Effects of a nurse-led eHealth programme on functional outcomes and quality of life of patients with stroke: a pooled analysis of randomized controlled trials.

Background: Stroke remains a leading cause of disability worldwide. Nurse-led eHealth programs have emerged as a potentially effective strategy to improve functional outcomes and quality of life in stroke survivors. However, the variability of study designs and outcomes measured across trials necessitates a pooled analysis to comprehensively assess the efficacy of these interventions. This protocol outlines the methodology for a pooled analysis that aims to synthesize evidence from randomized controlled trials (RCTs) evaluating nurse-led eHealth interventions for stroke patients. Methods and analysis: This pooled analysis will be conducted according to the PRISMA guidelines. We will include RCTs that evaluate nurse-led eHealth programs and report on functional outcomes or quality of life in stroke patients. Comprehensive searches of electronic databases including Pubmed, EMBASE, the Cochrane Library, CINAHL, and PsycINFO will be conducted with a predefined search strategy. Study selection will involve screening titles and abstracts, followed by full-text review using explicit inclusion and exclusion criteria. Data extraction will be undertaken independently by two reviewers. The risk of bias will be assessed through the Cochrane Risk of Bias tool. Additionally, the quality of evidence for each outcome will be evaluated using the GRADE approach. Meta-analyses will be performed using random-effects models, and heterogeneity will be quantified using the I2 statistic. Subgroup and sensitivity analyses will explore potential sources of heterogeneity. Discussion and conclusions: This pooled analysis is poised to provide a nuanced understanding of the effectiveness of nurse-led eHealth programs in stroke rehabilitation, leveraging a thorough methodological framework and GRADE tool to ensure robustness and reliability of evidence. The investigation anticipates diverse improvements in patient outcomes, underscoring the potential of personalized, accessible eHealth interventions to enhance patient engagement and treatment adherence. Despite the challenges posed by the heterogeneity of interventions and rapid technological advancements, the findings stand to influence clinical pathways by integrating eHealth into standard care, if substantiated by the evidence. Our study's depth and methodological rigor possess the potential to initiate changes in healthcare policy, advocating for the adoption of eHealth and subsequent investigations into its cost-efficiency. Ultimately, we aim to contribute rich, evidence-based insights into the burgeoning field of digital health, offering a foundational assessment of its applications in stroke care. Our data is expected to have a lasting impact, not only guiding immediate clinical decisions but also shaping the trajectory of future healthcare strategies in stroke recovery. Systematic review registration: Identifier (CRD42024520100: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=520100).

Comparative efficacy and safety of Chinese medicine injections as an adjunctive therapy for cervical cancer in Chinese patients: a network meta-analysis.

CONTEXT: Chinese medicine injections (CMIs) are widely used as adjuvant therapy for cervical cancer in China. However, the effectiveness of different types of CMIs remains uncertain. OBJECTIVE: To assess the effectiveness and safety of CMIs when used in conjunction with radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), particularly in combination with cisplatin (DDP), docetaxel plus cisplatin (DP), and paclitaxel plus cisplatin (TP). MATERIALS AND METHODS: Randomized controlled trials (RCTs) were searched in databases including CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science from inception to September 2023. We calculated the risk ratio with a 95% confidence interval and the surface under the cumulative ranking area curve (SUCRA) for the clinical efficacy rate (CER), the efficacy rate by Karnofsky Performance Status (KPS), and the rates of leukopenia reduction (LRR) and gastrointestinal reactions (GRR). RESULTS: Forty-seven RCTs were included, including nine CMI types: Aidi, Fufangkushen, Huangqi, Kangai (KA), Kanglaite (KLT), Renshenduotang, Shenqifuzheng (SQFZ), Shenmai (SM), and Yadanzi. KLT and KA were likely optimal choices with radiotherapy for CER and KPS, respectively. KA and KLT were optimal choices with RT + DDP for CER and GRR, respectively. KLT was the likely optimal choice with RT + DP for CER and KA for both KPS and GRR. SM and SQFZ were the likely optimal choices with RT + TP for CER and LRR, respectively. CONCLUSIONS: The optimal recommendation depends on whether CMIs are used with radiotherapy or concurrent chemoradiotherapy. More high-quality RCTs are needed to confirm further and update the existing evidence.

Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis.

BACKGROUND: Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022. RESULTS: Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. CONCLUSIONS: Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.

The Addition of Fish Oil to Cognitive Behavioral Case Management for Youth Depression: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.

BACKGROUND: Clinical trials suggest that long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) (fish oil) may reduce depressive symptoms in adults with major depressive disorder. Therefore, n-3 PUFAs may be a potential treatment for depression in youth. METHODS: Participants were 15- to-25 year-old individuals with major depressive disorder who sought care in one of three government-funded mental health services for young people in metropolitan Melbourne, Perth, or Sydney, Australia. Participants were randomly assigned in a double-blind, parallel-arm design to receive either fish oil (840 mg of eicosapentaenoic acid and 560 mg of docosahexaenoic acid) or placebo capsules as adjunct to cognitive behavioral case management. All participants were offered 50-minute cognitive behavioral case management sessions every 2 weeks delivered by qualified therapists (treatment as usual) at the study sites during the intervention period. The primary outcome was change in the interviewer-rated Quick Inventory of Depressive Symptomatology, Adolescent Version, score at 12 weeks. Erythrocyte n-3 PUFA levels were assessed pre-post intervention. RESULTS: A total of 233 young people were randomized to the treatment arms: 115 participants to the n-3 PUFA group and 118 to the placebo group. Mean change from baseline in the Quick Inventory of Depressive Symptomatology score was -5.8 in the n-3 PUFA group and -5.6 in the placebo group (mean difference, 0.2; 95% CI, -1.1 to 1.5; p = .75). Erythrocyte PUFA levels were not associated with depression severity at any time point. The incidence and severity of adverse events were similar in the two groups. CONCLUSIONS: This placebo-controlled trial and biomarker analysis found no evidence to support the use of fish oil for treatment in young people with major depressive disorder.

Crowd-sourcing and automation facilitated the identification and classification of randomized controlled trials in a living review.

OBJECTIVES: To evaluate an approach using automation and crowdsourcing to identify and classify randomized controlled trials (RCTs) for rheumatoid arthritis (RA) in a living systematic review (LSR). METHODS: Records from a database search for RCTs in RA were screened first by machine learning and Cochrane Crowd to exclude non-RCTs, then by trainee reviewers using a Population, Intervention, Comparison, and Outcome (PICO) annotator platform to assess eligibility and classify the trial to the appropriate review. Disagreements were resolved by experts using a custom online tool. We evaluated the efficiency gains, sensitivity, accuracy, and interrater agreement (kappa scores) between reviewers. RESULTS: From 42,452 records, machine learning and Cochrane Crowd excluded 28,777 (68%), trainee reviewers excluded 4,529 (11%), and experts excluded 7,200 (17%). The 1,946 records eligible for our LSR represented 220 RCTs and included 148/149 (99.3%) of known eligible trials from prior reviews. Although excluded from our LSRs, 6,420 records were classified as other RCTs in RA to inform future reviews. False negative rates among trainees were highest for the RCT domain (12%), although only 1.1% of these were for the primary record. Kappa scores for two reviewers ranged from moderate to substantial agreement (0.40-0.69). CONCLUSION: A screening approach combining machine learning, crowdsourcing, and trainee participation substantially reduced the screening burden for expert reviewers and was highly sensitive.

Research trends of worldwide ophthalmologic randomized controlled trials in the 21st century: A bibliometric study.

Background: Randomized controlled trials (RCTs) are often considered the gold standard and the cornerstone for clinical practice. However, bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet. This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century. Methods: Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection. The number of publications, country/region, institution, author, journal, and research hotspots of RCTs were analyzed using HistCite, VOSviewer, CiteSpace, and Excel software. Results: 2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs, with the United States leading in the number of volumes and research field, and the Moorfields Eye Hospital contributing to the most publications. Ophthalmology received the greatest number of publications and co-citations. Jeffrey S. Heier owned the most publications and Jost B. Jonas owned the most co-citations. The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy, glaucoma, dry eye disease (DED), and cataracts, and anti-vascular endothelial growth factor (VEGF) therapy (ranibizumab), topical ocular hypotensive medication, laser trabeculoplasty. Anti-VEGF therapy for age-related macular degeneration (AMD), DME (diabetic macular edema), and DED, the use of new diagnostic tools, and myopia were the hottest research highlights. Anti-VEGF therapy, prompt laser, triamcinolone, and verteporfin photodynamic therapy for AMD, DME, and CNV (choroidal neovascularization), DED, myopia, and open-angle glaucoma were the research hotspots with the longest duration. The future research hotspots might be DED and the prevention and control of myopia. Conclusions: Overall, the number of global ophthalmologic RCTs in the 21st century was keeping growing, there was an imbalance between the regions and institutions, and more efforts are required to raise the quantity, quality, and global impact of high-quality clinical evidence in developing countries/regions.

The Weight-loss Effect of GLP-1RAs Glucagon-Like Peptide-1 Receptor Agonists in Non-diabetic Individuals with Overweight or Obesity: A Systematic Review with Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials.

BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are new drugs for the treatment of obesity. OBJECTIVE: To assess the weight-loss effects of GLP-1RAs in the treatment of patients with overweight or obesity without diabetes. METHODS: This is a systematic review with meta-analysis and trial sequential analysis. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from their inception to January 1, 2022. Eligible trials report on outcomes including body weight (BW), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), or total body fat (TBF). Mean differences (MDs) and standardized mean differences (SMDs) were summarized using random-effects models. RESULTS: Forty-one trials involving 15,135 participants were included. Compared with controls, GLP-1RAs significantly reduced BW (MD -5.319 kg, 95% CI: -6.465, -4.174), BMI (MD -2.373 kg/m2, 95% CI: -2.821, -1.924), WC (MD -4.302 cm, CI:-5.185 to -3.419), WHR (MD -0.011, CI -0.015 to -0.007), but not TBF (MD -0.320%, CI -1.420 to -0.780). Trial sequential analysis (TSA) supported conclusive evidence of the effects of GLP-1RAs on BW, BMI, and WC for weight loss. GLP-1RAs had nonlinear dose-response relationships with weight loss. Extensive sensitivity analyses demonstrated the robustness of the results, though the GRADE certainty of the evidence ranged from high to very low. High to moderate GRADE certainty of evidence suggested semaglutide as the most effective GLP-1RA agent, with the best efficacy and low to moderate risk of adverse effects. CONCLUSIONS: The present study provides conclusive evidence for the effect of GLP-1RAs on weight loss in a nonlinear dose-response manner in patients with obesity or overweight without diabetes. In terms of changes in BW, BMI, and WC, there is firm evidence for the overall weight-loss effects of GLP-1RAs. Of the GLP-1RAs, semaglutide might be the most effective agent.

[Analysis on status quo of outcomes and measurement instruments of randomized controlled trials of acupuncture for post-stroke dysphagia].

OBJECTIVE: To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia. METHODS: RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed. RESULTS: A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes. CONCLUSION: The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.

Effects of curcumin/turmeric supplementation on glycemic indices in adults: A grade-assessed systematic review and dose-response meta-analysis of randomized controlled trials.

INTRODUCTION: Glycemic control is of utmost importance both as a preventive measure in individuals at risk of diabetes and in the management of patients with disturbed glycemia. Turmeric/curcumin has been extensively studied in this field. In the present systematic review and meta-analysis, we aimed at investigating the impact of turmeric/curcumin supplementation on glycemic control. METHODS: Major online databases (PubMed, Scopus, Web of Science, Cochrane Library and Google Scholar) were systematically searched from inception up to October 2022. Relevant randomized controlled trials (RCTs) meeting our eligible criteria were included. Weighted mean differences (WMDs) with confidence intervals (CIs) were expressed using a random-effect model. Subgroup analyses were conducted to find the sources of heterogeneities. To detect risk of bias in the included studies, we used the Cochrane risk-of-bias tool. The registration number was CRD42022374874. RESULTS: Out of 4182 articles retrieved from the initial search, 59 RCTs were included. Our findings suggested that turmeric/curcumin supplementation was significantly effective in improving fasting blood sugar (WMD: 4.60 mg/dl; 95% CI: 5.55, -3.66), fasting insulin levels (WMD: 0.87 µIU/ml; 95% CI: 1.46, -0.27), hemoglobin A1c (HbA1c) (WMD: 0.32%; 95% CI: 0.45, -0.19), and homeostatic model assessment of insulin resistance (HOMA-IR) (WMD: 0.33; 95% CI: 0.43, -0.22). CONCLUSION: Our results indicate that turmeric/curcumin supplementation can be considered as a complementary method in the management of disturbed glycemia.

Effect of Vitamin D Supplementation on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Dysmenorrhea causes pain and inconvenience during menstruation. In addition to medication, natural compounds are widely used to relieve various types of pain. In this study, we aimed to assess the effects of vitamin D (vit. D) supplementation in relieving the symptoms of primary dysmenorrhea. A comprehensive systematic database search of randomized controlled trials (RCTs) was performed. Oral forms of vit. D supplementation were included and compared with a placebo or standard care. The degree of dysmenorrhea pain was measured with a visual analogue scale or numerical rating scale. Outcomes were compared using the standardized mean difference (SMD) and 95% confidence intervals (CIs) in a meta-analysis. RCTs were assessed using the Cochrane risk-of-bias v2 (RoB 2) tool. The meta-analysis included 8 randomized controlled trials involving 695 participants. The results of the quantitative analysis showed a significantly lower degree of pain in the vit. D versus placebo in those with dysmenorrhea (SMD: -1.404, 95% CI: -2.078 to -0.731). The results of subgroup analysis revealed that pain lessened when the average weekly dose of vit. D was over 50,000 IU, in which dysmenorrhea was relieved regardless of whether vit. D was administered for more or less than 70 days and in any dose interval. The results revealed that vit. D treatment substantially reduced the pain level in the primary dysmenorrhea population. We concluded that vit. D supplementation is an alternative treatment for relieving the pain symptoms of dysmenorrhea.

Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study.

BACKGROUND AND OBJECTIVE: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions. METHODS: Through a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared. RESULTS: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44-28.19), 14.17 (13.98-14.37) and 21.06 (20.69-21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items. CONCLUSION: Although the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

Effects of Intrauterine Infusion of Autologous Platelet-Rich Plasma in Women Undergoing Treatment with Assisted Reproductive Technology: a Meta-Analysis of Randomized Controlled Trials.

Purpose This meta-analysis was conducted to systematically retrieve relevant randomized controlled trials (RCTs) and evaluate the effects of intrauterine infusion of autologous platelet-rich plasma (PRP) in women with thin endometrium, implantation or pregnancy failure undergoing treatment with assisted reproductive technology (ART). Methods We conducted a systematic review and meta-analysis of the retrieved RCTs. Studies on the intrauterine infusion of PRP in women undergoing treatment with ART that were published in PubMed, the Cochrane library, Web of Science, and Embase from inception until June 2022 were included. The data were extracted and analyzed independently using the fixed-effects or random-effects model according to heterogeneity. Results Seven RCTs involving 861 patients (435 in the intervention group and 426 in the control group) were included. The rates of clinical pregnancy (risk ratio [RR]: 2.51; 95% confidence interval [CI]: 2.0-3.13; P < 0.00001), chemical pregnancy (RR: 1.96; 95% CI: 1.58-2.45; P < 0.00001), live births (RR: 7.03; 95% CI: 3.91-12.6; P < 0.00001), and implantation (RR: 3.27; 95% CI: 1.42-7.52; P = 0.005) were significantly higher in the women who received PRP infusion than in the control group. No significant differences were noted in the miscarriage rate (RR: 0.98; 95% CI: 0.39-2.42; P = 0.96) between the two groups. Conclusion In summary, intrauterine infusion of PRP may be an effective therapy for women with thin endometrium and recurrent implantation failure (RIF) undergoing treatment with ART. More population-based RCTs are warranted to verify the efficacy of our evidence.

Effect of Vitamin D Supplementation on Depression in Adults: A Systematic Review of Randomized Controlled Trials (RCTs).

Vitamin D is a nutrient potentially beneficial in the treatment of depression. The study aimed to carry out a systematic review of the studies assessing the influence of vitamin D supplementation on depression within Randomized Controlled Trials (RCTs). The systematic review was prepared on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42020155779). The peer-reviewed studies available within PubMed or Web of Science databases until September 2021 were taken into account. The number of screened records was 8514, and 8 records were included. Two independent researchers conducted screening, including, reporting, and risk of bias assessment using the revised Cochrane risk-of-bias tool for randomized trials. The included studies presented a population of patients with major depressive disorders or general depression, as well as bipolar depression or postpartum depression. The majority of included studies were conducted for 8 weeks or 12 weeks, while one study was conducted for 6 months. Within the large number of included studies, a daily dose of 1500 IU, 1600 IU, or 2800 IU was applied, while within some studies, a vitamin D dose of 50,000 IU was applied weekly or biweekly. Among applied psychological measures of depression, there were various tools. In spite of the fact that the majority of included studies (five studies) supported the positive effect of vitamin D supplementation for the psychological measure of depression, for three studies the positive influence was not supported. A medium risk of bias was indicated for six studies, while a high risk of bias was defined for only two studies, due to deviations from the intended interventions and in measurement of the outcome, as well as for one study, also arising from the randomization process and due to missing outcome data. Based on conducted assessment, it should be emphasized that there are only four studies supporting the positive influence of vitamin D supplementation for the psychological measure of depression of the medium risk of bias, while two studies of a medium risk of bias did not support it. Taking this into account, the conducted systematic review is not a strong confirmation of the effectiveness of vitamin D supplementation in the treatment of depression.

Supplementation of Vitamin D and Mental Health in Adults with Respiratory System Diseases: A Systematic Review of Randomized Controlled Trials.

Vitamin D is indicated to be beneficial for the prevention and treatment of both respiratory health and mental health problems, while mental health issues are a common consequence of diseases of the respiratory system. The aim of the presented systematic review was to gather available evidence regarding the influence of the supplementation of vitamin D on mental health in adults with respiratory system diseases obtained within randomized controlled trials (RCTs). The systematic review was conducted on the basis of the PubMed and Web of Science databases in agreement with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), while being registered within the database of the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42020155779). A total of 8514 studies published before September 2021 were screened and 5 RCTs were included, which were assessed using the revised Cochrane risk-of-bias tool for randomized trials. Screening, inclusion, reporting, and assessment were conducted by two researchers independently. The studies focused on the assessment of patients with chronic obstructive pulmonary disease, but also increased susceptibility to respiratory tract infections, pulmonary tuberculosis, and bronchial asthma. The studies were conducted for various periods of time-from 2 months to a year-while the dose of vitamin D applied was also diverse-from 4000 IU applied daily, to 100,000 IU applied weekly, or monthly. The psychological measures applied within the studies allowed the assessment, mainly, of quality of life, but also well-being, and depression. For the majority of studies, some concerns regarding risk of bias were defined, resulting from the randomization process and selection of reported results; however, for one study, the risk was even defined as high. Within the included studies, three studies confirmed a beneficial effect of vitamin D (including those with a high risk of bias), but two studies did not confirm it. Taking into account the evidence gathered, in spite of a positive influence of vitamin D on mental health in individuals with increased susceptibility to respiratory tract infections and bronchial asthma, the conducted systematic review is not a strong confirmation of the beneficial effect of the supplementation of vitamin D on mental health in adults with respiratory system diseases.

Assessing the Highest Level of Evidence from Randomized Controlled Trials in Omega-3 Research.

Over the years, there has been heightened interest in the health benefits of n-3 polyunsaturated fatty acids (PUFA) in reducing chronic diseases such as, cardiovascular disease (CVD), cancer, type 2 diabetes, and acute macular degeneration (AMD). Due to inconsistent findings in the evidence, a review to critically examine the plethora of evidence from randomized controlled trials (RCTs) in n-3 PUFA research was undertaken. The aim of this review is to study the highest level of evidence and to identify gaps in n-3 PUFA research. RCTs were originally designed for pharmaceutical research and later adopted for nutrition and food-related research. RCTs with active diseases assume that n-3 PUFA will have "drug" like effects, and this high expectation may have led to the inconsistent evidence in the literature. The inconsistency in the literature may be related to varying doses of n-3 PUFA, sources of n-3 PUFA (food vs. supplement; plant vs. marine), type of n-3 PUFA (mixture vs. purified), trial duration, population characteristics, sample size, and genetic variation. For future research, there is a need to distinguish between primary and secondary prevention, and to focus RCTs on primary prevention of chronic diseases by n-3 PUFA which is lacking in the literature.

Do Couple-Based Interventions Show Larger Effects in Promoting HIV Preventive Behaviors than Individualized Interventions in Couples? A Systematic Review and Meta-analysis of 11 Randomized Controlled Trials.

This systematic review and meta-analysis aims to compare the effects of couple-based prevention interventions against individual-level interventions on HIV prevention in randomized controlled trials (RCTs), identify potential moderators, and assess study quality. Eleven RCTs were included, comprising 3933 couples in the intervention group and 7125 individuals in the individual control group, predominantly in heterosexual couples from the USA and Africa. Couple-based interventions had a more significant effect in promoting condom use and HIV testing. Education levels of high school or above, residence in low- and middle-income countries, and intervention design incorporating HIV counseling and testing were associated with higher odds of condom use. The quality assessment analysis identified methodological and theoretical heterogeneity factors. Evidence of couple-based HIV prevention RCTs among men who have sex with men, injecting drug users, sex workers, and transgender women warrant further investigation. Recommendations are made to improve the quality and replicability of future intervention studies.

RESUMEN: Esta revista sistemática y metanálisis tiene por objeto comparar los efectos de las intervenciones de prevención basadas en pareja con las a nivel individual en la prevención del VIH en ensayos controlados aleatorios (ECA), identificar posibles moderadores y evaluar la calidad de los estudios. Se incluyeron once ECA, que comprendían 3.933 parejas en el grupo de intervención y 7.125 personas en el grupo de control individual, la mayoría de las cuales eran heterosexuales de EE.UU. y de África. Las intervenciones basadas en pareja son más eficaces para promover el uso de preservativos y pruebas del VIH. Los niveles de educación secundaria o superior, los países de ingresos bajos y medianos, y los diseños de intervención que incluyen pruebas y asesoramiento sobre el VIH se relacionan con más uso de preservativos. El análisis de evaluación de la calidad ha identificado factores de heterogeneidad metodológica y teórica. Las pruebas de ECA basadas en pareja para la prevención del VIH en hombres que tienen sexo con hombres, consumidores de drogas inyectables, trabajadoras sexuales y mujeres transgénero necesitan más investigación. Se hacen recomendaciones para mejorar la calidad y replicabilidad de futuros estudios de intervención.

Sex and Gender in Randomized Controlled Trials of Adults Receiving Maintenance Dialysis: A Meta-epidemiologic Study.

RATIONALE & OBJECTIVE: How sex and gender concepts are incorporated into randomized controlled trials (RCTs) in adults with kidney failure receiving maintenance dialysis is largely unknown. We describe these practices in published journal articles as well as investigate the proportion of women and female participants in these studies. STUDY DESIGN: Meta-epidemiologic study. SETTING & STUDY POPULATIONS: RCTs in maintenance dialysis. SELECTION CRITERIA FOR STUDIES: Trials published in high-impact journals in 2000-2020. DATA EXTRACTION: Implemented in duplicate with conflicts resolved by a third reviewer. ANALYTICAL APPROACH: Meta-regression was performed to identify trial characteristics independently associated with the proportion of women and female participants. RESULTS: Among 561 included RCTs, 69.7% were parallel and 28.0% were crossover in design; 80.6% were conducted in the hemodialysis population; and 25% of trials compared the treatment of interest with a placebo arm, 25% with a usual care treatment arm, and 50% with an active alternative therapy arm. Of the RCTS, 37.6% were masked. The median size was 60 (IQR, 26-151) participants, and the median follow-up period was 154 (IQR, 42-365) days. The mean proportion of women or female participants was 0.40±0.13 (SD): 39.0% of trials reported sex, and 26.6% reported the gender of the participants. Also, 56.2% referred to participants as females, 25.3% referred to participants as women, and 15.5% referred to both females and women. No trial characteristic other than region (ß of 0.062 [95% CI, 0.007-0.117] for Asia) was associated with the proportion of women or female participants. Considering trial design and conduct, 2.7% of trials used sex and/or gender as an inclusion criterion, 26.6% as an exclusion criterion, 4.5% for randomization, 4.8% for subgroup analyses, and 15.7% for covariate adjustment. LIMITATIONS: Only high-impact journal articles were studied; and the included studies lacked pediatric trials, those addressing chronic kidney disease or kidney transplantation, any trials from Africa and underrepresentation of other regions, and missing data. CONCLUSIONS: RCTs in dialysis are representative of the general dialysis population with regard to sex and gender but they uncommonly report both and often do not include either in their reporting or analysis.

Analysis on status quo of outcomes and measurement instruments of randomized controlled trials of acupuncture for post-stroke dysphagia / 中国针灸

OBJECTIVE@#To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia.@*METHODS@#RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed.@*RESULTS@#A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes.@*CONCLUSION@#The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.

Mediterranean diet for the prevention of gestational diabetes: a meta-analysis of randomized controlled trials.

INTRODUCTION: It is elusive that whether that Mediterranean diet helps prevent gestational diabetes. This meta-analysis aims to study the efficacy of Mediterranean diet for gestational diabetes mellitus. METHODS: We have systematically searched PubMed, EMbase, Web of science, EBSCO and Cochrane library databases, and included randomized controlled trials (RCTs) that reported the effect of Mediterranean diet on gestational diabetes. RESULTS: We included five eligible RCTs in this meta-analysis. Compared with control intervention for pregnant women, Mediterranean diet could substantially decrease the incidence of gestational diabetes mellitus (OR = 0.64; 95% CI = 0.51 to 0.79; p < 0.0001), HOMA-IR (MD = -0.29; 95% CI = -0.50 to -0.09; p = 0.004), insulin treatment (OR = 0.39; 95% CI = 0.22 to 0.68; p = 0.0009) and gestational weight gain (MD = -0.74; 95% CI = -1.21 to -0.28; p = 0.002), but demonstrated no obvious impact on the admission of neonatal unit (OR = 0.75; 95% CI = 0.47 to 1.20; p = 0.24). CONCLUSIONS: Mediterranean diet can effectively prevent gestational diabetes mellitus.

The potential value of observational studies of elective surgical interventions using routinely collected data.

PURPOSE: To assess the apparent validity of observational studies of elective arthroplasty interventions. METHODS: Data from the nationwide Dutch Arthroplasty Register were used. The first case study compared surgical approaches for total hip arthroplasty (posterolateral approach vs. straight lateral approach), where allocation of the intervention was assumed to be mostly independent of patient characteristics. The second case study compared fixation methods (cemented vs. uncemented), where choice of fixation method was expected to depend on patient characteristics. The potential for confounding was quantified by differences between intervention groups and the impact of confounding adjustment. RESULTS: The study of posterolateral approach versus straight lateral approach included 73,750 and 16,557 patients, respectively, and showed no meaningful differences in patient characteristics between treatment groups (standardized mean differences <0.1) and also no relevant impact of confounding adjustment (Z-scores <1). The study of cemented versus uncemented total hip arthroplasty (THA) included 29,579 and 79,360 patients, respectively. Several meaningful imbalances were observed in patient characteristic between the two treatment groups (standardized mean differences >0.1), as well as a relevant impact of confounding adjustment (Z-scores >2). CONCLUSIONS: This study provides insight in the reasoning behind the credibility of observational studies of surgical interventions using routinely collected data and when confounding is expected to have a major impact and thus additional precautions to limit confounding are needed.