Romeo Brambilla

A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

BackgroundClinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke.MethodsThis was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates.ResultsCompared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm.ConclusionsCPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided evidence on how CPs can work.Trial registrationClinicalTrials.gov ID: [NCT00673491].

Reducing Stroke In-Hospital Mortality: Organized Care Is a Complex Intervention

To the Editor: We read with great interest the article by Saposnik et al regarding the escalating levels of access to in-hospital care and stroke mortality.1 Many authors agree that the management of the patients in stroke care units has been the most substantial advance in stroke care; however, the mechanism by which the stroke care unit management improves outcomes remains uncertain.2 Therefore, in their article Saposnik et al argued that the stroke unit admission does not automatically imply receiving comprehensive care and appropriate interventions, and they analyzed the impact of the organized care in stroke mortality. We suggest that this issue should be further analyzed. We conducted an observational study to this purpose. Retrospective data were collected with standard report forms from the medical records of 253 consecutive patients admitted for ischemic strokes in 29 Italian hospitals in June 2004. Patients with hemorrhagic strokes and …

Sodium oxybate in maintaining alcohol abstinence in alcoholic patients with and without psychiatric comorbidity.

Sodium oxybate (SMO) is a GABA-ergic drug currently used for the treatment of alcohol-dependence in some European countries. In particular, clinical studies have shown a role of SMO in promoting alcohol abstinence, as well as in relieving withdrawal symptoms. The aim of this study was to describe alcohol abstinence and the onset of craving for and abuse of SMO in alcohol-dependent subjects with and without psychiatric co-morbidity. Forty-eight patients were enrolled and classified into two groups: group A (20 alcoholics without any psychiatric co-morbidity) and group B (28 alcoholics with a psychiatric co-morbidity). All patients were treated with oral SMO (50 mg/kg of body weight t.i.d.) for 12 weeks. Alcohol abstinence as well as alcohol drinking during the 12 weeks of treatment did not differ between the two groups at the end of treatment (p=0.9). In addition, a reduction of alcohol intake in both groups has been observed (p<0.0001). On the other hand, craving for SMO was significantly more frequent in group B than group A (p=0.001). Cases of SMO abuse were observed in almost 10% of group B patients. In conclusion, alcohol abstinence achieved through SMO administration does not differ in patients with and without psychiatric co-morbidity. However, alcoholics with co-morbid borderline disorders appear to be at high risk of developing craving for and abuse of the drug; therefore, SMO may not be indicated in these patients.

Sodium oxybate in maintaining alcohol abstinence in alcoholic patients according to Lesch typologies: a pilot study.

Sodium oxybate (SO) is a γ-amino-butyric acid (GABA)-ergic drug currently used for the treatment of alcohol dependence (AD) in some European countries. The aim of this study was to describe the effect of SO administration in alcoholics classified according to Lesch alcoholism typology (LAT). Forty-eight patients were enrolled and classified into four groups according to LAT. All patients were treated with oral SO (50 mg/kg of body weight t.i.d.) for 12 weeks. All patients significantly reduced their alcohol intake (p<0.001). Alcohol abstinence during the 12 weeks of treatment did not differ between the four groups at the end of treatment. Craving for SO did not significantly differ amongst groups; cases of SO abuse were very limited and were observed in almost 10% of patients. In conclusion, our study showed an overall efficacy of SO in the treatment of AD irrespective of LAT categories. However, our results confirm that alcoholics with psychiatric co-morbidity, particularly with a borderline personality disorder of Axis II, are at a greater risk of developing craving for and abuse of the drug: until craving for alcohol and craving for SO are characterized in depth, SO should be used with caution in these patients.

Problematic internet use among high school students: Prevalence, associated factors and gender differences

This study aimed to measure the prevalence of Problematic Internet Use (PIU) among high school students and to identify factors associated with PIU underlining gender differences. The students filled a self-administered, anonymous questionnaire collecting information on demographic characteristics and patterns of Internet use. Multiple logistic regression analysis was performed to identify factors associated with PIU in the overall sample and by gender. Twenty-five schools and 2022 students participated in the survey. Prevalence of PIU was 14.2% among males and 10.1% among females. Males 15-year-olds and females 14-year-olds had the highest PIU prevalence that progressively lowered with age among females. Only 13.5% of pupils declared parents controlled their Internet use. The sensation of feeling lonely, the frequency of use, the number of hours of connection, and visiting pornographic websites were associated with the risk of PIU in both genders. Attending vocational schools, the activities of chatting and file downloading, and the location of use at Internet point among males, and younger age among females were associated with PIU, whilst information searching was protective among females. PIU could become a public health problem in the next years. The physical and mental health consequences should be studied.

Il gamma-idrossibutirrato (GHB) nel trattamento a medio/lungo termine della dipendenza da alcol: una revisione sistematica

AIM Gamma-hydroxybutyric acid (GHB) is used to treat alcohol withdrawal syndrome (AWS) at short term, and to reduce alcohol relapses among alcohol dependent subjects at mid-term. The objective of this paper is to synthesize results of a Cochrane review on efficacy of GHB for treating alcohol dependence at mid-term. METHODS The search strategy was conducted on MEDLINE, EMBASE, PsycINFO, CINAHL and on the Cochrane Library. Pharmaceutical companies were contacted and references of papers were checked in order to identify unpublished studies. Randomized controlled trials (RCT), clinical controlled trials (CCT), and controlled prospective studies (CPS) were considered. Three authors blindly evaluated the quality of the studies and extracted the data. RESULTS Seven RCT studies evaluating efficacy of GHB for treating alcohol dependence at mid-term were included in the review; all were conducted in Italy. GHB appears to be more effective than placebo on alcohol abstinence (RR 2.63; 1.22-5.71), controlled drinking (RR 2.43; 1.07-5.54), relapses to heavy drinking (RR 0.37; 0.21-0.63), and number of daily drinks (MD -4.60; -6.18,-3.02). GHB appears to be more effective than naltrexone on alcohol abstinence (RR 1.78; 1.21-2.62) but not on other outcomes. The effect on Alcohol Craving Scale favours GHB vs placebo (MD -4.50; -5.81,-3.19), vs naltrexone (MD -1.90; -2.45,-1.35) and vs disulfiram (MD -1.40; -1.86,-0.94). Side effects are similar to naltrexone and disulfiram. DISCUSSION The low number of available studies, the low sample size and the low quality of the included studies limit the validity of the results and suggest the need of conducting new high-quality randomized trials with appropriate sample size.AIM Gamma-hydroxybutyric acid (GHB) is used to treat alcohol withdrawal syndrome (AWS) at short term, and to reduce alcohol relapses among alcohol dependent subjects at mid-term. The objective of this paper is to synthesize results of a Cochrane review on efficacy of GHB for treating alcohol dependence at mid-term. METHODS The search strategy was conducted on MEDLINE, EMBASE, PsycINFO, CINAHL and on the Cochrane Library. Pharmaceutical companies were contacted and references of papers were checked in order to identify unpublished studies. Randomized controlled trials (RCT), clinical controlled trials (CCT), and controlled prospective studies (CPS) were considered. Three authors blindly evaluated the quality of the studies and extracted the data. RESULTS Seven RCT studies evaluating efficacy of GHB for treating alcohol dependence at mid-term were included in the review; all were conducted in Italy. GHB appears to be more effective than placebo on alcohol abstinence (RR 2.63; 1.22-5.71), controlled drinking (RR 2.43; 1.07-5.54), relapses to heavy drinking (RR 0.37; 0.21-0.63), and number of daily drinks (MD -4.60; -6.18,-3.02). GHB appears to be more effective than naltrexone on alcohol abstinence (RR 1.78; 1.21-2.62) but not on other outcomes. The effect on Alcohol Craving Scale favours GHB vs placebo (MD -4.50; -5.81,-3.19), vs naltrexone (MD -1.90; -2.45,-1.35) and vs disulfiram (MD -1.40; -1.86,-0.94). Side effects are similar to naltrexone and disulfiram. DISCUSSION The low number of available studies, the low sample size and the low quality of the included studies limit the validity of the results and suggest the need of conducting new high-quality randomized trials with appropriate sample size.