OBJECTIVES:

Capture of patient-reported outcome data electronically (ePRO) has historically been with provisioned devices (PD). More recently, alternative approaches such as using a participant’s smartphone (‘bring your own device’ or BYOD) for capturing PRO data have gained traction. This study aimed to compare PD versus BYOD in terms of compliance and equivalence of PRO data.

METHODS:

Participants with COPD recruited for this observational, cross-over study completed PRO measures daily (EXAcerbations of Chronic pulmonary disease Tool [EXACT^®]) and weekly (COPD Assessment Test [CAT] and Patient Global Impression of Severity [PGIS]) on either device (PD or BYOD) for 15 days, then switched to the other device type to complete the same measures for another 15 days. The EXACT^® was scored using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD™) algorithm. Daily and weekly compliance were evaluated descriptively. Equivalence was evaluated within each completion period among stable participants using intraclass correlation coefficients (ICC) derived from mixed model ANOVAs adjusting for cross-over sequence, period, and time (day/week). Two one-sided tests (TOST) were employed using adjusted means derived from the ICC model, with 10%, 20%, and 40% of total score tested as equivalence margins.

RESULTS:

Sixty-four participants were enrolled (mean age [SD]: 59.0 [10.55]; 65.6% female; 51.6% Black/African American). Self-reported technology comfort was high with 79.7% reporting being “quite a bit” or “very” comfortable. Compliance (e.g., 5 of 7 days completed) was also high (BYOD=89.7%-100%; PD=76.9%-100%). The CAT and E-RS: COPD™ scores correlated well with PGIS (r>0.50). Both COPD assessments demonstrated equivalence between PD and BYOD administration (ICCs 0.863-0.908). TOST equivalence was achieved for both measures at the 10% level (p>0.05).

CONCLUSIONS:

The findings demonstrated high compliance across both device types and score equivalence for the E-RS: COPD™ and CAT between PD and BYOD. The study suggests BYOD may be a complementary approach to PD for collecting PRO data in COPD studies.