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Biomedical subjects

L Candelise

Publications and source records attributed to L Candelise.

At least 19 recordsLinked to original sources
PubMed2006

Stroke units in Italy.

It is well known that stroke is associated with high morbidity and mortality. Previous studies and metaanalysis provide evidence favouring care of stroke patients in Stroke Units (SU). We published data on SU coverage for seven Italian regions during 2000-2001. The aim of this study is to conduct a new recent survey of SUs in the entire national territory and to evaluate changes in number of SUs and in organisation of in-hospital care in the seven Italian regions evaluated in our previous survey. Hospital services were identified through the diagnosis-related groups (DRG 14) from national hospital discharge registers. We selected services recording at least 50 acute stroke discharges per year. The characteristics of hospital services were obtained from a structured questionnaire submitted by phone by trained researchers to the doctors in charge of services. A SU was defined as a ward that admits acute stroke patients cared for in dedicated beds and by dedicated staff. Out of 676 hospital services evaluated during 2003-2004, 68 were SUs. The national coverage for SU services was 10%, ranging from 0% to 50% in different regions. In 2003-2004 SUs admitted 10% of the total national acute stroke cases. SUs have a more facilitated access to diagnostic evaluations and also seem to be better organised than general wards. Between 2000 and 2004 the number of SUs increased from 7% to 11% in the seven regions evaluated in our first survey. Notwithstanding we found an increase of 30% in the number of SUs, at least in the regions previously evaluated, there is still a shortage of SU beds and high regional heterogeneity.

Hospital Units↗
PubMed2006

Stroke Unit care in Italy. Results from PROSIT (Project on Stroke Services in Italy). A nationwide study.

The future challenge for improving stroke patients' outcome will be to implement new Stroke Units (SUs) worldwide. However the best SU model remains uncertain. The aim of this study was to evaluate the number of SUs and the quality characteristics of acute stroke care in Italy. We conducted a SU survey in Italy, interviewing the directors of the hospital wards that discharged at least 50 acute stroke patients a year. A SU was defined as an acute ward area with stroke-dedicated beds and staff. To compare the quality of care provided in SUs with that in general wards (GWs) we investigated the characteristics of five domains: hospital setting, unit setting, staffing, process of care and diagnostic investigations. We identified 68 SUs and 677 GWs. Multivariate logistic regression analyses demonstrated that SUs compared to GWs had higher quality scores in unit setting (ROC area=0.9721), staffing (ROC area=0.8760) and care organisation (ROC area=0.7984). The hospital setting (ROC area=0.7033) and the availability of rapid diagnostic investigations (ROC area=0.7164) had lower power in discriminating SU from GW. In Italy in 2003/04 only 9% of the hospital services had organised SU care. The study demonstrated that SUs admitted more than 100 patients per year, had more monitoring equipment and staffing time, and practised multidisciplinary meetings and early mobilisation. The utility of these structural and performance characteristics needs validation from outcome studies.

Female↗
PubMed2005

Antidepressant drugs for narcolepsy.

BACKGROUND: Narcolepsy is a disorder of the central nervous system, the main symptoms of which are excessive daytime sleepiness (EDS) and cataplexy (an abrupt and reversible decrease in or loss of muscle tone, affecting the limbs and/or trunk, elicited by emotional stimuli). Narcolepsy has an adverse impact on people's quality of life. Together with stimulant drugs (used to control EDS), antidepressants are usually recommended to counteract cataplexy. In addition, some antidepressants are also reported to improve EDS. OBJECTIVES: To evaluate the effects of antidepressant drugs on EDS, cataplexy, quality of life, and their side effects in people with narcolepsy. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2003), MEDLINE (1966 to 2003), EMBASE (1980 to 2003), PsycINFO (1872 to 2003), and CINAHL (1981 to 2003). Bibliographies of identified articles were reviewed to find additional references. Unpublished randomised trials were searched for by consulting governmental and non-governmental clinical trial registers, disease-specific websites, investigators and experts in the field, pharmaceutical companies/manufacturers. SELECTION CRITERIA: Parallel or cross-over randomised or quasi-randomised controlled trials testing the treatment of narcolepsy with any type of antidepressant drug versus no treatment, placebo, or another antidepressant drug. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion and extracted data. Outcomes were: (a) elimination of EDS; (b) mean reduction of EDS; (c) elimination of cataplexy; (d) 50% or greater reduction in cataplexy frequency; (e) mean reduction of cataplexy; (f) mean improvement in quality of life; (g) adverse events; (h) withdrawal from treatment. MAIN RESULTS: Two cross-over trials were included. The methodological quality of both studies was unclear and so the influence of common biases was impossible to define. As the trials tested two different comparisons (one femoxetine versus placebo, the other fluvoxamine versus clomipramine) meta-analysis was not performed. In the first trial (10 participants) femoxetine had no significant effect in eliminating or reducing EDS; a significant reduction of cataplexy was in favour of femoxetine. Mild and transient side effects were reported in the femoxetine treatment period by two participants. In the second trial the authors inappropriately treated the trial design as a parallel study and no conclusions can be reached in favour of either drug. AUTHORS' CONCLUSIONS: There was no good quality evidence that antidepressants are effective for narcolepsy or improve quality of life. Despite the clinical consensus recommending antidepressants for cataplexy there is scarce evidence that antidepressants have a positive effect on this symptom. There is a clear need for well-designed randomised controlled trials to assess the effect of antidepressants on narcolepsy.

Antidepressive Agents↗
PubMed2005

Stroke units and general wards in seven Italian regions: the PROSIT study.

PROSIT (research PROject on Stroke services in ITaly) is a study performed to evaluate number and work organisation of acute in-hospital services (stroke units, SU) and general wards (GW), in seven Italian regions (Liguria, Lombardia, Lazio, Veneto, Friuli-Venezia-Giulia, Emilia Romagna, Toscana), which have a population of 29,169,811 inhabitants and a relative ratio of 225/100,000 hospitalisations for acute stroke. The registers of hospital discharges from January to December 1999 were looked at identify to services recording at least 50 acute stroke discharges (DRG14) per year. A structured questionnaire investigating stroke service characteristics was submitted to the doctors in charge of the identified units and completed in the presence of an external observer between October 2000 and February 2001. SUs were identified as units with dedicated beds (at least 80%) and team (at least 1 physician and 1 nurse) for acute stroke patients. SUs are still uncommon in many Italian regions because only, as 7% of the wards evaluated were found to be a SU and less than 10% of acute stroke patients resulted to be admitted to a SU. Great heterogeneity was found between the different regions surveyed. The most striking differences between SUs and GW were related to the staffing and care organisation, with higher number/patients ratio in SUs as far as physicians and nurses, speech therapists and social workers were concerned.

Age Factors↗
PubMed2001

The Cochrane collaboration in neurology: acquisitions, research, and new initiatives.

The Cochrane Collaboration (CC) is an international organization involving 16 national centers around the world, set up in response to the need for collecting all randomized controlled trials on health care interventions, with the aim of facilitating and coordinating the preparation, maintenance and dissemination of periodic systematic reviews of these trials. These are prepared by Collaborative Review Groups (CRGs) working together in an area of common interest under the guidance of an editorial team, supported by national Cochrane centers. Nine CRGs are involved in each neurological field, with more than 300 reviewers and members of editorial teams. For a review to be called a 'Cochrane review', it must be structured in the format outlined in the Cochrane Handbook. It is then published and disseminated through the Cochrane Database of Systematic Reviews (CDSR) in the Cochrane Library (CL). Each Cochrane review is prepared using the Review Manager software distributed to CRGs by CC. The editorial team is responsible for assembling an edited module of reviews prepared by CRGs for incorporation and dissemination using electronic media through the CDSR located in the CL. The CL contains information about the CC and 4 other databases: the Database of Abstracts of Reviews of Effectiveness, the Cochrane Controlled Trials Register, the Cochrane Review Methodology Database and the NHS Economic Evaluation Database. The authors use an example of Cochrane reviews about cerebrovascular disorders to illustrate that the CL is a powerful source of evidence for answering clinical questions and providing information as a basis for therapeutic decisions, for the improvement of neurological practice. A new initiative, the Cochrane Neurological Network, has recently been set up with the aim of improving communication among neurological CRGs, and between them and health care professionals interested in neurological diseases so as to update neurologists on the activity of the CC.

Cooperative Behavior↗
PubMed2000

Gangliosides for acute ischaemic stroke.

BACKGROUND: Gangliosides may have a protective effect on the central and peripheral nervous systems. OBJECTIVES: The objective of this review was to assess the effect of exogenous gangliosides in acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register (last searched: March 1999) and contacted drug companies. SELECTION CRITERIA: Randomised trials of gangliosides compared with placebo or standard treatment in people with definite or presumed ischaemic stroke. Trials were included if people were randomised within 15 days of symptom onset and if mortality data were available. DATA COLLECTION AND ANALYSIS: One reviewer applied the inclusion criteria. Two reviewers independently extracted the data. Trial quality was assessed. MAIN RESULTS: Eleven trials involving 2257 people were included. All the trials tested purified monosialoganglioside GM1. Only three trials described the randomisation procedure. Follow-up was between 15 to 180 days. Death at the end of follow-up showed no significant difference (odds ratio 0.91, 95% confidence interval 0.73 to 1.14). There was no difference shown between early (within 48 hours) and delayed treatment. For disability, two trials showed an improved Barthel index score with gangliosides (weighted mean difference 8.6, 95% confidence interval 1.2 to 16.0). In two trials, eight patients experienced adverse effects that led to discontinuation of ganglioside treatment, seven had skin reactions and one developed Guillain-Barré syndrome. REVIEWER'S CONCLUSIONS: There is not enough evidence to conclude that gangliosides are beneficial in acute stroke. Caution is warranted because of reports of sporadic cases of Guillain-Barré syndrome after ganglioside therapy.

Brain Ischemia↗
PubMed2000

Corticosteroids or ACTH for acute exacerbations in multiple sclerosis.

BACKGROUND: Corticosteroids are often used to improve the rate of recovery from acute exacerbation in multiple sclerosis (MS) patients. However, it is still unclear just how relatively effective these agents are and the type of drug, optimal dose, frequency, duration of treatment and route of administration are unknown. OBJECTIVES: The object of this review was to determine the efficacy and safety of corticosteroids or ACTH in reducing the short and long term morbidity from MS. Moreover, we wished to examine from indirect comparisons if the effect of corticosteroids is different according to different doses and drugs, routes of administration, length of treatment. SEARCH STRATEGY: A search strategy developed for the Cochrane MS Group (last searched: June 1999) completed with handsearching and personal contacts with trialists and pharmaceutical companies was used. SELECTION CRITERIA: All randomised, double-blind, unconfounded trials comparing corticosteroids or ACTH to placebo in patients with MS, treated for acute exacerbations, without any age or severity restrictions, were evaluated. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected articles for inclusion, assessed trials' quality and extracted the data. A third reviewer cross-checked them and disagreements were resolved by a joint discussion. MAIN RESULTS: Six trials contributed to this review; a total of 377 participants (199 treatment, 178 placebo) were randomised. The drugs analysed were methylprednisolone (MP) (four trials, 140 patients) and ACTH (two trials, 237 patients). Overall, MP or ACTH showed a protective effect against the disease getting worse or stable within the first five weeks of treatment (odds ratio[OR]=0.37, 95% confidence interval [CI] 0.24-0.57) with some but non significant greater effect for MP and intravenous administration. Short (five days) or long (15 days) duration of treatment with MP did not show any significant difference. Only one study (with 51 patients) reported data after one year of follow-up: no difference between oral MP and placebo in the prevention of new exacerbations or improvement in long term disability was detected. No data are available beyond one year of follow-up to indicate whether steroids or ACTH have any effect on long-term progression. One study reported that a short term treatment with high dose intravenous MP was not attended by adverse events. On the contrary, gastrointestinal symptoms and psychic disorders were significantly more common in the oral, high-dose MP than in the placebo group. Weight gain and edema were significantly more frequent in the ACTH group than in controls. REVIEWER'S CONCLUSIONS: We found evidence favouring the corticosteroid MP for acute exacerbation in MS patients. Data are insufficient to reliably estimate effect of corticosteroids on prevention of new exacerbations and reduction of long-term disability. Studies assessing long term risk/benefit and adverse effects of corticosteroids in MS patients are urgently needed.

Adrenocorticotropic Hormone↗
PubMed2000

Steroids for multiple sclerosis and optic neuritis: a meta-analysis of randomized controlled clinical trials.

We conducted a meta-analysis of randomized controlled clinical trials on steroid treatment for multiple sclerosis and optic neuritis. Of the 25 trials comparing steroids and controls without steroid treatment that we identified 12 were selected for this review. A meta-analysis was conducted to calculate the overall odds ratio across the studies for the numbers of patients without functional improvement and with new relapses. The trials included a total of 1714 patients: 998 with multiple sclerosis and 716 with optic neuritis. Any type of corticosteroids or adrenocorticotropic hormone (ACTH) treatment was considered, as was any dosage, route of administration, and length of treatment. Main outcome measures were: (a) number of multiple sclerosis patients who did not improve by at least one point on the EDSS or equivalent scale, or number of optic neuritis patients without complete recovery of visual acuity at 8 or 30 days and at longer follow-up; (b) number of multiple sclerosis patients with at least one new relapse, or number of optic neuritis patients in whom definite multiple sclerosis was diagnosed at longer follow-up. We found that corticosteroids or ACTH produced a significant improvement in disability or visual acuity at 30 days (odds ratio 0.49; 95% CI 0.37-0.64). The improvement was not statistically significant at longer follow-up (0.85; 95% CI 0.67-1.09). The treatment did not significantly reduce the number of patients with relapses (0.74; 95% CI 0.54-1.01). Both low and high doses were effective for 30-day improvement, but only high-dose and short-term therapy were factors that identified subgroups with some reduction in the risk of new relapse. However, the power of the statistical analysis to detect a reliable difference in the subgroups was low. Steroid treatment is therefore effective in accelerating short-term recovery in patients with multiple sclerosis or optic neuritis. Whether steroids are also effective in reducing the risk of relapse, and the optimal dose and length of treatment must still be determined.

Disability Evaluation↗
PubMed2000

Streptokinase in acute ischemic stroke: an individual patient data meta-analysis : The Thrombolysis in Acute Stroke Pooling Project.

BACKGROUND AND PURPOSE: Three major randomized controlled trials of streptokinase in acute ischemic stroke were curtailed because of safety concerns. The prospective Thrombolysis in Acute Stroke Pooling Project (TAS-PP) was established to examine the aggregate data to identify factors influencing the effect of streptokinase. METHODS: Individual patient data from the Australian Streptokinase Trial (ASK), Multicentre Acute Stroke Trial-Europe (MAST-E), Multicentre Acute Stroke Trial-Italy (MAST-I), and Glasgow Trial (Glasgow) were pooled. Multivariate modeling determined the interaction between treatment effect and delay from symptom onset to treatment, predicted baseline risk, age, concomitant aspirin or heparin use, and the presence of early CT signs on the outcomes of 10-day death, death and disability, or death alone at 3 or 6 months. RESULTS: Patients' records were pooled (total 1292 patients; streptokinase, n=653, no streptokinase n=639). The subgroup analysis of treatment effect according to delay from symptoms to inclusion shows only a trend toward a better treatment effect with shorter delay, which is not statistically significant for any outcome. Heavier patients in MAST-E may have had a lower (non significant) risk from the fixed dose of 1.5 million units of streptokinase. Concomitant aspirin increased the excess mortality rates in streptokinase-treated patients (17% without aspirin versus 91% with aspirin, P=0.005). The presence of early CT scan signs did not increase the detrimental effect of streptokinase. CONCLUSIONS: Few factors influenced the response to streptokinase. However, earlier administration, lower doses of streptokinase, and avoidance of concomitant aspirin should be considered if further streptokinase trials in acute stroke are planned.

Acute Disease↗
PubMed1999

The influence of baseline prognostic variables on outcome after thrombolysis. MAST-Italy Collaborative Group.

Thrombolysis increases case fatality but reduces the proportion of disabled survivors in recent trials in acute ischaemic stroke, although some trials show much higher mortality rates than others. One possible explanation for the different outcomes between trials is that the treatment effect with thrombolysis varies with baseline prognostic factors such as stroke severity. We examined the interaction between baseline risk and thrombolysis on outcome using individual patient data from the Multicentre Acute Stroke Trial-Italy (MAST-I). A multiple logistic regression of the MAST-I data was performed to identify which factors, identifiable at randomisation, most strongly predict a poor functional outcome. We then stratified the patients into those with severe strokes and those with mild strokes and examined the effect of thrombolysis on (a) case fatality and (b) dependency at 6 months after the stroke in the 157 patients who received streptokinase alone and the 156 controls. Streptokinase was found to cause an absolute increase of about 3% in case fatality in both "severe" and "mild" strokes; however, there was a 12% reduction in the number of dead or dependent "mild" strokes but a 6% increase in "severe" strokes. The number of patients was small, and therefore neither finding was statistically significant. In this exploratory analysis, the hazard with streptokinase appears similar in "severe" and "mild" strokes, but the benefit may be greater in "mild" strokes. Thrombolysis may be more effective in patients with "mild" strokes, but more information is required to confirm this hypothesis.

Aged↗
PubMed1999

Hemorrhage after an acute ischemic stroke.MAST-I Collaborative Group.

BACKGROUND AND PURPOSE: Hemorrhagic transformation is frequently seen on CT scans obtained in the subacute phase of ischemic stroke. Its prognostic value is controversial. METHODS: We analyzed 554 patients with acute ischemic stroke enrolled in the Multicenter Acute Stroke Trial-Italy (MAST-I) study in whom a second CT scan was performed on day 5. Presence of 1) intraparenchymal hemorrhages (hematoma or hemorrhagic infarction), 2) extraparenchymal bleeding (intraventricular or subarachnoid) and 3) cerebral edema (shift of midline structure, sulcal effacement or ventricular compression) alone or in association were evaluated. Death or disability at 6 months were considered as "unfavorable outcome." RESULTS: Patients who developed intraparenchymal hemorrhages, extraparenchymal bleeding, or cerebral edema had unfavorable outcome (83%, 100%, and 80%, respectively), but multivariate analysis demonstrated that only extraparenchymal bleeding (collinearity) and cerebral edema (OR=6.8; 95% CI, 4.5 to 10.4) were significant independent prognostic findings. Unfavorable outcome correlated with size of intraparenchymal hemorrhage (chi2 for trend=30.5, P<0.0001). Nevertheless, when a large hematoma was present the negative effect was mostly due to concomitant extraparenchymal bleeding (chi2=51.6, P<0.0001), and when hemorrhagic infarction was detected the negative effect was mostly explained by the association with cerebral edema (chi2=36.6, P<0.0001). CONCLUSIONS: Extraparenchymal bleeding and cerebral edema are the main prognostic CT scan findings in the subacute phase of ischemic stroke. Stroke patients with a high risk for developing these 2 types of brain damage should be identified. Measures to prevent and adequately treat their development should be implemented.

Acute Disease↗
PubMed1997

Reliability of hemorrhagic transformation diagnosis in acute ischemic stroke.

BACKGROUND AND PURPOSE: Diagnosis of hemorrhagic transformation (HT) could influence the prognosis and the management of acute ischemic stroke. The interobserver reliability of CT-scan HT classification is evaluated in the present study. METHODS: Fifty 5-day CT scans of patients enrolled in the Multicenter Acute Stroke Trial-Italy (MAST-I) were reviewed independently by two neuroradiologists and one neurologist with CT training. They evaluated the presence and type of intraparenchymal HT (hemorrhagic infarction types I, II, and III and intracerebral hemorrhage) (five-item scale), as well as the presence of intraventricular and/or subarachnoid bleeding according to standardized definitions. RESULTS: Agreement for exclusion of HT and intraventricular/ subarachnoid bleeding was good between the neuroradiologists (kappa = 0.70 and kappa = 0.72) and excellent between the neurologist and each neuroradiologist (kappa = 0.87 and kappa = 0.77, kappa = 0.83, and kappa = 0.81, respectively). The overall agreement for the five-item HT scale between the two neuroradiologists was good (kappa n = 0.65) because of discordance over the last three items. Better overall agreement was obtained with a three-item scale: no hemorrhage, petechial type I hemorrhagic infarction, and other HT (type II and type III hemorrhagic infarction and intracerebral hemorrhage) together (kappa w = 0.82 CONCLUSIONS: Exclusion of HT is a reliable CT diagnosis when made by neuroradiologists and also by a neurologist with CT training. Five- and three-item scales of HT types showed good to excellent reliability. The validity of the scale for predicting short- and long-term outcome should be evaluated in future studies.

Acute Disease↗
PubMed1996

Thrombolytic therapy. From myocardial to cerebral infarction. The MAST-I Group. Multicentre Acute Stroke Trial.

Thrombolysis is proposed for the acute treatment of cerebral infarction as it is able to recanalize occluded arteries and thus potentially restore normal perfusion of the cerebral parenchyma, but the results concerning the efficacy of this treatment are still inconclusive. However, it has been fully demonstrated that thrombolytic treatment, leads to a significant reduction in mortality, in patients with acute myocardial infarction. Data from all of the pilot studies using SK or tPA treatment in acute stroke are described in this review, which underlines the incidence of hemorrhagic transformation (hemorrhagic infart and parenchymal hematoma) and its possible correlation to clinical worsening. Pharmacological, experimental and clinical studies encourage the carrying out of large-scale clinical trials using thrombolytics in patients with acute cerebral infarction. Significant data relating to ongoing controlled clinical trials will be available in the near future; only after the analysis of these results will it be possible to confirm the efficacy of thrombolytics in acute stroke.

Animals↗
PubMed1994

The Italian Longitudinal Study on Aging (ILSA): design and methods.

The Italian Longitudinal Study on Aging (ILSA) is a population-based, longitudinal study of the health status of Italians aged 65-84 years. The main objectives of ILSA are the study of the prevalence and incidence rates of common chronic conditions in the older population, and the identification of their risk and protective factors. ILSA is also designed to assess age-associated physical and mental functional changes. A random sample of 5632 individuals, stratified by age and gender using the equal allocation strategy, was identified on the demographic lists of the registry office of eight municipalities: Genova, Segrate (Milano), Selvazzano-Rubano (Padova), Impruneta (Firenze), Fermo (Ascoli Piceno), Napoli, Casamassima (Bari), and Catania. An extensive investigation, including interviews, physical exams, and laboratory tests, was conducted at baseline to identify the presence of cardiovascular disease (ischemic heart disease, hypertension, congestive heart failure, arrhythmia, intermittent claudication), diabetes, impaired glucose tolerance, thyroid dysfunction, dementia, parkinsonism, stroke, and peripheral neuropathy, as well as assess physical and mental functional status. The baseline examination was carried out between March 1992 and June 1993; a second comprehensive examination will begin in March 1995. An interim hospital discharge data survey and a mortality survey are currently ongoing to assess the hospitalization rate and the cause-specific mortality rate in this study cohort.

Aged↗
PubMed1992

Venous thromboembolism in acute stroke. Prognostic importance of hypercoagulability.

To assess the incidence, risk factors, and clinical importance of deep vein thrombosis in acute stroke, we studied 70 consecutive patients who underwent hemostasis screening at the time of entry into the study and followed up these patients with serial venous Doppler examinations and the iodine 125-labeled fibrinogen uptake test. Mortality was significantly higher among the 20 patients who developed a deep vein thrombosis, and eight of them had necropsy evidence of pulmonary embolism. Severity of leg paresis and a shortened activated partial thromboplastin time were significantly associated with subsequent deep vein thrombosis with multivariate analysis. Significantly higher levels of fibrinopeptide A were found in patients with postmortem evidence of pulmonary embolism. Deep vein thrombosis is a frequent complication of acute stroke and may influence the prognosis by inducing pulmonary embolism. Our findings allow rapid identification of high-risk patients who may benefit maximally from prophylactic treatment of venous thromboembolism.

Adult↗