What Is Patient-Level Prediction? Personalizing Risk with Real-World Data

With the growing adoption of personalized medicine and the increasing availability of large-scale healthcare data, the ability to anticipate clinical outcomes at the individual patient level is becoming a fundamental component of modern medical decision-making. Healthcare systems, payers, and researchers are seeking ways to move beyond generalized treatment guidelines and toward tailored, data-driven approaches.

 

To enable this shift, a standardized and interoperable data infrastructure is essential. This is where the OMOP Common Data Model (CDM) and the OHDSI (Observational Health Data Sciences and Informatics) open-science collaborative come into play. The OMOP CDM harmonizes diverse real-world datasets, such as electronic health records, claims, and registries, into a common format that supports scalable and reproducible analytics. OHDSI, built around this data model, offers a suite of tools and methods for generating real-world evidence (RWE), including capabilities for Patient-Level Prediction (PLP).

PLP within the OHDSI ecosystem provides a robust methodology for generating individualized risk models using harmonized real-world data (RWD).

 

This article explains what PLP is, how it functions within the OMOP/OHDSI environment, and why it plays a critical role in advancing precision health strategies.

 

What Is Patient-Level Prediction?

 

Patient-Level Prediction refers to the development of statistical or machine learning (ML) models that estimate the probability of a specific clinical outcome for an individual patient, based on their own historical data and characteristics.

 

For example, we may ask:

  • What is the probability that a newly diagnosed diabetic patient will have a heart attack within the next year?
  • Can we predict which patients are likely to discontinue a medication due to side effects?

 

Unlike population-level descriptive analytics, PLP focuses on individual risk estimation, enabling clinicians, researchers, and payers to make more personalized, proactive decisions.

 

How PLP Works in the OHDSI/OMOP Ecosystem

 

The OHDSI community provides an open-source pipeline for patient-level prediction using the OMOP CDM. This pipeline is implemented through the PatientLevelPrediction R package and integrated with the ATLAS user interface.

 

Here’s a step-by-step overview:

 

1. Cohort Definition

  • Define the target population (e.g., patients starting Drug X).
  • Define the outcome of interest (e.g., hospitalization for heart failure within 6 months).

 

2. Feature Engineering

  • Automatically derive predictors from the patient’s OMOP-recorded data, including:
    • Demographics (e.g., age, sex)
    • Conditions and diagnoses
    • Medications
    • Procedures
    • Lab results
    • Healthcare utilization

 

3. Model Development

  • Choose and train ML algorithms:
    • Regularized logistic regression (e.g., LASSO)
    • Gradient boosting (e.g., XGBoost)
    • Random forests
    • Neural networks (for complex nonlinear patterns)

 

4. Model Validation

  • Evaluate model performance using:
    • AUC (Area Under the ROC Curve) for discrimination
    • Calibration plots for reliability of predictions
    • Other metrics like sensitivity, specificity, and PPV
  • Perform internal and external validation across multiple databases.

 

5. Interpretation and Risk Stratification

  • Identify the most predictive features.
  • Classify patients into risk strata (e.g., low, moderate, high risk).
  • Visualize risk distribution and potential intervention impact.

 

Why Patient-Level Prediction Matters

 

PLP enables a shift from generalized evidence to individualized insights:

  • Precision Medicine: Tailor interventions based on a patient's predicted risk.
  • Clinical Decision Support: Alert providers about patients at high risk for complications.
  • Population Health: Identify high-risk individuals for preventive outreach.
  • Regulatory Use: Support pharmacovigilance, label expansions, and safety surveillance.
  • Payer Decisions: Improve care management and resource allocation.

 

Tools for PLP in OHDSI

  • ATLAS: GUI for designing prediction studies, visualizing data, and generating study packages.
  • PatientLevelPrediction R package: Scripted access to all stages of the PLP pipeline.
  • Data mapped to OMOP CDM: Enables portability and reproducibility of models across diverse datasets.

 

Real-World Use Cases

  • Predicting risk of stroke in atrial fibrillation patients to guide anticoagulant therapy.
  • Forecasting risk of hospitalization among patients with chronic obstructive pulmonary disease (COPD).
  • Anticipating treatment failure in cancer patients based on real-world progression markers.

 

Final Thoughts

Patient-Level Prediction represents a frontier in real-world evidence (RWE) generation. By leveraging standardized data structures (OMOP) and scalable tools (OHDSI), it empowers researchers and clinicians to generate individualized, actionable insights from large real-world datasets. As healthcare systems move toward more proactive, predictive care models, fluency in PLP concepts and tools will become increasingly valuable for epidemiologists, data scientists, clinicians, and RWE professionals alike.

Whether you’re planning your first prediction study or looking to integrate personalized analytics into your broader data strategy, understanding the fundamentals of PLP is a smart step toward the future of precision health.

 

Useful resources:

 

By Nadia Barozzi

Passionate about data-driven insights and the advancement of Real World Evidence research, drug safety and pharmacovigilance.