Evidence-Based Medicine ( EBM ): What does it really mean?

1. Evidence-Based Medicine (EBM):What does it really mean? Presented by Dr khamis Elessi BSc, MD, MSc, DipAcu Board in rehab. medicine

2. Ahmad, is a 40y/o patient referred to you as the doctor in charge after seeing a neurologist and was previously prescribed pregabalin 150 mg BID for the treatment of spasticity. • Never heard of it? Now as doctor in charge, what do you do? • Prescribe another drug that you are familiar with? • Call the referring Doctor? • Call your Senior? • Search for the drug on the internet? • Just continue with the drug?

3. Traditional Sources of Medical Information • Internet • Colleagues / Patients • Conferences • Drug Reps • Textbooks • Journals

4. “Evidence-based medicine is the conscientious, explicit, & judicious use of best available evidence in making decisions about the care of individual patients” David Sackett, 1996 Original “Official” Definition of EBM

5. EBM Can improve: • Medical and Nursing care for Patient. • Quality of Clinical Care • Public Health in general • Overall goal is Improving the quality of patients’ lives…

6. Principles of EBM EBM has 2 fundamentals principles • Hierarchy of Evidence • Insufficiency of Evidence alone

7. Hierarchy of Evidence: Things to Consider EBM is only as good as the data available A quality case-control study is more meaningful than a flawed RCT Thus, systematic reviews of RCTs are not necessarily best evidence

8. Insufficiency of Evidence alone • Evidence is never enough alone but needs to be coupled with clinical experience and patient choices & values • Evidence • Expertise • Expectation

9. Why is EBM important? • New types of evidence are being generated which can create changes in the way patients are treated • Although evidence is needed on a daily basis, usually physicians don’t get it due to • Lack of time • Out-of-date textbooks, and • Disorganization of the up-to-date journals • Too many articles are inconsistent, even contradictory • Most reviews are not systematic; instead are subjective

10. There is big gap between research and practice There are Wide variations in clinical practice ~40% of clinical decisions not supported by any strong evidence Many Ineffective treatments are adopted/maintained Pharmaceutical companies influence clinical decisions Over-reliance on clinical experience & expert opinion There are Concerns about cost & quality in medicine To avoid medico-legal suits Why we Need to learn EBM

11. Why bother with EBM? The amount of information is growing exponentially, but our attention is not. The low cost of production of poor quality information results in high quality information being drowned out. Too much information creates a poverty of attention. The cost of finding specific information rises as the amount of information increases. Too many journals/articles / no time to read

12. Review the World Literature Fortnightly* *"Kill as Few Patients as Possible" - Oscar London 5,000? per day 1,500 per day 95 per day Medical Articles Per Year

13. A shocking news • New knowledge evolves very quickly. • Medical school knowledge quickly becomes outdated and/or forgotten. • 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 your teachers know which half,” said Dr. Sydney Burwell, Dean of Harvard Medical school.

14. Sample of Information Retention A study showed that about 50% read only 1 Hr/week So, other half read more than 1 Hr/week

15. Examples of our ignorance of Evidence • Corticosteroid for preterm Birth ( P5) • Corneal Patching • SIDS • Arryhthmiasuppression • Ecainide/flecainide(P6) • Arrhythmia suppression • RCT increased mortality • Disease specific vs. patient specific outcomes

16. Patching corneal abrasion compared with placebo • The standard practice of both family physicians & ophthalmologists has always been to patch the eyes of patients with simple uncomplicated Corneal abrasions as well as prescribing mydriatic agent and antibiotics eye drops.. • However, no one ever asked if patching was beneficial, It was just common sense. • There has been at least 5 RCT’s of patch VS no patch and each has come up with the same answer. • patches offer no benefit and may ever slow down the healing process and increase patients discomfort.

17. Prevention of SIDS…”Back to Sleep” • Doctors I western countries traditionally recommend that babies sleep on their stomach. • It was thought tat by sleeping on their back infants at risk of regurgitation & aspiration leading to SIDS. • In 1980’s, some MD’s asked the question, is there any evidence to support the practice of sleeping infants on their stomach?.

18. Prevention of SIDS…”Back to Sleep” • As it turn out case control & Ecological studies found dramatic decrease among I children who sleeps o their backs leading to the national “Back to Sleep” program. • Had some one asked the question 20 years earlier, tens of thousands of lives might have been saved.

19. higher need for EBM !!!! • in 1994 17% of family Practitioners thought that aspirin had no effect on the survival of patients having an MI & stroke (evidence was available from1988) . • LBP & Disc Sx !!!! • Many Variation in prescribing, diagnostic tests, management of chronic conditions (DM, HTN).

20. How to apply EBM? • It may be argued that MDs and other health care providers have always used & continue to use evidence, expertise & Px values in decision making. • This may be true for very good MDs. The difference lies in emphasis, rigor and understanding. • The 4 steps model for accessing, appraising evidence, which make the process easy & more systematic. • It may help you refine some of the pre-EBM notions and concepts you used to have.

21. Steps in Practicing EBM • Ask specific question to reach the required information • Acquire the best available evidence with which you can answer that question. • Critically Appraise that evidence for its validity, impact, and applicability. → Decision • Apply the evidence with your clinical expertise & patient’s preferences & values.

22. Clinical Questions • Background - “What is it?” • General information on a condition or disease • Foreground – “What do I do for this patient?” • Patient • Intervention/Investigation • Comparison Intervention/Investigation • Outcome (Patient-Oriented)

23. The ‘PICO’ principle • Questions are often vaguely formulated, which makes finding answers in the medical literature a challenge. • Properly structured question will make it easy to find answers which is an essential first step in EBP. • Most questions can be divided into four components: • P =Population and clinical problem • I =Intervention or “exposure”(indicator or index)* • C =Comparator • O =Outcome (diagnosis/screening, prognosis, therapy, event, harm, or prevention)

24. How To Structure Clinical Questions P – Patient population / problem What are you trying to address Does gender/age influence clinical care I - Intervention / Area of interest What will you do for the patient? Drugs, surgery, diet, exercise C – Comparison intervention / status Alternatives to your chosen intervention? Against other interventions, gold standard, or no treatment O – Measurable outcome of interest What will be improved for the patient? Less risk of fracture, fewer hospitalizations, etc.

25. Filtering the Evidence: The “Big Four” • Diagnosis question • How well does it confirm or exclude a diagnosis? • Therapy question • Does it do more good than harm? • Etiology question • How well does it identify a cause for a disease? • Prognosis question • How well does it predict clinical course over time?

26. How To Structure Clinical Questions Preferred design to answer different questions

27. Clinical Questions - “PICO” Example 1: • In a 5 year old child with conjunctivitis (patient) will topical antibiotics (intervention) compared to no treatment (comparison) lead to quicker symptom relief (outcome)?

28. Example 2

29. Steps in Practicing “Pull” EBM • Ask specific question to reach the required information • Acquire the best available evidence with which you can answer that question. • Critically Appraise that evidence for its validity, impact, and applicability. → Decision • Apply the evidence with your clinical expertise & patient’s preferences & values.

30. Evidence Pyramid: Types of information(Quality of Evidence) • Filtered Information • Systematic Reviews/ Meta-Analyses • Critically-Appraised Topics (Synthesis) • Critically-Appraised Articles (Synopsis) • Unfiltered Information • Randomized Controlled Trials • Cohort Studies • Case-Controlled Studies/Case Series and Reports • Background Info(Textbooks)/Expert Opinion

32. Steps in Practicing “Pull” EBM • Ask specific question to reach the required information • Acquire the best available evidence with which you can answer that question. • Critically Appraise that evidence for its validity, impact, and applicability. → Decision • Apply the evidence with your clinical expertise & patient’s preferences & values.

34. Step 3: Critically appraise the evidence (cont.) There are 4 issues in critical appraisal: • Relevance: refers to the extent to which the research paper matches your needs. • Validity: is the extent to which the results are free from bias. (selection Bias, Randomization, Measurement bias, Analysis bias • Consistency: refers to the extent to which the results are similar across different analysis in the study & are in agreement with evidence from other studies • Importance & significance of Results ( analyzed in light of type of Study

37. Step 3: Critically appraise the evidence (cont.) Critique requires knowledge of basic epidemiology (study designs) and biostatistics: ASSUMING you have the right study design: • Check appropriate sample size, randomization, treatment allocation, analysis, etc. • Sensitivity, specificity, prevalence, likelihood ratios • Absolute risk reduction, relative risk reduction, odds ratios, number needed to treat, numbers needed to harm. • General Rule: • Meta-analysis of RCT’s > RCT > Cohort > Case Control > Case Series > Case Report. • Retrospective studies weaker than prospective studies

38. Step 4: Steps in Practicing EBM • Ask specific question to reach the required information • Acquire the best available evidence with which you can answer that question. • Critically Appraise that evidence for its validity, impact, and applicability. → Decision • Apply the evidence with your clinical expertise & patient’s preferences & values.

39. Making best practice decision requires sound judgment based on the integration of best research evidence Clinical expertise Patient’s values As patient participates in care decisions, you are practicing TRUE evidence based medicine Applying EBM helps you Make best decisions in medicine

40. Final advises on EBM • Be ready to “surrender” to a better evidence when found. • Do not become entrenched in what has been done for years • A bad idea done by MANY for LONG time, still baddea • Not all claims to be “evidence based”, is really EBM • Use High quality sources (Cochrane, AHRQ, ACP Journal Club, Clinical Evidence, InfoRetriever. • Retrospective studies weaker than prospective studies • Discard Questionable results developed by poor methodology