Limitations in the evidence for safe and effective medications for older people

2017 ◽  
pp. 189-194
Author(s):  
Antonio Cherubini ◽  
Graziano Onder
Keyword(s):  
Clinical Trials ◽  
Cognitive Impairment ◽  
Clinical Practice ◽  
Older Patients ◽  
Best Practice ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Geriatric Syndromes ◽  
Published Evidence ◽  
Based Medicine

In the last decades, evidence-based medicine has emerged as the approach to promote the best clinical practice for health problems. It collates the best published evidence, preferentially based on randomized clinical trials, to guide clinical practice. However, the growing older population challenges the evidence underpinning ‘best practice’. Many older patients are characterized by multimorbidity and polypharmacotherapy, present various degrees of functional and cognitive impairment, and are at risk of developing geriatric syndromes. For these reasons they have been almost systematically excluded from clinical trials. In addition, the results of clinical trials are difficult to apply to patients with these characteristics, given the high risk of drug–drug and drug–disease interactions. An effort to promote a greater involvement of older patients in clinical research is needed, using specific measures to facilitate the participation of complex older patients, who are representative of those treated in clinical practice.

scholarly journals HYPOLIPIDEMIC THERAPY IN STROKE PREVENTION: EXISTING STANDARDS, EVIDENCE-BASED MEDICINE DATA AND REAL PRACTICE

2018 ◽  
Vol 14 (3) ◽  
pp. 434-440 ◽  
Author(s):  
O. V. Gaisenok ◽  
A. N. Rozhkov ◽  
A. S. Lishuta
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Cardiovascular Diseases ◽  
Evidence Based Medicine ◽  
Stroke Prevention ◽  
Randomized Clinical Trials ◽  
Lipid Lowering ◽  
Evidence Based ◽  
Based Medicine ◽  
Statin Use

Cardiovascular diseases occupy a leading position in morbidity, mortality and disability in most countries. Ischemic heart disease and stroke lead in the structure of mortality from cardiovascular diseases. The issues of lipid-lowering therapy with statins in the aspect of stroke prevention are discussed in the article. The main risk factors of atherosclerosis and their prevalence are presented. Topical standards for statin use, evidence-based medicine data obtained in randomized clinical trials, and evidence from actual clinical practice are covered. Possible promising areas of statin use for the prevention of acute cerebrovascular accident are also considered. Combination therapy together with other lipid-lowering drugs, as well as drugs of other pharmacological groups, the use of statins from earlier ages, the practical implementation of pleiotropic effects of statins can be attributed to the latter. The authors clearly demonstrate that the actual practice of using statins lags significantly behind the ideal, reflected in the recommendations and randomized clinical trials. Adherence to medical recommendations is one of the key factors in this. The main factors that can influence the increase of adherence of patients to taking statins and increase the effectiveness of their application in real clinical practice are presented.

NCCN Guidelines for Survivorship Expanded to Address Two Common Conditions

2014 ◽  
Vol 12 (5S) ◽  
pp. 825-827 ◽  
Author(s):  
Elizabeth Kvale ◽  
Susan G. Urba
Keyword(s):  
Clinical Trials ◽  
Cognitive Impairment ◽  
Clinical Practice ◽  
Peripheral Neuropathy ◽  
Cancer Pain ◽  
Practice Guidelines ◽  
Strong Evidence ◽  
Evidence Based ◽  
Nccn Guidelines

The NCCN Clinical Practice Guidelines in Oncology for Survivorship include a new section on cancer-associated cognitive impairment and an expanded section on adult cancer pain that more completely addresses chemotherapy-induced peripheral neuropathy. These additions to the guidelines are the result of increasing awareness that long-term cancer survivors struggle with many late effects. Both the assessment and the management of cognitive impairment still lack a strong evidence-based foundation. The management of peripheral neuropathy, including the use of anti-depressants and opioids, often in combination, is backed by data primarily derived from clinical trials performed for various types of peripheral neuropathy.

scholarly journals Evidence-based medicine in obstetrics: can levels B and C recommendations be elevated to level A recommendations?

2009 ◽  
Vol 2 (2) ◽  
pp. 63-66
Author(s):  
◽  
Suneet P Chauhan ◽  
Eugene Chang ◽  
Brian Brost ◽  
Barbara Assel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Obstetric Practice ◽  
Geographically Dispersed ◽  
Based Medicine

In this study, 65% (132/195) of level B/C obstetric recommendations are amenable to randomized clinical trials (RCTs) and seven were identified as most needed. The purpose of the survey was to evaluate levels B and C recommendations in obstetric practice bulletins (PBs) regarding the feasibility of performing RCT to elevate each subject to level A evidence. Eleven geographically dispersed physicians with experience in research reviewed levels B and C recommendations for the ethical and logistical feasibility of performing an RCT. In the 35 obstetric PBs, 195 level B/C recommendations were reviewed. The majority considered 47 (24%) topics unethical for an RCT and thought 16 (11%) did not need an RCT, thus leaving 132 (67%) levels B and C recommendations available for an RCT. Two-thirds of levels B and C recommendations in obstetric PB are amenable to RCTs and potentially becoming level A evidence.

scholarly journals Evidence-based approaches to comparing the effectiveness of modern cardiology interventions: trends, bias and prospects

2020 ◽  
Vol 25 (8) ◽  
pp. 4037
Author(s):  
S. R. Gilyarevsky ◽  
Yu. N. Belenkov
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Drug Use ◽  
Propensity Score ◽  
Observational Studies ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Improved Methods

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.

scholarly journals Guidelines for Composing and Assessing a Paper on the Treatment of Pain: A Practical Application of Evidence-Based Medicine Principles to the Mint Randomized Clinical Trials

Pain Medicine ◽  
2018 ◽  
Vol 19 (11) ◽  
pp. 2127-2137 ◽  
Author(s):  
Zachary L McCormick ◽  
Yakov Vorobeychik ◽  
Jatinder S Gill ◽  
Ming-Chih J Kao ◽  
Belinda Duszynski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Practical Application ◽  
Based Medicine

scholarly journals Clinical Trials: What, Where, When?

2018 ◽  
Vol 73 (5) ◽  
pp. 314-320
Author(s):  
Olga S. Kobyakova ◽  
Ivan A. Deev ◽  
Evgeny S. Kulikov ◽  
Roman I. Shtykh ◽  
Igor D. Pimenov ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Professional Community ◽  
New Drugs ◽  
Evidence Based ◽  
Literature Analysis ◽  
Complete Knowledge ◽  
Reliable Knowledge ◽  
Based Medicine

Currently randomized clinical trials (RCTs) are a key stage in the development of new drugs. Despite the huge scale of the CT market, general awareness of the issue remains low and the society has formed a number of stereotypes and misconceptions about CTs. The presented review of Russian and foreign studies provides the information on the level of general awareness of clinical research in different countries, as well as among patients and practitioners. The conducted literature analysis demonstrates that awareness of clinical trials remains low both in society at large and among patients or in the professional community of practitioners. According to foreign studies, only 20–30% of respondents have heard anything about medical research while a relatively small percentage of respondents have more complete knowledge of RCTs. Among practitioners, only one in five is sufficiently informed about CTs while, according to different data, only about half fully realize what evidence-based medicine is and understand the importance of CTs as a source of reliable knowledge in everyday practice.

scholarly journals Treatment of macular diseases: an overview of key randomized clinical trials

2022 ◽  
Vol 14 (4) ◽  
pp. 137-148
Author(s):  
E. V. Bobykin ◽  
O. V. Morozova ◽  
N. S. Beresneva
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Social Impact ◽  
Randomized Clinical Trials ◽  
Vision Loss ◽  
Age Related Macular Degeneration ◽  
Evidence Based ◽  
Age Related ◽  
Macular Diseases ◽  
Based Medicine

Macular diseases are traditionally a serious issue in ophthalmology, which has great social impact due to widespread occurrence and significant vision loss, often irreversible. Over the past few decades, the possibilities for the diagnosis and treatment of pathologies of the retina and choroid have been significantly expanded. Randomized clinical trials provided ophthalmologists with valuable information on the natural course and treatment strategies of common retinal diseases from the viewpoint of evidence-based medicine. However, due to the large number of trials conducted, it is often difficult to make an adequate choice of data to be used in daily practice. In this review, we systematize the most valuable randomized clinical trials. To this end, we selected 42 randomized clinical studies conducted between 1979 and 2019 and focused on the treatment of age-related macular degeneration (AREDS 1, AREDS 2, ANCHOR, MARINA, PrONTO, CATT, IVAN, VIEW 1, VIEW 2, EVEREST II, PLANET, SEVEN-UP, ALTAIR, HAWK, HARRIER), choroidal neovascularization of multiple etiology (myopic, post-inflammatory, angioid-streak-related, etc. — RADIANCE, REPAIR, MYRROR, MINERVA), diabetic eye lesions (diabetic retinopathy and diabetic macular edema — ETDRS, DRCR.net Protocols B, I, S and T, RISE, RIDE, VIVID-DME, VISTA-DME, MEAD, FAME), retinal vein occlusions (BVOS, CVOS, SCORE-CRVO, SCORE-BRVO, BRAVO, CRUISE, GALILEO, COPERNICUS, VIBRANT), as well as retinopathy of prematurity (CRYO-ROP, ETROP, RAINBOW). The review summarizes the main results of these studies, which confirm the effectiveness and safety of such treatment methods as antiVEGF and photodynamic therapy, retinal laser photocoagulation, cryotherapy, corticosteroids and nutraceuticals from the viewpoint of evidence-based medicine. For greater clarity, we provide a table summarizing information on each of the randomized clinical trials considered.

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.

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