Quality in Primary Care Open Access

Introduction

Diabetes is a chronic condition associated with mul-tiple late complications, reduced life expectancy,[1] and a marked limitation in the quality of life.[2] Mortality among people with diabetes is about twice that in the normal population, and life expectancy is about 5–10 years shorter. The disease, its complications and late-onset consequences cause a dramatic burden for health systems.[3–5]

This position paper focuses on the pivotal role of primary care in the management of people with diabetes mellitus, and targets policymakers in the European Union and its member states. We argue the need for a concerted approach to define how programmes to manage diabetes mellitus should be designed, devel-oped, implemented and evaluated to ensure the highest level of quality care delivery across the different Euro-pean healthcare systems.

Definition and classification of diabetes mellitus

Diabetes mellitus is a group of endocrine disorders characterised by hyperglycaemia as a consequence of disturbed secretion or function of insulin. Chronic hyperglycaemia in diabetic subjects is associated with long-term complications and decreased functioning of several organs and tissues, especially the heart and blood vessels, the eyes, kidneys and the nervous system.

The following four types of diabetes can be classi-fied:[6,7]

1 type 1 diabetes: disordered insulin secretion due to destruction of the beta-cells in the pancreas with mostly absolute deficiency of insulin. A special form with slowly developing deficiency of insulin secretion is known as latent autoimmune diabetes of adults (LADA)

2 type 2 diabetes: disorder of insulin effects (insulin resistance) with relative deficiency of insulin (typ-ically a disorder of glucose-dependent insulin secretion)

3   other specific types of diabetes: these are caused by diseases of the exocrine pancreas or other endo-crine organs, or might develop due to pharmaco-logical causes, genetic defects or syndromes or infections

4 gestational diabetes: this type develops for the first time during pregnancy as a disorder of glucose tolerance.

Diabetes mellitus is diagnosed primarily by measure-ments of elevated fasting glucose values on at least two different days in plasma or full blood. Quality assurance of tests is an absolute requirement. Devices designed for self-measurements by patients are not accepted to establish the diagnosis.[6] In suspected clinical situations and in case of contradictory results, the diagnosis is based on the oral glucose tolerance test. An impaired fasting glucose and an impaired glucose tolerance (to-gether known as prediabetes) have been defined with their specific lower and upper limits and are consid-ered the early forms in the development of diabetes.[7] The determination of glycosylated haemoglobin (HbA_1c) alone is currently not suited for making the diagnosis and is used exclusively for monitoring long-term care and for aiding decisions on management.[6,7]

While type 1 diabetes, with its typical symptoms and acute onset, is usually diagnosed quite early, the diagnosis of type 2 diabetes is usually preceded by a longer symptom-free interval. However, insulin re-sistance and a disorder of insulin secretion does exist in these patients long before the disease becomes manifest, which very often already at this time leads to an increased risk of stroke, myocardial infarction and peripheral arterial disease.[7] Measures for preven-tion and early recognition of type 2 diabetes are therefore of prime importance.

Epidemiology

Type 1 diabetes only accounts for 5–15% of all diabetic patients. Type 2 diabetes is the most common form of the disease and accounts for approximately 90% of all people suffering from diabetes. Usually, type 2 dia-betes is diagnosed after the age of 35 years; however, over the last few years, there has been an increase in the prevalence of type 2 diabetes among adolescents.[8] Furthermore, evidence suggests that there is a high proportion of people with undiagnosed diabetes.[9,10]

The impact of diabetes on health in Europe can hardly be underestimated. Unfortunately, sources of data on diabetes and data collection are different. In 2003, however, the International Diabetes Federation estimated that about 48 million people in Europe suffer from diabetes. This corresponds to a prevalence of 7.8%, which is expected to rise to 9.1% by 2025. By 2025 the direct cost of diabetes is expected to represent between 7% and 13% of the total health expenditure.[4]

Diabetes has a dramatic impact on mortality, mor-bidity, daily functioning[11] and quality of life: diabetes patients have three to four times as much risk of dying from cardiovascular diseases. Diabetes is still the most common cause of blindness at a working age, one of the most common causes of kidney failure, and the most common cause of leg amputation.[5,12]

Reasons for concern and central questions

There is ample evidence that the typical long-term relationship between patients with chronic conditions and their general practitioner (GP)/family physician, with multiple consultations and health checks over time offers a very good opportunity to assess risk factors or early suspicious symptoms and to identify patients with increased risk for developing diabetes or another chronic disease.[13] Although the quality of diabetes care in many healthcare systems is gradually improving, this holds for a part of the patient popu-lation only.[14–19] Furthermore, besides the high pro-portion of people with undiagnosed diabetes, there is still a wide variation in quality of care, with rates of recommended care processes being unacceptably low in some healthcare settings.[19–24]

What are the reasons for that variation in the quality of care? What lessons can be learned? What are our recom-mendations in order to improve diabetes care in Europe?

Methodology and process

To improve diabetes care in Europe, the position paper in 2006 put forward arguments for the chronic care model as a conceptual basis,[25–27] and its founda-tion rooted in primary care has been underlined. The following general principles have been summarised:

patients should be active and empowered partners in diabetes care

diabetes care should be provided by an inter-disciplinary team

quality monitoring is a prerequisite for e&ffcient diabetes management

information and communication technology are crucial to facilitate integrated diabetes care

prevention and early detection of diabetes require more attention.

Based on these conclusions, the current position paper aims to provide some more-specific recommenda-tions. A survey was conducted in the autumn of 2007 via a network of participating GPs, experts and spe-cialists in the field of diabetes. They were recruited via Wonca network organisations and their partners in the field of diabetes (see Box 1). Reports from 15 countries were received. A workshop was organised in Vienna in December 2007 with the following participants: Luk Van Eygen, Belgium; Domingo Orozco, Spain; Rurik Imre, Hungary; Hakan Yaman, Turkey; Susanne Pusarnig, Austria; Astrid Knopp, Austria; and Manfred Maier, Austria. At the workshop, the reports received from different countries were discussed and the draft version of the position paper was reviewed. As a result, the lessons learned and conclusions drawn were for-mulated and included in the position paper. Several calls for comments to the subsequent draft versions resulted in a lively discussion via the internet, and it was possible to include additional contributions or suggestions by colleagues (see Box 1) in the final version of this position paper.

Experiences and practices

Background information from 15 European countries that was relevant for diabetes care – most of it unpub-lished in the scientific literature – could be collected by our survey (see Table 1). In addition, the scientific literature was searched accordingly. Some key issues are now summarised.

National strategies for diabetes care

Based on available data many countries lack a national strategy for diabetes care. Such a strat-egy, however, apparently supports the quality of care provided and the outcome of diabetes care achieved.

As can be seen from Table 1, only seven countries have a national strategy for diabetes care in place. In Romania, a new comprehensive protocol for diabetes care was offered to doctors and patients in 2007. In Hungary, a programme exists, but it is hardly imple-mented,[28] and in six countries there is no national strategy at all. In the UK, a National Service Frame-work was published in 2001 with the aim of improving the quality of care of people with diabetes and of reducing variations in care.[29]

Furthermore, only Spain,[30,31] France, Slovenia, Lithuania and the Netherlands have implemented a disease registry for patients with the disease. Registers might be implemented only at the secondary level (Slovenia) or only in some regions (Denmark,[32] the Netherlands,[33] UK[34]), or only for patients taking part in a structured disease-management programme (Germany, Austria); in France, registration is incom-plete, the same seems to be true for Romania.

Similarly, only Finland, Slovenia, Turkey,[35] Lithuania and the Netherlands[36] have some form of screening programme in place. In Austria, Belgium and the UK, there is opportunistic screening;[6] in all other coun-tries, apparently, there is no national screening pro-gramme for people at risk for developing diabetes or for people so far undiagnosed with the disease.

Care providers

If the responsibility for the management of dia-betes care is not allocated to a predefined level of care or a predefined group of health professionals, outcome appears to be unsatisfactory. A well-developed primary healthcare system, where people with diabetes type 2 are managed, appears to be a good foundation for better outcomes. Voca-tional training and status for GPs, however, are different across Europe, and specific training in diabetes care for GPs has only recently been introduced in some countries.

Across the nations surveyed, medical care for people with diabetes is provided by both GPs and specialists. Although the majority of people with type 2 diabetes are managed in primary care by GPs in France, Finland, Belgium, Spain, Lithuania, Denmark, Switzerland, Austria and the Netherlands, responsibility for patients is not always clearly defined. In the Netherlands, shared diabetes care has been implemented to a large extend with well-defined guidelines for referral from primary care to hospital-based care. GPs, specialists/ diabetologists and diabetes nurses work together in regional networks. In the UK, the majority of people are cared for in primary care;[37] however, there has recently been a shift in reducing the proportion of people being cared for in secondary care, and instead new intermediate care models are now being imple-mented in a community setting.[38] In all other countries, patients are cared for primarily by specialists at speci-fied institutions or at the secondary level in a hospital.

Even among countries that have implemented a structured programme for the care of people with diabetes, clear allocation of responsibility for the co-ordination of care exists only in Hungary, Lithuania, Denmark, the Netherlands and the UK. In all other countries with a structured care programme, respon-sibility for co-ordinating care and managing patients seems to be left to market forces between GPs and internists.

Vocational training to become a specialist in pri-mary care, or specific training of GPs to care for patients with diabetes differs across Europe. Specific training in some way or another exists in the majority of countries: in Spain specialty training for general practice was already introduced in 1982; in other countries specific training for GPs to improve the care of people with diabetes has been introduced during the last few years, mostly in relation to a structured programme for screening or care (Austria, Germany,[39,40] UK[38]).

Patient involvement and support for self-management

In order to improve care and outcome of people with diabetes, active participation of well-informed patients, their commitment, their sense of re-sponsibility and their motivation for adequate self-management appear to be necessary. Based on their long-lasting relationship with their patients and on the knowledge of their individual psycho-social background, GPs are in a perfect position to support and foster patient involvement.

While providers are experts in the medical field of diabetes, people with diabetes themselves are experts in the field of living with diabetes.[41] It seems logical to make use of that expertise and activate it to improve care and outcome. As GPs are in a very good position to understand that decisions made by individual patients– especially outside of hospitals in the community setting[42] – are influenced more by their own personal beliefs of diabetes than by medical concepts, joint agreements between patients and co-ordinating phys-icians on diagnostic procedures and treatment options are necessary. Thereby, individual risks and patients’ preferences have to be taken into account,[43] owing to the patient centeredness of primary care.[44] This im-plies active patient participation and commitment – i.e. patient-empowerment. Although these strategies have been implemented already, they have so far proven to be effective on a rather small scale only.[45–47]

Apparently, the potential of patient empowerment has been recognised recently. In 10 out of 15 countries some form of patient empowerment such as a struc-tured education programme has been implemented, and the need for picking up responsibility for one’s own health has been emphasised (see Table 1).

Quality of care provided

Though diabetes guidelines exist in almost all countries across Europe, the level of adherence to these guidelines is unknown or unsatisfactory. The quality of care provided is unknown or unsatisfactory in most countries, mainly due to the lack of reliable data.

Overall, very little is known about the quality of care provided to people with diabetes in Europe. In par-ticular, reliable and valid data, which can be used for assessment and evaluation of outcomes, are not available in most countries. An exception is the Netherlands; based on available data (see Table 2) it can be con-cluded that the outcome of care is known and can be judged to be good.[21,33,48–51] Also in the UK, the qualityof care was good;[52] however, it has improved further since the introduction of a pay for performance contract in 2004.[53] In all other countries the outcome is believed to be either unsatisfactory,[54,55] or possibly acceptable.

Surprisingly, national guidelines, believed to be a prerequisite for quality care, exist in all but two countries (Switzerland and Germany). These have been imple-mented dating back as early as 1989 (Netherlands); the majority of guidelines are said to be evidence based and are updated more or less regularly. Ministries of health, specialists, GPs or an interdisciplinary group of professionals are mainly responsible for the develop-ment of these guidelines. From the available data it seems clear that the development of guidelines by the ministry or by specialists does not support adherence among primary care physicians. In contrast, adher-ence to guidelines that have been developed by GPs and specialists together appears to be better.[33]

Context of care provision  

The context of where and how diabetes care is provided appears to be important. A framework with gate keeping, a list system for patients, and structured programmes accompanied by finan-cial incentives seems to be supportive for adher-ence and good outcomes.   

  Finland, Spain, Slovenia, Lithuania, Denmark, the UK and the Netherlands have healthcare systems with gatekeeping and a patient list in place (see Table 1). In countries like Germany, Belgium, Hungary or France, gatekeeping is either voluntary or implemented at the regional level only

• Most countries provide care for people with diabetes at the community level, or are at least encouraging community-based care (Turkey). In Romania, Slovenia, Turkey and Hungary, care at least in part is provided at specialised clinics or institutions, for example in Romania it is provided for diabetic patients on insulin therapy

During the last 10–15 years, ten countries have implemented some form of structured programme for the care of diabetic patients.39,56 Seven of them have supported implementation or continuation of the programme by financial incentives for the care provider, the patient or both.57 Among them are the Netherlands and UK with good outcomes in diabetes care (Braken, personal communication),21,33,48–52 or countries that have good data,53 or have moderate to good adherence to guidelines.33

Monitoring, feedback and research

Many countries lack quality monitoring or systematic research of the diabetes care provided. This may cause insufficient information and feedback at the political level.   

Among the 15 countries surveyed, only Finland, the UK and the Netherlands have a quality monitoring system in place at the primary care level. Other coun-tries have implemented quality monitoring either at the regional level or in secondary care, or within a structured disease-management programme.[39,55]

The majority of countries show some research activities at the primary care level. In Europe, however, only the UK, Denmark and the Netherlands have a strong international research record;[51,57] so far, little or no research is done in Austria, Switzerland, Romania or France. It is not the aim of this paper to identify the reasons for this difference in research activities. It is common knowledge, however, that an appropriate infrastructure and funding situation for research would help to bridge the gap between process and outcome of health services provided and health policy.[58,59]

Lessons learned

From the country reports provided (see Tables 1 and 2), and from the literature it can be concluded:

1 care of people with diabetes is differently organised across Europe. The level and degree of organisation varies widely and apparently depends on both the

status of the healthcare system and the level of professional involvement

2 o&ffcial data on the prevalence of diabetes vary widely (1.8–10%); sources of data and data collec-

tion are different. As a consequence, prevalence or incidence data are hardly comparable

3 in almost all countries, diabetes is believed to be underdiagnosed and the prevalence of type 2 dia-

betes is believed to be underestimated

4 in most countries, the quality of care is unknown but perceived to be unsatisfactory

5 in most countries, the acceptance/adherence to guidelines is unknown and seems to be unsatisfac-

tory. The development of guidelines alone or their simple availability does not necessarily improve quality of care for patients with diabetes

6 countries that have a monitoring system and are registering patients with diabetes have a better quality of care than countries without such a register

7 countries with a tradition of research in primary care have much better information and data on quality of diabetes care than countries without that tradition.

Positive highlights of this survey have also been ident-ified; in many countries:

there is a trend towards disease-management pro-grammes/structured programmes for care of people with diabetes

specific guidelines for managing people with dia-betes have been developed with primary care input in most countries

there is a trend towards patient empowerment, emphasising patient-centred medical care

specific training to become a GP or to train GPs specifically for the care of people with diabetes is developing in some countries

there is a trend to recognise GPs as co-ordinators of structured care programmes.

Some negative highlights were also found; in many countries:

•there is a lack of reliable epidemiological data

•there is a lack of data for outcome measures or of data on the quality of care

•there is a lack of research at the level of primary care

•adherence to guidelines is not known

•structured screening or prevention programmes are scarce.

It should be kept in mind that data about adherence to guidelines and about the quality of care from the hospital-based diabetes care across almost all Euro-pean countries also hardly exist.

Recommendations

Based on the information and data collected or avail-able, the current position paper extends the evidence summarised in 2006,[25] and provides further recom-mendations to improve the quality of care for diabetic patients.

General recommendation

To improve the quality of diabetes care and to develop a sound and sustainable evidence base for decisions in health policy regarding diabetes care, we strongly recommend:

•to recognise the importance of a well-developed primary care workforce in this endeavour

•to promote and strengthen primary care by:

– increasing education and training

– providing a supportive environment for care provision and research at the primary care level including the allocation of research funds

– developing methods for collection of routine data and monitoring

– positioning primary care at the centre of health-care systems in Europe.

Specific recommendations

1 An interdisciplinary team of professionals should agree on common goals and on a national strategy for the care of patients with diabetes.

2  Initiatives aiming to improve the quality of care must be evidence based and should be developed by an interdisciplinary team including all parties involved, in order to facilitate implementation and adherence.

3 Programmes should be implemented, conducted, co-ordinated, adapted to individual patients and

evaluated at the community level by trained pri-mary care physicians (and their teams).

4 Systematic education or training should be offered to care providers and patients.

5 Comprehensive registers for patients with diabetes should be established and maintained as a stand-ardised source of reliable information.

6 Implementation of initiatives to improve the qual-ity of care and outcome should be supported by incentives for providers and patients.

Conclusions

The different stages of developments in the organis-ation of diabetes care in Europe illustrate the tran-sition process European health systems are going through. They were designed in the middle of the 20th century to deal mainly with acute diseases, but due to the progress of medicine and the ageing of the Euro-pean population, the focus has shifted towards chronic disease management. Diabetes care is one of the fields where the implementation of these changes has pro-gressed furthest so far. Important choices have to be made, which affect not just diabetes care, but also the overall healthcare organisation. In 2006 we strongly pleaded for a diabetes care model rooted in primary care.[25] Primary care offers holistic, comprehensive and continuing care to the diabetes patient in a person-alised and e&ffcient way.[60] Evidence has clearly shown

that well-structured primary care can provide high-

_{quality diabetes care.}13,21,33,36,48–50,52,54,61

It is clear that at present many healthcare and primary care systems in Europe have been unable to take up this task. In addition to global payment systems, patients’ listing and a gatekeeper role for the GP,[25] we recommend:

•Adevelopment of strategies and national guidelines by all players involved

•Aprovision of incentives to improve adherence to such guidelines in primary care

•Aco-ordination of structured programmes at the community level and adaptation to individual patients by a well-developed primary care work-force

•Aregistration of patients

•Aeducation of patients and training of professionals and regular evaluation of such programmes through health services research projects.

So far, there is no evidence available to recommend population-based screening programmes. Therefore, screening programmes for impaired glucose tolerance among high-risk individuals, which are considered in some countries,[62] should be a focus for research before implementing them on a population level.

These proposed reforms will not only have their impact on diabetes care, but will strengthen the pos-ition of primary care within each healthcare system and make the future implementation of other disease-management programmes for chronic conditions in primary care easier. We strongly believe, therefore, that

the lessons learned and recommendations listed for the disease entity ‘diabetes mellitus’ most likely will be very similar for other chronic conditions as well.

Therefore, the debate on the diabetes care organis-ation, its consensual development and harmonisation, its e&ffcient implementation and systematic evaluation at the national level reflects the fundamental choices the European healthcare systems, professionals and consumers have to make at the beginning of the 21st century in the face of the demographic developments.

Acknowledgementss

Contributing authors: Gu¨nther Egidi, Wim de Grauw, Guy Rutten, Patricia Sunaert, Johan Wens, Torsten Lauritzen, Liisa Hiltunen, Patrick Chevallier, Jean-Pierre Lebeau, Gu¨nther Egidi, Leonas Valius, Frans van der Horst, Henk van Dam, Dan Pletea, Fernando Alvarez-Guisasola,Xavier Cos,JankoKersnik,Christoph Hollenstein and Kamlesh Khunti.

Peer group: Bruno Kissling, Harald Abholz,. Erika Baum, Michael Kochen and Niklaus Egli.Thanks also to Diederik Aarendonk.

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