Development of the Medical Device Economic Evaluation Methodological Quality (DEEM-Q) Assessment Checklist

Economic evaluations increasingly inform adoption and reimbursement decisions for medical devices; yet, existing quality assessment tools were largely developed for pharmaceuticals and may not adequately capture device-specific methodological challenges. The objective of the medical Device Economic Evaluation Methodological Quality assessment study was to develop a consensus-based instrument for assessing the methodological quality of economic evaluations of medical devices.

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 2-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.

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.

The Device Economic Evaluation Methodological Quality assessment 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. A companion explanation and elaboration document has been developed to support consistent interpretation and application across decision contexts.