[Assessment of subjective physical well-being in heart failure : Validation of the FEW16 questionnaire]. / Erfassung des subjektiven körperlichen Wohlbefindens bei Herzinsuffizienz : Validierung des FEW16-Fragebogens.

INTRODUCTION: Improvement in the quality of life (QoL) is a major goal of therapy for heart failure (HF) patients. Physical well-being as an important component of QoL has not yet been sufficiently covered by disease-specific assessment instruments. The aim of the study was to validate the questionnaire for assessing subjective physical well-being (FEW16) in HF patients with preserved ejection fraction (HFpEF) from the exercise training in diastolic heart failure (Ex-DHF­P) trial. METHOD: A total of 64 HFpEF patients (65 years, 56 % female) were randomized to usual routine treatment with (n = 44) or without training (n = 20). At baseline and 3 months, patients were clinically evaluated and assessed using appropriate questionnaires on the QoL (SF36), physical well-being (FEW16) and depression (PHQ-D). RESULTS: The FEW16 showed good values for Cronbachs' alpha coefficients (0.85-0.93). The cross-validity with SF36 and PHQ-D was highly significant but more so for psychological aspects. At baseline, the FEW16 score correlated with age, the subscale resilience with age and the 6 min walking distance test. At follow-up, the total and resilience scores had improved in the training group. In contrast to the SF36, the FEW16 did not detect differences between the groups in Ex-DHF­P. DISCUSSION: The FEW16 questionnaire showed good internal consistency and correlation with SF36, its total score and resilience had improved after training; however, it did not reflect different changes between the study groups. The FEW16 is therefore more suited to assess general/mental well-being than the subjective physical well-being.

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.

AIMS: 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. METHODS AND 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.