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Project Information

DETERMINING TRADEOFFS AMONG HEALTH BENEFITS, ADVERSE EVENTS, AND RESOURCE USE ASSOCIATED WITH FOOD ALLERGY TREATMENT

Agency:
AHRQ

HHS/Agency for Healthcare Research and Quality

Project Number:
1K08HS024599-01
Contact PI / Project Leader:
GREENHAWT, MATTHEW JASON
Awardee Organization:
UNIVERSITY OF COLORADO DENVER

Description

Abstract Text:
 DESCRIPTION (provided by applicant): 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
Project Terms:
No terms available

Details

Contact PI / Project Leader Information:
Name:  GREENHAWT, MATTHEW JASON
Other PI Information:
Not Applicable
Awardee Organization:
Name:  UNIVERSITY OF COLORADO DENVER
City:  AURORA    
Country:  UNITED STATES
Congressional District:
State Code:  CO
District:  06
Other Information:
Fiscal Year: 2016
Award Notice Date: 30-Jun-2016
DUNS Number: 041096314
Project Start Date: 01-Jul-2016
Budget Start Date: 01-Jul-2016
CFDA Code: 226
Project End Date: 30-Jun-2019
Budget End Date: 30-Jun-2017
Agency: ?

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HHS/Agency for Healthcare Research and Quality
Project Funding Information for 2016:
Year Agency

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

FY Total Cost
2016 AHRQ

HHS/Agency for Healthcare Research and Quality

$151,416

Results

i

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