THU0248 UTILITY OF A MOBILE PHONE BASED APPLICATION TO COLLECT PATIENT REPORTED OUTCOME INFORMATION FROM SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Background Patient Reported Outcomes (PROs) can provide important data about the impact of a disease on an individual subject and/or the quality of the response to medication. However, in most circumstances, PRO information is collected only intermittently and usually at the point of care or treatment. The development of mobile technology to collect PRO data provided the opportunity to acquire this information more frequently, in real time, and in the subject’s normal environment. Objectives To test the utility of a smart phone application (app) to collect PRO information in subjects with systemic lupus erythematosus (SLE). Methods A smart phone app was developed that collects data from a number of PRO instruments, including FACIT-F(fatigue), SF-36 (health-related quality of life) and patient global assessment (PtGA). Subjects with SLE were involved in the initial development and evaluation of the acceptability of the app. To test the utility of this app, a multi-center clinical study (VALUE, NCT03142711) was carried out in collaboration with subjects with SLE, in whom PRO information was collected with the app daily (PtGA) or weekly (FACIT-F and SF-36) in the subject’s environment and also with the app and a standard paper form monthly at each clinical site. Demographic information, compliance and intra-class correlation coefficients between information collected with the app and using a paper form at the clinical site were assessed. Results Of the 80 subjects enrolled in this study, 91.3% were women; 57.5%, 16.3% and 17.5% identified themselves as of European, African or Asian ancestry, respectively. The mean age of the subjects was 42.6 years and the mean duration of education was 15.6 years. Overall compliance with completing the PRO instruments with the app at the scheduled time was 88%. To determine the consistency of information collected with the app, PRO instruments were completed on three occasions: a) in standard fashion using a paper form and b) using the app, separated by an interruption at the clinical site. The mean (SD) PtGA scores at baseline, month 1 and month 2 were 3.3(2.4), 3.5(2.4) and 3.5(2.5) using the app and 3.2(2.4), 3.5(2.3) and 3.3(2.4) using the paper form. The Intraclass Correlation Coefficient (ICC) and 90%CI were 0.97 (0.96-0.98), 0.96 (0.94-0.97) and 0.95(0.93-0.97) at the three time points, respectively. For the FACIT-F instrument, the mean (SD) score with the app was 33.2(11.7), 31.0(12.6) and 32.3(12.7) and with the paper form was 34.1(11.6), 32.0(12.2) and 32.0(12.5) at the 3 time points with ICCs of 0.94(0.91-0.96), 0.96(0.95-0.98) and 0.96(0.94-0.97), respectively. For the SF-36 Physical Functioning score, the mean (SD) with the app was 66.3(26.1), 65.5(26.9) and 67.4(25.8) and with the paper form was 68.4(25.1), 66.1(26.6) and 67.6(25.8) for the 3 time points, respectively. The ICCs were 0.96(0.94-0.97), 0.94(0.91-0.96) and 0.96 (0.94-0.97) for the 3 time points, respectively. Conclusion Compliance with completion of PRO instruments using a mobile app was excellent and the content collected with the app conformed with that collected using a standard paper form. Since patient compliance with the use of a mobile app to collect PRO information and the consistency of the information obtained compared to that obtained in standard fashion using a paper form were high, the app affords the potential opportunity to acquire frequent and highly reliable information about the impact of disease and response to medication in individual subjects with SLE. Acknowledgement The study was sponsored by the Lupus Research Alliance and funded by Pfizer. Development and support of the app was provided by TCS. Disclosure of Interests Brooke Williams: None declared, Bridget Muckian: None declared, Christine Peschken Consultant for: AstraZeneca, Richard Furie Grant/research support from: Biogen, UCB Pharma, but not in the last 12 months, Consultant for: Biogen, UCB Pharma, but not in the last 12 months, Elena Massarotti: None declared, vanja sikirica Shareholder of: Pfizer, Employee of: Pfizer, Steven Gilbert Shareholder of: Pfizer, Employee of: Pfizer, Martin Hodge Shareholder of: Pfizer, Employee of: Pfizer, Peter Lipsky Consultant for: Consulting fees from Horizon Pharma