Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials
Pugh SL, Rodgers JP, Yeager KA, Chen RC, Movsas B, Bonanni R, Dignam J, and Bruner DW. Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials. Int J Radiat Oncol Biol Phys 2020.
International journal of radiation oncology, biology, physics
PURPOSE: To assess reasons patients do not consent to patient-report outcome (PRO) and electronic PRO data capture components of clinical trials and potential selection bias by having a separate consent.
METHODS: Selected XXXX trials were included based on disease site and inclusion of PROs and electronic PRO data capture via VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), as separate consent questions. Reasons for not participating were assessed. Pretreatment characteristics between patients who did and did not consent were tested using chi-square and t-tests for univariate comparisons and logistic regression for multivariable analyses.
RESULTS: 10 trials were selected in head and neck (HN), prostate, gynecological, breast, lung, and gastrointestinal cancers with 4 of these trials having electronic PRO data capture. Most patients consented to the PRO component (75.3%) but not electronic PRO data capture (37.8%). More white patients consented to PROs than non-whites across all trials (odds ratio [OR]=0.53, 95% confidence interval [CI]: 0.45-0.63, p<0.001) and more patients with education after high school consented compared to those with less education (OR=1.71, 95% CI: 1.46-2.02, p<0.001). Patients who are younger, white and a never or former smoker are more likely to participate in electronic PRO data capture (OR=0.63, 95% CI: 0.47-0.85, p=0.002; OR=0.60, 95% CI: 0.44-0.82, p=0.001; OR=0.57, 95% CI: 0.41-0.78, p=0.001, respectively).
CONCLUSIONS: These results suggest that a patient's race, age, and education may impact whether a patient chooses to consent or is offered to participate in PRO and/or electronic PRO data capture components. More investigation is needed but this analysis provides support for making PROs integrated in the trial.
ePub ahead of print