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Developing Developing a guidelinea guideline
The EBM workshopThe EBM workshop
A.A.Haghdoost, MD; PhD of EpidemiologyA.A.Haghdoost, MD; PhD of EpidemiologyAhaghdoost@kmu.ac.irAhaghdoost@kmu.ac.ir
EBM workshop Developing guideline A.A.Haghdoost
Definition
Clinical practice guidelines are recommendations for clinicians
and consumers about optimal and appropriate care for specific
clinical situations
EBM workshop Developing guideline A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
Recommendation sources
Practice
Recommendations
Education
Recommendations
Organization
& Policy
Recommendations
EBM workshop Developing guideline A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
Target groupsPractitioners in different scientific levels
Patients and their relatives
Community
Health policy makers
Organizations such as insurance companies
EBM workshop Developing guideline A.A.Haghdoost
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 A.A.Haghdoost
Internet sources
CDC Recommendations:– 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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
American Diabetes Association
EBM workshop Developing guideline A.A.Haghdoost
National Guideline Clearinghousehttp://www.guideline.gov/index.asp
EBM workshop Developing guideline A.A.Haghdoost
NICE organization in UKwww.nice.org.uk
EBM workshop Developing guideline A.A.Haghdoost
NICE organization in UK/public health
http://www.nice.org.uk/page.aspx?o=home
EBM workshop Developing guideline A.A.Haghdoost
NICE organization in UK /clinicalhttp://www.publichealth.nice.org.uk/page.aspx?o=home
EBM workshop Developing guideline A.A.Haghdoost
Sign organization in Scotland http://www.sign.ac.uk
EBM workshop Developing guideline A.A.Haghdoost
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 A.A.Haghdoost
Pubmed
EBM workshop Developing guideline A.A.Haghdoost
Implementation
Evaluation
Review
DevelopmentDissemination
Guidelines
Developing steps
Pilot studyPilot study
revisionrevision
stakeholdersstakeholders Patients andPatients andcommunitycommunity
EBM workshop Developing guideline A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
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 A.A.Haghdoost
Guideline and medical practice
BestEvidence
ClinicalExpertise
The Patient
EBP!
Clinically relevant research,
the literature
Practitioner’s knowledge
& experience
Individual’s characteristics & values
EBM workshop Developing guideline A.A.Haghdoost
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
OrganizationsOrderingRaising fundsimplementing
EBM workshop Developing guideline A.A.Haghdoost
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
1. To prioritize our needs
2. To find the best available recommendations around the world for each topics
3. To develop our methodology
4. To ……
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