A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial

the ProtecT prostate cancer trial

Jenny L. Donovan*, Grace J. Young, Eleanor I. Walsh, Chris Metcalfe, J. Athene Lane, Richard M. Martin, Marta K. Tazewell, Michael Davis, Tim J. Peters, Emma L. Turner, Nicola Mills, Hanan Khazragui, Tarnjit K. Khera, David E. Neal, Freddie C. Hamdy, ProtecT Study Group

*Corresponding author for this work

Research output: Contribution to journalArticle

5 Citations (Scopus)
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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.

Original languageEnglish
Pages (from-to)35-46
Number of pages12
JournalJournal of Clinical Epidemiology
Publication statusPublished - 1 Apr 2018
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2018. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.


  • Clinical trial
  • Comprehensive cohort
  • External validity
  • Generalizability
  • Prostate cancer
  • Randomized

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