Efficacy of a training programme for the management of diabetes mellitus in the hospital: A randomized study (stage 2 of GOVEPAZ healthcare).

AIMS: To assess the efficacy of a structured educational intervention for health professionals on the appropriateness of inpatient diabetes care and on some clinical outcomes in hospitalised subjects. METHODS: A multicentre (6 regional hospitals) cluster-randomized (2:1) two parallel-group pragmatic intervention trials, as a part of the GOVEPAZ study, was conducted in three clinical settings, that is, Internal Medicine, Surgery and Intensive Care. Intervention consisted of a 2-month structured education of clinical staff to inpatient diabetes care. Twelve wards - 2 for each hospital - and 6 wards - 1 for each hospital - were randomized to usual care and to the intervention arm, respectively. Consecutively hospitalised diabetic subjects (n = 524, age 74 ± 14 years, 57% males, median HbA1C 57 mmol/mol) were included. The clinical appropriateness of inpatient diabetes management was assessed by a previously validated multi-domain performance score (PS). Clinical outcomes included hypoglycemia, glucose control biomarkers, clinical conditions at discharge and inpatient mortality rate. RESULTS: A numerically, but not statistically significant, higher PS (+0.94; 95% C.I.: -0.53 - +2.4) was achieved in the intervention than in the usual care wards. Hypoglycemias (p = 0.32), glucose control (p = 0.89) and survival rates (p = 0.71) were similar in the two experimental arms. Plasma glucose on admission (OR = 1.52 per 1 SD; C.I. 1.07-2.17; p = 0.021) and the number of hypoglycemic events per patient (OR = 1.55 per 1 SD; C.I.:1.11-2.16; p = 0.011) were independently associated with the inpatient mortality rate. CONCLUSIONS: Structured education of the clinical staff failed to improve the inpatient appropriateness of diabetes care or clinical outcomes. In-hospital hypoglycemia was confirmed to be an independent indicator of death risk.

A performance score of the quality of inpatient diabetes care is a marker of clinical outcomes and suggests a cause-effect relationship between hypoglycaemia and the risk of in-hospital mortality.

AIMS: To build a tool to assess the management of inpatients with diabetes mellitus and to investigate its relationship, if any, with clinical outcomes. MATERIALS AND METHODS: A total of 678 patients from different settings, Internal Medicine (IMU, n = 255), General Surgery (GSU, n = 230) and Intensive Care (ICU, n = 193) Units, were enrolled. A work-flow of clinical care of diabetes was created according to guidelines. The workflow was divided into five different domains: (a) initial assessment; (b) glucose monitoring; (c) medical therapy; (d) consultancies; (e) discharge. Each domain was assessed by a performance score (PS), computed as the sum of the scores achieved in a set of indicators of clinical appropriateness, management and patient empowerment. Appropriate glucose goals were included as intermediate phenotypes. Clinical outcomes included: hypoglycaemia, survival rate and clinical conditions at discharge. RESULTS: The total PS and those of initial assessment and glucose monitoring were significantly lower in GSU with respect to IMU and ICU (P < .0001). The glucose monitoring PS was associated with lower risk of hypoglycaemia (OR = 0.55; P < .0001), whereas both the PSs of glucose monitoring and medical therapy resulted associated with higher in-hospital survival only in the IMU ward (OR = 6.67 P = .001 and OR = 2.38 P = .03, respectively). Instrumental variable analysis with the aid of PS of glucose monitoring showed that hypoglycaemia may play a causal role in in-hospital mortality (P = .04). CONCLUSIONS: The quality of in-hospital care of diabetes may affect patient outcomes, including glucose control and the risk of hypoglycaemia, and through the latter it may influence the risk of in-hospital mortality.

Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications.

AIMS: To assess the effectiveness of the intermittent-scanned continuous glucose monitoring (isCGM) system in preventing severe hypoglycemic episodes and in improving glucose parameters and quality of life. METHODS: Four hundred T1D individuals were enrolled in a prospective real-word study with an intermittently scanned continuous glucose monitoring device during the 12-months follow-up. The primary endpoint was the incidence of severe hypoglycemic events. RESULTS: 82% of subjects were naïve to the use of the device (group A) and 18% were already wearing the system (group B). The cumulative incidence of severe hypoglycemia (SH) at 12 months was 12.06 per 100 person-year (95% CI: 8.35-16.85) in group A and 10.14 (95% CI: 4.08-20.90) in group B without inter-group differences. In group A there was a significant decrease in SH at 12 months compared to 3 months period (p = 0.005). Time in glucose range significantly increased in both groups accompanied with a significant decrease in glucose variability. HbA1c showed a progressive significant time-dependent decrease in group A. The use of the device significantly improved the perceived quality of life. CONCLUSION: This study confirmed the effectiveness of the isCGM in reducing hypoglycemic risk without glucose deterioration, with potential benefits on adverse outcomes in T1D individuals. TRIAL REGISTRATION: ClinicalTrials.gov registration no. NCT04060732.

[Effectiveness of the kit Conversation Map in the therapeutic education of diabetic people attending the Diabetes Unit in Carpi, Italy]. / Un efficace strumento per l'autoeducazione terapeutica del paziente diabetico: la Conversation Map. L'esperienza del Centro di Diabetologia di Carpi.

We implemented the "Diabetes conversations", programme of the International Diabetes Federation-Europe, characterised by the use of the Conversation Map, an educational interactive kit addressed to groups of diabetic patients on: Living with diabetes, What is diabetes, Healthy diet and physical activity, Initiating insulin therapy. After at least three month from the end of the 4-session course, clinical data of 63 participants from the first 10 groups--age (mean +/- std dev) 61.7 +/- 10.2 years, 56% women, 18.5% T1DM-improved: fasting glycemia decreased from 152.9 +/- 55.2 to 138.2 +/- 38.9 mg/dl (P < 0.05), HbA1c from 8.2 +/- 1.2 to 7.8 +/- 1.4% (P < 0.01), BMI from 27.6 +/- 15.1 to 25.5 +/- 15.5 kg/m2 (P < 0.02). The patients' satisfaction about the topics and the educational materials was very high.The Conversation Maps are useful because: (a) contribute to improve glycometabolic control; (b) educate patients on the main topics related to diabetes; (c) give to the nurse a key and active role in patients'education; (d) facilitate the connection between knowledge and behaviour; (e) involve the volunteers of the diabetic association as tutors; (f) improve the relationship and the communication between the doctor/nurse and the patient.

Handwriting characteristics in patients with overt autoimmune hypothyroidism: a prospective case-control study.

PURPOSE: Previous studies have demonstrated handwriting changes in patients with overt hyperthyroidism due to Graves' disease. The aim of the present study was to investigate handwriting features in patients affected by overt autoimmune hypothyroidism. METHODS: Thirty subjects - 24 females and 6 males, mean and median age of 50.15 ± 16.8 years and 52.5 years, respectively - with overt hypothyroidism (OH) related to Hashimoto's thyroiditis (Group 1), and 30 age- and sex-matched euthyroid individuals (Group 2) were recruited to write a "standard text". Group 1 patients repeated the text once the euthyroid state was reached on L-T4 substitution therapy. Group 2 subjects wrote the text again 1 to 4 weeks thereafter. The letters underwent a detailed analysis by a handwriting expert, through inspection, a stereoscopic microscope and a magnifying glass. Furthermore, the time that both Groups took to go through with the text was clocked. RESULTS: None of the handwriting variables differed significantly within each Group and between the two Groups. Hypothyroid patients took significantly more time to go through with the text compared to the time taken once they became euthyroid (3.29 ± 1.66 vs 2.63 ± 1.55 minutes, respectively) and the time taken by the control group (p < 0.01). Of note, three Group 1 patients missed to copy some words or even whole sentences on the paper while they were overtly hypothyroid. CONCLUSIONS: The present study demonstrates that handwriting speed is able to disclose the impact of thyroid hormone deficiency on the central nervous system's functions. In particular, the longer time taken to go through with the text and the sentences missed by some hypothyroid patients, are the counterpart of psychomotor slowdown, impaired attention and memory loss peculiar to OH.

[Prevention of diabetes mellitus complications and improvement of early diagnosis at a population level, through the implementation of integrated disease management in the Modena region]. / Prevenzione delle complicanze del diabete mellito e miglioramento della capacità di diagnosi precoce a livello di popolazione attraverso l'implementazione della gestione integrata nella provincia di Modena.

We evaluated the effectiveness of diabetes mellitus disease management, implemented in Modena province since ten years, on the prevention of complications and early diagnoses at a population level. Time trends show that diabetic patients had significantly decreasing values over time of age, diabetes duration, and glycated haemoglobin; and increasing percentage over time of new-onset diabetes and optimal glycaemic control. That indicates an improved ability of early diagnosis and care of diabetes mellitus. It indicates at a population level that the Local Health Unit, as health system, promoted diabetes prevention and its complications.

[Assessment of a nursing protocol for the management of hyperglicaemia in hospitalized patients]. / Valutazione dell'introduzione di un protocollo a gestione infermieristica per il trattamento ed il monitoraggio del paziente con iperglicemia in ospedale.

AIM: To assess the effectiveness of a nurse-led protocol for the management of hypo/ hyperglicaemia in a medical ward. METHODS: Protocols for standard therapy, and parenteral intensive insulin therapy for severe hypo/hyperglycaemia in hospitalised patients were implemented. PERIOD: march-november 2007. RESULTS: 189 patients (19%) were labelled as "hyperglycaemic" at admission in Emergency Department. Median (+/-IQR) age was 77 (70-84) years, 41% were men, with known diabetes 74%, 18% had skin ulcers. Median glycaemia at admission was 144.5 (98-220) mg/dl. Thirty-six percent of patients was euglycaemic (60-126 mg/dl), 3% hypoglycaemic (<60 mg/dl). The glicaemic values ranged from 127-140 mg/dl (9% patients), from 141-280 mg/dl, (40%patients) and > 280 mg/dl (12% patients). The glicaemic values of the 14 patients requiring the intravenous intensive insulin regimen remained in a safe range (80-250 mg/dl) in the first 15 hours from the infusion start. No patient experienced a life-threatening hypoglycaemia nor hypoglycaemic coma. After three days on standard therapy, glicaemic levels were acceptable: 142 (98-185) pre-breakfast, 144(107-200) pre-lunch, 131 (102-190) pre-dinner, 183 (123-230) mg/dl postprandial. CONCLUSION: Data showed the effectiveness and safety of a nurse-led protocol for the care of hyperglicaemia in a medical ward.

Comparing outcomes of carotid endarterectomy with international benchmarks: audit from an Italian vascular surgery department.

BACKGROUND: The aim of this study was to compare the outcomes of carotid endarterectomy (CEA) in the current practice of our department of vascular surgery with international benchmarks. METHODS: In-patient data from 488 CEA performed in both symptomatic 145 (29.7%) and asymptomatic 343 (70.3%) patients with a > or = 60% stenosis at the level of the internal carotid artery. Comprehensive retrospective review of the records for all the CEAs performed during a 2-year period. The main outcome measures were death rate, and fatal and non-fatal stroke rates perioperatively, and at 30 and 180 days. RESULTS: The fatal and non-fatal stroke rates of symptomatic patients were: 0.7% perioperatively, 0.7% at 30 days, and 0.7% at 180 days. The fatal and non-fatal stroke rates of asymptomatic patients were: 0.6% perioperatively, 0.6% at 30 days, and 0.3% at 180 days. The death rates of symptomatic patients were 0% for all time periods. The death rates of asymptomatic patients were: 0% perioperatively, 0% at 30 days, and 0.3% at 180 days. CONCLUSIONS: The present comprehensive audit shows that our surgeons achieve CEA outcomes comparable with international benchmarks.

[Implementing simple tools for clinical practice in primary care: reports from the Project Diabetes registry addressed to primary care groups in Modena]. / Messa a punto di strumenti semplici per il governo clinico nella medicina territoriale: la reportistica per nucleo di cure primarie dal registro del Progetto Diabete di Modena.

We implemented simple tools for Clinical Practice in Primary Care, i.e. reports of Diabetes Project's Registry addressed to Primary Care Groups in Modena in order to promote the clinical practice through a detailed peer-review of program indicators. The efforts of health organisations to involve the general practitioners in clinical practice should be improved by implementing audit-and-feedback tools of simple interpretation for clinical practice.

[GPs' self-perception of their own role compared with hospital, ambulatory, academic, and health organisation physicians]. / Auto-percezione del ruolo professionale in medicina generale nel confronto con il medico specialista.

Aim of the present study was to explore how the 76 general practitioners (GPs) - serving Carpi district (90,000 residents) - value their own role compared with the hospital, ambulatory, academic, and health organisation physicians'. GPs had a positive self-image only in comparison with health organisation doctors (7 vs 7 grades). GPs disappointed with themselves when comparing their role with ambulatory (-1.6 grades), academic (-1.9 grades) and hospital doctors (-2.2 grades). Secondarily, GPs perceived patients' valuing their professional role mostly 'subordinate' to the other physicians', except health organisation colleagues'.

Correlates of age at natural menopause in the cohorts of EPIC-Italy.

A large number of studies have investigated the factors correlated to age at natural menopause in several populations. However, information on genetics and life-style factors influencing the age of onset of menopause in different populations is of current scientific interest. Specifically, for Italian women there are no large population-based data. The EPIC-Italy collaboration is a source of data of this kind; moreover, the geographical distribution of the cohorts (recruited in northern, central and southern Italy) is an added value as regards the scientific interest of these data. A number of biological and life-style-related factors have been analyzed to evaluate their association to the age at natural menopause in 14,454 menopausal women of the EPIC-Italy collaboration. As regards life-style and environmental factors, the main results are: a) women living in different areas of the country have different ages of onset of natural menopause; b) educational level is significantly associated to this age and may explain part of the between-center difference; c) cigarette smoking appears as a major correlate and probably determinant of the age at natural menopause across all the Italian cohorts; d) alcohol consumption does not have any relationship with the age at natural menopause; e) the use of oral contraceptives may influence age at natural menopause. As regards biological factors, short cycles and low parity have been found associated with earlier menopause. Overall, the results concerning menstrual cycles, parity, and cigarette smoking are consistent with the hypothesis that the number of oocytes in the ovary is pre-determined and any acceleration or impairment of the ovarian function leads to reduce the duration of the reproductive life.

EPIC-Italy cohorts and multipurpose national surveys. A comparison of some socio-demographic and life-style characteristics.

BACKGROUND: EPIC-Italy cohort study recruited subjects who voluntarily accepted to participate in the project. From the self-selected bases of the population sample, some bias could derive in the data interpretation when risk estimation for cancer disease related to life-style factors is the principal concern. Knowledge of the bias related to self-selected sampling is important for better directing the interpretation of the EPIC-Italy study results. METHODS: We investigated the characteristics of volunteer subjects recruited in the EPIC-Italy cohorts and compared them with those of the randomly selected subjects recruited in the Multipurpose ISTAT Surveys realized in the same period (1993-1998) in which the EPIC-cohorts were recruited. RESULTS: We found some differences, and in particular a different attitude towards cigarettes smoking and wine consumption, between the EPIC cohort and the Multipurpose ISTAT Surveys, as well as among geographical areas within the EPIC cohort. CONCLUSIONS: The uneven distribution of some characteristics suggests that the self-selected subjects were characterized by an overall lower consumption of wine and cigarette smoking even when the educational level was considered. This could suggest a generally more healthy life-style among subjects recruited on a volountary bases.

Physical activity in the EPIC-Italy centers.

The European Prospective Investigation into Cancer and nutrition offers the opportunity to explore patterns of physical activity in a large series of healthy adults enrolled in the different local cohorts of the Italian section of the European EPIC project. Physical activity is considered one of the means by which chronic disease could be prevented. Subjects in the EPIC study completed a life-style questionnaire, with a section dedicated to the assessment of physical activity at work and during leisure time. Time spent in the various activities was transformed into an index of physical activity (physical activity level, PAL) and an activity index that includes intense activity (PAL; intense activity included). Quintiles of these indexes were computed in order to observe the distribution of subject characteristics according to levels of physical activity. In general, the population was characterized by low levels of physical activity at work, with more than 50% of the sample reporting sedentary occupations. During leisure time, only a small percentage of subjects compensated for the inactivity at work by engaging in energy-consuming activities. In particular, organized fitness activities were reported by a small percentage of people, whereas walking was the most common sort of physical activity. Specific types of activity seemed to characterize subjects in the different areas of the country, reflecting local traditions or specific living situations. Detailed information about physical activity habits, together with a description of other characteristics, could help in designing physical activity promotion programs in different Italian populations and age groups.

The impact of Graves' disease and its treatment on handwriting characteristics.

BACKGROUND: Thyroid hormones are crucial for metabolism in all tissues in humans, including the nervous system and muscles, and could thus affect handwriting, which is the synthesis of complex and fine movements. Hyperthyroidism, characterized by symptoms such as tremor and weakness, could affect handwriting, although this has not been studied yet. The aim of this study was to evaluate handwriting characteristics before and after therapy for hyperthyroid Graves' disease (GD). METHODS: Twenty-two patients (15 women, 7 men) with untreated GD (median age: 44 years; range: 20-70 years) were asked to write a "standard text" before and 12 months after being rendered euthyroid. The letters underwent a standardized detailed analysis by a handwriting expert, through inspection and stereoscopic microscope and magnifying glass. RESULTS: All patients demonstrated handwriting variations, perceptible even to direct observation. Graphological examination showed statistically significant changes after patients become euthyroid, in the following parameters: size of letters (4.5±1.1 vs. 5.9±1.3 mm; p<0.01), distance between letters (62.9±1.1 vs. 55.2±0.8 mm; p<0.01), width of letters (1.75±0.06 vs. 2.2±0 .06 mm; p<0.01), distance between words (216.2±3.2 vs. 198.7±2.4 mm; p<0.01), extension of letters (8.7±0.2 vs. 7.7±0.2 mm; p<0.01), angles (17±0.3 vs. 15.8±0.4 mm; p<0.01), and groove depth (0.2±0.05 vs. 0.4±0.05 mm; p<0.01). CONCLUSIONS: Hyperthyroid GD was associated with significant changes in handwriting in all patients. Following recovery from hyperthyroidism, a state of hypertrophic and contracted handwriting resulted in greater fluency and fluidity. Variations in handwriting should be included as signs/symptoms in GD.

A single-center experience in open and endovascular treatment of hemodynamically unstable and stable patients with ruptured abdominal aortic aneurysms.

OBJECTIVE: To retrospectively compare a single center's immediate and mid-term outcomes of ruptured abdominal aortic aneurysm open and endovascular repair (EVAR) for two patient groups-hemodynamically stable and unstable patients-in the same time period. METHODS: Patients presenting at our center with confirmed rupture of an abdominal aortic aneurysm between December 1999 and April 2006 were considered according to an intention-to-treat model with EVAR. Patients with symptomatic or acute (but not ruptured) AAAs were not included in this study. Thirty-three patients underwent EVAR, and 91 underwent open repair. Seventy-two patients (EVAR, 45%; open, 63%) were classified as hemodynamically unstable at arrival, and 52 were classified as stable (EVAR, 55%; open, 37%). Ninety-seven percent of EVAR procedures commenced under local anesthesia, and 100% of open repairs occurred with general anesthesia. Overall successful graft deployment, 30-day mortality, overall reintervention rate, and complications were the study primary end points. RESULTS: Overall successful graft deployment for EVAR was 91%; for open repair, it was 96%. Overall 30-day mortality for EVAR was 30% (unstable, 53%; stable, 11%), and the rate was 46% for open repair (unstable, 61%; stable, 21%). The EVAR postoperative reintervention rate (within 30 days) was 15% (unstable, 20%; stable, 11%), and for open repair it was 10% (unstable, 9%; stable, 15%). We recorded a 27% severe complication rate for EVAR patients (unstable, 40%; stable, 17%), and for patients treated with open repair, it was 33% (unstable, 35%; stable, 29%). Our overall EVAR eligibility rate was 52%, and our overall EVAR treatment rate was 27%. CONCLUSIONS: Our study's overall results for EVAR remain encouraging when compared with those of conventional repair, but large randomized trials are required to confirm the efficacy of the procedure.