Clinical Practice Guidelines <ul><li>“ systematically developed statements to assist practitioner and patient decisions ab...
<ul><li>I. Are the results of the study valid? </li></ul><ul><li>Primary Guides:  </li></ul><ul><ul><li>Were all important...
<ul><li>II. What were the results? </li></ul><ul><li>Are practical, clinically important, recommendations made?   </li></u...
Are recommendations valid? <ul><li>Did guideline developers use appropriate methods and evidence to support the recommenda...
How was consensus sought? <ul><li>Who was explicitly involved in assigning values to outcomes? </li></ul><ul><li>Who were ...
Processes to establishing a clinical guideline <ul><li>MEDLINE citations from articles </li></ul><ul><li>Expert consultant...
Is the guideline likely to have accounted for recent developments? <ul><li>Guideline may be out of date by the time publis...
What are the results? <ul><li>Are practical, clinically important recommendations made? </li></ul><ul><ul><li>Recommendati...
Levels of Evidence  <ul><li>I   Evidence obtained from at least one properly randomized controlled trial. </li></ul><ul><l...
What is the Strength of Evidence to Support Recommendations? <ul><li>Inferences about the health effects of interventions ...
Grades of Recommendations for a specified level of baseline risk <ul><li>A1   RCTs, no heterogeneity, CI all on one side o...
Will the recommendation help you in caring for your patients? <ul><li>Does the purpose of the guideline meet your use for ...
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Clinical Practice Guidelines powerpoint_logo3

  1. 1. Clinical Practice Guidelines <ul><li>“ systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Field MJ, Lohr KN, Eds. Clinical practice guidelines: Directions for a new program.(1990)Washington, D.C. National Academy Press) </li></ul><ul><li>They represent an attempt to distill a large body of medical knowledge into a convenient, readily useable format. They gather, appraise and combine evidence, addressing all the issues relevant to a clinical decision. </li></ul>
  2. 2. <ul><li>I. Are the results of the study valid? </li></ul><ul><li>Primary Guides: </li></ul><ul><ul><li>Were all important options and outcomes clearly specified? </li></ul></ul><ul><ul><li>Was an explicit and sensible process used to identify, select, and combine evidence? </li></ul></ul><ul><li>Secondary Guides: </li></ul><ul><ul><li>Was an explicit and sensible process used to consider the relative value of different outcomes? </li></ul></ul><ul><ul><li>Is the guideline likely to account for important recent developments? </li></ul></ul><ul><ul><li>Has the guideline been subject to peer review and testing? </li></ul></ul><ul><li>From Hayward R et al., Evidence Based Medicine Working Group </li></ul>Outline for Evaluating a Practice Guideline
  3. 3. <ul><li>II. What were the results? </li></ul><ul><li>Are practical, clinically important, recommendations made? </li></ul><ul><li>How strong are the recommendations? </li></ul><ul><li>What is the impact of uncertainty associated with the evidence and values used in the guidelines? </li></ul><ul><li>III. Will the results help me in caring for my patients? </li></ul><ul><li>Is the primary objective of the guideline consistent with your objective? </li></ul><ul><li>Are the recommendations applicable to your patients? </li></ul>Outline for Evaluating a Practice Guideline (continued)
  4. 4. Are recommendations valid? <ul><li>Did guideline developers use appropriate methods and evidence to support the recommendations made? </li></ul><ul><li>Were all important outcomes considered that would matter to patients? </li></ul><ul><li>(e.g., ACP HRT guideline gave priority to outcomes contributing to major morbidity and mortality—cardiovascular, hip fractures, endometrial cancer, but acknowledged menstrual function and changes in mood may be important to many women) </li></ul><ul><li>Was an explicit and sensible process used to identify, select, and combine evidence? </li></ul><ul><li>(developers should specify a focused question, define appropriate evidence using select inclusion criteria, conduct a comprehensive search, and examine validity of results) </li></ul>
  5. 5. How was consensus sought? <ul><li>Who was explicitly involved in assigning values to outcomes? </li></ul><ul><li>Who were the members of the expert panels performing this task? Often they are dominated by members of specialty groups. Were they over-represented? </li></ul><ul><li>Panels consisting of a balance of research methodologists, practicing generalists and specialists, and public representatives are more likely to have considered diverse views. </li></ul><ul><li>Were members screened for possible conflicts of interest? </li></ul>
  6. 6. Processes to establishing a clinical guideline <ul><li>MEDLINE citations from articles </li></ul><ul><li>Expert consultants to identify studies about treatment options and outcomes </li></ul><ul><li>Conduct of formal overviews, including meta-analyses, providing summary estimates of relative risks of main outcomes </li></ul>
  7. 7. Is the guideline likely to have accounted for recent developments? <ul><li>Guideline may be out of date by the time published, because of new studies that have emerged on the issue </li></ul><ul><li>Does the authority identify dates where evidence was considered and potential new studies that could change the guideline? </li></ul><ul><li>For instance, the ACP HRT guideline gave dates for evidence considered (1970-1991) and date of final approval (March 1992), but did not alert readers to new emerging studies (PEPI, HERS, WHI) </li></ul>
  8. 8. What are the results? <ul><li>Are practical, clinically important recommendations made? </li></ul><ul><ul><li>Recommendations should give practical, unambiguous advice </li></ul></ul><ul><ul><li>Are the benefits of following the recommendations worth the expected harms and costs? </li></ul></ul><ul><ul><li>What is the relative vs. absolute risk of the outcome? </li></ul></ul><ul><li>Strength of the recommendations are influenced by: </li></ul><ul><ul><li>The quality of the investigations which provide the evidence </li></ul></ul><ul><ul><li>The magnitude and consistency of positive outcomes relative to negative outcomes (adverse effects, burden to patient and health care system, costs) </li></ul></ul><ul><ul><li>The relative value placed upon different outcomes </li></ul></ul><ul><ul><li>There could be strong randomized clinical trial evidence, but the effect size the outcome could be marginal and there could be significant costs and discomforts that reduce the strength of a recommendation </li></ul></ul>
  9. 9. Levels of Evidence <ul><li>I Evidence obtained from at least one properly randomized controlled trial. </li></ul><ul><li>II-1 Evidence obtained from well-designed controlled trials without randomization. </li></ul><ul><li>II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group. </li></ul><ul><li>II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin in the 1940s) could also be regarded as this type of evidence. </li></ul><ul><li>III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees. </li></ul><ul><li> Canadian Task Force on the Periodic Health Examination: The periodic health examination: 2. 1987 update. Can Med Assoc J 1988;138:618-26. </li></ul>
  10. 10. What is the Strength of Evidence to Support Recommendations? <ul><li>Inferences about the health effects of interventions are weakened when there are unexplained major differences in effects in different studies </li></ul><ul><li>Guidelines based on randomized trials are stronger when the results of individual studies are similar, and weaker when major differences between studies (heterogeneity) is present. </li></ul><ul><li>If the evidence linking interventions and outcomes came from overviews of articles, you could apply the criteria for a valid overview and schema to decide on the strength of evidence supporting recommendations </li></ul>
  11. 11. Grades of Recommendations for a specified level of baseline risk <ul><li>A1 RCTs, no heterogeneity, CI all on one side of threshold NNT. </li></ul><ul><li>A2 RCTs, no heterogeneity, CI overlaps threshold NNT. </li></ul><ul><li>B1 RCTs, heterogeneity, CI all on one side of threshold NNT. </li></ul><ul><li>B2 RCTs, heterogeneity, CI overlaps threshold NNT. </li></ul><ul><li>C1 Observational Studies, CI all on one side of threshold NNT. </li></ul><ul><li>C2 Observational Studies, CI overlaps threshold NNT. </li></ul><ul><li>RCT - Randomized controlled trial </li></ul><ul><li>CI - Confidence interval </li></ul><ul><li>NNT - Number needed to treat to avoid one unwanted outcome </li></ul>
  12. 12. Will the recommendation help you in caring for your patients? <ul><li>Does the purpose of the guideline meet your use for it? (some guidelines may be for clinical decision making, quality assurance, or directed at specialists vs. generalists) </li></ul><ul><li>Do the recommendations apply to your patients? (is your patient population representative of that for which the guideline was developed?) </li></ul>

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