The COMBAT Project

• Research type

  Research Study

• Full title

  The COMBAT Project - Core Post Operative Morbidity Set for Paediatric Brain Tumours

• IRAS ID

  326584

• Contact name

  Conor Mallucci

• Contact email

  conor.mallucci@alderhey.nhs.uk

• Sponsor organisation

  Alder Hey Children's NHS Foundation Trust

• Clinicaltrials.gov Identifier

  Study 1968, COMET Database Registration

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  BACKGROUND
  Brain and central nervous system tumours are the most common cause of cancer death in children under 18. Surgery is usually the first line treatment for these tumours. Reporting of harms following surgery is difficult because of differences in tumour type and location. To make the best use of research and clinical studies of surgery and to ensure patients are offered the best treatments we need to be able to compare the complications or harms associated with them. We can’t do this now because different studies report different complications and measure them in different ways.
  This study aims to solve this by agreeing which harms are the most important and should be reported in all research and clinical studies of surgery for children’s brain tumours. One way to do this is to create a ‘core outcome set’ (COS) which is a list of harms that should be reported in all research and clinical studies.

  METHODS
  We will look at previous research and carry out interviews with patients and carers to create a list of important harms. This list will be used in an online survey completed by three groups of people: patients, parents/carers and health professionals/researchers. The survey will ask how important each harm on the list is to measure and report following surgery. A final smaller meeting will be held discuss the results of the survey and agree the final COS. Patients and carers will be involved in all stages of this project including in the Study Advisory Group guiding the development of this project, interviews, survey and final meeting.

  OUTPUT/IMPACT
  We will publish the final COS in academic journals and present it at conferences. The COMBAT Project will provide a way to compare research and clinical services and will provide building blocks for future research.
  

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  24/WM/0219

• Date of REC Opinion

  7 Jan 2025

• REC opinion

  Further Information Favourable Opinion