Ten recommendations for assessing the comparative effectiveness of therapeutic medical devices: a targeted review and adaptation

Petra Schnell-Inderst; Theresa Hunger; Annette Conrads-Frank; Marjan Arvandi; Uwe Siebert

doi:10.1016/j.jclinepi.2017.09.022

Ten recommendations for assessing the comparative effectiveness of therapeutic medical devices: a targeted review and adaptation

J Clin Epidemiol. 2018 Feb:94:97-113. doi: 10.1016/j.jclinepi.2017.09.022. Epub 2017 Oct 28.

Authors

Petra Schnell-Inderst¹, Theresa Hunger², Annette Conrads-Frank², Marjan Arvandi², Uwe Siebert³

Affiliations

¹ Department of Public Health, Health Services Research and Health Technology Assessment, Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center I, 6060 Hall i. T, Austria. Electronic address: petra.schnell-inderst@umit.at.
² Department of Public Health, Health Services Research and Health Technology Assessment, Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center I, 6060 Hall i. T, Austria.
³ Department of Public Health, Health Services Research and Health Technology Assessment, Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center I, 6060 Hall i. T, Austria; Department of Health Policy and Management, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston 02115, MA, USA; Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 101 Merrimac St., STE 1010, Boston 02114, MA, USA.

PMID: 29107757
DOI: 10.1016/j.jclinepi.2017.09.022

Abstract

Objectives: The aim of this study was to review existing guidance on the methods for evaluation of the comparative effectiveness (CE) of therapeutic medical devices (TMDs) and develop recommendations for systematic reviews (SRs) of CE of TMDs as part of health technology assessments.

Study design and setting: We performed a targeted literature review of evaluation frameworks and recommendations for evaluation methods for TMDs and related technologies. An electronic database search was combined with systematic screening of tables of content of selected journals and scanning the reference lists of relevant papers.

Results: We identified a framework for SRs of complex interventions (FSRCIs) and three documents providing detailed methodology for TMD evaluation. We applied the FSRCIs to TMD evaluation taking into account the more complex composition of the intervention, its rapid, incremental development, as well as the dependency of treatment effects on contextual factors and user proficiency. In 10 recommendations, including a template for a logic model for TMD, we summarized relevant factors that should be systematically considered.

Conclusion: The quality of SRs of CE assessments of TMDs can be improved by applying these recommendations. This also may require an increase of the quality of primary studies.

Keywords: Comparative effectiveness; Health technology assessment; Implants; Medical devices; Methodology; Recommendations.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Comparative Effectiveness Research
Cost-Benefit Analysis
Equipment and Supplies / economics*
Humans
Models, Theoretical
Practice Guidelines as Topic
Technology Assessment, Biomedical / economics*