Digital Solution for Collection of Patient-reported Outcome Measures in Patients with Systemic Lupus Erythematosus: A Randomised, Crossover, Agreement Study

Line Uhrenholt¹, Simone Høstgaard², Julie Pedersen², Robin Christensen³, Lene Dreyer¹, Henrik Leffers⁴, Peter C Taylor⁵, Vibeke Strand⁶, Sren Jacobsen⁴, Anne Voss⁷, Jon Gregersen⁸ and Salome Kristensen¹, ¹Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, ²Department of Clinical Medicine, Aalborg University, Aalborg, Denmark, ³Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Copenhagen, Denmark, ⁴Copenhagen Lupus and Vasculitis Clinic, Centre for Rheumatology and Spine Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, ⁵University of Oxford, Oxford, United Kingdom, ⁶Stanford University School of Medicine, Portola Valley, CA, ⁷Department of Rheumatology, Odense University Hospital, Odense C, Denmark, ⁸Department of Nephrology, Aalborg University Hospital, Aalborg, Denmark, Aalborg, Denmark

Meeting: ACR Convergence 2021

Keywords: Crossover Study, Equivalence, Patient reported outcomes, Smartphone Application, Systemic lupus erythematosus (SLE)

Session Information

Date: Monday, November 8, 2021

Title: SLE – Diagnosis, Manifestations, & Outcomes Poster III: Outcomes (1257–1303)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Patient-reported outcome measures (PROMs) provide the physician with an important insight into the patients’ perception of lupus disease activity. Technology and the widespread use of digital platforms have made it possible for patients to access and respond to disease specific PROMs from home using their own device.

This study aims to assess agreement in various PROMs, with Systemic Lupus Erythematosus Activity Questionnaire (SLAQ) global health as primary outcome, between a web application (app) on the patient’s own smartphone/tablet and an outpatient touchscreen among patients with SLE.

Methods: The study was a randomised, crossover, agreement trial (NCT04411407). Patients diagnosed with SLE for ≥ 12 months was assessed for eligibility. Participants were randomised in a 1:1 ratio to: 1) Group web app → touchscreen i.e. PROMs answered on the web app and after a “washout period” on the outpatient touchscreen or 2) Group touchscreen → web app i.e. vice versa. The “washout period” was pre-specified to be one to two days to minimise recall bias. Agreement between the two device types was assessed using mixed linear models.

Results: In total, 34 patients were enrolled as visualised in Figure 1.

An excellent agreement for SLAQ global health between the two device types was observed, visualised in the Bland-Altman plot (Figure 2). Mean difference in SLAQ global health between the two device types was -0.21, (95% confidence interval [95% CI]: -0.65 to 0.23) (Table 1); thus, equivalence was demonstrated as the 95%CI was within the pre-specified equivalence margin of ± 0.75. Furthermore, equivalence was proven for all other PROMs except Visual Analogue Scale (VAS) global health. However, the observed difference in VAS global health is within the limits of the pre-specified minimum clinically important difference (MCID); thus, not anticipated to have any clinical relevance.

Thirty-one (91.2%) patients preferred the DANBIO web app over the outpatient touchscreen.

Conclusion: To our knowledge, equivalence between two electronic device types has not previously been demonstrated for a collection of various PROMs among patients with SLE. A very high patient preference for the web app was observed. Implementation of the device is expected to be of great value for patients with SLE; thereby, improving management of their disease.

Figure 1: Flow diagram of patient recruitment

Figure 2: Bland-Altman plot on SLAQ global health registered on the two device types

Table 2: Comparison between intervention groups for all PROMs

Disclosures: L. Uhrenholt, None; S. Høstgaard, None; J. Pedersen, None; R. Christensen, None; L. Dreyer, BMS, 5, Galderma, 6, Eli Lilly, 6, Janssen, 6; H. Leffers, None; P. Taylor, Celgene, 5, Galapagos, 2, 5, Gilead Sciences, 2, 5, AbbVie, 1, GSK, 2, Janssen, 2, Eli Lilly, 2, Pfizer Inc, 2, Roche, 2, Nordic Pharma, 2, Fresenius, 2, Bristol-Myers Squibb, 2, Sanofi, 2, Celltrion, 2, UCB, 2, Biogen, 2; V. Strand, Abbvie, 2, Amgen, 2, Genentech / Roche, 2, Janssen, 2, Novartis, 2, Pfizer, 2, Sanofi, 2, UCB, 2, Bristol-Myers Squibb, 2, Boehringer Ingelheim, 2, Celltrion, 2, Arena, 2, Gilead, 2, GlaxoSmithKline, 2, Ichnos, 2, Inmedix, 2, Kiniksa, 2, Merck, 2, Myriad Genetics, 2, Regeneron Pharmaceuticals, Inc., 2, Samsung, 2, Sandoz, 2, Setpoint, 2, Galapagos, 2, Horizon, 2, Lilly, 2, Rheos, 2, R-Pharma, 2, Scipher, 2, Sun Pharma, 2; S. Jacobsen, None; A. Voss, None; J. Gregersen, None; S. Kristensen, None.

To cite this abstract in AMA style:

Uhrenholt L, Høstgaard S, Pedersen J, Christensen R, Dreyer L, Leffers H, Taylor P, Strand V, Jacobsen S, Voss A, Gregersen J, Kristensen S. Digital Solution for Collection of Patient-reported Outcome Measures in Patients with Systemic Lupus Erythematosus: A Randomised, Crossover, Agreement Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/digital-solution-for-collection-of-patient-reported-outcome-measures-in-patients-with-systemic-lupus-erythematosus-a-randomised-crossover-agreement-study/. Accessed .

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