Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials

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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.

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ePub ahead of print