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The Open Microscopy Environment (OME) Data Model and XML file: open tools for informatics and quantitative analysis in biological imaging.

The Open Microscopy Environment (OME) defines a data model and a software implementation to serve as an informatics framework for imaging in biological microscopy experiments, including representation of acquisition parameters, annotations and image analysis results. OME is designed to support high-content cell-based screening as well as traditional image analysis applications. The OME Data Model, expressed in Extensible Markup Language (XML) and realized in a traditional database, is both extensible and self-describing, allowing it to meet emerging imaging and analysis needs.

Computational Biology↗

The PAH mutation analysis consortium database: update 1996.

A website (http://www.mcgill.ca/pahdb ) is maintained by the curators for a Consortium (88 investigators, 28 countries) and all other users; it serves a relational database for human locus-specific genetic variation in a defined DNA sequence (GenBank U49897); (100 kb on human chromosome 12q24.1, gene symbol PAH). The intragenic nucleotide variation is both rare (Q< 0.01), extensive (>320 different mutations) and phenotype modifying, causing hyperphenylalaninemia by impairing phenylalanine hydroxylase function (see OMIM 261600), as well as polymorphic and neutral, the latter providing informative locus-specific haplotypes (>1200 different mutation/haplotype associations). The PAH database contains both offline core components (mutations, population associations and data source information) and several accessory online components: (i) relative frequencies of mutations by populations/regions (expanding file); (ii) data on genotype- phenotype correlations both in vitro and in vivo (new file); (iii) polymorphic haplotype structures (new file); (iv) intron sequence data (new file for design of primers); (v) description of mouse homologues (new file for mutations and phenotypes); (vi) the predicted PAH gene mutability profile (improved graphic); (vii) a clinical field for patient use (new interface with database). The website home page has been revised and a counter is recording >15 visits per day. Linkages to other mutation databases and an alliance of mutation database curators (new) are expanding. The primary 'electronic publication' reports now vastly exceed print reports. PAHdb serves as a prototype for obtaining, storing and distributing records of human genetic variation.

Animals↗

Risk factors for motor vehicle collision-related eye injuries.

OBJECTIVE: To evaluate the association between specific occupant, collision, and vehicle characteristics and the risk of motor vehicle collision (MVC)-related eye injury. METHODS: The 1988-2001 National Automotive Sampling System Crashworthiness Data System files were used. The Crashworthiness Data System is a national probability sample of passenger vehicles involved in police-reported tow-away MVCs. The risk of eye injury was calculated according to specific occupant (eg, age, seat belt use) and collision (eg, DeltaV [estimated change in velocity], vehicular intrusion) characteristics. The association between eye injury and these characteristics was calculated using risk ratios and associated 95% confidence intervals. RESULTS: The incidence of eye injuries in MVCs has progressively increased since 1998. Frontal air bag deployment was associated with a statistically significant, 2-fold (risk ratio, 2.13 [95% confidence interval, 1.56-2.91]) increased risk of eye injury, whereas seat belt use was associated with a 2-fold (risk ratio, 2.17 [95% confidence interval, 1.89-2.44]) reduced eye injury risk. In late-model vehicles, frontal air bags are the most common cause of MVC-related eye injury. Older age, female sex, seat position, vehicle weight, and collision severity were also associated with eye injury risk. CONCLUSIONS: Seat belt use is the most effective means of occupant protection against MVC-related eye injury. For front-seated occupants in frontal collisions, the adverse effect of frontal air bags on the risk of eye injury should be considered against their protective effect for fatal injury.

Accidents, Traffic↗

Collection and storage of data for evoked potential studies: a database.

A detailed description of a set of programs is presented which is designed for use with subjects tested in a research laboratory primarily with visual evoked potentials (VEPs). It has been written in a way which accommodates other modalities such as brain-stem auditory evoked potentials (BAEPs) and somatosensory evoked potentials (SEPs). It can be used in a clinic or a hospital for collecting patient information, data recordings, and analysis. The programs are implemented on an LSI-11/23 microcomputer and allow for initial subject data entry, entry of data acquired at subsequent visits, data analysis, lists of patient files and data sorts and tabulations. In their present form they are intended to be run by a staff who have little experience with computers and technical skills.

Computers↗

Peritoneal dialysis adequacy and risk of death.

BACKGROUND: The purpose of this study was to evaluate the relationship between dialysis dose, patient characteristics, and medical comorbidities on mortality in chronic peritoneal dialysis patients. METHODS: This work comprised a study cohort of 1446 patients obtained from a random sample of chronic peritoneal dialysis patients from each dialysis center in three southeastern states. Data collected on a standardized form were used to calculate weekly Kt/V urea and creatinine clearance. Data were linked to Network files containing data on patient demographic and medical comorbidities. RESULTS: Both weekly Kt/V urea and creatinine clearance were measured at least once in only 60.5% of continuous ambulatory peritoneal dialysis (CAPD) patients and 63.7% of cycler patients. Among the 873 patients who had at least one calculable adequacy measure, the mean (+/-SD) weekly Kt/V urea was 2.13 +/- 0.55, and the normalized mean weekly creatinine clearance was 62.9 +/- 20.4 L/week/m2. During the seven month period of follow-up, there were 140 deaths. In separate logistic regression models that included all of the studied risk factors, using separate variables for the urinary and peritoneal components of dialysis adequacy, each 10 L/week/1.73 m2 increase in the urinary component of weekly creatinine clearance was associated with a 40% decreased risk of death, and each 0.1 unit increase in the urinary component of weekly Kt/V urea was associated with a 12% decreased risk of death. In contrast, the dialysate components of neither weekly creatinine clearance nor weekly Kt/V urea were predictive of death. Other factors that were associated with an increased risk of death included increasing age, diabetes mellitus as the cause of end-stage renal disease (ESRD), and a history of myocardial infarction. CONCLUSIONS: Residual renal function, as expressed by weekly creatinine clearance or Kt/V urea, is an important predictor of death in chronic peritoneal dialysis patients. The nonsignificant findings regarding peritoneal clearances and mortality may possibly be secondary to the narrow range of peritoneal clearances in this study cohort.

Adolescent↗

Risk factors for rupture of abdominal aortic aneurysm based on three-dimensional study.

PURPOSE: Factors influencing the development or rupture of abdominal aortic aneurysms (AAAs) have not yet been confirmed. This study delineated the risk factors for rupture of AAAs as evaluated by means of a combination of three-dimensional (3D) reconstruction and clinical data analysis. METHODS: The study population comprised Japanese patients in whom an atherosclerotic AAA had been diagnosed between January 1980 and December 1997. We obtained 3D-based data by means of computer-aided 3D reconstruction from computed tomography studies of AAAs. The data included the tortuosity of the aneurysm, maximum transverse diameter, length of the aneurysm, aneurysmal volume, aneurysmal surface area, largest aneurysmal cross-sectional area, ratio of transverse aneurysmal diameter to the length of the aneurysm (T/L), and amount of mural thrombus. Clinical data were collected from patient files. All data were assessed by means of multivariate analysis for their predictive value for expansion or rupture of AAA. RESULTS: The most efficient predictor of annual expansion rate of maximum transverse diameter (EX-D) was a combination of largest aneurysmal cross-sectional area, tobacco use, and tortuosity. The most efficient predictor of annual expansion rate of aneurysmal volume (EX-V) was a combination of aneurysmal volume and blood urea nitrogen level. The most efficient predictors of aneurysmal rupture was a combination of EX-D, diastolic blood pressure, and T/L. CONCLUSION: Three-dimensional-based data on aneurysmal morphology, including T/L, largest aneurysmal crosssectional area, and aneurysmal volume, had strong predictive value for expansion and rupture of AAAs.

Aged↗

Methadone-related deaths and mortality rate during induction into methadone maintenance, New South Wales, 1996.

The aims of this study were to describe the causes of death in cases found positive for methadone post-mortem, the proportion of cases involving methadone syrup, and of this group, the proportion not registered in methadone maintenance treatment (MMT) at time of death, and the number of deaths during induction into MMT in New South Wales in 1996. Coronial files of cases were reviewed. Data on file with the Pharmaceutical Services Branch, NSW Health Department on number of people admitted to and discharged from MMT in 1996, and details of methadone treatment for cases in MMT, were examined. Eighty-seven methadone positive cases were identified, of which 62 (71%) died of drug-related causes. Of 9835 people inducted into MMT in 1996, seven died within the first 7 days (21% of all deaths in MMT), for an overall mortality rate (MR) of 7.1 deaths per 10,000 inductions (95% CI 1.8-12.4). Fifty-one per cent (51%) of methadone syrup-related cases occurred in people not registered in MMT. This high proportion of diversion related deaths continues to be of concern. The findings reinforce to providers of MMT the necessity of careful procedures for initiation of treatment and support the need for ongoing surveillance of methadone related deaths both in and out of MMT.

Adult↗

Lamotrigine: an antiepileptic agent for the treatment of partial seizures.

OBJECTIVE: To review the current literature on lamotrigine and its use as an antiepileptic drug (AED). DATA SOURCES: MEDLINE and bibliographic literature searches pertaining to lamotrigine were performed. Additionally, Burroughs Wellcome provided a comprehensive bibliography, data on file, and investigator's brochure. DATA SELECTION: The selection of reported data for this review includes both controlled and uncontrolled studies as well as case reports and unreported data from both European and US trials. DATA SYNTHESIS: Lamotrigine is effective as an adjunctive agent in the treatment of complex and simple partial seizures with or without secondary generalization. Anecdotal reports suggest that the spectrum of activity may include other seizure types, but controlled studies substantiating these reports are needed. Lamotrigine has a favorable pharmacokinetic profile, including a long half-life, low serum protein binding, and lack of mixed-function oxidase enzyme induction. It is likely that the drug induces metabolism through the glucuronidation pathway, although probably not to a clinically significant extent. Concurrent use of enzyme-inducing AEDs increase lamotrigine's clearance, whereas valproic acid decreases it. Adverse effects are primarily central nervous system-related, with dizziness, diplopia, ataxia, and somnolence reported in at least 10% of the patients treated. The incidence of these effects is higher in patients treated concomitantly with carbamazepine and may represent a pharmacodynamic interaction. The occurrence of rash may limit lamotrigine's use and was the most common cause for discontinuation in clinical trials (2.3%). The incidence of rash is higher in patients comedicated with valproic acid. CONCLUSIONS: Lamotrigine appears to be a safe and effective new AED for patients with refractory partial seizures when used as an adjunctive agent. It has a favorable pharmacokinetic profile allowing for once- or twice-daily dosing and adverse effects appear mild and transient. Additional studies are required to confirm efficacy in other seizure types.

Adolescent↗

Ceftibuten: a new expanded-spectrum oral cephalosporin.

OBJECTIVE: To review the antimicrobial activity, pharmacokinetics, clinical efficacy, and tolerability of ceftibuten, a new expanded-spectrum oral cephalosporin. DATA SOURCES: Literature was identified by a MEDLINE search (January 1983-June 1996) of the medical literature, review of English-language literature and bibliographies of these articles, and data on file. STUDY SELECTION: Clinical efficacy data were selected from all published and unpublished trials and abstracts that mentioned ceftibuten. Additional information concerning in vitro susceptibility, safety, chemistry, and pharmacokinetic profile of ceftibuten also was reviewed. DATA SYNTHESIS: Ceftibuten, an oral expanded-spectrum cephalosporin, has a broad spectrum of activity against many gram-negative and selected gram-positive organisms, including Streptococcus pneumoniae, Streptococcus pyogenes, Moraxella catarrhalis, and Haemophilus influenzae. Ceftibuten is stable to hydrolysis by many common beta-lactamases. Ceftibuten is rapidly and almost completely absorbed from the gastrointestinal tract and is primarily eliminated renally as unchanged drug. The elimination half-life of ceftibuten is slightly longer than 2 hours. Efficacy has been demonstrated in a number of clinical trials in adults and children with upper and lower respiratory tract infections (e.g., acute otitis media, pharyngitis, sinusitis, bronchitis) and urinary tract infections. The adverse effect profile is equal to that of comparator agents. CONCLUSIONS: Ceftibuten is an alternative to other antimicrobial agents with convenient once-daily dosing in the treatment of upper and lower respiratory tract infections. Similar to other oral expanded-spectrum cephalosporins, ceftibuten has antimicrobial activity against common pathogens of the respiratory tract and is stable in the presence of many beta-lactamases. The clinical choice of an oral expanded-spectrum cephalosporin will be based on patient acceptance, frequency of administration, and cost.

Administration, Oral↗

Impact of laboratory testing on DRG coding and reimbursement--results of a data base research.

We filed an Australian data base with about 7 million well-documented clinical cases for comorbidities, which can be proven, supported or excluded by laboratory testing and which have an impact on DRG reimbursement. The result was a list of 123 DRGs being shifted to a higher severity level by documenting one out of 157 complications. For better visualization of the more than 4,000 combinations, we developed a computer program, which allows the laboratory to develop its own diagnostic pathways for these complications in a simple Excel format.

Australia↗

[A general solution to the linkage of anonymous medical data].

The necessity for confidentiality entails that most medical data on files do not allow for a precise identification of patients. A statistical pattern has been defined to assess the average difference between the real (unknown) number of patients in the file and the approximate number derived by linkage from indirect available data (date of birth, sex,...). An example is here given, which allows for the epidemiological use of anonymous data concerning hospitalized patients at the Assistance Publique-Hôpitaux de Paris. This method is of general application for all files of anonymous data.

Confidentiality↗

Co-morbidity of 'clinical trial' versus 'real-world' patients using cardiovascular drugs.

PURPOSE: To examine discrepancies between co-morbidity of patients included in pre-marketing clinical trials of cardiovascular drugs and patients from daily practice, representing the actual users after marketing, and to investigate the availability of data regarding co-morbidity in registration files. METHODS: Data were collected from phase III trials of registration files of 16 drugs, registered in the Netherlands in the period 1985 through 1994 for the indications hypertension, angina pectoris or hypercholesterolemia, and from a general practitioners database. Patients were selected who used drugs from the same therapeutic classes for the same indication as the patients in the pre-marketing trials. Prevalences of concomitant cardiovascular, endocrine and metabolic diseases were compared between pre- and postmarketing populations. Discrepancies were defined as more than 10% difference in prevalences. RESULTS: Data regarding co-morbidity were present in 13 out of 16 registration files and differed in format of reporting. For all indications, coexisting cardiovascular, endocrine and metabolic diseases were less prevalent in the pre-marketing populations, except ischemic heart disease, which was more prevalent coexisting with angina pectoris and hypercholesterolemia. Discrepancies were found for hypertensive disease, heart failure, diabetes mellitus and myocardial infarction. CONCLUSIONS: Phase III trials testing cardiovascular drugs included patients with concomitant cardiovascular, endocrine and metabolic diseases, but discrepancies were present with patients in daily practice. Development of guidelines for uniform collection and reporting of co-morbidity data in pre-marketing trials is recommended, as well as further utilization of data.

Angina Pectoris↗

Perl-speaks-NONMEM (PsN)--a Perl module for NONMEM related programming.

The NONMEM program is the most widely used nonlinear regression software in population pharmacokinetic/pharmacodynamic (PK/PD) analyses. In this article we describe a programming library, Perl-speaks-NONMEM (PsN), intended for programmers that aim at using the computational capability of NONMEM in external applications. The library is object oriented and written in the programming language Perl. The classes of the library are built around NONMEM's data, model and output files. The specification of the NONMEM model is easily set or changed through the model and data file classes while the output from a model fit is accessed through the output file class. The classes have methods that help the programmer perform common repetitive tasks, e.g. summarising the output from a NONMEM run, setting the initial estimates of a model based on a previous run or truncating values over a certain threshold in the data file. PsN creates a basis for the development of high-level software using NONMEM as the regression tool.

Computer Simulation↗

Development of on-line real-time menu management system.

An on-line, real-time menu management system was developed as a module of the integrated computer-assisted food management system implemented at the University of Missouri-Columbia Health Sciences Center Department of Nutrition and Dietetics. This system supplants a former automated form generating system and permits flexibility in menu design. The major data base in the system is the Master Menu File, which is updated using real-time processing. This file contains data about each occurrence of menu items and is interfaced with existing recipe files to produce numerous printed documents and to display the menu on a video display terminal. The major benefits of the system are flexibility and elimination of typing of worksheets. Entering a new menu or changes to the menu require only a brief amount of time; new revised documents relative to the menu can be generated on the same day. Some of the types of documents available from this system are: master menu, nutrient syllabi, menu audit, and food production forms. The menu is available on-line at all times for reference by dietitians and supervisors. The Master Menu File will be utilized more fully as new modules are designed to interface with the Menu Management System. Production forecasting, patient menu printing, and individualized diet planning are three potential enhancements to the system which will utilize data in the Master Menu File. The file was designed to accommodate additional data as the system in further matured.

Food Service, Hospital↗

User discipline in a personal computer-based filing of ultrasound records.

The discipline of entering ultrasound examination data in a personal computer file was studied over two periods. During the first period (19 weeks), the use of the computer was limited to one laboratory. During the second period (14 weeks), the computer was shared by three laboratories operating in nearby premises. During the study, 2857 (89%) of a total of 3209 ultrasound examinations performed were duly recorded in the data file. The frequency of failure to enter data was markedly higher during the second period (7-45%) than during the first period (5%) of the study. Overall, there was a highly significant (p less than 0.001) tendency to enter pathological findings at the expense of normal and non-diagnostic findings. The ease of access to the computer and the number of examinations recorded appear to determine user conscientiousness in filing data. Selection and omission of data impair the usefulness of the data log in research.

Humans↗

Extensible biosignal (EBS) file format: simple method for EEG data exchange.

Increasing use of computer technology in EEG research requires the creation of standardized data formats to transmit, exchange, analyze or modify mainly EEG/MEG as well as mere general polygraphic data. The extensible biosignal file format (EBS) has been designed for easy use. The concept of the EBS format is a simple structure of variable size, consisting of one fixed and two variable headers and a data section. In the variable header, any information can be stored in attributes. The data are archived in one of 3 organizational forms: channel order, temporal order, or compressed. The format supports various data types, multiple biosignals (ECG, EEG, MEG, polygraph), annotations, processing history, location diagrams (CGM), 16 hit ISO 10646 character set, random access to large amounts of data, global or private extensions, self-identification, and multiple tools for conversion, modification and visualization which are freely available in source code.

Brain↗

Are national hospital data adequate for coding injury severity?

The purpose of this study was to determine whether accurate severity scores, using the abbreviated injury scale (AIS), could be produced from hospital discharge data held on the National Health Statistics Centre (NHSC) computer files. The data from two New Zealand trauma studies, in which AIS scores had been assigned to patient injuries, were linked to the patient data on NHSC computer files and AIS scores assigned for those injuries that were present. Sixty-five percent of the injuries for which a link was made were scorable and of these, there was 54% agreement between the AIS scores generated from NHSC data and the scores from the trauma studies. Percent agreement varied with body area, whether the injury was from a single or multiple injury victim, and with the severity of injury. Recommendations include a revision of data collection and NHSC data coding to incorporate AIS scores, and to educate medical personnel regarding AIS in order that they collect appropriate information so that AIS may be coded on the patient's discharge form.

Data Collection↗

Absence of relation between sick leave caused by musculoskeletal disorders and exposure to magnetic fields in an aluminum plant.

This is a study of the relationship between occupational exposure to magnetic fields in pot rooms and occurrence of sick leave caused by musculoskeletal disorders. The average exposure to static magnetic fields was 8 mT in the pot rooms. Ripple fields were recorded as well. A cohort of 342 exposed workers and 222 unexposed workers from the same electrolysis plant was retrospectively followed for 5 years. The reference group had a type of work similar to the exposed group except for the exposure to magnetic fields. The occurrence of sick leave and the diagnoses causing the sick leave were obtained from the Occupational Health Care Unit: these data were stored in their computer files. The data were complete. No relationship between the occurrence of sick leave caused by musculoskeletal disorders and exposure to magnetic fields was found. This was the case for both the annual number of periods of sick leave and the total number of days with sick leave. The results must be interpreted with caution due to limitations in the design and available data. Also, static magnetic fields constituted the major exposure, and the results may be different when related to work in other types of magnetic-field exposure.

Adult↗