Table 2.
Quality assessment | Summary of findings | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
No. of participants (studies) | Risk bias | Inconsistency | Indirectness | Imprecision | Publication bias | Overall quality of evidence | Study event rates (%) | RE (95% CI) | Anticipated absolute effects | ||
Temporary cessation of VKA alone | Temporary cessation of VKA + vitamin K administration | Risk with temporary cessation of VKA alone | Risk 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%.