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

Area of Science:

• Health Economics
• Medical Device Evaluation
• Health Technology Assessment

Background:

• Existing quality assessment tools for economic evaluations were primarily designed for pharmaceuticals.
• These tools may not adequately address the unique methodological challenges of medical device evaluations.
• High-quality economic evaluations are crucial for informing adoption and reimbursement decisions for medical devices.

Purpose of the Study:

• To develop a consensus-based instrument for assessing the methodological quality of economic evaluations of medical devices.
• To create a practical tool for researchers, reviewers, and decision-makers in the field.
• To address the limitations of existing tools in capturing device-specific methodological issues.

Main Methods:

• A systematic review identified candidate items from existing quality assessment tools and guidelines.
• A two-round modified e-Delphi study involved 40 health economists experienced in Canadian medical device evaluation.
• Items were retained based on consensus ratings (≥70% critical, ≤15% not important) and pilot tested for clarity and consistency.

Main Results:

• The initial 49 items were refined to a 39-item checklist, the DEEM-Q.
• The checklist covers general economic evaluation domains and device-specific considerations like evidence gaps, learning curves, and incremental innovation.
• Pilot testing confirmed the checklist's clarity, applicability, and consistent application.

Conclusions:

• The DEEM-Q is the first consensus-based checklist specifically for assessing the methodological quality of medical device economic evaluations.
• It offers a practical and reliable tool for evaluating the quality of economic evidence for medical devices.
• A companion document supports consistent interpretation and application of the DEEM-Q across various decision contexts.