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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
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...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734442/ https://www.ncbi.nlm.nih.gov/pubmed/28669969 http://dx.doi.org/10.1136/bmjopen-2017-017267 |
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author | Young, Amber Brookes, Sara Rumsey, Nichola Blazeby, Jane |
author_facet | Young, Amber Brookes, Sara Rumsey, Nichola Blazeby, Jane |
author_sort | Young, Amber |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-5734442 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-57344422017-12-20 Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set Young, Amber Brookes, Sara Rumsey, Nichola Blazeby, Jane BMJ Open Evidence Based Practice 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). BMJ Publishing Group 2017-07-02 /pmc/articles/PMC5734442/ /pubmed/28669969 http://dx.doi.org/10.1136/bmjopen-2017-017267 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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/ |
spellingShingle | Evidence Based Practice Young, Amber Brookes, Sara Rumsey, Nichola Blazeby, Jane Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title | Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title_full | Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title_fullStr | Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title_full_unstemmed | Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title_short | Agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
title_sort | agreement on what to measure in randomised controlled trials in burn care: study protocol for the development of a core outcome set |
topic | Evidence Based Practice |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734442/ https://www.ncbi.nlm.nih.gov/pubmed/28669969 http://dx.doi.org/10.1136/bmjopen-2017-017267 |
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