Brain and other CNS tumours are the most common solid tumour site in paediatric populations aged 0-14, and the most common cause of cancer death in these populations.1 Paediatric brain tumours are associated with high morbidity which may have life long consequences for survivors, both from the disease process and the surgical and medical interventions required to treat them.
Reporting post operative morbidity in paediatric brain tumours is associated with several challenges. Paediatric CNS tumours are highly heterogeneous, anatomically distributed, and associated with location-specific symptoms and morbidity. This creates several challenges when attempting to report and classify post-operative morbidity. For instance, pre-surgical neurological condition can be variable at diagnosis and may contribute to cumulative post-operative morbidity, possibly complicated by pre-existing comorbidities also. Pathology and location may dictate the aggressiveness of surgical intent and the level of post-operative morbidity which is acceptable to achieve adequate disease control. Finally, many children will go on to have adjuvant therapies which in themselves may compound overall tumour-associated morbidity.
Transparent and reproducible morbidity reporting helps to manage patient and parent expectations, provides a standardised way to compare harms in clinical or research studies and provides a benchmark to compare clinical services. There are a variety of morbidity tools that are currently used to report surgical harms, but their application in post operative paediatric brain tumour patients has proven inadequate. Existing tools underestimate the importance of post operative neurological or cognitive deficit, and if no intervention is required for the post operative deficit it incurs a lower grading of morbidity. Expected post operative morbidity was not incorporated into these tools, and they failed to consider that complications may improve with time after surgery. This highlighted the difficulties faced with reporting post operative complications following brain tumour surgery in the paediatric population and highlighted a need for a dedicated paediatric neuro-oncology surgical morbidity tool. This is exacerbated because there is no common language to report and measure surgical morbidity post operatively following paediatric brain tumour surgery.2
The COMBAT project aims to develop a core set of adverse outcomes for children undergoing CNS tumour resection. The project will identify post-operative harm outcomes which are determined to be of significance to both healthcare professionals, and patients and their families. Two systematic literature reviews will identify post operative harms reported in clinical trials and studies and patient reported outcomes following paediatric brain tumour surgery. These outcomes will be prioritised through an international eDelphi survey and then then be ratified through a consensus meeting including patients and their representatives, and healthcare professionals, including clinicians and researchers. In addition, a standardised method of measuring each of the morbidity outcome measures will be determined. A long-term outcome will be the construction of a morbidity reporting tool and the ability to predict patient-specific likeliness of surgical morbidity.
Study Management group:
Miss Sandhya Trichinopoly Krishna - Alder Hey Children's NHS Foundation Trust and University of Liverpool (Principal Investigator)
Prof Carol Gamble - University of Liverpool (Chief Investigator)
Prof Conor Mallucci - Alder Hey Children's NHS Foundation Trust and University of Liverpool (Chief Investigator)
Dr Nicola Harma - University of Liverpool (Co-Investigator)
Prof Michael Jenkinson - The Walton Centre NHS Foundation Trust and University of Liverpool (Co-Investigator)
Prof Barry Pizer - Alder Hey Children's NHS Foundation Trust (Co-Investigator)
Mr Christopher P. Millward - Alder Hey Children's NHS Foundation Trust and University of Liverpool (Co-Investigator)
Disease Category: Neurology
Disease Name: Brain Tumor
Age Range: 0 - 21
Sex: Either
Nature of Intervention: Surgery
- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Families
- Methodologists
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
Step 1 - Systematic review of trial outcomes and patient and caregiver reported outcomes
Step 2 - eDelphi survey - clinicans and parents (and patients if appropriate)
Step 3 - Consensus meeting
Step 4 - Determine how each outcome should be measured and construct a morbidity tool for predicting and classifying post op morbidity in surgical neuro-oncology patients