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Articles by A. Nicolucci
Total Records ( 8 ) for A. Nicolucci
  A. Nicolucci , A. Maione , M. Franciosi , R. Amoretti , E. Busetto , F. Capani , D. Bruttomesso , P. Di Bartolo , A. Girelli , F. Leonetti , L. Morviducci , P. Ponzi and E. Vitacolonna
  Aims  The aim of this case-control study was to compare quality of life (QoL) and treatment satisfaction in adults with Type 1 diabetes (T1DM) treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).

Methods  Consecutive patients aged between 18 and 55 years, and attending diabetes clinics for a routine visit, completed the Diabetes-Specific Quality-of-Life Scale (DSQOLS), the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the SF-36 Health Survey (SF-36). Case (CSII) and control subjects (MDI) were recruited in a 1 : 2 ratio.

Results  Overall, 1341 individuals were enrolled by 62 diabetes clinics; 481 were cases and 860 control subjects. Cases had a longer diabetes duration and were more likely to have eye and renal complications. Age, school education, occupation and HbA1c were similar. Of control subjects, 90% followed glargine-based MDI regimens and 10% used NPH-based MDI regimens. On multivariate analysis, after adjusting for socioeconomic and clinical characteristics, scores in the following areas of the DSQOLS were higher in cases than control subjects: diet restrictions (β = 5.96; P < 0.0001), daily hassles (β = 3.57; P = 0.01) and fears about hypoglycaemia (β = 3.88; P = 0.006). Treatment with CSII was also associated with a markedly higher DTSQ score (β = 4.13; P < 0.0001) compared with MDI. Results were similar when CSII was compared separately with glargine- or NPH-based MDI regimens.

Conclusions  This large, non-randomized, case-control study suggests quality of life gains deriving from greater lifestyle flexibility, less fear of hypoglycaemia, and higher treatment satisfaction, when CSII is compared with either glargine-based or NPH-based MDI regimens.

  A. Nicolucci , M. C. Rossi , A. Arcangeli , A. Cimino , G. De Bigontina , D. Fava , S. Gentile , C. Giorda , I. Meloncelli , F. Pellegrini , U. Valentini and G. Vespasiani
  Aims  We evaluated the impact of a continuous quality improvement effort implemented by a network of Italian diabetes clinics operating in the national healthcare system.

Methods  This was a controlled before-and-after study involving 95 centres, of which 67 joined the initiative since 2004 (group A) and 18 were first involved in 2007 (group B, control). All centres used electronic medical record systems. Information on quality indicators was extracted for the period 2004-2007. Data were centrally analysed anonymously and results were published annually. Each centre's performance was ranked against the ‘best performers’. We compared quality indicators between the two groups of centres over 4 years.

Results  Over 100 000 Type 2 diabetes mellitus patients were evaluated annually. The proportion of patients with glycated haemoglobin levels < 7% increased by 6% in group A (2007-2004 difference) and by 1.3% in group B. The proportion of patients with low-density lipoprotein-cholesterol < 100 mg/dl improved by over 10% in both groups. The rate of patients with blood pressure values ≤ 130/85 mmHg increased in group A (+6.4%), but not in group B (-1.4%). The use of insulin increased in group A only (+5.2%), while the use of statins increased by over 20% in both groups.

Conclusions  A physician-led quality improvement effort, based on the systematic evaluation of routine data, is effective in improving the performance of a large number of diabetes clinics. The small percentage increase in the number of patients at target, if applied to large numbers of patients, would translate into a significant impact on public health.

  N. Musacchio , A. Lovagnini Scher , A. Giancaterini , L. Pessina , G. Salis , F. Schivalocchi , A. Nicolucci , F. Pellegrini and M. C. E. Rossi
  Aims  Several chronic care models for diabetes have been implemented in Italy, although conclusive data on their effectiveness are lacking. In the Cusano-Milanino diabetes clinic, patients with Type 2 diabetes with a stable disease/therapy (i.e. a steady level of HbA1c without need for therapy changes) are included in the SINERGIA programme: diabetologists, nurses and dietitians empower patients and telemedicine resources are utilized efficiently.

Methods  Clinical outcomes measured in the year before and after the initiation of SINERGIA were compared. A generalized hierarchical linear regression model for repeated measures was used.

Results  Altogether, 1004 patients were included; baseline characteristics were (mean ± sd): age 66.6 ± 6.2 years, 54.1% male, diabetes duration 10.8 ± 7.7 years, BMI 29.5 ± 4.8 kg/m2, HbA1c 6.9 ± 0.9% (52 ± 14 mmol/mol); 72.9% of patients were treated with anti-hypertensive drugs; 32.7% were treated with lipid-lowering drugs. After a median follow-up of 12 months (range 6-24 months), the proportion of patients with HbA1c≤ 7.0% (≤ 53 mmol/mol) increased from 32.7 to 45.8% (P < 0.0001), while those with HbA1c≥ 9% (≥ 75 mmol/mol) decreased from 10.5 to 4.3% (P < 0.0001). Patients with LDL cholesterol < 100 mg/dl (< 2.59 mmol/l) increased from 40 to 47% (P < 0.0001), while those with LDL cholesterol ≥ 130 mg/dl (≥ 3.36 mmol/l) decreased from 26.6 to 19.7%; blood pressure levels were slightly improved. The mean number of face-to-face encounters decreased from (median and range) 2.8 (2.3-3.4) to 2.3 (1.9-2.7) (P < 0.0001) visits per patient/year.

Conclusions  The SINERGIA model is effective in improving metabolic control and major cardiovascular risk factors, while allowing diabetologists to dedicate more time to patients with more acute disease.

  M. Franciosi , G. Lucisano , F. Pellegrini , A. Cantarello , A. Consoli , L. Cucco , R. Ghidelli , G. Sartore , L. Sciangula and A. Nicolucci
  Aims  To estimate the efficacy of a self-monitoring-based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy.

Methods  This was an open-label, randomized, pilot study, primarily led by diabetes nurses. Patients were randomly allocated to either a self-monitoring-based disease management strategy or usual care (ratio 3:1) and followed up for 6 months. Education was centred on how to modify lifestyle according self-monitoring readings. Self-monitoring of blood glucose results were discussed during monthly telephone contact. The primary endpoint was mean change in HbA1c levels, estimated with an ANOVA for repeated measures. All analyses were intention to treat.

Results  Three diabetic clinics recruited 62 patients, of whom five were lost to follow-up. At baseline, both groups had a mean HbA1c value of 7.9% ± 0.6% (63 ± 6 mmol/mol). After 6 months, mean HbA1c reduction was 1.2 ± 0.1% (-13 ± 1 mmol/mol) in the intervention group and 0.7 ± 0.2 (-8 ± 2 mmol/mol) in the control group, with an absolute mean difference between groups of -0.5% (95% CI -0.9 to -0.0%; P = 0.04) (-5 mmol/mol, 95% CI -10 to 0). At study end, 61.9% of patients in the intervention group and 20.0% in the control group reached the target level of HbA1c < 7.0% (< 53 mmol/mol) (P = 0.005). Body weight reduction was significantly greater in the intervention group than in the control group (between-group absolute mean difference: -3.99 kg; 95% CI -7.26 to -0.73; P = 0.02). Therapy changes were more frequent in the control group.

Conclusions  A self-monitoring disease management strategy, primarily led by diabetes nurses and allowing a timely and efficient use of self-monitoring readings, is able to improve metabolic control, primarily through lifestyle modifications leading to weight loss.

  R. I. G. Holt , A. Nicolucci , K. Kovacs Burns , M. Escalante , A. Forbes , N. Hermanns , S. Kalra , M. Massi-Benedetti , A. Mayorov , E. Menendez-Torre , N. Munro , S. E. Skovlund , I. Tarkun , J. Wens and M. Peyrot
 

Aims

The second Diabetes Attitudes, Wishes and Needs (DAWN2) study sought cross-national comparisons of perceptions on healthcare provision for benchmarking and sharing of clinical practices to improve diabetes care.

Methods

In total, 4785 healthcare professionals caring for people with diabetes across 17 countries participated in an online survey designed to assess diabetes healthcare provision, self-management and training.

Results

Between 61.4 and 92.9% of healthcare professionals felt that people with diabetes needed to improve various self-management activities; glucose monitoring (range, 29.3-92.1%) had the biggest country difference, with a between-country variance of 20%. The need for a major improvement in diabetes self-management education was reported by 60% (26.4-81.4%) of healthcare professionals, with a 12% between-country variance. Provision of diabetes services differed among countries, with many healthcare professionals indicating that major improvements were needed across a range of areas, including healthcare organization [30.6% (7.4-67.1%)], resources for diabetes prevention [78.8% (60.4-90.5%)], earlier diagnosis and treatment [67.9% (45.0-85.5%)], communication between team members and people with diabetes [56.1% (22.3-85.4%)], specialist nurse availability [63.8% (27.9-90.7%)] and psychological support [62.7% (40.6-79.6%)]. In some countries, up to one third of healthcare professionals reported not having received any formal diabetes training. Societal discrimination against people with diabetes was reported by 32.8% (11.4-79.6%) of participants.

Conclusions

This survey has highlighted concerns of healthcare professionals relating to diabetes healthcare provision, self-management and training. Identifying between-country differences in several areas will allow benchmarking and sharing of clinical practices.

  A. Nicolucci , K. Kovacs Burns , R. I. G. Holt , M. Comaschi , N. Hermanns , H. Ishii , A. Kokoszka , F. Pouwer , S. E. Skovlund , H. Stuckey , I. Tarkun , M. Vallis , J. Wens and M. Peyrot
 

Aims

The second Diabetes Attitudes, Wishes and Needs (DAWN2) study aimed to assess psychosocial outcomes in people with diabetes across countries for benchmarking.

Methods

Surveys included new and adapted questions from validated questionnaires that assess health-related quality of life, self-management, attitudes/beliefs, social support and priorities for improving diabetes care. Questionnaires were conducted online, by telephone or in person.

Results

Participants were 8596 adults with diabetes across 17 countries. There were significant between-country differences for all benchmarking indicators; no one country's outcomes were consistently better or worse than others. The proportion with likely depression [WHO-5 Well-Being Index (WHO-5) score ≤ 28] was 13.8% (country range 6.5-24.1%). Diabetes-related distress [Problem Areas in Diabetes Scale 5 (PAID-5) score ≥ 40] was reported by 44.6% of participants (17.2-67.6%). Overall quality of life was rated ‘poor’ or ‘very poor’ by 12.2% of participants (7.6-26.1%). Diabetes had a negative impact on all aspects investigated, ranging from 20.5% on relationship with family/friends to 62.2% on physical health. Approximately 40% of participants (18.6-64.9%) reported that their medication interfered with their ability to live a normal life. The availability of person-centred chronic illness care and support for active involvement was rated as low. Following self-care advice for medication and diet was most common, and least common for glucose monitoring and foot examination, with marked country variation. Only 48.8% of respondents had participated in diabetes educational programmes/activities to help manage their diabetes.

Conclusions

Cross-national benchmarking using psychometrically validated indicators can help identify areas for improvement and best practices to drive changes that improve outcomes for people with diabetes.

  K. Kovacs Burns , A. Nicolucci , R. I. G. Holt , I. Willaing , N. Hermanns , S. Kalra , J. Wens , F. Pouwer , S. E. Skovlund and M. Peyrot
 

Aims

The second Diabetes Attitudes, Wishes and Needs (DAWN2) study examined the experiences of family members of people with diabetes for benchmarking and identifying unmet needs or areas for improvement to assist family members and those with diabetes to effectively self-manage.

Methods

In total, 2057 family members of people with diabetes participated in an online, telephone or in-person survey designed to assess the impact of diabetes on family life, family support for people with diabetes and educational and community support.

Results

Supporting a relative with diabetes was perceived as a burden by 35.3% (range across countries 10.6-61.7%) of respondents. Over half of respondents [51.4% (22.5-76.0%)] rated their quality of life as ‘good’ or ‘very good’. However, distress about the person with diabetes was high, with 61.3% (31.5-86.4%) worried about hypoglycaemia. The impact of diabetes on aspects of life was felt by 51.8% (46.9-58.6%). The greatest negative effect was on emotional well-being [44.6% (31.8-63.0%)], although depression was less common [11.6% (4.2-20.0%)]. Many respondents did not know how to help the person with diabetes [37.1% (17.5-53.0%)] and wanted to be more involved in their care [39.4% (15.5-61.7%)]. Participation in diabetes educational programmes was low [23.1% (9.4-43.3%)], although most of those who participated found them helpful [72.1% (42.1-90.3%)].

Conclusions

Diabetes has a negative impact on family members of people with diabetes. DAWN2 provides benchmarking indicators of family members' psychosocial needs that will help identify the support required for, and from, them to improve the lives of people with diabetes and their families.

  C. B. Giorda , A. Nicolucci , F. Pellegrini , C. K. Kristiansen , B. Hunt , W. J. Valentine and G. Vespasiani
 

Aims

The Associazione Medici Diabetologi-annals initiative is a physician-led quality-of-care improvement scheme that has been shown to improve HbA1c concentration, blood pressure, lipid profiles and BMI in enrolled people with Type 2 diabetes. The present analysis investigated the long-term cost-effectiveness of enrolling people with Type 2 diabetes in the Associazione Medici Diabetologi-annals initiative compared with conventional management.

Methods

Long-term projections of clinical outcomes and direct costs (in 2010 Euros) were made using a published and validated model of Type 2 diabetes in people with Type 2 diabetes who were either enrolled in the Associazione Medici Diabetologi-annals initiative or who were receiving conventional management. Treatment effects were based on mean changes from baseline seen at 5 years after enrolment in the scheme. Costs and clinical outcomes were discounted at 3% per annum.

Results

The Associazione Medici Diabetologi-annals initiative was associated with improvements in mean discounted life expectancy and quality-adjusted life expectancy of 0.55 years (95% CI 0.54-0.57) years and 0.48 quality-adjusted life years (95% CI 0.46-0.49), respectively, compared with conventional management. Whilst treatment costs were higher in the Associazione Medici Diabetologi-annals arm, this was offset by savings as a result of the reduced incidence and treatment of diabetes-related complications. The Associazione Medici Diabetologi-annals initiative was found to be cost-saving over patient lifetimes compared with conventional management [€ 37,289 (95% CI 37,205-37,372) vs € 41,075 (95% CI 40,956-41,155)].

Conclusions

Long-term projections indicate that the physician-led Associazione Medici Diabetologi-annals initiative represents a cost-saving method of improving long-term clinical outcomes compared with conventional management of people with Type 2 diabetes in Italy.

 
 
 
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