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Statistical analyses of longitudinal data with drop-outs based on direct likelihood, and using all the available data, provide unbiased and fully efficient estimates under some assumptions about the drop-out mechanism. Unfortunately, these assumptions can never be tested from the data. Thus, sensitivity analyses should be routinely performed to assess the robustness of inferences to departures from these assumptions. However, each specific scientific context requires different considerations when setting up such an analysis, no standard method exists and this is still an active area of research. We propose a flexible procedure to perform sensitivity analyses when dealing with continuous outcomes, which are described by a linear mixed model in an initial likelihood analysis. The methodology relies on the pattern-mixture model factorisation of the full data likelihood and was validated in a simulation study. The approach was prompted by a randomised clinical trial for sleep-maintenance insomnia treatment. This case study illustrated the practical value of our approach and underlined the need for sensitivity analyses when analysing data with drop-outs: some of the conclusions from the initial analysis were shown to be reliable, while others were found to be fragile and strongly dependent on modelling assumptions. R code for implementation is provided. [ABSTRACT FROM AUTHOR]

When fitting marginal models to correlated outcomes, the so-called sandwich variance is commonly used. However, this is not the case when fitting mixed models. Using two data sets, we illustrate the problems that can be encountered. We show that the differences or the ratios between the naive and sandwich standard deviations of the fixed effects estimators provide convenient means of assessing the fit of the model, as both are consistent when the covariance structure is correctly specified, but only the latter is when that structure is misspecified. When the number of statistical units is not too small, the sandwich formula correctly estimates the variance of the fixed effects estimator even if the random effects are misspecified, and it can be used in a diagnostic tool for assessing the misspecification of the random effects. A simple comparison with the naive variance is sufficient and we propose considering a ratio of the naive and sandwich standard deviation out of the [3/4; 4/3] interval as signaling a risk of erroneous inference due to a model misspecification. We strongly advocate broader use of the sandwich variance for statistical inference about the fixed effects in mixed models. [ABSTRACT FROM AUTHOR]