The difference between study recommendations, stated policy, and actual practice in a clinical trial

作者: J.R. Goffin , C. Savage , D. Tu , L. Shepherd , T.J. Whelan

DOI: 10.1093/ANNONC/MDH303

关键词:

摘要: Background: We determined whether physicians involved in a clinical trial adhere to the study recommendations or stated policy of their treatment centre with respect administration boost radiation after breast conserving surgery. Patients and methods: Boost was by survey at 25 oncology centres randomised plus nodal Canada. Actual practice compared recommendations. Results: Among 248 subjects, 201 (81%) were treated according [k = 0.40, 95% confidence intervals (CI) 0.27 ‐ 0.52; P<0.0001], indicating only fair moderate agreement between actual practice, while 232 (94%) (k 0.59, CI 0.40‐ 0.77; P<0.0001), near substantial (P 0.88 for z-test difference). In multivariate analysis, subjects who had invasive disease resection margin more likely get than those margins clear tumour 2 mm [odds ratio (OR) 49, 7.6‐ 322; P<0.0001].

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