):  
Laura Sampietro-Colom ◽  
Jose Asua ◽  
Eduardo Briones ◽  
Jordi Gol ◽  
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Decision ◽  
Health Technology ◽  
Policy Coordination ◽  
Public Healthcare ◽  
Regional Government ◽  
Health Care Environment ◽  
Health Technologies

Objectives: The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain.Methods: A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain.Results: HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work.Conclusions: HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.

GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS

2015 ◽  
Vol 31 (6) ◽  
pp. 457-465 ◽  
Author(s):  
Laura Sampietro-Colom ◽  
Krzysztof Lach ◽  
Iris Pasternack ◽  
Jean-Blaise Wasserfallen ◽  
Americo Cicchetti ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Large Scale ◽  
Good Practice ◽  
Policy Decision ◽  
Health Technology ◽  
Assessment Process ◽  
Local Context ◽  
Good Practices ◽  
Guiding Principles

Objectives: Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units.Methods: A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units.Results: Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project.Conclusions: Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

scholarly journals SCIENTIFIC AND SOCIAL VALUE JUDGMENTS FOR ORPHAN DRUGS IN HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (4) ◽  
pp. 218-232 ◽  
Author(s):  
Elena Nicod ◽  
Panos Kanavos
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Orphan Drugs ◽  
Social Value ◽  
European Medicines Agency ◽  
Final Decision ◽  
Value Judgments ◽  
Accountability For Reasonableness ◽  
The Impact

Objectives: We explore how broader aspects of a treatment's value and the impact of the condition on patients not captured by routine health technology assessment (HTA) methods using clinical and economic evidence, defined as “other considerations,” may influence HTA processes in different settings.Methods: Countries included were England, Scotland, Sweden, and France. Data sources were the publicly available reports on HTA recommendations. Ten drugs with European Medicines Agency orphan designation and appraised in England were selected. Qualitative thematic analysis was used to systematically identify and code all “other considerations” based on a previously developed methodological framework, which also coded whether it was provided by stakeholders, and how it influenced the decision.Results: A classification framework of scientific and social value judgments was developed and used throughout the study. A total of 125 “other considerations” were identified and grouped into ten subcategories based on the information provided. Eighteen to 100 percent of these, depending on the agency, were put forward as one of the main reasons for the final decision potentially contributing to accepting a higher incremental cost-effectiveness ratio or uncertain evidence. Some of these were nonquantified or nonelicited and pertained to the assessor's judgment. A taxonomy of these value judgments was created to be used in future cases. Results also contributed to better defining the determinants of social value and improving accountability for reasonableness.Conclusions: The systematic identification of the scientific and social value judgments enables to better understanding the dimensions of value, which can be used to improve their transparency and consistent use across decisions and settings.

Pharmacological treatment of oro-facial pain - health technology assessment including a systematic review with network meta-analysis

2017 ◽  
Vol 44 (10) ◽  
pp. 800-826 ◽  
Author(s):  
B. Häggman-Henrikson ◽  
P. Alstergren ◽  
T. Davidson ◽  
E. D. Högestätt ◽  
P. Östlund ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Pharmacological Treatment ◽  
Facial Pain ◽  
Meta Analysis ◽  
Health Technology

scholarly journals International guidelines for self-report and proxy completion of paediatric health-related quality of life measures: a protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052049
Author(s):  
Christine Mpundu-Kaambwa ◽  
Gang Chen ◽  
Kim Dalziel ◽  
Nancy Devlin ◽  
Julie Ratcliffe
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Guidelines And Recommendations

IntroductionMeasures of health-related quality of life (HRQoL), accompanied by the values (or utilities) required to estimate quality-adjusted life-years, are crucial for determining health benefits within economic evaluation and health technology assessment. Several generic and condition-specific measures or instruments of HRQoL, accompanied by values, currently exist for application with child populations. However, there is a lack of a structured summary of guidelines and recommendations for applying these measures in practice. This protocol describes a systematic review of guidelines and recommendations for child and proxy completion of child-specific measures of HRQoL. The aims of the review are to (1) identify and summarise published guidelines and recommendations for existing child-specific measures of HRQoL, (2) determine whether the identified guidelines and recommendations differ by instrument and child characteristics, (3) identify current gaps in these guidelines and recommendations and (4) identify best practices for child self and proxy assessment in paediatric HRQoL measurement for economic evaluation and health technology assessment.Methods and analysisThe review will identify, collate and synthesise published guidelines and recommendations for existing child-specific utility measures of HRQoL. Electronic databases to be searched include the Cochrane Library, Medline, Scopus, Web of Science, EconLit, PsycINFO, CINAHL, Embase and Informit. The search will be extended to websites of (1) international organisations for health technology assessment, (2) regulation, health economics and HRQoL outcomes research and (3) instrument developers. Three reviewers will independently screen titles and abstracts against the inclusion criteria. A narrative synthesis will describe the key features of the guidelines identified.Ethics and disseminationEthical approval is not required as the proposed systematic review will not use primary data. A paper of the systematic review will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42020207160.

scholarly journals Prognostic biomarkers to identify patients likely to develop severe Crohn’s disease: a systematic review

2021 ◽  
Vol 25 (45) ◽  
pp. 1-66
Author(s):  
Steve Halligan ◽  
Darren Boone ◽  
Lucinda Archer ◽  
Tariq Ahmad ◽  
Stuart Bloom ◽  
...  
Keyword(s):  
Systematic Review ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Meta Analysis ◽  
Severe Disease ◽  
Health Technology ◽  
Risk Of Bias ◽  
Clinical Biomarkers

Background Identification of biomarkers that predict severe Crohn’s disease is an urgent unmet research need, but existing research is piecemeal and haphazard. Objective To identify biomarkers that are potentially able to predict the development of subsequent severe Crohn’s disease. Design This was a prognostic systematic review with meta-analysis reserved for those potential predictors with sufficient existing research (defined as five or more primary studies). Data sources PubMed and EMBASE searched from inception to 1 January 2016, updated to 1 January 2018. Review methods Eligible studies were studies that compared biomarkers in patients who did or did not subsequently develop severe Crohn’s disease. We excluded biomarkers that had insufficient research evidence. A clinician and two statisticians independently extracted data relating to predictors, severe disease definitions, event numbers and outcomes, including odds/hazard ratios. We assessed risk of bias. We searched for associations with subsequent severe disease rather than precise estimates of strength. A random-effects meta-analysis was performed separately for odds ratios. Results In total, 29,950 abstracts yielded just 71 individual studies, reporting 56 non-overlapping cohorts. Five clinical biomarkers (Montreal behaviour, age, disease duration, disease location and smoking), two serological biomarkers (anti-Saccharomyces cerevisiae antibodies and anti-flagellin antibodies) and one genetic biomarker (nucleotide-binding oligomerisation domain-containing protein 2) displayed statistically significant prognostic potential. Overall, the strongest association with subsequent severe disease was identified for Montreal B2 and B3 categories (odds ratio 4.09 and 6.25, respectively). Limitations Definitions of severe disease varied widely, and some studies confounded diagnosis and prognosis. Risk of bias was rated as ‘high’ in 92% of studies overall. Some biomarkers that are used regularly in daily practice, for example C-reactive protein, were studied too infrequently for meta-analysis. Conclusions Research for individual biomarkers to predict severe Crohn’s disease is scant, heterogeneous and at a high risk of bias. Despite a large amount of potential research, we encountered relatively few biomarkers with data sufficient for meta-analysis, identifying only eight biomarkers with potential predictive capability. Future work We will use existing data sets to develop and then validate a predictive model based on the potential predictors identified by this systematic review. Contingent on the outcome of that research, a prospective external validation may prove clinically desirable. Study registration This study is registered as PROSPERO CRD42016029363. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 45. See the NIHR Journals Library website for further project information.

Sign in / Sign up

Export Citation Format

Share Document