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At least 199 records · Page 11Linked to original sources
PubMed2003

Development of common data elements: the experience of and recommendations from the early detection research network.

There have been an increasing number of large research consortia in recent years funded by the National Cancer Institute (NCI) to facilitate multi-disciplinary, multi-institutional cancer research. Some of these consortia have central data collection plans similar to a multi-center clinical trial whereas others plan to store data locally and pool or share the data at a later date. Regardless of the goal of the consortium, there is a need to standardize the way certain data are collected and stored, transferred, or reported across the institutions involved. This communication is a report of the process and current status of the development of common data elements (CDEs) by the Early Detection Research Network (EDRN). The development of the CDEs involved several stages with each stage requiring input from multi-disciplinary experts in oncology, epidemiology, biostatistics, pathology, informatics, and study coordination. An effort was made to be consistent with other consortia developing similar CDEs and to follow data standards when available. Initial focus was on identifying the minimum data that would be necessary to collect on all EDRN study participants and EDRN specimens. There are currently CDEs in the development or pilot phase for eight different organ sites and 13 different types of specimen procurements and plans to develop CDEs for 12 or more additional types of specimens.

Data Collection↗
PubMed1998

10th NCI-EORTC Symposium on New Drugs in Cancer Therapy: Dutch Treat Revisited.

Scientific meetings, like living organisms, tend to evolve over time. For example, the yearly ASCO meeting, which began as a small American academic oncology gathering emphasizing clinical research, has grown into a large, international forum which increasingly emphasizes best standard of care and reimbursement issues [Editor's note: see ASCO review by Chabner, Friedberg in this issue, page 263]. One meeting which has remained true to its initial mission is the NCI-EORTC Symposium on New Drugs in Cancer Therapy which occurs every two years in Amsterdam. Originally organized to help coordinate phase I cancer drug development between the United States and Europe, the meeting fills an important scientific niche. Largely because of the clinical trials standards which have been shared in this forum, phase I data from Europe are now used to launch phase II cancer trials in the United States. Today, the meeting focus-really, the meeting's challenge-remains cancer drug development in Europe and the United States.

Journal Article↗
PubMed2005

SNOMED CT: electronic health record enhances anesthesia patient safety.

This article discusses the importance of electronic health records (EHRs) in anesthesiology, emphasizing the critical role of standardized clinical terminology in the EHR's structure. SNOMED Clinical Terms (SNOMED CT), developed by SNOMED International, a division of the College of American Pathologists, in collaboration with the United Kingdom's National Health Service, offers a controlled healthcare terminology with comprehensive coverage of diseases, clinical findings, etiologies, therapies, procedures, and outcomes. Recommended as the core general terminology for electronic patient medical record information in the United States, it offers flexibility in expressing clinical concepts, enabling clinicians to say things in multiple ways and still be understood. SNOMED CT's comprehensive, scientifically validated clinical terminology enables a consistent way of capturing, sharing, and aggregating health data across specialties and sites of care. Its benefits range from facilitating system interoperability to allowing greater shared access to patient health information where and when it is needed. The article concludes by informing readers of access to English and Spanish language editions of SNOMED CT's core content, which recently was licensed through the National Library of Medicine, a part of the National Institutes of Health within Department of Health and Human Services.

Anesthesia↗
PubMed2001

[Clinical laboratory data and reference intervals standardized in Fukuoka].

In Fukuoka whose population is approximately five million inhabitants, surveys on the accuracy of laboratory data have been performed by the Fukuoka Prefecture Medical Association for the last 30 years. We have been attempting to evaluate the data for routine use since 1988, and it has become possible to share laboratory data between all institutions in Fukuoka prefectures. As a result, reference intervals for 23 clinical chemistry analytes were established in 1995, to which were added in 1996 five serum protein constituents that have been utilized for clinical examinations. Methods for documentations and monitorings the data obtained in the prefecture were also established, standardization of the above analytes extended to 97% of the institutions in the prefecture. Results for 14 of the 23 clinical chemistry analytes have become highly reliable and clinically useful as differences between institutions in terms of results have narrowed. Standardization of other analytes is now in progress.

Aged↗
PubMed2002

Shared decision-making strategies for early prostate cancer.

Prostate cancer remains one of the most prevalent and least understood of all human malignancies. Pathologic evidence suggests that neoplastic changes of the prostate epithelium begin early in a man's adult life, but do not become clinically evident or relevant until decades later. The natural history of this enigmatic disease is heterogeneous, ranging from a benign and indolent course to one that rapidly progresses, causing significant morbidity and mortality. The divergent aspects of prostate cancer are underscored by vast differences in incidence and mortality statistics, causing consternation among clinicians and patients regarding the relative value of early detection, screening, and treatment strategies. Competing risks and perceived benefits of proposed treatment options including surgery, radiation therapy, hormonal deprivation, watchful waiting, and newer technologies are complex. Given these uncertainties, how should patients integrate these data and what role must physicians play in the process? Here we present a summary of shared decision making for men with localized prostate cancer. We approach this task by using a clinical case scenario to discuss issues relating to incidence and mortality trends, uncertainty regarding natural history, biopsy techniques and concerns, relevant tumor and clinical data, patient information gathering through Web-based resources, as well as support and advocacy groups, outcomes implications, and methods patients use to approach treatment decisions. We present a unified platform for shared decision-making strategies regarding prostate cancer in clinical practice.

Decision Making↗
PubMed1994

Towards a standard query model for sharing decision-support applications.

Many clinical decision-support applications are created in a centralized manner, but distributed widely for local use. When such applications include queries to electronic patient databases, the queries must be translated to conform to local database specifications. Because no well-defined standard model of clinical data exists, the translation process is ad hoc, costly, and error-prone. In this paper, we propose an abstract formalism, called the Standard Query Model Framework, for specifying a standard clinical data model and for supporting the automated and reliable translation of queries that appear in shared decision-support applications. We present the components of this framework, discuss their desirable features, and describe a prototype that we have developed for relational patient databases. We also highlight the outstanding research issues relevant to our approach.

Database Management Systems↗
PubMed2026

Genomic Characterisation of Carbapenem-Resistant Klebsiella pneumoniae and Enterobacter hormaechei Clinical Isolates from Nigeria: Evidence of Resistance, Virulence, and Putative Plasmid-Mediated Gene Sharing.

The global proliferation of carbapenem-resistant Enterobacterales (CRE) constitutes one of the most urgent public health threats, yet high-resolution genomic data from sub-Saharan Africa remain critically scarce. We applied whole-genome sequencing (WGS) and comparative phylogenomics to characterise antimicrobial resistance determinants, virulence genes, and mobile genetic elements (MGEs) in three carbapenem-resistant clinical isolates originating from three tertiary hospitals (selected from a broader surveillance collection spanning four facilities) in Osun State, southwestern Nigeria. We purposively selected three isolates, two Klebsiella pneumoniae subsp. pneumoniae (K22, ST411; K31, ST17) and one Enterobacter hormaechei subsp. steigerwaltii (K32, ST45) from a broader surveillance collection of 27 carbapenem-non-susceptible Enterobacterales, to represent phenotypically and genotypically divergent lineages. Resistome analysis revealed extensive plasmid-associated β-lactam and aminoglycoside resistance in K31 (including blaCTX-M-15, blaOXA-1, and blaTEM-1). K32 harboured an intrinsic chromosomal blaACT-17 AmpC gene, while IS26 and ISEcp1 insertion sequences, consistent with transposon-mediated mobilisation, flanked its acquired aminoglycoside and sulfonamide resistance cassettes. K22 lacked detected acquired carbapenemase, ESBL, or plasmid-mediated AmpC genes, indicating that its carbapenem-resistant phenotype may involve non-carbapenemase mechanisms such as porin alteration or efflux-mediated reduced susceptibility; however, this mechanism requires confirmation by direct ompK35/ompK36 sequence analysis and/or phenotypic outer membrane protein profiling. Virulome profiling identified a broader repertoire of siderophore, adhesion, and biofilm genes in both K. pneumoniae isolates than in E. hormaechei. Phylogenomic analysis demonstrated that K22 and K31 cluster within the broader K. pneumoniae population framework but represent distinct high-risk lineages (ST411 and ST17) rather than a single clonal outbreak. Analysis also identified a shared plasmid backbone between K31 and K32, supporting interspecies horizontal gene transfer. These descriptive genomic findings identify clinically relevant resistance and virulence determinants in three purposively selected carbapenem-resistant Enterobacterales from Nigerian tertiary-care hospitals. The detection of shared resistance elements between K. pneumoniae and E. hormaechei suggests possible plasmid-mediated gene sharing. Still, larger WGS studies with long-read sequencing and patient-level epidemiological data are required to define transmission and dissemination patterns.

Nigeria↗
PubMedDate not supplied

Commentary: applying hospital quality indicators to clinical practice.

Hospitals use various methods to establish performance benchmarks. This may include cooperative data shared between organizations to allow broad, general comparisons. These can, however, be misinterpreted as representing standards of patient care. In the authors' institution, a more complete examination was made of one of these quality indicators when it appeared quality indicator standards were in conflict with standards of patient care. The authors conclude that quality indicators are valuable when screening a hospital, just as we utilize screening tests to identify patients at potential risk. Neither should we apply broad quality indicators as standards of care without a full understanding of their strengths and weaknesses and the foundation on which they are built.

Accreditation↗
PubMed1998

Role of the clinical microbiology laboratory in the diagnosis of infections.

The proper use and interpretation of clinical microbiology test results may be complicated but critical to the care of cancer patients. The microbiology laboratory director is often available to offer advice concerning the differential diagnosis, choice of specimens, as well as the optimal stains and cultures to facilitate diagnosis. Additionally, the rapid interpretation of Gram-stained smears provides useful, occasionally lifesaving, information relative to the etiologic diagnosis and empiric antimicrobial therapy. The microbiology laboratory director should also provide further interpretation of culture and antimicrobial testing results that allow the clinical service to focus on the most critical data. Person-to-person or telephone conversations discussing important laboratory information should be followed up by a written summary report placed in the patient's chart so all services involved share the same interpretation (Figure 2). The clinical service has an important responsibility to communicate with the laboratory to optimize care of the patient with cancer. The laboratory compiles data collected from groups of patients that is available and useful to physicians. Review and discussion of test utilization is essential for cost-effective, quality health care. This may include analysis of blood cultures documenting an acceptable level of contamination, appropriate number collected per day, and sufficient blood volume per culture. In addition, information about changing resistance patterns or nosocomial transmission can be provided to the clinician. As patients with malignancies become more complex and their infections increasingly difficult to treat, regular interaction between the laboratory and clinician is likely to improve patient care.

Diagnosis, Differential↗
PubMedDate not supplied

Attitudes and beliefs for effective pediatric nurse practitioner and physician collaboration.

INTRODUCTION: The purpose of this study was to explore the attitudes and beliefs of pediatric nurse practitioners (PNPs) and pediatricians concerning collaborative practice relationships and to explore the themes that emerged to establish a definition of collaborative practice between PNPs and pediatricians as it applies to current practice trends. METHODS: Twenty-four PNP and pediatrician dyads were identified through a random sampling technique from a list of names of certified PNPs obtained from the National Certification Board of Pediatric Nurse Practitioners and Nurses. Questionnaires were mailed to certified PNPs and the collaborating pediatrician. Data were collected and analyzed using both quantitative and qualitative methodology. RESULTS: All PNPs and pediatricians were board certified and most had 6 or more years experience in a collaborative practice. The qualitative data revealed that open communication and a relationship built on mutual trust and respect, sharing of knowledge, and clinical expertise are essential components of a collaborative practice relationship if the shared goal of excellent patient care is to be achieved. Attitudes of importance in a collaborative practice relationship rated significantly higher by the PNPs included "respect for you as a professional" and "advocate for child health issues." CONCLUSION: The data revealed that the words "supervision" and "independence" should be changed to "consultation" when describing a contemporary collaborative practice relationship between a nurse practitioner and physician.

Attitude of Health Personnel↗
PubMed2003

Comparison of electrodiagnostic abnormalities and criteria in a cohort of patients with chronic inflammatory demyelinating polyneuropathy.

BACKGROUND: Current electrodiagnostic criteria for chronic inflammatory demyelinating polyneuropathy (CIDP) are research oriented favoring specificity over sensitivity. Application of such criteria in clinical practice may miss the diagnosis in potentially treatable patients. OBJECTIVES: To analyze the electrophysiologic abnormalities in a cohort of patients with clinically defined CIDP, to compare these data with published electrodiagnostic criteria, and to identify a set of abnormalities that is shared by all patients with CIDP. DESIGN: Retrospective medical record review. SETTING: Academically based neuromuscular clinic. Patients Fifteen patients with clinically diagnosed relapsing sensorimotor CIDP. INTERVENTIONS: Administration of intravenous immunoglobulin or prednisone. MAIN OUTCOME MEASURES: Electrodiagnostic studies. RESULTS: All patients had electrodiagnostic abnormalities in at least 3 nerves with possible partial conduction block or demyelinating range abnormalities in at least 1 nerve. The diagnostic sensitivities of 5 published CIDP criteria were as follows: the Ad Hoc Subcommittee of the American Academy of Neurology AIDS Task Force (40%), Saperstein et al (47%), Nicolas et al (53%), Hughes et al for the Inflammatory Neuropathy Cause and Treatment Group (60%), and Thaisetthawatkul et al (70%). CONCLUSIONS: Current electrodiagnostic criteria for CIDP are insensitive and may fail to diagnose the condition in a substantial number of patients. More inclusive criteria that allow identification of patients in routine clinical practice are needed.

Action Potentials↗
PubMed2005

Dolphin project--cooperative regional clinical system centered on clinical information center.

In 2001, a system was created to improve patient service, improve the quality of medical care, and achieve efficient medical care. A Data Center was established to accumulate and manage clinical information in the regions and share clinical information safely and appropriately. The system has already been in operation for 3 years. Even though a patient may have been examined at multiple hospitals, his medical record information will be integrated at the Center. This ensures medical care continuity and enables the patient to view his own medical records at home. Its usefulness in obtaining informed consent has been demonstrated as well. XML instances established in the MML standards (MML (Medical Markup Language): http.//www.medxml.net/E_mml30/mmlv3_E_index.htm Accessed July 2004; Jpn. J. Med. Informatics (JJMI) 17(3):203-207, 1997; J. Med. Syst. 24(3):195-211, 2000; J. Med. Syst. 27(4):357-366, 2003; J. Med. Syst. 28(6):523-533, 2004) are used for Electronic Medical Record System data exchange between the Data Center and each medical institution. The openness provided by XML makes it possible to connect diverse electronic medical records to the Center. As of the year 2004, over 10 types of electronic medical records have an MML interface, enabling connection to the Center.

Cooperative Behavior↗
PubMed2005

Codes, classifications, terminologies and nomenclatures: definition, development and application in practice.

The Primary Care Informatics Working Group of EFMI is working to help develop the core theory of primary care informatics (PCI). Codes, classifications, terminologies and nomenclatures form an important part of the science of PCI, as they allow clinical information to be readily stored and processed in information systems. This article provides definitions and a history of the International Classification for Primary Care (ICPC), and of the Read code and the Systematized Nomenclature for Medicine (SNOMED). The Working Group wishes to encourage shared definitions and an understanding of the practical application of structured data to improve quality in clinical practice.

Ambulatory Care Information Systems↗
PubMed2005

Is it time to prescribe statins to patients with calcified aortic stenosis?

Aortic stenosis (AS) is a common disease especially in the older population. It is associated with high mortality and morbidity. Recent data suggest that coronary artery disease and AS share common risk factors. Retrospective studies suggest that statins might slow the progression of AS but there are no randomized clinical trial data available. It would seem that statins can be considered for medical treatment of AS; however, this needs to be investigated in future randomized clinical trials.

Aortic Diseases↗
PubMed2006

The NIH MRI study of normal brain development.

MRI is increasingly used to study normal and abnormal brain development, but we lack a clear understanding of "normal". Previous studies have been limited by small samples, narrow age ranges and few behavioral measures. This multi-center project conducted epidemiologically based recruitment of a large, demographically balanced sample across a wide age range, using strict exclusion factors and comprehensive clinical/behavioral measures. A mixed cross-sectional and longitudinal design was used to create a MRI/clinical/behavioral database from approximately 500 children aged 7 days to 18 years to be shared with researchers and the clinical medicine community. Using a uniform acquisition protocol, data were collected at six Pediatric Study Centers and consolidated at a Data Coordinating Center. All data were transferred via a web-network into a MYSQL database that allowed (i) secure data transfer, (ii) automated MRI segmentation, (iii) correlation of neuroanatomical and clinical/behavioral variables as 3D statistical maps and (iv) remote interrogation and 3D viewing of database content. A population-based epidemiologic sampling strategy minimizes bias and enhances generalizability of the results. Target accrual tables reflect the demographics of the U.S. population (2000 Census data). Enrolled subjects underwent a standardized protocol to characterize neurobehavioral and pubertal status. All subjects underwent multi-spectral structural MRI. In a subset, we acquired T1/T2 relaxometry, diffusion tensor imaging, single-voxel proton spectroscopy and spectroscopic imaging. In the first of three cycles, successful structural MRI data were acquired in 392 subjects aged 4:6-18:3 years and in 72 subjects aged 7 days to 4:6 years. We describe the methodologies of MRI data acquisition and analysis, using illustrative results. This database will provide a basis for characterizing healthy brain maturation in relationship to behavior and serve as a source of control data for studies of childhood disorders. All data described here will be available to the scientific community from July, 2006.

Adolescent↗
PubMed1997

Frataxin is reduced in Friedreich ataxia patients and is associated with mitochondrial membranes.

Friedreich ataxia is a progressive neurodegenerative disorder caused by loss of function mutations in the frataxin gene. In order to unravel frataxin function we developed monoclonal antibodies raised against different regions of the protein. These antibodies detect a processed 18 kDa protein in various human and mouse tissues and cell lines that is severely reduced in Friedreich ataxia patients. By immunocytofluorescence and immunocytoelectron microscopy we show that frataxin is located in mitochondria, associated with the mitochondrial membranes and crests. Analysis of cellular localization of various truncated forms of frataxin expressed in cultured cells and evidence of removal of an N-terminal epitope during protein maturation demonstrated that the mitochondrial targetting sequence is encoded by the first 20 amino acids. Given the shared clinical features between Friedreich ataxia, vitamin E deficiency and some mitochondriopathies, our data suggest that a reduction in frataxin results in oxidative damage.

Amino Acid Sequence↗
PubMed2004

Argyrophilic grain disease: a late-onset dementia with distinctive features among tauopathies.

Argyrophilic grain disease (AgD) is a late-onset dementia morphologically characterized by the presence of abundant spindle-shaped argyrophilic grains (ArG) in neuronal processes and coiled bodies in oligodendrocytes. AgD changes consist of the microtubule-associated protein tau in an abnormally and hyperphosphorylated state and are mainly found in limbic regions, for example, in the hippocampus, the entorhinal and transentorhinal cortices and the amygdala. AgD shows a significant correlation with advancing age, and it became apparent from recent clinicopathological studies that it might account for approximately 5% of all dementia cases. Further immunohistochemical and biochemical studies revealed that AgD is a four-repeat (4R) tauopathy similar to PSP and corticobasal degeneration (CBD), but distinct from Alzheimer's disease (AD) and Pick's disease. Moreover, a common genetic background regarding the tau gene haplotype has been suggested for AgD, PSP and CBD. However, although there are currently only limited data available, AgD seems to be clinically distinct from PSP and CBD and shares rather features of (mild) AD or other forms of 'limbic' dementias, among them senile dementia with tangles and the localized form of AD.

Age of Onset↗