The BPRS-E as predictor of length of stay in a residential facility.
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Biomedical subjects
Publications and source records attributed to Corrado Barbui.
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OBJECTIVE: International differences are thought to exist in dosages used by clinicians treating mood disorders. This study examined international dosage differences in antidepressant clinical trials, using a database formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine. METHODS: This systematic review included 132 studies. A detailed set of methodological features and results were abstracted from the original publications and entered into an electronic database. Mean and maximum fluoxetine dosages were compared across countries. To evaluate the dosages of comparison medications, a defined daily dosage (DDD) ratio was calculated as the trial mean dosage divided by the DDD for that drug. RESULTS: Both the maximum and mean dosages for fluoxetine and comparison medications were higher in trials conducted in the US (fluoxetine weighted mean dosage 49.18 mg; 95% CI, 41.30 to 57.05), compared with trials conducted in Europe (fluoxetine weighted mean dosage 29.98 mg; 95% CI, 25.28 to 34.68). Since most clinical trials were conducted in Europe or the US, we could not determine whether different dosages tended to be used in other regions. CONCLUSIONS: International differences in prescriber behaviour may influence, and in turn be influenced by, the conduct of clinical trials. It is difficult to reconcile such differences with the principles of evidence-based medicine.
BACKGROUND: The prevalence of major depression (MD) in persons with nonpsychiatric medical conditions is an indicator of clinical need in those groups, an indicator of the feasibility of screening and case-finding efforts, and a source of etiologic hypotheses. This analysis explores the prevalence of MD in the general population in relation to various long-term medical conditions. METHODS: We used a dataset from a large-scale Canadian national health survey, the Canadian Community Health Survey (CCHS). The sample consisted of 115 071 subjects aged 18 years and over, randomly sampled from the Canadian population. The survey interview recorded self-reported diagnoses of various long-term medical conditions and employed a brief predictive interview for MD, the Composite International Diagnostic Interview Short Form for Major Depression. Logistic regression was used to adjust estimates of association for age and sex. RESULTS: The conditions most strongly associated with MD were chronic fatigue syndrome (adjusted odds ratio [AOR] 7.2) and fibromyalgia (AOR 3.4). The conditions least strongly associated were hypertension (AOR 1.2), diabetes, heart disease, and thyroid disease (AOR 1.4 in each case). We found associations with various gastrointestinal, neurologic, and respiratory conditions. CONCLUSIONS: A diverse set of long-term medical conditions are associated with MD, although previous studies might have lacked power to detect some of these associations. The strength of association in prevalence data, however, varies across specific conditions.
In many countries, prescribing guidelines recommend the use of atypical or second-generation antipsychotics (SGAs) in the first-line treatment of individuals with newly diagnosed schizophrenia. This recommendation has increased the utilisation of these agents and, consequently, produced a progressive increase in the proportion of total direct costs in schizophrenia accounted for by drug therapy. In this still-evolving context of care, it becomes relevant to critically investigate the literature base on the relative cost effectiveness of each SGA in comparison with the others, the purpose being to ascertain whether the data reveal any one agent to be truly more cost effective than the others.A systematic search of economic evaluations comparing two or more SGAs yielded 19 studies meeting the inclusion criteria. Of these, 11 were retrospective database or chart review analyses, six were observational prospective or mirror-image studies, and two were randomised clinical trials. Olanzapine and risperidone were compared in 16 studies, two studies compared clozapine, olanzapine and risperidone, and one compared clozapine and risperidone. While experimental studies indicated an absence of differences among the SGAs in terms of total expenditure, database analyses found contrasting evidence. These latter studies, although susceptible to bias and confounding, should theoretically provide an added dimension, in that they are based on observations from 'real world' practice. However, there were too many potential threats to the validity of these analyses to draw a firm conclusion that any one agent is truly more cost effective than the others. In this uncertain situation, clinicians and policy makers should be aware that indirect evidence from independent randomised controlled trials comparing individual SGAs with haloperidol suggested similar cost effectiveness. As healthcare providers in different settings are ultimately the ones who pay for new innovations, it seems appropriate that they commission research into the cost effectiveness of SGAs.
OBJECTIVE: This study investigated the impact of the increasing consumption of selective serotonin reuptake inhibitors (SSRIs) and newer anti-depressants on the following public health indicators: (1) suicide rates, (2) proportion of completed suicides by poisoning with solid or liquid substances, and (3) hospital admissions for depression and proportion of admissions for depression that were first admissions. METHOD: Data collected by IMS Health on antidepressants dispensed in Italy from 1983 to 2000 were obtained from the Italian Ministry of Health, while data on suicide deaths from 1955 to 2000 were obtained from the Italian National Institute of Statistics. RESULTS: In Italy from 1983 to 2000, the use of tricyclic antidepressants remained substantially stable, and the use of SSRIs and newer agents dramatically increased. In contrast, suicide rates for males decreased from 1955 to 1974 and subsequently increased, reaching a peak in 1985 and then declining. In females, suicide rates remained substantially stable until 1978. A subsequent increase occurred up to 1985, followed by a steady decline. Suicide by poisoning using solids or liquids dropped by nearly 50% from 1986 to 2000. Admissions to the hospital for depression showed an erratic pattern; however, no decline was observed. No change was observed in the rate of first admissions for depression. CONCLUSION: Despite a reduction in suicides by poisoning using solids or liquids, the analysis of long-term trends in suicide did not suggest that increases in antidepressant prescribing lie behind recent reductions in population suicides. Furthermore, in Italy, newer antidepressants had no impact on the total number of admissions for depression or on the proportion of all admissions that were first admissions.
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OBJECTIVES: The present study investigated whether the increased number of psychotropic agents available in Italy in the last 20 years increased the proportion of inpatients being treated with individual medication classes and the proportion receiving combined treatments with agents of the same class or of different classes. METHODS: This study was conducted in South-Verona, Italy. From the local Psychiatric Case Register (PCR) all patients consecutively admitted to the inpatient unit during the years 1981/1982, 1991/92 and 2001/02 were extracted. Drug use at discharge was derived from clinical records, while service use data were extracted from the PCR. RESULTS: During the six years surveyed 160 patients were admitted in 1981/82, 139 in 1991/92 and 228 in 2001/02. An increasing proportion of subjects receiving antipsychotic, antidepressant and benzodiazepine treatment at discharge was observed. In addition, we found an increasing proportion of patients receiving two or more psychotropic drugs at discharge, which accounted for almost 80% of cases in 2001/02. The number of psychotropic agents prescribed at hospital discharge was positively correlated with the total consumption of psychotropic drugs. A relevant proportion of patients were also dispensed agents for medical conditions, yielding an average number of 3.2 prescriptions in 2001/02. The Lavik score, a summary index of service use, indicated that subjects admitted in 1981/82 were moderate users of psychiatric services, while those admitted in 1991/92 and in 2001/02 were high users of psychiatric services. CONCLUSION: This study documented emerging trends toward polypharmacotherapy and higher total doses. Additional pharmacoepidemiological research is needed to clarify both the beneficial and, potentially, adverse effects associated with these trends in psychiatric pharmacotherapy.
OBJECTIVE: The present study compared recent trends in benzodiazepine and antidepressant consumption in Italy and projected their global sales in the future. We investigated whether the increasing use of antidepressants is associated with a progressive reduction in benzodiazepine use. METHODS: Data concerning actual quantities of benzodiazepines and antidepressants dispensed in Italy from 1995 to June 2003 were obtained from IMS Health. For each agent, the number of defined daily doses (DDDs) per 1000 inhabitants per day and the annual expenditure in Euros was calculated. RESULTS: During the 9-year period, benzodiazepine consumption remained substantially stable, accounting for 50 DDDs/1000 per day in 2003. In the same period, antidepressant consumption dramatically rose, from 9 DDDs/1000 per day in 1995 to 26 DDDs/1000 per day in 2003, an increase of nearly three times. While the use of tricyclic antidepressants declined by one-third and that of other older agents remained substantially stable, the use of selective serotonin-reuptake inhibitors and newer agents (venlafaxine, mirtazapine, reboxetine) increased by 623%. Global consumption of antidepressants was projected to increase still further, and, in 2007, the total sales of antidepressants were projected to be similar to the total sales of benzodiazepines. The value of benzodiazepine sales increased from 322 million to 565 million Euros, an increase of 43%; similarly, the value of antidepressant sales increased from 186 million to 569 million Euros, an increase of 67%. CONCLUSIONS: In Italy, the consumption of benzodiazepines was not affected by the increased prescribing of selective serotonin-reuptake inhibitors and newer antidepressants.
OBJECTIVE: This study estimated service and non-service costs in a random sample of patients attending a community psychiatric mental health centre in Italy. METHODS: A randomly selected sample of patients identified during 1 week of routine clinical activity was enrolled. Information was collected using the Italian-language checklist Questionario Economico per l'attivita clinica dei Servizi Psichiatrici (QESP). Costs were classified in two categories: service costs (from the provision of services) and non-service costs (loss of productivity and informal care). RESULTS: One hundred and twenty patients were included. Patients suffering from schizophrenia and related disorders (n = 50) had a mean age of 44.5 years (S.D. 12.9), and patients with other diagnoses (n = 70) had a mean age of 44.9 years (S.D. 14.8). More patients in the schizophrenia group were single, living alone, had a low educational level and a higher unemployment rate. In patients suffering from schizophrenia, the monthly service cost per patient was nearly double that for patients with other diagnoses. Non-service costs associated with patients' lack of job opportunities were more than three times higher for patients with schizophrenia. Non-service costs associated with patients' and care-givers' time off work were similar in the two groups. In the multivariate analysis, being unemployed was associated with higher service costs. Younger age, length of illness and diagnosis of schizophrenia were determinants of higher non-service costs. The latter three independent variables were also associated with overall (service and non-service) costs. CONCLUSION: The present study estimated service and non-service costs under routine circumstances to provide information on costs that community psychiatric services, patients and care-givers sustain when dealing with psychiatric problems.
Italian statistics on psychiatric bed availability, voluntary and compulsory admissions were examined from 1979 to 1997. Although the number of psychiatric beds dropped by 62.5%, the absolute number of compulsory admissions has remained substantially stable. The proportion of all admissions that were compulsory decreased from 17.1% to 11%. This study shows that a shift to community care was not associated with an increase in compulsory admissions in Italy.
BACKGROUND: The patterns of antidepressant drug prescribing have rarely been studied in large and geographically defined catchment areas. In the present study, we examined the prevalence and distribution of antidepressant prescribing in Lombardy, a northern Italy region of nine million inhabitants. METHODS: This study used the Regional Administrative Database of Lombardy. This database includes all prescriptions reimbursed by the National Health System in the population living in this region. All antidepressant prescriptions dispensed from the 1st January to the 31st December 2001 were extracted and prevalence data calculated by dividing antidepressant users by the total number of male and female residents in each age group. RESULTS: During the study period, 404,238 individuals were dispensed antidepressants, yielding a prevalence of use of 2.85 (95% confidence interval 2.84, 2.87) per 100 males and 5.92 (95% confidence interval 5.90, 5.94) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old individuals. The majority of individuals received a pharmacological treatment with selective-serotonin reuptake inhibitors only, slightly more than 12% received a treatment with tricyclic antidepressants. General practitioners issued the majority of antidepressant prescriptions. CONCLUSIONS: The very high rates of antidepressant drug prescribing detected in late life suggest the need of characterising these individuals in terms of medical and psychiatric characteristics, needs and quality of life. It also suggests the need for pragmatic clinical trials, carried out in the general practice, with the aim of assessing whether antidepressants are effective in these conditions.
The behavior that accompanies schizophrenia and related disorders interferes with professional and social activities. As a result, schizophrenia is one of the most costly psychiatric illnesses. Direct medical costs associated with schizophrenia were estimated from the Italian National Health Service perspective. This was a multicenter observational 1-year study conducted in 14 Italian community mental health centers (CMHCs). Eligible patients were those with a diagnosis of schizophrenia or schizoaffective or schizophreniform disorder who had been followed by the CMHCs for at least 2 years at study entry. Exactly 643 patients were enrolled in the study. The mean direct cost per year was 6,964 (27,025 for schizophrenia and 6,587 for patients with related psychotic disorders) (1998 exchange rate U.S.$1 = 1.121). The present study provides further estimates of the cost of schizophrenia treatment in Italian mental health services and highlights the variability in the single cost components across clinically defined subgroups of patients.
Despite most studies of antipsychotic efficacy and safety having been conducted in young patients with schizophrenia, antipsychotic agents are often prescribed in elderly subjects with psychotic symptoms. The aim of this study was to document and describe the level of antipsychotic exposure among elderly subjects. We used the Regional Administrative Database of Lombardy, a region of northern Italy with more than 1.6 million elderly inhabitants, to extract all antipsychotic prescriptions dispensed during 2001 to subjects aged 65 years or above. Prevalence data were calculated by dividing antipsychotic users by the total number of male and female residents in each age group. During the 12 months surveyed 35 363 subjects received at least one antipsychotic prescription, yielding a prevalence of use of 2.18 subjects per 100 inhabitants (95% confidence interval 2.16-2.20). Almost two-thirds were prescribed first-generation agents only, and thioridazine, a first-generation agent associated with prolonged QTC interval, and which is restricted in most European countries, was the most prescribed agent. However, risperidone and olanzapine accounted for 30% of antipsychotic use for all subjects. The majority of patients were also prescribed agents for medical disorders. Because the population of Lombardy is approximately one-sixth of the entire Italian population, it can be assumed that there are over 200 000 elderly subjects annually exposed to these agents in Italy. This generates particular concern because elderly patients are vulnerable to the adverse effects of antipsychotics, and recent warnings have indicated that there are cerebrovascular risks associated with risperidone and olanzapine therapy.
The present study investigated whether the outcome of randomized clinical trials studying fluoxetine favored fluoxetine, where this was the experimental agent, and favored comparator antidepressants in trials where fluoxetine was the reference agent. A systematic review of all double-blind, randomized clinical trials comparing fluoxetine with any other antidepressant drug in patients suffering from depression was carried out. Thirty-seven studies meeting the inclusion criteria were analyzed. A metaregression analysis indicated that, after adjusting for possible confounders, studies where fluoxetine was the experimental agent were positively associated with treatment effect, indicating a significant advantage for fluoxetine. The evidence that the outcome of fluoxetine trials varied according to whether this drug was used as a new compound or a reference one suggests the presence of bias.
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OBJECTIVE: To assess patients' opinions on the perceived benefit of treatment delivered during their stay in a residential facility. METHOD: We administered the Opinions on Curative Factors Questionnaire (OCFQ), which was developed from previous studies and assesses several treatment modalities and therapeutic factors, to a sample of 157 severely ill psychiatric patients admitted to a residential facility. RESULTS: All therapeutic factors tested by the OCFQ were considered helpful or very helpful by most of those sampled. The item with the highest score was "talking to doctor," followed by "free pass," "medication," "visitors," "nonhospital setting," "making friends with patients," "structure of daily life," "support from team," and "talking to nurses." The least-valued item was "group activities." CONCLUSION: Psychiatric patients consider several treatment factors to be helpful, especially those based on individual approaches or on a less restrictive therapeutic milieu that allows interactions with the outside world. These results may be a valuable contribution to improving treatment planning in residential facilities.
Schizophrenia is a serious mental illness that imposes a considerable burden not only on those who are ill, but also on their families, neighbours and the wider society. Costs associated with treating people with schizophrenia are those derived from the use of a wide range of services provided by public psychiatric facilities and/or by voluntary and private agencies. In addition, a large part of the economic impact of schizophrenia is related to the difficulties that patients encounter in finding and keeping paid employment. The introduction of second-generation antipsychotics (SGAs), also defined as atypicals, has increased the therapeutic options available for individuals with schizophrenia. Potential benefits of these agents include a more favourable profile in terms of positive and negative symptoms, less adverse effects and better cognitive functioning than first-generation antipsychotics (FGAs). As a consequence, SGAs might favourably affect the capacity, seriously impaired in schizophrenia, of finding and keeping paid employment. To date, only 13 published studies have investigated the effect of SGA agents on employment and work productivity. Clozapine was studied in eight studies, while both olanzapine and risperidone were studied in three. Clozapine emerged as the SGA with at least some effect on work status. However, all but one clozapine study enrolled only a few individuals and did not adopt an experimental design, making it very difficult to judge the validity and generalisability of findings. Taken together, studies found little benefit, in terms of employment and work productivity, for the use of SGAs compared with FGAs. The evidence available suggests that until data demonstrate a robust effect of newer agents on employment, it remains mandatory for mental health professionals to use the most effective drug treatment together with non-pharmacological interventions, such as vocational rehabilitative programmes nested into models of community psychiatric care, which have proven effect on the capacity of finding and keeping paid employment. This will ensure that the economic impact of schizophrenia is most effectively contained.
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