Shannon van Hoorn

124 Chapter 5 ABSTRACT Background Patient Reported Outcomes Measurement Information System (PROMIS) measures can be used to measure patient-reported outcomes. PROMIS measures, including Computer Adaptive Tests (CATs) and short forms, have demonstrated the ability to adequately assess outcomes in patients with hemophilia. It is, however, unclear if PROMIS measures are suitable for patients with von Willebrand disease (VWD), inherited platelet function disorders (IPFDs) and rare bleeding disorders (RBDs). Objective To evaluate the feasibility, measurement properties, and relevance of PROMIS measures in adults with VWD, IPFDs and RBDs. Methods In this cross-sectional multicenter study, adults with VWD, IPFDs and RBDs completed nine PROMIS measures and the Short Form-36 version 2 (SF-36v2) electronically. Feasibility was determined by the number of completed items and floor/ceiling effects. Measurement properties included construct validity based on a multitrait-multimethod analysis and reliability using the reliability coefficient and greatest lower bound. Relevance was evaluated based on comparison with the Dutch general population. Results In total, 111 patients (median age 57 years [IQR 44-67], 60% VWD, 16% IPFD, 24% RBD) participated. Mean number of items answered varied from 5.3 to 8.7 (range 4-12) per PROMIS CAT. Construct validity was supported for all CATs and all instruments had a good reliability (≥0.70). The PROMIS measures had less ceiling effects than the SF-36v2. Conclusion The PROMIS measures are a feasible, valid and reliable alternative for the SF36v2 in patients with primarily non-severe forms of VWD. The relevance of the selected measures was limited. Additional research is necessary to evaluate the PROMIS measures in adults with IPFDs and RBDs.

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