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    Improving surgical randomized controlled trials (RCTs) requires careful outcome selection and measurement. Addressing these challenges ensures trial results accurately reflect surgical intervention value for clinical practice.

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    Area of Science:

    • Clinical Trials Methodology
    • Surgical Research
    • Evidence-Based Medicine

    Background:

    • Randomised controlled trials (RCTs) in surgery present unique design and conduct challenges.
    • Surgical RCT outcomes are often ill-defined, inconsistently measured, and prone to bias.
    • Historical focus on short-term outcomes limits the clinical utility of surgical trial results.

    Purpose of the Study:

    • To address critical issues in surgical trial outcomes: selection, measurement, and bias reduction.
    • To explore solutions and current initiatives for improving outcome assessment in surgical RCTs.
    • To highlight best practices in surgical trial outcome reporting.

    Main Methods:

    • Review of challenges in surgical trial outcome selection and measurement.
    • Discussion of strategies to minimize bias in outcome assessment.
    • Examination of existing initiatives and examples of good practice.

    Main Results:

    • Improved outcome selection requires understanding trial design and purpose, emphasizing patient-centered outcomes.
    • Core outcome sets and blinding of assessors can enhance outcome measurement and reporting.
    • Pragmatic trials necessitate patient-centered outcome assessments alongside short-term measures.

    Conclusions:

    • Enhanced understanding of trial design and patient-centered outcomes can resolve historical issues in surgical trial reporting.
    • Utilizing core outcome sets and novel blinding methods will improve outcome measurement.
    • Collaboration between surgeons and methodologists is crucial for effective surgical RCTs and clinically relevant outcomes.