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Table 2 GRADE assessment of confidence in estimates of effect in randomized trials

From: Percutaneous closure versus medical therapy for stroke with patent foramen Ovale: a systematic review and meta-analysis

Outcome

No. of participants (trials)

Risk of bias

Consistency

Directness

Precision

Publication bias

Quality

Odds ratio (95% CI)

Composite outcome

2776 (4)

No serious limitations

No serious limitations

Serious limitations§

No serious limitations

Not detected

Moderate

0.62 (0.44, 0.88)

Recurrent ischemic stroke

3440 (5)

No serious limitations

Serious limitations†

No serious limitations

No serious limitations

Not detected

Moderate

0.41 (0.19, 0.89)

TIA

3336 (5)

No serious limitations

No serious limitations

No serious limitations

Serious limitations¶

Not detected

Moderate

0.81 (0.56, 1.17)

All-cause death

3391 (5)

No serious limitations

No serious limitations

No serious limitations

Serious limitations¶

Not detected

Moderate

0.84 (0.40, 1.74)

Atrial fibrillation or atrial flutter

3391 (5)

No serious limitations

No serious limitations‡

No serious limitations

No serious limitations

Not detected

High

5.74 (3.08, 10.70)

Pulmonary embolism

2531 (4)

No serious limitations

No serious limitations

No serious limitations

Serious limitations¶

Not detected

Moderate

3.03 (1.06, 8.63)

Major bleeding

3283 (5)

No serious limitations

No serious limitations‡

Serious limitations§

Serious limitations¶

Not detected

Low

1.01 (0.55, 1.86)

  1. GRADE Grading of Recommendations Assessment, Development and Evaluation, OR odds ratio, TIA transient ischemic attack
  2. †Moderate to substantial heterogeneity: I2 = 59%
  3. ‡I2 = 31 and 32% respectively. Did not downgrade for mild heterogeneity
  4. §Definitions of the composite outcome and major bleeding varied across trials. In 2 trials, peripheral embolism or systemic embolism was included in the definition of composite outcome
  5. ¶95% confidence interval (CI) suggests potential for benefit and harm. Low number of outcome events