DART2 2003.

Methods	Diet and Angina Randomised Trial (DART2) RCT, 2 × 2, (oily fish or capsulesn‐3 EPA + DHA vs nil, also no specific advice, also fruit, vegetables and oats vs no specific advice), 3‐9 years Summary risk of bias: moderate or high
Participants	Men treated for angina N: 1571 intervention, 1543 control (all analysed for events) Control level of risk for CVD: high Men: 100% Mean age in years (SD): 61.1 (NR) intervention, 61.1 (NR) control Age range: unclear Smokers: 25% intervention, 23% control Hypertension: 49% intervention, 47% control Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49%: lipid lowering, beta‐blockers Medications taken by some, but less than 20% of the control group: not reported Location: UK Ethnicity: not reported
Interventions	Type: dietary advice (to eat more oily fish or take fish oil capsules) Comparison: EPA + DHA vs unclear (not total fat, SFA or alcohol, presumably CHO and/or protein but not clear) Intervention: most (1109) advised to eat at least 2 weekly portions of fatty fish OR take MaxEPA capsules, 3/d (0.5 g EPA/d). But 462 participants were sub‐randomised to receive only fish oil capsules, not dietary fish advice. Dose: aimed for 0.5 g/d EPA. Control: none specific sensible eating advice that did not include either of the interventions. Compliance: postal dietary questionnaire suggested dietary EPA intake increased by 2.4 g /week intervention, 0.2 g /week control Dietary achievements Total fat intake, (change from baseline to 6 months): control −8.6 g/d (SD 20.9), intervention −5.2 (g/d SD 21.4) (MD 3.4 g/d) Saturated fat intake, (change from baseline to 6 months): control −3.5 g/d (SD 9.3), intervention −2.8 g/d (SD 9.4), (MD 0.7 g/d) PUFA intake (change from baseline to 6 months): control −1.6 g/d (SD 5.4), intervention −0.1 g/d (SD 5.8) (MD 1.5 g/d) PUFA n‐3 intake (change from baseline to 6 months): EPA, control 0.12 g/week (SD 0.73), intervention 2.65 g/week (SD 1.35) (MD 2.53 g/week) PUFA n‐6 intake: not reported MUFA intake: not reported CHO intake: not reported Protein intake: not reported Trans fat intake: not reported Duration of intervention: 36 to 108 months
Outcomes	Main study outcome: total mortality Dropouts: none for mortality Available outcomes: total and CV deaths, sudden death, stroke, heart failure, cancer deaths Response to contact: yes (data provided)
Notes	Some of each group were also advised on high fruit, vegetables and oat diets, and those who received neither fish nor fruit advice received 'non‐specific' dietary advice. All those whose BMI > 30 kg/m2 in both groups received weight reduction advice. Study funding: probably British Heart Foundation, Seven Seas Ltd, Novex Pharma Ltd and the Fish Foundation (these were acknowledged)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly allocated"
Allocation concealment (selection bias)	Unclear risk	Pre‐prepared sequentially numbered enveloped opened by dietitian (unclear if envelopes were opaque)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Dietary advice, so not possible for participants to be blinded to intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were not aware of study allocation (Prof Burr stated he did not know assignments)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Hospital notes and death registers were flagged to catch all outcome data
Selective reporting (reporting bias)	Unclear risk	No study protocol was found, or trials registry entry
Attention	High risk	More attention was paid to those given dietary advice
Compliance	Unclear risk	Postal dietary questionnaire suggested dietary EPA intake increased by 2.4 g/week intervention, 0.2 g/week control
Other bias	Low risk	None noted