treatment, outcome and plans for the final phase dr barbara a gregson trial director
TRANSCRIPT
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Treatment, outcome and plans for the final phase
Dr Barbara A Gregson
Trial Director
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Treatments
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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
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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
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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
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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)
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Outcomes
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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
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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 • 3 patients have withdrawn following randomisation.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.
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Modified Rankin Scale at six months
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Glasgow Outcome Scale at six months
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Outcome and age
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Outcome and volume of haematoma
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Outcome and GCS
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Plans for the final phase
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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
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Recruitment pattern by month- up to 31 March 2011
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Recruitment pattern by quarter- up to 31 March 2011
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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
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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
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Publications
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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.
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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.