Collaboration with patients in the design of patient-reported outcome measures: capturing the experience of fatigue in rheumatoid arthritis.

OBJECTIVE: Patient-reported outcome measures (PROMs) need to include concepts and language relevant to patients and be easily understood. These studies aimed to develop draft PROMs to measure rheumatoid arthritis (RA) fatigue and its impact by collaborating with patients to identify language and experiences, create draft PROM items, and test them for comprehension, with decisions supported throughout by a patient research partner.
METHODS: In study 1, interview transcripts of RA patients describing their fatigue (n = 15) were subjected to content and inductive thematic analysis to identify fatigue language and experiences. In study 2, 3 focus groups of RA patients (n = 17) explored these and developed the wording for visual analog scales (VAS) and identical numerical rating scales (NRS), then a draft multi-item questionnaire was developed with the patient research partner. Study 3 comprised 15 RA patients who completed the PROMs during cognitive interviewing to explore understanding.
RESULTS: Studies 1 and 2 identified key patient terminology (fatigue, exhaustion) and 12 potential fatigue concepts (Cognition, Coping, Duration, Emotion, Energy, Frequency, Impact, Planning, Quality of Life, Relationships, Sleep, and Social Life). Patients' proposals were clarified into draft screening VAS/NRS for fatigue severity, effect, and coping, plus a draft 45-item questionnaire. Study 3 showed that 14 questions required clarification or revision of response options.
CONCLUSION: Collaboration with patients enabled development of draft RA fatigue PROMs grounded in the patient data, strengthening face and content validity and ensuring comprehension. The draft conceptual framework that emerged has resulted in draft PROMS ready for item reduction, and testing of construct and criterion validity and reliability.