Type 2 diabetes is one of the most common

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1 Q Manage Health Care Vol. 15, No. 1, pp c 2006 Lippincott Williams & Wilkins, Inc. The Need for Quality Management in Primary Health Care in Cyprus: Results From a Medical Audit for Patients With Type 2 Diabetes Mellitus Theodora Zachariadou, MD; Loukia Makri, MSc; Henri E. J. H. Stoffers, MD, PhD; Anastasios Philalithis, PhD, AKC, MBBS, MRCP, MSc; Christos Lionis, MD, PhD Objectives: To assess the quality of clinical management regarding metabolic and blood pressure control in a cohort of patients with type 2 diabetes in the primary health care setting of Cyprus. Subjects and Methods: Medical care, received by 296 patients with type 2 diabetes from 4 primary care health centers in Cyprus, was assessed for 1 year. Data were collected retrospectively using chart review and a telephone survey. Most recent values of HbA 1c, fasting blood glucose, blood pressure, and lipid values were used to assess attainment to internationally accepted treatment targets. Results: Mean age was 70 years, 75% of patients being older than 65. Average diabetes duration was 13 years. Almost 90% of patients had visited a general practitioner during 1 year, on average 8.3 times. Hypertension and hyperlipidemia were present in 67% and 32% of patients, respectively. Overall, diabetes care provided by the 4 primary care health centers appeared to be suboptimal with regard to frequency of metabolic and blood pressure measurements as well as targets reached. Only 10.5% of all patients had at least 1 HbA 1c value recorded, and 77.4% of them had HbA 1c levels of 8% or more. Of the patients who had a low-density lipoprotein cholesterol measurement during the examined year (29.4%), only 20.7% had a value less than 100 mg/dl. Only 34.5% of patients used lipid-lowering agents, and only 15.9% were receiving aspirin. Conclusion: Our findings suggest that the management of type 2 diabetes is suboptimal in the primary health care setting of Cyprus. A multifaceted intervention, already in progress in 2 health centers, is expected to improve the quality of diabetes care. Key words: primary health care, quality management, type 2 diabetes Type 2 diabetes is one of the most common chronic diseases, with increasing prevalence over the last 30 years. It has been estimated that between the years 1995 and 2025 the prevalence of diabetes in adults will increase by 35% for the whole world. 1 Furthermore, type 2 diabetes is a major contributor to the development of cardiovascular disease, leading to increased mortality, 2 particularly, among patients with concomitant hypertension or hyperlipidemia. 3 In Cyprus, a new national health plan has recently been approved by law, introducing the gatekeeper role for general practitioners in the primary health care services. Taking this reform into consideration, a collaborative agreement between the Ministry of Health and the School of Medicine of the University of Crete was signed. The objective of this project is to improve quality management in the primary From the Nicosia General Hospital (Dr Zachariadou) and the Statistical Service of Cyprus (Ms Makri), Nicosia, Cyprus; the Department of General Practice, Maastricht University, Maastricht, the Netherlands (Dr Stoffers); and the Department of Social and Family Medicine, School of Medicine, University of Crete, Heraklion, Greece (Drs Philalithis and Lionis). Dr Zachariadou is a PhD student at the University of Crete, Heraklion, Greece. Corresponding author: Theodora Zachariadou, MD, 1, Spyrou Lambrou, 1082, Nicosia, Cyprus ( andthe@ cytanet.com.cy). 58

2 The Need for Quality Management in Primary Health Care in Cyprus 59 health care setting through educational and research programs. In the framework of this collaboration, a pilot study conducted in 4 primary care health centers in the Nicosia area revealed the 10 most common chronic diseases that general practitioners encounter in their daily practice. 4 The 3 most common conditions, that is, type 2 diabetes mellitus, hypertension, and hyperlipidemia were selected for further analysis in the current quality assessment study. The aim of the present study was to assess the quality of clinical management in patients with type 2 diabetes regarding their metabolic status and treatment of hypertension, in the primary health care setting of Cyprus. The study was performed prior to the introduction of a multifaceted quality improvement intervention. METHODS AND SUBJECTS Primary care health centers We selected patients with type 2 diabetes from 4 primary care health centers (PCHCs) and assessed the care they received during 1 year (from January 2, 2002, until December 31, 2002). The 4 PCHCs enrolled in the study 2 urban and 2 rural centers were located in the Nicosia area and were selected using specific selection criteria. Selection was based on the size of the population served by each PCHC, the opening hours of the PCHC, the number of general practitioners as well as their postgraduate education and years of experience in primary health care, and the number of nurses and administrative staff at each PCHC. The selected PCHCs were paired (with 2 urban and 2 rural PCHCs in each pair) to enable comparisons at the next phase of the study. Patients From the total number of patients with type 2 diabetes and/or hypertension and/or hyperlipidemia, an initial sample of 4633 patients from the 4 PCHCs was identified. Out of these, a random selection of 1097 patients yielded 296 available medical records of patients with type 2 diabetes for chart abstraction and further study. Of these patients, 68 (23%) had only type 2 diabetes; 133 (44.9%) had type 2 diabetes and hypertension; 31 (10.5%) had type 2 diabetes and hyperlipidemia; and 64 (21.6%) had type 2 diabetes, hypertension, and hyperlipidemia. Participants were considered diabetic if the diagnosis of type 2 diabetes was registered by their general practitioners in their medical records or by documentation of oral hypoglycemic drugs or insulin in their medication list or if they had a fasting serum glucose level of 126 mg/dl (7.0 mmol/l) or more according to international criteria for the diagnosis of type 2 diabetes. 5 7 Hyperlipidemia in patients with type 2 diabetes was defined as a diagnosis of hyperlipidemia already registered in their medical files; or, as at least 1 measurement of total cholesterol levels higher than 200 mg/dl (5.2 mmol/l) within the 12-month period of the study, and/or at least 1 measurement of low-density lipoprotein (LDL) cholesterol level higher than 100 mg/dl (2.6 mmol/l), and/or at least 1 measurement of triglycerides higher than 150 mg/dl (1.7 mmol/l) recorded in their medical files; or, when patients were on hypolipidemic medication as recorded in their medical record. Patients were considered hypertensive if they had a diagnosis of hypertension registered in their medical files, if they were on antihypertensive medication, or if they had at least 3 consecutive measurements of blood pressure higher than 140/90 mm Hg recorded in their medical records within the year examined. Patients not seen for more than 1 year were excluded. DATA COLLECTION Data were collected through a combination of chart abstraction by the first author (T.Z.) and a telephone survey to collect any supplementary information that was missing from the patients medical records, conducted by the nurses of the 4 PCHCs. The nurses were trained by T.Z. A variety of parameters recorded in the medical files at each patient s visit during the study period were entered into a database. These data provided information on patient demographics, metabolic status, cardiovascular risk factors, comorbidity, and drug treatment. To assess attainment of treatment

3 60 QUALITY MANAGEMENT IN HEALTH CARE/VOLUME 15, ISSUE 1, JANUARY MARCH 2006 goals for risk factors, the most recent glycosylated hemoglobin (HbA 1c ), systolic (SBP) and diastolic blood pressure (DBP), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) values recorded in the medical records were used. The most updated medication lists were used for analysis of management effectiveness. Questions asked in the telephone interview included self-reported history of diabetes, hypertension, stroke, and coronary heart disease, as well as smoking behaviour. Medical diagnoses were coded by T.Z. according to the ICD-10, 8 and medications were coded using ATC codes. The biochemical methods used for measuring HbA 1c, FBG, TC, LDL and HDL cholesterol, and TG levels were the standard methods used by the clinical biochemistry department of Nicosia General Hospital. The biochemistry department uses daily internal controls and participates in 3 external quality assessment programs. Measures of clinical management effectiveness As standards of metabolic control for diabetes, we applied the recommendations of the St Vincent Declaration criteria. 7 For lipid control, we used the recommendations of the US National Cholesterol Education Program. 9 For blood pressure control, the recommendations of the US Joint National Committee on Detection, Evaluation, and Treatment of Blood Pressure (JNCVI) were applied. 10 For patients with diabetes, these recommendations can be summarized as follows: Evaluation of FBG and HbA 1c levels every 3 to 6 months, that is, at least twice a year Yearly screening of blood pressure and lipid levels (TC, LDL and HDL cholesterol, and TG levels) Target values were defined as follows 7,9,10 : Glucose: HbA 1c as 7%, FBG <120 mg/dl (6.7 mmol/l) Lipids: TC <200 mg/dl (5.2 mmol/l), LDL cholesterol <100 mg/dl (2.6 mmol/l), HDL cholesterol >40 mg/dl (1.2 mmol/l) and TG <150 mg/dl (1.7 mmol/l) Blood pressure: SBP/DBP <130/85 mm Hg. We searched the medical records for at least 1 test for HbA 1c, FBG, TC, LDL and HDL cholesterol, TG, and BP measurements during the study period. If more than 1 measurement was identified we used the most recent value for further analysis. Statistical analysis Analysis of the patient population was mainly descriptive. t test was performed to test for differences on continuous variables between groups (eg, gender, location of PCHC). The association between certain categorical variables was examined using χ 2 tests. Logistic regression analysis was used to identify independent effects of covariates (age, gender, and location of PCHC) with specific outcomes (BP control, glycemic and lipid control). Statistical analysis was performed using the statistical software program SPSS Version The level of significance used was P <.05. Ethics Before initiation, the Ethics Committee of Cyprus approved this retrospective study. RESULTS Patient characteristics Table 1 presents the demographic and clinical characteristics of the 296 patients with type 2 diabetes mellitus. Mean age was 70 years and 74.7% of all patients were 65 years or older. More females were included in the study (58.8% female vs 41.2% male). The average number of encounters with the general practitioners in 1 year was 8.3 (SD 3.9). The mean duration of diabetes was 13 years. Two thirds of all patients were hypertensive, with a mean duration of hypertension of 10 years (SD 9). Relevant comorbidity consisted of hyperlipidemia (32.1%), coronary artery disease (9.1%), and stroke or transient ischemic attack (4.1%). Patients were visiting relevant specialists, such as the cardiologist (97 patients, 60.2%), the diabetologist (29 patients, 19.2%), and the ophthalmologist (10 patients, 7.0%). Data regarding the smoking habits of the patients were reported for only 38.2% of

4 The Need for Quality Management in Primary Health Care in Cyprus 61 Table 1 PATIENT DEMOGRAPHICS AND CLINICAL CHARACTERISTICS (N = 296) Characteristic No. (%) or mean ± SD Age, y 70 ± 10 (range 34 94) Gender Female 174 (58.8) Male 122 (41.2) Diabetes (according to medical record) Duration of diabetes, y 13 ± 11 Current diabetes treatment Insulin alone 35 (11.8) Oral medication alone 194 (65.5) Insulin and oral medication 13 (4.4) Neither insulin nor oral medication 54 (18.3) Cardiovascular comorbidity (according to medical record) Hypertension 199 (67.2) Hyperlipidemia 95 (32.1) Coronary artery disease 27 (9.1) Stroke or transient ischemic attack 12 (4.1) Smoking status (telephone interview) Unknown 183 (61.8) Nonsmoker 98 (33.1) Smoker 15 (5.1) the participating patients. Of these, 13.3% currently smoked. Metabolic and blood pressure control With regard to number of visits per year, frequency of testing, and mean values of biochemical parameters and blood pressure, there were no statistically significant differences between male and female patients. Glycemic control Within the examined year, only 31 (10.5%) patients had their HbA 1c recorded in their medical records and on average (8.9% of these patients) it was above the target value (Table 2). Of those, 22.6% had values at 7% to 8% whereas 77.4% had values of 8% or more. There were no data available for patients with HbA 1c less than 7% (Table 3). At least 1 FBG was recorded in 66.6% of all patients; their mean value of 155 mg/dl (8.5 mmol/l) was above the target value (Table 2). FBG values were within the acceptable range for 44.6% of the patients, whereas 15.7% of the patients had FBG levels higher than 200 mg/dl (11.0 mmol/l) (Table 3). In multivariate logistic regression analysis, the interaction between age and gender was associated with poorer glycemic control. Women aged 65 years and older were 2 times more likely to have FBG levels of 140 mg/dl (OR 2.1; 95% confidence interval 0.3 to12.7) or more. Lipid control The proportion of patients with 1 or more measurements of total cholesterol was 49.7%, and 29.4% of the participating patients had at least 1 measurement of LDL cholesterol (Table 2). A total of 36.1% and 20.7% of these patients, respectively, met the particular targets of TC levels lower than 200 mg/dl (5.2 mmol/l) and LDL cholesterol levels lower than 100 mg/dl (2.6 mmol/l) (Table 3). In 28% of all Table 2 DIABETES CARE RECEIVED BY PATIENTS DURING 12 MONTHS (N = 296) No. (%) of Measurements patients Mean ± SD Glucose 1 HbA 1c 31 (10.5) HbA 1c,% 8.9 ± FBG 197 (66.6) FBG, mg/dl 155 ± 49.2 Lipids 1 TC 147 (49.7) TC, mg/dl 214 ± LDL 87 (29.4) LDL, mg/dl 127 ± HDL 83 (28.0) HDL, mg/dl 54 ± TG 141 (47.6) TG, mg/dl 205 ± Blood pressure (81.4) SBP, mm Hg 137 ± 15.8 DBP, mm Hg 82± 7.2 HbA 1c indicates glycosylated hemoglobin; FBG, fasting blood glucose; TC, total cholesterol; LDL, low-density lipoprotein cholesterol; HDL, high-density lipoprotein cholesterol; TG, triglycerides; SBP, systolic blood pressure; DBP, diastolic blood pressure. Values are for those patients for whom data were available.

5 62 QUALITY MANAGEMENT IN HEALTH CARE/VOLUME 15, ISSUE 1, JANUARY MARCH 2006 Table 3 METABOLIC AND BLOOD PRESSURE CONTROL OF PATIENTS WITH TYPE 2 DIABETES Measurement No. (%) of patients HbA 1c level (n = 31) Good 7% Not available Acceptable 7 8% 7 (22.6) Poor 8% 24 (77.4) Fasting blood glucose level (n = 197) Good <120 mg/dl 44 (22.3) Acceptable mg/dl 44 (22.3) Poor 140 mg/dl 109 (55.4) Total cholesterol level (n = 147) Good <200 mg/dl 53 (36.1) Acceptable mg/dl 68 (46.2) Poor >250 mg/dl 26 (17.7) LDL cholesterol level (n = 87) Good <100 mg/dl 18 (20.7) Acceptable mg/dl 28 (32.2) Poor 130 mg/dl 41 (47.1) HDL cholesterol level (n = 83) Good 40 mg/dl (for men) 21 (72.4) Good 50 mg/dl (for women) 26 (48.1) Triglyceride level (n = 141) Good <150 mg/dl 53 (37.6) Acceptable mg/dl 33 (23.4) Poor >200 mg/dl 55 (39.0) BP level (n = 241) Good <130/85 mm Hg 53 (22.0) Poor 130/85 mm Hg 188 (78.0) participating patients, we found at least 1 value of HDL (Table 2), and 86.7% of these had HDL cholesterol levels of 40 mg/dl (1.1 mmol/l) or more. Of all patients, 47.6% underwent at least 1 TG test (Table 2), 39% of whom had poor control (Table 3). Blood pressure control Blood pressure (BP) values were noted in 81.4% of the medical records, revealing mean values of 137 mm Hg and 82 mm Hg for SBP and DBP, respectively (Table 2). All together, only 22% of the entire cohort met the target BP of less than 130/85 mm Hg (Table 3). Moreover, 49% of the patients had an SBP of 140 mm Hg or more and 21.6% had a DPB of 90 mm Hg or more. Medication use Regarding antidiabetic treatment, 18.3% of the patients with type 2 diabetes were treated by diet only. Medication is described in Table 1. Sulfonylureas were the most commonly prescribed antidiabetic agents (68.8%) given either as monotherapy or in combination. Among hypertensive patients, the most commonly prescribed drugs were angiotensinconverting enzyme (ACE) inhibitors (55.8%), followed by β-blockers, calcium channel blockers, angiotensin receptor blockers, and finally thiazide diuretics. Almost 60% of the hypertensive patients used more than 1 antihypertensive drug (Table 4). All together, 34.5% of the participating patients were on lipid-lowering drugs, of whom 76.5% were receiving only a statin, 18.6% a fibrate, and 4.9% a combination of both (Table 4). The overall rate of prophylactic aspirin use was low in this cohort (15.9%). Table 4 PHARMACOLOGICAL TREATMENT OF COMORBID CONDITIONS IN PATIENTS WITH TYPE 2 DIABETES Treatment No. (%) of patients Hypertension (n = 199) ACE inhibitors 111 (55.8) β-blockers 62 (31.2) Calcium blockers 59 (29.7) Angiotensin receptor blockers 42 (21.1) Thiazide diuretics 30 (15.1) Number of antihypertensive drugs 1 82 (41.2) 2 70 (35.2) 3 35 (17.6) 4 12 (6.0) Dyslipidemia (n = 102) Statins only 78 (76.5) Fibrates only 19 (18.6) Combination of statins and fibrates 5 (4.9) Aspirin (n = 296) 47 (15.9%)

6 The Need for Quality Management in Primary Health Care in Cyprus 63 Urban vs rural PCHC There were no statistically significant differences between the urban and rural PCHCs with regard to age and gender distribution. There also was no statistically significant difference regarding the frequency of testing for glycemic and lipid parameters. However, the mean number of blood pressure measurements was lower in the rural as compared to the urban PCHCs (4.3 vs 5.7). Mean values for SBP, FBG, and LDL were comparable between urban and rural PCHCs. But, mean DBP (83.9 vs 80.2, P =.000), mean TC levels (226.5 vs 209.9, P =.037), and mean TG levels (253.1 vs 188.4, P =.008) were higher in the rural as compared to the urban centers. Regarding medication use, we found a statistically significant association between the use of ACE inhibitors and location of the PCHC (P =.036, <.05), with fewer patients receiving ACE inhibitors in the rural PCHC (30.7% vs 42.6%). In multivariate logistic regression analysis, poorer TG control was associated with the location of the PCHCs. Patients who visited the 2 rural PCHCs were almost 12 times (PCHC 1: OR 11.7, 95% confidence interval ) and 2 times (PCHC 2: OR 2.1, 95% confidence interval ) more likely to have TG levels of 150 mg/dl or more than those visiting the urban PCHCs. DISCUSSION Our study is the first to examine the quality of care for type 2 diabetes patients in the primary health care setting in Cyprus. Mean age of our diabetic patients was 70 years, 75% being older than 65, and the mean duration of their diabetic condition was 13 years. Almost 90% of them had visited the general practitioner during that 1 year, with a mean number of 8 consultations. More than 80% of patients used diabetic medication. Hypertension and hyperlipidemia were present in 67% and 32%, respectively. Smoking status was unknown in more than 60% of all patients. Overall, diabetes care provided by the 4 PCHCs appeared to be suboptimal with regard to frequency of metabolic and blood pressure measurements (Table 2) as well as targets reached (Table 3). Both urban PCHCs performed better with regard to number of blood pressure measurements, reached targets for DBP, TC, and TG and use of ACE inhibitors. Several limitations of the present study must be acknowledged. This analysis was performed in only 4 PCHCs in the Nicosia area and thus the results cannot be generalized to other PCHCs or in other areas of the island. Furthermore, we identified a lot of missing data regarding several variables. Thus, results must be interpreted with some caution since the control of patients with missing data is unknown. In addition, we could not account for longitudinal trends in clinical management, given the variation in availability of data. Finally, given the retrospective analysis of registered data we could only make use of quantitative data, for example, findings of laboratory results and blood pressure measurements, and we did not gain insight into recommendations directed toward patient education, medication compliance, and lifestyle advice. Diabetes control The age distribution of diabetic patients in our study appears to be comparable with that of other studies. 11,12 Also the mean duration of diabetes seen in this study (13 years) is comparable with values from other studies. 11 Among our patients, almost 90% had been seen at least once by their general practitioner, with an average number of 8 consultations during the study year. Only 19% of them had also visited a diabetologist. These findings, in accordance with results from other studies, 13 show that general practitioners could (and should) play an important role in the management of patients with type 2 diabetes. It was surprising to notice that in our study, HbA 1c was found to be recorded in the medical files of only 31 patients (10.5%). For the other patients, we can only assume that either it was not monitored or it was simply not registered in their medical records. Although the mean HbA 1c (8.9%) for our cohort was similar in comparison to other studies, the overall control of our patients was worse

7 64 QUALITY MANAGEMENT IN HEALTH CARE/VOLUME 15, ISSUE 1, JANUARY MARCH 2006 Cardiovascular risk management The high frequency of cardiovascular comorbidity (hypertension, hyperlipidemia) found in our study was also reported by others. 15 It is reflected by the fact that 60% of our patients had also been seen by a cardiologist during the study period. These findings emphasize the need for tight control of cardiovascular risk factors by general practitioners and other specialists involved in (cardio)vascular medicine. An important finding of our study was the low rate for aspirin prescription (15.9%) in comparison to other studies. 15,17 As suggested by the results of the UK. Prospective Diabetes Study 18 and by the American Diabetes Association, 19 adult individuals with diabetes who have 1 or more risk factors for CVD (smoking, coronary artery disease, hypertension, lipid abnormalities) or who are 30 years or older should receive aspirin for primary prevention. Our data suggest that this guideline was not met by more than 80% of our patients. Tight blood pressure control in hypertensive patients with type 2 diabetes reduces the risk for macrovascular and microvascular complications. 20 In our study, values fitting recommendations for ideal BP control (<130/85 mm Hg) were found in only 22% of the patients. Similar findings were obtained by McFarlane et al, 17 whereas in a French study the specific proportion was 35%. 21 This finding points out the need for further training of general practitioners to increase their adherence to hypertension guidelines. The same is true with regard to lipid control. Only one third of our patients were receiving medication for hyperlipidemia. Approximately 60% of all TC levels were above 200 mg/dl (17.7% > 250 mg/dl), and of all LDL measurements almost 50% were above 130 mg/dl. These findings were comparable to those of studies from other countries. 22,23 A noteworthy finding of our study was the difference in mean TC and TG levels between patients from urban and rural health centers, indicating a poorer control of the patients who visited the 2 rural health centers. Possible explanations might be the different educational background of the rural population in comparison to the urban population and the increased consumption of meat and dairy products in relation to their occupation (farming and animal breeding). Implications This study provided an overview of current medical management of type 2 patients in the primary health care setting in Cyprus. It was evident from the results of our study that, despite the availability of medication for the management of type 2 diabetes and concomitant cardiovascular risk factors, control is not optimal according to international standards. Thus, there is a certain room for improvement. For daily practice, audit, and research purposes, the quality of medical record keeping should be improved to obtain a more comprehensive view of the management of the patients with diabetes and other chronic diseases. Moreover, audit-enhanced monitoring should be implemented in the primary health care setting as part of a quality system. As part of the continuous medical education programs, general practitioners should be trained in the implementation of standardized guidelines and ensuring continuity of care in their everyday practice. In addition to regular review and intensive management of the patients by their general practitioners, it is important to understand that in order to achieve a good diabetic control, patients should adhere to lifelong medication use and lifestyle modification. Therefore, intensification of patient education, to achieve active patient participation, is another valuable component of diabetes care. CONCLUSION The findings of this study in Cyprus are comparable to others in documenting that clinical practice guidelines for chronic diseases such as cardiovascular diseases and diabetes are not followed for a substantial proportion of patients. The implementation of a multifaceted intervention in 2 of the 4 participating PCHCs including the introduction of an electronic patient record system, dissemination of clinical guidelines, and regular feedback should allow substantial progress in this matter.

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