Conversion of Functional Assessment of Chronic Illness Therapy-Fatigue to Patient-Reported Outcomes Measurement Information System Fatigue Scores in Two Phase III Baricitinib Rheumatoid Arthritis Trials
Study shows that conversions from FACIT-F to PROMIS Fatigue are feasible and applicable for RA clinical trials.
The Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), developed for use in cancer patients, has been validated for measuring fatigue in RA, and is often the tool used in European clinical trials; with 10 out of its 13 items being relevant for patients with RA.
The Patient-Reported Outcomes Measurement Information System (PROMIS), developed and calibrated in the United States, is used across a range of chronic medical conditions. However, to date, no RA randomised clinical trials have used this tool for reporting fatigue.
In this study, Bingham, et al. converted the FACIT-F scores obtained in two RA clinical trials of baricitinib onto the PROMIS Fatigue metric to gauge the performance of PROMIS Fatigue measures in RA clinical trials.