SHOT 1996.

Methods	SHunt Occlusion Trial (SHOT) RCT, parallel (omega 3 vs nil), 4 arms, 1 year Summary risk of bias: moderate or high
Participants	People admitted for coronary bypass grafting N: 317 intervention, 293 control Level of risk for CVD: high Men: 86% intervention, 88% control Mean age in years (SD): 59.9 (8.7) intervention, 59.4 (8.8) control Age range: unclear Smokers: 19% intervention, 20% control Hypertension: 20% intervention, 25% control Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: antihypertensives Medications taken by some, but less than 20% of the control group: not reported Location: Norway Ethnicity: not reported
Interventions	Type: supplement (capsule) Comparison: EPA + DHA vs nil Intervention: 4 fish‐oil concentrate soft gelatin capsules/d (Omacor; Pronova AS, Oslo,Norway) containing 51% EPA and 32% DHA ethyl esters and 3.7 mg vitamin E as an antioxidant. Dose: 3.3 g/d EPA + DHA Control: no treatment Compliance: capsule count, 88% taken, serum EPA + DHA rose in the intervention group (176 to 257 mg/L at 9 months) and fell in the control group (170 to 169 mg/L at 9 months) Length of intervention: 12 months
Outcomes	Main study outcome: CABG graft patency Dropouts: 15 intervention, 14 control Available outcomes: deaths, CV deaths, MI, stroke, repeat CABG, combined CV events, lipids, side effects Response to contact: yes
Notes	The study had 4 arms; aspirin; warfarin; fish oil + aspirin; and warfarin + fish oil. The first 2 groups are combined as the control and the last two combined as intervention. Dietary assessment suggested total diet plus supplement intakes as follows: 2.7 g/d EPA + DHA at baseline, 5.5 g/d at 9 months intervention, 2.5 g/d at baseline, 2.2 g/d at 9 months control group Study funding: in part by Pronova and Nycomed Pharma
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers were provided in consecutively sealed envelopes generated centrally
Allocation concealment (selection bias)	Unclear risk	Envelopes not reported as opaque
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open trial, no blinding apart from outcome assessors so participants and study personnel were aware of assignments. However, author suggested in personal communication that participants were not aware of their assignments.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors (radiologists) reported as blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reasons for attrition and exclusions stated, numbers clear, dropouts < 20% per year
Selective reporting (reporting bias)	Unclear risk	No study protocol or trials register entry was found
Attention	Low risk	Appeared equivalent between arms
Compliance	Low risk	Capsule count, 88% taken, serum EPA + DHA rose in the intervention group (176 to 257 mg/L at 9 months) and fell in the control group (170 to 169 mg/L at 9 months)
Other bias	Low risk	No further bias noted