Objective To develop a core outcome set for international burn research.
Design Development and international consensus, from April 2017 to November 2019.
Methods Candidate outcomes were identified from systematic reviews and stakeholder interviews. Through a Delphi survey, international clinicians, researchers, and UK patients prioritised outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining outcomes were agreed. A consensus meeting with voting was held to finalise the core outcome set.
Results Data source examination identified 1021 unique outcomes grouped into 88 candidate outcomes. Stakeholders in round 1 of the survey, included 668 health professionals from 77 countries (18% from low or low middle income countries) and 126 UK patients or carers. After round 1, one outcome was discarded, and 13 new outcomes added. After round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting. Outcome merging and voting, in two rounds, with prespecified thresholds agreed seven core outcomes: death, specified complications, ability to do daily tasks, wound healing, neuropathic pain and itch, psychological wellbeing, and return to school or work.
Conclusions This core outcome set caters for global burn research, and future trials are recommended to include measures of these outcomes.
To develop a core outcome set for international burn research.
ContributorsAmber Young, Anna Davies, Carmen Tsang, Jamie Kirkham, Tom Potokar, Nicole Gibran, Zephanie Tyack, Jill Meirte, Teruichi Harada, Baljit Dheansa, Jo Dumville, Chris Metcalfe, Rajeev Ahuja, Fiona Wood, Sarah Gaskell, Sara Brookes, Sarah Smailes, Marc Jeschke, Murat Ali Cinar, Nukhba Zia, Amr Moghazy, Jonathan Mathers, Sian Falder, Dale Edgar and Jane Mary Blazeby
Disease Category: Orthopaedics & trauma
Disease Name: Burns
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Families
- Patient/ support group representatives
- Service commissioners
- Service users
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
Set-up: The protocol will need writing with input from patients, parents and multidisciplinary professionals. The protocol will define the COS scope in terms of:
1. Specific condition (burn type)
2. Patient group (age, use of parents, siblings)
3. Treatment type (surgery, other care)
4. Study type the COS will be used for
Recruitment of stakeholders for the Delphi survey. Formation of a Study Steering Group with an independent chair and a patient representative (PW will be invited). Ethical and other research approvals will be processed.
Identifying outcome long-list, definitions and measurement tools
• Systematic Review using the Cochrane Register, EMBASE, MEDLINE to identify studies on burn surgery and care. Outcomes measured, outcome definitions, outcome measurement method and time-point after injury will be collected. Outcomes will be grouped under domains. Outcome domains and outcomes will be assessed for suitability of domain name and outcome grouping. A separate literature review will update a previous published review on patient reported outcomes after burn care.
• Qualitative interviews: patients, parents, siblings, multidisciplinary staff and NHS commissioners will be recruited through services distant to my service to allow patients to be interviewed without knowledge of my clinical role. Patient demographic details and injury information will be collected along with staff roles and experience. All stakeholders will be invited to take part in semi-structured interviews.
• Sample Size: to be determined.
• Data Analysis: will be in consultation with a patient representative using a systematic approach. Themes will be derived.
• Outcome Long-list, outcome definitions and outcome measurement instruments identified by the systematic review and qualitative interviews will be produced. Consideration will be given to agreeing different core outcomes for patient sub-groups.
Determining Core Outcomes: the Delphi methodology enables stakeholders to participate in a process which assesses the extent of agreement (consensus measurement) and resolves disagreement (consensus development). Patients, parents, healthcare professionals and commissioners will be invited. Surgeons, therapists and nurses will be separated into different groups. There will be a joint consensus meeting with healthcare professionals, commissioners, families and patients to finalise the COS.
Delphi Pilot: The Delphi survey will be developed to ensure ease of completion, using appropriate terminology and phrasing and piloted before use.
Delphi Survey: will be undertaken in three rounds including patients, parents, NHS commissioners and professionals. Participants will score outcomes. Repeated reflection and scoring will increase the likelihood of stakeholder convergence. Scoring will be based on ‘consensus include’, ‘consensus not to include’ and ‘no consensus’ dependent on percent agreement.
COSMIN methodology will be used to determine how core outcomes should be measured and to assess the quality of each measurement tool identified in the systematic review.