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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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The Effects of Oral Probiotic Supplementation in Postmenopausal Women with Overweight and Obesity: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Gut microbiota has been identified as a unique endocrine organ linked to the development of cardiovascular disease and other illnesses, especially deteriorated in overweight and obese postmenopausal women. The object of this systematic review and meta-analysis aimed to assess the effects of oral supplementation with probiotics for overweight and obese postmenopausal women. We performed a systematic search for randomized controlled trials (RCTs) from inception to April 2022 in MEDLINE, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov. We also performed a hand search by reviewing reference lists to identify trials. The risk of bias in individual studies was assessed with the Cochrane risk of bias tool for randomized trials (RoB). Two reviewers independently selected studies and collected data. There were 6 studies from 5 RCTs with 281 participants in this systematic review. Compared with the placebo, the probiotics supplementation group had reductions in insulin (MD - 4.20 IU/L (95% CI - 8.11 to - 0.30 IU/L), I-2 = 54%), HOMA-IR (MD - 1.25 (95% CI - 2.49 to - 0.01), I-2 = 50%), and TNF-alpha (MD - 0.12 pg/mL (95% CI - 0.22 to - 0.01 pg/mL), I-2 = 44%). Improvements were also shown in body adiposity and lipid profile, but these effects were nonsignificant. In addition to body adiposity and cardiovascular risk markers, one trial showed the administration of probiotics also had an effect on iron metabolism. In conclusion, probiotics have a potential benefit on glucose metabolism and inflammatory process in overweight and obese postmenopausal women, but this effect is mild. It demonstrates that oral probiotics supplementation can be a complementary treatment for improving the fitness of postmenopausal women with overweight and obesity.
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Long-term exposure to particulate matter on cardiovascular and respiratory diseases in low- and middle-income countries: A systematic review and meta-analysis
BackgroundLong-term exposure to particulate matter (PM) has essential and profound effects on human health, but most current studies focus on high-income countries. Evidence of the correlations between PM and health effects in low- and middle-income countries (LMICs), especially the risk factor PM1 (particles < 1 mu m in size), remains unclear. ObjectiveTo explore the effects of long-term exposure to particulate matter on the morbidity and mortality of cardiovascular and respiratory diseases in LMICs. MethodsA systematic search was conducted in the PubMed, Web of Science, and Embase databases from inception to May 1, 2022. Cohort studies and case-control studies that examine the effects of PM1, PM2.5, and PM10 on the morbidity and mortality of cardiovascular and respiratory diseases in LMICs were included. Two reviewers independently selected the studies, extracted the data, and assessed the risk of bias. Outcomes were analyzed via a random effects model and are reported as the relative risk (RR) with 95% CI. ResultsOf the 1,978 studies that were identified, 38 met all the eligibility criteria. The studies indicated that long-term exposure to PM2.5, PM10, and PM1 was associated with cardiovascular and respiratory diseases: (1) Long-term exposure to PM2.5 was associated with an increased risk of cardiovascular morbidity (RR per 1.11 mu g/m(3), 95% CI: 1.05, 1.17) and mortality (RR per 1.10 mu g/m(3), 95% CI: 1.06, 1.14) and was significantly associated with respiratory mortality (RR 1.31, 95% CI: 1.25, 1.38) and morbidity (RR 1.08, 95% CI: 1.02, 1.04); (2) An increased risk of respiratory mortality was observed in the elderly (65+ years) (RR 1.21, 95% CI: 1.00, 1.47) with long-term exposure to PM2.5; (3) Long-term exposure to PM10 was associated with cardiovascular morbidity (RR 1.07, 95% CI 1.01, 1.13), respiratory morbidity (RR 1.43, 95% CI: 1.21, 1.69) and respiratory mortality (RR 1.28, 95% CI 1.10, 1.49); (4) A significant association between long-term exposure to PM1 and cardiovascular disease was also observed. ConclusionsLong-term exposure to PM2.5, PM10 and PM1 was all related to cardiovascular and respiratory disease events. PM2.5 had a greater effect than PM10, especially on respiratory diseases, and the risk of respiratory mortality was significantly higher for LMICs than high-income countries. More studies are needed to confirm the effect of PM1 on cardiovascular and respiratory diseases.
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White rice consumption and risk of cardiometabolic and cancer outcomes: A systematic review and dose-response meta-analysis of prospective cohort studies
White rice is the food more than half of the world's population depends on. White rice intake can significantly increase the glycemic load of consumers and bring some adverse health effects. However, the quality of evidence implicating white rice in adverse health outcomes remains unclear. To evaluate the association between white rice consumption and the risk of cardiometabolic and cancer outcomes, a systematic review and dose-response meta-analysis of the relevant publications were performed. Twenty-three articles including 28 unique prospective cohorts with 1,527,198 participants proved eligible after a comprehensive search in four databases. For the risk of type 2 diabetes mellitus (T2DM), the pooled RR was 1.18 (16 more per 1000 persons) for comparing the highest with the lowest category of white rice intake, with moderate certainty evidence. Females presented a higher risk (23 more per 1000 persons) in subgroup analysis. And every additional 150 grams of white rice intake per day was associated with a 6% greater risk of T2DM (5 more per 1000 persons) with a linear positive trend. We found no significant associations between white rice intake and risk of cardiovascular diseases (CVD), CVD mortality, cancer, and metabolic syndrome. In conclusion, moderate certainty evidence demonstrated that white rice intake was associated with T2DM risk, with a linear positive trend. However, low to very low certainty of evidence suggested that no substantial associations were found between white rice intake and other cardiometabolic and cancer outcomes. More cohorts are needed to strength the evidence body.
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Effects of Nutritional Interventions on Cardiovascular Disease Health Outcomes in Aboriginal and Torres Strait Islander Australians: A Scoping Review.
Nutrition interventions can support Aboriginal and Torres Strait Islander peoples to reduce their risk of cardiovascular disease (CVD). This review examines nutritional interventions aiming to improve CVD outcomes and appraises peer-reviewed interventions using an Aboriginal and Torres Strait Islander Quality Appraisal Tool. Five electronic databases and grey literature were searched, applying no time limit. Two reviewers completed the screening, data extraction and quality assessment independently. The study quality was assessed using the South Australian Health and Medical Research Institute and the Centre of Research Excellence in Aboriginal Chronic Disease Knowledge Translation and Exchange Aboriginal and Torres Strait Islander Quality Appraisal Tool (QAT). Twenty-one nutrition programs were included in this review. Twelve reported on anthropometric measurements, ten on biochemical and/or hematological measurements and sixteen on other outcome domains. Most programs reported improvements in measurable CVD risk factors, including reduced body mass index (BMI), waist circumference (WC), weight, blood pressure and improved lipid profiles. Most programs performed well at community engagement and capacity strengthening, but many lacked the inclusion of Indigenous research paradigms, governance and strengths-based approaches. This review highlights the need for contemporary nutrition programs aimed at improving cardiovascular health outcomes to include additional key cultural components.
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Economic evaluation of the utilization of telemedicine for patients with cardiovascular disease: a systematic review.
Cardiovascular disease is one of the major causes of mortality in the world, with high human and financial burdens on communities. Telemedicine is a tool for providing services for patients that are difficult to access or in need of immediate care. The aim of this study was to systematically review economic evaluation studies that compared telemedicine with usual care for cardiovascular patients. A systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and related articles published up to December 2018 were searched in different databases (PubMed, Embase, SCOPUS, Global Health, Google Scholar, Magiran, SID). The articles were selected based on inclusion and exclusion criteria. Consolidated health economic evaluation reporting standards statement checklist was used to qualitatively evaluate the papers. Overall, 20 articles were included in the study. The studies used quality-adjusted life years to measure outcomes. The highest and lowest values of Incremental Cost-effectiveness Ratio were $515,082 and $2099 that had been reported in the UK and New Zealand, respectively. Most of the items of the checklist were reported and the quality of most of the studies was excellent and very good. According to the results, telemedicine improves the clinical outcomes and results in considerable saving in costs. Utilizing telemedicine concurrent with the usual care for service delivery is more cost-effective. The reviewed studies had been conducted in high-income countries, hence, it is essential to be cautious when generalizing the results and applying them in health systems policymaking.
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Economic evaluations of pharmacist-led medication review in outpatients with hypertension, type 2 diabetes mellitus, and dyslipidaemia: a systematic review.
Objectives: To evaluate the health economics evidence based on randomized controlled trials of pharmacist-led medication review in pharmacotherapy managed cardiovascular disease risk factors, specifically, hypertension, type-2 diabetes mellitus and dyslipidaemia in ambulatory settings and to provide recommendations for future evaluations. Methods: A systematic review was carried out according to the Cochrane Handbook for Systematic Reviews. PubMed (Medline), Scopus, Web of Science, National Health System Economic Evaluation Database (NHS EED), Cochrane Library, and Econlit were searched and screened by two independent authors. Incremental cost-effectiveness ratio was the main outcome. Risk of bias was assessed with the Effective Practice and Organisation of Care tool by the Cochrane Collaboration. Economic evaluation quality was assessed with the he Consensus Health Economic Criteria list (CHEC list). Results: 5636 records were found, and 174 were retrieved for full-text review yielding 11 articles. Eight articles deemed the intervention as cost effective and two as dominant. Two cost-utility analyses were performed yielding ICERs of $612.7 and $59.8 per QALY. Four articles were considered to perform a high-quality economic evaluation and four had a low risk of bias. Future economic evaluations should consider cost-utility analysis, to describe usual care thoroughly, and use time horizons that capture the effect of cardiovascular disease prevention, a societal perspective and uncertainty analysis. Conclusion: Pharmacist-led medication review has proven to be cost effective in various studies in different settings. Policy decision makers are advised to undertake local economic evaluations reflecting the gaps observed in this systematic review and published literature. If this is not possible, a transferability assessment should be conducted.
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The effectiveness of self-management mobile phone and tablet apps in long-term condition management: A systematic review
BACKGROUND: Long-term conditions and their concomitant management place considerable pressure on patients, communities, and health care systems worldwide. International clinical guidelines on the majority of long-term conditions recommend the inclusion of self-management programs in routine management. Self-management programs have been associated with improved health outcomes; however, the successful and sustainable transfer of research programs into clinical practice has been inconsistent. Recent developments in mobile technology, such as mobile phone and tablet computer apps, could help in developing a platform for the delivery of self-management interventions that are adaptable, of low cost, and easily accessible. OBJECTIVE: We conducted a systematic review to assess the effectiveness of mobile phone and tablet apps in self-management of key symptoms of long-term conditions. METHODS: We searched PubMed, Embase, EBSCO databases, the Cochrane Library, and The Joanna Briggs Institute Library for randomized controlled trials that assessed the effectiveness of mobile phone and tablet apps in self-management of diabetes mellitus, cardiovascular disease, and chronic lung diseases from 2005-2016. We searched registers of current and ongoing trials, as well as the gray literature. We then checked the reference lists of all primary studies and review papers for additional references. The last search was run in February 2016. RESULTS: Of the 9 papers we reviewed, 6 of the interventions demonstrated a statistically significant improvement in the primary measure of clinical outcome. Where the intervention comprised an app only, 3 studies demonstrated a statistically significant improvement. Interventions to address diabetes mellitus (5/9) were the most common, followed by chronic lung disease (3/9) and cardiovascular disease (1/9). A total of 3 studies included multiple intervention groups using permutations of an intervention involving an app. The duration of the intervention ranged from 6 weeks to 1 year, and final follow-up data ranged from 3 months to 1 year. Sample size ranged from 48 to 288 participants. CONCLUSIONS: The evidence indicates the potential of apps in improving symptom management through self-management interventions. The use of apps in mHealth has the potential to improve health outcomes among those living with chronic diseases through enhanced symptom control. Further innovation, optimization, and rigorous research around the potential of apps in mHealth technology will move the field toward the reality of improved health care delivery and outcomes.
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The effectiveness of mobile-health behaviour change interventions for cardiovascular disease self-management: A systematic review
BACKGROUND: Mobile wireless devices (mHealth) have been used to deliver cardiovascular disease self-management interventions to educate and support patients in making healthy lifestyle changes. This systematic review aimed to determine the effectiveness of mHealth interventions on behavioural lifestyle changes and medication adherence for cardiovascular disease self-management. METHODS: A comprehensive literature search was conducted from inception through to 3 March 2015 using MEDLINE, PubMed, PsycINFO, EMBASE and The Cochrane Library. Eligible studies used an experimental trial design to determine the effectiveness of an mHealth intervention to change lifestyle behaviours in any cardiovascular disease population. Data extracted included intervention and comparison group characteristics with a specific focus on the use of behaviour change techniques. RESULTS: Seven studies met our inclusion criteria and were included in the qualitative synthesis. All interventions were delivered in part by mobile phone text messaging. Three studies were effective at improving adherence to medication and two studies increased physical activity behaviour. No effects were observed on dietary behaviour or smoking cessation, measured in one study each. Simple text messaging interventions appeared to be most effective; however, no clear relationships were found between study findings and intervention dose, duration or behaviour change techniques targeted. CONCLUSIONS: Our review found mHealth has the potential to change lifestyle behaviour. Results are still limited to a small number of trials, inconsistent outcome measures and ineffective reporting of intervention characteristics. Large scale, longitudinal studies are now warranted to gain a clear understanding of the effects of mHealth on behaviour change in the cardiovascular disease population
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Primary care organisational interventions for secondary prevention of ischaemic heart disease: A systematic review and meta-analysis
BACKGROUND: Ischaemic heart disease (IHD) is the most common cause of death worldwide. AIM: To determine the long-term impact of organisational interventions for secondary prevention of IHD. DESIGN AND SETTING: Systematic review and meta-analysis of studies from CENTRAL, MEDLINE((R)), Embase, and CINAHL published January 2007 to January 2013. METHOD: Searches were conducted for randomised controlled trials of patients with established IHD, with long-term follow-up, of cardiac secondary prevention programmes targeting organisational change in primary care or community settings. A random-effects model was used and risk ratios were calculated. RESULTS: Five studies were included with 4005 participants. Meta-analysis of four studies with mortality data at 4.7-6 years showed that organisational interventions were associated with approximately 20% reduced mortality, with a risk ratio (RR) for all-cause mortality of 0.79 (95% confidence interval [CI] = 0.66 to 0.93), and a RR for cardiac-related mortality of 0.74 (95% CI = 0.58 to 0.94). Two studies reported mortality data at 10 years. Analysis of these data showed no significant differences between groups. There were insufficient data to conduct a meta-analysis on the effect of interventions on hospital admissions. Additional analyses showed no significant association between organisational interventions and risk factor management or appropriate prescribing at 4.7-6 years. CONCLUSION: Cardiac secondary prevention programmes targeting organisational change are associated with a reduced risk of death for at least 4-6 years. There is insufficient evidence to conclude whether this beneficial effect is maintained indefinitely
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Primary care organisational interventions for secondary prevention of ischaemic heart disease: A systematic review and meta-analysis
BACKGROUND: Ischaemic heart disease (IHD) is the most common cause of death worldwide. AIM: To determine the long-term impact of organisational interventions for secondary prevention of IHD. DESIGN AND SETTING: Systematic review and meta-analysis of studies from CENTRAL, MEDLINE((R)), Embase, and CINAHL published January 2007 to January 2013. METHOD: Searches were conducted for randomised controlled trials of patients with established IHD, with long-term follow-up, of cardiac secondary prevention programmes targeting organisational change in primary care or community settings. A random-effects model was used and risk ratios were calculated. RESULTS: Five studies were included with 4005 participants. Meta-analysis of four studies with mortality data at 4.7-6 years showed that organisational interventions were associated with approximately 20% reduced mortality, with a risk ratio (RR) for all-cause mortality of 0.79 (95% confidence interval [CI] = 0.66 to 0.93), and a RR for cardiac-related mortality of 0.74 (95% CI = 0.58 to 0.94). Two studies reported mortality data at 10 years. Analysis of these data showed no significant differences between groups. There were insufficient data to conduct a meta-analysis on the effect of interventions on hospital admissions. Additional analyses showed no significant association between organisational interventions and risk factor management or appropriate prescribing at 4.7-6 years. CONCLUSION: Cardiac secondary prevention programmes targeting organisational change are associated with a reduced risk of death for at least 4-6 years. There is insufficient evidence to conclude whether this beneficial effect is maintained indefinitely
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Information and communication technology-enabled person-centered care for the "big five" chronic conditions: scoping review.
Background: Person-centered information and communication technology (ICT) could encourage patients to take an active part in their health care and decision-making process, and make it possible for patients to interact directly with health care providers and services about their personal health concerns. Yet, little is known about which ICT interventions dedicated to person-centered care (PCC) and connected-care interactions have been studied, especially for shared care management of chronic diseases. The aim of this research is to investigate the extent, range, and nature of these research activities and identify research gaps in the evidence base of health studies regarding the "big 5" chronic diseases: diabetes mellitus, cardiovascular disease, chronic respiratory disease, cancer, and stroke. Objective: The objective of this paper was to review the literature and to scope the field with respect to 2 questions: (1) which ICT interventions have been used to support patients and health care professionals in PCC management of the big 5 chronic diseases? and (2) what is the impact of these interventions, such as on health-related quality of life and cost efficiency? Methods: This research adopted a scoping review method. Three electronic medical databases were accessed: PubMed, EMBASE, and Cochrane Library. The research reviewed studies published between January 1989 and December 2013. In 5 stages of systematic scanning and reviewing, relevant studies were identified, selected, and charted. Then we collated, summarized, and reported the results. Results: From the initial 9380 search results, we identified 350 studies that qualified for inclusion: diabetes mellitus (n=103), cardiovascular disease (n=89), chronic respiratory disease (n=73), cancer (n=67), and stroke (n=18). Persons with one of these chronic conditions used ICT primarily for self-measurement of the body, when interacting with health care providers, with the highest rates of use seen in chronic respiratory (63%, 46/73) and cardiovascular (53%, 47/89) diseases. We found 60 relevant studies (17.1%, 60/350) on person-centered shared management ICT, primarily using telemedicine systems as personalized ICT. The highest impact measured related to the increase in empowerment (15.4%, 54/350). Health-related quality of life accounted for 8%. The highest impact connected to health professionals was an increase in clinical outcome (11.7%, 41/350). The impacts on organization outcomes were decrease in hospitalization (12.3%, 43/350) and increase of cost efficiency (10.9%, 38/350). Conclusions: This scoping review outlined ICT-enabled PCC in chronic disease management. Persons with a chronic disease could benefit from an ICT-enabled PCC approach, but ICT-PCC also yields organizational paybacks. It could lead to an increase in health care usage, as reported in some studies. Few interventions could be regarded as "fully" addressing PCC. This review will be especially helpful to those deciding on areas where further development of research or implementation of ICT-enabled PCC may be warranted.
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