PRODIS 1996.
Methods | RCT Double‐blind Loss to follow‐up reported: yes |
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Participants | Persistent AF (mean duration: 5 months). n = 56 Men: 68% Age (mean): 60 (SD 11) years Structural heart disease: 65%. LAD: 46 mm. LVEF: NS |
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Interventions | Disopyramide 750 mg/day vs propafenone 900 mg/day Method of AF cardioversion: electrical 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 | Participants "were randomly assigned", but method not described. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind, double‐dummy employed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes predefined in the study and all outcomes of interest expected were reported. |
Other bias | Low risk | No other bias apparent. |