title: Validation of the FEW16 questionnaire for the assessment of physical well-being in patients with heart failure with reduced ejection fraction: results from the CIBIS-ELD study.
abstract: OBJECTIVE
  Patients with heart failure (HF) commonly suffer from severe impairment of quality of life (QoL). One main goal of HF treatment is improvement of QoL. Physical well-being is an essential component of QoL. To enable assessment of physical well-being in HF patients, we validated the FEW16 questionnaire in a prospective study with patients from the Cardiac Insufficiency Bisoprolol Study in ELDerly.
  
  
  RESULTS
  In 127 HF patients (age 73 ± 5.5 years, 72% male, 60% New York Heart Association class II, left ventricular ejection fraction 37 ± 8.5%), we measured physical well-being (FEW16), QoL [36-Item Short-Form Health Survey (SF36)], and depressive symptoms [PRIME MD Patient Health Questionnaire German short version for depression (PHQ-D)] at baseline and two follow-up visits, and correlated FEW16 scores with QoL data and clinical parameters. FEW16 mean scores are 3.04 ± 1.04 at baseline, 3.19 ± 0.94 after 3 months, and 2.77 ± 0.94 after 2-4 years. We assessed data quality, scale assumptions, and construct validity and reliability. Cronbach's alpha for subscales resilience: 0.84; ability to enjoy: 0.80; vitality: 0.88; inner peace: 0.87; total score: 0.95. Intraclass correlation coefficient (ICC) is 0.87 (95% CI 0.84-0.89, ICC (1.4). Pearson's correlations of FEW16 with SF36 and PHQ-D were significant. Six minutes walking distance and heart rate correlated significantly with the FEW16 total score.
  
  
  CONCLUSIONS
  The FEW16 showed good reliability, internal consistency, and intraclass correlation. FEW16 scores correlated well with psychological and physical well-being (SF36) and clinical markers of exercise tolerance (6 min walk test and heart rate). Our results indicate a strong correlation of self-reported physical well-being with psychological factors. FEW16 values at baseline predicted the development of several aspects of QoL during beta-blocker up-titration.
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: E
authors.initials: E
authors.lastname: Tahirović
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: D J
authors.initials: DJ
authors.lastname: Lashki
authors.affiliation: Department of Internal Medicine - CardiologyCharité University Medicine BerlinGermany; German Center for Cardiovascular Research (DZHK)Site BerlinGermany.
authors.forename: T D
authors.initials: TD
authors.lastname: Trippel
authors.affiliation: Medical Clinic for Cardiology and Pulmonology, Campus Benjamin Franklin Charité University Medicine Berlin Germany.
authors.forename: V
authors.initials: V
authors.lastname: Tscholl
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: M
authors.initials: M
authors.lastname: Fritschka
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: L
authors.initials: L
authors.lastname: Musial-Bright
authors.affiliation: HealthTwiSt GmbH Berlin Germany.
authors.forename: A
authors.initials: A
authors.lastname: Busjahn
authors.affiliation: Department of Prevention and Health Promotion, School of Public Health Bielefeld University Bielefeld Germany.
authors.forename: P
authors.initials: P
authors.lastname: Kolip
authors.affiliation: Comprehensive Heart Failure Center University of Würzburg Germany.
authors.forename: S
authors.initials: S
authors.lastname: Störk
authors.affiliation: Centre of Internal Medicine and Dermatology, Clinic for Internal Medicine and Psychosomatics Charité University Medicine Berlin Germany.
authors.forename: M
authors.initials: M
authors.lastname: Rauchfuß
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: S
authors.initials: S
authors.lastname: Inkrot
authors.affiliation: Department of Cardiology and Department of Research and EducationGeneral Hospital Celje, Slovenia and Faculty of Medicine, University of LjubljanaCeljeSlovenia; Faculty of MedicineUniversity of LjubljanaLjubljanaSlovenia.
authors.forename: M
authors.initials: M
authors.lastname: Lainscak
authors.affiliation: Clinical Center Niš, Department of Internal Medicine University of Niš Serbia.
authors.forename: S
authors.initials: S
authors.lastname: Apostolović
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: J
authors.initials: J
authors.lastname: Vesković
authors.affiliation: Cardiology Department Zvezdara University Medical Center Belgrade Serbia.
authors.forename: G
authors.initials: G
authors.lastname: Lončar
authors.affiliation: Center for Stroke Research Charité University Medicine Berlin Germany.
authors.forename: W
authors.initials: W
authors.lastname: Doehner
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: C
authors.initials: C
authors.lastname: Zelenak
authors.affiliation: Department of Internal Medicine - Cardiology Charité University Medicine Berlin Germany.
authors.forename: H D
authors.initials: HD
authors.lastname: Düngen
keywords: FEW16; Heart failure; Physical well‐being; Quality of life (QoL); Validation