TY - JOUR
T1 - Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
T2 - Measurement Properties of Novel Patient-Reported Symptom Measures
AU - of the Patient-Reported Outcome Consortium's Asthma Working Group
AU - Gater, Adam
AU - Nelsen, Linda
AU - Coon, Cheryl D.
AU - Eremenco, Sonya
AU - O'Quinn, Sean
AU - Khan, Asif H.
AU - Eckert, Laurent
AU - Staunton, Hannah
AU - Bonner, Nicola
AU - Hall, Rebecca
AU - Krishnan, Jerry A.
AU - Stoloff, Stuart
AU - Schatz, Michael
AU - Haughney, John
AU - Coons, Stephen Joel
N1 - Funding Information:
Critical Path Institute is supported by the Food and Drug Administration (FDA), United States of the US Department of Health and Human Services (HHS) and is 54.2% funded by FDA/HHS totaling $13,239,950, and 45.8% funded by nongovernment source(s) totaling $11,196,634. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS, or the US government. For more information, please visit FDA.gov.
Funding Information:
Funding for this research was provided by the following Patient-Reported Outcome Consortium members: Allergan; AstraZeneca AB, United States; Boehringer Ingelheim; Genentech; GlaxoSmithKline LLC, United States; Janssen Global Services, LLC; Merck, Sharp & Dohme Corp.; Novartis Pharma AG, United States; Pfizer, Inc; and Sanofi, France.
Funding Information:
Funding for this research was provided by the following Patient-Reported Outcome Consortium members: Allergan; AstraZeneca AB, United States; Boehringer Ingelheim; Genentech; GlaxoSmithKline LLC, United States; Janssen Global Services, LLC; Merck, Sharp & Dohme Corp.; Novartis Pharma AG, United States; Pfizer, Inc; and Sanofi, France. Critical Path Institute is supported by the Food and Drug Administration (FDA), United States of the US Department of Health and Human Services (HHS) and is 54.2% funded by FDA/HHS totaling $13,239,950, and 45.8% funded by nongovernment source(s) totaling $11,196,634. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS, or the US government. For more information, please visit FDA.gov. Conflicts of interest: A. Gater, N. Bonner, and R. Hall report being employees of Adelphi Values Ltd who received payment from the Patient-Reported Outcome Consortium's Asthma Working Group at the Critical Path Institute to conduct the research reported in this manuscript. L. Nelsen reports being a salaried employee and stock owner of GlaxoSmithKline. C. D. Coon reports personal fees from Adelphi Values during the conduct of the study. S. Eremenco has nothing to disclose. S. O'Quinn reports being an employee of AstraZeneca during the conduct of the study. A. H. Khan reports being an employee of Sanofi during the conduct of the study. L. Eckert reports being an employee of Sanofi during the conduct of the study. H. Staunton was an employee of Adelphi Values Ltd during the conduct of this study and is now an employee and shareholder of Roche Products Limited. J. A. Krishnan reports research funding from US National Institutes of Health, Patient Centered Outcomes Research Institute, Sergey Brin Family Foundation, Regeneron, and Sanofi and is also a member of the US National Asthma Education Prevention Program 2020 Update Guideline writing committee, and the Global Initiative for Asthma. S. Stoloff has nothing to disclose. M. Schatz reports grants from Merck, ALK, and Teva and personal fees from UpToDate and the American Academy of Allergy, Asthma & Immunology outside the submitted work. J. Haughney reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, and Teva, outside the submitted work. S. J. Coons has nothing to disclose.
Funding Information:
Conflicts of interest : A. Gater, N. Bonner, and R. Hall report being employees of Adelphi Values Ltd who received payment from the Patient-Reported Outcome Consortium’s Asthma Working Group at the Critical Path Institute to conduct the research reported in this manuscript. L. Nelsen reports being a salaried employee and stock owner of GlaxoSmithKline. C. D. Coon reports personal fees from Adelphi Values during the conduct of the study. S. Eremenco has nothing to disclose. S. O’Quinn reports being an employee of AstraZeneca during the conduct of the study. A. H. Khan reports being an employee of Sanofi during the conduct of the study. L. Eckert reports being an employee of Sanofi during the conduct of the study. H. Staunton was an employee of Adelphi Values Ltd during the conduct of this study and is now an employee and shareholder of Roche Products Limited. J. A. Krishnan reports research funding from US National Institutes of Health, Patient Centered Outcomes Research Institute, Sergey Brin Family Foundation, Regeneron, and Sanofi and is also a member of the US National Asthma Education Prevention Program 2020 Update Guideline writing committee, and the Global Initiative for Asthma. S. Stoloff has nothing to disclose. M. Schatz reports grants from Merck, ALK, and Teva and personal fees from UpToDate and the American Academy of Allergy, Asthma & Immunology outside the submitted work. J. Haughney reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, and Teva, outside the submitted work. S. J. Coons has nothing to disclose.
Publisher Copyright:
© 2021 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - Background: The Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents. Objective: To determine scoring and evaluate the measurement properties of the ADSD/ANSD. Methods: Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a Patient Global Impression of Severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores. Results: A demographically and clinically diverse sample (n = 130 adolescents; n = 89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal-components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α = 0.94-0.95) and test-retest reliability (intraclass correlation coefficient = 0.86-0.95) were strong. Strong correlations (r = 0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (P < .001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings. Conclusions: The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.
AB - Background: The Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents. Objective: To determine scoring and evaluate the measurement properties of the ADSD/ANSD. Methods: Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a Patient Global Impression of Severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores. Results: A demographically and clinically diverse sample (n = 130 adolescents; n = 89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal-components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α = 0.94-0.95) and test-retest reliability (intraclass correlation coefficient = 0.86-0.95) were strong. Strong correlations (r = 0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (P < .001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings. Conclusions: The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.
KW - Asthma
KW - Clinical outcome assessment
KW - Patient-reported outcome measure
KW - Reliability
KW - Validity
UR - http://www.scopus.com/inward/record.url?scp=85121439590&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2021.11.026
DO - 10.1016/j.jaip.2021.11.026
M3 - Article
AN - SCOPUS:85121439590
SN - 2213-2198
VL - 10
SP - 1249
EP - 1259
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 5
ER -