Assessing Asthma Symptoms in Adolescents and Adults

Qualitative Research Supporting Development of the Asthma Daily Symptom Diary

Adam Gater, Linda Nelsen, Sarah Fleming, J. Jason Lundy, Nicola Bonner, Rebecca Hall, Chris Marshall, Hannah Staunton, Jerry A. Krishnan, Stuart Stoloff, Michael Schatz, John Haughney, Patient-Reported Outcome Consortium’s Asthma Working Group

Research output: Contribution to journalArticle

2 Citations (Scopus)
3 Downloads (Pure)

Abstract

Background
Despite the widespread availability of patient-reported asthma questionnaires, instruments developed in accordance with present regulatory expectations are lacking. To address this gap, the Patient-Reported Outcome (PRO) Consortium’s Asthma Working Group has developed a patient-reported asthma daily symptom diary (ADSD) for use in clinical research to assess outcomes and support medical product labeling claims in adults and adolescents with asthma.

Objectives
To summarize the qualitative research conducted to inform the initial development of the ADSD and to provide evidence for content validity of the instrument in accordance with the Food and Drug Administration’s PRO Guidance.

Methods
Research informing the initial development and confirming the content validity of the ADSD is summarized. This comprised a review of published qualitative research, semi-structured concept elicitation interviews (n = 55), and cognitive interviews (n = 65) with a diverse and representative sample of adults and adolescents with a clinician-confirmed diagnosis of asthma in the United States to understand the asthma symptom experience and to assess the relevance and understanding of the newly developed ADSD.

Results
From the qualitative literature review and concept elicitation interviews, eight core asthma symptoms emerged. These were broadly categorized as breathing symptoms (difficulty breathing, shortness of breath, and wheezing), chest symptoms (chest tightness, chest pain, and pressure/weight on chest), and cough symptoms (cough and the presence of mucus/phlegm). Conceptual saturation was achieved and differences in the experience of participants according to socio-demographic or clinical characteristics were not observed. Subsequent testing of the ADSD confirmed participant relevance and understanding.

Conclusions
The ADSD is a new patient-reported asthma symptom diary developed in accordance with the Food and Drug Administration’s PRO Guidance. Evidence to date supports the content validity of the instrument. Item performance, reliability, and construct validity will be assessed in future quantitative research.
Original languageEnglish
Pages (from-to)440-450
Number of pages11
JournalValue in Health
Volume19
Issue number4
Early online date30 Mar 2016
DOIs
Publication statusPublished - Jun 2016

Fingerprint

Qualitative Research
Asthma
Research
Thorax
Interviews
United States Food and Drug Administration
Cough
Respiration
Product Labeling
Respiratory Sounds
Mucus
Chest Pain
Reproducibility of Results
Dyspnea

Keywords

  • asthma
  • content validity
  • patient-reported outcomes
  • symptoms

Cite this

Gater, A., Nelsen, L., Fleming, S., Lundy, J. J., Bonner, N., Hall, R., ... Patient-Reported Outcome Consortium’s Asthma Working Group (2016). Assessing Asthma Symptoms in Adolescents and Adults: Qualitative Research Supporting Development of the Asthma Daily Symptom Diary. Value in Health, 19(4), 440-450. https://doi.org/10.1016/j.jval.2016.01.007

Assessing Asthma Symptoms in Adolescents and Adults : Qualitative Research Supporting Development of the Asthma Daily Symptom Diary. / Gater, Adam; Nelsen, Linda; Fleming, Sarah; Lundy, J. Jason; Bonner, Nicola; Hall, Rebecca; Marshall, Chris; Staunton, Hannah; Krishnan, Jerry A.; Stoloff, Stuart; Schatz, Michael; Haughney, John; Patient-Reported Outcome Consortium’s Asthma Working Group.

In: Value in Health, Vol. 19, No. 4, 06.2016, p. 440-450.

Research output: Contribution to journalArticle

Gater, A, Nelsen, L, Fleming, S, Lundy, JJ, Bonner, N, Hall, R, Marshall, C, Staunton, H, Krishnan, JA, Stoloff, S, Schatz, M, Haughney, J & Patient-Reported Outcome Consortium’s Asthma Working Group 2016, 'Assessing Asthma Symptoms in Adolescents and Adults: Qualitative Research Supporting Development of the Asthma Daily Symptom Diary', Value in Health, vol. 19, no. 4, pp. 440-450. https://doi.org/10.1016/j.jval.2016.01.007
Gater, Adam ; Nelsen, Linda ; Fleming, Sarah ; Lundy, J. Jason ; Bonner, Nicola ; Hall, Rebecca ; Marshall, Chris ; Staunton, Hannah ; Krishnan, Jerry A. ; Stoloff, Stuart ; Schatz, Michael ; Haughney, John ; Patient-Reported Outcome Consortium’s Asthma Working Group. / Assessing Asthma Symptoms in Adolescents and Adults : Qualitative Research Supporting Development of the Asthma Daily Symptom Diary. In: Value in Health. 2016 ; Vol. 19, No. 4. pp. 440-450.
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abstract = "BackgroundDespite the widespread availability of patient-reported asthma questionnaires, instruments developed in accordance with present regulatory expectations are lacking. To address this gap, the Patient-Reported Outcome (PRO) Consortium’s Asthma Working Group has developed a patient-reported asthma daily symptom diary (ADSD) for use in clinical research to assess outcomes and support medical product labeling claims in adults and adolescents with asthma.ObjectivesTo summarize the qualitative research conducted to inform the initial development of the ADSD and to provide evidence for content validity of the instrument in accordance with the Food and Drug Administration’s PRO Guidance.MethodsResearch informing the initial development and confirming the content validity of the ADSD is summarized. This comprised a review of published qualitative research, semi-structured concept elicitation interviews (n = 55), and cognitive interviews (n = 65) with a diverse and representative sample of adults and adolescents with a clinician-confirmed diagnosis of asthma in the United States to understand the asthma symptom experience and to assess the relevance and understanding of the newly developed ADSD.ResultsFrom the qualitative literature review and concept elicitation interviews, eight core asthma symptoms emerged. These were broadly categorized as breathing symptoms (difficulty breathing, shortness of breath, and wheezing), chest symptoms (chest tightness, chest pain, and pressure/weight on chest), and cough symptoms (cough and the presence of mucus/phlegm). Conceptual saturation was achieved and differences in the experience of participants according to socio-demographic or clinical characteristics were not observed. Subsequent testing of the ADSD confirmed participant relevance and understanding.ConclusionsThe ADSD is a new patient-reported asthma symptom diary developed in accordance with the Food and Drug Administration’s PRO Guidance. Evidence to date supports the content validity of the instrument. Item performance, reliability, and construct validity will be assessed in future quantitative research.",
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AU - Lundy, J. Jason

AU - Bonner, Nicola

AU - Hall, Rebecca

AU - Marshall, Chris

AU - Staunton, Hannah

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N2 - BackgroundDespite the widespread availability of patient-reported asthma questionnaires, instruments developed in accordance with present regulatory expectations are lacking. To address this gap, the Patient-Reported Outcome (PRO) Consortium’s Asthma Working Group has developed a patient-reported asthma daily symptom diary (ADSD) for use in clinical research to assess outcomes and support medical product labeling claims in adults and adolescents with asthma.ObjectivesTo summarize the qualitative research conducted to inform the initial development of the ADSD and to provide evidence for content validity of the instrument in accordance with the Food and Drug Administration’s PRO Guidance.MethodsResearch informing the initial development and confirming the content validity of the ADSD is summarized. This comprised a review of published qualitative research, semi-structured concept elicitation interviews (n = 55), and cognitive interviews (n = 65) with a diverse and representative sample of adults and adolescents with a clinician-confirmed diagnosis of asthma in the United States to understand the asthma symptom experience and to assess the relevance and understanding of the newly developed ADSD.ResultsFrom the qualitative literature review and concept elicitation interviews, eight core asthma symptoms emerged. These were broadly categorized as breathing symptoms (difficulty breathing, shortness of breath, and wheezing), chest symptoms (chest tightness, chest pain, and pressure/weight on chest), and cough symptoms (cough and the presence of mucus/phlegm). Conceptual saturation was achieved and differences in the experience of participants according to socio-demographic or clinical characteristics were not observed. Subsequent testing of the ADSD confirmed participant relevance and understanding.ConclusionsThe ADSD is a new patient-reported asthma symptom diary developed in accordance with the Food and Drug Administration’s PRO Guidance. Evidence to date supports the content validity of the instrument. Item performance, reliability, and construct validity will be assessed in future quantitative research.

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