Patient-reported outcome measures in systemic lupus erythematosus by a web-based application: a randomised, crossover, agreement study

Journal article

Objectives: Patient-reported outcome measures (PROMs) are evaluated in randomized controlled trials (RCTs) in patients with systemic lupus erythematosus (SLE), but not widely used in clinical practise. However, interest in incorporating PROMs into the management of SLE are increasing as PROMs provide a unique insight in the patient’s perception of lupus disease activity. The objective was to assess agreement in PROMs answered using a web app vs an outpatient touchscreen among patients with SLE.

Methods: In a crossover, RCT, SLE patients answered the following PROMs in a random order using the web app and the outpatient touchscreen: Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) Global Health, SLAQ Symptom score, SLAQ Total score, SLAQ Worsening, Pain Visual Analog Scale (VAS), Fatigue VAS, Patient Global Health VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Acceptable Symptom State (PASS) and an Anchoring Question. Equivalence between the two device types was demonstrated if the 95% confidence interval (95%CI) of the difference in PROM scores was within the prespecified equivalence margins. Agreement between the two device types was assessed using mixed linear models.

Results: Thirty-four patients with SLE were included. Equivalence was demonstrated between the two device types for SLAQ Global Health with a difference of -0.21, (95%CI: -0.65 to 0.23). Moreover, equivalence was also found for HAQ-DI, Pain Visual Analog Scale (VAS) and Fatigue VAS whereas only comparability within the limits of the Minimal Clinically Important Difference (MCID) was demonstrated for VAS Patient Global Health. Statistically comparability was demonstrated for SLAQ Total score, SLAQ Worsening, PASS and Anchoring Question (no predefined MCID/equivalence margins available). However, a statistically significant difference between device types was observed for SLAQ Symptom score of -0.56, (95%CI: -1.10 to 0.01). The difference was, however, very small when considering the scale range of 0-24; thus, not judged to be of clinical relevance. Preference for the web app was very high (91.2%).

Conclusion: For the first time ever, equivalence and comparability between two electronic device types for various PROMs were demonstrated among patients with SLE. Implementation of the device is expected to improve management of SLE.

Authors: Uhrenholt, L; Høstgaard, S; Pedersen, JF; Christensen, R; Dreyer, L

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: SAGE Publications
• Journal: Lupus
• Volume: 30
• Issue: 13
• Pages: 2124-2134
• Publication date: 2021-10-31
• Acceptance date: 2021-09-20
• DOI: 10.1177/09612033211051641
• EISSN: 1477-0962
• ISSN: 0961-2033
• Language: English
• Keywords: FFR