PASSReviewer 1· 85% conf
Statistical analysis is generally rigorous: tests are named (McNemar, z-test, Wald), exact p-values are reported for primary outcomes, effect sizes with 95% CIs are provided, and software is identified. Assumptions are not explicitly verified but the methods are standard for paired noninferiority trials. Data presentation includes per-group n and proportions with CIs.
Evidence
paraphrase[Methods, Statistical analyses]
“For the primary outcomes (CDR and RR), we conducted noninferiority testing using the following approach: ... One-sided 97.5% CIs were established for the difference in proportions (AI standard) for the CDR and RR. ... If noninferiority was demonstrated for a given outcome, we proceeded to test for superiority using a paired exact McNemar test.”paraphrase[Table 2]
“CDR ... P < 0.001 bc | RR ... P = 0.997 d”paraphrase[Table 2]
“CDR ... 15.2 (6.6, 24.4) | RR ... 14.8 (9.0, 20.6)”PASSReviewer 2· 85% conf
Statistical tests are named, effect sizes are reported with 95% CIs, and software is identified. However, some p-values are given as thresholds (e.g., P < 0.001) rather than exact values.
Evidence
paraphrase[Methods, Statistical analyses]
“For the primary outcomes (CDR and RR), we conducted noninferiority testing using the following approach... One-sided 97.5% CIs were established... If noninferiority was demonstrated, we proceeded to test for superiority using a paired exact McNemar test.”paraphrase[Results, Table 2]
“CDR: 7.3 (6.3, 8.2) vs 6.3 (5.5, 7.2); absolute difference 1.0 (0.4, 1.5)”direct quote[Results, Table 2]
“P < 0.001 bc”WARNReviewer 3· 65% conf
Statistical methods are well described with effect sizes and CIs throughout, but p-values are reported as thresholds/rounded values and the reported PPV P = 0.500 appears inconsistent with a z-test on the stated proportions.
Evidence
direct quote[Methods, Statistical analyses; Table 2 footnote]
“For the CDR and RR, initially, one-tailed McNemar paired tests were applied for the noninferiority analyses.”direct quote[Table 2]
“increase in the CDR of 15.2% (95% CI 6.6%, 24.4%)”paraphrase[Table 2]
“P < 0.001”