DART 1989.

Study characteristics
Methods	Factorial RCT Diet And Reinfarction Trial (DART) Summary risk of bias: moderate to high
Participants	Men recovering from an MI (UK) CVD risk: high Control: randomised 1015, analysed unclear Intervention: randomised 1018, analysed unclear Mean years in trial: control 1.9, randomised 1.9 % male: 100% Age: mean control 56.8, intervention 56.4 (< 70) Ethnicity: not stated Statins use allowed? Unclear, but there do not appear to have been any medication‐based exclusion criteria and included participants were taking anti‐hypertensives, anti‐anginals, anti‐coagulants, anti‐platelet, digoxin and "other cardiac drugs". % taking statins: Not reported, but only 5.4% were taking "other cardiac drugs" which may have included statins.
Interventions	Reduced and modified fat vs usual diet Control aims: no dietary advice on fat, weight reducing advice if BMI > 30 Intervention aims: reduce fat intake to 30%E, increase P/S to 1.0, weight‐reducing advice if BMI > 30 Note: This was a factorial trial, and so some in each group were randomised to increased fatty fish and/or increased cereal fibre. Control methods: dietitians provided 'sensible eating' advice without specific information on fats. Intervention methods: dietitians provided the participants and their wives with initial individual advice and a diet information sheet; participants were revisited for further advice, recipes, encouragement at 1, 3, 6, 9, 12, 15, 18 and 21 months. Intervention delivered individually face‐to‐face by a dietitian Total fat intake, %E (through study): cont 35 (SD 6), int 31 (SD 7) (mean difference ‐4.00, 95% CI ‐4.57 to ‐3.43) significant reduction Saturated fat intake, %E (through study): cont 15 (SD3), int 11 (SD3), (mean difference ‐4.00, 95% CI ‐4.26 to ‐3.74) significant reduction PUFA intake (through study)⁑: cont 7 (SD unclear), int 9 (SD unclear), (mean difference 2.00, 95% CI 1.57 to 2.43 assuming SDs of 5) significant increase PUFA n‐3 intake: EPA, cont 0.6 (SD 0.7) g/wk, Int 2.4 (SD 1.4) g/wk PUFA n‐6 intake: not reported MUFA intake (through study)⁑: cont 13 (SD unclear), int 11 (SD unclear) (mean difference ‐2.00, 95% CI ‐2.43 to ‐1.57 assuming SDs of 5) significant reduction CHO intake (through study): cont 44 (SD 6), int 46 (SD 7) (mean difference 2.00, 95% CI 1.43 to 2.57) significant increase Protein intake (through study): cont 17 (SD 4), int 18 (SD 4) (mean difference 1.00, 95% CI 0.65 to 1.35) significant increase Trans fat intake: not reported Replacement for saturated fat: PUFA and CHO (by dietary aims), PUFA, CHO and protein (by dietary achievements), main PUFA Style: diet advice Setting: community ⁑Estimated by subtraction (assuming total fat = SFA + PUFA + MUFA) or using the ratio (assuming P/S = PUFA/SFA)
Outcomes	Stated trial outcomes: mortality, reinfarction Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: cardiovascular deaths (including stroke deaths) plus non‐fatal MI Secondary outcomes: cancer deaths, total MI, non‐fatal MI, CHD mortality, CHD events (total MI) Tertiary outcomes: total and HDL cholesterol
Notes	Study duration: 24 months Study aim was to achieve low fat diet with raised P/S ratio and saturated fat intake in the intervention group was significantly lower than in the control group. SFA reduction aimed and achieved. Total serum cholesterol, difference between intervention and control, mmol/L: ‐0.26 (95% CI ‐0.36 to ‐0.16), statistically significant reduction Trial dates: Study dates not reported (published in 1989) Funding: Welsh Scheme for the Development of Health and Social Research, Welsh Heart Research Foundation, Flora Project, Health Promotion Research Trust. (Seven Seas Health Care and Duncan Flockhart provided the MaxEPA capsules and Norgene provided 'Fybranta' tablets ‐ but these were not used in the comparison discussed in this systematic review) Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised using sealed envelopes
Allocation concealment (selection bias)	Unclear risk	Unclear if envelopes were opaque
Blinding of participants and personnel (performance bias) All outcomes	High risk	Very difficult to blind trials where participants need to make their own dietary changes
Blinding of outcome assessment (detection bias) CVD outcomes	Low risk	Quote: "outcome assessors were not aware of study allocation" (Prof Burr, personal communication). Method of blinding not stated
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Blinding is not relevant in assessment of mortality
Incomplete outcome data (attrition bias) All outcomes	Low risk	GPs contacted for information on mortality and morbidity when participants did not attend
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as we asked all trialists for data
Free of systematic difference in care?	High risk	Different levels of advice appear to have been provided. See control and intervention methods in the Interventions section of the table of Characteristics of included studies
Stated aim to reduce SFA	Low risk	Aim to reduce SFA stated
Achieved SFA reduction	Low risk	SFA reduction achieved
Achieved TC reduction	Low risk	Statistically significant TC fall
Other bias	Low risk	None noted