Oncology patients were found to understand and accept the Trials within Cohorts design
Young-Afat, Danny A.; Gal, Roxanne; Gerlich, Sophie; Burbach, Johannes P.M.; van der Velden, Joanne M.; van den Bongard, Desireé H.J.G.; Intven, Martijn P.W.; Kasperts, Nicolien; May, Anne M.; van der Graaf, Rieke; van Gils, Carla H.; Verkooijen, Helena M.
(2021) Journal of Clinical Epidemiology, volume 130, pp. 135 - 142
(Article)
Abstract
Background and Objective: The Trials within Cohorts design aims to reduce recruitment difficulties and disappointment bias in pragmatic trials. On cohort enrollment, broad informed consent for randomization is asked, after which cohort participants can be randomized to interventions or serve as controls without further notification. We evaluated patients’ recollection, understanding,
... read more
and acceptance of broad consent in a clinical oncology setting. Methods: We surveyed 610 patients with cancer participating in ongoing TwiCs; 482 patients (79%) responded, of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12–18 months after cohort enrollment), and a random sample of 62 cohort participants who had not been selected for interventions (1–6 months after cohort enrollment). Results: Shortly after providing cohort consent, 76% of patients (238/312) adequately remembered whether they had given broad consent for randomization. Of patients randomly offered interventions, 76% (82/108) remembered giving broad consent for randomization; 41% (44/108) understood they were randomly selected, 44% (48/108) were not interested in selection procedures, and 10% (11/108) did not understand selection was random. Among patients not selected for interventions, 42% (26/62) understood selection was random; 89% felt neutral regarding the scenario of “not being selected for an intervention while your data were being used in comparison with patients receiving interventions,” 10% felt reassured (6/62) and 2% scared/insecure (2/62). Conclusion: Patients adequately remember giving broad consent for randomization shortly after cohort enrollment and after being offered an intervention, but recollection is lower in those never selected for interventions. Patients are acceptant of serving as control without further notifications.
show less
Download/Full Text
Keywords: Cohort studies, Informed consent, Randomized controlled trials, Study design, Trials within Cohorts, Patient Participation/psychology, Humans, Middle Aged, Male, Colorectal Neoplasms/therapy, Patient Selection, Netherlands, Aged, 80 and over, Adult, Female, Surveys and Questionnaires, Biomedical Research/standards, Bone Neoplasms/therapy, Neoplasm Metastasis/therapy, Medical Oncology/standards, Aged, Breast Neoplasms/therapy, Research Design, Clinical Trials as Topic/standards, Cohort Studies, Practice Guidelines as Topic, Epidemiology, Journal Article, Review
ISSN: 0895-4356
Publisher: Elsevier USA
Note: Publisher Copyright: © 2020 The Author(s)
(Peer reviewed)