scholarly journals Evidence-based review of the role of reoperation in the management of malignant glioma

1998 ◽  
Vol 4 (6) ◽  
pp. E13 ◽  
Author(s):  
Clifford B. Soults ◽  
Greg S. Canute ◽  
Timothy C. Ryken

Using an evidence-based approach to available clinical studies, the authors examined the role of reoperation in the management of malignant glioma. A review of 1270 Medline-referenced articles spanning the period from 1966 through March 1998 was undertaken using the key words “glioblastoma” and “astrocytoma.” Using an evidence-based four-tiered grading system, the authors found only 14 articles that met their inclusion criteria. Of these, 11 were graded as Class III (retrospective case series) and three as Class II (prospective nonrandomized studies). There were no Class I reports (randomized clinical trials), and all Class IV reports (opinion reports) were excluded. The authors of 10 Class III and one Class II articles supported the role of reoperation in increasing survival time or quality of life in selected patients; however, the results of multivariate analysis in two Class II and one Class III article did not support prolonged survival. The authors conclude that there was insufficient evidence to support either a standard or a guideline for reoperation in malignant glioma given the current status of the literature. Selection bias was a major factor in these studies. With continued interest in clinical trials for recurrent malignant glioma, the role of reoperation needs to be addressed in case-controlled or randomized fashion to establish either standards or guidelines on this commonly debated issue.

1999 ◽  
Vol 91 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Michael G. Fehlings ◽  
Charles H. Tator

Object. The authors conducted an evidence-based review of the literature to evaluate critically the rationale and indications for and the timing of decompressive surgery for the treatment of acute, nonpenetrating spinal cord injury (SCI). Methods. The experimental and clinical literature concerning the role of, and the biological rationale for, surgical decompression for acute SCI was reviewed. Clinical studies of nonoperative management of SCI were also examined for comparative purposes. Evidence from clinical trials was categorized as Class I (well-conducted randomized prospective trials), Class II (well-designed comparative clinical studies), or Class III (retrospective studies). Examination of studies in which animal models of SCI were used consistently demonstrated a beneficial effect of early decompressive surgery, although it is difficult to apply these data directly to the clinical setting. The clinical studies provided suggestive (Class III and limited Class II) evidence that decompressive procedures improve neurological recovery after SCI. However, no clear consensus can be inferred from the literature as to the optimum timing for decompressive surgery. Many authors have advocated delayed treatment to avoid medical complications, although good evidence from recent Class II trials indicates that early decompressive surgery can be performed safely without causing added morbidity or mortality. Conclusions. There is biological evidence from experimental studies in animals that early decompressive surgery may improve neurological recovery after SCI, although the relevant interventional timing in humans remains unclear. To date, the role of surgical decompression in patients with SCI is only supported by Class III and limited Class II evidence. Accordingly, decompressive surgery for SCI can only be considered a practice option. Furthermore, analysis of the literature does not allow definite conclusions to be drawn regarding appropriate timing of intervention. Hence, there is a need to conduct well-designed experimental and clinical studies of the timing and neurological results of decompressive surgery for the treatment of acute SCI.


1999 ◽  
Vol 6 (1) ◽  
pp. E3 ◽  
Author(s):  
Michael G. Fehlings ◽  
Charles H. Tator

The authors conducted an evidence-based review of the literature to evaluate critically the rationale and indications for and the timing of decompressive surgery for the treatment of acute, nonpenetrating spinal cord injury (SCI). The experimental and clinical literature concerning the role of, and the biological rationale for surgical decompression for acute SCI was reviewed. Clinical studies of nonoperative management of SCI were also examined for comparative purposes. Evidence from clinical trials was categorized as Class I (well-conducted randomized prospective trials), Class II (well-designed comparative clinical studies), or Class III (retrospective studies). Studies in which animal models of SCI were used consistently demonstrated a beneficial effect of early surgical decompression, although it is difficult to apply these data directly to the clinical setting. The clinical studies provided suggestive (Class III and limited Class II) evidence that decompressive procedures improve neurological recovery after SCI. However, no clear consensus can be inferred from the literature as to the optimum timing of decompressive surgery. Many authors have advocated delayed treatment to avoid medical complications, although there is good evidence from recent Class II trials that early decompressive surgery can be performed safely without added morbidity or mortality. There is biological evidence from experimental studies in animals that early surgical decompression may improve neurological recovery after SCI, although the relevant interventional timing in humans remains unclear. To date, the role of surgical decompression in patients with SCI is only supported by Class III and limited Class II evidence. Accordingly, decompressive surgery for SCI can only be considered a practice option. Furthermore, analysis of the literature does not allow definite conclusions to be drawn regarding appropriate timing of intervention. Hence, there is a need to conduct well-designed experimental and clinical studies of the timing and neurological results of surgical decompression for the treatment of acute SCI.


2020 ◽  
Vol 25 (8) ◽  
pp. 4037
Author(s):  
S. R. Gilyarevsky ◽  
Yu. N. Belenkov

The article discusses the limitations of the evidence from observational studies. Modern approaches to reducing bias in observational studies are discussed in detail, in particular, propensity score matching, which has become popular in recent years. The main differences between randomized and observational studies are discussed. Arguments against the observational studies and improved methods of analysis to compare the treatments’ effectiveness in clinical practice are presented. The role of observational studies as a source of evidence is discussed. The article points out the validity of performing large-scale prospective observational studies to assess the effects of postmarketing drug use in clinical practice, as well as to obtain data on drug use in patients that differ from those in randomized clinical trials.


2006 ◽  
Vol 86 (11) ◽  
pp. 1520-1533 ◽  
Author(s):  
Sarah Blanton ◽  
David M Morris ◽  
Michelle G Prettyman ◽  
Karen McCulloch ◽  
Susan Redmond ◽  
...  

Abstract Participant recruitment is considered the most difficult aspect of the research process. Despite the integral role of recruitment in randomized clinical trials, publication of data defining the recruitment effort is not routine in rehabilitation initiatives. The recruitment process for the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial illustrates obstacles to and strategies for participant accrual and retention that are inherent in rehabilitation clinical trials. The purpose of this article is to increase awareness of the multiple facets of recruitment necessary for successful clinical trials, thus supporting the continued development of evidence-based practice in physical therapy. The Recruitment Index is presented as a variable to measure recruitment efficacy. In addition, ethical aspects of recruitment are explored, including informed consent and the concept of therapeutic misconception.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 976
Author(s):  
Fiorenzo Moscatelli ◽  
Francesco Sessa ◽  
Anna Valenzano ◽  
Rita Polito ◽  
Vincenzo Monda ◽  
...  

At the end of 2019, a new coronavirus (COVID-19) appeared on the world scene, which mainly affects the respiratory system, causing pneumonia and multi-organ failure, and, although it starts with common symptoms such as shortness of breath and fever, in about 2–3% of cases it leads to death. Unfortunately, to date, no specific treatments have been found for the cure of this virus and, therefore, it is advisable to implement all possible strategies in order to prevent infection. In this context, it is important to better define the role of all behaviors, in particular nutrition, in order to establish whether these can both prevent infection and improve the outcome of the disease in patients with COVID-19. In the literature, it is widely shown that states of malnutrition, overweight, and obesity negatively affect the immune system, leading to viral infections, and several studies have shown that nutritional interventions can act as immunostimulators, helping to prevent viral infections. Even if several measures, such as the assumption of a specific diet regimen, the use of dietary supplements, and other similar interventions, are promising for the prevention, management, and recovery of COVID-19 patients, it is important to highlight that strong data from randomized clinical trials are needed to support any such assumption. Considering this particular scenario, we present a literature review addressing several important aspects related to diet and SARS-CoV-2 infection, in order to highlight the importance of diet and supplementation in prevention and management of, as well as recovery from COVID-19.


Author(s):  
Natalia A. Vyatkina

The term "evidence-based medicine" is being increasingly used by various sources of information today, and becomes a discussion subject of professional communities and ordinary citizens. Apart from a brief insight into the origin and development of evidence-based medicine in the world and in Russia, the article deals with the anthropological analysis of the attitudes of the modern Russian physicians and patients towards both the understanding of the term and the current status, prospects and possible risks of the development of this discipline in our country. The views of respondents about the role of pharmaceutical companies, the state and the balance between the development and implementation of clinical guidelines and individual cases are considered. The article presents the arguments of patients about whether there is still a "physician blessed by God" and whether it is important for them that the person who they address for help works in the paradigm of evidence-based medicine. Physicians question whether healing itself is still an art, or evidence-based medicine has finally turned it into a business and well-organized mechanism, which could protect them from criminal prosecution in a critical situation.


2021 ◽  
Vol 12 ◽  
Author(s):  
Safaet Alam ◽  
Taslima Binte Kamal ◽  
Md. Moklesur Rahman Sarker ◽  
Jin-Rong Zhou ◽  
S. M. Abdur Rahman ◽  
...  

COVID-19, transmitted by SARS-CoV-2, is one of the most serious pandemic situations in the history of mankind, and has already infected a huge population across the globe. This horrendously contagious viral outbreak was first identified in China and within a very short time it affected the world's health, transport, economic, and academic sectors. Despite the recent approval of a few anti-COVID-19 vaccines, their unavailability and insufficiency along with the lack of other potential therapeutic options are continuing to worsen the situation, with valuable lives continuing to be lost. In this situation, researchers across the globe are focusing on repurposing prospective drugs and prophylaxis such as favipiravir, remdesivir, chloroquine, hydroxychloroquine, ivermectin, lopinavir-ritonavir, azithromycin, doxycycline, ACEIs/ARBs, rivaroxaban, and protease inhibitors, which were preliminarily based on in vitro and in vivo pharmacological and toxicological study reports followed by clinical applications. Based on available preliminary data derived from limited clinical trials, the US National Institute of Health (NIH) and USFDA also recommended a few drugs to be repurposed i.e., hydroxychloroquine, remdesivir, and favipiravir. However, World Health Organization later recommended against the use of chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir in the treatment of COVID-19 infections. Combining basic knowledge of viral pathogenesis and pharmacodynamics of drug molecules as well as in silico approaches, many drug candidates have been investigated in clinical trials, some of which have been proven to be partially effective against COVID-19, and many of the other drugs are currently under extensive screening. The repurposing of prospective drug candidates from different stages of evaluation can be a handy wellspring in COVID-19 management and treatment along with approved anti-COVID-19 vaccines. This review article combined the information from completed clinical trials, case series, cohort studies, meta-analyses, and retrospective studies to focus on the current status of repurposing drugs in 2021.


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