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Asthma Outcomes Workshop and Report

Workshop Report Development and Summary

The Asthma Outcomes in Clinical Research: Report of the Asthma Outcomes Workshop (Asthma Outcomes Workshop Report), published in March 2012 as a supplement to the Journal of Allergy and Clinical Immunology, covers seven domains of asthma clinical research outcome measures: biomarkers, composite scores of asthma control, exacerbations, health care utilization and costs, pulmonary physiology, quality of life, and symptoms.

Core, Supplemental, and Emerging Asthma Outcome Measures

The report represents the recommendations of the workshop participants for core, supplemental, and emerging outcomes:

  • Core asthma outcome measures are a selective set of asthma outcomes to be considered as requirements in the funding of NIH-initiated asthma clinical trials and large observational studies.
  • Supplemental asthma outcome measures are asthma outcomes for which standard definitions can or have been developed, methods for measurement can be specified, and validity has been proven, but whose inclusion in funded clinical asthma research is optional.
  • Emerging asthma outcome measures have the potential to expand or improve current aspects of disease monitoring and to improve translation of basic and animal model-based asthma research into clinical research, but are not yet standardized and require further development and validation.

Summary tables for core and supplemental asthma outcome measures can be found in the Overview article of the Supplement. Their titles are as follows:

  • Recommendations for core asthma outcomes for NIH-initiated clinical research for adults and adolescents (≥12 years of age)
  • Recommendations for core asthma outcomes for NIH-initiated clinical research for children (5-11 years of age)
  • Recommendations for supplemental asthma outcomes for NIH-initiated clinical research for adults
  • Recommendations for supplemental asthma outcomes for NIH-initiated clinical research for children

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Workshop Planning Committee, Subcommittee, and Executive Committee

The Asthma Outcomes Workshop was organized by a consortium of governmental and non-governmental organizations, including NIAID; the National Heart Lung, and Blood Institute; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network. Representatives from these organizations formed a Planning Committee to oversee the workshop.

See the members of the Planning Committee.

The Planning Committee selected the Workshop co-chairs and 79 experts in the areas of adult and pediatric asthma, pulmonology, allergy/immunology, pharmacology, biostatistics, primary care, and behavioral/social science.

All selected Workshop experts served on subcommittees for the seven domains of asthma outcomes: biomarkers, composite scores of asthma control, exacerbations, health care utilization and costs, pulmonary physiology, quality of life, and symptoms. Each subcommittee had two co-chairs selected by the Planning Committee.

The subcommittees defined the scope of their topic, conducted a literature review, drafted their report and recommendations, and revised their report after the workshop.

See the co-chairs and members of the seven subcommittees.

The co-chairs of each subcommittee and the Planning Committee members served as the Executive Committee to organize the development of the workshop report and to review and approve the final workshop report.

To contribute to the evaluation of the draft reports, the Executive Committee invited workshop discussants to present critiques on the subcommittee reports. The Executive Committee also invited workshop participant observers from groups involved in quality improvement, guidelines development, or health policy, as well as representatives from other federal agencies with asthma programs, the pharmaceutical industry, healthcare policy groups, and public voluntary organizations.

See a list of workshop discussants and workshop participant observers.

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Support for the Workshop Report

Support for the literature searches, travel, lodging, and conference logistics for workshop participants from non-governmental organizations was provided by the organizations represented on the Planning Committee and by a grant from the Robert Wood Johnson Foundation. NIAID, NHLBI, NICHD, NIEHS, and the U.S. Environmental Protection Agency provided support for the publication of the workshop report.

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Drafting, Review, and Final Report

Each subcommittee defined the scope of their topic; conducted a literature review with assistance from the RAND Corporation; drafted their article and recommendations; and revised their article after the workshop.

The workshop report is composed of seven articles, one from each subcommittee. In addition, an eighth article “Mediators of asthma outcomes," was written by the members of the Quality of Life subcommittee, who recognized that factors such as patient adherence, level of asthma self-management skills, and exposure to stress can have considerable influence on a wide range of asthma outcomes.

The Executive Committee reviewed and approved each subcommittee's final recommendations.

The final Asthma Outcomes in Clinical Research: Report of the Asthma Outcomes Workshop were published in March 2012 as a supplement to the Journal of Allergy and Clinical Immunology.

Read the complete Asthma Outcomes Workshop Report.

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Last Updated February 29, 2012

Last Reviewed February 06, 2012