Collaboration with patients in the design of patient-reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis
Version of Record online: 23 MAY 2010
Copyright © 2010 by the American College of Rheumatology
Arthritis Care & Research
Volume 62, Issue 11, pages 1552–1558, November 2010
How to Cite
Nicklin, J., Cramp, F., Kirwan, J., Urban, M. and Hewlett, S. (2010), Collaboration with patients in the design of patient-reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis. Arthritis Care Res, 62: 1552–1558. doi: 10.1002/acr.20264
- Issue online: 2 NOV 2010
- Version of Record online: 23 MAY 2010
- Manuscript Accepted: 12 MAY 2010
- Manuscript Received: 8 NOV 2009
- Unrestricted educational grant from GlaxoSmithKline
- Research grant from Above and Beyond Charity, University Hospitals Bristol
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.
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.
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.
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.