Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies.

OBJECTIVES: To synthesize the findings of cognitive interview and usability studies performed to assess the measurement equivalence of patient-reported outcome (PRO) instruments migrated from paper to electronic formats (ePRO), and make recommendations regarding future migration validation requirements and ePRO design best practice. METHODS: We synthesized findings from all cognitive interview and usability studies performed by a contract research organization between 2012 and 2015: 53 studies comprising 68 unique instruments and 101 instrument evaluations. We summarized study findings to make recommendations for best practice and future validation requirements. RESULTS: Five studies (9%) identified minor findings during cognitive interview that may possibly affect instrument measurement properties. All findings could be addressed by application of ePRO best practice, such as eliminating scrolling, ensuring appropriate font size, ensuring suitable thickness of visual analogue scale lines, and providing suitable instructions. Similarly, regarding solution usability, 49 of the 53 studies (92%) recommended no changes in display clarity, navigation, operation, and completion without help. Reported usability findings could be eliminated by following good product design such as the size, location, and responsiveness of navigation buttons. CONCLUSIONS: With the benefit of accumulating evidence, it is possible to relax the need to routinely conduct cognitive interview and usability studies when implementing minor changes during instrument migration. Application of design best practice and selecting vendor solutions with good user interface and user experience properties that have been assessed in a representative group may enable many instrument migrations to be accepted without formal validation studies by instead conducting a structured expert screen review.

Measurement Equivalence of Patient-Reported Outcome Measure Response Scale Types Collected Using Bring Your Own Device Compared to Paper and a Provisioned Device: Results of a Randomized Equivalence Trial.

OBJECTIVES: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device). METHODS: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire. RESULTS: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference). CONCLUSIONS: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach.

Feasibility of the "Bring Your Own Device" Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool.

BACKGROUND: Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device" (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model's feasibility in research settings. OBJECTIVE: To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. METHODS: 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD" or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). RESULTS: The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices. CONCLUSIONS: Results indicate that the BYOD model is feasible in health research settings and improves participant experience, calling for further BYOD model validity assessment. Although group differences in medication adherence decline were insignificant, the greater trend of decline in provisioned device users warrants further investigation to determine if trends reach significance over time. Significantly higher application engagement rates and effect of engagement on medication adherence in the BYOD subgroup similarly imply that greater application engagement may correlate to better medication adherence over time.