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A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health-Related Quality-of-Life Instruments Part I: Instrument Development and Content Validity
Objectives: Health-related quality-of-life (HRQoL) instruments for cardiovascular diseases (CVD) have been commonly used to measure important patient-reported outcomes (PROs) in clinical trials and practices. This study aimed at systematically identifying and assessing the content validity of CVD-specific HRQoL instruments in clinical studies. Methods: The research team searched Cumulative Index to Nursing and Allied Health Literature, Embase, and PubMed from inception to January 20, 2022. The research team included studies that reported the development and content validity for CVD-specific instruments. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating content validity of PROs. Content analysis was used to categorize the items included in the instruments. Results: The research team found 69 studies reporting the content validity of 40 instruments specifically developed for CVD. Fourteen (35.0%) were rated "sufficient" with very low to moderate quality of evidence. For PRO development, all instruments were rated "doubtful" or "inadequate." Twenty-eight (70.0%) instruments cover the core concepts of HRQoL. Conclusions: The quality of development and content validity vary among existing CVD-specific instruments. The evidence on the content validity should be considered when choosing HRQoL instrument in CVD clinical studies and health economic evaluations.
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Validation of China Health-Related Outcomes Measures-Cardiovascular Disease
Objectives: China Health -Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference -based health -related quality of life instruments for China. CHROME -cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. Methods: This validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based healthrelated quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test -retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item -level performance. Results: A total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n =16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach 's alpha and intraclass correlation coefficient were .0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4 -level response options. Wording of 3 items were modified by referring wordings of reference instruments. Conclusion: The validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.
期刊论文
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Comparison of the measurement properties of the EQ-5D-5L and SF-6Dv2 among overweight and obesity populations in China
Objective To evaluate and compare the measurement properties of the EQ-5D-5L and SF-6Dv2 among Chinese overweight and obesity populations.Methods A representative sample of Chinese overweight and obesity populations was recruited stratified by age, gender, body mass index (BMI), and area of residence. Social-demographic characteristics and self-reported EQ-5D-5L and SF-6Dv2 responses were collected through the online survey. The agreement was assessed using intraclass correlation coefficients (ICC). Convergent validity and known-group validity were examined using Spearman's rank correlation and effect sizes, respectively. The test-retest reliability was assessed using among a subgroup of the total sample. Sensitivity was compared using relative efficiency and receiver operating characteristic.Results A total of 1000 respondents (52.0% male, mean age 51.7 years, 67.7% overweight, 32.3% obesity) were included in this study. A higher ceiling effect was observed in EQ-5D-5L than in SF-6Dv2 (30.6% vs. 2.1%). The mean (SD) utility was 0.851 (0.195) for EQ-5D-5L and 0.734 (0.164) for SF-6Dv2, with the ICC of the total sample was 0.639 (p < 0.001). The Spearman's rank correlation (range: 0.186-0.739) indicated an acceptable convergent validity between the dimensions of EQ-5D-5L and SF-6Dv2. The EQ-5D-5L showed basically equivalent discriminative capacities with the SF-6Dv2 (ES: 0.517-1.885 vs. 0.383-2.329). The ICC between the two tests were 0.939 for EQ-5D-5L and 0.972 for SF-6Dv2 among the subgroup (N = 150). The SF-6Dv2 had 3.7-170.1% higher efficiency than the EQ-5D-5L at detecting differences in self-reported health status, while the EQ-5D-5L was found to be 16.4% more efficient at distinguishing between respondents with diabetes and non-diabetes.Conclusions Both the EQ-5D-5L and SF-6Dv2 showed comparable reliability, validity, and sensitivity when used in Chinese overweight and obesity populations. The two measures may not be interchangeable given the systematic difference in utility values between the EQ-5D-5L and SF-6Dv2. More research is needed to compare the responsiveness.
期刊论文
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Revascularisation versus optimal medical therapy (OMT) for the treatment of chronic coronary syndrome (CCS)
Authors' objectives: Background The aim of this health technology assessment (HTA) is to evaluate the safety, effectiveness, cost, cost-effectiveness and budget impact of revascularisation with percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or both (i.e. PCI or CABG) in comparison to optimal medical therapy (OMT) in patients with chronic coronary syndrome (CCS). Ethical, legal, social and organisational issues related to the interventions are also explored.
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