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Sensitivity analysis for clinical trials with missing continuous outcome data using controlled multiple imputation: A

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Summary
This summary is machine-generated.

Sensitivity analysis is crucial for clinical trials with missing data. This guide explains controlled multiple imputation (MI) methods, including delta-based and reference-based MI, to assess the impact of unobserved data on continuous outcomes.

Keywords:
clinical trialscontrolled multiple imputationmissing datamultiple imputationsensitivity analysis

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Data Analysis

Background:

  • Missing data from loss to follow-up or intercurrent events are common in clinical trials.
  • Assessing the impact of assumptions about unobserved data is essential via sensitivity analysis.
  • Controlled multiple imputation (MI) offers robust techniques for handling missing data.

Purpose of the Study:

  • To provide an overview of controlled multiple imputation (MI) techniques for sensitivity analysis.
  • To offer a practical guide for using MI with continuous outcome data in clinical trials.
  • To illustrate the application of these methods with real-world trial data.

Main Methods:

  • Introduces delta-based MI, adding an offset (δ) to assess impact of worse/better outcomes.
  • Explains reference-based MI, using observed data from other trial arms for imputation.
  • Demonstrates methods using data from pediatric eczema and chronic headache trials.
  • Provides Stata code for practical implementation.

Main Results:

  • Controlled MI techniques, including delta-based and reference-based imputation, are accessible for sensitivity analysis.
  • The choice of delta in delta-based analysis requires careful consideration.
  • Rubin's variance estimator is justified for reference-based analysis, providing anchored inference.

Conclusions:

  • Controlled multiple imputation provides valuable tools for sensitivity analysis in clinical trials with missing continuous outcomes.
  • Practical implementation is facilitated by provided Stata code.
  • Understanding and applying these MI techniques enhances the reliability of clinical trial results.