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Treatment, outcome and plans for the final phase

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

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  1. Treatment, outcome and plans for the final phase Dr Barbara A Gregson Trial Director

  2. Treatments

  3. 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

  4. 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

  5. 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

  6. 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)

  7. Outcomes

  8. 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

  9. 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 • 3 patients have withdrawn following randomisation.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

  10. 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

  11. 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

  12. Outcome and age

  13. Outcome and volume of haematoma

  14. Outcome and GCS

  15. Plans for the final phase

  16. Recruitment rate over time

  17. Recruitment pattern by month- up to 31 March 2011

  18. Recruitment pattern by quarter- up to 31 March 2011

  19. 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

  20. 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

  21. Publications

  22. 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.

  23. 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.

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