Developing a guideline

1
Developing a guideline

• The EBM workshop
• A.A.Haghdoost, MD PhD of Epidemiology
• Ahaghdoost_at_kmu.ac.ir

2
Definition

• Clinical practice guidelines are recommendations
  for clinicians and consumers about optimal and
  appropriate care for specific clinical situations

3
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)

4
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)

5
Recommendation sources
6
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)

7
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

8
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

9
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

10
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

11
Target groups

• Practitioners in different scientific levels
• Patients and their relatives
• Community
• Health policy makers
• Organizations such as insurance companies

12
Types of evidences for users

• Primary literature
• Original research
• Secondary literature
• Systematic reviews, Meta analyses
• Translation (tertiary) literature
• Guidelines, protocols, care plans

13
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

14
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

15
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

16
American Diabetes Association
17
National Guideline Clearinghousehttp//www.guidel
ine.gov/index.asp
18
NICE organization in UKwww.nice.org.uk
19
NICE organization in UK/public health
http//www.nice.org.uk/page.aspx?ohome
20
NICE organization in UK /clinicalhttp//www.publi
chealth.nice.org.uk/page.aspx?ohome
21
Sign organization in Scotland http//www.sign.ac.
uk
22
Finding guidelines in Medline

• Indexed in the Publication Type PT field
  (most accurate)
• Practice Guideline
• Guideline
• diabetes mellitus AND practice guidelinept

23
Pubmed
24
Developing steps
stakeholders
Patients and community
revision
Pilot study
25
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.

26
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

27
Finding the best evidences

• Find best scientific evidence that is applicable
  to the specific clinical situation
• individual patients 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

28
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

29
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

30
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

31
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

32
Guideline and medical practice
33
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
• implementing

34
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