The randomized trial of mammography screening that was not-A cautionary tale.

ABSTRACT: Two randomized trials were conducted in Canada in the 1980s to test the efficacy of breast cancer screening. Neither of the trials demonstrated benefit. Concerns were raised regarding serious errors in trial design and conduct. Here we describe the conditions that could allow subversion of randomization to occur and the inclusion of many symptomatic women in a screening trial. We examine anomalies in data where the balance would be expected between trial arms. "Open book" randomization and performance of clinical breast examination on all women before allocation to a trial arm allowed women with palpable findings to be mis-randomized into the mammography arm. Multiple indicators raising suspicion of subversion are present including a large excess in poor-prognosis cancers in the mammograph

SUBMITTER: Yaffe MJ 

PROVIDER: S-EPMC8892036 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature