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Author Notes:

Anne M. Fitzpatrick, Ph.D.

Emory University Department of Pediatrics, 2015 Uppergate Drive, Atlanta, Georgia 30322.

Telephone: 404-727-9112

Facsimile: 404-712-0920

anne.fitzpatrick@emory.edu

The authors would like to acknowledge Dr. William W. Busse for his input regarding the tool development and for his review of the manuscript.

Anne M. Fitzpatrick: Nothing to disclose.

Dr. Szefler reports consultancy fees from Merck, Boehringer-Ingelheim, Genentech, GlaxoSmithKline, Aerocrine, Novartis, Astra Zeneca, Daiichi Sankyo, Roche, Sanofi, Regeneron and Teva; grants from GlaxoSmithKline, outside the submitted work.

Dr. Mauger reports non-financial support from Merck, non-financial support from Boerhinger-Ingleim, non-financial support from GSK, non-financial support from TEVA, non-financial support from Vifor, outside the submitted work.

Brenda R. Phillips: Nothing to disclose.

Dr. Denlinger reports personal fees from AstraZeneca, personal fees from Sanofi, personal fees from GSK, outside the submitted work.

Dr. Moore reports consultancy fees from AstraZeneca, Sanofi, and GlaxoSmithKline; and is the principal investigator in multicenter clinical trials with sponsors Astrazeneca, GSK, Pearl Therapeutics, and Sanofi.

Ronald L. Sorkness: Nothing to disclose.

Dr. Wenzel reports grants and personal fees from AstraZeneca , grants from Beohringer-Ingelheim, grants from GSK, grants from Novartis, grants and personal fees from Sanofi , personal fees from Pieris , personal fees from Up to Date, outside the submitted work; In addition, Dr. Wenzel has a patent null pending.

Peter J. Gergen: Nothing to disclose.

Dr. Bleecker reports other 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, personal fees from ERB has also served as a paid consultant for AztraZeneca, MedImmune, Boehringer Ingelheim, Glaxo Smith Kline, Novartis, Regeneron, and Sanofi Genzyme, outside the submitted work.

Dr. Castro reports personal fees from Astra-Zeneca, Aviragen, Boehringer-Ingelheim, Boston Scientific, Elsevier, Genentech, 4D Pharma, Mallinckrodt, Neutronic, Nuvaira, Teva, Theravance and VIDA; grants from Boehringer-Ingelheim, Chiesi, Genentech, Novartis, Sanofi-Aventis, Vectura; all outside the submitted work.

Dr. Erzurum reports serving as the Chair of the American Board of Internal Medicine Pulmonary Disease Board, outside the submitted work.

Dr. Fahy reports consultancy fees from Boehringer Ingelheim, Pieris, Entrinsic Health Solutions, Sanofi Genzyme; and is a named inventor on three patents, outside the submitted work.

Dr. Gaston reports minority ownership in Respiratory Research, Inc., and intellectual property regarding the treatment of severe asthma.

Dr. Israel reports personal fees from AstraZeneca, personal fees from Novartis, personal fees from Philips Respironics, personal fees from Regeneron Pharmaceuticals, personal fees and other from TEVA Specialty Pharmaceuticals, grants from Genentech, non-financial support from Boehringer Ingelheim, non-financial support from GlaxoSmithKline, non-financial support from Merck, non-financial support from Sunovion, non-financial support from TEVA, grants from Sanofi, personal fees from Bird Rock Bio, personal fees from Nuvelution Pharmaceuticals, personal fees from Vitaeris, Inc, grants from Boehringer Ingelheim, non-financial support from TEVA Specialty Pharmaceuticals, personal fees from Sanofi Genzyme, personal fees from Merck, personal fees from Entrinsic Health Solutions, personal fees from GlaxoSmithKline, other from Vorso Corp., personal fees from Pneuma Respiratory , personal fees from 4D Pharma, outside the submitted work.

Bruce D. Levy: Nothing to disclose.

Deborah A. Meyers: Nothing to disclose.

Dr. Teague reports salary support from the University of Virginia Ivy Foundation (Endowed Chair); Grant support from Panera Bread, TEVA Respiratory, Astra Zeneca and Sanofi/Regeneron; Advisory Boards for Sanofi/Regeneron, TEVA Respiratory, GSK, Genentech, Aviragen; Speaker Bureaus with personal fees from Genentech/Novartis, TEVA Respiratory (QVAR); and Writing committees for the American College of Allergy and Immunology, outside the submitted work.

Dr. Ross reports grants from National Institutes of Health, during the conduct of the study; grants from Ohio Department of Jobs and Family Services, non-financial support from Sunovion, non-financial support from Merck, non-financial support from BI, grants and non-financial support from TEVA, non-financial support from GSK, grants from Astra Zeneca, grants from Roche, outside the submitted work.

Dr. Bacharier reports personal fees from GlaxoSmithKline, personal fees from Genentech/Novartis, personal fees from Merck, personal fees from DBV Technologies, personal fees from Teva, personal fees from Boehringer Ingelheim, personal fees from Sanofi/Regeneron, personal fees from Vectura, personal fees from Circassia, personal fees from AstraZeneca, outside the submitted work.

Dr. Ly reports grants from Vertex 2017, personal fees from Gilead 2017, outside the submitted work.

Wanda Phipatanakul: Nothing to disclose.

Kristie R. Ross: Nothing to disclose.

Dr. Zein reports research support from the Cleveland Clinic.

Dr. Jarjour received honorarium from Astra Zeneca and Boehringer Ingelheim for consultation unrelated to the submitted work. Dr. Jarjour also served on the ABIM Pulmonary Disease Test Committee, outside the submitted work.

Subjects:

Research Funding:

Supported by NHLBI to the Severe Asthma Research Program (SARP): U10 HL109086 U10 HL109146 U10 HL109164 U10 HL109168 U10 HL109172 U10 HL109250 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) UL1 TR002378 (Emory University).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Allergy
  • Immunology
  • Asthma control
  • asthma severity classification
  • severe asthma
  • psychometric testing
  • tool development
  • HEALTH-RELATED QUALITY
  • CORTICOSTEROID RESPONSES
  • OF-LIFE
  • CHILDREN
  • OUTCOMES
  • RELIABILITY
  • CRITERION
  • FEATURES
  • BURDEN
  • COHORT

Development and initial validation of the Asthma Severity Scoring System (ASSESS)

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Journal Title:

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Volume:

Volume 145, Number 1

Publisher:

, Pages 127-139

Type of Work:

Article | Post-print: After Peer Review

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.

Copyright information:

2019

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/rdf).
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