Presentation (CTI)

OBJECTIVES: Economic evaluations increasingly inform adoption and reimbursement decisions for medical devices. However, existing methodological quality assessment tools often fail to capture several features commonly associated with medical devices, such as learning curve effects, organizational impact, incremental innovation, and diversity in design and use. The objective of the medical Device Economic Evaluation Methodological Quality assessment (DEEM-Q) study was to develop a consensus-based instrument for assessing the methodological quality of economic evaluations of medical devices.
METHODS: Candidate items were identified through a systematic review of existing methodological quality assessment tools and economic evaluation guidelines, including those from Canada’s Drug Agency. A two-round modified e-Delphi study was conducted with 40 health economists experienced in Canadian medical device evaluation (response rates: 100% and 90% for Rounds 1 and 2, respectively). Using a 9-point importance scale, items were retained if ≥70% of participants rated them as critical (scores 7-9) and ≤15% rated them as not important (scores 1-3). The resulting checklist underwent pilot testing for clarity, applicability, and consistency.
RESULTS: The initial 49 items were refined to 39, covering general economic evaluation domains (decision problem, comparators, perspective, time horizon, modeling, analysis, and uncertainty) and device-specific considerations (evidence gaps, learning curve, organizational impacts, incremental innovation, and diversity). Pilot testing confirmed clarity and consistent application.
CONCLUSIONS: The DEEM-Q represents the first consensus-based checklist for assessing the methodological quality of medical device economic evaluations. It provides a practical tool for researchers, reviewers, and decision-makers. Future work will include a companion explanation and elaboration paper to support its consistent application and adaptation as methods in medical device evaluation continue to evolve.