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

Document Type

Article

Publication Date

6-23-2020

Publication Title

Int J Radiat Oncol Biol Phys

Abstract

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.

Medical Subject Headings

Age Factors; Chi-Square Distribution; Clinical Trials as Topic/statistics & numerical data; Educational Status; Electronic Health Records/statistics & numerical data; Female; Humans; Informed Consent/statistics & numerical data; Logistic Models; Male; Middle Aged; Neoplasms/ethnology/psychology/therapy; Odds Ratio; Patient Participation/statistics & numerical data; Patient Reported Outcome Measures; Retrospective Studies; Selection Bias; Symptom Assessment/statistics & numerical data

PubMed ID

32590048

ePublication

ePub ahead of print

Volume

108

Issue

4

First Page

950

Last Page

959

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