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Biomedical subjects

G Tognoni

Publications and source records attributed to G Tognoni.

At least 109 records · Page 6Linked to original sources
PubMed1996

The prognostic value of predischarge quantitative two-dimensional echocardiographic measurements and the effects of early lisinopril treatment on left ventricular structure and function after acute myocardial infarction in the GISSI-3 Trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico.

BACKGROUND: Left ventricular dilatation and a low ejection fraction after acute myocardial infarction are independent indicators of a poor prognosis. ACE inhibitors have been shown to decrease left ventricular dilatation after myocardial infarction. In the GISSI-3 trial, patients were randomly assigned, within 24 h of onset of myocardial infarction symptoms, to 6 weeks of treatment with lisinopril, nitroglycerin, both or neither, in an open, 2 x 2 factorial design. The study showed that early treatment in relatively unselected patients with lisinopril decreases mortality at 6 weeks and severe left ventricular dysfunction. We assessed (1) the prognostic value of pre-discharge 2-D echocardiographic variables, and (2) the effects of lisinopril on the progression of left ventricular dilatation. METHODS AND RESULTS: 2-D echocardiograms were available pre-discharge in 8619 GISSI-3 trial patients discharged alive. In 6405 of these patients, a 2-D echocardiographic study was also available at 6 weeks, and at 6 months. Pre-discharge end-diastolic and end-systolic volumes, and ejection fraction predicted 6-month mortality and non-fatal clinical congestive heart failure (P < 0.01). The increase in left ventricular volumes over time was significantly reduced by 6 weeks' lisinopril treatment in patients with wall motion asynergy pre-discharge of > or = 27%. Patients with wall motion asynergy < 27% showed no dilatation and lisinopril did not affect volumes at 6 months. Patients randomized to lisinopril also had smaller volumes after withdrawal of treatment at 6 weeks. Lisinopril did not affect left ventricular ejection fraction. CONCLUSIONS: 2-D echocardiography independently contributes to pre-discharge risk stratification in terms of 6-month mortality and clinical heart failure after myocardial infarction, and early, short-term treatment with lisinopril in unselected myocardial infarction patients attenuates left ventricular dilatation; an effect evident in patients with larger infarcts. These results probably only partly explain the effect of lisinopril on total mortality concentrated in the first week after infarction.

Aged↗
PubMed1996

A positive relation between high hemoglobin values and the risk of ischemic stroke. Progetto 3A Investigators.

We examined the relationship between the hemoglobin concentration and the risk of ischemic stroke using data from a hospital-based case-control study. A total of 143 patients (age 30-69 years) with a diagnosis of cerebral infarction confirmed by computerized tomography scan and 143 age- and sex-matched controls entered the study. Hemoglobin was higher in the patients with stroke (14.2 +/- 1.6 g/l, mean +/- SD) than in controls (13.7 +/- 1.6 g/l; p < 0.05). Compared with subjects with hemoglobin levels of less than 13 g/l (reference category), the relative risk of ischemic stroke, after allowance for potential risk factors, was 2.0 (95% CI 0.8-4.9) for the 13-13.9 g/l quartile, 2.8 (95% CI 1.2-6.5) for the 14-14.9 g/l quartile, and 3.2 (95% CI 1.4-7.4) for the 14 + g/l quartile (chi 2 for linear trend 7.27, p < 0.01). We conclude that the hemoglobin concentration may be an indicator of risk for ischemic stroke.

Adult↗
PubMed1996

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. RESEARCH DESIGN AND METHODS: We designed a case-control study that enrolled 886 patients with long-term diabetic complications and 1,888 control subjects without complications from 35 diabetic outpatient clinics and 49 general practitioners offices during a 6-month period. Selected socioeconomic, pathophysiologic, self-care, health care, and lifestyle information were collected for all patients. RESULTS: A logistic regression analysis showed that several factors are related to the development of major diabetic complications. Among patient characteristics, male sex (odds ratio [OR] = 1.8, 95% CI 1.4-2.3) and age (OR = 1.7, 95% Cl 1.2-2.4 for patients between 50 and 69 years of age as opposed to those younger than 50 years of age) were associated with an increased risk of complication. Among clinical variables, the type and the duration of diabetes were the most important predictors of diabetic complications. The presence of hypertension was also associated with the development of diabetic complications, particularly when it was poorly controlled by treatment (OR = 3.1, 95% CI 2.3-4.3). Patients who needed help to reach a health care facility and those who did not regularly attend such a facility were at higher risk of developing complications (OR = 1.5, 95% CI 1.2-1.9; OR = 1.7, 95% CI 1.3-2.2, respectively). Educational aspects were also related to the outcome: patients who did not receive any kind of educational intervention had an increased risk of developing complications (OR = 4.1, 95% CI 1.7-9.7), while self-management of insulin therapy had a protective effect (OR = 0.6, 95% CI 0.5-0.8). The summary attributable risk related to avoidable risk factors (i.e., uncontrolled hypertension, poor compliance with visit scheduling, inadequate diabetes education, no self-management of insulin treatment) was 0.39. CONCLUSIONS: Our data suggest that, by removing avoidable risk factors, the number of diabetic complications considered could be reduced by more than one-third. The case-control methodology represents an efficient way of monitoring clinical practice and relating it to important outcomes. It can be of help for policy makers in identifying the more effective strategies and in tailoring specific interventions aimed at improving the quality of the care delivered to diabetic patients.

Adult↗
PubMed1996

Feasibility of randomised clinical trials in rare diseases: the case of polycythemia vera.

Although it has long been recognised as the only reliable instrument for producing scientific evidence on the benefit/risk profile of therapeutic interventions, the technology of randomised clinical trials (RCT) is far from being the backbone of medical knowledge. Randomised clinical trials in polycythemia vera have been carried out when their methodology was being built up and, therefore, was rather unsatisfactory. Now we have aggressive cytoreductive treatments with chemotherapeutic agents loaded with doubts on long-term safety, while phlebotomy and preventive antiplatelet therapy are left to personal preferences because of debatable results of old, low-power clinical trials. A complex profile of uncertainties requires a simple, but articulated strategy of care and research to allow at the same time a reasonable transfer of the best available validated knowledge and a timely investigation of the most relevant questions. Without doubts, multi-country, collaborative RCTs is the key (not isolated or abstract) element of the current scenario. The declared background hypothesis is the willingness of a medical caring community of being, at the same time and with the same patients, a research community. The trial design comes in as the simplest technical way to deal with uncertainty. Data to be collected, criteria, contents, intensity of follow-up, and documentation of the events are exactly the same as those which are planned and adopted in routine care. One of the greatest achievements of the multicenter trials with this orientation has been to produce a "core" of data and practices, on which the main analyses will be made, but which at the same time reflect an optimal level of assistance to the majority of patients. The purpose of this paper is therefore twofold: a) to provide a brief methodological review of the controlled evidence available for the direction of therapeutic practice for PV: b) to outline and discuss the opportunity, general design, and feasibility of research strategies where a comparative large-scale trial between therapeutic alternatives could play a central role.

Cohort Studies↗
PubMed1996

[Psychological characteristics of patients with infarction: results of the GISSI-2. Italian Group for the Study of Survival in Myocardial Infarction (GISSI)].

OBJECTIVE: To provide a thorough psychological examination of patients with documented myocardial infarction (MI) enrolled in a multicenter randomized clinical trial (GISSI-2). The psychosocial variables examined include: state variables (anxiety, health-related fears, depression), psychophysical well-being in the three months preceding the acute event (depressive mood, impaired sense of well-being, perceived stress) and trait variables (Type-A Behavior (TAB), neuroticism, introversion/extroversion, social anxiety and feelings of guilt in interpersonal relationships). POPULATION AND SETTING: A total of 2705 patients (12.5% females) admitted to 166 Italian Coronary Care Units. METHODS: Patients were administered the CBA-H, a standardized questionnaire with dichotomous responses (true/false), for a total of 152-item grouped into 16 scales. For each scale, the frequency of scores above cut-off values was computed and compared to patients' clinical and sociodemographic profile. RESULTS: Over one third of all patients scored above the clinical cut-off for anxiety and health-related fears, and 15% showed a depressive pattern. Forty percent of patients reported depressive mood and a diminished sense of well-being in the past three months preceding MI, and more than half perceived themselves as stressed. About one third of the sample overtly exhibited TAB traits and half reported neuroticism scores in the clinical range. One half of our sample could be identified as extrovert, and 14% as introverted. Feelings of guilt and social anxiety were registered respectively in 40% and 12% of the sample. A worse psychological profile was associated to female gender, older age, lower education, living alone and a worse cardiac asset. CONCLUSION: The study has documented the association between clinical, sociodemographic and psychological variables in a large sample of patients with IMA. While the impact of psychological variables upon patients' clinical outcome is to be evaluated, these data may be helpful in promoting the comprehensive and effective care of IMA patients.

Aged↗
PubMed1996

[Hospital management of the acute cerebrovascular patient. Results of a study carried out in the region of Abruzzo].

Acute cerebrovascular disease is a major cause of morbility, disability and mortality. Despite its enormous importance in term of public health, considerable uncertainty still exists regarding the efficacy and cost-effectiveness of many routine clinical practices currently used in the management of stroke. A multicenter study was conducted on 204 patients (100 males and 104 females; mean age 71.5 years; range 21-94) consecutively admitted in 12 hospitals in Abruzzo (Southern Italy) from September 1, 1990 to December 31, 1990, because of sudden onset of neurological deficit which was presumed to be of a vascular origin. One hundred and ninety-six patients were hospitalized less than 24 hours after stroke onset. Cerebral computerized tomography was performed in 135 patients, but only 43 had the examination within 24 hours of symptoms onset. Other instrumental investigations (carotid doppler, transcranial doppler, echocardiography, etc.) were rarely performed. Ischemic stroke was diagnosed in 69 patients, intraparenchimal hemorrhagic stroke in 33, sub-arachnoid hemorrhage in 10, undefined stroke in 40 and transient ischemic attack in 49. Antioedema were largely used in the first 48 hours after admission, and osmotic diuretics (glycerol and mannitol) were preferred to steroid treatment. Antiplatelet drugs (25.8%), calcium antagonists (20.1%) and barbiturates (19.1%) were also frequently prescribed. In conclusion, our study had shown an absolute lackness of standard criteria for management of patients with acute cerebrovascular disease.

Adult↗
PubMed1995

A trial of goal-oriented hemodynamic therapy in critically ill patients. SvO2 Collaborative Group.

BACKGROUND: Hemodynamic therapy to raise the cardiac index and oxygen delivery to supranormal may improve outcomes in critically ill patients. We studied whether increasing the cardiac index to a supranormal level (cardiac-index group) or increasing mixed venous oxygen saturation to a normal level (oxygen-saturation group) would decrease morbidity and mortality among critically ill patients, as compared with a control group in which the target was a normal cardiac index. METHODS: A total of 10,726 patients in 56 intensive care units were screened, among whom 762 patients belonging to predefined diagnostic categories with acute physiology scores of 11 or higher were randomly assigned to the three groups (252 to the control group, 253 to the cardiac-index group, and 257 to the oxygen-saturation group). RESULTS: The hemodynamic targets were reached by 94.3 percent of the control group, 44.9 percent of the cardiac-index group, and 66.7 percent of the oxygen-saturation group (P < 0.001). Mortality was 48.4, 48.6, and 52.1 percent, respectively (P = 0.638), up to the time of discharge from the intensive care unit and 62.3, 61.7, and 63.8 percent (P = 0.875) at six months. Among patients who survived, the number of dysfunctional organs and the length of the stay in the intensive care unit were similar in the three groups. No differences in mortality among the three groups were found for any diagnostic category. A subgroup analysis of the patients in whom hemodynamic targets were reached revealed similar mortality rates: 44.8, 40.4, and 39.0 percent, respectively (P = 0.478). CONCLUSIONS: Hemodynamic therapy aimed at achieving supranormal values for the cardiac index or normal values for mixed venous oxygen saturation does not reduce morbidity or mortality among critically ill patients.

Adult↗
PubMed1995

Antiarrhythmic drug prescription in patients after myocardial infarction in the last decade. Experience of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI).

BACKGROUND: Recent clinical trials have shown increased, rather than decreased, mortality in patients treated with antiarrhythmic drugs after acute myocardial infarction. OBJECTIVE: To determine whether these findings had an impact on prescription of antiarrhythmic drugs after acute myocardial infarction. METHODS: We retrospectively analyzed the class I and III antiarrhythmic prescription data of 38,072 patients with acute myocardial infarction enrolled in three large randomized clinical trials endorsed by a highly representative sample (about 75%) of Italian coronary care units during the last 10 years. The first study was conducted in 1984 to 1985; the second, in 1988 to 1989; the pilot for the third, in 1991; and the third, in 1991 to 1994. RESULTS: Total class I and III antiarrhythmic prescriptions after acute myocardial infarction was halved during the last decade, from 11.9% at discharge and 14.4% at follow-up in 1984 to 1985 to 5.8% and 5.8%, respectively, in 1991 to 1994. The trend was independent of the different distributions in the three studies of the patients' characteristics associated with antiarrhythmic use (ie, age > or = 70 years, anterior acute myocardial infarction, ventricular fibrillation during hospitalization, and Killip class > or = 2 at randomization). The same decreasing trend was observed for each antiarrhythmic drug. The drug most widely used was amiodarone, accounting for about half of the antiarrhythmic prescriptions, followed by mexiletine hydrochloride and propafenone hydrochloride; flecainide acetate was dropped from the prescription list after the publication of the Cardiac Arrhythmia Suppression Trial results. CONCLUSION: The negative results of the recent clinical trials on class I antiarrhythmic drug use after acute myocardial infarction have been rapidly transferred into routine clinical practice in Italy, since the proportion of patients who received class I and III antiarrhythmic drugs after acute myocardial infarction was halved from the early 1980s to the early 1990s.

Aged↗
PubMed1995

Serum cholesterol and risk of ischemic stroke: results of a case-control study. On behalf of PROGETTO 3A Investigators.

BACKGROUND: While a positive relation between serum cholesterol and the risk of myocardial infarction has been consistently reported, the association between serum cholesterol and the risk of ischemic stroke lacks consistency. To further investigate the strength of cholesterol as a risk factor for myocardial infarction and stroke we conducted a comparative study. METHODS: A case-control study was conducted from 1990 to 1992. A network of 21 hospitals in Abruzzo, southern Italy, was created. First, computerized tomography scans confirmed ischemic stroke patients (230 with median age: 64; range: 31-69 years) and 230 sex- and age-matched controls with acute disorders unrelated to known cardiovascular risk factors. Acute myocardial infarction patients (513) and 513 matched controls were simultaneously recruited for a parallel study comparison. Total serum cholesterol concentration was measured within the first 48 hr following admission and the response to a structured questionnaire was evaluated. RESULTS: The mean (standard deviation) serum cholesterol level was 220.7 mg/dl (50.9) among stroke patients and 201.5 mg/dl (41.6) among controls (P < 0.0001). Compared with the lowest quintile (< 160 mg/dl), the odds ratio of ischemic stroke for patients in the highest quintile (> 240 mg/dl), after simultaneous adjustment for other potentially confounding covariates, was 2.6 (95% confidence interval: 1.4-4.8). A significant linear trend in risk was found (chi 2 1 df = 7.27, P < 0.01). Within each total serum cholesterol quintile, adjusted odds ratios for myocardial infarction were higher than that for ischemic stroke, and a stronger linear trend in risk was found (chi 2 1 df = 21.3, P < 0.0001). CONCLUSIONS: Our data confirm the strong linear relationship between total serum cholesterol and the risk of myocardial infarction and suggest that, at least in our population, cholesterol seems to be an indicator of ischemic stroke risk.

Adult↗
PubMed1995

Attributable risks for nonfatal myocardial infarction in Italy. GISSI-EFRIM investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

BACKGROUND: The proportions of nonfatal acute myocardial infarctions (AMI) in Italy attributable to cigarette smoking, body mass, serum cholesterol level, hypertension, diabetes, and family history of AMI (attributable risks, AR) were estimated using data from a case-control study on 614 incident cases of AMI before age 75 with no history of ischemic heart disease and 792 control subjects admitted to the same hospitals where cases were identified for acute, nonneoplastic, cardio- or cerebrovascular conditions not known or suspected to be related to cigarette smoking. METHODS: The study was conducted between September 1988 and June 1989 within the framework of the GISSI-2 clinical trial. We assumed a multiplicative model and thus the risk attributable to several factors combined is not the sum of those attributable to the single factors. RESULTS: Overall the AR of smoking was 49%, and for cholesterol, body mass, family history of AMI, hypertension, and diabetes the AR were 49, 16, 14, 13, and 6%, respectively. Together these factors explained 85% of AMI cases. Though differences emerged for each single factor, the proportion of AMI explained by the six factors together was approximately the same for both sexes, while these factors accounted for 97% of AMI cases before age 50 (and smoking alone for 70%) and for 80% after age 50. CONCLUSIONS: This study confirms that interventions on well-defined risk factors could, in principle, lead to the avoidance of the great majority of myocardial infarctions in this population (i.e., about 80% before age 75 and about 95% before age 50).

Adult↗
PubMed1995

Mental health care in the primary health care setting: a collaborative study in six countries of Central America.

The results of a naturalistic epidemiological study conducted in 6 Central American countries in collaboration with the WHO/PAHO Regional Office are reported, aimed at describing the patients with mental distress presenting to the primary health care setting, the interventions enacted and the evolution of the patients over the 6 months following recruitment. A total of 812 patients were recruited by the personnel of 11 primary health care centres. A high degree of heterogeneity was observed with respect to the patients' characteristics and the patterns of care provided. The factors potentially contributing to the heterogeneity, identified through multivariate analyses, are discussed in detail against the specific background differences between countries and between areas within each country. Interestingly albeit expectedly, besides the differences in health care provision and availability, social needs appear to influence both interventions and outcomes.

Adolescent↗
PubMed1995

Parental and primary care physicians' views on the management of chronic diseases: a study in Italy. The Italian Collaborative Group on Paediatric Chronic Diseases.

A survey on the burden and quality of care and the parental and primary care physicians' views on management of eight chronic illnesses and disabilities was conducted from 1990 to 1993. Data were collected on 993 children and adolescents from family interviews and physicians' postal questionnaires. Approximately 70% of patients used two or more services for care management and 149 children were treated outside their region. Only 36% of the physicians were case managers and half of these agreed that better communication with other care providers could facilitate their role. A wide difference in parental satisfaction was found between medical and disabling conditions. Approximately 90% of the parents expressed satisfaction with care for children with coeliac disease (112/120), asthma (80/89) and diabetes (98/111), whereas approximately one-third of parents of children with cerebral palsy and Down's syndrome were dissatisfied (88/242 and 72/189, respectively). Primary care physicians expressed similar satisfaction with case management. Distance from hospital, the need for more information on disease management and financial aid were the sources of greatest dissatisfaction. Children with disabling diseases had more problems integrating at school than children with other chronic disorders. Closer interaction between health services, providers and families is necessary to manage the needs of disabled (Italian) children better.

Absenteeism↗
PubMed1995

Acute myocardial infarction treatments in 58 Italian hospitals: a drug utilization survey.

OBJECTIVES: To provide an updated and comprehensive profile of therapeutic practice in the management of acute myocardial infarction (AMI) in a sample of Italian hospitals, and to test the possible role of a network of hospital pharmacists in providing drug utilization data. DESIGN: Prospective drug utilization survey. Participating pharmacists collected information on patients consecutively admitted to the hospital with a suspected AMI. The form reproduced those adopted in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico trials. SETTING: Fifty-eight general hospitals in Italy belonging to the National Health Service, 6 of which are teaching hospitals. Thirty-four hospitals recruited patients from a coronary care unit, 10 from intensive monitoring beds in cardiology wards, and 14 from an intensive care unit. PARTICIPANTS: The study population consisted of patients consecutively admitted with a suspected AMI from May 31 through July 5, 1993. MAIN OUTCOME MEASURES: The management of AMI in terms of the use of drugs and nonpharmacologic treatments is described. RESULTS: Of the 676 patients recruited for the study, 47.8% received thrombolytic therapy; alteplase was the preferred agent (55.4% of treated patients). The use of thrombolytic therapy varied significantly according to different demographic and clinical parameters such as age, sex, delay from the onset of symptoms to admission, and Killip scale class. During the first day of hospitalization 63.9% of patients received aspirin, 83.3% received nitrates, 24.8% received beta-blockers, and 77.1% received heparin therapy. CONCLUSIONS: Thrombolytic therapy was prescribed in a higher percentage of patients than is reported in the US, but lower than that reported in large trials. That a low percentage of patients who experienced a long delay between the onset of symptoms and admission as well as elderly patients received thrombolytic therapy reflects the lower expectations of clinicians for these subgroups of patients. A low proportion of patients received aspirin therapy. This study showed that in Italy an institutional network of hospital pharmacists could be interested observers of therapeutic practice, but further training is needed before high-quality data can be collected.

Adrenergic beta-Antagonists↗