SOCESP 1999.
Methods | RCT Open‐label Loss to follow‐up reported: yes |
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Participants | AF lasting < 6 months. Type: recent onset 61%, persistent 39% (mean duration: NS). n = 121 Men: 59% Age (mean): 54 (SD 13) years Structural heart disease: 54%. LAD: 39 mm. LVEF: 68% |
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Interventions | Quinidine 700 mg/day vs sotalol 240 mg/day Method of AF cardioversion: both pharmacological and electrical, % NS Warfarin discretionary |
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Outcomes | At 6 months: Mortality Proarrhythmia Adverse effects AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation not detailed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals were well detailed but unclear whether there were other participants lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes and expected outcomes of interest were well reported. |
Other bias | Low risk | No other bias apparent. |