Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation

Challenges in evaluating surgical innovation

Patrick L Ergina et al. Lancet. .

Abstract

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

PubMed Disclaimer

Figures

Figure
Figure
Complexity of a surgical intervention
See this image and copyright information in PMC

References

    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. - PubMed
    1. Taggart DP. CABG is still the best treatment for multivessel and left main disease, but patients need to know. Ann Thorac Surg. 2006;82:1966–75. - PubMed
    1. McCulloch P, Altman DG, Campbell WB, et al. for the Balliol Collaboration No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374:1105–12. - PubMed
    1. Solomon MJ, McLeod RS. Clinical studies in surgical journals—have we improved? Dis Colon Rectum. 1993;36:43–48. - PubMed
    1. Wente MN, Seiler CM, Uhl W, Buchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20:263–69. - PubMed

Publication types