European Journal of General Practice
ISSN: 1381-4788 (Print) 1751-1402 (Online) Journal homepage: http://www.tandfonline.com/loi/igen20
Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe Tomasz Tomasik, Adam Windak, Bohumil Seifert, Janko Kersnik & Jacek Jozwiak To cite this article: Tomasz Tomasik, Adam Windak, Bohumil Seifert, Janko Kersnik & Jacek Jozwiak (2014) Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe, European Journal of General Practice, 20:4, 253-259 To link to this article: http://dx.doi.org/10.3109/13814788.2013.877130
Published online: 13 Feb 2014.
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Date: 12 September 2015, At: 21:01
European Journal of General Practice, 2014; 20: 253–259
Original Article
Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe
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Tomasz Tomasik1, Adam Windak1, Bohumil Seifert2, Janko Kersnik3 & Jacek Jozwiak4 1Department
of Family Medicine, Chair of Internal Medicine and Gerontology, Jagiellonian University Medical College, Krakow, Poland, 2Department of General Practice, First Faculty of Medicine, Charles University, Prague, Czech Republic, 3Department of Family Medicine, University Ljubljana, Ljubljana, Slovenia, 4Department of Public Health, Czestochowa University of Technology, Czestochowa, Poland KEY MESSAGE: · GPs in Central and Eastern Europe (CEE) set treatment goals for HbA1c and blood pressure below the levels recommended within the international guidelines for management of type 2 DM. · GPs in CEE still are in favour of a ‘the lower the better ’ treatment approach, although usually they do not reach these goals.
ABSTRACT Background: Primary care physicians have an important role in the care of patients with Type 2 diabetes but little is known about this issue in Central and Eastern European countries. Objectives: To investigate the treatment goals of patients with type 2 diabetes mellitus (type 2 DM) set by primary care physicians in Central and Eastern European countries and illustrate inter-country variation. Methods: A cross-sectional survey of primary care physicians randomly chosen in nine countries. A validated questionnaire was used. Physicians reported treatment goals for patients with type 2 DM. Results: A total of 44.1% of physicians, reported the acceptance of HbA1c ⬍ 6.5% (48 mmol/mol) as a treatment goal, whilst 40% chose lower levels (⬍ 6.1%; 43 mmol/mol). In all countries, 62% of physicians set FPG at a level of ⬍ 6.0 mmol/l. Most respondents set low BP levels as a goal of therapy (47% of physicians in all countries: BP ⬍ 130/80 mmHg and 48% ⬍ 120/80 mmHg). A TC level ⬍ 4.5 mmol/l and a LDL-C level ⬍ 2.5 mmol/l were reported as the targets for patients with diabetes by 51% and 69% of all respondents, respectively. The overall differences between all the countries were statistically significant (P ⬍ 0.01). Conclusion: For patients with diabetes approximately half of physicians set treatment goals at levels that were recommended within the international guidelines. Most of them set treatment goals for HbA1c and BP at very low levels. Educational efforts to raise awareness about new treatment goals are needed. Keywords: diabetes mellitus type 2, primary health care, Central and Eastern Europe
INTRODUCTION Achievement of glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), blood pressure (BP) and cholesterol (TC and LDL-C) targets remain fundamental to the effective management of patients with type 2 diabetes mellitus (type 2 DM) (1). During the first decade of this century, several European guidelines related to cardiovascular disease (CVD) and diabetes have recommended increasingly
tighter targets for the control of risk factors (2–4). Stone et al., compared national guidelines for type 2 diabetes from eight West European countries. Although, there were variations in terms of the specific recommendations they exhibited the same approach (5). This approach may be described as ‘the lower the better ’ (6). It was in accordance with the wishes of most clinicians, who prefer to have clear and simple recommendations.
Correspondence: T. Tomasik, Department of Family Medicine, Jagiellonian University Medical College, 4 Bochenska Street, 31–061 Krakow, Poland. Tel: ⫹ 48 12 430 55 93. Fax: ⫹ 48 12 430 55 84. E-mail: [email protected] (Received 3 July 2013; accepted 19 November 2013) ISSN 1381-4788 print/ISSN 1751-1402 online © 2014 Informa Healthcare DOI: 10.3109/13814788.2013.877130
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At the end of the decade, the ACCORD trial was stopped early, since mortality increased due to intensive glycaemic control (7). Moreover, re-appraisal of hypertension guidelines was published in 2009 and highlighted the lack of research evidence to justify lowering SBP ⬍ 130 and DBP ⬍ 80 mmHg in patients with diabetes (8). One year later, therapy targeting low systolic blood pressure (below 120 mmHg) was shown not to reduce major cardiovascular events in the patients (9). The European Society of Cardiology and another nine societies issued a new version of the European Guidelines on CVD prevention in 2012 (1). Other organizations also updated their recommendations (10). These introduced important changes concerning HbA1c and BP targets in patients with diabetes. Primary care physicians are key professionals for the provision of CVD prevention in Europe (1). Although they have an important role in the care of patients with diabetes, little is known about this issue in Central and Eastern European countries. Papers, which reveal unsatisfactory management, are published mainly in the national languages (11). No studies related to setting of treatment targets for patients with type 2 DM from this part of Europe are available. International comparative data might provide important insights into the delivery of primary care for patients with diabetes. Aims of this study are: (1) investigating the treatment goals of patients with type 2 DM set by primary care physicians in Central and Eastern European countries, (2) illustrating inter-country variation and (3) analysing the correlation between physicians’ characteristics and their chosen treatment goals. We focused on glycaemia, blood pressure and cholesterol control in patients with diabetes.
The size of the samples was based on the country’s population and expected response rate. The size varied from 150 in the smaller countries (EE, HU, LV, LT, SK, SL) to 500 in the larger countries (BG, CZ, PL). The required response was at least 50 responses in the smaller countries and 100 in the larger ones; in total, we aimed to collect at least 600 responses. Procedure and measurement A questionnaire consisting of three parts was developed, reviewed, validated and rigorously translated into all the languages. One part of the questionnaire was devoted to the care of patients with cardiovascular problems and contained five questions devoted to the treatment goals for patients with type 2 DM. All of these questions had a predefined set of answer options. An anonymous questionnaire was distributed by post and answers were collected between October 2007 and February 2008. The questionnaire has already been published as a supplement to the previous paper (12). We measured physicians’ reported treatment goals (HbA1c, FPG, BP, TC, LDL-C) for patients with type 2 DM. All respondents were asked to answer questions devoted to BP and cholesterol control while only physicians declaring that they had responsibility for the care of diabetic patients responded to the questions relating to glycaemia control. In addition, we collected data about professional characteristics of the respondents. To investigate the correlation between physicians’ characteristics and their reported treatment goals we analysed the following variables: age and experience in General Practice in years, practice locality (urban/rural/mixed), specialty in family medicine/general practice (FM/GP) and gender.
METHODS A detailed description of the study methods has been already published, therefore, only a short summary is provided below (12,13). Design We performed a cross-sectional survey of primary care physicians in Central and Eastern European countries. Setting The study was carried out in primary care in nine countries; Bulgaria (BG), the Czech Republic (CZ), Estonia (EE), Hungary (HU), Lithuania (LT), Latvia (LV), Poland (PL), Slovakia (SK) and Slovenia (SL). Participants In total, 3000 primary care physicians were randomly chosen from relevant national registers of physicians.
Statistical analysis Mean and standard deviation were calculated to present the quantitative characteristics of the respondents and the distribution of qualitative characteristics. To compare the countries’ results the Pearson Chi-square test was used, which shows the differences in the responses distribution between countries. For analysing the correlation between physicians’ age and their treatment goals, the Kruskal–Wallis test was used, while the Pearson Chi-square test was applied for significance-testing of the relationship between two categorical variables. Sensitivity analysis To check whether the self-perceived responsibility for the care of patients with type 2 DM influence the study results we repeated all analysis on the subgroup of respondents declaring that they had this responsibility. We performed a one-way sensitivity analysis and compared this subgroup with the entire group of respondents.
83/10/7 55/18/27 52/28/20 57/24/19 65/23/13 76/16/8 46/31/23 41/36/23 26/29/45 58/22/20
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85/9/6 57/18/24 51/29/20 56/24/20 65/23/13 77/16/8 47/29/23 54/20/27 33/30/37 59/21/20
All
Urbanization (% urban/rural/ mixed area)
Statistical significance was set at the 0.05 level for all analysis. The study protocol conforms to the ethical guidelines of the 1975 Helsinki Declaration. Ethical Committee approval was not sought because the study did not involve patients or human material and was conducted under the terms of all relevant local legislation.
Responsible for diabetes care
Treatment targets in patients with diabetes
4 98 98 87 83 99 97 100 78 80 6 98 96 87 83 99 96 100 77 82 9.3 (6.1) 22.0 (9.8) 18.2 (8.9) 22.0 (11.5) 9.0 (4.9) 19.3 (9.3) 16.5 (7.3) 22.4 (9.8) 18.3 (9.1) 18.2 (10.2) 9.2 (6.0) 21.9 (9.6) 17.9 (9.0) 21.8 (11.4) 9.0 (4.9) 19.1 (9.3) 16.6 (7.3) 22.6 (8.4) 18.4 (9.1) 18.5 (10.0) 66 70 92 40 68 92 60 67 66 66 66 71 92 41 68 91 62 77 66 67 GP/FM, general practice/family medicine.
44.0 (6.7) 52.1 (9.0) 48.1 (8,2) 53.4 (10.4) 45.1 (9.6) 49.4 (8.2) 46.5 (6.4) 51.0 (10.3) 46.1 (7.8) 49.0 (9.10 44.1 (6.9) 52.0 (8.7) 48.3 (8.2) 53.5 (10.3) 45.1 (9.6) 49.3 (8.1) 46.4 (6.6) 51.8 (8.1) 46.2 (7.7) 49.3 (9.0) 114 214 51 144 31 77 100 57 79 867 BG CZ EE HU LT LV PL SK SL Total
104 139 50 138 31 75 96 22 58 713
Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Country
Physicians with specialty in GP/FM (%) Years of experience in general practice Mean (SD) Gender (% female) Age of respondents in years Mean (SD) Respondents (n)
The questionnaire was returned by 867 of the 3000 primary care physicians consulted (a response rate of 28.9%). The minimum required number of responses was obtained in all the countries except Lithuania (31 responses). Non-respondents do not differ from respondents in gender or location of practice (cities/ towns/villages). Responsibility for the care of patients with type 2 DM was reported by 713 (82.4%) of physicians (ranging from 38% in Slovakia to 100% in Lithuania). The detailed characteristics of all respondents and those who declared responsibility for the care of patients with diabetes are presented in Table 1. There were no statistically significant differences in any of the respondents’ characteristics between these groups. Other information about the respondents has already been published elsewhere (12,13). In the case of patients with type 2 DM, nearly half of physicians (44.1%) reported the acceptance of HbA1c ⬍ 6.5% (48 mmol/mol) as the treatment goal, whilst 40.0% of respondents chose lower levels (⬍ 6.1%; 43 mmol/mol) and 15.8% higher level (⬍ 7.0%; 53 mmol/mol). Details about target levels of HbA1c and FPG in particular countries are presented in Table 2. Most physicians (62%) in all the countries set treatment goals for FPG at a level of ⬍ 6.0 mmol/l and only in Slovenia did half of the respondents tend to accept the level of ⬍ 7.0 mmol/l. The overall differences between all the countries are statistically significant for both targets HbA1c level (P ⬍ 0.0001) and FPG level (P ⬍ 0.01). Forty-eight per cent of respondents in all countries set very low BP levels as a goal of therapy (⬍ 120/80 mmHg), 47% of physicians accepted BP ⬍ 130/80 mmHg and 5% level ⬍ 140/90. The differences between the countries included in the study were statistically significant (P ⬍ 0.001). A TC level of less than 4.5 mmol/l and a LDL-C level of less than 2.5 mmol/l were reported as the targets for patients with diabetes by 51% and 69% of all respondents, respectively (the differences between countries were statistically significant P ⬍ 0.01). Details about target levels of BP and cholesterol in particular countries are presented in Table 3. Physicians after specialist training in FM/GP more frequently reported acceptance of a HbA1c target below 6.1% (43 mmol/mol) in comparison with physicians
Table 1. Characteristics of respondents in countries included in the study.
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RESULTS
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Table 2. Percentage of primary care physicians responsible for diabetes care reporting acceptance of specific HbA1c and FPG treatment targets in patients with type 2 diabetes mellitus. HbA1c (%) Respondents’ country (n)
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BG (104) CZ (139) EE (50) HU (138) LT (31) LV (75) PL (96) SK (22) SL (58)
declared the responsibilities for the care of diabetic patients (data not shown). However even these differences were not statistically significant (P ⫽ 0.771). There were also no differences in the correlation between physicians’ characteristics and their treatment goals of BP, TC and LDL-C between the group of all respondents and the group declaring that they had responsibility for diabetes care.
FPG (mmol/ l)
⬍ 6.1
⬍ 6.5a
⬍ 7.0
⬍ 6.0a
⬍ 7.0
⬍ 7.8
35 72 22 39 30 33 29 47 21
53 25 46 46 17 58 59 47 41
12 4 32 16 53 10 11 5 38
59 59 64 66 68 54 79 59 45
30 38 34 32 26 42 18 36 50
11 4 2 2 6 4 3 5 5
DISCUSSION Main findings In this observational, cross-sectional study, we found that a high percentage of primary care physicians reported that they were responsible for provision of care to patients with type 2 DM in Central and Eastern European countries. Approximately half of primary care physicians in Central and Eastern European countries set treatment goals at levels that were recommended within the international guidelines between 2007 and 2011 (2–4). Surprisingly, a large proportion of physicians kept too low HbA1c and BP management targets (Tables 2 and 3). Statistically significant differences in setting treatment goals were revealed between countries included in this study.
HbA1c, glycated haemoglobin; FPG, fasting plasma glucose. aThe level recommended by European guidelines (3) in the period of the survey.
without specialist training (41.5% and 32.6% respectively; P ⬍ 0.05). The same target was reported by 40.4% of physicians practising in cities and towns and 36.1% of physicians from villages (P ⬍ 0.01). There was no correlation between BP treatment goals in patients with diabetes and respondents’ professional characteristics. Physicians who completed specialist training in FM/GP more frequently declared acceptance of TC targets less than 4.5 mmol/l and LDL-C less than 2.5 mm/l (54% and 71%, respectively) in comparison with physicians without specialist training (39% and 56%, respectively; P ⬍ 0.001). Sensitivity analysis revealed that there were only minor and statistically insignificant differences in the setting of BP, TC, LDL-C goals between the respondents who declared that they had responsibility for diabetes care and those who did not. The biggest difference was observed in Slovakia, where TC ⬍ 4.5 mmol/l and ⬍ 5 mmol/l were reported as the targets by 28% and 37% of all respondents, respectively (Table 3). The same goals were set by 23% and 45% of the respondents who
Strengths and limitations We have to take into account the limitations of this selfreported mail survey. General practitioners (GPs) might have overestimated their everyday practices and might have given us biased socially desired accounts of their behaviours. Another limitation is the modest response rate (28.9%), which is anyway typical for physician mailed surveys, whose response rate lies within the range of 10% to 45% (14). The study ’s design did not permit us to validate self-reported data against actual practice using medical records or other means of observation of
Table 3. Percentage of primary care physicians reporting acceptance of specific BP, TC and LDL-C treatment targets in patients with type 2 diabetes mellitus. BP (mmHg) Respondents’ country (n) BG (114) CZ (214) EE (51) HU (144) LT (31) LV (77) PL (100) SK (57) SL (79)
TC (mmol/l)
LDL-C (mmol/l)
⬍ 120/80
⬍ 130/80a
⬍ 140/90
⬍ 160/95
⬍ 4.5a
⬍ 5.0
⬍ 5.2
⬍ 6.5
⬍ 8.0
⬍ 2.5a
⬍ 3.0
⬍ 4.0
⬍ 6.0
45 58 33 48 45 53 33 67 35
39 38 61 50 48 42 64 32 64
17 3 6 2 6 5 2 2 1
0 0 0 0 0 0 1 0 0
26 53 31 69 13 58 57 28 79
26 23 41 13 26 31 26 37 21
32 17 20 15 35 6 17 35 0
14 7 8 3 26 3 0 0 0
2 0 0 0 0 1 0 0 0
48 68 61 79 55 72 73 66 87
34 25 37 18 13 26 18 30 10
10 6 2 3 23 0 9 2 3
8 0 0 0 10 1 0 2 0
BP, blood pressure; TC, total cholesterol; LDL-C, LDL-cholesterol. aThe level recommended by European guidelines (3) in the period of the survey.
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Treatment targets in patients with diabetes routine practice. Information from a survey conducted between October 2007 and February 2008 may seem to be a little outdated, however, it was 2012 when new guidelines was issued (1). During this year, the improvement in physicians’ knowledge about new treatment targets and rules guiding decisions on the goals of therapy is of special importance. The strength of the study lies in the fact that it was performed in an identical manner and with rigorous procedure in primary care in the countries where we lacked reports on the quality of care in FM/GP. They postulate that physicians’ practice patterns should be even more systematically surveyed was highlighted previously (15). Another strength is that we managed to collect responses from large, nationally representative samples and we analysed responses from 867 family physicians/general practitioners. With the exception of one country (Lithuania) the intended number of respondents (more than 100 in big and more than 50 in small countries) was achieved (Table 1). Comparison with other studies Only a few studies aimed at investigating treatment target goals for patients with diabetes set by primary care physicians were performed so far. Reiner et al., reported results from a questionnaire survey in Croatia. They revealed that 53% of physicians (two thirds of whom were primary practice physicians) indicated LDL-C treatment goals for patients with diabetes conforming to the Joint European guidelines and 40% of them considered also optimal BP (16). In another study, 123 general practices were surveyed in Nottingham, UK. The most commonly set targets for BP in patients with diabetes was less than 140/80 mmHg (indicated by 83% of respondents) and for HbA1c in the range 6.5–7.5% (48–58 mmol/ mol) indicated by 78% of respondents (17). A short while ago the International Society of Hypertension performed a global survey in the management of hypertension. There was some variation in the preferred targets for BP lowering in patients with type 2 DM. Fiftytwo per cent of respondents preferred targets of less than 130/80 mmHg, however, they were members of 31 national societies of hypertension, which permits us to assume there was a high proportion of specialists in these groups (18). Canadian family physicians were also aware of the guideline recommended treatment goals for patients with diabetes. Target levels for HBA1c, BP and LDL-C were correctly set by 74%, 60% and 88% of physicians, respectively (19). Interpretation and implication of the study’s findings This study, although based solely on self-reported physician practice patterns, provides surprising and important information concerning management targets in diabetes
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treatment. For patients with type 2 DM, about half of primary care physicians in Central and Eastern European countries set treatment goals for HbA1c and BP at levels that were below those recommended by the internationally accepted guidelines (2,3) in the period when the survey was carried out (Tables 2 and 3). This indicates that physicians were erroneously convinced that the lower levels of HbA1c and BP produce better outcomes for patients with diabetes. They showed a very strong acceptance of the ‘the lower the better ’ approach to the treatment. It is not unexpected, as also international guidelines of that time revealed some ambiguity in the target HbA1c level (2,5,20,21). These results might also be an echo of trust in pharmaceutical representatives and their heavy drug promotion through emphasis on the importance of reaching tight target levels (22). The higher percentage of physicians who received specialist training in FM/GP and reported inappropriate target for HbA1c can be possibly explained by the gaps in vocational or continuous medical education at that time. Although we cannot explain this finding based on our study results, there is a possibility that too little emphasis was put on patient safety and potential harm resulting from unnecessary treatment in FM/GP training. GPs deal with all health problems regardless of the age, sex, or any other characteristic of the person and manage both acute and chronic diseases of individual patients (23). One can assume that of all medical specialties it is FM/GP, which requires from providers the knowledge of the widest range of therapy goals. Since these goals are often expressed by a numerical value of a specific parameter, it creates a challenge for doctors. Alternatively, GPs have a unique opportunity to detect the various risk factors early and treat patients to the recommended target (1). Our study suggests that in Central and Eastern European countries information about the current goals of therapy is not effectively provided to physicians. To improve this situation more educational initiatives should be taken on and new teaching methods, appropriate for adults, should be implemented. Additionally, regular upgrade and dissemination of clinical guidelines should be undertaken by independent professional organizations. After decades of experience, diabetes research, which included thousands of patients, provides information about the benefits and pitfalls of goal-oriented therapy (24). Even so, experts’ opinions about optimal targets are divided. Physicians have to accept the fact that a discussion about ‘how low is too low’ will continue and treatment goals will change. A new version of the European Guidelines on CVD prevention, issued in 2012, provides an example of this situation (1). Within these major changes concerning glycaemic control, modest changes concerning BP management and minor changes related to lipid control were introduced. Lowering
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HbA1c ⬍ 7.0% (53 mmol/mol) was indicated as a reasonable goal for most adults with diabetes. More (⬍ 6.5%; 48 mmol/mol)) and less stringent (⬍ 8.0%; 64 mmol/mol) HbA1c goals may be appropriate for carefully selected individuals. BP targets for patients with diabetes are recommended to be ⬍ 140/80 mmHg. Variation in the target LDL-cholesterol levels exists and this ranges between 1.8 and 2.5 mmol/l (1). Primary care physicians should be aware of the current treatment goals. Moreover, they should appropriately inform the patient and together set individual targets. The goals should be based on the patient ’s clinical characteristics (e.g. prognosis, co-morbidities, pregnancy, hypoglycaemia) and their response to therapy. They should also reflect an agreement between the patient and his/her physician and ensure that the patient ’s needs and preferences are respected (25). We should be aware of the fact that patient-centred care is in contradiction with the paternalistic approach to the treatment of the patient, which is prevalent in most Central and Eastern European countries following decades of Communism. Patients here are still uninvolved in real decision making (26). Physicians’ approach should be changed and specific methods for individualized treatment goals should be applied in a primary care setting. Interpreting the results of our study it should be taken into account that even though the targets for patients with diabetes were set at very low levels, the efforts made by the doctors and patients to achieve these targets would not have been effective. It has been shown that in in Central and Eastern European countries the situation concerning diabetes control is far from being optimal (11,27).
Conclusion Most primary care physicians from Central and Eastern Europe accept responsibility for the care of patients with type 2 DM, but they tend to set treatment goals below the level specified in the European guidelines. There is little relationship between physicians’ individual characteristics and their self-reported glucose, blood pressure and cholesterol targets. However, there are significant variations between countries. Effective quality improvement measures at the primary health care level and modern continuous medical education of family physicians/general practitioners should be implemented in Central and Eastern European countries in order to relieve the burden of diabetes mellitus.
ACKNOWLEDGEMENTS The authors of this article should like to thank all partners from Central and Eastern European countries for help in data collection.
FUNDING This study in the phase of planning and data collection was supported by an unrestricted grant from Zentiva. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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ISSN: 1381-4788 (Print) 1751-1402 (Online) Journal homepage: http://www.tandfonline.com/loi/igen20
Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe Tomasz Tomasik, Adam Windak, Bohumil Seifert, Janko Kersnik & Jacek Jozwiak To cite this article: Tomasz Tomasik, Adam Windak, Bohumil Seifert, Janko Kersnik & Jacek Jozwiak (2014) Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe, European Journal of General Practice, 20:4, 253-259 To link to this article: http://dx.doi.org/10.3109/13814788.2013.877130
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Date: 12 September 2015, At: 21:01
European Journal of General Practice, 2014; 20: 253–259
Original Article
Treatment targets in patients with type 2 diabetes set by primary care physicians from Central and Eastern Europe
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Tomasz Tomasik1, Adam Windak1, Bohumil Seifert2, Janko Kersnik3 & Jacek Jozwiak4 1Department
of Family Medicine, Chair of Internal Medicine and Gerontology, Jagiellonian University Medical College, Krakow, Poland, 2Department of General Practice, First Faculty of Medicine, Charles University, Prague, Czech Republic, 3Department of Family Medicine, University Ljubljana, Ljubljana, Slovenia, 4Department of Public Health, Czestochowa University of Technology, Czestochowa, Poland KEY MESSAGE: · GPs in Central and Eastern Europe (CEE) set treatment goals for HbA1c and blood pressure below the levels recommended within the international guidelines for management of type 2 DM. · GPs in CEE still are in favour of a ‘the lower the better ’ treatment approach, although usually they do not reach these goals.
ABSTRACT Background: Primary care physicians have an important role in the care of patients with Type 2 diabetes but little is known about this issue in Central and Eastern European countries. Objectives: To investigate the treatment goals of patients with type 2 diabetes mellitus (type 2 DM) set by primary care physicians in Central and Eastern European countries and illustrate inter-country variation. Methods: A cross-sectional survey of primary care physicians randomly chosen in nine countries. A validated questionnaire was used. Physicians reported treatment goals for patients with type 2 DM. Results: A total of 44.1% of physicians, reported the acceptance of HbA1c ⬍ 6.5% (48 mmol/mol) as a treatment goal, whilst 40% chose lower levels (⬍ 6.1%; 43 mmol/mol). In all countries, 62% of physicians set FPG at a level of ⬍ 6.0 mmol/l. Most respondents set low BP levels as a goal of therapy (47% of physicians in all countries: BP ⬍ 130/80 mmHg and 48% ⬍ 120/80 mmHg). A TC level ⬍ 4.5 mmol/l and a LDL-C level ⬍ 2.5 mmol/l were reported as the targets for patients with diabetes by 51% and 69% of all respondents, respectively. The overall differences between all the countries were statistically significant (P ⬍ 0.01). Conclusion: For patients with diabetes approximately half of physicians set treatment goals at levels that were recommended within the international guidelines. Most of them set treatment goals for HbA1c and BP at very low levels. Educational efforts to raise awareness about new treatment goals are needed. Keywords: diabetes mellitus type 2, primary health care, Central and Eastern Europe
INTRODUCTION Achievement of glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), blood pressure (BP) and cholesterol (TC and LDL-C) targets remain fundamental to the effective management of patients with type 2 diabetes mellitus (type 2 DM) (1). During the first decade of this century, several European guidelines related to cardiovascular disease (CVD) and diabetes have recommended increasingly
tighter targets for the control of risk factors (2–4). Stone et al., compared national guidelines for type 2 diabetes from eight West European countries. Although, there were variations in terms of the specific recommendations they exhibited the same approach (5). This approach may be described as ‘the lower the better ’ (6). It was in accordance with the wishes of most clinicians, who prefer to have clear and simple recommendations.
Correspondence: T. Tomasik, Department of Family Medicine, Jagiellonian University Medical College, 4 Bochenska Street, 31–061 Krakow, Poland. Tel: ⫹ 48 12 430 55 93. Fax: ⫹ 48 12 430 55 84. E-mail: [email protected] (Received 3 July 2013; accepted 19 November 2013) ISSN 1381-4788 print/ISSN 1751-1402 online © 2014 Informa Healthcare DOI: 10.3109/13814788.2013.877130
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At the end of the decade, the ACCORD trial was stopped early, since mortality increased due to intensive glycaemic control (7). Moreover, re-appraisal of hypertension guidelines was published in 2009 and highlighted the lack of research evidence to justify lowering SBP ⬍ 130 and DBP ⬍ 80 mmHg in patients with diabetes (8). One year later, therapy targeting low systolic blood pressure (below 120 mmHg) was shown not to reduce major cardiovascular events in the patients (9). The European Society of Cardiology and another nine societies issued a new version of the European Guidelines on CVD prevention in 2012 (1). Other organizations also updated their recommendations (10). These introduced important changes concerning HbA1c and BP targets in patients with diabetes. Primary care physicians are key professionals for the provision of CVD prevention in Europe (1). Although they have an important role in the care of patients with diabetes, little is known about this issue in Central and Eastern European countries. Papers, which reveal unsatisfactory management, are published mainly in the national languages (11). No studies related to setting of treatment targets for patients with type 2 DM from this part of Europe are available. International comparative data might provide important insights into the delivery of primary care for patients with diabetes. Aims of this study are: (1) investigating the treatment goals of patients with type 2 DM set by primary care physicians in Central and Eastern European countries, (2) illustrating inter-country variation and (3) analysing the correlation between physicians’ characteristics and their chosen treatment goals. We focused on glycaemia, blood pressure and cholesterol control in patients with diabetes.
The size of the samples was based on the country’s population and expected response rate. The size varied from 150 in the smaller countries (EE, HU, LV, LT, SK, SL) to 500 in the larger countries (BG, CZ, PL). The required response was at least 50 responses in the smaller countries and 100 in the larger ones; in total, we aimed to collect at least 600 responses. Procedure and measurement A questionnaire consisting of three parts was developed, reviewed, validated and rigorously translated into all the languages. One part of the questionnaire was devoted to the care of patients with cardiovascular problems and contained five questions devoted to the treatment goals for patients with type 2 DM. All of these questions had a predefined set of answer options. An anonymous questionnaire was distributed by post and answers were collected between October 2007 and February 2008. The questionnaire has already been published as a supplement to the previous paper (12). We measured physicians’ reported treatment goals (HbA1c, FPG, BP, TC, LDL-C) for patients with type 2 DM. All respondents were asked to answer questions devoted to BP and cholesterol control while only physicians declaring that they had responsibility for the care of diabetic patients responded to the questions relating to glycaemia control. In addition, we collected data about professional characteristics of the respondents. To investigate the correlation between physicians’ characteristics and their reported treatment goals we analysed the following variables: age and experience in General Practice in years, practice locality (urban/rural/mixed), specialty in family medicine/general practice (FM/GP) and gender.
METHODS A detailed description of the study methods has been already published, therefore, only a short summary is provided below (12,13). Design We performed a cross-sectional survey of primary care physicians in Central and Eastern European countries. Setting The study was carried out in primary care in nine countries; Bulgaria (BG), the Czech Republic (CZ), Estonia (EE), Hungary (HU), Lithuania (LT), Latvia (LV), Poland (PL), Slovakia (SK) and Slovenia (SL). Participants In total, 3000 primary care physicians were randomly chosen from relevant national registers of physicians.
Statistical analysis Mean and standard deviation were calculated to present the quantitative characteristics of the respondents and the distribution of qualitative characteristics. To compare the countries’ results the Pearson Chi-square test was used, which shows the differences in the responses distribution between countries. For analysing the correlation between physicians’ age and their treatment goals, the Kruskal–Wallis test was used, while the Pearson Chi-square test was applied for significance-testing of the relationship between two categorical variables. Sensitivity analysis To check whether the self-perceived responsibility for the care of patients with type 2 DM influence the study results we repeated all analysis on the subgroup of respondents declaring that they had this responsibility. We performed a one-way sensitivity analysis and compared this subgroup with the entire group of respondents.
83/10/7 55/18/27 52/28/20 57/24/19 65/23/13 76/16/8 46/31/23 41/36/23 26/29/45 58/22/20
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85/9/6 57/18/24 51/29/20 56/24/20 65/23/13 77/16/8 47/29/23 54/20/27 33/30/37 59/21/20
All
Urbanization (% urban/rural/ mixed area)
Statistical significance was set at the 0.05 level for all analysis. The study protocol conforms to the ethical guidelines of the 1975 Helsinki Declaration. Ethical Committee approval was not sought because the study did not involve patients or human material and was conducted under the terms of all relevant local legislation.
Responsible for diabetes care
Treatment targets in patients with diabetes
4 98 98 87 83 99 97 100 78 80 6 98 96 87 83 99 96 100 77 82 9.3 (6.1) 22.0 (9.8) 18.2 (8.9) 22.0 (11.5) 9.0 (4.9) 19.3 (9.3) 16.5 (7.3) 22.4 (9.8) 18.3 (9.1) 18.2 (10.2) 9.2 (6.0) 21.9 (9.6) 17.9 (9.0) 21.8 (11.4) 9.0 (4.9) 19.1 (9.3) 16.6 (7.3) 22.6 (8.4) 18.4 (9.1) 18.5 (10.0) 66 70 92 40 68 92 60 67 66 66 66 71 92 41 68 91 62 77 66 67 GP/FM, general practice/family medicine.
44.0 (6.7) 52.1 (9.0) 48.1 (8,2) 53.4 (10.4) 45.1 (9.6) 49.4 (8.2) 46.5 (6.4) 51.0 (10.3) 46.1 (7.8) 49.0 (9.10 44.1 (6.9) 52.0 (8.7) 48.3 (8.2) 53.5 (10.3) 45.1 (9.6) 49.3 (8.1) 46.4 (6.6) 51.8 (8.1) 46.2 (7.7) 49.3 (9.0) 114 214 51 144 31 77 100 57 79 867 BG CZ EE HU LT LV PL SK SL Total
104 139 50 138 31 75 96 22 58 713
Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Responsible for diabetes care All Country
Physicians with specialty in GP/FM (%) Years of experience in general practice Mean (SD) Gender (% female) Age of respondents in years Mean (SD) Respondents (n)
The questionnaire was returned by 867 of the 3000 primary care physicians consulted (a response rate of 28.9%). The minimum required number of responses was obtained in all the countries except Lithuania (31 responses). Non-respondents do not differ from respondents in gender or location of practice (cities/ towns/villages). Responsibility for the care of patients with type 2 DM was reported by 713 (82.4%) of physicians (ranging from 38% in Slovakia to 100% in Lithuania). The detailed characteristics of all respondents and those who declared responsibility for the care of patients with diabetes are presented in Table 1. There were no statistically significant differences in any of the respondents’ characteristics between these groups. Other information about the respondents has already been published elsewhere (12,13). In the case of patients with type 2 DM, nearly half of physicians (44.1%) reported the acceptance of HbA1c ⬍ 6.5% (48 mmol/mol) as the treatment goal, whilst 40.0% of respondents chose lower levels (⬍ 6.1%; 43 mmol/mol) and 15.8% higher level (⬍ 7.0%; 53 mmol/mol). Details about target levels of HbA1c and FPG in particular countries are presented in Table 2. Most physicians (62%) in all the countries set treatment goals for FPG at a level of ⬍ 6.0 mmol/l and only in Slovenia did half of the respondents tend to accept the level of ⬍ 7.0 mmol/l. The overall differences between all the countries are statistically significant for both targets HbA1c level (P ⬍ 0.0001) and FPG level (P ⬍ 0.01). Forty-eight per cent of respondents in all countries set very low BP levels as a goal of therapy (⬍ 120/80 mmHg), 47% of physicians accepted BP ⬍ 130/80 mmHg and 5% level ⬍ 140/90. The differences between the countries included in the study were statistically significant (P ⬍ 0.001). A TC level of less than 4.5 mmol/l and a LDL-C level of less than 2.5 mmol/l were reported as the targets for patients with diabetes by 51% and 69% of all respondents, respectively (the differences between countries were statistically significant P ⬍ 0.01). Details about target levels of BP and cholesterol in particular countries are presented in Table 3. Physicians after specialist training in FM/GP more frequently reported acceptance of a HbA1c target below 6.1% (43 mmol/mol) in comparison with physicians
Table 1. Characteristics of respondents in countries included in the study.
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RESULTS
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Table 2. Percentage of primary care physicians responsible for diabetes care reporting acceptance of specific HbA1c and FPG treatment targets in patients with type 2 diabetes mellitus. HbA1c (%) Respondents’ country (n)
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BG (104) CZ (139) EE (50) HU (138) LT (31) LV (75) PL (96) SK (22) SL (58)
declared the responsibilities for the care of diabetic patients (data not shown). However even these differences were not statistically significant (P ⫽ 0.771). There were also no differences in the correlation between physicians’ characteristics and their treatment goals of BP, TC and LDL-C between the group of all respondents and the group declaring that they had responsibility for diabetes care.
FPG (mmol/ l)
⬍ 6.1
⬍ 6.5a
⬍ 7.0
⬍ 6.0a
⬍ 7.0
⬍ 7.8
35 72 22 39 30 33 29 47 21
53 25 46 46 17 58 59 47 41
12 4 32 16 53 10 11 5 38
59 59 64 66 68 54 79 59 45
30 38 34 32 26 42 18 36 50
11 4 2 2 6 4 3 5 5
DISCUSSION Main findings In this observational, cross-sectional study, we found that a high percentage of primary care physicians reported that they were responsible for provision of care to patients with type 2 DM in Central and Eastern European countries. Approximately half of primary care physicians in Central and Eastern European countries set treatment goals at levels that were recommended within the international guidelines between 2007 and 2011 (2–4). Surprisingly, a large proportion of physicians kept too low HbA1c and BP management targets (Tables 2 and 3). Statistically significant differences in setting treatment goals were revealed between countries included in this study.
HbA1c, glycated haemoglobin; FPG, fasting plasma glucose. aThe level recommended by European guidelines (3) in the period of the survey.
without specialist training (41.5% and 32.6% respectively; P ⬍ 0.05). The same target was reported by 40.4% of physicians practising in cities and towns and 36.1% of physicians from villages (P ⬍ 0.01). There was no correlation between BP treatment goals in patients with diabetes and respondents’ professional characteristics. Physicians who completed specialist training in FM/GP more frequently declared acceptance of TC targets less than 4.5 mmol/l and LDL-C less than 2.5 mm/l (54% and 71%, respectively) in comparison with physicians without specialist training (39% and 56%, respectively; P ⬍ 0.001). Sensitivity analysis revealed that there were only minor and statistically insignificant differences in the setting of BP, TC, LDL-C goals between the respondents who declared that they had responsibility for diabetes care and those who did not. The biggest difference was observed in Slovakia, where TC ⬍ 4.5 mmol/l and ⬍ 5 mmol/l were reported as the targets by 28% and 37% of all respondents, respectively (Table 3). The same goals were set by 23% and 45% of the respondents who
Strengths and limitations We have to take into account the limitations of this selfreported mail survey. General practitioners (GPs) might have overestimated their everyday practices and might have given us biased socially desired accounts of their behaviours. Another limitation is the modest response rate (28.9%), which is anyway typical for physician mailed surveys, whose response rate lies within the range of 10% to 45% (14). The study ’s design did not permit us to validate self-reported data against actual practice using medical records or other means of observation of
Table 3. Percentage of primary care physicians reporting acceptance of specific BP, TC and LDL-C treatment targets in patients with type 2 diabetes mellitus. BP (mmHg) Respondents’ country (n) BG (114) CZ (214) EE (51) HU (144) LT (31) LV (77) PL (100) SK (57) SL (79)
TC (mmol/l)
LDL-C (mmol/l)
⬍ 120/80
⬍ 130/80a
⬍ 140/90
⬍ 160/95
⬍ 4.5a
⬍ 5.0
⬍ 5.2
⬍ 6.5
⬍ 8.0
⬍ 2.5a
⬍ 3.0
⬍ 4.0
⬍ 6.0
45 58 33 48 45 53 33 67 35
39 38 61 50 48 42 64 32 64
17 3 6 2 6 5 2 2 1
0 0 0 0 0 0 1 0 0
26 53 31 69 13 58 57 28 79
26 23 41 13 26 31 26 37 21
32 17 20 15 35 6 17 35 0
14 7 8 3 26 3 0 0 0
2 0 0 0 0 1 0 0 0
48 68 61 79 55 72 73 66 87
34 25 37 18 13 26 18 30 10
10 6 2 3 23 0 9 2 3
8 0 0 0 10 1 0 2 0
BP, blood pressure; TC, total cholesterol; LDL-C, LDL-cholesterol. aThe level recommended by European guidelines (3) in the period of the survey.
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Treatment targets in patients with diabetes routine practice. Information from a survey conducted between October 2007 and February 2008 may seem to be a little outdated, however, it was 2012 when new guidelines was issued (1). During this year, the improvement in physicians’ knowledge about new treatment targets and rules guiding decisions on the goals of therapy is of special importance. The strength of the study lies in the fact that it was performed in an identical manner and with rigorous procedure in primary care in the countries where we lacked reports on the quality of care in FM/GP. They postulate that physicians’ practice patterns should be even more systematically surveyed was highlighted previously (15). Another strength is that we managed to collect responses from large, nationally representative samples and we analysed responses from 867 family physicians/general practitioners. With the exception of one country (Lithuania) the intended number of respondents (more than 100 in big and more than 50 in small countries) was achieved (Table 1). Comparison with other studies Only a few studies aimed at investigating treatment target goals for patients with diabetes set by primary care physicians were performed so far. Reiner et al., reported results from a questionnaire survey in Croatia. They revealed that 53% of physicians (two thirds of whom were primary practice physicians) indicated LDL-C treatment goals for patients with diabetes conforming to the Joint European guidelines and 40% of them considered also optimal BP (16). In another study, 123 general practices were surveyed in Nottingham, UK. The most commonly set targets for BP in patients with diabetes was less than 140/80 mmHg (indicated by 83% of respondents) and for HbA1c in the range 6.5–7.5% (48–58 mmol/ mol) indicated by 78% of respondents (17). A short while ago the International Society of Hypertension performed a global survey in the management of hypertension. There was some variation in the preferred targets for BP lowering in patients with type 2 DM. Fiftytwo per cent of respondents preferred targets of less than 130/80 mmHg, however, they were members of 31 national societies of hypertension, which permits us to assume there was a high proportion of specialists in these groups (18). Canadian family physicians were also aware of the guideline recommended treatment goals for patients with diabetes. Target levels for HBA1c, BP and LDL-C were correctly set by 74%, 60% and 88% of physicians, respectively (19). Interpretation and implication of the study’s findings This study, although based solely on self-reported physician practice patterns, provides surprising and important information concerning management targets in diabetes
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treatment. For patients with type 2 DM, about half of primary care physicians in Central and Eastern European countries set treatment goals for HbA1c and BP at levels that were below those recommended by the internationally accepted guidelines (2,3) in the period when the survey was carried out (Tables 2 and 3). This indicates that physicians were erroneously convinced that the lower levels of HbA1c and BP produce better outcomes for patients with diabetes. They showed a very strong acceptance of the ‘the lower the better ’ approach to the treatment. It is not unexpected, as also international guidelines of that time revealed some ambiguity in the target HbA1c level (2,5,20,21). These results might also be an echo of trust in pharmaceutical representatives and their heavy drug promotion through emphasis on the importance of reaching tight target levels (22). The higher percentage of physicians who received specialist training in FM/GP and reported inappropriate target for HbA1c can be possibly explained by the gaps in vocational or continuous medical education at that time. Although we cannot explain this finding based on our study results, there is a possibility that too little emphasis was put on patient safety and potential harm resulting from unnecessary treatment in FM/GP training. GPs deal with all health problems regardless of the age, sex, or any other characteristic of the person and manage both acute and chronic diseases of individual patients (23). One can assume that of all medical specialties it is FM/GP, which requires from providers the knowledge of the widest range of therapy goals. Since these goals are often expressed by a numerical value of a specific parameter, it creates a challenge for doctors. Alternatively, GPs have a unique opportunity to detect the various risk factors early and treat patients to the recommended target (1). Our study suggests that in Central and Eastern European countries information about the current goals of therapy is not effectively provided to physicians. To improve this situation more educational initiatives should be taken on and new teaching methods, appropriate for adults, should be implemented. Additionally, regular upgrade and dissemination of clinical guidelines should be undertaken by independent professional organizations. After decades of experience, diabetes research, which included thousands of patients, provides information about the benefits and pitfalls of goal-oriented therapy (24). Even so, experts’ opinions about optimal targets are divided. Physicians have to accept the fact that a discussion about ‘how low is too low’ will continue and treatment goals will change. A new version of the European Guidelines on CVD prevention, issued in 2012, provides an example of this situation (1). Within these major changes concerning glycaemic control, modest changes concerning BP management and minor changes related to lipid control were introduced. Lowering
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HbA1c ⬍ 7.0% (53 mmol/mol) was indicated as a reasonable goal for most adults with diabetes. More (⬍ 6.5%; 48 mmol/mol)) and less stringent (⬍ 8.0%; 64 mmol/mol) HbA1c goals may be appropriate for carefully selected individuals. BP targets for patients with diabetes are recommended to be ⬍ 140/80 mmHg. Variation in the target LDL-cholesterol levels exists and this ranges between 1.8 and 2.5 mmol/l (1). Primary care physicians should be aware of the current treatment goals. Moreover, they should appropriately inform the patient and together set individual targets. The goals should be based on the patient ’s clinical characteristics (e.g. prognosis, co-morbidities, pregnancy, hypoglycaemia) and their response to therapy. They should also reflect an agreement between the patient and his/her physician and ensure that the patient ’s needs and preferences are respected (25). We should be aware of the fact that patient-centred care is in contradiction with the paternalistic approach to the treatment of the patient, which is prevalent in most Central and Eastern European countries following decades of Communism. Patients here are still uninvolved in real decision making (26). Physicians’ approach should be changed and specific methods for individualized treatment goals should be applied in a primary care setting. Interpreting the results of our study it should be taken into account that even though the targets for patients with diabetes were set at very low levels, the efforts made by the doctors and patients to achieve these targets would not have been effective. It has been shown that in in Central and Eastern European countries the situation concerning diabetes control is far from being optimal (11,27).
Conclusion Most primary care physicians from Central and Eastern Europe accept responsibility for the care of patients with type 2 DM, but they tend to set treatment goals below the level specified in the European guidelines. There is little relationship between physicians’ individual characteristics and their self-reported glucose, blood pressure and cholesterol targets. However, there are significant variations between countries. Effective quality improvement measures at the primary health care level and modern continuous medical education of family physicians/general practitioners should be implemented in Central and Eastern European countries in order to relieve the burden of diabetes mellitus.
ACKNOWLEDGEMENTS The authors of this article should like to thank all partners from Central and Eastern European countries for help in data collection.
FUNDING This study in the phase of planning and data collection was supported by an unrestricted grant from Zentiva. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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