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Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set
  1. Amber Young1,
  2. Sara Brookes1,
  3. Nichola Rumsey2,
  4. Jane Blazeby1
  1. 1 School of Social and Community Medicine, Faculty of Health Sciences, University of Bristol, Bristol, UK
  2. 2 Centre for Appearance Research, Department of Health & Social Sciences, Faculty of Health & Applied Sciences, Frenchay Campus, University of the West of England, Frenchay Campus, Bristol, UK
  1. Correspondence to Dr Amber Young; amber.young1{at}nhs.net

Abstract

Introduction In 2004, nearly 11 million severely burn-injured patients required medical care worldwide. Burns cause prolonged hospitalisation and long-term disability. Although mortality has been reduced, morbidity remains significant.Burn care is costly and decision-making is challenging. A range of procedures are performed at different times after injury; new technology is emerging and alternate care pathways are regularly introduced. Data to guide evidence-based decision-making are lacking. Researchers use different outcomes to assess recovery, so it is not possible to combine trial information to draw meaningful conclusions. Early recovery measures include length of hospital stay, healing time and treatment complications. Longer-term outcomes include issues with function, cosmesis and psychological health. Reporting an agreed set of the most important outcomes (core outcome set (COS)) in randomised controlled trials (RCTs) will allow effective evidence synthesis to support clinical decisions. Patient input will ensure relevance.

Methods and analysis The aim is to produce a burn COS for RCT reporting. A long list of outcomes will be identified through systematic reviews of clinical and patient-reported outcomes. Additional outcomes will be identified from interviews with patients over 10 years, parents of children of any age and multidisciplinary professionals. A two-stage modified Delphi exercise will be undertaken to prioritise and condense the list, with patients (n=150) at different stages of recovery. We will also include nursing, therapy (n=100) and medical staff (n=100). A reduced list will be taken to consensus meetings with families and clinical staff to achieve a final COS.

Ethics and dissemination A COS will reduce outcome reporting heterogeneity in burn care research, allowing more effective use of research funding and facilitating evidence synthesis and evidence-based clinical decision-making. Stakeholders will include journal editors, health commissioners, researchers, patients and professionals. The study has ethical approval and is registered with Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/798?result=true).

  • burn
  • scald
  • thermal injury
  • outcomes
  • recovery
  • core outcome set
  • Delphi survey
  • protocol

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors AEY wrote the paper and conceived the project with the support of Professor JB. Professor JB and Dr SB contributed knowledge of core outcome set development. Professor NR contributed knowledge on qualitative research. Professors JB and NR and Dr SB edited and critically revised the paper. All authors have read and approved the manuscript.

  • Funding This work was supported by an National Institute for Health Research Doctoral Research Fellowship DRF-2016-09-031. JB and SB are part funded by the Medical Research Council ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures—MR/K025643/1).

  • Competing interests JB is an NIHR Senior Investigator. All other authors declare no competing interests.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval South West Frenchay Research Ethics Committee (ref: 17/SW/0025 IRAS 221625).

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

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