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. 2016 Feb 15;2016(2):CD004128. doi: 10.1002/14651858.CD004128.pub4

Bernard 2002.

Methods Randomization: pre‐hospital
Participants Total number of participants 77, mean age 66 years, 33% female
Out‐of‐hospital cardiac arrest of cardiac cause, ventricular fibrillation as first cardiac rhythm, comatose after resuscitation
Participating sites: Australian university and community hospitals
Multi‐centre: yes
Language: English
Allocation concealment: not applicable (odd and even days)
Outcome assessor blind: yes
Intention‐to‐treat analysis: yes
Groups comparable: more females and more bystander CPR in hypothermia group
Follow‐up > 80% of randomly assigned participants: yes
Interventions Therapeutic hypothermia vs standard pre‐hospital treatment protocols and intensive care treatment
Means of cooling: ice packs placed around head, neck, torso and limbs
Cooling rate: time from ROSC to target temperature: 2 hours
Target temperature: 33°C
Duration of cooling: 12 hours after target temperature was reached
Rewarming: passive after 12 hours, active after 18 hours
Outcomes Survival with good neurological function to be sent home or to a rehabilitation facility at discharge
In‐hospital death
Haemodynamic, biochemical and haematological effects of hypothermia
For IPD analysis, best ever reached CPC during hospital stay and CPC discharge provided
Notes Randomization: odd and even days
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Odd and even days
Allocation concealment (selection bias) High risk Odd and even days
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Treating personnel not blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Complete follow‐up
Other bias Low risk No other major biases seen
Funding Unclear risk No information provided
Blinding of outcome assessment (detection bias) Good neurologic outcome 
 All outcomes Low risk Outcome assessment blinded
Blinding of outcome assessment (detection bias) Survivial 
 Survival Low risk Outcome assessment blinded