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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. - PowerPoint PPT Presentation
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Treatment, outcome and plans for the final phase
Dr Barbara A Gregson
Trial Director
Treatments
Study Flow Chart
• 5 Days GCS Monitoring• Day 5 CT • Discharge / 2 week form
6 month outcome questionnaire
Diagnostic CT
Equipoise
Consent to STICH II
Telephone randomisation service (24 hours) or web service
Initial Conservative Treatment
Early Surgery
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)
Outcomes
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 • 3 patients have withdrawn following randomisation.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.
Modified Rankin Scale at six months
Glasgow Outcome Scale at six months
Outcome and age
Outcome and volume of haematoma
Outcome and GCS
Plans for the final phase
Recruitment rate over time
Six month period patients recruited during period
centre-months of recruitment
patients per centre per month
Dec 06 – May 07 8 20 0.4
June 07 – Nov 07 18 111 0.162
Dec 07 – May 08 32 204 0.157
June 08 – Nov 08 45 314 0.143
Dec 08 – May 09 66 417 0.158
June 09 – Nov 09 71 462 0.154
Dec 09 – May 10 68 515 0.132
June 10 – Nov 10 71 560 0.127
Recruitment pattern by month- up to 31 March 2011
Recruitment pattern by quarter- up to 31 March 2011
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
Publications
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: [email protected]
• Tel: +44 191 222 5761• Fax: +44 191 222 5762
• Address: Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AEDepartment 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.