PMID- 34719299 OWN - NLM STAT- MEDLINE DCOM- 20220223 LR - 20220223 IS - 1477-0962 (Electronic) IS - 0961-2033 (Linking) VI - 30 IP - 13 DP - 2021 Nov TI - Patient-reported outcome measures in systemic lupus erythematosus by a web-based application: A randomized, crossover, agreement study. PG - 2124-2134 LID - 10.1177/09612033211051641 [doi] AB - 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 practice. However, interest in incorporating PROMs into the management of SLE is increasing as PROMs provide a unique insight into the patient's perception of lupus disease activity. The objective was to assess agreement in PROMs answered using a web app versus 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, SLAQ Total, 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 margin. 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 VAS, and Fatigue VAS whereas only comparability within the limits of the Minimal Clinically Important Difference (MCID) was demonstrated for VAS Patient Global Health. Statistical comparability was demonstrated for SLAQ Total, SLAQ Worsening, PASS, and Anchoring Question (no predefined MCID/equivalence margins available). However, a statistically significant difference between device types was observed for the SLAQ Symptom 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, it was 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 the management of SLE. FAU - Uhrenholt, Line AU - Uhrenholt L AUID- ORCID: 0000-0002-4047-7175 AD - Department of Rheumatology, 53141Aalborg University Hospital, Aalborg, Denmark. AD - Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark. AD - Section for Biostatistics and Evidence-Based Research, 542252the Parker Institute, Copenhagen, Denmark. AD - DANBIO, 70590Rigshospitalet Glostrup, Glostrup, Denmark. FAU - Hostgaard, Simone AU - Hostgaard S AD - Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark. FAU - Pedersen, Julie F AU - Pedersen JF AD - Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark. FAU - Christensen, Robin AU - Christensen R AD - Section for Biostatistics and Evidence-Based Research, 542252the Parker Institute, Copenhagen, Denmark. AD - Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, 11286Odense University Hospital, Odense, Denmark. FAU - Dreyer, Lene AU - Dreyer L AD - Department of Rheumatology, 53141Aalborg University Hospital, Aalborg, Denmark. AD - Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark. FAU - Leffers, Henrik C B AU - Leffers HCB AD - Copenhagen Lupus and Vasculitis Clinic, Centre for Rheumatology and Spine Diseases, 53146Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. FAU - Taylor, Peter C AU - Taylor PC AD - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, 6396University of Oxford, Oxford, UK. FAU - Strand, Vibeke AU - Strand V AD - Division of Immunology/Rheumatology, 6429Stanford University School of Medicine, Palo Alto, California, USA. FAU - Jacobsen, Soren AU - Jacobsen S AD - Copenhagen Lupus and Vasculitis Clinic, Centre for Rheumatology and Spine Diseases, 53146Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. AD - Department of Clinical Medicine, Faculty of Health Science, 4321University of Copenhagen, Copenhagen, Denmark. FAU - Voss, Anne AU - Voss A AD - Department of Rheumatology, 11286Odense University Hospital, University of Southern Denmark, Odense, Denmark. FAU - Gregersen, Jon W AU - Gregersen JW AD - Department of Nephrology, 53141Aalborg University Hospital, Aalborg, Denmark. FAU - Kristensen, Salome AU - Kristensen S AD - Department of Rheumatology, 53141Aalborg University Hospital, Aalborg, Denmark. AD - Department of Clinical Medicine, 1004Aalborg University, Aalborg, Denmark. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20211031 PL - England TA - Lupus JT - Lupus JID - 9204265 SB - IM MH - Fatigue MH - Humans MH - *Lupus Erythematosus, Systemic/diagnosis/therapy MH - Pain MH - Patient Reported Outcome Measures MH - Severity of Illness Index MH - Surveys and Questionnaires OTO - NOTNLM OT - Systemic lupus erythematosus OT - crossover study OT - equivalence OT - minimally clinically important difference OT - patient-reported outcome measures OT - smartphone application EDAT- 2021/11/02 06:00 MHDA- 2022/02/24 06:00 CRDT- 2021/11/01 05:21 PHST- 2021/11/02 06:00 [pubmed] PHST- 2022/02/24 06:00 [medline] PHST- 2021/11/01 05:21 [entrez] AID - 10.1177/09612033211051641 [doi] PST - ppublish SO - Lupus. 2021 Nov;30(13):2124-2134. doi: 10.1177/09612033211051641. Epub 2021 Oct 31.