Table 2B.

Strength of Evidence Domains For Prediction of Bleeding Risk^a

Outcome	Number of Studies (Subjects)	Risk of Bias	Consistency	Directness	Precision	SOE and Effect (95% CI)
Summary c-statistic (Patients on Warfarin)
BRI	4 (11,939)	Observational/Moderate	Consistent	Direct	Precise	SOE=Moderate Limited risk discrimination ability (c-statistic ranging from 0.56 to 0.65)
HEMORR2HAGES	10 (115,348)	Observational/Moderate	Consistent	Direct	Imprecise	SOE=Moderate Limited risk discrimination ability (c-statistic ranging from 0.53 to 0.78)
HAS-BLED	11 (194,839)	Observational/Moderate	Consistent	Direct	Imprecise	SOE=Moderate Modest risk discrimination ability (c-statistic ranging from 0.50 to 0.80)
ATRIA	7 (76,163)	Observational/Moderate	Inconsistent	Direct	Imprecise	SOE=Insufficient
ABC	1 (22,998)	Observational/Moderate	NA	Direct	Precise	SOE=Low Limited risk discrimination (c-statistic of 0.65 in validation study)
Comparative Risk Discrimination Abilities
Major bleeding events among patients with AF on warfarin	13 (351,985)	Observational/Moderate	Consistent	Direct	Imprecise	SOE=Moderate Favors HAS-BLED
Intracranial hemorrhage among patients with AF on warfarin	2 (71,597)	Observational/Moderate	NA	Direct	Precise	SOE=Low No evidence of a difference
Major bleeding events among patients with AF on aspirin alone	3 (177,538)	Observational/Moderate	Inconsistent	Direct	Imprecise	SOE=Low No evidence of a difference
Major bleeding events among patients with AF not on antithrombotic therapy	6 (310,607)	Observational/Moderate	Consistent	Direct	Imprecise	SOE=Low No evidence of a difference

^aC-statistics given are for categorical risk scores unless otherwise noted.

ABC=age, biomarkers, clinical history; AF=atrial fibrillation; ATRIA=Anticoagulation and Risk Factors in Atrial Fibrillation; BRI=Bleeding Risk Index; CHADS₂=Congestive heart failure, Hypertension, Age ≥75, Diabetes mellitus, prior Stroke/transient ischemic attack (2 points); CHA₂DS₂-VASc=Congestive heart failure/left ventricular ejection fraction ≤ 40%, Hypertension, Age ≥75 (2 points), Diabetes mellitus, prior Stroke/transient ischemic attack/thromboembolism (2 points), Vascular disease, Age 65–74, Sex category female; CI=confidence interval; HAS-BLED=Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 65 years), Drugs/alcohol concomitantly; HEMORR₂HAGES=Hepatic or renal disease, Ethanol abuse, Malignancy, Older (age >75 years), Reduced platelet count or function, Re-bleeding risk (2 points), Hypertension (uncontrolled), Anemia, Genetic factors, Excessive fall risk, Stroke; INR=international normalized ratio; KQ=Key Question; NA=not applicable; SOE=strength of evidence