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. 2020 Feb 24;135(20):1788–1810. doi: 10.1182/blood.2019003603

Table 3.

Evidence profile for bleeding-related prognostic factors

No. of studies Certainty assessment domains Overall certainty in the evidence about this prognostic factor Relative effect (95% CI)
Study design Risk of bias Indirect Inconsistent Imprecise Publication 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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