title: Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study.
abstract: BACKGROUND
  Few 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  The 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).
  
  
  CONCLUSIONS
  More 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.
authors.affiliation: Pneumology Department, Hospital Universitari Vall d'Hebron, Ciber de Enfermedades Respiratorias (CIBERES), P. de la Vall d'Hebron, 119-129, Barcelona, Spain. mmiravitlles@vhebron.net.
authors.forename: Marc
authors.initials: M
authors.lastname: Miravitlles
authors.affiliation: Medical Department I, Fürth Hospital, Fürth, Germany. med1@klinikum-fuerth.de.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Worth
authors.affiliation: Servicio de Neumología, Hospital Arnau de Vilanova, Valencia, Spain. jjsoler@telefonica.net.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Soler Cataluña
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK. david@respiratoryresearch.org.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Pneumology Unit, Ospedale Clinicizzato SS. Annunziata, Chieti, Italy. debened@unich.it.
authors.forename: Fernando
authors.initials: F
authors.lastname: De Benedetto
authors.affiliation: Cochin Hospital, Paris Descartes University, Paris, France. nicolas.roche@cch.aphp.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Roche
authors.affiliation: Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark. Nina.Skavlan.Godtfredsen@regionh.dk.
authors.forename: Nina Skavlan
authors.initials: NS
authors.lastname: Godtfredsen
authors.affiliation: University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. T.van.der.Molen@med.umcg.nl.
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.affiliation: Department of Respiratory Medicine and Allergology, Lund University Hospital, Lund, Sweden. Claes-Goran.Lofdahl@med.lu.se.
authors.forename: Claes-Göran
authors.initials: CG
authors.lastname: Löfdahl
authors.affiliation: Medical Affairs, Almirall, Barcelona, Spain. laura.padulles@almirall.com.
authors.forename: Laura
authors.initials: L
authors.lastname: Padullés
authors.affiliation: Medical Affairs, Almirall, Barcelona, Spain. anna.ribera@almirall.com.
authors.forename: Anna
authors.initials: A
authors.lastname: Ribera
mesh_terms: D000368:Aged; D001007:Anxiety / Q000453:epidemiology / Q000523:psychology; D002940:Circadian Rhythm; D003863:Depression / Q000453:epidemiology / Q000523:psychology; D004417:Dyspnea / Q000453:epidemiology / Q000503:physiopathology; D005060:Europe / Q000453:epidemiology; D005260:Female; D005541:Forced Expiratory Volume; D006304:Health Status; D006801:Humans; D008168:Lung / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D015995:Prevalence; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000453:epidemiology / Q000503:physiopathology / Q000523:psychology; D012720:Severity of Illness Index; D012890:Sleep; D011795:Surveys and Questionnaires; D013997:Time Factors