developing a guideline the ebm workshop a.a.haghdoost, md; phd of epidemiology ahaghdoost@kmu.ac.ir

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 ……