scholarly journals Current Status of Cell-Based Therapy in Patients with Critical Limb Ischemia

2020 ◽  
Vol 21 (23) ◽  
pp. 8999
Author(s):  
Frantisek Jaluvka ◽  
Peter Ihnat ◽  
Juraj Madaric ◽  
Adela Vrtkova ◽  
Jaroslav Janosek ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Critical Limb Ischemia ◽  
Evidence Based Medicine ◽  
Odds Ratio ◽  
Limb Ischemia ◽  
Current Evidence ◽  
Evidence Based ◽  
Cell Based Therapy ◽  
Meta Analyses ◽  
Based Medicine

(1) Background: The treatment of peripheral arterial disease (PAD) is focused on improving perfusion and oxygenation in the affected limb. Standard revascularization methods include bypass surgery, endovascular interventional procedures, or hybrid revascularization. Cell-based therapy can be an alternative strategy for patients with no-option critical limb ischemia who are not eligible for endovascular or surgical procedures. (2) Aims: The aim of this narrative review was to provide an up-to-date critical overview of the knowledge and evidence-based medicine data on the position of cell therapy in the treatment of PAD. The current evidence on the cell-based therapy is summarized and future perspectives outlined, emphasizing the potential of exosomal cell-free approaches in patients with critical limb ischemia. (3) Methods: Cochrane and PubMed databases were searched for keywords “critical limb ischemia and cell therapy”. In total, 589 papers were identified, 11 of which were reviews and 11 were meta-analyses. These were used as the primary source of information, using cross-referencing for identification of additional papers. (4) Results: Meta-analyses focusing on cell therapy in PAD treatment confirm significantly greater odds of limb salvage in the first year after the cell therapy administration. Reported odds ratio estimates of preventing amputation being mostly in the region 1.6–3, although with a prolonged observation period, it seems that the odds ratio can grow even further. The odds of wound healing were at least two times higher when compared with the standard conservative therapy. Secondary endpoints of the available meta-analyses are also included in this review. Improvement of perfusion and oxygenation parameters in the affected limb, pain regression, and claudication interval prolongation are discussed. (5) Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective.

scholarly journals Current Status of Cell-Based Therapy in Patients with Critical Limb Ischemia

2020 ◽  
Author(s):  
Frantisek Jaluvka ◽  
Peter Ihnat ◽  
Juraj Madaric ◽  
Vaclav Prochazka
Keyword(s):  
Cell Therapy ◽  
Critical Limb Ischemia ◽  
Evidence Based Medicine ◽  
Limb Ischemia ◽  
Current Status ◽  
Current Evidence ◽  
Evidence Based ◽  
Cell Based Therapy ◽  
Meta Analyses ◽  
Based Medicine

Background: The treatment of peripheral arterial disease (PAD) is focused on improving perfusion and oxygenation in the affected limb. Standard revascularization methods include bypass surgery, endovascular interventional procedures, or hybrid revascularization. Cell-based therapy can be an alternative strategy for patients with no-option critical limb ischemia who are not eligible for endovascular or surgical procedures. Aims: This review offers an up-to-date critical overview of the knowledge and data of evidence-based medicine on the position of cell therapy in the treatment of PAD. It provides an overview of current evidence and appraises the future perspectives of cell-based therapy, emphasizing the potential of exosomal cell-free approaches in patients with critical limb ischemia. Results: Meta-analyses focused on cell therapy problems in PAD treatment confirm a significantly greater chance of limb salvage in the first year after the cell therapy administration. The opportunity of defect healing is at least two times higher when compared with the standard conservative therapy. Secondary endpoints of the available meta-analyses are also included in this review. Improvement of perfusion and oxygenation parameters in the affected limb, pain regression, and claudication interval prolongation are discussed. Conclusions: The available evidence-based medicine data show that this technique is safe, associated with minimum complications or adverse events, and effective.

scholarly journals Revisiting Statistics and Evidence-Based Medicine: On the Fallacy of the Effect Size Based on Correlation and Misconception of Contingency Tables

2021 ◽  
Author(s):  
Sergey Roussakow
Keyword(s):  
Effect Size ◽  
Evidence Based Medicine ◽  
Binary Data ◽  
Contingency Tables ◽  
Evidence Based ◽  
Mean Square ◽  
Bias Analysis ◽  
Contingency Coefficient ◽  
Meta Analyses ◽  
Based Medicine

Abstract BACKGROUND: Evidence-based medicine (EBM) is in crisis, in part due to bad methods, which are understood as misuse of statistics that is considered correct in itself. The correctness of the basic statistics related to the effect size (ES) based on correlation (CBES) was questioned. METHODS: Monte Carlo simulation of two paired binary samples, mathematical analysis, conceptual analysis, bias analysis. RESULTS: Actual effect size and CBES are not related. CBES is a fallacy based on misunderstanding of correlation and ES and confusion with 2 × 2 tables that makes no distinction between gross crosstabs (GCTs) and contingency tables (CTs). This leads to misapplication of Pearson’s Phi, designed for CTs, to GCTs and confusion of the resulting gross Pearson Phi, or mean-square effect half-size, with the implied Pearson mean square contingency coefficient. Generalizing this binary fallacy to continuous data and the correlation in general (Pearson’s r) resulted in flawed equations directly expressing ES in terms of the correlation coefficient, which is impossible without including covariance, so these equations and the whole CBES concept are fundamentally wrong. misconception of contingency tables (MCT) is a series of related misconceptions due to confusion with 2 × 2 tables and misapplication of related statistics. Problems arising from these fallacies are discussed and the necessary changes to the corpus of statistics are proposed resolving the problem of correlation and ES in paired binary data. CONCLUSIONS: Two related common misconceptions in statistics have been exposed, CBES and MCT. The misconceptions are threatening because most of the findings from contingency tables, including meta-analyses, can be misleading. Since exposing these fallacies casts doubt on the reliability of the statistical foundations of EBM in general, we urgently need to revise them.

scholarly journals THERAPEUTIC METHODS IN CEREBRAL PALSY FROM THE STANDPOINT OF EVIDENCE-BASED MEDICINE

2019 ◽  
Vol 21 (3) ◽  
pp. 168-174
Author(s):  
Leila A. Pak ◽  
K. V. Zherdev ◽  
L. M. Kuzenkova ◽  
A. L. Kurenkov ◽  
B. I. Bursagova
Keyword(s):  
Cerebral Palsy ◽  
Stem Cell ◽  
Evidence Based Medicine ◽  
Vagal Stimulation ◽  
Clinical Manifestations ◽  
Evidence Based ◽  
Complementary Treatment ◽  
Epidural Stimulation ◽  
Meta Analyses ◽  
Based Medicine

In the article the authors consider such methods of the alternative/complementary treatment of the cerebral palsy (CP), presented in the modern domestic and foreign literature, as metabolic (amino acid composites), metamer (I.A. Skvortsov), intravenous administration of baclofen, antiepileptic (vagal stimulation, levetiracetam), acupuncture, transcranial cerebral micropolarization, epidural stimulation, modified motion-induced restriction therapy (MMIRT), stem cell therapy, as well as some other complementary/palliative approaches to the correction of clinical manifestations of various forms of CP. The final part of the article presents the attitude of modern evidence-based medicine to the main methods of the alternative/complementary treatment of cerebral palsy. These data are based almost exclusively on international systematic reviews and relevant meta-analyses.

scholarly journals Pearls for Interpreting Neurosurgical Systematic Reviews and Meta-Analyses: Lessons From a Collaborative Effort

Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 435-441 ◽  
Author(s):  
Victor M Lu ◽  
Christopher S Graffeo ◽  
Avital Perry ◽  
Michael J Link ◽  
Fredric B Meyer ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Lessons Learned ◽  
Evidence Based ◽  
Cranial Neuralgia ◽  
The Individual ◽  
Meta Analyses ◽  
Based Medicine ◽  
Over Time

Abstract Systematic reviews and meta-analyses in the neurosurgical literature have surged in popularity over the last decade. It is our concern that, without a renewed effort to critically interpret and appraise these studies as high or low quality, we run the risk of the quality and value of evidence-based medicine in neurosurgery being misinterpreted. Correspondingly, we have outlined 4 major domains to target in interpreting neurosurgical systematic reviews and meta-analyses based on the lessons learned by a collaboration of clinicians and academics summarized as 4 pearls. The domains of (1) heterogeneity, (2) modeling, (3) certainty, and (4) bias in neurosurgical systematic reviews and meta-analyses were identified as aspects in which the authors’ approaches have changed over time to improve robustness and transparency. Examples of how and why these pearls were adapted were provided in areas of cranial neuralgia, spine, pediatric, and neuro-oncology to demonstrate how neurosurgical readers and writers may improve their interpretation of these domains. The incorporation of these pearls into practice will empower neurosurgical academics to effectively interpret systematic reviews and meta-analyses, enhancing the quality of our evidence-based medicine literature while maintaining a critical focus on the needs of the individual patients in neurosurgery.

Evidence-based medicine in anaesthesia

2017 ◽  
Author(s):  
Ann Merete Møller
Keyword(s):  
Evidence Based Medicine ◽  
Meta Analysis ◽  
Consort Statement ◽  
Current Evidence ◽  
Evidence Based ◽  
Clinical Question ◽  
Clinical Expertise ◽  
Clinical Databases ◽  
Patient Values ◽  
Based Medicine

Evidence-based medicine (EBM) is defined as ‘The judicious use of the best current evidence in making decisions about the care of individual patients’. Evidence-based medicine (EBM) is meant to integrate clinical expertise with the best available research evidence and patient values. The purpose of EBM is to assist clinicians in making the best decisions. Practising EBM includes asking an answerable, well-defined clinical question, searching for information, critically appraising information retrieved, extracting data, synthesizing data, and making conclusions about the overall effect. The clinical question includes information of the following elements: the population, the intervention, and the clinically relevant outcomes in focus. The clinical question is a tool to make the focus of the question clearer, and an aid to build the following search strategy. A comprehensive and reproducible literature search is essential for conducting a high-quality and up-to-date search. The search should include all relevant clinical databases. Papers retrieved after the search must be critically appraised and evaluated for the risk of bias. Evidence-based methods are used in the production of systematic reviews, and the development of clinical guidelines. Whether a meta-analysis should be performed depends on the quality and nature of the extracted data. Practising EBM may be challenged by a lack of well-performed trials, various types of bias (including publication bias), and heterogeneity between existing trials. Several tools have been constructed to help the process; examples are the CONSORT statement, the PRISMA statement, and the AGREE instrument.

scholarly journals What is a multiple treatments meta-analysis?

2012 ◽  
Vol 21 (2) ◽  
pp. 151-153 ◽  
Author(s):  
A. Cipriani ◽  
C. Barbui ◽  
C. Rizzo ◽  
G. Salanti
Keyword(s):  
Evidence Based Medicine ◽  
Treatment Effects ◽  
Meta Analysis ◽  
Evidence Based ◽  
Relative Efficacy ◽  
Analytical Technique ◽  
Multiple Treatments ◽  
Meta Analyses ◽  
Based Medicine ◽  
Indirect Comparisons

Standard meta-analyses are an effective tool in evidence-based medicine, but one of their main drawbacks is that they can compare only two alternative treatments at a time. Moreover, if no trials exist which directly compare two interventions, it is not possible to estimate their relative efficacy. Multiple treatments meta-analyses use a meta-analytical technique that allows the incorporation of evidence from both direct and indirect comparisons from a network of trials of different interventions to estimate summary treatment effects as comprehensively and precisely as possible.

‘Evidence-based’, ‘Cost-Effective’ and ‘Preference-Driven’ Medicine: Decision Analysis Based Medical Decision Making is the Pre-Requisite

1996 ◽  
Vol 1 (2) ◽  
pp. 104-113 ◽  
Author(s):  
Jack Dowie
Keyword(s):  
Decision Making ◽  
Decision Analysis ◽  
Evidence Based Medicine ◽  
Medical Decision Making ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Medical Decision ◽  
Evidence Based ◽  
Meta Analyses ◽  
Based Medicine

Three broad movements are seeking to change the world of medicine. The proponents of ‘evidence-based medicine’ are mainly concerned with ensuring that strategies of proven clinical effectiveness are adopted. Health economists are mainly concerned to establish that ‘cost-effectiveness’ and not ‘clinical effectiveness’ is the criterion used in determining option selection. A variety of patient support and public interest groups, including many health economists, are mainly concerned with ensuring that patient and public preferences drive clinical and policy decisions. This paper argues that decision analysis based medical decision making (DABMDM) constitutes the pre-requisite for the widespread introduction of the main principles embodied in evidence-based medicine, cost-effective medicine and preference-driven medicine; that, in the light of current modes of practice, seeking to promote these principles without a prior or simultaneous move to DABMDM is equivalent to asking the cart to move without the horse; and that in fact DABMDM subsumes and enjoins the valuable aspects of all three. Particular attention is paid to differentiating between DABMDM and EBM, by way of analysis of various expositions of EBM and examination of two recent empirical studies. EBM, as so far expounded, reflects a problem-solving attitude that results in a heavy concentration on RCTs and meta-analyses, rather than a broad decision making focus that concentrates on meeting all the requirements of a good clinical decision. The latter include: Ensuring that inferences from RCTs and meta-analyses to individual patients (or patient groups) are made explicitly; paying equally serious attention to evidence on values and costs as to clinical evidence; and accepting the inadequacy of ‘taking into account and bearing in mind’ as a way of integrating the multiple and distinct elements of a decision.

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