Developing and testing a Core Outcome Set for Burn Injury in Children and Young Adults

The aim is to develop a core outcome set (COS) to be measured and reported in all burns clinical trials involving children, adolescents and young adults. A COS is a minimum set of outcomes that are defined and measured in a standardised way. This dataset should reflect the interests of patients of different ages, families, healthcare professionals and NHS commissioners. This research would also aim to identify the most accurate and reproducible way to measure these outcomes.

Research questions:
•What clinical and patient / parent-reported outcomes have been reported in burns research?
•What short-term outcomes are most important (core set) to burned patients, families, multidisciplinary professionals and the NHS (clinical efficacy)?
•What long-term outcomes are most important to burned patients, professionals and the NHS (patient-centred, clinical effectiveness)?
•How should the outcomes be measured, such that the valid tools are practical, acceptable and feasible to use in research and audit?
•Is it possible to identify surrogate outcomes (from the clinical efficacy set) that predict the longer term COS variables (clinical effectiveness set)?

Specific Objectives:
•Production of two COSs at different time points after burn injury in patients aged 4 weeks to 24 years that are relevant to patients, families, burn professionals and NHS commissioners.
•Identification of high quality tools to reproducibly measure individual outcomes within the COSs.
•Explore the associations between the two sets of core outcomes

The population we have chosen for these aims is up to the age of 24 years using the NIHR definition of children and young people, rather than up to 16 years, as the majority of issues facing a 16 year old burn victim will be just as pertinent to a 24 year old. However we have chosen not to include all adults as many of the adult burns occur in the elderly as a result of accidents and falls, and their outcomes and treatment options differ widely from those of children and young people. We have also excluded neonates (up to 4 weeks of age) as aetiology and outcomes vary considerably in this very small group of children.

Contributors

PI: Dr Amber Young
Supervisor: Professor Jane Blazeby

Publication

Journal: BMJ Medicine
Volume: 1
Issue:
Pages: e000183 -
Year: 2022
DOI: 10.1136/bmjmed-2022-000183

Further Study Information

Current Stage: Completed
Date: October 2016 - October 2019
Funding source(s): NIHR DRF


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Burns

Target Population

Age Range: 0 - 25

Sex: Either

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Families
- Patient/ support group representatives
- Service commissioners
- Service users

Study Type

- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- COS for practice

Method(s)

- 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.