THER202 LEC06 CPG and Critical Appraisal and Application REFORMAT

Ther 202: Pharmacotherapeutics

EXAM

CLINICAL PRACTICE GUIDELINES: CRITICAL APPRAISAL AND APPLICATION LECTURE 6 OUTLINE I. Objectives II. Introduction III. CPG Rationale IV. CPG Development

18 July 2012 V. VI. VII. VIII. IX.

CPG Anatomy Difficulties with CPGs Critical Appraisal Applicability Clinical Trial Guides to Applicability

I. OBJECTIVES     

To define clinical practice guidelines To discuss the process of CPG development To describe the structure of CPG’s To list some potential problems with CPG’s To give some pointers regarding the use of CPG’s

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1295 guidelines at www.guideline.gov o 103 guidelines are on endocrinology Guidelines have been developed about various health concerns Many guidelines abroad were developed because of pressure from HMO’s or gov’t insurance (processing of reimbursement claims) Guideline Development Model: Clinical researches  Journal & conferences  Guideline development  Dissemination  Practitioner  Patient

II. INTRODUCTION   

III. RATIONALE  

Improvement of patient care delivered by both the individual physician & groups of doctors (medical orgs, subspecialty societies) Strategies for improving quality of health care: o Continuing medical education (CME) activities like conventions or post-graduate courses o Generic strategies which are hospital-based or institutional programs like quality of care audits o Development of clinical practice guidelines (CPGs)

Dr. Cecilia A. Jimeno

5. Consensus Building o Develop judgments by consensus in a conference usually o For each intervention, decide if you will recommend (or not recommend) their use. o Panelists cast their votes re. Various options 6. Public forum o Opportunity for stakeholders to react to the guidelines; o Stage of feedback and ratifications o Reactions may be the basis for modifications & further votes by panel members 7. Plan the implementationo Discuss the best way to make sure that the guidelines are implemented. 8. Monitor implementation and impact of the CPG on the practice of groups of physicians o Identify & monitor measures of success of the guideline. * We have CPG for Filipino with HPN, but rarely used, because other CPG are more comprehensive, all the efforts were put into waste, so in coming up with guideline, appraise first the applicability of other existing CPGs

V. CPG ANATOMY 

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Clinical Practice Guidelines  User-friendly statements that bring together the best external evidence & other knowledge or experience necessary for decision making about a specific health problem.  CPG’s = Research evidence + experience (expert opinion)  Tool for clinicians to bridge the gap of current practice and associated outcomes with that of alternative medicine

IV. CPG DEVELOPMENT (refer to the appendix for flowchart) 1. Organization a. Who will be involved in the project?  Administrative group  Technical group (TRC)  Expert panel b. What is the issue or topic?  Usually broad & disease-based c. What has previously been done?  Appraise available guidelines for validity and applicability to the local setting.  Then, decide if new guidelines need to be made d. What should be studied? Identify research questions 2. Search and retrieve - systematic review of the literature to make reasonable estimates of the effect of different interventions. a. Appraise validity and applicability- critical appraisal of the literature b. For each study, analyze the study design and decide if the results are credible c. Analyze if the results are applicable to the different types of pts you see, the types of treatment you use, and the specific outcomes you expect 3. Evidence grading o For each outcome, summarize the results of different studies o Then grade the evidence according to a standardized scale 4. Synthesis of evidence o For each intervention, summarize the evidence (net benefit/harm) across outcomes since the literature may be voluminous.

Pat, Marcel, IC

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Question or Issue o May be a phrase or question; may be about definitions of disease; burden of illness; causation or risk factors for a disease; what tests to use or management approach Recommendation o 1 or 2 statements which represent the recommendations of the consensus panel regarding the issue after they have examined the evidence presented by the TRC Summary of Evidence o Brief review & synthesis of the available literature o Key points  Characteristics of available local & foreign studies (RCT’s, observational data, case reports)  Validity of the studies  Actual results & the estimates of effectiveness or relevant statistics  Applicability of results to our local patient profile Evidence Grade o Usually a numerical rank which represents how good the evidence is o Others just give labels: good, moderate, poor, very poor evidence, scarce data o Grade is determined by the study design, study quality (validity), consistency and applicability of the study to the specified health problem (directness)

Figure 1. Evidence grading (New Zealand Guidelines Group)

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Strength of Recommendation: o Represents the judgment of the consensus panel regarding how forcefully they would make the recommendation based on the evidence they have reviewed plus their own experience in their practice o Usually represented by letters of the alphabet or specific actions (do it, don’t do it, probably do it, probably don’t do it) o Grades of Recommendation A Consistent level 1 studies B Consistent level 2 or 3 studies OR extrapolations from level 1 studies C Level 4 studies OR extrapolations from level 2 or 3 studies D Level 5 evidence or troublingl inconsistent or inconclusive studies of any level

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Ther 202 CLINICAL PRACTICE GUIDELINES: CRITICAL APPRAISAL AND APPLICATION

VI. DIFFICULTIES WITH CPG’S 

Organizations use various systems to grade the quality of evidence, there are as many grading schemes of evidence, as there are bodies which make CPG’s Differences & shortcomings in these grading systems: may be confusing and impede effective communication Some groups combine strength of recommendation & level of evidence into one label (usually letters of the alphabet)

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Evidence Grade & Strength of Recommendation: Evidence supporting this recommendation is of classes: A, B o If aspirin is contraindicated, consider use of clopidogrel (Plavix®) or ticlopidine (Ticlid®). For more information, please refer to the NGC summary of the ICSI guideline Stable Coronary Artery Disease. (Canadian Diabetes Association

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More recent guidelines: ADA says o Consider aspirin therapy (75–162 mg/ day) as a primary prevention strategy in those with type 1 or type 2 diabetes at increased cardiovascular risk (10-year risk >10%). o This includes most men >50 years of age or women >60 years of age who have at least one additional major risk factor (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (C) Furthermore, there is no sufficient evidence to recommend aspirin for primary prevention in lower risk individuals, such as men