Development and initial validation of the Asthma Severity Scoring System (ASSESS) - 05/01/20
, Stanley J. Szefler, MD c, d, David T. Mauger, PhD e, Brenda R. Phillips, MS e, Loren C. Denlinger, MD, PhD f, Wendy C. Moore, MD g, Ronald L. Sorkness, PhD f, Sally E. Wenzel, MD h, Peter J. Gergen, MD, MPH i, Eugene R. Bleecker, MD j, Mario Castro, MD k, Serpil C. Erzurum, MD l, John V. Fahy, MD m, Benjamin M. Gaston, MD n, Elliot Israel, MD o, Bruce D. Levy, MD o, Deborah A. Meyers, PhD j, W.Gerald Teague, MD p, Leonard B. Bacharier, MD q, Ngoc P. Ly, MD r, Wanda Phipatanakul, MD, MSc s, Kristie R. Ross, MD n, Joe Zein, MD l, Nizar N. Jarjour, MD fAbstract |
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.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : Asthma control, asthma severity classification, severe asthma, psychometric testing, tool development
Abbreviations used : ACT, AQLQ, ASSESS, ATS, CASI, ERS, GINA, ICS, MID, SARP
Plan
| Supported by the National Heart, Lung, and Blood Institute’s the Severe Asthma Research Program (SARP): U10 HL109086, U10 HL109146, U10 HL109152, U10 HL109164, U10 HL109168, U10 HL109172, U10 HL109250, and U10 HL109257. In addition, this program is supported through the following National Institutes of Health National Center for Advancing Translational Sciences awards: UL1 TR001420 (Wake Forest University), UL1 TR000427 (University of Wisconsin), UL1 TR001102 (Harvard University), and UL1 TR002378 (Emory University). |
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| Disclosure of potential conflict of interest: S. J. Szefler reports consultancy fees from Merck, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Aerocrine, Novartis, AstraZeneca, Daiichi Sankyo, Roche, Sanofi, Regeneron, and Teva and grants from GlaxoSmithKline outside the submitted work. D. T. Mauger reports nonfinancial support from Merck, nonfinancial support from Boehringer Ingelheim, GlaxoSmithKline, TEVA, and Vifor outside the submitted work. L. C. Denlinger reports personal fees from AstraZeneca, Sanofi, and GlaxoSmithKline outside the submitted work. W. C. Moore reports consultancy fees from AstraZeneca, Sanofi, and GlaxoSmithKline and is the principal investigator in multicenter clinical trials with sponsors AstraZeneca, GlaxoSmithKline, Pearl Therapeutics, and Sanofi. S. E. Wenzel reports grants and personal fees from AstraZeneca and Sanofi; grants from Boehringer Ingelheim, GlaxoSmithKline, and Novartis; and personal fees from Pieris and UpToDate outside the submitted work and has a patent null pending. E. R. Bleecker reports other support from ERB has undertaken clinical trials through his employer, Wake Forest School of Medicine and University of Arizona, for AstraZeneca, MedImmune, Boehringer, Ingelheim, Genentech, Johnson and Johnson (Janssen), Novartis, Regeneron, and Sanofi Genzyme; has received personal fees from ERB; and had served as a paid consultant for AztraZeneca, MedImmune, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Regeneron, and Sanofi Genzyme outside the submitted work. M. Castro reports personal fees from AstraZeneca, Aviragen, Boehringer Ingelheim, Boston Scientific, Elsevier, Genentech, 4D Pharma, Mallinckrodt, Neutronic, Nuvaira, Teva, Theravance, and VIDA and grants from Boehringer Ingelheim, Chiesi, Genentech, Novartis, Sanofi Aventis, Vectura outside the submitted work. S. C. Erzurum reports serving as the Chair of the American Board of Internal Medicine Pulmonary Disease Board outside the submitted work. J. V. Fahy reports consultancy fees from Boehringer Ingelheim, Pieris, Entrinsic Health Solutions, and Sanofi Genzyme and is a named inventor on 3 patents outside the submitted work. B. M. Gaston reports minority ownership in Respiratory Research and intellectual property regarding the treatment of severe asthma. E. Israel reports personal fees from AstraZeneca, Novartis, Philips Respironics, and Regeneron Pharmaceuticals; personal fees and other support from TEVA Specialty Pharmaceuticals; grants from Genentech, Sanofi and Boehringer Ingelheim; nonfinancial support from Boehringer Ingelheim, GlaxoSmithKline, Merck, Sunovion, and TEVA; personal fees from Bird Rock Bio, Nuvelution Pharmaceuticals, and Vitaeris; nonfinancial support from TEVA Specialty Pharmaceuticals; personal fees from Sanofi Genzyme, Merck, Entrinsic Health Solutions, and GlaxoSmithKline; other support from Vorso; and personal fees from Pneuma Respiratory and 4D Pharma outside the submitted work. W. G. Teague reports salary support from the University of Virginia Ivy Foundation (Endowed Chair); reports grant support from Panera Bread, TEVA Respiratory, AstraZeneca, and Sanofi/Regeneron; served on advisory boards for Sanofi/Regeneron, TEVA Respiratory, GlaxoSmithKline, Genentech, and Aviragen; served on speakers’ bureaus with personal fees from Genentech/Novartis and TEVA Respiratory (QVAR); and served on writing committees for the American College of Allergy and Immunology outside the submitted work. L. B. Bacharier reports personal fees from GlaxoSmithKline, Genentech/Novartis, Merck, DBV Technologies, Teva, Boehringer Ingelheim, Sanofi/Regeneron, Vectura, Circassia, and AstraZeneca outside the submitted work. N. Ly reports grants from Vertex 2017 and personal fees from Gilead 2017 outside the submitted work. K. R. Ross reports grants from the National Institutes of Health during the conduct of the study; grants from the Ohio Department of Jobs and Family Services; nonfinancial support from Sunovion, Merck, Boehringer Ingelheim, and GlaxoSmithKline; grants and nonfinancial support from TEVA; and grants from AstraZeneca and Roche outside the submitted work. J. Zein reports research support from the Cleveland Clinic. N. N. Jarjour received honorarium from AstraZeneca for consultation unrelated to the submitted work and served on the ABIM Pulmonary Disease Test Committee outside the submitted work. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 145 - N° 1
P. 127-139 - janvier 2020 Retour au numéro
Article précédent
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