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Find video protocols related to scientific articles indexed in Pubmed.
Expert opinion of nephrologists about the effectiveness of low-protein diet in different stages of chronic kidney disease (CKD).
Int J Food Sci Nutr
PUBLISHED: 09-29-2014
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Abstract No clinical trials have specifically explored the benefits of low-protein diet in patients with different stages of chronic kidney disease (CKD) 3B. In the absence of RCTs, expert opinion may be a valid surrogate to estimate treatment effectiveness. A questionnaire-based survey of a large sample of nephrologists from Southern Italy was conducted to explore benefits of low-protein diet (LPD) in delaying dialysis entry in different CKD stages. For the case vignettes describing eight different patient profiles with various CKD stages, nephrologists reported expected benefits as time delay of dialysis entry. Information was collected through questionnaires filled by 88 nephrologists from different Southern Italian hospitals. On average, nephrologists estimated the highest delay in starting dialysis due to LPD in stages 3B (15 months) and 3A (14 months), and the lowest for 5 stage (3 months). According to opinion of a large sample of Southern Italian nephrologists, low-protein diet may be more efficacious if started in CKD stage 3B than 4 and 5.
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Safety profile of biological medicines as compared with non-biologicals: an analysis of the italian spontaneous reporting system database.
Drug Saf
PUBLISHED: 09-27-2014
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Biologicals are important treatment options for various chronic diseases. After the introduction of the first biosimilars, animated debate arose in the scientific community about the actual benefit-risk profile of these drugs. In this context, a comparative safety evaluation of biologicals and biosimilars in clinical practice is warranted.
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Effects of a computerized decision support system in improving pharmacological management in high-risk cardiovascular patients: A cluster-randomized open-label controlled trial.
Health Informatics J
PUBLISHED: 09-12-2014
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This study was aimed to investigate the effects of computerized decision support system in improving the prescription of drugs for cardiovascular prevention. A total of 197 Italian general practitioners were randomly allocated to receive either the alerting computerized decision support system integrated into standard software (intervention arm) or the standard software alone (control arm). Data on 21230 patients with diabetes, 3956 with acute myocardial infarction, and 2158 with stroke were analysed. The proportion of patients prescribed with cardiovascular drugs and days of drug-drug interaction exposure were evaluated. Computerized decision support system significantly increased the proportion of patients with diabetes prescribed with antiplatelet drugs (intervention: +2.7% vs. control: +0.15%; p < 0.001) or lipidlowering drugs (+4.2% vs. +2.8%; p = 0.001). A statistically significant decrease in days of potential interactions has been observed only among patients with stroke (-1.2 vs. -0.5 days/person-year; p = 0.001). In conclusion, computerized decision support system significantly increased the use of recommended cardiovascular drugs in diabetic patients, but it did not influence the exposure to potential interactions.
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Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012.
Expert Opin Drug Saf
PUBLISHED: 08-30-2014
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To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database.
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Effectiveness of risk minimization measures for cabergoline-induced cardiac valve fibrosis in clinical practice in Italy.
J Neural Transm
PUBLISHED: 07-30-2014
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On June 2008, the European Medicines Agency (EMA) introduced changes to the Summary of Product Characteristics (SPC) for cabergoline and pergolide, to reduce the risk of cardiac valvulopathy in users of these drugs. To assess the effectiveness of EMA recommendations in Italian clinical practice, we retrospectively reviewed medical charts of patients with degenerative Parkinsonism treated with cabergoline in three large Italian clinics between January 2006 and June 2012. The prevalence and the severity of cardiac valve regurgitation were assessed in patients who stopped cabergoline therapy prior to June 2008 or continued therapy after that date. In addition, the proportion of patients undergoing echocardiographic examination in each cohort was evaluated. A total of 61 patients were available for evaluation. The proportion of patients who underwent a baseline echocardiographic examination increased from 64 % in the period before the 2008 SPC changes to 71 % among those who continued treatment after that date. However, only 18 and 29 % of patients underwent at least two echocardiographic examinations during the pre-SPC and cross-SPC change period, respectively. No severe cardiac valve regurgitation was documented in any of the study patients using cabergoline either prior or after 26th June 2008. Our findings show that the 2008 changes to the SPC resulted in an increase in physicians' awareness of cabergoline-induced valvulopathy risk in Italy. However, only a small percentage of patients underwent serial echocardiography. Further efforts are needed to achieve better compliance with the prescribing guidelines for cabergoline treated patients in clinical practice.
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Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest.
Drug Saf
PUBLISHED: 07-03-2014
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The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. This presents an opportunity to establish an open-source community effort to develop a global knowledge base, one that brings together and standardizes all available information for all drugs and all health outcomes of interest (HOIs) from all electronic sources pertinent to drug safety. To make this vision a reality, we have established a workgroup within the Observational Health Data Sciences and Informatics (OHDSI, http://ohdsi.org) collaborative. The workgroup's mission is to develop an open-source standardized knowledge base for the effects of medical products and an efficient procedure for maintaining and expanding it. The knowledge base will make it simpler for practitioners to access, retrieve, and synthesize evidence so that they can reach a rigorous and accurate assessment of causal relationships between a given drug and HOI. Development of the knowledge base will proceed with the measureable goal of supporting an efficient and thorough evidence-based assessment of the effects of 1,000 active ingredients across 100 HOIs. This non-trivial task will result in a high-quality and generally applicable drug safety knowledge base. It will also yield a reference standard of drug-HOI pairs that will enable more advanced methodological research that empirically evaluates the performance of drug safety analysis methods.
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Are the safety profiles of antipsychotic drugs used in dementia the same? An updated review of observational studies.
Drug Saf
PUBLISHED: 05-27-2014
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With an increase in the global prevalence of dementia, there is also an increase in behavioural and psychological symptoms of dementia (BPSD) for which antipsychotic drugs are often used. Despite several safety warnings on antipsychotic use in dementia, there is little evidence to support the efficacy of antipsychotics in individual BPSD symptoms or to evaluate the drug safety profile by individual antipsychotic drug. There is emerging but scarce evidence that suggests an inter-drug variability between antipsychotic safety outcomes in BPSD. The objective of this review was to examine the existing literature on antipsychotic drug use in dementia patients; in particular to see whether inter-drug differences regarding antipsychotic safety were reported. A literature search was conducted for observational studies published in the English language from 2004 to 2014 that reported the risk of all-cause mortality, cerebrovascular events, pneumonia and other outcomes such as hip/femur fracture, deep vein thrombosis (DVT) and hyperglycaemia. Six of 16 mortality studies (38%), 7 of 28 stroke studies (25%), 1 of 6 pneumonia (17%) studies and 2 of 6 fracture studies (33%) investigated inter-drug safety outcomes in elderly patients/dementia patients, while to our knowledge, there are no studies investigating the inter-drug variation of deep-vein thrombosis and hyperglycaemia risk. The results of the observational studies provide mixed results on the safety of antipsychotics in BPSD but it is clear that there are differences between the safety profiles of antipsychotic drugs. Robust evidence of such inter-drug variability could significantly improve patient safety as antipsychotics become more targeted to clinical risk factors.
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New therapeutic strategies under development to halt the progression of renal failure.
Expert Opin Investig Drugs
PUBLISHED: 04-03-2014
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Chronic kidney disease (CKD) is a pathological condition associated with high morbidity and mortality. Accordingly, prevention of CKD onset and progression is mandatory. As pharmacological agents already used in clinical practice are not yet able to halt the progression of renal damage, new therapeutic strategies are being explored.
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Detecting adverse drug reactions following long-term exposure in longitudinal observational data: The exposure-adjusted self-controlled case series.
Stat Methods Med Res
PUBLISHED: 04-02-2014
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Most approaches used in postmarketing drug safety monitoring, including spontaneous reporting and statistical risk identification using electronic health care records, are primarily suited to pick up only acute adverse drug effects. With the availability of increasingly larger electronic health record and administrative claims databases comes the opportunity to monitor for potential adverse effects that occur only after prolonged exposure to a drug, but analysis methods are lacking. We propose an adaptation of the self-controlled case series design that uses the notion of accumulated exposure to capture long-term effects of drugs and evaluate extensions to correct for age and recurrent events. Several variations of the approach are tested on simulated data and two large insurance claims databases. To evaluate performance a set of positive and negative control drug-event pairs was created by medical experts based on drug product labels and review of the literature. Performance on the real data was measured using the area under the receiver operator characteristics curve. The best performing method achieved an area under the receiver operator characteristics curve of 0.86 in the largest database using a spline model, adjustment for age, and ignoring recurrent events, but it appears this performance can only be achieved with very large data sets.
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Systemic antibiotic prescribing to paediatric outpatients in 5 European countries: a population-based cohort study.
BMC Pediatr
PUBLISHED: 02-18-2014
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To describe the utilisation of antibiotics in children and adolescents across 5 European countries based on the same drug utilisation measures and age groups. Special attention was given to age-group-specific distributions of antibiotic subgroups, since comparison in this regard between countries is lacking so far.
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Changes in the prescribing pattern of antidepressant drugs in elderly patients: an Italian, nationwide, population-based study.
Eur. J. Clin. Pharmacol.
PUBLISHED: 01-15-2014
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Despite the high use of antidepressants (ADs) among the elderly, there is limited information about the prescribing pattern of these drugs in the Italian elderly population. The aim of this study was to analyze the trend in the use of ADs in the Italian elderly patients in the years 2003-2009, and specifically, to evaluate rates and predictors of AD treatment discontinuation in depressed older patients.
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Pattern of statin use in southern italian primary care: can prescription databases be used for monitoring long-term adherence to the treatment?
PLoS ONE
PUBLISHED: 01-01-2014
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We sought to evaluate the prescribing pattern of statins according to national and regional health policy interventions and to assess specifically the adherence to the therapy in outpatient setting in Southern Italy.
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The burden of nephrotoxic drug prescriptions in patients with chronic kidney disease: a retrospective population-based study in Southern Italy.
PLoS ONE
PUBLISHED: 01-01-2014
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The use of nephrotoxic drugs can further worsening renal function in chronic kidney disease (CKD) patients. It is therefore imperative to explore prescribing practices that can negatively affect CKD patients.
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Clinical and economic burden of adverse drug reactions.
J Pharmacol Pharmacother
PUBLISHED: 12-19-2013
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Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic as well as clinical costs as they often lead to hospital admission, prolongation of hospital stay and emergency department visits. Randomized controlled trials (RCTs) are the main premarketing methods used to detect and quantify ADRs but these have several limitations, such as limited study sample size and limited heterogeneity due to the exclusion of the frailest patients. In addition, ADRs due to inappropriate medication use occur often in the real world of clinical practice but not in RCTs. Postmarketing drug safety monitoring through pharmacovigilance activities, including mining of spontaneous reporting and carrying out observational prospective cohort or retrospective database studies, allow longer follow-up periods of patients with a much wider range of characteristics, providing valuable means for ADR detection, quantification and where possible reduction, reducing healthcare costs in the process. Overall, pharmacovigilance is aimed at identifying drug safety signals as early as possible, thus minimizing potential clinical and economic consequences of ADRs. The goal of this review is to explore the epidemiology and the costs of ADRs in routine care.
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Prescribing pattern of glucose lowering drugs in the United Kingdom in the last decade: a focus on the effects of safety warnings about rosiglitazone.
Br J Clin Pharmacol
PUBLISHED: 08-07-2013
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In the last decade, new glucose lowering drugs (GLDs) have been launched, and also several warnings regarding their safety. The cardiovascular safety of thiazolidinediones (TZD) has been questioned. We analyzed the prescription pattern of GLDs from 2000 to November 2009 in the United Kingdom (UK) using the THIN database with special focus on the effects of the safety warnings about rosiglitazone issued in May 2007 and January 2008.
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High Prevalence of Poor Quality Drug Prescribing in Older Individuals: A Nationwide Report From the Italian Medicines Agency (AIFA).
J. Gerontol. A Biol. Sci. Med. Sci.
PUBLISHED: 08-02-2013
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Poor quality of drug prescribing in older persons is often associated with increased drug-related adverse events, hospitalization, and mortality. The present study describes a set of prescribing quality indicators developed by the Geriatrics Working Group of the Italian Medicines Agency (AIFA) and estimates their prevalence in the entire elderly (?65 years) population in Italy.
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Additional risk minimisation measures in the EU - are they eligible for assessment?
Pharmacoepidemiol Drug Saf
PUBLISHED: 06-28-2013
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"Additional" risk minimisation measures (aRMMs) can be necessary to optimise the benefit-risk balance of a drug. Evaluation of effectiveness of these measures has become mandatory with the new European Union (EU) pharmacovigilance legislation in force since July 2012. The aim of this study was to classify the aRMMs in the EU with a special emphasis on the possibilities to analyse the effectiveness of these aRMMs in existing electronic healthcare databases (EHDs).
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Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries.
Drug Saf
PUBLISHED: 04-18-2013
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Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and adolescents.
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Effects of LAquila earthquake on the prescribing pattern of antidepressant and antipsychotic drugs.
Int J Clin Pharm
PUBLISHED: 03-17-2013
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Background Natural disasters provoke an increase in mental and medical disorders in survivors. Monitoring drug prescription changes after natural disasters can provide an indirect evaluation of trauma impact in the population. Moreover, it could be useful to both identify risk categories that require special assistance and assess possible drug abuse or misuse. Objective To assess the effects of earthquake that occurred on April 6, 2009 on the use of antidepressant and antipsychotic drugs in the province of LAquila. Setting General population of LAquila and Caserta provinces from Southern Italy. Method In a retrospective, drug utilization study we identified all the persons who received at least one dispensing of antidepressant and/or antipsychotic drugs during the period April 1st, 2008-March 31st, 2010. Main outcome measure The monthly prevalence of use of these drugs, 1 year prior and after the date of earthquake in LAquila was compared between the two provinces, LAquila and Caserta. All the analyses were stratified by age groups, gender and drug classes. Results We observed an increase in the use of antipsychotic drugs and, to lesser extent, of antidepressant agents (mostly typicals and tryciclics, respectively) in the first 2 months after the earthquake in LAquila but not in Caserta. This increase was almost two-fold higher in women older than 75 years. After the first 2 months from the earthquake, the use of antidepressants and antipsychotics was stabilized at the pre-earthquake levels in LAquila. Conclusion The earthquake determined a short-term increase in the use of antipsychotics (mostly haloperidol and promazine) and, to lesser extent, of antidepressants (i.e. tryciclics), especially in older women of LAquila.
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Postmarketing safety surveillance : where does signal detection using electronic healthcare records fit into the big picture?
Drug Saf
PUBLISHED: 02-05-2013
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The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drugs clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of spontaneous reports of adverse drug reactions. Vast improvements in computing capabilities have provided opportunities to automate signal detection, and several worldwide initiatives are exploring new approaches to facilitate earlier detection, primarily through mining of routinely-collected data from electronic healthcare records (EHR). This paper provides an overview of ongoing initiatives exploring data from EHR for signal detection vis-à-vis established spontaneous reporting systems (SRS). We describe the role SRS has played in regulatory decision making with respect to safety issues, and evaluate the potential added value of EHR-based signal detection systems to the current practice of drug surveillance. Safety signal detection is both an iterative and dynamic process. It is in the best interest of public health to integrate and understand evidence from all possibly relevant information sources on drug safety. Proper evaluation and communication of potential signals identified remains an imperative and should accompany any signal detection activity.
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A reference standard for evaluation of methods for drug safety signal detection using electronic healthcare record databases.
Drug Saf
PUBLISHED: 01-15-2013
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The growing interest in using electronic healthcare record (EHR) databases for drug safety surveillance has spurred development of new methodologies for signal detection. Although several drugs have been withdrawn postmarketing by regulatory authorities after scientific evaluation of harms and benefits, there is no definitive list of confirmed signals (i.e. list of all known adverse reactions and which drugs can cause them). As there is no true gold standard, prospective evaluation of signal detection methods remains a challenge.
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Drug-induced acute myocardial infarction: identifying prime suspects from electronic healthcare records-based surveillance system.
PLoS ONE
PUBLISHED: 01-01-2013
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Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in real-world settings.
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Identification of acute myocardial infarction from electronic healthcare records using different disease coding systems: a validation study in three European countries.
BMJ Open
PUBLISHED: 01-01-2013
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To evaluate positive predictive value (PPV) of different disease codes and free text in identifying acute myocardial infarction (AMI) from electronic healthcare records (EHRs).
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The risk of new onset heart failure associated with dopamine agonist use in Parkinsons disease.
Pharmacol. Res.
PUBLISHED: 07-22-2011
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The aim of present study was to investigate the risk of heart failure associated with dopamine agonist use in patients with Parkinsons disease. The data sources of this study were four different population-based, healthcare databases in United Kingdom, Italy and Netherlands. A case control study nested within a cohort of Parkinsons disease patients who were new users of either dopamine agonist or levodopa was conducted. Incident cases of heart failure were identified and validated, using Framingham criteria. Controls were matched to cases on age, gender and database. To estimate the risk of newly diagnosed heart failure with ergot and non-ergot derived dopamine agonists, as compared to levodopa, odds ratios and 95% confidence intervals were calculated through conditional logistic regression. In the cohort of 25,459 Parkinsons disease patients (11,151 new users of dopamine agonists, 14,308 new users of levodopa), 518 incident heart failure cases were identified during follow-up. Compared to levodopa, no increased risk of heart failure was found for ergot dopamine agonists (odds ratio: 1.03; 95% confidence interval: 0.69-1.55). Among non-ergot dopamine agonists, only pramipexole was associated with an increased risk of heart failure (odds ratio: 1.61; 95%confidence interval: 1.09-2.38), especially in the first three months of therapy (odds ratio: 3.06; 95% confidence interval: 1.74-5.39) and in patients aged 80 years and older (odds ratio: 3.30; 95% confidence interval: 1.62-7.13). The results of this study indicate that ergot dopamine agonist use in Parkinsons disease patients was not associated with an increased risk of newly diagnosed heart failure. Among non-ergot dopamine agonists, we observed a statistically significant association between pramipexole use and heart failure, especially during the first months of therapy and in very old patients.
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EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection.
Stud Health Technol Inform
PUBLISHED: 06-21-2011
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The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases. EU-ADR data sources consist of eight databases in four countries (Denmark, Italy, Netherlands, and United Kingdom) that are virtually linked through distributed data network. A custom-built software (Jerboa©) elaborates harmonized input data that are produced locally and generates aggregated data which are then stored in a central repository. Those data are subsequently analyzed through different statistics (i.e. Longitudinal Gamma Poisson Shrinker). As potential signals, all the drugs that are associated to six events of interest (bullous eruptions - BE, acute renal failure - ARF, acute myocardial infarction - AMI, anaphylactic shock - AS, rhabdomyolysis - RHABD, and upper gastrointestinal bleeding - UGIB) have been detected via different data mining techniques in the two systems. Subsequently a comparison concerning the number of drugs that could be investigated and the potential signals detected for each event in the spontaneous reporting systems (SRSs) and EU-ADR network was made. SRSs could explore, as potential signals, a larger number of drugs for the six events, in comparison to EU-ADR (range: 630-3,393 vs. 87-856), particularly for those events commonly thought to be potentially drug-induced (i.e. BE: 3,393 vs. 228). The highest proportion of signals detected in SRSs was found for BE, ARF and AS, while for ARF, and UGIB in EU-ADR. In conclusion, it seems that EU-ADR longitudinal database network may complement traditional spontaneous reporting system for signal detection, especially for those adverse events that are frequent in general population and are not commonly thought to be drug-induced. The methodology for signal detection in EU-ADR is still under development and testing phase.
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Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases.
Gut
PUBLISHED: 06-02-2011
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Gastro-protective agents (GPA) are co-prescribed with non-steroidal anti-inflammatory drugs (NSAID) to lower the risk of upper gastrointestinal (UGI) events. It is unknown to what extent the protective effect is influenced by therapy adherence.
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Age-related changes in pharmacodynamics: focus on drugs acting on central nervous and cardiovascular systems.
Curr. Drug Metab.
PUBLISHED: 04-19-2011
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Aging is characterized by progressive impairment of functional capacities of all system organs, reduction in homeostatic mechanisms, and altered response to receptor stimulation. These age-related physiologic changes influence both pharmacokinetics and pharmacodynamics of drugs in elderly patients. Pharmacokinetic and pharmacodynamics changes as well as polypharmacy and comorbidities may alter significantly the effect of pharmacological treatment with advancing age. With the same drug concentration at the site of action, significant differences in the response to several drugs have been observed in older patients as compared to younger patients. Elderly patients are particularly suceptibles to the effects of frequently prescribed drugs acting on central nervous system, such as benzodiazepines, antidepressants, antipsychotics and lithium, with high potential for adverse drug reactions. Moreover, in older patients increased sensitivity to warfarin resulting in increased risk of bleeding has been previously documented. On the other hand, reduced effectiveness of conventional doses of cardiovascular drugs, such as diuretics and ?-blockers, has been observed. Due to pharmacodynamic changes, therefore, dose adjustment of the above mentioned cardiovascular and psychotropic drugs is recommended in elderly. Clinicians should be aware of the age-related physiologic changes affecting several organ systems and their implications on the effect of drugs that are commonly prescribed to elderly patients.
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Antipsychotic drug use and community-acquired pneumonia.
Curr Infect Dis Rep
PUBLISHED: 03-12-2011
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Antipsychotics are generally distinguished as atypical and typical agents, which are indicated in the treatment of acute and chronic psychoses and other psychiatric disorders. In April 2005, the US Food and Drug Administration issued a warning about the increased risk of all-cause mortality associated with atypical antipsychotic use in elderly patients with dementia. Pneumonia was one of the most frequently reported causes of death. The same warning was extended to typical antipsychotics in June 2008. In recent years, several observational studies have further explored the association between antipsychotic use, mainly in elderly patients, and the risk of fatal/nonfatal community-acquired pneumonia. The aim of this review is to revise and discuss the scientific evidence and biologic explanations for the association between atypical and typical antipsychotic use and pneumonia occurrence. Some general recommendations to clinicians are proposed to prevent the risk of pneumonia in patients requiring antipsychotic treatment.
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Design and evaluation of a semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European EU-ADR project.
Stud Health Technol Inform
PUBLISHED: 09-16-2010
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The overall objective of the EU-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight different databases, containing health records of more than 30 million European citizens, are involved in the project. Unique queries cannot be performed across different databases because of their heterogeneity: Medical record and Claims databases, four different terminologies for coding diagnoses, and two languages for the information described in free text. The aim of our study was to provide database owners with a common basis for the construction of their queries. Using the UMLS, we provided a list of medical concepts, with their corresponding terms and codes in the four terminologies, which should be considered to retrieve the relevant information for the events of interest from the databases.
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Prescribing pattern of anti-epileptic drugs in an Italian setting of elderly outpatients: a population-based study during 2004-07.
Br J Clin Pharmacol
PUBLISHED: 09-16-2010
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The aims of the study were to assess the trend of older and newer anti-epileptic drugs (AEDs) in the elderly population and to analyze the effects of a health-policy intervention with regard to AED use in general practice in a setting in Southern Italy.
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Risk of ischemic stroke associated with antidepressant drug use in elderly persons.
J Clin Psychopharmacol
PUBLISHED: 05-18-2010
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Competing hypotheses have been formulated about a possible association between selective serotonin reuptake inhibitors (SSRIs) and ischemic stroke. However, the relationship between antidepressant drug use and ischemic stroke is still unclear. The aim of the study was to assess the association between the use of different types of antidepressants and the risk of ischemic stroke in elderly outpatients. A population-based, nested, case-control study was conducted in persons 65 years and older in the Integrated Primary Care Information database (1996-2005). Cases were all patients with a validated first ischemic stroke. Controls were matched on year of birth, sex, and index date. Exposure to antidepressants was divided in current, past, and nonuse and further categorized by type (SSRI, tricyclic, and other antidepressants), dose, and duration. Conditional logistic regression was used to compare the risk of ischemic stroke between users of antidepressants and nonusers. Overall, 996 incident ischemic strokes were identified. Current use of SSRIs was associated with a significantly increased risk as compared with nonuse (odds ratio, 1.55; 95% confidence interval, 1.07-2.25) in elderly patients, particularly when used for less than six months. No associations were observed for current use of tricyclic and other antidepressant drugs. To summarize, compared with nonuse, only SSRI use seems to be associated with an increased risk of ischemic stroke in elderly patients, particularly as a short-term effect.
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Association of community-acquired pneumonia with antipsychotic drug use in elderly patients: a nested case-control study.
Ann. Intern. Med.
PUBLISHED: 04-07-2010
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According to safety alerts from the U.S. Food and Drug Administration, pneumonia is one of the most frequently reported causes of death in elderly patients with dementia who are treated with antipsychotic drugs. However, epidemiologic evidence of the association between antipsychotic drug use and pneumonia is limited.
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Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project.
Pharmacoepidemiol Drug Saf
PUBLISHED: 03-25-2010
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In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety.
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Cerebellar stroke in elderly patient with basilar artery agenesia: a case report.
J Stroke Cerebrovasc Dis
PUBLISHED: 02-04-2010
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We report a case of a 76-year-old woman admitted to our institution with sudden onset of dizziness and vertigo followed by vomiting and blurred vision. Her medical history was remarkable for hypertension, diabetes, and ischemic stroke in the territory of the left cerebral median artery. Her symptoms were suggestive of a cerebellar stroke. Computed tomography brain scan and neck vessel ultrasounds produced normal findings. A 24-hour blood pressure monitoring showed a reverse dipping pattern. Magnetic resonance imaging examination was performed, showing a hyperintense ischemic focus involving pons and left middle cerebellar peduncle, on T2-weighted images. On Time-of-flight (TOF)-3-dimensional magnetic resonance angiography, there was a marked reduction of basilar artery signal. The digital subtraction angiography showed a vertebrobasilar system anomaly. The right vertebral artery was hypoplastic with few thin terminal spinal branches. The left vertebral artery was vicarious to the right one in intracranial tract. V3 to V4 tract showed multiple atherosclerotic wall irregularities. The basilar common trunk was absent. An abnormal posterior inferior cerebellar artery replaced the anterior inferior cerebellar artery and superior cerebellar artery. Right posterior inferior cerebellar artery, anterior inferior cerebellar artery, and superior cerebellar artery arose from ipsilateral V4 tract. This case is the first description of pure basilar agenesia. The symptoms might be related to temporary decrement of the flow in the left vertebral artery. Furthermore, the reverse dipping pattern together with the aging, hypertension, and diabetes had probably contributed to a hemodynamic malfunction of the cerebral vascular system.
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Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?
Pharmacoepidemiol Drug Saf
PUBLISHED: 09-17-2009
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Data mining on electronic health records (EHRs) has emerged as a promising complementary method for post-marketing drug safety surveillance. The EU-ADR project, funded by the European Commission, is developing techniques that allow mining of EHRs for adverse drug events across different countries in Europe. Since mining on all possible events was considered to unduly increase the number of spurious signals, we wanted to create a ranked list of high-priority events.
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A semantic approach for the homogeneous identification of events in eight patient databases: a contribution to the European eu-ADR project.
Stud Health Technol Inform
PUBLISHED: 09-12-2009
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The overall objective of the eu-ADR project is the design, development, and validation of a computerised system that exploits data from electronic health records and biomedical databases for the early detection of adverse drug reactions. Eight different databases, containing health records of more than 30 million European citizens, are involved in the project. Unique queries cannot be performed across different databases because of their heterogeneity: Medical record and Claims databases, four different terminologies for coding diagnoses, and two languages for the information described in free text. The aim of our study was to provide database owners with a common basis for the construction of their queries. Using the UMLS, we provided a list of medical concepts, with their corresponding terms and codes in the four terminologies, which should be considered to retrieve the relevant information for the events of interest from the databases.
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The EU-ADR project: preliminary results and perspective.
Stud Health Technol Inform
PUBLISHED: 09-12-2009
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The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we describe the project framework and the preliminary results.
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Drug safety information through the internet: the experience of an Italian website.
Drug Saf
PUBLISHED: 04-03-2009
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The Internet may play a crucial role in the prompt provision of updated drug safety information. Nevertheless, limited knowledge of the English language among healthcare professionals or suboptimal search skills constitute barriers to widespread and appropriate use of the Internet for this purpose in Italy. In order to provide accurate information on drug safety and to promote the reporting of adverse drug reactions, in 1999 the clinical section of the Italian Society of Pharmacology created the website www.farmacovigilanza.org, financially supported by a non-profit foundation. The website promptly and independently provides news published in the international literature on drug safety, translated into Italian. The site also contains specific sections dedicated to adverse reactions to herbal products and cosmetic preparations.
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Use of antipsychotics in elderly patients with dementia: do atypical and conventional agents have a similar safety profile?
Pharmacol. Res.
PUBLISHED: 03-18-2009
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Pharmacological treatment of dementia addresses two main clinical features of the disease: cognitive deterioration with predominantly memory loss and behavioural and psychological symptoms (BPSD). While cholinesterase inhibitors are recommended in an attempt to delay memory loss and disability, what should be considered the most appropriate pharmacological treatment for BPSD has remained questionable. Antipsychotic medications, conventional and atypical agents, have been increasingly utilized in clinical practice but only a small number of clinical studies have investigated their relative cost-benefit ratio. This review focuses on the safety of atypical and conventional antipsychotics when used in patients with BPSD. Overall, atypical and conventional antipsychotics are associated with a similarly increased risk for all-cause mortality and cerebrovascular events. Relative to atypical agents users, patients being treated with conventional antipsychotics have an increased incidence of cardiac arrhythmias and extrapyramidal symptoms. Conversely, users of atypical antipsychotics are exposed to an increased risk of venous thromboembolism and aspiration pneumonia. Also, metabolic effects (i.e. increased risk of diabetes, weight gain) have consistently been documented in clinical studies with atypical antipsychotics, although this effect tends to be attenuated with advancing age and in elderly patients with dementia. Antipsychotics, both conventional and atypical, should be used with caution only when nonpharmacologic approaches have failed to adequately control BPSD. More effective interventions are necessary to improve postmarket drug safety in vulnerable populations.
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Newer and older antiepileptic drug use in Southern Italy: a population-based study during the years 2003-2005.
Epilepsy Res.
PUBLISHED: 02-23-2009
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To analyse the prescribing pattern of newer and older antiepileptic drugs (AEDs) during the years 2003-2005.
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Acute cerebellar ataxia following meningococcal group C conjugate vaccination.
J. Child Neurol.
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Acute cerebellar ataxia is the most common cause of childhood ataxia, usually resulting from infections or vaccinations. Cases of acute cerebellar ataxia have been reported as a consequence of several viral and bacterial infections as well as immunizing agents, such as varicella, influenza, hepatitis B, and diphtheria-pertussis-tetanus vaccines. Although immunization with meningococcal group C conjugate vaccines has been associated with several neurological side effects, acute cerebellar ataxia has not been previously reported. The authors describe a case of a 12-year-old girl exhibiting acute cerebellar ataxia following meningococcal group C conjugate vaccination. In this patient, cerebellar symptoms started within 24 hours from the vaccination, and infective causes have been ruled out by serum and liquoral analyses. Magnetic resonance imaging findings were normal. Progressive clinical improvement was obtained after corticosteroid treatment. This case increases the small number of postvaccinal ataxias and contributes to further clarifying the complex pathogenesis of this disorder.
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Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU-ADR project.
J Am Med Inform Assoc
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The aim of this research was to automate the search of publications concerning adverse drug reactions (ADR) by defining the queries used to search MEDLINE and by determining the required threshold for the number of extracted publications to confirm the drug/event association in the literature.
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Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project.
J Am Med Inform Assoc
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Data from electronic healthcare records (EHR) can be used to monitor drug safety, but in order to compare and pool data from different EHR databases, the extraction of potential adverse events must be harmonized. In this paper, we describe the procedure used for harmonizing the extraction from eight European EHR databases of five events of interest deemed to be important in pharmacovigilance: acute myocardial infarction (AMI); acute renal failure (ARF); anaphylactic shock (AS); bullous eruption (BE); and rhabdomyolysis (RHABD).
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The EU-ADR corpus: annotated drugs, diseases, targets, and their relationships.
J Biomed Inform
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Corpora with specific entities and relationships annotated are essential to train and evaluate text-mining systems that are developed to extract specific structured information from a large corpus. In this paper we describe an approach where a named-entity recognition system produces a first annotation and annotators revise this annotation using a web-based interface. The agreement figures achieved show that the inter-annotator agreement is much better than the agreement with the system provided annotations. The corpus has been annotated for drugs, disorders, genes and their inter-relationships. For each of the drug-disorder, drug-target, and target-disorder relations three experts have annotated a set of 100 abstracts. These annotated relationships will be used to train and evaluate text-mining software to capture these relationships in texts.
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Adherence to gastroprotection during cyclooxygenase 2 inhibitor treatment and the risk of upper gastrointestinal tract events: a population-based study.
Arthritis Rheum.
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Guidelines recommend coprescription of gastroprotective agents (GPAs) in patients receiving cyclooxygenase 2 inhibitors (coxibs) who are at high risk of upper gastrointestinal (UGI) tract complications (i.e., patients with a previous complicated ulcer or with multiple risk factors). Suboptimal GPA adherence has been shown to diminish the gastroprotective effect during use of nonselective nonsteroidal antiinflammatory drugs, but little is known about the effect of GPA adherence during coxib treatment. We undertook this study to determine the association between GPA adherence and UGI tract events among patients receiving coxibs.
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How much are biosimilars used in southern Italy?: a retrospective analysis of epoetin utilization in the local health unit of Messina in the years 2010-2011.
BioDrugs
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Epoetins are one of the three biologics for which biosimilars are available in Italy. So far, there is a lack of Italian national/regional longitudinal data about epoetin use.
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Adverse drug reaction-related hospitalizations in persons aged 55 years and over: a population-based study in the Netherlands.
Drugs Aging
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Elderly individuals appear to be particularly at risk of developing adverse drug reactions (ADRs) because of higher rates of polypharmacy, age-related pharmacokinetic changes, pharmacodynamic variations and substantial co-morbidity levels. Thus, the increasing contribution of elderly individuals to the total population means ADR-related hospitalizations are expected to become more frequent. However, a recent study conducted in the Netherlands found that ADR-related hospitalizations had stabilized during the years 1997-2007. Nonetheless, this study did not take into account the number of medicines used.
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Risk minimization activities of centrally authorized products in the EU: a descriptive study.
Drug Saf
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: Since the new legislation on risk management, which came into force in November 2005, an EU Risk Management Plan (EU-RMP) is a required part of the authorization dossier of innovative drugs licensed in the EU. The EU-RMP can include additional risk minimization activities (RMAs) to strengthen the benefit-risk balance of a drug. This study describes the additional RMAs of centrally authorized medicinal products authorized between 1 January 1995 and 1 January 2010.
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Electronic healthcare databases for active drug safety surveillance: is there enough leverage?
Pharmacoepidemiol Drug Saf
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To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases.
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What is Visualize?

JoVE Visualize is a tool created to match the last 5 years of PubMed publications to methods in JoVE's video library.

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In developing our video relationships, we compare around 5 million PubMed articles to our library of over 4,500 methods videos. In some cases the language used in the PubMed abstracts makes matching that content to a JoVE video difficult. In other cases, there happens not to be any content in our video library that is relevant to the topic of a given abstract. In these cases, our algorithms are trying their best to display videos with relevant content, which can sometimes result in matched videos with only a slight relation.