NEWS & EVENTS

Asthma Outcomes Workshop

March 15 - 16 , 2010
NIH

Description

Having in mind that Asthma is a major public health concern that affects more than 25 million people in the USA, and recognizing the need for harmonization of data on asthma outcomes across asthma clinical studies, several NIH Institutes, the Agency for Healthcare Research and Quality, and the Merck Childhood Asthma Network convened an Asthma Outcomes Workshop.

The goals of the workshop were to develop standardized definitions and data-collection methods for specific outcomes for asthma clinical studies and to identify promising outcome measures for development and validation.These standardized outcomes will permit useful comparisons across interventional or observational clinical trials and genome-wide studies. They also will allow for greater data sharing and analysis.

The Asthma Outcomes Workshop brought together experts in asthma clinical research and representatives from federal agencies, the pharmaceutical industry, healthcare policy groups, and public voluntary organizations. The Planning Committee created seven subcommittee and selected  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.

  1. Biomarkers Subcommittee
  2. Composite Scores of Asthma Control Subcommittee
  3. Exacerbations Subcommittee
  4. Health Care Utilization and Costs Subcommittee
  5. Pulmonary Physiology Subcommittee
  6. Quality of Life Subcommittee
  7. Symptoms Subcommittee

Recap

Recommendations

The final Asthma Outcomes in Clinical Research: Report of the Asthma Outcomes Workshop was published in March 2012 as a supplement to the Journal of Allergy and Clinical Immunology. Standardized outcomes for clinical research in asthma were proposed for the asthma research community. Participating NIH institutes and other federal agencies will consider these recommendations in future agency-initiated clinical research initiatives in asthma.

  • 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.

Workshop Co-Chairs

  • William Busse, M.D., University of Wisconsin, Madison, WI
  • Wayne Morgan, M.D., University of Arizona, Tucson, AZ

Workshop Subcommittee Chairs

  • Stanley J. Szefler, M.D., National Jewish Health, Denver, CO
  • Sally Wenzel, M.D., University of Pittsburgh, PA
  • Michelle Cloutier, M.D., University of Connecticut, Hartford
  • Michael Schatz, M.D., M.S., Kaiser Permanente, San Diego, CA
  • Anne Fuhlbrigge, M.D., M.S., Brigham and Women’s Hospital, Boston, MA
  • David Peden, M.D., M.S., University of North Carolina at Chapel Hill
  • Lara Akinbami, M.D., National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, MD
  • Sean Sullivan, Ph.D., M.Sc., University of Washington, Seattle
  • Robert Tepper, M.D., Ph.D., Indiana University, Indianapolis
  • Robert Wise, M.D., Johns Hopkins University, Baltimore, MD
  • Sandra Wilson, Ph.D., Palo Alto Medical Foundation Research Institute, CA
  • Cynthia Rand, Ph.D., Johns Hopkins University, Baltimore, MD
  • Jerry Krishnan, M.D., Ph.D., University of Illinois at Chicago
  • Robert Lemanske, Jr., M.D., University of Wisconsin, Madison

Workshop Participants

  • Robert Brown, M.D., M.P.H., Johns Hopkins University, Baltimore, MD
  • Serpil Erzurum, M.D., Cleveland Clinic Foundation, OH
  • John Fahy, M.D., M.Sc., University of California, San Francisco
  • Robert Hamilton, Ph.D., Johns Hopkins University, Baltimore, MD
  • John Hunt, M.D., University of Virginia, Charlottesville
  • Hirohito Kita, M.D., Mayo Clinic, Rochester, MI
  • Andrew Liu, M.D., National Jewish Health, Denver, CO
  • Reynold Panettieri, Jr., M.D., University of Pennsylvania Medical Center, Philadelphia
  • Robert P. Schlemier, Ph.D., Northwestern University, Chicago, IL
  • Mario Castro, M.D., M.P.H., Washington University in St. Louis, MO
  • Noreen Clark, Ph.D., University of Michigan, Ann Arbor
  • H. William Kelly, PharmD, University of New Mexico, Albuquerque
  • Rita Mangione-Smith, M.D., M.P.H., University of Washington, Seattle
  • James Sheller, M.D., Vanderbilt University, Nashville, TN
  • Christine Sorkness, PharmD, University of Wisconsin, Madison
  • Stuart Stoloff, M.D., Independent Family Practice, Carson City, Nevada
  • Andrea Apter, M.D., M.Sc., MA, University of Pennsylvania, Philadelphia
  • Homer Boushey, M.D., University of California, San Francisco
  • Carlos Camargo, Jr., M.D., Dr.P.H., Massachusetts General Hospital, Boston
  • James Gern, M.D., University of Wisconsin, Madison
  • Peter Heymann, M.D., University of Virginia, Charlottesville
  • Fernando Martinez, M.D., University of Arizona, Tucson
  • David Mauger, Ph.D., Pennsylvania State University College of Medicine, Hershey, PA
  • William Teague, M.D., University of Virginia, Charlottesville
  • Jonathan Campbell, M.S., Ph.D., University of Colorado, Denver
  • Robert Grundmeier, M.D., Children’s Hospital of Philadelphia, PA
  • Tina Hartert, M.D., M.P.H., Vanderbilt University, Nashville, TN
  • Todd Lee, PharmD, Ph.D., University of Illinois at Chicago
  • Ronina Covar, M.D., National Jewish Health, Denver, CO
  • Charles Irvin, Ph.D., University of Vermont, Burlington
  • Carolyn Kercsmar, M.D., M.S., Cincinnati Children’s Hospital, OH
  • Monica Kraft, M.D., Duke University, Durham, NC
  • Mark Liu, M.D., Johns Hopkins University, Baltimore, MD
  • George O’Connor, M.D., Boston University, MA
  • Stephen P. Peters, M.D., Ph.D., Wake Forest Baptist Medical Center, Winston-Salem, NC
  • Ronald Sorkness, M.S., Ph.D., R.Ph., University of Wisconsin, Madison
  • Michael Cabana, M.D., M.P.H., University of California, San Francisco
  • Michael Foggs, M.D., Advocate Medical Group of Advocate Health Care, Chicago, IL
  • Jill Halterman, M.D., M.P.H., University of Rochester, NY
  • Lynn Olson, Ph.D., American Academy of Pediatrics, Elk Grove Village, IL
  • William Vollmer, Ph.D., Kaiser Permanente, Portland, OR
  • Rosalind Wright, M.D., M.P.H., Harvard Medical School, Boston, MA
  • Glorisa Canino, M.D., Ph.D., University of Puerto Rico, Rio Piedras
  • Kurtis Elward, M.D., M.P.H., Family Medicine of Albemarle, Charlottesville, VA
  • Meyer Kattan, M.D., Columbia University, NY
  • Elizabeth Matsui, M.D., M.H.S., Johns Hopkins University, Baltimore, MD
  • Herman Mitchell, Ph.D., Rho Federal Systems Division, Inc., Chapel Hill, NC
  • E. Rand Sutherland, M.D., M.P.H., National Jewish Health, Denver, CO
  • Bruce Bender, Ph.D., National Jewish Health, Denver, CO
  • Thomas Casale, M.D., Creighton University, Omaha, NE
  • Rosanna Coffey, Ph.D., Thomson Reuters (Healthcare), Inc., New York, NY
  • Gregory Diette, M.D., M.H.S, Johns Hopkins University, Baltimore, MD
  • Theresa Guilbert, M.D., University of Wisconsin, Madison
  • Elliot Israel, M.D., Harvard Medical School, Boston, MA
  • Tracy Lieu, M.D., M.P.H., Harvard Medical School, Boston, MA
  • Carole Ober, Ph.D., University of Chicago, IL
  • Paul O'Byrne, M.B., FRCP(C), McMaster University, Hamilton, ON
  • Cecilia Patino, M.D., University of Southern California, Los Angeles
  • Thomas Platts-Mills, M.D., Ph.D., University of Virginia, Charlottesville
  • Helen Reddel, M.B., B.S., Ph.D., Woolcock Institute of Medical Research, Victoria, Australia
  • Richard Shiffman, M.D., MCIS, Yale University, New Haven, CT
  • James Stout, M.D., M.P.H., University of Washington, Seattle
  • Kelan Tantisira, M.D., M.P.H., Harvard Medical School, Boston, MA
  • Stephen Teach, M.D., M.P.H, Children's National Medical Center, Washington, DC
  • Edward Zoratti, M.D., Henry Ford Health System, Sterling Heights, MI

NIH Staff

  • Michael Minnicozzi, Ph.D., NIAID, NIH, Bethesda, MD
  • Peter Gergen, M.D., M.P.H., NIAID, NIH, Bethesda, MD
  • Carol Blaisdell, M.D., M.Ed., NHLBI, NIH, Bethesda, MD
  • Robert Smith, Ph.D., NHLBI, NIH, Bethesda, MD
  • Alkis Togias, M.D., NIAID, NIH, Bethesda, MD
  • Virginia Taggart, M.P.H., NHLBI, NIH, Bethesda, MD
  • Michael Minnicozzi, Ph.D., NIAID, NIH, Bethesda, MD

Workshop Participant Observers

  • M. Beth Benedict, DrPH, J.D., RN, Centers for Medicare & Medicaid Services, Washington, DC
  • Frederick Bode, M.D., Sepracor, Inc., Marlborough, MA
  • Mary Brasler, EdD, M.S.N., Asthma and Allergy Foundation of America, Washington, DC
  • Debera Brown, Asthmatx, Inc., Sunnyvale, CA
  • Rebekah Buckley, M.P.H., CRT, Centers for Disease Control and Prevention, Atlanta, GA
  • Franklin Cerasoli, Ph.D., Pfizer, Inc., New York, NY
  • Badrul Chowdhury, M.D., Ph.D., Food and Drug Administration, Silver Spring, MD
  • Thomas Croxton, Ph.D., M.D., National Heart, Lung and Blood Institute, NIH, Bethesda, MD
  • Irene Dankwa-Mullan, M.D., M.P.H., National Center on Minority Health and Health Disparities, NIH, Bethesda, MD
  • Yamo Deniz, M.D., Hoffmann-La Roche, Inc., Basel, Switzerland
  • David Diaz-Sanchez, US Environmental Protection Agency, Washington, DC
  • Norman Edelman, M.D., American Lung Association, Washington, DC
  • Basil Eldadah, M.D., Ph.D., National Institute on Aging, NIH, Bethesda, MD
  • Matthew Fenton, Ph.D., NIAID, NIH, Bethesda, MD
  • Robinson Fulwood, Ph.D., MSPH, NHLBI, NIH, Bethesda, MD
  • Paul Garbe, D.V.M., M.P.H., National Center for Environmental Health Statistics, Centers for Disease Control and Prevention, Hyattsville, MD
  • Margarita Gomez, M.D., NIAID, NIH, Bethesda, MD
  • Karen Huss, Ph.D., M.S.N., RN, National Institute of Nursing Research, NIH, Bethesda, MD
  • James Kiley, Ph.D., NHLBI, NIH, Bethesda, MD
  • Deborah Kilstein, B.S.N., M.B.A., J.D., Association for Community Affiliated Plans, Washington, DC
  • Monroe King, D.O., National Institute on Aging, NIH, Bethesda, MD
  • Kathy Lampl, M.D., AstraZeneca Pharmaceuticals, Wilmington, DE
  • Shao-Lee Lin, M.D., Ph.D., Amgen, Inc., Washington, DC
  • Soeren Mattke, M.D., DSc, RAND Corporation, Santa Monica, CA
  • Patricia Noel, Ph.D., NHLBI, NIH, Bethesda, MD
  • Steve Pascoe, Ph.D., Novartis Pharma AG, Basel, Switzerland
  • Marshall Plaut, M.D., NIAID, NIH, Bethesda, MD
  • Zhaoxia Ren, M.D., Ph.D., NICHD, NIH, Bethesda, MD
  • Daniel Rotrosen, M.D., NIAID, NIH, Bethesda, MD
  • Nancy Santanello, M.D., M.S., Merck Research Laboratories, Whitehouse Station, NJ
  • Diana Schmidt, B.S., M.P.H., NHLBI, NIH, Bethesda, MD
  • Philip Silkoff, M.D., MBBS, MRCP, Centocor R&D, Inc., Malvern, PA
  • Liz Sloss, Ph.D., RAND Health, Santa Monica, CA
  • Alisa Smith, Ph.D., US Environmental Protection Agency, Washington, DC
  • David Stempel, M.D., GlaxoSmithKline, Middlesex, United Kingdom
  • Eileen Storey, M.D., M.P.H., National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Atlanta, GA
  • Gail Weinmann, M.D., NHLBI, NIH, Bethesda, MD
  • Carol Wilhoit, M.D., M.S., Blue Cross Blue Shield of Illinois