Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study

Rheumatology (Oxford). 2016 Jan;55(1):41-8. doi: 10.1093/rheumatology/kev282. Epub 2015 Aug 10.


Objective: Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability.

Methods: Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals.

Results: Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs.

Conclusion: Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission.

Keywords: RA; disease activity; outcomes research; patient perspective; patient reported outcomes; psychometrics; reliability; test–retest.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / diagnosis
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / psychology
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Patient Outcome Assessment*
  • Prospective Studies
  • Psychometrics / methods
  • Quality of Life*
  • Reproducibility of Results
  • Severity of Illness Index


  • Antirheumatic Agents