The COMBAT Project: study protocol for the development of a core outcome set for morbidity following surgery in paediatric brain tumour patients.

The COMBAT Project: study protocol for the development of a core outcome set for morbidity following surgery in paediatric brain tumour patients. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The COMBAT Project: study protocol for the development of a core outcome set for morbidity following surgery in paediatric brain tumour patients. Sandhya Trichinopoly Krishna, Nicola Harman, Conor Mallucci, Barry Pizer, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6063287/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 11 Aug, 2025 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract 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 ). paediatric child central nervous system brain tumour neuro-oncology surgery neurosurgery morbidity adverse outcome core outcome set. Full Text Supplementary Files Additionalfile1.docx Cite Share Download PDF Status: Published Journal Publication published 11 Aug, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Accept 27 Jul, 2025 Reviewers agreed at journal 23 Jul, 2025 Reviewers invited by journal 23 Jul, 2025 Editor assigned by journal 16 Jul, 2025 First submitted to journal 16 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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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.\u003c/p\u003e\u003ch2\u003eMethods and Analysis\u003c/h2\u003e\u003cp\u003eThis 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\u0026rsquo;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.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e\u003cp\u003eThere 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. 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