Abstract
Introduction
Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We report on the progress on establishing a minimal set of core domains for outcome measurement in distal radius fracture.
Materials and methods
Participants included an expert panel of orthopaedic surgeons, outcome researchers, patients, physiotherapists, industry representatives involved in distal radius research and partners in regulatory affairs. Decisions were made by review of evidence and theory and establishing group consensus.
Results
There was consensus that clinical research studies should include a proof of concept outcome that would directly assess the presumed direct benefit of the intervention. We identified a need for additional outcome measures for research including measures that provide more detail on pain and function; or that address supplemental concepts important to that study. Measures of fracture healing/alignment, grip strength, joint motion were recognized as commonly utilized secondary outcomes.
Discussion and Conclusion
Our approach provides preliminary steps in establishing core domains that have content relevant to patient goals (i.e. pain and function) and the providers’ treatment goals (i.e. strength, range of motion, function). The panel recommendations provide flexibility in establishing customized data collection for specific indications; but offer some core consistency.
