Protocol for the development of a core indicator set for reporting burn wound infection in trials: ICon-B study

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Abstract

Introduction

Systematic reviews of high-quality randomised controlled trials are necessary to identify effective interventions to impact burn wound infection (BWI) outcomes. Evidence synthesis requires that BWI is reported in a consistent manner. Cochrane reviews investigating interventions for burns report that the indicators used to diagnose BWI are variable or not described, indicating a need to standardise reporting. BWI is complex and diagnosed by clinician judgement, informed by patient-reported symptoms, clinical signs, serum markers of inflammation and bacteria in the wound. Indicators for reporting BWI should be important for diagnosis, frequently observed in patients with BWI and assessed as part of routine healthcare. A minimum (core) set of indicators of BWI, reported consistently, will facilitate evidence synthesis and support clinical decision-making.

Aims

The Infection Consensus in Burns study aims to identify a core indicator set for reporting the diagnosis of BWI in research studies.

Methods

(1) Evidence review: a systematic review of indicators used in trials and observational studies reporting BWI outcomes to identify a long list of candidate indicators; (2) refinement of the long list into a smaller set of survey questions with an expert steering group; (3) a two-round Delphi survey with 100 multidisciplinary expert stakeholders, to achieve consensus on a short list of indicators; (4) a consensus meeting with expert stakeholders to agree on the BWI core indicator set.

Ethics and dissemination

Participants will be recruited through professional bodies, such that ethical approval from the National Health Service (NHS) Health Research Authority (HRA) is not needed. The core indicator set will be disseminated through peer-reviewed publication, co-production with journal editors, research funders and professional bodies, and presentation at national conferences.

PROSPERO registration number

CRD42018096647.

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Most cited references 19

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Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Jamie Kirkham, Katherine Davis, Douglas G. Altman … (2017)

Background The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). Methods and findings An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1–9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. Conclusions The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

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Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions.

David J. Evans (2002)

A number of hierarchies of evidence have been developed to enable different research methods to be ranked according to the validity of their findings. However, most have focused on evaluation of the effectiveness of interventions. When the evaluation of healthcare addresses its appropriateness or feasibility, then existing hierarchies are inadequate. This paper reports the development of a hierarchy for ranking of evidence evaluating healthcare interventions. The aims of this hierarchy are twofold. Firstly, it is to provide a means by which the evidence from a range of methodologically different types of research can be graded. Secondly, it is to provide a logical framework that can be used during the development of systematic review protocols to help determine the study designs which can contribute valid evidence when the evaluation extends beyond effectiveness. The proposed hierarchy was developed based on a review of literature, investigation of existing hierarchies and examination of the strengths and limitations of different research methods. The proposed hierarchy of evidence focuses on three dimensions of the evaluation: effectiveness, appropriateness and feasibility. Research that can contribute valid evidence to each is suggested. To address the varying strengths of different research designs, four levels of evidence are proposed: excellent, good, fair and poor. The strength of the proposed hierarchy is that it acknowledges the valid contribution of evidence generated by a range of different types of research. However, hierarchies only provide a guide to the strength of the available evidence and other issues such as the quality of research also have an important influence.

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Infection in Burns.

William B. Norbury, David N. Herndon, Jessica D Tanksley … (2016)

Developments in critical care and surgical approaches to treating burn wounds, together with newer antimicrobial treatments, have significantly reduced the morbidity and mortality rates associated with this injury.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 14 May 2019

Volume: 9

Issue: 5

Electronic Location Identifier: e026056

Affiliations

[1 ] departmentCentre for Academic Child Health , University of Bristol , Bristol, UK

[2 ] departmentDepartment of Microbiology , Chelmsford Hospital , Chelmsford, UK

[3 ] departmentBurns and Plastic Surgery , Alder Hey Children’s NHS Foundation Trust , Liverpool, UK

[4 ] departmentCentre for Children’s Burns Research , University Hospitals Bristol NHS Foundation Trust , Bristol, UK

[5 ] departmentDivision of Nursing, Midwifery and Social work , The University of Manchester , Manchester, UK

[6 ] departmentDepartment of Plastic Surgery , Chelsea and Westminster Hospital NHS Foundation Trust , London, UK

[7 ] departmentDepartment of Surgery and Cancer , Imperial College London , London, UK

[8 ] departmentDepartment of Microbiology , Chelsea and Westminster Hospital NHS Foundation Trust , London, UK

[9 ] departmentNational Institute for Health Research Health Protection Research Unit , Imperial College London , London, UK

[10 ] departmentDepartment of Plastic Surgery and Burns , Queen Victoria Hospital NHS Foundation Trust , East Grinstead, UK

[11 ] departmentDepartment of Chemistry , University of Bath , Bath, UK

[12 ] departmentSchool of Pharmacy and Biomolecular Sciences , University of Brighton , Brighton, UK

[13 ] departmentDepartment of Plastic Surgery , Royal Free Hospital NHS Foundation Trust , London, UK

[14 ] departmentDepartment of Plastic Surgery , Royal Manchester Children’s Hospital , Manchester, UK

[15 ] departmentCentre for Children’s Burns Research, Bristol Royal Hospital for Children , University Hospitals Bristol NHS Foundation Trust , Bristol, UK

[16 ] departmentBristol Centre for Surgical Research , University of Bristol , Bristol, UK

Author notes

[Correspondence to ] Dr Anna Davies; anna.davies@ 123456bristol.ac.uk

Author information

Amber Young http://orcid.org/0000-0001-7205-492X

Article

Publisher ID: bmjopen-2018-026056

DOI: 10.1136/bmjopen-2018-026056

PMC ID: 6530370

PubMed ID: 31092650

SO-VID: 008b1545-9849-4799-b1f6-d5d6dad55233

License:

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/.

History

Date received : 15 August 2018

Date revision received : 21 February 2019

Date accepted : 28 March 2019

Funding

Funded by: MRC;

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special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: burn wound infection,systematic review,delphi survey,diagnostic indicators,burns

Data availability:

ScienceOpen disciplines: Medicine

Keywords: burn wound infection, systematic review, delphi survey, diagnostic indicators, burns

Protocol for the development of a core indicator set for reporting burn wound infection in trials: ICon-B study

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Abstract

Introduction

Aims

Methods

Ethics and dissemination

PROSPERO registration number

Related collections

JMIR: Research Protocols

Most cited references 19

Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions.

Infection in Burns.

Author and article information

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Affiliations

Author notes

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Article

History

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