Methods | RCT, parallel (n‐3 EPA + DHA vs unclear), 12 months Summary risk of bias: moderate to high |
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Participants | People with successful external cardioversion N: unclear intervention, unclear control (54 analysed intervention, 54 control) Level of risk for CVD: high Men: 70% intervention, 74% control Mean age in years (SD): 65.0 (mean for whole group, SD not reported) Age range: not reported Smokers: not reported Hypertension: not reported 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: not reported Medications taken by some, but less than 20% of the control group: not reported Location: Germany Ethnicity: not reported |
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Interventions | Type: supplement (probably, not described) Comparison: high EPA + DHA vs unclear placebo Intervention: described only as "PUFA" but included in systematic review (Mariani 2013) by Erdogan et al on effects of n‐3 PUFA. Dose: unclear Control: described only as "placebo" Compliance: not reported Length of intervention: 12 months |
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Outcomes | Main study outcome: atrial fibrillation relapse Dropouts: not reported Available outcomes: recurrent AF (reported in Mariani 2013), mortality (none) Response to contact: no reply to date |
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Notes | Funding source: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as triple blind, but no further details provided (only an abstract with some details in a related trial publication and some in a systematic review by the same author) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described, but analysis appears to have been carried out blind to intervention/control status |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number randomised not described |
Selective reporting (reporting bias) | Unclear risk | Unclear, no trial registry entry or protocol found |
Attention | Unclear risk | Not described |
Compliance | Unclear risk | Not described |
Other bias | Low risk | None noted |