Health-related quality of life (HRQOL) in patients with cardiovascular disease in Korea has rarely been studied, mostly due to the lack of a psychometrically validated disease-specific instrument. The purpose of this study was to develop and validate a cardiovascular specific-HRQOL questionnaire (CD-QOL).

The CD-QOL was developed and validated as follows; item generation, pilot study, and psychometric tests. Patients were recruited from three-university hospitals. The patients were asked to complete the preliminary questionnaire comprising the content-validated items, SF-36, and CES-D. The NYHA and KASI classifications were used to classify the functional performance of the patients. The data was analyzed using correlation, factor analysis, multidimensional scaling, multitrait/multi-item matrix, ANOVA, and Cronbach's alpha.

Preliminarily, thirty-nine items were generated. Factor analysisextracted a five-factor solution with a total of twenty-two items. One item was deleted based upon the MDS. The remaining items were moderately correlated with the subscales of the SF-36 and associated with depression measured with the CES-D. The mean scores of patients in NYHA and KASI class I were significantly higher than those in NYHA and KASI class II or/and III, which suggested patients with better functional performance were likely to have a better HRQOL. Cronbach's alphas of the total and subscales were all greater than 0.70.

The CD-QOL is a easily applicable instrument with excellent psychometric properties of content, criterion, factorial, convergent, and known-groups validity, and internal consistency reliability in Korean patients with cardiovascular disease.