1. Evidence-Based Medicine in Clinical Practice.
Title Page
Dr. Harry Gee
Dr. Chisale Mhango

2. "Every intervention is a two-edged sword."
Iain Chalmers
Quotation: interventions are meant to be beneficial but have side-effects. These can outweigh the benefits. The only way to know is be conducting properly controlled trials.

3. Practice Pradigms New paradigm Old paradigm
Unsystematic clinical experience
Pathophysiology
Content expertise & authoritarianism
New paradigm
Systematic clinical experience
Pathophysiology necessary but not sufficient
Rules of evidence
Pathophysiology is frequently implicated in clinical decision making. It often relies on intermediate outcomes, not key clinical outcomes that are of importance to patients. When unsupported by clinical studies, it may lead to erroneous decisions.
For example, infection is a pathophysiological feature of SROM and antibiotics should help but in practice some antibiotics increased neonatal complications (NEC). This illustrates a recurrent theme in EBM - choice of patient centred outcome (mortality, morbidity, quality of life ect) rather than disease centre outcomes such as stopping of arrhythmias, or fall in serum rhubarb level, is a key feature.

4. Pre-Requisites Questioning Desire for Improvement The Knowledge Gap
Honesty
Humility
Discerning
What is merely custom and practice?
Desire for Improvement
These key steps will be repeated again and again throughout the day. 4

5. Our Aims Understand EBM What is it? Why do we need it?
What are the benefits?
Who benefits?
Clear exposition of the purpose of Module 5

6. Our Objectives The key steps: Formulate a clinical question
Search the literature
Efficiently
Confidently
Appraise the evidence
Apply the evidence
What we want to achieve.

7. What is EBM?

8. Good Clinical Practice
Knowledge from best external evidence based on clinical research
Judgement from experience.
Understanding of patient's beliefs & preferences.
Definition:
We need to contextualise this regarding the practice in Malawi. Thus, external evidence may not work, e.g. Ext Ceph Version is of proven value but only if pregnant women are being seen at a time when it can be performed (in the evidence to date - 36 weeks). If not, there is not the opportunity to employ it and this seems to be the current state of affairs in Malawi.
We also need to refer back to Module 2 for values when adapting bullet point 3 - local patient beliefs and preferences.
Sackett 1996

9. Who Benefits?

10. Evidence Based Medicine
Conscientious, explicit and judicious use of current best evidence in making decisions about the care of an individual patient
This takes evidence beyond studies and statistical analysis to applying evidence to the needs of the individual patient.
This is the crux of practice. WHAT IS BEST FOR THIS PATIENT I HAVE TO TREAT?
Sackett. BMJ 1996;312:311-2

11. EBM for the Clinician Knowledge & Skills Proficiency Application
PRACTICE
Confidence
This Module will supply the skill but they need to be PRACTICED - only, then, will proficiency be achieved.

12. 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. 12

13. Asking the Right Questions
This is all important.

14. Etiognostic Research Diagnostic Research Prognostic Research
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
This summarises practice and how research fits in.
Prognostic Research
Therapy
Changes prognosis
Therapy Research
knowledge about therapeutic effectiveness
Clinical outcome

15. 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)
Self- exaplanatory

16. 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.
Simple guidance

17. PICO(D) Population Intervention Comparison Outcome (Design)
They have seen this before.
I want to develop the D part - awareness of appropriate DESIGN when evaluating papers. 17

18. Select best evidence Question Appropriate Study Type Up to Date
Relevant
Focussed
Appropriate Study Type
Up to Date
Selecting he best papers available. 18

19. Research Study Design

20. Research Design Diagnostic tests Cross sectional study Prognosis
Therapy
Patients’ Preferences
Cross sectional study
Cohort study
RCT
Qualitative research
Research design
BMJ 1997;315:1636

21. What resources could be searched?
Brainstorm!
Get participants to say what they think. Note it down on a flipchart. Do not make any comments whether positive or negative about their thoughts. Once you have collected reasonable number of thoughts over 2 minutes move to the next slide.

22. Why Should We Be Critical in Our Reading of the Literature?

23. Quality of the Medical Literature
Journal High Quality Articles
N Eng J Med 17%
Ann Intern Med 13%
JAMA 12%
BMJ %
Lancet %
Why do WE need to have critical skills?
Even in the best journals, only a minority are high quality publications.
Nearly all research studies have faults - if not all. We have to be able to identify these and judge their impact on the result. Otherwise we cannot apply the results to our practice with any confidence.

24. What do we mean by Research Quality?

25. 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
Self explanatory

26. Quality of a Study Validity Bias
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
Important concepts when appraising papers.

27. Bias
Conscious
Unconscious
Conflict of Interest

28. The Hawthorne Effect
What is it?

29. Hawthorne Effect Outcomes changed By virtue of doing the study
Irrespective of the intervention

30. 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: ;
Cook et al. Chest 1992;102:305s-311s;
Guyatt et al. JAMA 1993;270:
Levels of quality.
Why?
BIAS - greater as we come down the hierachy.

31. EBM Basic Skills Critically appraise GATE Frame RAMMbo CASP CAT maker
Formulate structured clinical question
PICO(D)
Search for evidence
Systematic
Select best evidence
Critically appraise
GATE Frame
RAMMbo
CASP
CAT maker
The tools under 'Critically appraise" are hyperlinked so that they can be demonstrated, if necessary - not essential. 31

32. 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

33. 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?”

34. Guidelines

35. 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
This will be seen in guidelines.
Remember- we still have to be critical about the primary studies - even RCTs and Systematic Reviews can be flawed!

36. 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
Again - will be seen in guidelines.

37. To Summarise

38. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
This is a schematic exposition of the process.

39. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
Develop answerable questions
This is a schematic exposition of the process.

40. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
Develop answerable questions
Search and obtain relevant articles
This is a schematic exposition of the process.

41. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
Develop answerable questions
Search and obtain relevant articles
This is a schematic exposition of the process.
Critical appraisal of evidence

42. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
Develop answerable questions
Decision making about diagnosis & treatment
Search and obtain relevant articles
This is a schematic exposition of the process.
Critical appraisal of evidence

43. Experience & Pathophysiology
Summary
Expertise,
Experience & Pathophysiology
Clinical problem
Develop answerable questions
Decision making about diagnosis & treatment
Search and obtain relevant articles
This is a schematic exposition of the process.
Critical appraisal of evidence

44. Performance Competence Proficiency Knowledge Skills Application
PRACTICE
Confidence
Performane - Competency AND Proficiency. 44

45. Are We Together ???