Making guidelines for communicable disease prevention and control Preben Aavitsland Department of Infectious Disease Epidemiology Norwegian Institute of.

Making guidelines for communicable diseaseprevention and control

Preben Aavitsland

Department of Infectious Disease Epidemiology

Norwegian Institute of Public Health

at

EpiTrain V, Vilnius, October 22 2007

Contents

• Background– Bad practice

– Varying practice

– The need for evidence

• Ten steps for making guidelines

Good guidelines?

”If he vomits, he’s more likely to choke the vomitus. Also, he tends to keep his head turned to the same side – usually toward the centre of the room. This may flatten the side of his head.”

SIDS mortality in England and Wales

From text books...

• Recommended sleeping position in books on child care

Variation in prescribing of antibiotics for acute otitis media

Froom J et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ 1990;300:582-6.

Experience

Many questions

• Disinfection of apartments of tuberculosis patients?

• How many doses of BCG vaccine?• Disinfestation of madrass of persons with

headlice?• Postexposure prophylaxis against HIV?• Regular screening of dairy workers for

Salmonella? And teachers?• Antibiotics to contacts of meningococcal

disease patients?

Why do we do what we do?

• Directive from Ministry?

• Learnt in medical school?

• Read in text-books?

• Tradition?

• Logic?

• Discussions with colleagues?

• Read in medical journals?

Why are guidelines needed?

• Variation in practice

• Practice ineffective or worse

• Guidelines must be based on the best evidence available

Ten steps

1. Justify need and refine subject2. Set up project and working group3. Identify previous guidelines4. Define objectives and users5. Identify and assess evidence6. Translate evidence into guidelines7. Get external review8. Plan and conduct implementation9. Plan evaluation10. Plan updating

1. Justify need and refine subject

• Justify need based on– Size of problem (morbidity, mortality, costs)

– Lack of consensus and variation in practice

– Evidence of poor application of evidence

– Evidence of ineffective services

• Refine the subject– What is actually needed?

– Specify the problem area

– Talk to users of guidelines

2. Set up project and working group

• Define a project– Resources, mandate, time frame

• Identify stakeholders– Everyone whose activities will be covered by the

guidelines

• Set up project group– Stakeholders

– ”Experts” from several disciplines (multidisciplinary)

– Patient groups? NGOs?

• Clarify commercial and other conflicts of interest

3. Identify previous guidelines

• Ask stakeholders

• Search Internet and books– www.who.int

– www.cdc.gov

– www.ecdc.europa.eu

• If found, assess relevance and quality– If ok, maybe you do not need to continue

4. Define objectives and users

Objectives

• Describe problem, situations and desired change

• Define relevant evaluation indicators– Process

– Quality

– Outcome

Methods

• How will the guidelines be developed?

• Transparent

Users

• Whom are the guidelines for?

5. Identify and assess evidence

Find evidence

• Look first for systematic reviews (Cochrane Library) and other reviews

• Then look for controlled trials (PubMed)

• Check references

• Ask group members

Assess evidence

• Is the evidence relevant to our objectives?

• Is the evidence valid? (Are the studies sound?)

• Grade the evidence

Hierarchy of evidence

1. Systematic review of randomised controlled trials

2. Individual randomised controlled trial

3. Non-randomised trial

4. Observational study (case-control, cohort)

5. Expert opinion (unsystematic review)

6. Personal experience

Searching for systematic reviews

• Cochrane library

• www.mrw.interscience.wiley.com/cochrane

• Search Cochrane Database of Systematic Reviews

• For instance: Are antibiotics helpful against conjunctivitis?

Searching for randomised trials

• Search PubMed

• www.ncbi.nlm.nih.gov/entrez/

• Limit to randomised controlled trials

6. Translate evidence into guidelines

• Intepret evidence– The quality (grade)

– The applicability to our objectives

– Costs versus benefits

– Knowledge of health care system

– Beliefs and values of group members

Grading of recommendations

• Very strong recommendation– Grade 1 evidence + applicability + benefits outweighs

costs

• Strong recommendation– Grade 2 evidence + applicability + benefits outweighs

costs

• Medium strong recommendation– Evidence of grade 3 + applicability + benefits

outweighs costs

• Weak recommendation– Evidence of grade 4 or lower + applicability + benefits

outweighs costs

7. Get external review

• Extra check of validity, clarity and applicability

• Include either individuals or organisations– Experts in the area ”sensible?”

– Experts in guidelines making ”sound method?”

– Potential users ”useful?”

• May improve acceptability

8. Plan and conduct implementation

• Many guidelines are useless and do not work

• Health care personell’s behaviour is very difficult to change

• Identify and address barriers and opposition to change

• Use sufficient resources for implementation

• Make an implementation strategy

Factors to help implementation

• Ownership

• Stepwise implementation

• Local adjustments

• Economical incentives

• Supervision from above

• Support

• Design of guidelines

• Use of Internet

• Integration in continuing education

• Opinion leaders

• Mass media

9. Plan evaluation

• Consider the objectives of the guidelines

• Measure effect– Compare groups or time periods

(quantitatively)

– Measure users’ compliance and satisfaction

– Measure patient outcomes?

10. Plan updating

• Updating is always needed– Assure quality and

relevance– Include new evidence,

new comments and evaluation results

– Remove old truths– Keep the users’ trust

• Authors are responsible, but simpler process

• Make a plan for update and inform users

• Starting point either– when new evidence

becomes available,– when evaluation is

finished, or– at specified time

• Www guidelines are easier to update, but how announce?

Outline of guidelines

• Background

• Objectives of guidelines

• Users of guidelines

• Methods for making the guidelines

• Guidelines

• Updating plan

• (Implementation plan)

• Literature

Conclusions

• Guidelines are needed

• We need guidelines based on evidence

• We should follow the ten steps for making guidelines

• Good implementation is crucial