Determination of sample size for various study designs in medical research: A practical primer.

Abstract

Formulating a research question and selecting an appropriate study design for answering that question are crucial initial steps in the research process. The population, intervention, control group, and outcomes measures (PICO time and setting [TS]) framework provides a practical guide in this regard, which stands for population, intervention, control, outcome, type of research question, and study design. The various study designs have their own merits and demerits, and implementing the methodology meticulously requires knowledge of all of these. Similarly, different methods of sample size calculation are warranted based on the most appropriate study design and outcome variables of interest. Sometimes, a <i>post</i> <i>hoc</i> power analysis can be performed after the sample size calculation, to check whether the study was adequately powered or not. There are multiple validated free software tools for sample size calculation, including Open-Epi, R, StatCalc, etc. The practice by most researchers of reporting significant <i>P</i> values is to be replaced by reporting effect sizes, as the latter is a much better estimate of the strength of association. This review provides a comprehensive, ready reckoner for busy family physicians to quickly identify the appropriate study design for answering any applied research questions in their minds and estimating the sample size required for the same.