Jennifer A Dantzer, Marcus S Shaker, Matthew Greenhawt
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引用次数: 0
Abstract
The current FDA paradigm may not fully capture important patient-centered outcomes or measure a primary outcome that is truly meaningful to patients. Patient reported outcome measures (PROMs) are standardized tools measuring the patient's experience in food allergy clinical trials, which can help support shared decision-making (SDM) and further our understanding of treatment impact. Food allergy PROMs include quality of life (QoL), health state utility (HSU), severity, and self-efficacy measures. Currently, FDA registration trials for product approval only consider a fixed increase in allergen threshold from pre-to-post intervention as a primary outcome (vs. a more flexible "X-fold" increase not accounting for an upper and lower specific threshold), though many use QoL as a secondary outcome for patient-centered assessment of treatment impact. Currently used QoL PROMs were not designed to measure change on therapy nor measure HSU (e.g., quantitative risk a patient may be willing to take to improve their current health), which can be used to determine therapy value. While the current paradigm for primary and secondary outcomes in food allergy clinical trials was appropriate at the early stages of food allergy therapy development when conceived in the late 2000's and early 2010's, in the 2020's these outcome choices risk being stagnant and outdated. As such, the current paradigm for food allergy outcomes should evolve to incorporate more patient-centered primary outcome measures which patient data indicate are meaningful, so outcomes more realistically reflect a therapy's impact. This evolution will better support SDM discussions as patients consider their therapy options and can inform new product development.
期刊介绍:
JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases.
This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders.
The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.