FAILReviewer 1· 85% conf
Most statistical criteria are met, but a demonstrable arithmetic error in Table 1 (percentage 448% for stage IVa in standard group) leads to a fail according to the scoring rule.
Evidence
direct quote[Table 1]
“IVa | 117 (41%) | 124 (448)”direct quote[Results, Efficacy outcomes]
“P=0.90”direct quote[Results, Efficacy outcomes]
“stratified hazard ratio 1.03 (95% CI 0.61 to 1.74)”PASSReviewer 2· 85% conf
Statistical tests are named (Cox proportional hazards, Kaplan-Meier, Pearson χ², Fisher's exact, Mann-Whitney U, GEE), exact p-values and 95% confidence intervals are reported for primary and many secondary outcomes, effect sizes with CIs are provided, software is identified, and data presentation is clear (Kaplan-Meier curves, tables with n and percentages, means and SDs). Assumptions verification is not explicitly reported but is acceptable in the context of a large clinical trial using standard methods. No arithmetical impossibilities were detected.
Evidence
direct quote[Results, Efficacy outcomes]
“five year local relapse-free survival ... stratified hazard ratio 1.03 (95% CI 0.61 to 1.74); P=0.90”direct quote[Methods: Statistical analysis]
“We calculated ... using the Kaplan-Meier method, with hazard ratios ... estimated using a stratified Cox proportional hazards model ... Pearson’s χ2 test or Fisher’s exact test ... Mann-Whitney U test ... generalised estimating equations”direct quote[Methods: Statistical analysis]
“We used SPSS software (version 25.0) and R (version 4.3.1) for all statistical analyses.”PASSReviewer 3· 90% conf
Statistical methods are thoroughly described, exact p-values and CIs are reported, and software is identified. A minor typo in a table does not affect mathematical plausibility.
Evidence
direct quote[Abstract; Results, Efficacy outcomes]
“stratified hazard ratio 1.03 (95% CI 0.61 to 1.74); P=0.90”direct quote[Methods, Statistical analysis]
“We used SPSS software (version 25.0) and R (version 4.3.1) for all statistical analyses.”direct quote[Results, Table 1]
“IVa: 124 (448)”