Quality of diabetes care predicts the development of cardiovascular events: results of the AMD-QUASAR study.

OBJECTIVE: The QUASAR (Quality Assessment Score and Cardiovascular Outcomes in Italian Diabetes Patients) study aimed to assess whether a quality-of-care summary score predicted the development of cardiovascular (CV) events in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In 67 diabetes clinics, data on randomly selected patients were extracted from electronic medical records. The score was calculated using process and outcome indicators based on monitoring, targets, and treatment of A1C, blood pressure, LDL cholesterol, and microalbuminuria. The score ranged from 0 to 40. RESULTS: Overall, 5,181 patients were analyzed; 477 (9.2%) patients developed a CV event after a median follow-up of 28 months. The incidence rate (per 1,000 person-years) of CV events was 62.4 in patients with a score of <15, 41.0 in those with a score between 20 and 25 and 36.7 in those with a score of >25. Multilevel analysis, adjusted for clustering and case-mix, showed that the risk to develop a new CV event was 84% higher in patients with a score of <15 (incidence rate ratio [IRR] = 1.84; 95% confidence interval [CI] 1.29-2.62) and 17% higher in those with a score between 15 and 25 (IRR = 1.17; 95% CI 0.93-1.49) compared with those with a score of >25. Mean quality score varied across centers from 16.5 ± 7.5 to 29.1 ± 6.3. When the score was tested as the dependent variable, it emerged that 18% of the variance in the score could be attributed to setting characteristics. CONCLUSIONS: Our study documented a close relationship between quality of diabetes care and long-term outcomes. A simple score can be used to monitor quality of care and compare the performance of different centers/physicians.

Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study.

OBJECTIVE: Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction. RESEARCH DESIGN AND METHODS: Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit. RESULTS: Of 130 patients (aged 35.7 +/- 9.4 years; diabetes duration 16.5 +/- 10.5 years), 11 dropped out. Time for education was 6 h (range 2-15 h) in group A and 12 h (2.5-25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 +/- 0.8 to 7.8 +/- 0.8% and group B from 8.4 +/- 0.7 to 7.9 +/- 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 +/- 4.4 to 30.3 +/- 4.5) than in group B (from 27.5 +/- 4.8 to 28.6 +/- 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS: DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions.

Interactive diary for diabetes: A useful and easy-to-use new telemedicine system to support the decision-making process in type 1 diabetes.

BACKGROUND: Widespread use of carbohydrate (CHO) counting is limited by its complex educational needs, but a telemedicine system could simplify the patients' training. METHODS: The Diabetes Interactive Diary (DID) was set up on patients' mobile phones and allowed to record the blood glucose values and quantify the total CHO intake during a meal, by choosing the specific food and the amount ingested from a list of pictures. It also suggested the most appropriate insulin bolus in relation to the patient's CHO/insulin ratio. Data were sent to the physician by Short Message Service (also known as text message). Two pilot studies were carried out to investigate the feasibility and acceptability of the system and its effectiveness in improving metabolic control. RESULTS: In the first study, 50 patients were involved in a survey with questionnaires administered before and 12 weeks after the start of the DID. The system was considered by almost all the patients as easy to use and very helpful. CHO counting and insulin bolus calculation were ranked as the most useful functions. In the second study, 41 consecutive patients using DID under routine clinical practice conditions were evaluated after a median of 9 months of follow-up. DID was associated with a nonstatistically significant reduction in fasting blood glucose (FBG), postprandial glucose (PPG), and hemoglobin A1c levels. FBG and PPG coefficient of variation (CV) values were significantly reduced: FBG-CV decreased by 6.7% (95% confidence interval -11.9, -1.6; P = 0.02), while PPG-CV decreased by 11.5% (95% confidence interval -19.3, -3.7; P = 0.01). No patients reported serious hypoglycemic episodes requiring medical intervention. CONCLUSIONS: DID can represent a useful, safe, and easy-to-use tool to help the patient with type 1 diabetes promote dietary freedom. Adjustment of insulin doses according to CHO intake allowed the reduction of glucose variability, increasingly recognized as an important, independent risk factor for cardiovascular events.

Baseline quality-of-care data from a quality-improvement program implemented by a network of diabetes outpatient clinics.

OBJECTIVE: To describe patterns of diabetes care and implement benchmarking activities at the national level. RESEARCH DESIGN AND METHODS: A total of 86 clinics participated, all using electronic medical records. Quality indicators were identified, and software was developed, enabling the extraction of the information needed for quality-of-care profiling. RESULTS: Overall, 114,249 patients with type 2 diabetes were seen during 2004. A1C was measured at least once in 88.0% of the patients, lipid profile in 64.6%, blood pressure in 77.2%, and microalbuminuria in 48.1%. Overall, 43.1% of individuals had A1C

Identifying patients with type 2 diabetes at high risk of microalbuminuria: results of the DEMAND (Developing Education on Microalbuminuria for Awareness of reNal and cardiovascular risk in Diabetes) Study.

BACKGROUND: We evaluated to what extent the presence of risk factors and their interactions increased the likelihood of microalbuminuria (MAU) among individuals with type 2 diabetes. METHODS: Fifty-five Italian diabetes outpatient clinics enrolled a sample of patients with type 2 diabetes, without urinary infections and overt diabetic nephropathy. A morning spot urine sample was collected to centrally determine the urinary albumin/creatinine ratio (ACR). A tree-based regression technique (RECPAM) and multivariate analyses were performed to investigate interaction between correlates of MAU. RESULTS: Of the 1841 patients recruited, 228 (12.4%) were excluded due to the presence of urinary infections and 56 (3.5%) for the presence of macroalbuminuria. Overall, the prevalence of MAU (ACR = 30-299 mg/g) was of 19.1%. The RECPAM algorithm led to the identification of seven classes showing a marked difference in the likelihood of MAU. Non-smoker patients with HbA1c <7% and waist circumference 98 cm and HbA1c >8% showed the highest likelihood of MAU (odds ratio = 13.7; 95% confidence intervals 6.8-27.6). In the other classes identified, the risk of MAU ranged between 3 and 5. Age, systolic blood pressure, HDL cholesterol levels and diabetes treatment represented additional, global correlates of MAU. CONCLUSIONS: The likelihood of MAU is strongly related to the interaction between diabetes severity, smoking habits and several components of the metabolic syndrome. In particular, abdominal obesity, elevated blood pressure levels and low HDL cholesterol levels substantially increase the risk of MAU. It is of primary importance to monitor MAU in high-risk individuals and aggressively intervene on modifiable risk factors.

Quality of diabetes care predicts the development of cardiovascular events: results of the QuED study.

BACKGROUND AND AIM: In the context of the QuED Study we assessed whether a quality of care summary score was able to predict the development of cardiovascular (CV) events in patients with type 2 diabetes. METHODS AND RESULTS: The score was calculated using process and intermediate outcome indicators (HbA1c), blood pressure, low-density lipoprotein cholesterol, microalbuminuria) and ranged from 0 to 40. Overall, 3235 patients were enrolled, of whom 492 developed a CV event after a median follow-up of 5 years. The incidence rate (per 1000 person-years) of CV events was 62.4 in patients with a score < or =10, 54.8 in those with a score between 15 and 20, and 39.8 in those with a score >20. In adjusted multilevel regression models, the risk to develop a CV event was 89% greater in patients with a score of < or =10 (rate ratio [RR]=1.89; 95% confidence interval [CI] 1.43-2.50) and 43% higher in those with a score between 10 and 20 (RR=1.43; 95% CI 1.14-1.79), as compared to those with a score >20. A difference between centers of 5 points in the mean quality score was associated with a difference of 16% in CV event risk (RR=0.84; 95% CI 0.72-0.98). CONCLUSION: Our study documented for the first time a close relationship between a score of quality of diabetes care and long-term outcomes.

Identifying patients at risk for microalbuminuria via interaction of the components of the metabolic syndrome: a cross-sectional analytic study.

BACKGROUND AND OBJECTIVES: The objective of this study was to investigate correlates of risk for having microalbuminuria in individuals with one or more cardiovascular risk factors. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The study involved 1919 individuals who attended general practice settings, were aged 55 to 75 yr, and did not have a history of cardiovascular events or diabetes but had one or more cardiovascular risk factors. A tree-based regression technique and multivariate analysis were used to identify distinct, homogeneous subgroups of patients with different likelihood of having microalbuminuria; interaction between correlates of microalbuminuria and risk for microalbuminuria was also investigated. RESULTS: The prevalence of microalbuminuria was 5.9%. Patients who did not have hypertension and had postload glycemia < 140 mg/dl showed the lowest prevalence of microalbuminuria (1.9%) and represented the reference class. The likelihood of microalbuminuria was seven times higher in men with hypertension and homeostatic model assessment levels in the upper tertile and four times higher in women with the same characteristics. Individuals with hypertension and lower homeostatic model assessment levels and normotensive individuals with postload glycemia > or = 140 mg/dl had a more than three-fold increased likelihood of having microalbuminuria. Treatment with statins was associated with a 54% reduction in the likelihood of having microalbuminuria, whereas levels of triglycerides > 150 mg/dl and fibrinogen levels in the upper tertile were associated with a significantly higher risk for microalbuminuria. CONCLUSIONS: The likelihood of having microalbuminuria in a population-based study of elderly individuals is strongly related to the interaction between the components of the metabolic syndrome, particularly hypertension, insulin resistance, and impaired glucose tolerance.

Clinical and psychological predictors of incidence of self-reported erectile dysfunction in patients with type 2 diabetes.

PURPOSE: We evaluated the predictors of the incidence of erectile dysfunction in patients with type 2 diabetes mellitus and identified subgroups of patients in whom the interaction between clinical and psychological characteristics determined an increase in the risk of erectile dysfunction. MATERIALS AND METHODS: The study was based on 670 individuals. The presence of erectile dysfunction and the severity of depressive symptoms were investigated with a questionnaire filled in every 6 months for 3 years. Poisson regression was used to calculate incidence rates. To evaluate interactions among the different variables and identify distinct and homogeneous subgroups in terms of incidence of erectile dysfunction, RECursive Partitioning and AMalgamation method was used. RESULTS: Overall erectile dysfunction developed in 192 men with type 2 diabetes, with an incidence rate of 166.3 per 1,000 person-years. Age, insulin treatment, hemoglobin A1c greater than 8.0%, total cholesterol greater than 3.88 mmol/l and severity of depressive symptoms represented independent predictors of erectile dysfunction. RECursive Partitioning and AMalgamation analysis identified 5 classes with a marked variation in the risk of erectile dysfunction. Patients with low levels of depressive symptoms and hemoglobin A1c 8.0% or less showed the lowest risk of erectile dysfunction. Compared with this subgroup patients with higher levels of depressive symptoms and treated with insulin had a 3-fold risk of erectile dysfunction. Age, smoking, high cholesterol levels and neuropathy were globally predictive variables associated with an increased risk of erectile dysfunction. CONCLUSIONS: The incidence of erectile dysfunction is predicted by modifiable risk factors. Even in diabetes, psychological problems can contribute to the pathogenesis of erectile dysfunction, in addition to organic causes.

Are Type 2 diabetic patients offered adequate foot care? The role of physician and patient characteristics.

In the context of a nationwide outcomes research program on Type 2 diabetes, we investigated physician and patient practices related to foot care. Patients filled in a questionnaire investigating whether they had received information about foot care, how often they had had their feet examined in the last year, and how often they usually checked their feet. Analyses were adjusted for patient case-mix and physician-level clustering. Overall, 3564 patients were recruited by 125 diabetes outpatient clinics (DOCs) and 103 general practitioners (GPs), of whom 6.8% suffered form lower limb complications. The presence of foot complications was correlated with insulin treatment, cigarette smoking, low levels of school education, and the presence of other diabetic complications. More than 50% of the patients reported that they had not had their feet examined by their physician and 28% referred that they had not received foot education. Patients with lower levels of school education and income, as well as overweight individuals, were less likely to receive foot education. Physicians tended to perform foot examination more often in males, low-income patients, those with foot complications, and those treated with insulin, but not in patients with the highest risk of foot complications, that is, those with diabetic neuropathy or peripheral vascular disease (PVD). GPs tended to perform foot examination less frequently than diabetologists do. Foot self-examination was not performed by 33% of the patients. Those individuals who had received foot education or had had their feet examined were more likely to check their feet regularly. A substantial proportion of Type 2 diabetic patients is not offered adequate foot care, even in the presence of major risk factors for lower limb complications. Patient knowledge and practices are strongly related to physicians' attitudes.

Longitudinal assessment of quality of life in patients with type 2 diabetes and self-reported erectile dysfunction.

OBJECTIVE: In the context of the QuED (Quality of Care and Outcomes in Type 2 Diabetes) project, we evaluated the longitudinal changes over 3 years in quality of life (QoL) in patients with type 2 diabetes according to the presence or the development of erectile dysfunction (ED). RESEARCH DESIGN AND METHODS: Patients were requested to fill in a questionnaire investigating the presence of ED and QoL (SF-36 Health Survey, depression symptoms [Center for Epidemiologic Studies-Depression], and quality of sexual life) every 6 months for 3 years. The analyses were based on multilevel models, adjusted for patient clinical and sociodemographic characteristics. RESULTS: The study involved 1,456 patients, of whom 34% reported frequent erectile problems at baseline; 192 developed ED during the follow-up. No changes in QoL measures were detected in patients without ED; in those with ED at baseline, a worsening in all SF-36 scales was observed, reaching statistical significance for physical functioning (P = 0.03). Among patients who developed ED during the study, a deterioration in all SF-36 dimensions and a worsening in depressive symptoms preceded the development of ED. The onset of ED was associated with a further marked worsening in physical functioning (P = 0.0008), general health perception (P = 0.02), and social functioning (P = 0.04) on SF-36 subscales, as well as in the summary physical and mental components scores (P = 0.04 and P = 0.07, respectively). The development of ED was also associated with a highly significant increase in depressive symptoms (P = 0.001) and a marked decrease in quality of sexual life (P < 0.0001). CONCLUSIONS: This longitudinal study documents for the first time the impact of ED onset on several aspects of QoL in patients with type 2 diabetes. The study also shows that QoL tended to further decrease during 3 years in patients with ED at baseline but not in those without this condition.

Twelve-year mortality results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for postmenopausal early-stage breast carcinoma patients (SITAM 01).

BACKGROUND: This study evaluated the impact on overall survival (OS) of 2 versus 5 years adjuvant tamoxifen in early breast carcinoma patients after 12 years of follow-up. METHODS: Women with breast carcinoma T1-3, N0-3, M0, aged 50-70 years, were eligible for this multicenter randomized Phase III trial. Patients event-free after 2 years of tamoxifen therapy (TAM) were randomly assigned to stop or continue TAM (20 mg/day) for an additional 3 years. The primary endpoint was disease-free survival. Secondary endpoints included OS and toxicity. RESULTS: From 1989 through 1996, 1901 patients were randomly assigned either to stop treatment (n = 958) or to continue TAM (n = 943). Overall, 98% of patients alive at the previous report (n = 1611) had updated information about OS, of whom 549 had died. The median duration of postrandomization follow-up was 115 months (interquartile range, 86-137). No statistically significant differences between the two arms were detected in the whole population (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.86-1.22) and in estrogen receptor (ER)-positive patients (HR, 0.90; 95% CI, 0.72-1.13). In the latter group, survival curves started to diverge after 90 months, showing a trend in favor of the 5-year arm. In younger (age < or =55 yrs) ER-positive patients longer TAM was associated with a 44% decrease in the risk of death (HR, 0.56; 95% CI, 0.31-1.00), while no clear benefit was documented in women older than 55 years of age (HR, 0.98; 95% CI, 0.77-1.25). CONCLUSIONS: The benefits of longer TAM on OS start to emerge only after 9 years from diagnosis and seem to be more relevant in younger ER-positive women.

Use of the diabetes risk score for opportunistic screening of undiagnosed diabetes and impaired glucose tolerance: the IGLOO (Impaired Glucose Tolerance and Long-Term Outcomes Observational) study.

OBJECTIVE: To evaluate an opportunistic screening strategy addressed to individuals with one or more cardiovascular risk factor, based on the Diabetes Risk Score (DRS) as the initial instrument, for the identification of individuals with type 2 diabetes or impaired glucose tolerance (IGT). RESEARCH DESIGN AND METHODS: The DRS, a simple self-administered questionnaire, was completed by individuals identified by general practitioners and presenting with one or more cardiovascular risk factor. All patients underwent a 2-h oral glucose tolerance test (OGTT). The optimal DRS cutoff was calculated by applying the receiver-operating characteristic curve. RESULTS: Overall, 1,377 individuals aged between 55 and 75 years received an OGTT and completed the DRS. Mean DRS values showed a marked variation according to glucose metabolism categories, as follows: 8.7 +/- 3.0 in normoglycemic individuals, 9.5 +/- 3.1 in individuals with impaired fasting glucose, 9.9 +/- 3.3 in individuals with IGT, and 12.0 +/- 3.5 in individuals with type 2 diabetes. The receiver-operating characteristic curve showed that, with a cutoff of 9, the sensitivity of DRS in detecting individuals with glucose abnormalities (type 2 diabetes or IGT) was 77% and the specificity 45%. The use of the DRS as an initial screening instrument, followed by the measurement of fasting blood glucose in individuals with a score > or =9 and by the OGTT in individuals with a fasting blood glucose between 5.6 and 6.9 mmol/l, would lead to the identification of 83% of the case subjects with type 2 diabetes and 57% of the case subjects with IGT, at a cost of an OGTT in 38% of the sample and a fasting blood glucose in 64%. CONCLUSIONS: The DRS can represent a valid inexpensive instrument for opportunistic screening and a useful alternative to indiscriminate fasting blood glucose measurement, not readily available in general practice.

Impact of physicians' beliefs and practices on cholesterol levels in patients with type 2 diabetes: a longitudinal assessment.

BACKGROUND: Clinical trials demonstrate significant benefit from cholesterol management for patients with type 2 diabetes. The aim of this work was to explore the correlates of lipid management in patients with type 2 diabetes, including the subjective beliefs of physicians, setting of care, and patient-related factors. METHODS: This longitudinal outcomes research study involved 2359 patients with type 2 diabetes recruited by 111 general practitioners and 214 physicians practicing in diabetes clinics. Physicians' beliefs were assessed through a questionnaire administered when the study started in 1998. Main outcome measures were total cholesterol (TC) and LDL cholesterol (LDL-C) levels over 3 years and the proportion of patients treated with lipid-lowering drugs (LLDs). RESULTS: Less than one-third of the physicians (27%) stated that they routinely started pharmacologic therapy for TC values > or =200 mg/dL (more aggressive), whereas 46% considered a TC level > or =240 mg/dL as the threshold for the initiation of treatment (less aggressive). During 3 years of observation, mean TC and LDL-C levels decreased from 215 +/- 40 mg/dL to 203 +/- 37 mg/dL and from 135 +/- 36 mg/dL to 126 +/- 35 mg/dL respectively, while the proportion of patients treated with LLDs increased from 13.2% to 24.6%; in particular, among individuals cared for by the more aggressive physicians, 30.0% were taking LLDs after 3 years, while only 17.7% of those followed by the less aggressive physicians and 18.1% of those followed by >1 physician were being treated with LLDs. Multilevel analysis showed that physicians' beliefs were an independent predictor of TC levels over the 3-year period. In patients treated with LLDs, TC levels decreased on average by 14%, and LDL-C levels decreased by 20%. CONCLUSION: Our data show that physicians' beliefs in more aggressive management strategies will result in better mean TC values over a 3-year period.

Identifying patients with type 2 diabetes with a higher likelihood of erectile dysfunction: the role of the interaction between clinical and psychological factors.

PURPOSE: We estimated the prevalence of erectile dysfunction in patients with type 2 diabetes and identified subgroups of patients in which the interaction among clinical, psychological and sociodemographic characteristics determined an increased likelihood of erectile dysfunction. MATERIALS AND METHODS: The presence of erectile dysfunction was based on patient self-reporting. Clinical information was collected by participating physicians. The severity of depressive symptoms was investigated using the Center for Epidemiological Studies Depression scale. To evaluate interactions among the variables investigated and identify distinct, homogeneous subgroups of patients with different odds ratios for erectile dysfunction a tree growing technique was used. RESULTS: In the 1,460 patients studied the prevalence of severe and mild-moderate erectile dysfunction was 34% and 24%, respectively. While severe erectile dysfunction was mainly related to the severity of diabetes, mild-moderate dysfunction was independent of clinical variables and only associated with the severity of depressive symptoms. The tree growing technique led to the identification of 6 classes characterized by a marked difference in the prevalence of severe erectile dysfunction of between 19% and 65%. Patients on diet alone showed the lowest prevalence of erectile dysfunction and were considered the reference category, while patients treated with insulin who had neuropathy represented the subgroup with the highest likelihood of erectile dysfunction (OR = 7.2, 95% CI 3.9 to 13.2). In patients treated with oral agents the odds ratio for erectile dysfunction was 2.7 (95% CI 1.8 to 3.9) for those with severe depressive symptoms and 1.9 (95% CI 1.3 to 2.7) for current/former smokers with low depressive symptoms. Patient age, retinopathy and cardiac-cerebrovascular disease were globally predictive variables associated with an increased likelihood of erectile dysfunction. CONCLUSIONS: Our data illustrate the interplay of clinical and psychological factors in determining the risk of erectile dysfunction in type 2 diabetes and can help identify those for whom much greater attention is needed to detect erectile problems.