This study will identify outcomes for people with spinal cord injury currently used internationally and nationally and outcomes that could be used and present them to stakeholder groups to ask for agreement on which should be measured every time we see someone with spinal cord injury for clinical, governance and research purposes in the UK. A conceptual framework for a core outcome set will also need to be agreed on, then the outcomes by representatives from the stakeholder groups for people with spinal cord injury (clinical and research professional bodies, charities and patient groups). A panel need to choose some instruments that measure these outcomes accurately, reliably, and for free. The best outcome measurement instruments will then be recommended to be used whenever anyone wants to measure the effect of an intervention for people with spinal cord injury in the UK. This is urgently needed as the future commissioning of services for people with spinal cord injury is uncertain, as is the national registry and the model for delivering services is changing with the introduction of regional networks.
Other COMET registered core outcome sets, while they did not create a core outcome set for people with spinal cord injury in the UK, will be used to inform this study. Study 2926 looked at quality of life and this can be used to inform Outcome Measurement Instruments selection, if QOL is an outcome chosen in development of the framework for the Delphi process. The study 1703 looked at traumatic spinal cord injury in the Netherlands and will be used in the systematic review that identifies potential outcomes, but sadly this COS misses more than 50% of patients who present with spinal cord injury, with a non-traumatic cause. The authors for study 583 will be contacted to see if in addition to the 3 broad domains they reached consensus on to be captured for clinical trials, more granular outcomes for use in research were agreed on. These can be used to inform this study, but does not answer the question about clinical use and did not provide recommended Outcome Measurement Instruments, which will be essential for a national registry and comparability in research. The Cauda Equina Core Outcome Set registered with COMET will also be used to inform potential outcomes for this study and I am corresponding with the author. In addition to this the International Consortium for Health Outcome Measurement (ICHOM) have developed a core outcome set for traumatic injuries (no just spinal cord), there is a minimal dataset agreed on internationally for spinal cord injury (no OMIs) and outcomes and OMIs poorly reported in the current national spinal cord injuries UK commissioning registry that will inform this study. This core outcome set is the first to look at outcomes for all causes of spinal cord injury, or for clinical and research purposes in the UK.
Principal Investigator: Dr Gemma Simons (Consultant Physical and Rehabilitation Medicine and Spinal Injuries)
Affiliations
University of Southampton
Hampshire, Isle of Wight NHS Healthcare Foundation Trust
Salisbury District Hospital NHS Foundation Trust
South west spinal cord injury Network
British Association of Spinal Cord Injury Specialists
British Society for Physical and Rehabilitation Medicine
Disease Category: Rehabilitation
Disease Name: Spinal cord injury (SCI)
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Rehabilitation
- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Policy makers
- Researchers
- Service commissioners
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Delphi process
- Systematic review
Development
Definition of Spinal Cord Injury – critical review
Understanding of where and how spinal cord injury outcomes are currently captured – critical review/methodological systematic review
Development of a list of unique spinal cord injury outcomes
Development of an outcome framework
Development of a list of outcome measurement instruments for each outcome chosen in the COS
Feasibility (in parallel with Development, and Evaluation)
Stakeholder engagement, including PPI and cross-sectional survey of experts
Evaluation
Delphi study: what outcomes should be used in a core outcome set for spinal cord injury
Delphi study: what outcome measurement instruments should be used for each outcome
Implementation
Adoption by National Database