Randomized Controlled Trials Studies Research Articles

What internet- and mobile-based interventions are currently available for adults with overweight or obesity experiencing symptoms of depression? A systematic review.

Given the high prevalence of overweight and obesity and high comorbidity of depressive symptoms, there is a need for low-threshold, accessible care approaches for people with overweight/obesity aimed at improving mental health. Internet and mobile-based interventions (IMI) represent an innovative complementary treatment option. This review systematically searches for IMI aimed at improving mental health in people with overweight/obesity. We conducted a systematic literature search according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria in the databases MEDLINE, Cochrane Library, PsycINFO, Web of Science and Google Scholar. Randomized controlled trials (RCTs) of IMI for adults with overweight/obesity and comorbid depressive symptoms aiming at improving mental health were screened and extracted. Study quality was assessed with RoB 2 (revised Cochrane Risk of Bias tool in RCTs). After excluding duplicates, n = 790 results were included in title and abstract screening. After full-text-screening of n = 26 studies, n = 3 RCT studies were included. All interventions aimed to reduce both weight and depressive symptoms. In two RCTs, a significant reduction in both depressive symptoms and weight was achieved. One RCT indicated a significant reduction in depressive symptoms, but not in weight. Two intervention had a duration of 6 months and were guided by health carers, the third takes 3 months and can be used without professional guidance. There is evidence that IMI are effective in improving mental health for people with overweight/obesity and comorbid depressive symptoms. However, currently there are few interventions aiming at reducing depressive symptoms, all targeting English-speaking people. As IMI for depressive symptoms can be easily integrated in the somatic therapy of obesity as additional option and has high public health potential, target group-adapted and low-threshold accessible interventions in different languages should be developed and implemented for improving mental health in people with overweight/obesity. Prospero registration number: CRD42023361771.

Interventions for Preventing Tobacco Uptake among Adolescents within School Setting in South-East Asia region: A Systematic Review

Abstract Background Tobacco users disproportionately reside in lower-and-middle income countries, with many people beginning consumption of tobacco in adolescence. Countries employ interventions in schools as a means of providing health education thereby creating mass awareness among them. However, research has mostly restricted to developed nations. Objective To examine the impact of interventions implemented in preventing tobacco uptake among adolescents in school setting in South-East Asia region. Method The protocol was registered prospectively on PROSPERO (CRD42022337341). Systematic search was conducted on 6 databases: PubMed, Embase, Scopus, CINAHL, ProQuest and Web of Science. Randomized Control Trials (RCT) and Cluster RCT conducted in school set-up in South-East Asia among adolescents below 18 years’ age were included. Articles between timeline 2002–2022 were considered. Results From a total of 963 articles, total of 13 studies were included. Four were RCT, while nine were Cluster RCT. Most of the studies were targeted at change in prevalence, followed change in knowledge and attitude towards tobacco and impact on susceptibility to use tobacco. Nine studies had interventions based on Health Promoting School Framework, three were Peer-led Interventions and one was Counsellor-centred Intervention. Risk of Bias assessment revealed eight studies had low risk of bias, two had some concerns while three were high risk studies. Conclusion Interventions that focus on building a holistic environment and go beyond the usual classroom environment have primarily been implemented and found to be effective in this region. There is a need for strong, high-quality RCT studies with standardised evaluation techniques to combat tobacco use among adolescents.

Enhancing Agricultural Extension Programs: A Practical Guide to Designing and Implementing Randomized Controlled Trials

Evidence-based practices in agricultural extension programs must be guided by precise evaluation strategies and reliable data. Methods like randomized controlled trials (RCTs) are vital for assessing specific program interventions. However, not all studies use experimental designs, and their quality varies, as noted in a 2010 World Bank study. RCTs, known for providing robust impact assessments, involve complex steps and are applied in various fields. This guide focuses specifically on RCTs used for agricultural extensions; a topic covered less often than clinical trials. More precisely, this guide provides (1) definitions and key steps for RCTs, (2) a simplified RCTs study design methodology, (3) an exploration of challenges and mitigation, and (4) a summary of relevant RCTs studies in extensions. This guide is formulated to enhance the present understanding of RCTs and elaborate on the ways to use them in their application in agricultural research. Furthermore, the goal here is to make sure that our policies and methods are presented with solid evidence. This approach is meant to encourage the implementation of agricultural practices that are not only more effective but also sustainable.

Effect of perioperative erythropoietin on postoperative morbidity and mortality after cardiac surgery: A meta-analysis of randomized controlled trials

ObjectiveCardiac surgery is known to have high rates of perioperative red blood cell (RBC) transfusions which are associated with increased postoperative mortality and morbidity. Perioperative erythropoietin (EPO) has been suggested to lower perioperative RBC transfusions, and the effect on postoperative morbidity or mortality is unknown. MethodsThe registered study protocol is available on PROSPERO (CRD42022314538). We searched the Pubmed, EMbase, and Cochrane CENTRAL databases for randomized controlled trials (RCT) of EPO in cardiac surgery. Outcomes were short-term mortality, acute kidney injury (AKI), re-operation, cerebrovascular accident (CVA), perioperative myocardial infarction (MI), infectious complications, and RBC transfusions. RCT studies of perioperative EPO that reported at least one prespecified outcome of interest were included. ResultsA total of 21 RCT’s (n = 2,763 patients) were included. Mortality analysis included 17 studies (EPO 1,272 patients, control 1,235) and showed no significant difference (risk difference (RD) 0.0004, 95%CI: -0.016, 0.009). EPO did not reduce the incidence of AKI (RD -0.006, 95% CI: -0.038, 0.026) and reoperation (RD 0.001, 95% CI: -0.013, 0.015). The incidence of CVA (RD -0.004, 95% CI: -0.015, 0.007) and perioperative MI (RD -0.008, 95% CI: -0.021, 0.005) was similar between the groups. ConclusionsAlthough EPO had been proven to reduce perioperative RBC transfusions, we did not find that it reduces the incidence of postoperative short-term mortality, AKI, and reoperation. The study results support that perioperative EPO is also safe, with no rise in thrombotic events, including CVA and perioperative MI.

Characterization and Potential Relevance of Randomized Controlled Trial Patient Populations in Revision Total Joint Arthroplasty: A Systematic Review.

Randomized controlled trial (RCT) studies in revision total joint arthroplasty (rTJA) are essential to investigate the effectiveness of interventions. However, there has been limited research investigating how patient cohorts comprising rTJA RCT samples resemble the US patient population undergoing rTJA in terms of demographic and clinical characteristics. Thus, the purpose of this systematic review was to compare the patient characteristics of rTJA RCT cohorts with the characteristics of national patient database cohorts. RCT studies for rTJA were aggregated. Patient demographics in this group were compared against HCUP NIS and ACS-NSQIP patient cohorts. Forty-six RCTs met inclusion criteria. There were 3,780 total patients across 46 RCTs. The average age of patients in the rTJA RCT cohort was 66.4 9.4 while the NIS cohort was 67.3 11.1 (d=0.08, effect size=small). The average BMI of the rTJA RCT cohort was 31.1 5.7 while the NSQIP cohort was 31.7 8.3 (d=0.08, effect size=small). For rTJA, effect sizes for age, BMI, sex, ethnicity, smoking, and diabetes were all small or very small. Overall, the rTJA RCT patient cohort does not differ significantly compared to the general patient population undergoing rTJA. Differences in demographic and clinical characteristics between the rTJA RCT cohort and database cohorts were minimal to small, indicating that these differences are unlikely to impact clinical outcomes.

The Effects of Hydrogen-Rich Water on Blood Lipid Profiles in Metabolic Disorders Clinical Trials: A Systematic Review and Meta-analysis

Context: Metabolic disorders are a growing global concern, especially in developed countries, due to their increasing prevalence. Serum lipid profiles, including triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL), are commonly used clinical biomarkers for monitoring the progression of these metabolic abnormalities. In recent decades, hydrogen-rich water (HRW) has gained attention as a safe and effective treatment, with regulatory effects on lipid peroxidation and inflammatory responses in clinical trials. Objectives: This systematic review and meta-analysis aim to evaluate the effectiveness of HRW therapy on blood lipid profiles in randomized controlled trials (RCTs) for metabolic disorders. Methods: Following the PRISMA guidelines, a search for RCT studies was conducted in the PubMed, Web of Science, Embase, and Google Scholar databases up to January 2024. Eight studies that met all eligibility criteria, including RCTs involving metabolic dysfunctions and evaluations of lipid profiles, were included for further analysis. Data extraction was followed by quality evaluation using the Jadad scoring system. Meta-analysis was conducted using STATA software. Results: The eight selected RCTs included a total of 357 patients with various metabolic disorders. All studies showed either no or low risk of bias. The overall levels of TG [95% CI: -0.27 (-0.47, -0.07)], TC [95% CI: -0.07 (-0.32, -0.18)], and LDL [95% CI: -0.06 (-0.28, 0.15)] demonstrated slight decreases across the studies. However, there was some heterogeneity in HDL levels [95% CI: -0.11 (-0.37, 0.14)] among the studies (I² = 37.32%). Meta-regression analysis further indicated a positive association between the outcomes and the duration of the intervention as a moderating factor. Conclusions: Hydrogen-rich water demonstrated modest lipid-lowering effects in patients with metabolic disorders. However, due to the observed heterogeneity in HDL variations, further long-term trials involving larger populations are needed to clarify these inconsistencies.

A scoping review of cane use in people who have had a stroke

BACKGROUND: Various types of canes are frequently utilised in stroke rehabilitation to support walking ability by compensating for hemiplegic gait. However, Randomised Controlled Trial (RCT) design varies considerably in the area of cane use following stroke and there is no scoping review published to date on this topic. Thus, it is crucial for better evidence informed clinical care and future research that RCT evidence regarding specific assistive walking devices is examined. OBJECTIVES: Identify and map the types of canes that currently exist and review their impact on the rehabilitation of functional mobility post-stroke. METHOD: The following databases were searched: PubMed/MEDLINE, Web of Science, and CINAHL in Ebsco. Two authors independently screened 425 titles, identifying 16 RCT studies for inclusion in the review. RESULTS: 16 studies were selected for review. Five different cane designs were identified, including one-point cane, three-point cane, quad cane, weight-supported feedback cane, and rolling cane. Twelve studies were crossover RCT and four were parallel RCT. Stroke phase varied widely among subjects included in the studies and outcome measures utilised and resultant findings are heterogeneous. CONCLUSION: More evidence is required to clearly indicate the effect of canes on people who have had a stroke and parallel long-term RCTs with follow-up assessment are lacking. Furthermore, there is a lack of research examining variations in new cane designs that specifically target motor function in people who have had a stroke at specific stages. Future research should aim to address the identified inconsistencies and knowledge gaps to facilitate novel and evidence-informed clinical care regarding assistive walking devices for post stroke rehabilitation.

Functional Role of Extracellular Vesicles in Skeletal Muscle Physiology and Sarcopenia: The Importance of Physical Exercise and Nutrition.

Extracellular vesicles (EVs) play a key role in intercellular communication by transferring miRNAs and other macromolecules between cells. Understanding how diet and exercise modulate the release and content of skeletal muscle (SM)-derived EVs could lead to novel therapeutic strategies to prevent age-related muscle decline and other chronic diseases, such as sarcopenia. This review aims to provide an overview of the role of EVs in muscle function and to explore how nutritional and physical interventions can optimise their release and function. A literature review of studies examining the impact of exercise and nutritional interventions on MS-derived EVs was conducted. Major scientific databases, including PubMed, Scopus and Web of Science, were searched using keywords such as 'extracellular vesicles', 'muscle', 'exercise', 'nutrition' and 'sarcopenia'. The selected studies included randomised controlled trials (RCTs), clinical trials and cohort studies. Data from these studies were synthesised to identify key findings related to the release of EVs, their composition and their potential role as therapeutic targets. Dietary patterns, specific foods and supplements were found to significantly modulate EV release and composition, affecting muscle health and metabolism. Exercise-induced changes in EV content were observed after both acute and chronic interventions, with a marked impact on miRNAs and proteins related to muscle growth and inflammation. Nutritional interventions, such as the Mediterranean diet and omega-3 fatty acids, have also shown the ability to alter EV profiles, suggesting their potential to improve cardiovascular health and reduce inflammation. EVs are emerging as critical mediators of the beneficial effects of diet and exercise on muscle health. Both exercise and nutritional interventions can modulate the release and content of MS-derived EVs, offering promising avenues for the development of novel therapeutic strategies targeting sarcopenia and other muscle diseases. Future research should focus on large-scale RCT studies with standardised methodologies to better understand the role of EVs as biomarkers and therapeutic targets.

Effects of Vitamin D Supplementation and Baseline Vitamin D Status on Acute Respiratory Infections and Cathelicidin: A Randomized Controlled Trial

Abstract Background Vitamin D supplementation may lower the risk of acute respiratory infection (ARI), and the effects may be mediated through the induction of cathelicidin production. Objective To study the effect of vitamin D supplementation on ARI and cathelicidin concentration in a randomized controlled trial (RCT) and to study the associations between baseline serum 25 hydroxyvitamin D (25(OH)D) and ARIs and cathelicidin concentrations in a 14-week follow-up study. Methods In the RCT study, the participants were randomized into 2 groups to receive either 20 µg of vitamin D3 or an identical placebo daily. Blood samples were obtained 3 times, at the beginning (study week 0), mid-term (study week 6), and at the end of the study period (study week 14). The follow-up study had 412 voluntary young men from 2 different locations and seasons (January and July). The primary outcomes were the number of ARIs diagnosed and the number of days off because of ARI. Results In the RCT, vitamin D supplementation had no effect on ARI or days off because of ARI. However, regardless of the group, vitamin D insufficiency (<50 nmol/L) was associated with increased ARI. In the 14-week follow-up study, insufficient serum 25(OH)D at baseline was also associated with increased risk of ARI (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.2–3.7) and also days-off duty (OR, 2.3; 95% CI, 1.3–4.0) and was inversely associated with cathelicidin concentration (OR, 0.49; 95% CI, .24–.99). Conclusions Sufficient serum 25(OH)D may be preventive against acute respiratory infection and the preventive effect could be mediated through the induction of cathelicidin production. Clinical Trial Registry number: NCT05014048. https://clinicaltrials.gov/study/NCT05014048?term=NCT05014048&rank=1

The impact of exercise training on muscle sympathetic nerve activity: a systematic review and meta-analysis.

The purpose of this systematic review and meta-analysis was to examine the effects of exercise training on muscle sympathetic nerve activity (MSNA) in humans. Studies included exercise interventions [randomized controlled trials (RCTs), nonrandomized controlled trials (non-RCTs), or pre-to-post intervention] that reported on adults (≥18 yr) where MSNA was directly assessed using microneurography, and relevant outcomes were assessed [MSNA (total activity, burst frequency, burst incidence, amplitude), heart rate, blood pressure (systolic blood pressure, diastolic blood pressure, or mean blood pressure), and aerobic capacity (maximal or peak oxygen consumption)]. Forty intervention studies (n = 1,253 individuals) were included. RCTs of exercise compared with no exercise illustrated that those randomized to the exercise intervention had a significant reduction in MSNA burst frequency and incidence compared with controls. This reduction in burst frequency was not different between individuals with cardiovascular disease compared with those without. However, the reduction in burst incidence was greater in those with cardiovascular disease [9 RCTs studies, n = 234, mean difference (MD) -21.08 bursts/100 hbs; 95% confidence interval (CI) -16.51, -25.66; I2 = 63%] compared with those without (6 RCTs, n = 192, MD -10.92 bursts/100 hbs; 95% CI -4.12, -17.73; I2 = 76%). Meta-regression analyses demonstrated a dose-response relationship where individuals with higher burst frequency and incidence preintervention had a greater reduction in values post-intervention. These findings suggest that exercise training reduces muscle sympathetic nerve activity, which may be valuable for improving cardiovascular health.NEW & NOTEWORTHY This systematic review and meta-analysis suggests exercise training reduces muscle sympathetic nerve activity (MSNA), which may be valuable for improving cardiovascular health. The reduction in burst incidence was greater among individuals with cardiovascular disease when compared with those without; exercise training may be particularly beneficial for individuals with cardiovascular disease. Meta-regression analyses demonstrated a dose-response relationship, where individuals with higher sympathetic activity preintervention had greater reductions in sympathetic activity post-intervention.

Summary of Evidence on the Impact of Mindfulness Training on Anxiety Levels of Pregnant Women

Background: Mental health during pregnancy is a global health problem, the percentage of pregnant women with antenatal anxiety or mood disorders ranges from 15% and 25%, with generalized anxiety disorder as the most common factor in the illness. Most of the research findings show a relationship between mothers’ psychological distress and poor prognosis for either the mother or the infant. Low well-being during pregnancy has significant adverse impacts on both mother and infant. Therefore, it is important to focus on antenatal anxiety and psychological stress in pregnant women. Mindfulness training, defined as an intentional and non-judgmental awareness of experience in the present moment, it is the most common intervention for antenatal education. Although the impact of positive thinking interventions on antenatal maternal well-being has been increasingly examined, the results still have not been systematically evaluated. Aim: This paper aims to systematically evaluate the effects of positive thinking interventions on evidence of antenatal anxiety in pregnant women and current research methods with a population of pregnant women by evaluating five studies of Randomized Controlled Trials (RCTs) using the CASP checklist tool. Summarize the implications of the evaluation results for future studies, and finally provide practical insights and research recommendations. Methods: Firstly, the research topic is identified: patient/problem: pregnancy anxiety; intervention: intervention in positive thinking; comparison: usual care. A complete internet-based search of five databases was conducted through Academic Search Complete, Medical Line, CINAHL, Health Source: Nursing/Academic Edition and Google Scholar to identify randomized controlled trials assessing positive thinking training versus postnatal depression controls. To select higher quality and relevant articles, the author rechecked titles and abstracts exclusion criteria and manually searched five peer-reviewed RCT articles from the last five years by further evaluating reference lists, while focusing on assessing interventions, measurement scale outcomes, study sample results, strengths and limitations. Secondly, randomized controlled trials were assessed using the CASP Randomized Controlled Trial Criteria Checklist. This version has now been updated to the 2020 Access Guide. Results: This paper provides a specific review of five RCT studies by using the CASP assessment tool, and concludes that positive thinking training shows potential benefits in terms of prenatal depression, anxiety and negative affect levels. From a comparison of the five intervention modalities of the positive thinking intervention, Mindfulness-integrated Cognitive Behavior Therapy (MICBT) had the broadest range of interventions and the most comprehensive curriculum. Most of the studies had small sample sizes of participants and an increase in sample size and longer follow-up time through comparative analysis would be beneficial to generalizability, therefore a sample size of 50 people on average between the intervention and control groups was chosen as appropriate, with a follow-up time of at least one month and three months. Also, the presence of potential bias was mentioned in these studies, by comparing randomized classification methods it was found that the smaller the base difference present through computer allocation and single-blind allocation, the less systematic bias there was. The choice of measurement instruments did not conflict with the sample size, the cultural background of the population and the findings. However, positive effects on anxiety and stress during pregnancy were less consistent with the assessment tool for the intervention group. Self-report instruments are highly sensitive and idiosyncratic, coupled with the tendency of participants to interact with researchers to produce bias. Therefore, when selecting a measurement tool, the best approach is to combine a self-report instrument with a researcher’s assessment. The literature highlights the increased interest in this area in recent years. Coupled with the prevalence of methodological issues and variation between studies, the current review is timely and necessary to determine intervention effects and best practice for future research. Findings: Mindfulness training is a useful intervention for improving anxiety and stress during pregnancy, but future research recommendations must follow robust methodological criteria with expanded sample sizes and longer follow-ups to examine the effects of positive thinking interventions during pregnancy.

Evaluating EEG neurofeedback in sport psychology: a systematic review of RCT studies for insights into mechanisms and performance improvement.

Electroencephalographic Neurofeedback Training (EEG NFT) aims to improve sport performance by teaching athletes to control their mental states, leading to better cognitive, emotional, and physical outcomes. The psychomotor efficiency hypothesis suggests that optimizing brain function could enhance athletic ability, indicating the potential of EEG NFT. However, evidence for EEG-NFT's ability to alter critical brain activity patterns, such as sensorimotor rhythm and frontal midline theta-key for concentration and relaxation-is not fully established. Current research lacks standardized methods and comprehensive studies. This shortfall is due to inconsistent EEG target selection and insufficient focus on coherence in training. This review aims to provide empirical support for EEG target selection, conduct detailed control analyses, and examine the specificity of electrodes and frequencies to relation to the psychomotor efficiency hypothesis. Following the PRISMA method, 2,869 empirical studies were identified from PubMed, Science Direct, Web of Science, Embase, CNKI, and PsycINFO. Thirteen studies met the inclusion criteria: (i) proficient skill levels; (ii) use of EEG; (iii) neurofeedback training (NFT); (iv) motor performance metrics (reaction time, precision, dexterity, balance); (v) control group for NFT comparison; (vi) peer-reviewed English-language publication; and (vii) randomized controlled trial (RCT) design. Studies indicate that NFT can enhance sports performance, including improvements in shooting accuracy, golf putting, and overall motor skills, as supported by the psychomotor efficiency hypothesis. EEG NFT demonstrates potential in enhancing sports performance by optimizing performers' mental states and psychomotor efficiency. However, the current body of research is hampered by inconsistent methodologies and a lack of standardized EEG target selection. To strengthen the empirical evidence supporting EEG NFT, future studies need to focus on standardizing target selection, employing rigorous control analyses, and investigating underexplored EEG markers. These steps are vital to bolster the evidence for EEG NFT and enhance its effectiveness in boosting sport performance.

The effect of psychosocial interventions on anxiety and depression in congenital heart disease population: a systematic review and explorative meta-analysis

Abstract Introduction Patients with congenital heart disease (CHD) face various psychological challenges throughout their clinical journey, mainly attributed to symptoms of anxiety and depression. Approximately 19-43% of adults with CHD experience symptoms of depression and/or anxiety. In this scenario, addressing anxiety and depression through psychological interventions (PIs) becomes crucial. However, no available syntheses of the efficacy of PIs on anxiety and depression in the population with CHD have been performed thus far. Purpose To explore the efficacy of PIs on anxiety and depression within the CHD population. Methods We have conducted a systematic review up to January 2024 in these databases: PubMed, CINAHL, SCOPUS, and EMBASE. The study selection process adhered to specific inclusion criteria: (a) patients of all ages with CHD, (b) randomized controlled trial studies (RCTs), (c) published in English between 2000 and 2023, (d) focusing on PIs targeting anxiety and depression as outcomes. Cohen’s d was calculated to quantify and standardize the effect sizes between groups (treatment group vs. control group, considering an intention-to-treat approach) and within groups (from baseline to the last follow-up) to compute a cumulative effect size (Cohen’s d) per each study that controls potential differences of the outcome scores at the baseline in each study. Random-effect models were applied to pool each primary study's effect size (Stata 18 with the "metan.ado" add-on). Results Out of 558 records identified, only 3 RCTs met the inclusion criteria. These studies, published between 2017 and 2021, predominantly involved adults with CHD. None was conducted in Europe. Three main PIs were tested: Rational Emotive Behaviour Therapy, Mindfulness-based Stress Reduction, and Cognitive-Behaviour Therapy. Instead, the Hamilton Depression Rating Scale and Beck Depression Inventory were utilized, while the Hospital Anxiety and Depression Scale was employed to assess both depression and anxiety. For depression (N_intervention group = 93, N_control group = 85), the overall Cohen’s d was -1.04 [95% CI: -2.00, -0.07; p ≤ 0.001] with a moderate level of heterogeneity among studies (I² = 31.53%; Q(2) = 2.79; p = 0.25) as illustrated in Figure 1. Therefore, the findings indicate a moderate statistically significant effect of PIs in reducing depression up to three months post-intervention. Conversely, for anxiety (N_intervention group = 51, N_control group = 43), the overall Cohen’s d was 0 [95% CI: -0.96 +0.97; p ≤ 0.001] as illustrated in Figure 2. Conclusions This study summarizes the current evidence and brings the need for more attention in performing research employing PIs in adults with CHD. In fact, the paucity of available included RCTs sustains the need for more research. The results of this study highlight that PIs appear to be effective in reducing depression, while the studies performed in this population do not support evidence about anxiety.Figure 1.Figure 2.

The efficacy and safety of inhaled antibiotics for pneumonia: A systematic review and meta-analysis

ObjectivesThe aim of this study was to evaluate the efficacy and safety of inhaled antibiotics for adults with pneumonia by meta-analysis. MethodsLiterature retrieval was completed through five databases (PubMed, Embase, Cochrane Library, Web of Science and Scopus) by the deadline of May 31, 2024. The process of study selection and data extraction were performed independently by two reviewers. The quality of observational studies and randomized controlled trial (RCT) studies were evaluated by Newcastle Ottawa scale and Jadad scale, respectively. The primary outcomes included mortality, clinical cure, and microbiological cure. Secondary outcomes were recurrence and renal impairment. ResultsThere were 30 studies were analyzed, including 12 RCT studies and 18 observational studies. Inhaled antibiotics did not significantly reduce mortality in RCT studies (odds ratio (OR) = 1.06, 95 % confidence interval (CI): 0.80–1.41). Inhaled antibiotics were associated with higher rates of clinical cure (OR = 1.47 95%CI: 0.82–2.66 in RCT studies and OR = 2.09, 95%CI: 1.36–3.21 in observational studies) and microbiological cure (OR = 7.00 in RCT studies and OR = 2.20 in observational studies). Subgroup analysis showed patients received inhaled antibiotics combined with intravenous administration and inhaled amikacin had better improvements of mortality, clinical cure and microbiological cure. Inhaled antibiotics were not associated with recurrence. The pooled OR of renal impairment were 0.65 (95%CI: 0.27–1.13; I-squared = 43.5 %, P = 0.124) and 0.63(95%CI: 0.26–1.11; I-squared = 69.0 %, P = 0.110) in RCT studies and observational studies, respectively. ConclusionsInhaled antibiotics decreased risk of renal impairment and achieved significant improvements of clinical and microbiological cure in patients with pneumoniae.

Systematic Review of Cellular, Acellular, and Matrix-like Products and Indirect Treatment Comparison Between Cellular/Acellular and Amniotic/Nonamniotic Grafts in the Management of Diabetic Foot Ulcers.

Significance: This Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant review focuses on the efficacy of cellular, acellular, and matrix-like products (CAMPs) in the management of diabetic foot ulcers (DFUs) based on published randomized controlled trials (RCTs). Recent Advances: Although CAMPs have been incorporated into the clinical algorithm for chronic wounds, evidence is lacking to comparatively evaluate the efficacy of these products. Critical Issues: Level 1 RCT studies are the gold standard to evaluate the efficacy of different treatment approaches; however, due to differences in surgical techniques, patient demographics, and compliance, standard-of-care (SOC) outcomes in the wound care space can vary significantly between different RCTs, making it difficult to compare them against each other. Future Directions: To mitigate variability between different RCTs, wound closure outcomes can be reported as risk ratios (RRs). This review of all the currently published RCTs (with a similar trial design) in patients with DFU and RRs confirms that CAMPs adjunct to SOC result in statistically superior wound closure outcomes in DFUs, when compared with SOC alone, with a RR of 1.72 [1.56, 1.90], p < 0.00001. Enough evidence is still lacking to determine a statistical difference between broad categories of cellular/acellular and amniotic/nonamniotic CAMPs, and hence, decision makers should consider published head-to-head comparative studies, real-world evidence, and cost-effectiveness evidence between individual CAMPs to decide on which to use in practice.

Detailed regimens for the prolonged β-lactam infusion therapy

A recent systematic review and meta-analysis of randomized controlled trials (RCTs) evaluated the efficacy and safety of prolonged versus intermittent β-lactam infusion in adult sepsis patients. The findings revealed a significant decrease in all-cause mortality and marked clinical success in the prolonged infusion group. Unfortunately, however, the manuscript lacked data and discussion for the specific regimens of prolonged β-lactam infusion defined in the included 15 RCT studies, which are herein additionally provided. Excluding one RCT, all protocols adopted a continuous infusion for the prolonged treatment. Except for three RCTs, dosages and timings of bolus injection were clearly defined. The total daily antibiotic dose for the continuous therapy was equivalent to those recommended for intermittent therapy. We believe this supplementary data aids clinicians in providing prolonged β-lactam infusions, contributing to enhanced treatment outcomes for patients suffering from severe sepsis or septic shock.

The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke – protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab)

BackgroundBody weight unloaded treadmill training has shown limited efficacy in further improving functional capacity after subacute rehabilitation of ischemic stroke patients. Dynamic robot assisted bodyweight unloading is a novel technology that may provide superior training stimuli and continued functional improvements in individuals with residual impairments in the chronic phase after the ischemic insult. The aim of the present study is to investigate the effect of dynamic robot-assisted versus standard training, initiated 6 months post-stroke, on motor function, physical function, fatigue, and quality of life in stroke-affected individuals still suffering from moderate-to-severe disabilities after subacute rehabilitation.MethodsStroke-affected individuals with moderate to severe disabilities will be recruited into a prospective cohort with measurements at 3-, 6-, 12- and 18-months post-stroke. A randomised controlled trial (RCT) will be nested in the prospective cohort with measurements pre-intervention (Pre), post-intervention (Post) and at follow-up 6 months following post-intervention testing. The present RCT will be conducted as a multicentre parallel-group superiority of intervention study with assessor-blinding and a stratified block randomisation design. Following pre-intervention testing, participants in the RCT study will be randomised into robot-assisted training (intervention) or standard training (active control). Participants in both groups will train 1:1 with a physiotherapist two times a week for 6 months (groups are matched for time allocated to training). The primary outcome is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment from pre-post intervention on the intention-to-treat population. A per-protocol analysis will be conducted analysing the differences in change scores of the participants demonstrating acceptable adherence. A priori sample size calculation allowing the detection of the minimally clinically important between-group difference of 6 points in the primary outcome (standard deviation 6 point, α = 5% and β = 80%) resulted in 34 study participants. Allowing for dropout the study will include 40 participants in total.DiscussionFor stroke-affected individuals still suffering from moderate to severe disabilities following subacute standard rehabilitation, training interventions based on dynamic robot-assisted body weight unloading may facilitate an appropriate intensity, volume and task-specificity in training leading to superior functional recovery compared to training without the use of body weight unloading.Trial RegistrationClinicalTrials.gov. NCT06273475.Trial status: Recruiting.Trial identifier: NCT06273475.Registry name: ClinicalTrials.gov.Date of registration on ClinicalTrials.gov: 22/02/2024.

Effectiveness of team-based care interventions in improving blood pressure outcomes among adults with hypertension in Africa: a systematic review and meta-analysis

ObjectiveWe evaluated the effectiveness of team-based care interventions in improving blood pressure (BP) outcomes among adults with hypertension in Africa.DesignSystematic review and meta-analysis.Data sourcePubMed, CINAHL, EMBASE, Cochrane Library, HINARI and...

A Meta-Analysis of Dextrose Infusion as Perioperative Strategy on Preventing Postoperative Nausea and Vomiting

Introduction: Dextrose infusion was introduced as a non-pharmacological perioperative strategy to decrease the PONV incidence. However, current published studies reported remain inconsistent and debatable results regarding the efficacy. This research was conducted to improve the evidence-based perioperative strategies of administering dextrose infusion to prevent PONV. Method: A literature search was conducted for randomized controlled trial studies (RCTs) in patients who administered dextrose infusion compared to other infusion fluid perioperatively. A quantitative analysis using Review Manager 5.4 was performed with a 95% confidence interval that was visualized in the forest plot graph using the fixed-effects or random-effects model based on the heterogeneity. Results: A total of 18 RCTs studies analyzed demonstrated there were significant differences in composite PONV (RR, 0.66, 95% CI 0.60, 0.74; P &lt; 0.00001; I2=46%), patients with postoperative antiemetic rescue requirements (RR, 0.67, 95% CI 0.53, 0.86; P &lt; 0.001; I2=68%), and postoperative blood glucose levels (SMD, 2.63, 95% CI 1.76, 3.50; P &lt; 00001; I2=97%). However, there were insignificant results in PONV severity (SMD, -0.94, 95% CI -2.20, 0.31; P = 0.14; I2=97%), patients with analgesic requirements (RR, 0.84, 95% CI 0.60, 1.19; P = 0.33; I2=81%), dose of analgesic requirements (SMD, -2.31, 95% CI -5.76, 1.14; P = 0.19; I2=99%), and PACU stay (MD, -24.73, 95% CI -66.07, 16.61; P &lt; 0.24; I2=99%). Conclusion: This meta-analysis demonstrated that administering dextrose infusion perioperatively prevents both the PONV incidence and postoperative rescue antiemetic requirements, and also increase postoperative blood glucose levels. However, dextrose infusion is not associated with reducing the PONV severity, postoperative analgesic requirements, a dose of postoperative analgesic use, and PACU stay. .

The Effect of Using Ofloxacin Ear Drops in Traumatic Tympanic Membrane Healing: A Systematic Review and Meta-Analysis.

Objectives: To evaluate the effectiveness of ofloxacin ear drops versus no intervention in the repair of traumatic tympanic membrane (TM) perforations from randomized controlled trials (RCTs). Data Sources: Medline/PubMed, CENTRAL, Clinical Trials.Gov, and Google Scholar. Study Selection: Inclusion criteria: (1) English language; (2) RCT studies; (3) reported the outcomes on the application of ofloxacin and outcomes of spontaneous healing. Exclusion criteria: (1) studies without a control group; (2) patient with severe otologic disease such as chronic suppurative otitis media or ossicular disruption or patients with craniocerebral injury; (3) studies with no pretreatment values or single-arm clinical studies. Data Extraction: Country, year of publication, number of participants in each arm, patient characteristics such as age, sex, intervention details, laterality, cause of TM perforation, position of perforation, follow-up time, hearing gain, rate of TM closure, and closure time. Results: A total of 6 RCTs studies were analyzed. A total of 502 participants were included; the relative risk for closure rate of ofloxacin treatment was 1.18 [95% confidence interval (CI), 1.08 to 1.28, P < .001] and the mean difference (MD) for healing time was -18.4 (95% CI, -19.96 to -16.82, P < .001), suggesting ofloxacin has a significant effect on closure of TM perforations. However, no clinically significant effect in hearing (SMD: 0.21, 95% CI, 0.02 to 0.40, P = .03) was seen in ofloxacin group. Also, patients in the ofloxacin group were associated with a 13% reduction in the risk of infections compared to their observation-assigned counterparts, but this estimate was not statistically significant. Conclusion: Ofloxacin use in patients with traumatic TM perforation is effective in reducing healing time and increasing rate of TM perforation closure. No evidence of increased risk of hearing loss or infection rates are encountered when ofloxacin is prescribed to patients with traumatic TM perforation.