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An All-in-One Convenient Patient Safety Outcome Assessment Tool Improves Study Patient Reported Outcome Compliance through Real time Data Collection

Nicole C. Hank, Laura Christians, Brandon McCravey

Background: Subject diaries are utilized in approximately 25% of all clinical trials and are an essential component for gathering patient reported outcomes. Depending on the study design, various methods are utilized to capture patient reported outcomes either through paper, electronic means, or handheld devices. Regardless of how data is being collected, study participants can easily become overwhelmed with the complexity and tedium of recording daily outcomes, which subsequently can lead to inefficient, non- compliant reporting. Even though Adverse Event (AE) reporting and changes in concomitant medication collection are vital in validating the safety and efficacy of an investigational product, the gold standard for collecting real time data is still lacking. Therefore, a standard, all-encompassing, simple patient safety outcome tool is warranted in clinical trials.

Methods: Twenty subjects who were concurrently enrolled in a clinical trial that included either paper or electronic diaries at Perseverance Research Center (PRC) were consented and enrolled in the RTD-01 study. Diary compliance and satisfaction questionnaires were administered to consented study participants. After registering study participants’ cellular information, a two-way SMS mobile messaging service was deployed regarding changes in health (AEs) and concomitant medications daily to study participants for 6 weeks. Daily text message responses were uploaded to an FDA 21 CFR Par 11 compliant study portal. At the end of their 6 weeks of participation, study participants completed additional diary outcome compliance and satisfaction questionnaires.

Results: All participants completed the full 6 weeks of the study. Study data supported the primary objective of the RTD-01 study, demonstrating on average a 95.7% compliance in daily AE and concomitant medication reporting. A paired t-test was utilized to determine mean changes in responses for satisfaction and compliance diary questionnaires at Baseline and at Week 6. Both compliance diary responses and satisfaction diary responses demonstrated statistically significant mean changes from Baseline to Week 6 (p=0.012, p=0.001). In addition, study participants reported the SMS two-way texting tool was more convenient (M = 1.1, SD=0.5), p=0.00001, and less time consuming (M=1.6, SD=0.9) than their current study diary (M=3, SD=1.3), p=0.002.

Conclusion: Inaccurate data or failure to report health and medication changes over the course of a clinical study could affect an investigational product’s safety and efficacy results. Data from the RTD-01 study demonstrated that capturing real time data through implementation of a two-way SMS texting tool not only improves participant compliance but also eliminates inaccurate reporting, recall bias and enhances the quality of data being collected. Overall, satisfaction in utilizing a real time text messaging tool improves engagement and compliance, providing future clinical trials with a non- antiquated patient reported outcome measuring tool that can replace paper or electronic diaries.