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Table 4 Recommendations for analyses in malaria chemoprevention in pregnancy trials based on key safety outcomes from the systematic review

From: Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials

Safety outcome type after treatment

Examples

Optimal statistical method(s)

Time to event

Time to infection/infestation occurrence, time to abortion

Survival methods (e.g. Kaplan–Meier plots, log rank test followed by cox regression model)

Longitudinal continuous outcomes

QTc prolongation, haemoglobin, vital signs

Mixed effects linear/nonlinear models

Recurrent events

recurrent hospitalizations, recurrent anaemia, recurrent opportunistic infections

Recurrent event models (e.g. Poisson model, negative binomial, Andersen Gill model)

Safety outcomes with informative missing data,

Treatment switching, Dropout/withdrawal due to AE (i.e. AE-induced non-adherence)

Causal inference methods (e.g. mediation analysis)

Multivariate outcomes

Abortion, miscarriage Haemoglobin, QTc, alanine aminotransferase level

Multivariate methods: methods for multiple outcomes (e.g. multivariate regression models based on outcome type), methods for repeated outcomes (e.g. multivariate longitudinal analysis, recurrent events models), advanced graphs

Laboratory measurements with temporal variations

Vital signs, haemoglobin

Advanced graphical methods, multivariate methods

Count

Seizure episodes, dizziness episodes

Incidence rate followed by Models for count data (Poisson regression, negative binomial regression)

Outcomes with zero inflated counts

Seizure episodes, dizziness episodes, nausea episodes

Models for counts (Poisson zero inflated models, negative binomial zero-inflated models)