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Event Monitoring (event + monitoring)
Selected AbstractsThe Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event MonitoringJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2007STEVEN A. ROTHMAN M.D. Introduction: Ambulatory electrocardiographic monitoring systems are frequently used in the outpatient evaluation of symptoms suggestive of a cardiac arrhythmia; however, they have a low yield in the identification of clinically significant but infrequent, brief, and/or intermittently symptomatic arrhythmias. The purpose of this study was to compare the relative value of a mobile cardiac outpatient telemetry system (MCOT) with a patient-activated external looping event monitor (LOOP) for symptoms thought to be due to an arrhythmia. Methods and Results: The study was a 17-center prospective clinical trial with patients randomized to either LOOP or MCOT for up to 30 days. Subjects with symptoms of syncope, presyncope, or severe palpitations who had a nondiagnostic 24-hour Holter monitor were randomized. The primary endpoint was the confirmation or exclusion of a probable arrhythmic cause of their symptoms. A total of 266 patients who completed the monitoring period were analyzed. A diagnosis was made in 88% of MCOT subjects compared with 75% of LOOP subjects (P = 0.008). In a subgroup of patients presenting with syncope or presyncope, a diagnosis was made in 89% of MCOT subjects versus 69% of LOOP subjects (P = 0.008). MCOT was superior in confirming the diagnosis of clinical significant arrhythmias, detecting such events in 55 of 134 patients (41%) compared with 19 of 132 patients (15%) in the LOOP group (P < 0.001). Conclusions: MCOT provided a significantly higher yield than standard cardiac loop recorders in patients with symptoms suggestive of a significant cardiac arrhythmia. [source] Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindolePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2003Nicholas Moore Abstract Background Automated measures of reporting disproportionality in databases of spontaneous reports of adverse drug reactions are an emerging tool to identify drug-related alerts. Sertindole, a new atypical neuroleptic known to prolong the QT interval, was suspended in November 1998 because the proportion of reports of fatal reactions suggesting arrhythmia among all reports with sertindole was almost ten times higher than that for other atypical neuroleptics in the UK. This excess risk was not predicted in preclinical data and had not been found in premarketing trials. Method Reporting patterns over time were analysed. Prescription Event Monitoring (PEM) studies and a large retrospective cohort allowed for the comparison of actual death rates with atypical neuroleptics, and to assess which proportion of the deaths that occurred were reported. Results There were indications of possible skewing of reporting related to notoriety, surveillance and market size effects. Death rates in PEM studies were essentially similar between sertindole and other neuroleptics. Cardiac deaths had been two to three times more often reported than other causes of death. Conclusion Proportional reporting ratios indicate differential reporting of possible reactions, not necessarily differential occurrence. There was no indication of an actual increase of risk of all causes or cardiac deaths during sertindole treatment, but only an increased risk of its being reported. The suspension of sertindole was rescinded by Committee on Proprietary Medicinal Products (CPMP) in October 2001. Copyright © 2003 John Wiley & Sons, Ltd. [source] Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring ProgrammePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2001DTM&H, David M. Coulter MB Abstract Purpose The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. Methods The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. Results Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. Conclusion Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information. Copyright © 2001 John Wiley & Sons, Ltd. [source] Prospective cohort study of adverse events monitored by hospital pharmacistsPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2001Angela Emerson BPharm, MRPharmS Abstract Purpose To examine the feasibility of pharmacist-led intensive hospital monitoring of adverse events (AEs) associated with newly marketed drugs. Subjects/setting 303 patients admitted to Southampton Hospitals who were prescribed selected newly marketed drugs during their inpatient stay in 1998. Methods Prospective observational study. Patients were identified from computerized pharmacy records, clinical pharmacist ward rounds, dispensary records or via nursing staff. The pharmacist reviewed medical notes and recorded AEs, suspected adverse drug reactions (ADRs) and reasons for stopping drugs. Outcomes Incidence of AEs, ADRs; proportionate agreement between the physician's and pharmacist's event recording. Results 303 patients were monitored. Of the patients taking newly marketed drugs 92% were identifiable using pharmacy computer systems and pharmacist ward visits. There were 21 (7%) suspected ADRs detected during this pilot study. The types of adverse events detected were broadly similar to those identified by general practice-based prescription event monitoring. However, biochemical changes featured more frequently than in general practice. Differences between adverse events recorded by pharmacist and physician were systematic and attributed to differences in event coding. Conclusion Pharmacist-led monitoring in a typical NHS hospital setting was effective at detecting ADRs in newly marketed drugs. However, this effort might have been substantially less time-consuming and more effective were electronic patient records (EPRs) available. Pharmacy computer systems are not designed to be patient focused and are therefore unable to identify patients taking newly marketed drugs. It is argued that future EPR and computerised patient-specific prescribing systems should be designed to capture this data in the same way as some US systems are currently able to do. Copyright © 2001 John Wiley & Sons, Ltd. [source] A Cumulative Sum scheme for monitoring frequency and size of an eventQUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, Issue 6 2010Zhang Wu Abstract This article proposes a Cumulative Sum (CUSUM) scheme, called the TC-CUSUM scheme, for monitoring a negative or hazardous event. This scheme is developed using a two-dimensional Markov model. It is able to check both the time interval (T) between occurrences of the event and the size (C) of each occurrence. For example, a traffic accident may be defined as an event, and the number of injured victims in each case is the event size. Our studies show that the TC-CUSUM scheme is several times more effective than many existing charts for event monitoring, so that cost or loss incurred by an event can be reduced by using this scheme. Moreover, the TC-CUSUM scheme performs more uniformly than other charts for detecting both T shift and C shift, as well as the joint shift in T and C. The improvement in the performance is achieved because of the use of the CUSUM feature and the simultaneous monitoring of T and C. The TC-CUSUM scheme can be applied in manufacturing systems, and especially in non-manufacturing sectors (e.g. supply chain management, health-care industry, disaster management, and security control). Copyright © 2009 John Wiley & Sons, Ltd. [source] | ||||||||||