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Lookup NU author(s): Dr Edgar Paez-Gueyraud
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2018 The Authors Objectives: Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Study Design and Setting: Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. Results: The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. Conclusion: The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice.
Author(s): Donovan JL, Young GJ, Walsh EI, Metcalfe C, Lane JA, Martin RM, Tazewell MK, Davis M, Peters TJ, Turner EL, Mills N, Khazragui H, Khera TK, Neal DE, Hamdy FC, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Holding P, Hughes O, Kockelbergh R, Kynaston H, Mason M, Oxley J, Paul A, Paez E, Rosario DJ, Rowe E, Staffurth J
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Epidemiology
Year: 2018
Volume: 96
Pages: 35-46
Online publication date: 27/12/2017
Acceptance date: 11/12/2017
Date deposited: 19/03/2018
ISSN (print): 0895-4356
ISSN (electronic): 1878-5921
Publisher: Elsevier USA
URL: https://doi.org/10.1016/j.jclinepi.2017.12.019
DOI: 10.1016/j.jclinepi.2017.12.019
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