Developing a guideline The EBM workshop A.A.Haghdoost, MD; PhD of Epidemiology Ahaghdoost@kmu.ac.ir

Definition Clinical practice guidelines are recommendations for clinicians and consumers about optimal and appropriate care for specific clinical situations EBM workshop Developing guideline

When one needs a guideline Institute of Medicine (IOM) criteria – clinical practice guidelines are useful when: the problem is common or expensive there is great variation in practice patterns there is enough scientific evidence to determine appropriate and optimal care (IOM , 1992) EBM workshop Developing guideline

Developing methods Single author - expert opinion Single author - systematic literature review Consensus panel using expert opinion only Consensus panel using evidenced-based approach (AHCPR methodology) EBM workshop Developing guideline

Recommendation sources Practice Recommendations Education Organization & Policy EBM workshop Developing guideline

EBM guideline “Systematically developed statements (based on best available evidence) to assist practitioner and patient decisions about appropriate health care for specific clinical (practice) circumstances” (Field & Lohr, 1990) EBM workshop Developing guideline

Formal or informal guidelines are the basis for all clinical practice Basis for most clinical decisions Foundation of clinical teaching Mental short-cuts and memory aids for common or complex problems Primary method to evaluate care patterns and monitor standards of care EBM workshop Developing guideline

Types of recommendations clinical assessment / treatment management of cardiac arrest (ACLS) risk assessment / prevention drugs to use in pregnancy (ACOG) administrative insurance pre-approval for surgery EBM workshop Developing guideline

Functions(1) Improve patient care Reduce variation in care Transfer research evidence into practice Promote nursing knowledge base Assist with clinical decision making Identify gaps in research Stop interventions that have little effect or cause harm Reduce cost EBM workshop Developing guideline

Functions(2) Improving physician practice increase effectiveness / decrease harms (better clinical outcomes / cost-effectiveness) Increasing consumer knowledge understand potential benefits / harms Building quality into healthcare systems using practice guidelines, quality indicators Guiding government / employer policies guide programs / policies on healthcare EBM workshop Developing guideline

Target groups Practitioners in different scientific levels Patients and their relatives Community Health policy makers Organizations such as insurance companies EBM workshop Developing guideline

Types of evidences for users Primary literature Original research Secondary literature Systematic reviews, Meta analyses Translation (tertiary) literature Guidelines, protocols, care plans EBM workshop Developing guideline

Internet sources CDC Recommendations: American Academy of Neurology http://www2.cdc.gov/mmwr/mmwr_rr.html American Academy of Neurology Practice Advisories, Practice Parameters, Therapeutic and Technology Assessments, Credentialing Guidelines, Ethics Statements and Other AAN Position Statements http://www.aan.com/public/practiceguidelines/list.htm EBM workshop Developing guideline

Internet sources American Academy of Pediatrics Policy Statements http://www.aap.org/policy/pprgtoc.cfm Clinical Guidelines http://www.aap.org/policy/paramtoc.html American College of Cardiology http://www.acc.org/clinical/guidelines/index.html EBM workshop Developing guideline

Internet sources American Diabetes Association Clinical Practice Recommendations http://www.diabetes.org/DiabetesCare/Supplement199/default.asp Canadian Medical Association - CPG Infobase http://www.cma.ca/cpgs/index.htm Search engine Lists by category, title, titles by developer Recent additions EBM workshop Developing guideline

American Diabetes Association EBM workshop Developing guideline

National Guideline Clearinghouse http://www.guideline.gov/index.asp EBM workshop Developing guideline

NICE organization in UK www.nice.org.uk EBM workshop Developing guideline

NICE organization in UK/public health http://www. nice. org. uk/page EBM workshop Developing guideline

NICE organization in UK /clinical http://www. publichealth. nice. org EBM workshop Developing guideline

Sign organization in Scotland http://www.sign.ac.uk EBM workshop Developing guideline

Finding guidelines in Medline Indexed in the “Publication Type” [PT] field (most accurate) Practice Guideline Guideline diabetes mellitus AND practice guideline[pt] EBM workshop Developing guideline

Pubmed EBM workshop Developing guideline

Developing steps Guidelines Implementation Evaluation Review Development Dissemination Guidelines stakeholders Patients and community revision Pilot study EBM workshop Developing guideline

Revision Guidelines should be evaluated at least once every three years, although in subject areas that are prone to rapid change this may need to occur more frequently. EBM workshop Developing guideline

Steps Define clinical question to be answered (for a specific clinical situation) Find best scientific evidence relevant to the specific clinical question (using systematic methods) Rely on best evidence to guide clinical decision-making EBM workshop Developing guideline

Finding the best evidences Find best scientific evidence that is applicable to the specific clinical situation individual patient’s clinical situation program or policy decision Use evidence to guide decision-making does the likelihood of benefit outweigh likelihood of harm enough to justify the cost? same question applies to individual and society EBM workshop Developing guideline

Developing steps define clinical questions of interest develop summary of evidence on: clinical efficacy (potential benefits) potential harms / projected costs weigh likelihood of benefit versus likelihood of harms, and consider costs develop finding / recommendation statements document all aspects of the process EBM workshop Developing guideline

Strength of evidence ratings for guideline recommendations(1) A = Strong research based evidence multiple relevant, high quality studies B = Moderate research based evidence one relevant, high quality study C = Limited research based evidence one adequate study, somewhat relevant D = Panel opinion based on information not meeting criteria for A-C EBM workshop Developing guideline

Strength of evidence ratings for guideline recommendations(2) Ia Meta-analysis or systematic review of randomized control trials Ib At least one randomized controlled trial IIa At least one well-designed controlled study without randomization. IIb At least one other type of well-designed quasi-exp. study without randomization III Well-designed non-exp. descriptive studies IV Expert committee reports or opinions and/or clinical experiences of respected authorities EBM workshop Developing guideline

Guideline and medical education Background questions – general knowledge about a disorder Look for info in Reference sources: UpToDate, MDConsult, MICROMEDEX, etc. Foreground questions – specific knowledge about managing a patient or disorder Apply EBP techniques, use MEDLINE and other EBP resources EBM workshop Developing guideline

Guideline and medical practice Clinically relevant research, the literature Practitioner’s knowledge & experience Individual’s characteristics & values EBM workshop Developing guideline

Guideline and health related organizations Health ministry developing or ordering? raising funds implementing distributing Medical Universities Developing Adding evidence Criticizing and evaluation Educating students Legal system Justice based on the guidelines Organizations Ordering Raising funds EBM workshop Developing guideline

Do we need a special organization to develop guidelines? Yes, even if we do not need to develop Iranian guidelines, because at least we need To prioritize our needs To find the best available recommendations around the world for each topics To develop our methodology To …… EBM workshop Developing guideline