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      Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods—study protocol

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          Abstract

          Background

          Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues.

          The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs.

          Methods

          We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way.

          Discussion

          Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

          Electronic supplementary material

          The online version of this article (10.1186/s13643-018-0743-4) contains supplementary material, which is available to authorized users.

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          Most cited references8

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          Putting Public Health Ethics into Practice: A Systematic Framework

          It is widely acknowledged that public health practice raises ethical issues that require a different approach than traditional biomedical ethics. Several frameworks for public health ethics (PHE) have been proposed; however, none of them provides a practice-oriented combination of the two necessary components: (1) a set of normative criteria based on an explicit ethical justification and (2) a structured methodological approach for applying the resulting normative criteria to concrete public health (PH) issues. Building on prior work in the field and integrating valuable elements of other approaches to PHE, we present a systematic ethical framework that shall guide professionals in planning, conducting, and evaluating PH interventions. Based on a coherentist model of ethical justification, the proposed framework contains (1) an explicit normative foundation with five substantive criteria and seven procedural conditions to guarantee a fair decision process, and (2) a six-step methodological approach for applying the criteria and conditions to the practice of PH and health policy. The framework explicitly ties together ethical analysis and empirical evidence, thus striving for evidence-based PHE. It can provide normative guidance to those who analyze the ethical implications of PH practice including academic ethicists, health policy makers, health technology assessment bodies, and PH professionals. It will enable those who implement a PH intervention and those affected by it (i.e., the target population) to critically assess whether and how the required ethical considerations have been taken into account. Thereby, the framework can contribute to assuring the quality of ethical analysis in PH. Whether the presented framework will be able to achieve its goals has to be determined by evaluating its practical application.
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            Mapping the integration of social and ethical issues in health technology assessment.

            Since its inception, the field of health technology assessment (HTA) has stressed the need for consideration of ethical and social issues. However, few concepts or analytic tools have been developed, and because of the complexity of the endeavor and a lack of integration of work already produced, such concepts remain difficult to apply in HTA. Through a descriptive "map" of concepts, tools, and processes, we summarize the most tangible efforts on the part of HTA producers to address social and ethical issues. A literature review and content analysis of HTA reports in the Centre for Reviews and Dissemination database enables a synthesis of the reflections on, initiatives around, and gaps in knowledge related to the integration of social and ethical issues in HTA. We examine: (i) the aim of integrating ethical and social issues in HTA, (ii) the theoretical approaches used, (iii) the methods and processes applied, and (iv) the implications for HTA producers. We highlight two levels at which social and ethical issues can be considered: throughout the production process of HTA reports and as part of the organizational structure of HTA agencies. Given the profound societal changes that occur in relation to healthcare technology development, HTA producers have a responsibility to inform and enlighten technology-related public and policy debates. Fulfilling this role, though, requires that socioethical dimensions of technology and HTA are made explicit.
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              Supporting the use of health technology assessments in policy making about health systems.

              The objective of this study is to profile the health technology assessments (HTAs) produced in Canada and other selected countries and assess their potential to inform policy making about health systems in jurisdictions other than the ones for which they were produced, and to develop and pilot test prototypes for packaging and assessing the relevance of HTAs for health system managers and policy makers. We compiled an inventory of all HTAs that were produced by nine HTA agencies between September 2003 and August 2006; coded the title and abstract of each HTA according to the technologies assessed, methods used, and whether or not context-specific actionable messages were provided; developed a prototype for a structured, decision-relevant HTA summary and for a relevance-assessment form; and pilot-tested the prototypes using semistructured telephone interviews with a purposive sample of Canadian healthcare managers and policy makers. Our review of the 223 HTAs identified that: (i) 44 HTAs addressed health system arrangements (20 percent); (ii) 205 incorporated a systematic review (92 percent), whereas only 12 incorporated a sociopolitical assessment using explicit methods (5 percent); and (iii) 50 contained context-specific actionable messages (22 percent). Our interviews identified significant support for both the general idea of an HTA summary and the prototype's specific elements, but mixed views about using peer assessments of relevance. Those involved in supporting the use of HTAs in policy making about health systems may wish to produce structured decision-relevant summaries for their systematic review-containing HTAs to increase the prospects for their HTAs being used outside the jurisdiction for which they were produced.
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                Author and article information

                Contributors
                tim.mathes@uni-wh.de
                gerald.willms@aqua-institut.de
                stephanie.polus@uni-wh.de
                constance.stegbauer@aqua-institut.de
                melanie.messer@uni-bielefeld.de
                corinna.klingler@med.uni-muenchen.de
                heidi.ehrenreich@bv.aok.de
                dea.niebuhr@pg.hs-fulda.de
                georg.marckmann@med.uni-muenchen.de
                ansgar.gerhardus@uni-bremen.de
                dawid.pieper@uni-wh.de
                Journal
                Syst Rev
                Syst Rev
                Systematic Reviews
                BioMed Central (London )
                2046-4053
                23 May 2018
                23 May 2018
                2018
                : 7
                : 79
                Affiliations
                [1 ]ISNI 0000 0000 9024 6397, GRID grid.412581.b, Institute for Research in Operative Medicine, , Witten/Herdecke University, ; Ostmerheimer Str. 200, 51109 Cologne, Germany
                [2 ]AQUA Institute for Applied Quality Improvement and Research in Health Care, Maschmuehlenweg 8-10, 37073 Goettingen, Germany
                [3 ]ISNI 0000 0001 0944 9128, GRID grid.7491.b, Faculty of Health Science, , Bielefeld University, ; Universitätsstr. 25, 33615 Bielefeld, Germany
                [4 ]ISNI 0000 0004 1936 973X, GRID grid.5252.0, Institute of Ethics, History and Theory of Medicine, , LMU Munich, ; Lessingstr. 2, 80689 Munich, Germany
                [5 ]AOK-Bundesverband, Rosenthaler Str. 31, 10178 Berlin, Germany
                [6 ]Department of Nursing and Health Sciences, University of Applied Sciences, Leipziger Straße 123, 36037 Fulda, Germany
                [7 ]ISNI 0000 0001 2297 4381, GRID grid.7704.4, Department for Health Services Research, Institute for Public Health and Nursing Research, , University of Bremen, ; Grazer Str. 4, D-28359 Bremen, Germany
                [8 ]ISNI 0000 0001 2297 4381, GRID grid.7704.4, Health Sciences Bremen, , University of Bremen, ; Bremen, Germany
                Article
                743
                10.1186/s13643-018-0743-4
                5966916
                29792224
                faae6b09-4b71-4783-a9a0-0933154adcab
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 20 July 2017
                : 10 May 2018
                Categories
                Protocol
                Custom metadata
                © The Author(s) 2018

                Public health
                public health,health promotion,health technology assessment,methodology review
                Public health
                public health, health promotion, health technology assessment, methodology review

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