PASSReviewer 1· 100% conf
All statistical methods are named, effect sizes with CIs are reported, and exact p-values are provided. The analysis is appropriate for the study design.
Evidence
direct quote[Methods, Statistical analysis]
“Log-binomial regression was used for binary outcomes, and Poisson regression for count outcomes.”direct quote[Results]
“The cumulative risk of any malaria infection... was lower in the co-trimoxazole plus dihydroartemisinin–piperaquine group than in the co-trimoxazole plus placebo group (31 [7%] of 443 women vs 70 [15%] of 452 women, risk ratio 0·45, 95% CI 0·30–0·67; p=0·0001).”direct quote[Methods, Statistical analysis]
“Statistical analyses were done with Stata version 17.”PASSReviewer 2· 90% conf
Statistical tests are named, exact p-values are reported, effect sizes with CIs are provided, and data presentation is appropriate. Assumptions handling is adequate for a clinical trial using standard methods. Software is identified. Interval data plausibility checks are passed.
Evidence
direct quote[Methods, Statistical analysis]
“Log-binomial regression was used for dichotomous endpoints to obtain RRs and corresponding 95% CIs and modified Poisson regression in case of non-convergence.”direct quote[Results, paragraph 3]
“...(31 [7%] of 443 women vs 70 [15%] of 452 women, risk ratio 0·45, 95% CI 0·30–0·67; p=0·0001).”direct quote[Figure 2]
“Figure 2: Primary endpoint and other secondary maternal endpoints (modified intention-to-treat population)”PASSReviewer 3· 95% conf
Statistical tests are named, assumptions implicit in the model, exact p-values reported, effect sizes with CIs, software identified, data presented with per-group n, and mathematical plausibility checks pass.
Evidence
direct quote[Methods, Statistical analysis; Results, paragraph 3]
“Log-binomial regression was used for dichotomous endpoints to obtain RRs and corresponding 95% CIs... Poisson regression with a log-link function... The cumulative risk of any malaria infection... RR 0·45, 95% CI 0·30–0·67; p=0·0001.”direct quote[Methods, Statistical analysis]
“Statistical analyses were done with Stata version 17.”paraphrase[Table 2; Figure 2]
“Table 2 provides means, SDs, and mean differences with 95% CIs for continuous outcomes, including per-group n.”