PNS110 Compliance with Epro Is High and Consistent across Age Groups with Patients Using Their Own Smartphones in FULLY Decentralized Clinical Trials

Abstract

Electronic patient reported outcomes (ePRO) have been collected for use in clinical trials on provisioned, locked-down devices for decades. However, only more recently has it become feasible to collect ePRO using “bring your own device” (BYOD) models in which patients are using their smartphones to complete required study assessments. Whether or not patients would sufficiently comply with electronic symptoms diaries on their own smartphones has been an open question. Herein, we show the results from pooled analysis of clinical trials in which patients completed diaries using their smartphones. There were patients (n=176) across 2 studies (dermatology and women’s health) who completed questionnaires electronically either daily or weekly for 12 weeks using the Obvio-19 app on their personal smartphones (Android or iOS) to report their symptoms. Participants’ used their smartphones consisting of 43.8% Android, 50.6% iOS, and 5.7% unidentified ranging in age from 35 to 65. Questionnaires (n=12,274) were completed. The overall average compliance for completion of electronic questionnaires on a daily or weekly schedule was 92.3% + 11.9%. The ePRO questionnaire compliance was 93.6% + 10.6% for ages 35 to 50 (n=85) and 91.0% + 13.0% for ages 51 to 65 (n=91) with a p value of 0.16 between groups, indicating that there was no impact of age on ePRO questionnaire compliance on their personal smartphones. Further, compliance was consistently high and stable throughout the duration of the 12-week studies. In summary, these data demonstrate that patients using their personal smartphones consistently completed their ePRO symptoms questionnaires at an overall compliance in excess of 92% and that the age of the participant did not affect the compliance rate suggesting that the more mature participant is not affected by the ever-growing use of technology in the industry.