Evaluation of the Functional Status Questionnaire in Heart Failure: A Sub-study of the Second Cardiac Insufficiency Bisoprolol Survival Study (CIBIS-II)
- 356 Downloads
We evaluated a generic quality of life (QoL) Functional Status Questionnaire (FSQ), in patients with chronic heart failure (CHF). The FSQ assesses the 3 main dimensions of QoL: physical functioning, mental health and social role. It also includes 6 single item questions about: work status, frequency of social interactions, satisfaction with sexual relationships, days in bed, days with restricted activity and overall satisfaction with health status. The FSQ was compared to the Minnesota Living with Heart Failure questionnaire (MLwHF).
Methods and results
The FSQ was evaluated in a substudy (n = 340) of the second Cardiac Insufficiency Bisoprolol Survival study (CIBIS-II), a placebo-controlled mortality trial. 265 patients (75%) patients completed both questionnaires at 6 months of follow-up. Both questionnaires indicated substantially impaired QoL. The FSQ demonstrated high internal consistency (Cronbach’s α > 0.7 for all items except “social activity” = 0.66) and construct and concurrent validity. After 6 months, the only item on either questionnaire to show a difference between the placebo- and bisoprolol-treatment groups was the single item FSQ question about “days in bed” (p = 0.018 in favour of bisoprolol).
The FSQ performed well in this study, provided additional information to the MLwHF questionnaire and allowed interesting comparisons with other chronic medical conditions. The FSQ may be a useful general QoL instrument for studies in CHF.
Key wordsHeart failure Quality of life Functional status questionnaire Minnesota living with heart failure questionnaire
- 1.Hobbs FDR, Kenkre JE, Roalfe AK, et al. Impact of heart failure and left ventricular systolic dysfunction on quality of life. A cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population. Eur Heart J. 2002;23:1867–76.PubMedCrossRefGoogle Scholar
- 7.Rector TS, Kubo SH, Cohn JN. Patient’s self assessment of their congestive heart failure. Part 2: content, reliability and validity of a new measure: the Minnesota Living with Heart Failure questionnaire. Heart Fail. 1987;3:198–219.Google Scholar
- 9.Soderback I, Schult ML, Nordemar R. Assessment of patients with chronic back pain using the Functional Status Questionnaire. Scand J Rehab Med. 1993;25:139–43.Google Scholar
- 17.Design of the cardiac insufficiency bisoprolol study II (CIBIS II). The CIBIS II Scientific Committee. Fundam Clin Pharmacol. 1997; 11:138–42Google Scholar
- 21.Hjalmarson A, Goldstein S, Fagerberg B, et al. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure the metoprolol CR/XL randomized intervention trial in Congestive Heart Failure (MERIT-HF). JAMA. 2000;283:1295–302.PubMedCrossRefGoogle Scholar
- 26.Colucci WS, Packer M, Bristow MR, et al. Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure. US Carvedilol Heart Failure Study Group. Circulation. 1996;942:800–6.Google Scholar
- 27.Packer M, Colucci WS, Sackner-Bernstein JD, et al. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective randomized evaluation of carvedilol on symptoms and exercise. Circulation. 1996;94:2793–9.PubMedGoogle Scholar