Table 16.
Outcomes | Illustrative Comparative Risksa (95% CI) |
Relative Effect (95% CI) | No of Participants (Studies) | Quality of the Evidence (GRADE) | |
Assumed Risk, Control | Corresponding Risk, Oral Anticoagulation | ||||
Death; follow-up: median 1 y |
457 per 1,000 |
430 per 1,000 (398- 471) |
RR, 0.94 (0.87-1.03) |
1,604 (5) |
Moderateb |
VTE; follow-up: 1 y |
43 per 1,000 |
6 per 1,000 (1-52) |
RR, 0.15 (0.02-1.2) |
315 (1) |
Moderatec |
Major bleeding; follow-up: median 1 y |
22 per 1,000 |
93 per 1,000 (41-213) |
RR, 4.24 (1.85-9.68) |
1,282 (4) |
Moderated |
Minor bleeding; follow-up: 1 y |
79 per 1,000 |
264 per 1,000 (131-532) |
RR, 3.34 (1.66-6.74) |
851 (3) |
Moderated |
Health-related quality of life: not reported | Not estimable | Not estimable | Not estimable | … | Not estimable |
The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
We downgraded because of lack of blinding of patients and providers in four out of five studies, it was unclear whether allocation was concealed in two studies, and only one study clearly used ITT analysis.
We downgraded because the precision of the estimate does not exclude a patient-important benefit (the lower limit of RR still suggests a benefit that might be relevant given the high baseline risk).
We downgraded because lack of blinding of patients and providers in three out of four studies, it was unclear whether allocation was concealed in two studies, and only one study clearly used ITT analysis.