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Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures

BACKGROUND: An understanding of the experience of patients with progressive fibrosing interstitial lung disease (PF-ILD) is needed to select appropriate patient-reported outcome measures (PROMs) to evaluate treatment effect in clinical trials. METHODS: A systematic literature review was conducted to...

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Autores principales: Wijsenbeek, Marlies, Molina-Molina, Maria, Chassany, Olivier, Fox, John, Galvin, Liam, Geissler, Klaus, Hammitt, Katherine M., Kreuter, Michael, Moua, Teng, O'Brien, Emily C., Slagle, Ashley F., Krasnow, Anna, Reaney, Matthew, Baldwin, Michael, Male, Natalia, Rohr, Klaus B., Swigris, Jeff, Antoniou, Katerina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9062300/
https://www.ncbi.nlm.nih.gov/pubmed/35509443
http://dx.doi.org/10.1183/23120541.00681-2021
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author Wijsenbeek, Marlies
Molina-Molina, Maria
Chassany, Olivier
Fox, John
Galvin, Liam
Geissler, Klaus
Hammitt, Katherine M.
Kreuter, Michael
Moua, Teng
O'Brien, Emily C.
Slagle, Ashley F.
Krasnow, Anna
Reaney, Matthew
Baldwin, Michael
Male, Natalia
Rohr, Klaus B.
Swigris, Jeff
Antoniou, Katerina
author_facet Wijsenbeek, Marlies
Molina-Molina, Maria
Chassany, Olivier
Fox, John
Galvin, Liam
Geissler, Klaus
Hammitt, Katherine M.
Kreuter, Michael
Moua, Teng
O'Brien, Emily C.
Slagle, Ashley F.
Krasnow, Anna
Reaney, Matthew
Baldwin, Michael
Male, Natalia
Rohr, Klaus B.
Swigris, Jeff
Antoniou, Katerina
author_sort Wijsenbeek, Marlies
collection PubMed
description BACKGROUND: An understanding of the experience of patients with progressive fibrosing interstitial lung disease (PF-ILD) is needed to select appropriate patient-reported outcome measures (PROMs) to evaluate treatment effect in clinical trials. METHODS: A systematic literature review was conducted to develop a preliminary conceptual model of the symptoms experienced by patients with PF-ILD and the impacts the disease has on them. An online survey and consensus meetings were then conducted with 12–14 stakeholders (patients, clinicians, regulatory and payer advisors) to refine the conceptual model and critically appraise how key concepts should be measured by PROMs. PROMs assessed included Living with Idiopathic Pulmonary Fibrosis, Living with Pulmonary Fibrosis, the King's Brief Interstitial Lung Disease questionnaire, Cough and Sputum Assessment Questionnaire, Evaluating Respiratory Symptoms, Leicester Cough Questionnaire, Functional Assessment of Chronic Illness Therapy (Dyspnoea/Fatigue) and St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis. RESULTS: The literature review identified 36 signs/symptoms and 43 impacts directly or indirectly related to pulmonary aspects of PF-ILD. The most relevant symptoms identified by participants included shortness of breath on exertion, fatigue and cough; relevant impacts included effects on physical functioning, activities of daily living and emotional wellbeing. These are presented in a conceptual model. Consensus opinion was that existing PROMs need further modification and validation before use in clinical trials. CONCLUSIONS: The conceptual model improves understanding of the symptoms and impacts that living with PF-ILD has on patients’ wellbeing. It can help to inform the choice of PROMs in clinical trials and highlight aspects to assess in the clinical care of patients with PF-ILD.
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spelling pubmed-90623002022-05-03 Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures Wijsenbeek, Marlies Molina-Molina, Maria Chassany, Olivier Fox, John Galvin, Liam Geissler, Klaus Hammitt, Katherine M. Kreuter, Michael Moua, Teng O'Brien, Emily C. Slagle, Ashley F. Krasnow, Anna Reaney, Matthew Baldwin, Michael Male, Natalia Rohr, Klaus B. Swigris, Jeff Antoniou, Katerina ERJ Open Res Original Research Articles BACKGROUND: An understanding of the experience of patients with progressive fibrosing interstitial lung disease (PF-ILD) is needed to select appropriate patient-reported outcome measures (PROMs) to evaluate treatment effect in clinical trials. METHODS: A systematic literature review was conducted to develop a preliminary conceptual model of the symptoms experienced by patients with PF-ILD and the impacts the disease has on them. An online survey and consensus meetings were then conducted with 12–14 stakeholders (patients, clinicians, regulatory and payer advisors) to refine the conceptual model and critically appraise how key concepts should be measured by PROMs. PROMs assessed included Living with Idiopathic Pulmonary Fibrosis, Living with Pulmonary Fibrosis, the King's Brief Interstitial Lung Disease questionnaire, Cough and Sputum Assessment Questionnaire, Evaluating Respiratory Symptoms, Leicester Cough Questionnaire, Functional Assessment of Chronic Illness Therapy (Dyspnoea/Fatigue) and St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis. RESULTS: The literature review identified 36 signs/symptoms and 43 impacts directly or indirectly related to pulmonary aspects of PF-ILD. The most relevant symptoms identified by participants included shortness of breath on exertion, fatigue and cough; relevant impacts included effects on physical functioning, activities of daily living and emotional wellbeing. These are presented in a conceptual model. Consensus opinion was that existing PROMs need further modification and validation before use in clinical trials. CONCLUSIONS: The conceptual model improves understanding of the symptoms and impacts that living with PF-ILD has on patients’ wellbeing. It can help to inform the choice of PROMs in clinical trials and highlight aspects to assess in the clinical care of patients with PF-ILD. European Respiratory Society 2022-05-03 /pmc/articles/PMC9062300/ /pubmed/35509443 http://dx.doi.org/10.1183/23120541.00681-2021 Text en Copyright ©The authors 2022 https://creativecommons.org/licenses/by/4.0/This article is open access and distributed under the terms of the Creative Commons Attribution Licence 4.0.
spellingShingle Original Research Articles
Wijsenbeek, Marlies
Molina-Molina, Maria
Chassany, Olivier
Fox, John
Galvin, Liam
Geissler, Klaus
Hammitt, Katherine M.
Kreuter, Michael
Moua, Teng
O'Brien, Emily C.
Slagle, Ashley F.
Krasnow, Anna
Reaney, Matthew
Baldwin, Michael
Male, Natalia
Rohr, Klaus B.
Swigris, Jeff
Antoniou, Katerina
Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title_full Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title_fullStr Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title_full_unstemmed Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title_short Developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
title_sort developing a conceptual model of symptoms and impacts in progressive fibrosing interstitial lung disease to evaluate patient-reported outcome measures
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9062300/
https://www.ncbi.nlm.nih.gov/pubmed/35509443
http://dx.doi.org/10.1183/23120541.00681-2021
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