Perspectives on the Adoption of Electronic Resources for Use in Clinical Trials

2011 ◽  
pp. 19-28
Author(s):  
Maricarmen D. Planas-Silva ◽  
Rhoda C. Joseph
Keyword(s):  
Clinical Trials ◽  
Information Dissemination ◽  
Human Subjects ◽  
Evidence Based ◽  
Process Data ◽  
Electronic Resources ◽  
Data Collection Process ◽  
New Treatments ◽  
Based Medicine ◽  
The Impact

Clinical trials are specific medical studies that use human subjects for the advancement of medicine. Evidence-based medicine requires the use of clinical trials to evaluate new treatments, devices, drugs, and modalities for the prevention and treatment of diseases. Clinical trials have not been particularly aggressive in their adoption of information technology (IT). In this analysis, we examine the impact of electronic resources on the execution and management of clinical trials. Further, we present a theoretical model showing the main areas of clinical trials that can be directly impacted by the adoption of electronic resources. The four areas identified are recruitment, data collection, process data management, and information dissemination.

scholarly journals Microfracture: State of the Art in Cartilage Surgery?

Cartilage ◽  
2017 ◽  
Vol 9 (4) ◽  
pp. 339-345 ◽  
Author(s):  
Florian Frehner ◽  
Jan P. Benthien
Keyword(s):  
Clinical Trials ◽  
Impact Factor ◽  
Sports Medicine ◽  
Time Frame ◽  
Evidence Based ◽  
Yearly Average ◽  
The Mean ◽  
Based Medicine ◽  
Number Of Citations ◽  
The Impact

Objective This study is a literature review from 2010 to 2014 concerning the quality of evidence in clinical trials about microfracture in attempt to repair articular cartilage. We have decided to focus on microfracturing, since this seems to be the best documented technique. Interest in evaluation of publication quality has risen in orthopaedic sports medicine recently. Therefore, we think it is necessary to evaluate recent clinical trials being rated for their evidence-based medicine (EBM) quality. We also compared the mean impact factor of the journals publishing the different studies as an indicator of the study’s citation and evaluated for a change over the studied time frame. Design To measure the EBM level, we applied the modified Coleman Methodology Score (CMS) introduced by Jakobsen. The impact factor, which is a measurement of the yearly average number of citations of articles recently published in that journal, was evaluated according to self-reported values on the corresponding journal’s website. Results We found that the mean CMS has not changed between 2010 and 2014. The mean impact factor has also not changed between 2010 and 2014. The CMS variance was high, pointing to different qualities in the evaluated studies. There is no evidence that microfracturing is superior compared to other cartilage repair procedures. Conclusion Microfracture cannot be seen as an evidence based procedure. Further research needs to be done and a standardization of the operating method is desirable. There need to be more substantial studies on microfracturing alone without additional therapies.

The future of clinical trials

2010 ◽  
pp. 45-47
Author(s):  
Perry Nisen ◽  
Patrick Vallance
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Medicine ◽  
20Th Century ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
Scientific Evaluation ◽  
New Treatments ◽  
Based Medicine ◽  
Short Section

Clinical trials are the bedrock of evidence-based medicine. Introduced in the mid 20th century, they heralded a move away from opinion and anecdote to a more scientific evaluation of new treatments. Indeed, it could be argued that it is the clinical trial and the application of scientific method to determine which treatments work that distinguishes ‘medicine’ from ‘alternative medicine’. The aim of this short section is to outline the way in which clinical trials are likely to evolve over the next few years....

A 15-Year Review of Clinical Practice Patterns and Evidence-Based Medicine in Carpometacarpal Joint Arthroplasty

Hand ◽  
2021 ◽  
pp. 155894472110604
Author(s):  
Nikhil D. Shah ◽  
Selcen Yuksel ◽  
Daniel C. Sasson ◽  
Aaron M. Kearney ◽  
Michael W. Neumeister ◽  
...  
Keyword(s):  
Evidence Based Medicine ◽  
Practice Patterns ◽  
Joint Arthroplasty ◽  
Thrombosis Prophylaxis ◽  
Evidence Based ◽  
Process Data ◽  
Vein Thrombosis ◽  
Based Medicine ◽  
National Practice ◽  
Cmc Joint

Background: The purpose of this study was to help understand national practice patterns in carpometacarpal (CMC) arthroplasty and how they have evolved with evidence-based recommendations over the past 15 years. Methods: The American Board of Plastic Surgery (ABPS) started collecting practice data on primary CMC joint arthroplasty in 2006 as a portion of its continuous certification (CC) process. Data on primary CMC arthroplasty from May 2006 through December 2013 were reviewed and compared to those from January 2014 to March 2020. National practice trends observed in these data were evaluated. Comprehensive evidence-based medicine reviews published in 2008, 2011, 2013, and 2017 were reviewed alongside the CC data. Results: In all, 570 primary CMC joint arthroplasty cases were included from May 2006 to March 2020. The average age at the time of repair was 62 years and the patient population was predominantly female (79%). Most cases were done under general anesthesia (69%), and there was an increase in the use of regional anesthesia with nerve block when our 2 cohorts were compared (27% vs 37%; P = .020). A trapezium excision with flexor carpi radialis tendon ligament reconstruction was the most popular technique (72%) and an increase in the use of simple trapeziectomy was observed (6% vs 14%; P = .001). One-third of patients did not receive any form of deep vein thrombosis prophylaxis. Conclusions: The ABPS CC data provide a databank that allows for direct observation of national practice trends and sheds light on potential avenues for improvement in patient care.

Clinical epidemiology in complementary medicine (discussion)

2021 ◽  
pp. 465-474
Author(s):  
Yuriy Olegovich Novikov ◽  
Mikhail Borisovich Tsykunov ◽  
Ayrat Rafikovich Shayakhmetov
Keyword(s):  
Complementary Medicine ◽  
Clinical Epidemiology ◽  
Response To Treatment ◽  
Evidence Based ◽  
New Paradigm ◽  
Treatment And Prevention ◽  
Healthcare It ◽  
Analytical Review ◽  
Based Medicine ◽  
The Impact

The article presents an analytical review of the literature on the application of the principles of evidence-based medicine in modern healthcare. It is noted that in some areas of medicine, scientifically based standards of treatment significantly fall behind the general trends. Complementary medicine, including osteopathy, is an important healthcare resource, the use of which is officially recognized in 94 countries around the world. However, despite certain achievements in the treatment and prevention of many chronic diseases, there are scientific articles that criticize its effectiveness. Therefore, the relevance of obtaining new, strictly evidence-based data on the impact of osteopathy on health is beyond doubt. For osteopathy, as for other types of complementary medicine, a new paradigm of evidence-based clinical research is probably needed. Three types of the organism response to treatment — instant, fast and delayed — are identified.

scholarly journals Bias against Vitamin C in Mainstream Medicine: Examples from Trials of Vitamin C for Infections

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 62
Author(s):  
Harri Hemilä ◽  
Elizabeth Chalker
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Common Cold ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
The Third ◽  
Nutritional Recommendations ◽  
Mainstream Medicine ◽  
The Common ◽  
Based Medicine

Evidence has shown unambiguously that, in certain contexts, vitamin C is effective against the common cold. However, in mainstream medicine, the views on vitamin C and infections have been determined by eminence-based medicine rather than evidence-based medicine. The rejection of the demonstrated benefits of vitamin C is largely explained by three papers published in 1975—two published in JAMA and one in the American Journal of Medicine—all of which have been standard citations in textbooks of medicine and nutrition and in nutritional recommendations. Two of the papers were authored by Thomas Chalmers, an influential expert in clinical trials, and the third was authored by Paul Meier, a famous medical statistician. In this paper, we summarize several flaws in the three papers. In addition, we describe problems with two recent randomized trial reports published in JAMA which were presented in a way that misled readers. We also discuss shortcomings in three recent JAMA editorials on vitamin C. While most of our examples are from JAMA, it is not the only journal with apparent bias against vitamin C, but it illustrates the general views in mainstream medicine. We also consider potential explanations for the widespread bias against vitamin C.

scholarly journals Intestinal Microbiota and Allergy. Probiotics and Prebiotics in Prevention and Treatment of Allergic Diseases

2019 ◽  
Vol 16 (1) ◽  
pp. 7-18 ◽  
Author(s):  
Svetlana G. Makarova ◽  
Leyla S. Namazova-Baranova ◽  
Oksana A. Ereshko ◽  
Dmitry S. Yasakov ◽  
Pavel E. Sadchikov
Keyword(s):  
Immune Response ◽  
Clinical Trials ◽  
Intestinal Microbiota ◽  
Practical Interest ◽  
Allergic Diseases ◽  
Evidence Based ◽  
Prevention And Treatment ◽  
The Impact ◽  
Positive Results ◽  
Intestinal Microbiocenosis

Intestinal microbiota is the factor that identifies considerably the human health. The impact of the microbial factor on a child begins long before his birth. Children have certain features in forming of immune response and intestinal microbiocenosis even before birth. Decline in diversity of intestinal microbiota is common in children with allergic disease even during first months of life, before allergic pathology development. Capabilities for microbiota development adjustment are sufficiently restricted. However it is clinically proven that early (within the first hours of life) breastfeeding attachment, breastfeeding itself within at least first 6 months of life, the use of prebiotics in milk formulas as well as the use of probiotics can give positive results on allergy management. In this review we present results of recent metaanalyses and consensus papers of international medical communities about use of probiotics and prebiotics in prevention and treatment of allergic diseases. Despite great scientific and practical interest to this topic, authors of metaanalyses bring our attention to the lack of evidence-based clinical trials.

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

scholarly journals Are we failing clinical trials? A case for strong aggregate outcomes

2017 ◽  
Vol 48 (2) ◽  
pp. 177-186 ◽  
Author(s):  
D. W. Joyce ◽  
D. K. Tracy ◽  
S. S. Shergill
Keyword(s):  
Clinical Trials ◽  
Clinical Signs ◽  
Disease State ◽  
Disease States ◽  
Geometric Concepts ◽  
Underlying Disorder ◽  
Clinical Instrument ◽  
Based Medicine ◽  
The Impact ◽  
Underlying Pathology

Clinical trials in psychiatry inherit methods for design and statistical analysis from evidence-based medicine. However, trials in other clinical disciplines benefit from a more specific relationship between instruments that measure disease state (e.g. biomarkers, clinical signs), the underlying pathology and diagnosis such that primary outcomes can be readily defined. Trials in psychiatry use diagnosis (i.e. a categorical label for a syndrome) as a proxy for the underlying disorder, and outcomes are defined, for example, as a percentage change in a univariatetotal scoreon some clinical instrument. We label this approach to defining outcomesweak aggregationof disease state. Univariate measures are necessary, because statistical methodology is both tractable and well-developed for scalar outcomes, but we show that weak aggregate approaches do not capture disease state sufficiently, potentially leading to loss of information about response to intervention. We demonstrate how multivariate disease state can be captured using geometric concepts of spaces defined over routine clinical instruments, and show how clinically meaningful disease states (e.g. representing different profiles of symptoms, recovery or remission) can be defined as prototypes (geometric locations) in these spaces. Then, we show how to derive univariate (scalar) measures, which capture patient's relationships to these prototypes and argue these representstrong aggregatesof disease state that may be a better basis for outcome measures. We demonstrate our proposal using a large publically available dataset. We conclude by discussing the impact of strong aggregates for analyses in traditional and novel trial designs.

Evidence-Based Global Public Health

2013 ◽  
Author(s):  
Vincanne Adams
Keyword(s):  
Public Health ◽  
Health Care ◽  
Global Health ◽  
Experimental Research ◽  
Evidence Based ◽  
Global Public Health ◽  
The Social ◽  
Research Populations ◽  
Based Medicine ◽  
The Impact

This chapter examines the impact of “evidence-based medicine” (EBM) on global public health. An epistemic transformation in the field of global health is underway, and it argues that the impact of EBM has been twofold: (1) the creation of an experimental metric as a means of providing health care; and (2) a shift in the priorities of caregiving practices in public health such that “people [no longer] come first.” The production of experimental research populations in and through EBM helps constitute larger fiscal transformations in how we do global health. Notably, EBM has created a platform for the buying and selling of truth and reliability, abstracting clinical caregiving from the social relationships on which they depend.

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