Health status; Obstructive pulmonary diseases; Patient outcome assessment; Humans; Female; Male; Middle Aged; Adult; Surveys and Questionnaires; Severity of Illness Index; Clinical Relevance; Asthma/drug therapy; Asthma/therapy; Asthma/psychology; Asthma/physiopathology; Patient Reported Outcome Measures; Quality of Life; Asthma; Public Health, Environmental and Occupational Health
Abstract :
[en] [en] RATIONALE: Knowledge about the clinical importance of patient-reported outcome measures (PROMs) in severe asthma is limited.
OBJECTIVES: To assess whether and to what extent asthma exacerbations affect changes in PROMS over time and asthma-specific PROMs can predict exacerbations in adult patients with severe asthma in usual care.
METHODS: Data of 421 patients with severe asthma (62% female; mean age 51.9 ± 13.4 years; mean FEV1 67.5 ± 21.3%pred) from the U-BIOPRED cohort were analyzed. The included PROMs were: Asthma Control Questionnaire (ACQ5); Asthma Quality of Life Questionnaire (AQLQ); Hospital Anxiety and Depression scale (HADS); Epworth Sleepiness Scale (ESS); Medication Adherence Report Scale (MARS); Sino-Nasal Outcomes Test (SNOT20). Participants were assessed at baseline and after 12-18 months of usual care.
RESULTS: PROMs showed very weak to weak correlations with clinical characteristics such as age, body mass index, FEV1, FeNO and eosinophilic cell count. Patients presenting no exacerbations during follow-up showed a statistically significant improvement in all PROMs (except for MARS), whereas individuals experiencing > 2 exacerbations showed a deterioration. Baseline ACQ5 was a predictor of exacerbations with an AUC of 0.590 (95%CI 0.514-0.666).
CONCLUSIONS: The association of PROMs with clinical measures was poor in severe asthmatics. Moreover, PROMs were prone to changes in usual care, with exacerbations playing a key role. PROMs need to be systematically evaluated in severe asthma to improve clinical care based on specific patient's needs.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Meys, Roy; Department of Research and Development, Hornerheide 1, 6085 NM, Ciro, Horn, The Netherlands. roymeys@ciro-horn.nl ; NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. roymeys@ciro-horn.nl ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands. roymeys@ciro-horn.nl
Franssen, Frits M E; Department of Research and Development, Hornerheide 1, 6085 NM, Ciro, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
Van 't Hul, Alex J; Department of Pulmonary Diseases, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands
Bakke, Per S; Department of Clinical Science, University of Bergen, Bergen, Norway
Caruso, Massimo; Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy
Dahlén, Barbro; Lung/Allergy Clinic, Karolinska University Hospital Huddinge, Stockholm, Sweden
Fowler, Stephen J; Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, NIHR Biomedical Research Centre, University of Manchester and Manchester Academic Health Science Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK
Geiser, Thomas; Department of Pulmonary Medicine, University Hospital and University of Bern, Bern, Switzerland
Howarth, Peter H; NIHR Southampton Biomedical Research Centre, Faculty of Medicine, University of Southampton, Southampton, UK
Horváth, Ildikó; Department of Pulmonology, Semmelweis University, Budapest, Hungary ; National Koranyi Institute for Pulmonology, Budapest, Hungary
Krug, Norbert; Fraunhofer Institute for Toxicology and Experimental Medicine Hannover, Hannover, Germany
Behndig, Annelie F; Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden
Singer, Florian; Paediatric Respiratory Medicine, Children's University Hospital of Bern, University of Bern, Bern, Switzerland ; Division of Paediatric Pulmonology and Allergology, Department of Paediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria
Musial, Jacek; Department of Medicine, Jagiellonian University Medical College, Krakow, Poland
Shaw, Dominick E; Respiratory Research Unit, University of Nottingham, Nottingham, UK
Montuschi, Paolo; Catholic University of the Sacred Heart, Rome, Italy ; National Heart and Lung Institute, Imperial College, London, UK
Zee, Anke H Maitland-van der; Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Sterk, Peter J; Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Roberts, Graham; NIHR Southampton Biomedical Research Centre, Faculty of Medicine, University of Southampton, Southampton, UK ; The David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, UK
Kermani, Nazanin Z; National Heart and Lung Institute, Imperial College, London, UK
Louis, Renaud ; Université de Liège - ULiège > Département des sciences cliniques > Pneumologie - Allergologie
Andersson, Lars I; Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden ; Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden
Wagers, Scott S; BioSci Consulting, Maasmechelen, Belgium
Dahlén, Sven-Erik; Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden ; Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden ; Department of Respiratory Medicine and Allergy, Karolinska University Hospital, Stockholm, Sweden
Chung, Kian Fan; National Heart and Lung Institute, Imperial College, London, UK ; Respiratory Department, Royal Brompton & Harefield Hospital, London, UK
Adcock, Ian M; National Heart and Lung Institute, Imperial College, London, UK
Spruit, Martijn A; Department of Research and Development, Hornerheide 1, 6085 NM, Ciro, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
The scientific work of Roy Meys is funded by Lung Foundation Netherlands (#5.1.18.232). U-BIOPRED is supported through an Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115010, resources of which are composed of a financial contribution from the European Union\u2019s Seventh Framework Programme (FP7/2007\u20132013) and EFPIA companies\u2019 in-kind contribution ( www.imi.europa.eu ). We would also like to acknowledge help from the IMI-funded eTRIKS project (EU Grant Code no. 115446). This study is registered on ClinicalTrials.gov (identifier: NCT01982162).This paper is presented on behalf of the U-BIOPRED Study Group with input from the U-BIOPRED Patient Input Platform, Ethics Board and Safety Management Board. We thank all the members of each recruiting center for their dedicated effort, devotion, promptness and care in the recruitment and assessment of the participants in this study. A list of the members of the U-BIOPRED Study Group, all investigators and contributors, partner organizations, members of the ethics board, members of the patient input platform and members of the safety monitoring board can be found in the Online Data Supplement.
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