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A Scoping Review Focused on Cooperative Group Involvement in Surgical Randomized Controlled Trials.

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Cooperative group involvement in surgical trials is low but may improve quality. Greater participation could enhance research infrastructure and patient-centered outcomes in surgical randomized controlled trials (RCTs).

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Area of Science:

  • Surgery
  • Clinical Trials
  • Health Services Research

Background:

  • Surgical randomized controlled trials (RCTs) face challenges in methodological and ethical standards, particularly in multicenter settings.
  • Cooperative groups (CGs), established in oncology, offer potential for enhancing surgical trial quality.
  • The impact of CGs on surgical RCTs remains underexplored.

Purpose of the Study:

  • To map the methodological and ethical quality of phase III surgical RCTs published from 2016-2020.
  • To assess the potential impact of cooperative group (CG) involvement on surgical trial quality.

Main Methods:

  • Systematic search of ten major surgical journals for RCTs published between January 2016 and December 2020.
  • Assessment of methodological quality using the Jadad scale and ethical quality using the Berdeu score.
  • Analysis of study characteristics including sample size, funding, multicenter design, and CG involvement.

Main Results:

  • 520 surgical RCTs were included, with a mean Jadad score of 10.0 and Berdeu score of 0.8.
  • Only 10% of trials involved a CG, but these showed trends toward higher methodological quality (Jadad 10.4 vs. 9.97) and more quality-of-life assessments (28% vs. 13%).
  • CG-led trials were significantly more likely to have public funding (56% vs. 33%).

Conclusions:

  • Cooperative group involvement in surgical RCTs is limited but associated with improved methodological practices.
  • CG involvement may lead to broader outcome measures, such as quality of life assessments.
  • Increased CG participation could strengthen surgical research infrastructure and promote patient-centered trial design.