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Schwerpunkt

Prominent strategy but rare in practice: shared decision-making and patient decision support technologies in the UK Rhodri Evans1, Adrian Edwards1, Angela Coulter2, Glyn Elwyn1, 1

Department of Primary Care and Public Health, Cardiff University, Cardiff, Wales, UK Picker Institute Europe, Oxford, UK

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Abstract In the UK there has recently been considerable financial investment in the publicly funded health service, NHS, but it is unclear whether this has resulted in improvements in patient participation and shared decisionmaking. There has been encouragement from central government in the form of initiatives such as copying referral letters. Progress, however, has been slow, and the quality of materials, for example, available to patients is highly variable. Nonetheless, there are other organisations, outside of central government, which are active in this field. The Picker Institute, for example, is involved in research, policy and the development of initiatives to improve patient participation. Two of the most important arenas for shared decision-making implementation in the UK are education and the development of patient decision

support technologies (PDSTs). In the case of medical education, whilst there has been some recognition at policy level, implementation, to date, has been limited across both undergraduate and postgraduate curricula. Similarly, the development of PDSTs has been unplanned and fragmented, though is gaining momentum in a number of clinical domains. In terms of barriers and support for shared decision-making implementation in the UK, attention has been focused on the role of financial incentives for healthcare organisations, and on the role of Information Technology, specifically the potential benefits to patients of the h3.3 National Programme for IT. The legislative framework in the UK is conducive to the implementation of shared decision-making, and there is a growing body of research literature, albeit focused on PDSTs.

Key words: Shared decision-making, patient participation, National Health Service, patient decision support technologies As supplied by publisher

Herausragende Strategie, aber selten Umsetzung in der Praxis Zusammenfassung In Großbritannien wurden in ju¨ngster Zeit betra¨chtliche Investitionen in die o¨ffentliche Gesundheitsversorgung NHS (National Health Service) geta¨tigt, aber es ist unklar, ob dies zu Verbesserungen der Patientenbeteiligung und der Partizipativen Entscheidungsfindung fu¨hren wird. Die Regierung unterstu¨tzt entsprechende Initiativen, beispielsweise das Anfertigen einer

Kopie des U¨berweisungsbriefes fu¨r Patienten. Der Fortschritt war allerdings langsam und die Qualita¨t beispielsweise der Materialien fu¨r Patienten ist sehr unterschiedlich. Trotzdem gibt es andere Organisationen außerhalb der Regierung, die in diesem Bereich aktiv sind. Das Picker Institut beispielsweise ist bescha¨ftigt mit Forschung und mit der Entwicklung von

Corresponding author: Professor Glyn Elwyn, Department of Primary Care and Public Health, Centre for Health Science Research, Cardiff University, Health Park, Cardiff,

Wales, UK, CF14 4YS. E-Mail: [email protected] (G. Elwyn) Z.a¨rztl. Fortbild. Qual.Gesundh.wes. (ZaeFQ) doi:10.1016/j.zgesun.2007.02.027

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ARTICLE IN PRESS Initiativen, um die Beteiligung von Patienten zu erho¨hen. Zwei der wichtigsten Ansatzpunkte fu¨r die Implementierung von Partizipativer Entscheidungsfindung in Großbritannien sind die medizinische Ausbildung und die Entwicklung von Entscheidungshilfen. Im Falle der medizinischen Ausbildung, obwohl es die entsprechende Erkenntnis auf gesundheitspolitischer Ebene gegeben hat, ist die Implementierung bisher begrenzt, sowohl in der studentischen Ausbildung als auch in postgraduierten Curricula. A¨hnlich ungeplant und fragmentiert zeigt sich die Entwicklung von Entscheidungshilfen, obwohl deren Einsatz in einigen klinischen allma¨hlich Bereichen allma¨hlich in Gang kommt. Bezu¨glich der Barrieren

und der Unterstu¨tzung fu¨r die Implementierung der Partizipativen Entscheidungsfindung in Großbritannien liegt ein Schwerpunkt auf der Rolle von finanziellen Anreizen fu¨r gesundheitliche Einrichtungen der Gesundheitsversorgung und auf der Bedeutung der Informationstechnologie (IT), insbesondere auf dem potentiellen Nutzen des h3.3 Nationalen Programms fu¨r IT fu¨r Patienten. Der gesetzliche Rahmen in Großbritannien fo¨rdert die Implementierung von Partizipativer Entscheidungsfindung und es gibt eine wachsende Anzahl von Forschungsliteratur, obgleich fokussiert auf Entscheidungshilfen.

Schlu¨sselwo¨rter: Partizipative Entscheidungsfindung, Patientenbeteiligung, National Health Service, medizinische Entscheidungshilfen Wie vom Gastherausgeber eingereicht

Introduction Healthcare in the UK is dominated by the publicly-funded National Health Service (NHS), a state-run organisation, the responsibility for which lies with the respective departments of health in England, Scotland and Wales. Within the NHS, primary healthcare is mostly delivered by General Practitioners, independent contractors who are accountable to primary care organisations. Secondary and tertiary healthcare, on the other hand, is the responsibility of hospitals which act either alone or in clusters. Since 1999 the NHS has received substantially increased public funding, and it is forecasted in 2007 to account for almost 8% of UK Gross Domestic Product (GDP), in comparison with 5.4% in 1997 when the current administration took office [1]. As a consequence, and in contrast to many other developed countries, the NHS has been able to increase its spending on staff and infrastructure [2]. What is less clear, however, is the degree to which this investment has resulted in a service that involves patients in decisions about their care – what is often called shared decision-making. This discussion paper will attempt to explore that question.

1. Level of patient participation at macro, meso and micro levels In 2003 a document, The Informed Patient: Study Report, described the context and current state of patient information, both in the UK and in Europe [3]. The report was the product

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of a consensus conference in Cambridge, UK, and, as part of their ‘informed patient vision’, the conference suggested a framework for Europe: ‘to ensure the ongoing availability of timely, high-quality, accessible, understandable, reliable, and relevant information for patient and carers [3]’. In a subsequent conference, Dublin 2004, the framework was placed in the wider context of shared decisionmaking in Europe: ‘to more fully involve patients in their health, decision-making about treatment, and in the management of their care [4]’. In terms of encouraging patient participation in treatment decisions in the UK, there has been some encouragement from central government, specifically the Department of Health (DoH), England. In the strategy document, ‘Better information, better choices, better health,’ a series of initiatives was outlined, ‘opening the relationship between patients and professionals [5]’. These included copying referral letters to patients and training for professionals in the skills required for shared decision-making [5]. However, progress has been relatively slow in most of these areas. Moreover, the quality of information materials available to UK patients is still highly variable, with many failing to provide accurate, reliable and sufficiently detailed clinical information to assist patients in decision-making. In particular, few materials include a clear presentation of the likely outcomes of treatment, few mention clinical controversies or uncertainties, and many fail to acknowledge the patient’s decisionmaking role [6].

Outside central government, one of the most important organisations that promotes patient participation in the UK, and internationally, is The Picker Institute, http://www.pickereurope.org/. There are three ‘strands’ to its activities: i) Measurement: ‘researching and evaluating patient experience.’ ii) Improvement: ‘leading initiatives that make improvements happen.’ iii) Policy: ‘building evidence to inform health policy.’ The combination of academic rigour and media savvy has enabled The Picker Institute to be an effective and critical advocate for patient participation, as evident in its report, Engaging patients in their healthcare – how is the UK doing relative to other countries? This highlighted significant weaknesses in the UK, in the involvement of patients, when compared with six other countries including Germany and the USA. Specifically, patients in the UK were less likely to have been involved in treatment decisions, less likely to participate with their doctors in a medication review, and less likely to have been given information about sideeffects or ‘clear instructions’ about ‘managing their treatment [7]’. The challenge faced in the UK, and wider-afield, in improving the level of patient participation, has been made clear in the research literature. Little et al, for instance, found that doctors’ perceptions of patient expectations was more important than patients’ expectations themselves in terms of their effect on consultation outcomes [8]. Similarly, Middleton et al recently reported the difficulties faced by patients in expres-

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ARTICLE IN PRESS sing their concerns during consultations [9]. In summary, macro policy developments do not seem to have had much impact on the micro level, where clinicians meet patients.

2. Present state of shared decision-making implementation in the health care system The implementation of shared decisionmaking in the UK can be considered along two lines: education, and the development of Patient Decision Support Technologies (PDSTs).

(i) Education Educating health professionals in shared decision-making serves two purposes. Not only does the consultation style of the clinicians improve, but they may also become more inclined to use, and direct their patients to, shared decision makingbased interventions. It is therefore encouraging to see that the need to teach shared decision-making skills is recognised at a policy level in the UK. For example, in an assessment of the needs of patients, in terms of information and participation, the UK Postgraduate Medical and Educational Training Board concludes: ‘This presents the need for change in the way that future doctors will interact with their patients and something, therefore, that we must consider in future postgraduate medical education and training [10]’. However, as recently reported, there is a long way to go before this is implemented throughout undergraduate and postgraduate training [11]. In terms of shared decision-making in postgraduate education, General Practice is in the vanguard in the UK, as it has been over many years in its development of communication skills training, in comparison with the hospital specialties. Siriwardena et al recently assessed the ‘concurrent validity’ of one of the elements of the UK GP professional examination, ‘Member of the Royal College of General Practitioners (MRCGP)’: the consulting skills assessment of ‘sharing management options’ against the ‘OPTION’ scale for

shared decision-making. They found that candidates who performed best in the MRCGP exhibited the highest OPTION scores [12].

(ii) Implementation of patient decision support technologies (PDSTs) Patient decision support technologies (PDSTs), commonly known as patient decision aids, have been developed in the UK over the last 5 years for a range of health conditions. It cannot be argued, however, that the implementation has been comprehensive or planned. Instead, the development and testing of these interventions has been led by researchers, with very limited translation into routine practice. One of the clinical areas to receive the greatest attention has been urology, not least because of the growing incidence of prostate cancer and the uncertainty pertaining to both its detection and treatment. The decision in the UK to implement a programme of informed choice in PSA testing, The Prostate Cancer Risk Management Programme (PCRMP), instead of a prostate cancer screening programme, as in, for instance, the USA, led directly to the production of two PDSTs: one paper based, [13] and the other a web-based PDST, Prosdex (Fig. 1) [14]. Treatment, both of prostate cancer and Benign Prostatic Hyperplasia (BPH), has also been the subject of PDST programmes. The Picker Institute, for instance, recently reported on a programme to help the decision-making of patients with either BPH or early prostate cancer, and found that both staff and patients valued the programme; moreover, men’s knowledge about their condition and the implications of treatment improved after the intervention [15].

3. Mechanisms of support or barriers to shared decision-making in the system (i) Financial incentives Targeted financial incentives play an increasingly important part in the funding structure of the UK NHS, particu-

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larly in primary care following the advent of the new GP contract in 2003 [16]. A key part of this contract is the ‘Quality and Outcomes Framework (QOF),’ in which incentives are linked to performance indicators across a range of domains, clinical and nonclinical, and especially so in chronic diseases such as diabetes [17]. Financial rewards are also awarded to practices for the completion and discussion of patient experience questionnaires, filled in by patients after consultations with clinicians. These questionnaires do not, however, focus on shared decision-making [18], and there is a broader, and important, question of whether a remuneration system based on targeted financial incentives leads to improved shared decision-making in healthcare systems? Does the contrary, in fact, hold true? Whilst focusing on specific ‘targets’, will clinicians neglect the ‘softer,’ less easily-quantifiable aspects of the consultation such as shared decision-making? [19]

(ii) Information Technology Effective shared decision-making is clearly dependent on information being available to both clinician and patient. Hopes were therefore raised in the UK in 2002 by the launch of the h3.3 billion National Programme for IT, one of the largest ever public-sector investment projects in Europe [20]. Amidst its ambitious goals was the creation of a ‘spine,’ which would hold an electronic record for all English patients, accessible from all NHS organisations and by patients themselves. In addition, a parallel set of information initiatives was launched, including the National Electronic Library for Health, mainly aimed at health professionals [21], and NHS Direct Online, www.nhsdirect.nhs.uk, a health information website for patients which also has an interactive ‘self-help’ guide to give advice about common symptoms [22]. Unfortunately, however, this informatics revolution in the UK has encountered a number of setbacks, mostly related to delays in the delivery of IT products and concerns from clinicians that they have been insufficiently con-

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Fig. 1. Prosdex, a web-based PSA decision explorer: www.prosdex.com. Developed by Cardiff University for the UK Prostate Cancer Risk Management Programme (PCRMP); funded by Cancer Research UK and the UK NHS Cancer Screening Programme.

sulted in the process [23]. It is hoped that this will not lead to clinician and patient disaffection with technological innovations designed to encourage shared decision-making, or indeed with promotion of shared decision-making itself.

4. Influence of patients’ rights on shared decisionmaking implementation Arguably the UK is fertile ground for shared decision-making as its legislative framework is historically grounded in libertarian values. The Data Protection Act 1998, [24] and The Freedom of Information Act 2000, [25] for instance, have helped to entrench patients’ rights in terms of their personal data. There is also an active public debate on ethics led by organisations such as The Nuffield Council on Bioethics, [26] and the difficult questions that arise from such discussions have, in fact, helped to develop SDM in the UK. Marteau, for example, developed the concept, and a measure of, informed

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choice for pregnant women considering tests for Down’s Syndrome, in part due to concerns about the dilemma facing such women [27]. In terms of protecting patients’ rights with respect to their doctors, the General Medical Council has the responsibility of regulating doctors in the UK. Currently it is facing strong pressure to reform and become more accountable to the public, and this is reflected in its recently revised guidance to doctors, Good Medical Practice, in which, notably, shared decision-making is highlighted: ‘to communicate effectively you must share with patients, in a way they can understand, the information they want or need to know about their condition, its likely progression, and the treatment options available to them, including associated risks and uncertainties [28]’. Finally, patient choice has developed over the last few years to become a policy priority across the UK political spectrum [29]. Partly to encourage efficiency through market-based reforms, and partly to maintain public support for the NHS, the DoH in

England brought out proposals for patients, in consultation with their GPs, to have the right to choose between different providers of specialist healthcare services, using bespoke computer software [30,31]. In contrast, other countries in the UK have maintained their dirigiste, centralised approach to healthcare planning [32], lending the potential, over the next few years, for potentially fruitful comparative research.

5. Institutions which help to transfer shared decision-making into practice Apart from central government and its affiliated bodies, the sector which has proven to be most open to, and willing to fund, interventions to promote shared decision making in the UK has been the charitable sector. In a sense this not a surprise, as these charities are directly accountable to the fundraising public. Cancer Research UK, for instance, is funding work into prostate

Z.a¨rztl. Fortbild. Qual.Gesundh.wes. 101 (2007) 247–253 www.elsevier.de/zaefq

ARTICLE IN PRESS cancer and breast cancer decision aids [14], and Diabetes UK has been involved in work on presenting risk information to patients with diabetes, a project funded by the British Medical Journal publishing group [33]. The involvement of the BMJ group reflects the growing interest of the private sector in initiatives to promote shared decision-making in the UK. Moreover, there is interest internationally in this opening UK market, as shown by the establishment in the UK of a division of Health Dialog, a USA-based shared decision-making organisation that is specifically interested in health coaching [34]. Undoubtedly, charities and other private organisations can make a valuable contribution to the translation of shared decision-making into practice. There is a risk, however, that overreliance on these organisations may result in shared decision-making implementation becoming fragmented, according to the respective interests of these organisations. It should be stressed, however, that improving shared decision-making more generally in UK healthcare is not the responsi-

bility of sector.

the

private/charitable

6. Present shared decision-making research and research funding on the national level Shared Decision-Making research in the UK has tended to focus on interventions, principally PDSTs, [35–38] and the literature base was recently reviewed in a report by the Picker Institute Europe on patient-focused interventions [39]. Significantly, a set of quality-assurance criteria for PDSTs was established in 2006 by the IPDAS collaboration, a Delphi consensus process led by Elwyn & O’Connor [40]. The research base is weaker, however, with respect to health-economic analyses of these PDSTs, notwithstanding the rigorous cost-effectiveness analyses seen in individual trials [41,42]. Apart from patient-focused interventions, there has also been some research on educational interventions, specifically for clinicians, to promote shared decisionmaking; and, as in other countries,

the results have been largely positive in achieving involvement [43,44] Fig. 2. This survey does not argue against the importance of evaluating shared decision-making interventions. Indeed, we call for more such research. However, there is a risk that other, more fundamental, research on shared decisionmaking will be neglected. Charles and Murray, for instance, recently argued for the need to re-examine the applicability of widely-accepted models of shared decision-making to different healthcare contexts [45].

7. Future perspectives of shared decision-making in the country This survey has demonstrated that shared decision-making implementation in the UK works best when focused and targeted at areas of specific clinical uncertainties. This trend is likely to continue, as seen with the current interest in implementing shared decision-making in: abdominal aortic aneurysm screening, a condition for which elective surgery is safer than

Fig. 2. Informedhealthchoice www.informedhealthchoice.com is a research group at Cardiff University, UK, that develops and evaluates Patient Decision Support Technologies. Z.a¨rztl. Fortbild. Qual.Gesundh.wes. 101 (2007) 247–253 www.elsevier.de/zaefq

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ARTICLE IN PRESS emergency surgery, but carries a risk of death; and Human Papilloma Virus immunisation for girls, where parents of girls 9 to 10 year old are confronted by a decision that relates to the future sexual behaviour of their daughters. The wider extension of shared decision-making into UK clinical practice will be dependent on education, both at undergraduate and postgraduate level for clinicians, and experience and demand from patients [46,47]. Leadership will also be necessary, and here the Royal Colleges can play a vital role, in association with the regulatory authorities. In terms of research, the future will undoubtedly see further evaluations of shared decision-making interventions, principally PDSTs. It is hoped that these evaluations will not only consider their clinical effectiveness, but will also assess their benefits in terms of health-economics benefits. Policymakers will require such evidence before shared decision-making can become more fully implemented.

Competing interests RE, AE and GE are actively involved in the development and evaluation of Patient Decision Support Technologies and instigated the establishment of informedhealthchoice.com. AC is Chief Executive of Picker Institute Europe.

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Curriculum A¨rztliches Qualita¨tsmanagement: 4. Auflage 2007

Magazin

hat dies zu einer Vielzahl von sozialgesetzlichen Vorschriften zu Qualita¨tsmanagement und Qualita¨tssicherung gefu¨hrt. Diese bedu¨rfen dringend einer Zusammenfu¨hrung und Verschlankung im Rahmen eines umfassenden Qualita¨tsmanagementkonzepts fu¨r das Gesundheitswesen, das den Leistungserbringern im Gesundheitswesen die erforderlichen Freira¨ume zur Qualita¨tsweiterentwicklung und kontinuierlichen Verbesserung aus Eigeninitiative wiedergibt. Festzuhalten ist außerdem, dass in Anbetracht der begrenzten Ressourcen im GKV-System der Patient mehr Eigenverantwortung wird u¨bernehmen mu¨ssen. Fu¨r die A¨rzteschaft bedeutet dies, dass Verfahren des Qualita¨tsmanagements und der Qualita¨tssicherung noch sta¨rker als bisher unter dem Blickwinkel des Benefits fu¨r den Patienten betrachtet werden mu¨ssen. Das Curriculum Qualita¨tssicherung fasst die ’’ in der a¨rztlichen Aus-, Weiter- und Fortbildung von Studenten und A¨rzten zu beachtenden Aspekte einer wissenschaftlich begru¨ndeten und praktisch anwendbaren Qualita¨tssicherung zusammen. Der erfolgreich abgeschlossene Kurs soll die Absolventen dazu befa¨higen, Qualita¨tsmanagement mit spezifischen a¨rztlichen Inhalten im Versorgungsalltag zu implementieren. A¨rztekammern, Kassena¨rztlichen Vereinigungen und Kassena¨rztlicher Bundesvereinigung als Ko¨rperschaften o¨ffentlichen Rechts sowie der Bundesa¨rztekammer als Arbeitsgemeinschaft der deutschen A¨rztekammern obliegt auf unterschiedlicher gesetzlicher Grundlage die Sicherung der Qualita¨t der a¨rztlichen Berufsausu¨bung. Die dabei auftretenden medizi-

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nischen und methodischen Probleme fu¨r die a¨rztliche Selbstverwaltung ko¨nnen nur in enger Zusammenarbeit mit den wissenschaftlich-medizinischen Fachgesellschaften und den a¨rztlichen Berufsverba¨nden gelo¨st werden. Durch die Zusammenarbeit von Wissenschaft und Praxis kann die medizinische Versorgung der Patienten in Praxis und Krankenhaus noch besser und sicherer werden. Die gemeinsame Herausgabe eines Werkes u¨ber das a¨rztliche Qualita¨tsmanagement als Leitlinie fu¨r die Aus-, Weiter- und Fortbildung ist daher ein konsequenter Schritt der a¨rztlichen Spitzenorganisationen in Deutschland, um trotz knapper Ressourcen auch in Zukunft eine den medizinisch-wissenschaftlichen Erkenntnissen entsprechende individuelle Versorgung der Patienten zu sichern.

’’

Die U¨bernahme von Verantwortung fu¨r die Qualita¨t und Sicherheit der Patientenversorgung za¨hlt zum professionellen a¨rztlichen Selbstversta¨ndnis. Als ausdru¨ckliche Verpflichtung fu¨r den Arzt wurde die Qualita¨tssicherung 1988 in der Berufsordnung fu¨r A¨rzte verankert. Nachdem bereits durch die vom Deutschen A¨rztetag 1992 verabschiedete (Muster-)Weiterbildungsordnung verlangt wurde, dass Facha¨rzte Kenntnisse und Erfahrungen auf dem Gebiet der Qualita¨tssicherung in ihrem Fachgebiet nachweisen mu¨ssen, ist im Zuge der letzten Novellierung der (Muster-)Weiterbildungsordnung im Jahr 2003 eine Zusatzbezeichnung A¨rztliches Qualita¨tsmanagement ’’ eingefu¨hrt worden. Auch in der Approbationsordnung fu¨r A¨rzte ist die Vermittlung von Kenntnissen in der Qualita¨tssicherung vorgeschrieben. In den Heilberufsgesetzen der Bundesla¨nder ist die Qualita¨tssicherung als Aufgabe der A¨rztekammern festgelegt. In Anbetracht des in den letzten Jahren gestiegenen Wirtschaftlichkeits- und Wettbewerbsdruck im Gesundheitswesen haben Qualita¨tssicherung und Qualita¨tsmanagement in der medizinischen Versorgung ein starkes o¨ffentliches Interesse erlangt. Zahlreiche von der A¨rzteschaft entwickelte Initiativen zur Qualita¨tssicherung und Qualita¨tsmanagement wurden zwischenzeitlich vom Gesetzgeber aufgegriffen und in sozialgesetzliche Vorschriften und Richtlinien u¨berfu¨hrt, teilweise leider in der zu stark vereinfachenden Erwartung, durch Qualita¨tskontrollen Wirtschaftlichkeits- und Effizienzreserven im Gesundheitswesen heben zu ko¨nnen. Im Ergebnis

risk communication aids in general practice. Fam Pract 2004;21:337–46. [45] Murray E, Charles C, Gafni A. Shared decision-making in primary care: Tailoring the Charles et al. model to fit the context of general practice. Pat Educ Couns 2006;62:205–11. [46] Edwards A, Elwyn G. Developing professional ability to involve patients in their care: pull or push? Quality Health Care 2001;10:129–34. [47] Longo MF, Cohen DR, Hood K, Edwards A, Robling M, Elwyn G, et al. Involving patients in primary care consultations: assessing preferences using Discrete Choice Experiments. BJGP 2006;56:35–42.

Prof. Dr. Dr. h. c. J.-D. Hoppe Pra¨sident der Bundesa¨rztekammer und des Deutschen A¨rztetages Dr. A. Ko¨hler Vorstandsvorsitzender der Kassena¨rztlichen Bundesvereinigung Prof. Dr. A. Enke Pra¨sident der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften Das Curriculum kann herunter geladen werden unter http://www.bundesaerztekammer.de/page. asp?his=1.120.1116.4714

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