| Methods | Randomisation: dietitian allocated by opening a sealed envelope containing a card which indicated a diet to be advised (following the taking of a diet history by that dietitian) Allocation concealment: Unclear Participants masked: No Providers masked: No Outcome assessors masked: Yes Summary risk of bias: medium or high |
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| Participants | N: 1015 int., 1018 Control Level of risk for CVD: High (post-MI) Male: 100% Mean age, sd: 56.7 int., 56.4 control Age range: Unclear Smokers: 61.7% int., 62.2% control Hypertension: 22.7% int., 24.6% control Location: UK |
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| Interventions | Type: dietary advice (to eat more oily fish) Intervention: Advised to eat at least 2 weekly portions of 200-400g fatty fish (mackerel, herring, kipper, pilchard, sardine, salmon, trout). If this was not possible, given MaxEPA capsules, 3/d (0.5g EPA/d). 191 of 883 participants were taking MaxEPA at 2 years. Advice was reinforced 3-monthly. Control: No such dietary advice or capsules. Compliance: 7 day weighed food diary of a random sub-sample indicated intake of 2.5g/week EPA int., 0.8g/week EPA control. Length of intervention: 24 mo |
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| Outcomes | Main study outcome: total mortality, reinfarction, CV death Dropouts: none for mortality Available outcomes: total and CV deaths, MI, combined CV events Response to contact: Yes |
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| Notes | Some of each group were also advised on low fat and/or high fibre diets, all participants who smoked were advised to stop and all with a BMI >30 were given weight reduction advice, regardless of randomisation arm | |
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Allocation concealment? | Unclear | B - Unclear |