Recommended for further appraisal for use in benefit-risk assessment.

    1. Description

    PrOACT-URL is a generic decision-making guide with eight steps: Problems, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk attitudes, and Linked decisions.

    2. Quantitative frameworks

    PrOACT-URL framework covers the important aspects for structuring a decision-making problem. The framework itself is generic and can be applied to any decision-making problem, but the EMAas Benefit-Risk Project adapted PrOACT-URL to decision-making of medicines. The summary of its components is shown below:

    An instructional template for structuring a benefit-risk decision-making of medicines using PrOACT-URL (with example) can be downloaded here

    PrOACT-URL advocates the use of an "Effects Table". An effects table consists of the key information that is to be used in the benefit-risk assessment model.

    This method was tested in the Efalizumab, Natalizumab, Rimonabant, Rosiglitazone and Telithromycin case studies.

  • 3. References

  • [1] Hunink M, Glasziou P, Siegel J, Weeks J, Pliskin J, Elstein A, et al. Decision making in health and medicine: Integrating evidence and values. Cambridge: Cambridge University Press; 2001.
    [2] Hammond JS, Keeney RL, Raiffa H. Smart choices. A practical guide to making better life decisions. New York: Broadway Books; 2002.
    [3] European Medicines Agency. Benefit-risk methodology project work package 3 report: Field tests. London: European Medicines Agency; 31 Aug 2012. URL: Report no: EMA/718294/2011.