EBM • David Sackett and his collegues in 1990 bun vers tel len
• The definition of EBM as;
– integrating the best research evidence with clinical expertise and patient values
• in order to achieve the best possible patient
management
Evidence Based Medicine Board
EBM • …is to improve the quality of the information on which decisions are based • …to help practitioners to avoid ‘information overload’ • …to find and apply the most useful buggulamak information
Evidence Based Medicine Board
Clinical decision making
I (MEDULA)
Evidence Based Medicine Board
Why do we need EBM?
ayr lle • There is a large information gap between research and clinical practice. • As so much research is published all the time, clinicians understandably are unaware of most of it, or do not have the b naber ‘tools’ to assess its quality. Sdegerlend ned
Evidence Based Medicine Board
Why do we need EBM? • Researchers, on the other hand, do not understand the information needs of clinicians and continue to present their work in a way that is not easily accessible to busy practitioners. • In 1972, British epidemiologist Archie Cochrane highlighted the fact that most treatment-related decisions were based on – information from the vast and variable quality scientific literature, gen s – on expert opinion, – or, worse of all, on trial and error. sderenetmmayor Evidence Based Medicine Board • Cochrane sonernek proposed that researchers and practitioners should collaborate internationally to systematically review all the best clinical trials (that is,randomised controlled trials, or RCTs), specialty by specialty. • This highlighted the gaps that existed between research and clinical practice and started to convince some doctors of the benefits of an evidence based approach to bridge this gap.
Evidence Based Medicine Board
The Cochrane Collaboration S s b rl g • Found in response to Cochrane’s call for systematic, up-to-date reviews of all relevant randomised controlled trials of health care. • In the early 1990s, funds were provided by the UK National Health Service to establish a Cochrane Centre in Oxford. • The approach was further outlined at an international meeting organised by the New York Academy of Sciences in 1993 • http://www.cochrane.org Evidence Based Medicine Board Evidence Based Medicine Board Corticosteroids for Preterm Birth Premature 1972 t r lm outcomes • improved ssony.l for preterm babies when mothers were given a short course of corticosteroid before the birth. 1972-89 • Six more RCTs were published which all confirmed these fidings Kad ndo5umuzman • During this time, most obstetricians were still unaware that corticosteroid treatment was so effective and so did not treat women about to give birth early with corticosteroids. 1989 • First systematic review published 1989-91 • Seven more studies reported. • Corticosteroid treatment reduces the odds of babies dying from complications of immaturity by 30 to 50% but thousands of babies have died or suffered unnecessarily since 1972 because doctors did not know about the eff ectiveness of the treatment.
Evidence Based Medicine Board
“flecainide” • The history of the use of the drug flecainide to treat heart attacks in the United States in the 1980s • A dramatic example of the gap between research and clinical practice, and the reliance on evidence of a mechanism rather than an outcome. • A ‘safe g ven and long-acting antiarrhythmic drug that protects against ventricular fibrillation’ would save millions of lives. • In response to this challenge, a paper was published in the New England Journal of Medicine introducing a new drug called flecainide — a local anaesthetic derivative that suppresses arrhythmia. • The paper described a study in which patients who had just had heart attacks randomly received placebo or flecainide and were then switched from one to the other (a cross-over trial). • The researchers counted the numberdeneme of preventricular contractions (PVCs) as a measure of arrhythmias. The patients on flecainide had fewer PVCs than the patients on placebo. When the flecainide patients were ‘crossed over’ to the placebo, the PVCs increased again.
Evidence Based Medicine Board
Evidence Based Medicine Board • “flecainide reduces arrythmias and arrythmias cause heart attacks” • therefore, people who have had heart attacks should be given flecainide. • The results were published in the New England Journal of Medicine and flecainide was approved by the United States Food and Drug Adminstration and became fairly standard treatment for heart attack in the United States (although it did not catch on in Europe or Australia). • Almost immediately after the first trials were complete, however, other researchers had started gathering information on the survival of the patients (the outcome) instead of the PVC rate (the mechanism). • This showed that over the 18 months following treatment, more than 10% of people who were given flecainide died, which was double the rate of deaths among a placebo group. • In other words, despite a perfectly good mechanism for the usefulness of flecainide (it reduces arrhythmias), the drug was clearly toxic and, overall, did much more harm than good. Evidence Based Medicine Board • Unfortunately, because the initial studies had been widely published in medical texts, it was a long time before doctors caught up with the subsequent poor outcome data, which did not attract as much attention. • Meanwhile, about 200,000 people were being treated with flecainide in the United States by 1989. Based on the trial evidence, this would have caused tens of thousands of additional heart attack deaths due to the use of flecainide. • Although there was published information, doctors were systematically killing people with flecainide because they did not know about the good quality outcome-based research.
Evidence Based Medicine Board
What does the flecainide example tell us? • In the flecainide example, the initial research was widely disseminated because it was based on a traditional mechanistic approach to medicine and because it offered a ‘cure’. • Doctors continued to prescribe flecainide because they believed that it worked. They did not know that they needed to look for further information. Evidence Based Medicine Board Overall… • We need a better way to find information, even when we do not know that we need it. • In other words, up to-date, good-quality research findings need to be available to all medical practitioners on a routine basis. • The type of research is important. • We must move away from a traditional mechanistic approach and look for empirical evidence of effectiveness using a clinically relevant outcome (eg survival, improved quality of life). Evidence Based Medicine Board • ‘Kill as few patients as possible’ • ‘Review the world literature fortnightly-15 days’.
Evidence Based Medicine Board
Advantages • EBM helps doctors keep up to date across a very wide spectrum of information. • MEDLINE and similar databases have several advantages. • Patients like this empirical approach because it is easier to understand and allows them to share in decision making. • Decision making can be shared between the doctor and patient based on empirical evidence of risks and benefits. This reduces the chances of future litigation. • Electronic searching can reveal other useful information that is of benefit to the patient.
Evidence Based Medicine Board
The steps
Formulate an answerable question
Track down the best evidence
EBMT Szn sr Rapid critical appraisal of controlled trials degerlend me
Apply the evidence (clinical expertise and patient values)
Evaluate the effectiveness and efficiency of the process
Idegelend nek Evidence Based Medicine Board Evidence Based Medicine Board • Patient-Who is the patient • Intervention- Diagnostic tests 1 Medahale • Control- Compare with… • Outcome Sonus
Evidence Based Medicine Board
Evidence Based Medicine Board The steps
Formulate an answerable question
Track down the best evidence
EBMT Rapid critical appraisal of controlled trials
Apply the evidence (clinical expertise and patient values)
Evaluate the effectiveness and efficiency of the process
Evidence Based Medicine Board
Search the databeses? PubMed • http://www.pubmed.com E
Cochrane library • http://www.cochrane.org
Evidence Based Medicine Board
The steps
Formulate an answerable question
Track down the best evidence
EBMT Rapid critical appraisal of controlled trials
Apply the evidence (clinical expertise and patient values)
Evaluate the effectiveness and efficiency of the process
Evidence Based Medicine Board
Are the results are valid and geger clinically useful ? • Were the groups of subjects representative and comparable? 1 Hems la • Was the outcome measurement accurate? s dog v • Was a placebo used? • Could the results have been due to chance?
Evidence Based Medicine Board
The steps
Formulate an answerable question
Track down the best evidence
EBMT Rapid critical appraisal of controlled trials
Apply the evidence (clinical expertise and patient
values)
Evaluate the effectiveness and efficiency of the process
Evidence Based Medicine Board
Apply the evidence • Is the treatment feasible in my setting? 1 m nk n • Is my patient so different to those in the study that the results cannot apply? • What alternatives are available? • Will the potential benefits of treatment outweigh the potential harms of treatment Is ag r basmall for my patient? • What does my patient think about it? Evidence Based Medicine Board Evidence Based Medicine Board The steps
Formulate an answerable question
Track down the best evidence
EBMT Rapid critical appraisal of controlled trials
Apply the evidence (clinical expertise and patient values)
Evaluate the effectiveness and efficiency of the process
ter m l h Evidence Based Medicine Board • It is important to keeppdegerlend records of ne your clinical questions, research results and critical appraisal of evidence, to follow up patients where you have applied the results of your searches and to record and, where appropriate, publish, outcomes.
• Are you asking any questions at all?
• What is your success rate in asking answerable questions?
• How is your searching going?
• Are you critically appraising your search results?
• Are you applying your evidence in clinical practice?
Evidence Based Medicine Board
Pharmacogenetics
Grapefruit, inhibites metabolism on CYP3A4 gene and also delays clearance of some drugs ten zlenne Evidence Based Medicine Board http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm Evidence Based Medicine Board Dosages for CYP2D6 Drug PM (%) IM (%) EM (%) UM (%)
polymorphism] – AA genotypes have to use low dose of Warfarin with respect to GA and GG
Evidence Based Medicine Board
1879 Flemming indicated their roles in mitosis 1888 Waldeyer named as “chromosome” 1905 X0 and XY have been identified 1912 47 for male and 48 for female 1923 Painter found 48 chromosomes in sperm 1930 Painter chromosome number was between 8 and 100 1930-1950 number of chromosomes was not so important 1950 techniques advanced
There were problems for harvesting chromosomes…
tophama Evidence Based Medicine Board l sk n • Nature Genetics reported an article regarding a novel mutation in an eplipsy family in 2003 • However, the original DNA was contaminated with 3 DNAs • The study group collected DNA from 10 of the family members instead of 16 members as they refused !!! • Other studies did not reveal this mutation… • In fact….
Evidence Based Medicine Board
EBM and Cancer • Retinoblastoma-RB1 • Li-Fraumeni syndrome (LFS)-TP53 • Familial Adenomatous Polyposis-APC • Hereditary Nonpolyposis Colon Cancer- MSH2/MLH1 • Inherited Breast Cancer-BRCA1&2 • Medullary thyroid carcinoma-RET
Evidence Based Medicine Board
EBM and Cancer therapy • In Non-small cell cancer patients – if there is mutation in Exons 18,19 and 21 of EGFR gene • Tyrosine kinase inhibitor therapy can be applied • In the patients that ALK gene rearrangements have been detected – ALK inhibitors can be applied
Evidence Based Medicine Board
EBM and Cancer therapy-2 • In Colorectal cancer patients – If the codons of 12,13 and 61 of KRAS gene is wild type and – No V600E mutation in BRAF gene • anti-EGFR therapy can be (EGFR moAbs) applied
Evidence Based Medicine Board
To do…. • CME • E-Learning • Web sites • Open sources • E-books
Evidence Based Medicine Board
References • Evidence-Based Medicine http://www.evidence-basedmedicine.com • Clinical Evidence http://www.clinicalevidence.com
Evidence Based Medicine Board
EBM Practice Term I http://www.ncbi.nlm.nih.gov/pubmed/ www.pubmed.com 157.387 2.859.352 104.282 22.314 Meta analyses + review •5 years 6.139 5.526 http://lib.gazi.edu.tr/ http://bidb.gazi.edu.tr/ Proxy Sunucusu Ayarları
Xin Yan Et Al - External Qi of Yan Xin Qigong Differentially Regulates The Akt and Extracellular Signal-Regulated Kinase Pathways and Is Cytotoxic To Cancer Cells But Not To Normal Cells
Xin Yan Et Al - External Qi of Yan Xin Qigong Differentially Regulates The Akt and Extracellular Signal-Regulated Kinase Pathways and Is Cytotoxic To Cancer Cells But Not To Normal Cells
