advisory forum, 29-30 september 2005 producing guidelines johan giesecke

Advisory Forum, 29-30 September 2005

Producing guidelines

Johan Giesecke


Targets• To assure:

– Standardization – Timeliness– Flexibility– Acceptance and compliance in EU MS

• Need to balance top-to-bottom and bottom-to-top processes

?


Until next AF

• ECDC will look into the 'international' ones – WHO, CDC, etc.

• You are asked to look into your national guidelines:

What already exists? Useful for Europe? Gaps?


Four parts

A. Set prioritiesB. Select Working Party membersC. Produce guidelinesD. Assure acceptance


A. Setting priorities


Prioritisation criteriaCriteria GradePublic Health importance 0 to 5Differences in policy between MS 0 to 3Differences cause difficulties 0 to 3Existing guidelines are weak, not up to date, not evidence based, inconsistent, not appliable to the EU context

0/1 for each item (total: 0 to 5)

Political desire, media pressing, enthusiasm of National Institutes

0/1 for each item (total: 0 to 3)

Substantial resources committed 0 to 3


Already suggested themes (1)

• contact tracing and prophylaxis for – (i) meningococcal meningitis (or other infectious disease)

after a case on an aeroplane, train, boat, etc• prophylaxis (gammaglobulin, vaccination) for

contacts of hepatitis A • testing for MRSA carriage in health-care workers and

patients moving between countries• TB contact tracing• public health measures in epizootics of avian flu

(already being looked into)


Already suggested themes (2)

• restricting social interaction (quarantine, school closures etc) in influenza pandemic

• screening immigrants (TB, HIV, etc where not covered by IHR regulations)

• defining which food-borne outbreaks should be reported under the new zoonosis directive


B. Selection of Working Parties


Two options

1. Pre-defined list by MS/AF2. Contact AF for names when needed


Option 1: Formation of a large database of experts from each MS

• Each MS, under the coordination of the AF representative, selects a roster of experts

• Each MS defines its own rules for the selection• The database may be updated on a regular basis• The fields of interest of each expert are recorded in

the database by a keyword system


Option 1: Choosing from database

• When required a WP is defined by SAU and appropriate SP(s)

• Members of WP are from:– the database of experts– SPs– the list of experts not included in the SPs

taking into account criteria for geographical and disciplinary/professional representation

• A WP should be composed of 6-10 members


Option 2

• Just like the Commission, the ECDC is responsible for forst draft of any guidelines

• Head of SAU contacts AF by email for already existing papers in each MS, that could be used – and for name of contact person

• Translations• ECDC brings in additional help ("Working Parties") as

needed


C. Work of the parties


Preliminary search and systematic review

• ECDC and AF collaborate to collect all available scientific and technical documentation, including existing guidelines from EU and non-EU countries

• Systematic literature review – task for the Panels?


Draft document and scientific consensus

• ECDC prepares a preliminary version of the guideline according to – collected documentation– literature review – its own knowledge and technical expertise

• Draft reviewed AF• Put on website for wide comments?


Definitive document production and approval

• ECDC collects every opinion from both scientific and technical aspect

• Final draft seen by AF• ECDC Director approves the guideline


D. Assure ownership(most important)


Acceptability assessment

• Acceptance and compliance in each MS should play a keyrole in the guideline delivery process

• AF members should assess acceptance according their own rules and depending on the complexity of the guideline

• Public or restricted conferences could be organised in the MSs


Diffusion and monitoring

• SAU provides as wide as possible diffusion of the guideline

• Monitoring of guideline implementation in MSs should be a task by SAU and AF members

• Specific surveys could be undertaken


Questions to AF

1. List of priorities to be decided at next AF meeting. Input from you needed during October. to Work Plan for 2006

2. Roster of WP experts or nomination each time by AF?

3. Pre-publication of draft on ECDC web site?

4. How follow up acceptance and implementation?


Guidelines Factory Inc.

advisory forum, 29-30 september 2005 producing guidelines johan giesecke

Documents