Embedding Education into Diabetes Practice (Frontiers in Diabetes)

Embedding Education into Diabetes Practice

Frontiers in Diabetes Vol. 18

Series Editors

M. Porta Turin F.M. Matschinsky

Philadelphia, Pa.

Embedding Education into Diabetes Practice

Volume Editors

M. Porta V. Miselli M. Trento V. Jörgens

Turin Scandiano Turin Düsseldorf

29 figures, 2 in color, and 21 tables, 2005

Basel · Freiburg · Paris · London · New York · Bangalore · Bangkok · Singapore · Tokyo · Sydney

Frontiers in Diabetes Founded 1981 by M. Belfiore, Catania

Massimo Porta, MD, PhD

Valerio Miselli, MD

Department of Internal Medicine, University of Turin, Turin

Diabetes Unit, Hospital of Scandiano, Scandiano

Marina Trento, MD

Viktor Jörgens, MD

Department of Internal Medicine, University of Turin, Turin

European Association of the Study of Diabetes, Düsseldorf

Bibliographic Indices. This publication is listed in bibliographic services, including Current Contents® and Index Medicus. Drug Dosage. The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any change in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. © Copyright 2005 by S. Karger AG, P.O. Box, CH–4009 Basel (Switzerland) www.karger.com Printed in Switzerland on acid-free paper by Reinhardt Druck, Basel ISSN 0251–5342 ISBN 3–8055–7961–6

Contents

VII Preface 1 Therapeutic Patient Education: From Classroom to Life. Embedding Education and Thoughts about Darwin Assal, J.-P. (Geneva) 13 The Struggle for Life. Past, Present and Future of Diabetes Education in Europe Jörgens, V. (Düsseldorf) 23 Methodology and Therapeutic Education Miselli, V.; Accorsi, P. (Scandiano) 40 The Diabetes Education Study Group of the EASD and Its Activities to Improve the Education of People with Diabetes Maldonato, A. (Rome) 51 Integration of Diabetes Education in Type 2 Diabetes Care Rutten, G. (Utrecht) 62 Group Education for Type 2 Diabetes. The Minneapolis Experience Franz, M.J. (Minneapolis, Minn.) 70 Structured Treatment and Teaching Programmes for Patients with Diabetes mellitus and Hypertension in Germany Gruesser, M.; Jörgens, V. (Düsseldorf) 83 Impact of Education on the Quality of Diabetes Care in Germany Müller, U.A.; Sämann, A.; Kloos, C. (Jena); Schiel, R. (Heringsdorf)

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97 Learning, Health Behavior and Quality of Life Modifications over 5 Years in People with Type 2 Diabetes Managed by Group Care Trento, M.; Passera, P.; Borgo, E.; Bajardi, M.; Cavallo, F.; Porta, M. (Turin) 108 Rationale, Design and Preliminary Results of ROMEO (Rethink Organization to Improve Education and Outcomes). A Randomized Controlled Multicenter Trial of Group Care in the Management of Type 2 Diabetes Porta, M.; Trento, M. (Turin) 117 A Cost Effectiveness Analysis of Group Care in Type 2 and Type 1 Diabetes Bondonio, P.; Trento, M.; Porta, M. (Turin) 132 Evidence-Based Patient Education in Diabetes and Beyond – Application to Other Chronic Diseases. From Obedience Training to Informed Decision Making Mühlhauser, I. (Hamburg) 147 Author Index 148 Subject Index

Contents

VI

Preface

Patient education has long been the Cinderella of diabetes care, often considered non-scientific, non-evidence-based, non-standardized: in two words, almost non-serious. Until recently, there may have been a number of good reasons for thinking so, basically because the evidence gathered on the results of education was very limited or anecdotal and that which was available did not always support its efficacy in terms of favorable patient outcome. The situation has evolved over the past few years, though. Randomized controlled clinical trials of old and new approaches have been completed and, most importantly, outcomes have been re-defined not only in terms of clinical results but also of patient-oriented indicators such as quality of life and the ability to cope with living with a chronic disease. This volume collects manuscripts based upon the proceedings of a Postgraduate Course of the European Association for the Study of Diabetes, held in Turin in spring 2004. On that occasion, some of the best-known researchers in the field shared and discussed their experience with a captive audience of very involved parties. The initial chapters cover the rationale, history, methodologies and some of the international initiatives that contributed to making education an integral part of modern diabetes care. They are followed by updated reports of results of clinical trials and/or practical experiences carried out in North America, the Netherlands, Germany and Italy. Descriptions are given of the methods used in general practice and hospital settings to train patients on, among others, nutrition, self-care and how to prevent the occurrence of complications. Studies on the economic impact of patient education have so far been conspicuously missing and the volume includes a cost-efficacy

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analysis of the Group Care approach developed in Italy. The last chapter takes a look into the future, describing how similar principles can be embedded successfully in the care of people suffering from chronic diseases other than diabetes. What emerges is clearly that many old caveats may no longer be justified. Patient education, or clinical pedagogy, is becoming a discipline in its own right. It requires trained personnel to plan and run it, with precious little space left for improvisation. Operators should remember that they are not addressing children or medical students (both of which often receive the same treatment), but grown-ups. Adults should not be spoken down to, as they want to be shown why they are being taught what and need to be actively involved in the learning process. Once the patronizing has been got rid of, the results can be obtained and measured, just as for any other form of clinical intervention. Cinderella has come of age and the prince is now looking for a matching shoe. Let’s see how the story unfolds. Massimo Porta

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 1–12

Therapeutic Patient Education: From Classroom to Life Embedding Education and Thoughts about Darwin

Jean-Philippe Assal Division of Therapeutic Education for Chronic Diseases Hospital Geneva, Collaborating Centre Geneva, Geneva, Switzerland

Abstract Therapeutic education of patients plays an immense role in the efficacy of treatments. Thanks to sound psychosocial and educational approaches to patients, there is a significant decrease of acute episodes of many chronic diseases. But these proofs often seem weak in the presence of the disbelief the many clinicians have: how can therapeutic patient education compete with pharmacological agents and evidence-proved medicine? To compare both is a mistake many clinicians make. One is bound to biology, the other deals with the coping process of the person who suffers from the disease and has to learn how to manage the treatment. But this disbelief of many health care providers has had and continues to have deleterious effects on the implementation of patient therapeutic education. This paper tries to provide some hints on how to help and follow patients suffering from chronic conditions. Copyright © 2005 S. Karger AG, Basel

Educational Darwinism

When I was asked to give a lecture about therapeutic education of patients I had just finished reading a book about the life of Charles Darwin. This man had not followed a classical training in the science of nature; he took the opportunity of being ‘the scientist’ of a ship sent around the world. During this voyage, which lasted for 3 years, each event was the cause of astonishment. He noted carefully all his observations, he took many samples, noted many questions that should be clarified later. Although his approach was intuitive and descriptive, he showed a unique sense of observation for the nature of flowers and animals which progressively led him to the concept of evolution. His ideas were nevertheless blocked by the Anglican Church. The strengths of observation

were confronted by the everlasting beliefs of the church which puts man as a human being directly created by God. In this sense, this label ‘Educational Darwinism’ is a kind of metaphor illustrating two opposite aspects: (1) an illustration of an intuitive process which already announced a true scientific approach; (2) the disbelief of a given establishment (the church as well as universities) with its strong effect in blocking the widespread distribution of an important observation and discovery. Therapeutic education of patients plays an immense role in the efficacy of treatments. Thanks to sound psychosocial and educational approaches to patients there is a significant decrease of acute episodes in many chronic diseases such as diabetes, bronchial asthma, arterial hypertension and other cardiovascular disorders. But, these proofs often seem weak in the presence of the disbelief the many clinicians have: how can therapeutic patient education compete with pharmacological agents and evidence-proved medicine? To compare both is a mistake many clinicians do. One is bound to biology, the other deals with the coping process of the person who suffers from the disease and has to learn how to manage the treatment. However, this disbelief of many health care providers has had and continues to have deleterious effects on the implementation of patient therapeutic education. Despite a theoretical interest in patient education, this complementary approach to treatment is far from implemented in medical practice. The general title of the book mentions ‘embedding education’. To embed means to fix, even more, to fix firmly and deeply, in our case to fix an idea in the mind of the patient. Embedding education… I wonder if the concept of embedding is not too strong. Patient education relies not only on a content which has to be understood but also on a flexible and supportive attitude that both patient and the health care provider have to promote and maintain. Diabetes in practice is a disease which has to be biologically treated and an illness which is perceived psychologically by the patient; the dimension of illness is tightly bound to the patient’s own experience. Table 1 gives a series of terms allowing comparison between disease and illness in different languages. The distinction between disease and illness is important to master. Health care delivery is quite different among these two dimensions. In a hospital setting, such as in intensive care or in the emergency unit, the investment to treat the disease is at its peak whereas for the long-term follow-up of several chronic diseases health care providers have to invest much in the field psychosocial support of the patient and so have to deal mainly with the dimension of the illness. This is often the case in chronic alcoholism, chronic obstructive pulmonary disease, and a whole variety of neurological diseases. Whenever health care providers want to reach the level of integrated care, they will be forced to manage the most simultaneously possible and with the same level of attention

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Table 1. Comparison between disease and illness and their expression in different languages Language

Disease

Illness

English

Biomedical dimension Physiopathology Epidemiology, statistics Maladie Krankheit Malattia Enfermedad

Patient’s perception Patient’s experience Health beliefs Être malade Krank sein Stare male Estoy enferma

French German Italian Spanish

the disease and the illness of each patient. Many diabetologists have been aware of these two dimensions of care and have opened a dual way for therapy which has become a model medicine in general and a specific approach for patients with chronic diseases (table 1). Schematically, one could represent this dipole between disease and illness by three classical medical situations: (a) acute medical care in a hospital setting; (b) chronic, long-term care; (c) patient associations and their role in health care delivery. This distinction is not only schematic, it underlines the mode of functioning of doctors. The greater the skills acquired in the field of disease (application of new diagnostic technology, and a rational approach to therapy following the recommendations of evidence based medicine) the lesser there will be space given to the illness, in other terms for the coping process of the patient. The reverse is also true: physicians who are mainly preoccupied by the psychosocial well-being of the patient and his/her family do not intervene as rapidly as hoped when one biomedical problem has to be solved. Again, quality of long-term care firstly requires from the health care provider first of all sound training at the biomedical level as well as training and supervision into the fields of therapeutic patient education, psychosocial approach and support in the field of coping strategies in order to motivate the patient to better manage his or her disease.

Acute and Chronic Care

Not enough emphasis has been put at the level of medical nursing schools on the difference between these two dimensions of care. The difference is so great that some consider acute and chronic care as two totally different specialties. Table 2 enumerates some of the differences.

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Table 2. Differences between acute and long-term care Acute care

Long-term care

Doctor controls directly No place for error

Patient controls Patient’s error ⫽ favorable learning opportunity Patient needs therapeutic education Intuitive education with peers Few learning opportunities Psychosocial and educational model including the biomedical one ⬎80% of cases Resistance of the medical institution Cost rather limited

Patient requires information Education at medical school Many learning opportunities Biomedical model ⬍10% of cases Funding easy Medical cost elevated

In acute situations, the best doctor is the most efficient, the fastest diagnostician and the quickest worker, who shortens the hospital stay most. This phase of training plays a great role in establishing the initial medical identity: identification with a group of medical colleagues ready to fight (the term is not exaggerated) against illness, with selfless devotion day and night at the cost of great effort, often sacrificing 24–36 h on end to ensure proper medical surveillance over complicated cases, living the life of a multi-disciplinary team, ‘always ready’, witnesses to and connoisseurs of the latest in pathophysiological knowledge and the ultimate in therapeutic facts. This initial medical identity is followed by biomedical understanding and mastery of therapeutic techniques, not without considerable physical stress. It is an admirable, efficient, technical, scientific identity that celebrates modern medicine with power over illness through the direct control of the physician. He is the healer. This medicine also has, of course, its limitations but when treatment fails, the doctor’s professional identity will protect him from feeling guilty with, perhaps, an ‘I did everything that could be done’ attitude. However, hospitalized patients account for less than 10% of all those who need treatment.

Crisis Situation

The concept of ‘crisis’ can be defined as a patient’s pressing demand for relief from a sudden, stressful discomfort, e.g. chest or abdominal pain. The patient who presents these symptoms triggers a chain of actions programmed to establish a diagnosis in the physician. Biological data lead to a decision through

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the circuit of differential diagnosis: Is it a vascular condition, an infection? Is the pain due to malignancy, or to a spasm, etc? Each element constitutes part of a decision tree where the specificity and accuracy of every biological examination leads to a diagnosis with a certain degree of reliability. The establishment of an organic diagnosis is intimately related to the degree of biomedical experience. Such experience allows the doctor to work increasingly rapidly, to gain time to initiate the specific treatment. In a crisis situation, speed of action is often decisive, as for example in myocardial infarction, where mortality is in direct proportion to the time lapsed between the first sign of chest pain and the beginning of treatment. In an emergency situation the cardinal points ‘acute illness, physician, treatment, patient’ could be schematically described as follows:

Acute Illness

• • • • • •

The signs and symptoms are evident and of sudden onset The crisis presents an important risk, often fatal There is urgent need for rapid diagnosis and quick treatment The approach is of a reductionist type; only the essential is taken care of It is a model of early medical training Represents less than 10% of all medical consultations

• • • • • • • • • •

The physician Waits; is ready to act in case of emergency Is conscious of his professional efficacy Concentrates on the very specific aspects of the crisis or emergency Personally directs the diagnosis, the treatment and the follow-up Works within a multi-disciplinary team Manages the emergency through a biotechnological type of approach Needs a patient who accepts the treatment, a ‘passive’ patient Once the crisis is over, has no ties with the patient any more Often overlooks the psychological dimension of the patient Often does not know the identity of his patient

• • • •

The treatment Is codified, often with a precise algorithm Requires hourly and/or daily evaluation Is of short duration Is directly related to the emergency

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The patient • Suffers directly • Needs immediate relief • Submits to treatment, ‘collaborates’ passively • Is thankful and admiring towards the treating personnel Let us consider the physician’s professional path. After the above-mentioned initial period of activity, two paths may be open to him: he either continues his hospital work or he goes into private practice, opens an office and offers his services to deal with health problems of an out-patient population. The latter path is more common. Will his early training, his first professional identity, allow him to be as effective as he was in the hospital atmosphere which he has left? This is not so sure. Long-Term Follow-Up of Patients

An important part of out-of-hospital activity is the long-term care of patients suffering from chronic illnesses such as cardiovascular diseases (arterial hypertension, angina, claudication, cardiac insufficiency), metabolic and nutritional diseases (diabetes, dyslypidemia, high blood urea, overweight), rheumatological conditions (arthritis, backache, rheumatism), neurological diseases (cerebral arteriosclerosis, Alzheimer’s disease, epilepsy, Parkinson’s disease), pulmonary conditions (chronic bronchitis, obstructive syndromes, bronchial asthma), gastrointestinal diseases (gastroduodenal ulcer, colonic conditions, cholecystopathies, hepatitis). Each one of these conditions has probably been seen within the hospital in an acute stage, such as pulmonary edema, diabetic coma, herniated disc, epileptic attack, acute asthma, gastrointestinal hemorrhage, jaundice, etc. There the physician will have learned to treat the emergency and to have ‘cured’ it. But he will not have learned to treat these illnesses on a long-term basis, most of which cannot be cured but can well be kept under control. Although these diseases are different, they share certain common characteristics: Chronic Illness

• • • • • •

Is often incurable Is silent outside acute exacerbations If there is pain, it tends to be persistent Often there is little relationship between complaints and biological findings Its progress is unpredictable May be related to the patient’s lifestyle

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• • • • • • • • • • • •

The treatment Is important for survival and/or daily comfort Has variable effects Often necessitates the training of the patient to ensure its management Implies daily discipline Usually takes the patient’s time Often interferes with social life The Patient May not be cured of the illness, but can control it Must manage the treatment according to various factors related to his private life Outside acute episodes, his illness is usually silent As soon as surveillance weakens the disease relapses Must be trained to act rapidly in case of crisis Must accept a certain degree of loss of his integrity

The physician Prescribes the treatment but only indirectly controls the illness Must train his patient for treatment; must share his medical power Must manage the illness often in its silent phase Must urgently treat the acute episodes Must be vigilant to detect late complications Must ensure psychological and social support Must be prepared to accept a new medical identity The medical identity associated with the treatment of acute illness imprisons the physician often in a stereotyped functional mode and prevents him from being fully effective in his new role for long-term care. He is bound by biomedical and pharmacological specificities and finds it difficult to adapt himself to the requirements of long follow-up of these chronic patients. It is not easy to follow-up a patient over many months or years. The difficulty lies less in diagnostic or therapeutic problems than in the vast area of patientdoctor relationships, in the organization of time and in the process of consultations. Very little attention has been focused on the dynamics of long-term chronic care, as though the initial training of the physician, based on crisis management, was enough to ensure effective follow-up. A physician’s identity, linked to treating acute cases, interferes with his capacity to train his chronic patient for crisis management, as if by training the patient the physician loses his medical role of healer. One might even deduce that to ensure good follow-up in chronic illness the physician is in need of occasional crises to comfort himself in his identity as a care provider. Subjects presented in continuing education symposia of the usual

• • • • • • •

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type illustrate this situation very well; they deal with patho-physiology, pharmacokinetics, secondary effects, rapid diagnosis, treatment of recurrence, all fundamental elements in medicine to understand disease, but which do not help the doctor understand the patient better and look after his chronic condition. It seems urgently necessary to develop follow-up training programmes for physicians at all levels, from medical school to continuing education. Several themes must be particularly covered if follow-up in chronic illness is to be efficient and effective: A series of consultations with alternative objectives (table 3) One possible approach is what we call ‘consultation with alternative objectives’. Such a consultation should provide better contact with the patient as a whole and help the physician pass from the classical model of medical inventorying, to the model of complete patient profile enriched with psychosocial dimensions. To ensure better concordance between the patient’s long-term treatment and his quality of life it is indispensable that the above-mentioned dimensions be taken into consideration. This kind of follow-up should allow the doctor to personally explore the various sub-systems on which each individual depends, to utilize the resulting information for better treatment and, consequently, to ensure the delivery of care that respects the needs of the sick person. In this manner the physician can integrate the various factors directly or indirectly involved in the management of the illness. Each individual ‘person’ must be considered as the most ‘complex’ element in the organic sub-system and the most ‘simple’ in the social system (fig. 1). Consultation with alternative objectives consists of systematically taking an objective in the organic sub-system and an alternative one in the psychosocial sub-system. A chronic disease has important repercussions not only at the somatic level but also at the psychological, family, professional and social levels. Interference among these four sub-systems often presents difficulties in the quality of long-term care in chronic illness... ‘I cannot accept these restrictions due to my bronchial asthma’, ‘My spouse cannot understand my handicap... ’, ‘When I do not report to work because of acute asthma, my colleagues think I am putting it on... ’, ‘I stay away from friends as I cannot stand their smoking...’, ‘For me this sickness is not a lung trouble but a social loneliness problem... ’. In medical practice such feelings are expressed only when the doctor encourages his patient to speak up. One way of dealing with all these problems is shown in table 3, where communication with the patient is organized around the different sub-systems. In an initially organocentric approach the physician first explains to the patient his biomedical profile, the steps that he will take to organize the treatment and how he will assess the effects. In an initially psychosocial approach, the

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Table 3. Integrating the subsystems and planning objectives for long-term follow-up Biomedical subsystem (8 themes) 1 Carrying out the medical checkup 2 Lab work, X-rays 3 Explaining the results to the patient 4 Discussing the reason of treatment 5 Asking the patient if he experienced difficulties in following the treatment and discussing the possible solutions if necessary 6 Evaluating the effect of the treatment with the patient 7 Explaining how the doctor will evaluate the effect of treatment 8 Explaining what the patient can evaluate Psychological subsystem (6 themes) 9 Discussing with patient how he copes with the disease (Coping) 10 How does the patient find the necessary energy to follow the treatment day after day? (Empowerment) 11 How does he react to his diagnosis? 12 How does he react to the kind of treatment he is receiving? Would he have other proposals? (Health beliefs) 13 Could some hopes and fears be described? 14 For the management of the disease, how does the patient define his role and that of the healthcare provider? (locus of control) Family and/or the next important person subsystem (3 themes) 15 How is the family, or the next important person, reacting to the disease? 16 Have they received information or training for the management of the disease? If not, how could it be provided? 17 How do they contribute to the patient’s disease and management? Professional subsystem (3 themes) 18 Who knows about the disease at the place of work? 19 What arrangements have been made, if any, with the employer? 20 How does the disease interfere with the professional activity? Sociocultural subsystem (2 themes) 21 How is the disease and its treatment interfering with social life? 22 What kind of attitude does he think society has when faced with this disease? (Social health beliefs) Therapeutic education (3 themes) 23 How has his therapeutic education been provided? 24 Evaluation of the ability the patient has to face significant situations with his disease in his daily life 25 Which solutions have been chosen for better management of his treatment?

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Universe Nations Nation Culture, Society Profession Family Distribution

Two persons

Person

of subsystems

Nervous syst. Organ, Organs Tissues Cells Nuclei Genes

Fig. 1. Tissues, organs, person, society: from the unity to the whole.

physician might begin by finding out how the patient perceives his illness, what it means to him, how he foresees the organization of the treatment programme, and how he would learn to interpret biological results. To give due weight to these various sub-systems of the individual such an approach cannot be accomplished in just one consultation. A follow-up that integrates these different dimensions can be developed progressively over a series of consultations, at each one of which a new aspect of the illness, and of the treatment, is introduced. Thanks to its dynamic structure, set up in advance between the doctor and the patient, in which each is an active interlocutor, the monotony of consultations is broken and communication maintained. Let us consider these staged consultations. At the initial visit, for example, the physician tries to find out how the patient reacts to his illness, establishes a medical record and takes time to explain to him the measures that will be taken for his treatment. At a second consultation, when the results of the tests are back, the physician explains the results and discusses the manner in which the treatment will be followed at home and how the tests must be interpreted (blood sugar, peak flow values for an asthmatic, prothrombin time if he is on anticoagulants, etc.). Both should then consider the dosage of medication that the patient thinks he should take for this or that situation in daily life. This offers a real educational session for self-directed learning. The patient’s own experience of his illness must also be discussed; this is perhaps the appropriate moment for the patient to write down how, for example, he lives with his illness within the family circle, whether he has had to curtail his social activities due to the requirements of the treatment, or whether any professional problems have arisen.

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At the third consultation, it may sometimes be necessary to take up in further detail the problems of self-controlled treatment, as in diabetes, or the management of symptom-free phases, as in hypertension. Further consultations should continue to enlarge upon the various aspects not only of the disease, but particularly of the illness (table 1). Integrated long-term follow-up should therefore be quite creative whilst following the objectives described in the various sub-systems. It is only through such an approach that monotony and ‘burn-out’ of patients, and their healthcare providers, can be avoided. Conclusions

Taking care of a patient with chronic illness implies a profound modification in the physician’s direct relationship with the illness. It becomes necessary to complete this fundamental dimension with another role, quite complex for a doctor, that of helping the patient to manage his treatment on his own, of guiding him to become independent and responsible. Even though many physicians can master these two different therapeutic roles, almost nothing is taught in early as well as continuing medical education to prepare the practitioner for the therapeutic demands made by the many problems of long-term treatment and follow-up. The World Health Organisation has recently been interested in the longterm follow-up of patients and is currently preparing several documents which should highlight the size of the problem and propose training models for healthcare providers. It is significant that 80 diseases or conditions are acknowledged as chronic by WHO where specific therapeutic education programmes and new interactive follow-up strategies have been shown to dramatically improve the adherence of patients to their treatment, and to their quality of life. In this perspective diabetes has been, and is, certainly the most studied model in the world of health care delivery. Suggested Reading 1

2

3

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Assal J-P, Golay A, Jacquemet S: Therapeutic patient education: Revisiting the therapeutic approach of long-term follow-up for the 21st century; in Turtle R, Kaneko T, Osato S (eds): Diabetes in the New Millenium. Sydney, The Endocrinology and Diabetic Research Foundation of the University of Sydney, 1999, vol 45, pp 453–464. Assal J-P: Revisiting the approach to treatment of long-term illness: From the acute to the chronic state. A need for educational and managerial skills for long-term follow-up. Patient Education and Counseling 37, 1999, No 2, pp 99–111. World Health Organisation: Regional Office for Europe, Copenhagen. Report of a WHO Working Group. Therapeutic Patient Education. Continuing Education Programmes for Healthcare Providers in the Field of Prevention of Chronic Diseases, 1998. Guilbert J-J: Educational Handbook for Health Personnel, ed 6. Geneva, World Health Organization, 1998, Offset publ No 35.

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Lacroix A, Assal J-Ph: Therapeutic Education of Patients. New Approaches to Chronic Illness, 2nd updated edition. Paris, Editions Maloine, 2003. Charles Darwin: Please consult the web-site: http://www.aboutdarwin.com/.

Prof. Jean-Philippe Assal Foundation for Research and Training in Patient Education, 52 Bd de St-Georges CH–1205 Geneva (Switzerland) Tel. ⫹41 22 321 6630, Fax ⫹41 22 321 6628 E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 13–22

The Struggle for Life Past, Present and Future of Diabetes Education in Europe

Viktor Jörgens European Association for the Study of Diabetes, Düsseldorf, Germany

Abstract Diabetes education has a long history in Europe. The first person to introduce patient education in type 2 diabetes was Apollinaire Bouchardat, in his book ‘Le Diabète Sucré’ (1883). Another key person was Karl Stolte, who introduced insulin dose adjustment for normal eating. Structured education, provided in groups of patients, was introduced in Europe by Jean-Philippe Assal in the late 1970s and was, from there, implemented in numerous places throughout Europe. The most recent convincing study came from the UK, an ambulatory programme called DAFNE. A major achievement of European diabetology has been the training of diabetes educators. As an example, the development and increase in diabetes educators in Germany over the past twenty years is given. This article ends with recommendations for future research in patient education and honors Michael Berger, who was important in promoting not only evidence-based medicine in diabetology, but also the implementation of educational programmes in Germany and further afield. Copyright © 2005 S. Karger AG, Basel

Apollinaire Bouchardat (fig. 1) was the very first diabetologist to emphasise self-testing of the urine for glucose following patient education as a basis of the long-term treatment of diabetes. He wrote: This daily urine test performed by the patient is of tremendous importance. If patients fail to do this they may either remain on a useless dietary regime and will neglect diet in the long run or, even worse, they will not follow the diet when it is really necessary. This daily measurement of glucosuria is like the compass that guides the sailor on unknown oceans [1]. The Bouchardat approach to educate people with type 2 diabetes and obesity, to follow a low-calorie diet until blood-glucose values get better, and to advise more exercise, is still valid today. Weight reduction and increased exercise substantially reduce insulin resistance and are the most effective initial treatments

Fig. 1. Prof. Apollinaire Bouchardat (1806–1886).

of type 2 diabetes known to date. They are also a means of delaying the manifestation of type 2 diabetes. Following the introduction of insulin therapy, all leading diabetologists of the 1920s immediately noticed that patient education in insulin-treated persons with diabetes was an absolutely vital tool to diabetes management. Nevertheless, the first treated patients, such as Leonard Thomson in Toronto, and pioneers of insulin therapy, like E.P. Joslin in Boston, continued the strict and inflexible dietary regimes used in the pre-insulin era. The pioneer of modern insulin therapy, who was for many years forgotten, was Karl Stolte (fig. 2). Professor Karl Stolte was a pediatrician. He held the Chair of Pediatrics at the University of Breslau, today known as Wroclaw in Poland. At the time Breslau was the second largest medical university in Germany and the building where he worked still serves today as a part of the University Clinic of Pediatrics in Wroclaw. When Stolte started to think about an improvement in insulin therapy in diabetic children, the teaching of children and their parents in Germany was of an incredibly low quality. Still, in 1939 a children’s hospital in Berlin gave the

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Fig. 2. Prof. Karl Stolte (1881–1951).

following advice to the parents of the children: Never change the timing of injections or the prescribed meals following the injections of insulin as sweating, hunger, trembling, high pulse rate, problems of vision, etc. may occur. First, eat a slice of sausage or cheese, and if symptoms continue half a slice of bread, half a cup of milk or juice, or perhaps a sugar cube. The diet was extremely rigid and there was no education concerning the adaptation of the preprandial dosage of short-acting insulin based upon urine testing and the desired composition of meals. Strange exchange lists were provided giving amounts of nutrients containing 12 g of carbohydrate, like 230 g of ripe gooseberries and 500 g of unripe gooseberries, or, even worse, 1,250 g of cranberries. Nobody knows what the patients did with these lists and nobody cared about questioning the glycemic effects of the different nutrients.

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Karl Stolte started in his department what he called the ‘Bedarfsgerechte Insulin-Therapie bei freier Kost’, which can be translated to ‘Dose Adjustment for Normal Eating’ – the title of the recent study in the UK. Stolte simply asked the patients to test the preprandial glucosuria and to inject as much insulin as the children desired in order to eat carbohydrates in the mixed meal following the injection. In addition, he gave more preprandial insulin when preprandial urine tests contained higher degrees of glucose. In his memoirs, Stolte describes the case of the diabetic child who saw a birthday cake of a non-diabetic patient on the ward and also wanted to eat a cake for his birthday the next day. On his round, Stolte heard this comment and promised the child to turn up with a cake the following day that all the children with diabetes would be able eat. A young internist, who had just moved from Oscar Minkowski’s department of internal medicine to the department of pediatrics, and who was very much in favor of a very strict diet where sugar containing nutrients in insulin treated patients were totally forbidden, was extremely nervous about this and expected the children to fall into a coma. Stolte discussed with the children how much insulin should be injected before eating and, together with the professor, they had their piece of cake. The tests before the following meal in the evening were astonishingly good and even the conservative young internist was convinced [2]. Stolte evaluated his approach between 1926 and 1936. The mortality rate in the children he took care of dropped from 30 to 10%, liberalizing the diet and improving the education [3]. Stolte’s liberal ideas did not fit into the German approach to medicine in the 1930s. His main opponent, the internist Gerhard Katsch from Greifswald, fought his whole life against what the enemies of Stolte called ‘Free diet in diabetes’. He and other mainstream diabetologists at the time, such as Ferdinand Bertram in West Germany, were against self-adaptation of the insulin dosage based upon urine tests and prescribed a very strict diet and fixed insulin treatment. This happened in many countries for several decades. A pioneer of modern patient education, whose approach was copied in numerous institutions throughout Europe, was Jean-Philippe Assal (fig. 3), who created the first diabetes teaching and treatment unit in Geneva in the late 1970s. No element of his approach was new in pedagogy or medicine; he simply took the decision to structure patient education with the help of specialists and to make it an integral part of the care provided by the health care team. He changed the diabetes unit of the Geneva University to a specialized education unit with a 5-day education and treatment programme. Patients were trained to cope with their diabetes on an ambulatory basis and to take decisions for the adjustment of their treatment on their own [4]. Many young diabetologists from all over Europe participated in the patient courses and returned home telling their heads of department that their units had to change. Many of them, including myself,

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Fig. 3. Jean-Philippe Assal.

succeeded. Not only Jean-Philippe Assal but also many other diabetologists all over Europe, like Michael Berger (fig. 4) and John Alivisatos, recognized that a major shift should be made to improve patient education, including research into patient education in diabetes. This was the reason why the Diabetes Education Study Group of EASD was founded. The first symposium, organized by the Diabetes Education Study Group, took place in Geneva in 1979. In figure 5, the cover of the programme and the programme of a round-table discussion chaired by Michael Berger can be seen. Alivisatos, Ari, Nerup Pirart and myself contributed to discussions on the future of patient education in Europe. DESG continued to organize research-orientated workshops and symposia all over Europe and became a cornerstone of the strength of European diabetology. Karl Stolte introduced Dose Adjustment for Normal Eating (DAFNE). The DAFNE study was published in 2002 in the British Medical Journal [5]. The

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Fig. 4. Michael Berger (1944–2002).

results were very positive and the patients were enthusiastic about participating in the trial. A total of 169 people with diabetes were randomly selected for either immediate DAFNE (n ⫽ 84) or delayed DAFNE (n ⫽ 85). From those selected, 141 completed the course. Follow-ups took place 2 weeks before the courses, 6 months later and 12 months later in both groups. The delayed DAFNE group received the training course after half a year. The results were striking: after 6 months the intervention group who received DAFNE immediately decreased HbA1c by about 1%, whereas the delayed DAFNE group remained in relatively bad metabolic control. Once the waiting group participated in the programme, they achieved the same improved metabolic control. After the 6 months, the group who had first received DAFNE worsened metabolic control a little, but

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Fig. 5. The first symposium of DESG.

there was still a better control compared to the initial value. Not only did the metabolic control improve but the most striking result was the enthusiasm of the patients. Psychological testing for quality of life gave impressive results and was highly significant, especially for more freedom with having a normal eating behavior. One patient commented ‘It has given me a real reason for doing blood tests’. The DAFNE intervention did not, against expectations, significantly increase hypoglycemia. This result was in contrast to the observations of the DCCT in the USA, where better metabolic control was followed by a significant increase in severe hypoglycemia. Comparing the data in DCCT and DAFNE, the difference can only be explained by the fact that DCCT did not have a structured approach to patient education. There was no stringent curriculum in the different centers, which explains the substantial difference in incidence and prevalence of severe hypoglycemia between these centers. In DAFNE there was also no weight gain, similar to numerous studies performed by our Düsseldorf team, which are summarized in the article of M. Gruesser in this volume. The liberalization of the diabetes diet also did not lead to any changes in the lipid profile. Sadly, the DAFNE approach is not yet offered to all patients with type 1 diabetes in the UK,

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whereas in Germany, the only endorsed education programme for disease management programmes in type 1 diabetes is a DAFNE approach.

What to do for Patient Education in 2004 and Beyond

Still today, in the majority of European countries, patient education in diabetes is not accepted by the authorities as a medical act and is, therefore, not paid for in many health care systems. It may help to use the wording ‘therapeutic patient education’ for what is essential in diabetology in order to make authorities understand the tremendous importance of this part of treatment. In many countries, there is still no financial recognition for health care providers i.e. no payment for patient education in diabetes. In countries, which have substantially progressed in the last year, there is a lot of work involved with continuously improving patient education programmes and introducing specific approaches for certain target groups, e.g. immigrants, very old patients and pregnant women with diabetes. Another important area of research into patient education is the large number of people with diabetes and mood disorders, or other psychological problems, e.g. anorexia or bulimia. It is not finally clear if these psychiatric disorders are more frequent in people with diabetes, but nevertheless, they are at least as frequent as in the general population and represent a substantial problem in patient education, which can not be solved by the medical pedagogical/school approach. The European Association for the Study of Diabetes, recognizing the importance of research in this area, gave a group of physicians and psychologists the opportunity to create a study group on diabetes and psychology, which is now very active and holds numerous meetings on research into psychology and diabetes.

Diabetes Educators:The Key for Successful Implementation of Patient Education at the National Level

From the very beginning, education was mainly provided by diabetes educators in Professor Assal’s unit. At the time he started this approach, there were very few places in Europe where specialised personnel provided patient education. As an example, the very first full-time diabetes teaching nurse in Germany was employed 25 years ago in the unit of Michael Berger in Düsseldorf. The first national course in Germany for diabetes educators was held in Düsseldorf under his chairmanship in 1984, under the roof of the German Diabetes Association. Since 1984, the German Diabetes Association has created, in the three month course, 1750 diabetes educators. The so-called diabetes assistants were introduced

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in 1993 by the German Diabetes Association; 3677 of them were formed in a one month course in 35 centers for the Association. They mainly work in type 2 diabetes education in the in- and outpatient setting. This large number of diabetes educators in Germany has been the key for success of improved patient education and care. Diabetes educators not only serve the patients directly by educating them but also have a tremendously important role in training other nurses and health care providers in diabetes care and education, and even in postgraduate training for general practitioners and other physicians. Joslin stated that ‘diabetes is a disease for nurses’. Sadly, it took diabetologists worldwide two decades to understand this message. There are still some places in Europe without specific training for diabetes educators, but in many places Joslin’s message is understood and thousands of educators, teamed with medical doctors, take care of patient education. A major challenge of patient education is the close cooperation between clinical research and health care providers in diabetes care and education. It is an enormous responsibility for diabetes educators to continuously question the scientific content of educational objectives. Mistakes of the past, where for decades wrong information without scientific basis was given to the patients without ever questioning scientifically the truth of the information, must certainly be avoided in the future. Michael Berger gave several examples of such mistakes in his Claude Bernard lecture held in Stockholm in 1995 [6]. He mentioned in his lecture not only the sad history of diet education in diabetes but also the mistakes that were made for decades educating people with diabetes about muscle exercise – a topic to which he personally contributed scientific knowledge. For a long period of time, people on insulin who wanted to perform bicycle exercise, received the advice that they should inject the insulin into the arm or abdomen and not into the exercising leg to avoid hypoglycemia. They were not advised to substantially decrease the insulin dosage. Michael Berger and his co-workers, in very simple straightforward controlled trials, proved that the change of the injection site under this condition was significant but totally irrelevant. He emphasized that patients should be educated to decrease the insulin dosage before rigorous exercise imitating what happens under non-diabetic conditions where insulin secretion is substantially lowered during muscle exercise in order to permit the liver to release large amounts of glucose to be burned in the muscles. Michael Berger wrote in his Claude Bernard article: ‘We must constantly try to incorporate scientific critical thinking into clinical medicine, but on the other hand, we need to confront basic science with clinical questions and real endpoint problems’ [6]. In order to follow Michael Berger’s advice, a substantial amount of research is still needed to achieve an effective and evidence-based therapeutic patient education in diabetes.

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References 1 2 3 4 5 6

Bouchardat A: De la glucosurie ou le diabète sucré et son traitement hygiénique. Paris, Librairie Germer Baillière, 1883. Berger M: Bedarfsgerechte Insulin-Therapie bei freier Kost, der Beitrag von Karl Stolte zur klinischen Diabetologie. Mainz, Kirchheim-Verlag, 1999. Rinke S, Berger M: Die ersten Jahre der Insulintherapie. Munich, Zuckschwerdt, 1983. Lacroix A, Assal J-P: Therapeutic Education of Patients: New Approaches to Chronic Illness, ed 2. Paris, Maloine, 2003. DAFNE: The DAFNE Trial Results. Br Med J 2002;325:746. Berger M: To bridge science and patient care in diabetes. Diabetologia 1996;39:749–757.

Dr. Viktor Jörgens European Association for the Study of Diabetes, Rheindorfer Weg 3 DE–40591 Düsseldorf (Germany), Tel. ⫹49 211 75 84 69 0 Fax ⫹49 211 75 84 69 29, E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 23–39

Methodology and Therapeutic Education Valerio Miselli, Paola Accorsi Diabetes Unit, AUSL Reggio Emilia, Hospital of Scandiano, Scandiano, Italy

Abstract Patient Education in the field of Diabetes Care has been centred for many years on the health care provider’s perspective. Recently more attention has been focused on the learner’s point of view, that is how does a person learn meaningfully. Most guidelines on the management of type 2 diabetes include dietary modification and physical activity goals, but it is important to consider only the type of interventions that can make a long-term difference. Several key models have reasonable evidence for their effectiveness: cognitive behavioral, motivational interview, trans-theoretical model based on the stages of change, behavior change counselling, social learning theory and empowerment, although not all of them have been successfully tested in diabetes care. There are three areas to be considered when looking at the core requirement of an effective lifestyle modification program: the first is that the program must be integrated in routine diabetes care. The second is the philosophical approach adopted by the health care professional. The third is how you do it, focusing on importance, confidence and competence. In order to have people develop the life skills required to prevent complications we must recognize that giving information is not only a pot filling exercise. Collaboration with the patient is essential in setting any education program and initially the view point must be considered. The model of behavior change is described and further concepts of theory and practice are explored, focusing on the concepts ‘learning and taking control’, rather than on ‘education and teaching’. Copyright © 2005 S. Karger AG, Basel

We all recognize the gap between what could be achieved and what is actually achieved in diabetes care. Many people have tried empirically to change this issue. Most activities were centered on the needs of the health care providers. However, more and more awareness has focused on the learner’s perspective – that is, how a person learns meaningfully.

The ‘Physiology of Learning’

Way before educational science was formed and became interested in adult education, the Swiss educator Heinrich Pestalozzi (1746–1827), gave the teachers of his time some recommendations that are still valid in the field of patient education [1]. They can be divided into six steps: 1. Show concrete examples before starting to speak 2. Start with the simplest facts, those closest and best known to the student 3. Progress from simple facts to more complex situations, taking great care not to jump too fast and miss the intermediary steps. To illustrate the notion of continuity, Henrich Pestalozzi took the example of the slowly progressive growth of an organism 4. Progress very slowly in order to avoid unnecessary tiredness or tension in the student 5. Foster personal work and creativity; through this you may encourage independence 6. Make links between what has been understood and practiced in a given field with other sectors of life where they can be of use. In doing so, you help the integration of the student into society Educational development in the field of patient care in diabetes has followed two basic lines from the 1970s to the 1990s [2] (table 1). One is orientation towards content/description of what the patient has to do. The other implies a new relationship between the physician/nurse/dietitian and the patient. Listening to the patient’s way of experiencing his disease, its treatment and promoting his understanding of it, becomes a main task [3]. Most guidelines on the management of type 2 diabetes incorporate dietary modification and physical activity goals, but it is important to consider whether there is any clear evidence that interventions delivered in a real-world context can make a long-term difference. The difficulty is that the vast majority of published psychological/educational interventions seem to take a quick-fix inoculation approach to lifestyle modification. That is, they provide relatively brief interventions that are supposed to change a patient’s lifestyle completely. Unfortunately, we know this does not really work, as most people can stick to a diet for a short time, but then revert back to old habits [4, 5]. To achieve a sustainable change in lifestyle, a step-by-step approach is required. Only a small number of studies have delivered lifestyle modification over an extended period and as part of routine care, yet they do offer us some positive models to follow. Recent publications demonstrating diabetes prevention in Finnish and North American patients with impaired glucose tolerance have demonstrated the potential benefits of lifestyle modification interventions, but there is scope

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Table 1. Development of educational concepts in therapeutic education 1970s

1980s

1990s

Educational orientation

Instruction information

Problemoriented

Active learning

Art of knowledge

Medical facts on diabetes

Individual experience

Communicative competence

Authoritative, prescribing

Role

Health care provider

Well-defined medical problems Group discussions centered around teaching devices Health care provider Instructor

Dialogue

Interactive teacher

Deep learning based on patient’s understanding Qualitative differences in understanding Active reflection in the meeting with the patient

Tutor

for further studies in type 2 diabetes [6, 7]. The United Kingdom Prospective Diabetes Study (UKPDS) of course demonstrated that dietary modification alone was not an effective long-term intervention for maintaining tight glycemic control, but this was also the case for sulphonylurea, metformin and insulin monotherapy [8]. However, it should be noted that in the UKPDS, diet modification was systematically applied only in the early stages, again following the inoculation model of lifestyle modification. Furthermore, and just as importantly, taking medication and monitoring diabetes need to be as much of a focus of behavior change approaches as should diet and exercise, given the well-documented low concordance rates. The literature demonstrates that using a model will result in better outcomes than using nothing to guide educational intervention (at least in adolescence) but this has not been overtly tested in adults with type 2 diabetes [9]. Unfortunately, no head-to-head evaluations exist of different models that we are aware of. However, there are several key models which have accumulated reasonable evidence for their effectiveness (though not necessarily in diabetes): cognitive behavioral [10], motivational interviewing [11], trans-theoretical model (stages of change) [12], behavior change counseling [13], social learning theory [14] and ‘empowerment’ [15]. The first three of these models are quite complex, in that they require a specific set of techniques to be used, depending on the nature of the patient assessed and require a great deal of training to be delivered

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effectively. The last three models share a great deal in terms of their underlying approach to the issue of lifestyle modification. There are three areas to be considered when looking at the core requirements of an effective lifestyle modification programme. The first regards the programme: it must be integrated into routine diabetes care and be an ongoing process. Lifestyle modifications are usually only sustained if they are achieved in a step-by-step process, focusing on one or two steps at a time; thus, they take time and need continued support. The second area involves the philosophical approach adopted by the health care professional. When professionals think they know what is best for patients – telling patients what to do and how to do it, anticipating patients’ barriers to change, attempting to tell patients how to overcome barriers – little change is achieved. In contrast, when professionals engage patients in discussion about their health – what patients want to achieve and how they want to achieve it – when they help patients explore barriers and support patents’ problem-solving efforts, then behavioral changes are likely to be favored. Getting patients engaged, involved and investing in their own diabetes care are the key issues. The third area deals with how to go about this. Focusing on importance, confidence and competence is a good start. Exploring both your own and the patient’s views about the importance of diabetes control and lifestyle issues is essential. If it is not important, then no change will occur. Talking about complications and scaring patients is not a discussion about importance. To convince someone of the need for change, they need to understand how things like glycemic control, blood pressure and dyslipidemia are related to complications and how a different lifestyle may make a difference. It is very important to focus on possible or desirable elements of change. However, wanting is not enough; we need to support patients in turning desires into actions. This is where confidence and competence come in. The historical management of type 2 diabetes starts with lifestyle modification, adding medication where necessary. The current evidence base does not provide clear support for this; furthermore, the historical approach gives other messages to the patient. He can gain the perception that type 2 diabetes is a ‘mild’ condition, especially when accompanied by similar messages coming from health care professionals and the culturally prevalent belief that theirs is not a serious condition. Moreover, the issue of failure on diet and exercise (or oral hypoglycemic therapy) can drive a whole host of negative beliefs about the self to the forefront and contribute to depressed mood, which is a major barrier to behavior change. An individual decision also has to be made as to how long to attempt lifestyle modification before deciding it is not working, as well as how to determine it is not working. Otherwise, there is a risk of diabetes causing macrovascular and

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microvascular damage, or the development of depression, thereby preventing lifestyle change. The beginning of oral therapy does not of course mean the cessation of lifestyle modification. There are a lot of conflicting and confusing explicit and implicit messages within these scenarios – even if just one health care professional is involved – without bringing in the multidisciplinary team. The role of lifestyle modification and the aggressive treatment of glycemic control, hypertension and dyslipidemia in type 2 diabetes are thus not mutually exclusive, but complementary. The likelihood is that increasing numbers of patients will receive metformin, angiotensin-converting enzyme inhibitors and statins early in the course of their type 2 diabetes on the basis of large randomized controlled trials published over recent years; successful lifestyle modification thus incorporates diet, exercise and medications [16]. The key to resolving these issues is to be honest with the patients, curious about how they would like to manage things and respectful of their answers. The patients need to be helped to make informed choices about their condition, as they are ultimately the ones who are really in charge and in control of it, whether through action or inaction [17]. One of the main aspects of care in patients with diabetes is that of trying to establish good glycemic control and lifestyle behavior to prevent complications. To help people develop the life skills required to prevent complications, we must all recognize that giving information should not just be seen as ‘pot filling’. It is also easy to believe that once you have given somebody information, he or she will readily act on this information, but recent health promotion studies have clearly shown that this is not the case [6, 7]. It is important to focus any teaching on the patient’s agenda – identifying the patient’s needs and trying to motivate him or her towards turning those needs into the patient’s ‘wants’. Walker [18] suggested that meaningful education has to be learner-centered: this can be time-consuming, but it is time well spent in the long term. Collaboration (not coertion) with the patient is essential in setting out any education programme. Initially, the patient’s viewpoint must be sought – try to find out what he or she already knows about potential complications. Any teaching should be suitable to the patient as an individual and this will require an in-depth assessment of personal needs. The patient must be able to understand and follow the education programme in order to succeed and therefore the health professional must regularly assess the progress of the patient’s learning, pacing the session and its content accordingly. Often people will experiment and, consequently, make mistakes as they learn. This is not to be seen as negative, but identified as normal; encouragement will help people understand that we all make mistakes; the important thing is to learn from them [17]. In fact, we often learn the most from our mistakes. Mistakes are frequently made in blood-glucose testing, perhaps because initial teaching was inadequate.

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It is vital that people be taught the correct way confidently, with no blame being attached. It is easy for health professionals to make some patients feel guilty. Where to teach somebody can be important, although if the learner really wants to learn, location appears to be unimportant. Ideally, any environment that is conducive to learning will be relaxed and comfortable – the patient will ‘want to come here’. While it is common for doctors to wear uniforms and sit behind a desk, there may be times when this is inappropriate. If the desk or uniform is a barrier, a skilled teacher can overcome this. Any teaching/learning environment needs to be established within an open and honest relationship, with health professionals recognizing that they may not know all the answers. If they are ready to give advice, then they should be as up-to-date as possible. The development of training programmes from local specialist diabetes teams can sometimes assist with these skills. Any goals that are jointly set with the patient must be achievable (within reach of the patient). This has been shown clearly to work, for example, in achieving some weight loss. If a target is set that is too great to achieve or that will take too long to achieve will be very difficult for that person to succeed in accomplishing. Goals should be set so that short-term success is obtainable [17, 18]. Small triumphs will motivate patients to move on to further goal-setting. At the end of each education session, it is vital that both parties evaluate what has happened so that progress can be monitored and achievements assessed. This is an ideal opportunity to allow for the repetition of any information necessary.

Behavior Change

While trying to encourage patients to make changes, it may be difficult to understand just how well a patient is doing. A model of change can be of help in understanding that people go through various stages toward achieving change and, while relapse may occur, it should not be seen as failure [19]: • Pre-contemplation: The person is not interested in changing a ‘risky’ lifestyle. He or she may be unaware of the risks being run. • Contemplation: Once aware of potential risks, an individual may start to think about making changes. • Action: When the possible benefits of change are seen, the individual prepares for change, often needing extra skills and support. Initial changes tend to require positive decisions; clear goals and achievable plans are necessary for success at this stage. • Maintaining change: Once changes are made, the individual has to adjust to a new behavior. Occasionally, maintaining this new behavior is difficult, requiring constant support to avoid ‘relapse’.

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Relapsing: Relapse is normal and should not be seen as failure (for patient or helper). Assistance can then be provided to move once again into the contemplative stage. This model has been adapted locally for use with people who live with diabetes, using a ‘five-phase’ structure. During each phase, individuals go through the ‘change process’. Once individuals are maintaining changes and are prepared to make further changes, they will progress to the next phase.

•

Making changes Benefits outweighing costs Maintaining change New behavior patterns Considering how to change Weighing benefits and risks Not yet ready to change Relapsing does not necessarily mean failure Thinking about change May not be interested in making changes This model describes what happens to people as they change in everyday life, where people have different needs and they do not need the same kind of help. Unfortunately, too many Diabetes Centers have been action-oriented, revolving around the small percentage of people who are ready to take action, typically less than 20% [19].

Concepts for Theory and Practice

Learning By focusing on the concepts learning and taking control, rather than on education and teaching, we wish to move the focal point of learning from ‘the teacher who teaches’, to the processes that take place in ‘the pupil’ and the interaction between ‘teacher’ and ‘pupil’. Learning is an individual process that takes place in each and every person, arising from the interaction between individual experience and new knowledge. This invariably means that no one can learn from you; each person must learn for him/herself.

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Health care professionals who want people with chronic diseases to learn about their own disease and take responsibility for it must remember that learning does not automatically take place just by telling the ‘patient’ something. What health care professionals can do is to prepare the terrain so that useful and permanent learning can take place. This entails ensuring that what is to be learnt is capable of differentiation and individualization. It is useful to know what the person who wants to learn already knows and which strategies toward attaining proficiency he normally uses. New information can be more easily understood on the basis of knowledge already acquired. The aim of learning is to give people with diabetes the opportunity to be less dependent upon the health providers and more self-reliant. Teaching and Education Teaching is a social process that takes place between two or more individuals. Upon hearing the concept teaching about chronic diseases, many people think of a doctor or nurse telling the person with the chronic disease how their life must be lived. At best, teaching will lead to learning, but this is not inevitable. Once again, it must be pointed out that if teaching is to impart learning, the person with the chronic disease must ‘get out there’ and take responsibility for his own learning. Education is a concept close to teaching. For some individuals and in some situations, these concepts are synonymous. It may be true to say that to educate someone requires more from the teacher than just teaching. Instruction and Information Instruction can be used to demonstrate the correct way of performing a particular skill. The person who is being instructed can then try it himself and get expert help to get it right. Instruction is also described as copying an action. The idea of copying an action may sound a bit defensive and passive. Instructing people on how to measure blood-glucose, administrate and inject insulin must not only involve blind copying, it must also confirm that learning has actually taken place [3]. Instruction and information are sometimes used as synonymous concepts. Both instruction and information can be conveyed through written material. Information is distinguished from instruction, in that knowledge or guidance is a one-way process. Health care professionals inform users about, for instance, the consequences of diabetes. The information is given on the basis of experience and accumulated knowledge and, for the users, appears as more or less convincing. One-way information does not necessarily lead to learning and a change of behavior in the recipient, but it may do so. Whatever learning information may

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have bought about in the recipient can, if necessary, be verified by asking the person questions. Guidance Guidance is often defined as help for self-help. One of the conditions for successful guidance is that there exist a relationship of trust between the guide and the guided. In this way, confidence in the situation can be created. The basic skills a guide should have are related to listening and empathy – specifically, the ability to understand the other person’s experiences. In addition, it is also essential that the person who is being guided feels that he is understood. In the guidance of people with diabetes and other chronic diseases, it is important to have as a basis the person’s own understanding, experiences and ethical values. As a guide, your task is as much to ask the right questions as it is to give the right answers. Being a good listener gives you the chance to pick up on problems that need to be discussed further. One of the greatest challenges for guides is to get individuals to present what he/she wants or needs to discuss or find an answer to. The aim of guidance is to render people with a chronic disease more selfreliant, less afraid to take responsibility and more confident in making decisions on the basis of their own experience and knowledge. Taking Control The concept of taking control is both difficult and comprehensive. It can mean ‘to be a master over someone or something’. The concept of strategy for mastering suggests that it pertains to a struggle where the idea is to act wisely in order to win. Taking control is not a phenomenon restricted to people with chronic diseases. On the contrary, it is a common concern of mankind that can be found in all spheres of life. What is special – in the case of taking control of a chronic disease such as diabetes – is that without having chosen to, one is placed face- to-face with health problems that can have grave consequences if they are not properly treated. The regulation of diabetes has a clear-cut technical and medical side that must be controlled. Permanent, serious health problems also carry an emotional and existential burden that must be continuously addressed. In social interaction, great demands are placed upon somebody with a chronic disease if he is to avoid stigmatization, prejudice and rejection. Traditionally, health care professionals have focused more on technical and medical challenges than on the psychological and social conditions for taking control. It is the case, however, that good-quality results from medical treatment are very difficult to achieve if problems in other spheres of life require excessive attention and energy.

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In modern research concerned with ‘taking control’, attention has turned away from actions and strategies that create problems and diseases, focusing on strategies that promote advances in quality of life, well-being and health. In relation to diabetes this means that health care professionals and patients need to cooperate to find the tools patients need in order to live life on their own terms. General recommendations for treatment characterized by prohibition and limitation often promote nothing more than protest and neglect, while individualization and selfdetermination encourage initiative and positive lifestyle choices [3, 17, 18]. Learning by Doing This concept is frequently used to describe learning that takes place when we do, perform, experience or practice something. It is often ‘silent’ knowledge we acquire in this way. We can repeat something we have learned. This is a prevalent method in learning about diabetes. Combined with theorizing and summarizing, preferably with a guide, this can be a very useful method with which to acquire everyday knowledge. Learning by Imitation This is a method whereby knowledge is conveyed by other people’s behaviour. Other people are seen as positive or negative models or ideals that can be copied. Parents are often models for their children, whether they want or do not want to be so. When it comes to learning about diabetes, people with experience can act as models, consciously or unconsciously. Everyone needs models and ideals. There is therefore no reason to avoid the conscious use of models and ideals in relation to diabetes. Trial and Error This concept describes learning that takes place when one attempts to do something new and learns from the experience. One learns by trial and error. There is good reason to ask what one actually learns by making mistakes. Another angle on this can be to gain personal experience within areas where one is more likely to succeed. This can be described as ‘trial and taking control’ instead of trial and error. To succeed can be inherently motivating and stimulate the inclination to try again. A strategy such as this necessitates a highly adapted and organised situation. Motivation Motivation is often a key factor in learning. We say that someone is motivated or that someone is not motivated. For those who desire to optimize an environment for learning, motivation is important. We can comprehend the concept of motivation through the word ‘motive’, as in the motive for

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an action. An example of this might be ‘hunger’ which gives rise to the motivation to find food. We often speak about the ‘pleasure’ of learning or the lack of it. When someone has the inclination to learn, they have a need for learning. The challenge of motivation in regard to education – learning and teaching – is that the ‘teacher’ is convinced that the ‘pupils’ have a need to learn, but the ‘pupils’ do not share this conviction. The art of motivating people toward learning is all about stimulation; influencing the emotions and the mind to discover and acknowledge a need to learn. The aim is to create curiosity and eagerness to learn by helping participants discover their own need to learn. There are various suitable methods and techniques. The simplest frequently consist of being inquisitive – being interrogative instead of narrative. To query what one wants to learn more about, to let the participants take part in defining their learning needs and the form of tuition often stimulates the appetite for learning. A deeply oriented approach to learning could be described this way: ‘In order to help a patient to learn, the health care provider has to give him only a few facts, those truly indispensable for daily treatment, and to ask the patient to solve some simple problems, let him make all sorts of comparisons with other situations and be quite happy about errors, all of which may well represent the ideal way to help patients learn, providing that primary attention is given to the causes of errors.

Health Care Professional Burnout

Successful diabetes management involves individualized self-care goals, persistent problem-solving efforts based on specific problems encountered by the patient, and ongoing provider support. These behaviors require time, perseverance, enthusiastic endorsement and flexibility in adapting to the individual needs of each patient. Despite concerted effort, treatment outcomes often fall short of the expectations of providers. Feelings of disappointment, frustration, and failure can lead to provider burnout [20]. Burnout is a physical and psychological response to chronic job stress factors that occurs primarily in the care-giving, helping, or people-oriented professions [21]. Chronic job stress factors often involve: (1) unrealistic expectations and demands (2) non-reciprocated care-giving in emotionally draining, stressful situations. Definitions of burnout include negative changes in provider attitudes and behaviors as a result of chronic interpersonal and emotional stress at work [20–22]. Sample definitions include: • A state of physical, emotional, and mental exhaustion • Progressive loss of idealism, energy, and purpose

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•

Feelings of helplessness and hopelessness, emotional drain, negative selfconcept and negative attitudes toward work, life and other people • The depletion of one’s physical and mental resources…by excessively striving to reach unrealistic goals imposed by oneself or one’s society Provider burnout generally results in a lack of provider energy and the inability to respond effectively to the demands of the job [20, 22]. Provider burnout usually involves one or more of the following three characteristics: • Emotional exhaustion • Depersonalization • Reduced personal accomplishments Emotional exhaustion means being emotionally overextended and depleted. Providers who work overtime and have overly excessive time demands are more likely to experience emotional exhaustion. Providers who are emotionally exhausted may try to reduce or minimize contact with patients. Many dysfunctional emotional patterns, such as frustration and irritation, can develop. Provider frustration and irritation with patients can result in provider-patient distancing. Depersonalization is a term that is used to describe the impersonal and insensitive responses of providers who develop burnout. Providers may become disengaged from and insensitive to patients, particularly when patients are experiencing failures and difficulties, which is, unfortunately, precisely when patients’ needs are highest. This distance in the patient-provider relationship increases feelings of failure for both parties. Patients need to feel accepted and supported, especially when they have failed to meet both their own and others’ expectations. Failing within a supportive environment is an important part of patients’ acceptance of themselves and promotes continued efforts towards selfmanagement. If people feel supported and encouraged when they are unsuccessful with self-management techniques, they can recover quicker and feel stronger than before. Provider burnout inhibits the recovery process [22]. Providers may develop the attitude that patients do not want to get well or help themselves. Unless there are serious problems with low self-worth and depression, patients desire health, well-being and control over their lives. A sense of incompetence, feelings of failure and lack of job satisfaction can further escalate the burnout process. Little research has been conducted on burnout among providers who care for people with diabetes, but some predictors seem to emerge. Provider burnout results from a combination of factors that interrelate with each other in complex ways [21]: • High job-related stresses (e.g. overcommitment, lack of staff support, inadequate funding and institutional support, low control over work demands, lack of job security)

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•

Low satisfaction in work and interpersonal relationships (e.g. dissatisfaction with workload, emotional exhaustion, poor relationships with colleagues and staff, low support from family and friends) • Care-giving to patients with chronic or severe debilitating problems (e.g. cancer, AIDS, victims of abuse, chronic disease) The individuals most susceptible to burnout all have a common characteristic: they give much more of themselves than they receive in return [23]. For providers who care for patients with diabetes, burnout is more likely to develop when: • Unrealistic patient and provider goals and expectations have been set • A consistent and positive approach toward the patient has not been used by the provider • Too much responsibility for ongoing patient support and problem-solving has been undertaken by the provider, rather than using support systems in the patient’s life and community • Appropriate referrals and resources have been under-utilized It is important that health care providers understand the burnout process by analyzing the problems of solitude and the lack of recognition of the value of professional work. Strategies for early recognition of possible victims of this syndrome must be set in health institutions, especially those dealing with chronic diseases.

Team Approach for Diabetes Management

The interdisciplinary, integrated care team as a model for the treatment of chronic illness is not a new concept. Its benefits have been supported in the treatment of a variety of disorders. Adoption of this model is relatively new to diabetes, however, and requires a shift in how diabetes providers view their roles and relationships, both with patients and with professionals in other disciplines [24]. The interdisciplinary, integrated diabetes treatment team includes physicians, nurses, dietitians, and sometimes behavioral scientists with special interest and training in the management of diabetes. The team may also extend to health care professionals who can help meet special or specific needs within the scope of the core team’s expertise. Podiatrists, exercise physiologists, ophthalmologists, pharmacists, specialists in maternalchild care and gerontologists may all have a place within the diabetes care team. The existence of a diabetes care team implies the development of a comprehensive diabetes care program ensuring that standards of care are met. Care should be research-based and outcome-focused. Mutual support of team members will encourage ongoing professional development.

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Integrated care is defined as patient-centered and goal-directed, with equal emphasis given to education, counseling, and medical treatment. Key elements of the interdisciplinary team’s action include shared leadership with common goals, shared professional identity and collaborative, rather than consultative, relationships among members. Interdisciplinary care requires changes in team organization. In traditional medical models of care, the roles of team members and the work performed by each member are defined by the physician. The interdisciplinary model demands a shift toward shared leadership, which promotes mutual problem-solving, open communication and team cohesiveness. Undoubtedly, most organizations will still be inclined to identify a physician as team leader, but the nature of that leadership role must evolve away from the traditional physician leadership role. The responsibilities of diabetes nurse clinicians include but need not be limited to providing diabetes education, assisting in the choice of insulin regimen, adjusting insulin dosage, teaching patients problem-solving skills, helping patients work through self-management problems and developing educational and motivational strategies to promote patients’ self-management. The role of dietitians goes beyond the identification of an appropriate meal plan. Working individually with patients to design meal algorithms, dietitians highlight appropriate, realistic nutrition and exercise goals, negotiate dietary strategies and provide ongoing patient support, tailoring programs to meet patients’ specific lifestyle and motivational needs. A team is a group of individuals with similar interests and different areas of professional expertise. In interdisciplinary care, members share a common professional identity as part of the team, as well as a common purpose. Sharing a common professional identity does not suggest that members give up their unique contributions as physician, nutritionist, nurse, or behavioral scientist. Rather, all members bring specific expertise and a valuable point of view to the group. There is a great need for tolerance and the encouragement of flexible roles within a team. Collaborative practice allows the matching of provider expertise and style to specific patient needs and goals. If optimal glucose control of a patient’s type 2 diabetes is achieved through diet alone, then the dietitian could be that patient’s primary provider. In this scenario, the dietitian would be responsible for assuring that all standards of diabetes care for that patient are met, for coordinating the appropriate referrals to do so, and for providing expert advice on dietary intervention for diabetes self-management [24]. Similar beneficial effects of an integrated, interdisciplinary approach to chronic disease management have been demonstrated with conditions other than diabetes. These include but are by no means limited to chronic pain, rheumatoid arthritis, chronic fatigue syndrome and mental illness [23].

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Patient-Education Models for Diabetes as Recommended by the National Institute for Clinical Excellence (NICE)

It is recommended that structured patient education be made available to all people with diabetes at the time of initial diagnosis and then as required on an ongoing basis, based on a formal, regular assessment of need. There is insufficient evidence currently available to recommend a specific type of education or to provide guidance on the setting for, or frequency of, sessions. However, to achieve maximum effectiveness some principles of good practice are clear: • Educational interventions should reflect established principles of adult learning • Education should be provided by an appropriately-trained multidisciplinary team to groups of people with diabetes, unless group work is considered unsuitable for an individual • Sessions should be accessible to the broadest range of people, taking into account culture, ethnicity, disability and geographical issues, and could be held either in the community or at a local diabetes center • Educational programmes should use a variety of techniques to promote active learning, engaging individuals in the process of learning and relating the content of programmes to personal experience. Programmes should be adapted wherever possible to meet the different needs, personal choices and learning styles of people with diabetes, and should be integrated into routine diabetes care over the long term Multidisciplinary teams providing education should include at least one diabetes specialist nurse (or a nurse-practitioner with experience in diabetes) who has knowledge of the principles of patient education and a dietitian. Although not formally assessed in this appraisal, input from other disciplines, such as podiatry, has potential value. The composition of the team and the way in which members interact may vary between programmes, but team functioning should be tailored to the needs of different groups of people with diabetes.

Education Is as Important as Insulin, Oral Drugs and Proper Food for People with Diabetes

Therapeutic education of people with diabetes should preferably be an active process run by the people with diabetes themselves. They should learn about diabetes for their own survival, rather than be taught by health professionals. Active learning processes are facilitated by using problem-based learning processes, by interactive educational methods, by group teaching, by emphasizing practical aspects and by being concrete rather than abstract.

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In a chronic disease like diabetes, the aim of the learning process is to empower the person with diabetes to make his own decisions and to make him independent of the healthcare system, using it for advice rather than for care and instruction. Active learning should be preferred to passive teaching. The ‘golden moment’ of education is when the person with diabetes has a problem, contacts his adviser, discusses the problem and, together with his adviser, finds a solution which is then found to work. Availability is therefore an essential part of diabetes healthcare delivery [25].

References 1 2 3 4 5

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7 8

9 10

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Theman J: Consequences for treatment – pedagogical research for life – long patient education. Abstract. ‘Patient Education 2000’. Patient Education and Counseling, suppl to vol 23, 1994. Hess R, Weigand G: La relation pédagogique. Paris, Armand Colin, 1994, pp 27–30. Rosenquist J, Theman J, Assal P: New developments in diabetes education, The Desg Teaching Letter, Geneva, 1995. Glasgow Re, Toobert DJ, Hampson S: Effects of a brief office-based intervention to facilitate diabetes dietary self-care management. Diabetes Care 1996;19:835–842. Glasgow Re, La chance P, Toobert DJ, et al: Long terms effects and costs of brief behavioral dietary intervention for patients with diabetes delivered from the medical office. Patient Educ Counsel 1997;23:175–184. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilane-Parikka P, KeinanenKiukaanniemi S, Laasko M, Louheranta A, Rastas M, Salminen V, Uusitupa M: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;334:1343–1350. Diabetes Prevention Research Group: Reduction in the evidence of type 2 diabetes with lifestyle intervention or metformin, N Engl J Med 2002;346:393–403. UKPDS Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–853. Hampson SE, Skinner TC, Hart J, Storey L, Gage H, Foxcroft D, et al: Behavioural interventions for adolescents with type 1 diabetes: How effective are they? Diabetes Care 2000;23:1416–1422. Campbell EM, Redman S, Moffit PS, Sanson-Fisher RW: The relative effectiveness of educational and behavioural instruction programs for patients with NIDDM: A randomized controlled trial. Diabetes Educ 1996;22:379–386. Smith DE, Kratt PP, Heckemeyer CM, Mason DA: Motivational interviewing to improve adherence to a behavioural weight-control program for older obese women with NIDDM. Diabetes Care 1997;20:52–54. Ruggiero L: Helping people with diabetes change behaviour: From theory to practice. Diabetes Spectrum 2000;13:125–132. Rollnick S, Mason P, Butler C: Health behaviour change: A guide for practitioners, London, Churchill-Livingstone, 1999. Bandura A: Health promotion from the perspective of social cognitive theory, Psychol Health 1998;13:623–650. Skinner TC, Cradock S: Empowerment: what about the evidence? Pract Diabetes Int 2000;17: 91–95. American Diabetes Association: Standards of medical care for patients with diabetes mellitus. Diabetes Care 2003;26(suppl 1):s33–s50. Coles CR: Diabetes education: Letting the patient into the picture. Pract Diabetes 1990;7: 110–112.

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18 19 20 21

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23 24 25

Walker R: Education: Principles and practice. Diab Nurs 1991;2:4–7. Prochaska JO, Diclemente CC: Towards a comprehensive model of change; in Miller WR, Heater N (eds): Treating Addictive Behaviours, Processes of Change. New York, Plenum, 1986. Cindy L, Hanson PD: Understanding and treating provider burnout; in Anderson B, Rubin RR (eds): Practical Psychology for Diabetes Clinicians. Am Diabetes Assoc 1996:173–181. Maslach C: Stress, burnout and workaholism; in Kilburg RR, Nathan PE, Thoreson RW (eds): Professionals in Distress: Issues, Syndromes, and Solutions in Psychology. Am Psychol Assoc 1986;53:75. Snibbe JR, Radcliffe T, Weisberger C, Richards M, Kelly J: Burnout among primary care physicians and mental health professionals in a managed health care setting, Psychol Rep 1989;65: 775–780. Lacroix A, Assal JP: Therapeutic Education of Patients. Paris, Ed Maloine, 2003, pp 75–78. Bayless M, Martin C: The team approach to intensive diabetes management. Diabetes Spectrum 1998;11:33–37. Jervell J: Education is as important as insulin, oral drugs and proper food for people with diabetes. Pract Diab Int 1996;13:142.

Valerio Miselli Diabetes Unit, Hospital of Scandiano, Via Martiri IT–42019 Scandiano (RE), Italy, Tel. ⫹39 0522 850 332 Fax ⫹39 0522 850 411, E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 40–50

The Diabetes Education Study Group of the EASD and Its Activities to Improve the Education of People with Diabetes Aldo Maldonato La Sapienza University, 2nd Medical School, Rome, Italy

Abstract In this paper, the activities of the Diabetes Education Study Group (DESG) are presented. Since its foundation in 1979, the DESG had among its aims to improve the quality of life of people with diabetes and to foster their independence. A few assumptions informed the DESG activity since the beginning: appropriate self-management by the patients requires knowledge skills and motivation, whose improvement is largely doctors’ and other health professionals’ responsibility. To be effective in their counseling activity health professionals need to acquire skills in the domain of human sciences that are not usually taught in medical schools. Health professionals also need to change traditional attitudes for an empathic listening and a share of treatment responsibility with their patients. Based on these assumptions, the DESG concentrated on the following activities: interactive workshops, which in the years have become a sort of trademark of the DESG, and which are described here in detail; publications both for health professionals and for patients, a comprehensive web-site for health professionals, and a basic curriculum in therapeutic patient education. The future of therapeutic patient education in the field of diabetes is discussed. Copyright © 2005 S. Karger AG, Basel

The Diabetes Education Study Group (DESG) was founded in 1979 upon the initiative of Jean-Philippe Assal, as a section of the European Association for the Study of Diabetes. According to its Constitution, its aim is ‘to improve the quality of life of the diabetic patient through the development and evaluation of educational programmes designed to foster independence for the patient, to improve the quality of metabolic control, to emphasize the importance of prevention and early recognition of the disease and to encourage relevant research’.

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Fig. 1. Medline papers on Quality of Life per year: related QoL; papers dealing with diabetes-related QoL.

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papers dealing with health-

It is worth considering the two items here outlined in the quotation from the 1979 DESG Constitution. Quality of life is nowadays acknowledged as a primary therapeutic objective, but in those years the concern for diabetesrelated quality of life was just beginning, and in fact the first single Medline paper on this topic is from 1980 (fig. 1). Having patients’ independence as a major aim has occasionally being criticized over the years by conservative health professionals; however, nowadays the empowerment of people with diabetes is considered the most appropriate goal for effective patient education. Empowerment is defined as ‘helping people discover and use their innate ability to gain mastery over their diabetes’. In this perspective, ‘patient education is seen as a process of teaching and counseling designed to help our patients discover more effective problem-solving strategies. Our responsibility is to provide our patients with the resources necessary to achieve their own diabetes care goals’ [1]. Therefore since its foundation the DESG has anticipated issues whose relevance has been increasingly recognized in the past 25 years. In the pursuit of these goals, the DESG has organized many workshops and congresses, and has published many documents on specific educational topics, both for health professionals and for patients. DESG activities have been reproduced at the national level throughout Europe, and in other continents as well. National study groups, although not

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official sections of the DESG, refer in their name and/or in their constitution to the parent body as a source of continuing inspiration. Examples include the Italian GISED (Gruppo Italiano di Studio per l’Educazione sul Diabete) founded in 1980, the French DESG de Langue Française founded in 1991, and many other organizations active both Western and Eastern countries. The written documents produced by the DESG have been translated into more than twenty languages and distributed all over the world. In 1999, the DESG has published a comprehensive Website where all DESG publications can be found and freely downloaded.

DESG History and Structure

The history of the DESG from its very beginning in 1977, its gestation, choice of name and logo, and the first few years’ activities were described by Assal et al. [2] in 1982. A more recent history of the DESG can be found in the Chairman’s Annual Reports, given at the annual meetings of the General Committee, and which are published in the DESG Website (section, History; heading, Chairman’s Reports). The DESG is chaired by a President and an Executive Committee composed of six members including at least 2 non-physician health professionals. The decision-making body is the General Committee, composed of two representatives per country. Their current number is 65 and the represented countries are 35. Membership of the DESG is limited to persons actively involved in the education of diabetic patients. Applicants must be endorsed by two active members. At the end of the year 2003, the updated list of DESG members included 798 health professionals from 85 European and non-European countries.

The DESG Approach

Up to the 1970s, the education of diabetic patients had been practiced by isolated pioneers and had just recently been accepted as a powerful therapeutic tool in the United States, thanks to the demonstration of its efficiency [3]. However, facing the widespread failure to translate optimal diabetes care into daily practice, the prevailing attitude of doctors and other health care providers was still to consider the diabetic patient, albeit not responsible for his care, guilty nevertheless for the failure. From the beginning, the DESG approach has been based on a few assumptions that have guided its activity throughout the years [4]. People with diabetes

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do not necessarily cheat or lie more than anybody else. If they do not accept our advice, they either do not know why or how, they perceive the cost/benefit ratio as too high, or they have not yet come to terms with this particular life-long disease. As a consequence, the responsibility of health care providers caring for people with diabetes extends far beyond the traditional tasks of diagnosis and medication. It includes informing patients, training them to acquire the required skills, and providing them with the resources enabling them to take informed decisions about their diabetes management. To be effective, health care providers need to acquire numerous skills that are not traditionally included in professional curricula, and that belong to the domain of the human sciences: pedagogy, psychology, sociology, anthropology, and bioethics. In addition, a profound change is required in the attitude of doctors, nurses and dieticians interacting with people with diabetes, from the traditional, authoritarian, paternalistic attitude, to an attitude of acceptance, empathic listening, and encouragement to share the responsibility of treatment choice and day to day implementation. Despite all the difficulties to be faced in acquiring new professional skills and in changing roles and attitudes, the effort is worth making because it is the only way to improve our effectiveness in the treatment of chronic diseases. Given the therapeutic role of patient education, doctors must be involved in the entire process, as the members of the multi-professional team who carry the responsibility for the planning and implementation of the educational process. In accordance with these assumptions, the DESG has concentrated on: Increasing the awareness of doctors, nurses, dieticians and other HCP • caring for people with diabetes about the difficulties they encounter in educating people with diabetes. • Encouraging health care providers to find ways to overcome these difficulties by improving their skills, their attitudes, and some aspects of the structure where they work. • Applying existing models, or developing new ones, to better understand what influences the motivation of different people with diabetes to learn and properly treat themselves. • Fostering research in the field of therapeutic patient education, and developing and evaluating educational programs for patients, based on current educational trends. • The activities which have been accomplished in accordance with the above are briefly summarized here.

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Workshops

The DESG has developed a format of interactive workshop which through the years has become a sort of trademark of his. It typically consists of a fulltime, 5-day meeting, with 30–60 participants. Several aspects of therapeutic patient education, kept logically together by the general title of the workshop which is almost always different, are analyzed and worked upon. A comprehensive list of the workshops held so far is published on the DESG Website (section, History; heading, Past Workshops). Examples of workshop titles are: ‘To listen and to learn’, ‘Which objectives in diabetes education?’, ‘Which methodologies for patient education?’, ‘Improving long-term follow-up of people with chronic diseases’, and ‘Diabetes and management of long-term complications: amputations, neuropathies, blindness’. Formal Lectures Based on the principle of learning by doing, the DESG workshops have always given priority to group activities. The time devoted to formal lectures is limited to less than 25% of the total working time. Many lectures are given by experts in disciplines other than diabetes. Examples are Elena Benaduce, psycho-pedagogue; Jack Bresnahan, editorialist and musician; Bernard Crettaz, ethnologist; Vincenzo Di Bonaventura, theatre actor; Danilo Dolci, sociologist; Vincenzo Graziani, psychologist; Jean-Jacques Guilbert, medical pedagogue; Marcos Malavia, set designer and mime; Hassan Massoudy, Arab calligrapher; Ilario Rossi, anthropologist; Guido Ruffino, pedagogue; Caroline Simonds, clown; Sandro Spinsanti, bio-ethicist. Interactive Group Sessions Interactive group sessions take 75–80% of working time. They consist most often of one of the following: • Group discussions on certain aspects of the topic introduced by the lecturer. These are held in small groups of 10–15 people, using the technique of Metaplan®, which facilitates interaction among group members and the production of a written document, ready to be reported in the plenary session. They are particularly useful to analyze difficulties, find solutions, plan actions, or establish priorities, both in the education of people with diabetes and in the training of HCP. • Experiential learning. People with diabetes are faced with new tasks to accomplish and new skills to acquire. HCP can only sense how difficult it can be to learn something new, and which help is useful and which is not, if the they are confronted with new tasks, usually not related to diabetes.

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Experimenting with handicaps. When the topic of the workshop includes helping people with diabetes face late complications, participants are given simple tasks that have to be performed with one of the handicaps that may accompany late complications: loss of vision, loss of foot sensory capacity, amputation of a leg, etc. The aim is to increase the awareness of the burdens of diabetes complications and improve Health Care Providers’ empathic attitude. • Role-playing. This well-known technique is used when dealing with attitudes of both patients and Health Care Providers. It helps to try and illustrate less effective or more effective attitudes in the HCP/patient relationship. One particular characteristic of DESG workshops is the strict enforcement of the principle of learning by doing: therefore every activity is both an occasion to focus on a specific aspect of TPE, and an opportunity to experiment a learning method that can also be adopted with patients. A second hallmark is creativity, which is known to be associated with more effective teaching: an effort has always been made to renew teaching methods, exercises, perspectives and metaphors, as an example of what Health Care Providers are expected to do in their own practice to meet the different requirements of their patients. Another typical feature is the use of art – mostly music, but sometimes painting as well – to ‘tune’ participants’ minds to the topic of the day: this again is both a tool and a suggestion to search in art, the utmost expression of human intuitive understanding of reality, a shortcut to help patients’ acceptance of the disease and its treatment. More than 3,000 doctors, nurses, dieticians, and other health professionals have participated in DESG workshops, many of them more than once. A good deal of them have been able to reproduce similar activities in their respective countries all over Europe, thereby initiating the desired snowball effect which is estimated to have significantly improved the way diabetic patients are cared for in many European Diabetes Centers. In recent years, participants are the General Committee members.

•

Teaching Letters

From 1983 to 1988, the DESG produced a series of twenty teaching letters (TL) during four 3-day workshops in Switzerland and Greece. They consist of 4 pages each, and have been translated into 26 languages. Updating was started in 1995. In 1998, the DESG started a new series, drafting five TL, during a 5-day workshop in Italy. In 2002, a new series of five TL was drafted in Italy.

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Table 1. List of the teaching letters (updated and new) 1 2 3 4 5 6 7 8 9

Oral agents Hypoglycaemia Self-monitoring Putting a patient on a diet Counseling on late complications Foot care Patient education: a lifelong process ... Therapeutics and education… (with poster) Help your patients to improve self-management: Building a therapeutic chain (poster) 10 Managing the patient with excess weight and diabetes 11 Checklist for diabetic patient education 12 How to improve follow-up in the long term disease 13 Motivating the diabetic patient 14 My patient is poorly controlled, how do I approach this problem? 15 Right from the start... education at the time of diagnosis 16 Diabetic retinopathy and therapeutic education 17 Educational approach to the elderly diabetic patient 18 Group versus individual therapeutic patient education 19 Therapeutic diabetes education in camp settings 20 The function of psycho-social support in diabetes education 21 Therapeutic education: what a diabetes centre should provide 22 Planning an educational program 23 Diabetes education and cost control: time to measure 24 Evaluating diabetes education 25 Use, misuse and abuse of AV aids 26 Education to the use of hi-tech devices (pumps, glucose-sensors, open/closed loops) 27 Physical activity and diabetes 28 Emotional intelligence in diabetes care 29 Quality of life, an outcome of diabetes education 30 Assessing and improving quality in diabetes education

The current number is 30. An updated list of TLs is shown in table 1. The documents can be read and downloaded from the DESG Website (section, OurMaterials; heading, Teaching Letters). The Five-Minute Education Kit

This is a document for health professionals and patients, produced in 1994, during two 3-day workshops in Switzerland, by 57 health care providers from 24 countries [5].

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Table 2. The 5-min survival kit 1 2 3 4 5 6

Prevention of hypoglycaemia: Initiating an insulin treatment Intercurrent illness, sick-day rules and acetone Meal planning: type 1 diabetes Meal planning: type 2 diabetes Weight loss: type 2 diabetes Prevention of foot lesions. For patients having no vascular or neuropathic problems 7 Loss of pain sensation. Long-term complications and prevention of amputations 8 Follow-up of eye problems 9 Pregnancy and diabetes

Even 5 min can be part of life-long learning. Shortage of time makes it even more necessary to identify the most efficient strategies. This is why we have developed the concept of the Survival Kit for Health Care Providers and Patients, the concept being: Don’t teach, but at least give just the key information to your patient.’ The document covers 9 topics, with 2 pages each: • one is a guideline for health care providers; • one, repeated, is a summary in the form of a hand-out for patients. The nine titles of the 5-min Survival Kit are listed in table 2. The documents can be read and downloaded from the DESG Website (section, OurMaterials; heading, Survival Kit).

Patient Education Basics

These documents have been produced by the DESG with the general practitioner in mind. Dealing in particular with type 2 diabetes, which is most commonly managed in general practice, they address two essential questions: • How can we deliver, in a few minutes, useful information to the patient regarding better management of his/her diabetes? • How can we be sure that the patient will follow advice once he/she returns home? Recently, the 18 Patients Education Basics, whose list is shown in table 3, have been summarized in a comprehensive booklet for people with type 2 diabetes: the title is ‘You have type 2 diabetes: meaning and implications’.

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Table 3. List of patient education basics for type 2 diabetes 1 How to prevent low blood sugar 2 Lose weight by eating better 3 Diabetic retinopathy and follow-up of eye problems 4 Prevention of foot problems 5 ‘You have type 2 diabetes’ – meaning and Implications 6 Preventing late diabetic complications 7 Ageing and diabetes management 8 Improving follow-up in the long-term disease 9 Blood glucose monitoring: a must in diabetes management 10 Diabetes treatment and ‘the others’(the role of the family and the social environment) 11 Prevention of heart problems 12 Physical exercise: a therapy for diabetes at all ages 13 Intercurrent diseases: a challenge for diabetes control 14 Preventing diabetes in your relatives 15 Losing weight: mission possible 16 Diabetes and the other risk factors 17 Drugs for type 2 diabetes 18 When insulin treatment may be necessary

The documents can be read and downloaded in the original editorial aspect, from the DESG Website (section, Our-Materials; heading, Patient Education Basics).

DESG Website

As a result of a 3-day workshop, held in Italy in November 1998 with 11 members from eight European countries, all experts in therapeutic education and informatics, a comprehensive Website of the DESG was planned, in order to improve communication between members and make all published material on diabetes education easily available. The DESG Website (www.desg.org) was officially opened on September 1st, 1999. It is intended for HCPs involved in TPE in the field of diabetes. Patients are directed to several informative sites for them. For reasons of privacy, the list of members and the General Committee are in a restricted area of the site, accessible to members only. The members’ area may allow for internal exchanges. The Website has also been used to launch an inquiry on the educational needs of Health Care Providers, planned during a 5-day workshop held in

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Italy in March 2000. A 26-item questionnaire has been published on the Website to evaluate the need of training/updating in the topics relevant to Therapeutic Patient Education, as perceived by the Health Care Providers world-wide.

Basic Curriculum in Therapeutic Patient Education

It was drafted by a multi-professional group of DESG experts during a 5-day workshop (Orvieto, Italy, 2000), and edited by the Executive Committee during a 2-day meeting (Rome, 2001). Its aim is to propose a model of basic systematic training of health care providers in TPE based on the indications of the WHOEurope Working Group Report [6]. The curriculum is based on 8 one-day modules (for a total of 64 hours), and allows for different formats of implementation, according to local needs [7]. Each one-day module has been subdivided into four 2-hour sessions. Each session, usually dedicated to attaining a specific educational objective, should consist mainly of interactive activities involving the participants. Long enough intervals during the course, or a follow-up meeting after 6–12 months, may be used to plan tasks with the participants to be performed at home and then verified. The suggested number of participants should not exceed 30–35, in order to allow group work in two to three groups of 10–15, with the possibility of splitting into smaller groups of 4–5 for some activities. The DESG Curriculum has already been implemented in several countries: e.g. Austria (2002–2003) by DESG-Austria, Israel (2003), UAE (2003) by DESG Abu-Dabi, and Italy (2003–2004) by GISED. In Italy the first course was based on four 2-day meetings, and 35 HCP attended the course. A second course, based on three 3-day meetings, is planned for 2004–2005.

Conclusions

Although much has changed regarding the treatment of people with diabetes in the last 25 years, much still remains to do in order to increase both the quality and the implementation of Therapeutic Patient Education in the field of Diabetes. Medical science is making astonishing progress, and the cure and prevention of diabetes appear closer and closer. This may have induced some scientists to forget the essential role of Therapeutic Patient Education. This attitude parallels that of those who contend that diabetes can

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be fully explained on the basis of psychosocial disorder, and pretend to treat it accordingly. The DESG commitment has always been to bridge between these two attitudes, filling the gap between medical research and human sciences, and in the future it will continue to act on the same line.

Acknowledgements The activity of the DESG, including the creation of the Website, was made possible through the generous collaboration of Servier Research Group, Paris, France. This partnership started in 1979 and has continued since, with the interruption of years 1992–1994, when the sponsorship was granted by Novo Nordisk, Copenhagen.

References 1 2 3 4 5

6

7

Anderson R, Funnell M: The Art of Empowerment: Stories and Strategies for Diabetes Educators. ADA, 2000. Assal JPh, Berger M, Canivet J: History and aims of the Diabetes Education Study Group. International Congress Series No. 624. Amsterdam, Excerpta Medica, 1982, pp 3–7. Miller LV, Goldstein J: More efficient care of diabetic patients in a county-hospital setting. N Engl J Med 1972;286:1388–1390. Golay A, Bloise D, Maldonato A: The education of people with diabetes; in Pickup I, Williams G (eds): Textbook of Diabetes mellitus. Oxford, Blackwell Science, 2003, pp 38.1–38.13. Assal JPh, Golay A, Visser APh (eds): New Trends in Patient Education: A trans-cultural and interdisease approach. Proceedings of Patient Education 2000. Int Congr Treatment of Chronic Diseases, Geneva, 1994. Amsterdam, Elsevier, 1995. Report of a WHO Working Group on Therapeutic Patient Education: Continuing Education Programmes for Healthcare Providers in the Field of Prevention of Chronic Diseases. Copenhagen, WHO-Europe, 1998. DESG Working Group: Basic Curriculum for Health Professionals in Diabetes Therapeutic Education. The Diabetes Education Study Group of the EASD.

Prof. Aldo Maldonato Diabetes Unit, Ospedale S.Andrea IT–00189-Rome (Italy), Tel. ⫹39 06 8034 5335 Fax ⫹39 06 4938 4791, E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 51–61

Integration of Diabetes Education in Type 2 Diabetes Care Guy Rutten Julius Center for Health Sciences and Primary Care, Department of General Practice, University Medical Center, Utrecht, the Netherlands

Abstract General knowledge of diabetes, adherence to medication, lifestyle changes, and selfmonitoring of blood glucose are surrogate end points. Diabetes self-management training programs should emphasize the need for a multifaceted attack against the risk factors for both macro- and microvascular disease, be collaborative and have repetitive educational sessions. Because a target-driven attitude of diabetes care providers is of major importance, the integration of education in daily practice is important. An educational programme by a diabetes nurse in 54 type 2 diabetes patients treated in primary care with maximal dosages of oral hypoglycemic agents but with HbA1c ⱖ7.0 led to a clinically relevant improvement in HbA1c level without any change of medication. The lack of structured follow-up resulted in disappointing effects on the long-term. Questions remain as to the extent of which the different parts of the programme contributed to the result. Nevertheless, because the course was short and the educational materials were simple and cheap, it could be embedded in daily practice, on the condition that a well-trained and confident practice/diabetes nurse is available. Effective diabetes self-management programs must be noncomplex, individualized to a person’s lifestyle, reinforced over time and respecting an individual’s habits, they should primarily focus on medication adherence, be cheap and very practical. Copyright © 2005 S. Karger AG, Basel

In 1989, European health care authorities, patient organizations and diabetes experts convened a conference in Saint Vincent (Italy), which resulted in the well-known ‘Saint Vincent Declaration’ [1]. The motivation for this meeting stemmed from the notion that the impact of diabetes was seriously underestimated. The Declaration established ambitious goals for diabetes care. In the decade after the Declaration results from long-term trials became available, along with the introduction of more powerful treatment options for

cardiovascular risk factors [2–8]. One of the main findings of the United Kingdom Prospective Diabetes Study (UKPDS) was that ‘intensive’ glucose control compared with ‘conventional’ treatment, resulted in a significant reduction of microvascular end-points, but not of macrovascular complications or total mortality [4]. Conversely, tight control of blood pressure appeared more successful in preventing macrovascular complications than tight glucose control [7, 8]. The UKPDS gave cause for considerable dispute concerning the interpretation of its results and the implications for daily practice [9–14]. By now it is accepted that within the realms of diabetes care, glycemic control is just one of the key areas, and that reducing blood pressure, treating hyperlipidemia and stopping smoking are also of importance [15]. To achieve all these targets, in current guidelines self-management education is considered an essential part of the approach of patients with type 2 diabetes [16]. Some countries are addressing this need. For example, the US government has supported a national diabetes education programme. One of the goals of Healthy People 2010 is to increase to 60% (from the 1998 baseline of 40%) the proportion of diabetes patients that receive formal diabetes education [17]. A statement: ‘Considerable energy and resources are required to set up and maintain educational programmes, but the costs per individual is small compared with that of treating the consequences of uncontrolled diabetes’ [18]. This article deals with the role of education in diabetes care. It addresses three fundamental questions: (1) Should people with diabetes be educated? (2) How effective is diabetes education? (3) How should formal education be organized?

The Need for Patient Education

Educational programmes should focus on general knowledge of diabetes, adherence to medication, lifestyle changes, and if possible self-monitoring of blood glucose [19]. Lifestyle changes mostly concern dietary changes, stopping smoking and increasing physical activity. The goal for educating people with diabetes is to improve their individual self-efficacy and, accordingly, their selfmanagement ability [20]. Each diabetes care provider will agree with the above mentioned topics of diabetes education, but one should realize that all these topics are only tools to achieve what really matters. Tools that might be measured as surrogate end points of diabetes education. In fact diabetes patient education only makes sense if it succeeds in long-standing improvements of outcome measures that matter. After receiving formal diabetes education individuals with diabetes should be able to improve their glycemic control, to decrease their manipulable cardiovascular risk factors, to improve their quality of life and to enhance their health service utilization. As a consequence, only

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Table 1. Effectiveness of self-management training programmes [21] Surrogate end-point

Effect

Remarks

Correlation with outcome measures ‘that matter’

Knowledge

Positive

No consistent correlation with HbA1c%

Dietary changes

Positive

Follow-up measurements until 12 months Almost all selfreported changes

Physical activity

Positive/ negative

Blood glucose self-monitoring

Feasible

Application of foot care Enhancing coping skills

Feasible Feasible

Unclear why positive or negative result

Follow-up 1 year

Hardly any correlation with improvement in body weight or glycaemic control Combination with dietary advice: better QoL after 18 months No corresponding improvement of HbA1c%, even not after combination with adjustment of diet and physical activity Decrease in foot lesions ⫾ Correlation with HbA1c% unclear

those elements of diabetes education are of interest which are positively related to the four above-mentioned outcome measures. We will address this issue on the basis of a systematic review of 72 randomized controlled trials regarding the effectiveness of self-management training in type 2 diabetes [21].

The Effectiveness of Self-Management Training

From the systematic review it appears that training programmes succeed in increasing diabetes patients’ knowledge on diabetes. The measured increase of knowledge is even more impressive after regular reinforcement sessions, but the correlation between increase of knowledge and improvement of glycemic regulation is not consistent. The same applies to other surrogate endpoints: even if they may have been improved after self-management training programmes for diabetes patients, their impact on the most relevant outcome measures is weak (table 1).

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Looking primarily towards biomedical variables, from the Norris’ review we may conclude that self-management education for adults with type 2 diabetes type 2 improves HbA1c levels at immediate follow-up, and increased contact time increases the effect. The benefit declines 1–3 months after the intervention ceases, suggesting that learned behaviors change over time. One should keep in mind, however, that only a few studies with follow-up ⬎6 months could be included. Collaborative interventions were more favorable than ‘didactic’ [21, 22]. Education may also succeed in decreasing the participants’ body weight. The review brings up 13 studies with a positive effect on weight. This effect mainly depends on regular contacts or reinforcement sessions. However, there were only four positive studies with follow-up ⬎6 months. Regarding lipids and blood pressure, the effects of self-management training programs were both positive and negative. Positive studies were interactive, individualized and with repetitive interventions. The only long-lasting study with a follow-up period of 5 years and regular 3-monthly educational sessions did not show any difference in cardiovascular disease between those who received education and did not receive education. No improvements could be demonstrated in the use of health care facilities after diabetes education. Not even one cost-benefit analysis of diabetes education could be identified [21]. We might draw the following conclusions: • Diabetes education should not primarily focus on surrogate endpoints such as knowledge, self-monitoring of blood glucose, dietary changes or physical exercise • Diabetes self-management training programmes should emphasize the need for a multifaceted attack against the well-known risk factors for both macro- and microvascular disease • Collaborative education instead of didactic sessions should be provided • Repetitive educational sessions are obligatory In fact, these conclusions were already drawn about a decade ago. De Weerdt et al. [23] concluded that integrating education with other therapies, such as intensified blood glucose lowering therapies, is needed. In 1995, Clement [24] stated that education is most effective when combined with healthcare provider medication adjustment and reinforcement of educational messages. As a consequence, the question arises of how diabetes self-management education can be integrated in daily diabetes care, so that it can be combined with medication adjustment. The importance of the latter is strongly supported by a study we performed in general practice: in 288 patients ⬍76 years and with an HbA1c ⬎7% (mean age 60 years, 45% male, mean duration of diabetes 4.6 years, mean BMI 29.2) a clinically significant reduction in HbA1c from 8.8 to 7.3% was achieved, after a mean of three consultations per patient over a period of 14 weeks. The number of patients with poor control (HbA1c ⬎8.5%)

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decreased by 60%. This result was attained simply by adjusting oral medication according to the level of the fasting blood glucose, together with a rigorous appointment policy [25]. These findings support the results of a systematic review which concluded that a target-driven attitude of diabetes care providers is of major importance [26]. On the contrary, a patient-centered care did not prove to be beneficial in improving biomedical outcomes [27]. Should this finding have consequences for diabetes education? For example, should diabetes education primarily focus on improving adherence to medication, or would that mean a step backwards [28]? The answer on this question is strongly related to the third question of this article, the integration of education in daily practice.

The Organization of Diabetes Education

Since about 20 years general practitioners (GPs) have acquired more responsibility in the surveillance of their diabetic patients, with a gradual transition from secondary to primary care, not necessarily driven by guidelines nor by working agreements with local specialists [29–32]. In parallel to this, the general opinion became widely accepted that patients should be treated at the lowest possible echelon of care, without compromising quality. In the Netherlands this process resulted with the publication of the first guidelines on the treatment of type 2 diabetes for general practitioners, published by the Dutch College of General Practitioners (DCGP) [33]. In the last 10 years guidelines became more evidence-based. Although this feature should favor the use of recommendations [34], it appeared difficult to implement them in daily practice [35–37]. Research in primary care both in and outside the Netherlands revealed significant variability in the delivery of diabetes care, while a substantial percentage of patients did not reach the targets of glycemic control, or other cardiovascular risk factors [38, 39]. Both contextual, physician and patient factors are held responsible for this deficit [38–42]. Prompting systems that recall patients for appointments, adherence to standard management protocols including well-defined targets, outreach visits from trained facilitators as well as well-trained and confident practice nurses are features of more successful care [43, 44]. In the Netherlands, several long-term programmes were initiated to improve adherence to the diabetes guidelines from the DCGP. A number of these initiatives were scientifically evaluated. For example, in the Utrecht Diabetes Programme glucose and lipid levels and diastolic blood pressure had improved significantly after inclusion [45]. Also the results in academic practices were very positive and improving over a large number of years [46]. Other programmes showed increased physical examination and laboratory testing in

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diabetic patients (so-called process measures), but the effects on glycemic control and cardiovascular risk factors (i.e. outcome measures) were variable. Besides, it remained unclear whether the results were a consequence of the organizational model or of prescribing medications more adequately [46–48]. The same problem often arises when the effect of education embedded in daily diabetes care is measured. In that case a more appropriate prescribing of medication might be a confounder. Therefore we studied the efficacy in the short and long-term of an educational programme in 54 type 2 diabetes patients treated in primary care with maximal dosages of oral hypoglycemic agents but still inadequately controlled (HbA1c ⱖ7.0%), to assess the net effect of education [50]. Patients were randomly assigned to an individual collaborative educational programme by a skilled diabetes nurse (DN group), or to usual care by their general practitioner (UC group). The programme focused on: general information on diabetes; reinforcing compliance with actual medication; importance of physical exercise and losing body weight; and nutritional advice. All patients were also taught how to control their blood glucose at home on a regular basis, for which they were given a blood glucose meter and necessary materials. During six months, six sessions were given, at intervals of 3–6 weeks. The sessions took between 15 and 45 min, resulting in a total contact time of approximately 2.5 h. After the course HbA1c had changed from 8.2 to 7.2% in the DN group, and from 8.8 to 8.4% in the UC group. Adjusted for baseline values, sex and duration of diabetes, mean HbA1c % in the DN group fell by 0.6% more than in the UC group (95% CI 0.03, 1.2; p ⫽ 0.039). Finally, adjusted for baseline values, mean body weight in the DN group fell by 2.0 kg more than in the UC group (95% CI 0.4, 3.6; p ⫽ 0.013). One year after the last session of the programme, the difference between the mean change in HbA1c in the two groups was 0.2% in favor of the DN group, not statistically significant. The study demonstrates that in the short term structured individual education by a diabetes nurse led to a significant and clinically relevant improvement in HbA1c level. Moreover, the net effect of education was studied since medication was not changed in both groups during 6 months. The lack of structured follow-up resulted in disappointing effects on the long-term. Questions remain as to the extent of which of the different parts of the programme contributed to the result and whether the educational materials or the working method of the diabetes nurses were (most) responsible. It is hard to consider SMBG apart from the other aspects of the programme. This might be of importance, because the use of SMBG in all diabetic patients is widely promoted [51], although its value is still a matter of debate [52]. A meta-analysis of randomized trials failed to show any benefit from SMBG in patients with type 2 diabetes [53]. Moreover, it is suggested that a daily use of SMBG in type 2 diabetes is associated with higher levels of distress, worries and depressive symptoms, because most patients, even those treated with insulin, may not be

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Open information meeting Professional designed material

Use of check-list

Uniformity in education

Educated educators

Participation partner

Access

Reimbursement

Integrated part of care 0

20

40

60

80

100

Fig. 1. Percentage of Dutch opinion leaders on diabetes (n ⫽ 56) that think elements of optimal diabetes education very important (n ⫽ 56).

capable to translate all the information into clear adjustments of their treatments [54]. For the time being, we agree with the statement of Franciosi et al. [54], which implies: ‘SMBG should be an integral part of a wider educational strategy devoted to the promotion of patient autonomy’. For daily practice this means that SMBG may be used by patients on insulin therapy, and patients who need feedback as part of a structured educational programme such as we studied. Nevertheless, because our course was short and the educational materials were simple and cheap, it could be embedded in daily practice, on the condition that each general practice (or outpatient clinic) has a well-trained and confident practice/diabetes nurse. The literature is divided regarding the relative merits of group versus individual education [21]. Taking into account that individual therapy might be easier to be integrated in daily care, that self-efficacy is a crucial mediating variable, and that involving people with diabetes in their own care may improve the results of education [20], embedded individual diabetes education is likely to have a greater potential.

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The importance of integration of education in diabetes care was also felt by a sample of 56 Dutch experts in diabetes care, opinion leaders, clinicians and scientists as well. The most important feature of diabetes education should be its integration in diabetes care (fig. 1) [55].

Discussion

Diabetes education is held a cornerstone in modern diabetes treatment. All managed care organizations in the US have made comprehensive changes to their systems to encourage and support better care, including more support for selfmanagement by patients [56]. Supporting self-management means the use of effective self-management support strategies that include assessment, goal setting, action planning, problem solving, and follow up [57]. Goal setting is related to self-efficacy and should be targeted to realistic goals that really matter. Action planning will not be realized if the support strategies are expensive and burdensome for patients or health care professionals. Problem-solving primarily needs mutual understanding with our patients about the origin of the problems in achieving the goals that doctors, diabetes nurses and dieticians put forward. If health care providers set demanding targets, which often require important changes in patient’s lifestyle, they may cause problems for patients that did not exist before diagnosis. It is striking that the prevalence of depression decreases linearly with increasing insulin resistance among women without diabetes and then increases among women with diabetes. This finding might be due to patients developing depression as a result of this diagnosis [58]. Random allocation to a more stringent target appeared to be associated with a greater perceived burden of treatment and less positive affect [59]. Diabetes education should take the shortest and simplest way to achieve what is feasible and of importance for a patient’s life. And last but not least: education without regular follow-up is more or less worthless. As Anderson [60] noted already in 1990: effective diabetes self-management programs must be noncomplex, individualized to a person’s lifestyle, reinforced over time and respecting an individual’s habits. We would like to add to this list of requirements: self-management programs should primarily focus on adherence to medication, be cheap and very practical.

References 1 2

Diabetes Care and Research in Europe: The Saint Vincent declaration. Diabet Med 1990;7:360. DCCT Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977–986.

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3

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8

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17 18 19 20 21 22 23

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Prof. Guy Rutten, MD, PhD University Medical Center Utrecht Julius Center for Health Sciences and Primary Care HP Stratenum 6.131, PO Box 85060 NL–3508 AB Utrecht (The Netherlands) Tel. ⫹31 30 2538154, Fax ⫹31 302539028 E-Mail [email protected]

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Group Education for Type 2 Diabetes The Minneapolis Experience

Marion J. Franz Nutrition Concepts by Franz, Minneapolis, Minn., USA

Abstract Type 2 Diabetes BASICS is a group education program. It consists of four sessions with a total of 5–7 h of education and is team taught by diabetes dietitian and nurse specialists. The emphasis is on empowering patients to self-manage their diabetes with a curriculum based on ‘need to know’ rather than ‘nice to know’ topics. Central to the curriculum are lifestyle interventions which also have been prioritized. The first priority is to implement lifestyle interventions that improve glycemia as lifestyle changes on blood glucose are observed almost immediately. The food and meal planning approach used is carbohydrate counting which focuses on total carbohydrate intake, energy intake, and postprandial glucose levels and is the second priority. The third priority is to encourage increased physical activity; the goal for patients is to accumulate 30 min or more of activity nearly every day. The fourth priority is to monitor outcomes to determine if target goals are being achieved or if a change in medication(s) is necessary. In a randomized clinical trial comparing group or individual educational settings, decreases in HbA1c levels from 8.2–9% at baseline to 6.5% at 6 months were achieved by both interventions. Copyright © 2005 S. Karger AG, Basel

Type 2 Diabetes BASICS [1] is a group education program for persons with type 2 diabetes that is ‘embedded’ in Staged Diabetes Management (SDM), a practice management program developed at the International Diabetes Center (IDC) in Minneapolis, Minn., USA [2]. Primary care physicians at Park Nicollet Health Services (a large primary care and multi-specialty medical center with numerous satellite medical clinics in Minneapolis) and diabetes educators receive training in SDM for type 2 diabetes in which at diagnosis for type 2 diabetes patients are to be referred for self-management education to diabetes dietitian and nurse specialists at the IDC located in the main center of Park Nicollet. Outcomes from the program have been collected and reported [3].

The objectives of this paper are to (1) describe the group education program; (2) review evidence used to develop the lifestyle interventions for the self-management training program; (3) present the outcomes comparing the BASICS education program curriculum applied either in a group or individual settings, and (4) summarize the benefits from group education for both patients and professionals.

Type 2 Diabetes BASICS Education Program

Group education is defined as two or more but less than 10 patients. All patients in the group are similar in their stage of diabetes management, which in this case means they are newly diagnosed or in need of a review of selfmanagement skills, and are treated with nutrition therapy alone or a combination of nutrition therapy and oral glucose-lowering agents. In addition they all speak and understand the same language and do not require an interpreter. Patients are encouraged to bring with them at no additional cost family members or other support persons. The BASICS program consists of four sessions with a total of 5–7 h of education. The initial session is 3 h, the 2-week follow-up session 2 h, and the 3- and 6-month sessions 1 h. Group sizes are 4–8 and are team taught by diabetes dietitian and nurse specialists. Of importance, the program is an adult education program emphasizing empowering the patient by increasing knowledge, facilitating self-management behavior changes, and modifying perceptions, while achieving clinical success [3]. The curriculum includes topics based on ‘need to know’ versus ‘nice to know’ information and is staged to provide specific content at appropriate times. The conceptual framework for BASICS is based on the following models: • Adult learning model: supports self-management and control; incremental ‘need to know’ information presented in a supportive environment • Public health model: focuses on prevention of disease (long-term complications) and promotion of healthy living • Health belief model: addresses the patient’s belief that behavior change can control diabetes • Transtheoretical model: incorporates moving a patient from precontemplation to action using cognitive learning concepts At session 1, patients are asked to arrive 20 min early during which time they complete a pre-knowledge test, adult diabetes history form including medication and food histories, and are monitored for blood pressure, height and weight. If a recent hemoglobin A1c is available it is recorded or the patient is scheduled to

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have one done. The session begins with a welcome and introduction of staff and participants and covers an introduction to diabetes management, food planning (carbohydrate counting), and self blood glucose monitoring. The assignment for the next session is to keep food and blood glucose records. Session 2 follows in 2 weeks and covers a record book review, blood glucose highs and lows, carbohydrate counting review, lipids and heart-healthy eating, and alcohol. At the end of this session participants identify personal goals. Other topics covered in sessions 3 and 4 include problem solving for blood glucose values out of range, sick day management, blood pressure targets, foot care, review of estimating food portions, dining out, physical activity, balancing stress, the natural progress of diabetes over time, and monitoring for diabetes complications. For the first 2 weeks, patients check their blood glucose level fasting, before and 2 h after the start of their largest meal. After blood glucose levels become more stable, patients test less frequently, generally 2 or 3 days a week. The goals are to achieve plasma glucose goals of 90–130 mg/dl before meals, ⬍180 mg/dl 2 h after meal, and an A1c of less than 6.5–7%. Patients strive to have 50% of their blood glucose readings in the target range. This recommendation is based on research in which A1c values were correlated with average blood glucose readings and percentages of blood glucose measurements within, above, and below a target range of 70–150 mg/dl [4]. To achieve an A1c of ⬍7%, 49% of the readings needed to be in target range and no more than 33% above and no more than 18% below.

Lifestyle Interventions

Lifestyle interventions have been prioritized (fig. 1). The first priority is to focus on lifestyle changes that improve blood glucose control. This was chosen as the first priority because the impact of lifestyle changes on blood glucose values are observed almost immediately. Lifestyle strategies to improve lipids and blood pressure are addressed in follow-up sessions. Because it is the balance between carbohydrate and insulin that determines blood glucose values, especially postprandially, the second priority is to introduce carbohydrate counting. Carbohydrate counting controls total carbohydrate intake, energy intake, and postprandial glucose levels. The third priority is to set goals for physical activity. It is essential that food and blood glucose records be used to determine if lifestyle changes alone will improve glycemia and other metabolic parameters or if medications need to be added or changed. Therefore, the fourth priority is to provide feedback to the patient and the referring physicians regarding outcomes from lifestyle interventions.

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Emphasize blood glucose control

Medical nutrition therapy

Focus on carbohydrate foods, portions, and number of servings per meal Encourage physical activity Use food records with blood glucose monitoring data

Fig. 1. Prioritizing nutrition recommendations.

Carbohydrate Counting The food and meal planning strategy used is carbohydrate counting. It has been found to be useful for all persons with diabetes and emphasizes the total amount of carbohydrate consumed rather than the source (starch or sugar) or the type (glycemic index). The basic concepts of carbohydrate counting are that patients need to know what foods are carbohydrate, average portion sizes for one carbohydrate serving, and how many servings to select for meals and snacks (if desired). Foods are grouped into three categories: carbohydrate, meat and meat substitutes, and fats. Food sources of carbohydrate are starches, starchy vegetables, fruits, low-fat milk, and desserts. One carbohydrate serving is the amount of food that contains 15 g of carbohydrate. Nonstarchy vegetables are considered ‘free foods’ and patients are encouraged to eat raw and green and leafy vegetables, moderate portions of lean meats and meat substitutes, and to be cautious in their fat intake, choosing healthy types of fat [5, 6]. Women often start with 3 or 4 carbohydrate servings per meal and men with 4–5; 1–2 can be chosen for a snack. Day-to-day consistency is emphasized and individuals are asked to test post-meal with the goal being a blood glucose ⬍160–180 mg/dl. Patients provide feedback as to the feasibility of this amount and to any changes they desire. In a study done previously at the IDC using this approach, it was reported that in patients with a diagnosis of diabetes of less than 6 months, A1c values were decreased by ⬃2% and in patients with average 4-year duration of diabetes by ⬃1% [7]. Furthermore, the outcome of this intervention is known by 6 weeks to 3 months and at this point it can be determined if target goals are achieved by nutrition therapy alone or if changes in medications are needed. For some patients already on glucose-lowering medications, medications can be discontinued or the dose reduced. Other patients may require the addition

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of medications. The majority of the improvements from the BASIC interventions are achieved by 3 months [3]. Carbohydrate counting has been reported to be useful for patients with type 1 diabetes in the Diabetes Control and Complications Trial [8] and more recently in the DAFNE study [9]. Based on these results it was determined that it also would be helpful to persons with type 2 diabetes and would assist them in reducing energy intake and controlling blood glucose levels. Investigators in the United Kingdom Prospective Diabetes Study (UKPDS), reported a fall in A1c of ⬃2% during the first 3 months using intensive diet and a 5% weight loss [10]. They suggested the initial glucose response was more related to a decrease in energy intake than to weight loss and that the decrease in body weight was a secondary response to the decrease in energy intake. Furthermore, Rory Holman stated, ‘The real problem is the progressive decrease in beta cell function… we are now duty-bound to explain this to our patients at the onset… and not to castigate them because they failed to diet’ [11]. Physical Activity Individuals are encouraged to begin a physical activity such as walking for 20 min, one or two times per week. The goal is for patients to accumulate 30 min or more of moderate intensity physical activity nearly every day. Physical activity improves insulin resistance independent of weight loss [12], acutely lowers blood glucose concentrations, and decreases all-cause mortality rates in adults with diabetes [13]. In an observational cohort study the all-cause death rates in men with diabetes were calculated across quartiles of fitness and body mass categories [14]. Study participants were 2,196 men with diabetes who had undergone a maximal exercise test and body composition assessment between 1970 and 1995, with mortality follow-up to 1997. Risk of all-cause mortality was inversely related to cardiorespiratory fitness and independent of body mass index (BMI) or body fat percentage. Previously, this same group had reported that low fitness is a risk factor for mortality in men with diabetes [15] and for women [16]. Goal Setting Goal setting is an important component of the self-management program. Patients are encouraged to select one or two goals at a time related to their diabetes. Common self-management goals are consistent carbohydrate servings for meals, regular physical activity, and monitoring blood glucose as needed. Goals must be specific, written in behavioral language, realistic for the patient, and positive. The goal must state what they are going to do, when they are going to do it, and why they are going to do it. The ‘why’ relates to quality of life or a health belief.

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The Natural Progression of Diabetes The natural history of diabetes is also explained to patients. This is done to help them understand that treatment options may change over time and that a therapy that once worked for an individual may no longer be effective as diabetes changes over time. An important goal is to control blood glucose levels. For many individuals insulin injections may be needed at some point and insulin regimens can be adapted to fit most lifestyles. It is not that ‘diet fails’ or that ‘diabetes pills fail’ but the disease changes as the ‘beta cells fail’ and the changes are not their ‘fault.’ Understanding the progression of diabetes helps increase patient’ readiness for therapy changes in the future. Food and Blood Glucose Records Food and blood glucose records are used to improve metabolic control. Food records are compared with the food plan to assess whether the initial food plan was feasible for the patient to implement and whether medical goals are being met. Consistency in carbohydrate intake is emphasized and the results of blood glucose tests pre-and post the largest meal are used to determine if food and activity changes are needed or if medication adjustments are required. Changes in therapy are recommended if blood glucose levels or A1c have not shown a downward trend, if the patient has lost weight with no improvement in glucose, or if the patient is doing well with the food plan and physical activity and further lifestyle interventions are unlikely to improve medical outcomes [17]. Primary care providers are responsible for specific medication changes.

Follow-Up

After the initial teaching sessions, primary care physicians are encouraged to refer their patients to the Assessment Center at the IDC annually. The assessment includes an HbA1c test, lipid profile, blood pressure check, kidney function (albumin test), retinal photograph, and foot examination. During the visit, diabetes self-care skills and food and meal planning are reviewed with a dietitian and nurse. A behavioral specialist talks to each patient about how they feel their day-to-day diabetes management is going. At the end of the visit, the patient receives their test results, meets with a nurse practitioner to discuss specific recommendations for follow-up care and to develop a personal action plan. All results are then sent directly to the patient’s physician. Within a few weeks of this appointment, the patient and their physician meet to discuss results and the personal action plan.

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Evaluation

In a randomized clinical trial, 170 patients with type 2 diabetes were randomly assigned to either group (n ⫽ 87) or individual (n ⫽ 83) educational settings provided by the diabetes team (dietitian and nurse) [3]. Outcomes included changes in knowledge, self-management behaviors, HbA1c, weight, BMI, health-related quality of life, patient attitudes, and change in the medication regimen and were assessed at baseline and after the 2-week, 3-month, and 6-month education sessions. Both educational settings had similar improvements in all of the measures. In the patients receiving group education, HbA1c decreased from 9.0 ⫾ 1.6% at baseline to 6.5 ⫾ 0.7% at 6 months (p ⬍ 0.01) and in the patients receiving individual education, from 8.2 ⫾ 1.7% to 6.5 ⫾ 0.9% (p ⬍ 0.01). Without a major emphasis on weight reduction, patients in the group sessions lost 2.6 kg at 6 months and patients in the individual sessions 4.7 kg. The changes in HbA1c and weight were not statistically significant between groups but the change from baseline was significant (p ⬍ 0.01) for both.

Benefits of Group Education

There are benefits to patients, educators, and primary care physicians from a group diabetes education program that is embedded in a large medical center in Minneapolis, Minnesota. In summary, the benefits of group education are the following: • Participants receive support and motivation to change from one another • Group members learn from one another and from the discussion of common questions and concerns • Educators use a curriculum which provides consistency in the education program; patients complete assessment tools which assist in the efficient use of time • Responsibility for evaluation of outcomes and for decision-making is shared by the educators and patients • Educators enjoy groups!

References 1 2

Rickheim P, Flader J, Carstensen KM: Type 2 Diabetes BASICS. A Complete Curriculum for Diabetes Education. Minneapolis, IDC Publishing, 2000. Mazze R, Strock E, Simonson G, Bergenstal R, Etzwiler D: Staged Diabetes Management Decision Paths, ed 3. Minneapolis, International Diabetes Center; 2001.

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3 4 5 6 7

8 9

10 11 12

13 14

15

16 17

Rickheim PL, Weaver TW, Flader JL, Kendall DM: Assessment of group versus individual diabetes education. Diabetes Care 2002;25:269–274. Brewer KW, Chase HP, Owen S, Garg DK: Slicing the pie. Correlating HbA1c values with average blood glucose values in a pie chart form. Diabetes Care 1998;21:209–212. International Diabetes Center: My Food Plan. Minneapolis, IDC Publishing, 2004. American Diabetes Association and American Dietetic Association. Basic Carbohydrate Counting. Alexandria/Chicago, American Diabetes Association/American Dietetic Association, 2003. Franz MJ, Monk A, Barry B, McClain K, Weaver T, Cooper N, Upham P, Bergenstal R, Mazze RS: Effectiveness of medical nutrition therapy provided by dietitians in the management of noninsulin-dependent diabetes mellitus: A randomized, controlled clinical trial. J Am Diet Assoc 1995;95:1009–1017. The DCCT Research Group: Nutrition interventions for intensive therapy in the Diabetes Control and Complications Trial. J Am Diet Assoc 1993;93:768–772. DAFNE Study Group: Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: Dose adjustment for normal eating (DAFNE) randomized controlled trial. BMJ 2002;325:746–752. UK Prospective Diabetes Study 7: Response of fasting plasma glucose to diet therapy in newly presenting type II diabetic patients. Metabolism 1990;39:905–912. Bloomgarden ZT: European Association for the Study of Diabetes Annual Meeting, 1999. Diabetes Care 2000;23:1016. Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW: Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care 2003;26:557–562. Gregg EW, Gerzoff RB, Caspersen CJ, Williamson DF, Narayan CJ: Relationship of walking and mortality among US adults with diabetes. Arch Intern Med 2003;163:1440–1447. Church TS, Cheng YJ, Earnest CP, Barlow CE, Gibbons LW, Priest EL, Blair SN: Exercise capacity and body composition as predictors of mortality among men with diabetes. Diabetes Care 2004;27:83–88. Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN: Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Diabetes Care 2000;132:605–611. Farrell SW, Braun L, Barlow CE, Cheng YJ, Blair SN: The relation of body mass index, cardiorespiratory fitness, and all-cause mortality in women. Obes Res 2002;10:417–423. Franz MJ, Reader D, Monk A: Implementing Group and Individual Medical Nutrition Therapy for Diabetes. Alexandria, American Diabetes Association, 2002.

Marion J. Franz, MS, RD, CDE Nutrition Concepts by Franz, Inc. 6635 Limerick Drive Minneapolis, MN 55439 (USA) Tel. ⫹1 952 941 6751, Fax ⫹1 952 941 6734 E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 70–82

Structured Treatment and Teaching Programmes for Patients with Diabetes mellitus and Hypertension in Germany Monika Gruesser, Viktor Jörgens EASD, Düsseldorf, Germany

Abstract For many years, patient education programmes for people with diabetes and hypertension have been evaluated in the health care system. Since 1991, office-based physicians have been remunerated for providing structured treatment teaching programmes for outpatients with diabetes mellitus. Today, with the nationwide implementation of disease management programmes for diabetes and coronary heart disease, these programmes have become more and more popular. To date, four different programmes have been implemented in the German healthcare system. Remuneration costs amount to 130 EUR per patient and completed course. Data collected on people with diabetes or hypertension demonstrate the efficacy of the programmes at the treatment level. The results demonstrate the practicability and the efficacy of the implementation of programmes as an integral part of the disease management in routine care. Copyright © 2005 S. Karger AG, Basel

Diabetes Care in the German Health Care System

In Germany, ambulatory care is exclusively provided by physicians in private practices. Since 1991, structured education and teaching programmes have been implemented in these practices. The different programmes and their evaluation are described in this article.

Programme for People with Non-Insulin-Treated Type 2 Diabetes

In a prospective controlled trial, a structured teaching and treatment programme for non-insulin-treated type 2 diabetic outpatients [1, 2] was successfully evaluated [3]. In this trial, due to a relevant weight reduction, the

number of patients requiring oral anti-diabetic agents or insulin was more than 50% lower in the intervention group. Following the publication of this trial in 1991, the German compulsory health insurances, and the physicians’ association in ambulatory health care, with the support of the German Diabetes Association, decided to provide this programme nationwide and to remunerate physicians for the work involved. This was the very first recognition of patient education in the German ambulatory health care system and, to our knowledge, the first time worldwide that costs for structured patient education in diabetes care have been covered at the national level. A prerequisite for remuneration was that physicians and their personnel attend a structured postgraduate seminar. Following the implementation, a study was carried out in Hamburg to evaluate the effects of this programme in routine primary health care [4]. The effects in Hamburg, where the multiplication of the programme was carried out by local diabetologists, were similar to the results of the previous controlled trial carried out under ‘laboratory conditions’ by our team [3]. As this programme is strictly based upon an initial non-drug treatment of type 2 diabetes, and emphasizes weight reduction as the most effective initial treatment, the costs for education are lower than the money saved by reducing the use of oral antidiabetic agents [4]. This positive cost-benefit analysis – even without considering the possible long term savings of improved diabetes care – was the most important argument for health insurances. Later, the programme was adopted by several countries. A multicenter study from South America again demonstrated the effects of the programme, which are given in detail in table 1 [5]. To date, over 25,000 physicians in Germany have participated in the postgraduate courses of the programme. Remuneration costs amount to 100 EUR per patient per course. So far, material for over 1,200,000 patients has been compiled by the physicians. The publishing house, Deutsche Ärzte-Verlag, owned by the German physicians’ associations, handles programme provision, including continuous updating of information on the web (Patientenschulungsprogramme.de). The material used for patient education in the physician’s offices consists of a set of posters, a set of colored cards of original-sized nutrients, which are used for diet education representing nutrients with 100 calories on each picture, a curriculum log book, and memory cards for the teaching personnel as well as material for the patients (fig. 1).

Programme for Conventional Insulin Therapy

A structured treatment and teaching programme for patients with conventional insulin therapy [6] was evaluated in a prospective controlled trial [7]. As

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Table 1. A model educational programme for people with type 2 diabetes without insulin: a cooperative Latin American implementation study [5] n

446

Age, years Diagnosis of diabetes, years % female BMI

54.6 ⫾ 10.1 8.00 ⫾ 13 36 31.5 ⫾ 5.6 Fasting blood glucose, mg/dl 191 ⫾ 63 184 ⫾ 59 158 ⫾ 52 158 ⫾ 56* 158 ⫾ 49* 157 ⫾ 54*

–6 months 0 1 month 4 months 8 months 12 months

HbA1c, %

Weight, kg

9.0 ⫾ 2.0 8.9 ⫾ 2.1 – 8.3 ⫾ 3.3 7.9 ⫾ 1.7* 7.8 ⫾ 1.6*

84.6 ⫾ 14.7 83.2 ⫾ 14.9 81.8 ⫾ 14.9** 81.4 ⫾ 14.5** 81.2 ⫾ 14.3** 81.2 ⫾ 15.2**

*p ⬍ 0.001; **p ⬍ 0.05 (compared with month 0)/mean ⫾ (SD)/HbA1c normal range 4.3–5.8%.

Fig. 1. Educational material for patients with DM type 2 without insulin.

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Table 2. A structured ambulatory programme is as effective as the same programme used during inpatient care [10] Inpatients

Outpatients

p

Patients Women/men Age, years Diagnosis of diabetes, years BMI Self-monitoring, % patients HbA1c, %

70 48/22 63.7 ⫾ 10.0 9.47 ⫾ 5.5 29.2 ⫾ 6.9 7.1 10.3 ⫾ 2.2

70 48/22 64.5 ⫾ 8.2 9.48 ⫾ 5.2 28.3 ⫾ 4.5 22.9 10.4 ⫾ 1.6

n.s. n.s. n.s. 0.02 n.s.

Reevaluation Patients Insulin, IU/kg body weight Injections/day BMI HbA1c, %

70 0.41 ⫾ 0.2 2 ⫾ 0.67 29.5 ⫾ 6.6 8.1 ⫾ 1.7

70 0.43 ⫾ 0.24 2.1 ⫾ 0,6 28.9 ⫾ 4.4 8.4 ⫾ 1.7

n.s. n.s. n.s. n.s.

it was considered unethical to introduce insulin therapy without patient education, a study was carried out comparing the same programme with ambulatory patients and during inpatient treatment in the diabetes unit of the University Hospital of Jena. The question was: If there is no difference in outcome, should the programme be promoted using outpatients? The data, which are given in detail in table 2, convinced the health insurances to remunerate physicians in ambulatory care for providing the programme – aiming at a reduction of health care costs due to less hospitalization. The inpatients programme was attended by 70 patients, and 70 patients for the outpatients programme. There was no difference between sex, age or duration of diabetes, BMI and initial HbA1c. At re-evaluation, HbA1c substantially decreased in both groups by 2% in the inpatient group and 2.2% in the outpatient group. Body weight did not significantly increase in contrast to many other studies, which initiated conventional insulin therapy. We explain this observation by the structured educational intervention. The first state in Germany to implement this programme was Brandenburg. Here, we evaluated the implementation of the programme, which was organized by local diabetologists providing the postgraduate courses [8]. The results of this study were the following: The medical and educational content of the training course were rated positively by the interviewed physicians: 90% rated the content as ‘good’ and ‘useful’; 10% reported that they had learnt ‘nothing new’. The time schedule of the training course for physicians (1 day) and the additional educational training of the office staff (1.5 days) were rated as

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follows: 88% found the time frame adequate, 11% felt the training course was too long, 1% too short. The teaching material was also rated ‘very good’ or ‘good’ with no changes suggested by 95% of the physicians (n ⫽ 84), 5% of the physicians suggested changes or additional material. Of the 103 physicians, 60% had performed at least one programme in their practice by the time of re-evaluation. The other 41 physicians gave the following main reasons for not yet conducting a course in their practice: lack of time to organize the group teaching 27%; lack of time of the assistant 15%; insufficient number of interested patients 15%; referral to specialized practice 12%; reconstruction/move of office 12% (the study was carried out shortly after the reunification of Germany). In the 8 months after participating in the training courses, the 62 practices performed an average of 4.2 courses (⫾6.6; range 1–43) with 2.7 patients per course. Of these physicians, 69% indicated that the programme facilitated the care of their patients; 14.5% reported no change after the programme, 11% had no opinion, 5% indicated a negative effect on patient care. Of the physicians, 4% noticed more frequent patient consultation after the programme, 4% less frequent, and 92% an unchanged rate of consultation (n ⫽ 53). The results on the patients’ level were similar to the controlled study, which was described above: HbA1c decreased substantially. To date, nearly 13,000 physicians in Germany have participated in the postgraduate courses. Remuneration costs amount to 130 EUR per patient per course. In each course, up to 4 patients can participate in the five sessions, which are carried out over four weeks. Material for 340,000 patients has so far been ordered in the Deutscher Ärzte-Verlag. In a further study, performed by the Friedrich Schiller University Jena (Prof. U.A. Müller), the positive effect of the implementation of this programme on the quality of patient care was evaluated in a population-based prospective study [9].

Programme for Preprandial Insulin Therapy

As an alternative to conventional insulin therapy, a structured treatment and teaching programme for patients with preprandial [10] regular insulin therapy was developed at the University of Düsseldorf in cooperation with the Friedrich Schiller University Jena. The main advantage of starting insulin therapy with preprandial injections of regular insulin before main meals is the liberalization of ‘diet’ and daily life style (e.g. timing of meals). The patients do not need to plan meals or snacks, as is necessary when insulin therapy is initiated predominantly with longer-acting insulin. In this programme, intermediate-acting insulin (bedtime NPH) is started when 3 injections of preprandial regular human insulin

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are no longer sufficient to achieve good metabolic control. In Germany, this programme is increasingly being used in ambulatory care as an alternative to conventional insulin therapy. Physicians are remunerated for the five sessions of the programme, which can be provided to groups of up to four patients. The sixth session is also remunerated when long-acting insulin at bedtime becomes necessary. This session is mostly provided in a one-to-one teaching session, when this additional injection is required. Three studies were carried out evaluating this programme. In an uncontrolled pilot study, a formative evaluation of the programme was carried out [11]. The results were encouraging. Patients’ compliance to blood glucose monitoring and self adaptation of the insulin dosage was unexpectedly high and metabolic control improved substantially without observing any severe hypoglycemic events. The study included 77 patients with a mean age of 53.3 years. Two years after the programme, HbA1c had decreased from 9.2 to 7.4. Of the patients, 88% adapted their insulin dosage independently. Following these encouraging results, a prospective controlled trial was performed [12]. In this study, 66 patients participated in the new programme in private practice. Their results were compared with 64 matched controls, which started insulin therapy with the conventional strategy using mixtures of regular and NPH-insulin. In this study, HbA1c was significantly lower in the group having followed the preprandial therapy with regular insulin. No severe hypoglycemic event was observed; the total insulin dosage in both groups was not statistically different. The third study evaluated the implementation of this programme in routine care [13]. The programme was implemented in seven private practices. The physicians and their personnel had been trained in the past to perform patient education programmes for type 2 diabetes. For the new programme, a 4-hour course, explaining the different approach, was carried out. Following the seminar, the practices consecutively recruited patients for the programme. A total of 117 patients were recruited, of which 55 were female, and the mean age was 61.7 ⫾ 11 years. The age at diagnosis of diabetes was 49.1 ⫾ 12.7 years. HbA1c decreased from 9.4 ⫾ 1.5 initially, to 7.7 ⫾ 1.3 after 7 months (p ⬍ 0.0001). No severe hypoglycemia was observed. BMI was 31.2 before, and 31.4 seven months after the programme (n.s.). Before the programme, the patients measured blood glucose seven times per week (7.0 ⫾ 9.0), seven months later 22.0 ⫾ 6.5 measurements per week were performed. Seven months after the programme, 75.4% of the patients adapted their insulin dosage without any assistance. We concluded that patients’ compliance to the objectives of the programme was very high. This might be explained by the advantages of a free diet and lifestyle. Metabolic control achieved values, which fulfilled the targets set by recent studies [14, 15].

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Fig. 2. Educational material for patients with hypertension.

Programme for People with Hypertension

It has been demonstrated that a structured treatment and teaching programme results in a substantial improvement of the compliance to both pharmacological and non-pharmacological antihypertensive treatment and, therefore, results in a major improvement of blood pressure control [16–18]. Especially in people with diabetes, the need for better care of hypertension has become increasingly important following the results of the UKPDS [19]. Similar to diabetes care, the quality of hypertension treatment can be substantially improved enabling the patient to play an active role in his daily care. Our group developed a structured treatment and teaching programme for patients with hypertension (fig. 2) [20]. Following formative evaluation, this programme was evaluated in a prospective randomized controlled trial [21, 22] (table 3): 100 patients participated in the programme. Another 100 patients continued routine care. Systolic and diastolic blood pressure remained unchanged in the control group. In the intervention group, a relative improvement of systolic and diastolic blood pressure was observed: after 3 years a reduction of systolic 10 and diastolic 9 mm Hg was observed; changed use of antihypertensive agents was unable to explain this improvement. We therefore conclude that the improvement in blood pressure was due to an increased compliance of patients to the medication. Based upon these results, with the support of the German Ministry of Health, we conducted a model project implementing the

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Table 3. Results of a prospective controlled trial of the structured treatment and teaching programme for people with hypertension [14] Controls (n ⫽ 100; 57 female)

Interventions (n ⫽100; 53 female)

Age, years 50.7 ⫾ 6.7 Weight, kg 83.7 ⫾ 13.2 Blood pressure, mm Hg Before 159/97.7 After 18 months 157/95.8 After 36 months 155.9/94.5

51 ⫾ 5.6 81.7 ⫾ 13.9

162/100.6 153.9/94.6 152/91.6

Table 4. Evaluation of the implementation of the programme for hypertension in Mecklenburg-Vorpommern and Westfalen-Lippe into routine care; patient data – results before and after (median 22.5 weeks, range 2–40) participation in the programme [19] n (pairs)

Systolic BP, mm Hg* Diastolic BP, mm Hg* Body weight, kg BMI

Baseline

Follow-up

p

Mean difference [95% CI]

mean ⫾ SD range

mean ⫾ SD range

211

158 ⫾ 17

115–227

148 ⫾ 16

110–225

ⱕ0.001

86 ⫾ 8

61–115

ⱕ0.001

52–132

86 ⫾ 15

50–128

ⱕ0.001

29.9–46.9

30.6 ⫾ 5.2

19.5–46.9

ⱕ0.001

–10.0 [(–12.2)–(–7.9)] –5.2 [(–6.4)–(–3.9)] –2.0 [(–2.4)–(–1.6)] –0.7 [(–0.8)–(–0.6)]

211

92 ⫾ 9

73–116

214

88 ⫾ 15

191

31.3 ⫾ 5.3

*Means of two office BP measurements.

programme in ambulatory health care in two German regions (MecklenburgVorpommern and Westfalen-Lippe) [23]. The results of this study are given in table 4. In this study, a postgraduate course for primary care physicians and their teaching personnel was performed by local specialists for hypertension.

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Nevertheless, the results of the multiplication were similar to the prospective controlled trial performed by our group. Blood pressure decreased significantly at follow-up after an average of 22 weeks and the body weight of the patients decreased significantly – weight reduction being the most relevant non-pharmacological intervention in obese hypertensive patients represents an important part of the curriculum. This programme consists of four sessions, which are provided for up to four patients in ambulatory care with a weekly interval, meaning that the entire curriculum finishes after four weeks. The programme is being increasingly implemented in the German health care system as part of the disease management programmes. Recent data support the tremendous importance of patient education and hypertension enabling the patients to perform blood pressure selfmeasurements. The recent work of Bobrie et al. [24] demonstrated that blood pressure self-monitoring values correlated far better to hard endpoints than blood pressure values measured by physicians or their personnel. In the future, it will become mandatory to include structured education for blood pressure selfmeasurement in all trails aiming at hard endpoints in hypertension. The programme for hypertension education, published by our group, was implemented in 2004 in 10,000 offices, and a total of 190,000 patients had received the patient education material.

Structured Teaching and Treatment Programme for Intensified Insulin Therapy

Intensified insulin therapy, which became the standard treatment in people with type 1 diabetes and in people with type 2 diabetes with relevant insulin deficiency, requires a more extensive curriculum than insulin therapy in type 2 diabetes. According to many studies, curricula for structured education aimed at people with intensified insulin therapy require at least 20 h of education. Structured patient education for intensified insulin therapy was implemented in the 1980s in some places in Europe. We are proud to have participated in probably the most active group setting up and evaluating programmes for type 1 diabetes in Europe. Following formative evaluation and prospective controlled studies, a landmark study was published by Muehlhauser et al. [25]. This randomized prospective controlled trial compared 100 patients with standard therapy, without self-monitoring, with the outcome of 100 patients with intensified insulin therapy who performed blood glucose self-monitoring and who had participated in a structured teaching and treatment programme in the University Clinic of Bucharest, Romania. The mean age of the patients was 26 years. The outcome was striking. Whereas in the group with standard treatment, HbA1c

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after 1 year continued to be high, in the intervention group HbA1c dropped by 3% (from 12.3 to 9.3%, measured with micro-columns with an upper normal value of 8). The question remained how to implement such a programme in the German health care system, and therefore, the German government funded a 6-year trial in nine city hospitals in Germany, which was finally published in 1993 [26]. In the study, 579 consecutively recruited type 1 diabetic patients form 9 city hospitals, and 118 patients from the University of Düsseldorf (patient age: 26 ⫾ 7 years, duration of diabetes: 8 ⫾ 7 years) participated in a structured 5-day treatment and teaching programme. The patients were re-evaluated after 1, 2 and 3 years. They would trade in performing independently intensive insulin therapy including liberalization of diet and blood glucose self-monitoring. Before this study, it was frequently argued that liberalization of diet, based upon self-monitoring, may lead to an increase in body weight, may worsen metabolic control, and may lead to a decrease in HbA1c, increased the incidence of hypoglycemia. All these speculations could be ruled out by the results of the study. The introduction of intensified insulin therapy was extremely successful. Before the programme, only 13% were on intensified insulin therapy, after 3 years, 80% accepted and practiced this therapy. The so-called compliance to blood glucose monitoring with over two measurements per day was extremely high and exceeded 70% in the third year. The insulin dosage per kilogram body weight per day did not significantly increase over time and the body mass index of patients continued to be in the range of 23 at 1, 2 and 3 years. There was a slight increase in the first year, which is explained by patients who were in severe insulin deficiency at the moment of the education programmes, and therefore, gained weight in the first year. The levels of glycated hemoglobin substantially decreased without an increase of the frequency of the incidence and prevalence of severe hypoglycemia defined by loss of consciousness or injection of glucagons. This finding was in contrast to some other data, especially the DCCT. The difference between the data may be explained by the total lack of a structured education programme, which was not introduced in the DCCT centers, and this response was the reason that the incidence of severe hypoglycemia was dramatically different between the centers in the DCCT. The results described above were based on an inpatient education programme. Pieber et al. [27] published the results of an outpatients’ programme based upon the same curriculum. The results were very similar. Recently in Germany, disease management programmes for type 1 diabetes were introduced into the health care system. The education programme for intensified insulin therapy we evaluated over many years also received accreditation from the national health authorities and the Germany Diabetes Association. The education material consists of a set of posters and a lot of material to teach dose adaptation and liberalized diet [28–30] (fig. 3).

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Fig. 3. Educational material for patients with intensified insulin therapy.

Conclusions

Over the last two decades in Germany, patient education has become an integral part of ambulatory health care for people with chronic diseases. The implementation of diabetes education programmes was always at the forefront of this development. Nevertheless, problems are still occurring in other chronic diseases and special target groups of people with diabetes, like immigrants. In addition, more precise evaluation data on the population-based quality of care have to be provided to continuously monitor the quality of education and care of different patient groups with diabetes.

References 1

2

3

Berger M, Gruesser M, Joergens V, Kronsbein P, Muehlhauser I: Behandlungs- und Schulungsprogramm für Typ-2-Diabetiker, die nicht Insulin spritzen, ed 6. Köln, Deutscher Aerzte-Verlag, 2004. Joergens V, Gruesser M: Three years’ experience after national introduction of teaching programs for type II diabetic patients in Germany: How to train general practitioners. Patient Educ Counsel 1995;26:195–202. Kronsbein P, Joergens V, Muehlhauser I, Scholz V, Venhaus A, Berger M: Evaluation of a structured treatment and teaching programme of non-insulin-dependent diabetes. Lancet 1988;ii: 1407–1411.

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4

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6 7

8

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20 21

22

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Gruesser M, Bott U, Ellermann P, Kronsbein P, Joergens V: Evaluation of a structured treatment and teaching program for non-insulin-treated type 2 diabetic outpatients in Germany after the nationwide introduction of reimbursement policy for physicians. Diabetes Care 1993;16:1268–1275. Gagliardino JJ, Etchegoyen G: A model educational program for people with type 2 diabetes: A cooperative Latin American implementation study (PEDNID-LA). Diabetes Care 2001;24: 1001–1007. Berger M, Gruesser M, Joergens V, Kronsbein P: Behandlungs- und Schulungsprogramm für Typ2-Diabetiker, die Insulin spritzen, ed 5. Köln, Deutscher Aerzte-Verlag, 2004. Mueller UA, Mueller R, Starrach A, Hunger-Dathe W, Schiel R. Joergens V, Gruesser M: Should insulin therapy in type 2 diabetic patients be started on an out- or inpatient basis? Results of a prospective controlled trial using the same treatment and teaching program in ambulatory care and a university hospital. Diab Metabol 1998;24:251–255. Gruesser M, Hartmann P, Schlottmann N, Joergens V. Structured treatment and teaching program for type 2 diabetic patients on conventional insulin treatment: evaluation of reimbursement policy. Patient Educ Counsel 1996;29:123–130. Schiel R, Braun A, Rillig A, Ross I, Mueller UA: Patient education and better general health care improve the outcome of insulin therapy: A prospective, population-based survey (JEVIN). Diabetologia 2002;(suppl 2):A314. Berger M, Gruesser M, Joergens V: Behandlungs- und Schulungsprogramm für Typ-2-Diabetiker, die Normalinsulin spritzen, ed 3. Köln, Deutscher Aerzte-Verlag, 2004. Kalfhaus J, Berger M: Insulin treatment with preprandial injections of regular Insulin in middleaged type 2 diabetic patients. A two years observational study. Diab Metab 2000;26:197–201. Rauchfuß J, Kielstein H, Woellner W, Reuter H M, Boeger W, Lange W, Banduhn K, Joergens V, Mueller UA: Vor dem Essen Insulin: Supplementäre (SIT) versus konventionelle Insulintherapie (CIT) bei jüngeren Patienten mit Diabetes mellitus Typ 2. Diab Stoffwechsel 2001;10(suppl 1). Gruesser M, Hoffstadt, K, Joergens V: Structured outpatient education and treatment Programs for patients with diabetes mellitus and/or hypertension. Dis Manage Health Outcome 2003;11: 217–223. UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–353. UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865. Hinson J, Riordan K, Hemphill D, Randolph C, Fonseca V: Hypertension education: an important and neglected part of the diabetes education curriculum? Diabetes Educ 1997;23:166–170. Konrady AO, Brodskaya IS, Soboleva AV, Polunicheva YV: Benefits of the implementation of structured educational program in hypertension management. Med Sci Monit 2001;7:397–402. Cuspidi C, Sampieri L, Macca G, Fusi V, Salerno M, Lonati L, Severgnini B, Michev I, Magrini F, Zanchetti A: Short and long-term impact of a structured educational program on the patient’s knowledge of hypertension. Ital Heart J 2000;1:839–843. Gray A, Clarke P, Farmer A, Holman R: Implementing intensive control of blood glucose concentration and blood pressure in type 2 diabetes in England: Cost analysis (UKPDS 63). BMJ 2002; 325:860–863. Gruesser M, Joergens V: Behandlungs- und Schulungsprogramm für Patienten mit Hypertonie, ed 4. Köln, Deutscher Aerzte-Verlag, 2004. Muehlhauser I, Sawicki PT, Didjurgeit U, Joergens V, Trampisch HJ, Berger M: Evaluation of a structured treatment and teaching programme on hypertension in general practice. Clin Exp Hypertens 1993;15:125–142. Sawicki PT, Muehlhauser I, Didjurgeit U, Reimann M, Joergens V, Bender R, Berger M: Strukturoptimierung der antihypertensiven Therapie. Langzeitergebnisse einer randomisierten prospektiven Studie in Arztpraxen. Dtsch Aerztebl 1993;90:1736–1741. Gruesser M, Hartmann P, Schlottmann N, Lohmann FW, Sawicki PT, Joergens V: Structured patient education for out-patients with hypertension in general practice: A model project in Germany. J Hum Hypertens 1997;11:501–506.

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Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM: Cardiovascular prognosis of ‘masked hypertension’ detected by blood pressure self-measurement in elderly treated hypertensive patients. JAMA 2004;291:1342. Muhlhauser I, Bruckner I, Berger M, Cheta D, Jorgens V, Ionescu-Tirgoviste C, Scholz V, Mincu I: Evaluation of an intensified insulin treatment and teaching programme as routine management of type 1 (insulin-dependent) diabetes. The Bucharest-Dusseldorf Study. Diabetologia 1987;30:681–690. Jorgens V, Grusser M, Bott U, Muhlhauser I, Berger M: Effective and safe translation of intensified insulin therapy to general internal medicine departments. Diabetologia 1993;36:99–105. Pieber TR, Holler A, Siebenhofer A, Brunner GA, Semlitsch B, Schattenberg S, Zapotoczky H, Rainer W, Krejs GJ: Evaluation of a structured teaching and treatment programme for type 2 diabetes in general practice in a rural area of Austria. Diab Med 1995;12:349–354. Gruesser M, Joergens V: Behandlungs- und Schulungsprogramm für Patienten mit intensivierter Insulintherapie, ed 2. Mainz, Kirchheim-Verlag, 2005. Gruesser M, Joergens V: Im Restaurant; Apfelstrudel bis Zanderfilet. Interaktive Ernährungsberatung, ed 1. Köln, Deutscher Ärzte-Verlag, 2003. Gruesser M, Joergens V: Getränkeset, ed 1. Köln, Deutscher Ärzte-Verlag, 2005.

Dr. Viktor Jörgens EASD, Rheindorfer Weg 3 DE–40591 Düsseldorf (Germany), Tel. ⫹49 211 75 84 69 0 Fax ⫹49 211 75 84 69 29, E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 83–96

Impact of Education on the Quality of Diabetes Care in Germany Ulrich Alfons Müllera, Alexander Sämanna, Christof Kloosa, Ralf Schielb a

Friedrich Schiller University, Jena, and bInselklinik Heringsdorf GmbH, Ostseeheilbad Heringsdorf, Germany

Abstract This article summarizes population-based data measuring the quality of diabetes care in Germany. For more than 10 years, structured educational programmes for different forms of diabetes treatment have been implemented in hospitals and in the ambulatory health care system throughout Germany. These population-based data indicate that the quality of care in type 2 diabetes in Germany is not as poor as many people assume. Copyright © 2005 S. Karger AG, Basel

A working group of the German Diabetes Association since 1991 continuously collected data on people with type 1 diabetes following educational programmes that demonstrated substantial improvements in long-term care (www:med.uni-jena.de/akd). In contrast to data from the DCCT, these centers managed on a routine care level, to substantially decrease incidences and prevalence of hypoglycemia in type 1 diabetic patients. The center where the author works is located in the former eastern part of Germany. His group was able to provide data comparing the quality of diabetes care in insulin-treated patients through the time of change from centrally administered diabetes care to modern liberalized treatment and eating. The data demonstrate that modern education had been successfully implemented and metabolic control had not worsened despite a substantial liberalization of patients’ lifestyles. Patient education is the cornerstone of diabetes care, which can only become effective if patient responsibility for treatment is introduced into diabetic therapy. As an essential part of diabetes treatment, therapeutic patient education has to be evaluated as carefully as all other medical interventions.

Educational programs should be carefully planned and evaluated in controlled trials and, even more importantly, efforts should be made to measure the overall quality of care following the implementation of these programs. In this process, the effect of patient education cannot be separated from other parts of the treatment, like improved insulin therapy or self-monitoring. Finally, all interventions and therapeutic efforts should lead to improved well-being and quality of care for the patient [1].

How to Define the Quality of Diabetes Care

Patients and physicians define quality of care differently from one another. Physicians tend to put in the foreground measurable values and hard endpoints. Thus, their definition includes HbA1c levels, the frequency of severe hypoglycemia, hospitalization, the incidence of diabetic complications and life expectancy. Patients definition of better quality of care is focused on immediate consequences of therapeutic interventions with a direct impact on their dayto-day life. Consequently, they strive not to suffer from restrictions of diet and prefer treatments that are not a burden to their everyday routines. Additionally, they fight for social rights, such as free access and availability of monitoring material and insulin. Since reunification, the former East Germany has achieved substantial progress. Under the former GDR government almost no blood glucose monitoring material was available and quite rigid dietary and insulin regimes were promoted. Nowadays, based upon modern patient education, insulin therapy has become flexible and, based upon the principle of dose-adjustment for normal eating, educational programmes have been implemented.

How to Measure the Quality of Diabetes Care

The hard data, finally counting for health care authorities and representing a measure of the summary of all medical efforts in diabetes care on the public health level, include the following: HbA1c is the only available long-term parameter for glucose control serving as a valid marker for the risk of developing late diabetic complications. The incidence of severe hypoglycemia is a marker relevant in type 1 diabetes and less important in type 2 diabetes because of the low incidence rates. Ketoacidosis/diabetic coma is also a marker only useful for type 1 diabetes because the incidence in patients with type 2 diabetes is extremely low.

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Hospitalization rates are a very important marker for the cost-effectiveness of educational interventions in diabetes. The first landmark study, which proves the impact of diabetes educational programmes, evaluated the hospitalization rate in a Los Angeles hospital [2] and later on in Düsseldorf Germany [3]. The impact of diabetes and its complications itself and diabetes therapy on the quality of life: several tests have been evaluated to measure quality of life, specifically in people with diabetes [4–7].

Difficulties and Pitfalls Comparing Outcomes in Diabetes Care: The Case of HbA1c

Many years passed following the discovery of glycosylated hemoglobin by Rahbar in Tehran before its estimation was used for the first time to measure the impact of diabetes education. To our knowledge, the first attempt to evaluate a structured program and to measure the outcome by using glycated hemoglobin was presented to the 40th ADA Annual Meeting in 1980 [8]. Since then, the methodology of HbA1c measurement has improved substantially and it has been used in numerous scientific studies evaluating patient education. In Germany, the implementation of structured teaching and treatment programs on a nationwide basis was monitored and accompanied by a working group of the German Diabetes Association collecting data from large numbers of hospitals nationwide on a voluntary basis to check the outcome of patients following the intervention [9, 10]. Initially, no procedure of standardization of HbA1c measurements was existent and there were substantial problems comparing the results of different centers. In order to compare the centers, the laboratories measuring HbA1c in the respective hospitals were asked to provide the mean normal range of the applied HbA1c measuring method which varied substantially from 4.6% to 6.5% of total hemoglobin (fig. 1). HbA1c was then adjusted according to the different normal values, and for comparison of different centers, the relative HbA1c was calculated representing the absolute value of each patients measured HbA1c divided by the mean normal value of healthy subjects in the respective laboratory. This adjustment permits a valid comparison between the centers as a basis of discussion on how to improve the outcome [11].

The Quality of Care for People with Type 2 Diabetes in Germany

For various reasons, some health care politicians and diabetologists in Germany claim that the overall quality of care for people with type 2 diabetes is very low. The data used for these statements came from the German part of the

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Fig. 1. Difficulties in comparing outcome parameters of diabetes care: mean normal range of different laboratories (ASD, Germany 1998).

Code 2 Study, which summarized that good metabolic control (defined as HbA1c below 6.5) was only achieved by 26% of the patients with type 2 diabetes in the study [12]. This statement that treatment quality is extremely bad was widely spread by the media not taking into account that the authors had precisely explained in the paper that the study was not population-based, stemming from patients referred to diabetologists. Since the publication of this study, convincing population-based data have been collected in Germany documenting the good quality of treatment. In 1997, our group initiated a project to evaluate the quality of diabetes therapy in primary care by an annual analysis of all HbA1c values of Thuringian patients with diabetes (Thuringia: 2,421,871 inhabitants, 23 urban and rural districts). In 2002, all HbA1c tests were analyzed by 20 participating medical laboratories between January 1st and March 31st; each HbA1c test was identified by the postal code of the Thuringian General Practitioner who ordered the test and adjusted by a standardization procedure (mean normal of healthy subjects 5%). In total, we collected 59.702 HbA1c tests (2.5 HbA1c tests per 100 inhabitants, about 50% of all type 2 diabetes patients in Thuringia receive one HbA1c test/quarter [13]. The adjusted mean HbA1c was 6.75%, 36.4% of all HbA1c tests were above 7.0% and 3.0% of all HbA1c values above 10.0%.

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< 6.5 6.5–6.6 6.7–6.8

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Greiz Saalfeld rudolstadt

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Fig. 2. HbA1c-mapping Thuringia 2002: Mean HbA1c [%] in 23 Thuringian districts, Sonneberg excluded from analysis because of lack of data.

Figure 2 demonstrates an HbA1c map of Thuringia indicating the mean HbA1c in 23 districts of Thuringia. The study is an attempt to collect populationbased data on the quality of metabolic control of patients with type 2 diabetes. The analysis is complicated by the fact that the frequency of HbA1c testing varies between districts. We continue the study to observe possible changes over time. Nevertheless, based upon these data, we conclude that the quality of diabetes care in our region is not as bad as it was supposed to be. Furthermore, the data can support the planning of population-based interventions in the frame of disease management programmes and for the estimation of potential costs of interventions in high-risk patients. The results in Thuringia (fig. 3), which differ substantially from the data published in the German part of the Code 2 Study, are in agreement with several other results that have been evaluated in Germany in recent years, supporting the assumption of generally good control of metabolism in diabetic patients. Apart

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12,000

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6,000 HbA1c 7⬍10:31% (43% age ⬎70) 4,000 SD ⫽ 0.28 Mean ⫽ 1.32 n ⫽ 50,762.00 2,000 ⬎⫽10:3% 0 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 3.25 3.50

Relatives HbA1c

Fig. 3. Quality of diabetes care in Thuringia 2002. 4th quarter 2001 or 1st quarter 2002 in all laboratories measuring HbA1c for physicians in Thuringia. Relative HbA1c in a healthy person ⫽ 1.0.

from our population-based collection of HbA1c values in Thuringia, five other studies have been carried out in Germany. The Central Research Institute for Ambulatory Health Care collected data from 124,800 patients with diabetes in the North-Rhine area, in the frame of a diabetes care model project. A total of 61.1% of the patients had an HbA1c below 7% [14]. Gruesser et al. [15] evaluated HbA1c and other parameters in people insured by the Volkswagen Health Insurance company in the city of Wolfsburg, representing 50% of the total population. HbA1c of 41.6% of people with diabetes was below 7%. The group of Landgraf in Munich evaluated HbA1c in 190,590 patients [16]. The data were not strictly population based but came from randomly chosen physicians in ambulatory care. In 60.8%, HbA1c was below 7%. Rothe et al. [17] in Dresden evaluated the quality of diabetes care in 241,391 patients in Saxony. HbA1c was below 7% in 72.3% of people. Future interventions in type 2 diabetes should focus on the relatively small group of patients still suffering from poor metabolic control in our country

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whereas disease management programs should focus on younger people with type 2 diabetes and poor metabolic control. This target groups, according to our data, seem smaller than expected and their metabolic problems could be solved in a foreseeable future.

Political Changes in East Germany and Their Impact on the Quality of Diabetes Care

The city of Jena, where our university is located, was part of the former German Democratic Republic (GDR). Until November 1989 it was nearly impossible to cross the border between Thuringia and West Germany. Diabetes care was centralized and special outpatient clinics were taking care of nearly all people with diabetes. General practitioners and internists who worked in stateowned institutions for ambulatory care did not take part in the long-term care of the majority of diabetic people. During this time, blood glucose monitoring was almost nonexistent and the lack of modern insulin injection devices, such as pens, did not encourage the patients to switch to intensified insulin therapy. Patients were prescribed fixed diets with snacks and only very few of them adapted their insulin dosage. There was no modern patient education, the information for patients was paternalistic and still followed the instructions of the leading diabetologists in the central research institute for diabetes. A document for the objectives of patient information during these times is available in the patient book published by Katsch and his successors in Karlsburg [18]. The reunification of the two parts of Germany began in October 1990 and a dramatic change in ambulatory health care took place. Instead of working as state employees in ambulatory care, physicians had to open private practices, and ambulatory health care was exclusively provided by private practitioners and specialists. All state-owned centralized institutions for ambulatory care of people with diabetes were closed and the nationwide influence of the central administration for diabetes care disappeared. This unique experiment to change the structures of health care system completely resulted in controversial political discussions for multiple reasons. Our university had the unique opportunity of collecting population-based data in our area on insulin-treated patients before and after the dramatic political change. It must be mentioned that our group was the only institution in the former GDR collecting population-based data on HbA1c already under the former GDR government [19]. In addition, we implemented patient education programmes in our area at a very early stage, and it can be assumed that we have the highest percentage of patients having followed five different structured educational programmes, which are now implemented in disease management

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Table 1. JEVIN study: how diabetes care changed from 1989 to 1999 1989

1999

All patients taken care of by their district diabelologist 100% pork (or beef) insulin No pens, no plastic syringes Rigid diet plans Nearly no self-monitoring No HbA1c measurement No structured patient education

Shared care with a diabetologist if patient desires 100% human insulin, 95% using a pen Pens and plastic syringes Diet liberalized Self-monitoring available for all patients HbA1c for all patients 5 different structured patient education programmes

programmes for diabetes in Germany [20], which are described in the article by Gruesser in this issue [pp. 70–82]. The goal of the JEVIN Study was to describe and improve diabetes care before and after changing from a socialist centralized system to a private decentralized system. We evaluated all insulin-treated patients aged between 16 and 60 years living in Jena in 1989/1990 [19] and compared the data to the results evaluated in 1999/2000 [21]. The major changes in diabetes care are listed in table 1. Whereas in the first evaluation in 1989/1990, 100% of people with type 1 and type 2 diabetes were taken care of by diabetologists, this percentage substantially decreased in 1994/1995 [22] and 1999/2000 [21, 23] (fig. 4). During the same period of time, the majority of people with insulin-treated diabetes participated in structured educational programmes. This percentage increased from 0% under socialist times to well over 80% by the end of the millennium (fig. 5). In contrast to the times of the centralized socialist system where blood glucose monitoring was almost unused, blood glucose monitoring was successfully introduced into routine care with an average frequency of 28 blood glucose monitoring in type 1, and a frequency of 21 in type 2 on insulin treatment (fig. 6). Combination therapy was promoted in our area during socialist times and 50% of people on insulin treatment received oral anti-diabetic agents in addition. This form of treatment was almost eliminated by the year 2000 where only 4.1% of insulintreated patients received oral agents in addition to insulin. This radical change in the structure of care and the tools used in diabetes day-to-day management was accompanied by changes in HbA1c (fig. 7). Figure 7 demonstrates that metabolic control in patients with type 2 diabetes on insulin treatment improved substantially over time dropping from 8.9 to 7.35, which is as an average close to the goals of the major studies DCCT and UKPDS. The metabolic control of people with type 1 diabetes, which under ‘GDR’ times was

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already at a relatively good level of 7.6, worsened initially after political change and returned to an average of 7.4% in 1999/2000 (fig. 7). In contrast to the past, HbA1c measurement became a routine parameter in diabetes care. It is known from the literature that long-term monitoring of glycosylated hemoglobin levels on their own has an effect on metabolic control in insulin-dependent diabetes. In 1990, Larsen et al. [24] published a study of 240 patients on insulin where patients were assigned to 2 groups, which were comparable in age, sex, duration of diabetes and initial HbA1c levels. They followed the patients for 1 year and the hemoglobin A1c concentration was measured at 3-month intervals. The values were used to assess glycemic control and to modify therapy in one of the two groups. The other health care providers were not aware of the values and relied on blood or urine glucose measurements to monitor metabolic control. The results were striking: among the 222 patients still being followed after 1 year, the mean HbA1c values significantly decreased from 10.1 to 9.5% (p ⬍ 0.005) in the group using HbA1c in ambulatory care, whereas the initial 1-year values of the control group were 10.0 and 10.1 at reevaluation. The patients in the group whose hemoglobin A1c level was monitored were seen and their insulin regimes changed more often but they were hospitalized for acute care of their diabetes less frequently than those in the controlled group. A similar decrease in HbA1c values occurred in the control group in the following year when their health care providers knew the HbA1c levels [24]. We assume that the introduction of HbA1c measurement in the patients in our area

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Fig. 5. JEVIN study: structured patient education.

may also have contributed substantially to the improvement of care, especially in the large number of patients with type 2 diabetes, mainly taken care of by primary care physicians.

Impact of Patient Education on Severe Hypoglycemia

Over many years, the nationwide working group for structured diabetes therapy from the German Diabetes Association evaluated the frequency of severe hypoglycemia following the introduction of intensified treatment and education. Data from over 10,000 patients accumulated over a period of 12 years are available. In 10,912 patients, the incidence of severe hypoglycemia per patient per year defined as loss of consciousness or requiring IV glucose or the injection of glucagon decreased significantly from 0.335 to 0.164 cases per patients per year. At the same time, relative HbA1c decreased from 1.62 to 1.43 (absolute value 8.1, 7.15). Severe ketoacidosis was eradicated: it decreased from 0.093 cases per patient per year to 0.030 cases. Hospitalization in days per year also decreased from 5.89 to 3.76. These data demonstrate that in Germany the implementation of intensified insulin therapy in combination with structured educational programs was able to substantially improve metabolic control in type 1 diabetic patients without increasing but decreasing the incidence of severe hypoglycemia [25]. These findings achieved in routine health care, are in contrast to the DCCT

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1989/90 Blood glucose self-monitoring/week (median)

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results where a positive correlation between the incidence of severe hypoglycemia and glycosylated hemoglobin was observed [26]. The authors of the DCCT summarized that intensified insulin treatment which effectively improved metabolic control is necessarily accompanied by a higher incidence of severe hypoglycemia comparing to conventional insulin therapy. They assumed that intensified treatment would cause even more frequent severe hypoglycemia when applied to less selected and less motivated populations in the clinical practice setting.

How Can This Difference between the Nationwide Data in Germany and the DCCT in the USA Be Explained?

Analyzing in more detail the data in different centers contributing patients to the DCCT, it was observed that the incidence of severe hypoglycemia varied substantially between the different DCCT centers. It is less known that the DCCT intervention was not accompanied by a structured educational program being the same in all centers. Education was intensified in the intervention group of patients, mainly on a one-to-one basis. The substantial differences between the centers concerning hypoglycemia may simply be explained by variations in the educational approach, e.g. how patients were educated to adjust their insulin dosage on their own. Consequently, the difference in hypoglycemic incidence

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found in the DCCT and the working group may be due to the widespread implementation of structured treatment and teaching programs in Germany.

Quality of Blood Pressure Control

In the JEVIN Trial, we were also able to evaluate the quality of blood pressure control in insulin-treated patients between the years 1989/1990, 1994/1995 and 1999/2000 [23]. It is well known that blood pressure control is essential in order to avoid not only cardiovascular endpoints but also to decrease the incidence and to slow the worsening of specific diabetic microvascular complications such as retinopathy and nephropathy. In our population-based study, we observed that blood pressure control improved over time. Over the years, the average systolic blood pressure decreased from 150.6 to 137.4, and 139.5 mm Hg in 1999/2000. Diastolic blood pressure decreased from 91.4 to 82.1, and 84.1 mm Hg in the last evaluation in 1999/2000. Similar results were observed in patients with type 1 diabetes where diastolic blood pressure dropped from 84.9 to 79.6 and 80 mm Hg at the last evaluation. Systolic blood pressure in type 1 diabetes decreased from 135.1 to 128.9 and 130.9 mm Hg [21, 23]. These data demonstrate that the quality of blood pressure control in our population improved. This cannot be explained by a change in the availability of medication as the usual drugs for hypertension treatment were available for free to all patients in the former political system. It may be that the importance of blood pressure control was not emphasized enough by diabetologists. In the past this may have been a long-term effect of the school of Katsch in Greifswald [18] who wrote repeatedly

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in his patient book ‘the diabetic should not know his blood pressure values. They are usually misunderstood and do nothing but create uncertainty and worry’.

Future Goals for Interventions

Our data are the basis for planning future interventions in diabetes education and care. Based upon our data we can assume in our state about 80% of people with diabetes actually reach the therapeutic goals regarding metabolic control. Therefore, future interventions in education and care have to identify and focus on the 20% of patients who have not yet reached this therapeutic goals. Approaches aiming at an evidence-based disease management have to identify these high-risk patients and attract them to efforts of re-education and more intensified care. We have to learn more about this high-risk group. It is known that the metabolic control of people with low education, low social status, of immigrants, and persons with mood disorders and other specific problems require specific intervention and care. Research in these areas will be of substantial importance in the future.

References 1 2 3

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Berger M, Mühlhauser I: Implementation of intensified insulin therapy: A European perspective. Diab Med 1995;12:201–208. Miller LV, et al: More efficient care of diabetic patients in a county hospital setting. NEJM 1972;286:1388–1391. Mühlhauser I, Klemm AB, Boor B, Scholz V, Berger M: Krankenhausaufenthalts- und Arbeitsunfähigkeitszeiten bei Patienten mit Typ-I-Diabetes. Einfluß eines Diabetes-Behandlungs- und -Schulungsprogrammes. Dtsch Med Wochenschr 1986;111:854–857. Bradley C: The diabetes treatment satisfaction questionnaire: DTSQ; in Bradley C, (ed): Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice. Chur, Harwood Academic Publishers, 1994. Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R. The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: The ADDQoL. Qual Life Res 1999;8:79–91. Bradley C: The 12-item well-being questionnaire: Origins, current stage of development, and availability. Diabetes Care 2000;23:875. Bott U, Mühlhauser I, Overmann H, Berger M: Validation of a diabetes-specific quality of life scale for patients with type 1 diabetes. Diabetes Care 1998;21:757–769. Jörgens V, et al: Beneficial effects of diabetes teaching: Importance of self-management by the patients (abstract). Diabetes 1980;29:27A. Müller UA, Femerling M, Reinauer KM, Risse A, Voss M, Jörgens V, Berger M, Mühlhauser I, for the ASD: Intensified treatment and education of type-1 diabetes mellitus as clinical routine: A nation-wide quality-circle experience in Germany. Diabetes Care 1999;22(suppl 2): B29–B34. Sämann A, Kloos C, Femerling M, Risse A, Hemmann D, Jecht M, Müller UA, für die Arbeitsgemeinschaft strukturierte Diabetestherapie (ASD): Jahresbericht 2002 der Arbeitsgemeinschaft für strukturierte Diabetestherapie (ASD) der Deutschen Diabetes-Gesellschaft. Diab Stoffwechsel 2003;12:199–204.

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Müller UA, Femerling M, Risse A, Schumann M, Use G, Jörgens V, Berger M, für die ASD (‘Arbeitsgemeinschaft Strukturierte Diabetes Therapie’ der Deut-schen Diabetesgesellschaft): Ausbildung der Patienten mit Typ-1-Diabetes zur Selbst-therapie in den Kliniken der Arbeitsgemeinschaft für strukturierte Diabetestherapie (ASD) in Deutschl and 1998. Med Klin 2000;95:359–368. Liebl A, Neiss A, Spannheimer A, Reitberger U, Wagner T, Gortz A: Costs of type 2 diabetes in Germany: Results of the CODE-2 study. Dtsch Med Wochenschr 2001,126:585–589. Sämann A, Kaiser J, Hunger-Dathe W, Schiel R, Müller UA: Population-based measurement of quality of diabetes care using HbA1c values in the state of Thuringia/Germany. Exp Clin Endocr Diab 2004;112:531–537. Altenhofen L, Haß W, Oliveira J, Brenner G: Modernes Diabetesmanagement in der ambulanten Versorgung: Ergebnisse der wissenschaftlichen Begleitung der Diabetesvereinbarung in der KV Nordrhein. ‘Wissenschaftliche Reihe der KBV’. Köln, Deutsches Ärzte-Verlag, 2002, vol 57. Jörgens V, Grüsser M, Hartmann P: Vorsorgeuntersuchung zur Früherkennung der Folgeschäden bei Diabetes mellitus. Modellprojekt Wolfsburg. Diabetes Stoffwechsel 1998;7:25–28. Andratschke S, Eberl S, Piehlmeir W, Renner R, Landgraf R: Prospektive Daten zur Ergebnisqualität (1998–1999) bei Diabetikern: Darstellung zweier Qualitätsmanagementsyst (QM)-Projekte: Diabcare Bavaria und Prosit (abstract). Diab Stoffw 2001;10(suppl 1):110–111. Schulze J, Kunath H, Rothe U, Range U, Prettin C, Verlohren HJ, Fischer S: Quality of diabetes management in the free Saxony state – Scientific evaluation of the Saxony model for managing diabetes. EVA group. Gesundheitswesen 1996;58(suppl 2):144–148. Katsch G, Mohnike G, bearbeitet von Michaelis D: Aceton bis Zucker Nachschlagebuch für Zuckerkranke, ed 6. Leipzig, Thieme, 1970. Müller UA, Ross IS, Klinger H, Geisenheiner S, Chantelau EA: Quality of centralized diabetes care: a population-based study in the German Democratic Republic 1989–1990. Acta Diabetol 1993;30:166–172. Grüsser M, Hoffstadt K, Jörgens V: Structured outpatient education and treatment programs for patients with diabetes mellitus and/or hypertension. Dis Managem Health Outcomes 2003;11: 217–223. Schiel R, Voigt U, Ross IS, Braun A, Rillig A, Hunger-Dathe W, Stein G, Müller UA: Structured diabetes therapy and education improves the outcome of patients with insulin treated diabetes mellitus: The 10 year follow-up of a prospective, population-based survey on the quality of diabetes care (the JEVIN trial). Clin Exp Diab Endocrinol 2005; in press. Schiel R, Müller UA, Sprott H, Schmelzer A, Mertes B, Hunger-Dathe W, Ross IS: The JEVINtrial: A population-based survey on the quality of diabetes care in Germany – 1994/95 compared to 1989/90. Diabetologia 1997;40:1350–1357. Schiel R, Müller UA: Structured treatment and teaching programs and an improvement in private health care lead to a better quality of diabetes care. JEVIN, a population-based trial 1989/90 up to 1999/2000. Med Klin 2003;98:303–312. Larsen ML, Horder M, Mogensen EF: Effect of long-term monitoring of glycosylated hemoglobin levels in insulin-dependent diabetes mellitus. N Engl J Med 1990;323:1021–1025. Mueller UA, Samann A: Evaluated education and treatment centers for type 1 diabetes reduce the frequency of severe hypoglycemic events by 50% while improving HbA1c in patients with intensive insulin therapy – 11 year data of the working group for structured diabetes therapy in Germany (ASD). Diabetologia 2003;46(suppl 2)A35–A36. The Diabetes Control and Complication Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986.

Ulrich Alfons Müller, MD, MSc Department of Internal Medicine Medical School, Friedrich-Schiller University Jena DE–07743 Jena (Germany), Tel. ⫹49 3641 934 840, Fax ⫹49 3641 934 008 E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 97–107

Learning, Health Behavior and Quality of Life Modifications over 5 Years in People with Type 2 Diabetes Managed by Group Care Marina Trentoa, Pietro Passeraa, Enrica Borgoa, Marina Bajardia, Franco Cavallob, Massimo Portaa Departments of aInternal Medicine and bPublic Health and Microbiology, University of Turin, Turin, Italy

Abstract This chapter describes the time-course changes of knowledge, health behavior and quality of life in patients with type 2 diabetes managed by Group Care, as compared with individually delivered care and education. A 5-year randomized, controlled clinical trial comparing group versus individual care was run in a hospital-based secondary care diabetes unit. 120 patients with non-insulin-treated type 2 diabetes were enrolled and randomly allocated to group or individual care. The main outcome measures were: knowledge of diabetes, health behavior, quality of life, HbA1c, body mass index and HDL cholesterol. Knowledge and health behavior improved from year 1 with Group Care and worsened among controls (p ⬍ 0.001, both). Quality of life improved from year 2 with Group Care while worsening with individual care (p ⬍ 0.001). HbA1c progressively increased among controls (⫹1.7%, 95% CI 1.1⫺2.2) but not Group Care patients (p ⬍ 0.001) in whom BMI decreased (⫺1.4; 95% CI ⫺2.0–0.7) and HDLcholesterol increased (⫹0.14 mmol/l; 95% CI 0.07–0.22). Adults with type 2 diabetes acquire knowledge and conscious behavior if exposed to educational procedures and settings tailored to their needs. Better cognitive and psychosocial results are associated with more favorable clinical outcomes. Copyright © 2005 S. Karger AG, Basel

Patient education facilitates self-management of diabetes [1] and has evolved to become a cornerstone of quality-oriented diabetes care [1–3]. Education should be a systematic patient-centered process [4] permitting to acquire and retain knowledge and skills necessary to live as satisfactory a life as possible, even with a disease [5]. Patients with chronic diseases are often adults

for which a specific andragogic, rather than pedagogic, approach is required [6]. In particular, specific teaching models are necessary to induce appropriate health behavior. Grown-ups differ from school-age individuals because they have their own life experience, maturity, independence, self-direction and a desire to contribute. They need to know why they learn something and will learn it more readily if it relates to everyday life [5, 6]. However, teaching methods and programmes are often not tailored to, and are sometimes at conflict with, patients’ needs and learning abilities [7], which may result in failure to adopt correct and durable health behavior [8,9]. In addition, objectives, teaching techniques and learning processes applied to diabetes education are seldom described in the literature [8, 10, 11]. We have developed a model to manage type 2 diabetes mellitus (T2DM) by a systemic group education approach which, over a 4-year observation, resulted in sustained body weight reduction, increased HDL-cholesterol and stabilization of HbA1c [12, 13]. In contrast, control patients managed by traditional oneto-one clinical and education sessions experienced progressive worsening of metabolic control, in accordance with the results of previous trials of intensified care [14]. Furthermore, Group Care improved knowledge of diabetes, health behavior and quality of life [12, 13]. In this paper, we describe the timecourse modifications of the above cognitive and psycho-social variables over a 5-year follow-up.

Patients and Methods 120 patients with non-insulin-treated T2DM gave their informed consent to participate in a randomized, controlled clinical trial of group versus individual diabetes care. Eight did not fulfil the inclusion criteria and, of the reminder, 56 were divided in 6 education groups while the other 56 continued with traditional one-to-one consultations and education sessions. Group sessions were held every 3 months, with 1–2 physicians and an educationist (MTr) acting as facilitators. None of the patients moved from one treatment to the other during the study period. Of those who did not complete follow-up, 6 patients died (3 on Group Care and 3 controls), 19 moved to other clinics (10 Group Care and 9 controls), and 3 could not be traced (1 on Group Care and 2 controls). Of the patients who completed followup, those on Group Care included 20 males, age was 60 ⫾ 8 and known duration of diabetes was 8.8 ⫾ 5.8 years. Corresponding values for controls were: 22 males, 61 ⫾ 8 and 10.1 ⫾ 7.8 years. Schooling and occupation were similar to those reported for the 4-year follow-up [13]. Drop-outs and patients who continued follow-up did not differ for any of the variables measured at baseline. Details of the clinical and educational approaches adopted for group and individual care were given previously [12, 13]. Group Care was based upon a systemic education approach [10, 11, 15]. Planning included educational diagnosis [5], definition of learning goals, development of procedures, including the facilitators’ attitudes towards the patients, programme

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definition and overall assessment of intervention efficacy in terms of specific knowledge, health behavior, quality of life and clinical outcomes [9, 12, 13]. The curriculum was intentionally kept to a minimum of essential concepts [16] to be transmitted by hands-on activities, group work, problem-solving exercises, real life simulations and role playing. The programme included: the burden of overweight, choosing food and planning meals, physical exercise, checking and improving metabolic control, smoke cessation, correct assumption of medication, and preventing complications. This curriculum, initially divided into 4 sessions, was repeated in years 1–2, then spread over 7 sessions in years 3–4 and started again in year 5 to allow more in-depth discussion and learning. Formal teaching, and medical or scientific jargon were avoided as much as possible. In order to stimulate observation, technical and cognitive skills and conscious choices, simple support material, such as food models and graduated containers, was developed. To induce positive group dynamics [13, 15], the patients were encouraged to report on personal experience and stimulated to describe, interpret, discuss and compare real life situations [6, 17]. Reports of unknowingly wrong behavior were not criticized but used as a source of positive learning. Facilitators tried to stimulate learning by proposing problems that stimulated the patients’ solving, rather than mnemonic, abilities [17, 18]. Throughout the sessions, we constantly tried to obtain feedback on how much of the topic being covered had been retained by the patients [18]. To minimize anxiety and the consequent resorting to avoidance strategies in the patients, complications and relevant risk factors were addressed later on, after the sessions on weight and eating control had presumably induced some degree of mastery on the patients’ reactions and behavior [19]. At baseline and after 1, 2, 3, 4 and 5 years, 3 questionnaires were administered to measure: (a) Knowledge of diabetes, using a questionnaire developed by the Education Study Group of the Italian Society for Diabetes (GISED) [20], made up of 38 items and modified to simplify some terms. The areas explored included general definitions and academic notions about diabetes (e.g. symptoms, carbohydrates, insulin and insulin resistance, glycemia, glycosuria, ketone bodies, treatment of diabetes, oral agents, calories), as well as practical knowledge (food exchanges, fiber, exercise, glycated hemoglobin, hypoglycemia, monitoring, self-management, foot care). Correct answers scored 1 point and wrong answers scored none. (b) Health behavior (‘Condotte di Riferimento’) (CdR) [12, 13] with a purpose-built 16 item questionnaire that assessed diabetes-related problem-solving knowledge rather than compliance or adherence behavior. Questions posed hypothetical situations using the ‘What would you do if …’ format to test whether the subjects could identify the underlying health problems and react correctly. The CdR questionnaire covered eating beliefs and habits, physical activity, therapy (mostly hypoglycemia and appropriate assumption of prescribed drugs) and complications (mostly prevention by regularly consulting with the health care team, exercise and foot care). Correct answers scored 1 point and wrong ones scored none. (c) Quality of life, using a modified version of the DQOL questionnaire [21] which had been translated into Italian and re-validated [22]. The questionnaire was modified, by leaving out 6 questions (Items 1–3 and 5–7 from the ‘Worry: Social/Vocational’ section) which, in the original version, were only pertinent to young insulin dependent subjects. The modified questionnaire (DQOL/Mod) included 39 items; answers were along a 5-point Likert scale, from 1 (very satisfied) to 5 (very dissatisfied). The ‘Satisfaction’ section included 14 items and explored the patients’ psychological well-being. The ‘Impact’ test, 20 items, mostly

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Fig. 1. Modifications of knowledge of diabetes, measured by the GISED questionnaire, in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares). assessed the practical consequences of diabetes on everyday life. Finally, the 5-item ‘Worry: Social-Vocational’ Section investigated diabetes-related anxiety, with special reference to clinical conditions. All questionnaires were checked for internal consistency, by Cronbach’s alpha coefficient [23], and for internal validity by cluster analysis [24]. Patients with literacy problems were helped to complete the questionnaires. Statistical Analysis Results within treatment groups are expressed as mean ⫾ SD. Differences between baseline and year 5 values within treatment groups are expressed as mean and 95% CI. Changes in cognitive, psychosocial and clinical variables from year 1 to year 5 between the two groups were tested by an analysis of covariance approach, adjusted for baseline differences in the two groups. A multivariate regression model was fitted, using as dependent variable the calculated DQOL/Mod) and for each clinical variable. Group Care (coded 0/1), baseline values of the dependent variable, age, length of attendance, duration of diabetes (coded in years) and schooling (coded in a 5-level ordinal scale and introduced in the model as dummy variables) were used as independent variables.

Results

Descriptive analysis suggests that knowledge of diabetes kept increasing throughout the observation period among the patients randomized to Group Care, more rapidly so over the first 2 years (p ⬍ 0.001). On the contrary, patients followed by traditional one-to-one care tended to gradually reduce their knowledge (fig. 1). Points that were mostly not modified by either intervention

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Fig. 2. Modifications of health behavior (Condotte di Riferimento ⫽ CdR) in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares).

included those that were more technical and theory-based. Patients on Group Care improved their scores on the practical questions but also on some of the more academic ones. Answers to the CdR questionnaire followed a similar pattern, suggesting that health behavior had already improved after the first year (p ⬍ 0.001) and was still rising at year 5. The areas that improved were: assuming treatment properly, recognizing symptoms of poor control, preventing acute and chronic complications, weight control, food choices, smoke cessation. Health behavior showed an inverse relationship with the baseline level of schooling, specifically suggesting that low levels of schooling are significantly correlated with a lower score in this variable. Control patients, on the contrary, exhibited slow gradual worsening of their health behavior (fig. 2). It took 2 years for quality of life to improve in the patients managed by Group Care (p ⬍ 0.001). This variable worsened among controls, also since year 2 (fig. 3). Changes in the satisfaction, impact and worry sub-areas followed a pattern similar to that of the parental scale. BMI (fig. 4), HDL cholesterol (fig. 5), triglyceride and creatinine improved over 5 years in the patients on Group Care but not in a way significantly different from controls. HbA1c (fig. 6) remained stable in the patients on Group Care but increased among controls, showing a significant difference between the two groups (p ⬍ 0.001). On multivariate analysis, Group Care per se was the major factor associated with improved knowledge, health behavior and quality of life, entered as

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Fig. 3. Modifications of quality of life in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares). Lower scores indicate better quality of life.

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Fig. 4. Modifications of the BMI in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares).

dependent variables (p ⬍ 0.001, all). The effect of Group Care was independent of schooling, age, duration of diabetes and length of attendance in our clinic. Knowledge seemed to act as a determinant of health behavior in the Group Care, while no such relationship held within the individual care controls. On the other hand, neither variable influenced DQOL/Mod in either group, suggesting that the effect of what is learned on diabetes and how it is put into effect is not sufficient to improve quality of life.

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70 65

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Fig. 5. Modifications of HDL cholesterol in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares).

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Fig. 6. Modifications of glycated hemoglobin (HbA1c) in the patients managed by Group Care (diamonds) and in the controls followed by one-to-one care and education (squares).

Finally, modifications of the clinical variables did not correlate with knowledge, health behavior or quality of life, as assessed by the 3 questionnaires.

Conclusions

This intervention study describes the 5-year modifications of learning, health behavior and quality of life in patients with a chronic disease, T2DM,

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managed by a programme specifically designed to continuously deliver health education in one with care. The results of this model suggests that, in contrast with reports of their declining cognitive function [25], diabetic adults are able to acquire new knowledge and conscious behavior, independently of schooling and age, if exposed to procedures and settings specifically tailored to their needs and characteristics. On the contrary, patients followed by the traditional one-to-one approach, although treated according to optimized care criteria, which, in fact, kept their HbA1c levels below those of the patients in the UKPDS of similar known duration of diabetes [14] and allowed to reduce their cardiovascular risk [13], experienced progressive deterioration of knowledge, health behavior and quality of life. Improving scores of diabetes knowledge among patients on Group Care shows that information delivered was successfully retained over 5 years. Presumably, improved knowledge was a result of the peculiar teaching approach, patient/provider relationship and permanent educational reinforcements [6, 26] that were built in the Group Care model [12, 13]. Multivariate analysis suggests that the changes depended on the treatment modality, and that Group Care successfully transmitted not only knowledge but, more importantly, enabled each patient to elaborate this knowledge at his/her own pace and relate it to his/her life context [5, 9]. This is shown by the fact that, in Group Care, improvement in health behavior correlated strongly with increasing knowledge on diabetes. Indeed, Group Care aimed at modifying the existing reference system, thus providing guidance to eating, exercise and healthy practices in general. We aimed at modifying lifestyle in the patients by increasing awareness of risks, problems and solutions which may arise in the course of life with diabetes, rather than inducing passive behavioral changes. It is worth mentioning that in our analysis health behavior showed an inverse relationship with schooling, specifically suggesting that low levels of schooling are significantly correlated with a lower score in this variable. Health behavior seem therefore to be a result not only of greater knowledge, but also of a more complex ‘educated lifestyle’ determinant. According to Knowles’s andragogy theory [4], adults will learn new notions if: (i) the teacher takes into account their personal experience and responsibility in making autonomous decisions; (ii) such notions help to cope with real life situations, and (iii) they respond to internal motivations. On the contrary, adults will resist new concepts if they clash with established habits and experience. Failure to adhere to these requirements when communicating with patients may account for why cognitive abilities were found to decrease in people with type T2DM in cross-sectional studies [27–31] and to decline rapidly in longitudinal ones [26]. Although some authors disagree with these findings [32], progressively worsening cognitive function could explain the decrease in knowledge of diabetes observed over 5 years in our control patients,

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who received individual education session with a more traditional approach. Stimulation by the group approach may have reversed such spontaneous decline. Quality of life was the variable that showed more inertia to change. This is not surprising because quality of life is linked to self-perception and relationships with society at large. Multivariate analysis confirmed that changes in quality of life were independent of acquired knowledge, health behavior or clinical improvements and depended only on the treatment modality. Possibly, group dynamics and peer identification may improve self-perception and selfesteem, reduce disease-related anxiety and, ultimately, induce a feeling of wellbeing in spite of diabetes. Not only were the 3 questionnaires validated for internal coherence and consistency but for none of the measured variables was a ceiling effect observed, indicating that they had been well calibrated to detect variations within the range to be observed. It is often repeated in the literature that new models should be developed to empower patients and build strategies that enable them to cope with chronic diseases [33–35]. While education can empower patients to take on greater responsibility for the management of their disease, long-term success cannot be achieved without the cooperation, support and facilitation of health professionals, whose role demands understanding of the theories underlying patient education and the relevant communication skills. This reinforces the argument for integration of medical and social sciences into professional education so that partnerships with patients can be realized. Within this philosophy, responsibility for management of the disease resides with the patients and the primary role of the health professional becomes one of supporter and educator [36]. We suggest that managing T2DM by systemic education-based Group Care may represent a suitable intervention model. Interactive group consultations are a feasible, cost-effective form of outpatient diabetes care [12, 13]. Whether appropriate adaptations of the teaching programme could make this model useful for other chronic conditions remains to be ascertained by similar randomized controlled clinical trials. Acknowledgements This paper was supported by funds from the University of Turin (fondi ex-60%). Marina Trento is recipient of a grant from Compagnia di San Paolo, Turin.

References 1 2

Lacroix A, Assal JP: L’éducation thérapeutique des patients. Paris, Vigot, 1999, pp 1–205. Clement S: Diabetes self-management education: A technical review. Diabetes Care 1995; 18:1204–1214.

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Funnell MM, Haas LB: National standards for diabetes self-management-education programs. Diabetes Care 1995;18:100–110. Newman P, Peile E: Learning in practice. Valuing learner’s experience and supporting further growth: Educational models to help experienced adult learners in medicine. BMJ 2002; 325:200–202. World Health Organization: Therapeutic Patient Education. Report of a World Health Organization Working Group. Copenhagen, WHO, Regional Office for Europe, 1998. Knowles MS: The Adult Learner: A Neglected Species. Houston, Gulf Publishing Company, 1997. Hunt LM, Arar NH, Larme AC: Contrasting patient and practiotioner perspectives in the management of NIDDM. Western J Nurs Res 1997;20:656–682. Albano MG, Jacquemen S, Assal JP: Patient education and diabetes research: A failure! Going beyond the empirical approaches. Acta Diabetol 1998 ;35:207–214. D’Ivernois JF, Gagnayre R: Apprendre à éduquer le patient, approche pédagogique. Paris, Vigot, 1995. Norris SL, Engelgau MM, Venkat Narayan KM: Effectiveness of self-management training in type 2 diabetes: A systematic review of randomized controlled trials. Diabetes Care 2001; 24:561–587. Norris SL, Lau J, Smith SJ, Schmid CH, Engelagau MM: Self-management education for adults with type 2 diabetes: A meta-analysis of the effect on glycemic control. Diabetes Care 2002; 25:1159–1171. Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M: Group visits improve metabolic control in type 2 diabetes: A 2-year follow-up. Diabetes Care 2001;24:995–1000. Trento M, Passera P, Bajardi M, Tomalino M, Grassi G, Borgo E, Donnola C, Cavallo F, Bondonio P, Porta M: Lifestyle intervention by group care prevents deterioration of type 2 diabetes: A 4-year randomized controlled clinical trial. Diabetologia 2002;45:1231–1239. UKPDS Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–853. Poctzar J: Approque systémique appliquée à la pédagogie. Paris, ESF, 1999. Anderson L: Health care communication and selected psychosocial correlates of adherence in diabetes management. Diabetes Care 1990;3:66–77. Guilbert JJ: Guide pédagogique pour les personnels de santé. OMS Publication offset, ed 35. Géneve, OMS, 2001. Von Korff M, Gruman J, Schaefer J, Curry S, Wagner E: Collaborative management of chronic illness. Ann Internl Med 1997;27:1097–1102. Bandura A: Self-Efficacy in Changing Societies. London, Cambridge University Press, 1995. Gruppo di Studio per l’Educazione sul Diabete – GISED: Questionario per la valutazione delle conoscenze, dei comportamenti e degli atteggiamenti dei diabetici. Diabete 1993;5:54–56. The DCCT Research Group: Reliability and validity of a diabetes quality-of-life measure for the Diabetes Control and Complications Trial (DCCT). Diabetes Care 1998;11:725–732. Mannucci E, Mezzani B, Conti A, Rotella CM: Valutazione della qualità della vita nei pazienti adulti diabetici di tipo I. Il Diabete 1994;6:223–228. Cronbach LJ: Essentials of Psychological Testing, ed 3. New York, Harper & Row, 1970. Reber A: Dictionary of Psychology. London, Penguin, 1995, p 127. Fontbonne A, Berr C, Ducimetière P, Alpérovitch A: Changes in cognitive abilities over a 4-year period are unfavorably affected in elderly diabetic subjects: Results of the epidemiology of vascular aging study. Diabetes Care 2001;24:366–370. Retting B, Shrauger D, Recker R, Gallagher T, Wiltse H: A randomized study of the effects of a home diabetes program. Diabetes Care 1986;9:173–178. Knopman D, Boland LL, Mosley T, Howard G, Liao D, Szklo M, McGovern P, Folsom AR: for the atherosclerosis risk in communities (ARIC) study investigators. Neurology 2001;56:42–48. Perlmuter LC, Hakami MK, Hodgson-Harrigton C, Ginsberg J, Katz J, Singer DE, Nathan DM: Decreased cognitive function in aging non insulin dependent diabetic patients. Am J Med 1994; 77:1043–1048.

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Asimakopoulou KG, Hampson SE, Morrisht NJ: Neuropsychological functioning in older people with type 2 diabetes: The effect of controlling for confounding factors. Diab Med 2002; 19:311–316. Heelkala EL, Niskanen L, Viinamaki H, Partanen J, Uusitupa M: Short-term and long-term memory in elderly patients with NIDDM. Diab Med 1995;18:681–685. Logroscino G, Kang JH, Grodstein F: Prospective study of type 2 diabetes and cognitive decline in women aged 70–81 years. BMJ 2004;328:548. Atiea JA, Moses JL, Sinclair AJ: Neuropsychological function in older subjects with non insulin dependent diabetes mellitus. Diab Med 1995;12:679–685. Venkat Narayan KM, Benjamin E, Gregg EW, Norris SL, Engelgau MM: Diabetes translation research: Where are we and where do we want to be? Ann Intern Med 2004;140(suppl):958–963. Berry LL, Siders K, Wilder SS: Innovations in access to care: a patient-centered approach. Ann Intern Med 2003;139:568–574. Eyre H, Kahn R, Robertson RM, ACS/ADA/AHA Collaborative Writing Committee: Preventing cancer, cardiovascular disease, and diabetes: A common agenda for the American Cancer Society, the American Diabetes Association, and the American Heart Association. Diabetes Care 2004; 27:1812–1824. Cooper HC, Booth K, Gill G: Health Education Research. Theory Practice. London, Oxford University Press, 2003, vol 18, pp 191–206.

Dr. Marina Trento Department of Internal Medicine, University of Turin corso AM Dogliotti 14, IT–10126 Turin (Italy) Tel. ⫹39 011 6632354, Fax ⫹39 011 6634751 E-Mail [email protected]

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Rationale, Design and Preliminary Results of ROMEO (Rethink Organization to Improve Education and Outcomes) A Randomized Controlled Multicenter Trial of Group Care in the Management of Type 2 Diabetes

M. Porta, M. Trento Dipartimento di Medicina Interna, Università di Torino, Turin, Italia

Abstract Scarcity of resources, expertise and evidence-based models have so far limited delivery of patient-centered therapeutic education in clinical routine. We have developed and validated a Group Care approach that is applicable to everyday practice and cost-effective in improving metabolic control, knowledge of diabetes, health behavior and quality of life in type 2 diabetes. A clinical trial (ROMEO) was planned to evaluate the applicability and reproducibility of Group Care in other centers and in a larger patient population. ROMEO is a multicenter, randomized, controlled clinical trial of group versus individual care in the routine management of type 2 diabetes. Eight hundred and twelve patients aged ⬍80, with non-insulin-treated diabetes of ⱖ1 year known duration, were recruited in 13 centers and will be followed for 4 years. Analysis will be by intention-to-treat. Preliminary baseline measurements include HbA1c, fasting blood glucose, body weight and waist/hip ratio, blood lipids, knowledge of diabetes, health behavior and quality of life. If this trial will confirm that Group Care can be successfully implemented in different clinics, a novel clinicopedagogic tool will have been acquired to support patient-centered education, improve lifestyle and outcomes, enhance providers’ attitudes and competencies and ameliorate diabetes care organization. Copyright © 2005 S. Karger AG, Basel

Lifestyle intervention reduces progression from impaired glucose tolerance to type 2 diabetes mellitus (T2DM) [1] and improves metabolic control [2, 3] while preventing microvascular and macrovascular outcomes [4]

in established T2DM. In clinical practice, however, advice on eating, exercise and smoking remains ancillary to pharmacological intervention. As it increases weight [2, 4], intensive hypoglycemic treatment reverses one effect of lifestyle intervention. In addition, metabolic control may inevitably deteriorate as, although intensively treated, T2DM progresses [2]. Hence, the need for feasible, more effective approaches to lifestyle intervention. We have shown that T2DM is managed effectively by a Group Care model based upon interactive education and reserving individual medical attention to elective situations. This approach improved clinical outcomes while reducing the dosage of hypoglycemic agents, ameliorated patients’ quality of life and operators’ satisfaction and permitted more rational use of the typically limi ted resources available in busy diabetes clinics [5, 6]. ROMEO (Ripensare l’Organizzazione per Migliorare l’Educazione e gli Outcome ⫽ Rethink Organization to iMprove Education and Outcomes) was started as a multicenter randomized controlled clinical trial to: 1. Evaluate if our Group Care model can be successfully transferred to other diabetes clinics 2. Verify if our results can be reproduced elsewhere 3. Assess the clinical impact of group care in a larger patient population.

Methods Study Population Overall, 812 patients aged ⬍80, with T2DM of ⱖ1 year known duration, treated by either diet alone or diet and oral agents. Study Design The study will run for 4 years. Recruited patients will be randomly allocated within each centre to either group or individual care. Informed consent will be obtained in accordance with the Helsinki Declaration. Group sessions will be held every 3 months. Controls will be seen every 3 months, or more frequently if necessary, by the same physicians in charge of group sessions. Self-care knowledge and practice will be checked annually and one-to-one educational reinforcement offered accordingly by the same personnel involved in group activities, with special reference to eating habits, home monitoring, if practiced, and preventing complications. The Programme for Systemic Group Care The systemic approach to group care was described previously [5, 6]. The programme includes seven 1-hour sessions, held 3 months apart, and is repeatable every 2 years. The curriculum covers: the burden of overweight, choosing food, meal planning, physical exercise, checking and improving metabolic control, smoke cessation, assuming medication and preventing complications.

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Education is mostly through hands-on activities, group work, problem-solving, real life simulations and role playing. One-two members of the team (usually doctors, nurses, dieticians) act as facilitators in groups of up to 10 patients. Patients remain in the same groups over time, to reinforce cohesion and interpersonal relationships. Centre Recruitment and Training of Health Care Personnel Twelve clinics in Italy have joined ROMEO (see list below). Training of the operators started with 4 meetings in our Department, covering: Principles and aims of therapeutic education • Presentation and discussion of Group Care, detailing every step of the 7-session pro• gramme Presentation and comments of videos obtained, with the patients’ approval, during the • group sessions Practical, interactive activities (a: Let’s pretend we are the patients; b: Let’s try to run a • Group Care session) Investigators also had the opportunity to observe group visits in our clinic, live and videotaped. After these meetings, investigators were asked to verify the feasibility of implementing Group Care in their own centers. In particular, they analyzed their own clinical organization and facilities, identified personnel interested in running the groups, and proposed adaptations to make the model workable in their own environment. Further operator training was by site visits from our clinic to all centers during the programme and will include videotaping local sessions to evaluate providers’ performance by key element checklists [7], and document alternative ways of delivering educational messages. Facilities Group sessions are run in the participating centers using available rooms after rearranging the furniture for the occasion. Support material was standardized by producing ‘packages’, color-coded by center, which included instructions, manuals, questionnaires, patients’ handouts, didactic material (fig. 1, 2) and stationery. Outcomes Baseline data include sex, age, duration of diabetes and of previous follow-up in clinic, schooling, occupation, self-monitoring of blood glucose, previous structured diabetes education, smoking habits and cardiovascular events. Primary outcomes will include HbA1c, fasting blood glucose, body weight, W/H ratio, blood lipids, knowledge of diabetes, health behavior and quality of life (QoL). Secondary outcomes will include assessment of hypoglycemic and antihypertensive medication, systolic and diastolic blood pressure, cardiovascular risk score, ECG signs of ischemia, and QT interval length and dispersion. Body weight, fasting blood sugar (glucose-oxidase) and HbA1c will be measured every 3 months by local laboratories. Comparisons will be carried out within centers as well as between centers, avoiding the need for centralized HbA1c measurements. Yearly screening for complications will include assays of blood urea nitrogen, serum creatinine, total and HDL cholesterol, triglyceride, ECG and sitting blood pressure. Knowledge of diabetes, health behavior and QoL will be re-measured at years 2, QoL and health behavior also at year 4. Cardio-vascular events (angina, myocardial infarction, stroke, claudicatio intermittens and amputation) will be recorded annually and documented. An Excel-based electronic spreadsheet was purpose-designed to collect clinical and biochemical data, to facilitate final collation and processing.

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Fig. 1. Display of educational material.

Fig. 2. Details of educational material.

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Measurements Knowledge of diabetes will be measured by a 79-item questionnaire developed by the Education Study Group of the Italian Society for Diabetes (GISED) [8]. Health behavior will be measured by a previously described 21-item questionnaire (‘Condotte di Riferimento’ ⫽ CdR) [5, 6] testing whether patients can identify problems and react appropriately. QoL will be measured by a modified version of the DQOL (DQOL/Mod) [9]. Patients with literacy problems will be helped by health operators. Hypoglycemic treatment will be assessed as class of medication (diet alone, oral agents) at the beginning of study, and overall modifications prescribed according to clinical judgment. Antihypertensive medication will be quantified as number of classes of drugs administered. Cardiovascular risk will be assessed by a prediction model from the Framingham Heart Study [10]. ECG will be analyzed for ischemia by Minnesota Code [11] and for QT interval length and dispersion as described previously [12]. Influence of Group Care on lifestyle will be checked by administering an externally validated dietary habits questionnaire at year 3 of follow-up [13].

Statistics Analysis will be by intention-to-treat. Power calculations for this study indicate that 550 patients (including probands ⫹ controls) will be sufficient to detect a 0.5% variation in HbA1c levels (between 8.0% and 7.5%) with an ␣ ⫽ 0.05 and a ␤ statistical power of 95%. Differences between baseline and final values will be checked first within groups by parametric or nonparametric tests, as applicable. Subsequently, significant increases/decreases will be included as dependent variables in a general linear model in which age, duration of diabetes, schooling and being followed by group visits or individual care will be taken as independent variables. The possible influence of clustering effects, for patients followed in the different centers will be taken into account in the multivariate model.

Systematic Errors To minimize performance bias, as no study of this kind can be double-blind, investigators will not know which patients in their general clinics will serve as controls. Although the number of patients should minimize selection bias, results will be adjusted, on multivariate analysis, for any variable that might differ at baseline between patients on group and individual care. Attrition bias will be dealt with by keeping track of all drop-outs for intention-to-treat analysis. Finally, all outcomes will be measured blindly with respect to treatment group.

Results

The preliminary data obtained in the first 812 patients recruited are summarized in tables 1–3. In spite of the randomization procedure, the patients who will be followed by Group Care have higher body mass index and waist/hip ratio, although they are matched by all other clinical and socio-economic characteristics.

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Table 1. Clinical data of patients enrolled

n M/F Age Known duration of diabetes, years Attendance in clinic before study, years Family history of DM (N/Y/no data) Health behavior (CdR) Knowledge of diabetes (GISED) Quality of life (DQOL/Mod) Owns glucose meter (N/Y/no data) Self-monitoring (N/Y/no data) Previous structured education (N/Y/no data) Smoking (never-stopped/Y7no data) Hypertension (N/Y/no data) Baseline EKG Height, cm Body weight, kg Body Mass Index Waist/hip ratio Fasting blood glucose, mg/dl HbA1c Total cholesterol, mg/dl HDL cholesterol, mg/dl Triglyceride, mg/dl

Group Care

Controls

417 218/199 65.3 ⫾ 8.4 11.8 ⫾ 7.4 5.8 ⫾ 5.0 44.4/51.3/4.3% 10.9 ⫾ 3.5 40.0 ⫾ 15.8 68.1 ⫾ 16.0 36.2/62.1/1.7% 32.9/65.5/1.7% 91.8/6.2/1.9% 77.9/18.0/4.1% 29.5/68.1/2.4% 83.9% 163.1 ⫾ 9.0 81.6 ⫾ 14.9 30.6 ⫾ 4.5 0.93 ⫾ 0.12 167.9 ⫾ 47.8 7.6 ⫾ 1.5 212.6 ⫾ 39.3 49.2 ⫾ 13.2 165.7 ⫾ 110.3

395 176/209 66.0 ⫾ 8.5 12.6 ⫾ 7.1 6.1 ⫾ 4.5 38.2/57.7/4.1% 10.8 ⫾ 3.4 40.6 ⫾ 14.8 69.1 ⫾ 15.8 38.2/57.7/4.1% 36.7/59.0/4.3% 92.2/4.1/3.8% 80.2/15.4/4.4% 33.7/62.5/2.8% 85.8% 163.6 ⫾ 9.5 78.3 ⫾ 14.9 29.2 ⫾ 4.8 0.88 ⫾ 0.13 169.2 ⫾ 49.4 7.7 ⫾ 1.5 210.2 ⫾ 41.6 50.5 ⫾ 13.7 155.9 ⫾ 98.8

n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. n.s. p ⬍ 0.002 p ⬍ 0.001 p ⬍ 0.001 n.s. n.s. n.s. n.s. n.s.

Discussion

The traditional one-to-one therapeutic relationship leads to active prescription of diet, medication and advice on healthy practices but may not stimulate durable patient cooperation. It is well established that health education should not limit itself to providing information on disease and treatment options, because most notions are either not retained or easily forgotten. Adult education is a complex process which cannot be undertaken by busy clinicians who do not have specific training and tend to deliver classroom ‘teaching’ to individual patients or groups of them. Sociocultural barriers make traditional top-down academic teaching particularly ineffective [3]. For education to become a useful therapeutic tool, patients should be involved in interactive techniques and group settings are particularly effective because they add motivation, experience and peer identification [7].

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Table 2. Socioeconomic data of the patients enrolled Group Care, %

Controls, %

Schooling No formal education First 3 years of primary school Primary school Middle school High school University degree

1.9 3.8 41.5 21.3 13.9 1.2

1.3 3.8 45.8 23.5 13.9 0.5

Occupation Housewife Retired White collar worker Blue collar worker Other

29.3 48.4 5.8 6.0 6.5

20.8 49.9 11.9 7.6 5.3

Table 3. Cardiovascular events at baseline

None Angina Myocardial infarction Stroke Claudication Amputations No data

Group Care, %

Controls, %

79.9 1.9 4.3 2.6 1.2 0 8.4

75.9 3.8 5.3 2.0 0.8 0 9.4

For lifestyle intervention to be feasible in everyday practice, patient education and health care should merge into a continuing clinico-pedagogic process, the outcomes of which should be measurable and persistent. In our experience [5, 6] routine Group Care was found more effective than the one-to-one approach in promoting appropriate health behavior, better knowledge of diabetes and, ultimately, improving metabolic control (by stabilizing HbA1c, lowering BMI and increasing HDL cholesterol) and quality of life in the medium to long term. Group Care required a novel programme and re-organization of current practice, but additional time and resources were minimal and the procedure was feasible and cost-effective. If ROMEO will confirm that better metabolic control and quality of life can be achieved by the Group Care model in a wider population of patients, a

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novel tool for diabetes management will have been validated to support patientcentered therapeutic education, enhance attitudes, knowledge and competencies of health care providers, and provide a new model for health care organization to improve diabetes outcomes.

Acknowledgements The ROMEO project was initially financed by donations from local branches of Novo Nordisk and Roche Diagnostici and is now supported by an EFSD/JDRF/Novo Nordisk Type 2 Research Grant.

ROMEO Investigators E. Ansaldi, F. Malvicino, M. Battezzati, P. Maresca, C. Cappa, C. Palenzona, G. Rosti, Alessandria; L. Gentile, T. Miroglio, E. Repetti, Asti; G. Morone, F. Travaglino, Biella; A.M. Sanna, M. Floris, L. Carboni, Cagliari; A. Chiambretti, R. Fornengo, Chivasso (Torino); S. Gamba, M. Carlini, Ospedale Maria Vittoria, Torino; M. DeAndrea, A. Grassi, A. Mormile, Osp. Mauriziano, Torino; G. Corigliano, M. Corigliano, I. Vaccarella Napoli; M. Patella, G. Bax, L. Zanetti, C. Piasenti, D. Fedele Padova; P. Accorsi, U. Pagliani, V. Miselli, Scandiano (Reggio Emilia); L. Tonutti, C. Taboga, Udine; L. Richiardi, C. Condò, P. Gennari, Osp. Valdese Torre Pellice (Torino).

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Tuomilehto J, Lindström J, Eriksson JG Valle TT, Hamalainen H, Ilanne-Parikka P, KeinanenKiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350. UKPDS Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1988;352:837–853. Norris SL, Engelgau MM, Venkat Narayan KM: Effectiveness of self-management training in type 2 diabetes: A systematic review of randomized controlled trials. Diabetes Care 2001;24:561–587. Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O: Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 2003:348:383–393. Trento M, Passera P, Tomalino M Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M: Group visits improve metabolic control in type 2 diabetes: A 2-year follow-up. Diabetes Care 2001;24:995–1000. Trento M, Passera P, Bajardi M , Grassi G, Borgo E, Donnola C, Cavallo F, Bondonio P, Porta M: Lifestyle intervention by group care prevents deterioration of type 2 diabetes: A 4-year randomized controlled clinical trial. Diabetologia 2002;45:1231–1239. Lacroix A, Assal JP: L’éducation thérapeutique des patients. Paris, Vigot, 1998. Vespasiani G, Nicolucci A, Erle G, Trento M, Piselli V: Validazione del questionario sulla conoscenza del diabete GISED 2001. G It Diabetol 2002;22:109–120. The DCCT Research Group: Reliability and validity of a diabetes quality-of-life measure for the Diabetes Control and Complications Trial (DCCT). Diabetes Care 1988;11:725–732.

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Wilson PWF, D’Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB: Prediction of coronary hearth disease using risk factor categories. Circulation 1998;97:1837–1847. Rose GA, Blackhorn H, Gilum RF, Prineas RJ: Cardiovascular Survey Methods, ed 2. Geneva, WHO, 1982, Monogr 56. Veglio M, Borra M, Stevens LK, Fuller JH, Cavallo Perin P, the EURODIAB IDDM Complications Study Group: The relation between QTc interval prolongation and diabetic complications. The EURODIAB IDDM Complications Study Group. Diabetologia 1999;42:68–75. Panico S, Dello Iacovo R, Celentano E, Galasso R, Muti P, Salvatore M, Mancini M: Progetto ATENA, a study on the etiology of major chronic diseases in women: Design, rationale and objectives. Eur J Epidemiol 1992;8:601–608.

Dr. Marina Trento Dipartimento di Medicina Interna, Università di Torino Corso AM Dogliotti 14, IT––10126 Turin (Italy) Tel. ⫹39 011 6336487, Fax ⫹39 011 6634751, E-Mail [email protected]

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 117–131

A Cost Effectiveness Analysis of Group Care in Type 2 and Type 1 Diabetes Piervincenzo Bondonioa, Marina Trentob, Massimo Portab Departments of aEconomics and bInternal Medicine, University of Torino, Turin, Italy

Abstract Different types of economic analyses are sometimes delivered to compare different health procedures. In this chapter, we apply a cost-effectiveness analysis to a validated Group Care approach for diabetic patients, as compared with traditional, individually delivered care and education. Working on a differential basis, differential (and greater) costs associated with Group Care are opposed to its differential (and better) outcomes. Costs comprise differential direct costs, either paid by the Italian National Health System (mainly staff costs) or by patients (transportation and opportunity costs of time allocated to the two procedures). As the main endpoint in either case (a 4-year follow-up for type 2 with 90 patients, and a 3-year follow-up for type 1, with 62 patients, in both cases randomly assigned to the 2 competing procedures), we chose differential scores in perceived quality of life, which proved meaningful and statistically robust. Resulting cost-effectiveness ratios are EUR 2.28 per point in the DQOL score for type 2 diabetes, and EUR 19.46 for patients with type 1. This was in both cases a very reasonable additional burden that – from a societal point of view – makes future extensions of Group Care very attractive. The robustness of the results are discussed and tested in sensitivity analyses, run by changing the end-points and/or cost composition. Copyright © 2005 S. Karger AG, Basel

In Italy, as well as other developed countries [1], diabetes is a widespread illness, with a prevalence rate of about 3% [2], of which 9/10 are type 2, and 1/10 type 1. As a consequence, diabetes exerts a high impact, as evaluated from any perspective including social and economic. Social costs of type 2 diabetes in eight selected European countries were recently investigated in the CODE-2 study ([3] for Italy, [4] for Germany; [5] for a general survey). The main results, while confirming and assessing the high economic relevance of diabetes in all the investigated countries, both in absolute and relative terms, stressed the major

relevance of costs related to treating complications compared to those absorbed by the treatment of the illness as such. Hence, the relevance of reducing the incidence of complications also from the societal and economic points of view. Group Care as an educational approach has something to add in this respect as the challenging complexity of diabetes care can be faced with increased hope of success only if increasingly effective pharmaceuticals are associated with novel approaches to care delivery and healthier and more appropriate individual life behaviors [6]. Both issues are central to the Group Care approach to type 1 and 2 diabetes, many aspects of which are explored in this volume.

Objectives

Provided that Group Care is, by some relevant point of view, more effective than traditional programmes of individual one-to-one visits, are its results also cost-effective? And are they economically feasible, in the double meaning of being easily replicable in differentiated organizational contexts and worth their cost to society? This chapter aims at making such an analysis, adopting a microeconomic approach, which, although general, has been adapted to the specific circumstances in which clinical trials have been run, both with non-insulin-treated type 2 diabetes patients (reviewed after 4 years) [7], and type 1 diabetes insulindependent patients, in a 3-year follow-up [8]. Previous papers have described and discussed the original clinical settings of Group Care to which this economic analysis refers [9], its multicentric extension (the ROMEO project [10] and chapter by Porta and Trento [this vol., pp. 108–116], and results at 2 [11] and 5 years for type 2 [12, 13].

Research Design and Methods

Choice and Measurement of Relevant Costs The first problem one has to solve when starting an economic evaluation can be expressed as follows: ‘Which kind of costs shall I take into account?’ The question can be posed in other ways, for instance: ‘Which kind of costs shall I exclude, for any good reason (because they are not relevant, in principle or in practice; they are not eligible for the case in point; they are relevant in principle but not accountable in practice, and so on)?’ Knowing which costs are included and which are excluded from an economic evaluation is imperative in order to make possible comparisons of

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results obtained in different analyses and has been the object of many attempts to define good general practice rules [14, 15]. In principle, when comparing different health interventions, four main categories of resources are at stake, all of them converging in forming the ‘costs numerator’ of the cost-effectiveness ratio, the denominator of which measures the (differential) changes in health status, or health effects [15]. The cost numerator includes changes in the use of health care resources, of non-healthcare resources, of informal caregivers’ time, and of patients’ time for treatment. All of the above items need (1) to be identified and measured, and (2) to be valued in monetary terms. A commonly used alternative classification of resource costs distinguishes between ‘direct’ and ‘indirect’ costs, the former being ‘the value of all the goods, services, and other resources that are consumed in the provision of an intervention or in dealing with the side effects or other current and future consequences linked to it’ (that is to say, changes in use of health care resources, and in use of non-health care resources) [14, p. 123]. The latter are costs incurred as a consequence of treatment: changes in resource use due to productivity gains or losses related to illness or death. Among direct costs are all kinds of use of resources, be they borne by health organizations (the Italian National Health Service – INHS – in our case) for health care personnel, tests, drugs and provision of other medical facilities, or by the patients themselves and their caregivers, if any, for attending the health care programme (no matter if bought on the market or offered on a volunteer basis). Resources allocated by the patients seeking care, as an actual expenditure incurred in reaching the premises where care is delivered (transportation costs) or as opportunity cost of their time spent for following the procedure, are an inherent part of direct costs. Indirect or productivity costs refer to costs associated with morbidity (lost or impaired ability to work or to engage in leisure activities due to the illness) and with mortality (frequently measured as lost income from death), unless the denominator of the cost-effectiveness ratio already captures the full value of that time (as happens when quality-adjusted life-years – QALY – is used as a measure of outcome). Outcome Measurement The choice of outcome measures makes the difference among different kinds of economic evaluations. In one, more ‘economic’, type of analysis (the cost-benefit analysis) outcomes are valued in monetary terms, so that the cost-benefit ratio is positive when its value is less than one (or the monetary value of outcomes is bigger than the monetary value of costs). To use costbenefit analysis in health services requires assigning monetary values to

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human lives, the crucial outcomes at stake, which is possible using many and different methods, all of them highly controversial and ending in substantially different results. Such difficulties explain why this kind of analysis, although in principle preferred by economists, is seldom used in practice. In cost-effectiveness analysis the outcome measures are expressed in physical, nonmonetary units. This choice avoids solving the difficult problem of giving a reasonable and universally accepted value to human life, but limits the comparability of results obtained to situations in which physical outcome measures are the same. Hence, the preference given to general endpoints, whenever feasible, like survival life years gained, which permit comparisons between different health procedures and illnesses [15]. However, reference to surrogate endpoints is considered useful to model the actual health effects, even if they do not allow direct comparisons. In clinical and economic studies of patient education models for diabetes [15, 16, Miselli and Accorsi, this vol., pp. 23–39] surrogate endpoints are often used. These are measures of metabolic control (HbA1c), risk factors for cardiovascular disease (e.g. cholesterol and triglycerides), body mass index and weight, as measures of obesity, which again is related to risk of developing cardiovascular diseases. Other variables are indicators of progression of diabetes to long-term complications associated with poor regulation of blood glucose, such as retinopathy and neuropathy, whilst rates of hospital admission are an indicator of the general health of patients, whether BG is under control or not. Other measures refer to quality of life (QoL), behaviors and cognitive abilities on how patients are managing, day-by-day, their diabetes. When QoL scores are at stake, and are associated with years of survival expressed in QALYs, or other measures like healthy years equivalent (HYE) (for a discussion of limits of quality measures [17]), the economic analysis which considers differential costs of differential QALYs is named cost-utility analysis. Economic Analysis as a Differential Analysis The economic analysis developed in this chapter is of the cost-effectiveness type. As such, it is a differential analysis: the cost effectiveness ratios of Group Care for type 1 and 2 diabetes are calculated with sole reference to differential outcomes and differential costs. This choice implies that each time there is an overlapping of costs between the two compared alternatives (Group Care and traditional, individual consultation care) common costs are not accounted for. Other recent papers, in a different perspective, give full account of costs associated to diabetes in Italy, in the perspective of social costs (within the CODE 2 project) [3], and in terms of direct medical costs [18].

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Cost-Effectiveness of Group Care in Type 2 Diabetes

Design [7, 13] A randomized controlled clinical trial has been carried out, which involved 56 patients with non-insulin-treated type 2 diabetes managed by systemic Group Care (with 15 educational sessions held every 2–3 months for 4 years, with one or two physicians and an educationalist acting as facilitators), and 56 control patients scheduled for one-to-one visits with the same physicians in charge of the group sessions, blinded to their status. Primary outcomes (for a classification, see Johannesson et al. [19]) included measurements of body weight, fasting blood glucose, HbA1c, blood lipids, knowledge of diabetes, health behaviors and QoL. Secondary outcomes included assessment of diabetic retinopathy, hypoglycemic medication, microalbuminuria, systolic and diastolic blood pressure, Framingham score for cardio-vascular risk, antihypertensive and lipid-lowering medication. Costs were evaluated within a microeconomic approach, from a quasisocietal perspective, and attention was paid to differences between group and traditional procedures. Two types of direct costs were calculated: those paid by the INHS for staff and educational materials and those incurred by patients and their caregivers, if any. INHS costs included clinical procedures and pharmacological treatment , normalized to an average duration of 1,547 days, assuming full compliance. Information on type and dosage of assumed pharmaceuticals were driven from individual case notes and valued using the prices of year 2000. Costs paid by the INHS for blood, urine and other routine tests were omitted, being the same for Group Care and control patients; mortgage rates for premises and equipment (educational materials included), as well as for learning costs of the (new) procedure of Group Care incurred by staff, were negligible and therefore not included. Patients’ differential costs refer to expenditures paid to attend clinics: round trip costs between home and hospital, plus opportunity cost of time spent by patients and their caregivers for attending the two procedures. Timing of clinic procedures was measured during 12 Group Care sessions, including preparation of case notes before individual consultations and at the end of sessions, and 5 clusters of individual, one-to-one visits. INHS average, unitary and comprehensive costs for staff employed were collected from the Hospital’s administration and applied according to time spent. After validation, two similar questionnaires adapted from a previous work [20] (for a more compact version currently used by centers in the ROMEO project, see ‘Appendix’) were administered to both Group Care and control patients (a 10-item questionnaire for Group Care and a 9-item questionnaire for control patients) to collect information on transportation time and costs, presence or absence of caregivers, and

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subjective evaluation of opportunity cost of time. They were filled by 48 of the 56 patients enrolled (85.7% response). All costs, originally expressed in Italian Lire (ItL) of the year 1999 (2000 for pharmaceuticals), are now reported in Euros (EUR 1
ItL 1,936.27).

Results

Clinical Results Data from 45 patients out of the initial 56 in Group Care and from 45 control patients of the original 56 were available for analysis at year 4. Group patients received an average of 15.8 sessions (range 13–17), and control patients had 12.5 (range 6–17) one-to-one visits. HbA1c remained stable from baseline to year 4 in group patients, but worsened in controls (p  0.001). BMI and body weight (both with p  0.001) decreased and HDL cholesterol increased (p  0.001) in group but not in control patients. After adjusting for age, duration of illness and education only HbA1c and urea remained statistically different between group and control patients. Knowledge of diabetes (GISED), health behaviors (CdR) and quality of life (DQoL/Mod) scores improved in the group (p  0.001) and worsened in the control patients (p
0.004 for GISED; p  0.001 for CdR and DQoL/Mod). The absolute cardiovascular risk did not change over the period in either group, while dosage of hypoglycemic agents decreased among group and increased among the control patients (p  0.001). Economic Results On average, Group Care required 34 min for preliminary checking of blood tests and case notes, 45 min for the session and 24 min for elective individual visits. An average of 8.4 patients attended the 12 sessions monitored, resulting in 12.4 min per patient session or 196 min spent by INHS staff per patient over the study. Visiting 58 patients individually during the 5 clinics monitored required 698 min: 12.0 min per patient, or 150 min of INHS staff time per patient over the study. Direct costs to INHS and patients are shown in table 1. Staff costs to see one patient in Group Care were EUR 7.06/session or 111.50 over the entire observation period. Direct costs for hand-out materials were estimated in EUR 0.52/patient session, or EUR 7.75 over the entire period. In total, EUR 119.25 was spent by the INHS for each patient on Group Care. Seeing patients individually cost the INHS EUR 7.03/patient-visit for staff and EUR 0.70 for hand-outs, or EUR 90.44 for the 12.5 average consultations over the study period. The average cost of pharmacological treatment over the study

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Table 1. Cost analysis (T2DM)* Cost-Effectiveness of Group Care

Costs and outcome

Staff costs Other costs Costs of drugs Total direct costs to INHS Transportation costs Patient time costs Total costs Differential DQoL/Mod scores Cost effectiveness ratio

Group Care

Controls

Difference Group Care–Controls

One treatment

4 years treatment

One treatment

4 years treatment

4 years treatment

7.06 0.52

111.50 7.75 537.03 656.69 48.45 126.43 831.57 23.60

7.03 0.70

87.94 2.50 536.43 627.11 38.34 66.37 731.82 19.20

23.57 5.25 0.60 29.58 10.11 60.06 99.75 43.80 2.28

3.07 8.00

3.07 5.31

Modified from Trento et al. [7, p. 1236]. *All monetary values are in Euros of the year 1999 (2000 for pharmaceuticals).

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period was EUR 537.03/patient on Group Care and EUR 536.43/patient for controls. Transportation costs were EUR 3.07/patient visit, or EUR 48.45 over the study period, for patients on Group Care and EUR 38.34 for controls. Average transportation time was 38 min per patient visit. Patients on Group Care spent on average 48 min per session and controls 12 min per visit, not inclusive of time spent in waiting room. Patients on Group Care were accompanied by others in 20.8% of cases: they and their caregivers spent 104 min per consultation, or 1,643 min over the study period. Corresponding figures for the control patients and caregivers were 37.5%, 69 min/per visit, and 850 min in total. Only 46.9% of patients in this survey were able to value their time spent to reach and attend the clinics and the remaining cost-opportunity estimates showed an unacceptably high dispersion. Hence, more reliable values obtained previously from a similar population [20] were applied, after adjusting for inflation. The resulting average estimated value of staff time was EUR 0.077 per min, with a total cost of EUR 126.43 per patient on Group Care and EUR 66.37 per control patient. In total, each patient on Group Care cost EUR 831.57 and each control EUR 731.82 with a difference of EUR 99.75 per patient treated over the observation period. Taking the differential DQoL/Mod score as a proxy outcome, each incremental improvement in quality of life for patients on Group Care was obtained with an expenditure (i.e. a cost-effectiveness ratio) of EUR 2.28.

Discussion

Differentials in direct costs born by INHS are about EUR 30 per patient, over a period of 4 years, which seems a very promising result in view of an extension of this procedure to the increasing population of type 2 diabetes patients, in Italy as well as in other developed countries. Besides, that differential could become even thinner should Group Care sessions be run by well-trained nurses, nutritionists and other professionals, whose cost is lower than that of physicians. Diffusion of Group Care could be extended well beyond the precincts of diabetes clinics, breaking bonds posed by scarcity of specialized resources if it became a common practice among general practitioners (about obvious advantages of integration between diabetes clinics and GP practices [21]). Previous studies had shown that a reduced need for hypoglycemic medication due to patient education resulted in lower expenses for pharmaceuticals [22, 23]. Although in this study the average overall cost of hypoglycemic agents were similar for patients on Group Care and controls, drug usage decreased

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among the former and increased in controls. Moreover, the final daily cost of hypoglycemic agents decreased from baseline in 33.3% of patients on Group Care and 13.3% of controls. The average final daily cost for pharmaceuticals had increased by 35.2% among patients on Group Care and 86.9% among controls, suggesting that costs may remain lower in the future for the former. Two differential intermediate outcomes among group and control patients were meaningful and statistically robust, signaling a relative superiority of Group Care (HbA1c and urea nitrogen), as well as two other final nonclinical outcomes (health behaviors and knowledge of diabetes). The impossibility of unifying the above positive results in a unitary outcome (which needs giving each of them a definite weight in composing that outcome) prevents from calculating a comprehensive cost-effectiveness ratio. Relating total differential costs to each such differential outcomes a cost-effectiveness ratio of EUR 62.34 is obtained per each of the 1.6 percentage improvement of total HbA1c in differences between baseline and 4 years average values among group and control patients, and of EUR 34.04 per each mol/l urea nitrogen, calculated in the same way. Assuming as endpoints the 15.4 differential GISED scores (knowledge of diabetes), each score was obtained at a cost of EUR 6.47; the 7.5 average differential scores of improvement in health behaviors were obtained at a cost of EUR 13.3 each.

Cost-Effectiveness of Group Care in Type 1 Diabetes

Design Based upon the promising results obtained in patients with T2DM [7, 9, 11–13], the Group Care approach was extended to T1DM patients. To that purpose, 62 people with T1DM were randomly selected, of which 31 were assigned to 5 groups of 6–7 persons each, while 31 control patients continued with the traditional one-to-one visit programme. Details on choice criteria, education programme and procedures, and clinical results have been described and discussed elsewhere [8]. A discussion within 4 focus groups with T1DM patients showed which topics they expected to be treated in the sessions and thus allowed to set an initial 9-session Group Education programme. At the end of these 9 sessions, a second round of focus groups was held, which brought to a redefinition of educational and health objectives in a new 9-visit programme. During the 36-month observation period reported, 15 Group Care sessions were delivered, planned to last 40–50 min, one every 2–3 months, where a doctor and a psychopedagogist acted as facilitators, according to adult learning methodological principles [24, 25]. Control patients continued to follow usual 2- to 3-monthly

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individual consultations in the diabetes clinic, receiving individual education sessions from the same psychopedagogist involved in Group Care: they received 15 individual visits in the 36-month observation period. Body weight, fasting blood sugar and HbA1c were measured at each visit; total and HDL cholesterol and microalbuminuria/creatinuria ratio were measured yearly. Hypoglycemic and severe hypoglycemic episodes were assessed retrospectively. Three questionnaires were administered at baseline and after 3 years to measure quality of life (Italian translation of the original DQoL questionnaire [26]), knowledge of T1DM (GISED 57 items [27]), and health behaviors (30-item purpose-built for T1DM [8]). Similar to the study on T2DM, economic analysis was of the costeffectiveness type (additional costs associated with additional results of Group Care compared with traditional individual consultations), carried from a quasisocietal point of view (including direct costs incurred by the INHS and by the patients). Costs were expressed in Euros of the year 2002, based on the average salaries of professionals involved and an accurate timing of all procedures. Costs of insulin, diagnostic materials and tests, and of personnel time to update clinical records were omitted, because they did not differ between Group Care and controls. Differential mortgage costs of premises and materials were negligible, hence ignored. Transportation costs and opportunity cost of time spent with alternative procedures was assessed by questionnaire (see ‘Appendix’).

Results

Clinical Results Nonattendance to scheduled appointments was 4.3% for group and 16.7% for control patients. Quality of life improved in Group Care patients, but worsened in controls, while knowledge of diabetes and health behaviors, respectively, improved and remained unchanged (p  0.001, results confirmed by multivariate analysis [8]; table 2). Proper clinical variables (HbA1c, total and HDL cholesterol) showed instead no or not statistically significant differences between group and control patients. Also in this case, the differential in quality of life scores was taken as the main nonclinical end-point outcome, to which economic analysis was tailored.

Economic Results

Based upon the average duration and number, personnel times and unitary costs of the two procedures (Group Care session  individual consultation, on the

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Cost-Effectiveness of Group Care

Table 2. Knowledge of diabetes, health behaviors and quality of life at baseline and year 3 in patients on Group Care (n
30) and controls on individual care (n
28) (T1DM) Group Care

Knowledge of diabetes (GISED score) Health behaviours (CdR –T1DM score) Quality of life (DQoL score)

Controls

Baseline

4 years

Difference

Baseline

4 years

Difference

44.34  6.97

47.45  6.03

3.10 (1.56 to 4.65 )*

43.10  6.8

43.34  6.8

0.24 (0.32 to 0.80)

21.48  3.18

25.28  2.66

3.79 (2.61 to 4.98)*

22.38  3.1

22.28  3.5

0.10 (0.41 to 0.21)

79.37  13.3

70.55  12.2

8.82 (12.51 to  5.14)*

80.72  11.52

84.06  11.35

3.34 (2.38 to 430)*

Modified from Trento et al. [8] *p  0.001

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Table 3. Cost-effectiveness analysis (T1DM)* Costs and outcomes

Group Care patients

Control patients

Difference group-control

Total INHS direct costs Total patients’ costs Total direct costs Differential DQoL scores Cost-effectiveness ratio

271.25 661.95 933.20 8.82 (5.14 to 12.51)

120.15 576.45 696.60 3.34 (4.30 to 2.38)

151.10 85.50 236.60 12.16 19.46

* All monetary values are in Euros of the year 2002

one hand; control visit, on the other), direct costs for the INHS over 3 years totaled EUR 271.24 per patient in Group Care, and EUR 120.15 per control (table 3). Patient transportation costs were EUR 526.95 for both procedures. Opportunity-cost of time spent in clinic, as estimated by patients themselves, because of differences in times respectively allocated, was EUR 135.00 per group and EUR 49.50 for control patients, totaling EUR 661.95 and EUR 576.45. The total cost differential between the Group Care and the control procedure was therefore EUR 236.60 over 3 years. That meant a cost-effectiveness ratio of EUR 19.46 per each of 12.16 differential DQoL scores.

Discussion

Group Care was confirmed to be a feasible and cost-effective approach to deliver continuing education also to T1DM patients [8]. The programme costs were calculated as if nurses and dieticians participated in group sessions, as happens in other clinics that joined the ROMEO project [8, Porta and Trento, this vol., pp. 108–116]. The choice of differential DQoL scores as an endpoint was made because it was impossible, with available data, to translate our results in QALYs, the outcome traditionally used in cost-utility analyses. Hence, this analysis is a cost-effectiveness rather than a cost-utility one. Taking into account the other two nonclinical endpoints considered (knowledge of diabetes and health behaviors), the cost-effectiveness ratio was EUR 82.73 per GISED score (number of differential scores
2.86) and EUR 60.82 per CdR-T1DM score (number of differential scores
3.89).

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One should consider that those results, although encouraging per se, would appear even better if it were possible to aggregate these three positive differential results into one single score, to be used as denominator of a ratio whose nominator already sums up all differential direct costs between the two procedures. To assess the robustness of the cost-effectiveness ratios, two types of sensitivity analysis were undertaken, showing that: (1) A reduced and less costly team, composed of well-trained nurses and dieticians, could substitute the physician and highly experienced psychopedagogist who ran the programme in our setting, without hindering its efficacy, but reducing by 34% the additional cost spent per point in quality of life (and/or per score of knowledge of diabetes and health behavior. (2) Since patients on Group Care miss much less appointments than controls, differential costs rise if one takes into account the actual attendance rates. Either way, these remain highly appealing economic results, which pinpoint the usefulness of extending the Group Care model to T1DM patients well beyond the precincts of our clinic, as an integrated clinical and educational approach to other chronic diseases [see Mühlhauser, this vol., pp. 132–146].

References 1 2

3 4 5 6 7

8

9

10

World Bank: World Development Report 1993. Oxford, Oxford University Press, 1993. Garancini MP: L’epidemiologia del diabete non insulino-dipendente e delle ridotta tolleranza al glucosio; in Società Italiana di Diabetologia (ed): Il diabete in Italia. Milano, Editrice Kurtis, 1996, pp 17–30. Lucioni C, Garancini MP, Massi-Benedetti M, Mazzi S, Serra G: The costs of type 2 diabetes in Italy. A CODE 2 sub-study. Treat Endocrinol 2003;2:121–133. Liebl A, Neiss A, Spannheimer A, Reitberger U, Wagner T, Görtz A: Costs of type 2 diabetes in Germany. Results of the CODE-2 study. Dtsch Med Wochenschr 2001;20:585–589. Jönsson B: Revealing the cost of type II diabetes in Europe. Diabetologia 2002;7:5–12. Konen JC: Why are we surprised by our failures? The bewildering complexity of diabetes care. NC Med J 2003;2:80–82. Trento M, Passera P, Bajardi M, Tomalino M, Grassi G, Borgo E, Donnola C, Cavallo F, Bondonio P, Porta M: Lifestyle intervention by Group Care prevents deterioration of type II diabetes: A 4-year randomized controlled clinical trial. Diabetologia 2002;45:1231–1239. Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Brescianini A, Tomelini M, Giuliano S, Cavallo F, Miselli V, Bondonio P, Porta M: A 3-year prospective randomized controlled clinical trial of Group Care in type I diabetes. Nutr Metabol Cardiovasc Dis; in press. Trento M, Passera P, Tomalino M, Pagnozzi F, Pomero F, Vaccari P, Bajardi M, Molinatti GM, Porta M: Therapeutic group education in the follow-up of patients with non-insulin treated, noninsulin dependent diabetes mellitus. Diab Nutr Metab 1998;11:212–216. Gentile L, Borgo E, Bruno G, Grassi G, Miselli V, Morone G, Passera P, Veglio M, Trento M, Bondonio P, Miroglio T, Cavallo F, Porta M: ROMEO: Ripensare l’Organizzazione per Migliorare l’Educazione e gli Outcome. Visite per gruppi di educazione terapeutica: trasferimento del metodo di lavoro clinico nel progetto di ricerca multicentrica. Giorn It Diab Metab 2004;24:9–16.

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11

12

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14 15

16 17 18 19 20

21 22 23 24 25 26 27

Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M: Group visits improve metabolic control in type 2 diabetes: A 2-year follow-up. Diabetes Care 2001;24: 995–1000. Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, Porta M: A 5-year randomized controlled study of learning, problem solving ability, and quality of life modifications in people with type 2 diabetes managed by Group Care. Diabetes Care 2004;3:670–675. Trento M, Passera P, Borgo E, Bajardi M, Cavallo F, Porta M: Learning, health behaviors and quality of life modifications over 5 years in people with type 2 diabetes managed by Group Care. Front Diabetes. Basel, Karger, 2005, vol 18, pp 97–107. Gold MR, Siegel JE, Russell LB, Weinstein MC (eds): Cost-Effectiveness in Health and Medicine. New York, Oxford University Press, 1996. Loveman E, Cave C, Green C, Royle P, Dunn N, Waugh N: The clinical and cost-effectiveness of patient education models for diabetes: A systematic review and economic evaluation. Health Technol Assess 2003:7. Norris SL, Engelgau MM, Venkat Narayan KM: Effectiveness of self-managed training in type 2 diabetes: A systematic review of randomized controlled trials. Diabetes Care 2001;3:561–587. Luce BR, Manning WG, Siegel JE, Lipscomb J: Estimating costs in cost-effectiveness analysis. In Gold et al. [14, chap 6]. Garattini L, Chiaffarino F, Cornago D, Coscelli C, Parazzini F: Direct medical costs uniquivocally related to diabetes in Italian specialized centres. Eur J Health Econom 2004;5:15–21. Johannesson M, Jönsson B, Karlsson G: Outcome measuremet in economic evaluation. Health Econ 1996;4:279–296. Porta M, Rizzitiello A, Tomalino M, Trento M, Minonne A, Pomero F, Gamba S, Castellazzi R, Montanaro M, Sivieri R, Orsi R, Molinatti GM, Bondonio P: Comparison of the cost-effectiveness of three approaches to screening for and treating sight-threatening diabetic retinopathy. Diabetic Metab 1999;25:44–53. Sturmberg JP, Overend D: General practice based diabetes clinics. An integration model. Aust Fam Physn 1999;3:240–245. Kronsbein P, Jörgens V, Mühlhauser I, Scholz V, Venhaus A, Berger M: Evaluation of a structured treatment and teaching programme on non-insulin-dependent diabetes. Lancet 1988;ii:1407–1410. Gagliardino JJ, Etchegoyen G for the PEDNID-LA Research Group: A model educational programme for people with type 2 diabetes. Diabetes Care 2001;24:1001–1007. Knowles MS: The Adult Learner: A Neglected Species. Houston, Gulf Publishing Company, 1997. Newman P, Peile E: Learning in practice. Valuing learner’s experience and supporting further growth: Educational models to help experienced adult learners in medicine. BMJ 2002;325:200–202. Mannucci E, Mezzani B, Conti A, Rotella CM: Valutazione della qualità della vita nei pazienti adulti diabetici di tipo I. Il Diabete 1994;6:223–228. Gruppo di Studio per l’Educazione sul Diabete – GISED: Questionario per la valutazione delle conoscenze, dei comportamenti e degli atteggiamenti dei diabetici. Diabete1993;5:54–56.

P. Bondonio, Professor of Economics Department of Economics, University of Torino 53, via Po, I–10124 Turin, Tel. 39 011 6702713 Fax 39 011 6702762, E-Mail [email protected]

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Appendix

Interview scheme for Group Care patients Patient

Age:

Sex:

F

ⵧ

M

ⵧ

No: Profession: Address: 1. Usually: a) How long (how many minutes) does it take for you to take part in a Group Care session?

• • • •

Arrival time: Waiting time and session: Leaving time: Total time:

b) How did you travel? c) What are your travel costs? (EUR) (petrol and parking your car; bus/train round trip ticket) d) Have you an accompanying person? YES ⵧ NO ⵧ • (If YES) accompanying person’s profession: • Additional travel expenditures (EUR) (if any) for the accompanying person: 2. For you, is it a sacrifice giving up activities (e.g. job, or leisure if you don’t work) you would have done had you not come here to take part in the session? a) YES ⵧ NO ⵧ b) (If YES) express your degree of discomfort: (small) 1 2 3 4 5 (big) c) (If YES) should someone offer you money to compensate you for the discomforts you suffered, which amount of money would (EUR) you believe to be fair? 3. All in all, how satisfied are you with the Group Care procedure you are following? (Not at all) 1 2 3 4 5 (completely) 4. Taking into account your ‘degree of satisfaction’ (see previous answer), which amount of money does better correspond to the value you ascribe to each session? (EUR) Final comments (if any)

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Porta M, Miselli V, Trento M, Jörgens V (eds): Embedding Education into Diabetes Practice. Front Diabetes. Basel, Karger, 2005, vol 18, pp 132–146

Evidence-Based Patient Education in Diabetes and Beyond – Application to Other Chronic Diseases From Obedience Training to Informed Decision Making

Ingrid Mühlhauser Unit of Health Sciences and Education, University of Hamburg, Hamburg, Germany

Abstract Diabetes education is a model to illustrate milestones in the evolution of patient education from obedience training to participation in medical decision making. The present article focuses some new developments in diabetes education and its evaluation, application to other chronic diseases, and patient and consumer participation in medical decision making. Traditionally, patient education has mainly aimed at increasing patient compliance to physician defined therapeutic goals and treatment strategies. Diabetes self-management programmes have been most effective and have served as models for other chronic conditions such as asthma bronchiale, hypertension and anticoagulation therapy. To further strengthen their rights and their autonomy, patients need to become involved in medical decision making with respect to their individual therapeutic goals as well as concerning their therapeutic options to pursue these goals. The need to have the patients participate in these decisions becomes particularly obvious when long-term therapeutic efforts, even if carried out by the patients with perfection, do not lead to the elimination of the complications attributed to the disease, but much rather to a quantitative change of the risk to develop them. Examples are presented such as anticoagulation therapy in atrial fibrillation, treatment of persons with multiple sclerosis and screening for breast or colorectal cancer. Information as a basis for informed decision making has to be evidence based and presented in an unbiased format. This includes information of the benefits, lack of benefits and unwanted effects as well as burdens of various interventions. Regarding diagnostic procedures consequences of falsepositive and false-negative results have to be communicated. Outcome data have to be presented as natural frequencies rather than relative differences. In order to avoid framing of data equal emphasis has to be put on the proportion of persons who are likely to benefit and those who are unlikely to benefit or likely to be harmed. The concept of patient participation in medical decision making represents a fundamental challenge for the future development particularly of the care of patients with chronic diseases. Copyright © 2005 S. Karger AG, Basel

Diabetes Education as a Model

Diabetes education may serve as a good example illustrating milestones in the evolution of patient education and patient participation in medical decision making. In addition, evaluation of diabetes education programmes may serve as a model for compiling evidence on complex interventions. The present article focuses some new developments in diabetes education and its evaluation, application to other chronic diseases, and patient and consumer participation in medical decision making. The article reports on personal experience by referring to recent projects of the author as a member of the diabetes and education research groups at the diabetes center of the University of Düsseldorf and the Unit of Health Sciences and Education at the University of Hamburg, Germany.

Diabetes Education – From Obedience Training to Self-Management

Traditionally, treatment and patient information were expert-based rather than evidence-based as reflected by a variety of non-evidence based dogmas [1]. Prohibition of sugar consumption (‘Zuckerverbot’) is just one example. The Zuckerverbot was based on misinterpretation of animal experiments carried out by Dr. Allen early last century [1]. Hence, diabetes education was restricted to dietary training. Regular self-monitoring (of urine glucose) was not an obligatory part of treatment and patients with type 1 diabetes were not allowed to change insulin dosages themselves. The primary educational goal was to increase patient compliance to strict dietary regimens. Figure 1 displays a typical example for the material used in patient education. The poor patients were not only forbidden to consume sweets or cakes, but they were also not allowed to talk. Diabetes education was reduced to obedience training [2]. Systematic assessment of the outcome of this approach was missing, but acute and late complications appeared to be frequent. Towards the end of the 1970s, the increasing acceptance of a causal relationship between glycemic control and microangiopathy led to the formulation of near-normalization of metabolic control as a primary therapeutic goal. The introduction of glycosylated hemoglobin (HbA1c) measurements confronted physicians and patients with their ill success to achieve this ambitious objective. In 1979, the Diabetes Education Study Group (DESG) of the European Diabetes Association (EASD) was founded. Education, encouragement, and training of the patient to actively take over increasing parts of his/her therapy in order to stepwise render him/her more independent from physicians and medical institutions became primary objectives of patient education. A main

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Fig. 1. A typical example for the material used in patient education. (Original drawing taken from a paper published by the Swiss Diabetes Association, 1981.)

objective of diabetes education was the training of the patients in self-adaptation of insulin dosages to variable amounts and timing of carbohydrate intake. Sugar consumption was not prohibited. Meals could be skipped altogether. No snacks were prescribed. The success of this treatment and teaching approach has been documented in a large number of controlled trials carried out by a variety of research groups all over the world [3, 4].

Framework for Evaluation of Education Programmes

The particular problems related to the evaluation of diabetes treatment and teaching programmes including systematic reviews on self-management

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programmes have been discussed recently [4]. Diabetes education programmes are complex interventions. Their evaluation is difficult because of problems in identifying and separately assessing the effect of the various components of the intervention. A phased approach defining the sequential stages of a continuum of increasing evidence has been proposed as a framework for the design and evaluation of such complex interventions [5]: pre-clinical or theoretical phase, modelling of the components of the intervention, exploratory trials, randomized controlled trials, and phase of implementation including replication and transfer to different settings. At present it is not possible to readily extract the information on such a continuum of evidence for diabetes programmes from databases such as Medline or The Cochrane Library. Replication, transferability and implementation trials might have been carried out by different authors than the core (randomized) controlled trials. In addition, the identity of the intervention can become apparent only by scrutinizing the original articles. Hence such publications usually can not be identified by conventional methods of searching databases and screening abstracts. Systematic reviews on the effectiveness of patient education and self-management training programmes typically attempt to dissect the programmes into single components and to evaluate them separately [6–8]. Studies using complex interventions are usually excluded or included only if the reviewers feel they can isolate the educational component to examine it separately. In addition, problems with respect to the definition of outcome measures have become apparent. Definition of one common outcome measure for different programmes disregarding the complexity of effectiveness parameters of the original studies will lead to misinterpretations; for example, the use of HbA1c as an isolated outcome variable without considering treatment goals, intended changes in medication or weight or inseparable effects on hypoglycemia. The methodology used in these systematic reviews are not suitable to evaluate complex interventions [4]. Improvement of methodology is urgently needed.

Education and Self-Management Application to Other Chronic Disease

Hip Fracture Prevention by Hip Protectors Traditional adherence increasing educational interventions may still be very effective. Recently, we have evaluated a programme to increase adherence to the use external hip protection [9–12]. Hip fractures are a major cause of disability among the elderly. External hip protectors can effectively reduce the impact of falls and thereby the risk of the hip fracturing. However, acceptance

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of hip protectors is poor. We have developed a two-part intervention, consisting of a structured theory-based single education session and provision of free equipment, directed at nursing staff and residents to encourage the use of hip protectors. The intervention was evaluated in a randomized controlled trial showing a reduction of hip fractures by about 40% [10, 11]. Arterial Hypertension Hypertension as a model for patient education is comparable to type 2 diabetes. Care for patients with hypertension is characterized by under- and overdiagnosis and under- and overtreatment. Similar to diabetes, hypertension is often asymptomatic and its optimal control needs daily and lifelong adherence to a medical regimen that entails possible side effects. Patient compliance is poor. Providing patients with sufficient information about the disease and its treatment in combination with blood pressure self-monitoring increases patient adherence to dietary and drug treatment and improves control of hypertension. Based on the experiences gained during the development of the diabetes treatment and teaching programme for non-insulin-dependent diabetes [13] the development and evaluation of a hypertension treatment and teaching programme was initiated in the mid-1980s [4]. Components of the programme and conditions for long-term success are comparable for type 2 diabetes and hypertension. Thus, the hypertension programme is similar in design and organization: education for small groups of patients comprising four weekly sessions, delivered by paramedics in out-patient clinics or in the physician’s office, written curriculum and teaching materials; structured preparatory course for physician and staff. Important components of the programme are correct blood pressure measurements, a validated diagnosis of hypertension and systematic blood pressure self-monitoring by the patients, active involvement of patients in decision making and adaptation of drug therapy. The programme was evaluated according to the phased approach of a continuum of increasing evidence for complex interventions [4]. The intervention leads to improvement of blood pressure control and at the same time to reductions of prescriptions and changes of antihypertensive medication indicating better adherence to prescribed treatment [4]. In combination with intensified care the programme led to a significant reduction in morbidity and mortality in type 1 diabetes [14, 15]. Asthma Bronchiale Patients with bronchial asthma are confronted with comparable problems as patients with type 1 diabetes. The disease is characterized by unpredictable fluctuations with acute and sometimes life threatening asthma attacks. Patients with severe asthma face frequent hospital admissions and impairment of quality

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of life. Self-monitoring by measuring peak flow may inform the patient in advance about deterioration of the disease. Effective symptomatic treatment is available including the administration of short courses of cortisone during exacerbations. We have developed a treatment and teaching programme following the model of the 5-day inpatient programme for patients with type 1 diabetes. Patients trained in self-management including peak-flow self-monitoring and self-adaptation of medication can substantially reduce severe asthma attacks and numbers of hospital admissions [16, 17]. At present, the programme is used at various centers in Germany and has been adopted to be carried out as an outpatient programme as well [18]. Oral Anticoagulation Control of oral anticoagulation therapy is often inadequate. A structured treatment and teaching programme based on self-monitoring of blood coagulation (international normalized ratio) and self-adjustment of oral anticoagulation has been shown to result in improved accuracy of anticoagulation therapy results and in treatment-related quality-of-life measures [19].

Medical Decision Making by Patients and Consumers

At present, diabetes education programmes to train and motivate patients to therapeutic autonomy are regarded as crucial to increase both the patients’ quality of care and independence. However, almost invariably the patients remain excluded from medical decision processes, i.e. to define their individual therapeutic objectives and to select a certain treatment strategy. Thus, it is generally assumed to be in the diabetic patient’s interest that HbA1c levels are (near-) normalized and that body weight, LDL-cholesterol levels and blood pressure should be aggressively treated until ideal standards are reached. With the patients becoming more and more knowledgeable and independent through the successful implementation of patient education in diabetes, their right to actively participate or eventually even to assume responsibility in these medical decision processes is becoming obvious. Clearly, most of the therapeutic efforts the patients are asked to make will, even if diligently carried out, not lead to the elimination of the vascular complications attributed to their diabetes, but much rather serve to decrease the likelihood/risks for the occurrence of such complications over time. It is in this context that the patients should be involved in the decision making processes themselves balancing the risks they are prepared to take against the efforts they are prepared to make – rather than having the physicians or other parties making these decisions on their part [20].

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The active involvement of patients and consumers in decision making about preventive, therapeutic or diagnostic interventions is increasingly advocated [21]. Evidence-based medicine (EBM) explicitly integrates patients’ values and preferences in treatment decisions. The basis for informed patient/consumer decision making is the communication of evidence-based scientific data in a format that can be understood by non-medically trained persons [22]. In the UK, the General Medical Council has produced ethical guidelines for the procedures necessary to obtain patients’ informed consent prior to undergoing any medical intervention, i.e. investigation or treatment [23]. These guidelines are quite specific in stating that patients must be given sufficient information in order to enable them to exercise their right to make informed decisions about their care. Ideally, this information needs to include details of the diagnosis, and the likely prognosis if the condition is left untreated; potential uncertainties about the diagnosis and options for further investigation prior to treatment; options for treatment or management of the condition, including the option not to treat; for each therapeutic option, the probabilities of success, the risks of failure, or harm as well as any lifestyle changes which may be caused by or necessitated by the treatment need to be explained using accurate data; finally, advice as to whether a proposed treatment is experimental and a reminder that patients have a right to seek a second opinion need to be given. With regard to diagnostic procedures, including screening tests, a doctor or other party should explain the purpose of the investigation, the likelihood of positive and negative findings, including false negative and false positive results; uncertainties and risks, important medical, social or financial consequences, follow-up plans, including counseling and support services [23]. In general, the physician should abstain from making assumptions about patients’ views; and information must not be withheld because of the possibility that the patient or consumer might become upset or decide to refuse a suggested investigation or treatment. Furthermore, the physician has to declare any potential conflicts of interest due to financial benefits, and the patients should be allowed sufficient time to reflect before and after they make a decision [23]. Traditionally, in medical decision making patients or consumers rely on experts’ opinions. Decisions are being made by intuitively evaluating the credibility of information sources and based upon own preferences. Expert opinions are usually presented as simplified statements such as ‘this treatment is better than another treatment’ or ‘this treatment saves lives’. Under such conditions individual judgment of potential benefits or harm is not possible. Traditionally, health education has been aimed at persuading the public to adopt a specific recommendation or behavior, e.g. increasing the consumption of fruits and vegetables, decreasing the consumption of saturated fats or eggs, or participating in

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Fig. 2. Cartoon depicting a patient presenting information picked up on the internet during a consultation [from ref. 21, with permission].

screening programmes. This approach contrasts with the communication of evidence based information on objective pros and cons of such general recommendations enabling persons to make informed decisions concerning health related behavior or respective life style changes [20]. The question is not whether patients should or should not participate in medical decision making. Patients and lay people cannot be ‘protected’ any longer from disquieting and worrying information. Free access to almost all medical information via the internet is used and appreciated by the public. Physicians are challenged by patients who present their internet downloads during consultations (fig. 2). Patients have always made medical decisions, for example, by adhering to prescriptions or not. But, such decision making is usually done without availability of necessary information. Thus, active support of this new development of patient involvement in medical decision making could result in high quality information and real informed decision making.

Presenting Evidence-Based Patient Information

Currently available information materials for patients/consumers do not fulfil the quality criteria required for unbiased evidence-based patient information [24]. A well-known problem in communicating scientific data is

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represented by the phenomenon of framing-of-data [25]. The particular way study results are presented exerts a substantial influence upon decisions by patients, health care providers and health policy makers alike. Thus, the impact of framing of outcome data as either relative or absolute differences is substantial [26, 27]. Furthermore, outcome data can be framed by either emphasizing achievable benefits or the lack of such benefits. So far, studies evaluating the communication of treatment results usually focus on the patients who might benefit from the respective interventions. In order to objectively communicate outcome data the entire spectrum of data presentation must be given, i.e. the proportion of persons who are likely to benefit as well as the proportion of persons who are unlikely to benefit or likely to be harmed as a result of the intervention should be presented with equal emphasis irrespective of whether results are communicated by illustrations or numbers [20].

Examples of Evidence-Based Information in Diabetes

Table 1 presents a possible scenario of evidence-based information for patients with type 2 diabetes on the basis of recent data provided by the UKPDS [28]. A detailed description of the extraction and presentation of the data from the UKPDS has been published previously [20]. In short, the UKPDS reported a 12% (95% CI 1–21%, p ⬍ 0.03) reduction of the primary combined outcome ‘any diabetes related endpoint’ between the ‘intensified therapy’ group with a median HbA1c value of 7.0% and the ‘conventional therapy’ group with a median HbA1c value of 7.9% over 10 years. A comprehensive estimation of the potential benefit-harm relation would have to include information on secondary effects and quality of life aspects. In this context, the patient would have to be informed what his personal extra contribution/effort would have to be over a period of 10 years. This effort would include sustained extra efforts concerning drug/insulin therapy, blood glucose self-monitoring (not quantified in the UKPDS) and the therapeutic side effects, such as an increased incidence of hypoglycemia and weight gain. On the other hand, avoidance of hospitalizations and of diagnostic and therapeutic procedures (e.g. laser therapy for retinopathy) attributed to diabetes related complications should be presented [20]. Framing of data is even more important for primary prevention studies. Recent primary diabetes prevention studies have reported 25–60% reductions in diabetes by lifestyle or drug therapy interventions. Table 2 displays the data of one of those studies. Relative risk reduction for the risk of diabetes was 51% corresponding to an absolute risk reduction of 15%. However, related to fasting

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Table 1. To what extent can intensified therapy prevent ‘any diabetes related endpoint’? [20] With conventional therapy of 100 newly diagnosed patients 46 have at least one endpoint over the next 10 years With intensified therapy of 100 newly diagnosed patients 41 have at least one endpoint over the next 10 years With conventional therapy of 100 newly diagnosed patients 54 do not have an endpoint over the next 10 years With intensified therapy of 100 newly diagnosed patients 59 do not have an endpoint over the next 10 years Out of 100 newly diagnosed patients with intensified therapy 5 have a benefit over the next 10 years as they do not have an endpoint as a result of intensified therapy Out of 100 newly diagnosed patients with intensified therapy 95 have no benefit over the next 10 years since they would not have had an endpoint with conventional therapy (54 patients) or they will have an endpoint despite intensified therapy (41 patients)

Table 2. Framing of data in diabetes prevention studies [Diabetes Prevention Program Research Group. NEJM 2002;346:393–403] Risk of diabetes over 3 years Control group

Intervention group

Relative risk reduction

Absolute risk reduction

Risk of diabetes Fasting BG, mmol/l

29% 6.2

14% 5.9

51%

HbA1c, %

6.1

6.0

15% Difference 0.3 Difference 0.1

blood glucose levels or HbA1c levels these findings relate to minimal changes of negligent clinical relevance. More details with respect to this example have been published recently [29]. The public will have to be informed about relevant outcome data by presentation of natural frequencies rather than relative risk reductions. Framing of data will also lead to different decisions in hypertension care [30, 31]. Many patients may prefer not to take treatment for mild hypertension if the risks were fully explained. In one study, almost all patients would have accepted treatment using a relative risk reduction model whereas less than

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half would have accepted treatment with a personal probability of benefit model [30].

Informed Decision Making – Application to Other Diseases

Anticoagulation in Atrial Fibrillation Anticoagulation in atrial fibrillation has been used frequently as an example of sharing decisions with patients [32, 33]. Effectiveness of oral anticoagulation is well documented by randomized controlled trials and meta-analyses. In high-risk subjects warfarin may reduce stroke incidence by as much as 70%. However, there are unwanted effects by minor and major bleeding and treatment may interfere with patients’ quality of life. Protheroe et al. [33] have investigated the impact of patients’ preferences for the treatment of atrial fibrillation, by using individualized decision analysis combining probability and utility assessments into a decision tree. They found that a vast majority of their on average 77-year-old participants stated a preference to be involved in shared decision making about their medical care. Taking patients’ preferences into account would have resulted in substantially fewer prescriptions of warfarin than under published guideline recommendations. In addition, there was marked disagreement between the decision analysis and guideline recommendations. Thus, even very old patients may opt for informed decision making. However, simple tools to present the necessary information to the patients are still lacking. Multiple Sclerosis Multiple sclerosis is a chronic recurrent disorder. Etiology and pathogenesis have still not been clarified. The course of the disease is variable and hardly predictable. Relapses are of great importance for most patients. There is a high level of anxiety and uncertainty associated with the unpredictable occurrence and the possible long-term effects of relapses. In addition, treatment is an area of uncertainty both for treatment of acute relapses with high-dose corticosteroids and long-term preventive treatment with immune therapy. This makes multiple sclerosis a field where informed shared decision making could be of advantage for the patients [34]. We are currently developing information and education programmes for patients with multiple sclerosis [34, 35]. Most patients indicated that they preferred an autonomous role in treatment decisions giving the shared decision and the informed choice model the highest priority [35]. However, the information patients with multiple sclerosis would need to make informed decisions is complex. Thus, information models are urgently needed to offer these patients participation in decision making.

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Screening Programmes Providing the public evidence-based, unbiased and understandable information is particularly relevant for population based screening programmes, such as breast cancer, colorectal cancer, cervix cancer or prostate cancer screening. Evidence from randomized controlled trials is available for breast cancer and colorectal cancer screening whereas such studies are not yet available for cervix cancer and prostate cancer screening. It has been repeatedly shown that the quality of the information provided to the public is poor, biased and market driven [36, 37]. Information usually emphasizes benefits without mentioning lack of benefit, uncertainties and harm of screening. The benefit is usually presented as relative percent rather than absolute percent or natural frequencies. Such approaches have led to misconceptions and irrational enthusiasm for screening programmes [38]. At the University of Hamburg we have developed evidence-based information for breast and colorectal cancer screening following the criteria for the development of such information [39–41]. However, in people not used to this kind of information, presentation of evidence-based data may lead to cognitive dissonance and paradox reactions of consumers [42]. This is an area which needs further research on educational approaches.

Training Courses in Clinical Research Competencies for Patients’ and Consumers’ Representatives

Consumer involvement in health care issues has increasingly been promoted [43]. However, until now patients rarely participate in the planning, conduct or interpretation of medical research. Consumers have skills that complement those of researchers and they argue for research that addresses issues of clinical relevance [44]. Therefore, their participation could increase the quality of clinical trials. Motivated and highly educated consumers could play an important role as negotiators for change and improvement in medical research. This is particularly relevant for chronic diseases. In Germany, like in other countries, no structures exist for consumers to play an active part in research. So far, patients are invited to work in guideline-development or to comment on physician prepared patient-information such as consent sheets. During the last two years we have performed basic training courses on evidence-based medicine (EBM) for consumers to enhance consumer and patient involvement in the planning and appraisal of research and the development of patient-information material [45]. The development, evaluation and implementation of curricula for EBM training courses for different target

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groups has been a major part of our research [46]. So far, about 150 patients and consumers have accomplished our basic courses [45].

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Berger M: To bridge science and patient care in diabetes. Diabetologia 1996;39:749–757. Mühlhauser I, Berger M: Diabetes education and insulin therapy: When will they ever learn. J Intern Med 1993;233:321–326. Berger M, Mühlhauser I: Diabetes care and patient oriented outcomes. JAMA 1999;281: 1676–1679. Mühlhauser I, Berger M: Patient education – evaluation of a complex intervention. Diabetologia 2002;45:1723–1733. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al: Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321: 694–696. Norris SL, Engelgau MM, Narayan KMV: Effectiveness of self-management training in type 2 diabetes: A systematic review of randomized controlled trials. Diabetes Care 2001;24: 561–587. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM: Self-management education for adults with type 2 diabetes: A meta-analysis of the effects on glycemic control. Diabetes Care 2002;25: 1159–1171. Renders CM, Valk GD, Griffin S, Wagner EH, Eijk van JT, Assendelft WJJ: Interventions to improve the management of diabetes mellitus in primary care, outpatient, and community settings (Cochrane Review). In: The Cochrane Library, Issue 4, 2001. Oxford, Update Software (also: Diabetes Care 2001;24:1812–1833). Warnke A, Meyer G, Mühlhauser I: Für alle Fälle: Prävention von Hüftgelenksfrakturen durch externen Hüftschutz. Köln, Deutscher Ärzteverlag, 2003. Meyer G, Warnke A, Bender R, Mühlhauser I. Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial. BMJ 2003;326:76–78. Warnke A, Meyer G, Bender R, Mühlhauser I: Predictors of adherence to the use of hip protectors in nursing home residents. J Am Geriatr Soc 2004;52:340–345. Warnke A, Meyer G, Bott U, Mühlhauser I: Validation of a quality of life questionnaire measuring the subjective fear of falling in nursing home residents. Z Gerontol Geriatr 2004;37:459–466. Kronsbein P, Jörgens V, Mühlhauser I, Scholz V, Venhaus A, Berger M: Evaluation of a structured treatment and teaching programme on non-insulin-dependent diabetes. Lancet 1988;ii:1407–1411. Sawicki PT, Mühlhauser I, Didjurgeit U, Baumgartner A, Bender R, Berger M: Intensified antihypertensive therapy is associated with improved survival in type 1 diabetic patients with nephropathy. J Hypertens 1995;13:933–938. Trocha AK, Schmidtke C, Didjurgeit U, Mühlhauser I, Bender R, Berger M, Sawicki PT: Effects of intensified antihypertensive treatment in diabetic nephropathy: Mortality and morbidity results of a prospective controlled 10-year study. J Hypertens 1999;17:1497–1503. Mühlhauser I, Richter B, Kraut D, Weske G, Worth H, Berger M: Evaluation of a structured treatment and teaching programme on asthma. J Intern Med 1991;230:157–164. Trautner C, Richter B, Berger M: Cost-effectiveness of a structured treatment and teaching programme on asthma. Eur Respir J 1993;10:1485–1491. Munks-Lederer C, Dhein Y, Richter B, Worth H: Evaluation of a structured education program for adult outpatients with asthma. Pneumologie 2001;55:84–90. Sawicki PT, for the Working Group for the Sptudy of Patient Self-Management of Oral Anticoagulation: A structured teaching and self-management program for patients receiving oral anticoagulation: A randomized controlled trial. JAMA 1999;281:145–150.

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45 46

Berger B: Training in wissenschaftlicher Kompetenz für Patienten- und Verbrauchervertreter: Entwicklung und Validierung eines Messinstruments (abstract). ZAeFQ 2004;98(suppl):625. Schlömer G, Meyer G, Mühlhauser I: Skills in evidence-based health care for professionals allied to health (diabetes educators) – Curriculum issues. XI Cochrane Colloquium, Abstract Book, 2003.

Prof. Dr. med. Ingrid Mühlhauser Universität Hamburg, IGTW-Gesundheit, Martin-Luther-King Platz 6 DE–20146 Hamburg (Germany), Tel. ⫹49 40 428 38 3988 Fax ⫹49 40 428 38 3732, E-Mail [email protected]

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Author Index

Accorsi, P. 23 Assal, J.-P. 1

Gruesser, M. 70

Passera, P. 97 Porta, M. 97, 108, 117

Jörgens, V. 13, 70 Bajardi, M. 97 Bondonio, P. 117 Borgo, E. 97 Cavallo, F. 97 Franz, M.J. 62

Rutten, G. 51 Kloos, C. 83 Maldonato, A. 40 Miselli, V. 23 Mühlhauser, I. 132 Müller, U.A. 83

Sämann, A. 83 Schiel, R. 83 Trento, M. 97, 108, 117

147

Subject Index

Acute illness characteristics 5 crisis situation 4, 5 long-term follow-up 6 patient perspective 6 physician perspective 5 treatment 5 Alivisatos, John 17 Anticoagulation therapy, evidence-based patient education 137, 142 Assal, Jean-Philippe 1, 16, 17, 20, 40 Asthma, evidence-based patient education 136, 137 BASICS program, see Type 2 Diabetes BASICS Behavioral change, modeling 28, 29 Berger, Michael 17, 18, 20, 21 Body mass index (BMI) Group Care outcomes compared with individual education in type 2 diabetes 101 ROMEO findings of Group Care in type 2 diabetes 113, 114 self-management training end point 54 Bouchardat, Apollinaire 13, 14 Burnout, health care providers 33–35 Chronic illness characteristics 6 follow-up difficulty 7

series of consultations with alternative objectives 8–11 World Health Organization initiatives 11 patient perspective 7 physician perspective 7 treatment 7 Cost-effectiveness analysis, Group Care economic analysis as differential analysis 120 outcome measures 119, 120, 128 relevant cost selection and measurement 118, 119 robustness of cost-effectiveness ratios 129 type 1 diabetes clinical results 126, 127 economic results 126, 128 study design 125, 126 type 2 diabetes clinical results 122, 125 economic results 122–124 medication usage 124, 125 primary outcomes 121 questionnaires 121, 131 DAFNE study, see Dose Adjustment for Normal Eating study Darwinism, see Educational Darwinism Decision making, see Informed decision making Depersonalization, health care provider burnout 34

148

Diabetes Education Study Group (DESG) aims 40, 41, 50 curriculum in therapeutic patient education 49 education approach 42, 43 foundation 17, 40, 42, 133 national study groups 41, 42 publications five-minute education kit 46, 47 patient education basics 47, 48 structure 42 teaching letters 45, 46 Website 48, 49 workshops interactive group sessions 44, 45 lectures 44 participants 45 Dose Adjustment for Normal Eating (DAFNE) study, findings 17–19 Dutch College of General Practitioners (DCGP), diabetes management guidelines 55 Dyslipidemia Group Care outcomes compared with individual education in type 2 diabetes 101 ROMEO findings of Group Care in type 2 diabetes 113, 114 Economic analysis, see Cost-effectiveness analysis, Group Care Education, see also Evidence-based patient education importance in diabetes management 37, 38 teaching comparison 30 Educational Darwinism disease versus illness acute versus chronic care 3, 4 comparisons in different languages 3 overview 1–3 European Association for the Study of Diabetes (EASD) Diabetes Education Study Group, see Diabetes Education Study Group diabetic education studies 20

Subject Index

Evidence-based patient education anticoagulation therapy 137, 142 asthma 136, 137 diabetes education as model 133 evolution 133, 134 framing of data 140–142 hip fracture prevention by hip protectors 135, 136 hypertension 136 medical decision making in patients and consumers 137–139 multiple sclerosis 142 presenting information to patients 139, 140 program evaluation framework 134, 135 training courses 143, 144 Follow-up acute-illness long-term follow-up 6 chronic-illness follow-up difficulty 7 series of consultations with alternative objectives 8–11 World Health Organization initiatives 11 Type 2 Diabetes BASICS 67 German Diabetes Association, educator training 20, 21 German structured education and treatment programs education effects on the quality of diabetes care blood pressure control 94, 95 East Germany political changes and impact 89–92 HbA1c as marker 85–88, 91 JEVIN Study 90, 94 measurement 84, 85 overview 84 prospects for intervention 95 quality-of-care definition 84 severe hypoglycemia 92–94 type 2 diabetes 85–89 hypertension 76–78 insulin programs conventional therapy 71, 73, 74

149

German structured education and treatment programs (continued) insulin programs (continued) intensified therapy 78, 79 preprandial therapy 74, 75 prospects 80 type 2 diabetes 70, 71 Goal setting 28, 58, 66 Group education, see Cost-effectiveness analysis, Group Care; ROMEO; Type 2 diabetes; Type 2 Diabetes BASICS Guidance, definition and aims 31 HbA1c Group Care outcomes compared with individual education in type 2 diabetes 101, 104 marker for education effects on the quality of diabetes care 85–88, 91 ROMEO findings of Group Care in type 2 diabetes 113, 114 self-management training end point 54 Hip fracture, evidence-based patient education for prevention by hip protectors 135, 136 Hypertension evidence-based patient education 136 German structured education and treatment program 76–78 Information, definition 30, 31 Informed decision making anticoagulation therapy 142 medical decision making in patients and consumers 137–139 multiple sclerosis 142 screening programs 143 Instruction, copying an action 30 Italy, diabetes epidemiology 117 JEVIN Study 90, 94 Learning definition and goals 29, 30 doing and learning 32 environment 28 imitation 32

Subject Index

Knowles’s andragogy theory 104 motivation 32, 33 Lifestyle modification barriers 24 behavioral change modeling 28, 29 behavioral models 25, 26 patient perspective 26, 27 program development 26 Type 2 Diabetes BASICS, see Type 2 Diabetes BASICS Mistakes diabetic patients in self-care 27, 28 trial and error by patients 32 Motivation, importance in learning 32, 33 Multiple sclerosis, evidence-based patient education 142 National Institute for Clinical Excellence (NICE), patient education models 37 Pestalozzi, Heinrich 24 Quality of life Group Care outcomes compared with individual education in type 2 diabetes 101, 105 research growth 41 therapeutic objective 41 ROMEO aims 109 study design 109, 110, 112, 114 Saint Vincent Declaration 51, 52 Self-management training education integration with medical care 54, 58 efficacy body weight outcomes 54 end points 53, 54 HbA1c levels 54 goals 52, 53 program requirements 58 self-monitoring of blood glucose 56, 57 Stolte, Karl 14–17 Stress, health care providers 33, 34

150

Taking control, concept 31, 32 Teaching definition 30 education comparison 30 environment 28 evidence-based patient education 139, 140 Pestalozzi’s recommendations 24 Team approach, diabetes management 35, 36 Type 2 diabetes economic analysis, see Cost-effectiveness analysis, Group Care German structured education and treatment programs 70, 71 Group Care efficacy compared with individual education, see also ROMEO; Type 2 Diabetes BASICS body mass index 101 dyslipidemia 101 HbA1c 101, 104 knowledge of diabetes 100–102 modification of health behavior 101 quality of life 101, 105 study design 98–100

Subject Index

Type 2 Diabetes BASICS benefits of group education 68 conceptual framework 63 evaluation of efficacy 68 follow-up 67 lifestyle interventions carbohydrate counting 65, 66 goal setting 66 natural progression of disease education 67 physical activity 66 prioritization 64 recording of food and blood glucose 67 session duration and structure 63, 64 Staged Diabetes Management integration 62 United Kingdom Prospective Diabetes Study (UKPDS) dietary modification impact 25, 66 evidence-based patient education 140, 141 glycemic control versus blood pressure control outcomes 52

151