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

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          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 (FEV 1), 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 FEV 1 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.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12931-014-0122-1) contains supplementary material, which is available to authorized users.

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          Most cited references26

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          Chronic obstructive pulmonary disease

          Summary Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow obstruction that is only partly reversible, inflammation in the airways, and systemic effects or comorbities. The main cause is smoking tobacco, but other factors have been identified. Several pathobiological processes interact on a complex background of genetic determinants, lung growth, and environmental stimuli. The disease is further aggravated by exacerbations, particularly in patients with severe disease, up to 78% of which are due to bacterial infections, viral infections, or both. Comorbidities include ischaemic heart disease, diabetes, and lung cancer. Bronchodilators constitute the mainstay of treatment: β2 agonists and long-acting anticholinergic agents are frequently used (the former often with inhaled corticosteroids). Besides improving symptoms, these treatments are also thought to lead to some degree of disease modification. Future research should be directed towards the development of agents that notably affect the course of disease.
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            International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results.

            More than 200 published studies from most medical settings worldwide have reported experiences with the Hospital Anxiety and Depression Scale (HADS) which was specifically developed by Zigmond and Snaith for use with physically ill patients. Although introduced in 1983, there is still no comprehensive documentation of its psychometric properties. The present review summarizes available data on reliability and validity and gives an overview of clinical studies conducted with this instrument and their most important findings. The HADS gives clinically meaningful results as a psychological screening tool, in clinical group comparisons and in correlational studies with several aspects of disease and quality of life. It is sensitive to changes both during the course of diseases and in response to psychotherapeutic and psychopharmacological intervention. Finally, HADS scores predict psychosocial and possibly also physical outcome.
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              The hospital anxiety and depression rating scale: A cross-sectional study of psychometrics and case finding abilities in general practice

              Background General practitioners' (GPs) diagnostic skills lead to underidentification of generalized anxiety disorders (GAD) and major depressive episodes (MDE). Supplement of brief questionnaires could improve the diagnostic accuracy of GPs for these common mental disorders. The aims of this study were to examine the usefulness of The Hospital Anxiety and Depression Rating Scale (HADS) for GPs by: 1) Examining its psychometrics in the GPs' setting; 2) Testing its case-finding properties compared to patient-rated GAD and MDE (DSM-IV); and 3) Comparing its case finding abilities to that of the GPs using Clinical Global Impression-Severity (CGI-S) rating. Methods In a cross-sectional survey study 1,781 patients in three consecutive days in September 2001 attended 141 GPs geographically spread in Norway. Sensitivity, specificity, optimal cut off score, and Area under the curve (AUC) for the HADS and the CGI-S were calculated with Generalized Anxiety Questionnaire (GAS-Q) as reference standard for GAD, and Depression Screening Questionnaire (DSQ) for MDE. Results The HADS-A had optimal cut off ≥8 (sensitivity 0.89, specificity 0.75), AUC 0.88 and 76% of patients were correctly classified in relation to GAD. The HADS-D had by optimal cut off ≥8 (sensitivity 0.80 and specificity 0.88) AUC 0.93 and 87% of the patients were correctly classified in relation to MDE. Proportions of the total correctly classified at the CGI-S optimal cut-off ≥3 were 83% of patients for GAD and 81% for MDE. Conclusion The results indicate that addition of the patients' HADS scores to GPs' information could improve their diagnostic accuracy of GAD and MDE.
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                Author and article information

                Contributors
                mmiravitlles@vhebron.net
                med1@klinikum-fuerth.de
                jjsoler@telefonica.net
                david@respiratoryresearch.org
                debened@unich.it
                nicolas.roche@cch.aphp.fr
                Nina.Skavlan.Godtfredsen@regionh.dk
                T.van.der.Molen@med.umcg.nl
                Claes-Goran.Lofdahl@med.lu.se
                laura.padulles@almirall.com
                anna.ribera@almirall.com
                Journal
                Respir Res
                Respiratory Research
                BioMed Central (London )
                1465-9921
                1465-993X
                21 October 2014
                21 October 2014
                2014
                : 15
                : 1
                : 122
                Affiliations
                [ ]Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES), P. de la Vall d’Hebron, 119–129, Barcelona, Spain
                [ ]Medical Department I, Fürth Hospital, Fürth, Germany
                [ ]Servicio de Neumología, Hospital Arnau de Vilanova, Valencia, Spain
                [ ]Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK
                [ ]Pneumology Unit, Ospedale Clinicizzato SS. Annunziata, Chieti, Italy
                [ ]Cochin Hospital, Paris Descartes University, Paris, France
                [ ]Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark
                [ ]University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
                [ ]Department of Respiratory Medicine and Allergology, Lund University Hospital, Lund, Sweden
                [ ]Medical Affairs, Almirall, Barcelona, Spain
                Article
                122
                10.1186/s12931-014-0122-1
                4220061
                25331383
                66b5a6e2-ce3b-4828-b1d7-bdb4d0da3488
                © Miravitlles et al.; licensee BioMed Central Ltd. 2014

                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.

                History
                : 14 July 2014
                : 30 September 2014
                Categories
                Research
                Custom metadata
                © The Author(s) 2014

                Respiratory medicine
                anxiety,assess,copd,depression,dyspnoea,health status,observational,relationship,sleep quality,symptoms

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