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Keywords:

  • missing data;
  • bias;
  • clinical research;
  • imputation;
  • multiple imputation;
  • statistical analysis

In part 1 of this series, the authors describe the importance of incomplete data in clinical research, and provide a conceptual framework for handling incomplete data by describing typical mechanisms and patterns of censoring, and detailing a variety of relatively simple methods and their limitations. In part 2, the authors will explore multiple imputation (MI), a more sophisticated and valid method for handling incomplete data in clinical research. This article will provide a detailed conceptual framework for MI, comparative examples of MI versus naive methods for handling incomplete data (and how different methods may impact subsequent study results), plus a practical user's guide to implementing MI, including sample statistical software MI code and a deidentified precoded database for use with the sample code.