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Updated: Jan 1, 2026

An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
[External validation of the ORACLE bleeding risk score using the database of the RECORD 3 registry]
L O Minushkina1, A D Erlikh2, V A Brazhnik3
1Central State Medical Academy, President Affairs Department RF.
Insights
The ORACUL score effectively predicts bleeding risk in acute coronary syndrome (ACS) patients during hospitalization and post-discharge. This validation confirms its utility for managing bleeding complications in ACS.
Area of Science:
- Cardiology
- Clinical Risk Assessment
- Medical Informatics
Background:
- Acute coronary syndrome (ACS) patients face significant bleeding risks, necessitating accurate predictive tools.
- Existing risk assessment scales may require validation in diverse patient populations.
- The ORACUL score was developed to assess bleeding risk in ACS patients.
Purpose of the Study:
- To externally validate the domestic ORACUL (ОРАКУЛ) score for bleeding risk assessment.
- To evaluate the ORACUL score's performance in an independent cohort of ACS patients.
Main Methods:
- External validation using the RECORD-3 observational study database.
- Inclusion of 2370 patients hospitalized for ACS across 47 centers in Russia.
- Analysis of in-hospital and 6-month post-discharge bleeding events.
Main Results:
- The ORACUL score demonstrated good diagnostic value for in-hospital bleeding risk (C-statistic 0.691).
- For 6-month post-discharge bleeding risk, the C-statistic was 0.628.
- The score showed sufficient sensitivity and specificity for predicting bleeding events in both periods.
Conclusions:
- External validation confirms the ORACUL score's statistical power.
- The ORACUL score is suitable for predicting bleeding risk during hospitalization and after discharge in ACS patients.
Aim:
To validate a domestic scale for assessment risk of bleeding ORACUL (ОРАКУЛ) based on an independent sample of patients with acute coronary syndrome (ACS).
Materials And Methods:
External validation of the ORACUL score was carried out using database of an independent observational study RECORD-3 which comprised data from all patients hospitalized for 1 month (march-april 2015) in 47 centers of 37 cities in 21 regions of Russia. Total number of included patients was 2370, mean age 64.2±11.96 years, 821 patients (34.6%) had ST-elevation, other patients - non-ST elevation ACS.
Results:
The following bleeding events were registered in RECORD-3: bleedings during hospitalization (n=34, 1.43%), inhospital bleedings requiring withdrawal of antithrombotic treatment (n=16, 0.68%), inhospital bleedings, which required drug or surgical treatment or hemotransfusion (n=16, 0.68%). Forty eight hemorrhagic complications were registered during 6 months of observation after hospital discharge. Diagnostic value of the ORACUL score for estimation of risk of bleedings during index hospitalization was good (C-criterion 0.691±0.050; р<0.001), sensitivity of the model was 58.1%, specificity 79.9%. Earlier on the cohort of patients of the ORACUL study diagnostic value of the score for inhospital bleedings was found to be 0.777±0.046. Difference of diagnostic values was inessential. For estimation of the bleeding risk during 6 months of post discharge observation area under the ROC curve (C-criterion) was 0.628±0.045 (р=0.003), sensitivity and specificity of the model were 53.9 and 73.7%, respectively. On the ORACUL study cohort AUC 0.748±0.048 (р=0.071).
Conclusion:
External validation confirmed that statistical power of the OCACUL score is sufficient for prediction of bleedings during both periods of hospitalization and after hospital discharge.
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