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. 2017 Oct 26;12(10):e0186856. doi: 10.1371/journal.pone.0186856

Table 2. Summary of Findings table.

Summary of Findings table
Outcomes Anticipated absolute effects Relative effect (Trial Sequential Analysis-adjusted confidence interval) № of participants (trials) Quality of the evidence (GRADE) Comments
Risk with rhythm control strategy Risk with rate control strategy
All-cause mortality 141 per 1000 134 per 1000 1.05 (0.90 to 1.122) 8668 (18 trials) ⊕⊝⊝⊝ - Very low quality of evidence caused by risk of bias (-2) and imprecision (-1). Trial Sequential Analysis showed that there was not enough information to confirm or reject a RRR of 15% or more. All trials had high risk of bias, mostly because of ‘blinding of participants and personnel’, ‘incomplete outcome data bias’, and ‘for-profit bias’.
Serious adverse events 462 per 1000 419 per 1000 1.10 (0.99 to 1.22) 8789 (21 trials) ⊕⊝⊝⊝ - Very low quality of evidence caused by risk of bias (-2) and imprecision (-1). Trial Sequential Analysis showed that there was not enough information to confirm or reject a RRR of 15% or more. All trials had high risk of bias, mostly because of ‘blinding of participants and personnel’, ‘incomplete outcome data bias’, and ‘for-profit bias’.
Quality of life Quality of life showed a significant effect of rhythm control versus rate control on the SF-36 physical component score (MD 6.93, Trial Sequential Analysis-adjusted confidence interval -3.16 to 17.02). 1796 (8 trials) for SF-36 physical component score ⊕⊝⊝⊝ - Very low quality of evidence caused by risk of bias (-2), imprecision (-1), and inconsistency (-1). Trial Sequential Analysis for all 3 meta-analyses showed that there was not enough information to confirm or reject our anticipated intervention effects. All trials had high risk of bias, mostly because of ‘blinding of participants and personnel’, ‘incomplete outcome data bias’, and ‘for-profit bias’. All meta-analysis had high levels of heterogeneity. However, the differences were mostly between low and high intervention effects (i.e., not very serious inconsistency).
The meta-analyses of SF-36 mental component score showed nonsignificant results (MD 3.33, Trial Sequential Analysis-adjusted confidence interval -4.47 to 11.13). 1796 (8 trials) for SF-36 mental component score
The meta-analysis of Minnesota Living With Heart Failure Questionnaire showed nonsignificant results (MD -7.13, 95% CI -16.19 to 1.94). 404 (6 trials) for Minnesota Living With Heart Failure Questionnaire
Stroke 35 per 1000 34 per 1000 1.04 (0.33 to 3.28) 8114 (13 trials) ⊕⊝⊝⊝ - Very low quality of evidence caused by risk of bias (-2), imprecision (-1), and publication bias (-1). Trial Sequential Analysis showed that there was not enough information to confirm or reject a RRR of 15% or more. All trials had high risk of bias, mostly because of ‘blinding of participants and personnel’, ‘incomplete outcome data bias’, and ‘for-profit bias’.
Ejection fraction Rhythm control strategies versus rate control strategies significantly increased the mean ejection fraction (MD 4.20, Trial Sequential Analysis-adjusted confidence interval -2.37 to 10.77). 428 (7 trials) ⊕⊝⊝⊝ - Very low quality of evidence caused by risk of bias (-2), imprecision (-1), and inconsistency (-1). Trial Sequential Analysis showed that there was not enough information to confirm or reject our anticipated intervention effects. All trials had high risk of bias, mostly because of ‘blinding of participants and personnel’, ‘incomplete outcome data bias’, and ‘for-profit bias’. All meta-analysis had high levels of heterogeneity. However, the differences were mostly between low and high intervention effects (i.e., not very serious inconsistency).

Summary of Findings table based on GRADE [15, 3840]. The Summary of Findings table summarizes our main results and use five GRADE criteria (risk of bias; inconsistency of results; indirectness of evidence; imprecision; and publication bias) to assess the quality of the body of evidence.