1 GUIDELINES as a way of harmonisation in Europe: Pro’s and Con’s Prof. Dr. Jan. A. Swinkels Psychiatrist Professor in clinical guideline development in health care

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

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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)

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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

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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