Background: Development of a standardized approach to assess key elements of disease activity in rheumatology clinical trials has been the goal of Outcome Measures in Rheumatology Clinical Trials (OMERACT), American College of Rheumatology (ACR), and European League Against Rheumatism (EULAR).1,2,3 The core sets of measures developed include assessments and composite indices incorporating use of patient-reported outcomes (PROs) and clinical measures and clinicians’ assessments to quantify disease activity over time.2 PROs are important indicators of disease activity and variability, and they are increasingly used to evaluate treatment effectiveness. Little is known about PROs that patients with rheumatic conditions find most important to convey their experience with their condition and its treatment.
Objectives: To examine PROs selected by patients with rheumatic conditions in the ArthritisPower registry to identify symptoms they found most important to track digitally.
Methods: Adult US patients within the ArthritisPower registry with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), osteoporosis (OP), osteoarthritis (OA), and fibromyalgia syndrome (FMS) were invited via email to participate in this study. Enrolled participants (pts) were prompted to select ≤10 PRO symptom measures they felt were important to track for their condition at baseline via the ArthritisPower app. At 3 subsequent time points (Month [m] 1, m2, m3), pts were given the option to continue tracking their previously selected PRO measures or to add, remove and/or select different measures. At m3, pts completed an exit survey to prioritize ≤5 measures from all measures selected during study participation and to specify other symptoms not available that they would have wanted to track. Measures were rank-ordered based on number of pts rating the item as their 1st, 2nd, 3rd, 4th or 5th choice and weighted by multiplying the rank number by its inverse for a single, weighted summary score for each measure. Values were summed across all pts to produce a summary score for each measure.
Results: Among pts who completed initial selection of PRO assessments at baseline (N=253), 184 pts confirmed or changed PRO selections across m1-3. Mean (SD) age of pts was 55.7 (9.2) yrs, 89.3% female, 91.3% White, mean disease duration of 11.6 (10.6) yrs. The majority (64.8%) self-reported OA, followed by RA (48.6%), FMS (40.3%), PsA (26.1%), OP (21.0%), AS (15.8%) and SLE (5.9%), not mutually exclusive, and were similar to the overall ArthritisPower population. The average number of instruments (SD) selected for baseline completion was 7.0 (2.5), 7.1 (2.4) at m1, 7.2 (2.4) at m2, and 7.0 (2.5) at m3. The top 5 PROs ranked by pts overall as most important (weighted summary score) for tracking were Fatigue (71), Physical Function (58), Pain Intensity (50), Pain Interference (49), Duration of Morning Joint Stiffness (41) (Figure 1). Fatigue, Physical Function, and Pain were consistently in the top 5 across diseases while Depression was more frequent among pts with OA, AS and FMS. Pts’ PRO selections showed stability over time except for the RA Flare measure which decreased from 70.5% of RA pts at baseline to 13.6% at m3.
Conclusion: The symptoms prioritized by pts included fatigue, physical function, pain, and joint stiffness. Pts‘ choices were consistent over time. These findings provide insights into symptoms rheumatology patients find most important and will be useful to inform design of future patient-centric clinical trials and real-world evidence generation.
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Disclosure of Interests: W. Benjamin Nowell: None declared, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Kelly Gavigan: None declared, Zhihong Cai Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Anabela Cardoso Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Shilpa Venkatachalam: None declared, Julie Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jennifer Workman Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB
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