The Protection of the Person is Central in CIOMS International Ethical Guidelines

2014 ◽  
Vol 3 (4) ◽  
pp. 270-272
Author(s):  
Michel Vallotton ◽  
Sian Fluss ◽  
Gian Sjolin Forsberg
Keyword(s):  
Clinical Trials ◽  
Selection Criteria ◽  
Meta Analysis ◽  
Epidemiological Studies ◽  
Nongovernmental Organization ◽  
Evidence Based ◽  
Ethical Guidelines ◽  
The Subject ◽  
Based Medicine ◽  
And Storage

In this brief article the authors report on the objectives of this nongovernmental organization and, most particularly, on the protection of the person in its International Ethical Guidelines for the fields of clinical trials and epidemiological studies. They emphasize the terminology used to describe the subjects or the populations involved in these studies. They discuss the possibility and nature of harm to persons involved in such studies, and justify the requirement for informed consent also for the persons involved in epidemiological studies. Finally, they consider the roles of such trials and studies as the basis for evidence-based medicine, including cases when their results are pooled in meta-analysis. This methodology is the subject of examination by a CIOMS Working Group of  problems concerning identification and selection criteria, analysis and interpretation of results (including unpublished results), and storage of data.

scholarly journals Cochrane method for evaluating the efficacy of drugs, national contribution to international Cochrane collaboration

2019 ◽  
Vol 10 (4) ◽  
pp. 31-39
Author(s):  
D. L. Varganova ◽  
C. S. Pavlov ◽  
A. A. Svistunov
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
State Level ◽  
Cochrane Collaboration ◽  
Historical Background ◽  
Evidence Based ◽  
Based Medicine

Modern approaches in medicine are based on the principles of evidence-based and balanced decisions in the age of personalized evidence-based medicine. Cochrane collaboration plays an important role in the development of evidence-based medicine; it’s methodology of meta-analysis, summarizing the scientific evidence from randomized clinical trials (RCTs) to answer the clinical questions about safety and effectiveness of various medical interventions. The article provides a brief historical background on the main milestones in the development of the methodology of evidence-based medicine, on the formation of Cochrane collaboration. The authors explain the concept of meta-analysis and systematic review, their types, methodological features and current requirements. The article defines the sequence of writing a metaanalysis: determing a task, inclusion and exclusion criteria, systematic search for randomized clinical trials, methodological assessment of studies, error risk assessment, meta-analysis models: fixed and random effects; determination of heterogeneity, presentation of meta-analysis results, assessment of confidence level using the GRADE system. The domestic experience of establishing evidence-based medicine in Russia and the contribution to the Cochrane international collaboration are represented separately: the opening of the first branch of the North European Cochrane Cooperation Center in Russia in 1998, the development of educational activities, the work of the Russian clone of the Cochrane Hepatobiliary Group and the appearance of the first qualitative meta-analysis, written by Russian authors, the introduction of an adapted system and the development of a national system for supporting medical decisions. The policy of introducing evidence-based medicine at the state level, legal acts, and the prospects for the development of evidence-based medicine in Russia are reflected.

Essential Dental Public Health

2013 ◽  
Author(s):  
Blánaid Daly ◽  
Paul Batchelor ◽  
Elizabeth Treasure ◽  
Richard Watt
Keyword(s):  
Public Health ◽  
Health Promotion ◽  
Vital Role ◽  
Evidence Based ◽  
Dental Public Health ◽  
Oral Health Promotion ◽  
Dental Practitioners ◽  
The World ◽  
The Subject ◽  
Based Medicine

Public health is a key concern of modern dental practitioners as they continue to play a vital role in the health of populations across the world. The second edition of Essential Dental Public Health identifies the links between clinical practice and public health with a strong emphasis on evidence-based medicine. Fully revised and updated for a second edition, this textbook is split into four parts covering all the need-to-know aspects of the subject: the principles of dental public health, oral epidemiology, prevention and oral health promotion, and the governance and organization of health services. Essential Dental Public Health is an ideal introduction to the field for dentistry undergraduates, as well as being a helpful reference for postgraduates and practitioners.

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 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 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....

General considerations

2020 ◽  
pp. 11-72
Keyword(s):  
Intensive Care ◽  
Meta Analysis ◽  
Surgical Patient ◽  
Evidence Based ◽  
Paediatric Surgery ◽  
Neurologically Impaired ◽  
Legal Requirements ◽  
Day Case Surgery ◽  
Case Surgery ◽  
Based Medicine

This chapter covers the general considerations in safely and effectively performing paediatric surgery. It starts with the ethical and legal requirements, including withdrawal of treatment, treating children in the Jehovah’s Witness faith, and safeguarding. It then outlines evidence-based medicine, including meta-analysis, statistics, and reporting trials. Transport of the sick child, anaesthesia, analgesia, intensive care, sepsis, and the use of antibiotics in children are all covered. Day-case surgery, from its history to indications, pre- and postoperative care, and proper documentation, is described. Pre-assessment, care of the neurologically impaired child, basics of vascular access and radiology, and nutrition in the surgical patient are all covered.

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