Grading the Evidence Developing the Typhoid Statement. Manitoba 10 th Annual Travel Conference April 26, 2012

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1 Grading the Evidence Developing the Typhoid Statement Manitoba 10 th Annual Travel Conference April 26, 2012

2 Disclosure of Potential Conflict of Interest Alexandra Henteleff MEd, BN, RN Certificate in Travel Health Grading the Evidence Developing the Typhoid Statement Financial Disclosure Consulting Fees: Innovative Solutions Health Plus Other: Employee Winnipeg Regional Health Authority

3 Presentation Overview Brief Overview of Evidence Based Medicine(EBM) The Evidence Cycle Typhoid statement development using a systematic EBM process where we are now Final note

4 What is evidence based medicine? Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values - Dave Sackett Clinical Expertise Best Research Evidence Evidence Based Medicine

5 Why Evidence Based Practice? How many articles are published per month in the area of family practice? a b c d

6 Why Evidence Based Practice? Explosion of literature Literature is published at a a rate of nearly 8000* articles per month in family practice There are many evidence based review resources that synthesize and critically appraise literature. By using these resources, clinicians can make evidence based decisions in a focused and timeefficient manner *Alper et al (2004). How much effort is needed to keep up with literature relevant for primary care?

7 Why Evidence Based Practice? In an average practice, how many questions arise for every patient seen? a.for every 3 patients seen 2 questions arise b.for every 2 patients seen 3 questions arise c.for every patient seen 1 question arises

8 Why Evidence Based Practice? Unmet Information Needs Practitioner information needs are not being met For every 3 patients seen 2 questions are generated* Synthesized evidence based practice resources can be easy to use and quickly connect practitioners to evidence based answers to their clinical questions *Covell et al (1985). Information needs in office practice: are they being met?

9 Why Evidence Based Practice? On average, how many years does it take to integrate research into everyday practice? a. 5 b. 10 c. 14 d. 17

10 Why Evidence Based Practice? Implementation Delays It takes an average of 17 years for clinical research to be fully integrated into everyday practice Prior to the the early 90s it was recommended that infants sleep on their stomachs despite evidence available in the 1970s that this contributed to SIDs Evidence based resources take into account evidence from a wide variety of fields thus offering clinicians opportunity for greater exposure to evidence

11 Evidence Based Approach Emphasizes the use of a systematic approach to aid clinical decision making De emphasizes intuition and unsystematic clinical experiences Stresses the examination of evidence from clinical research. Requires efficient, systematic literature searching Relies on formal rules and processes to evaluate the evidence evaluating the clinical literature

12 Evidence Based Clinical Guidelines Clinical Guidelines are only as good as the evidence and judgments they are based on

13 Evidence Based Medicine and CATMAT CATMAT has a long history of producing evidence based statements. CATMAT produced it s own statement on evidence based medicine in

14 Evidence Based Medicine EBM continues to evolve and now there is greater emphasis on: Quality of evidence Transparency Balance 14

15 The Evidence Cycle The 5 As Assess the problem Ask a clear answerable question Acquire evidence from appropriate sources Appraise (grade) the evidence Apply the evidence in practice

16 Assess the Problem EBM always begins with identifying the clinical problem/question that arises from the care of the patient or population

17 ASK the question Construct a question that is relevant to the clinical problem/situation and helps to guide the process for finding an answer A well phrased question considers the Patient or Problem Intervention Comparison (if applicable not always present) Outcomes (PICO)

18 Patient Intervention Comparison Intervention Outcome Applying PICO is a systematic way to identify important concepts in a case, and formulate a question for searching

19 Searching: finding good answers

20 AQUIRE the evidence Using the well structured question leads into a well built search strategy which includes: General Information Filtered Resources Unfiltered Resources

21 APPRAISE the evidence Appraise the evidence for its validity (closeness to the truth) and applicability (usefulness in practice) Three basic questions that need to be answered for every type of study What are the results? Are the results valid? Will the results help in caring for my patient or addressing the problem?

22 Why is it important to grade evidence? People draw conclusions about the quality of evidence strength of recommendations Systematic and explicit approaches can help protect against errors resolve disagreements facilitate critical appraisal communicate information

23 Approaches to Grading the Evidence There is wide variation in the approaches used to grade evidence US Preventive Services Task Force Grading System National Advisory Committee on Immunization(NACI) GRADE Approach (Grading of Recommendations Assessment, Development and Evaluation)

24 US Preventive Services Task Force Grading System Levels of Recommendation Levels of Evidence Categor y A B C D I Definition Strongly recommends routinely provide services to eligible patients. Recommends routinely provide service to eligible patients. Makes no recommendation to routinely provide services. Recommends against routinely providing services. Insufficient evidence (in quality or quantity) to make a recommendation Good Fair Poor Magnitude of Net Benefit Substantial Moderate Small Zero/Negative Annals of Int Med 2007;147 (2)

25 Evidence based recommendations for Immunization Methods of the National Advisory Committee on Immunization (NACI) Category A B C D E I Levels of Recommendation Definition there is good evidence to recommend immunization there is fair evidence to recommend immunization existing evidence is conflicting and does not allow making a recommendation for or against immunization there is fair evidence to recommend against immunization. there is good evidence to recommend against immunization. there is insufficient evidence (in quality or quantity) to make a recommendation Levels of Evidence Good Fair Poor CCDR 2009; 35 (ACS-1)

26 GRADE* Approach Quality of Evidence High Quality Moderate Low Very Low Based on: Methodological quality of evidence Likelihood of bias Recommendation Strong Weak Based on: Trade off between benefits and downsides Patient values and preferences Grading of Recommendations Assessment, Development and Evaluation

27 Judgments about the quality of evidence The quality of the evidence (i.e. our confidence) depends on: Study design (e.g. RCT, case control study) Study quality/limitations (protection against bias) Consistency of results across studies Directness of the evidence as it applies to the: Patient (Population) or Problem Intervention Comparison (if any) Outcomes

28 Levels of Evidence Some research designs provide stronger levels of evidence. The hierarchy can be graphically shown as a pyramid

29 Judgments about the Quality of the Evidence Quality of Evidence (i.e. our confidence) may be REDUCED when there is: Sparse or imprecise data Evidence of reporting bias may be INCREASED when there is: A strong association A dose response relationship

30 Strength of Recommendation The degree of confidence that the desirable effects of adherence to a recommendation outweigh the undesirable effects. Desirable Effects Health Benefits Less Burden Savings Undesirable Effects Harms More burden Costs

31 EBM Recommendations Recommendations should clearly: Evaluate the quality of evidence Provide a summary of the evidence (and gaps) Quality Quantity Consistency Describe the balance of potential benefits and harms Identify patient/practitioner values and preferences

32 The Updated Typhoid Statement A journey through the process of developing an evidence based medicine CATMAT statement

33 Background The CATMAT statement on Typhoid was published in 1994 The CATMAT evidence based medicine working group decided this statement was appropriate for piloting the proposed process for statement development A CATMAT working group was created

34 Goals An evidence based statement A systematic review of the evidence Synthesis of the evidence Recommendations that guide practitioners regarding: Vaccine effectiveness Guidance for vaccine recommendation based on: Destination Duration of Travel Sub Populations

35 Typhoid Statement Brainstorming the Research Questions Is the typhoid vaccine effective in preventing typhoid among Canadian Travellers? What are the harms associated with typhoid vaccine? What is the incidence of typhoid in Canadian travellers?

36 Typhoid Statement Brainstorming the Research Questions What factors are associated with the incidence of typhoid in Canadian travellers? What other preventative measures reduce the risk of acquiring typhoid? Are treatments available to reduce typhoid mortality and morbidity?

37 Literature Reviews 1. General literature review on typhoid and travel General search on typhoid and travel Searched databases Ovid MEDLINE & Embase Restricted to (conducted in July 2010) Resulted in 227 citations 2. Systematic reviews Effectiveness of the typhoid vaccine Effectiveness of treatments used to treat typhoid

38 General literature review General literature review on typhoid and travel General search on typhoid and travel Searched databases Ovid MEDLINE & Embase Restricted to (conducted in July 2010) Resulted in 227 citations

39 General literature review (cont.) We narrowed the search to articles: in English and French related to the following topic areas Epidemiology and disease characteristics Risk for travellers (destination, duration, sub population) Preventative measures Treatment

40 2. Systematic Reviews The Cochrane Collaboration Systematic Reviews Vaccines for preventing typhoid fever in 2009 Azithromycin for treating uncomplicated typhoid and paratyphoid fever (enteric fever) in 2008 Fluoroquinolones for treating typhoid and paratyphoid fever (enteric fever) in 2008 Additionally: The WHO Background document: The diagnosis, treatment and prevention of typhoid fever, 2003

41 Where we are now? Through an iterative process with members of the working group with the support from the CATMAT Secretariat a draft version of the Typhoid statement is underway Information from the literature has been synthesized The evidence is being evaluated

42 Next Steps Based on the results of the evidence evaluation: Develop recommendations Finalize the statement Final review by the full Committee Make ready for publicatione frames)

43 Grading CATMAT Statements Statements should be based on good systematic reviews of the literature All current grading systems have limitations Using any EBM or grading system is time intensive but supports evidence informed clinical decision making

44 Final Note Quality of evidence must be based on the entire body of evidence There must be transparency on how recommendations are made There is a balance between: quality of data balance of harms & benefits value & preferences

45 What is evidence based medicine? Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values - Dave Sackett Clinical Expertise Best Research Evidence Evidence Based Medicine

46 Thank you

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