March 5, 2012 (Orlando, Florida) — There are new requirements for asthma researchers if they want their studies to be funded by the US National Institutes of Health (NIH), according to a report released by the Asthma Outcomes Workshop here at the American Academy of Allergy, Asthma and Immunology 2012 Annual Meeting.
The report, entitled Standardizing Asthma Outcomes in Clinical Research, proposes definitions for outcomes in asthma studies, "which we hope will be included in ongoing and future NIH research," said workshop cochair Wayne Morgan, MD, from the University of Arizona in Phoenix.
Inclusion of these outcomes will be "considered as requirements in the funding of NIH-initiated asthma clinical trials and large observational studies," according to the report, which was funded by the NIH, the Agency for Healthcare Research and Quality, and the Merck Childhood Asthma Network.
The aim of the initiative is to "translate" asthma studies into a common scientific language by characterizing study participants, outcomes, and methodologies in a homogeneous way, said workshop cochair Alkis Togias, MD, from the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.
Asthma research needs a "common denominator" so that studies can be pooled and compared; "that is what we're missing right now," he said in a press conference.
Use of the proposed outcomes will provide "consistency, at least in the core measurements, from one study to another.... This is a very major step forward," added workshop cochair William Busse, MD, from the University of Wisconsin in Madison.
The 141-page document contains reports from 7 subcommittees, each charged with defining core outcomes for specific areas of asthma research: biomarkers, composite scores of asthma control, exacerbations, healthcare utilization and costs, quality of life (QOL), and symptoms.
The criteria used by each subcommittee to choose a core outcome included the most important clinical aspects of asthma, evidence for the validity of an outcome, and the potential for standardization of an outcome, Dr. Morgan explained.
In addition to core outcomes, each subcommittee identified "supplemental" and "emerging" outcomes; the inclusion of these "in funded clinical asthma research will be optional."
In terms of biomarkers, 10 measures were identified. Only multiallergen screening to establish atopic status was recommended as a core outcome for use in all asthma clinical trials.
Composite scores for measuring asthma control core outcomes for adults and children older than 12 years are the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ). For children younger than 12 years, the Childhood Asthma Control Test (cACT) is proposed as a supplemental outcome.
Although asthma exacerbations are "central to the challenge we have with asthma," there is still a lack of clarity in terms of their definition, said Dr. Morgan.
To this end, the group defined an exacerbation outcome as "a worsening of asthma requiring the use of systemic corticosteroids or [for patients already on corticosteroids] an increase to prevent a serious outcome."
Outcomes for healthcare utilization and costs should include asthma-specific hospital admissions, emergency department visits, outpatient visits, and medication use, according to the report.
For pulmonary physiology, the core outcome should be spirometry for all patients 5 years and older, including forced expiratory volume in 1 second (FEV1), forced vital capacity, and FEV1/forced vital capacity ratio.
The committee wrestled with the QOL domain and had no core outcome recommendations," said Dr. Morgan. Although the committee recommended many QOL outcomes as supplemental, it was felt that core outcomes "didn't focus adequately on the impact of asthma on the quality of an individual's life, compared with the impact of asthma symptomatology per se," he said.
However, the committee did make a number of recommendations for further research into how to develop QOL measures.
Similarly, with symptom outcomes," the committee decided there were no core outcomes," he explained. It was felt that more needs to be done to get solid well-validated standardized methodologies for symptom outcomes." Instead, a number of supplemental outcomes are recommended, including the Asthma Symptom Utility Index and the pediatric asthma caregiver diary.
Although the outcomes document clearly targets research, the ultimate goal is improved patient care, the committee notes. "Through research is improved science, therefore improved treatment," said Dr. Togias.
"Critical to any research sponsored by the NIH is the eventual translation of this information into improved patient care," added Dr. Busse.
The report provides "important structure to allow us to look at outcomes...and better identify what individual is going to respond best to various therapies," Dr. Busse said. "I think this can improve the efficiency with which we treat the disease. If you could have a better idea when you're seeing a patient as to what they're more likely to respond to, you're going to be more efficient with their time and your time."
The 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; and a grant from the Robert Wood Johnson Foundation. Publication of the material was funded by the above-named and by the US Environmental Protection Agency. Dr. Morgan reports serving as a consultant for Genentech, Novartis, and the Cystic Fibrosis Foundation; receiving research support from the NIH-NHLBI CARE network and the Cystic Fibrosis Network; and being a speaker for Phadia. Dr. Togias has disclosed no relevant financial relationships. Dr. Busse reports being on the advisory board for Centocor and Merck; serving as a consultant for Amgen, AstraZeneca, Novartis, GlaxoSmithKline, MedImmune, Genentech, and Boehringer Ingelheim; being on the Actelion Data Safety Monitoring Board; and receiving research support from the NIH.
American Academy of Allergy, Asthma and Immunology (AAAAI) 2012 Annual Meeting: Presented March 3, 2012.
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