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Reporting bias in breast reconstruction clinical trials: Which and when clinical trials get published.
Olaiya, Oluwatobi R; Abraha, Beraki; Ogbeide, Obehi Jacob; Huynh, Minh N Q; Amin, Asmarah; McRae, Mark H; Coroneos, Christopher J; Mbuagbaw, Lawrence.
Afiliación
  • Olaiya OR; Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada. Electronic address: tobi.olaiya@medportal.ca.
  • Abraha B; Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.
  • Ogbeide OJ; Faculty of Science, York University, Toronto, ON, Canada.
  • Huynh MNQ; Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
  • Amin A; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
  • McRae MH; Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
  • Coroneos CJ; Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada.
  • Mbuagbaw L; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, ON, Canada; Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada.
J Plast Reconstr Aesthet Surg ; 91: 399-406, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38461624
ABSTRACT

BACKGROUND:

Reporting bias refers to the phenomenon in which the reporting of research findings is influenced by the nature of the results. Without the totality of evidence, clinical practice may be misguided. The objective of this work was to examine the extent of reporting bias in clinical trials of breast reconstruction surgery.

METHODS:

We searched and extracted data from all completed breast reconstruction clinical trials published in ClinicalTrials.gov from database inception to August 2020. Investigators sought to identify published full manuscripts of the registered trials. The primary outcome was classified as positive or nonpositive and trials were classified as industry or nonindustry funded. Time to publication in a peer-reviewed journal was computed and compared using time-to-event analysis. Trial characteristics associated with publication were evaluated using logistic regression.

RESULTS:

A total of 156 clinical trials were identified, of which, 53 trials were published. The median time to publication was 22 months (IQR, 13-35 months). Industry-funded studies were associated with a longer time to publication (HR = 2.4, p = 0.023) and publication in lower-impact journals (OR = 3.7, p = 0.048). Randomized clinical trials were associated with faster times to publication than nonrandomized studies (aHR = 3.2, p = 0.030). Statistical significance and the effect size were not associated with time to publication.

CONCLUSIONS:

We found no evidence that industry-funded trials were more likely to report a positive primary outcome. However, industry-funded trials were associated with a longer time to publication and publication in lower-impact journals.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Modelos Logísticos Límite: Humans Idioma: En Revista: J Plast Reconstr Aesthet Surg Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Modelos Logísticos Límite: Humans Idioma: En Revista: J Plast Reconstr Aesthet Surg Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos