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

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.