Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings

Stacie Hudgens; Louise Newton; Sonya Eremenco; Mabel Crescioni; Tara Symonds; Philip C G Griffiths; David S Reasner; Bill Byrom; Paul O'Donohoe; Susan Vallow; Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium

doi:10.1186/s41687-022-00521-3

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings

J Patient Rep Outcomes. 2022 Nov 26;6(1):119. doi: 10.1186/s41687-022-00521-3.

Affiliations

¹ Clinical Outcomes Solutions, 1820 E River Rd, Suite 220, Tucson, AZ, 85718, USA. stacie.hudgens@clinoutsolutions.com.
² Clinical Outcomes Solutions, Folkestone, UK.
³ Critical Path Institute, Tucson, USA.
⁴ College of Public Health, University of Arizona, Tucson, USA.
⁵ Imbria Pharmaceuticals, Boston, MA, USA.
⁶ Signant Health, London, UK.
⁷ Medidata Solutions, London, UK.
⁸ Novartis Services Inc, East Hanover, NJ, USA.

Abstract

Objective: To quantitatively compare equivalence and compliance of patient-reported outcome (PRO) data collected via provisioned device (PD) versus bring your own device (BYOD).

Methods: Participants with stable chronic obstructive pulmonary disease (COPD) completed the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT^®) daily and COPD Assessment Test™ (CAT) and Patient Global Impression of Severity (PGIS) of COPD weekly on either PD or BYOD for 15 days, then switched device types for 15 days. EXACT was scored using the Evaluating Respiratory Symptoms in COPD (E-RS^®: COPD) algorithm and equivalence assessed using intraclass correlation coefficients (ICCs) adjusting for cross-over sequence, period, and time. Two one-sided tests (TOSTs) used ICC adjusted means with 10%, 20%, and 40% of total score tested as equivalence margins. Compliance and comfort with technology were assessed. Equivalence across 3 device screen sizes was assessed following the second completion period.

Results: Participants (N = 64) reported high comfort with technology, with 79.7% reporting being "quite a bit" or "very" comfortable. Weekly compliance was high (BYOD = 89.7-100%; PD = 76.9-100%). CAT and E-RS: COPD scores correlated well with PGIS (r > 0.50) and demonstrated equivalence between PD and BYOD completion (ICC = 0.863-0.908). TOST equivalence was achieved within 10% of the total score (p > 0.05). PRO measure scores were equivalent across 3 different screen sizes (ICC = 0.972-0.989).

Conclusions: Measure completion was high and scores equivalent between PD and BYOD, supporting use of BYOD in addition to PD for collecting PRO data in COPD studies and in demographically diverse patient populations.

Keywords: BYOD; Bring your own device; COPD; PRO; Patient-reported outcome.