Evidence-Based Medicine in Clinical Practice. Dr. Harry Gee Dr. Chisale Mhango ETATMBA Module 5 "Every intervention is a twoedged sword." Iain Chalmers ETATMBA Module 5 Practice Pradigms Old paradigm New paradigm Unsystematic clinical experience Systematic clinical experience Pathophysiology Pathophysiology necessary but not sufficient Content expertise & authoritarianism Rules of evidence Pre-Requisites • Questioning – The Knowledge Gap – Honesty – Humility – Discerning • What is merely custom and practice? • Desire for Improvement ETATMBA Module 5 Our Aims • Understand EBM – What is it? – Why do we need it? – What are the benefits? – Who benefits? ETATMBA Module 5 Our Objectives The key steps: – Formulate a clinical question – Search the literature • Efficiently • Confidently – Appraise the evidence – Apply the evidence ETATMBA Module 5 What is EBM? ETATMBA Module 5 Good Clinical Practice • Knowledge from best external evidence based on clinical research • Judgement from experience. • Understanding of patient's beliefs & preferences. Sackett 1996 ETATMBA Module 5 Who Benefits? ETATMBA Module 5 Evidence Based Medicine Conscientious, explicit and judicious use of current best evidence in making decisions about the care of an individual patient Sackett. BMJ 1996;312:311-2 ETATMBA Module 5 EBM for the Clinician • Knowledge & Skills • Proficiency – Application – PRACTICE – Confidence ETATMBA Module 5 The 5 Steps Towards Evidence Based Practice 1. Ask the right clinical question: Formulate a searchable question 2. Collect the most relevant publications: Efficient Literature Searching Select the appropriate & relevant studies 3. Critically appraise and synthesize the evidence. 4. Integrate best evidence with personal clinical expertise, patient preferences and values: Applying the result to your clinical practice and patient. 5. Evaluate the practice decision or change: Evaluating the outcomes of the applied evidence in your practice or patient. ETATMBA Module 5 Asking the Right Questions ETATMBA Module 5 Clinical Process and knowledge requirements Research evidence sought from literature searches Etiology knowledge about causation Etiognostic Research Patient presentation knowledge about diagnosis Testing •History •Examination •Investigations Diagnostic Research Diagnosis knowledge about prognosis Therapy •Changes prognosis knowledge about therapeutic effectiveness Clinical outcome Prognostic Research Therapy Research The Question - Why is it so Important? •A good answerable question will help us focus on evidence that is relevant to a patient’s clinical needs, (or your own knowledge needs). •They can suggest high yield search strategies •They can suggest the forms that useful answers might take (i.e. what is best research design to answer our question) ETATMBA Module 5 Formulating Clinical Questions • There is no right or wrong way to turn a scenario/knowledge need into a question. • Just make sure it is concise, clinical and uses appropriate language (avoid colloquialism, in favour of technical language). • Ask one question at a time. ETATMBA Module 5 PICO(D) • • • • • ETATMBA Module 5 Population Intervention Comparison Outcome (Design) Select best evidence • Question – Relevant – Focussed • Appropriate Study Type • Up to Date ETATMBA Module 5 Research Study Design ETATMBA Module 5 Research Design • Diagnostic tests Cross sectional study • Prognosis Cohort study • Therapy RCT • Patients’ Preferences Qualitative research ETATMBA Module 5 BMJ 1997;315:1636 What resources could be searched? ETATMBA Module 5 Why Should We Be Critical in Our Reading of the Literature? ETATMBA Module 5 Quality of the Medical Literature Journal N Eng J Med Ann Intern Med JAMA BMJ Lancet High Quality Articles 17% 13% 12% 9% 8% What do we mean by Research Quality? ETATMBA Module 5 Quality of a Study The confidence that the study design, conduct and analysis has minimized biases in addressing the research question The better the quality, the higher is the likelihood that the results produced in the study are credible Quality of a Study Validity – The degree to which the results of an observation are correct for the patients being studied. Bias – A process that tends to produce results that depart systematically from the true values existing in the study population. Fletcher et al, 1988; Murphy, 1976 Bias • Conscious • Unconscious • Conflict of Interest ETATMBA Module 5 The Hawthorne Effect What is it? ETATMBA Module 5 Hawthorne Effect • Outcomes changed • By virtue of doing the study • Irrespective of the intervention ETATMBA Module 5 Hierachy of Evidence Experimental studies – Randomized controlled trials Controlled Observational studies – Case-control studies Uncontrolled Observational studies – Case series – Case reports Sacks et al. Am J Med 1982;72:233-240; Cook et al. Chest 1992;102:305s-311s; Guyatt et al. JAMA 1993;270:2598-2601 ETATMBA Module 5 EBM Basic Skills • Formulate structured clinical question • PICO(D) • Search for evidence • Systematic • Select best evidence • Critically appraise • GATE Frame • RAMMbo • CASP • CAT maker ETATMBA Module 5 AT-A-GLANCE • • • • • • • • • Acronym Title Aim Groups Limbs – Intervention v Comparator Absolute Risk Reduction Number Needed to Treat (NNT) Clinical Conclusion Education for patients/carers ETATMBA Module 5 • • • • • • • • • AT-A-GLANCE Acronym: is there a study name? as a mnemonic Title: Full title, authors, institute, journal, full reference Aim: specific aim of the study and why, what outcomes were used? Groups: who were the research subjects, inclusion criteria, exclusion criteria, who excluded by chance or bias Limbs – Intervention v Comparator, ? Versus placebo, ? Blinded, how randomised, Absolute Risk Reduction: What the main results?, what the main results on the outcomes studied, other main results, ? Side-effects, other harm events Number Needed to Treat (NNT): How many people do you need to treat to have one beneficial effect? Eg how many people to save a life? How many treated to have side-effects? Clinical Conclusion: What are the main clinical conclusions for you and the team? Can the results be implemented locally? ? Change in guideline needed? ? Clinical audit needed? Education for patients/carers: How can you explain the results to a patient/guardian prior to consent and explanation? State what you will actually say eg “Research has shown that………what do you think?” Guidelines ETATMBA Module 5 Levels of evidence Level Type of evidence I Evidence obtained from at least one randomised controlled trial or from meta-analysis of randomised controlled trials II Evidence obtained from at least one well-designed controlled study without randomisation III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case control studies IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities Grading of recommendations Grade Recommendation A (Evidence level I) Requires at least one randomised controlled trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation B (Evidence levels II, III) Requires availability of well-conducted clinical studies but not randomised clinical trials on the topic of recommendation C (Evidence level IV) Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality To Summarise ETATMBA Module 5 Summary Clinical problem Expertise, Experience & Pathophysiology Summary Clinical problem Develop answerable questions ETATMBA Module 5 Expertise, Experience & Pathophysiology Summary Clinical problem Develop answerable questions Search and obtain relevant articles ETATMBA Module 5 Expertise, Experience & Pathophysiology Summary Clinical problem Develop answerable questions Search and obtain relevant articles ETATMBA Module 5 Expertise, Experience & Pathophysiology Critical appraisal of evidence Summary Clinical problem Develop answerable questions Search and obtain relevant articles ETATMBA Module 5 Expertise, Experience & Pathophysiology Decision making about diagnosis & treatment Critical appraisal of evidence Summary Clinical problem Develop answerable questions Search and obtain relevant articles ETATMBA Module 5 Expertise, Experience & Pathophysiology Decision making about diagnosis & treatment Critical appraisal of evidence Performance • Competence – Knowledge – Skills • Proficiency – Application – PRACTICE – Confidence ETATMBA Module 5 Are We Together ??? ETATMBA Module 5