Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review

IntroductionBurn 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 i...

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Published inBMJ open Vol. 9; no. 12; p. e033472
Main Authors Young, Amber, Reeves, Barnaby C, Cheng, Hung-Yuan, Wasiak, Jason, Muir, Duncan, Davies, Anna, Blazeby, Jane
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 18.12.2019
BMJ Publishing Group LTD
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ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2019-033472

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Abstract IntroductionBurn 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 analysisA 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 disseminationNo 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 numberCRD42018111020.
AbstractList 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. 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. 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. CRD42018111020.
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.
IntroductionBurn 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 analysisA 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 disseminationNo 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 numberCRD42018111020.
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.INTRODUCTIONBurn 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.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.METHODS AND ANALYSISA 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.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.ETHICS AND DISSEMINATIONNo 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.CRD42018111020.PROSPERO REGISTRATION NUMBERCRD42018111020.
Author Wasiak, Jason
Cheng, Hung-Yuan
Young, Amber
Blazeby, Jane
Davies, Anna
Reeves, Barnaby C
Muir, Duncan
AuthorAffiliation 6 Austin Health Clinical School of Nursing , Latrobe University , Heidelberg , Victoria , Australia
3 Bristol Trials Centre (BRI-Hub) , Bristol Medical School, University of Bristol , Bristol , UK
1 Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School , University of Bristol , Bristol , UK
5 Olivia Newton John Cancer Wellness & Research Centre, Department of Radiation Oncology , Austin Health , Heidelberg , Victoria , Australia
4 Population Health Sciences , Bristol Medical School, University of Bristol , Bristol , UK
2 Paediatric Anaesthesia , University Hospitals Bristol NHS Foundation Trust , Bristol , UK
7 Centre for Academic Child Health , University of Bristol , Bristol , UK
8 NIHR Biomedical Research Centre , University of Bristol and University hospitals Bristol NHS Foundation Trust , Bristol , UK
AuthorAffiliation_xml – name: 8 NIHR Biomedical Research Centre , University of Bristol and University hospitals Bristol NHS Foundation Trust , Bristol , UK
– name: 4 Population Health Sciences , Bristol Medical School, University of Bristol , Bristol , UK
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  fullname: Blazeby, Jane
  organization: NIHR Biomedical Research Centre, University of Bristol and University hospitals Bristol NHS Foundation Trust, Bristol, UK
BackLink https://www.ncbi.nlm.nih.gov/pubmed/31857316$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_1093_burnst_tkaa039
crossref_primary_10_1136_bmjopen_2021_052528
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Issue 12
Keywords cochrane
randomised controlled trials as topic
consort
bias
burns
quality
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Snippet IntroductionBurn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies...
Burn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires...
Introduction Burn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies...
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proquest
pubmed
crossref
bmj
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Open Access Repository
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Index Database
Enrichment Source
Publisher
StartPage e033472
SubjectTerms Bias
Burns
Burns - therapy
Citation management software
cochrane
Collaboration
consort
Human subjects
Humans
Injuries
Intervention
Laboratories
quality
randomised controlled trials as topic
Randomized Controlled Trials as Topic - standards
Research Methods
Systematic review
Systematic Reviews as Topic
Validity
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Title Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review
URI https://bmjopen.bmj.com/content/9/12/e033472.full
https://www.ncbi.nlm.nih.gov/pubmed/31857316
https://www.proquest.com/docview/2347575929
https://www.proquest.com/docview/2329730554
https://pubmed.ncbi.nlm.nih.gov/PMC6937119
https://doaj.org/article/71e07d9df45f45f9a2fbef6cbb683058
Volume 9
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