Asthma outcomes workshop: Overview

doi:10.1016/j.jaci.2011.12.985

Journal of Allergy and Clinical Immunology

Volume 129, Issue 3, Supplement, March 2012, Pages S1-S8

https://doi.org/10.1016/j.jaci.2011.12.985 Get rights and content

Background

Asthma clinical research will highly benefit from standardization of major outcomes in terms of definition and assessment methodology. This will permit useful comparisons across interventional or observational studies and will allow more effective data sharing.

Objective

National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality convened a workshop involving 7 expert subcommittees to propose which asthma outcomes should be assessed with standardized methodology in future asthma clinical research studies.

Methods

Each subcommittee utilized comprehensive literature reviews and expert opinion to compile a list of asthma outcomes and classified them as either core (required in future studies), supplemental (to be used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.

Results

Outcomes for study participant characterization, as well as for prospective clinical trial intervention and observational studies, were proposed for adults and children, and methodologies for outcome collection and reporting were determined. Furthermore, the workshop identified areas in which new outcomes or instruments for their measurement need to be developed and validated.

Conclusions

Standardized outcomes for clinical research in asthma have been proposed. Participating NIH institutes and other federal agencies will consider these recommendations in future clinical research initiatives in asthma.

Section snippets

Objectives

An Asthma Outcomes workshop was convened in Bethesda, Md, on March 15 and 16, 2010, by a consortium of several National Institutes of Health (NIH) institutes and the Agency for Healthcare Research and Quality. The 2 key objectives of the workshop were (1) to establish standard definitions and data collection methodologies for validated outcome measures in asthma clinical research with the goal of enabling comparisons across asthma research studies and clinical trials and (2) to identify

Members of the workshop

The Asthma Outcomes workshop was organized by a consortium of governmental and nongovernmental organizations, 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; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network. Representatives of the above organizations

Development of the workshop report

The workshop report is comprised of 7 individual articles, 1 from each subcommittee. Each subcommittee met through frequent telephone conference calls and e-mail exchanges over the course of 9 months to prepare a draft report on its respective topic. The subcommittees were responsible for defining the scope of their topic, conducting appropriate literature reviews, drafting their report and recommendations for discussion by all workshop participants, and revising their report following the

Support

Contributions from the organizations represented on the Planning Committee and a grant from the Robert Wood Johnson Foundation provided all funds for the literature searches, travel, lodging, and conference logistics for workshop cochairs Drs Busse and Morgan, subcommittee members, and discussants. All other meeting participants travelled at their own expense. Contributions from National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Diseases; Eunice Kennedy

Key recommendations

•
A summary of the key workshop proposals for core and supplemental measures are presented in Table II, Table III, Table IV, Table V. Each subcommittee’s individual article provides discussion and references to the scientific literature that support these recommendations.
•
In some instances the subcommittees were unable to identify core outcomes. This reflected either the lack of adequate validation and standardization or the opinion of subcommittee members that the content of an existing tool may

Mediators of asthma outcomes

The Quality of Life Subcommittee recognized that such factors as patient adherence, level of asthma self-management skills, and exposure to stress can have considerable influence on a wide range of asthma outcomes and not just the patients’ perceptions of the impact of asthma on their quality of life. Although the review of these mediators was beyond the scope of any 1 subcommittee’s topic, the Quality of Life Subcommittee offers a brief summary of these factors and their potential influence to

References (3)

L.J. Akinbami et al.
Asthma prevalence, health care use, and mortality: United States, 2005-2009
(2011)

There are more references available in the full text version of this article.

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: The Asthma Outcomes workshop was funded by contributions from 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; the National Institute of Environmental Health Sciences; the Agency for Healthcare Research and Quality; and the Merck Childhood Asthma Network, as well as by a grant from the Robert Wood Johnson Foundation. Contributions from the National Heart, Lung, and Blood Institute; the National Institute of Allergy and Infectious Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute of Environmental Health Sciences; and the US Environmental Protection Agency funded the publication of this article and all other articles in this supplement.

: Disclosure of potential conflict of interest: W. W. Busse is on the Advisory Board for Centocor and Merck; is a consultant for Amgen, AstraZeneca, Novartis, GlaxoSmithKline, MedImmune, Genentech, and Boehringer Ingelheim; is on the Actelion Date Safety Monitoring Board; and has received research support from the National Institutes of Health (NIAID and NHLBI). W. J. Morgan is a consultant for Genentech, Novartis, and the Cystic Fibrosis Foundation; has received research support from the NIH-NHLBI CARE Network and the Cystic Fibrosis Network; and is a speaker for Phadia. The rest of the authors declare that they have no relevant conflicts of interest.

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