scholarly journals Therapeutic Evidence of Human Mesenchymal Stem Cell Transplantation for Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Baocheng Xie ◽  
Minyi Chen ◽  
Runkai Hu ◽  
Weichao Han ◽  
Shaobo Ding
Keyword(s):  
Cerebral Palsy ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Meta Analysis ◽  
Human Mesenchymal Stem Cell ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Quality Evidence

Cerebral palsy (CP) is a kind of movement and posture disorder syndrome in early childhood. In recent years, human mesenchymal stem cell (hMSC) transplantation has become a promising therapeutic strategy for CP. However, clinical evidence is still limited and controversial about clinical efficacy of hMSC therapy for CP. Our aim is to evaluate the efficacy and safety of hMSC transplantation for children with CP using a meta-analysis of randomized controlled trials (RCTs). We conducted a systematic literature search including Embase, PubMed, ClinicalTrials.gov, Cochrane Controlled Trials Register databases, Chinese Clinical Trial Registry, and Web of Science from building database to February 2020. We used Cochrane bias risk assessment for the included studies. The result of pooled analysis showed that hMSC therapy significantly increased gross motor function measure (GMFM) scores (standardized mean difference SMD=1.10, 95%CI=0.66‐1.53, P<0.00001, high-quality evidence) and comprehensive function assessment (CFA) (SMD=1.30, 95%CI=0.71‐1.90, P<0.0001, high-quality evidence) in children with CP, compared with the control group. In the subgroup analysis, the results showed that hMSC therapy significantly increased GMFM scores of 3, 6, and 12 months and CFA of 3, 6, and 12 months. Adverse event (AE) of upper respiratory infection, diarrhea, and constipation was not statistically significant between the two groups. This meta-analysis synthesized the primary outcomes and suggested that hMSC therapy is beneficial, effective, and safe in improving GMFM scores and CFA scores in children with CP. In addition, subgroup analysis showed that hMSC therapy has a lasting positive benefit for CP in 3, 6, and 12 months.

scholarly journals TRADE-OFFS BETWEEN EPISTEMIC AND MORAL VALUES IN EVIDENCE-BASED POLICY

2018 ◽  
Vol 35 (1) ◽  
pp. 49-78 ◽  
Author(s):  
Donal Khosrowi
Keyword(s):  
Controlled Trials ◽  
Evidence Based ◽  
Epistemic Values ◽  
High Quality ◽  
Political Values ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Evidence Based Policy ◽  
Trade Offs ◽  
Quality Evidence

Abstract:Proponents of evidence-based policy (EBP) call for public policy to be informed by high-quality evidence from randomized controlled trials. This methodological preference aims to promote several epistemic values, e.g. rigour, unbiasedness, precision, and the ability to obtain causal conclusions. I argue that there is a trade-off between these epistemic values and several non-epistemic, moral and political values. This is because the evidence afforded by standard EBP methods is differentially useful for pursuing different moral and political values. I expand on how this challenges ideals of value-freedom and -neutrality in EBP, and offer suggestions for how EBP methodology might be revised.

scholarly journals Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach

2019 ◽  
Vol 29 (5) ◽  
pp. 672-679 ◽  
Author(s):  
Leila Rooshenas ◽  
Sangeetha Paramasivan ◽  
Marcus Jepson ◽  
Jenny L. Donovan
Keyword(s):  
Qualitative Research ◽  
Comparative Effectiveness ◽  
Quantitative Data ◽  
Randomized Trials ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Health Care Interventions ◽  
High Quality Evidence ◽  
Quality Evidence

Randomized controlled trials (RCTs) can provide high quality evidence about the comparative effectiveness of health care interventions, but many RCTs struggle with or fail to complete recruitment. RCTs are built on the principles of the experimental method, but their planning, conduct, and interpretation can depend on complex social, behavioral, and cultural factors that may be best understood through qualitative research. Most qualitative studies undertaken alongside RCTs involve interviews that produce data that are used in a supportive or supplicatory role, but there is potential for qualitative research to be more influential. In this article, we describe the research methods underpinning the “QuinteT” (Qualitative Research Integrated Within Trials) approach to understand and address RCT recruitment difficulties. The QuinteT Recruitment Intervention (QRI) brings together multiple qualitative strategies and quantitative data and uses triangulation to understand recruitment issues rapidly. These nuanced understandings are used to inform the implementation of collaborative actions to improve recruitment.

scholarly journals Does the Source of Mesenchymal Stem Cell Have an Effect in the Management of Osteoarthritis of the Knee? Meta-Analysis of Randomized Controlled Trials

Cartilage ◽  
2020 ◽  
pp. 194760352095162
Author(s):  
Madhan Jeyaraman ◽  
Sathish Muthu ◽  
Parvez Ahmad Ganie
Keyword(s):  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Osteoarthritis Of Knee ◽  
Randomized Controlled

Study Design Meta-analysis. Objectives To compare the efficacy and safety of bone marrow(BM)–derived mesenchymal stem cell(MSCs) and adipose-derived(AD) MSCs in the management of osteoarthritis of knee from randomized controlled trials(RCTs) available in the literature. Materials and Methods We conducted electronic database searche from PubMed, Embase, and Cochrane Library till May 2020 for RCTs analyzing the efficacy and safety of MSCs in management of osteoarthritis of knee. Visual Analog Score(VAS) for Pain, Western Ontario McMaster Universities Osteoarthritis Index(WOMAC), Lysholm Knee Scale(Lysholm), Whole-Organ Magnetic Resonance Imaging Score(WORMS), Knee Osteoarthritis Outcome Score(KOOS), and adverse events were the outcomes analyzed. Analysis was performed in R platform using OpenMeta[Analyst] software. Results Nineteen studies involving 811 patients were included for analysis. None of the studies compared the source of MSCs for osteoarthritis of knee and results were obtained by pooled data analysis of both sources. At 6 months, AD-MSCs showed significantly better VAS( P<0.001, P=0.069) and WOMAC( P=0.134, P=0.441) improvement than BM-MSCs, respectively, compared to controls. At 1 year, AD-MSCs outperformed BM-MSCs compared to their control in measures like WOMAC( P=0.007, P=0.150), KOOS( P<0.001; P=0.658), and WORMS( P<0.001, P=0.041), respectively. Similarly at 24 months, AD-MSCs showed significantly better Lysholm score( P=0.037) than BM-MSCs( P=0.807) although VAS improvement was better with BM-MSCs at 24 months( P<0.001). There were no significant adverse events with either of the MSCs compared to their controls. Conclusion Our analysis establishes the efficacy, safety, and superiority of AD-MSC transplantation, compared to BM-MSC, in the management of osteoarthritis of knee from available literature. Further RCTs are needed to evaluate them together with standardized doses.

scholarly journals Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review

2019 ◽  
Vol 10 (6) ◽  
pp. 775-783
Author(s):  
Amit Jain ◽  
Majd Marrache ◽  
Andrew Harris ◽  
Varun Puvanesarajah ◽  
Brian J. Neuman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Structural Allograft ◽  
Patient Reported ◽  
Spine Degeneration ◽  
Quality Evidence

Study Design: Systematic literature review. Objective: Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. Methods: Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. Results: Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. Conclusion: Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. Level of Evidence: II.

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

scholarly journals The effectiveness of M-Health associated with cardiac rehabilitation on functional capacity and cardiovascular risk factors: a systematic review and meta-analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A C Campagnolo Goncalves Toledo ◽  
N Soares De Almeida ◽  
A Pierucci ◽  
A Straioto Salomao ◽  
I Ribeiro Lemes ◽  
...  
Keyword(s):  
Functional Capacity ◽  
Meta Analysis ◽  
Medium Term ◽  
Short Term ◽  
High Quality ◽  
Quality Of Evidence ◽  
High Quality Evidence ◽  
Quality Evidence

Abstract Introduction Smartphone applications for health (M-Health) seem to overcome barriers to access Cardiovascular Rehabilitation Programs (CRP), because of their high degree of acceptance and also their potential to influence the frequency of physical exercise in weight loss. Objective To analyze the effectiveness of the combination of M-Health and CRP compared to CRP alone on functional capacity, adherence to CRP, management of cardiovascular risk factors in cardiac patients. Design Systematic Review and Meta-Analysis. Methods The following databases were used Medline via Ovid, EMBASE, Central, PEDro and SPORTDiscus via EBSCOhost from their inception until July/2020. We included randomized controlled trials investigating the effects of M-Health in combination with CRP compared to CRP alone in adults with heart disease, and the interventions with M-Health consisted of text messages, e-mails, and applications. The primary outcome of this review was functional capacity, measured by VO2peak, or self-reported physical activity (METs.min/week). PEDro scale was used to assess the methodological quality of the studies and the GRADE approach to assess the overall quality of evidence. Pooled estimates were calculated using a random effect model to obtain mean difference (MD) or standardized mean differences (SMD) and their respectives 95% confidence intervals (CI). Results Nineteen RCTs were eligible, the median risk of bias was 7 out of 10 points. The primary endpoint was analyzed by subgroups, time of intervention and kind of type CRP, eigthteen of these studies assessed functional capacity. CRP in combination with a m-health intervention was more effective than CRP alone in improving VO2peak, ml/min/kg, (MD: 0.84, CI: 0.30 to 1.38; I2=0%, high quality evidence, 12 trials, n=1889) at short-term follow-up, but at medium-term follow-up (MD: 0.84, CI: −0.26 to 1.41; I2=0%, high quality evidence, 8 trials, n=927,). Similarly, CRP associated with m-health was superior to CRP alone in increasing self-reported at short-term, METs.min/week, (MD:1.31, CI: −0.24 to 2.37; I2 = not aplicable, very low quality evidence, 1 trial, n=18), and at medium-term follow-up (MD: 0.18, CI: −0.01 to 0.36; I2=56%, moderate quality evidence, 4 trials, n=1107). Conclusion High quality of evidence shows that M-Health improves cardiorespiratory fitness at short-term follow-up. In addition, supervised program showed to be more effective than non-supervised. Funding Acknowledgement Type of funding sources: None.

Robot-Assisted versus Conventional Total and Unicompartmental Knee Arthroplasty: A Meta-analysis of Radiological and Functional Outcomes

2020 ◽  
Author(s):  
Brian Zhaojie Chin ◽  
Sharon Si Heng Tan ◽  
Kasia Chen Xi Chua ◽  
Gideon Richard Budiono ◽  
Nicholas Li-Xun Syn ◽  
...  
Keyword(s):  
Knee Arthroplasty ◽  
Unicompartmental Knee Arthroplasty ◽  
Functional Outcomes ◽  
Meta Analysis ◽  
Robot Assisted ◽  
High Quality ◽  
High Quality Evidence ◽  
Unicompartmental Knee ◽  
Conventional Methods ◽  
Quality Evidence

AbstractThe study aims to provide an up-to-date systematic review and meta-analysis comparing radiological and functional outcomes of total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA) using either robotic assistance or conventional methods from the latest assemblage of evidence. This study was conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and MOOSE (Meta-analysis of Observational Studies in Epidemiology) guidelines. All studies in PubMed, EMBASE, Medline, and Cochrane that reported radiological and functional outcomes after TKA or UKA with either robotic or conventional methods were included in the review. Selected endpoints for random effects, pairwise meta-analysis included operative details, radiological outcomes (mechanical axis, component angle deviation, and outliers), and functional outcomes (American Knee Society Score, Knee Society Function Score, revision and complication rate, range of motion (ROM), Hospital for Special Surgery score, and Western Ontario and McMaster Universities Osteoarthritis Index). A total of 23 studies comprising 2,765 knees were included from the initial search. Robot-assisted TKA and UKA were associated with significantly better component angle alignment accuracy (low-to-high quality evidence) at the cost of significantly greater operation time. Robot-assisted UKA was found to have significantly better short-term functional outcomes compared with conventional UKA (moderate-to-high quality evidence). Robot-assisted TKA, however, did not exhibit significantly better short- and midterm subjective knee outcome scores compared with its conventional counterpart (high-quality evidence). Robot-assisted TKA and UKA were associated with nonstatistically significant improved ROM and lesser rates of revision. Robot-assisted total and unicompartmental knee arthroplasty leads to better radiological outcomes, with no significant differences in mid- and long-term functional outcomes compared with conventional methods for the former. Larger prospective studies with mid- and long-term outcomes are required to further substantiate findings from the present study.

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