Presentation (CTI)

OBJECTIVES: High-quality economic evaluations are essential for guiding healthcare resource allocation. However, existing economic evaluation methodological quality assessment tools were developed primarily for pharmaceuticals and often overlook methodological complexities relevant to medical devices, including incremental innovation, learning curve effects, organizational impacts, and dynamic pricing. To address this gap, we developed the medical Device Economic Evaluation Methodological Quality (DEEM-Q) checklist and created an accompanying Explanation and Elaboration (E&E) guide to support its consistent and context-appropriate application.
METHODS: The E&E was developed by expanding each of the 39 DEEM-Q checklist items, organized within 18 methodological domains, into structured explanatory text. Content was informed by a structured review of methodological literature, insights from the expert panel that guided the checklist’s development, and published economic evaluations of medical devices selected to illustrate both best practices and common challenges.
RESULTS: In contrast to scoring systems, DEEM-Q supported by the E&E offers a qualitative, structured framework for critical appraisal.The E&E provides detailed interpretive guidance for applying both general principles of economic evaluation (e.g., perspective, comparators, time horizon) and device-specific considerations (e.g., learning curve effects, organizational impact, incremental innovation). Each item includes (i) an item description, (ii) rationale for inclusion, (iii) recommended methodological approach, and (iv) representative example.
CONCLUSIONS: The DEEM-Q E&E document complements the checklist by offering structured guidance for researchers, reviewers, editors and HTA bodies. By promoting consistent interpretation and application of the checklist, it enhances the transparency and rigor of medical device economic evaluations, thereby supporting better evidence-informed decision-making.