Study Designs

A published article providing an introductory overview of the study designs and outcome measures most commonly used in clinical research:

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What this resource offers

This article is intended to be a primer on research methods for clinicians and active researchers, to enable them to read the medical literature critically. It assumes minimal experience with statistics. The article:

  • Describes both observational and experimental study designs. 
  • Discusses how to assess which study design is most appropriate for a given research question and includes an oft-cited flow chart. 
  • Describes a range of outcome measures and discusses which are most appropriate for a given research question.  

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Who created it

This article was written by David A. Grimes, MD, and Kenneth F. Schulz, PhD, both leaders in the field of evidence-based medicine. 

Both were affiliated with the non-profit Family Health International and were clinical professors at the University of North Carolina School of Medicine. Dr. Grimes was inducted into the Institute of Medicine in 2007. Dr. Schulz is the first author of the well-known CONSORT 2010 Statement for reporting the results of randomized clinical trials. 

Citation: David A. Grimes and Kenneth F. Schulz. Lancet 359: 57-61 (2002); DOI:https://doi.org/10.1016/S0140-6736(02)07283-5