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Despite the fact that several pharmacological and educational interventions have been proven to improve diabetes outcomes in the context of randomized clinical trials, the transferability of these results to clinical practice can encounter obstacles represented by physicians' knowledge and beliefs, structural and organizational constraints, and patients' clinical and socio‐economical characteristics. Outcomes research represents a fundamental tool to investigate the extent to which trials results can be reproduced under routine clinical conditions, to evaluate clinical behavior in areas of uncertainty, and to ascertain which features of diabetes care are more important to improve clinical outcomes and quality of life. This report will discuss some of the results of the QuED (Quality of Care and Outcomes in Type 2 Diabetes) study, to exemplify the yield of an outcomes research approach to a complex, chronic disease. The QuED Study is a nation‐wide initiative aimed at assessing the relationship between the quality of care delivered to subjects with type 2 diabetes and outcomes. The study involved 101 outpatient diabetes clinics and 103 General Practitioners (GPs) in Italy. Overall, 3,437 patients have been enrolled and followed up for 5 years at 6‐month intervals. Quality of life was evaluated through questionnaires filled in by the patients at 6‐month intervals for 3 years. A physicians' survey was also conducted to investigate physician's beliefs regarding metabolic control, blood pressure, and lipid control. Given the multiplicity of the sources of information, the study allowed for matching physicians' beliefs and practices with intermediate and long‐term clinical and humanistic outcomes. Drug Dev. Res. 67:280–286, 2006. © 2006 Wiley‐Liss, Inc.

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.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.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 ≤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).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. Cancer 2005. © 2005 American Cancer Society.

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.