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Newly proposed asthma outcome measures will help standardize and improve results from the hundreds of millions of dollars the National Institutes of Health (NIH) spends annually to study asthma, according to the Merck Childhood Asthma Network, Inc. (MCAN), the nation’s only organization focused solely on childhood asthma. Even though years of research have led to groundbreaking improvements in better understanding and managing asthma, MCAN noted that the inability to compare results across many studies has hindered the nation’s efforts to find long-term solutions and reduce childhood asthma disparities.

This set of proposed outcome measures, published as a supplement to the March issue of the Journal of Allergy and Clinical Immunology, will be officially released at the annual meeting of the American Academy of Allergy Asthma & Immunology (AAAAI) in Orlando on March 3. NIH and other agencies will consider these outcomes in future clinical research initiatives later this year, which according to MCAN will permit the comparison of results across many large federally supported studies.

“For years, researchers, clinicians and others have worked to close the wide gap between the treatment that is recommended for children with asthma and the treatment most of them receive. We’ve struggled with an inability to make ‘apples to apples’ comparisons with research outcomes that could lead to improvements in management,” said Dr. Floyd Malveaux, Executive Director of MCAN and former Dean of the College of Medicine at Howard University. “This move towards standardization is a huge step in the right direction. It paves a way to reducing disparities in asthma management and treatment, especially for the most vulnerable children among us.”

In 2010, several federal agencies, non-governmental organizations and industry representatives gathered in Bethesda, Md., to identify how the nation might overcome the lack of outcomes standards in asthma clinical research. The meeting was organized by several NIH institutes, including the National Institute of Allergy and Infectious Diseases; the National Heart, Lung, and Blood Institute; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; and the National Institute of Environmental Health Sciences, as well as the Agency for Healthcare Research and Quality and MCAN. The report of the meeting recommended a standardization of outcome measures that these federal agencies will consider implementing in the coming months.

Dr. Malveaux also noted that there is great potential for increased ability to duplicate successful interventions in some of the country’s neediest communities, identify areas for cost reduction and, through data-sharing, reduce disparities in the communities hardest hit by asthma. Although other endpoints may be proposed by researchers, the NIH has identified seven outcome categories that are important in clinical studies. These categories include:

• Symptoms: Asthma symptoms are used to assess the impact of interventions on health outcomes. Although current tools have shortcomings, the report reviews key instruments and encourages further development of new ones.
• Exacerbations: Future studies will report exacerbations or worsening of asthma requiring the use of systemic corticosteroids.
• Biomarkers: The report identified ten biomarkers relevant to disease progression and response to treatment, with particular emphasis on reporting multi-allergen screening.
• Lung Function: Lung function outcomes are of central importance for future asthma clinical research, and spirometry and bronchial reversibility measures are considered key in diagnosing and determining disease severity.
• Quality of Life: Measures of asthma’s impact on a patient’s life as essential for characterizing patient populations and assessing the benefits or harms of specific asthma interventions; no core measures have been identified to date.
• Asthma Control Questionnaire Results: Several questionnaire instruments, including the Asthma Control Questionnaire (ACQ) and Asthma Control Test (ACT), were identified.
• Healthcare Utilization and Costs: Collecting and reporting information on healthcare utilization, intervention resources and indirect impact of asthma will be encouraged so that costs can be calculated and cost-effectiveness analyses can be conducted across several asthma studies.

The final outcomes standards report entitled “Asthma Outcomes in Clinical Research: Report of the Asthma Outcomes Workshop” is available online at http://www.jacionline.org/issues?issue_key=S0091-6749%2812%29X0003-4. MCAN provided financial support for the 2010 NIH Outcomes Workshop and follow-up activities.

This review identifies economic values of home-based, multi-trigger, multi-component interventions with an environmental focus and presents ranges for the main economic outcomes (e.g., program costs, benefit-cost ratios and incremental cost-effectiveness ratios). A previous review concluded that these interventions were effective in reducing asthma morbidity among children and adolescents. Of the 1,551 studies identified for inclusion in the review, 13 were selected. Each of these had program costs ranging from $231-$14,858 per participant per year.  This range was affected by completeness of their program cost data, level of intensity of the environmental remediation, the type of educational component included, the professional status of the home visitor and the frequency of visits by the home visitor. The study ultimately found that the benefits from these kinds of interventions can "match or even exceed their program costs" and that "these programs provide a good value for dollars spent on the interventions."

EICA was one of 14 community-based initiatives conducted by the Minneapolis/St. Paul Partners for Asthma Action (formerly Controlling Asthma in American Cities Project). EICA was an in-home program with goals of:

1. Reducing asthma symptoms by lessening exposure to environmental asthma triggers in the home environment.
2. Reducing school absences.
3. Decreasing health service utilization and thereby reducing health care costs.

EICA was modeled after two successful home-environment modification programs for children with asthma in the Minneapolis and St. Paul metropolitan area—Environmental Action for Children’s Health led by Minneapolis Environmental Regulatory Services and funded by the Department of Housing and Urban Development and the Minnesota Department of Health’s Reducing Environmental Triggers for Asthma funded by the Environmental Protection Agency.