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.

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.

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.

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.

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.

BACKGROUND: With the increasing burden of chronic and age-related diseases, and the rapidly increasing number of patients receiving ambulatory or outpatient-based care, nurse-led services have been suggested as one solution to manage increasing demand on the health system as they aim to reduce waiting times, resources, and costs while maintaining patient safety and enhancing satisfaction. OBJECTIVES: The aims of this review were to assess the clinical effectiveness, economic outcomes and key implementation characteristics of nurse-led services in the ambulatory care setting. DESIGN: A systematic review was conducted using the standard Cochrane Collaboration methodology and was prepared in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. DATA SOURCES: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE EBSCO, CINAHL EBSCO, and PsycINFO Ovid (from inception to April 2016). REVIEW METHODS: Data were extracted and appraisal undertaken. We included randomised controlled trials; quasi-randomised controlled trials; controlled and non-controlled before-and-after studies that compared the effects of nurse-led services in the ambulatory or community care setting with an alternative model of care or standard care. RESULTS: Twenty-five studies of 180,308 participants were included in this review. Of the 16 studies that measured and reported on health-related quality of life outcomes, the majority of studies (n = 13) reported equivocal outcomes; with three studies demonstrating superior outcomes and one demonstrating inferior outcomes in comparison with physician-led and standard care. Nurse-led care demonstrated either equivalent or better outcomes for a number of outcomes including symptom burden, self-management and behavioural outcomes, disease-specific indicators, satisfaction and perception of quality of life, and health service use. Benefits of nurse-led services remain inconclusive in terms of economic outcomes. CONCLUSIONS: Nurse-led care is a safe and feasible model of care for consideration across a number of ambulatory care settings. With appropriate training and support provided, nurse-led care is able to produce at least equivocal outcomes or at times better outcomes in terms of health-related quality of life compared to physician-led care or standard care for managing chronic conditions. There is a lack of high quality economic evaluations for nurse-led services, which is essential for guiding the decision making of health policy makers. Key factors such as education and qualification of the nurse; self-management support; resources available for the nurse; prescribing capabilities; and evaluation using appropriate outcome should be carefully considered for future planning of nurse-led services.

OBJECTIVE: To review the evidence to determine the effects of psychological interventions on self-care and psychological and health outcomes in patients with chronic heart failure (CHF). METHODS: We evaluated the effectiveness of randomized controlled trials using psychological methods or theory on self-care behaviors, anxiety and depression levels, HRQoL, and physical function. Studies published in English, from January 2006 to December 2016, were considered. We searched published and unpublished studies in the following electronic databases: CINAHL, Cochrane Library, EMBASE, PubMed, PsycINFO, Scopus, Web of Science, and ProQuest Dissertations and Theses. Risk of bias was assessed using a standard procedure based on the Cochrane Collaboration tool described in the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: A total of 29 articles, consisting of 25 studies with 3837 participants, were included in this systematic review. Findings showed that despite heterogeneity between studies, psychological interventions tend to improve self-care in CHF patients without clinical depression and cognitive impairment. Pooled results also revealed that the intervention effect on short-term HRQoL, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), was in favor of the intervention group (combined MD -7.53, 95% CI -12.83 to -2.23); however, such effect disappeared as the length of time from the intervention increased. The intervention effects on the participants` anxiety level, as measured by HADS, and physical function, as measured by 6MWT, were not statistically significant. DISCUSSION: Efforts aimed at promoting self-care were the cornerstone of HF disease management. Nurses play an important role in patient education and secondary prevention. Compared to other professionals, nurses have more patient contact opportunities and are more holistic in all aspects of disease management; therefore, more nurses can be trained to incorporate the brief psychological techniques (such as motivational interviews and cognitive behavior therapy) to maximize intervention effectiveness. The main limitation of the review is the moderate to high level of heterogeneity among the included studies, which may partially undermine the reliability and reproducibility of the results. Because of the heterogeneity among the studies, a conclusion on the optimal format and forms of the intervention could not be drawn. Replication of the studies will be required in the future to isolate the active intervention component and to identify the ideal intervention format and dosage.

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.

The aim of this meta-analysis was to evaluate the effect of telephone-based interventions on prognostic outcomes and health-related quality of life (HRQoL) in breast cancer patients and survivors. A systematic search of the Cochrane Library, Web of science, Medline, EMBASE, CNKI and CBM database was carried out. Randomised, controlled trials (RCTs) examining the effects of telephone-based intervention versus a control group receiving no telephone intervention, on prognostic outcomes and HRQoL with breast cancer were included. A meta-analysis was conducted to quantify the effects of telephone-based interventions on anxiety, depression, fatigue, self-efficiency, physiological function, social-domestic function and quality of life. In total, 14 studies involving 2002 participants were included. Due to the effect of telephone-based interventions, statistically significant results were found on anxiety (standard mean difference [SMD] = -0.16, 95% confidence intervals [CI] [0.01, 0.30], p = .04), self-efficiency (SMD = 0.22, 95% CI [-0.34, -0.10], p = .0004), social-domestic function (SMD = 0.19, 95% CI [-0.35, -0.03], p = .02) and quality of life (SMD = 0.54, 95% CI [-1.00, -0.08], p = .02). Although the effects on depression, fatigue and physiological function were in the expected direction, these effects were not statistically significant (p > .05) based on the insufficient evidence

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.

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.

CONTEXT: The role of exercise intervention for patients with Non-small cell lung cancer (NSCLC) has not been systematically reviewed to date. OBJECTIVE: To identify, evaluate and synthesize the evidence examining (1) the effect of exercise intervention on exercise capacity, health related quality of life (HRQoL), physical activity levels, cancer symptoms and mortality for patients with NSCLC; and (2) the safety and feasibility of exercise intervention for a population with NSCLC. DATA SOURCES: A systematic review of articles using the electronic databases MEDLINE (1950-2010), CINAHL (1982-2010), EMBASE (1980-2010), TRIP (1997-2010), Science Direct (1994-2010), PubMed (1949-2010), Cochrane Library (2010), Expanded Academic ASAP (1994-2010), Meditext Informit (1995-2010), PEDRO (1999-2010) and DARE (2010). Additional studies were identified by manually cross referencing all full text reports and personal files were searched. No publication date restrictions were imposed. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Randomised controlled trials (RCTs), case-control studies and case series assessing exercise intervention to improve exercise capacity, HRQoL, level of daily physical activity, cancer symptoms or mortality of patients with NSCLC were included. Only articles available in English and published in a peer reviewed journal were included. DATA EXTRACTION: A data collection form was developed by one reviewer and data extracted. Data extraction was cross checked by a second reviewer. RESULTS AND DATA SYNTHESIS: 16 studies on 13 unique patient groups totalling 675 patients with NSCLC met the inclusion criteria. The majority of studies were case series (n=9) and two RCTs were included. Studies exercising participants pre-operatively reported improvements in exercise capacity but no change in HRQoL immediately post exercise intervention. Studies exercising participants post-treatment (surgery, chemotherapy or radiotherapy) demonstrated improvements in exercise capacity but conflicting results with respect to the impact on HRQoL immediately post exercise intervention. Heterogeneity among studies was observed and a meta-analysis was deemed inappropriate. PRISMA guidelines were followed in reporting this systematic review. CONCLUSION: Exercise intervention for patients with NSCLC is safe before and after cancer treatment. Interventions pre-operatively or post-cancer treatment are associated with positive benefits on exercise capacity, symptoms and some domains of HRQoL. The majority of studies are small case series therefore results should be viewed with caution until larger RCTs are completed. Further research is required to establish the effect of exercise during and after cancer treatment and in the advanced stage of disease, the optimum type of exercise training and the optimum setting for delivery.