Methodologically rigorous clinical research.
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.
Ann Arbor, Mich. From the Department of Neurosurgery, and the Section of Plastic Surgery, Department of Surgery, University of Michigan.
Lynda J-S
LJ
Yang
Kate W-C
KW
Chang
Kevin C
KC
Chung
D035843:Biomedical Research; D003657:Decision Making; D019317:Evidence-Based Medicine / Q000379:methods* / Q000592:standards; D006801:Humans; D013518:Surgery, Plastic / Q000379:methods* / Q000592:standards