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. Author manuscript; available in PMC: 2014 Nov 13.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2
Methods RCT of 2 years duration
Participants 197 patients admitted to hospital for acute MI, unstable angina pectoris or after coronary artery bypass grafting. 82.2% male. Mean age: 55 years
n=98 for intervention group and n=99 for usual care group.
Interventions EX: lifestyles intervention program (low fat diet, regular exercise, smoking cessation, psychosocial support and education, delivered by nurses on the rationale for pharmacological and lifestyle measures)
Usual care
Outcomes Total mortality
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk ȁrandomised’
Allocation concealment (selection bias) Low risk ‘[Randomization] was performed with pre-prepared sealed opaque envelopes containing details on group allocation.
The patients opened the envelopes themselves so that their allocation to IP or UC was revealed to them without the prior knowledge of the study investigators’
Blinding (performance bias and detection bias)
All outcomes
Unclear risk Unclear in terms of assessment of outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High risk 17.8 % lost to follow up, no description of withdrawals or dropouts
Selective reporting (reporting bias) Unclear risk No information reported.