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Treatment, outcome and plans for the final phase. Dr Barbara A Gregson Trial Director. Treatments. Study Flow Chart. Initial Conservative Treatment. Early Surgery. Diagnostic CT. Equipoise. Consent to STICH II. Telephone randomisation service (24 hours) or web service.
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Treatment, outcome and plans for the final phase Dr Barbara A Gregson Trial Director
Study Flow Chart Initial Conservative Treatment EarlySurgery Diagnostic CT Equipoise Consent to STICH II Telephone randomisation service (24 hours) or web service • 5 Days GCS Monitoring • Day 5 CT • Discharge / 2 week form 6 month outcome questionnaire
STICH II - treatments • Early surgery • Craniotomy performed as soon as possible (within 12 hours) • Best medical treatment • Initial conservative treatment • Best medical treatment • Delayed evacuation if patient deteriorates and it becomes clinically appropriate
Compliance with treatment allocation: surgery group • Of those randomised to surgery: • 43% had surgery in under 3 hours • 27% had surgery between 3-6 hours • 21% had surgery between 6-12 hours • 4% had surgery in over 12 hours • 6% did not have surgery
Compliance with treatment allocation: conservative group • Of those randomised to initial conservative treatment: • 20% had surgery. • Of those having surgery: • 32% had surgery in under 12 hours (6% of total)
Outcome measurement • Confirm patient’s status (any major adverse events) and address • Six month structured postal questionnaire sent by STICH Office to patient for completion by patient or carer • Primary • Extended GOS • Secondary • Rankin • EuroQol • Residence • Focal deficits • Other problems • Analysis by intention to treat
Outcome for first 350 patients • 6 month primary outcome data obtained for 329 (94%) patients (20/04/2011) • 75 died (23%), • 254 completed postal questionnaires were returned. • 3 patients have withdrawn following randomisation. • Residence at 6 months • 9% living at home alone 23% with Severe Disability • 78% living with family 51% with SD • 13% in residential/nursing homes 60% with SD in residential 88% with SD in nursing homes. EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems
Modified Rankin Scale at six months EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems
Glasgow Outcome Scale at six months EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems
Review of progress towards final recruitment target Target total Planned recruitment (Extension 29/08/08) Actual recruitment Planned recruitment (Dec 2009 to bring on target) Assuming 15 per month Assuming 12 per month Area enlarged in following slide
Review of progress towards final recruitment target Target total Planned recruitment (Extension 29/08/08) Actual recruitment Planned recruitment (Dec 2009 to bring on target) Assuming 15 per month Assuming 12 per month
Conclusions • Crossover rates are lower than in STICH but could be lower still. • Ongoing six month follow up rate is 94%. • 34% of patients make either a good recovery or have moderate disability according to the Glasgow Outcome Scale. • To attain our target of 600 patients centres need to continue to develop their patient screening strategies and increase their recruitment rates. • All sites who recruit patients will be acknowledged in the publication of the final results.
To join the study contact: • Website: www.research.ncl.ac.uk/stich • Email: stich@ncl.ac.uk • Tel: +44 191 222 5761 • Fax: +44 191 222 5762 • Address: Neurosurgical Trials Unit Newcastle University 3-4 Claremont Terrace Newcastle upon Tyne NE2 4AE Department of Health Disclaimer: The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Department of Health.