A consortium of federal agencies and nongovernmental organizations has published a report proposing a set of common measures and data-collection methods for use in asthma clinical research. Asthma Outcomes in Clinical Research: Report of the Asthma Outcomes Workshop, which appears as a supplement to the March 2012 issue of the Journal of Allergy and Clinical Immunology, resulted from a meeting organized by the National Institutes of Health, the Agency for Healthcare Research and Quality and the Merck Childhood Asthma Network, Inc., with additional support for the publication from the U.S. Environmental Protection Agency. NIH contributors were 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.

NIH-funded research has led to many improvements in the management and treatment of asthma, a chronic lung condition that affects more than 25 million people in the United States. However, asthma clinical research has lacked a common set of outcomes, measures used by researchers to assess a disease during the course of a study. This lack of standardization has made it difficult to compare results between individual studies and to share data across studies, thus hindering the progress of asthma research.

The report identifies standard definitions and methodologies for measuring seven groups of outcomes that are important in asthma clinical studies: symptoms, exacerbations (asthma attacks), biomarkers (biological substances that indicate disease state), lung function, quality of life, asthma control questionnaire results, and health care utilization and costs. By using the same set of outcome measures in asthma clinical studies, researchers will be able compare their results more efficiently. This proposed standardization across asthma studies promises to enhance the development of prevention and treatment strategies and lead to improvements in the quality of asthma care.

Based on the recommendations of the report, NIH and other federal agencies will require the inclusion of the proposed outcomes in future government-funded asthma clinical research.

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Alkis Togias, M.D., section chief, Allergy, Asthma and Airway Biology Branch, Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases (NIAID), and Virginia Taggart, M.P.H., program director, Division of Lung Diseases, National Heart, Lung, and Blood Institute (NHLBI), are available for comment.

NIH experts will be available to comment during and after a press conference about the workshop report at the annual meeting of the American Academy of Allergy, Asthma & Immunology, on March 3, 2012, at 2 p.m. Eastern Time. Watch the press conference live.

To schedule interviews, please contact the NIAID Office of Communications at (301) 402-1663, .(JavaScript must be enabled to view this email address), or the NHLBI Office of Communications at (301) 496-4236, .(JavaScript must be enabled to view this email address).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at http://www.nichd.nih.gov. NICHD support was provided through the Best Pharmaceuticals for Children Act program, which seeks to improve pediatric therapeutics through preclinical and clinical drug trials that lead to drug labeling changes.

The Agency for Healthcare Research and Quality’s (AHRQ) mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As 1 of 12 agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services. AHRQ was formerly known as the Agency for Health Care Policy and Research.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

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