STARS 1992.

Methods	RCT
Participants	Men with angina referred for angiography (UK) CVD risk: high Control: unclear randomised (30?), analysed 24 Intervention: unclear how many randomised (30?), analysed 26 Mean years in trial: control 2.9, intervention 3.0 % male: 100 age: mean control 53.9, intervention 48.9 (all <66)
Interventions	Reduced and modified fat diet vs usual diet Control aims: no diet intervention but advised to lose weight if BMI>25 Intervention aims: total fat 27%E, SFA 8‐10%E, omega‐3 and omega‐6 PUFA 8%E, increase in plant‐derived soluble fibre, dietary cholesterol 100mg/1000kcal, advised to lose weight if BMI>25 Control methods: usual care but no formal dietetic counselling Intervention methods: Usual care plus dietetic assessment of diet and advice Total fat intake (through study): int 27 (sd unclear), cont 37 (sd unclear)%E Saturated fat intake (through study): int 9 (sd unclear), cont 17 (sd unclear)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: angiography Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: cardiovascular deaths, non‐fatal MI, angina, stroke, CABG, angioplasty Secondary outcomes: cancer deaths (none), stroke, total MI Tertiary outcomes: total, HDL, LDL cholesterol, TGs (weight and BP "remained similar" but were not reported)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"blinded random cards issued centrally by statistician advisor"
Allocation concealment (selection bias)	Low risk
Blinding (performance bias and detection bias) All outcomes	High risk	Physician blinding: unclear Participant blinding: inadequate
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear, deaths, cancer and CV events are drop‐outs ‐ unclear if any data missing
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias	Low risk
Free of systematic difference in care?	High risk	Usual care in both groups, dietetic counselling only in the intervention group. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat?	High risk	Intervention group also encouraged to increase plant derived soluble fibre