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Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.
McKechnie, Tyler; Kazi, Tania; Wang, Austine; Zhang, Sophia; Thabane, Alex; Nanji, Keean; Staibano, Phillip; Park, Lily J; Doumouras, Aristithes; Eskicioglu, Cagla; Thabane, Lehana; Parpia, Sameer; Bhandari, Mohit.
Afiliación
  • McKechnie T; Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. Electronic address: tyler.mckechnie@medportal.ca.
  • Kazi T; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Wang A; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Zhang S; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Thabane A; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
  • Nanji K; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Division of Ophthalmology, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • Staibano P; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Division of Otolaryngology Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
  • Park LJ; Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
  • Doumouras A; Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Eskicioglu C; Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Thabane L; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada; Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa.
  • Parpia S; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
  • Bhandari M; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
J Clin Epidemiol ; 170: 111335, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38548230
ABSTRACT

OBJECTIVES:

Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY

DESIGN:

This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness.

SETTING:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021.

RESULTS:

After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported.

CONCLUSION:

The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto / Estudios de Factibilidad / Lista de Verificación Límite: Humans Idioma: En Revista: J Clin Epidemiol Asunto de la revista: EPIDEMIOLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
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: Ensayos Clínicos Controlados Aleatorios como Asunto / Estudios de Factibilidad / Lista de Verificación Límite: Humans Idioma: En Revista: J Clin Epidemiol Asunto de la revista: EPIDEMIOLOGIA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos