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Digital optical archiving of medical records in hospital information systems--a practical approach towards the computer-based patient record?

The large number of inpatients and outpatients in university hospitals leads to high costs of medical documentation and to an increasing number of medical documents. Due to legal regulations, these medical records have to be stored for 30 years. This implies spatial, organizational, and economical problems. At present, conventional archiving in hospitals often does not satisfy the need to make medical records available for health-care professionals in a systematic and timely manner. From 1989 to 1993 a pilot study on "digital optical archiving of medical records" was carried out at Heidelberg University Hospital. The study has shown the feasibility of digital optical archiving in hospital s if done under certain conditions. In 1995, Heidelberg University Hospital adopted a procedure for "digital optical archiving of medical records". The digital optical archive will first be filled with the medical records of the department of neurosurgery and the endoscopic and echographic images and reports of the department of internal medicine. It is to be expected that this procedure will gradually lead to an integrated functionality on health-care professional workstations, to a hospital-wide use of an electronic patient record, and to media-independent document management systems. The paper focuses on the potentials of digital optical archiving as an integral part of hospital information systems, and on the requirements for the systematic managements of hospital information systems with respect to digital optical archives.

Archives↗

Detection of ALK gene rearrangements in formalin-fixed, paraffin-embedded tissue using a fluorescence in situ hybridization (FISH) probe: a search for optimum conditions of tissue archiving and preparation for FISH.

BACKGROUND: It is widely known that the efficiency of fluorescence in situ hybridization (FISH) probes applied to formalin-fixed, paraffin-embedded tissues is affected by the conditions under which the tissues are fixed and embedded. However, relatively few studies address exactly how tissue archiving conditions affect the performance of FISH probes. We report our experience based on use of an ALK FISH probe, during the validation of its diagnostic utility. METHODS: We applied the probe to 77 formalin-fixed, paraffin-embedded tissue blocks archived from 1991 through to 2000, and studied the interrelationship between the archival age (which ranged up to 10 years), type and condition of tissue, duration required for optimum hydrolysis, and obtainability of hybridization signals. RESULTS: We found that as archival age and tissue collagen content increased, not only did hydrolysis times have to be prolonged in order to yield interpretable hybridization signals, but also the likelihood of blocks becoming non-signaling increased. The most striking positive correlations were seen between the archival age of signaling lymphoid blocks and their requisite hydrolysis times. CONCLUSIONS: The difficulty in applying FISH on archival tissue increases with its archival age and collagen content, and may necessitate changes in laboratory protocol accordingly.

Anaplastic Lymphoma Kinase↗

The concept of archiving unedited and edited digital coronary angiograms.

Digital image data acquired during cardiac catheterization will soon be archived on standardized digital storage media. However, with the enormous amount of generated data, considerable time will be wasted at later reviewing or at conferences, or when performing additional quantitative studies. As a result major advantages of a digital acquisition and archiving technique will be lost. The concept of two way archiving includes an unedited (primary) digital archive as well as a (secondary) archive edited by operator guided "intelligent" data reduction (IDR). IDR is based upon the elimination of useless and redundant frame sequences (FS), documentation of coronary interventions on one representative single frame (F) and on the reduction of relevant FS and physiological data to and ECG-controlled representative cardiac cycle (CC). With a heart rate of 72/min and an acquisition rate of 12.5 F/s a documentation of each FS may be obtained with only 10 F. A redundancy-free set of 130 F of a diagnostic study as well as only 41-85 F of an interventional study will be archived on an individual 3.5" MOD or on a CD-R. Two cardiologists and two cardiosurgeons studied independently 24 IDR-edited and the corresponding unedited digital angiograms and found no significant differences in the diagnostically relevant coronary morphology and left ventricular function. IDR provides an edited digital coronary angiogram, e.g. a set of images free of redundance and without loss of relevant information. Uneditable FS can be archived in their unedited (primary) form. IDR is managed on-line by an operator interacting with the angiographer.

Angiography, Digital Subtraction↗

Retroactive DNA analysis for sex determination and dystrophin gene by polymerase chain reaction with archived cytogenetic slides.

We describe a rapid and efficient diagnostic method for sex determination and the dystrophin gene by the polymerase chain reaction (PCR) using archived cytogenetic slides. Archived cytogenetic slides stored for about 4 years at room temperature were used. To confirm whether DNA analysis is possible using the archived cytogenetic slides, we extracted the DNA from the slides and amplified the Y centromeric region (DYZ3), the X centromeric region (DXZ1) and the exon 46 of the dystrophin gene. Of the 50 cases, 24 were peripheral bloods, 13 were amniotic fluid cells, 5 were chorionic villus samplings and 8 were cord bloods. The PCR related sex determination in 22 females and 28 males, showed 100% concordance with the results of chromosome analysis, and all cases showed positive band for the exon 46 of the dystrophin gene. Of the 50 cases of the archived cytogenetic slides, we were fortunate enough to obtain the fresh blood sample from one fetus whose karyotype showed 45,X[34]/46,X,+mar[145] to compare the results of the gDNA with that from archived cytogenetic slide. To confirm whether the marker chromosome was derived from Y chromosome, we studied the six loci (PABY, SRY, RPS4Y (SY16, 17), ZFY, DYS14) on the short arm, one locus (DYZ3) on the centromere and one locus (DYZ1) on the long arm. Of the 8 loci studies, all PCR related Y chromosome showed positive band from both gDNA obtained from cord blood and archived cytogenetic slides. We could conclude from the above results that the marker chromosome was derived from the Y chromosome. We believe our experiment is rapid and efficient for studies of over 10 independent loci from a single slide which has been kept in storage for up to 4 years and that archival Giemsa-stained cytogenetic slide repositories represent valuable DNA resources for clinical and forensic studies.

DNA↗

Sharing and archiving data is fundamental to scientific progress.

The persuasive argument for sharing and archiving data is that scientists must build on the shoulders of other scientists, that science is cumulative and replicative, and that science must be open. Sharing and archiving data are just a small part of all that is implied by that principle, but it is inextricably part of our obligation as social and behavioral scientists to conduct our work in the open. Only then can others see and understand what we did, and only then will someone have a chance to confirm that we were right, or to prove that we were wrong. Moreover, data archiving and sharing create opportunities for addressing questions not envisioned by the initial investigators. Indeed, by supplementing or pooling archived data, new and original data sets can be created that permit analyses well beyond the purpose or scope of the initial data collection. Of course, the creativity and labor of initial investigators should be protected, and the privacy of research participants must be safeguarded. These protections and safeguards, however, are not antithetical to data archiving and sharing. They simply raise questions about when and how data archiving and sharing should take place. In our view, the benefits of properly archived and shared data for outweigh the potential for harm. As indicated above, this is a perspective shared by several funding agencies of behavioral and social research, including the NIA.

Data Collection↗

Surveillance of childhood influenza virus infection: what is the best diagnostic method to use for archival samples?

Despite the clinical importance of influenza virus in pediatric respiratory infections, the optimal set of diagnostic tests to use when conducting studies using archival samples is not clear. In this study, we compared diagnostic tests for influenza virus in 75 children younger than 5 years of age who presented with symptomatic respiratory infection during one of four influenza seasons, had negative viral cultures for other respiratory pathogens, and had both an archival nasal aspirate obtained at the time of illness and serology spanning that influenza season. For all eligible children, we compared the results of viral culture performed at the time of collection with serology and PCR of archival nasal aspirates. Using real-time viral culture as the "gold standard," the test characteristics of PCR of archival nasal aspirates (sensitivity, 82%; specificity, 100%) and serology (sensitivity, 82%; specificity, 87%) were similar. The relatively low sensitivity of PCR of archival nasal samples in this study compared to that of PCR of fresh samples in a previous study suggests that RNA degradation occurred despite storage of the specimens at -70 degrees C. RNA degradation would also explain why only 11 (52%) of 21 archival nasal samples that had positive influenza virus cultures at the time of collection had positive repeat cultures in the summer of 2000. Thus, in archival specimens stored at -70 degrees C, PCR was more sensitive than viral culture. However, testing of fresh specimens had the highest yield in this study. Studies of optimal methods for specimen storage are needed.

Child, Preschool↗

[Individual archiving of digital angiocardiograms].

CD-R will be introduced internationally as a standardized individual archive and exchange medium allowing individual solutions for long-term archiving in a catheterization laboratory. The concept of digital archiving on two CD-R includes a long-term primary basic archive and a secondary one edited by intelligent (medical) data reduction (IDR). The basic archive is automatically composed by a background process consisting of unprocessed images or image series and is fundamental for further transfers, storage, presentations and additional studies. The digital working archive comprises a set of images and image series edited by IDR, as well as the results of morphometric studies as well as identification and documentation data. IDR is based upon the elimination of useless and redundant images series, documentation of coronary interventions on one single representative image and on the reduction of relevant images series and physiological data into an ECG-controlled representative cardiac cycle. IDR edits a redundancy-free set of 130 images (diagnostic study) or only 85 images of an interventional study. Two cardiologists and two cardiosurgeons independently studied 24 IDR-edited angiograms and the corresponding unedited digital angiograms and found no significant differences in the diagnostically relevant coronary morphology and left ventricular function. This study shows that an edited angiogram may not only serve for digital archiving but also form the basis for further evaluation or copies.

Angiocardiography↗

The European Radiobiology Archives (ERA)--content, structure and use illustrated by an example.

The European Radiobiology Archives (ERA), supported by the European Commission and the European Late Effect Project Group (EULEP), together with the US National Radiobiology Archives (NRA) and the Japanese Radiobiology Archives (JRA) have collected all information still available on long-term animal experiments, including some selected human studies. The archives consist of a database in Microsoft Access, a website, databases of references and information on the use of the database. At present, the archives contain a description of the exposure conditions, animal strains, etc. from approximately 350,000 individuals; data on survival and pathology are available from approximately 200,000 individuals. Care has been taken to render pathological diagnoses compatible among different studies and to allow the lumping of pathological diagnoses into more general classes. 'Forms' in Access with an underlying computer code facilitate the use of the database. This paper describes the structure and content of the archives and illustrates an example for a possible analysis of such data.

Animals↗

Data archiving in animal experimentation: merits, challenges, and a case study.

Electronic data archives may supplement the traditional peer-reviewed journal article. The merits of data archiving include public service, a more complete research project, overcoming barriers to limited-access research resources, and increasing the impact of a scientific project. A case study of chimpanzee timing performance in space is derived from the NASA Life Sciences Data Archive (http://lsdajsc. nasagov). An analysis of the archived data suggests that the scalar property (a form of Weber's law) applies to timed performance of a chimpanzee in orbit of the earth. Challenges associated with data archives are discussed. Although significant challenges are associated with archiving electronic data, these difficulties are outweighed by its merits.

Animal Experimentation↗

Proposal for the creation of a Web-based heterogeneous distributed archive for psychological data.

This report presents a proposal to create archives of data from psychological research and associated metadata Web pages and link them into a heterogeneous distributed archive on the World-Wide Web. Several specific recommendations are made concerning some of the issues faced by the data archivist and data archive user hoping to use the Web. In particular, a recommendation is made to create a publicly accessible Web page for each data set and place keywords, experimental methods, data descriptions, pointers to journal articles, and pointers to other archive Web pages pertinent to this data set on this metadata Web page. If the archivist includes a special keyword (PsychologyDataArchive) on the metadata Web page, Web-based search engines will automatically be able to subset all participating data archives for indexing and semantic analysis. The secondary data analyst can then include the word PsychologyDataArchive in his Web search and will be able to effectively find relevant participating Web data archives.

Archives↗

Archive selection for the MICAS, a multi-vendor incremental approach to PACS.

From the time a decision was made to purchase an archive until a purchase order was issued took approximately 10 months. During this period an RFI was developed, issued and the results analyzed. Technical discussions were held and site visits were made. To ensure that current information was available, a complete review of available multi-modality DICOM compliant archives were made at the 1997 RSNA. With this information in-hand and the future development path for MICAS specified, a detailed RFQ was developed, responses were received and evaluated. A purchase order was to be issued by the end of the first quarter 1998. The archive vendor will have been selected by the time this paper appears in print. The oral presentation of this work will review the responses of the archive vendors and present the basis for selection. It is planned to publish our findings. The archive is the heart and brains of PACS. It controls information acquisition, distribution and storage plus work flow. It is critical that DICOM compliance and interoperability between all components of the PACS be an absolute requirement, especially for the archive.

Academic Medical Centers↗

Integration, acceptance testing, and clinical operation of the Medical Information, Communication and Archive System, phase II.

The Medical Information, Communication and Archive System (MICAS) is a multivendor incremental approach to picture archiving and communications system (PACS). It is a multimodality integrated image management system that is seamlessly integrated with the radiology information system (RIS). Phase II enhancements of MICAS include a permanent archive, automated workflow, study caches, Microsoft (Redmond, WA) Windows NT diagnostic workstations with all components adhering to Digital Information Communications in Medicine (DICOM) standards. MICAS is designed as an enterprise-wide PACS to provide images and reports throughout the Strong Health healthcare network. Phase II includes the addition of a Cemax-Icon (Fremont, CA) archive, PACS broker (Mitra, Waterloo, Canada), an interface (IDX PACSlink, Burlington, VT) to the RIS (IDXrad) plus the conversion of the UNIX-based redundant array of inexpensive disks (RAID) 5 temporary archives in phase I to NT-based RAID 0 DICOM modality-specific study caches (ImageLabs, Bedford, MA). The phase I acquisition engines and workflow management software was uninstalled and the Cemax archive manager (AM) assumed these functions. The existing ImageLabs UNIX-based viewing software was enhanced and converted to an NT-based DICOM viewer. Installation of phase II hardware and software and integration with existing components began in July 1998. Phase II of MICAS demonstrates that a multivendor open-system incremental approach to PACS is feasible, cost-effective, and has significant advantages over a single-vendor implementation.

Compact Disks↗

Utilization of polymerase chain reaction on archival cytologic material: a comparison with fresh material with special emphasis on cerebrospinal fluids.

Use of the polymerase chain reaction (PCR) for the detection of B- and T-cell clonality, Epstein-Barr virus (EBV) and Human Herpes Virus 8 (HHV 8) infection is gaining increasing importance as a diagnostic modality. These tests are usually performed on fresh specimens. There are instances when fresh material is not available and there is a clinical utility for the performance of PCR on archival material via slide scrape lysates (SSL). However, the suitability of archival material may be questioned. Records were searched for all archival cytology cases submitted for SSL molecular diagnostics tests since 1998. Results for each case were analyzed for PCR amplification status and individual test results. A randomly chosen control group of equivalent cytologic samples submitted fresh was evaluated for comparison of amplification status. In all, 241 PCR runs were performed on SSL of archival material from 112 cytologic samples (89 cerebrospinal fluids (CSFs), 13 fine-needle aspirates (FNAs), 10 effusions). Out of these samples, 95 (85%) had amplifiable DNA, as assessed by a positive reaction for glyceraldehyde phosphate dehydrogenase (GAPDH). For the control group, 320 PCR runs were performed on 112 fresh cytologic samples (89 CSFs, 13 FNAs, 10 effusions). In total, 102 samples (91%) had amplifiable DNA. There was no statistical difference in the amplification yield between the two groups (P = 0.2177). A morphologic review of 16 of the 17 SSL archival cytologic cases that did not show amplification revealed 11/16 to be of sparse cellularity. Molecular diagnostic tests are performed routinely on fresh cytologic samples with excellent results. At times critical decisions on patient care may need to be made when fresh tissue is not available for molecular diagnostic tests. SSL of archival cytologic material can be used with excellent results for molecular diagnostic tests when fresh material is not available or when the cytologic diagnosis needs further clarification.

B-Lymphocytes↗

Optimization of ribonucleic acid detection from archival Guinea pig temporal bone specimens.

HYPOTHESIS: The choice of ribonucleic acid (RNA) isolation protocol coupled with modifications to RNA extraction and detection procedures may result in a more reliable method to detect gene expression in archived temporal bones. BACKGROUND: A large number of archival temporal bones exist. Retrospective analysis of these specimens using techniques of RNA extraction will greatly enrich our understanding of the pathophysiology of specific otologic diseases. However, archival human temporal bones are aged and embedded in paraffin or celloidin, rendering isolation and manipulation of nucleic acid in preserved specimens difficult, especially as it pertains to RNA degradation. Despite some reports of moderate success in the recent past, RNA isolation and gene expression using polymerase chain reaction (PCR) analysis continues to be challenging and unreliable. Archival guinea pig temporal bone specimens were used to develop and optimize a protocol for RNA extraction and gene expression analysis using PCR and quantitative PCR methods. The genes amplified comprise housekeeping genes and genes associated with the glutamate pathway. METHODS: Archival celloidin-embedded guinea pig temporal bones were collected from the senior author's collection of experimental hydropic inner ear specimens. RNA from this tissue was extracted using the protocol described previously in 16animals and using a modified trizol extraction technique in 10 animals. Gene expression analysis was performed on the extracted RNA. Analysis included two housekeeping genes, GAPDH and 18S, as well as three mediators of the glutamate pathway, glutamate aspartate transporter, glutamate synthetase, and inducible nitric oxide synthase. RESULTS: Compared with the standard extraction protocol, the trizol-based extraction technique showed greater reliability and reproducibility of RNA detection. The housekeeping gene GAPDH or 18S was detected in 7 of 36 attempts with the standard protocol versus 9 of 9 using the modified extraction method (P < 0.001). The gene of interest, glutamate aspartate transporter, was detected in 3 of 26 attempts with the standard protocol versus 12 of 13 attempts using the modified extraction method (P < 0.001). Quantification of messenger RNA levels was then achieved using quantitative PCR methods. CONCLUSION: Improved reliability for detection of gene expression and demonstration of reproducibility were accomplished by modification of RNA extraction technique and standard reverse transcriptase PCR protocol. In addition, we also showed that gene expression from archival material can be quantified by real-time PCR.

Animals↗

Comparing personality scales across time: an illustrative study of validity and consistency in life-span archival data.

The goals of this study were: (a) to examine whether personality scales, meaningful in contemporary terms, could be derived from archival data; and (b) to use these scales to aid our understanding of the relation of personality to mortality. NEO PI-R data and a battery of archival items, taken from Terman's Life Cycle Study, were collected on two new samples (sample 1 mean age = 11.9, n = 167; sample 2 mean age = 22.2, n = 203). Measurement invariance of the archival scales was assessed, and validity was examined using both rational analyses and associations with the Five Factor Model. It was demonstrated that interpretable scales can be derived from 50- to 70-year-old archival data. The archival adult personality data were then used to predict mortality. Conscientiousness remains the strongest personality predictor of longevity. Criteria for establishing the validity of archivally derived scales are suggested.

Adolescent↗

The influence of age of template DNA derived from archival tissue on the outcome of the polymerase chain reaction.

The analysis of DNA from archival tumour tissue for molecular alterations has been facilitated by the use of the polymerase chain reaction (PCR). Degradation of tissue prior to fixation and the nature of the fixative used influence successful amplification from archival tissue. Age of the archival tissue may also be a factor. To determine if this was so, DNA was extracted from 30 archival specimens of spleen spanning a 15 year period. Polymerase chain reaction was performed on all specimens using primers for exon 2 (307 bp) and exon 9 (1278 bp) of the hypoxanthine phosphoribosyl transferase (HPRT) gene. It was not possible to show that the age of archival tissue had an influence on the capacity to amplify exon 2 of the HPRT gene. It was not possible to amplify exon 9 of the HPRT gene from archival tissue.

DNA, Neoplasm↗

Nucleic acid amplification of Mycobacterium tuberculosis complex DNA from archival fine needle aspiration smear scrapings vs. fresh fine needle aspirates of tuberculous lymphadenitis.

OBJECTIVE: To assess the efficacy of the nucleic acid amplification (NAA) technique for Mycobacterium tuberculosis (MTB) complex from archival fine needle aspirate (FNA) smear scrapings of confirmed cases of extrapulmonary tuberculosis (EPTB) for a retrospective diagnosis of EPTB as compared to NAA from fresh FNA material from the same cases. STUDY DESIGN: Smear scrapings from 51 cases; 33 cases of tuberculous lymphadenitis (from patients who had undergone NAA 1 year before for MTB from fresh FNA material); 13 negative controls from nontuberculous, archival FNA smears; and 5 known acid-fast bacilli (AFB)-positive sputum smears, were subjected to NAA using the IS6110 primer sequence of M tuberculosis. Ziehl-Neelsen staining was done in all the smears. RESULTS: Of the 33 cases of tuberculous lymphadenitis, 15 (45.4%) were AFB positive and 18 (64.5%) AFB negative. MTB NAA was positive in 73.3% (11 of 15 AFB-positive cases) in the freshly aspirated material and was observed in 60% (9 of 15 AFB-positive cases) when done on DNA extracted from the archival smear scrapings of the same cases. Similarly, in the 18 AFB-negative cases, MTB NAA positivity was 72.2% (13 of 18) on fresh material and 44.4% (8 of 18) on archival smear scrapings from the same AFB-negative cases. Overall NAA positivity was 51.5% for archival smear scrapings as compared to 71% for fresh FNA of the same cases. CONCLUSION: Low NAA sensitivity of MTB DNA in archival material of known tuberculous cases limits the routine use of NAA based retrospective molecular diagnosis of MTB complex.

Biopsy, Fine-Needle↗

PACS in practice: the status of the PACS project at the St. Radboud University Hospital. Part B. A digital image archive: information analysis and development.

In accordance with the bottom-up approach in the field of the Picture Archiving and Communication System (PACS), a pilot study was performed with regard to the archiving of digital diagnostic images. A prototype has been developed to determine what information has to be stored in the digital archive and what requirements the users have in accessing these data. Firstly an organization analysis of the department of diagnostic radiology with respect to the archiving of images was performed. A variant of the ISAC method was used for this purpose. This resulted in a set of activity diagrams. Thereafter an information analysis was performed according to the Nijssen Informal Analysis Method (NIAM). This resulted in a Conceptual Schema (CS). Two other prototypes of relational Image Database Management Systems (IDBMS) are described and a description of a general modular structure of an IDBMS is given. By means of a Prototype of a Digital Archive (PDA) the department of diagnostic radiology was shown what might be expected from a digital archive and how the information will be presented to the users.

Database Management Systems↗