EBM-3rd YY Med student Dr. M. Attia 2024 PDF
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Assiut University
2024
Prof. Dr. Mahmoud Attia Abd El Aty
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This document is lecture notes on evidence-based medicine presented by Prof. Dr. Mahmoud Attia Abd El Aty at Assiut University. The lecture covers concepts, clinical questions, and information management. It focuses on the critical appraisal of medical research.
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Evidence-based Medicine/EBM Presented by Prof.Dr. Mahmoud Attia Abd El Aty Public Health and Community Medicine Faculty of Medicine -Assiut University, Egypt Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Evidence-Based Medicin...
Evidence-based Medicine/EBM Presented by Prof.Dr. Mahmoud Attia Abd El Aty Public Health and Community Medicine Faculty of Medicine -Assiut University, Egypt Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Evidence-Based Medicine/EBM Learning Objectives Prof. Mahmoud Attia Abd elaty-Public Definition of Evidence-based Medicine. Health-Assiut Faculty of Medicine Identification of the basis of medical practice Identification of Multistep of EBP process Differentiation between expert/opinion based medicine and EBM. Formulating EBM question using PICO Format Content of the lecture Definition of EBM-Basic concept–Hierarchy/level of Evidence Medical Knowledge VS Clinical Experience Opinion/consensus/expert-based”VS Evidence based Medicine The basis of medical practice-clinical state and circumstances The needs and uses of EBM - Multistep of EBP process EBM-Appraise the evidence/information critically-Step-3 EBM-Clinical/ Research Question using PICO Format. A brief History-definition The term ‘evidence-based medicine’ (EBM) was first used by a Canadian, David Sackett and his collegues at McMaster University in Ontario, Canada in the early 1990s. Prof. Mahmoud Attia Abd elat Health-Assiut Faculty of Me They have subsequently refined the definition of EBM as integrating the best research evidence with clinical expertise and patient values to achieve the best possible patient management. EBM is about trying to improve the quality of the information on which decisions are based. EBM uses the scientific method to organize and apply current data to improve healthcare decisions. Thus, the best available science is combined/integrated with the healthcare professional's clinical experience and the patient's values, preferences, concerns, and expectations to arrive at the best medical decision for the patient(Tenny S and Varacallo M,2024). There are 5 main steps for applying EBM to clinical practice: Basic concept of (EBP)-A model for evidence-based clinical decisions : Best evidence available information + Physician clinical expertise + the patient's preferences → make optimal decisions about patient care. Don’t forget to allow for individual human differences and personal preferences and clinical circumstances Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine HIERARCHY OF EVIDENCE Evidence Pyramid LEVELS OF EVIDENCE * ↓ Level ↓ Type of evidence * I At least 1 RCT with proper randomization, considered the gold standard of evidence. * II.1 Derived from controlled trials without randomization. * II.2 Well-designed cohort or case-control studies. * III Expert committees/opinions. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Evidence-based practice leads to 1. Reduced variations in a clinician's practices. 2. Enhancement of best practice. 3. Reduced costs. 4. Improved quality of health care. 5. Increased patient satisfaction. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine In daily practice the need for valid information about diagnosis, prevention, treatment, prognosis, and harm are growing. The answer for such questions must be based on solid research evidence rather than on opinion, speculationsالتكهنات, or even past "undocumented and untested“ experiences. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Size of Medical Knowledge /EBM Lineal growth of medical research:1,600 new articles per day, 5000 biomedical,95 Trials in 2005 11,000 diseases,1 disease per day for 30 years ; 30,000 abnormalities (symptoms, signs, lab, X-ray,) 3,200 drugs (cf FDAs 18,283 products Past knowledge and practice might be outdated or inadequate Coping with the information flood. But clinicians are (currently) poorly equipped to tell good from bad research. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Medical Knowledge VS Clinical Experience Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine “Opinion/consensus-based” Medical practice Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine The commonest questions that arise are - Examples of clinical Qs What is the best diagnostic modality to ask for ? With the appearance of the exercise ECHO technique, should a cardiologist shift from doing exercise ECG to exercise ECHO for diagnosing significant coronary heart disease ? What is the best treatment should I prescribe ? Given the large number of NSAIDs in the market, which is best for relieving arthritis or back pain ? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine WHAT IS THE BASIS OF YOUR MEDICAL PRACTICE? Prof. Mahmoud Attia Abd elaty-Public If you checked all 4 items… Health-Assiut Faculty of Medicine A. Training, clinical experience and consultation with other professionals (BUT… Past knowledge and practice might be outdated or inadequate ). B. Convincing evidence (non-experimental) from articles,case reports, product literature, etc (but this evidence may be biased,outdated, incorrect, or not applicable to your patient). C. Patient Preferences, beliefs, expectations/alternative. The patient should be involved in all important decisions, Conflict will appear(endoscope vs surgical-injections vs syrups-"natural“ approaches vs drugs).Better cooperation and compliance. D. Active search of Randomized Controlled Trials, Systematic Reviews, Meta-Analysis reports. You are practicing EBM. What is meant by clinical state and circumstances Evidence recommends surgery but patient is unfit. Evidence recommends a drug but it is too expensive or unavailable at the hospital or even the whole country. Evidence recommends ICU admission but basically no ICU is available in the hospital, or no empty beds are there. What is new in EBM? Clinicians always use clinical expertise Clinicians always respect patients’ values & preferences Clinicians always consider clinical state and circumstances Clinicians always use evidence Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Skills and learning needs The overload problem of rapidly evolving new research. ⚫ 11,000 diseases; 1,600 new articles per day Factors that effect impact on care ⚫ Learning need; Validity; Learning efficiency Skills needed in information management 1. Recognize learning needs 2. Efficiently find the best evidence 3. Discriminate good from poor evidence 4. Understand how to apply evidence with patients What is EBM? EBM means using clinical expertise to integrate: ✓ Current best research evidence ✓ Patient preferences and values ✓ Clinical state and circumstances To make Optimal Decisions about patient care In the practice of EBM, it is the physician’s duty to find the best and most current information and apply it for the benefit of the patient. Best practice = evidence + expertise + patient context and values Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Best evidence available information + Physician clinical expertise + the patient's preferences → make optimal decisions about patient care Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Why we need EBM? New research is rapidly evolving. E.g. 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 effectiveness of the treatment. * This highlighted the gaps that existed between growing research and clinical practice and started to convince some doctors of the benefits of an evidence based approach to bridge this gap. Patients are educating themselves, ask tough questions, and are ready to take legal actions/Litigation الدعاوى القضائيةagainst the doctors. Hospitals encourage the use of treatment algorithms. Insurance companies are requiring stricter criteria for supplying medical services. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine What are the uses of EBM? 1. It provides a common language in which different parties can make optimal transparent decisions: To introduce a new expensive drug: Bring (doctors, representatives of patients, industry, and government) together – and calculate number needed to treat (NNT). To allocate an empty room to be Rehabilitation or Smoking Cessation chest clinic: A quantitative study from each department To buy a new equipment: Do cost-benefit analysis Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine What are the uses of EBM? 2-It provides an efficient framework for post- graduate education and self-directed, life-long learning. The education activities including: Attending lectures and conferences, reading journals, textbooks and clinical practice guidelines, electronic , clinical attachments , small group learning , and talking to colleagues or specialists. Clinical Evidence is available on the internet at: http://www.clinicalevidence.com 3. - By identifying the questions for which no satisfactory evidence exists (evidence D), EBM generates an agenda for needed health research Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Three factor that influence the impact of learning on patient outcomes Learning need ⚫ How important are the knowledge gaps? Validity ⚫ How valid is the information being learned? Learning efficiency ⚫ How quick and complete is learning? Effect = need x validity x efficiency Basic Steps of EBM Progressive, sequential approach of Basic Steps of EBM →↑improved quality of care Prof. Mahmoud Attia Abd elaty-Public and best patient outcomes+satisfaction +↓cost. Health-Assiut Faculty of Medicine Multistep of Evidence-Based Practice process Step Zero: Cultivate a spirit of inquiry EBM Step1:Ask / formulate answerable clinical questions in PICO format/principal. Step 2: Acquire the evidence systematically-Track down the best evidence. Step3:Appraise the evidence/information critically - Aggregating: Step 4: Apply the best evidence Step 5: Assess the performance. Evaluate the effectiveness and efficiency of the process 1-4. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Step 6: Disseminate EBP results Multistep of Evidence-Based Practice process Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Multistep of Evidence-Based Practice process Step Zero: Cultivate a spirit of inquiry /تنمية روح االستقصاء In patient with head injuries, how supine positioning compare with elevating the head of the be 30 degrees affect intracranial pressure? Step 1: Ask answerable clinical questions in PICOT format. (T: time ). Translating a practical issue or problem into an answerable question. Patient-focused, problem-oriented. Clarifies your goal or need, Converting the need for information (about prevention, diagnosis, prognosis, therapy, causation,.. etc) → into an answerable question. The question must be : Important –Interesting –Answerable. A good question will: Define your information need -Identify key search concepts - Enable you to decide appropriate resources to search Step 2: Acquire the evidence. systematically searching for and retrieving best evidence. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Multistep of Evidence-Based Practice process-Cont Step3:Appraise the evidence/information critically.تقييم األدلة بشكل نقدي Evaluate evidence for quality and usefulness. Focus on how to use research reports. Once articles are selected for review, they must be rapidly appraise to determine which are most: valid, reliable, relevant/ applicable to the clinical question/or your patient - Were the valid, reliable instrument used to measure the outcome. Appraisal varies depending on the source of evidence 1-Where and how is evidence gathered? 2-Is it the best evidence available? 3-Is it sufficient to reach a conclusion? 4-Might it be biased in a particular direction? If so, why? *Using the best available evidence from multiple sources to optimize decisions. Aggregating: – weighing and pulling together the evidence. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Multistep of Evidence-Based Practice process-Cont Step 4: Apply the best evidence. incorporating the evidence into a decision-making process. Implement/ Integrate useful findings in clinical practice(evidence) with clinical expertise and patient preferences and values. * Research evidence alone is not sufficient to justify a change in practice. Clinical expertise, base on patient assessments, laboratory data, imaging and data from outcomes management programs, as well as patients’ preferences and values are important components of EBP. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Multistep of Evidence-Based Practice process-Cont. Step5: Assess the performance. Evaluating the effectiveness and efficiency in executing Steps 1-4 and seeking ways to improve them both for next time. Evaluate the outcomes of the practice decisions or changes based on evidence. Monitor/Evaluate: information, interventions, and EBM process. Step 6: Disseminate EBP results. EBP rounds in your institution, presentations in your institution, presentations at local, regional, international conferences, and reports in peer-reviewed journals, professional newsletters- Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Appraise the evidence critically,Step3-FIVE ELEMENTS 1 - What is the research question ? 2 - What is the design of the study ? 3 - Assess the study validity. 4 - Assess the study results. 5 - Assess the study generalizability or applicability Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Multistep of EBP:Appraise the evidence critically,Step3 Comprehensive checklist of how to critically appraise a scientific journal article. Critical appraisal of “the Introduction” 1.Does the article attempt to answer the same question as your clinical question? 2.Is the article recently published (within 5 years) or is it seminal مؤثرة/(أساسيةi.e. an earlier article but which has strongly influenced later developments)? 3.Is the journal peer-reviewed? 4.Do the authors present a hypothesis? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Steps of Appraise the evidence critically,Step3 Critical appraisal of “the Methods” 5.Is the study design valid for your question? 6.Are both inclusion and exclusion criteria described? 7.Is there an attempt to limit bias in the selection of participant groups? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine 8.Are there methodological protocols (i.e. blinding) used to limit other possible bias? 9.Do the research methods limit the influence of confounding variables? 10.Are the outcome measures valid for the health condition you are researching? Critical appraisal of scientific literature is a necessary skill for healthcare students, thus determine whether the results are valid. meta-analysis of all available studies is the best level of evidence. erent clinical questions EBP-Find the Evidence-Step3 For most types of clinical questions, a well-done systematic review or meta-analysis of all available studies is the best level of evidence. The following list outlines the best study methodologies to answer different clinical question ↓Type of question ↓Ideal/suggested type of study Therapy Randomised control trial (RCT)-cohort > case control Prevention RCT | Cohort Study | Case Control Prospective, blind controlled trial comparison to gold Diagnosis standard Cohort study | Case Control | Case series or Case Prognosis report Etiology/Harm RCT | Cohort study | Case control Prof. Mahmoud Attia Abd elaty-Public Cost analysis Economic analysis Health-Assiut Faculty of Medicine Clinical Question- EBM The First, the Hardest, and the most important step Through a Foreground question. we are Converting the need for information (about prevention, diagnosis, prognosis, therapy, causation,…. etc) into an answerable question using PICO format. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine The most common types of clinical questions Etiology: the relationship between an exposure or causal factor and a patient developing a condition. Diagnosis: the validity and reliability of a diagnostic test or screening method. Therapy: the most beneficial treatment or prevention for a condition (intervention could be drug therapy, surgery, physical therapy, etc.). Prevention: How to reduce the chance of disease through identification and modification of risk factors. Prognosis: the likely disease progression for patients with or without treatment. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM QUESTION Prof. Mahmoud Attia Abd elaty-Public EBM QUESTION: ( Examples) Health-Assiut Faculty of Medicine (P) PATIENT : type of patient or population Ex: 47 yr male with DM2 and cellulitis toe,- 25 yr female with DVT and chest pain (E) EXPOSURE: environmental, personal, biological Ex:Tobacco,diet,drug,TB, pregnancy or menopause,allergy (I ) INTERVENTION : clinical intervention Ex: medication, procedure, test, surgery, radiation, drug, vaccine (C) COMPARISON : compare alternative treatment Ex: other prior, new or existing therapy (O ) OUTCOME : clinical outcome of interest Ex: ↓death rate in 5 yrs, ↓ infections, fewer hospitalizations Use the PICO to break down your question Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Example (1): HCV confirmed cases were subjected randomly to two types of treatment (standard treatment and new treatment) and followed up to determine the cure rate. Refine research questioner using PICO. P- …………. I- …………… C- ………….. O- ………….. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Refine research question using PICO P- …..HCV positive cases I- …..New treatment C-….. Standard treatment O- …..Cure rate RQ: In HCV positive patients, does the new treatment increase the cure rate as compared to standard treatment? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Refine research question using PICO Format Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Example (2) Develop a clinical question for the case: Susan is a smoker and just found out that she is 3 months pregnant. She quit smoking immediately. But she is worried if her developing baby was harmed and if the baby is at risk for having developmental problems. She is asking you if smoking during the first trimester can harm her baby? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine P-….. babies of mothers who smoke I-(Exposure) ….smoking of mothers in first trimester C-…. nothing O- ….increase risk of developmental problems RQ: Are babies of mothers who smoke during their first trimester at an increased risk of developmental disabilities? EBM- Research question using PICO Format Example (3) Hassan, a 56 year old man, comes in for repeat prescription for his chronic hypertension. - He is on Atenolol 50 mg per day. His wife, who is diabetic for the last 3 years, was started on Capoten tablets last month because she developed high BP. Hassan asked you: can he be shifted to Capoten too? Construct an answerable question. In elderly hypertensive males (P), would Capoten (I) compared to Atenelol (C) result in better blood pressure control (O)? Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Example (4):you have a four month old baby admitted to your ward with viral bronchiolitis. The child’s symptoms get progressively worse and you wonder whether giving corticosteroids might help the child improve and reduce the length of hospital stay. You decide to use ‘‘clinical score’’ as a measure of improvement. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine The key components of your clinical question would be: Patient or problem: 4 month old baby with viral bronchiolitis. Intervention: corticosteroids. Comparison:no corticosteroids. Outcomes: clinical score, length of hospital stay. A four part clinical question may be formulated as follows: In a 4 month old baby with viral bronchiolitis, does the administration of corticosteroids compared with not giving corticosteroids improve clinical score and reduce length of hospital stay? EBM- Research question using PICO Format Example (5): A 28-year-old male presents with recurrent furunculosis for past 8 months; these episodes have been treated with drainage and several courses of antibiotics but keep recurring. He asks if recurrences can be prevented Refine research question using PICO. P- …………. I- …………… C- ………….. O- ………….. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Example (5): PICO Format- RQ: _ Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine EBM- Research question using PICO Format Example (6): Jeff , a smoker of more than 30 years, has come to see you about something unrelated. You ask him if he is interested in stopping smoking. He tells you he has tried to quit smoking unsuccessfully in the past. A friend of his, however, successfully quit with accupuncture. Should he try it? Other interventions you know about are nicotine replacement therapy and antidepressants. Develop a clinical research question using P I C O: P- …………. I- …………… C- ………….. O- ………….. Question:……………………………………………. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine What made spread of EBM possible 1. Availability of cheap computers/Internet. 2. Progress in information technology (IT) 3. The development of statistical methods for tracking down and appraising evidence. 4. The creation of systematic reviews of the effects of health care (as Cochrane Library). 5. The creation of evidence-based journals, databases and websites. Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine Prof. Mahmoud Attia Abd elaty-Public Health-Assiut Faculty of Medicine