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Biomedicines Jun 2024The cerebellum is emerging as a promising target for noninvasive brain stimulation (NIBS). A systematic review was conducted to evaluate the effects of cerebellar NIBS... (Review)
Review
The cerebellum is emerging as a promising target for noninvasive brain stimulation (NIBS). A systematic review was conducted to evaluate the effects of cerebellar NIBS on both motor and other symptoms in stroke rehabilitation, its impact on functional ability, and potential side effects (PROSPERO number: CRD42022365697). A systematic electronic database search was performed by using PubMed Central (PMC), EMBASE, and Web of Science, with a cutoff date of November 2023. Data extracted included study details, NIBS methodology, outcome measures, and results. The risk of bias in eligible studies was also assessed. Twenty-two clinical studies involving 1016 participants were finally included, with a focus on outcomes related to post-stroke motor recovery (gait and balance, muscle spasticity, and upper limb dexterity) and other functions (dysphagia and aphasia). Positive effects were observed, especially on motor functions like gait and balance. Some efficiency was also observed in dysphagia rehabilitation. However, findings on language recovery were preliminary and inconsistent. A slight improvement in functional ability was noted, with no serious adverse effects reported. Further studies are needed to explore the effects of cerebellar NIBS on post-stroke non-motor deficits and to understand how cerebellar engagement can facilitate more precise treatment strategies for stroke rehabilitation.
PubMed: 38927555
DOI: 10.3390/biomedicines12061348 -
Biomedicines Jun 2024The efficacy and safety of PD-L1 inhibitors in the treatment of cervical cancer is an ongoing research question. This review aims to establish a clear profile of... (Review)
Review
BACKGROUND AND OBJECTIVES
The efficacy and safety of PD-L1 inhibitors in the treatment of cervical cancer is an ongoing research question. This review aims to establish a clear profile of atezolizumab, examining its impact on survival outcomes, response rates, and safety measured by serious adverse events (SAEs).
MATERIALS AND METHODS
A literature search was conducted using PubMed, Scopus, and Web of Science, focusing on articles published up to February 2024. The review followed the PRISMA guidelines and synthesized outcomes from four randomized trial studies involving atezolizumab administered at 1200 mg IV every three weeks, alone or in combination with chemoradiotherapy.
RESULTS
A total of 284 patients received atezolizumab, the majority being advanced stage cervical cancer (IVA-IVB). Median follow-up times ranged from 9 weeks to 32.9 months. It was found that combining atezolizumab with standard therapies extended median progression-free survival (PFS) from 10.4 to 13.7 months and overall survival (OS) from 22.8 to 32.1 months, according to the phase III trial. Monotherapy and initial treatment settings with atezolizumab also showed promising efficacy, with disease-free survival rates at 24 months reaching 79% compared to 52% with standard therapy alone. However, the treatment was associated with high rates of SAEs, reaching up to 79% in more intensive treatment combinations.
CONCLUSIONS
Atezolizumab demonstrates significant potential in improving PFS and OS in patients with cervical cancer, supporting its inclusion as a first-line treatment option. Despite the efficacy benefits, the high incidence of SAEs necessitates careful patient selection and management strategies to mitigate risks. This systematic review supports the continued evaluation of atezolizumab in broader clinical trials to refine its therapeutic profile and safety measures in the context of cervical cancer treatment.
PubMed: 38927498
DOI: 10.3390/biomedicines12061291 -
BMC Musculoskeletal Disorders Jun 2024An increasing body of evidence suggests that home-based exercise (HBE) therapy has significant therapeutic effects on knee osteoarthritis (KOA) and hip osteoarthritis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
An increasing body of evidence suggests that home-based exercise (HBE) therapy has significant therapeutic effects on knee osteoarthritis (KOA) and hip osteoarthritis (HipOA), and it has advantages such as cost savings, strong operability, and good compliance compared with hospitalization and exercise courses.
OBJECTIVE
To evaluate the efficacy of HBE in the treatment of KOA and HipOA.
METHODS
A systematic search was conducted in PubMed, Cochrane, Web of Science, and Embase to collect randomized controlled trials. The retrieval time was from database establishment until March 6, 2024. Stata 15.1 software was used for data analysis.
RESULTS
A total of 16 randomized controlled trials involving 3,015participants were included, with 1,519 participants in the intervention group and 1,496 in the control group. The meta-analysis showed that, compared to the control group, HBE can significantly improve pain [SMD=-0.38, 95% CI (-0.58, -0.18); P = 0.001], joint function [SMD=-0.60, 95% CI (-1.01, -0.19); P = 0.004], balance ability [SMD=-0.67, 95% CI (-1.00, -0.34); P = 0.001], mobility (ADL) [SMD = 0.51, 95% CI (0.19, 0.82); P = 0.002] in patients with KOA and HipOA. There is no statistical difference in the improvement of joint stiffness [WMD = -0.80, 95% CI (-1.61, 0.01); P = 0.052]. In addition, subgroup analysis showed that HBE significantly improved pain, joint function, and balance ability in KOA patients compared with the control group. HipOA patients showed significant improvement in pain and joint function; However, HBE only improved activity ability in patients with comorbidities of KOA and HipOA.
CONCLUSION
HBE can effectively alleviate pain, improve joint function, and enhance physical function in patients with KOA and HipOA. However, more high-quality randomized controlled trials (RCTs) with large sample sizes and long-term interventions are needed to validate the efficacy of HBE due to limitations in the methodology and consistency of indicator outcomes in the included RCTs.
REGISTRATION NUMBER
We've registered with PROSPERO, and the number is CRD42023443085.
Topics: Humans; Osteoarthritis, Hip; Osteoarthritis, Knee; Exercise Therapy; Treatment Outcome; Randomized Controlled Trials as Topic; Pain Measurement; Knee Joint; Home Care Services; Disability Evaluation
PubMed: 38926896
DOI: 10.1186/s12891-024-07585-w -
BMC Musculoskeletal Disorders Jun 2024Chronic low back pain (CLBP) is a frequent disease. It is a critical health concern that can influence functional capacity by restricting living activities.
BACKGROUND
Chronic low back pain (CLBP) is a frequent disease. It is a critical health concern that can influence functional capacity by restricting living activities.
OBJECTIVES
The current study is to investigate the effects of transcutaneous vagus nerve stimulation (TVNs) in the management of CLBP.
METHODS
We searched the databases on Google Scholar, PubMed, Web of Science, Cochrane, and Pedro for randomized clinical trial (RCT) studies published in any language that looked at the effectiveness of TVNs in people with chronic LBP. The inclusion criteria were PICO. Participants in the research were people (≥ 18 years) diagnosed with persistent low back pain for more than 3 months. Study quality was assessed using Cochrane ROB 2.
RESULTS
Our database search found 1084 RCT. A number of studies that were not necessary for the issue were removed, and the overall outcome was six trials. Risk of bias (ROB) evaluations at the study level (derived from outcomes) are reported. In the six studies, two (33.3%) had an overall uncertain ROB (i.e., some concerns), whereas one (16.7%) had a high overall ROB. Three trials (50%) had a low overall RoB.
CONCLUSION
There is still no evidence to support the use of transcutaneous vagus nerve stimulation as a viable therapeutic rehabilitation strategy. Therefore, we recommend high-quality trials and long-term follow-up to evaluate disability, quality of life, and pain outcomes in these patients.
Topics: Humans; Low Back Pain; Vagus Nerve Stimulation; Transcutaneous Electric Nerve Stimulation; Chronic Pain; Treatment Outcome; Randomized Controlled Trials as Topic; Pain Measurement
PubMed: 38926726
DOI: 10.1186/s12891-024-07569-w -
BMC Public Health Jun 2024Although physical activity (PA) is associated with significant health benefits, only a small percentage of adolescents meet recommended PA levels. This systematic review... (Meta-Analysis)
Meta-Analysis
DE-PASS best evidence statement (BESt): determinants of adolescents' device-based physical activity and sedentary behaviour in settings: a systematic review and meta-analysis.
BACKGROUND
Although physical activity (PA) is associated with significant health benefits, only a small percentage of adolescents meet recommended PA levels. This systematic review with meta-analysis explored the modifiable determinants of adolescents' device-based PA and/or sedentary behaviour (SB), evaluated in previous interventions and examined the associations between PA/SB and these determinants in settings.
METHODS
A search was conducted on five electronic databases, including papers published from January 2010 to July 2023. Randomized Controlled Trials (RCTs) or Controlled Trials (CTs) measuring adolescents' device-based PA/SB and their modifiable determinants at least at two time points: pre- and post-intervention were considered eligible. PA/SB and determinants were the main outcomes. Modifiable determinants were classified after data extraction adopting the social-ecological perspective. Robust Bayesian meta-analyses (RoBMA) were performed per each study setting. Outcomes identified in only one study were presented narratively. The risk of bias for each study and the certainty of the evidence for each meta-analysis were evaluated. The publication bias was also checked.
PROSPERO ID
CRD42021282874.
RESULTS
Fourteen RCTs (eight in school, three in school and family, and one in the family setting) and one CT (in the school setting) were included. Fifty-four modifiable determinants were identified and were combined into 33 broader determinants (21 individual-psychological, four individual-behavioural, seven interpersonal, and one institutional). RoBMAs revealed none or negligible pooled intervention effects on PA/SB or determinants in all settings. The certainty of the evidence of the impact of interventions on outcomes ranged from very low to low. Narratively, intervention effects in favour of the experimental group were detected in school setting for the determinants: knowledge of the environment for practicing PA, d = 1.84, 95%CI (1.48, 2.20), behaviour change techniques, d = 0.90, 95%CI (0.09, 1.70), choice provided, d = 0.70, 95%CI (0.36, 1.03), but no corresponding effects on PA or SB were found.
CONCLUSIONS
Weak to minimal evidence regarding the associations between the identified modifiable determinants and adolescents' device-based PA/SB in settings were found, probably due to intervention ineffectiveness. Well-designed and well-implemented multicomponent interventions should further explore the variety of modifiable determinants of adolescents' PA/SB, including policy and environmental variables.
Topics: Humans; Sedentary Behavior; Adolescent; Exercise; Adolescent Behavior; Randomized Controlled Trials as Topic
PubMed: 38926707
DOI: 10.1186/s12889-024-19136-y -
Scientific Reports Jun 2024This systematic review and meta-analysis addresses the effects of minimally invasive surgical techniques, specifically the Reverdin Isham osteotomy, on functional and... (Meta-Analysis)
Meta-Analysis
This systematic review and meta-analysis addresses the effects of minimally invasive surgical techniques, specifically the Reverdin Isham osteotomy, on functional and radiological outcomes in patients with moderate Hallux Valgus, a common foot deformity. The review included randomized and non-randomized controlled trials, as well as case reports, assessing the osteotomy in adults with moderate to severe Hallux Valgus. Searches were conducted in electronic databases such as MEDLINE and Web of Science up until July 2023, and the Joanna Briggs Institute's critical appraisal tool was used to assess the risk of bias. Meta-analytical analyses employed a random-effects model with small-sample correction, presenting results as standardized mean differences and mean differences with 95% confidence intervals. Seven studies involving 554 patients and 643 operated feet were included, showing significant improvements in AOFAS scores (an average improvement of 36 points from 28.61 to 45.16) and reductions in radiological angles such as the distal metatarsal angle and hallux valgus angle post-surgery (IMA improved by - 3.07° from - 4.68 to - 1.46, DMAA by - 6.12° from - 9.52 to - 2.71, and HVangle by - 15.27° from - 17.98 to - 12.57). Despite these positive outcomes, most studies exhibited risks of bias and other methodological limitations, impacting the generalizability of the results. Overall, the findings highlight the efficacy of the Reverdin Isham osteotomy in improving both functional and radiological parameters in patients with moderate Hallux Valgus, although further research is warranted to solidify these results. No specific funding was received for this study, and the protocol was registered on PROSPERO with the number CRD-42023445886.
Topics: Hallux Valgus; Osteotomy; Humans; Treatment Outcome; Radiography; Minimally Invasive Surgical Procedures
PubMed: 38926591
DOI: 10.1038/s41598-024-65440-3 -
Heart (British Cardiac Society) Jun 2024Despite restoration of epicardial blood flow in acute ST-elevation myocardial infarction (STEMI), inadequate microcirculatory perfusion is common and portends a poor...
BACKGROUND
Despite restoration of epicardial blood flow in acute ST-elevation myocardial infarction (STEMI), inadequate microcirculatory perfusion is common and portends a poor prognosis. Intracoronary (IC) thrombolytic therapy can reduce microvascular thrombotic burden; however, contemporary studies have produced conflicting outcomes.
OBJECTIVES
This meta-analysis aims to evaluate the efficacy and safety of adjunctive IC thrombolytic therapy at the time of primary percutaneous coronary intervention (PCI) among patients with STEMI.
METHODS
Comprehensive literature search of six electronic databases identified relevant randomised controlled trials. The primary outcome was major adverse cardiac events (MACE). The pooled risk ratio (RR) and weighted mean difference (WMD) with a 95% CI were calculated.
RESULTS
12 studies with 1915 patients were included. IC thrombolysis was associated with a significantly lower incidence of MACE (RR=0.65, 95% CI 0.51 to 0.82, I=0%, p<0.0004) and improved left ventricular ejection fraction (WMD=1.87; 95% CI 1.07 to 2.67; I=25%; p<0.0001). Subgroup analysis demonstrated a significant reduction in MACE for trials using non-fibrin (RR=0.39, 95% CI 0.20 to 0.78, I=0%, p=0.007) and moderately fibrin-specific thrombolytic agents (RR=0.62, 95% CI 0.47 to 0.83, I=0%, p=0.001). No significant reduction was observed in studies using highly fibrin-specific thrombolytic agents (RR=1.10, 95% CI 0.62 to 1.96, I=0%, p=0.75). Furthermore, there were no significant differences in mortality (RR=0.91; 95% CI 0.48 to 1.71; I=0%; p=0.77) or bleeding events (major bleeding, RR=1.24; 95% CI 0.47 to 3.28; I=0%; p=0.67; minor bleeding, RR=1.47; 95% CI 0.90 to 2.40; I=0%; p=0.12).
CONCLUSION
Adjunctive IC thrombolysis at the time of primary PCI in patients with STEMI improves clinical and myocardial perfusion parameters without an increased rate of bleeding. Further research is needed to optimise the selection of thrombolytic agents and treatment protocols.
PubMed: 38925881
DOI: 10.1136/heartjnl-2024-324078 -
European Respiratory Review : An... Apr 2024This review quantifies the mean treatment effect of exercise-based interventions on balance and falls risk in people with COPD. (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
This review quantifies the mean treatment effect of exercise-based interventions on balance and falls risk in people with COPD.
METHODS
A structured search strategy (2000-2023) was applied to eight databases to identify studies evaluating the impact of exercise-based interventions (≥14 days in duration) on balance or falls in people with COPD. Pooled mean treatment effects (95% confidence intervals (CIs), 95% prediction intervals (PIs)) were calculated for outcomes reported in five or more studies. Inter-individual response variance and the promise of behaviour change techniques (BCTs) were explored.
RESULTS
34 studies (n=1712) were included. There were greater improvements in balance post intervention compared to controls for the Berg Balance Scale (BBS) (mean 2.51, 95% CI 0.22-4.80, 95% PI -4.60-9.63), Timed Up and Go (TUG) test (mean -1.12 s, 95% CI -1.69- -0.55 s, 95% PI -2.78-0.54 s), Single-Leg Stance (SLS) test (mean 3.25 s, 95% CI 2.72-3.77 s, 95% PI 2.64-3.86 s) and Activities-specific Balance Confidence (ABC) scale (mean 8.50%, 95% CI 2.41-14.58%, 95% PI -8.92-25.92%). Effect on falls remains unknown. Treatment effects were larger in male mixed-sex groups for the ABC scale and SLS test, and in balance training other exercise-based interventions for the BBS and TUG test. Falls history was not associated with changes in balance. Meta-analysis of individual response variance was not possible and study-level results were inconclusive. Eleven promising BCTs were identified (promise ratio ≥2).
CONCLUSION
Evidence for the effect of exercise-based interventions eliciting clinically important improvements in balance for people with COPD is weak, but targeted balance training produces the greatest benefits. Future exercise interventions may benefit from inclusion of the identified promising BCTs.
Topics: Humans; Accidental Falls; Postural Balance; Pulmonary Disease, Chronic Obstructive; Exercise Therapy; Male; Treatment Outcome; Female; Aged; Risk Factors; Middle Aged; Recovery of Function; Lung
PubMed: 38925795
DOI: 10.1183/16000617.0003-2024 -
BMJ Open Jun 2024To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal...
OBJECTIVE
To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials' clinical and design characteristics.
DESIGN
A systematic review of published trials and trials submitted to public registries.
DATA SOURCES
The databases Medline, Cochrane Library and McMaster; six public clinical registries. All searches were done until 31 January 2023.
ELIGIBILITY CRITERIA
Trials submitted to registries and completed before January 2021. Prospective interventional trials published in peer-reviewed journals.
DATA EXTRACTION AND SYNTHESIS
The first author searched for trials that had (1) posted trial results in a public registry, (2) presented results in a peer-reviewed publication and (3) submitted a pretrial protocol to a registry before publication. Other extracted variables included trial design, number of participants, funding source, follow-up duration and cell type.
RESULTS
In total 124 trials were found in registries and literature databases. Knee osteoarthritis was the most common indication. Of the 100 registry trials, 52 trials with in total 2 993 participants had neither posted results in the registry nor published results. Fifty-two of the registry trials submitted a protocol retrospectively. Forty-three of the 67 published trials (64%) had registered a pretrial protocol. Funding source was not associated with compliance with reporting requirements. A discrepancy between primary endpoints in the registry and publication was found in 16 of 25 trials. In 28% of trials, the treatment groups used adjuvant therapies. Only 39% of controlled trials were double-blinded.
CONCLUSIONS
A large proportion of trials failed to comply with statutory requirements for the registration and reporting of results, thereby increasing the risk of bias in outcome assessments. To improve confidence in the role of MSCs for musculoskeletal disorders, registries and medical journals should more rigorously enforce existing requirements for registration and reporting.
Topics: Humans; Registries; Musculoskeletal Diseases; Mesenchymal Stem Cell Transplantation; Clinical Trials as Topic; Guideline Adherence; Research Design; Mesenchymal Stem Cells
PubMed: 38925685
DOI: 10.1136/bmjopen-2023-081343 -
Interdisciplinary Cardiovascular and... Jun 2024Transannular patch (TAP) repair of tetralogy of Fallot (ToF) relieves right ventricular tract obstruction but may lead to pulmonary regurgitation. Valve-sparing (VS)...
OBJECTIVES
Transannular patch (TAP) repair of tetralogy of Fallot (ToF) relieves right ventricular tract obstruction but may lead to pulmonary regurgitation. Valve-sparing (VS) procedures can avoid this but there is potential for residual pulmonic stenosis. We aimed to evaluate clinical and echocardiographic outcomes of TAP and VS repair for ToF.
METHODS
A systematic search of the PubMed, Embase, Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), and Web of Science databases was carried out to identify articles comparing conventional TAP repair and VS repair for ToF. Clinical and echocardiographic outcomes were meta-analyzed using random-effects models.
RESULTS
40 studies were included in this meta-analysis with data on 11,723 participants (TAP: 6,171; VS: 5,045). Participants that underwent a VS procedure experienced a significantly lower cardiopulmonary bypass time (MD: -14.97; 95% CI: -22.54, -7.41), shorter ventilation duration (MD: -15.33; 95% CI: -30.20, -0.46), and shorter lengths of both ICU (MD: -0.67; 95% CI: -1.29, -0.06) and hospital stay (MD: -2.30; 95% CI: [-4.08, -0.52). There was also a lower risk of mortality (RR: 0.40; 95% CI: [0.27, 0.60]) and pulmonary regurgitation (RR: 0.35; 95% CI: [0.26, 0.46]) associated with the VS group. Most other clinical and echocardiographic outcomes were comparable in the two groups.
CONCLUSIONS
This meta-analysis confirms the well-established increased risk of pulmonary insufficiency following TAP repair, while also demonstrating that VS repairs are associated with several improved clinical outcomes. Continued research can identify the criteria for adopting a VS approach as opposed to a traditional TAP repair.
PubMed: 38924512
DOI: 10.1093/icvts/ivae124