Consistent with this shift in thinking in diabetes management, the FDA issued draft guidance in 2013 on the structured assessment of benefit and risk with the goal of facilitating drug regulatory decisions which are explicit and transparent. The recent combined statement from the American Diabetes Association and the European Association for the Study of Diabetes on patient-centered approaches to hyperglycemia in patients with type 2 diabetes highlights the importance of shared decision-making that considers all aspects of treatment options, including preferences for benefits and harms. Since views on the importance of treatment-related outcomes vary across patients, providers, regulatory decision-makers, and other stakeholders, both the probabilities of these heterogeneous outcomes and their importance to stakeholders must be considered when making decisions about diabetes medications. Beyond this multitude of choices, each medication class, and even a medication within a class, has different benefits and harms these treatment-related benefits and harms are often unknown at the time of initial Food and Drug Administration (FDA) approval, and they occur at different time points in the course of therapy. While metformin is the clear first-line medication for the pharmacologic treatment of type 2 diabetes, the choice of add-on medications is vast with 11 additional classes available. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are creditedĭata Availability: All data underlying the findings in our study are freely available in the manuscript and supplemental files.įunding: The analysis upon which this publication is based were performed under contract number HHSF2232010000072C, entitled, "Partnership in Applied Comparative Effectiveness Science," sponsored by the Food and Drug Administration, Department of Health and Human Services.Ĭompeting interests: The authors have declared that no competing interests exists. Received: AugAccepted: ApPublished: May 22, 2015Ĭopyright: © 2015 Maruthur et al. PLoS ONE 10(5):Īcademic Editor: Igor Linkov, US Army Engineer Research and Development Center, UNITED STATES Citation: Maruthur NM, Joy SM, Dolan JG, Shihab HM, Singh S (2015) Use of the Analytic Hierarchy Process for Medication Decision-Making in Type 2 Diabetes.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
January 2023
Categories |