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Am J Phys Med Rehabil. 2003 Oct;82(10 Suppl):S32-7.

Emerging standards in statistical practice: implications for clinical trials in rehabilitation medicine.

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1
Kessler Medical Rehabilitation Research and Education Corporation, West Orange, New Jersey 07052, USA.

Abstract

This article discusses selected issues in statistical practice that occur during the conduct of clinical trials in medical rehabilitation: (1) supplementing null hypothesis statistical testing and P values, (2) determining sample size and statistical power, (3) handling missing data, and (4) dealing with multiplicity (i.e., multiple endpoints, multiple statistical comparisons, and repeated measurements). Suggested strategies to address these issues are offered in light of the International Conference on Harmonisation guideline "Statistical Principles for Clinical Trials."

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