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Table 1 Summary of analysis plan

From: Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

Variables Intention-to-treat cohort Per Protocol cohort
Baseline characteristics No statistical comparisons will be performed None
Intervention and co-interventions Chi-square, Fisher’s exact test, Mann-Whitney U test, t test as applicable None
Primary outcome 1. Primary analysis: chi-square. Report relative risk. Generalized linear mixed model (GLMM) incorporating center/site as random effect. Report as adjusted relative risk. If a significant difference detected: relative risk reduction, absolute risk reduction and number needed to treat (or harm) will be reported
2. Secondary analyses: unadjusted Cox proportional analysis, Kaplan-Meier (KM) curves, adjusted Cox proportional analysis
1. Primary analysis: chi-square and relative risk. Generalized linear mixed model (GLMM) incorporating center/site as random effect. Report as adjusted relative risk. If a significant difference detected: relative risk reduction, absolute risk reduction and number needed to treat (or harm) will be reported.
2. Secondary analyses: unadjusted Cox proportional analysis, KM curves, adjusted Cox proportional analysis
Secondary outcomes Chi-square. Report relative risk None
Subgroup analyses Chi-square. Report relative risk None