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Clinical Trials Design, Scientific Rigor, and Higher-Level Evidence in Surgery | Research, Methods, Statistics | JAMA Surgery | vlog

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Editorial
Randomized Clinical Trials in Surgery
October 26, 2022

Clinical Trials Design, Scientific Rigor, and Higher-Level Evidence in Surgery

Author Affiliations
  • 1Department of Surgery, VA Boston Health Care System, Boston, Massachusetts
  • 2Boston University, Harvard Medical School, Boston, Massachusetts
  • 3Departments of Surgery and Biomedical Engineering, University of Virginia School of Medicine, Charlottesville
  • 4Editor, JAMA Surgery
JAMA Surg. 2022;157(12):1078-1079. doi:10.1001/jamasurg.2022.4880

There is a perception held by others in the health sciences that surgeons are not adequately assessing surgical procedures. In an Editorial in the Lancet in 1996, entitled, “Surgical Research or Comic Opera: Questions, but Few Answers,” Richard Horton criticized surgeons for their high reliance on case studies and stated that, if surgeons wished to retain their academic reputation, they must find imaginative ways to collaborate with epidemiologists to improve the design of the case series and to plan randomized trials.1 Furthermore, he quoted a medical statistician, Major Greenwell, who stated in 1923: “I should like to shame surgeons out of comic opera performances which they suppose are statistics of operations.”1 In a similar condemnation, David H. Spodick complained of “the repeated reporting of biased data from uncontrolled or poorly controlled trials, giving an illusion of success due to sheer quantity but that a thousand zeros look impressive on paper, but they still amount to zero.”1

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