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COMPREHENSIVE ASSESSMENT OF COMPLEX TECHNOLOGIES: INTEGRATING VARIOUS ASPECTS IN HEALTH TECHNOLOGY ASSESSMENT

Published online by Cambridge University Press:  07 August 2017

Kristin Bakke Lysdahl ,
Kati Mozygemba ,
Jacob Burns ,
Jan Benedikt Brönneke ,
James B. Chilcott ,
Sue Ward  and
Bjørn Hofmann
Kristin Bakke Lysdahl
Affiliation:
Centre for Medical Ethics, University of Oslo Faculty of Health Sciences, Oslo and Akershus University College of Applied SciencesKristin.Bakke.Lysdahl@usn.no
Kati Mozygemba
Affiliation:
Department of Health Services Research, University of Bremen Health Sciences Bremen
Jacob Burns
Affiliation:
Institute for Medical Informatics, Biometry and Epidemiology, LMU Munich
Jan Benedikt Brönneke
Affiliation:
Federal Joint Committee (G-BA)
James B. Chilcott
Affiliation:
ScHARR, University of Sheffield
Sue Ward
Affiliation:
ScHARR, University of Sheffield
Bjørn Hofmann
Affiliation:
Centre for Medical Ethics, University of Oslo The Norwegian University for Science and Technology (NTNU)
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Abstract

Objectives: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects.

Methods: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers.

Results: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods’ applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources.

Conclusions: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.

Keywords

Technology assessment biomedicalTechnology assessment (health)MethodsComplex health interventions
Type
Theme Submissions
Information
International Journal of Technology Assessment in Health Care , Volume 33 , Issue 5: Assessing Health Technologies in an Integrated Way-Results of the INTEGRATE-HTA Project , 2017 , pp. 570 - 576
Copyright
Copyright © Cambridge University Press 2017 

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References

REFERENCES

1. Petticrew, M. When are complex interventions ‘complex’? When are simple interventions ‘simple’? Eur J Public Health. 2011;21:397–398.Google Scholar
2. Datta, J, Petticrew, M. Challenges to evaluating complex interventions: A content analysis of published papers. BMC Public Health. 2013;13:568.CrossRefGoogle Scholar
3. Petticrew, M, Anderson, L, Elder, R, et al. Complex interventions and their implications for systematic reviews: A pragmatic approach. J Clin Epidemiol. 2013;66:1209–1214.CrossRefGoogle ScholarPubMed
4. Lysdahl, KB, Mozygemba, K, Burns, J, Brönneke, JB, Chilcott, JB, Hofmann, B, (eds.) Guidance for assessing effectiveness, economic aspects, ethical aspects, socio-cultural aspects and legal aspects. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
5. van Hoorn, R, Tummers, M, Kievit, W, van der Wilt, GJ, eds. Guidance for the assessment of treatment moderation and patients’ preferences. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
6. Pfadenhauer, L, Rohwer, A, Burns, J, et al. Guidance for the Assessment of context and implementation in health technology assessments (HTA) and systematic reviews of complex interventions: The context and implementation of complex interventions (CICI) framework. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
7. Rohwer, A, Booth, A, Pfadenhauer, L, et al. Guidance on the use of logic models in health technology assessments of complex interventions. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
8. Booth, A, Noyes, J, Flemming, K, et al. Guidance on choosing qualitative evidence synthesis methods for use in health technology assessments of complex interventions. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
9. Wahlster, P, Brereton, L, Burns, J, et al. Guidance on the integrated assessment of complex health technologies - The INTEGRATE-HTA Model. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
10. Lysdahl, KB, Hofmann, B. Complex health care interventions: Characteristics relevant for ethical analysis in health technology assessment. GMS Health Technol Assess. 2016;12:Doc01.Google ScholarPubMed
11. Brereton, L, Wahlster, P, Lysdahl, KB, et al. Integrated assessment of home based palliative care with and without reinforced caregiver support: ‘A demonstration of INTEGRATE-HTA methodological guidances’ – Executive Summary. 2016. http://www.integrate-hta.eu/downloads/ (accessed January 20, 2017).Google Scholar
12. EUnetHTA. Joint Action 2 Work Package 8. HTA Core Model version® 3.0. 2016. http://meka.thl.fi/htacore/BrowseModel.aspx (accessed January 20, 2017).Google Scholar
13. Kristensen, FB, Sigmund, H, eds.. Health technology assessment handbook. Copenhagen: Centre for Health Technology Assessment, National Board of Health; 2007.Google Scholar
14. Higgins, JPT, Green, S. Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011]: The Cochrane Collaboration; 2011. http://handbook.cochrane.org (accessed July 11, 2017).Google Scholar
15. Wells, GA, Shea, B, O'Connell, D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 2008. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp (accessed January 20, 2017).Google Scholar
16. Sterne, JA, Hernan, MA, Reeves, BC, et al. ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.Google Scholar
17. Shiell, A, Hawe, P, Gold, L. Complex interventions or complex systems? Implications for health economic evaluation. BMJ. 2008;336:1281–1283.Google Scholar
18. Squires, H, Chilcott, J, Akehurst, R, Burr, J, Kelly, MP. A framework for developing the structure of public health economic models. Value Health. 2016;19:588–601.Google Scholar
19. Hofmann, B, Oortwijn, W, Bakke Lysdahl, K, et al. Integrating ethics in health technology asssessment: Many ways to Rome. Int J Technol Assess Health Care. 2015;31:131–137.Google Scholar
20. Lehoux, P, Williams-Jones, B. Mapping the integration of social and ethical issues in health technology assessment. Int J Technol Assess Health Care. 2007;23:9–16.Google Scholar