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Notes: Abstract The rationale and design of a large, multicentre, prospective follow-up study on the outcome of severe mental disorders is presented. The study is currently under way in Italy, where psychiatric care has been uniquely characterised since 1978 by the statutory prohibition of admitting patients to psychiatric hospitals. The main purpose of the study is to describe the 5-year outcome of patients with a diagnosis of schizophrenia, paranoid disorder, affective psychosis, reactive psychosis or personality disorder with respect to five areas (clinical condition, personal autonomy, work, and family and social relationships); a secondary objective is to describe the heterogeneity of practices and resources of psychiatric services. The study is being carried out by 76 outpatient psychiatric services throughout the country, covering approximately onetenth of the Italian population.

Notes: Abstract Objective: To determine whether general practitioners (GP) who are readers of independent drug bulletins can be used as an international epidemiological observatory of the criteria adopted by “well informed” doctors in various countries in the management of mild hypertension. Design: Questionnaire study of GPs' diagnostic criteria for mild hypertension, routine investigation and management of patients with this diagnosis. Participants: 206 GPs readers of independent drug bulletins in 7 countries, comprising 95 known systematic readers of a local bulletin and 111 randomly selected regular subscribers. Main outcome measures: Response rate to the questionaire. Diagnostic criteria, routine investigations, and treatment used for patients with mild hypertension. Results: The study required two months for planning and implementation. Four countries out of eleven had a response rate ≤50% and were excluded; the frequency of responses from other countries was 69%. The average diastolic blood pressure (DBP) considered diagnostic of mild hypertension range from 94 mm Hg (lower threshold) to 106 (upper threshold). A minority (17%) of GPs routinely request the minimum recommended laboratory tests to assess patients. GPs routinely advise non-drug measures before starting a drug. Most would not start drug treatment in patients without other risk factors and a DBP below 100 mmHg. The top first choice drugs were diuretics and β-adrenoceptor blockers. Half of the doctors were able to quote some published guide to the management of mild hypertension, and 18% cited a relevant trial. Attitudes in diagnosing and treating mild hypertension differed widely between GPs and countries. Conclusions: GP readers of drug bulletins can be used quickly and inexpensively to assess the extent to which recommended diagnostic and therapeutic practices are accepted by “well informed” doctors. The results suggest that attitudes in managing mild hypertension vary widely among GPs and countries and differ remarkably from the recommendations of published guidelines.

Notes: Abstract Objective: To determine whether general practitioners (GP) who are readers of independent drug bulletins can be used as an international epidemiological observatory of the criteria adopted by “well informed” doctors in various countries in the management of mild hypertension. Design: Questionnaire study of GPs’ diagnostic criteria for mild hypertension, routine investigation and management of patients with this diagnosis. Participants: 206 GPs readers of independent drug bulletins in 7 countries, comprising 95 known systematic readers of a local bulletin and 111 randomly selected regular subscribers. Main outcome measures: Response rate to the questionaire. Diagnostic criteria, routine investigations, and treatment used for patients with mild hypertension. Results: The study required two months for planning and implementation. Four countries out of eleven had a response rate ≤ 50% and were excluded; the frequency of responses from other countries was 69%. The average diastolic blood pressure (DBP) considered diagnostic of mild hypertension range from 94 mm Hg (lower threshold) to 106 (upper threshold). A minority (17%) of GPs routinely request the minimum recommended laboratory tests to assess patients. GPs routinely advise non-drug measures before starting a drug. Most would not start drug treatment in patients without other risk factors and a DBP below 100 mmHg. The top first choice drugs were diuretics and β-adrenoceptor blockers. Half of the doctors were able to quote some published guide to the management of mild hypertension, and 18% cited a relevant trial. Attitudes in diagnosing and treating mild hypertension differed widely between GPs and countries. Conclusions: GP readers of drug bulletins can be used quickly and inexpensively to assess the extent to which recommended diagnostic and therapeutic practices are accepted by “well informed” doctors. The results suggest that attitudes in managing mild hypertension vary widely among GPs and countries and differ remarkably from the recommendations of published guidelines.

Notes: Abstract 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 β-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 underutilized 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.

Notes: Abstract 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 HbA1c, 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 HbA1c 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 ≥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.

Notes: Abstract The aim of this study was to evaluate the selection criteria and characteristics of the patients who have access to rehabilitation facilities after having experienced an acute stroke. Between January 1993 and February 1994, 383 patients were recruited in 13 hospitals in Lombardy, and telephonically followed up four months after study entry. The data were collected by members of the Associazione Volontari Ospedalieri (Hospital Volunteers' Association). The 4-month mortality rate was 23%. The primary selection criterion for gaining access to rehabilitation facilities was the degree of disability; the secondary factor was age. Rehabilitation facilities were not available to very severely afflicted or self-sufficient patients, but were preferentially made available to young, partially-dependent patients. A rehabilitative intervention within the first month was made available to fewer than 50% of the patients for whom it was indicated. The absence of care for elderly patients and the delay in its availability for those who actually receive it underline the need for new organisational methods. The data presented here also show that voluntary associations can work as observers of the health service. A more complete study is required in order to understand the real dimensions of the problem and the clinical and social characteristics of the population involved.

Notes: Abstract The history of pharmacological research and drug prescription for dementia is briefly overviewed. The Authors stress the intrinsic ambiguity of the area of dementia and the lack of any strong correlation between clinical manifestations and etiopathogenetic mechanisms. Moreover, they criticize the methodological flaws of most clinical trials, especially concerning sample size and duration of follow-up. They put forward some recommendations for future trials, favouring a more pragmatic approach, a larger number of subjects involved and a longer duration of follow-up. Finally they make out a case for establishing a multicenter observatory of the Commissions for human experimentation.