Randomized Controlled Trials Studies Research Articles

Resistance Training in Patients With Coronary Artery Disease, Heart Failure, and Valvular Heart Disease: A REVIEW WITH SPECIAL EMPHASIS ON OLD AGE, FRAILTY, AND PHYSICAL LIMITATIONS.

Current guidelines recommend individually adapted resistance training (RT) as a part of the exercise regime in patients with cardiovascular diseases. The aim of this review was to provide insights into current knowledge and understanding of how useful, feasible, safe, and effective RT is in patients with coronary artery disease (CAD), heart failure (HF), and valvular heart disease (VHD), with particular emphasis on the role of RT in elderly and/or frail patients. A review based on an intensive literature search: systematic reviews and meta-analyses published in 2010 or later; recent studies not integrated into meta-analyses or systematic reviews; additional manual searches. The results highlight the evaluation of effects and safety of RT in patients with CAD and HF with reduced ejection fraction (HFrEF) in numerous meta-analyses. In contrast, few studies have focused on RT in patients with HF with preserved ejection fraction (HFpEF) or VHD. Furthermore, few studies have addressed the feasibility and impact of RT in elderly cardiac patients, and data on the efficacy and safety of RT in frail elderly patients are limited. The review results underscore the high prevalence of age-related sarcopenia, disease-related skeletal muscle deconditioning, physical limitations, and frailty in older patients with cardiovascular diseases (CVD). They underline the need for individually tailored exercise concepts, including RT, aimed at improving functional status, mobility, physical performance and muscle strength in older patients. Furthermore, the importance of the use of assessment tools to diagnose frailty, mobility/functional capacity, and physical performance in the elderly admitted to cardiac rehabilitation is emphasized.

Meta-Analysis of the Effect of Nursing Intervention on Children with Type 2 Diabetes.

To systematically evaluate the effect of nursing intervention on children with type 2 diabetes. The randomized controlled trials (RCTs) on nursing intervention in children with type 2 diabetes in CNKI, VIP, WanFang, Chinese Biomedical Database (CBM), PubMed, The Cochrane Library, Embase, and Science were searched by the computer until July 2022. Two evaluators reviewed the articles, selected the information, and assessed their quality according to the inclusion criteria and exclusion criteria and then carried out meta-analysis with RevMan 5.3. A total of 5 RCT studies were kept, including 319 patients with type 2 diabetes (≤21 years old), where 162 patients were in the nursing group and 157 patients were in the control group. Meta-analysis revealed that, compared with routine nursing, nursing intervention could effectively control children's fasting blood glucose (FBG) (MD = -1.68, 95% CI (-2.19, -1.17), P < 0.00001), 2 h postprandial blood glucose (2hPG) (MD = -4.01, 95% CI (-4.70, -3.33), P < 0.00001), fasting insulin (FINS) (MD = -7.42, 95% CI (-10.63, -4.20), P < 0.00001), 2 h postprandial insulin (2hINS) (MD = -58.18, 95% CI (-103.24, -13.11), P = 0.01), triglycerides (TG) (MD = -0.41, 95% CI (-0.56, -0.25), P < 0.00001), and systolic blood pressure (SBP) (MD = -8.85, 95% CI (-14.67, -3.03), P = 0.003) and effectively maintain patients' blood glucose at a normal level (MD = -8.85, 95% CI (-14.67, -3.03), P = 0.003), where all the differences were statistically significant. The existing evidence showed that nursing intervention has a significant effect in controlling normal blood glucose and improving insulin utilization in children with type 2 diabetes, which can effectively improve the therapeutic effect on children.

Effects of Different Surgical Procedures on the Therapeutic Effects, Prognosis, and Major Complications of Acetabular Fractures in the Elderly of China: A Systematic Review and Meta-Analysis.

Objective Different surgical approaches were systematically evaluated to provide an evidence-based medical rationale for the application and promotion of acetabular fractures in the elderly of China. Methods Randomized controlled trials (RCT) of different surgical methods in the treatment of elderly acetabular fractures were searched in the PubMed, EMBASE, ScienceDirect, Cochrane Library, China Knowledge Network Database (CNKI), China VIP Database, Wanfang Database, and China Biomedical Literature Database (CBM). The search time threshold was set from the time the database was created to the current time. Investigators obtained data independently, and the bias risk of each included writing was reviewed using the Cochrane Manual 5.1.0 criterion. The meta data was analyzed using RevMan 5.4 statistical package. Results 6 RCT articles were included in the end. A total of 445 samples were analyzed by meta. All the six RCT literatures included in this meta-analysis reported the baseline status of patients, only 3 RCT mentioned “random assignment” without any explanation, and the rest did not mention “random” information. The five studies included all gave detailed intervention measures. The number and reasons of blind method and lost follow-up or withdrawal were not described in detail in 6 RCT articles. Through the meta-analysis excellent and good rate between the experimental group and the control group through 6 RCT studies, the heterogeneity test results were chi2 = 6.11, df = 4, P = 0.19 > 0.05, and I2 = 35%, without obvious heterogeneity at Z = 2.68 and P = 0.007. These results suggested that the total hip arthroplasty application has the same excellent rate as other surgical treatment methods, indicating that total hip arthroplasty has a significant effect on the treatment of elderly acetabular fractures. Through the meta-analysis hip-joint function score, the heterogeneity test results were chi2 = 56.16, df = 4, P < 0.00001, and I2 = 93%, with obvious heterogeneity. The great difference was discovered in hip function score between total hip arthroplasty and other surgical methods, showing that total hip arthroplasty can greatly improve hip-joint function. Then, the incidence of hip complications between the experimental cases and the control cases was calculated by meta. The heterogeneity test results were chi2 = 3.17, df = 4, P = 0.53 > 0.05, and I2 = 0%, without remarkable heterogeneity at Z = 3.05 and P = 0.002. This demonstrated that a significant difference was observed in the complication incidence, indicating that total hip arthroplasty displayed a lower incidence of hip-joint functional complications. Conclusion Total hip arthroplasty has a good prognosis and a low complication rate in the treatment of acetabular fractures in the elderly. However, more studies and longer follow-ups are needed to further validate the findings of this study.

Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities

BackgroundPeople with severe psychiatric disabilities and impaired autonomy, living in sheltered or supported housing facilities, often lead sedentary, solitary lives indoors and have significantly poorer health than others in the population. Meaningful everyday activities are important for the recovery towards an enrichening, agentic, social, and hopeful everyday life. The Everyday Life Rehabilitation (ELR) model—a person-centred activity- and recovery-oriented intervention—has shown positive outcomes in feasibility studies, and thus a randomised controlled trial (RCT) is required to establish the effectiveness of ELR, along with calculations of cost-effectiveness.MethodsThe ELR-RCT is a pragmatic, two-parallel-armed cluster RCT evaluating the effect and cost-effectiveness of using ELR from two measurement points over 6 months (pre-post intervention) and in three waves over 3 years. The primary outcome is recovering quality of life (ReQoL) at 6 months, and the secondary outcome is self-perceived recovery and daily functioning (RAS-DS) at 6 months. Additionally, Goal Attainment Scaling (GAS) will be used for the intervention group. Power analysis has been conducted for primary outcome measure. The first wave will include an internal pilot, to be evaluated after 6 months, used as basis for decisions on updating the required sample size and any other need for adaptations before continuing with the full-scale RCT in the second and third wave. All municipalities within a geographic area in northern Sweden, with a minimum of one sheltered or supported housing facility for people with severe psychiatric or neuropsychiatric disability, including access to occupational therapy, will be enrolled. Participants will be block-randomised to receive ELR plus treatment as usual (TAU) or TAU alone for a control period. The control group will thereafter receive delayed ELR. Occupational therapists and housing staff will receive an educational package, manuals, and tools, as well as reflections with colleagues during the intervention period. Housing managers will receive questions for monthly follow-up and coaching with staff.DiscussionThis is a protocol for both an internal pilot and full trial of the first RCT study using the ELR intervention model in sheltered or supported housing facilities, evaluating the effects together with cost-effectiveness.Trial registrationClinicalTrials.gov NCT05056415. Registered on 24 September 2021.

Nonsteroid anti-inflammatory drug choices in patients with juvenile idiopathic arthritis: A systematic review

Background: Disease-modifying anti-rheumatic drugs (DMARDs) are still a priority in treating juvenile idiopathic arthritis (JIA). The choice of drug therapy for the NSAIDs as an alternative to the therapy used in managing JIA cases due to the side effects of DMARDs. However, the former discussion of the choices therapy of NSAID therapy in JIA patients is still limited. This systematic review was conducted to present any choices of NSAIDs used for the treatment JIA and presented their effectiveness and adverse reaction compared with other NSAIDs used for treating JIA. Methods: Comprehensive electronic searches were performed in PubMed/Medline, EMBASE, and Cochrane Library, choosing Randomized Controlled Trials of NSAIDs for treating children with JIA up to January 2009. The risk of bias was assessed using the Cochrane Risk of Bias Tools for randomized controlled trials. Results: Eight eligible randomized controlled trials (RCT) out of 1309 studies were included, with a total of 1112 participants with JIA identified, addressing 19 kinds of interventions with nine types of medications. First RCT concluded that Celecoxib 3 mg/kg and Celecoxib 6 mg/kg were at least as effective as naproxen 7.5 mg/kg in terms of reducing clinical symptoms of arthritis and joint swelling. Second RCT concluded that Low Dose (0,3 mg/kg) and High Dose (0.6mg/kg) Rofecoxib showed a greater improvement than the Naproxen group to relieve the pain. The third RCT stated that good efficacy or satisfaction is most frequent in the participant with Meloxicam 0.125 mg/kg rather than Meloxicam 0.25 mg/kg or Naproxen 10 mg/kg. Fourth RCT concluded that Ibuprofen 30-40 mg/kg/d is an effective agent for symptomatic treatment of JIA and is well-tolerated in many children. Fifth RCT informed that Piroxicam show more effective in controlling the symptoms and improving function than Naproxen 10 mg/kg/day. Sixth RCT concluded that Acetylsalicylic acid 75 mg/kg/day has better efficacy than Naproxen 10 mg/kg/d in relieving the symptoms. The seventh study stated that both diclofenac sodium 2-3 mg/kg/day and acetylsalicylic acid 50-100 mg/kg/d at least as good as placebo. The last RCTs study stated that tolmetin 15 mg/kg/day decreased the duration of morning stiffness and reduced joint pain. Also, aspirin 50mg/kg/day resulted in ROM improvement in JIA patients. Conclusions: We present Celecoxib, Rofecoxib, Meloxicam, Ibuprofen, Piroxicam, Acetylsalicylic Acid (ASA), Diclofenac Sodium, Tolmetin Sodium, and Naproxen as the NSAIDs choice drugs on pediatric patient diagnosed with JIA. which has each adverse event on each therapy.

The effect of communication skills training on nurses’ moral distress: A randomized controlled trial

Background: Moral distress is one of the ethical concepts in healthcare which leads to negative consequences in patients and health care providers. Communication problems could result in moral distress in nurses. This study aimed to examine the effect of communication skills training on nurses’ moral distress. Methods: This is a randomized-controlled trial study. 53 nurses working in Jahrom University of Medical Sciences in southern Iran were selected randomly. Data were collected using the Hamric moral distress. Data were analyzed using SPSS 21. Findings: The results of Mann-Whitney test showed significant difference in the moral distress of nurses between the intervention and control groups (p<0.001) one month after the intervention. Wilcoxon test showed that the mean of moral distress in nurses was significantly lower after the intervention (p<0.001). Conclusion: The findings of this study indicate that program of communication skills training reduced moral distress in nurse.

Impact of probiotic supplementation on trimethylamine N-oxide (TMAO) in humans: A systematic review and meta-analysis of randomized controlled trials.

Some clinical trial studies have shown the effect of probiotic supplementation on trimethylamine N-oxide (TMAO) levels through regulation of intestinal microbiota. However, the relevant findings in this area are still contradictory. The aim of this systematic study and meta-analysis was to investigate the effects of probiotic supplementation on TMAO levels using randomized controlled trials (RCTs). Available databases including PubMed/Medline, Web of Science, Scopus, Cochrane Library, and Embase were searched to find relevant RCTs up to August 2021. In this study, we examined the population over 18 years of age using probiotics as an intervention group compared to the control group to evaluate TMAO as a final outcome. Effect size was expressed as weighted mean difference (WMD) and 95% confidence interval (CI). 8 RCT studies with 270 participants were included in this article. The results show that probiotic supplementation has no significant effect on TMAO levels compared to the control group (WMD-0.08μmol/L; 95% CI-0.76 to 0.60, P=0.813). Furthermore, the results of the analysis of the subgroups did not show a significant effect on this metabolite in both groups of healthy and unhealthy individuals following the intervention. However, probiotic supplementation further reduced TMAO in people less than 50 years of age compared to those over 50 years of age. This meta-analysis showed that probiotics did not have a significant effect on TMAO levels. However, further studies are needed to confirm the findings.

Continuous Subcutaneous Insulin Infusion (CSII) Combined with Oral Glucose-Lowering Drugs in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis of Randomized, Controlled Trials.

The clinical efficacy of continuous subcutaneous insulin infusion (CSII) therapy combined with six classes of oral glucose-lowering drugs (GLDs) (TZDs/metformin/acarbose/GLP-1 receptor agonist/SGLT-2 inhibitor/DPP-4 inhibitor) was evaluated by a network meta-analysis to provide an evidence-based reference in making a clinical decision on CSII combined with drugs in the treatment of type 2 diabetes. Data were retrieved from eight databases: the Chinese Journal Full-Text Database (CNKI), VIP Chinese Science and Technology Periodicals Full-Text Database (VP-CSFD), Wanfang Data Journal Paper Resource (WANFANG), China Biomedical Database (CBM), PubMed, Embase, Cochrane Library, and Web of Science. The retrieval period dated from the library’s construction to 27 June 2021. The search was for randomized, controlled trial studies (RCT) on insulin infusion (CSII) combined with oral hypoglycemic drugs (TZDs/metformin/acarbose/GLP-1 receptor agonist/SGLT-2 inhibitor/DPP-4 inhibitor) in the treatment of type 2 diabetes. Quality evaluation and data extraction were performed on the studies included, and network meta-analysis was performed with R4.0.1 software. A total of 56 publications was included in the final network meta-analysis, with a total sample size of 4395. Results based on the network meta-analysis were that CSII combined with a metformin works best on fasting blood glucose (FBG) and 2 h postprandial blood glucose (2hPG) and improves insulin resistance (lower HOMA-IR levels). CSII combined with a DPP-4 inhibitor had the best clinical effect in reducing glycosylated hemoglobin levels. Treatment with CSII combined with a DPP-4 inhibitor was the fastest way to achieve the blood glucose standard. In terms of insulin dosage, an insulin pump (CSII) combined with the GLP-1 receptor agonist can significantly reduce insulin dosage. Network meta-analysis evidence suggests that an insulin infusion (CSII) combined with oral hypoglycemic drugs can improve clinical efficacy in controlling blood sugar and improving insulin resistance, insulin dosage, and standard time. However, the most outstanding performance was that of insulin infusion (CSII) combined with metformin, which had the best clinical effect in controlling blood sugar and improving insulin resistance.

Effects of Inspiratory Muscle Training and High-Intensity Interval Training on Lung Function and Respiratory Muscle Function in Asthma.

Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. Although inspiratory muscle training (IMT) and high-intensity interval training (HIIT) are beneficial for patients with asthma, controversies persist. Therefore, we aimed to investigate the effects of IMT and HIIT on lung function and respiratory muscle function of subjects with asthma. We searched PubMed, Embase, Web of Science, and the Cochrane Library databases up to May 2021. Inclusion criteria were randomized controlled trials (RCTs) of subjects with asthma who received either IMT or HIIT. The outcome measures were changes in lung function and respiratory muscle function. A total of 13 RCTs (10 in IMT and 3 in HIIT) were included, with a total of 598 subjects. The meta-analysis showed a significantly improved FEV1 of the expected value (FEV1%pred) (mean difference [MD] 4.49% [95% CI 2.31-6.67], P < .001; I2 = 13%), FVC of the expected value (FVC % pred) (MD 5.72% [95% CI 3.56-7.88], P < .001; I2 = 0%), FEV1/FVC % (MD 5.01% [95% CI 2.45-7.58], P < .001; I2 = 25%), FVC (L) (MD 0.21 L [95% CI 0.03-0.40], P = .02; I2 = 0%), maximum inspiratory pressure (PImax) (MD 27.62 cm H2O [95% CI 6.50-48.74], P = .01; I2 = 96%), and PImax (%pred) (MD 27.35% [95% CI 6.94-47.76], P = .009; I2 = 83.5%) in the IMT group. There was no statistical significance in maximum expiratory pressure. IMT improved pulmonary function (FEV1%pred, FVC) and inspiratory muscle strength in subjects with stable asthma. Due to the small number of RCT studies included and the limited outcome measures involving HIIT, we were unable to draw conclusions about whether HIIT was beneficial in this meta-analysis. Moreover, clinical heterogeneity exists in different areas such as population and training programs; the above conclusions still need to be confirmed in future studies.

Challenges and solutions to the implementation of studies within a trial: The experiences of the PROMETHEUS programme

Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is however limited evidence available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers an opportunity to fill this evidence gap. While SWATs are generally easy to implement, a range of challenges to undertaking SWATs have also been identified, however there is limited detail regarding practical solutions to tackle these. Methods Information and observations collected from PROMETHEUS members and participating trials, focusing on SWATs across a wide range of questions and settings, was reviewed to identify the challenges and solutions of delivery of a programme of SWATs. Results A range of challenges to undertaking SWATs (e.g., obtaining governance approvals) were identified along with potential solutions to these, which were implemented accordingly during programme delivery. Central to the solutions to resolve SWAT challenges is education to develop knowledge and understanding in the wider research community on the importance, purpose, and key methodological principles in relation to SWATs. In addition, the sharing of experience, best practice or resources to prevent or help negotiate the barriers to undertaking SWAT evaluation is also recommended. Conclusions Potential solutions to the barriers experienced in the design, conduct and implementation of a programme of SWATs have been identified. As more SWATs are completed, this will further develop evidence to support the mitigation or removal of barriers and in doing so this should increase the efficiency of randomised controlled trials.

Effects of Acupuncture Combined with Biofeedback Therapy on Limb Motor Rehabilitation in Patients with Acute Stroke: Systematic Review and Meta-Analysis.

Objective The purpose of the systematic review is to verify the effect of biofeedback therapy on limb motor rehabilitation in patients with acute stroke and to provide evidence-based medicine for the promotion and use of biofeedback therapy. Methods The randomized controlled trials (RCT) of biofeedback therapy in the treatment of cerebral palsy were searched in PubMed, EMBASE, ScienceDirect, Cochrane Library, China National Knowledge Infrastructure (CNKI), China VIP Database, Wanfang Database, and Chinese Biomedical Literature Database (CBM). The starting time and ending time of this study are from the time of building the database of the number of pieces to October 31, 2018. The data included in this study were extracted by two independent researchers and evaluated the bias risk of all the literature included in the study according to the Cochrane manual 5.1.0 criteria. RevMan5.4 statistical software was used to analyze the collected data by meta. Results This systematic review included 9 RCT studies with a total of 1410 patients. The results of meta-analysis showed that there were significant differences in the improvement of lower limb muscle tension, comprehensive spasm scale score, EMG score, and passive range of motion of ankle joint between biofeedback therapy and routine rehabilitation therapy. Conclusion Biofeedback therapy can improve lower limb muscle tension, spasticity, EMG integral value, and passive range of motion of ankle joint in children with cerebral palsy and provide better conditions for improving the motor ability of lower extremities in children with cerebral palsy. However, more studies and follow-up with higher methodological quality and longer intervention time are needed to further verify.

Living through the psychological consequences of COVID-19 pandemic: a systematic review of effective mitigating interventions

ObjectiveThis review assesses interventions and their effectiveness in mitigating psychological consequences from pandemic.MethodPublished English literatures were searched from four databases (Medline, PubMed, Embase and PsycINFO) from January 2020 and September...

Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for Guiding Decisions on the Addition of a Run-In Period.

Run-In (RI) periods can be used to improve the validity of randomized controlled trials (RCTs), but their utility in Chronic Pain (CP) RCTs is debated. Cost-effectiveness analysis (CEA) methods are commonly used in evaluating the results of RCTs, but they are seldom used for designing RCTs. We present a step-by-step overview to objectively design RCTs via CEA methods and specifically determine the cost effectiveness of a RI period in a CP RCT. We applied the CEA methodology to data obtained from several noninvasive brain stimulation CP RCTs, specifically focusing on (1) defining the CEA research question, (2) identifying RCT phases and cost ingredients, (3) discounting, (4) modeling the stochastic nature of the RCT, and (5) performing sensitivity analyses. We assessed the average cost-effectiveness ratios and incremental cost effectiveness ratios of varied RCT designs and the impact on cost-effectiveness by the inclusion of a RI period vs. No-Run-In (NRI) period. We demonstrated the potential impact of varying the number of institutions, number of patients that could be accommodated per institution, cost and effectiveness discounts, RCT component costs, and patient adherence characteristics on varied RI and NRI RCT designs. In the specific CP RCT designs that we analyzed, we demonstrated that lower patient adherence, lower baseline assessment costs, and higher treatment costs all necessitated the inclusion of an RI period to be cost-effective compared to NRI RCT designs. Clinical trialists can optimize CP RCT study designs and make informed decisions regarding RI period inclusion/exclusion via CEA methods.

A systematic review and meta-analysis comparing radiofrequency catheter ablation with medical therapy for ventricular tachycardia in patients with ischemic and non-ischemic cardiomyopathies.

In patients with cardiomyopathy, radiofrequency catheter ablation (CA) for ventricular tachycardia (VT) is an adjunctive and alternative treatment option to long-term anti-arrhythmic drug therapy. We sought to compare CA with medical therapy for the management of VT in patients with ischemic and non-ischemic cardiomyopathies. MEDLINE, Cochrane, and ClinicalTrials.gov databases were evaluated for relevant studies. Eleven studies with 2126 adult patients were included (711 in CA, 1415 in medical therapy). In the randomized controlled trial (RCT) analysis, CA reduced risk of recurrent VT (risk ratio (RR) 0.79 [95% CI 0.67 to 0.93], p = 0.005), ICD shocks (RR 0.64 [95% CI 0.45 to 0.89] p = 0.008), and cardiac hospitalizations (RR 0.76 [95% CI 0.63 to 0.92] p = 0.005). There was no difference in all-cause mortality (RR 0.94, p = 0.71). In combined RCT and observational study analysis, there was a trend for reduction in all-cause mortality (RR 0.75 [95% CI 0.55 to 1.02] p = 0.07). In subgroup analysis of studies with mean left ventricular ejection fraction (LVEF) < 35%, CA demonstrated reduction in mortality (RR 0.71, p = 0.004), ICD shocks (RR 0.63, p = 0.03), VT recurrence (RR 0.76, p = 0.004), and cardiac hospitalizations (RR 0.75, p = 0.02). The subgroup of early CA prior to ICD shocks demonstrated reduction in ICD shocks (RR 0.57, p < 0.001) and VT recurrence (RR 0.74, p = 0.01). CA for VT demonstrated a lower risk of VT recurrence, ICD shocks, and hospitalization in comparison to medical therapy. The subgroups of early CA and LVEF < 35% demonstrated better outcomes.

Meta-analysis on efficacy of PCI treatment or conservative treatment among patients with chronic total occlusions

Objective: To compare the efficacy between percutaneous coronary intervention (PCI) and conservative medication treatment in chronic total occlusions (CTO) patients. Methods: It was a meta-analysis.Articles on drug therapy and PCI for complete coronary artery occlusion were retrieved from Pubmed, Embase and Web of Science databases. The search time was from the database construction to May 10, 2020, and the following search criteria were used for the search "chronic total occlusion" "percutaneous coronary intervention" and "medical therapy". References from searched literatures were also searched to identify more eligible studies. Randomized controlled trials (RCT) and cohort studies comparing efficacy of PCI versus oral medication as well as medication as initial therapy option for CTO patients with single or multiple lesions were included. The primary endpoints included all-cause death, cardiac death, recurrent myocardial infarction, re-revascularization, major adverse cardiac events (MACE) and stroke. Data were analyzed with ReviewManager5.3.0 software. Pooled effect size RR and 95%CI were calculated by randomization effect model. Heterogeneity was evaluated by I2. Bege test was used to evaluate publication bias. Subgroup analyses were performed for RCT and cohort studies. Results: A total of 1 079 articles were retrieved and 16 studies (RCT=4, cohort study=12) were included with 12 223 patients. Fourteen publications (RCT=4, cohort study=10) reported all-cause death post PCI and/or drug therapy. Results showed that risk of all-cause death was significantly lower in PCI group than in drug therapy group (RR=0.45,95%CI 0.39-0.53,P<0.001);subgroup analysis showed that risk of all-cause death was significantly lower in PCI group than in drug therapy group from cohort studies (RR=0.44,95%CI 0.38-0.52,P<0.001),but comparable in RCT (P=0.27). Thirteen studies (RCT=3, cohort study=10) reported cardiac death post PCI and/or drug therapy. Results showed that risk of cardiac death was significantly lower in PCI group than in drug therapy group (RR=0.44,95%CI 0.35-0.55,P<0.001);subgroup analysis showed that risk of cardiac death was significantly lower in PCI group than in drug therapy group in cohort studies (RR=0.43,95%CI 0.34-0.54,P<0.001),but not in RCT (P=0.25). Fourteen publications (RCT=4, cohort study=10) reported recurrent myocardial infarction post PCI and/or drug therapy. Results showed that risk of recurrent myocardial infarction was significantly lower in PCI group than in drug therapy group (RR=0.62,95%CI 0.44-0.88,P=0.007);subgroup analysis showed that risk of recurrent myocardial infarction was significantly lower in PCI group than in drug therapy group from cohort studies (RR=0.56,95%CI 0.40-0.78,P=0.000 5),but comparable in RCT (P=0.17). Fourteen publications (RCT=4, cohort study=10) reported re-revascularization post PCI and/or drug therapy. Results showed that risk of re-revascularization was comparable between PCI group and drug therapy group (P=0.91);subgroup analysis showed that risk of re-revascularization was comparable between PCI group and drug therapy group both in cohort study and RCT (P=0.60 and 0.41, respectively). Eleven publications (RCT=3, cohort study=8) reported MACE post PCI and/or drug therapy. Results showed that risk of MACE was significantly lower in PCI group than in drug therapy group (RR=0.74,95%CI 0.59-0.93,P=0.03);subgroup analysis showed that risk of MACE was significantly lower in PCI group than in drug therapy group in cohort studies (RR=0.72,95%CI 0.56-0.93,P=0.01), but not in RCT (P=0.8). Six publications (RCT=2, cohort study=4) reported stroke post PCI and/or drug therapy. Results showed that risk of stroke was comparable between PCI and drug therapy groups (RR=0.62,95%CI 0.32-1.20, P=0.15);subgroup analysis showed that risk of stroke was comparable between PCI and drug therapy groups both in cohort studies and RCT (P=0.48 and 0.32, respectively). Conclusion: Compared with oral drug therapy, PCI may have better efficacy for CTO patients based on results from this cohort study.

Comparing the effects of twice-daily exenatide and insulin on renal function in patients with type 2 diabetes mellitus: secondary analysis of a randomized controlled trial

This is a secondary analysis of a randomized controlled trial (RCT) on the effects of the glucagon-like peptide-1 receptor agonists exenatide and insulin aspartate 30 injection on carotid intima-media thickness....

Influencing adolescents' attitudes towards nicotine products: A systematic review.

Background and aim: Use of nicotine can harm adolescents’ brains and increase risk for future addiction to other drugs. Several international studies show that an acceptable attitude towards nicotine products increases the initiation or use of the products. Adolescents have limited or distorted knowledge about nicotine products. Many of them have a positive image of the properties and effects of nicotine products, which increases the chances of smoking or using snus. Yet, we know little about the relationship between youth nicotine use, youth attitudes towards nicotine products and the interventions to influence these attitudes. This systematic review synthesised adolescents’ attitudes towards nicotine products and the ways to influence them. Methods: Systematic searches were carried out from PubMed, MEDLINE, CINAHL, and MEDIC databases and were targeted to randomised controlled trial (RCT) studies published in 2010–2021. Results: A total of seven RCT studies were reviewed with a total population (age range 9–17 years, adolescents 11–17 years) of 15,974. Findings were classified into four categories: school-based interventions, tobacco prevention campaigns, advertisements’ influence on adolescents’ opinions towards nicotine products, and their responses to cigarette pack warnings. Conclusion: Based on this systematic literature review, particularly school-based interventions have an effect on adolescents’ attitudes towards smoking and preventing them from starting to smoke, when they are targeted before the age of puberty. School-based interventions should be further implemented and strengthened, as the school has been shown to have significant potential to support youth’s health. There is a need for further information about the most effective interventions in the different age groups and the qualitative studies on the topic.

Multicenter Randomized Controlled Trial of Surveillance Versus Endoscopic Therapy for Barrett’s Esophagus With Low-grade Dysplasia: The SURVENT Trial: Study Rationale, Methodology, Innovation, and Implications

Multicenter Randomized Controlled Trial of Surveillance Versus Endoscopic Therapy for Barrett’s Esophagus With Low-grade Dysplasia: The SURVENT Trial: Study Rationale, Methodology, Innovation, and Implications

Effect of 12 Weeks Vitamin D Supplementation (Alphacalcidol) on Blood Pressure in Elderly Women Patients

Background : Cardiovascular disease have overtaken communicable disease for being the main killer worldwide. Hypertension or high blood pressure is one of the risk factors. Elderly women statistically have a high prevalence of hypertension. Vitamin D is known to affect blood pressure and many studies showed the association between vitamin D and blood pressure with varying result. This study aim to evaluate the effect of vitamin D supplementation (alphacalcidol) for 12 weeks and change in blood pressure of elderly women patients in community health service clinic (KPKM) Medical Faculty Syarif Hidayatullah State Islamic University of Jakarta (FK UIN Jakarta), with pre and hypertension grade 1 patients in majority. Methods : Analytical pre-post study design was conducted as a part of an RCT (Randomized Controlled Trial) studies with 106 participants of elderly women (45 intervention group, 61 control group).Results : Vitamin D deficiency in the intervention group significantly decreased post-supplementation from 22.2% to 8.9%. Subgroup analysis showed the decrease in blood pressure is greater in the subgroup middle-age elderly than young-age elderly category. Even though there was a significant change in the diastolic blood pressure in the subgroup of middle-age elderly post supplementation (p=0.03), Mann-Whitney statistical analysis showed that 12 weeks vitamin D supplementation (alphacalcidol) did not significantly effect the pre and post systolic nor diastolic blood pressure (p&gt;0,05). Conclusion : The study did not found significant effect of 12 weeks Vitamin D (alphacalcidol) supplementation on blood pressure in elderly women patients.

Safety interventions for the prevention of accidents at work: A systematic review.

Safety interventions for the prevention of accidents at work: A systematic review.