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The National Research Council panel on prevention and treatment of missingdata in clinical trials recommends that primary analysis methods are carefullyselected before appropriate sensitivity analysis methods can be chosen. In thispaper, we recommend an appropriate primary analysis method for handling CD4count data from the IMPI trial and trials with similar settings. The estimandof interest in the IMPI trial is the effectiveness estimand hypothesis. Wediscussed, compared, and contrasted results from complete case analysis andsimple imputation methods, with the direct-likelihood and multiple imputationmethods. The simple imputation methods produced biased estimates of treatmenteffect. However, the maximum likelihood and the multiple imputation methodsproduced consistent estimates of treatment effect. The maximum likelihood orthe multiple imputation approaches produced unbiased and consistent estimates.Therefore, either the maximum likelihood or the multiple imputation methods,under the assumption that the data are missing at random can be considered asprimary analysis method when one is considering sensitivity analysis to dropoutusing the CD4 count data from the IMPI trial and other trials with similarsettings.

Primary analysis method for incomplete CD4 count data from IMPI trial and other trials with similar setting