Table 3.

Evidence profile for bleeding-related prognostic factors

No. of studiesCertainty assessment domainsOverall certainty in the evidence about this prognostic factorRelative effect (95% CI)
Study designRisk of biasIndirectInconsistentImprecisePublication bias
Age (≥65 vs <65)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ Age ≥65: OR, 1.95 (95% CI, 1.59-2.38) 
MODERATE 
Sex (male vs female)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.27 (95% CI, 1.09-1.47). 
MODERATE 
Anemia as a reason for admission (presence vs absence)34  
 2 Observational Serious*,‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 5.15 (95% CI, 2.45-10.81) 
MODERATE 
Morbid obesity (BMI ≥ 40 kg/m2 vs BMI < <40 kg/m2)34  
 1 Observational Serious‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 3.08 (95% CI, 1.35-7.02) 
MODERATE 
Low hemoglobin: defined as <13 g/dL in men and <11.5 g/dL in women (yes vs no)34  
 1 Observational Serious‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.33 (95% CI, 1.04-5.22) 
MODERATE 
Gastroduodenal ulcers (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.74 (95% CI, 1.42-5.26) 
MODERATE 
Rehospitalization (yes vs no)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.39 (95% 2.25-2.54) 
MODERATE 
Critical illness (yes vs no)8  
 1 Observational Serious* Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.10 (95% CI, 1.42-3.11). 
MODERATE 
Thrombocytopenia (yes vs no)8,33,34  
 3 Observational Serious*,†,‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ All: OR, 1.79 (95% CI, 0.97-3.29) 
MODERATE <50 × 109/L: OR, 3.37 (95% CI, 1.84-6.18) 
<150 × 109/L: OR, 1.30 (95% CI, 0.92-1.82) 
Blood dyscrasias defined as the presence of any bleeding disorders on admission (presence vs absence)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.70 (95% CI, 1.60-1.81) 
MODERATE 
Hepatic disease (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.53 (95% CI, 1.09-2.15) 
MODERATE 
Renal failure (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ Total: OR, 1.43 (95% CI, 1.06-1.93) 
MODERATE Any renal failure (RF): OR, 1.23 (95% CI, 0.92-1.65). 
Moderate RF (GFR 30-59 mL/min/m2): OR, 1.37(95% CI, 0.84-2.23) 
Severe RF (GFR <30 mL/min/m2): OR, 2.14 (95% CI, 1.22-3.75) 
Antithrombotic medication (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.28 (95% CI, 1.01-1.64) 
MODERATE 
CVC (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.37 (95% CI, 0.83-2.26) 
MODERATE 
Autoimmune disease (yes vs no)8  
 2 Observational Serious* Not serious Not serious Serious§ Undetected ⊕⊕○○ OR, 1.30 (95% CI, 0.77-2.19) 
LOW 
Hormone use: defined as estrogen intake (yes vs no)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 0.95 (95% CI, 0.82-1.10) 
MODERATE 
Malignancy (yes vs no)8,33  
 2 Observational Serious *,† Not serious Not serious Serious§ Undetected ⊕⊕○○ OR, 1.08 (95% CI, 0.42-2.77) 
LOW 
No. of studiesCertainty assessment domainsOverall certainty in the evidence about this prognostic factorRelative effect (95% CI)
Study designRisk of biasIndirectInconsistentImprecisePublication bias
Age (≥65 vs <65)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ Age ≥65: OR, 1.95 (95% CI, 1.59-2.38) 
MODERATE 
Sex (male vs female)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.27 (95% CI, 1.09-1.47). 
MODERATE 
Anemia as a reason for admission (presence vs absence)34  
 2 Observational Serious*,‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 5.15 (95% CI, 2.45-10.81) 
MODERATE 
Morbid obesity (BMI ≥ 40 kg/m2 vs BMI < <40 kg/m2)34  
 1 Observational Serious‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 3.08 (95% CI, 1.35-7.02) 
MODERATE 
Low hemoglobin: defined as <13 g/dL in men and <11.5 g/dL in women (yes vs no)34  
 1 Observational Serious‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.33 (95% CI, 1.04-5.22) 
MODERATE 
Gastroduodenal ulcers (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.74 (95% CI, 1.42-5.26) 
MODERATE 
Rehospitalization (yes vs no)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.39 (95% 2.25-2.54) 
MODERATE 
Critical illness (yes vs no)8  
 1 Observational Serious* Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 2.10 (95% CI, 1.42-3.11). 
MODERATE 
Thrombocytopenia (yes vs no)8,33,34  
 3 Observational Serious*,†,‡ Not serious Not serious Not serious Undetected ⊕⊕⊕○ All: OR, 1.79 (95% CI, 0.97-3.29) 
MODERATE <50 × 109/L: OR, 3.37 (95% CI, 1.84-6.18) 
<150 × 109/L: OR, 1.30 (95% CI, 0.92-1.82) 
Blood dyscrasias defined as the presence of any bleeding disorders on admission (presence vs absence)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.70 (95% CI, 1.60-1.81) 
MODERATE 
Hepatic disease (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.53 (95% CI, 1.09-2.15) 
MODERATE 
Renal failure (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ Total: OR, 1.43 (95% CI, 1.06-1.93) 
MODERATE Any renal failure (RF): OR, 1.23 (95% CI, 0.92-1.65). 
Moderate RF (GFR 30-59 mL/min/m2): OR, 1.37(95% CI, 0.84-2.23) 
Severe RF (GFR <30 mL/min/m2): OR, 2.14 (95% CI, 1.22-3.75) 
Antithrombotic medication (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.28 (95% CI, 1.01-1.64) 
MODERATE 
CVC (yes vs no)8,33  
 2 Observational Serious*,† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 1.37 (95% CI, 0.83-2.26) 
MODERATE 
Autoimmune disease (yes vs no)8  
 2 Observational Serious* Not serious Not serious Serious§ Undetected ⊕⊕○○ OR, 1.30 (95% CI, 0.77-2.19) 
LOW 
Hormone use: defined as estrogen intake (yes vs no)33  
 1 Observational Serious† Not serious Not serious Not serious Undetected ⊕⊕⊕○ OR, 0.95 (95% CI, 0.82-1.10) 
MODERATE 
Malignancy (yes vs no)8,33  
 2 Observational Serious *,† Not serious Not serious Serious§ Undetected ⊕⊕○○ OR, 1.08 (95% CI, 0.42-2.77) 
LOW 

Question: prognostic factors for medical patients; outcome: bleeding; setting: inpatient.

*

Certainty in evidence was downgraded for risk of bias, given that patients were enrolled both prospectively and retrospectively in Decousus et al.8  The retrospective enrollment of patients may have introduced classification bias.

†

Certainty in evidence was downgraded for risk of bias, given that the authors evaluated bleeding risk in medical patients after hospitalization, that may overestimate the magnitude of the association. This is possibly due to patients being discharged on thromboprophylaxis without proper risk stratification for bleeding placing unmonitored patients at a higher risk of having a bleeding event.

‡

Certainty in evidence was downgraded for risk of bias, given that the population is specific to hospitalized cancer patients who are at a higher risk of VTE and may be given thromboprophylaxis, placing them at a higher risk of having a bleeding event. This in turn may overestimate the magnitude of the association.

§

Certainty in evidence was downgraded for imprecision, given that the CI suggests that there may be no association.

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