EBM_week_1_2022.pdf

Mahmoud E.Elrggal, PharmD Evidence Based Medicine Course Introduction to Evidence Based Practice Mahmoud E. Elrggal After this lecture you should Know • Overview of the whole syllabus • Stages of development of EBP • The need for EBP ......Once Upon a time In 1972, Archie Cochrane highlighted th...

Mahmoud E.Elrggal, PharmD Evidence Based Medicine Course Introduction to Evidence Based Practice Mahmoud E. Elrggal After this lecture you should Know • Overview of the whole syllabus • Stages of development of EBP • The need for EBP ......Once Upon a time In 1972, Archie Cochrane highlighted the fact that most treatment-related decisions were not based on a systematic review of clinical research. Remember this Name ......Once Upon a time Rather, they were based on × Random selection of information from the vast and variable quality scientific literature × Expert opinion × or, worst of all, on trial and error. Once Upon a time ……… • Cochrane proposed that researchers and practitioners should collaborate internationally to systematically review all the best clinical trials, specialty by specialty. Once Upon a time ……… Cochrane ideas were taken up during the 1980s by Iain Chalmers who persuaded colleagues to join him and make care during pregnancy and childbirth the first area of clinical practice to be reviewed in this way. Once Upon a time ……… • Systematic Reviews 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. Back to sleep • Physicians in western countries traditionally recommended that babies sleep on their stomachs. It was thought that by sleeping on their backs infants were at risk for regurgitation and aspiration, leading to sudden infant death syndrome (SIDS). Back to sleep • In the 1980's, some physicians asked the question, "Is there any evidence to support the practice of sleeping babies on their stomachs?" As it turned out, casecontrol studies found a dramatic decrease in SIDS deaths among children sleeping on their backs, leading to the national "Back to Sleep" program. Steroids in prematurity • In 1973, a small study demonstrated that steroids given to women expected to deliver prematurely reduced the likelihood of death in their infants. Six further studies in the next 10 years had mixed results, primarily because they were all quite small. • Had a meta-analysis been done in 1983, it would have shown that the overall results of all the trials combined supported a beneficial effect of steroids , it might have changed practice much sooner and saved thousands of lives. However, it took another decade before these results were accepted and began to change practice. • The results of the first seven studies of steroids in prematurity, and the summary results (the diamond at the bottom of the diagram) are memorialized in the logo of the Cochrane Collaboration, shown at right. Lines completely to the left of the vertical bar represent a statistically significant benefit of steroids in preventing death. ......Once Upon a time • In the early 1990s, David Sackett and his colleagues at McMaster University in Ontario, Canada, introduced the term “Evidence-based medicine” What is Evidence Based Medicine ? Remember…... Medicine is the science of uncertainty and the art of probabilities What is Evidence Based Medicine ? The integration of the best research evidence with clinical expertise and patient values. “best research evidence” What does “best” mean? clinically relevant research. Patient centered clinical research The accuracy and precision of diagnostic tests The power of prognostic markers The efficacy and safety of therapeutic, rehabilitative, and preventive regimens “clinical expertise” EBM does not eliminate the need for: Noting signs and symptoms Taking a good history Interpreting results of tests Thinking analytically “patient values” • Risk aversion • Time preference • Living arrangements • Working arrangements • Medical care vs. other goods and services • Income? Evidence Based Medicine Vs Evidence Based Practice More inclusive of different areas of health care practice. Why Evidence Based Practice ? (Cont.) • EBM launched as a process by which advances in medical research may come into practical use so as to yield safer, better and more costeffective health care. Why Evidence Based Practice ? (Cont.) • More than 15 million medical papers have been published. • The number of medical journals is in excess of 5000. Why Evidence Based Practice ? (Cont.) Half of what you are taught as medical students will have been shown in ten years to be wrong. And the trouble is none of our teacher know which half. Charles Sidney Burwell Ex-Dean ,Harvard Medical School (1935-1949) Why Evidence Based Practice ? (Cont.) • It has been estimated that only some 10–15% of what is published today will be of lasting scientific value. • It has been estimated that half of today’s medical knowledge base will be out-of-date, erroneous or irrelevant in 10 years. Important Requirements! • Fundamental elements should be present in all studies, including: Appropriate qualifications of the researchers. Valid investigational methods & Proper research techniques. Appropriate analysis plus interpretation of the results. Questions for Assessing Clinical Trials Was the article published in a reputable, peer-reviewed journal? Journal, Peer-Review, and Investigators • Health care practitioners need to regularly access professional journals to assist them in keeping current in their practice responsibilities. Journal, Peer-Review, and Investigators An essential journal feature is the peer-review process. Journal, Peer-Review, and Investigators •Peer-reviewed articles are evaluated by someone other than the editorial staff. Journal, Peer-Review, and Investigators Two journal sections can be checked for information addressing whether the peer-review process is used: instruction for authors and journal scope/purpose. Journal, Peer-Review, and Investigators Please Check https://www.bmj.com/aboutbmj/publishing-model Journal, Peer-Review, and Investigators The primary purpose of these non-peer-reviewed publications is to generate profit. Predatory Journals https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7237319/ Types of Peer-Review • Open Peer Review • Single Blind • Double Blind • Post Publication For more details about types of peer review please read this page https://www.elsevier.com/reviewer/what-is-peer-review Questions for Assessing Clinical Trials What is The Journal Impact Factor? Journal, Peer-Review, and Investigators • Journal Impact Factor (IF) is from Journal Citation Report (JCR), a product of Thomson ISI (Institute for Scientific Information). Journal, Peer-Review, and Investigators IF = The number of times articles published in 2017-2018 were cited in indexed journals during 2019 The Number Of Articles, Reviews, Proceedings Or Notes Published In 2017-2018 Journal, Peer-Review, and Investigators Is it right to apply IF to evaluate the significance of an individual publication or to evaluate an individual researcher? Journal, Peer-Review, and Investigators •immediacy index The average number of times that an article published in a specific year within a specific journal is cited over the course of that same year Journal, Peer-Review, and Investigators •immediacy index Articles published early in the year has a better chance of being cited than one published later in the year. Factors affecting IF ? sociological: 1- the subject area of the journal. 2- the type of journal. 3- the average number of authors per paper statistical factors: 1- the size of the journal 2-the size of the citation measurement window. Subjectivity significant variation in mean impact according to subject field. Top journal in one field may have a lower impact than bottom journal in another field. There is a strong and significant correlation between the average number of authors per paper and the average impact factor for a subject area ■ So comparisons of impact factors should only be made for journals in the same subject areas. Article and Journal Type ■ Letters: Rapidly rises to citation peak, large proportion of cites in two year window but low absolute number. ■ Full Papers: Later citation peak, smaller proportion in two year window, but greater longevity. ■ Reviews: Latest citation peak, Proportion of cites within impact window is low - but high absolute number of cites. Article and Journal Type ■Here the average two-and five-year impact factors for around 200chemistry journals have been plotted against time. ■ The two-year impact factors show considerable variability, jumping up and down in value each year. ■The five-year measures, showing changes over time, present a much smoother curve. Journal, Peer-Review, and Investigators Research presented during a professional organization meeting, whether as a platform or poster, requires an abstract to be available for meeting attendees to review. Journal, Peer-Review, and Investigators These abstracts usually under go the peer-review process to be selected, but readers should be cautious of the abstract content. The peer-review process may not be as thorough and the entire study details are not available to the reader. Journal, Peer-Review, and Investigators Journal Supplement The purpose of such supplements is to publish a collection of articles related to a specific topic in a separate journal issue. Journal, Peer-Review, and Investigators Journal Supplement - Might be sponsored by an outside entity (i.e., pharmaceutical company) - Source of revenue for the journal. - The articles may undergo peer-review, but the process may not be as rigorous Journal, Peer-Review, and Investigators • Not all articles published in journal supplements should be automatically discarded or classified as inferior information. • An example of a very informative journal supplement is the American College of Chest Physicians' supplement addressing antithrombotic therapy. Questions for Assessing Clinical Trials Are the investigator's training/education/practice site adequate for the study objective Journal, Peer-Review, and Investigators •Properly trained and have active practice experience in the area of study. •Ethical and responsible to protect patients enrolled in the study Journal, Peer-Review, and Investigators • Persons with specialized credentials in biostatistics need to contribute with statistical analysis of the data. • Authors who are employees of a pharmaceutical company may be a source of potential bias. Journal, Peer-Review, and Investigators The Practice site • Should be a site that has the capability to perform the study (i.e.,have the resources to properly and completely perform the necessary study methods) • Beware, even prestigeious institutions can conduct poor clinical trials. The H-Index……What is it? Its importance? • The h-index is a measure of an author's number of publications and the number of times that each of those publications are cited elsewhere. • The value of h is equal to the number of papers (N) by a given author that are cited N or more times in other publications. The H-Index……What is it? Its importance? Questions for Assessing Clinical Trials Was the title unbiased? Title The decision to read an article often depends on its title Title A good title Criteria: Informative (Key words, study population and the type of the study) Unbiased Specific Concise (i.e., usually < 10 words) No Abbreviations Title • Comment on The following Titles: ? The clinical features of the overlap between COPD and asthma. ? Effect of soy and milk protein supplementation on serum lipid levels: a randomized controlled trial. ? The role of exercise training in heart failure. Abstract Did the abstract provide a clear overview of the purpose, methods, results, and conclusions of the study? Abstract • A concise overview of the study or a synopsis of the major principles of the article. • Abstracts include information addressing the article objective, methods, results, and conclusions. • A primary use of abstracts is for readers to obtain an immediate overview of the article to determine if the entire article should be read., Abstract Abstract • No abbreviations • Use generic name, not trade names, for chemicals and drugs. • Use numerals for all numbers, except those that begins a sentence. Abstract • Many journals now require abstracts to be prepared in an organized format (i.e., structured abstract) and usually must contain 500 words. • Structured abstract includes the following sections: objective, research design, clinical setting, participants, interventions, main outcome measurements, results, and conclusions., Abstract • Structured Abstract Abstract • Nonstructured Abstract Abstract Did the abstract contain information not found within the study? Abstract • Results of three published studies illustrate the dangers of reading only the abstract. • These studies provided evidence of omissions and discrepancies between the abstract and the manuscript in medical, psychology, and pharmacy journals. Abstract And Also……. It is even more worse when…….