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Risk Adjustment In Neurocritical care (RAIN)
Understanding recovery from head injury to inform care
NIHR HTA grant: 07/37/29NIHR CRN Portfolio Study ID: 7349
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Risk Adjustment In Neurocritical Care• RAIN• First “idea” (2001)• Adopted by NCCNet (March 2007)• Health Technology Assessment (HTA) themed call
in emergency medicine– Expression of interest (May 2007)– Outline proposal (October 2007)– Full proposal (February 2008)– Response to reviewers (May 2008)– Final full proposal (November 2008)– Contract signed (December 2008)
• National Institute for Health Research (NIHR) HTA grant number: 07/37/29
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Aim• To provide an accurate risk prediction
model for TBI to aid clinicians to evaluate
– clinical outcome(s)– effectiveness of care– whether, and best time, to transfer– cost-effectiveness of care
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Objectives of RAIN• To validate risk prediction models for
acute TBI• To evaluate the optimum location and
comparative costs of care• Why?
– TBI leading cause of death and disability worldwide
– Major cause of death/disabilitydisability in those aged under 40
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN phases• Study preparation
– March 2009 to August 2009 (six months)
• Collect/validate data– September 2009 to July 2011 (23 months)
• Validate models– March 2011 to October 2011 (eight months)
• Cost-effectiveness analysis– September 2010 to December 2011 (16 months)
• Report writing and dissemination– September 2010 to February 2012 (18 months)
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
InvestigatorsRole: design and conduct of RAIN
• Chief Investigator – Dr David Harrison Senior statistician,
ICNARC• Co-investigators
– Prof David Menon– Dr Martin Smith Neurocritical care– Dr Paddy Yeoman– Mr Peter Hutchinson Neurosurgery– Dr Fiona Lecky Emergency medicine – Dr Richard Grieve Health economics– Prof Kathy Rowan Director, ICNARC
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Study Steering GroupRole: overall supervision of RAIN on behalf of the funder (HTA) and sponsor (ICNARC)
• Investigators plus independent members– Prof Monty Mythen (Chair) Critical care– Mr Jonathan Hyam Neurosurgery– Dr Ian Tweedie Neuroanaesthesia– Ms Julie Bridgewater Lay representative
(Headway)• And…
– Dr Gita Prabhu Study Coordinator– Research fellow to be appointed
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Study Management GroupRole: day-to-day running of RAIN
• Emma Walmsley (Research Administrator)• David Harrison (Chief Investigator)• Gita Prabhu (Study Coordinator)• Phil Restarick (Research Coordinator)• Kathy Rowan (Co-investigator)
All based at ICNARC
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN (NIHR HTA: 07/37/29)• Appointments:
– Study Coordinator (Gita Prabhu)• December 2008
– Study Administrator (Andrew Craven)• February 2009
– Research Coordinator (Phil Restarick)• April 2009
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN (NIHR HTA: 07/37/29)• Ethics approvals (March 2009)
– England, Wales and Northern Ireland (09/MRE09/10)
– Scotland (09/MRE00/15)
• National Information Governance Board for Health and Social Care (NIGB) (August 2009) (ECC 2-06(d)/2009)
• Main R&D approved (August 2009)• Site specific R&D approvals (ongoing)• Portfolio adoption (August 2009)
• Final recruitment of units (ongoing)
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Comprehensive Local Research Network (CLRN) funding• England has been divided into 25 regions,
each of these is a CLRN (see next slide)• Each CLRN receives a budget to manage
and deliver research for its region• Many CLRNs have critical care leads (see
next slide)• RAIN is a NIHR CRN Portfolio study
(Study ID: 7349) so units taking part in the study in England are eligible to apply for funding for NHS support costs through their CLRN
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Comprehensive Local Research Network (CLRN) funding• Even if there is no critical care lead in
your CLRN, you can still apply for funding• RAIN fully adopted onto NIHR CRN
Portfolio following approval of main R&D • For further information on CLRN funding:
www.ukcrn.org.uk
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Systematic literature review• Update to Cochrane Injuries Group
systematic review (Perel et al. 2006)• Over 1800 abstracts reviewed for
eligibility• Three candidate risk prediction models
selected as…– developed on large multicentre databases– predicting six-month unfavourable outcome– have some degree of external validation
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset• Risk prediction models
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
J Neurotrauma 2005; 22:1025-39.
BMJ 2008; 336:425-9.
PLoS Med 2008; 5:e165.
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Hukkelhoven et al• Data
– two multicentre RCTs (n=2269)
• Variables in model– Age, GCS motor score, pupil reactivity,
hypoxia, hypotension, Marshall CT class, tSAH
• Validation– European Brain Injury Consortium (n=796)
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
CRASH Trial Collaborators• Data
– one multicentre RCTs (n=2482 – high income)
• Variables in model– Basic: Age, GCS, pupil reactivity, major
extracranial injury– CT: + five specified CT findings
• Validation– Slightly modified models validated in IMPACT
dataset (n=8509)
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Steyerberg et al (IMPACT)• Data
– Eight RCTs and three observational studies (n=8509)
• Variables in model– Core: Age, GCS motor score, pupil reactivity– Extended: + hypoxia, hypotension, Marshall
CT class, tSAH, extradural haematoma– Lab: + glucose, haemoglobin
• Validation– Core model and simplified extended model
validated in CRASH dataset (n=6681)
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Limitations of the models• Rely heavily on data from RCTs
– may not be representative of typical care
• Never validated in a critical care setting– not all models validated at all
• Hukkelhoven and IMPACT modelsdeveloped on older data – latest 1997
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Conclusion
“…further prospective validation in independent cohorts is needed to strengthen the
generalisability of the models…”
MRC CRASH Trial Collaborators
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset• Risk prediction models• Dataset/data collection burden
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset• Dataset developed to include
– all data required for the three models– plus variables to describe population with TBI
• To be collected in three types of units– neurocritical care unit in neuro. centre– general critical care unit in neuro. centre– general critical care unit outside neuro.
centre
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Data collection burden – adult TBI• Neurocritical care unit in neuro. centre
– average 7 per unit per month– range 4 to 10 per unit per month
• General critical care unit in neuro. centre– average 5.5 per unit per month– range 2.5 to 10 per unit per month
• General critical care unit outside neuro. centre– average 0.5 per unit per month– range 0 to 3 per unit per month
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN datasetDataset defined in seven sections:• Patient• TBI pre-hospital• Source• TBI at hospital• First CT• Outcome• GP
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset - Patient– Full name– Full postal address– Telephone number– Sex– NHS number– Hospital number– Date of birth– Residence/Dependency prior to hospital
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset – TBI pre-hospital– Date/Time of TBI– Cause/Type of TBI– Intoxication at time of TBI– Major extracranial injuries– Blood pressure– Oxygen saturation– Pupil reactivity/size– Glasgow Coma Score– AVPU
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset - Source– Date/Time of admission to hospital– Date/Time of admission to unit– Location prior to admission to the unit
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset – TBI at hospital– Temperature– Blood pressure– Heart rate– Oxygen saturation– Arterial blood gas– Serum glucose– Haemoglobin– Platelets– Coagulation (PT/APTT)– Pupil reactivity/size– Glasgow Coma Score
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset – First CT– Traumatic subarachnoid haemorrhage present – Brainstem pathology present – Basal cisterns – Third ventricle – Midline shift present – Lesion(s) present
• Petechial haemorrhages • High/mixed density lesion • Evacuation of haematoma • Volume of largest high/mixed density
lesion
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset - Outcome– CCMDS organ support– Confirmed diagnosis of TBI – Spinal cord injury present– Date/Time/Status on discharge from unit– Level of care received at discharge from unit– Expected outcome post hospital discharge– Location to which the patient was discharged– Date/Time of death/brainstem death– Date/Status on discharge from hospital
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
RAIN dataset - GP– GP Practice name– GP name/Address or Practice code
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Data entry/submission• Secure, web-based system• For Case Mix Programme (CMP), few CMP
fields duplicated to link datasets – RAIN and CMP data will be linked and
validated at ICNARC
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset• Risk prediction models• Dataset/data collection burden• Why take part?
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Why take part?• Contribute to improving the care of TBI
patients
• Gain insight into TBI care and have national comparative data for your unit
• Receive six month follow-up of your patients by the RAIN Study team
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset• Risk prediction models• Dataset/data collection burden• Why take part?• How to take part
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
How to take part• Identify a Local Collaborator (LC) who will be
responsible for the Study locally • Fill out the site-specific information for your
Trust• Attend a RAIN Dataset Familiarisation Course • LC responsible for completion of:
– assessment of First CT– assessment of expected outcome of patient
• Sign Research Agreement to indicate acceptance of LC responsibilities
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Responsibilities of the LCThe LC will be responsible for
– setting up a screening process to ensure that all eligible admissions (suspected/actual acute TBI) are recruited into the RAIN Study
– completing the First CT variables, according to the definitions, for all eligible admissions recruited to the RAIN Study
– completing the variable Expected outcome for all eligible admissions recruited to the RAIN Study
– ensuring access is available to the secure, web-based data entry system
– ensuring accurate and timely data collection and entry onto the secure, web-based system
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RAIN (NIHR HTA: 07/37/29)/ © ICNARC, RAIN Overview, September 2009
Scope – RAIN Study• Idea to research grant• Aim/objectives/phases• Infrastructure• Preparation• Local funding – CLRN• Literature review to inform dataset• Risk prediction models• Dataset/data collection burden• Why take part?• How to take part• Contact details
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Risk Adjustment In Neurocritical care (RAIN)
Understanding recovery from head injury to inform care
For further information about RAIN email: [email protected]
