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Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review
  1. Amber Young1,2,
  2. Barnaby C Reeves3,
  3. Hung-Yuan Cheng4,
  4. Jason Wasiak5,6,
  5. Duncan Muir4,
  6. Anna Davies7,
  7. Jane Blazeby1,8
  1. 1Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  2. 2Paediatric Anaesthesia, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
  3. 3Bristol Trials Centre (BRI-Hub), Bristol Medical School, University of Bristol, Bristol, UK
  4. 4Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  5. 5Olivia Newton John Cancer Wellness & Research Centre, Department of Radiation Oncology, Austin Health, Heidelberg, Victoria, Australia
  6. 6Austin Health Clinical School of Nursing, Latrobe University, Heidelberg, Victoria, Australia
  7. 7Centre for Academic Child Health, University of Bristol, Bristol, UK
  8. 8NIHR Biomedical Research Centre, University of Bristol and University hospitals Bristol NHS Foundation Trust, Bristol, UK
  1. Correspondence to Dr Amber Young; amber.young1{at}nhs.net

Abstract

Introduction Burn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting standards are unclear. This study will assess the risk of bias and adequacy of reporting in recent burn care RCTs using tools endorsed by the Cochrane Collaboration.

Methods and analysis A systematic literature review will be undertaken, assessing parallel group RCTs evaluating therapeutic interventions for patients with cutaneous burns. Literature searches will use Ovid Medline, Ovid Embase, Web of Science and the Cochrane Library. Separate searches for each database will include medical subject heading and free text terms including ‘burn’, ‘scald’, ‘thermal injury’ and ‘RCT’. Two reviewers will independently assess each study for inclusion. Risk of bias (RoB) will be assessed with the revised tool (RoB 2) and reporting completeness with the CONsolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. We will report a narrative synthesis of all studies, including domain specific, and overall risk of bias for the primary outcome of each trial. Inter-rater agreement for RoB 2 will be reported using Fleiss’s Kappa. For adherence to the CONSORT guidelines, we will generate a completeness of reporting index for the five domains.

Ethics and dissemination No ethics approval is required because published documents will be used. Findings of the study will be disseminated in a peer-reviewed journal and presented at conferences.

PROSPERO registration number CRD42018111020.

  • bias
  • burns
  • cochrane
  • consort
  • quality
  • randomised controlled trials as topic

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors AY wrote the paper and conceived the project with the support of JB and BR. H-YC devised the interactive study-specific data extraction spreadsheet. DM will contribute to data extraction and assisted in writing this paper. JB, BR, JW, AD and H-YC edited and critically revised the article. All authors have read and approved the manuscript. AY is the guarantor of the review.

  • Funding This work was supported by the National Institute for Health Research Doctoral Research Fellowship DRF-2016-09-031. The views expressed are those of the author(s) and not necessarily those of the National Health Service (NHS), the National Institute for Health and Research (NIHR) or the Department of Health and Social Care. JB is partly funded by the Bristol Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol; Grant no. BRC-1215-2001. JB is an NIHR Senior Investigator.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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