ABSTRACT

Statistics is a body of methods for learning from experience. Clinical research often draws on statistical methods, and a good understanding of their rationale is therefore important for clinicians as well as research investigators. This chapter examines the underlying logic of statistical methods as applied to clinical research. The discussion focuses on four key concepts: operational definition, the precise specification of terms and procedures; the infinite-data case, a way of considering what conclusions might be reached if the study were so large that statistical variation was negligible; probabilistic thinking, which focuses on the resemblance to be expected between the study’s outcome and what an infinitely large study would show; and induction, the process of reaching conclusions about future cases on the basis of the data in the present study. The design of an investigation needs to take these concepts into account. The publication reporting the study should disclose fully and clearly how the study was done and analyzed and how the authors interpret the results.