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Electronic Records (electronic + record)
Selected AbstractsMonitoring individual compliance in glaucoma patients used to topical therapyACTA OPHTHALMOLOGICA, Issue 2007AM BRON Purpose: Individual compliance with Brimonidine eye drops was studied in glaucoma patients and ocular hypertensives. Methods: Conventional Brimonidine vials were equipped with a microprocessor-controlled monitoring device capable to record date and time of each eye drop application including ambient temperature. After written informed consent, glaucoma and ocular hypertensive patients used to eye drop therapy were randomly assigned to Brimonidine therapy b.i.d or t.i.d daily for 4 weeks. Results: Twenty six males and fourteen females aged 69 ± 11 years [42-89] were enrolled in this study. According to the monitoring devices all patients were non-compliant with regard to total dose and coverage. Electronic records revealed a mean of 1.5 (range: 1.1-2.0) applications per day for patients assigned to Brimonidine 2x daily with a mean treatment interval of 16.8 hours (range: 12.1-22.2 h). Patients on Brimonidine 3x daily showed a mean rate of 1.9 (range: 1.8-2.7) applications per day and a mean treatment interval of 11.9 h (range: 9.1-13.9 h). One patient discontinued therapy after day 7 (12 applications) and one after day 1 (1 application only). No difference was observed between IOP at baseline and after one month (p=0.16). Conclusions: The monitoring devices permit to detect individual non-compliance with regard to missed doses, non-treatment intervals. Our data confirm the need for larger studies on individual compliance with topical ocular therapy in glaucoma. [source] Monitoring the care of lung cancer patients: linking audit and care pathwaysJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2001E. Kaltenthaler BSc Abstract Clinical audit plays an important role in monitoring the provision of care for patients whatever their condition. Care pathways define the steps and expected course of events in the care of patients with a specific clinical problem over a set time scale. This paper describes a study undertaken in a multisite cancer unit to develop a tool for monitoring the progress of lung cancer patients through a care pathway and auditing key standards within the pathway. Important issues associated with the development of this tool are highlighted. The process of developing this tool involved the following steps: a review of the literature dealing with the management of lung cancer patients; interviews with key personnel in primary, secondary, tertiary and palliative care; development of a paper-based series of forms representing key steps in the patient's care pathway; 3-month trial of the paper-based tool; analysis of completion rates and interviews with form users to evaluate effectiveness; and recommendations for creating an electronic record using the experience and lessons learned from the paper version. The paper forms developed through this multistage process were found to be acceptable to users and have the potential to provide accurate information at key points for audit throughout the patient's time within the health-care system for their lung cancer condition. The flexibility of this methodology allows it to be adapted readily to a variety of clinical situations and conditions. [source] Adapting Work Analysis to a Fast-Paced and Electronic Business WorldINTERNATIONAL JOURNAL OF SELECTION AND ASSESSMENT, Issue 4 2000Juan I. Sanchez The reliance of traditional job analysis on job incumbents as the primary source of work-analytic data is critically examined. It is argued that the sole use of incumbents is practically and theoretically unjustified. The incorporation of non-incumbents to the work analysis process is advocated, especially when abstract human attributes and strategic requirements are evaluated. The time and resource savings afforded by the use of mechanical estimation of work dimensions are also discussed. A revision of traditional formats of data collection in job analysis such as paper-and-pencil surveys and face-to-face interviews is proposed. Instead, the potential work-analytic uses of electronic records of work information nowadays available in electronic performance monitoring systems are outlined. [source] Technology survey indicates big case management problems from arbitration E-discovery are spreading, growing more expensiveALTERNATIVES TO THE HIGH COST OF LITIGATION, Issue 8 2009Deborah Rothman Handling discovery requests for electronic records has troubled judges, and is hitting arbitration processes hard. Deborah Rothman, of Los Angeles, and Thomas J. Brewer, of Seattle, surveyed members of a professional arbitrators' group to get a handle on how tribunals are dealing with the pervasive issues. In a concluding Part II next month, the authors predict E-discovery practices. [source] Formation process and preservation of a natural electronic archivePROCEEDINGS OF THE AMERICAN SOCIETY FOR INFORMATION SCIENCE & TECHNOLOGY (ELECTRONIC), Issue 1 2008Maria Esteva This paper presents a case of formation process study and preservation of the digital archive of a private organization. The archive was created in the late 1980's and maintained until 2005. The study was prompted by the archive's creators concerns about the resources involved, and the need to preserve their electronic records and systems vis-à-vis the presence of the signed and sealed paper documents. The approach used to study the digital archive was to consider it akin to an archaeological site. A formation process study of the archive's components was conducted using interview methods; primary and secondary sources; and metadata extraction, file viewers, and file transformation software. The study revealed information about the technical and social contexts involved in the archives' formation, and how its creators used it and valued it over time. The results informed the design of a preservation strategy aimed at maintaining the archives' integrity and authenticity and continuing documentation of its evolution. The attributes characterizing the archive led to the development of the concept of natural electronic archive. [source] Quality assurance implications for computerized systems following the Able Laboratories FDA InspectionQUALITY ASSURANCE JOURNAL, Issue 1 2006R. D. McDowall Abstract The quality assurance implications for hybrid systems (electronic records with handwritten signatures on the paper copies) following an inspection of a computerized system by the United States Food and Drug Administration (FDA) are explored. The major compliance problem occurred because the paper copies differed, sometime radically, from the electronic records contained within a chromatography data system. These non-compliances ultimately caused the inspected company to go bankrupt. Copyright © 2006 John Wiley & Sons, Ltd. [source] The road to compliance with electronic records and electronic signature rulesQUALITY ASSURANCE JOURNAL, Issue 4 2003Kathleen L. Reed Abstract Activities required for compliance with electronic records (e-records) and electronic signatures (e-signatures) rules go a long way toward meeting the Good Laboratory Practice (GLP) requirements for assuring the quality of the data collected and the overall integrity of the study. This paper describes one facility's journey on the road to compliance. Copyright © 2003 John Wiley & Sons, Ltd. [source] Linking data to electronic recordsQUALITY ASSURANCE JOURNAL, Issue 2 2003Heather Longden Abstract Today it is possible to maintain electronic records in a single application in compliance with 21 CFR Part 11. However, most electronic data for a sample in an analytical laboratory is spread across a number of software applications as well as traditional paper systems. This article will examine how it is possible to link both paper and electronic records together in hybrid systems. A case study is used to demonstrate the practical aspects of a totally electronic process. Copyright © 2003 John Wiley & Sons, Ltd. [source] 21 CFR Part 11: electronic records.QUALITY ASSURANCE JOURNAL, Issue 2 2002An interactive voice response system. Abstract A large full-service clinical research organization in the US needed to replace their legacy interactive voice response system which did not provide 21 CFR Part 11 compliant audit trails. They chose to custom-build the new software using C++ component architecture, eXtensible Markup Language (XML), Hypertext Markup Language (HTML), and Microsoft web telephony engine. The case study described in this article illustrates that when systems developers read, study, understand, and embrace 21 CFR Part 11 before designing and validating their product, the regulations are easily met. Copyright © 2002 John Wiley & Sons, Ltd. [source] Interleukin-6 genotype and risk for cerebral palsy in term and near-term infants,ANNALS OF NEUROLOGY, Issue 5 2009Yvonne W. Wu MD Objective Chorioamnionitis is associated with increased risk for cerebral palsy (CP) in term infants. A functional polymorphism in the interleukin-6 (IL-6) gene has been implicated in newborn brain injury. We studied whether the IL-6 -174 G/C polymorphism confers increased risk for CP in term infants. Methods This population-based case,control study included 334,333 live-born infants born at ,36 weeks gestation within Kaiser Permanente Medical Care Program from 1991 to 2002. Case patients (n = 250) were identified from electronic records and confirmed by chart review, and comprised all infants with spastic or dyskinetic CP not caused by developmental abnormalities who had a neonatal blood specimen available for study. Control patients (n = 305) were randomly selected from the study population. Results Compared with genotype GG, the less common CC genotype was associated with increased risk for overall CP (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.5,4.6), quadriparetic CP (OR, 4.1; 95% CI, 1.8,9.3), and hemiparetic CP (OR, 2.7; 95% CI, 1.3,5.7), after controlling for race. The C allele conferred increased risk for CP in both recessive and additive genetic models. In multivariate analysis controlling for race, independent risk factors for CP included CC genotype compared with GG (OR, 2.4; 95% CI, 1.3,4.4), clinical chorioamnionitis (OR, 4.6; 95% CI, 2.1,10.4), maternal age , 35 (OR, 2.6; 95% CI, 1.6,4.1), and male sex (OR, 1.6; 95% CI, 1.1,2.4). Interpretation Our data suggest that a functional polymorphism in the IL-6 gene is a risk factor for CP among term and near-term infants. Ann Neurol 2009;66:663,670 [source] Apgar score and dental caries risk in the primary dentition of five year oldsAUSTRALIAN DENTAL JOURNAL, Issue 3 2010AE Sanders Abstract Background:, Conditions in utero and early life underlie risk for several childhood disorders. This study tested the hypothesis that the Apgar score predicted dental caries in the primary dentition. Methods:, A retrospective cohort study conducted in 2003 examined associations between conditions at birth and early life with dental caries experience at five years. Dental examination data for a random sample of five-year-old South Australian children were obtained from School Dental Service electronic records. A questionnaire mailed to the parents obtained information about neonatal status at delivery (five-minute Apgar score, birthweight, plurality, gestational age) and details about birth order, weaning, and behavioural, familial and sociodemographic characteristics. Results:, Of the 1398 sampled children with a completed questionnaire (response rate = 64.6%), 1058 were singleton term deliveries among whom prevalence of dental caries was 40.1%. In weighted log-binomial regression analysis, children with an Apgar score of <=8 relative to a score of 9,10 had greater probability of dental caries in the primary dentition after adjusting for sociodemographic and behavioural covariates and water fluoridation concentration (adjusted PR = 1.47, 95% CI = 1.11, 1.95). Conclusions:, Readily accessible markers of early life, such as the Apgar score, may guide clinicians in identifying children at potentially heightened risk for dental caries and aid decision-making in allocating preventive services. [source] | |||||||||||||