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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.
期刊论文
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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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The nudge strategies for weight loss in adults with obesity and overweight: A systematic review and meta-analysis
Obesity and overweight conditions have become major health challenges worldwide. The exploration of effective weight loss strategies is essential. Nudges are currently advancing approaches that represent a new and better method for changing the behaviors of people. However, the effectiveness of nudge interventions on weight loss in overweight people who may be obese has not been synthesized in a systematic manner. In this study, a systematic literature search was performed. Only randomized controlled trials (RCTs) were considered. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated as summary statistics. In total, 25 RCTs involving a population of 5,929 individuals were included. Significant effects of the nudge strategy on weight loss (WMD: -0.96 kg, 95% CI: -1.49 to -0.43), body mass index (WMD: -0.3 kg/m2, 95% CI: -0.41 to -0.19) and waist circumference (WMD: -0.75 cm, 95% CI: -1.23 to -0.27) were observed. The subgroup analysis showed that the reduction in body weight associated with nudge interventions was significant in younger and more obese people. Moreover, the effect of nudge intervention on weight loss weakened over time. Overall, the nudge strategy can promote changes in weight loss, body mass index and waist circumference of adults, albeit at a mild magnitude and in particular types of individuals. Nudge strategies can be recommended to clinical practitioners and policy-makers to promote obesity management.
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