Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study

Marc Miravitlles; Heinrich Worth; Juan Soler Cataluña; David Price; Fernando de Benedetto; Nicolas Roche; Nina Godtfredsen; Thys van der Molen; Claes-Göran Löfdahl; Laura Padullés; Anna Ribera

doi:10.1186/PREACCEPT-1114873655135960

Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study

Marc Miravitlles, Heinrich Worth, Juan Soler Cataluña, David Price, Fernando de Benedetto, Nicolas Roche, Nina Godtfredsen, Thys van der Molen, Claes-Göran Löfdahl, Laura Padullés, Anna Ribera

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Abstract

BackgroundFew studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes.MethodsThe study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded.ResultsThe full analysis set included 727 patients: 65.8% male, mean¿±¿standard deviation age 67.2¿±¿8.8 years, % predicted FEV1 52.8¿±¿20.5%.In each part of the 24-hour day, >60% of patients reported experiencing ¿1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ¿2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p¿<¿0.001).Early morning and daytime symptoms were associated with the severity of airflow obstruction (p¿<¿0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p¿<¿0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient¿s physical activity level (p¿<¿0.05 for each period).ConclusionsMore than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.

Original language	English
Article number	122
Journal	Respiratory Research
Volume	15
Issue number	1
DOIs	https://doi.org/10.1186/PREACCEPT-1114873655135960
Publication status	Published - 21 Oct 2014

Bibliographical note

Acknowledgements
The authors would like to thank the study investigators at each of the participating centres for their contribution to the study. The full list of study investigators is available in Additional file 1. We would also like to thank Deborah McGregor, PhD, of Complete Medical Communications, who provided medical writing support funded by Almirall, S.A. Barcelona, Spain.

This study was funded by Almirall S.A., Barcelona, Spain. The study sponsor was involved in the design of the study, analysis of the data, review of the data, and review and approval of the manuscript. The sponsors placed no restrictions on statements made in the final version of the manuscript or on the decision to submit the manuscript for publication and all authors had full access to the data.

Keywords

anxiety
ASSESS
COPD
depression
dyspnoea
health status
observational
relationship
sleep quality
symptoms

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10.1186/PREACCEPT-1114873655135960

Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes
© 2014 Miravitlles et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Miravitlles, M., Worth, H., Soler Cataluña, J., Price, D., de Benedetto, F., Roche, N., Godtfredsen, N., van der Molen, T., Löfdahl, C.-G., Padullés, L., & Ribera, A. (2014). Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study. Respiratory Research, 15(1), Article 122. https://doi.org/10.1186/PREACCEPT-1114873655135960

Miravitlles, M, Worth, H, Soler Cataluña, J, Price, D, de Benedetto, F, Roche, N, Godtfredsen, N, van der Molen, T, Löfdahl, C-G, Padullés, L & Ribera, A 2014, 'Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study', Respiratory Research, vol. 15, no. 1, 122. https://doi.org/10.1186/PREACCEPT-1114873655135960

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title = "Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study",

abstract = "BackgroundFew studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes.MethodsThe study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded.ResultsThe full analysis set included 727 patients: 65.8% male, mean¿±¿standard deviation age 67.2¿±¿8.8 years, % predicted FEV1 52.8¿±¿20.5%.In each part of the 24-hour day, >60% of patients reported experiencing ¿1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ¿2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p¿<¿0.001).Early morning and daytime symptoms were associated with the severity of airflow obstruction (p¿<¿0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p¿<¿0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient¿s physical activity level (p¿<¿0.05 for each period).ConclusionsMore than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.",

keywords = "anxiety, ASSESS, COPD, depression, dyspnoea, health status, observational , relationship, sleep quality, symptoms",

author = "Marc Miravitlles and Heinrich Worth and {Soler Catalu{\~n}a}, Juan and David Price and {de Benedetto}, Fernando and Nicolas Roche and Nina Godtfredsen and {van der Molen}, Thys and Claes-G{\"o}ran L{\"o}fdahl and Laura Padull{\'e}s and Anna Ribera",

note = "Acknowledgements The authors would like to thank the study investigators at each of the participating centres for their contribution to the study. The full list of study investigators is available in Additional file 1. We would also like to thank Deborah McGregor, PhD, of Complete Medical Communications, who provided medical writing support funded by Almirall, S.A. Barcelona, Spain. This study was funded by Almirall S.A., Barcelona, Spain. The study sponsor was involved in the design of the study, analysis of the data, review of the data, and review and approval of the manuscript. The sponsors placed no restrictions on statements made in the final version of the manuscript or on the decision to submit the manuscript for publication and all authors had full access to the data.",

year = "2014",

month = oct,

day = "21",

doi = "10.1186/PREACCEPT-1114873655135960",

language = "English",

volume = "15",

journal = "Respiratory Research",

issn = "1465-9921",

publisher = "BioMed Central",

number = "1",

}

TY - JOUR

T1 - Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes

T2 - results from the ASSESS study

AU - Miravitlles, Marc

AU - Worth, Heinrich

AU - Soler Cataluña, Juan

AU - Price, David

AU - de Benedetto, Fernando

AU - Roche, Nicolas

AU - Godtfredsen, Nina

AU - van der Molen, Thys

AU - Löfdahl, Claes-Göran

AU - Padullés, Laura

AU - Ribera, Anna

N1 - Acknowledgements The authors would like to thank the study investigators at each of the participating centres for their contribution to the study. The full list of study investigators is available in Additional file 1. We would also like to thank Deborah McGregor, PhD, of Complete Medical Communications, who provided medical writing support funded by Almirall, S.A. Barcelona, Spain. This study was funded by Almirall S.A., Barcelona, Spain. The study sponsor was involved in the design of the study, analysis of the data, review of the data, and review and approval of the manuscript. The sponsors placed no restrictions on statements made in the final version of the manuscript or on the decision to submit the manuscript for publication and all authors had full access to the data.

PY - 2014/10/21

Y1 - 2014/10/21

N2 - BackgroundFew studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes.MethodsThe study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded.ResultsThe full analysis set included 727 patients: 65.8% male, mean¿±¿standard deviation age 67.2¿±¿8.8 years, % predicted FEV1 52.8¿±¿20.5%.In each part of the 24-hour day, >60% of patients reported experiencing ¿1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ¿2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p¿<¿0.001).Early morning and daytime symptoms were associated with the severity of airflow obstruction (p¿<¿0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p¿<¿0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient¿s physical activity level (p¿<¿0.05 for each period).ConclusionsMore than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.

AB - BackgroundFew studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes.MethodsThe study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded.ResultsThe full analysis set included 727 patients: 65.8% male, mean¿±¿standard deviation age 67.2¿±¿8.8 years, % predicted FEV1 52.8¿±¿20.5%.In each part of the 24-hour day, >60% of patients reported experiencing ¿1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ¿2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p¿<¿0.001).Early morning and daytime symptoms were associated with the severity of airflow obstruction (p¿<¿0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p¿<¿0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between symptoms and a patient¿s physical activity level (p¿<¿0.05 for each period).ConclusionsMore than half of patients experienced COPD symptoms throughout the whole 24-hour day. There was a significant relationship between night-time, early morning and daytime symptoms. In each period, symptoms were associated with worse patient-reported outcomes, suggesting that improving 24-hour symptoms should be an important consideration in the management of COPD.

KW - anxiety

KW - ASSESS

KW - COPD

KW - depression

KW - dyspnoea

KW - health status

KW - observational

KW - relationship

KW - sleep quality

KW - symptoms

U2 - 10.1186/PREACCEPT-1114873655135960

DO - 10.1186/PREACCEPT-1114873655135960

M3 - Article

C2 - 25331383

SN - 1465-9921

VL - 15

JO - Respiratory Research

JF - Respiratory Research

IS - 1

M1 - 122

ER -

Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study

Abstract

Bibliographical note

Keywords

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