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BMH4-98-3669
CLINICAL GUIDELINES IN EUROPE
OUTLINE
Background to the project
Objectives
The AGREE Instrument: validation process and results
Outcomes and impact of AGREE
Research & policy implications
Future developments
BACKGROUND to AGREE PROJECT
Clinical guidelines play a key role in healthcare improvement in most countries
Ensuring their quality is a shared concern
There is a need for consistent international guidance on guideline development and assessment
‘The whole is greater than the sum of its parts’
OBJECTIVES
Develop compatible approaches for the creation of clinical guidelines
Establish a structure for the appraisal and monitoring of clinical guidelines
Define relevant quality criteria
Promote and encourage the diffusion of these criteria through international exchanges and collaborative links
APPRAISAL OF GUIDELINES fOR RESEARCH & EVALUATION
(AGREE) INSTRUMENT
The AGREE Collaboration
September 2001
PURPOSE OF THE AGREE INSTRUMENT To provide a systematic framework for
appraising the quality of clinical guidelines
To help guideline developers follow a structured and rigorous methodology
To help policymakers decide which guideline to recommend for use in practice
To help health care providers assess guidelines before adopting recommendations in practice
WHAT IS A GOOD GUIDELINE?
‘Quality of clinical guidelines’ is the confidence that:
the potential biases of guideline development have been addressed adequately
the recommendations are both internally and externally valid, and are feasible for practice
STRUCTURE
23 items 4-point
Likert Scale
Six Six domainsdomains
1. Scope & purpose (3)
2. Stakeholder involvement (4)
3. Rigour of development (7)
4. Clarity & presentation (4)
5. Applicability (3)
6. Editorial independence (2)
User guide
Overall assessment
DEVELOPMENT PROCESS
Subgroup reviews literatureFirst draft circulated for comments First workshop, instrument modifiedFirst validation study Second workshop, instrument revised
Final validation study
VALIDATION PROCESS (1)
Phase 1Phase 1
The instrument was applied to 100 guidelines from 11 countries
All countries followed the same protocol
Each guideline was independently assessed by 4 appraisers (194 altogether)
Instrument was used in English
VALIDATION PROCESS (2)
Phase 2Phase 2
Refined instrument tested on 33 guidelines randomly selected from 1st study
Same countries participated
New set of appraisers recruited (70)
Each country assessed 3 guidelines
RESULTS
Over 90% of appraisers found the instrument and the user guide useful
Reliability was satisfactory for each domain
- Cronbach’s Alpha 0.64 - 0.88 - ICC 0.57 -0.91
There was suggestion of criterion validity
OUTCOMES
The AGREE Instrument has been translated into 7 European languages, more in preparation
Six papers have been published
All EU-funded projects are requested to assess guidelines with the AGREE Instrument
WHO has endorsed the AGREE Instrument
The Council of Europe has formally recommended its use
IMPACT OF AGREE
Guideline Assessment
• Europe• South East Asia• Middle East• Latin America• Australia• Canada
Education and training
Postgraduate courses
(Mc Master University, New Zealand, UK, France)
Guideline development
European Society Cardiology
National guidelines programmes
ResearchUSAUKCanada
“Both NICE and SIGN aim to meet the international
standard set by the AGREE guideline appraisal
instrument”
Joint NICE/SIGN statement on working together to improve patient careNICE website 18 April 2002
RESEARCH & POLICY IMPLICATIONS
The AGREE Instrument creates a common framework for assessing guidelines that can be applied internationally.
Can be used to compare quality of guidelines across countries and disease areas.
Provides standards for reporting of clinical guidelines published in medical journals.
Governmental agencies can use AGREE as basis for making policy decisions about guidelines
FURTHER DEVELOPMENTS: AM Project
Structured visits to 7 central & East
European countries
Dissemination workshops in 15
European countries
AGREE Training manual
& Evaluation form
Research programmeEU 6th Framework
G.I.N. The Guidelines International Network
The Association for Guideline REsearch and Evaluation
http://www.agreecollaboration.org
Website address