Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance.

OBJECTIVES: The aim of the study was to review existing recommendations on study design, conduct, analysis, and reporting for primary studies of therapeutic medical devices (TMDs) and the closely related field of interventional procedures. STUDY DESIGN AND SETTING: We performed a targeted literature review of publications with recommendations for study design, conduct, analysis, and reporting for primary studies of TMDs and related technologies. We combined an electronic database search with a systematic screening of tables of content of selected journals and scanning the reference lists of relevant articles. RESULTS: We identified 40 publications authored or commissioned primarily by regulators, health technology assessment agencies, and expert groups. We identified study designs of randomized clinical trials that specifically address the quick, incremental development of TMDs and provider and patient preferences. The importance of contextual factors for TMD interventions should be considered during the selection of patients, providers, and centers, as well as in data collection and analysis. We also identified guidance for the analysis and quantification of learning curves as well as for the design and analysis of large registries of high quality. CONCLUSION: The methodology to conduct primary research for TMDs should be disseminated to support improvement of the evidence base for health technology assessments.