Pharmacokinetic and pharmacodynamic differences between two low dosages of aspirin may affect therapeutic outcomes.

Background: Meta-analyses of the prevention of major vascular events by aspirin suggest therapeutic equivalence of all dosages. However, the optimal dosage still remains problematic, and a recent trial found aspirin 160 mg/day to be more effective than 80 mg/day for secondary prevention of ischaemic stroke.

Objective: To evaluate two low dosages of aspirin in terms of pharmacokinetics and pharmacodynamics (inhibition of platelet thromboxane generation and urinary excretion of thromboxane and prostacyclin metabolites).

The effectiveness, safety and epidemiology of the use of acarbose in the treatment of patients with type II diabetes mellitus. A model of medicine-based evidence.

Objective: To assess the efficacy, safety and extent of perceived indications of acarbose, a new antidiabetic agent, under routine clinical practice conditions in an unselected Northern Italian population of type II diabetic patients.

Methods: The study population was assigned to three different groups according to the physician's clinical judgement: group A (acarbose considered as an elective treatment); group B (acarbose considered to be of uncertain benefit): group C (acarbose deemed not to be appropriate). Group B patients were randomized either to continue their standard treatment or to add acarbose to it.

Long-term survival following neoadjuvant chemotherapy and radical surgery in locally advanced cervical cancer.

The aim of this study was to analyse the long-term survival and the relationships between prognostic factors at presentation, chemoresponsiveness and disease outcome in patients with locally advanced cervical cancer treated by neoadjuvant chemotherapy and radical surgery (RS). Two consecutive studies of neoadjuvant chemotherapy containing cisplatin, bleomycin plus/minus methotrexate followed by radical hysterectomy and systematic aortic and pelvic lymphadenectomy were carried out between January 1986 and September 1990 on 130 patients with > or = 4 cm stage IB2-III cervical cancer. Survival analysis was performed using the Kaplan and Meier test and Cox's multivariate regression analysis.

Risk factors for lower limb complications in diabetic patients. The Italian Study Group for the Implementation of the St. Vincent Declaration.

Diabetic lower extremity complications may be influenced by a number of factors, including those related to the interaction between patients and the health-care system. Our objective is to identify risk factors for the development of lower limb complications, by looking for classical clinical variables and those related to quality of care. A case-control study was carried out between December 1993 and June 1994 by interviewing 348 patients with lower-limb diabetic complications and 1050 controls enrolled from 35 diabetes outpatient clinics and 49 general practitioner's offices in Italy.

Patterns of care an Italian diabetic population. The Italian Study Group for the Implementation of the St Vincent Declaration, Società Italiana di Diabetologia, Associazione Medici Diabetologi.

We set out to describe patterns of care of an Italian diabetic population, with reference to the recommendations of the St Vincent Declaration. We investigated different aspects of care received by 2707 patients, of whom 2196 in the charge of 35 Diabetes Outpatient Clinics (DOCs) and 511 cared for by 49 General Practitioners (GPs). Data were collected by interviewing the patients, their physicians and by reviewing medical records.

A meta-analysis of trials on aldose reductase inhibitors in diabetic peripheral neuropathy. The Italian Study Group. The St. Vincent Declaration.

Peripheral neuropathy is one of the most common and disabling long-term sequelae of diabetes mellitus. Aldose reductase inhibitors (ARIs) have been proposed and are increasingly used in many countries for the prevention and treatment of diabetic neuropathy. The aim of this study was to review existing evidence on the effectiveness of ARIs in the treatment of peripheral diabetic neuropathy, with particular reference to the type and clinical relevance of the end point used and to the consistency of results across studies.

Epidemiology and determinants of blood glucose self-monitoring in clinical practice.

The aim of this study was to describe the epidemiology of self-monitoring of blood glucose and to identify specific characteristics of those subgroups of diabetic patients treated with insulin that are most likely to monitor their blood glucose according to medical recommendations. Data were collected on 1384 insulin-treated patients, enrolled from 35 diabetic outpatient clinics and 49 general practitioners' offices between December 1993 and June 1994. Seventeen Italian regions out of 20 were included in the study.

A comprehensive assessment of the avoidability of long-term complications of diabetes. A case-control study. SID-AMD Italian Study Group for the Implementation of the St. Vincent Declaration.

Objective: To identify and quantify risk factors for the development of long-term diabetic complications (i.e., critical limb ischemia, amputation, chronic renal failure [creatinine > 3 mg/dl], dialysis treatment, proliferative retinopathy, blindness), with particular emphasis on those variables that, being related to quality of care, can be considered avoidable.

Appropriateness and variation of surgical treatment of breast cancer in Italy: when excellence in clinical research does not match with generalized good quality care. Progetto Oncologia Femminile.

To assess appropriateness of surgical care delivered to breast cancer patients in Italy and quantify the use of unnecessary radical procedures, a retrospective charts review of patients treated in 1988-1989 was conducted. A series of 1724 consecutive patients (median age 61 years; range 17-89) treated in 63 hospitals selected from within 8 regions with newly diagnosed operable breast carcinoma was evaluated. Overall, 541 (38%) patients had inappropriate surgery with more than two thirds of it being accounted for by the use of unnecessary mutilating Halsted mastectomy.

A survey in Puglia: the attitudes and opinions of specialists, general physicians and patients on follow-up practice. G.S.Bio.Ca.M.

Background: The follow-up for breast cancer patients is a well established routine practice requiring the organization and coordination of many professional figures and a large expenditure of national health funds. To study the problems in practical clinical management of such a complicated health program in a typical population, a questionnaire survey of the opinions and attitudes of specialists, general practitioners and patients directly involved in clinical follow-up was performed in the Puglia region of Southern Italy.

Materials And Methods: A representative sample of specialists (n = 285), general practitioners (n = 263) and patients (n = 284) involved in the management of follow-up practice for breast cancer in Puglia received different questionnaires to ascertain their behaviour, attitudes, opinions, perception of the disease and the organizational requirements for treatment.

Variation in use of breast surgery and characteristics of hospitals' surgical staff.

Objective: To assess whether and how the characteristics of hospitals' surgical staff can predict utilization of breast conserving surgery. We anticipated that the use of the procedure was more frequent in hospitals with a greater proportion of younger and female surgeons on their staff.

Setting: Sixty-two hospitals with different level of organization for the care of cancer patient from eight Italian regions were included.

Inappropriate Halsted mastectomy and patient volume in Italian hospitals.

To study whether Halsted mastectomy was used only when properly indicated, a prospective survey was undertaken on the process of care of 985 breast cancer patients seen consecutively at 62 general hospitals in Northern and Central Italy. Overall, 79% of Halsted mastectomies were performed inappropriately. The procedure was less likely to be performed on more educated patients and, other factors considered, on those seen at hospitals with larger volume.

Is proper methodology associated with the use of a clinically relevant outcome measure? The case of randomized clinical trials on medical treatment of open-angle glaucoma.

Objective: The aim of this study was to assess critically the published literature concerning medical treatment of primary open-angle glaucoma (POAG), and to see whether trial methodologic quality was related to a clinically relevant outcome measure.

Methods: We identified and reviewed the methodologic quality of 102 published randomized clinical trials (RCTs) on treatment of POAG using an explicit protocol and explored the association between selected aspects of design and conduct and the studies' clinical relevance.

Results: Our analysis revealed serious methodologic problems with the trials reviewed.

[The adjuvant treatment of operable breast carcinoma. The current status and outlook].

Breast cancer represents one of the most frequent neoplasm: every year, in Italy, 25,000 new cases are diagnosed with more than 9,000 deaths. In Italy--and also in other countries--has been shown a broad variability in the use of diagnostic or therapeutic procedures caused by different hospitals' characteristics, patients' conditions and physicians' opinions. Among the different therapeutic options, post-surgical therapy, that extends the disease-free interval and survival, fills an important position in the cure of breast cancer in relation to the overview published on Lancet the 4th and the 11th January 1992.

Breast cancer surgery in 30 Italian general hospitals.

The utilization of limited surgery in patients with breast cancer operated between September 1986 and July 1988 was assessed using information collected within a cohort subsequently enrolled in a randomized clinical trial testing the efficacy of post-surgical follow up. Overall 30% had limited surgery, 61% had other more radical procedures and 9% are still undergoing an unnecessary Halsted mastectomy. Several factors were related to the lower likelihood of getting a conservative procedure: geographic distribution, age, level of education, quadrant and nodal state.

[Geographic variability in the appropriateness of surgical treatment of breast carcinoma].

To assess appropriateness of surgical care delivered to breast cancer patients in Italy and quantify the use of unnecessary radical procedures, a retrospective charts review of patients treated in 1988-1989 was conducted. Information about hospital characteristics was collected directly from administrative departments as a part of a national survey. A series of 1724 consecutive patients (median age 61 years; range 17-89) treated in 63 hospitals selected from within 8 regions, with newly diagnosed operable breast carcinoma was evaluated.

The influence of patient characteristics on the appropriateness of surgical treatment for breast cancer patients. Progetto Oncologia Femminile.

Background: Within the framework of a multi-annual educational intervention sponsored by the Ministry of Health and regional health authorities, patterns of the care delivered to breast cancer patients in Italian general hospitals were monitored in order to identify areas of practice whose quality was in need of improvement.

Design: Information on the diagnostic and therapeutic procedures in 63 general hospitals in eight Italian regions performed in 1724 consecutive breast cancer patients were retrospectively gathered from medical records. Quality of care was assessed by a diagnostic and therapeutic score based on the observed degree of compliance with previously established courses of action.

Randomized clinical trials on medical treatment of glaucoma. Are they appropriate to guide clinical practice?

A systematic quantitative and qualitative overview of published randomized clinical trials was undertaken to assess the yield of medical treatment on the outcome of patients with primary open angle glaucoma. Reports of 102 randomized clinical trials were published between 1975 and 1991, totalling about 5000 patients. Only 16% (16/102) of the trials were, however, properly designed (ie, comparing an active treatment with a placebo-treated or untreated control group) to answer the question of whether any medical treatment can effectively cure patients with primary open angle glaucoma.