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  11. Reporting Bias In Breast Reconstruction Clinical Trials: Which And When Clinical Trials Get Published

Reporting bias in breast reconstruction clinical trials: Which and when clinical trials get published

Oluwatobi R Olaiya1, Beraki Abraha2, Obehi Jacob Ogbeide3

  • 1Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada.

Journal of Plastic, Reconstructive & Aesthetic Surgery : JPRAS
|March 10, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Reporting bias in breast reconstruction surgery trials means results are selectively published. Industry-funded studies faced publication delays and appeared in less impactful journals, potentially affecting clinical practice.

Area of Science:

  • Medical research methodology
  • Surgical outcomes analysis
  • Publication ethics

Background:

  • Reporting bias, where research findings are selectively published based on results, can mislead clinical practice due to incomplete evidence.
  • Understanding reporting bias is crucial for evidence-based medicine, particularly in surgical fields.
  • Breast reconstruction surgery trials are a key area to investigate for potential reporting biases.

Purpose of the Study:

  • To investigate the extent of reporting bias in clinical trials for breast reconstruction surgery.
  • To identify factors influencing the publication of breast reconstruction trial results.
  • To assess the impact of funding source and trial design on publication timeliness and journal impact.

Main Methods:

  • A comprehensive search of ClinicalTrials.gov identified 156 completed breast reconstruction trials registered by August 2020.
Keywords:
Breast reconstructionEpidemiologyMethodologyPublication bias

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  • Data extraction focused on identifying published manuscripts, classifying primary outcomes (positive/nonpositive), and funding sources (industry/nonindustry).
  • Time-to-event analysis and logistic regression were used to compare publication times and identify factors associated with publication.

    • Main Results:

    • Out of 156 trials, only 53 were published, with a median publication time of 22 months.
    • Industry-funded trials showed a significantly longer time to publication (HR=2.4, p=0.023) and were more likely to be published in lower-impact journals (OR=3.7, p=0.048).
    • Randomized trials were published faster than nonrandomized ones (aHR=3.2, p=0.030), but statistical significance or effect size did not influence publication time.

    Conclusions:

    • While no evidence suggested industry-funded trials were more likely to report positive outcomes, they experienced publication delays and appeared in journals with lower impact.
    • The findings highlight potential reporting biases in breast reconstruction surgery research, with implications for evidence-based clinical decision-making.
    • Further research is needed to address publication delays and ensure timely dissemination of all trial results in breast reconstruction surgery.