Acceptability and content validity of patient‐reported measures considered from the rheumatoid arthritis patient's perspective

OBJECTIVE: To consider the acceptability and content validity of patient-reported outcome measures (PROMs) commonly used in rheumatoid arthritis (RA) by describing patients' perceptions of PROMs, and comparing patients' PROM responses with their verbal accounts of disease impacts. METHODS: We used a sequential mixed methods approach, combining analysis of interviews and PROM data (HAQ, FACIT-F, EQ-5D, SF36, and VAS for pain, fatigue, sleep, and patient global). Qualitative analysis of patients' perceptions of PROMs informed a subsequent comparison between patients' PROM data and verbal accounts of pain, fatigue, sleep, and functional limitations to assess their effectiveness for communicating disease impact. RESULTS: The study included eighteen patients. Although a few patients offered positive comments about PROMs, most doubted that PROMs could accurately convey their experience of symptoms and functional limitations. Patients discussed the ease of responding to questions, capturing and conveying symptoms, and concerns about the underreporting of symptoms and interpretation of responses. Compared with verbal accounts, PROMs often did not convey the personal significance of limitations; however, PROMs captured limitations that patients omitted or described with insufficient detail during interviews. Although verbal accounts of pain could be categorized into three levels of severity (pain without interference in activities, pain is not the worst ever experienced but interferes with activities, and pain is omnipresent), the pain VAS was more effective at conveying finer gradations in pain severity. CONCLUSION: Although patients may feel that PROMs have certain shortcomings, PROMs also have advantages relative to verbal discussion for communicating symptoms and disease impact.