A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

ABSTRACT:

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

SUBMITTER: Donovan JL 

PROVIDER: S-EPMC5854278 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature