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Endpoints and Outcomes After Immunotherapy for Food Allergy: What Is Meaningful for Patients?
Melanie Lloyd1, Nandinee Patel2, Daniel Munblit3
1Allergy Immunology, Murdoch Children's Research Institute, Parkville, VIC, Australia; Centre for Medicine Use and Safety, Monash University, Parkville, VIC, Australia.
Abstract:
Multiple novel interventions for food allergy are currently at various stages of development with the goal of reducing or eliminating allergic reactions. However, the relative success of these therapeutics in achieving meaningful, long-term improvements to patients' lives is difficult to determine as there is currently very limited understanding of the degree of alignment between clinical trial efficacy endpoints and patient-centered outcomes. Furthermore, outcome measures used in clinical trials of food allergy immunotherapies vary widely, are often misinterpreted, and not necessarily consistent with what patients expect to achieve through treatment. This review aims to assist clinicians in critically interpreting outcomes reported in clinical trials and accurately communicating risks and outcomes to patients when practicing shared decision-making.
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