UPMC Mercy hospital, Pittsburgh, PA Pittsburgh, PA, United States
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Akanksha Sharma1, shiri keret2, Raisa Lomanto Silva3, Tanya Chandra4, Joel Levin5, Siamak Moghadam-Kia3, Chester V. Oddis6 and Rohit Aggarwal6, 1UPMC Mercy Hospital, Pittsburgh, PA, 2Bnai Zion, Atlit, Israel, 3University of Pittsburgh Medical Center, Pittsburgh, PA, 4Georgetown University Hospital, Washington, DC, 5University of Pittsburgh, Katz Graduate School, Pittsburgh, PA, 6University of Pittsburgh, Pittsburgh, PA
Methods: "Myositis Patient Centered Tele-Research (MyPACER)" is a multi-center observational prospective study conducted over 6 months. The study had two cohorts, 1. Tele-Research Cohort (TRC): patients were remotely enrolled from any location in the United States, and 2. Center-Based Cohort (CBC): a traditional cohort with enrollment from the 2 myositis centers. Functional and Patient-Reported Assessments were completed monthly, including a health assessment questionnaire, patient global disease activity, PROMIS-physical function 20 and functional tests timed up-and-go (TUG), and sit-to-stand (STS)). Participants were asked to use their waist-based Fitbit (≥10 hours/day), ≥ 7 days/month. Average steps per minute & Average peak cadence were evaluated using Fitbit data.
Results: 120 IIM patients (mean age 55.5+/- 13.43, 75% females, 80.8% white), who completed baseline visit were enrolled in the study, comprising 82 in the Main TRC group, 21 in Local TRC and 17 in the local CBC (table 1). There were 51.7% DM, 39.2% PM, and 9.1% NM. The TRC and CBC cohorts were similar in demographics and disease subtypes. Age was significantly correlated with the average steps per minute (Ave Step/min) (p=0.01) but not with ave. peak cadence, showing a decrease in steps with advancing age. Gender, race/ethnicity or disease subtypes were not associated with PAM measures.
On data analysis, 90% patients completed at least one valid day on their Fitbit devices. The compliance with Fitbit was very high with participants wearing devices on most days of the week (Ave. = 6.52 days) for the most visits (Ave. 5.73 visits), with similar results for remote or local recruitment. Ave steps per minute and peak cadence showed strong test-retest reliability (r=0.89 and r=0.86, p< 0.0001 & p= 0.0001) and were strongly correlated within-patient. Regarding validity at baseline, ave steps/mins was significantly associated with myositis, skin disease, extra-muscular global, PROMIS physical function and functional tests, HAQ score but not with other myositis core set measures (Table 2).While the ave. peak cadence was significantly associated with MMT-8, physician and patient global disease activity as well as fatigue, myalgia, myositis, TUG, but not with HAQ, CK, and extra-muscular disease activity (Table 2).
Conclusion: In a large IIM cohort, Fitbit physical activity monitor variables demonstrates favorable compliance and psychometric properties with a strong test-retest reliability and association of several patient and physician-reported measures.
Table 1. Demographic characteristics of participants
Table 2: Cross-sectional association of Fitbit measures (average daily steps per minute, and average peak cadence) with various myositis outcome measures at baseline.
A. Sharma: None; s. keret: None; R. Lomanto Silva: None; T. Chandra: None; J. Levin: None; S. Moghadam-Kia: None; C. V. Oddis: Boehringer-Ingelheim, 5, Cabaletta, 5, EMD Serono, 5, Novartis, 5, Pfizer, 1; R. Aggarwal: Actigraph, 2, Alexion, 2, ANI Pharmaceuticals, 2, Argenx, 2, AstraZeneca, 2, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, CabalettaBio, 2, Capella Bioscience, 2, Corbus, 2, CSL Behring, 2, EMD Serono, 2, 5, Galapagos, 2, Horizon Therapeutics, 2, I-Cell, 2, Janssen, 2, 5, Kezar, 2, Kyverna, 2, Mallinckrodt, 5, Merck, 2, Octapharma, 2, Pfizer, 2, 5, Q32, 5, Roivant, 2, Sanofi, 2, Teva, 2.