PubMed · 15371405
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Bernard C K Choi. Statistical issues and quality indicators.. https://doi.org/10.1377/hlthaff.23.5.282
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In typical small-area studies of health and environment we wish to make inference on the relationship between individual-level quantities using aggregate, or ecological, data. Such ecological inference is often subject to bias and imprecision, due to the lack of individual-level information in the data. Conversely, individual-level survey data often have insufficient power to study small-area variations in health. Such problems can be reduced by supplementing the aggregate-level data with small samples of data from individuals within the areas, which directly link exposures and outcomes. We outline a hierarchical model framework for estimating individual-level associations using a combination of aggregate and individual data. We perform a comprehensive simulation study, under a variety of realistic conditions, to determine when aggregate data are sufficient for accurate inference, and when we also require individual-level information. Finally, we illustrate the methods in a case study investigating the relationship between limiting long-term illness, ethnicity and income in London.
The standard approach for analysing a randomized clinical trial is based on intent-to-treat (ITT) where subjects are analysed according to their assigned treatment group regardless of actual adherence to the treatment protocol. For therapeutic equivalence trials, it is a common concern that an ITT analysis increases the chance of erroneously concluding equivalence. In this paper, we formally investigate the impact of non-compliance on an ITT analysis of equivalence trials with a binary outcome. We assume 'all-or-none' compliance and independence between compliance and the outcome. Our results indicate that non-compliance does not always make it easier to demonstrate equivalence. The direction and magnitude of changes in the type I error rate and power of the study depend on the patterns of non-compliance, event probabilities, the margin of equivalence and other factors.
In this paper, we address the problem of calculating power and sample sizes associated with simultaneous tests for non-inferiority. We consider the case of comparing several experimental treatments with an active control. The approach is based on the ratio view, where the common non-inferiority margin is chosen to be some percentage of the mean of the control treatment. Two power definitions in multiple hypothesis testing, namely, complete power and minimal power, are used in the computations. The sample sizes associated with the ratio-based inference are also compared with that of a comparable inference based on the difference of means for various scenarios. It is found that the sample size required for ratio-based inferences is smaller than that of difference-based inferences when the relative non-inferiority margin is less than one and when large response values indicate better treatment effects. The results are illustrated with examples.