Occurrence Rate Of Adverse Events Research Articles

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.

Retrievable filters are increasingly implanted for prophylaxis in patients without pulmonary embolism (PE) but who may be at transient risk. These devices are often not removed after the risk of PE has diminished. This study employs decision analysis to weigh the risks and benefits of retrievable filter use as a function of the filter's time in situ. Medical literature on patients with inferior vena cava (IVC) filters and a transient risk of PE were reviewed. Weights reflecting relative severity were assigned to each adverse event. The risk score was defined as weight× occurrence rate and combines the frequency and severity for each type of adverse event. The value function in the decision model combines thefollowing risks: (1) risk in situ; (2) risk of removal, and (3)relative risk without filters. A decreasing net risk score represents a net expected benefit, and an increasing net risk score indicates the expected harm outweighs the expected benefit. The net risk score reaches its minimum between day 29 and 54 postimplantation. This is consistent with an increasing net risk associated with continued use of retrievable IVC filters in patients with transient, reversible risk of PE. The results were insensitive to reasonable variations in the assessed weights and adverse event occurrence rates. For patients with retrievable IVC filters in whom the transient risk of PE has passed, quantitative decision analysis suggests the benefit/risk profile begins to favor filter removal between 29 and 54 days after implantation.

81 BACTERIAL INFECTIONS, ENDOTOXEMIA AND SYSTEMIC INFLAMMATION IN CIRRHOSIS ARE ASSOCIATED WITH AN IMBALANCE OF VON WILLEBRAND FACTOR (VWF) AND ITS CLEAVING PROTEASE ADAMTS13

patient received 3 times infusion every the fourth day, with a follow-up for 52 weeks. The criteria for Adverse Event (AE) was mainly in accordance to the NCI-CTCAE 4.0 version. The study got an approval from IRB, and all subjects have signed ICF before study enrollment (ClinicalTrials.gov identifier: NCT01342250). Results: 20 patients were recruited (14 male and six female, mean age 54.2±5.9 years) from Nov 2010 to May 2011. 17 of them were diagnosed as HBV, while one was HCV. All patients were tolerant with the infusion. Two patients died for complications after 6 months of the first infusion. The overall survival rate was 90% at week 52. The most common AEs were fever, neutrophilia, hyperammonemia, hyperbilirubinemia, and prolonged prothrombin time (PT). Only one SAE (prolonged PT) might be related to cells infusion according to the investigator’s assessment, but the patient recovered soon, and survives well until now. The occurrence rate of AE doesn’t increase with cell dose escalation. Meanwhile, the mean level of pre-albumin almost doubled after 12 months, and increased from 74.55 to 104.61 g/L (P < 0.01). Total protein, albumin (P < 0.05). The Child–Turcotte–Pugh (CTP) score and SF-36 questionnaire were also improved significantly at 6 and 12 months (P < 0.05). Until now, no tumor occurrence was detected during 18 months after the first infusion. Conclusions: It is safe and tolerant when the cells dose escalated to 2x10 cells/per infusion for DLC patients on the dose limiting toxicity (DLT) test. The study suggests that hUCMSCs could improve clinical outcomes at 52 weeks of follow-up for these patients. And we will initiate a series of muti-center, randomized, blinded studies to explore the safety and efficacy further.

Application of root cause analysis in the management of pediatric transfusion adverse events

Objective To investigate the application of root cause analysis (RCA) in the management of pediatric transfusion adverse events,in order to reduce the occurrence rate of adverse events in pediatric transfusion.Methods Root cause analysis method was used from October 2011 to March 2012.Occurrence rate of adverse events,double check and accuracy of transfusion were compared before and after the implementation of RCA.Results Six months before RCA,the occurrence rate of adverse events was 0.32％ and six months after RCA was 0.03％,and the difference was statistically significant (x2 =19.146,P ＜ 0.01).The rate of double check and accuracy of transfusion were respectively 100％ and 98％ after RCA,which were higher than those before RCA (74％ and 83％),and the differences were statistically significant (x2 =29.885,13.085,respectively; P ＜ 0.01).Conclusions Root cause analysis can effectively control related factors during pediatric transfusion,reduce the occurrence rate of adverse events and improve transfusion safety. Key words: Hospital, pediatrics; Safety management; Root cause analysis; Transfusion adverse events

Antipsychotics and seizures: Higher risk with atypicals?

PurposeAlmost all antipsychotics have been associated with a risk of epileptic seizure provocation. Among the first-generation antipsychotics (FGA) chlorpromazine appears to be associated with the greatest risk of seizures among the second-generation antipsychotics (SGA) clozapine is thought to be most likely to cause convulsions. This information is largely based on studies that are not sufficiently controlled. Besides, information about the seizure risk associated with newer antipsychotics is scarce. MethodThe Pharmacovigilance Unit of the Basque Country (network of centers of the Spanish Pharmacovigilance System, SEFV) provided reporting data for adverse reactions (AR) from the whole SEFV to estimate the reporting odds ratio (ROR) for antipsychotics and seizures (“convulsions” as Single MedDra Query). Data was obtained from SEFV database from 1984 to the June 2011. ResultsThe total number of convulsions reported for SGA was 169 (total reported AR 3.204). The number of convulsions reported for FGA was 35 (total reported AR 2.051). 94 convulsions were reported in association with clozapine (total AR 1.052). The ROR for SGA versus FGA was 3.2 (CI 95%: 2.21–4.63). The ROR for SGA excluding clozapine versus FGA was 2.08 (CI 95%: 1.39–3.12). ConclusionOur results show that SGA may pose a higher risk of seizures than FGA, mainly, but not only due to clozapine. This is line with recent studies suggesting that some SGA carried a higher average risk of electroencephalographic abnormalities than many FGA. Nonetheless, It is well known that spontaneous reports do not allow strong inferences about adverse drug effects, because differences in reporting fractions by time, drug or type of event are difficult or even impossible to distinguish from differences in the occurrence rates of adverse events. Still, we consider that the possibility of SGA carrying a higher risk of seizure induction than FGA warrants further research.

Comparison of the Effects of a New 32-Gauge×4-mm Pen Needle and a 32-Gauge×6-mm Pen Needle on Glycemic Control, Safety, and Patient Ratings in Japanese Adults with Diabetes

This study was designed to evaluate two pen needles (PNs) with the same diameter but different lengths (4 mm and 6 mm) and different needle tip shapes (straight and tapered) to compare their effects on glycemic control, perceived pain, safety, patients' ease of use and preferences, and visual impression. In this prospective, open-label, controlled crossover study, 41 insulin-treated patients with type 1 or type 2 diabetes were randomized into either Group 1 (the 32-gauge × 4-mm PN was used during Study Period 1, then the 32-gauge × 6-mm PN was used during Study Period 2) or Group 2 (the order for using the PNs was reversed). The 32-gauge × 4-mm PN provided an equivalent glycemic control in diabetes patients as the 32-gauge × 6-mm PN, with an equivalent occurrence rate of adverse events. The 32-gauge × 4-mm PN was perceived as significantly less painful and rated as significantly more favorable than the 32-gauge × 6-mm PN according to the survey results on patients' ease of use and preferences and on their visual impressions. The 32-gauge × 4-mm PN was not only as safe and efficacious as the 32-gauge × 6-mm PN, but also was perceived as less painful, easier to use, and more favorable to Japanese adult patients with diabetes.

P-036 Analysis of events reported in the MAUDE database comparing neuroform, enterprise, and pipeline devices

Introduction/PurposeWe report on data in the Manufacturer and User Facility Device Experience (MAUDE) database for Neuroform (Boston Scientific), Enterprise (Cordis), and Pipeline (Covidien) devices with a focus on a 6-month...

Anesthetic management of cardiac tamponade after dual-chamber implantable cardioverter defibrillator implantation in a patient with dilated cardiomyopathy

We report a case of cardiac tamponade in a patient with dilated cardiomyopathy after undergoing dual-chamber implantable cardioverter-defibrillator (ICD) implantation. General anesthesia was required for subxiphoid pericardiotomy. Although the occurrence rate of adverse events with ICDs has been reported to be high, the acute onset of significant cardiac tamponade is uncommon as a short-term complication of ICD implantation. We describe our anesthetic management of cardiac tamponade in the ICD patient with dilated cardiomyopathy.

Methods developed to elucidate nursing related adverse events in Japan.

Financial resources for quality assurance in Japanese hospitals are limited and few hospitals have quality monitoring systems of nursing service systems. However, recently its necessity has been recognized. This study has cost effectively used adverse event occurrence rates as indicators of the quality of nursing service, and audited methods of collecting data on adverse events to elucidate their approximate true numbers. Data collection was conducted in July, August and November 2000 at a hospital in Tokyo that administered both primary and secondary health care services (281 beds, six wards, average length of stay 23 days). We collected adverse events through incident reports, logs, check-lists, nurse interviews, medication error questionnaires, urine leucocyte tests, patient interviews and medical records. Adverse events included the unplanned removals of invasive lines, medication errors, falls, pressure sores, skin deficiencies, physical restraints, and nosocomial infections. After evaluating the time and useful outcomes of each source, it soon became clear that we could elucidate adverse events most consistently and cost-effectively through incident reports, check lists, nurse interviews, urine leucocyte tests and medication error questionnaires. This study suggests that many hospitals in Japan could monitor the quality of the nursing service using these sources.

A prospective study of simplified omeprazole suspension for the prophylaxis of stress-related mucosal damage.

To determine the efficacy, safety, and cost of simplified omeprazole suspension in mechanically ventilated critically ill patients who have at least one additional risk factor for stress-related mucosal damage. Prospective, open-label study. Surgical intensive care and burn unit at a university tertiary care center. Seventy-five adult, mechanically ventilated patients with at least one additional risk factor for stress-related mucosal damage. Patients received 20 mL of simplified omeprazole suspension (containing 40 mg of omeprazole) initially, followed by a second 20-mL dose 6 to 8 hrs later, then 10 mL (20 mg) daily. Simplified omeprazole suspension was administered through a nasogastric tube, followed by 5 to 10 mL of tap water. The nasogastric tube was clamped for 1 to 2 hrs after each administration. The primary outcome measure was clinically significant gastrointestinal bleeding determined by endoscopic evaluation, nasogastric aspirate examination, or heme-positive coffee ground material that did not clear with lavage, which was associated with at least a 5% decrease in hematocrit. Secondary efficacy measures were gastric pH measured 4 hrs after omeprazole was first administered, mean gastric pH after omeprazole was started, and the lowest gastric pH during omeprazole therapy. Safety-related outcomes included the occurrence rate of adverse events and pneumonia. No patient experienced clinically significant upper gastrointestinal bleeding after receiving omeprazole suspension. The 4-hr postomeprazole mean gastric pH was 7.1, the mean gastric pH after starting omeprazole was 6.8, and the mean lowest pH after starting omeprazole was 5.6. The occurrence rate of pneumonia was 12%. No patient in this high-risk population experienced an adverse event or a drug interaction that was attributable to omeprazole. Simplified omeprazole suspension prevented clinically significant upper gastrointestinal bleeding and maintained gastric pH of > 5.5 in mechanically ventilated critical care patients without producing toxicity.

Intrahospital transport of critically ill pediatric patients

To determine the frequency of adverse events during intrahospital transport; to determine the requirement of therapeutic interventions during transport; to test the hypothesis that adverse events that occur during intrahospital transport are due to the transport process itself; and to determine the factors that predict the occurrence of adverse events and the requirement of major therapeutic interventions during transport. A two-phase study in which data were prospectively collected. In phase I, we examined the occurrence rate of adverse events, the requirement for therapeutic interventions, and the factors that predicted adverse events and the requirement of therapeutic interventions. In phase II, we tested the hypothesis that adverse events during transport were due to the transport process itself. A 250-bed university children's hospital with a 50-bed intensive care unit (ICU). Phase I of the study consisted of one hundred and eighty intrahospital transports in 139 patients. These transports included patients who were transferred: a) to the ICU from the operating room, emergency department, or the general ward; b) from the ICU to the operating room; and c) from the ICU for diagnostic or therapeutic procedures. Phase II of the study consisted of 89 transports in 85 patients. None. Vital signs and oxygen saturation were measured before and during transport. In phase I, there were no adverse events in 23.9% of transports. There was a significant change in at least one physiologic variable in 71.7% of transports, and at least one equipment-related mishap in 10% of transports. At least one major intervention was performed in 13.9% of transports in response to physiologic deterioration or an equipment-related mishap. There were no arrests or deaths during transport. The requirement for a major procedure was 34.4% in mechanically ventilated patients vs. 9.5% in nonventilated patients. Logistic regression analysis showed that both pretransport Therapeutic Intervention Scoring System and the duration of transport were significantly associated with the requirement of a major intervention and physiologic deterioration, while only the duration of transport was associated with an equipment-related event. The age of the patient and the number of escorts accompanying the transport did not affect the frequency of adverse events. Before transport in phase II study patients, no patient became hypothermic, the changes in physiologic variables were always < 20%, and there was no change > or = 5% in oxygen saturation. Hypothermia occurred in 11.2% of transports. A > or = 20% change in heart rate (15.7%), blood pressure (21.3%), and respiratory rate (23.6%) was seen only during transport. A > 5% change in oxygen saturation (5.6%) was seen only during transport. Serious physiologic deterioration occurs during intrahospital transport of critically ill children. Severity of illness and the duration of transport are associated with the occurrence of adverse events during transport. The team composition and equipment required on transport must be commensurate with the pretransport severity of illness and the anticipated duration of transport.