Measuring HRQoL following heart valve surgery: the HeartQoL questionnaire is a valid and reliable core heart disease instrument.

PURPOSE: Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery. DESIGN: This project involved a cross-sectional validity study and a test-retest reliability study. METHODS: Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)]. RESULTS: Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables. CONCLUSIONS: The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.

Quality of life in patients with myositis is associated with functional capacity, body composition, and disease activity-Baseline data from a randomized controlled trial.

OBJECTIVE: To investigate the potential associations between functional capacity, muscle strength, body composition, and disease-related measures and quality of life in patients with myositis. METHODS: Baseline measures of functional capacity (functional index 3 (FI3), 2-minute walk test (2MWT), timed up and go (TUG) and 30-s sit-to-stand (30-STS)), muscle strength (incl. leg and handgrip strength), maximal leg extensor power, body composition (appendicular lean mass, fat percentage/mass) and disease-related measures (disease activity & damage core sets) were examined for their associations with quality of life (physical- and mental component summary scores, Short Form 36 questionnaire (SF-36)) by means of Spearman's correlation analysis. RESULTS: A total of 32 patients with myositis were included. Positive correlations between SF-36 physical component summary score (PCS) and FI3, 30-STS, TUG, 2MWT, leg extensor power, leg strength, bench press strength, and handgrip strength were observed. In contrast, fat percentage and fat mass correlated negatively with PCS. In disease-related measures, Extramuscular global assessment, health assessment questionnaire, physician global damage, and patient global damage scores were negatively associated with SF-36 PCS. No correlations to the mental component summary score of SF-36 were observed. CONCLUSION: All measures of functional capacity were positively related to the SF-36 physical component summary score, indicating higher functional capacity positively affects quality of life in patients with myositis. Health assessment questionnaire and patient global damage scores demonstrated the strongest correlations with SF-36 physical component summary scores, further supporting these patient-reported outcomes as viable monitoring tools in patients with myositis.

Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients.

Background Patient-reported health-related quality of life is increasingly used as an outcome measure in clinical trials and as a performance measure to evaluate quality of care. The objective of this study was to assess the psychometric properties of the Danish HeartQoL questionnaire, a core heart disease-specific health-related quality of life questionnaire, in implantable cardioverter defibrillator recipients. Design This study involved cross-sectional and test-retest study designs. Method Implantable cardioverter defibrillator recipients in the cross-sectional study completed the HeartQoL, the Short-Form 36 Health Survey, and the Hospital Anxiety and Depression Scale. The HeartQoL structure, construct-related validity (convergent and discriminative) and reliability (internal consistency) were assessed. HeartQoL reproducibility (test-retest) was assessed in an independent sample of implantable cardioverter defibrillator recipients. Results Mokken scale analysis supported the bi-dimensional structure of HeartQoL among 358 implantable cardioverter defibrillator recipients. Convergent ( r > 0.72) and discriminative validity were confirmed. The HeartQoL scales demonstrated satisfactory internal consistency (Cronbach's alpha > 0.90). Test-retest reliability (two weeks interval) was assessed in 89 implantable cardioverter defibrillator recipients and found to be acceptable for each scale (intra-class correlation > 0.90). Conclusion The Danish HeartQoL questionnaire demonstrated satisfactory key psychometric attributes of validity and reliability in this implantable cardioverter defibrillator population. This study adds support for the HeartQoL as a core heart-specific health-related quality of life questionnaire in a broad group of patients with heart disease including implantable cardioverter defibrillator recipients.

Validating the HeartQoL questionnaire in patients with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is associated with impaired health-related quality-of-life (HRQL). When assessing HRQL, disease-specific and generic instruments are used, which may hinder outcome comparisons across studies. A newly developed core ischaemic heart disease-specific HRQL questionnaire, the HeartQoL, offers a single measurement instrument which may allow outcome comparisons across cardiac diseases. The aim of the study was to evaluate the psychometric properties of HeartQoL in an AF population treated with ablation by assessing its factor structure, construct validity, internal consistency, and test-retest reliability. DESIGN AND METHODS: Data were collected in two phases: (a) a cross-sectional study including 462 patients with AF/atrial flutter who completed the HeartQoL and the Short-Form 36 (SF-36), allowing for the evaluation of internal consistency, factor structure and construct validity; and (b) a longitudinal study including 55 patients completing HeartQoL twice to evaluate test-retest reliability. RESULTS: The two-factor structure of HeartQoL was largely confirmed in patients with AF. Internal consistency was high (Cronbach's alpha (α) ≥ 0.90) and test-retest reliability good (intra-class correlation ≥ 0.90). The construct validity was supported, as subscales of HeartQoL correlated strongly with similar (r ≥ 0.78) and weakly (r ≤ 0.47) with dissimilar subscales of SF-36. The HeartQoL demonstrated ability to distinguish between different clinical subgroups of patients, indicating sensitivity. CONCLUSION: The HeartQoL showed overall satisfactory psychometric properties, demonstrating it to be a valid instrument in the evaluation of HRQL in patients with AF treated with ablation. This suggests that HeartQoL may be a valuable instrument for making HRQL comparisons across the spectrum of cardiac diseases.