Autor: |
Hudgens, Stacie, Newton, Louise, Eremenco, Sonya, Crescioni, Mabel, Symonds, Tara, Griffiths, Philip C. G., Reasner, David S., Byrom, Bill, O'Donohoe, Paul, Vallow, Susan |
Předmět: |
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Zdroj: |
Journal of Patient-Reported Outcomes; 11/26/2022, Vol. 6 Issue 1, p1-11, 11p |
Abstrakt: |
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. Highlights: Historically, provisioned handheld devices [PD] have been provided to participants to enter patient-reported outcome (PRO) data during a clinical trial. Allowing participants to report data using their own smartphone or other internet-connected device (known as 'bring your own device' [BYOD]) is of growing interest. Measure completion was high for both device types when assessing daily and weekly compliance. Scores were found to be equivalent for both the Evaluating Respiratory Symptoms in COPD and COPD Assessment Test™ between PD and BYOD using 2 different methods. This study supports use of BYOD in addition to PD for collecting PRO data in COPD studies and contributes evidence that BYOD may be successfully employed in demographically diverse patient populations. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
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