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. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

DAPHNE 2008.

Methods RCT
Single‐blind
Loss to follow‐up reported: yes
Participants Bradycardia‐tachycardia sinus node disease with history of several episodes of AF or AFl and needing a pacemaker
AF type: 100% paroxysmal. n = 135
Men: 49.6%
Age (mean): 73 (SD 7) years
Structural heart disease: 71%. LAD: 43 mm. LVEF: 56%
Interventions Sotalol 167 mg/day (mean) vs beta‐blockers (atenolol or metoprolol)
Method of AF cardioversion: 100% spontaneous
Warfarin discretionary
Outcomes At 19 months:
Adverse effects
AF recurrence
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 concealment not described.
Blinding (performance bias and detection bias) 
 All outcomes High risk Single‐blind study.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Few participants were lost to follow‐up, were well balanced and well reported.
Selective reporting (reporting bias) Low risk All prespecified outcomes of interest were reported.
Other bias Unclear risk Restrictive inclusion criteria: only people with the bradycardia–tachycardia form of sinus node disease requiring pacemaker implantation were included.