AFFORD 2013.
| Methods | Multi‐center study to evaluate the effect of n‐3 fatty acids on arrhythmia recurrence in atrial fibrillation (AFFORD) RCT, parallel, (n‐3 EPA + DHA vs n‐6), 12 months Summary risk of bias: moderate or high |
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| Participants | People with symptomatic paroxysmal or persistent AF N: 165 intervention, 172 control. (analysed, intervention: 153 control: 163) Level of risk for CVD: high Men: 69% intervention, 65% control Mean age in years (SD): 60 (12) intervention, 62 (13) control Age range: not reported Smokers: not reported Hypertension: 45% intervention, 42% control Medications taken by at least 50% of those in the control group: oral anticoagulant Medications taken by 20%‐49%: beta‐blockers, angiotensin‐converting enzyme inhibitors, angiotensin receptor blockers Medications taken by some, but < 20%: none Location: Canada Ethnicity: not reported |
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| Interventions | Type: supplement (fish oil) Comparison: EPA + DHA vs omega 6 safflower oil Intervention: 4 × 1 g enteric‐coated fish oil capsules/d (1.6 g/d EPA + 0.8 g/d DHA, Genuine Health, Toronto, Ontario, Canada). Dose: +2.4 g/d EPA + DHA, Control: 4 ×1 g matching placebo capsules, 4 g/d safflower oil Compliance: omega‐3 index increased in intervention group, but not control, over the study Duration of intervention: 6 to 16 months |
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| Outcomes | Main study outcome: AF recurrence Dropouts: 21 intervention, 19 control Available outcomes: all‐cause mortality, stroke, AF recurrence,TIA, CV events, CRP (not usable) Response to contact: no |
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| Notes | Authors contacted about QoL, resource use and dietary habits Study funding: Canadian Institutes for Health Research and the Heart and Stroke Foundation of Quebec |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "[R]andomised" |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as double‐blind, but blinding not described or tested |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | An independent events committee adjudicated AF recurrences, bleeding, strokes, transient ischemic attacks, and deaths, but unclear if blinded to allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Participant flow well described. ITT analysis |
| Selective reporting (reporting bias) | High risk | NCT01235130 registered July 2010, recruitment March 2009‐March 2012, follow‐up finished December 2012. Results published 2014, but no data on quality of life, resource utilisation, or dietary habits (stated in registry) found |
| Attention | Low risk | No problem with attention bias |
| Compliance | Low risk | Omega‐3 index measured |
| Other bias | Low risk | None noted |