1

GUIDELINES as a way of harmonisation in Europe: Pro’s and

Con’s

Prof. Dr. Jan. A. Swinkels

PsychiatristProfessor in clinical guideline development in health care

j.a.swinkels@amc.uva.nl

Harmonisation Europe and health care

• Driven by ideals:– It is our moral duty to realise the 'idea of Europe' -

Europe founded on the values of democracy, rule of law, respect for human rights, prosperity and stability" concluded Mr. Cox, chairman of the European parliament

• Drive ideological: – Where is the power?

• Driven by facts and an ideal:– there are great inequalities in the health care it’s our

moral duty to diminish them, can guidelines helps?

3

Good healthcare

• Good standard (EB guidelines)• Effective (the size of the effect)• Safe (side effects, troublesome or dangerous)• Accepted (effect= quality x acceptation• Applicable (in and exclusion criteria)• Feasible (available, in time)• Patient directed (patient involvement)• Meets the real objective needs of the patients• Efficiency (value for money)

effectiveness

Introduction

4

5

CLINICAL GUIDELINES

Definition:

Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.

Institute of Medicine, Field and Lohr (1992)

Evidence based?

• Evidence ≠ proof

• A guideline is called evidence based after a search for the evidence even when there is not enough evidence

• Why?– No evidence is not the same for doing nothing

• Mono of multidisciplinary

7

WHY EB GUIDELINES?

• It’s difficult (impossible?) to keep up with the literature and judge the validity and implications of the research findings for there use in clinical practice– problems with information management

• There is considerable evidence of a gap between evidence and practice

8

9

BARRIERS RELATING TO INFORMATION MANAGEMENT

Identifying effective health care interventions.Health care professionals have difficulty in identifying and comprehending literature due to:– It’s to much– Poor presentation of research findings– No ‘just in time information’ and a lack of time to

search for information– Dispersion or scatter of relevant literature across a

large number of journals (ICT and search engines)– Difficulties in interpreting published evidence (new

knowledge is necessary)

10

Are EB guidelines needed?

• From research it’s clear that a considerable part of our patients didn’t get evidence based treatment (Wang e.a.2005, Young e.a.2001, Fernandez e.a. 2007, Lehman e.a. 2004, Leslie e.a. 2004, Weinmann e.a. 2005)

• So what, are EB treatments better than care as usual?

• EB treatments diminishes the burden of diseases. It’s possible to get an average profit of 25 % (Andrews e.a. 2004, Issakides 2004 e.a.)

Are EB guidelines needed?

• The last conclusion is on statistical epidemiological research, but is it confirmed by clinical studies?

• Yes: (Bauer e.a.2002, Adli e.a.2006, Supes e.a. 2004, Dennehy e.a.

2005), by the treatments themselves and by ‘measurement based care’

• Is this confirmed by implementation research of an EB guideline?

On a national level

14

IMPLEMENTING GUIDELINES

• Largely ineffective strategies - dissemination of written educational materials, didactic educational sessions

• Variable effectiveness - audit and feedback, local consensus conferences, opinion leaders consensus conferences

• Largely effective - reminders, educational outreach (for prescribing), patient mediated interventions, interactive educational workshops, multi-faceted interactive interventions(Grol e.a. 2001, 2003)

Disappointing results?

• We need more research findings to improve the implement ability of the guidelines– There is a high generalisation level, we need

information on subgroups• We need more research with effect modificators

(age ethnicity, co morbidity etc.)

• So more research in needed despite the circumstantial evidence

On an international level

Can we adopt a guideline developed elsewhere?

• Yes– But try to reduce ideological thinking– Use scientific evidence in the guideline– Adopt a coherent frame work for action

Con’s and pro’s

• Not simple select the best clinic or provider

• Private provision of care is not inherently better

• Not exclude the professionals

• Not exclude costs• Impossibilities

• Try to develop data and make them public

• Optimize the use of available evidence about what works and doesn’t works (use the Dutch guideline!)

• Use ADAPTE to make your own guideline

• Use effective implementation strategies

20

21

MEDICO-LEGAL ISSUES

• Do not in principle represent a barrier to implementation

• Use of guidelines protect against liability• Compliance with clinical guidelines is unlikely to

prove decisive in a medical negligence action, unless the intervention concerned is so well established that no responsible doctor acting with reasonable skill would fail to comply with it

• Non compliance is possible or sometimes necessary but needs to be documented

Take home messages

• EB Guidelines can help to improve the quality and safety of care in Europe

• Transparency is needed• For the public to make choices• Professionals are stimulated to work better• Economic reasons: value for money

• Make a plan to make use of the Dutch guideline by using ADAPTE and effective implementation methods

23

Literature