FRI0606 The lift study’s direct-to-patient design provides reliable self-reported data from lupus patients
Authors: A. Cheeks, L. Borisov, K. Warren, R. Terbrueggen
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Direct-to Patient (D2P) clinical studies that rely upon social media, mobile connectivity, wearables, self-collected patient samples, and patient reported outcome data have the potential to revolutionise health research by enabling population-scale studies without the cost and complexity of traditional multi-site trials. D2P studies are particularly interesting for longitudinal studies where the burden of participants travelling to a central site is high; however, the quality and reliability of patient reported outcome data is unclear<sup>1</sup>. <h3>Objectives</h3> The study evaluated the accuracy of self-reported data from a subset of patients in a 1000+participant D2P lupus study (www.theliftstudy.com) by comparing patient-reported data to medical records as well as genomic testing of individuals using participant-collected fingerstick blood samples. <h3>Methods</h3> The study was reviewed and approved by a central IRB (WIRB; Puyallup, WA). Subjects were recruited online across the U.S using social media. Electronically consented participants with self-reported lupus were asked to complete online surveys about their disease and drug history as well as provide medical record review (MRR) consent. A third party firm was employed for MRR and an independent physician summarised the following information: 1) participant age 2) confirmation of lupus 3) current lupus medications and 4) current steroid medications. <h3>Results</h3> Of the 1043 participants enrolled over the first 6 weeks of the study, 327 had completed all aspects of the study. Thirty-seven participants (11%) were selected at random for MRR. Average age was 44±12 years with 35 females and 2 males. Self-reported (SR) age at time of enrollment was 100% confirmed by MRR. Lupus diagnosis was confirmed in 100% of the participants by the MRR directly or by conclusion of the independent physician based upon review of the medical record. SR and MRR drug information showed variable concordance upon review, with several patients reporting medications at the time of the survey that were not confirmed in their medical records (table 1). Percent agreement was determined by comparing the SR vs. the MRR for each participant (data not shown). Overall, there was an 88% agreement between SR and MRR for each of the medications where at least 1 participant reported prescription. <h3>Conclusions</h3> Using a D2P study design, the resulting SR data corresponded well with the MRR for subject age, lupus diagnosis, and lupus medications. While there were some discrepancies in use of medications, many of these could be explained by the time-dependency of our questionnaire, where the date of prescription in the MRR was just outside of the 30 day window. The LIFT Study shows that a D2P study design is an effective method to rapidly enrol lupus patients and decrease study costs while collecting reliable self-reported data. <h3>Reference</h3> [1] Walitt, et al. J Rheumatol. 2008May;35(5):811–818. <h3>Disclosure of Interest</h3> A. Cheeks Employee of: DxTerity, L. Borisov Employee of: DxTerity, K. Warren Employee of: DxTerity, R. Terbrueggen Shareholder of: DxTerity, Employee of: DxTerity