Marco Comaschi

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.

Obesity and changes in urine albumin/creatinine ratio in patients with type 2 diabetes: The DEMAND Study

BACKGROUND AND AIMS Obesity is a potential risk factor for renal disease in non-diabetic subjects. It remains unclear whether this also applies to diabetic patients. We investigated whether obesity predicted changes in albumin excretion rate in individuals with type 2 diabetes. METHODS AND RESULTS Fifty Italian diabetes outpatient clinics enrolled a random sample of 1289 patients. A morning spot urine sample was collected to determine urinary albumin/creatinine ratio (ACR) at baseline and after 1 year from the study initiation. Progression of albumin excretion was defined as a doubling in ACR, while regression was defined as a 50% reduction. Multivariate logistic regression analyses were used to evaluate correlates of these outcomes. Data are expressed as odds ratios (OR) with 95% confidence intervals (CI). The risk of progression increased by 7% (OR=1.07; 95%CI 1.00-1.15) for every 5-cm increase in waist circumference measured at baseline, and by 17% (OR=1.17; 95%CI 1.03-1.33) for every one-unit increase in BMI during follow-up. The likelihood of regression was not independently associated with any of the variables investigated. The effect of obesity on progression of ACR was independent of metabolic control, blood pressure, treatment, and baseline level of albumin excretion. CONCLUSIONS We found a tight link between obesity and changes in albumin excretion in diabetic subjects, suggesting potential benefits of interventions on body weight on end-organ renal damage.

Association of physicians’ accuracy in recording with quality of care in cardiovascular medicine

Background Physicians’ adherence to cardiovascular (CV) guidelines has been found to be poor. In this regard, accuracy in keeping medical records could play an important role. This study was devised to describe which data are present in medical records from a large sample of physicians and to investigate the association and the link between completeness in recording and clinical appropriateness. Methods The data extracted from medical records of 1078 doctors (general practitioners, cardiologists, and diabetologists) were analyzed, with a focus on CV prevention. The percentage of recorded data of several CV clinical variables was calculated. A multivariate analysis was performed to investigate the association between doctors’ and patients’ characteristics and different patterns in recording. Finally, the completeness in recording was calculated with a score and plotted against three indicators of appropriateness. Results The only risk factor that achieved a good standard of registration was blood pressure (89%). Low-density lipoprotein and waist circumference were largely under-recorded, whereas lifestyle data collection was almost negligible. Age, specialization, and use of electronic records increase the accuracy in recording. When one CV risk factor was predominant, the probability of having other risk factors recorded was reduced. A significant increase in the proportion of patients treated according to guidelines was found in doctors who were more accurate in recording. Conclusion A link exists between accuracy in recording with both quality of care and adherence to guidelines. Specific training of all doctors in this field should be considered.

Analysis of midwall shortening reveals high prevalence of left ventricular myocardial dysfunction in patients with diabetes mellitus: the DYDA study

Background: Individuals with diabetes mellitus (DM) have a higher risk to develop heart failure. Clinical guidelines emphasize the importance of early diagnosis of left ventricular dysfunction (LVD) and preventive interventions in these patients. In this study we assessed the prevalence of LVD, systolic or diastolic, in DM patients without known cardiac disease recruited in the ‘left ventricular DYsfunction in DiAbetes (DYDA)’ study. Design and methods: We performed clinical, ECG, laboratory, and echocardiographic exams in 960 patients (61 ± 8 years, 59% hypertensive) recruited in the DYDA study from 37 Italian diabetes referral centres. ECG and echo exams were read in central facilities. Systolic LVD was defined as ejection fraction ≤50% or midwall shortening (MFS) ≤15%. Diastolic LVD was identified when transmitral E/A was out of the range of 0.75–1.5 or deceleration time of mitral E wave ≤140 msec. Results: Echocardiographic data were obtained in 751 patients (78.2%). Isolated systolic LVD was detected in 22.0% of patients, isolated diastolic LVD in 21.5%, and combined systolic and diastolic LVD in 12.7%. All patients with systolic LVD had MFS ≤15%, while only 9% had an ejection fraction ≤50%. Higher LV mass, relative wall thickness, prevalence of concentric geometry, and LV hypertrophy characterized the patients with LVD. Conclusions: LVD is present in more than half of DM patients without clinically detectable cardiac disease and is associated with LV hypertrophy and concentric LV geometry. One-third of patients exhibits systolic LVD detectable at the midwall level.

Global cardiovascular risk management in different Italian regions: An analysis of the evaluation of final feasible effect of control training and ultra sensitisation (EFFECTUS) educational program

BACKGROUND AND AIM The Final Evaluation Feasible Effect of Ultra Control Training and Sensitization (EFFECTUS) is an educational program, aimed at improving global CV risk stratification and management in Italy. The present study evaluates differences on clinical approach to global CV risk among physicians involved in the EFFECTUS program and stratified in three geographical macro-areas (North, Center, South) of our Country. METHODS AND RESULTS Physicians were asked to submit data already available in their medical records, covering the first 10 adult outpatients, consecutively seen in the month of May 2006. Overall, 1.078 physicians (27% females, aged 50 ± 7 years) collected data of 9.904 outpatients (46.5% females, aged 67 ± 9 years), among which 3.219 (32.5%) were residents in Northern, 3.652 (36.9%) in Central and 3.033 (30.6%) in Southern Italy. A significantly higher prevalence of major CV risk factors, including obesity, physical inactivity, hypertension and diabetes, was recorded in Southern than in other areas. Accordingly, Southern physicians more frequently prescribed antihypertensive, glucose and lipid lowering agents than other physicians, who paid significantly more attention to life-style changes in their clinical practice. CONCLUSIONS This analysis of the EFFECTUS study demonstrates a high prevalence of CV risk factors in Italy, particularly in Southern areas, and indicates some important discrepancies in the clinical management of global CV risk among physcians working in different Italian regions.

Predictors of early-stage left ventricular dysfunction in type 2 diabetes: results of DYDA study:

Background: Better knowledge of prevalence and early-stage determinants of subclinical left ventricular dysfunction (LVD) in type 2 diabetes would be useful to design prevention strategies. The objective of the LVD in Diabetes (DYDA) study was to assess these points in patients without established cardiac disease. Method: Baseline clinical, ECG, laboratory and echocardiographic data from 751 patients (61 ± 7 years, 59% hypertensive) recruited by 37 Italian diabetes clinics were analysed. Clinical history, life habits, laboratory data (NT-proBNP, HsCRP, HbA1c, serum glucose, lipids and creatinine, liver enzymes, microalbuminuria, glomerular filtrate) and data on microvascular complications and drug therapy were collected. Results: LVD was present in 59.9% of patients. Age (OR 1.05, 95% CI [1.02–1.07]), HbA1c (OR 1.27, 95% CI [1.09–1.49]), triglycerides (OR 1.003, 95% CI [1.001–1.006]), treatment with metformin (OR 1.62, 95% CI [1.09–2.40]) and doxazosine (OR 2.48, 95% CI [1.10–5.55]) were independent predictors of LVD. Glitazones were associated with reduced risk of diastolic dysfunction (OR 0.44, 95% CI [0.22–0.87]) whereas waist circumference and metformin were adversely associated with systolic dysfunction (OR 1.02, 95% CI [1.01–1.04] and 1.57, 95% CI [1.01–2.43], respectively). Conclusion: In asymptomatic and fairly controlled diabetic patients, age, worse HbA1c, traits of insulin resistance, such as visceral adiposity and triglycerides or treatment with metformin, and use of doxazosin indicate greater risk of LVD. Glitazones, at this stage, seem to be associated with better diastolic performance.

Global Cardiovascular Risk Assessment in Different Clinical Settings Basal Results of the EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra-Sensitisation) Programme

AbstractBackground: Cardiovascular diseases still represent the leading cause of morbidity and mortality, worldwide. Early detection and appropriate management of major cardiovascular risk factors in clinical practice may improve preventive strategies in Western countries, including Italy. Objective: To evaluate the prevalence of major cardiovascular risk factors and their impact on routine clinical practice of Italian general practitioners (GPs), cardiologists and diabetologists. Methods: The study involved physicians who participated in an educational project on cardiovascular risk management, the EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra-Sensitisation) programme. Physicians were asked to report data already available in their clinical records of the first ten consecutive adult outpatients during May 2006. Data collection included patients’ full medical history and therapies, physical examination (anthropometric parameters and blood pressure levels), laboratory results and diagnostic examinations. Data were then centrally analysed for global cardiovascular risk evaluation and cardiovascular risk profile characterization. The present study provides data from the baseline records of the EFFECTUS programme. Results: A total of 1078 physicians (73% males and 27% females, mean age 50 ± 7 years), of which 841 (78%) were GPs, 140 (13%) cardiologists and 97 (9%) diabetologists, included data from 9904 outpatients (5300 males and 4604 females, mean age 67 ± 9 years). In the overall population, 2504 (25%) subjects were obese, 7436 (75%) had hypertension, 5873 (59%) had dyslipidaemia, 3681 (37%) had diabetes mellitus and 2633 (27%) had a history of ischaemic heart disease, while 1102 (11%) and 1247 (13%) had cerebral or peripheral artery disease, respectively. Significant differences were reported in the prevalence of detected cardiovascular risk factors among physicians operating in different clinical settings. Moreover, different clinical habits were recorded. Conclusions: The present analysis illustrates a very high prevalence of cardiovascular risk factors, irrespective of the clinical settings in which patients were followed, in a vast Italian population. The study also describes differences in management of cardiovascular risk factors among physicians operating in different clinical settings.

Use of electronic support for implementing global cardiovascular risk management: Analysis of the results of the EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra Sensitisation) educational programme

AbstractIntroduction: The EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra Sensitisation) study is an educational programme, aimed at implementing global cardiovascular risk management in daily clinical practice in Italy. Objective: To evaluate global cardiovascular risk management among physicians stratified according to the use of conventional (CS) or electronic (ES) support for clinical data collection and registration. Methods: Involved physicians were asked to submit data into a study-designed, case-report form, covering the first ten adult outpatients consecutively seen in May 2006. A case-report form was made available on CS or ES, depending on physicians’ preferences and attitudes. All available data were centrally analysed for global cardiovascular risk assessment and cardiovascular risk profile characterization. Results: Overall, 1078 physicians (27% females, aged 50 ± 7 years) collected data from 9904 outpatients (46.5% females, aged 67 ± 9 years). 299 physicians used CS for 2672 (27.0%) patients, whereas the remaining 779 physicians used ES for 7232 patients (73.0%). A higher prevalence of obesity, diabetes mellitus, ischaemic heart disease (mostly previous myocardial infarction) and stroke, was recorded by physicians using CS compared with those using ES. Blood pressure and fasting glucose levels were significantly higher in the CS group than in the ES group, although a significantly higher number of antihypertensive, glucose and lipid-lowering prescriptions was reported in the former than in the latter group. Physicians using ES paid significantly more attention to collecting data concerning cardiovascular risk factors, which were also more up-to-date compared with those recorded by physicians using CS. Conclusions: This sub-analysis of the EFFECTUS study indicates a higher attention to the collection and management of data on major cardiovascular risk factors in physicians using ES than in those using CS. Our findings may suggest a potential way to improve global cardiovascular risk management in the clinical practices of Italy.

Inappropriately high left ventricular mass in patients with type 2 diabetes mellitus and no overt cardiac disease. The DYDA study.

Background An inappropriately high left ventricular mass (iLVM) may be detected in patients with diabetes mellitus. Several hemodynamic and nonhemodynamic factors stimulating LVM growth may actively operate in these patients. In this study, we assessed prevalence and factors associated with iLVM in patients with diabetes mellitus. Methods We analyzed baseline data from 708 patients (61 ± 7 years, 57% treated for hypertension) with type 2 diabetes mellitus without evidence of cardiac disease enrolled in the left ventricular dysfunction in diabetes study. iLVM was diagnosed by Doppler echocardiography as LVM more than 28% of the expected LVM predicted from height, sex and stroke work. Results iLVM was detected in 166 patients (23%), irrespective of concomitant hypertension. Patients with iLVM were more frequently women, had higher BMI and prevalence of metabolic syndrome, higher serum triglyceride levels and were treated more frequently with metformin and diuretics. In a multivariate model, female sex [odds ratio (OR) 1.502 (95% confidence interval (CI) 1.010–2.231), P = 0.04], higher serum triglyceride levels [OR 1.007 (95% CI 1.003–1.012), P < 0.001] and BMI [OR 1.220 (95% CI 1.116–1.335), P < 0.001] emerged independently related to iLVM. Conclusion iLVM is detectable in about a quarter of patients with type 2 diabetes mellitus without evidence of cardiac disease and is unrelated to blood pressure levels. The association between LVM and some components of metabolic syndrome in these patients may have important practical implications.

Impact of Diabetes Mellitus on the Clinical Management of Global Cardiovascular Risk: Analysis of the Results of the Evaluation of Final Feasible Effect of Control Training and Ultra Sensitization (EFFECTUS) Educational Program

The Evaluation of Final Feasible Effect of Ultra Control Training and Sensitization (EFFECTUS) study is aimed at implementing global cardiovascular (CV) risk management in Italy.