A unified framework for classification of methods for benefit-risk assessment

Area of Science:

• Pharmacoeconomics
• Health Technology Assessment
• Decision Analysis

Background:

• Benefit-risk analysis (BRA) is crucial for informed treatment decisions, involving trade-offs between risks and benefits.
• Existing BRA methods vary in transparency and rigor, necessitating a standardized approach.
• Patient-centeredness is key for effective BRA, ensuring methods reflect individual values.

Purpose of the Study:

• To propose a novel framework for classifying BRA methods.
• To standardize BRA classification using common mathematical notation.
• To compare BRA method results using a hypothetical case study.

Main Methods:

• Classified BRA methods into three categories: unweighted metrics, preference-weighted metrics, and decision-maker opinion-weighted metrics.
• Utilized a common mathematical notation for a unified comparison.
• Employed a hypothetical comparative analysis of two antiplatelet drugs (a and b).

Main Results:

• Unweighted metrics (e.g., number needed to treat/harm) were identified.
• Preference-weighted metrics (e.g., maximum acceptable risk, adjusted life-years) were detailed.
• Decision-maker weighted metrics (e.g., multicriteria decision analysis, benefit-less-risk analysis) were presented, showing mathematical relationships and potential interpretation differences.

Conclusions:

• A unified, patient-centered framework for classifying BRA methods was proposed.
• Classification is based on the type of weights used, a key differentiator.
• The framework aids in understanding and selecting appropriate BRA methods for diverse contexts.