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.
Decision-making in burn care is challenging and costly. 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 is 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 multi-disciplinary 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).

Strengths and limitations of this study:
• A Core Outcome Set for burn care will improve evidence synthesis in burn care.
• The study achieves stakeholder engagement from multi-disciplinary clinical staff and patients.
• There is international professional input.
• The outcomes chosen will need to reflect different stages of recovery after burn injury and different patient ages.
• Outcome measurement tools will need to be identified to assess the outcomes chosen.