title: Regional differences in health-related quality of life in elderly heart failure patients: results from the CIBIS-ELD trial.
abstract: OBJECTIVE
  Patient-reported outcomes such as health-related quality of life (HRQoL) are main treatment goals for heart failure (HF) and therefore endpoints in multinational therapy trials. However, little is known about country-specific differences in HRQoL and in treatment-associated HRQoL improvement. The present work sought to examine those questions.
  
  
  RESULTS
  We analysed data from the Cardiac Insufficiency Bisoprolol Study in Elderly (CIBIS-ELD) trial, in which patients from central and south-eastern Europe completed the HRQoL questionnaire SF-36 at baseline and the end of a 12-week beta-blocker up-titration (follow-up). 416 patients from Serbia (mean age 72.21 years, 69% NYHA-class I-II, 27.4% women) and 114 from Germany (mean age 73.64 years, 78.9% NYHA-class I-II, 47.4% women) were included. Controlling for clinical variables, the change in mental HRQoL from baseline to follow-up was modulated by Country: Serbian patients, Mbaseline= 37.85 vs. Mfollow-up= 40.99, t(526) = 5.34, p < .001, reported a stronger increase than Germans, Mbaseline= 37.66 vs. Mfollow-up= 38.23, t(526) = 0.68, ns. For physical HRQoL, we observed a main effect of Country, MSerbia= 39.28 vs. MGermany= 35.29, t(526) = 4.24, p < .001.
  
  
  CONCLUSIONS
  We observed significant differences in HF patients from Germany and Serbia and country-specific differences between Serbian and German patients in mean physical HRQoL. Changes in mental HRQoL were modulated by country. Those results may reflect psychological, sociocultural, aetiological differences or regional differences in phenotype prevalence. More importantly, they suggest that future multinational trials should consider such aspects when designing a trial in order to avoid uncertainties aligned to data interpretation and to improve subsequent treatment optimisation.
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Centre, Göttingen, Germany. Chavanon@uni-marburg.de.|German Centre for Cardiovascular Research DZHK, Partner Site Göttingen, Göttingen, Germany. Chavanon@uni-marburg.de.|Department of Psychology, Philipps-Universität Marburg, Gutenbergstraße 18, 35032, Marburg, Germany. Chavanon@uni-marburg.de.
authors.forename: Mira-Lynn
authors.initials: ML
authors.lastname: Chavanon
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.
authors.forename: Simone
authors.initials: S
authors.lastname: Inkrot
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Zelenak
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.|German Centre for Cardiovascular Research DZHK, Partner Site Berlin, Berlin, Germany.
authors.forename: Elvis
authors.initials: E
authors.lastname: Tahirovic
authors.affiliation: Clinic for Cardiovascular Diseases, Clinical Centre Nis, University of Niš, Niš, Serbia.
authors.forename: Dragana
authors.initials: D
authors.lastname: Stanojevic
authors.affiliation: Clinic for Cardiovascular Diseases, Clinical Centre Nis, University of Niš, Niš, Serbia.
authors.forename: Svetlana
authors.initials: S
authors.lastname: Apostolovic
authors.affiliation: Department of Cardiology, University Hospital Centre 'Dr Dragisa Misovic-Dedinje', Belgrade, Serbia.|School of Medicine, University of Belgrade, Belgrade, Serbia.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Sljivic
authors.affiliation: School of Medicine, University of Belgrade, Belgrade, Serbia.|Department of Cardiology, Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Arsen D
authors.initials: AD
authors.lastname: Ristic
authors.affiliation: School of Medicine, University of Belgrade, Belgrade, Serbia.|Emergency Department, Clinical Center of Serbia, Belgrade, Serbia.
authors.forename: Dragan
authors.initials: D
authors.lastname: Matic
authors.affiliation: School of Medicine, University of Belgrade, Belgrade, Serbia.|Department of Cardiology, Clinical Hospital Zvezdara, Belgrade, Serbia.
authors.forename: Goran
authors.initials: G
authors.lastname: Loncar
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.|German Centre for Cardiovascular Research DZHK, Partner Site Berlin, Berlin, Germany.
authors.forename: Jovan
authors.initials: J
authors.lastname: Veskovic
authors.affiliation: Department of Cardiology, University Hospital Medical Center Bezanijska Kosa, Belgrade, Serbia.
authors.forename: Marija
authors.initials: M
authors.lastname: Zdravkovic
authors.affiliation: Department of Internal Medicine, General Hospital Murska Sobota and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Mitja
authors.initials: M
authors.lastname: Lainscak
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.|German Centre for Cardiovascular Research DZHK, Partner Site Berlin, Berlin, Germany.
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Centre, Göttingen, Germany.|German Centre for Cardiovascular Research DZHK, Partner Site Göttingen, Göttingen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Herrmann-Lingen
authors.affiliation: Department of Internal Medicine-Cardiology, Charité University Medicine Berlin, Berlin, Germany.|German Centre for Cardiovascular Research DZHK, Partner Site Berlin, Berlin, Germany.
authors.forename: Hans-Dirk
authors.initials: HD
authors.lastname: Düngen
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage; D058671:Adrenergic beta-1 Receptor Antagonists / Q000008:administration & dosage; D000368:Aged; D017298:Bisoprolol / Q000008:administration & dosage*; D002227:Carbazoles / Q000008:administration & dosage*; D000077261:Carvedilol; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006333:Heart Failure / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology*; D006801:Humans; D008297:Male; D000071066:Patient Reported Outcome Measures; D011412:Propanolamines / Q000008:administration & dosage*; D011788:Quality of Life; D013318:Stroke Volume / Q000187:drug effects; D011795:Surveys and Questionnaires
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D058671:Adrenergic beta-1 Receptor Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D017298:Bisoprolol
keywords: Beta-blocker; Heart failure; Patient-reported outcomes; Quality of life