Progress in clinical research in surgery and IDEAL

Peter McCulloch, Chair of IDEAL and co-authors examined progress in surgical research and their findings are now published in The Lancet Online First

Joshua Feinberg, surgeon, researcher and member of the IDEAL Collaboration at Maimonides Medical Center, Brooklyn, New York describes the research undertaken to examine how surgical research has improved in the last two decades and whether the IDEAL Framework and Recommendations have contributed.

“The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. To address this, we conducted a review of the progress of methodology in clinical studies of surgery, and whether it is moving towards compliance with the IDEAL Recommendations.

To evaluate progress, we examined the surgical literature, focusing specifically on studies of surgical outcomes, in two periods 10 years apart, one before and one after the publications of the IDEAL Recommendations (2000-2004 and 2010-2014). Compliance with the following IDEAL recommendations were compared between the two time periods:

  • Use of standardised terminology
  • Definition and description of procedure
  • Prospective data collection
  • Explanation of modifications during early studies (2a)
  • Previous analysis of learning curves in pre-RCT studies
  • Use of quality control measures
  • Use of qualitative research to define RCT questions
  • Use of prior prospective cohort study to prepare for RCTs
  • Mention of pilot of feasibility studies to prepare for RCT
  • Masking reported in RCTs

The main findings of the study include:

IMPROVEMENT in the use of standard outcome measures, adoption of Consolidated Standards of Reporting Trials (CONSORT) standards, and assessment of the quality of surgery and of learning curves.

NO PROGRESS in the use of qualitative research or reporting of modifications during procedure development.

When discussing visions for the future, the paper concludes

“Surgical research is getting better, although it still has a long way to go…The IDEAL Framework and Recommendations have probably only contributed in a minor way to the improvements seen so far, but their influence is growing, they are useful as a tool to measure progress, and they represent a serious attempt to create a new framework for surgical research methodology.”

 

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