Asthma outcomes workshop: Overview - 02/03/12
Corresponding author: Alkis Togias, MD, Division of Allergy, Immunology and Transplantation (DAIT); National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH), 6610 Rockledge Dr, Bethesda, MD 20892-6601.Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Asthma clinical research, National Institutes of Health asthma initiatives, standardizing outcomes
Abbreviations used : ATS, EC, ERS, Feno, NIH, PROMIS
Plan
| 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. |
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| 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. |
Vol 129 - N° 3S
P. S1-S8 - mars 2012 Retour au numéro
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- Table of Contents
- Asthma outcomes: Biomarkers
- Stanley J. Szefler, Sally Wenzel, Robert Brown, Serpil C. Erzurum, John V. Fahy, Robert G. Hamilton, John F. Hunt, Hirohito Kita, Andrew H. Liu, Reynold A. Panettieri, Robert P. Schleimer, Michael Minnicozzi
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