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The COMBAT Project: study protocol for the development of a core outcome set for morbidity following surgery in
Sandhya Trichinopoly Krishna1,2,3, Nicola Harman4, Conor Mallucci5
1Department of Neurosurgery, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. sandhya.krishna1@nhs.net.
Insights
This study aims to develop a core outcome set for paediatric brain tumour surgery to standardize reporting of postoperative adverse events. This will improve data consistency and enable better comparisons across studies and clinical practices.
Area of Science:
- Neuro-oncology
- Paediatric Surgery
- Clinical Outcomes Research
Background:
- Central nervous system tumours are the most common solid tumours in children and a leading cause of cancer death.
- High morbidity is associated with paediatric brain tumours and their treatments.
- Current postoperative morbidity reporting is inconsistent due to varied outcome measures and lack of a common language.
Purpose of the Study:
- To develop a core outcome set (COS) for paediatric brain tumour surgery.
- To establish a standardized minimum set of postoperative outcomes for reporting.
- To improve the consistency and comparability of morbidity data in paediatric neuro-oncology.
Main Methods:
- Protocol development following COS-STAD and COS-STAP recommendations.
- Systematic literature review to identify reported adverse outcomes and their measurement.
- Qualitative interviews with patients and carers to identify patient-important outcomes.
- Two-round eDelphi survey with national and international stakeholders (clinicians, researchers, patients, carers) to achieve consensus on core outcomes.
- International consensus meeting to discuss and finalize the core outcome set.
Main Results:
- The COMBAT (Core Postoperative Morbidity Set for Paediatric Brain Tumours) Project will define a core set of adverse outcomes.
- Consensus will be reached on the most critical postoperative harms through a rigorous Delphi process.
- The developed COS will provide a standardized framework for outcome measurement.
Conclusions:
- A standardized approach to reporting postoperative morbidity in paediatric brain tumour surgery is urgently needed.
- The COMBAT project will establish a common language for measuring and reporting surgical morbidity.
- This will enhance the quality of research and clinical practice, facilitating comparisons across studies and services.
Background:
Central nervous system tumours affecting the brain and spine are the most common solid tumour site in the paediatric population and the most common causes of cancer death in children and young people. They are associated with high morbidity both from the tumour and the interventions used to treat them. Postoperative morbidity reporting following surgery for paediatric brain tumours is poor. This is due to variability of outcomes measured and reported and the lack of a common language when reporting adverse outcomes. One solution is to develop a core outcome set which will stipulate the minimum postoperative outcomes that should be reported. The COMBAT (Core Postoperative Morbidity Set for Paediatric Brain Tumours) Project will develop a core set of adverse outcomes that can be applied to paediatric brain tumour patients undergoing surgery.
Methods And Analysis:
This protocol has been developed using the COS-STAD (Core Outcome Set-Standards for Development) recommendations and the COS-STAP (Core Outcome Set-STAndardised Protocol Items) statement. A systematic review will identify adverse outcomes reported in the literature and how they are measured. Outcomes of importance to patients and their carers will be identified from semi-structured qualitative interviews with patients and their carers from Alder Hey Children's Hospital, Liverpool, UK. Consensus on the most important harms will be sought using a two-round eDelphi survey completed by national and international participants including health professionals, researchers, patients and their carers. Results of the eDelphi survey will be assessed against a pre-defined definition of consensus and discussed at an international consensus meeting attended by participants of the eDelphi survey.
Discussion:
There is a clear need for a common language to harmonise measurement and reporting of morbidity following surgery for paediatric brain tumour patients. This project will define postoperative adverse outcomes that are of critical importance to key stakeholders. It will standardise surgical morbidity outcome measurement and reporting in both research studies and routine clinical practice, enabling comparison across different trials, studies and clinical services. It will lay the groundwork for future research in paediatric brain tumour surgical morbidity.
Study Registration:
This study is registered with the COMET database as Study 1968 ( https://www.comet-initiative.org/Studies/Details/1968 ), registration date: 26/10/2021.
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