راهنماهای طبابت بالینی Clinical Practice Guidelines هدایت سالاری دکترای تخصصی سیاستگذاری سلامت salarihedayat@gmail.com

مطالب پزشکی مبتنی بر شواهد هرم شواهد طراحی سوال بالینی تعاریف و مفاهیم راهنماهای بالینی اهمیت و کاربرد راهنماهای بالینی چگونگی دستیابی به راهنماهای بالینی چگونگی استفاده از راهنماهای بالینی چگونگی ارزیابی کیفیت راهنماهای بالینی و نقد آنها بومی سازی راهنماهای بالینی ابزارهای بومی سازی راهنماهای بالینی salarihedayat@gmail.com

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What is evidence-based medicine? Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. Sackett, et al. BMJ 1996;312:71-72 In a much-quoted 1996 editorial, David Sackett, an early and prolific author on evidence-based medicine, defined evidence-based medicine (EBM) as the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” (A) (italics added) This characterization highlights the three important parts of evidence-based medical practice: the patient, the evidence, and careful application of generalized evidence to the individual patient. (A) Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996 Jan 13;312(7023):71-2. PMID: 8555924 (http://www.bmj.com/cgi/content/full/312/7023/71) salarihedayat@gmail.com

“A 21st century clinician who cannot critically read a study is as unprepared as one who cannot take a blood pressure or examine the cardiovascular system.” BMJ 2008:337:704-705 salarihedayat@gmail.com

What is Evidence-Based Medicine? “Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values” Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS: Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71-2. This definition of what EBM is and isn’t has gained wide acceptance and made it easier for us to get our points across. salarihedayat@gmail.com

EBM - What is it? Clinical Expertise Research Patient Preferences Evidence Patient Preferences “Explicit, judicious, and conscientious use of current best evidence from medical care research to make decisions about the medical care of individuals” Clinical expertise IS important! Why? Experience with patients: improves efficiency of diagnosis and treatment Improves ability to determine applicability of research data to your patients Allows consideration of patient preferences EBM is the process of systematically finding the most recent applicable research, appraising its validity, and using it as the basis for clinical decisions. Clinical Expertise improves efficiency of Dx and Rx considers patient preferences Overestimates usefulness of therapy -placebo effect - loss to follow-up “Have not all concerned physicians been doing this (EBM) for ages... ? The steps and recommendations of the EBM acolytes reek of obfuscations and platitudes.” WKC Morgan, London, Ontario Lancet, October 28, 1995

Traditional medicine Experiences Pathophysiology, references,… Patient value

Practice Pradigms Old paradigm Unsystematic clinical experience Pathophysiology 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. salarihedayat@gmail.com

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. salarihedayat@gmail.com 10

Background questions: What microbial organisms can cause community-acquired pneumonia? How does pneumonia cause egophony? What is the incidence of community-acquired pneumonia? salarihedayat@gmail.com

a.s Notice that the students’ questions ask for general or “background” knowledge about pneumonia, the disorder that presumably explains much of this patient’s acute illness. salarihedayat@gmail.com

A practitioners’ questions: In this patient are any clinical findings sufficiently powerful to confirm or exclude pneumonia? In this patient is a chest radiograph necessary for the diagnosis? In this patient is the probability of Legionella infection sufficiently high to warrant considering covering this organism with the initial antibiotic choice? In this patient , do clinical features predict outcome well enough that as a “low risk” patient can be treated safely at home? salarihedayat@gmail.com

Clinical questions generally fall into two categories: Background questions have to do with general information, the “lay of the land” of a certain medical topic, or just building one’s general fund of knowledge regarding a specific topic or condition or treatment. Foreground questions have to do with addressing a specific problem for a specific patient. It can be helpful to formulate “foreground” questions into the “PICO” format. Source: Huang X, Lin J, Demner-Fushman D. Evaluation of PICO as a knowledge representation for clinical questions. AMIA Annu Symp Proc. 2006:359-63. PMID: 17238363 salarihedayat@gmail.com

Samples Intensive treatment in patients with type II diabetes does not decrease mortality. Intensive treatment can lower blood glucose levels in patients with type II diabetes salarihedayat@gmail.com

Clinical Questions Foreground – “What do I do for this patient?” Intervention/Investigation Comparison Intervention/Investigation Outcome (Patient-Oriented) salarihedayat@gmail.com

Question components : PICO What types of Participants? What types of Interventions? What types of Comparison? What types of Outcomes?

Clinical Questions - “PICO” Example: In a 5 year old child with conjunctivitis (patient) will topical antibiotics (intervention) compared to no treatment (comparison) lead to quicker symptom relief (outcome)? In a 5 year old child with conjunctivitis (patient) will topical antibiotics (intervention) compared to no treatment (comparison) lead to improved cure rates (outcome)? salarihedayat@gmail.com

Acute Cough in primary care setting Patient Or Problem Intervention Comparison Outcomes Acute Cough in primary care setting

Acute Cough in primary care setting Patient Or Problem Intervention Comparison Outcomes Acute Cough in primary care setting Antibiotics

Acute Cough in primary care setting Patient Or Problem Intervention Comparison Outcomes Acute Cough in primary care setting Antibiotics No antibiotics

Acute Cough in primary care setting Duration and severity of illness Patient Or Problem Intervention Comparison Outcomes Acute Cough in primary care setting Antibiotics No antibiotics Duration and severity of illness

Evidence-based medicine Gathering medical information Evaluating quality of medical information Making medical decisions using best evidence salarihedayat@gmail.com

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Levels of Evidence Level 1: Randomized Clinical Trials Level 2: Head to Head Trial or Systematic Review of Cohort Studies Level 3: Case-Control Studies Level 4: Case-series Level 5: Expert Opinion salarihedayat@gmail.com

Levels of Evidence Type of Study Level of Evidence 1a 1b 2a 2b 3a 3b 4 Systematic reviews of randomized clinical trials (RCTs) 1b Individual RCTs 2a Systematic reviews of cohort studies 2b Individual cohort studies and low-quality RCTs 3a Systematic reviews of case-controlled studies 3b Individual case-controlled studies 4 Case series and poor-quality cohort and case-control studies 5 Expert opinion based on clinical experience Levels of Evidence To help clinicians critically review the external evidence they locate, Sackett et al. developed a hierarchical model to categorize most studies. It is important to note that these levels of evidence are not a rigid set of rules, but serve only as a set of guidelines for the critical appraisal of the literature. According to Sackett (BMJ 1996;312:71-2), the randomized trial (especially the systematic review of randomized trials) has become the “gold standard” for judging whether or not a particular treatment is beneficial. The practice of evidence-based medicine is not restricted to randomized trials. Studies from other levels may be better meet you needs for information or may be better in terms of quality. For example, although the cohort study design ranked lower than that of the randomized controlled trial, it may be the highest level of evidence (excluding systematic reviews) for other aspects of patient care (e.g., validity of diagnostic tests, assessing prognosis) or when randomized controlled clinical trials cannot be performed due to ethical concerns (e.g., study of harmful interventions or exposures). salarihedayat@gmail.com Adapted from: Sackett DL et al. Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. Churchill Livingstone; 2000.

CPG Clinical Practice guidelines have been defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. CLINICAL PRACTICE guidelines are being promoted as one strategy to assist clinical decision making to improve the effectiveness and reduce unnecessary costs of delivered health care services. salarihedayat@gmail.com

انواع شواهد Primary evidence Secondary evidence Tertiary evidence (CPG) salarihedayat@gmail.com

What makes a good guideline? Concepts What makes a good guideline? “Should provide extensive, critical and well-balanced information on the benefits and limitations of various interventions so that the practitioner can carefully judge individual cases” Derived from: Subcommittee of WHO. Summary of the 1993 WHO. BMJ 1993; 307: 1541-1546 salarihedayat@gmail.com

Guidelines Purpose “To make explicit recommendations with a definite intent to influence what physicians do” salarihedayat@gmail.com

GUIDELINE DEVELOPMENT PROCESS TOPIC SELECTION & SCOPE COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP Subject Groups Evidence Editing Review IDENTIFICATION & EVALUATION OF EVIDENCE FORMATION OF RECOMMENDATIONS & GRADING CONSULTATION &PEER REVIEW EDIT & PUBLICATION FORMULATION OF AUDIT & PEER REVIEW salarihedayat@gmail.com

بومی سازی راهنماهای بالینی ADAPTE tool kit salarihedayat@gmail.com

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