Aetion® Substantiate Spotlight: Turning Dosing Complexity Into Actions

Blog authored by: Michelle Skornicki, MPH; Natalie Schibell, MPH; Pippa Hodgkins; Renee Sajedian

Evaluating drug use in real-world data is complicated. Unlike controlled clinical trials, where dosages are strictly monitored and reported, real-world data involves a diverse mix of healthcare settings, variable prescribing and administration patterns, and “messy” data. As a result, researchers in real-world evidence and health outcomes studying the patient journey and treatment patterns face significant challenges. This complexity requires appropriate analytical tools to ensure that conclusions about dosing and coverage are reliable.

Aetion® Substantiate mitigates these obstacles by enabling users to generate more precise drug metrics, enhancing decision-making in clinical research and real-world evidence generation. By simplifying data management and streamlining workflows, Substantiate also allows researchers to work efficiently. 

Unlocking Advanced Dose Analysis With Drug Computation

At the core of Substantiate is its Drug Computation tool designed to tackle complex medication dosing challenges. This measure takes drug events as inputs and serves as the foundation for downstream measures—including Adherence, Drug Dose, Drug Coverage, and Drug Supply. The Drug Computation measure allows users to:

• Handle Stockpiling Nuances: Shift or adjust medication supply to accurately account for concurrent or subsequent coverage periods instead of overestimating or underestimating supply durations. By addressing stockpiling scenarios, this feature allows dose and coverage metrics to more accurately reflect real-world medication usage patterns.
• Calculate Daily Doses: Generate precise daily dose calculations using fields like strength, quantity, and days supply to ensure accuracy across datasets. These calculations provide a robust foundation for analyzing clinical and resource utilization outcomes based on dose received.
• Create Days Covered Metrics: Calculate the duration of medication coverage to support downstream analyses, including adherence and persistence. This capability provides critical insights into real-world treatment patterns, helping researchers identify gaps and optimize intervention strategies.

The flexibility of the Drug Computation tool allows researchers to customize calculations to align with specific therapeutic goals or study objectives, driving meaningful analyses.

Streamlining Analytical Workflows for Greater Efficiency

Substantiate is designed to optimize workflows, simplify complexity, and boost efficiency. By guiding researchers through structured processes, it minimizes manual effort and enhances productivity, as follows:

• Flexible Dose and Coverage Calculations: Substantiate enables the examination and calculation of medication doses, such as average daily dose or adjustments for overlapping prescriptions. The platform integrates data on multi-formulation medications (e.g., morphine dispensed in tablets, liquid, or IV), ensuring consistent and accurate analysis. 
• Consolidated Data Attributes: Substantiate allows the user to easily integrate key medication attributes—such as drug strength, days supplied, and prescribed quantities into a simple daily dose measurement. This precludes the need for complex coding and reduces manual errors.
• Reusability of Drug Computation Measures: Substantiate's drug computation measures can be reused across multiple analyses or studies, providing a consistent and reliable foundation for downstream research. This reusability significantly reduces redundancy, enhances efficiency, and ensures consistency in evidence generation.

By optimizing analytical workflows, Substantiate accelerates research timelines, enabling faster time to insights.

Example: Advancing Evidence in Corticosteroid Dosing

Measuring corticosteroid usage in real-world data presents a unique set of challenges due to the diversity of formulations—ranging from oral tablets to injectable solutions to topical applications—and the need for consistent, harmonized data to inform robust evidence generation. 

In a potential study evaluating corticosteroid utilization across varied formulations, Substantiate demonstrates its value by:

• Managing Overlapping Prescriptions: Resolving complexities associated with overlapping prescription data ensures accurate dose computations and consistent study outputs.
• Standardizing Metrics: Converting corticosteroid dosages into prednisone-equivalent units, creating a consistent baseline for intra- and inter-study comparisons while adhering to rigorous methodological standards.
• Identifying Dose Patterns: Facilitating the detection of outlier dosages relative to clinical guidelines.

Supporting Our Stakeholders

Substantiate transforms how researchers approach medication dose analysis by integrating precision, flexibility, and usability into workflows. Substantiate supports biopharma companies, health insurance payers, and regulatory bodies in achieving critical objectives:

• Enhance Patient Care: Gain insights into prescribing patterns, including dosing trends.
• Strengthen Credibility: Deliver transparent, reproducible analytics that foster trust with regulators and stakeholders, supporting confident decision-making.
• Advance Research: Drive evidence generation efforts with a guided, modular approach to dose and coverage calculations.

While the ability to generate detailed and reliable dose and coverage metrics ultimately depends on the richness and completeness of the raw data available, Substantiate can ensure better estimates and simplify analyses. 

With educational resources like the "Dosing and Coverage with Drug Computation Measures" training module, Aetion equips users with the tools and expertise needed to address complex research challenges with confidence and precision.

Ready to simplify dosing complexity? Explore how Substantiate can transform your evidence generation efforts and accelerate healthcare innovation. Contact us today to learn more.