Development of a new patient-reported outcome measure for Dupuytren disease: A study protocol.

Objectives: Dupuytren disease is a common condition that causes progressive finger contractures resulting in impaired hand function and difficulties in performing daily activities. Patient reported outcome measures (PROMs) are commonly used in research and clinical practice to evaluate treatment outcomes. Both general upper extremity PROMs and Dupuytren-specific PROMs are available, typically developed using conventional methodology based on classical test theory. However, most current PROMs have been shown to have low responsiveness and the relevance of included items have been questioned. In this study we aim to develop a new Dupuytren-specific PROM using modern measurement methodology based on item response theory (IRT). Methods: The study will be performed in three phases. In Phase 1, (completed), an expert group developed a questionnaire with a large number of potentially relevant items derived from existing PROMs and patient collaboration. In Phase 2, the questionnaire will be administered to 300 patients with Dupuytren disease, and their responses will be analyzed with IRT methodology to identify the best performing items to be included in the new PROM. In Phase 3, the new PROM will be administered to 300 additional patients for validation. Conclusion: This new Dupuytren-specific patient-reported outcome measure will help advance clinical research on Dupuytren disease.