Anne M Fitzpatrick1, Stanley J Szefler2, David T Mauger3, Brenda R Phillips3, Loren C Denlinger4, Wendy C Moore5, Ronald L Sorkness4, Sally E Wenzel6, Peter J Gergen7, Eugene R Bleecker8, Mario Castro9, Serpil C Erzurum10, John V Fahy11, Benjamin M Gaston12, Elliot Israel13, Bruce D Levy13, Deborah A Meyers8, W Gerald Teague14, Leonard B Bacharier15, Ngoc P Ly16, Wanda Phipatanakul17, Kristie R Ross12, Joe Zein10, Nizar N Jarjour4. 1. Department of Pediatrics, Emory University, Atlanta, Ga; Children's Healthcare of Atlanta, Atlanta, Ga. Electronic address: anne.fitzpatrick@emory.edu. 2. Children's Hospital Colorado, Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo. 3. Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa. 4. Department of Medicine, University of Wisconsin, Madison, Wis. 5. Department of Internal Medicine, Wake Forest University, Winston-Salem, NC. 6. Department of Medicine, University of Pittsburgh, Pittsburgh, Pa. 7. National Institute of Allergy and Infectious Diseases, Bethesda, Md. 8. College of Medicine, University of Arizona, Tucson, Ariz. 9. Department of Internal Medicine, Washington University, St Louis, Mo. 10. Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio. 11. Department of Medicine, San Francisco, Calif. 12. Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio. 13. Brigham and Women's Hospital, Harvard Medical School, Boston, Mass. 14. Department of Pediatrics, University of Virginia, Charlottesville, Va. 15. Department of Pediatrics, Washington University, St Louis, Mo. 16. Department of Pediatrics, University of California San Francisco, Cleveland, Ohio. 17. Division of Immunology, Boston Children's Hospital, Boston, Mass.
Abstract
BACKGROUND: Tools for quantification of asthma severity are limited. OBJECTIVE: We sought to develop a continuous measure of asthma severity, the Asthma Severity Scoring System (ASSESS), for adolescents and adults, incorporating domains of asthma control, lung function, medications, and exacerbations. METHODS: Baseline and 36-month longitudinal data from participants in phase 3 of the Severe Asthma Research Program (NCT01606826) were used. Scale properties, responsiveness, and a minimally important difference were determined. External replication was performed in participants enrolled in the Severe Asthma Research Program phase 1/2. The utility of ASSESS for detecting treatment response was explored in participants undergoing corticosteroid responsiveness testing with intramuscular triamcinolone and participants receiving biologics. RESULTS: ASSESS scores ranged from 0 to 20 (8.78 ± 3.9; greater scores reflect worse severity) and differed among 5 phenotypic groups. Measurement properties were acceptable. ASSESS was responsive to changes in quality of life with a minimally important difference of 2, with good specificity for outcomes of asthma improvement and worsening but poor sensitivity. Replication analyses yielded similar results, with a 2-point decrease (improvement) associated with improvements in quality of life. Participants with a 2-point or greater decrease (improvement) in ASSESS scores also had greater improvement in lung function and asthma control after triamcinolone, but these differences were limited to phenotypic clusters 3, 4, and 5. Participants treated with biologics also had a 2-point or greater decrease (improvement) in ASSESS scores overall. CONCLUSIONS: The ASSESS tool is an objective measure that might be useful in epidemiologic and clinical research studies for quantification of treatment response in individual patients and phenotypic groups. However, validation studies are warranted.
RCT Entities:
BACKGROUND: Tools for quantification of asthma severity are limited. OBJECTIVE: We sought to develop a continuous measure of asthma severity, the Asthma Severity Scoring System (ASSESS), for adolescents and adults, incorporating domains of asthma control, lung function, medications, and exacerbations. METHODS: Baseline and 36-month longitudinal data from participants in phase 3 of the Severe Asthma Research Program (NCT01606826) were used. Scale properties, responsiveness, and a minimally important difference were determined. External replication was performed in participants enrolled in the Severe Asthma Research Program phase 1/2. The utility of ASSESS for detecting treatment response was explored in participants undergoing corticosteroid responsiveness testing with intramuscular triamcinolone and participants receiving biologics. RESULTS: ASSESS scores ranged from 0 to 20 (8.78 ± 3.9; greater scores reflect worse severity) and differed among 5 phenotypic groups. Measurement properties were acceptable. ASSESS was responsive to changes in quality of life with a minimally important difference of 2, with good specificity for outcomes of asthma improvement and worsening but poor sensitivity. Replication analyses yielded similar results, with a 2-point decrease (improvement) associated with improvements in quality of life. Participants with a 2-point or greater decrease (improvement) in ASSESS scores also had greater improvement in lung function and asthma control after triamcinolone, but these differences were limited to phenotypic clusters 3, 4, and 5. Participants treated with biologics also had a 2-point or greater decrease (improvement) in ASSESS scores overall. CONCLUSIONS: The ASSESS tool is an objective measure that might be useful in epidemiologic and clinical research studies for quantification of treatment response in individual patients and phenotypic groups. However, validation studies are warranted.
Authors: Mitesh Patel; Janine Pilcher; Helen K Reddel; Victoria Qi; Bill Mackey; Tyronne Tranquilino; Dominick Shaw; Peter Black; Mark Weatherall; Richard Beasley Journal: J Allergy Clin Immunol Pract Date: 2014-07-25
Authors: Kian Fan Chung; Sally E Wenzel; Jan L Brozek; Andrew Bush; Mario Castro; Peter J Sterk; Ian M Adcock; Eric D Bateman; Elisabeth H Bel; Eugene R Bleecker; Louis-Philippe Boulet; Christopher Brightling; Pascal Chanez; Sven-Erik Dahlen; Ratko Djukanovic; Urs Frey; Mina Gaga; Peter Gibson; Qutayba Hamid; Nizar N Jajour; Thais Mauad; Ronald L Sorkness; W Gerald Teague Journal: Eur Respir J Date: 2013-12-12 Impact factor: 16.671
Authors: Loren C Denlinger; Brenda R Phillips; Ronald L Sorkness; Eugene R Bleecker; Mario Castro; Mark D DeBoer; Anne M Fitzpatrick; Annette T Hastie; Jonathan M Gaffin; Wendy C Moore; Michael C Peters; Stephen P Peters; Wanda Phipatanakul; Juan Carlos Cardet; Serpil C Erzurum; John V Fahy; Merritt L Fajt; Benjamin Gaston; Bruce D Levy; Deborah A Meyers; Kristie Ross; W Gerald Teague; Sally E Wenzel; Prescott G Woodruff; Joe Zein; Nizar N Jarjour; David T Mauger; Elliot Israel Journal: Am J Respir Crit Care Med Date: 2021-04-01 Impact factor: 21.405
Authors: Joy Alamgir; Masanao Yajima; Rosa Ergas; Xinci Chen; Nicholas Hill; Naved Munir; Mohsan Saeed; Ken Gersing; Melissa Haendel; Christopher G Chute; M Ruhul Abid Journal: medRxiv Date: 2021-04-06