EBQ:INTERACT-2 - Revision history

Ostermayer: Text replacement - "Category:Neuro" to "Category:Neurology"

2016-03-22T14:15:10Z

Text replacement - "Category:Neuro" to "Category:Neurology"

← Older revision		Revision as of 14:15, 22 March 2016
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	<references/>		<references/>

	[[Category:EBQ]][[Category:~~Neuro~~]]		[[Category:EBQ]][[Category:Neurology]]

Ostermayer: /* Primary Outcome */

2014-05-21T15:55:34Z

Primary Outcome

← Older revision		Revision as of 15:55, 21 May 2014
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	==Outcomes==		==Outcomes==
	===Primary Outcome===		===Primary Outcome===
	Poor outcome as defined by death or major disability (modified Rankin Scale >2) at 90 days.		;''Poor outcome as defined by death or major disability (modified Rankin Scale >2) at 90 days.''
	*Intensive BP group: 52%		*Intensive BP group: 52%
	*Guideline BP group: 55.6%		*Guideline BP group: 55.6%

Ostermayer: /* Secondary Outcomes */

2014-05-21T15:55:21Z

Secondary Outcomes

← Older revision		Revision as of 15:55, 21 May 2014
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	===Secondary Outcomes===		===Secondary Outcomes===
	''Death or major disability at 7 days''		;''Death or major disability at 7 days''
	*Intensive BP group: 76.5%		*Intensive BP group: 76.5%
	*Guideline BP group: 77.3%		*Guideline BP group: 77.3%
	::p=0.597		::p=0.597

	''Death or major disability at 28 days''		;'''Death or major disability at 28 days'''
	*Intensive BP group: 66.0%		*Intensive BP group: 66.0%
	*Guideline BP group: 68.1		*Guideline BP group: 68.1

Ostermayer: /* Subgroup analysis */

2014-05-21T15:54:47Z

Subgroup analysis

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	===Subgroup analysis===		===Subgroup analysis===
	Intracraneal Hematoma Volume		;''Intracraneal Hematoma Volume''
	*Intensive Group: 15.7ml initially vs 18.2ml at 24hrs		*Intensive Group: 15.7ml initially vs 18.2ml at 24hrs
	*Guideline Group: 15.1ml vs 20.6ml at 24hrs		*Guideline Group: 15.1ml vs 20.6ml at 24hrs

Ostermayer: /* Criticisms & Further Discussion */

2014-05-21T15:54:21Z

Criticisms & Further Discussion

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	*5% of patients withdrew from the intensive therapy group vs. 3% in the standard group without any clear explanation		*5% of patients withdrew from the intensive therapy group vs. 3% in the standard group without any clear explanation
	*The treating physicians were unblinded and outcome differences could be due to greater level of attention paid to the treatment group.		*The treating physicians were unblinded and outcome differences could be due to greater level of attention paid to the treatment group.
	*Although the disability assessment was blinded to treatment and the [[Modified Rankin ~~Score~~\|mRS]] is standardized, inter-rater reliability often differs by one or more points and makes neurologic disability assessment ambiguous. <ref>Banks et al. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. Epub 2007 Feb 1.</ref>		*Although the disability assessment was blinded to treatment and the [[Modified Rankin Scale\|mRS]] is standardized, inter-rater reliability often differs by one or more points and makes neurologic disability assessment ambiguous. <ref>Banks et al. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. Epub 2007 Feb 1.</ref>
	*No difference in morbidity or mortality was found and maintaining such intensive BP control may be an unnecessary use of critical care resources		*No difference in morbidity or mortality was found and maintaining such intensive BP control may be an unnecessary use of critical care resources


	==Funding==		==Funding==

Ostermayer at 15:52, 21 May 2014

2014-05-21T15:52:40Z

← Older revision		Revision as of 15:52, 21 May 2014
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	{{JC info		{{JC info
	\| title= ~~Intensive blood pressure reduction~~ in ~~acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial.~~		\| title=Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage
	\| abbreviation= INTERACT		\| abbreviation= INTERACT-2
	\| expansion= Intensive blood pressure reduction in acute cerebral haemorrhage trial		\| expansion= Intensive blood pressure reduction in acute cerebral haemorrhage trial
	\| published= 2008		\| published= 2008
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	\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1214609		\| fulltexturl= http://www.nejm.org/doi/full/10.1056/NEJMoa1214609
	\| pdfurl= http://www.nejm.org/doi/pdf/10.1056/NEJMoa1214609		\| pdfurl= http://www.nejm.org/doi/pdf/10.1056/NEJMoa1214609
	\| status = ~~Under Review~~		\| status = Complete
	}}		}}
	==Clinical Question==		==Clinical Question==
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	===Secondary Outcomes===		===Secondary Outcomes===
	*Secondary outcomes included all-cause mortality and cause-specific mortality, health-related quality of life, duration of initial hospitalization, residential care facility placement at 90 days~~, poor outcomes~~ at ~~7 days and~~ 28 days~~, and serious adverse events~~.		''Death or major disability at 7 days''
			*Intensive BP group: 76.5%
			*Guideline BP group: 77.3%
			::p=0.597

			''Death or major disability at 28 days''
			*Intensive BP group: 66.0%
			*Guideline BP group: 68.1
			::0.219

	===Subgroup analysis===		===Subgroup analysis===
	*Ordinal analysis for the modified Rankin score		Intracraneal Hematoma Volume
			*Intensive Group: 15.7ml initially vs 18.2ml at 24hrs
			*Guideline Group: 15.1ml vs 20.6ml at 24hrs
			::p=0.27

			*Ordinal analysis for the modified Rankin score showed a favorable shift in the distribution of scores on the modified Rankin scale to higher scores with intensive blood-pressure–lowering treatment.

	==Criticisms & Further Discussion==		==Criticisms & Further Discussion==
			*Patients in the intensive BP group started their treatment 20 minutes earlier and IV medications were the major therapy to reach target BP
			*5% of patients withdrew from the intensive therapy group vs. 3% in the standard group without any clear explanation
			*The treating physicians were unblinded and outcome differences could be due to greater level of attention paid to the treatment group.
			*Although the disability assessment was blinded to treatment and the [[Modified Rankin Score\|mRS]] is standardized, inter-rater reliability often differs by one or more points and makes neurologic disability assessment ambiguous. <ref>Banks et al. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. Epub 2007 Feb 1.</ref>
			*No difference in morbidity or mortality was found and maintaining such intensive BP control may be an unnecessary use of critical care resources

Ostermayer: /* Clinical Question */

2014-05-14T18:00:11Z

Clinical Question

← Older revision		Revision as of 18:00, 14 May 2014
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	}}		}}
	==Clinical Question==		==Clinical Question==
	Does aggressive and rapid lowering of blood pressure improve outcomes in patients with acute intracerebral hemorrhage?		'''Does aggressive and rapid lowering of blood pressure improve outcomes in patients with acute intracerebral hemorrhage?'''

	==Conclusion==		==Conclusion==
	'''Intensive lowering of blood pressure in patients with intracerebral hemorrhage did not result in a significant reduction death or severe disability but does appear to be safe.'''		'''Intensive lowering of blood pressure in patients with intracerebral hemorrhage did not result in a significant reduction death or severe disability but does appear to be safe.'''

Ostermayer: /* Conclusion */

2014-05-14T18:00:00Z

Conclusion

← Older revision		Revision as of 18:00, 14 May 2014
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	Does aggressive and rapid lowering of blood pressure improve outcomes in patients with acute intracerebral hemorrhage?		Does aggressive and rapid lowering of blood pressure improve outcomes in patients with acute intracerebral hemorrhage?
	==Conclusion==		==Conclusion==
	Intensive lowering of blood pressure in patients with intracerebral hemorrhage, did not result in a significant reduction death or severe disability but does appear to be safe.		'''Intensive lowering of blood pressure in patients with intracerebral hemorrhage did not result in a significant reduction death or severe disability but does appear to be safe.'''

	==Major Points==		==Major Points==

Ostermayer: /* Sources */

2014-05-14T17:59:35Z

Sources

← Older revision		Revision as of 17:59, 14 May 2014
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	*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_protocol.pdf Study Protocol]		*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_protocol.pdf Study Protocol]
	*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_appendix.pdf Supplemental Appendix]		*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_appendix.pdf Supplemental Appendix]
	*[~~Clinical trial registration~~ http://clinicaltrials.gov/ct2/show/NCT00716079]		*[http://clinicaltrials.gov/ct2/show/NCT00716079 Clinical trial registration ]
	<references/>		<references/>

	[[Category:EBQ]][[Category:Neuro]]		[[Category:EBQ]][[Category:Neuro]]

Ostermayer: /* Sources */

2014-05-14T17:59:18Z

Sources

← Older revision		Revision as of 17:59, 14 May 2014
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	*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_protocol.pdf Study Protocol]		*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_protocol.pdf Study Protocol]
	*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_appendix.pdf Supplemental Appendix]		*[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1214609/suppl_file/nejmoa1214609_appendix.pdf Supplemental Appendix]
			*[Clinical trial registration http://clinicaltrials.gov/ct2/show/NCT00716079]
	<references/>		<references/>

	[[Category:EBQ]][[Category:Neuro]]		[[Category:EBQ]][[Category:Neuro]]