Table 2. Assessment of quality of... | American Society of Hematology

Table 2.

Assessment of quality of evidence using GRADE approach

Quality assessment							No. of patients		Pooled event rate (95% CI)	Quality	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Outcome	Total	Pooled event rate (95% CI)	Quality	Importance
Effective management of major bleeding using the ISTH criteria
2	Observational	Very serious*	Not serious	Not serious	Very serious†	None	103	150	0.69 (0.61-0.76)	⊕◯◯◯ Very low	Critical
Effective management of major bleeding not using the ISTH criteria
8	Observational	Very serious*	Not serious	Not serious	Very serious†	None	143	190	0.77 (0.63-0.92)	⊕◯◯◯ Very low	Critical
Mortality
9	Observational	Very serious*	Not serious	Not serious	Very serious†	None	50	249	0.16 (0.07-0.26)	⊕◯◯◯ Very low	Critical
Thromboembolic complications
7	Observational	Very serious*	Not serious	Not serious	Very serious†	None	10	240	0.04 (0.01-0.08)	⊕◯◯◯ Very low	Critical

Quality assessment							No. of patients		Pooled event rate (95% CI)	Quality	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Outcome	Total	Pooled event rate (95% CI)	Quality	Importance
Effective management of major bleeding using the ISTH criteria
2	Observational	Very serious*	Not serious	Not serious	Very serious†	None	103	150	0.69 (0.61-0.76)	⊕◯◯◯ Very low	Critical
Effective management of major bleeding not using the ISTH criteria
8	Observational	Very serious*	Not serious	Not serious	Very serious†	None	143	190	0.77 (0.63-0.92)	⊕◯◯◯ Very low	Critical
Mortality
9	Observational	Very serious*	Not serious	Not serious	Very serious†	None	50	249	0.16 (0.07-0.26)	⊕◯◯◯ Very low	Critical
Thromboembolic complications
7	Observational	Very serious*	Not serious	Not serious	Very serious†	None	10	240	0.04 (0.01-0.08)	⊕◯◯◯ Very low	Critical

All studies were single-arm case series, the outcome assessors were not blinded, and the studies are at risk of selection bias.

Studies included very few patients and very few events.