FAILReviewer 1· 90% conf
Statistical methods are appropriate and well-named, assumptions checked, exact p-values and CIs reported, but statistical software is not identified and a clear numerical inconsistency (1,802 vs 1,602 for overall survival denominator) constitutes a demonstrable error, triggering a fail.
Evidence
absence[Methods, Statistical Analysis]
Statistical software not identified.direct quote[Results, Efficacy Analyses]
“A total of 94 patients died of 1,802 evaluated for the overall survival endpoint”direct quote[Results, Efficacy Analyses]
“hazard ratio, 0.88; 95% confidence interval, 0.60 to 1.28; P=0.51”PASSReviewer 2· 85% conf
Statistical methods are well-described, including tests, assumptions, exact p-values, and effect sizes with confidence intervals. However, the statistical software used is not identified. Data presentation is appropriate for a clinical trial.
Evidence
direct quote[Methods, Statistical Analysis]
“Differences between treatment arms were assessed by stratified log rank test... Assumption of proportionality of hazards between treatment groups was tested for all time-to-event endpoints.”direct quote[Results, Efficacy Analyses]
“Regional nodal irradiation did not significantly improve the interval until invasive breast cancer recurrence or death from breast cancer (hazard ratio 0.88; 95% confidence interval [CI], 0.60 to 1.28; P = 0.51).”absence[Methods, Statistical Analysis]
Statistical software is not identified.PASSReviewer 3· 85% conf
Statistical methods are adequately described with named tests, effect sizes and CIs reported, and proportional hazards assumption verified, but exact p-values for secondary endpoints are missing and statistical software is not identified.
Evidence
direct quote[Methods, Statistical Analysis]
“Differences between treatment arms were assessed by stratified log rank test...Assumption of proportionality of hazards between treatment groups was tested for all time-to-event endpoints.”direct quote[Results, Efficacy Analyses]
“Regional nodal irradiation did not significantly improve the interval until invasive breast cancer recurrence or death from breast cancer (hazard ratio 0.88; 95% confidence interval [CI], 0.60 to 1.28; P = 0.51).”absence[Methods, Statistical Analysis]
Statistical software not identified.