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
VL - 15
JO - Respiratory Research
JF - Respiratory Research
SN - 1465-9921
IS - 1
M1 - 122
ER -