Table 2.

GRADE evidence table

Quality assessmentSummary of findings
No. of participants (studies)Risk biasInconsistencyIndirectnessImprecisionPublication biasOverall quality of evidenceStudy event rates (%)RE (95% CI)Anticipated absolute effects
Temporary cessation of VKA aloneTemporary cessation of VKA + vitamin K administrationRisk with temporary cessation of VKA aloneRisk difference with temporary cessation of VKA + vitamin K administration (range)
Mortality (follow-up: 30-90 d; assessed with all-cause mortality) 
 860 (3 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 13/439 (3.0) 16/421 (3.8) RR = 1.24 (0.62-2.47) 30 per 1000 7 more per 1000 (11 fewer-44 more) 
Major bleeding (follow-up: mean, 90 d; assessed with fatal bleeding or bleeding requiring blood transfusion or admission) 
 801 (2 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 4/409 (1.0) 10/392 (2.6) RR = 2.43 (0.81-7.27) 10 per 1000 14 more per 1000 (2 fewer-61 more) 
Any thromboembolism (follow-up: mean, 90 d; assessed with venous or arterial thromboembolism) 
 801 (2 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 4/409 (1.0) 5/392 (1.3) RR = 1.29 (0.35-4.78) 10 per 1000 3 more per 1000 (6 fewer-37 more) 
Proportion reaching goal INR (follow-up: mean, 1 d; assessed with INR goal ranges: INR, 1.8-3.2; INR, 2.3-4.5; and INR, 2.0-4.0) 
 1025 (5 RCTs) S S NS S* None ⊕○○○ Very low 90/518 (17.4) 218/507 (43.0) RR = 1.95 (0.88-4.33) 174 per 1000 165 more per 1000 (21 fewer-579 more) 
Quality assessmentSummary of findings
No. of participants (studies)Risk biasInconsistencyIndirectnessImprecisionPublication biasOverall quality of evidenceStudy event rates (%)RE (95% CI)Anticipated absolute effects
Temporary cessation of VKA aloneTemporary cessation of VKA + vitamin K administrationRisk with temporary cessation of VKA aloneRisk difference with temporary cessation of VKA + vitamin K administration (range)
Mortality (follow-up: 30-90 d; assessed with all-cause mortality) 
 860 (3 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 13/439 (3.0) 16/421 (3.8) RR = 1.24 (0.62-2.47) 30 per 1000 7 more per 1000 (11 fewer-44 more) 
Major bleeding (follow-up: mean, 90 d; assessed with fatal bleeding or bleeding requiring blood transfusion or admission) 
 801 (2 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 4/409 (1.0) 10/392 (2.6) RR = 2.43 (0.81-7.27) 10 per 1000 14 more per 1000 (2 fewer-61 more) 
Any thromboembolism (follow-up: mean, 90 d; assessed with venous or arterial thromboembolism) 
 801 (2 RCTs) NS NS NS S* None ⊕⊕⊕○ Moderate 4/409 (1.0) 5/392 (1.3) RR = 1.29 (0.35-4.78) 10 per 1000 3 more per 1000 (6 fewer-37 more) 
Proportion reaching goal INR (follow-up: mean, 1 d; assessed with INR goal ranges: INR, 1.8-3.2; INR, 2.3-4.5; and INR, 2.0-4.0) 
 1025 (5 RCTs) S S NS S* None ⊕○○○ Very low 90/518 (17.4) 218/507 (43.0) RR = 1.95 (0.88-4.33) 174 per 1000 165 more per 1000 (21 fewer-579 more) 

Overall quality of evidence measured according to GRADE criteria.

RE, relative effect; NS, not serious; S, serious.

*

Lower and upper bounds of 95% CI may lead to different recommendations.

Four of the 5 studies did not blind patients and personnel, or outcome assessors.

I2 = 93%.

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