Asthma outcomes: Pulmonary physiology - 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.Abstract |
Background |
Outcomes of pulmonary physiology have a central place in asthma clinical research.
Objective |
At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to provide recommendations on the use of pulmonary function measures as asthma outcomes that should be assessed in a standardized fashion in future asthma clinical trials and studies to allow for cross-study comparisons.
Methods |
Our subcommittee conducted a comprehensive search of PubMed to identify studies that focused on the validation of various airway response tests used in asthma clinical research. The subcommittee classified the instruments as core (to be required in future studies), supplemental (to be used according to study aims and in a standardized fashion), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.
Results |
A list of pulmonary physiology outcomes that applies to both adults and children older than 6 years was created. These outcomes were then categorized into core, supplemental, and emerging. Spirometric outcomes (FEV1, forced vital capacity, and FEV1/forced vital capacity ratio) are proposed as core outcomes for study population characterization, for observational studies, and for prospective clinical trials. Bronchodilator reversibility and prebronchodilator and postbronchodilator FEV1 also are core outcomes for study population characterization and observational studies.
Conclusions |
The subcommittee considers pulmonary physiology outcomes of central importance in asthma and proposes spirometric outcomes as core outcomes for all future NIH-initiated asthma clinical research.
Le texte complet de cet article est disponible en PDF.Key words : Spirometry, airway responsiveness, peak expiratory flow monitoring, lung volumes, gas exchange
Abbreviations used : ATS, COPD, CV, Dlco, EIB, ERS, FEF25-75, FOT, FRC, FVC, LABA, MBW, MCID, MVV, NIH, PD15, PEF, PV, Raw, Rp, RV, SABA, sGaw, sRaw, TLC
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. |
|
| Disclosure of potential conflict of interest: R. S. Tepper has received research support from the NHLBI. R. S. Wise is a consultant for GlaxoSmithKline, AstraZeneca, Novartis, Boehringer-Ingelheim, Merck, and Sunovion; and has received research support from GlaxoSmithKline, Boehringer-Ingelheim, Merck, and Forest. R. Covar has received research support from the NHLBI. C. G. Irvin has received research support from the NIH and the American Lung Association. M. Kraft has received research support from GlaxoSmithKline, Merck, Asthmatx, Eumedics, Novartis, and Genentech. M. C. Liu has received research support from GlaxoSmithKline, MedImmune, Sanofi-Aventis, and Amgen. G. T. O'Connor is a consultant for Sunovion Inc and has received research support from Novartis. R. Sorkness has received research support from the NIH. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 3S
P. S65-S87 - mars 2012 Retour au numéro
Article précédent
- Asthma outcomes: Healthcare utilization and costs
- Lara J. Akinbami, Sean D. Sullivan, Jonathan D. Campbell, Robert W. Grundmeier, Tina V. Hartert, Todd A. Lee, Robert A. Smith
- Asthma outcomes: Quality of life
- Sandra R. Wilson, Cynthia S. Rand, Michael D. Cabana, Michael B. Foggs, Jill S. Halterman, Lynn Olson, William M. Vollmer, Rosalind J. Wright, Virginia Taggart
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?