KEY TAKEAWAYS
- The phase 2 & 3 trials aimed to investigate the effectiveness of a patient-targeted ePRO-E in increasing ePRO uptake and improving data quality within an NCTN.
- Researchers noticed that increased ePRO uptake with ePRO-E exposure emphasizes the impact of technology attitudes, while paper surveys still dominate.
The Patient Cloud ePRO app was adopted by the National Clinical Trials Network (NCTN) to facilitate capturing electronic patient-reported outcome (ePRO) data. This transition from paper surveys to electronic data collection offers numerous advantages, including real-time data access, control over data collection timing, accelerated data cleaning, and reduced data entry errors. However, despite these benefits, ePRO electronic data submission rates in NCTN trials, including those focused on Colorectal Cancer, have remained low, ranging from 17% to 38.7%.
Ellen Lavoie Smith and the research team aimed to test an intervention known as ePRO-E, designed to increase patient uptake of the ePRO app and encourage electronic data submission. Specifically, the objective was to assess whether a patient-targeted ePRO educational resource (ePRO-E) could effectively boost ePRO uptake (measured by the number of users) and enhance data quality, with high quality defined as a survey submission rate of ≥80%.
Researchers performed an inclusive analysis comparing ePRO uptake and data quality in 2 groups (N=69) within an NCTN R01-funded clinical trial (NCT04137107). The patient-targeted ePRO-E intervention, comprising educational resources (written material and a 6-minute animated YouTube video), aimed to address ePRO uptake barriers. Covariates included technology attitudes, age, sex, education, socioeconomic status, and comorbidity.
The intervention group’s ePRO uptake (78.8%) significantly surpassed that of the historical control group (47.1%) (P=0.03). Patients selecting ePRO over paper surveys demonstrated more positive/higher technology attitudes scores (P=0.03). After covariate adjustment, the odds of choosing ePRO were 4.7 times higher (95% CI; 1.2–17.8) (P=0.02) among intervention group patients and 5.2 times higher (95% CI; 1.3-21.6) (P=0.02) among those with high technology attitudes scores. However, the ePRO group’s 80% survey submission rate (30.6%) was notably lower than that of the paper data submission group (57.9%) (P=0.05).
The study concluded that ePRO-E exposure effectively increased ePRO uptake, while high technology attitudes correlated with ePRO selection. However, paper survey submission rates remained higher, indicating a need for ongoing staff support in electronic data collection. Technological innovations and continued support from research staff are imperative in monitoring electronic data collection processes to ensure the acquisition of the highest quality data.
The trial was sponsored by the Alliance for Clinical Trials in Oncology.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/14508
Clinical Trial: https://clinicaltrials.gov/study/NCT04137107
Smith EL, Cho Y, Hillman S., et al. (2024). “Patient-Targeted Education (ePRO-E) to Increase ePRO Uptake Within an Alliance Clinical Trial (A221805-SI1).” Presented at ONS 2024 (Abstract RS72).
