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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.
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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.
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A Comparison of Patient-Reported Outcome Measures of Quality of Life By Dialysis Modality in the Treatment of Kidney Failure: A Systematic Review.
Background: There is an increasing demand to incorporate patient-reported outcome measures (PROMs) such as quality of life (QOL) in decision-making when selecting a chronic dialysis modality. Objective: To compare the change in QOL over time among similar patients on different dialysis modalities to provide unique and novel insights on the impact of dialysis modality on PROMs. Design: Systematic reviews, randomized controlled trials, and nonrandomized controlled trials were examined via a comprehensive search strategy incorporating multiple bibliographic databases. Setting: Data were extracted from relevant studies from January 1, 2000 to December 31, 2019 without limitations on country of study conduction. Patients: Eligible studies included adults (≥18 years) with end-stage kidney disease of any cause who were prescribed dialysis treatment (either as lifetime treatment or bridge to transplant). Measurements: The 5 comparisons were peritoneal dialysis (PD) vs in-center hemodialysis (ICHD), home hemodialysis (HHD) vs ICHD, HHD modalities compared with one another, HHD vs PD, and self-care ICHD vs traditional nurse-based ICHD. Methods: Included studies compared adults on different dialysis modalities with repeat measures within individuals to determine changes in QOL between dialysis modalities (in-center or home dialysis). Methodological quality was assessed by the Scottish Intercollegiate Guidelines Network (SIGN 50) checklist. A narrative synthesis was conducted, synthesizing the direction and size of any observed effects across studies. Results: Two randomized controlled trials and 9 prospective cohort studies involving a combined total of 3711 participants were included. Comparing PD and ICHD, 5 out of 9 studies found significant differences (P < .05) favoring PD in the change of multiple QOL domains, including "physical component score," "role of social component score," "cognitive status," "role limitation due to emotional function," "role limitation due to physical function," "bodily pain," "burden of kidney disease," "effects of kidney disease on daily life," "symptoms/problems," "sexual function," "finance," and "patient satisfaction." Conversely, 3 of these studies demonstrated statistically significant differences (P < .05) favoring ICHD in the domains of "role limitation due to physical function," "general health," "support from staff," "sleep quality," "social support," "health status," "social interaction," "body image," and "overall health." Comparing HHD and ICHD, significant differences (P < .05) favoring HHD for the QOL domains of "general health," "burden of kidney disease," and the visual analogue scale were reported. Limitations: Our study is constrained by the small sample sizes of included studies, as well as heterogeneity among both study populations and validated QOL scales, limiting inter-study comparison. Conclusions: We identified differences in specific QOL domains between dialysis modalities that may aid in patient decision-making based on individual priorities. Trial registration: PROSPERO Registration Number: CRD42016046980. Primary funding source: The original research for this study was derived from the Canadian Agency for Drugs and Technologies in Health (CADTH) 2017 optimal use report, titled "Dialysis Modalities for the Treatment of End-Stage Kidney Disease: A Health Technology Assessment." The CADTH receives funding from Canada's federal, provincial, and territorial governments, with the exception of Quebec.
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Health-related quality of life, service utilization and costs of low language: A systematic review.
Background: Low language (LL) is a common childhood condition affecting 7-17% of children. It is associated with life-long adverse outcomes and can affect various aspects of a child's life. However, the literature on its impact on health-related quality of life (HRQoL), service use and costs are limited. To date, there has been no systematic review of the overall economic burden of LL. A systematic review regarding the economic burden of LL is important for clinical, educational, policy decision-making and theoretical aspects. We adopted the term 'low language' to refer to children whose language performance falls below well-recognized cut-points regardless of known or unknown aetiology. Aims: To review the literature systematically on how LL is associated with HRQoL, service utilization and costs. Methods & procedures: A systematic search was conducted across various databases, including MEDLINE, Embase, PsycINFO, CINAHL, up to July 2017. Data on study design, population and outcomes were extracted and screened by two pairs of reviewers with the revision of other experts in the panel on any discrepancies. The Effective Public Health Practice Project tool was used to assess the risk of bias of the included studies. The findings of the included studies were summarized in a narrative synthesis. Outcomes & results: We identified 22 relevant articles, of which 12 reported HRQoL and 11 reported service utilization and costs associated with LL. Preference-based instruments, which include the relative importance attached to different aspects of HRQoL, were less employed in the literature. Most studies found poorer HRQoL in children with LL compared with their peers. About half the families having children with LL did not actively seek professional help, and many families felt they did not receive sufficient services when needed. Healthcare costs associated with LL were substantial. Non-healthcare costs were largely unexplored. Conclusions & implications: LL was associated with reduced children's HRQoL, higher service use and costs. Under-servicing was evident in children with LL. LL also imposed large costs on the healthcare system. Further research is required to examine (1) the overall HRQoL of children with LL, in particular studies using and testing the performance of preference-based instruments; and (2) the service use and costs specific to LL, especially non-healthcare costs.
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Multimorbidity and quality of life at mid-life: A systematic review of general population studies.
There is substantial multimorbidity at mid-life but little is known about the strength of evidence on multimorbidity and health-related quality of life (HrQoL) at mid-life. This review addresses this gap, focusing on studies of the general population. PubMed, Web of Science, Embase and APA PsycNET databases were screened on 6 March 2017 for original research on multimorbidity and HrQoL in adults aged 40-65 years from the general population. Studies focused on index conditions, using single-item HrQoL measures, unlikely to represent the general population (e.g. primary care), and papers that were not in the English language were excluded. A narrative synthesis was presented due to heterogeneity in the measurement of multimorbidity. Of the 2557 articles, 83 underwent full text screening and 8 were included in the review. Included studies were of moderate to high quality and no exclusions were made on the basis of quality or bias. Multimorbidity was associated with poorer HrQoL at mid-life. Two cross-sectional studies found that adults with multimorbidity at early mid-life reported poorer HrQoL than adults with multimorbidity at late mid-life, while another found the reverse. Two distinct disease clusters were identified: mental health conditions and cardiovascular disease (CVD). Those in the mental health cluster reported poorer HrQoL than those in the CVD cluster, women more so than men. Limitations of the selected studies include lack of longitudinal evidence, use of self-reported conditions and no assessment of disease severity. Multimorbidity is associated with poor HrQoL at mid-life at the population level, with some evidence of differences in association with age and disease cluster and sparse evidence on sex differences. Longitudinal research using a weighted disease severity index and multimorbidity trajectories is needed to strengthen the evidence base.
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Effects of self-management on chronic kidney disease: A meta-analysis
BACKGROUND: Self-management programs may facilitate the improvement of outcomes in medical, role, and emotional management and health-related quality of life in patients with chronic kidney disease. Studies on the effect of three self-management tasks have reported conflicting findings. In addition, systematic reviews are unavailable. OBJECTIVE: This study evaluated the effects of self-management programs on medical, role, and emotional management and health-related quality of life in chronic kidney disease. DESIGN: Meta-analysis of randomized controlled studies. DATA SOURCES: The meta-analysis involved an online search of the English literature from PubMed, Cochrane, Web of Science, and CINAHL and the Chinese literature from the Airiti Library that were published from the inception of the websites until January 1, 2017. REVIEW METHODS: The meta-analysis was conducted to evaluate the effects of self-management on chronic kidney disease outcomes. Electronic databases were searched by using keywords: chronic kidney disease, end-stage renal disease, renal failure, dialysis, self-management, self-efficacy, empowerment, cognitive behavioral, and educational. The methodological quality of randomized controlled trials was assessed using the Cochrane Handbook. Data were analyzed using Comprehensive Meta-Analysis software 2.0. RESULTS: Eighteen randomized controlled trials met our inclusion criteria. The results revealed that the self-management program significantly enhanced the effects of self-management on outcomes of medical, role, and emotional management and health-related quality of life in patients with chronic kidney disease. The following Hedges' g (effect size) values were obtained: (1) interdialytic weight gain, -0.36 (95% confidence interval, -0.60 to -0.12, p<0.01); (2) self-efficacy, 0.57 (95% confidence interval, 0.18-0.96, p<0.01); (3) anxiety, -0.95 (95% confidence interval, -1.65 to -0.25, p=0.01); (4) depression, -0.63 (95% confidence interval, -0.85 to -0.41, p<0.01) (5) health-related quality of life for the mental component of the SF-36, 0.71 (95% confidence interval, 0.45-0.97, p<0.01); (6) the physical component of the SF-36, 0.61 (95% confidence interval, 0.35-0.86, p<0.01); and (7) the Kidney Disease Quality of Life, 0.41 (95% confidence interval, 0.17-0.65, p<0.01). DISCUSSION: This study revealed a small effect of self-management on interdialytic weight gain; medium effects on self-efficacy, depression, and health-related quality of life; and a large effect on anxiety. However, high-quality randomized controlled trial designs are required to confirm these results, although the existing evidence can guide clinical practitioners and health policy makers.
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Economic evidence for the prevention and treatment of atopic eczema: a protocol for a systematic review
Background: Eczema, synonymous with atopic eczema or atopic dermatitis, is a chronic skin disease that has a similar impact on health-related quality of life as other chronic diseases. The proposed research aims to provide a comprehensive systematic assessment of the economic evidence base available to inform economic modelling and decision making on interventions to prevent and treat eczema at any stage of the life course. Whilst the Global Resource of Eczema Trials (GREAT) database collects together the effectiveness evidence for eczema, there is currently no such systematic resource on the economics of eczema. It is important to gain an overview of the current state of the art of economic methods in the field of eczema in order to strengthen the economic evidence base further. Methods/design: The proposed study is a systematic review of the economic evidence surrounding interventions for the prevention and treatment of eczema. Relevant search terms will be used to search MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Economic Evaluation Database, Health Technology Assessment, Cumulative Index to Nursing and Allied Health Literature, EconLit, Scopus, Cost-Effectiveness Analysis Registry and Web of Science in order to identify relevant evidence. To be eligible for inclusion studies will be primary empirical studies evaluating the cost, utility or full economic evaluation of interventions for preventing or treating eczema. Two reviewers will independently assess studies for eligibility and perform data abstraction. Evidence tables will be produced presenting details of study characteristics, costing methods, outcome methods and quality assessment. The methodological quality of studies will be assessed using accepted checklists. Discussion: The systematic review is being undertaken to identify the type of economic evidence available, summarise the results of the available economic evidence and critically appraise the quality of economic evidence currently available to inform future economic modelling and resource allocation decisions about interventions to prevent or treat eczema. We aim to use the review to offer guidance about how to gather economic evidence in studies of eczema and/or what further research is necessary in order to inform this.
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