Parallel realities of guidelines and practice.
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Cardiology↗
Biomedical subjects
G Tognoni
Publications and source records attributed to G Tognoni.
Quality of care of children with chronic diseases in Alexandria, Egypt: the models of asthma, type I diabetes, epilepsy, and rheumatic heart disease. Egyptian-Italian Collaborative Group on Pediatric Chronic Diseases.
OBJECTIVES: To evaluate the quality of care delivered to children suffering from index chronic diseases using specific indicators of health care delivery and to study the predictors of suboptimal quality of care (SQC) and its outcome on children. DESIGN: Over a 9-month period, guidelines for optimal care were formulated. A specific questionnaire for every studied chronic disease was prepared in collaboration with the clinicians in charge of the diseased children (66% pediatricians and pediatric specialists and 34% adult specialists). The clinicians were asked to write the details of daily practice, ie, how these children were managed on a routine basis as well as in an emergency situation. A cross-sectional study was conducted over a 4-month period and included 953 children suffering from bronchial asthma (BA), childhood epilepsy (CE), type I diabetes mellitus (IDDM), and rheumatic heart disease (RHD). A systematic random sample of children was selected from children visiting the ambulatory settings of all children's hospitals. Every fourth child was selected on 2 randomly chosen days each week, while all diseased children admitted in the hospital settings of the children's hospitals during the study were included. A general form describing the impact of the diseases on the child was prepared. A network of clinicians was created in all children's hospitals; seminars were held during which the content validity of the questionnaire was tested. Items were evaluated for their internal consistency using the Cronbach alpha. According to the degree of adherence to the recent therapeutic guidelines concerning selected indicators of the quality of care specific to every disease, children were categorized as receiving optimal quality of care or SQC. These indicators were: the use of inhaled bronchodilators in acute asthmatic attacks in mild asthma and the use of the prophylactic drugs (inhaled sodium cromoglycate or inhaled beclomethasone) in moderate to severe chronic BA in between acute asthmatic attacks; compliance with antiepileptic drugs in epileptic children; regular performance of self-monitoring of blood glucose and/or urine testing in diabetic children; and compliance with prophylactic antibiotics in children suffering from RHD. The records of the outpatient clinics for ambulatory and hospitalized cases were reviewed to assess the degree of compliance with the prescribed management before the index visit. Sociodemographic characteristics and health care system-related predictors of SQC were analyzed via stepwise logistic regression analysis. The impact of illness on the child was assessed by 7 items which were: dependence on parents in domestic activities, level of activity compared with peers, mood compared with peers, level of socializing, degree of discomfort attributable to illness, level of physical disadvantage, and urinary incontinence. Factor analysis with Varimax rotation was performed on items related to the impact of illness. Parental satisfaction with care was rated as excellent, very good, fair, or poor. Information on school outcome was obtained by asking the caretakers whether the child was able to attend school regularly despite his sickness. Scholastic achievement was also rated as excellent, very good, good, and acceptable. Parents were asked whether the child had ever repeated a grade because of his sickness. SETTING: Ambulatory and hospital settings of all children's hospitals in Alexandria, Egypt. RESULTS: Only 52% of mild asthmatics were given inhaled bronchodilators during acute attacks and 6.84% of moderate to severe asthmatics were taking prophylactic drugs (inhaled sodium cromoglycate and/or inhaled beclomethasone) between acute attacks. Similarly, only 53 of 134 (39.6%) of diabetic children were regularly performing self-monitoring of blood glucose and/or urine testing. In contrast, in epileptic children, 121 of 173 (69.9%) were judged as being compliant by their managing clinicians and more than two
Adolescent↗
Breast self-examination practice and its impact on breast cancer diagnosis in Alexandria, Egypt.
This study estimated the frequency of breast-self examination practice and its possible relation to the stage of the disease at diagnosis and patient-related delay in diagnosis among newly diagnosed breast cancer patients. Breast self-examination was practiced in 10.4% of cases. It was performed by patients from higher socioeconomic levels and those with a positive family history of breast cancer or benign breast mass. There was significant association between failure to practise breast self-examination and diagnostic delay. We emphasize the need for breast self-examination awareness campaigns as a key measure for ensuring earlier diagnosis and hence better prognoses for breast cancer patients in our community.
Adult↗
The long-term prognostic significance of repeated blood pressure measurements in the elderly: SPAA (Studio sulla Pressione Arteriosa nell'Anziano) 10-year follow-up.
BACKGROUND: In young and middle-aged people, both systolic (SBP) and diastolic (DBP) blood pressure have a continuous, strong, and independent relationship with subsequent cardiovascular morbidity and mortality. These relationships are not well documented in older people and, until now, studies in the elderly do not provide homogeneous results on the importance of DBP compared with SBP as a cardiovascular risk factor. OBJECTIVE: To determine whether SBP and DBP are independent indicators of mortality risk in the elderly. DESIGN: An observational prospective cohort study to analyze the long-term prognostic significance of repeated SBP and DBP measurements in the elderly. PATIENTS AND METHODS: A total of 3858 outpatients 65 years or older (mean age [SD], 72.9 [4.9] years, 43.5% men) were selected randomly by 444 Italian National Health Service general practitioners in 1983. The population was followed up for 10 years. Crude and adjusted incidence rates of total and cardiovascular mortality were analyzed for classes of SBP and DBP based on the values recorded at the 2 initial visits 1 week apart and those measured during the first 12 months of follow-up. RESULTS: During the 10-year follow-up, 74 patients (1.9%) were lost to follow-up and 1561 (41.3%) died, 709 (45.4% of all deaths) from cardiovascular causes. A positive continuous, graded, strong, and independent association was observed with both total (P<.001) and cardiovascular (P<.001) mortality for SBP but not for DBP. The pattern was similar in both sexes, in persons younger and older than 75 years, regardless of preexisting cardiovascular diseases, and whether they had been receiving antihypertensive treatment at baseline. There was no J-shaped mortality curve in the subjects with the lowest SBP and DBP. CONCLUSIONS: These findings suggest that SBP, but not DBP, is a strong, positive, continuous, independent indicator of mortality risk in the elderly and should be stressed much more than DBP in the diagnosis and treatment of hypertension in this age group.
Aged↗
[Ethics committees of clinical research: new functions for a new scenario].
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Clinical Trials as Topic↗
Patterns of practice for acute myocardial infarction in a population from ten countries.
BACKGROUND: There is conclusive evidence from large scale randomized clinical trials (RCTs) that several treatments administered in the acute phase of a myocardial infarction (AMI) reduce mortality. However, only a minority of patients admitted with AMI receives at the appropriate treatments. OBJECTIVES: This study aims at (1) describe the utilization patterns for AMI; (2) determine the appropriateness of prescribing, measured as adherence to the ACC/ AHA guidelines; and (3) determine which factors are associated with the administration of thrombolytic agents. METHODS: The study was a multi-center survey carried out in ten countries (nine European and one Canadian province) over a 3-month period. Data were prospectively collected by clinical pharmacists. All consecutive patients admitted to the participating hospitals during the study period with a diagnosis of suspected AMI were included in the study. Rates of use were calculated as "overall utilization" and "adjusted utilization" (e.g., accounting for eligibility). RESULTS: Data were available on 1976 patients from 56 participating centers. The mean age of the patients was 65 years (range 25 95, SD = 12.6) and 29.7% were women. Adjusted utilization rates were 63.7% for thrombolysis, 88% for aspirin, and 65.9% for beta-adrenergic blocking agents. The most utilized thrombolytic agent was streptokinase (65.9%). The main reasons given by physicians for not administering thrombolysis was the delay from chest pain onset to admission. Patients admitted to teaching hospitals were less likely to receive aspirin than patients admitted to general hospitals (adjusted rate 90.1% vs 86%, P = 0.007), but they were more likely to undergo a primary invasive procedure (11.0% vs 2.5% P = 0.001). Multivariate analysis showed that age greater than 74 years, delay, prior myocardial infarction, and Killip scale were correlated with the non-utilization of thrombolysis. CONCLUSION: Recommended treatments are still under-utilized in patients with AMI. Increased utilization is required, particularly for elderly people. There is a wide variability among hospitals with different affiliations (teaching vs non teaching), demonstrating the different patterns of practice in various settings.
Adrenergic beta-Antagonists↗
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. Patients with type II diabetes mellitus were recruited from 17 diabetes outpatient clinics from one Italian region (Lombardy). A total of 1027 patients were recruited (group A: 283; group C: 494; group B: 250, of whom 124 were randomly assigned to standard treatment + acarbose and 126 to standard treatment alone). Acarbose was administered for 1 year at a median dose of 100 mg 3 times daily. Drug efficacy was evaluated in terms of mean HbAlc, pre- and post-prandial glycaemic values. Additional endpoints were the proportion of patients with HbA1c levels below 8% at the end of the study period and the proportion of subjects who needed a modification in the standard treatment. The safety and tolerability profiles of the drug were also investigated. Data on HbA1c, fasting and post-prandial blood glucose levels were analysed over time using repeated-measures analysis [Generalized Estimating Equation (GEE) models]. RESULTS: The analysis of Group B showed that, after treatment for 1 year, the mean reduction in HbA1c levels in the acarbose group with respect to the control group was 0.30% (95% confidence limits -0.60 +0.02; P = 0.07), while the mean reduction in post-prandial glycaemia was 17 mg-dl(-1) (95% c.l. -33.5 -0.8; P = 0.04). No difference resulted for fasting blood glucose levels. When looking at the baseline HbA1c levels, it emerged that the mean benefit associated with the use of acarbose was 0.14% (95% c.l. -0.6 +0.28; P = 0.5) in patients with HbAlc levels below 8%, 0.28% (95% c.l. -0.6 +0.05; P = 0.09) in those with values between 8% and 9.9% and 0.65% (95% c.l. -1.36 +0.06; P = 0.07) in those with values > or =10%. Only patients treated with diet+/-oral anti-diabetic agents (OAA) benefited from acarbose treatment (mean benefit = 0.37%, 95% c.l. -0.65 -0.08), while no effect was shown for insulin-treated subjects. The proportion of patients with HbA1c below 8% increased from 31% to 44% in the acarbose group and from 40% to 45% in the control group (absolute difference between baseline and end-of-study values = 8.0% in favour of acarbose-treated patients; P = 0.058). Patients treated with acarbose were significantly more likely to undergo a dose reduction in concomitant diabetic treatments compared with the control group; they were also less likely to require an increase in the dose of standard treatment and to start insulin during the study period. One third of the patients could not assume the drug for the whole study period, mainly due to gastrointestinal side-effects. CONCLUSIONS: The design adopted in this study allowed an integrated evaluation of the overall effectiveness of acarbose in clinical practice. The benefits of the drug in an unselected population of non-insulin-dependent diabetes mellitus (NIDDM) patients are significant but of marginal clinical relevance. Only a better definition of the subgroups of patients who are more likely to benefit from long-term treatment, particularly through possible postponement of secondary OAA failure, will allow a reliable definition of the cost-effectiveness of this complementary component of anti-diabetic strategy.
Acarbose↗
Pharmacoepidemiology of psychotropic drugs in patients with severe mental disorders in Italy. Italian Collaborative Study Group on the Outcome of Severe Mental Disorders.
OBJECTIVE: To describe the epidemiology of psychotropic drug use in a sample of Italian outpatient psychiatric services. METHODS: Drug-utilisation survey conducted within the framework of a broader prospective follow-up study with 67 Italian outpatient psychiatric services. RESULTS: The data concern 2322 patients recruited over a 3-year period. Three-quarters of the cohort were prescribed antipsychotic drugs, one-half received benzodiazepines and nearly one-third received antidepressants. The trends in drug use from 1994 to 1997 show that for patients with schizophrenia there has been a decrease in the prescription of typical neuroleptics: the use of haloperidol passed from 56% to 42.4% and that of chlorpromazine dropped from 13.5% to 6.1%; during the same period, an increasing use of the atypical compound risperidone was observed. Among patients suffering from unipolar affective psychosis, the prescriptions of tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) have not changed in time, while the proportion of patients receiving neuroleptic drugs has increased from 41% to 45.2%. In addition, the use of antiepileptic drugs and lithium increased, irrespective of diagnosis. Almost 40% of the patients on psychotropic drugs received three or more drugs. Finally, a positive association was found between the number of prescribed compounds and the daily dose administered. CONCLUSION: These data indicate that in the absence of a rational approach to drug use, a symptomatic approach is generally adopted, by which common sense, experience, information provided by non-independent agencies and other cultural parameters play an important role in the prescription strategy. Pharmacoepidemiology should more often consider the use of drugs as a dependent variable, to be investigated within the context of other clinical, cultural, social and setting-related parameters; this approach would enable a more comprehensive assessment of prescribing practices and strategies in routine clinical care.
Adult↗
Internet for clinical trials: past, present, and future.
The Internet and World Wide Web have recently been introduced into the management of some aspects of large-scale clinical trials such as remote randomization and data entry and the distribution of information on trial progress. Electronic mail and websites have also been used to enhance communication among people involved in a clinical trial. The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico acuto (GISSI) used telecommunications and the Internet in some recent large-scale clinical trials. GISSI constructed a website to keep the medical and cardiology community informed about the progress of its studies. Websites for clinical trials could play an important role in the future, especially in international clinical trials. The website could provide information such as study material and study news and tools such as electronic forums on protocol application for use by investigators around the world. This article describes the GISSI experience and outlines an appropriate structure for a clinical trial website.
Clinical Trials as Topic↗
Rationale and design of the Valsartan Heart Failure Trial: a large multinational trial to assess the effects of valsartan, an angiotensin-receptor blocker, on morbidity and mortality in chronic congestive heart failure.
BACKGROUND: To investigate the role of persistent angiotensin activity despite angiotensin-converting enzyme inhibitor therapy in the progression of heart failure, the Valsartan Heart Failure Trial has been designed to investigate the effect of the angiotensin-receptor blocker, valsartan, on morbidity and mortality. METHODS AND RESULTS: Nearly 5,000 patients with New York Heart Association classes II to IV heart failure, while receiving all standard therapy, are being randomized to treatment with valsartan, 160 mg twice daily, or placebo in a worldwide study. Follow-up will be continued until 906 deaths have been recorded. Additional end points will include the need for hospitalization, other major morbid events, quality--of life measurement, changes in neurohormone levels, and changes in left ventricular size and function. Substudies will explore exercise tolerance, arrhythmias, and magnetic resonance imaging. CONCLUSION: This study should help establish the role of angiotensin-receptor blockade in the treatment of heart failure.
Adolescent↗
[Assessment of early or delayed invasive treatment of patients with unstable angina/non-Q infarction. Study Group AVOID-PTCA].
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Adult↗
Dealing with hypertension in general practice. General implications of an Italian point of view. Several hundred Italian general practitioners who collaborated in the clinical and epidemiological projects.
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Aged↗
Ten-year follow-up of the first megatrial testing thrombolytic therapy in patients with acute myocardial infarction: results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study. The GISSI Investigators.
BACKGROUND: We conducted a 10-year follow-up of the 11 712 patients with acute myocardial infarction randomized in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study, the first large trial assessing thrombolytic therapy. METHODS AND RESULTS: Information on survival at 10 years was obtained for the 93% of all randomized patients through the census offices of their towns of residence. The difference in survival produced by streptokinase and sustained up to 1 year was still significant at 10 years (log-rank test, P=0.02), with the absolute benefit of 19 (95% CI 1 to 37) lives saved per 1000 patients treated. The time dependence of the extent of the benefit was confirmed, as the higher mortality rate reductions found in patients treated earlier were still present at 10 years. In the overall population, most of the benefit was obtained before hospital discharge (RR 0.81, 95% CI 0.72 to 0.90), since no difference in survival between thrombolyzed and control patients discharged alive was found at 10 years (RR 0.98, 95% CI 0.90 to 1.06). However, a slight albeit nonsignificant divergence of the survival curves of patients randomized within the first hour was observed [90 (95% CI 34 to 146) lives saved per 1000 at 10 years versus 72 (95% CI 37 to 107) lives saved at hospital discharge]. CONCLUSIONS: The benefits of a single intravenous infusion of 1.5 million units of streptokinase in prolonging survival of patients with acute myocardial infarction is sustained up to 10 years, with a still-evident trend in favor of the patients admitted earlier.
Age Factors↗
North-South twinning in paediatric haemato-oncology: the La Mascota programme, Nicaragua.
We describe the La Mascota twinning programme between La Mascota paediatric hospital in Managua, Nicaragua, and hospitals in Monza and Milan, Italy, and Bellinzona, Switzerland. The programme was based on the belief that an attempt to reduce the gap in mortality from cancer in childhood between developed and less developed countries should become an integral part of the care and research activity of a haemato-oncological department of a developed country and not simply an exercise in solidarity. This programme for acute lymphoblastic leukaemia shows that intellectual, organisational, and financial resources can be generated by a twinning programme. What is vital for such programmes is a long-term commitment to a comprehensive and holistic strategy that incorporates supply of drugs, training and supervision of health professionals, and the care of the children and of their parents.
Child↗
Hypertension Optimal Treatment (HOT) trial.
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Antihypertensive Agents↗
Administration of thrombolytic therapy to 17,944 patients with acute myocardial infarction: the GISSI-3 database.
BACKGROUND: There is growing interest in assessing therapy for acute myocardial infarction. Because thrombolysis was not a study therapy in the GISSI-3 trial, the decision about thrombolysis was left to the responsible physicians. We evaluated the data on thrombolytic therapy among patients with acute myocardial infarction enrolled in the GISSI-3 trial to study the relation between rate of prescription and the characteristics of patients and participating coronary care units. METHODS: Complete clinical data were available for 17,944 patients randomized between June 1991 and July 1993 from 200 coronary care units in Italy. Demographic and clinical information were obtained for each patient, and each coronary care unit was classified according to patient volume, level of technology, and wide geographic area in which it was located. A multivariate logistic regression was performed with administration of thrombolytic therapy as the dependent variable and previously defined clinical and structural variables as independent variables. RESULTS: The most important factor in administration of thrombolytic therapy was that less than 6 hours elapse from symptom onset to hospital admission (odds ratio [OR] 14.05; 95% confidence interval [CI] 12.3 to 16.0). Next were location of coronary care unit in southern Italy (OR 1.81; 95% CI 1.62 to 2.01), presence of ST elevation at entrance electrocardiogram ECG (OR 1.47; 95% CI 1.35 to 1.61), absence of previous myocardial infarction (OR 1.35; 95% CI 1.22 to 1.49), and presence of catheterization laboratory or cardiac surgery program or both in the same hospital (OR 1.24; 95% CI 1.14 to 1.35). Coronary care units with high or low patient volume did not show different rates of administration of thrombolytic agents. CONCLUSIONS: The GISSI-3 experience confirmed a high rate of prescription of thrombolytic therapy to patients admitted within 6 hours of symptom onset and those with ST-segment elevation on entrance electrocardiogram. It demonstrated that patients admitted to coronary care units with catheterization laboratories or cardiac programs or both have higher chances of receiving thrombolytic treatment than those admitted to hospitals without these capabilities.
Adult↗
Epidemiology of post-infarction risk stratification strategies in a country with a low volume of revascularization procedures. GISSI-Prognosis Investigators.
AIMS: The aims of the GISSI Prognosis Registry were to describe the diagnostic strategies initiated in acute myocardial infarction patients by a representative sample of Italian cardiological centres, and to determine which clinical or hospital characteristics were associated with the initiation of invasive diagnostic or therapeutic procedures. METHODS AND RESULTS: Baseline characteristics, major in-hospital events and the indication and results of invasive and non-invasive procedures were collected on 1489 acute myocardial infarction patients discharged alive from 65 Italian cardiological centres over a period of 3 months. Twenty-five percent of centres had on site catheterization laboratories while the rest did not. Statistical significance was analysed by chi-square tests for categorical variables. A two-sample Student t-test was used to compare continuous variables. The adjusted analysis was performed utilizing multiple logistic regression models. The most performed procedures were standard, non-invasive: 57.8% of the patients underwent an exercise stress test, 70.8% ambulatory ECG monitoring and 95.6% two-dimensional echocardiography. Nuclear or echocardiographic imaging tests were performed in 40% of acute myocardial infarction survivors. Overall, coronary angiography was planned in 549 patients (36.9%). Variables independently associated with the indication for coronary angiography were residual ischaemia, younger age, contraindication to exercise stress testing, level of patients' education, higher volume of non-invasive diagnostic tests, and male sex. Overall, during a 6-month follow-up period, coronary angiography, percutaneous transluminal coronary angioplasty and coronary artery bypass surgery were performed, respectively in 35%, 10% and 8% of the study population. CONCLUSIONS: The setting where cardiologists practise determines the patterns of care in acute myocardial infarction patients more than the characteristics of the patient. The absence of evidence-based guidelines on the more complex and expensive procedures favour empirical attitudes and practices. The confirmation in a prospective cohort of patients, which aims to represent the care of a whole country, suggests that more effort should be given to the implementation of controlled studies rather than periodical reformulation of guidelines not supported by hard data.
Aged↗