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Review
. 2012 Jun;129(6):979e-988e.
doi: 10.1097/PRS.0b013e31824eccb7.

Methodologically rigorous clinical research

Lynda J-S Yang  1 , Kate W-C Chang, Kevin C Chung
Affiliations
Review

Methodologically rigorous clinical research

Lynda J-S Yang et al. Plast Reconstr Surg. 2012 Jun.

Abstract

Background: Rigorous methodology increases the quality of clinical research by encouraging freedom from the biases inherent in clinical studies. As randomized controlled studies (clinical trial design) are rarely applicable to surgical research, the authors address the commonly used observational study designs and methodologies by presenting guidelines for rigor.

Methods: The authors performed a review of study designs, including cohort, case-control, and cross-sectional studies and case series/reports, and biases and confounders of study design.

Results: Details about biases and confounders at each study stage, study characteristics, rigor checklists, and published literature examples for each study design are summarized and presented in this report.

Conclusions: For those surgeons interested in pursuing clinical research, mastery of the principles of methodologic rigor is imperative in the context of evidence-based medicine and widespread publication of clinical studies. Knowledge of the study designs and their appropriate application, and strict adherence to study design methods can provide high-quality evidence to serve as the basis for rational clinical decision-making.

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Figures

Figure 1
Figure 1
Biases or confounding are encountered at all stages of study.
Figure 2
Figure 2
(A) Prospective cohort studies begin by recording the study population intervention, whereas (B) retrospective cohort studies require that data be collected after the intervention has been initiated.
Figure 3
Figure 3
Case-control studies begin with identification of the outcome of interest and patients who have the outcome of interest.
Figure 4
Figure 4
Cross-sectional studies examine a sample population at a single point in time.
Figure 5
Figure 5
Case series/reports describe the progress of patient interventions over time.
See this image and copyright information in PMC

References

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    1. [July 1, 2011];Guide to Clinical Preventive Services (U.S. Preventive Services Task Force) Anonymous. Available at: http://odphp.osophs.dhhs.gov/pubs/guidecps/pcpstoc.htm.
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Publication types