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Randomized controlled trials in surgery

M J Solomon1, A Laxamana, L Devore

  • 1Department of Surgery, University of Toronto, Canada.

Surgery
|June 1, 1994
PubMed
Summary
This summary is machine-generated.

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Surgical randomized controlled trials (RCT) are underrepresented in surgical journals and often lack surgeon principal investigators. Improving the quality and quantity of surgical RCTs is crucial for advancing evidence-based surgical practices.

Area of Science:

  • Surgery
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Randomized controlled trials (RCTs) are crucial for establishing evidence-based medical practices.
  • The role and quality of surgical RCTs, particularly those conducted by surgeons, require thorough investigation.

Purpose of the Study:

  • To determine the number of surgical RCTs performed by surgeons, published in surgical journals, or including a surgical arm.
  • To assess the characteristics and quality of these surgical RCTs.

Main Methods:

  • A MEDLINE search identified surgical RCTs published in 1990 across various general surgery subspecialties.
  • Data on funding, therapy type, surgical area, journal, country, and principal author were analyzed.
  • The completeness of the MEDLINE search was validated against a manual literature search.

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  • All identified RCTs were evaluated using Chalmers' qualitative score.
  • Main Results:

    • MEDLINE identified 202 surgical RCTs, representing 46% of those found through a manual search.
    • Surgeons were principal authors in only one-third of trials, and surgical therapies were compared in only one-quarter.
    • Less than one-third of trials were published in surgical journals, and only 22% received funding from peer-reviewed agencies.
    • Therapy type, journal type, and surgical area significantly influenced RCT quality.

    Conclusions:

    • A relatively low proportion and standard of surgical RCTs are performed by surgeons, published in surgical journals, or directly compare surgical therapies.
    • Potential factors include surgeon expertise in clinical trials, funding limitations, and methodological challenges specific to surgical research.
    • Alternative research designs may be needed to adequately assess surgical interventions.