Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials.
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
Odds Ratio
Patient Participation
/ statistics & numerical data
Patient Reported Outcome Measures
Retrospective Studies
Selection Bias
Symptom Assessment
/ statistics & numerical data
Journal
International journal of radiation oncology, biology, physics
ISSN: 1879-355X
Titre abrégé: Int J Radiat Oncol Biol Phys
Pays: United States
ID NLM: 7603616
Informations de publication
Date de publication:
15 11 2020
15 11 2020
Historique:
received:
17
12
2019
revised:
04
06
2020
accepted:
17
06
2020
pubmed:
27
6
2020
medline:
14
4
2021
entrez:
27
6
2020
Statut:
ppublish
Résumé
To assess the reasons why patients do not consent to patient-reported outcome (PRO) and electronic PRO data capture components of clinical trials and potential selection bias by having a separate consent. Selected NRG Oncology trials were included based on disease site and inclusion of PROs and electronic PRO data capture via VisionTree Optimal Care as separate consent questions. Reasons for not participating were assessed. Pretreatment characteristics between patients who did and did not consent were tested using χ Ten trials were selected in head and neck, prostate, gynecologic, 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 nonwhite patients across all trials (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.45-0.63; P < .001), and more patients with education after high school consented compared with those with less education (OR, 1.71; 95% CI, 1.46-2.02; P < .001). Patients who are younger (OR, 0.63; 95% CI, 0.47-0.85; P = .002), white (OR, 0.60; 95% CI, 0.44-0.82; P = .001), and a never or former smoker (OR, 0.57; 95% CI, 0.41-0.78; P = .001) are more likely to participate in electronic PRO data capture. These results suggest that a patient's race, age, and education can affect whether a patient chooses to consent or is offered to participate in PRO or electronic PRO data capture components. More investigation is needed, but this analysis provides support for making PROs integrated in the trial.
Identifiants
pubmed: 32590048
pii: S0360-3016(20)31317-1
doi: 10.1016/j.ijrobp.2020.06.030
pmc: PMC7572717
mid: NIHMS1616455
pii:
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
950-959Subventions
Organisme : NCI NIH HHS
ID : U10 CA180822
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180868
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189867
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233373
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
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