Food allergy is major public health disorder affecting nearly 15 million Americans, including 8% of US children, at a cost of $24.8 billion annually.1-3 Allergic reactions may occur on initial food exposure and range from mild to highly severe (e.g. anaphylaxis, and possible fatality) with poor predictability. Several promising treatments are under development, though none presently exist beyond allergen avoidance.2 Food allergy is associated with anxiety and poor child health related quality of life (HRQL), poor parent HRQL as a proxy for their child's experience, as well as poor parent HRQL as a spillover effect of a perpetual fear of the child reacting from an accidental exposure-something treatment could prevent.4-18 Food oral immunotherapy is a promising treatment in which allergic individuals are slowly desensitized to their allergen, allowing temporary tolerance to a dose of that food, and possible development of permanent tolerance.19-21 Data indicate moderate success for this approach, though not without significant adverse event rates, treatment failures, and unknown long-term benefits and outcomes.22-29 Food allergy primarily affects children, and parents make decisions regarding a potential treatment based not only on their own risk:benefit trade-offs and outcome preferences, but also those as a proxy for their child and based on spillover effects they experience.30,31 Therefore, a decision to offer a potentially high-risk therapy should ideally be carefully matched to a particular parent profile, though no methods have been developed to assess preference profiles for food allergy. Availability of these preference profiles would provide crucial understanding for parental decision-making regarding a therapy like food oral immunotherapy which has shown variable benefits, risks, and outcomes to date.26,29-33 I propose to use conjoint analysis to assess how parents value HRQL (their own and the child's proxy), health utility, and other attributes related to food oral immunotherapy, identify sub- groups of patterns that characterize parental decision making regarding therapy, and then use decision science modeling to forecast if sub-group patterns and variation in perception of risk/benefit trade-offs influence the benefits, risks, and costs of oral immunotherapy. Even the most beneficial therapy may be problematic within a population with poor tolerance for marginal therapeutic risk: benefit ratios. Though emerging data suggest food oral immunotherapy may work in selected individuals, identifying parental outcome preferences and decision-making patterns will help to understand the rage of benefits, risks, and costs of the therapy. This need i imperative given some community based allergists offer food oral immunotherapy as an off-label service through a regulatory loophole, despite its' ongoing phase II study in NIH sponsored trials, and an industry developed product entering into phase III trials that may soon be commercially available.32-35 This award will provide mentored, protected time to learn how to assess the benefits, risks, and costs for food oral immunotherapy. I seek to learn to apply conjoint analysis, an innovative technique in health care research, to identify sub-groups of parent attribute preferences and decision-making patters, and to learn how to perform decision science modeling to assess the health and economic outcomes of these patterns across a spectrum of risks-to-benefits of the therapy. Such training can help enhance patient-centered outcomes research, optimize future resource allocation with respect to potential therapy for food allergy, assist in providing clinical decision-making support to providers, and help understand other emerging food allergy treatments and their outcomes. This proposal addresses multiple priorities for AHRQ: children as a specially identified research population; career training objectives of innovative research approaches, decision-science modeling/analysis; and patient centered outcomes research in comparative effectiveness research through engaging stakeholder preference related to an innovative therapy. Understanding the cost, benefits, and health outcomes of food allergy treatment is highly relevant and applicable to future R01 or U level grants, and can help assess best- practice strategies, service utilization, future research pipeline applications (e.g. anti-IgE in combination with oral immunotherapy, epicutaneous immunotherapy, etc.), and management policy.36-39
Food allergy is a chronic pediatric illness affecting 8% of children at a cost of $24 billion annually to society, associated with poor parental health related quality of life as a spillover effect of the child's illness. Several promising food allergy treatmnts are under development but these carry significant potential risk of reaction/worsening course of allergy, and have questionable long-term benefit compared to food avoidance. I seek to explore influences on parental decision-making and preferences for high-risk treatment outcomes and determine if sub-groupings of parental preference patterns exist, to model the benefits, costs, and risks of such patterns to better understand the range of potential variation of a treatment.
| Shaker, M; Stukus, D; Chan, E S et al. (2018) ""To screen or not to screen"": Comparing the health and economic benefits of early peanut introduction strategies in five countries. Allergy 73:1707-1714 |
| Greenhawt, Matthew; DunnGalvin, Audrey (2018) Preliminary psychometric analyses and clinical performance of a caregiver self-efficacy scale for food allergy self-management. Ann Allergy Asthma Immunol 120:73-79 |
| Greenhawt, Matthew (2018) Environmental exposure to peanut and the risk of an allergic reaction. Ann Allergy Asthma Immunol 120:476-481.e3 |
| Kao, Lauren M; Greenhawt, Matthew J; Warren, Christopher M et al. (2018) Parental and parent-perceived child interest in clinical trials for food allergen immunotherapy. Ann Allergy Asthma Immunol 120:331-333.e1 |
| Greenhawt, Matthew; Marsh, Rebekah; Gilbert, Hannah et al. (2018) Understanding caregiver goals, benefits, and acceptable risks of peanut allergy therapies. Ann Allergy Asthma Immunol 121:575-579 |
| Lieberman, Jay Adam; Greenhawt, Matthew; Nowak-Wegrzyn, Anna (2018) The environment and food allergy. Ann Allergy Asthma Immunol 120:455-457 |
| Shaker, Marcus; Verma, Kanak; Greenhawt, Matthew (2018) The health and economic outcomes of early egg introduction strategies. Allergy 73:2214-2223 |
| Greenhawt, Matthew; Turner, Paul J; Kelso, John M (2018) Administration of influenza vaccines to egg allergic recipients: A practice parameter update 2017. Ann Allergy Asthma Immunol 120:49-52 |
| Nowak-Wegrzyn, Anna; Greenhawt, Matthew (2018) The importance of food allergy to the practicing clinician. Ann Allergy Asthma Immunol 120:227-228 |
| Egan, Maureen; Greenhawt, Matthew (2018) Common questions in food allergy avoidance. Ann Allergy Asthma Immunol 120:263-271 |
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