Methods | Randomised controlled trial with follow-up of 24 months. | |
Participants | 28 postmenopausal women with coronary heart disease, defined as atherosclerosis, MI, percutaneous transluminal coronary angioplasty, and/or coronary bypass graft surgery. Mean age: 64 years |
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Interventions | Randomised to PrimeTime program (very low-fat vegetarian diet, stress-management training, exercise, group support, and smoking cessation) or to usual care n=17 for PrimeTime program and n=11 for usual care | |
Outcomes | health-related quality of life: SF-36 at 24 months | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “randomized” |
Allocation concealment (selection bias) | Unclear risk | Not reported |
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 | 3/28 (10.7%) patients lost to follow-up, no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Unclear risk | No information reported. |