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. |
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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 |
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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. |