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.

This is the protocol for a Campbell systematic review. The objectives are as follows. The objectives of the present study are to answer the following questions: (1) What types of home-based interventions are currently being studied to prevent child neglect? (2) How effective are the different home-based interventions for preventing child neglect? (3) What are the causes of heterogeneity among included studies and their impact on study effects?

Background: Disturbances in immunological responses and modulation lead to implantation and pregnancy failure and might be involved in the pathogenesis of infertility. This project aimed to screen and identify immune-related genes as potential biomarkers for treatment.Methods: Gene expression profiles were obtained from Gene Expression Omnibus (GEO) databases. Differentially expressed genes (DEGs) were screened using GEO 2R to explore potential biomarkers. Protein-protein interaction (PPI) network analysis and functional enrichment analysis were applied to explore possible mechanisms. The deconvolution algorithm [referred to as Cell-type Identification by Estimating Relative Subsets of RNA Transcripts (CIBERSORT)] was employed to assess tissue-infiltrating immune cells. Western blot analysis and immunohistochemistry (IHC) were conducted for determination of protein levels.Results: In this research, we identified 24 candidate immune-related DEGs via combined DEGs and functional analysis. We also found that the ratio of M0 macrophages and resting mast cells was higher in infertile group (P<0.05), whereas the amounts of activated natural killer (NK) cells was significantly lower compared with the control group (P<0.05). Furthermore, we evaluated the relationship between immune cells and candidate genes and found that 17 genes were related to M0 macrophages, resting mast cells, or activated NK cells. The genes CD40, PRF1, and EDN3 were chosen based on validation from independent datasets. Finally, our clinical samples confirmed the expression of the 3 genes.Conclusions: The study recognized 3 genes that are signatures and could be potential biomarkers for unexplained infertility. These genes might guide the immunotherapy of these patients and become new treatment targets.

Background: The potential effectiveness of traditional Chinese medicine (TCM) against "epidemic diseases " has highlighted the knowledge gaps associated with TCM in COVID-19 management. This study aimed to map the matrix for rigorously assessing, organizing, and presenting evidence relevant to TCM in COVID-19 management.Methods: In this study, we used the methodology of evidence mapping (EM). Nine electronic databases, the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal, , gray literature, reference lists of articles, and relevant Chinese conference proceedings, were searched for articles published until 23 March 2022. The EndNote X9, Rayyan, EPPI, and R software were used for data entry and management.Results: In all, 126 studies, including 76 randomized controlled trials (RCTs) and 50 systematic reviews (SRs), met our inclusion criteria. Of these, only nine studies (7.14%) were designated as high quality: four RCTs were assessed as "low risk of bias " and five SRs as "high quality. " Based on the research objectives of these studies, the included studies were classified into treatment (53 RCTs and 50 SRs, 81.75%), rehabilitation (20 RCTs, 15.87%), and prevention (3 RCTs, 2.38%) groups. A total of 76 RCTs included 59 intervention categories and 57 efficacy outcomes. All relevant trials consistently demonstrated that TCM significantly improved 22 outcomes (i.e., consistent positive outcomes) without significantly affecting four (i.e., consistent negative outcomes). Further, 50 SRs included nine intervention categories and 27 efficacy outcomes, two of which reported consistent positive outcomes and two reported consistent negative outcomes. Moreover, 45 RCTs and 38 SRs investigated adverse events; 39 RCTs and 30 SRs showed no serious adverse events or significant differences between groups.Conclusion: This study provides evidence matrix mapping of TCM against COVID-19, demonstrating the potential efficacy and safety of TCM in the treatment and prevention of COVID-19 and rehabilitation of COVID-19 patients, and also addresses evidence gaps. Given the limited number and poor quality of available studies and potential concerns regarding the applicability of the current clinical evaluation standards to TCM, the effect of specific interventions on individual outcomes needs further evaluation.

AimsWe aimed to determine the effects of different exercise modalities in patients with type 2 diabetes mellitus (T2DM). MethodsWe searched PubMed, Embase, and the Cochrane Library from their inception until July 2020 to identify randomised controlled trials (RCTs) on exercise in adults with T2DM. Paired reviewers independently performed study selection, data extraction, and risk of bias assessment. The certainty of the evidence was assessed using the Confidence in Network Meta-Analysis (CINeMA) framework. ResultsA total of 106 RCTs that enroled eight exercise modalities with 7438 patients were included. Six exercise modalities, except unsupervised aerobic/resistance exercise, significantly reduced glycosylated haemoglobin (HbA1c), with mean differences (MDs) ranging from 0.71 (95% confidence interval [CI]: 0.34-1.08) to 0.34 (95% CI: 0.17-0.52), low to high certainty, in comparison with no exercise. The evidence of low to moderate certainty showed that supervised aerobic/resistance exercise improved glycaemic control, body weight, blood pressure, and blood lipid profiles compared with no exercise. Flexibility exercise may be associated with glycaemic control (HbA1c: MD = 0.71, 95% CI: 0.34-1.08); fasting plasma glucose (MD = 1.48, 95% CI: 0.78-2.17), and weight loss (MD = 1.80, 95% CI: 0.85-2.75) compared with controls, but not blood pressure and lipid profiles. Balance exercise showed the largest benefit in improving total cholesterol (MD = 52.81, 95% CI: 28.47-77.16) and low certainty. We found no significant differences between exercises and the triacylglycerol (TG) level. ConclusionsOverall, our network meta-analyses support the recommendation for exercise in patients with T2DM, especially supervised exercises. Limited evidence supports the benefits of flexibility and balance exercises. The effectiveness of exercise modalities for TG reduction remains unclear.

The abstract should read: This is the protocol for a Campbell systematic review. The objectives are as follows: (1) Which formal HBC services for people with dementia have been tested in an RCT? (2) How effective are the different formal HBC services in improving the physical and mental health outcomes of people with dementia? (3) What is the cost and patient's health service usage of different formal HBC services?

Objectives: This study aimed to conduct a systematic review of cost-utility studies of internet-based and face-to-face cognitive behavioral therapy (CBT) for depression from childhood to adulthood and to examine their reporting and methodological quality. Methods: A structured search for cost-utility studies concerning CBT for depression was performed in 7 comprehensive databases from their inception to July 2020. Two reviewers independently screened the literature, abstracted data, and assessed quality using the Consolidated Health Economic Evaluation Reporting Standards and Quality of Health Economic Studies checklists. The primary outcome was the incremental cost-effectiveness ratio (ICER) across all studies. To make a relevant comparison of the ICERs across the identified studies, cost data were inflated to the year 2020 and converted into US dollars. Results: Thirty-eight studies were included in this review, of which 26 studies (68%) were deemed of high methodological quality and 12 studies (32%) of fair quality. Despite differences in study designs and settings, the conclusions of most included studies for adult depression were general agreement; they showed that face-to-face CBT monotherapy or combination therapy compared with antidepressants and usual care for adult depression were cost-effective from the societal, health system, or payer perspective (ICER $241 212.4/quality-adjusted life-year [QALY] to $33 032.47/QALY, time horizon 12-60 months). Internet-based CBT regardless of guided or unguided also has a significant cost-effectiveness advantage (ICER $37 717.52/QALY to $73 841.34/QALY, time horizon 3-36 months). In addition, CBT was cost-effective in preventing depression (ICER $23 932.07/QALY to $26 092.02/QALY, time horizon 9-60 months). Nevertheless, the evidence for the cost-effectiveness of CBT for children and adolescents was still ambiguous. Conclusions: Fair or high-quality evidence showed that CBT monotherapy or combination therapy for adult depression was cost-effective; whether CBT-related therapy was cost-effective for children and adolescents depression remains inconclusive.

For patients with recurrent implantation failure (RIF), immune system imbalances have become the focus of research. The effects of different classes of immunotherapies on improving pregnancy outcomes have not been fully established. This network meta-analysis was performed to assess the impact of popular immunotherapies in women with RIF. We systematically searched the Cochrane Central Register of Controlled Trials, PubMed, Embase, and Web of Science databases as well as clinical trial registration websites. Randomized controlled trials comparing immunotherapeutic outcomes were included. We performed the random-effects network metaanalysis to compare efficacy measures. A total of 21 trials involving 2277 participants and 8 immunotherapies were eligible for this study. Patients that had been administered with PBMCs, G-CSF, PRP, and sirolimus exhibited higher CPR than those administered with the placebo (2.63, 1.71-4.06; 2.03, 1.35-3.05; 1.98, 1.02-3.84; 2.55, 1.36-4.79; and 3.95, 1.33-11.72, respectively). For IR, only PBMCs and G-CSF were significantly more effective than the placebo (2.92, 1.39-6.12; 2.66, 1.16-6.06, respectively). In terms of LBR, PBMCs (2.96, 1.67-5.27) and sirolimus (3.55, 1.18-10.64) were effective. However, r-hLIF (0.25, 0.10-0.62) had a reduced risk of LBR. No therapeutic regimen was found to have significantly decreased MR, but PBMCs exhibited the lowest rank among all interventions (0.28, 0.06-1.44). To improve clinical pregnancy while reducing miscarriage outcomes, PBMCs might be a beneficent therapeutic option for RIF in the future.