WorldWideScience

Sample records for standard clinical approaches

  1. Standard concentration infusions in paediatric intensive care: the clinical approach.

    Science.gov (United States)

    Perkins, Joanne; Aguado-Lorenzo, Virginia; Arenas-Lopez, Sara

    2017-05-01

    The use of standard concentrations of intravenous infusions has been advocated by international organisations to increase intravenous medication safety in paediatric and neonatal critical care. However, there is no guidance on how to identify and implement these infusions leading to great interunit variability. To identify the most appropriate clinical concentrations required by our paediatric intensive care unit (PICU) population with regard to accuracy of delivery and overall fluid allowance. Firstly a matrix was used to balance the concentration, dose and infusion volume (weight range 1.5-50 kg). Results were further refined considering: patient fluid allowance based on fluid volume targets, infusion pump accuracy and challenging each infusion against clinical scenarios requiring administration of multiple drug infusions found in PICU. Consideration was given to the standard concentrations routinely used in adults, in order to assess whether alignment with paediatrics was possible for some of the concentrations proposed. Finally a risk assessment of the infusions was conducted using the NPSA 20 tool. Twenty-five drugs identified as the most commonly used intravenous infusions in the unit. For the majority of the medicines, three weight bands of standard concentrations were necessary to cover the children's weight ranges and kept within predefined fluid requirements and accuracy of delivery. This work shows a patient focused systematic approach for defining and evaluating standardised concentrations in intensive care children. © 2016 Royal Pharmaceutical Society.

  2. New pricing approaches for bundled payments: Leveraging clinical standards and regional variations to target avoidable utilization.

    Science.gov (United States)

    Hellsten, Erik; Chu, Scally; Crump, R Trafford; Yu, Kevin; Sutherland, Jason M

    2016-03-01

    Develop pricing models for bundled payments that draw inputs from clinician-defined best practice standards and benchmarks set from regional variations in utilization. Health care utilization and claims data for a cohort of incident Ontario ischemic and hemorrhagic stroke episodes. Episodes of care are created by linking incident stroke hospitalizations with subsequent health service utilization across multiple datasets. Costs are estimated for episodes of care and constituent service components using setting-specific case mix methodologies and provincial fee schedules. Costs are estimated for five areas of potentially avoidable utilization, derived from best practice standards set by an expert panel of stroke clinicians. Alternative approaches for setting normative prices for stroke episodes are developed using measures of potentially avoidable utilization and benchmarks established by the best performing regions. There are wide regional variations in the utilization of different health services within episodes of stroke care. Reconciling the best practice standards with regional utilization identifies significant amounts of potentially avoidable utilization. Normative pricing models for stroke episodes result in increasingly aggressive redistributions of funding. Bundled payment pilots to date have been based on the costs of historical service patterns, which effectively 'bake in' unwarranted and inefficient variations in utilization. This study demonstrates the feasibility of novel clinically informed episode pricing approaches that leverage these variations to target reductions in potentially avoidable utilization. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. A comparison of two standard-setting approaches in high-stakes clinical performance assessment using generalizability theory.

    Science.gov (United States)

    Richter Lagha, Regina A; Boscardin, Christy K; May, Win; Fung, Cha-Chi

    2012-08-01

    Scoring clinical assessments in a reliable and valid manner using criterion-referenced standards remains an important issue and directly affects decisions made regarding examinee proficiency. This generalizability study of students' clinical performance examination (CPX) scores examines the reliability of those scores and of their interpretation, particularly according to a newly introduced, "critical actions" criterion-referenced standard and scoring approach. The authors applied a generalizability framework to the performance scores of 477 third-year students attending three different medical schools in 2008. The norm-referenced standard included all station checklist items. The criterion-referenced standard included only those items deemed critical to patient care by a faculty panel. The authors calculated and compared variance components and generalizability coefficients for each standard across six common stations. Norm-referenced scores had moderate generalizability (ρ = 0.51), whereas criterion-referenced scores showed low dependability (φ = 0.20). The estimated 63% of measurement error associated with the person-by-station interaction suggests case specificity. Increasing the number of stations on the CPX from 6 to 24, an impractical solution both for cost and time, would still yield only moderate dependability (φ = 0.50). Though the performance assessment of complex skills, like clinical competence, seems intrinsically valid, careful consideration of the scoring standard and approach is needed to avoid misinterpretation of proficiency. Further study is needed to determine how best to improve the reliability of criterion-referenced scores, by implementing changes to the examination structure, the process of standard-setting, or both.

  4. Clinical Approach to the Standardization of Oriental Medical Diagnostic Pattern Identification in Stroke Patients

    Directory of Open Access Journals (Sweden)

    Han Jung Kim

    2011-01-01

    Full Text Available In Korea, many stroke patients receive oriental medical care, in which pattern-identification plays a major role. Pattern-identification is Oriental Medicine's unique diagnostic system. This study attempted to standardize oriental medical pattern-identification for stroke patients. This was a community-based multicenter study that enrolled stroke patients within 30 days after their ictus. We assessed the patients' general characteristics and symptoms related to pattern-identification. Each patient's pattern was determined when two doctors had the same opinion. To determine which variables affect the pattern-identification, binary logistic regression analysis was used with the backward method. A total of 806 stroke patients were enrolled. Among 480 patients who were identified as having a certain pattern, 100 patients exhibited the Fire Heat Pattern, 210 patients the Phlegm Dampness Pattern, nine patients the Blood Stasis Pattern, 110 patients the Qi Deficiency Pattern, and 51 patients the Yin Deficiency Pattern. After the regression analysis, the predictive logistic equations for the Fire Heat, Phlegm Dampness, Qi Deficiency, and Yin Deficiency patterns were determined. The Blood Stasis Pattern was omitted because the sample size was too small. Predictive logistic equations were suggested for four of the patterns. These criteria would be useful in determining each stroke patient's pattern in clinics. However, further studies with large samples are necessary to validate and confirm these criteria.

  5. Standardizing documentation and the clinical approach to apnea of prematurity reduces length of stay, improves staff satisfaction, and decreases hospital cost.

    Science.gov (United States)

    Butler, T Jeffrey; Firestone, Kimberly S; Grow, Jennifer L; Kantak, Anand D

    2014-06-01

    Apnea of prematurity, a common disorder, can severely compromise an infant's condition unless correctly diagnosed and treated. Infants with a history of apnea of prematurity can be discharged home but then be rehospitalized for an apneic event, an apparent life-threatening event, or sudden infant death syndrome. The definition of a clinically significant cardiopulmonary event, such events' documentation, and the treatment approach were standardized, and discharge criteria were refined. A prospective, single-center comparison was conducted between a group of premature infants before and after implementation of the standard approach. Data were collected prospectively from August 1, 2005, through July 21, 2006, for the prestandard-approach group and from August 1, 2006, through September 16, 2007, for the standard-approach group. Twenty-two (35%) of the 63 infants in the prestandard-approach group experienced discharge delays because of poor documentation, whereby the clinician could not determine the safety of discharge. This resulted in 59 additional hospital days (mean length-of-stay [LOS] increase, 5.7 days). The standard-approach group of 72 infants experienced no discharge delays and no additional hospital days, and LOS decreased (all p apnea of prematurity occurred for 5 (7.9%) of the prestandard-approach group but none of the standard-approach group (p = .0203). Overall compliance with the standardization process has been maintained at > or = 96%. Implementation of a standard approach to the definition of apnea of prematurity and its treatment and documentation decreases LOS and reduces cost.

  6. Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach

    Science.gov (United States)

    PAWLOTSKY, JEAN–MICHEL; DUSHEIKO, GEOFFREY; HATZAKIS, ANGELOS; LAU, DARYL; LAU, GEORGE; LIANG, T. JAKE; LOCARNINI, STEPHEN; MARTIN, PAUL; RICHMAN, DOUGLAS D.; ZOULIM, FABIEN

    2009-01-01

    Treatment of chronic hepatitis B virus (HBV) infection is aimed at suppressing viral replication to the lowest possible level, and thereby to halt the progression of liver disease and prevent the onset of complications. Two categories of drugs are used in HBV therapy: the interferons, including standard interferon alfa or pegylated interferon alfa, and specific nucleoside or nucleotide HBV inhibitors that target the reverse-transcriptase function of HBV-DNA polymerase. The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. This article discusses HBV virologic markers and tests, and their optimal use both for planning and reporting clinical trials and in clinical practice. PMID:18242209

  7. DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer research

    Directory of Open Access Journals (Sweden)

    Andriy Fedorov

    2016-05-01

    Full Text Available Background. Imaging biomarkers hold tremendous promise for precision medicine clinical applications. Development of such biomarkers relies heavily on image post-processing tools for automated image quantitation. Their deployment in the context of clinical research necessitates interoperability with the clinical systems. Comparison with the established outcomes and evaluation tasks motivate integration of the clinical and imaging data, and the use of standardized approaches to support annotation and sharing of the analysis results and semantics. We developed the methodology and tools to support these tasks in Positron Emission Tomography and Computed Tomography (PET/CT quantitative imaging (QI biomarker development applied to head and neck cancer (HNC treatment response assessment, using the Digital Imaging and Communications in Medicine (DICOM® international standard and free open-source software. Methods. Quantitative analysis of PET/CT imaging data collected on patients undergoing treatment for HNC was conducted. Processing steps included Standardized Uptake Value (SUV normalization of the images, segmentation of the tumor using manual and semi-automatic approaches, automatic segmentation of the reference regions, and extraction of the volumetric segmentation-based measurements. Suitable components of the DICOM standard were identified to model the various types of data produced by the analysis. A developer toolkit of conversion routines and an Application Programming Interface (API were contributed and applied to create a standards-based representation of the data. Results. DICOM Real World Value Mapping, Segmentation and Structured Reporting objects were utilized for standards-compliant representation of the PET/CT QI analysis results and relevant clinical data. A number of correction proposals to the standard were developed. The open-source DICOM toolkit (DCMTK was improved to simplify the task of DICOM encoding by introducing new API

  8. Clinical quality standards for radiotherapy

    Science.gov (United States)

    2012-01-01

    Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

  9. Raising standards in clinical research

    DEFF Research Database (Denmark)

    Ohmann, C.; Canham, S.; Demotes, J.

    2017-01-01

    The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were c...

  10. Standards for Clinical Grade Genomic Databases.

    Science.gov (United States)

    Yohe, Sophia L; Carter, Alexis B; Pfeifer, John D; Crawford, James M; Cushman-Vokoun, Allison; Caughron, Samuel; Leonard, Debra G B

    2015-11-01

    Next-generation sequencing performed in a clinical environment must meet clinical standards, which requires reproducibility of all aspects of the testing. Clinical-grade genomic databases (CGGDs) are required to classify a variant and to assist in the professional interpretation of clinical next-generation sequencing. Applying quality laboratory standards to the reference databases used for sequence-variant interpretation presents a new challenge for validation and curation. To define CGGD and the categories of information contained in CGGDs and to frame recommendations for the structure and use of these databases in clinical patient care. Members of the College of American Pathologists Personalized Health Care Committee reviewed the literature and existing state of genomic databases and developed a framework for guiding CGGD development in the future. Clinical-grade genomic databases may provide different types of information. This work group defined 3 layers of information in CGGDs: clinical genomic variant repositories, genomic medical data repositories, and genomic medicine evidence databases. The layers are differentiated by the types of genomic and medical information contained and the utility in assisting with clinical interpretation of genomic variants. Clinical-grade genomic databases must meet specific standards regarding submission, curation, and retrieval of data, as well as the maintenance of privacy and security. These organizing principles for CGGDs should serve as a foundation for future development of specific standards that support the use of such databases for patient care.

  11. Clinical approach to diarrhea.

    Science.gov (United States)

    Corinaldesi, Roberto; Stanghellini, Vincenzo; Barbara, Giovanni; Tomassetti, Paola; De Giorgio, Roberto

    2012-10-01

    Diarrhea is defined as reduced stool consistency, increased water content and number of evacuations per day. A wide array of causes and pathophysiological mechanisms underlie acute and chronic forms of diarrhea. This review focuses on the major clinical aspects which should aid clinicians to diagnose chronic diarrhea. Clinical history, physical examination and stool evaluation and the predominant stool characteristic, i.e., bloody, watery, and fatty diarrhea, may narrow the differential diagnosis. Although mainly involved in acute diarrhea, many different infectious agents, including bacteria, viruses and protozoa, can be identified in chronic bloody/inflammatory diarrhea by appropriate microbiological tests and colonoscopic biopsy analysis. Osmotic diarrhea can be the result of malabsorption or maldigestion, with a subsequent passage of fat in the stool leading to steatorrhea. Secretory diarrhea is due to an increase of fluid secretion in the small bowel lumen, a mechanism often identified in gastroenteropancreatic neuroendocrine tumors. The evaluation of the fecal osmotic gap may help to characterize whether a chronic diarrhea is osmotic or secretory. Fatty diarrhea (steatorrhea) occurs if fecal fat output exceeds the absorptive/digestive capacity of the intestine. Steatorrhea results from malabsorption or maldigestion states and tests should differentiate between these two conditions. Individualized diagnostic work ups tailored on pathophysiological and clinical features are expected to reduce costs for patients with chronic diarrhea.

  12. Fault estimation - A standard problem approach

    DEFF Research Database (Denmark)

    Stoustrup, J.; Niemann, Hans Henrik

    2002-01-01

    This paper presents a range of optimization based approaches to fault diagnosis. A variety of fault diagnosis problems are reformulated in the so-called standard problem set-up introduced in the literature on robust control. Once the standard problem formulations are given, the fault diagnosis pr...

  13. Fault estimation - A standard problem approach

    DEFF Research Database (Denmark)

    Stoustrup, J.; Niemann, Hans Henrik

    2002-01-01

    This paper presents a range of optimization based approaches to fault diagnosis. A variety of fault diagnosis problems are reformulated in the so-called standard problem set-up introduced in the literature on robust control. Once the standard problem formulations are given, the fault diagnosis...... problems can be solved by standard optimization techniques. The proposed methods include (1) fault diagnosis (fault estimation, (FE)) for systems with model uncertainties; FE for systems with parametric faults, and FE for a class of nonlinear systems. Copyright...

  14. Standardized training in nurse model travel clinics.

    Science.gov (United States)

    Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

    2011-01-01

    International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to

  15. Standard Approaches to the Acetabulum Part 2: Ilioinguinal Approach.

    Science.gov (United States)

    Gänsslen, A; Grechenig, S T; Nerlich, M; Müller, M; Grechenig, W

    2016-01-01

    The ilioinguinal approach is one of the standard approaches in the treatment of displaced acetabular fractures used during the last decades (9). The meta-analysis of Giannoudis et al. showed that 21.9% of acetabular fractures were historically treated using this approach (3). One of the disadvantages of this study was, that studies focussing especially on posterior wall stabilization and studies dealing with more complex fracture types treated by extended approaches were integrated. Thus, these fracture types were overrepresented. Re-analysis excluding these data lead to an increase of the rate of anterior approaches to 25.9%. More recent data (years 2005-2007) from the German multicenter study showed that presently in almost 45% of the cases the single ilioinguinal approach was used and only 38% of patients were stabilized via the KocherLangenbeck approach (11). Historically, the Smith-Peterson approach (15, 17) and the iliofemoral approach were used to treat acetabular fractures. In the 60ies, based on the work by Letournel and Judet, the ilioinguinal approach was developed for acetabular fracture fixation (9). It is an extrapelvic approach resulting in an indirect reconstruction concept of the acetabulum without direct visualization of the articular acetabulum. The ilioinguinal approach was the standard anterior approach during the last 30-40 years. An important advantage is the reduced soft tissue detachment of periarticular muscles with only a small risk of developing heterotopic bone formation. The aim of the second part of "Standard approaches to the acetabulum" is to report on the special topics indication, positioning, exposure, incision, dissection, the anatomical basis of osteosynthesis and present results using ilioinguinal approach.

  16. An approach to setting radiation standards

    International Nuclear Information System (INIS)

    Adler, H.I.; Weinberg, A.M.

    1978-01-01

    To quantify the concept of a radiation dose which is small compared with the natural background it is suggested that this figure should be interpreted as the standard deviation (weighted with the exposed population) of the natural background. It is considered that this use of the variation in natural background radiation is less arbitrary and requires fewer unfounded assumptions than some current approaches to standard-setting. The standard deviation is an easily calculated statistic that is small compared with the mean value for natural exposures of populations. It is an objectively determined quantity and its significance is generally understood. Its determination does not omit any of the pertinent data. If, as a result of new measurements, additional information on the variance in natural background becomes available, the appropriate adjustment of the standard deviation is readily made and does not require new decisions and debate. (U.K.)

  17. Radiation safety standards : an environmentalist's approach

    International Nuclear Information System (INIS)

    Murthy, M.S.S.S.

    1977-01-01

    An integrated approach to the problem of environmental mutagenic hazards leads to the recommendation of a single dose-limit to the exposure of human beings to all man-made mutagenic agents including chemicals and radiation. However, because of lack of : (1) adequate information on chemical mutagens, (2) sufficient data on their risk estimates and (3) universally accepted dose-limites, control of chemical mutagens in the environment has not reached that advanced stage as that of radiation. In this situation, the radiation safety standards currently in use should be retained at their present levels. (M.G.B.)

  18. A standardized approach for iris color determination.

    Science.gov (United States)

    Niggemann, Birgit; Weinbauer, Gerhard; Vogel, Friedhelm; Korte, Rainhart

    2003-01-01

    Latanoprost, the phenyl-substituted prostaglandin F2alpha, has been found to be an effective agent for glaucoma therapy. This prostaglandin derivative exerts ocular hypotensive activity but is also associated with an untoward side effect, namely iris color changes. Latanoprost provoked iris color changes in cynomolgus monkeys and in multicenter clinical trials. Until now photographs were taken and compared with color plates to document these changes. The disadvantage of this method is obvious, i.e., the color luminance varies between measurements due to changes in the developer. Furthermore, subjective comparison of color changes relative to color plates rendered judgment subject to impression and opinion rather than to objective data. Therefore, a computerized method using a 3-CCD video camera attached to a slit lamp was developed. The signals were transferred to a computer and a single frame, which was "frozen" by means of a "grabber card." Camera and the computer had previously been calibrated and color plates were measured to check the standard conditions. They were evaluated by a software program displaying average color (as red, green, and blue values) of the selected area. This method provides a fast and accurate way to quantify color changes in the iris of both experimental animals and clinical trials.

  19. 42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  20. Standardization of I-123-meta-iodobenzylguanidine myocardial sympathetic activity imaging: phantom calibration and clinical applications

    NARCIS (Netherlands)

    Nakajima, Kenichi; Verschure, Derk O.; Okuda, Koichi; Verberne, Hein J.

    2017-01-01

    Purpose Myocardial sympathetic imaging with I-123-meta-iodobenzylguanidine (I-123-mIBG) has gained clinical momentum. Although the need for standardization of I-123-mIBG myocardial uptake has been recognized, the availability of practical clinical standardization approaches is limited. The need for

  1. 42 CFR 493.1417 - Standard; Clinical consultant qualifications.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing Moderate Complexity Testing § 493.1417 Standard; Clinical consultant qualifications. The clinical consultant must be qualified to consult with and render opinions to the laboratory's... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant qualifications. 493...

  2. 42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  3. 42 CFR 493.1455 - Standard; Clinical consultant qualifications.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing High Complexity Testing § 493.1455 Standard; Clinical consultant qualifications. The clinical consultant must be qualified to consult with and render opinions to the laboratory's... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant qualifications. 493...

  4. Evaluating Clinical Ethics Support: A Participatory Approach.

    Science.gov (United States)

    Metselaar, Suzanne; Widdershoven, Guy; Porz, Rouven; Molewijk, Bert

    2017-05-01

    The current process towards formalization within evaluation research, in particular the use of pre-set standards and the focus on predefined outcomes, implies a shift of ownership from the people who are actually involved in real clinical ethics support services (CESS) in a specific context to external stakeholders who increasingly gain a say in what 'good CESS' should look like. The question is whether this does justice to the insights and needs of those who are directly involved in actual CESS practices, be it as receivers or providers. We maintain that those actually involved in concrete CESS practices should also be involved in its evaluation, not only as respondents, but also in setting the agenda of the evaluation process and in articulating the criteria by which CESS is evaluated. Therefore, we propose a participatory approach to CESS evaluation. It focuses on (1) the concrete contexts in which CESS takes place, (2) reflective and dialogical learning processes, and (3) how to be democratic and inclusive. In particular, this approach to CESS evaluation is akin to realist evaluation, dialogical evaluation, and responsive evaluation. An example of a participatory approach to evaluating CESS is presented and some critical issues concerning this approach are discussed. © 2017 John Wiley & Sons Ltd.

  5. Blended Learning zur integrierten und standardisierten Vermittlung klinischer Untersuchungstechniken: Das KliFO-Projekt [A blended learning approach for the integrated and standardized teaching of clinical skills: The CliSO project

    Directory of Open Access Journals (Sweden)

    Brüchner, Kirsten

    2009-02-01

    Full Text Available [english] Objective: The medical faculties of LMU Munich and CAU Kiel have developed a joint blended learning concept for computer-based learning and practical training of clinical skills: "CliSO – Clinical Skills Online" (. CliSO is implemented in their core curricula with the intention to foster students’ medical examination skills at the preclinical and clinical level. Methods: Both partners contributed their special competencies in the fields of case-based learning (Munich: CASUS e-learning platform and systematic learning (Kiel: Nickels e-learning platform. The didactic concept comprises the integration of theory and practice. It combines the standardized teaching of the following three components: Clinical skills are trained and reviewed in face-to-face courses. In the e-learning environment, the well-directed combination of case-based and systematic learning together with the chosen diversity of media (video, audio, animation facilitates situated learning as well as the intelligible presentation of clinical skills and their biomedical background. Both faculties agreed on joint learning objectives and standards. Results and prospects: It was possible to apply the concept to the different target groups at both faculties (first and second study phases and the differently designed face-to-face courses (Kiel: students examine each other; Munich: patients are examined in addition. Evaluations and studies confirmed the success of this approach, so that a transfer of the concept to other faculties is intended. [german] Zielsetzung: Mit „KliFO – Klinische Fertigkeiten Online“ ( haben die Medizinischen Fakultäten der LMU München und der CAU Kiel ein gemeinsames Blended Learning-Konzept zum computergestützten Lernen und praktischen Trainieren von klinischen Untersuchungstechniken entwickelt und in Pflichtveranstaltungen der Curricula integriert. Ziele sind die Verbesserung der Vor- und Nachbereitung von Untersuchungskursen im

  6. A clinical approach to dyslipidaemia

    African Journals Online (AJOL)

    2009-03-20

    Mar 20, 2009 ... clinical consequences of the (luckily) very rare disorders in which. 'abnormal' sterol .... 'heart disease'. This should not be accepted unquestioningly as a positive family history, but further details must be obtained. • Severe monogenic dyslipidaemia is particularly ..... Jelly babies, wine gums, marshmallows.

  7. International Approaches to Clinical Costing

    DEFF Research Database (Denmark)

    Chapman, Christopher; Kern, Anja; Laguecir, Aziza

    This report has been commissioned by both HFMA and Monitor and the work has been led by Imperial College Business School’s Health Management Group. The report compares current approaches to costing, primarily across Europe. The findings reveal wide-ranging practices and uses for costing data...

  8. Standardized clinical photography: the role of flash.

    Science.gov (United States)

    Cariello, Angelino; Viana, Giovanni André; Osaki, Midori; Pamplona, André Luis; Höfling-Lima, Ana Luisa

    2012-01-01

    Medical photographic documentation is important for professional, research, and ethical concerns. This study analyzed the possible interference that the flash could cause on evaluation of lower eyelid cosmetic results. Standardized photographs with and without flash were taken of 10 patients with dermatochalasis. The photographs were evaluated by 3 independent observers, as before (without flash) and after (with flash) an alternative esthetic treatment of the lower eyelid. The observers rated the overall cosmetic improvement of the lower eyelid photographs on a visual analog scale. The 3 surgeons believed that there was improvement in cosmetic outcome from the first (without flash) to the second (with flash) picture. The results indicate that a simple flash addition in one of 2 consecutive photographs, taken seconds apart, could influence the impression of experienced surgeons on the final outcome of oculoplastic surgeries and may constitute a bias in observer-dependent studies.

  9. A Standardization Approach to Adjusting Pretest Item Statistics.

    Science.gov (United States)

    Chang, Shun-Wen; Hanson, Bradley A.; Harris, Deborah J.

    This study presents and evaluates a method of standardization that may be used by test practitioners to standardize classical item statistics when sample sizes are small. The effectiveness of this standardization approach was compared through simulation with the one-parameter logistic (1PL) and three parameter logistic (3PL) models based on the…

  10. Standards in clinical decision support: activities in health level seven.

    Science.gov (United States)

    Jenders, Robert A; Jenders, Robert Allen; Del Fiol, Guilherme; Kawamoto, Kensaku; Sailors, R Matthew

    2008-11-06

    Health Level Seven (HL7) has evolved into an international standards development organization (SDO) with a suite of standards. Prominent among these are formalisms related to clinical decision support, including the Arden Syntax, GELLO and Decision Support Service (DSS) standards. Continuing improvement in these standards and ongoing development of future decision support standards require wide participation in order to maximize their success. Accordingly, the purpose of the workshop is twofold. First, instructors will convey the latest developments regarding existing decision support standards and related efforts to develop new standards. Second, the instructors will solicit feedback so that attendees who do not participate in HL7 can have input into the standards activities of that organization. The instructors of this workshop, who are the co-chairs and/or members of the Clinical Decision Support Technical Committee of HL7, will review progress in these areas. They will present the details of the ongoing development of the extant Arden Syntax, GELLO and DSS standards. They will discuss work on current draft and proposed future standards, including the Infobutton communication and Order Set standards that are undergoing development in anticipation of certification as standards. Finally, they will solicit discussion regarding the future direction of standards development in these areas.

  11. A Hybrid Approach to Clinical Question Answering

    Science.gov (United States)

    2014-11-01

    participation in TREC, we submitted a single run using a hybrid Natural Language Processing ( NLP )-driven approach to accomplish the given task. Evaluation re...for the CDS track uses a variety of NLP - based techniques to address the clinical questions provided. We present a description of our approach, and...discuss our experimental setup, results and eval- uation in the subsequent sections. 2 Description of Our Approach Our hybrid NLP -driven method presents a

  12. The Development of the Standard Lithuanian Language: Ecolinguistic Approach

    Directory of Open Access Journals (Sweden)

    Vaida Buivydienė

    2014-06-01

    Full Text Available The theory of standard languages is closely linked with the standardization policy and prevailing ideology. The language ideology comprises its value, experience and convictions related to language usage and its dis - course being influenced at institutional, local and global levels. Recently, in the last decades, foreign linguists have linked the theories of the development of standard lan- guages and their ideologies with an ecolinguistic approach towards language standardization phenomena. The article is based on Einar Haugen ’s theory about the development of standard languages and ecolinguistic statements and presents the stages of developing the standard language as well as the factors having an influ - ence on them. In conclusion, a strong political and social impact has been made on the development of the standard Lithuanian language. The stages of the progress of the standard Lithuanian language have rapidly changed each other, some have been held very close to one another and some still have been taken part.

  13. A statistical approach to traditional Vietnamese medical diagnoses standardization

    International Nuclear Information System (INIS)

    Nguyen Hoang Phuong; Nguyen Quang Hoa; Le Dinh Long

    1990-12-01

    In this paper the first results of the statistical approach for Cold-Heat diagnosis standardization as a first work in the ''eight rules diagnoses'' standardization of Traditional Vietnamese Medicine are briefly described. Some conclusions and suggestions for further work are given. 3 refs, 2 tabs

  14. Organizational, technical, physical and clinical quality standards for radiotherapy

    Science.gov (United States)

    Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

    2012-01-01

    Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023

  15. DEVELOPING THE CONCEPTUAL APPROACH TO STANDARDIZATION OF VOCATIONAL EDUCATION

    Directory of Open Access Journals (Sweden)

    V. I. Blinov

    2013-01-01

    Full Text Available The paper analyzes educational standards as the key concept of modern education; their interrelation with the national qualifications system and professional standards being considered. The authors denote the reasons for changing the conceptual approach to the standard developments, and demonstrate the possible ways of educational quality assurance.Diversification and mobility of the modern qualifications along with the fast technological changes affects the educational content and knowledge acquisition, and requires the variable and flexible educational  curricula and management. The global development trends, concerning the educational quality standards, involve their orientation on the learning outcomes, which should be taken into account while developing the Federal State Educational Standards of the fourth generation. The authors reveal the structure of the future standard, outline its implementation stages, and demonstrate the mechanism guaranteeing the regulatory legal provision of professional education. 

  16. CLINICAL APPROACH TO THE FLOPPY CHILD

    African Journals Online (AJOL)

    Enrique

    CLINICAL APPROACH TO THE. FLOPPY CHILD. The floppy infant syndrome is a well-recognised entity for paediatricians and neonatologists and refers to an infant with generalised hypotonia presenting at birth or in early life. ... ily members in order to reach a definitive diagnosis, using a detailed family pedigree to assist ...

  17. Clinical perceptions of radiation therapy undergraduate competency standards.

    Science.gov (United States)

    Carmichael, Mary-Ann; Bridge, Pete

    2014-12-01

    The multifactorial nature of clinical skills development makes assessment of undergraduate radiation therapist competence level by clinical mentors challenging. A recent overhaul of the clinical assessment strategy at Queensland University of Technology has moved away from the high-stakes Objective Structured Clinical Examination (OSCE) to encompass a more continuous measure of competence. This quantitative study aimed to gather stakeholder evidence to inform development of standards by which to measure student competence for a range of levels of progression. A simple anonymous questionnaire was distributed to all Queensland radiation therapists. The tool asked respondents to assign different levels of competency with a range of clinical tasks to different levels of student. All data were anonymous and was combined for analysis using Microsoft Excel. Feedback indicated good agreement with tasks that specified the amount of direction required and this has been incorporated into the new clinical achievements record that the students need to have signed off. Additional puzzling findings suggested higher expectations with planning tasks than with treatment-based tasks. The findings suggest that the amount of direction required by students is a valid indicator of their level and has been adopted into the clinical assessment scheme. Further work will build on this to further define standards of competency for undergraduates.

  18. Approaches to setting organism-based ballast water discharge standards

    Science.gov (United States)

    Lee, Henry; Reusser, Deborah A.; Frazier, Melanie

    2013-01-01

    As a vector by which foreign species invade coastal and freshwater waterbodies, ballast water discharge from ships is recognized as a major environmental threat. The International Maritime Organization (IMO) drafted an international treaty establishing ballast water discharge standards based on the number of viable organisms per volume of ballast discharge for different organism size classes. Concerns that the IMO standards are not sufficiently protective have initiated several state and national efforts in the United States to develop more stringent standards. We evaluated seven approaches to establishing discharge standards for the >50-μm size class: (1) expert opinion/management consensus, (2) zero detectable living organisms, (3) natural invasion rates, (4) reaction–diffusion models, (5) population viability analysis (PVA) models, (6) per capita invasion probabilities (PCIP), and (7) experimental studies. Because of the difficulty in synthesizing scientific knowledge in an unbiased and transparent fashion, we recommend the use of quantitative models instead of expert opinion. The actual organism concentration associated with a “zero detectable organisms” standard is defined by the statistical rigor of its monitoring program; thus it is not clear whether such a standard is as stringent as other standards. For several reasons, the natural invasion rate, reaction–diffusion, and experimental approaches are not considered suitable for generating discharge standards. PVA models can be used to predict the likelihood of establishment of introduced species but are limited by a lack of population vital rates for species characteristic of ballast water discharges. Until such rates become available, PVA models are better suited to evaluate relative efficiency of proposed standards rather than predicting probabilities of invasion. The PCIP approach, which is based on historical invasion rates at a regional scale, appears to circumvent many of the indicated problems

  19. Standardization approaches in absolute quantitative proteomics with mass spectrometry.

    Science.gov (United States)

    Calderón-Celis, Francisco; Encinar, Jorge Ruiz; Sanz-Medel, Alfredo

    2017-07-31

    Mass spectrometry-based approaches have enabled important breakthroughs in quantitative proteomics in the last decades. This development is reflected in the better quantitative assessment of protein levels as well as to understand post-translational modifications and protein complexes and networks. Nowadays, the focus of quantitative proteomics shifted from the relative determination of proteins (ie, differential expression between two or more cellular states) to absolute quantity determination, required for a more-thorough characterization of biological models and comprehension of the proteome dynamism, as well as for the search and validation of novel protein biomarkers. However, the physico-chemical environment of the analyte species affects strongly the ionization efficiency in most mass spectrometry (MS) types, which thereby require the use of specially designed standardization approaches to provide absolute quantifications. Most common of such approaches nowadays include (i) the use of stable isotope-labeled peptide standards, isotopologues to the target proteotypic peptides expected after tryptic digestion of the target protein; (ii) use of stable isotope-labeled protein standards to compensate for sample preparation, sample loss, and proteolysis steps; (iii) isobaric reagents, which after fragmentation in the MS/MS analysis provide a final detectable mass shift, can be used to tag both analyte and standard samples; (iv) label-free approaches in which the absolute quantitative data are not obtained through the use of any kind of labeling, but from computational normalization of the raw data and adequate standards; (v) elemental mass spectrometry-based workflows able to provide directly absolute quantification of peptides/proteins that contain an ICP-detectable element. A critical insight from the Analytical Chemistry perspective of the different standardization approaches and their combinations used so far for absolute quantitative MS-based (molecular and

  20. 'Standard Shona' Approach to Teaching ChiShona Abandoned Or ...

    African Journals Online (AJOL)

    This study was undertaken to establish whether ChiShona teachers in Zimbabwe have abandoned the formerly 'Standard Shona' approach to ChiShona teaching. It was conducted in five provinces of Zimbabwe in the years 1997-2016. The study took a qualitative paradigm, with longitudinal study as the method. Interviews ...

  1. [Combining clinical pathway and patient education approaches].

    Science.gov (United States)

    Bonnabel, Laurence; Huteau, Marie-Ève; Filhol, Nathalie; Clottes, Edwige; Massin, Julie; Quenet, François; Stoebner-Delbarre, Anne

    2016-01-01

    The integration of the therapeutic education of the patient into a clinical pathway approach helps to optimise nursing practice. Despite some limits, this method allows the position of the caregiver to evolve, going beyond the required methodological framework. It results in the emergence of several new educational facets which are essential for the patient and enable them to become a player in their own care. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  2. The standardized surgical approach improves outcome of gallbladder cancer

    Directory of Open Access Journals (Sweden)

    Igna Dorian

    2007-05-01

    Full Text Available Abstract Background The objective of this study was to examine the extent of surgical procedures, pathological findings, complications and outcome of patients treated in the last 12 years for gallbladder cancer. Methods The impact of a standardized more aggressive approach compared with historical controls of our center with an individual approach was examined. Of 53 patients, 21 underwent resection for cure and 32 for palliation. Results Overall hospital mortality was 9% and procedure related mortality was 4%. The standardized approach in UICC stage IIa, IIb and III led to a significantly improved outcome compared to patients with an individual approach (Median survival: 14 vs. 7 months, mean+/-SEM: 26+/-7 vs. 17+/-5 months, p = 0.014. The main differences between the standardized and the individual approach were anatomical vs. atypical liver resection, performance of systematic lymph dissection of the hepaticoduodenal ligament and the resection of the common bile duct. Conclusion Anatomical liver resection, proof for bile duct infiltration and, in case of tumor invasion, radical resection and lymph dissection of the hepaticoduodenal ligament are essential to improve outcome of locally advanced gallbladder cancer.

  3. International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

    Science.gov (United States)

    Soares, Christopher

    2006-03-01

    In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

  4. E-health stakeholders experiences with clinical modelling and standardizations.

    Science.gov (United States)

    Gøeg, Kirstine Rosenbeck; Elberg, Pia Britt; Højen, Anne Randorff

    2015-01-01

    Stakeholders in e-health such as governance officials, health IT-implementers and vendors have to co-operate to achieve the goal of a future-proof interoperable e-health infrastructure. Co-operation requires knowledge on the responsibility and competences of stakeholder groups. To increase awareness on clinical modeling and standardization we conducted a workshop for Danish and a few Norwegian e-health stakeholders' and made them discuss their views on different aspects of clinical modeling using a theoretical model as a point of departure. Based on the model, we traced stakeholders' experiences. Our results showed there was a tendency that stakeholders were more familiar with e-health requirements than with design methods, clinical information models and clinical terminology as they are described in the scientific literature. The workshop made it possible for stakeholders to discuss their roles and expectations to each other.

  5. Is the Standard Monte Carlo Power Iteration Approach the Wrong Approach? Part 2

    Energy Technology Data Exchange (ETDEWEB)

    Booth, Thomas E. [Los Alamos National Laboratory

    2012-07-11

    The recent work 'Is the Standard Monte Carlo Power Iteration Approach the Wrong Approach?' speculated that the second eigenfunction could be built using essentially the same 'building brick' approach that obtained the first eigenfunction in LA-UR-12-21928. This note shows that the speculation was at least partially correct, but not complete.

  6. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    Science.gov (United States)

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  7. CDISC standard-based electronic archiving of clinical trials.

    Science.gov (United States)

    Kuchinke, Wolfgang; Aerts, J; Semler, S C; Ohmann, C

    2009-01-01

    Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF

  8. SPIRIT 2013 Statement: defining standard protocol items for clinical trials

    Directory of Open Access Journals (Sweden)

    An-Wen Chan

    Full Text Available The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  9. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J.

    2015-01-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. PMID:26188274

  10. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

  11. Clinical approach to syncope in children.

    Science.gov (United States)

    Moodley, Manikum

    2013-03-01

    Pediatric syncope is one of the most common neurological problems in the pediatric population in both the office setting and in the emergency department. The abrupt brief loss of consciousness is usually dramatic and alarming to patients, family, onlookers, and providers. The differential diagnosis of syncope is wide but most cases are benign. A comprehensive but focused history and a thorough clinical examination are usually the cornerstones in the diagnosis of high-risk patients. It should be noted that the evaluation of syncope in children is costly and testing provides a low diagnostic yield. This chapter reviews the various types of syncope and provides a succinct clinical approach to the diagnosis, investigation, and management of syncope in children. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Pediatric Stroke: Clinical Findings and Radiological Approach

    Directory of Open Access Journals (Sweden)

    Giuseppe Lanni

    2011-01-01

    Full Text Available This paper focuses on radiological approach in pediatric stroke including both ischemic stroke (Arterial Ischemic Stroke and Cerebral Sinovenous Thrombosis and hemorrhagic stroke. Etiopathology and main clinical findings are examined as well. Magnetic Resonance Imaging could be considered as the first-choice diagnostic exam, offering a complete diagnostic set of information both in the discrimination between ischemic/hemorrhagic stroke and in the identification of underlying causes. In addition, Magnetic Resonance vascular techniques supply further information about cerebral arterial and venous circulation. Computed Tomography, for its limits and radiation exposure, should be used only when Magnetic Resonance is not available and on unstable patients.

  13. A standardized clinical evaluation of phenotypic diversity in diabetic polyneuropathy.

    Science.gov (United States)

    Scholz, Joachim; Rathmell, James P; David, William S; Chad, David A; Broderick, Alithia C; Perros, Stephen G; Shin, Naomi S; Wells, Jenna L; Davis, John B; DiMaggio, Charles J; Wang, Shuang; Tate, Simon N

    2016-10-01

    Diabetic polyneuropathy (DPN) is a major cause of neuropathic pain and a frequent target condition in analgesic treatment trials. Differences in the clinical symptoms and signs associated with DPN suggest distinct pathophysiological mechanisms underlying nerve damage and dysfunction that are likely to have therapeutic relevance. The aim of this study was to develop a tool for the bedside assessment of painful neuropathies such as DPN that captures the diversity of phenotypes. Sixty-one patients with type 2 diabetes and painful neuropathy, 19 patients with painless DPN, 25 patients with type 2 diabetes but no clinical evidence of neuropathy, and 20 healthy control subjects completed a structured interview (47 items) and a standardized physical examination (39 items). After analyzing critical features of pain and painless symptoms and examining the outcome of physical tests of sensory function, we determined principal components of the phenotypic variance among patients. Increased sensitivity to mechanical or thermal stimuli and, to a lesser extent, the sensory quality of pain or paresthesia were the most discriminating elements of DPN phenotypes. Correlation patterns of symptoms and signs indicated the involvement of functionally distinct nerve fiber populations. We combined interview questions and physical tests identifying these differences in a shortened assessment protocol that we named Standardized Evaluation of Pain and Somatosensory Function (StEPS). The protocol StEPS generates a phenotypic profile of patients with neuropathy. Separate intensity ratings for spontaneous painful symptoms and pain evoked by standard stimuli support a detailed documentation of neuropathic pain and its response to analgesic treatment.

  14. Activating clinical trials: a process improvement approach.

    Science.gov (United States)

    Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

    2016-02-24

    The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

  15. IAEA safety standards and approach to safety of advanced reactors

    International Nuclear Information System (INIS)

    Gasparini, M.

    2004-01-01

    The paper presents an overview of the IAEA safety standards including their overall structure and purpose. A detailed presentation is devoted to the general approach to safety that is embodied in the current safety requirements for the design of nuclear power plants. A safety approach is proposed for the future. This approach can be used as reference for a safe design, for safety assessment and for the preparation of the safety requirements. The method proposes an integration of deterministic and risk informed concepts in the general frame of a generalized concept of safety goals and defence in depth. This methodology may provide a useful tool for the preparation of safety requirements for the design and operation of any kind of reactor including small and medium sized reactors with innovative safety features.(author)

  16. Virtual glaucoma clinics: patient acceptance and quality of patient education compared to standard clinics.

    Science.gov (United States)

    Court, Jennifer H; Austin, Michael W

    2015-01-01

    Virtual glaucoma clinics allow rapid, reliable patient assessment but the service should be acceptable to patients and concordance with treatment needs to be maintained with adequate patient education. This study compares experiences and understanding of patients reviewed via the virtual clinic versus the standard clinic by way of an extended patient satisfaction questionnaire (PSQ). One hundred PSQs were given to consecutive patients attending glaucoma clinics in October 2013. All 135 patients reviewed via the virtual clinic from April 2013 until August 2013 were sent postal PSQs in September 2013. Data were obtained for demographics, understanding of glaucoma, their condition, satisfaction with their experience, and quality of information. Responses were analyzed in conjunction with the clinical records. Eighty-five percent of clinic patients and 63% of virtual clinic patients responded to the PSQ. The mean satisfaction score was over 4.3/5 in all areas surveyed. Virtual clinic patients' understanding of their condition was very good, with 95% correctly identifying their diagnosis as glaucoma, 83% as ocular hypertension and 78% as suspects. There was no evidence to support inferior knowledge or self-perceived understanding compared to standard clinic patients. Follow-up patients knew more about glaucoma than new patients. Over 95% of patients found our information leaflet useful. Forty percent of patients sought additional information but less than 20% used the internet for this. A substantial proportion of glaucoma pathway patients may be seen by non-medical staff supervised by glaucoma specialists via virtual clinics. Patients are accepting of this format, reporting high levels of satisfaction and non-inferior knowledge to those seen in standard clinics.

  17. Virtual glaucoma clinics: patient acceptance and quality of patient education compared to standard clinics

    Directory of Open Access Journals (Sweden)

    Court JH

    2015-04-01

    Full Text Available Jennifer H Court,1 Michael W Austin1,21Department of Ophthalmology, Singleton Hospital, Swansea, Wales, UK; 2Department of Ophthalmology, Neath Port Talbot Hospital, Swansea, Wales, UKPurpose: Virtual glaucoma clinics allow rapid, reliable patient assessment but the service should be acceptable to patients and concordance with treatment needs to be maintained with adequate patient education. This study compares experiences and understanding of patients reviewed via the virtual clinic versus the standard clinic by way of an extended patient satisfaction questionnaire (PSQ.Patients and methods: One hundred PSQs were given to consecutive patients attending glaucoma clinics in October 2013. All 135 patients reviewed via the virtual clinic from April 2013 until August 2013 were sent postal PSQs in September 2013. Data were obtained for demographics, understanding of glaucoma, their condition, satisfaction with their experience, and quality of information. Responses were analyzed in conjunction with the clinical records.Results: Eighty-five percent of clinic patients and 63% of virtual clinic patients responded to the PSQ. The mean satisfaction score was over 4.3/5 in all areas surveyed. Virtual clinic patients’ understanding of their condition was very good, with 95% correctly identifying their diagnosis as glaucoma, 83% as ocular hypertension and 78% as suspects. There was no evidence to support inferior knowledge or self-perceived understanding compared to standard clinic patients. Follow-up patients knew more about glaucoma than new patients. Over 95% of patients found our information leaflet useful. Forty percent of patients sought additional information but less than 20% used the internet for this.Conclusion: A substantial proportion of glaucoma pathway patients may be seen by non-medical staff supervised by glaucoma specialists via virtual clinics. Patients are accepting of this format, reporting high levels of satisfaction and non

  18. The ART approach: clinical aspects reviewed.

    Science.gov (United States)

    Molina, Gustavo Fabián; Cabral, Ricardo Juan; Frencken, Jo E

    2009-01-01

    The success of ART as a caries management approach is supported by more than 20 years of scientific evidence. ART follows the contemporary concepts of modern cariology and restorative dentistry. It challenges treatment concepts such as step-wise excavation and the need for complete removal of affected dentine. The ART approach so far has mainly used high-viscosity glass-ionomer as the sealant and restorative material. Cariostatic and remineralization properties have been ascribed to this material which requires further research to establish its clinical relevance. The adhesion of high-viscosity glass-ionomer to enamel in pits and fissures is apparently strong, as its remnants, blocking the pits and fissures, have been considered a possible reason for the low prevalence of carious lesion development after the glass-ionomer has clinically disappeared from it. Encapsulated high-viscosity glass-ionomers may lead to higher restoration survival results than those of the hand-mixed version and should, therefore, not be neglected when using ART. Similarly, the use of resin-modified glass-ionomer with ART should be researched. The effectiveness of ART when compared to conventional caries management approaches has been shown in numerous studies. Proper case selection is an important factor for long-lasting ART restoration survival. This is based on the caries risk situation of the individual, the size of the cavity opening, the strategic position of the cavitated tooth and the presence of adequate caries control measures. As the operator is one of the main causes for failure of ART restorations, attending a well-conducted ART training course is mandatory for successful implementation of ART.

  19. Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation

    Science.gov (United States)

    Rink, Cameron L.; Wernke, Matthew M.; Powell, Heather M.; Tornero, Mark; Gnyawali, Surya C.; Schroeder, Ryan M.; Kim, Jayne Y.; Denune, Jeffrey A.; Albury, Alexander W.; Gordillo, Gayle M.; Colvin, James M.; Sen, Chandan K.

    2017-01-01

    Objective: (1) Develop a standardized approach to quantitatively measure residual limb skin health. (2) Report reference residual limb skin health values in people with transtibial and transfemoral amputation. Approach: Residual limb health outcomes in individuals with transtibial (n = 5) and transfemoral (n = 5) amputation were compared to able-limb controls (n = 4) using noninvasive imaging (hyperspectral imaging and laser speckle flowmetry) and probe-based approaches (laser doppler flowmetry, transcutaneous oxygen, transepidermal water loss, surface electrical capacitance). Results: A standardized methodology that employs noninvasive imaging and probe-based approaches to measure residual limb skin health are described. Compared to able-limb controls, individuals with transtibial and transfemoral amputation have significantly lower transcutaneous oxygen tension, higher transepidermal water loss, and higher surface electrical capacitance in the residual limb. Innovation: Residual limb health as a critical component of prosthesis rehabilitation for individuals with lower limb amputation is understudied in part due to a lack of clinical measures. Here, we present a standardized approach to measure residual limb health in people with transtibial and transfemoral amputation. Conclusion: Technology advances in noninvasive imaging and probe-based measures are leveraged to develop a standardized approach to quantitatively measure residual limb health in individuals with lower limb loss. Compared to able-limb controls, resting residual limb physiology in people that have had transfemoral or transtibial amputation is characterized by lower transcutaneous oxygen tension and poorer skin barrier function. PMID:28736682

  20. Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation.

    Science.gov (United States)

    Rink, Cameron L; Wernke, Matthew M; Powell, Heather M; Tornero, Mark; Gnyawali, Surya C; Schroeder, Ryan M; Kim, Jayne Y; Denune, Jeffrey A; Albury, Alexander W; Gordillo, Gayle M; Colvin, James M; Sen, Chandan K

    2017-07-01

    Objective: (1) Develop a standardized approach to quantitatively measure residual limb skin health. (2) Report reference residual limb skin health values in people with transtibial and transfemoral amputation. Approach: Residual limb health outcomes in individuals with transtibial ( n  = 5) and transfemoral ( n  = 5) amputation were compared to able-limb controls ( n  = 4) using noninvasive imaging (hyperspectral imaging and laser speckle flowmetry) and probe-based approaches (laser doppler flowmetry, transcutaneous oxygen, transepidermal water loss, surface electrical capacitance). Results: A standardized methodology that employs noninvasive imaging and probe-based approaches to measure residual limb skin health are described. Compared to able-limb controls, individuals with transtibial and transfemoral amputation have significantly lower transcutaneous oxygen tension, higher transepidermal water loss, and higher surface electrical capacitance in the residual limb. Innovation: Residual limb health as a critical component of prosthesis rehabilitation for individuals with lower limb amputation is understudied in part due to a lack of clinical measures. Here, we present a standardized approach to measure residual limb health in people with transtibial and transfemoral amputation. Conclusion: Technology advances in noninvasive imaging and probe-based measures are leveraged to develop a standardized approach to quantitatively measure residual limb health in individuals with lower limb loss. Compared to able-limb controls, resting residual limb physiology in people that have had transfemoral or transtibial amputation is characterized by lower transcutaneous oxygen tension and poorer skin barrier function.

  1. Current practices and challenges in the standardization and harmonization of clinical laboratory tests123

    Science.gov (United States)

    Vesper, Hubert W; Myers, Gary L; Miller, W Greg

    2016-01-01

    Effective patient care, clinical research, and public health efforts require comparability of laboratory results independent of time, place, and measurement procedure. Comparability is achieved by establishing metrological traceability, which ensures that measurement procedures measure the same quantity and that the calibration of measurement procedures is traceable to a common reference system consisting of reference methods and materials. Whereas standardization ensures traceability to the International System of Units, harmonization ensures traceability to a reference system agreed on by convention. This article provides an overview of standardization and harmonization with an emphasis on commutability as an important variable that affects testing accuracy. Commutability of reference materials is required to ensure that traceability is established appropriately and that laboratory results are comparable. The use of noncommutable reference materials leads to inaccurate results. Whereas procedures and protocols for standardizing measurements are established and have been successfully applied in efforts such as the Hormones Standardization Program of the CDC, harmonization activities require new, more complex procedures and approaches. The American Association for Clinical Chemistry, together with its domestic and international partners, formed the International Consortium for Harmonization of Clinical Laboratory Results to coordinate harmonization efforts. Reference systems, as well as procedures and protocols to establish traceability of clinical laboratory tests, have been established and continue to be developed by national and international groups and organizations. Serum tests of thyroid function, including those for the thyroid hormones thyroxine and triiodothyronine, are among the clinical procedures for which standardization efforts are well under way. Approaches to the harmonization of measurement procedures for serum concentrations of thyroid

  2. A standardized SOA for clinical data interchange in a cardiac telemonitoring environment.

    Science.gov (United States)

    Gazzarata, Roberta; Vergari, Fabio; Cinotti, Tullio Salmon; Giacomini, Mauro

    2014-11-01

    Care of chronic cardiac patients requires information interchange between patients' homes, clinical environments, and the electronic health record. Standards are emerging to support clinical information collection, exchange and management and to overcome information fragmentation and actors delocalization. Heterogeneity of information sources at patients' homes calls for open solutions to collect and accommodate multidomain information, including environmental data. Based on the experience gained in a European Research Program, this paper presents an integrated and open approach for clinical data interchange in cardiac telemonitoring applications. This interchange is supported by the use of standards following the indications provided by the national authorities of the countries involved. Taking into account the requirements provided by the medical staff involved in the project, the authors designed and implemented a prototypal middleware, based on a service-oriented architecture approach, to give a structured and robust tool to congestive heart failure patients for their personalized telemonitoring. The middleware is represented by a health record management service, whose interface is compliant to the healthcare services specification project Retrieve, Locate and Update Service standard (Level 0), which allows communication between the agents involved through the exchange of Clinical Document Architecture Release 2 documents. Three performance tests were carried out and showed that the prototype completely fulfilled all requirements indicated by the medical staff; however, certain aspects, such as authentication, security and scalability, should be deeply analyzed within a future engineering phase.

  3. Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian

    OpenAIRE

    Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook

    2017-01-01

    This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical di...

  4. New approaches for the standardization and validation of a real-time qPCR assay using TaqMan probes for quantification of yellow fever virus on clinical samples with high quality parameters.

    Science.gov (United States)

    Fernandes-Monteiro, Alice G; Trindade, Gisela F; Yamamura, Anna M Y; Moreira, Otacilio C; de Paula, Vanessa S; Duarte, Ana Cláudia M; Britto, Constança; Lima, Sheila Maria B

    2015-01-01

    The development and production of viral vaccines, in general, involve several steps that need the monitoring of viral load throughout the entire process. Applying a 2-step quantitative reverse transcription real time PCR assay (RT-qPCR), viral load can be measured and monitored in a few hours. In this context, the development, standardization and validation of a RT-qPCR test to quickly and efficiently quantify yellow fever virus (YFV) in all stages of vaccine production are extremely important. To serve this purpose we used a plasmid construction containing the NS5 region from 17DD YFV to generate the standard curve and to evaluate parameters such as linearity, precision and specificity against other flavivirus. Furthermore, we defined the limits of detection as 25 copies/reaction, and quantification as 100 copies/reaction for the test. To ensure the quality of the method, reference controls were established in order to avoid false negative results. The qRT-PCR technique based on the use of TaqMan probes herein standardized proved to be effective for determining yellow fever viral load both in vivo and in vitro, thus becoming a very important tool to assure the quality control for vaccine production and evaluation of viremia after vaccination or YF disease.

  5. Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

    Science.gov (United States)

    Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo

    2018-02-01

    Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

  6. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer

    DEFF Research Database (Denmark)

    Grønvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette

    2017-01-01

    Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients...

  7. Standardized approach for developing probabilistic exposure factor distributions

    Energy Technology Data Exchange (ETDEWEB)

    Maddalena, Randy L.; McKone, Thomas E.; Sohn, Michael D.

    2003-03-01

    The effectiveness of a probabilistic risk assessment (PRA) depends critically on the quality of input information that is available to the risk assessor and specifically on the probabilistic exposure factor distributions that are developed and used in the exposure and risk models. Deriving probabilistic distributions for model inputs can be time consuming and subjective. The absence of a standard approach for developing these distributions can result in PRAs that are inconsistent and difficult to review by regulatory agencies. We present an approach that reduces subjectivity in the distribution development process without limiting the flexibility needed to prepare relevant PRAs. The approach requires two steps. First, we analyze data pooled at a population scale to (1) identify the most robust demographic variables within the population for a given exposure factor, (2) partition the population data into subsets based on these variables, and (3) construct archetypal distributions for each subpopulation. Second, we sample from these archetypal distributions according to site- or scenario-specific conditions to simulate exposure factor values and use these values to construct the scenario-specific input distribution. It is envisaged that the archetypal distributions from step 1 will be generally applicable so risk assessors will not have to repeatedly collect and analyze raw data for each new assessment. We demonstrate the approach for two commonly used exposure factors--body weight (BW) and exposure duration (ED)--using data for the U.S. population. For these factors we provide a first set of subpopulation based archetypal distributions along with methodology for using these distributions to construct relevant scenario-specific probabilistic exposure factor distributions.

  8. Review. Evidence-based complementary oncology. Innovative approaches to optimize standard therapy strategies.

    Science.gov (United States)

    Beuth, Josef; Schierholz, Joerg Michael

    2007-01-01

    Cancer diseases demand diagnostic and therapeutic measures with proven quality, safety and efficacy. The basis for evaluation is clinical studies representing levels I or II (randomized controlled trials (RCT) or epidemiological cohort studies) in accordance with recommendations of the Centre for Evidence-based Medicine, University of Oxford, UK Regarding these claims, surgery, chemo-, radio- and hormone therapy have emerged as the gold standard in the treatment of carcinomas. These therapies have proven their cancer destructive potencies and their curative feasibilities, dependent on the particular cancer entity and stage. Complementary therapies are recommended to support and optimize the scientifically-based cancer standard treatment. Complementary medicine is currently widely debated by the oncological community, because the required scientific proof of safety and effectiveness for most of the therapeutic approaches has not yet been definitively provided. In the past years, basic research and clinical evaluation of defined complementary therapeutic concepts in oncology have been intensified in an attempt to integrate these procedures into evidence-based medicine. Scientifically-based therapies of complementary medicine cannot replace the well studied conventional cancer-destructive therapies such as surgery, chemo-, radio- or hormone therapy. Accordingly, they are by no means "alternative therapies". Complementary approaches in oncology that are recommended as additional to standard cancer destructive therapies claim to optimize this therapy. A great body of data emerging from scientifically sound clinical trials prove that defined complementary procedures are beneficial for the patients.

  9. Pediatric Dentistry: A Clinical Approach, 3rd Edition

    DEFF Research Database (Denmark)

    Pediatric Dentistry: A Clinical Approach, Third Edition provides a uniquely clear, comprehensive, and clinical approach to the dental treatment of children and adolescents. •Offers systematic coverage of all clinical, scientific and social topics relating to pediatric dentistry •Thoroughly revised...

  10. A systems approach to accepted standards of care: Shifting the blame

    Directory of Open Access Journals (Sweden)

    David G. Glance

    2011-09-01

    Full Text Available In healthcare, from a legal perspective, the standard ofacceptable practice has been generally set by the courts anddefined as healthcare professionals acting in a manner thatis widely accepted by their peers as meeting an acceptablestandard of care. This view, however, reflects the state ofhow practice “is” rather than what it “ought to be”. What isought to be depends on whether you take a “person” or“system” oriented approach to practice.The increasing pressures of lack of money and resources,and an ever-increasing need for care are bringing pressureon the health services to move to a system approach andthis is gaining acceptance both with clinicians and thuseventually the courts.A systems-type approach to healthcare will, by necessity,embrace clinical protocols and guidelines supported byclinical information systems. It will also see blame for errorsshifting from clinicians to the organisations that employthem.This paper argues that a continued use of a person-basedapproach to healthcare, developed through an historicalrecord of practice by individual clinicians, is no longeradequate defence in a case of supposed negligence.When the healthcare system has codified clinical guidelinesand digital data gathered across thousands of clinicians andtheir patients, it is possible to compute adequate levels ofcare and expect clinicians and the healthcare system ingeneral to meet these minimum standards.Future negligence decisions will rely on a systems-basedbest practice standard of care determined through evidencerather than opinion

  11. Natural language processing systems for capturing and standardizing unstructured clinical information: A systematic review.

    Science.gov (United States)

    Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis

    2017-09-01

    We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Clinical standard of neurosurgical disorder. (9) Disturbance of consciousness

    International Nuclear Information System (INIS)

    Ohta, Tomio

    2009-01-01

    Functional diagnosis of consciousness disturbance (CD) in acute and chronic stages is becoming more important along with the progress of morphological diagnosis by CT and MRI at the stroke and brain lesion. Here described and discussed are the definition of consciousness and unconsciousness, cause and scoring of CD by various scaling and clinical significance of the scale for therapy. The author's definition for consciousness is based on patients' self identity and orientation. The above CD is essentially caused by the increased intracranial pressure, which is evaluable by imaging as the increase is derived from the herniation by tumor or edema mainly through transtentorial (uncal, hippocampal) and/or foraminal (cerebellar tonsillar) pathways. Scaling of CD stands on three factors of validity, reliability and feasibility, of which standards of JCS (Japan coma scale) and GCS (Glasgow coma scale) have been widely employed. In discussion of merit/demerit of JCS and GCS, the author et al. have proposed a new scale ECS (emergency coma scale) with 3 levels of digit code for patient's response and behavior under CD. Therapeutic outcome is greatly affected by acute CD levels evaluable by scaling, in which awakening/alertness relates with mortality, and local symptom/consciousness, with morbidity. ECS is now globally getting around. (K.T.)

  13. Measuring students' approaches to learning in different clinical rotations.

    Science.gov (United States)

    Emilia, Ova; Bloomfield, Leah; Rotem, Arie

    2012-11-15

    Many studies have explored approaches to learning in medical school, mostly in the classroom setting. In the clinical setting, students face different conditions that may affect their learning. Understanding students' approaches to learning is important to improve learning in the clinical setting. The aim of this study was to evaluate the Study Process Questionnaire (SPQ) as an instrument for measuring clinical learning in medical education and also to show whether learning approaches vary between rotations. All students involved in this survey were undergraduates in their clinical phase. The SPQ was adapted to the clinical setting and was distributed in the last week of the clerkship rotation. A longitudinal study was also conducted to explore changes in learning approaches. Two hundred and nine students participated in this study (response rate 82.0%). The SPQ findings supported a two-factor solution involving deep and surface approaches. These two factors accounted for 45.1% and 22.5%, respectively, of the variance. The relationships between the two scales and their subscales showed the internal consistency and factorial validity of the SPQ to be comparable with previous studies. The clinical students in this study had higher scores for deep learning. The small longitudinal study showed small changes of approaches to learning with different rotation placement but not statistically significant. The SPQ was found to be a valid instrument for measuring approaches to learning among clinical students. More students used a deep approach than a surface approach. Changes of approach not clearly occurred with different clinical rotations.

  14. Different approaches of high speed data transmission standards

    OpenAIRE

    M. Ehlert

    2004-01-01

    A number of standards addresses the problem of high-speed data transmission on serial or serial-parallel data lines. Serial-parallel data transmission means the transmitted information is distributed on parallel data lines. Even though several standards exist, there are only a few basic techniques used in most of these standards. This paper is giving an overview of these different basic techniques used in the physical layer of today’s data transmission standards, for exam...

  15. The Body in Movement: A Clinical Approach

    OpenAIRE

    Probst, Michel; Diedens, Jolien

    2017-01-01

    Physiotherapy or body oriented therapy is often overlooked as an adjunctive treatment for patients with eating disorders (ED). However, the integration of physiotherapy is based on the physiotherapists’ experience in both the body and the body in movement, two important issues integral to eating disorder pathology. From our clinical experience, physiotherapeutic techniques represent a potent clinical addition to available treatments. Patients with eating disorders have an intense fear of gain...

  16. Clinical approach to inherited peroxisomal disorders

    NARCIS (Netherlands)

    Poggi-Travert, F.; Fournier, B.; Poll-The, B. T.; Saudubray, J. M.

    1995-01-01

    At least 21 genetic disorders have now been found that are linked to peroxisomal dysfunction. Whatever the genetic defect might be, peroxisomal disorders should be considered in various clinical conditions, dependent on the age of onset. The prototype of peroxisomal disorders is represented by

  17. Disciplining standard-setting : Which approach to choose (if any)?

    NARCIS (Netherlands)

    Kanevskaia, Olia; Jacobs, Kai; Blind, Knut

    In the world of continuous globalization, standards play a crucial role in transnational economic development. Being the drivers of harmonization and innovation, standards do not only facilitate production and exchange in goods and services, but also carry significant policy implications and create

  18. Disciplining standard-setting : Which approach to choose (if any)

    NARCIS (Netherlands)

    Kanevskaia, Olia

    2017-01-01

    In the world of continuous globalization, standards play a crucial role in transnational economic development. Being the drivers of harmonization and innovation, standards do not only facilitate production and exchange in goods and services, but also carry significant policy implications and create

  19. An Approach to Establishing International Quality Standards for Medical Travel

    Directory of Open Access Journals (Sweden)

    Ondřej eKácha

    2016-03-01

    Full Text Available Traveling abroad to receive a non-elective treatment is expanding each year. Such rising popularity of medical travel and the absence of clear minimum quality requirements in this area urgently calls for setting international standards to ensure good practice and patient safety. The aim of this study is to identify the key domains in medical travel where such quality standards should be established. Drawing from the evidence-based OECD framework and an extensive literature review, this study proposes three critical areas for international quality standards in medical travel: minimum standards of health care facilities and third-party agencies, financial responsibility and patient-centeredness. Several cultural challenges are subsequently introduced that may pose a barrier to the development of the guidelines and should be additionally taken into consideration. Establishing international quality standards in medical travel enhances the benefits to patients and providers, which is urgently needed given the rapid growth in this industry.

  20. Comparative effects of photodynamic therapy mediated by curcumin on standard and clinical isolate of Streptococcus mutans.

    Science.gov (United States)

    Tonon, Caroline C; Paschoal, Marco Aurélio; Correia, Marilia; Spolidório, Denise M P; Bagnato, Vanderlei S; Giusti, Juçaíra S M; Santos-Pinto, Lourdes

    2015-01-01

    The aim of this study was investigate the effect of photodynamic therapy (PDT) using curcumin (C) as a photosensitizing agent irradiated with an LED (L) in the blue wavelength as a light source on a standard and clinical isolate of Streptococcus mutans (S. mutans) in a planktonic suspension model. Suspensions of both strains were divided into 4 groups as follows: absence of C and L (control group: C-L-), with C and without L (C group: C+L-), absence of C with L (L group: C-L+) and presence of C and L (PDT group: C+L+). Three different concentrations of curcumin (0.75 mg/ml, 1.5 mg/ml and 3 mg/ml) and three light fluences of studied light source (24, 48 and 72 J cm(-2)) were tested. Aliquots of each studied group was plated in BHI agar and submitted to colony forming units counting (CFU/ml) and the data transformed into logarithmical scale. A high photoinactivation rate of more than 70% was verified to standard S. mutans strain submitted to PDT whereas the clinical isolate showed a lower sensitivity to all the associations of curcumin and LED. A slight bacterial reduction was verified to C+L- and C-L+, demonstrating no toxic effects to the isolated application of light and photosensitizer to both S. mutans strains tested. Photodynamic therapy using a combination of curcumin and blue LED presented a substantial antimicrobial effect on S. mutans standard strain in a planktonic suspension model with a less pronounced effect on its clinical isolate counterparts due to resistance to this alternative approach. Alternative antimicrobial approaches, as photodynamic therapy, should be encouraged due to optimal results against cariogenic bacteria aiming to prevent or treat dental caries.

  1. Clinical approaches to treatment of Internet addiction.

    Science.gov (United States)

    Przepiorka, Aneta Małgorzata; Blachnio, Agata; Miziak, Barbara; Czuczwar, Stanisław Jerzy

    2014-04-01

    Internet appearance was one of the main breakthroughs for the mankind in the latest decades. It revolutionized our lives in many aspects and brought about many undeniably positive changes. However, at the same time caused negative consequences. It has led to the emergence of the Internet addiction (IA). The paper is concerned with the issue of treatment of IA. The paper reviews the current findings on the approaches to IA treatment and evaluates their effectiveness. The main focus of the article concentrates on cognitive and pharmacologic treatment. The individual approach to IA treatment is advisable. Among drugs for the management of IA, antidepressants, antipsychotics, opioid receptor antagonists, glutamate receptor antagonists, and psychostimulants may be recommended. Some antiepileptics, and especially valproate, are considered as potential drugs for the treatment of IA. Effective therapy may require an individual approach and best results are expected when psychological and pharmacological treatments are combined. Copyright © 2014 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  2. Guidelines for Standard Photography in Gross and Clinical Anatomy

    Science.gov (United States)

    Barut, Cagatay; Ertilav, Hakan

    2011-01-01

    Photography has a widespread usage in medicine and anatomy. In this review, authors focused on the usage of photography in gross and clinical anatomy. Photography in gross and clinical anatomy is not only essential for accurate documentation of morphological findings but also important in sharing knowledge and experience. Photographs of cadavers…

  3. Integrated monitoring: Setting new standards for the next decade of clinical trial practice

    Directory of Open Access Journals (Sweden)

    Kamala Rai

    2011-01-01

    Full Text Available The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor′s organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.

  4. Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

  5. [Total hip replacement from a MIS-AL approach (comparison with a standard anterolateral approach)].

    Science.gov (United States)

    Kubes, J; Landor, I; Podskubka, A; Majernícek, M

    2009-08-01

    Minimally invasive surgery (MIS) techniques have recently become a powerful and effective marketing instruments that are often perceived by the patient as the criterion of the surgeon's and institution's standard. In addition to studies reporting the benefits of minimally invasive procedures, some authors have recently found no such benefits or even pointed out some disadvantages. In this paper we present our own view of this issue. Our definition of minimally invasive surgery: a minimally invasive procedure is such that an optimally placed incision using anatomical intervals without damage to muscle insertions allows us to gain a good view of the operating field and to safely perform the planned surgery. Because of this optimal approach it is possible to make skin incisions shorter. Between April 21, 2005, and December 28, 2006, the first 40 MIS hip procedures were performed at the Department of Orthopaedic Surgery of the ILF Bulovka. Forty patients who, in the same period, were operated on from an anterolateral standard approach and who met the same indication criteria, including age, comprised a control group. In both groups all routinely used types of implants were included. For objective assessment of potential differences between surgical outcomes of the two techniques, the following para- meters were recorded: operating time, peri-operative blood loss, pre- and post-operative Hb levels, Hb level on the first post- operative morning, amount of blood drained away with a Redon drain, number of anodyne applications (indirect evaluation of post-operative pain) and length of hospital stay. The parameters were compared for the cemented and the uncemented implants separately. The results were evaluated using the paired t-test, with the significance level set at a value of pMIS-AL results with those of the standard total hip replacement procedure did not show any significant differences, not even during further follow-up; by the end of 2008 no implant failure or

  6. Improving automobile fuel economy: new standards, new approaches

    Science.gov (United States)

    1991-12-01

    This report examines the major issues associated with developing new fuel : economy standards. It builds on work that the Office of Technology Assessment : conducted for its report, "Energy Technology Choices: Shaping Our Future." 118p.

  7. An Approach to Establishing International Quality Standards for Medical Travel.

    Science.gov (United States)

    Kácha, Ondřej; Kovács, Beáta E; McCarthy, Cormac; Schuurmans, Angela A T; Dobyns, Christopher; Haller, Elisa; Hinrichs, Saba; Ruggeri, Kai

    2016-01-01

    The number of individuals traveling abroad is increasing annually. The rising popularity of medical travel and the absence of clear minimum quality requirements in this area urgently call for the development of international standards to ensure good practice and patient safety. The aim of this study is to identify the key domains in medical travel where quality standards should be established. Drawing from the evidence-based OECD framework and an extensive literature review, this study proposes three critical areas for consideration: minimum standards of health-care facilities and third-party agencies, financial responsibility, and patient centeredness. Several cultural challenges have been introduced that may pose a barrier to development of the guidelines and should be taken into consideration. Establishing international quality standards in medical travel enhances benefits to patients and providers, which is an urgent necessity given the rapid growth in this industry.

  8. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  9. [Clinical gastroenterology--luxury or standard of service in gastroenterology?].

    Science.gov (United States)

    Birkner, B

    2005-12-01

    Gastroenterology is one of the important specialities in internal medicine. The reform of the training curriculum for internal medicine and the reimbursement for inpatient and outpatient services in gastroenterology threatens the existence of internal medicine and gastroenterology in Germany, too. The capacity for training in internal medicine and gastroenterology is reduced by a decrease in the number of hospital beds in academic and community training centres. The concentration on gastrointestinal endoscopy in outpatient gastroenterology will be a result of an increasing demand for gastrointestinal endoscopy services and the decreasing number of gastroenterology clinics, respectively. Therefore, clinical gastroenterology as a core service in gastroenterology will be steadily eliminated. This development will diminish clinical gastroenterology to gastrointestinal endoscopy by eliminating the clinical services for chronic gastroenterological conditions such as, e.g., IBD, chronic hepatitis, reflux disease, IBS and functional dyspepsia. In this way gastroenterology looses its central role in health care services in specialised internal medicine. In 2003 the American Gastroenterological Association position paper: "Training the Gastroenterologist of the Future: the Gastroenterology Core Curriculum" was published. It has emphasised the role of clinical gastroenterology in medical training and medical services, too. Clinical gastroenterology consists of an array of several disciplines, e.g., GI physiology, GI research, infectious diseases, hepatology, oncology and gastrointestinal endoscopy, which all contribute to the effectiveness and efficiency in health care service. Financial incentives and better prospects of leading positions for young gastroenterologists in clinical gastroenterology have to be accomplished in order to nourish clinical gastroenterology in Germany. The German Association of Gastroenterology should negotiate with the responsible authorities for

  10. Approaches to Increasing Ethical Compliance in China with Drug Trial Standards of Practice

    DEFF Research Database (Denmark)

    Rosenberg, Jacob

    2016-01-01

    researchers, and strong reinforcement by Chinese journal editors not to publish studies with these flaws, then research ethics and publication standards will probably improve. Other solutions to foster ethical practice of drug trials are discussed including Chinese initiatives directed at managing conflict......Zeng et al.'s Ethics Review highlights some of the challenges associated with clinical research in China. They found that only a minority of published clinical trials of anti-dementia drugs reported that they fulfilled the basic ethical principles as outlined in the Declaration of Helsinki....... With recent reports of scientific misconduct from China, there is an urgent need to find approaches to compel researchers to adhere to ethical research practices. This problem does not call for a simple solution, but if forces are joined with governmental regulations, education in ethics issues for medical...

  11. A Deep Learning Solution for Automatic Fetal Neurosonographic Diagnostic Plane Verification Using Clinical Standard Constraints.

    Science.gov (United States)

    Yaqub, Mohammad; Kelly, Brenda; Papageorghiou, Aris T; Noble, J Alison

    2017-12-01

    During routine ultrasound assessment of the fetal brain for biometry estimation and detection of fetal abnormalities, accurate imaging planes must be found by sonologists following a well-defined imaging protocol or clinical standard, which can be difficult for non-experts to do well. This assessment helps provide accurate biometry estimation and the detection of possible brain abnormalities. We describe a machine-learning method to assess automatically that transventricular ultrasound images of the fetal brain have been correctly acquired and meet the required clinical standard. We propose a deep learning solution, which breaks the problem down into three stages: (i) accurate localization of the fetal brain, (ii) detection of regions that contain structures of interest and (iii) learning the acoustic patterns in the regions that enable plane verification. We evaluate the developed methodology on a large real-world clinical data set of 2-D mid-gestation fetal images. We show that the automatic verification method approaches human expert assessment. Copyright © 2017 World Federation for Ultrasound in Medicine and Biology. Published by Elsevier Inc. All rights reserved.

  12. Measuring students’ approaches to learning in different clinical rotations

    Directory of Open Access Journals (Sweden)

    Emilia Ova

    2012-11-01

    Full Text Available Abstract Background Many studies have explored approaches to learning in medical school, mostly in the classroom setting. In the clinical setting, students face different conditions that may affect their learning. Understanding students’ approaches to learning is important to improve learning in the clinical setting. The aim of this study was to evaluate the Study Process Questionnaire (SPQ as an instrument for measuring clinical learning in medical education and also to show whether learning approaches vary between rotations. Methods All students involved in this survey were undergraduates in their clinical phase. The SPQ was adapted to the clinical setting and was distributed in the last week of the clerkship rotation. A longitudinal study was also conducted to explore changes in learning approaches. Results Two hundred and nine students participated in this study (response rate 82.0%. The SPQ findings supported a two-factor solution involving deep and surface approaches. These two factors accounted for 45.1% and 22.5%, respectively, of the variance. The relationships between the two scales and their subscales showed the internal consistency and factorial validity of the SPQ to be comparable with previous studies. The clinical students in this study had higher scores for deep learning. The small longitudinal study showed small changes of approaches to learning with different rotation placement but not statistically significant. Conclusions The SPQ was found to be a valid instrument for measuring approaches to learning among clinical students. More students used a deep approach than a surface approach. Changes of approach not clearly occurred with different clinical rotations.

  13. Epidemiology of social phobia: a clinical approach.

    Science.gov (United States)

    Faravelli, C; Zucchi, T; Viviani, B; Salmoria, R; Perone, A; Paionni, A; Scarpato, A; Vigliaturo, D; Rosi, S; D'adamo, D; Bartolozzi, D; Cecchi, C; Abrardi, L

    2000-02-01

    The recent epidemiologic studies report extremely varied rates for social phobia (SP). One of the reasons for this may be the difficulty in diagnosing SP, the boundaries of which are uncertain. A community survey was carried out using doctors with experience in clinical psychiatry as interviewers, and a clinical diagnostic instrument. Two thousand three hundred and fifty-five people (out of the 2,500 randomly selected from the population) living in Sesto Fiorentino, a suburb of Florence, Italy, were interviewed by their own general practitioner, using the MINI plus six additional questions. Six hundred and ten of the 623 subjects that were found positive for any form of psychopathology at the screening interview, and 57 negative subjects, were re-interviewed by residents in psychiatry using the Florence Psychiatric Interview (FPI). The FPI is a validated composite instrument that has the format of a structured clinical research record. It was found that 6.58% of subjects showed social anxiety not attributable to other psychiatric or medical conditions during their life. Social or occupational impairments meeting DSM-IV diagnostic requirements for SP was detected in 76 subjects (lifetime prevalence = 3.27%). Correction for age raises the lifetime expected prevalence to 4%. Sex ratio was approximately (F:M) 2:1. The most common fear was speaking in public (89.4%), followed by entering a room occupied by others (63.1%) and meeting with strangers (47.3%). Eighty-six point nine percent of subjects with SP complained of more than one fear. The mean age of onset (when the subjects first fully met DSM-IV criteria for SP) was 28.8 years, but the first symptoms of SP usually occurred much earlier, with a mean age of onset at 15.5 years. Ninety-two percent of cases with SP also showed at least one other co-morbid psychiatric disorder during their life. Lifetime prevalence of avoidant personality disorder (APD) was 3.6%. Forty-two point nine percent of cases with SP also had

  14. [Vertebrobasilar flow: clinical manifestations and diagnostic approaches].

    Science.gov (United States)

    Kovacević, M S; Jovanović, D; Bumbaserević, Lj; Pecić, O; Bugarski, C; Zidverc, J; Kovacević, D

    1996-01-01

    The role of the damaged function of the brain and brain stem of vascular origin is very important in human pathology, especially today when these lesions are frequent, and prevention and elimination of consequences are complex. In practice vertebrobasilar insufficiency is a very important diagnostic problem. The aim of the paper is to point to the most frequent symptoms of vertebrobasilar dysfunction and to evaluate some diagnostic (electrophysiologic and neuroradiologic) procedures for the detection of a lesion. The examination concerned the patients with symptoms and signs of the damaged vertebrobasilar torcular, hospitalized at the Department of Urgent Neurologu of the Clinical Centre of Serbia in Belgrade, from January 1 to December 31, 1990. The diagnosis was made on the basis of the clinical picture and electrophysiologic and neuroradiologic findings. On the basis of these findings the patients were divide in groups 1-5. According to the duration of symptoms and signs of the disease the following damages were observed: transitory ischaemic attack, reversible ischaemic neurologic dificiency and total ischaemic cerebral stroke. Fifty patients (36 men and 14 women), aged from 18 to 74 years, were examined. According to the localization of the lesion 20 patients belonged to group 2 (vascular area of a cerebelli inferior anterior). Definite infarct lesion was diagnosed in 32 patients (Table 1). The results of electrophysiologic examinations (auditive evoked potentials, somatosensorial evoked potentials, blink reflex, electroencephalographic screenint) were positive in 27-50% of examined patients (Tables 2, 3). The results of neuroradiologic examinations (vertebral angiography-19 patients and computed tomography-40 patients) were statistically significant in comparison to electrophysiologic results. In everyday practice the diagnosis of vertebrobasilar dysfunctions, and especially of transitory attacks of vertebrobasilar insufficiency, may be an important problem

  15. Comparison of two head-up displays in simulated standard and noise abatement night visual approaches

    Science.gov (United States)

    Cronn, F.; Palmer, E. A., III

    1975-01-01

    Situation and command head-up displays were evaluated for both standard and two segment noise abatement night visual approaches in a fixed base simulation of a DC-8 transport aircraft. The situation display provided glide slope and pitch attitude information. The command display provided glide slope information and flight path commands to capture a 3 deg glide slope. Landing approaches were flown in both zero wind and wind shear conditions. For both standard and noise abatement approaches, the situation display provided greater glidepath accuracy in the initial phase of the landing approaches, whereas the command display was more effective in the final approach phase. Glidepath accuracy was greater for the standard approaches than for the noise abatement approaches in all phases of the landing approach. Most of the pilots preferred the command display and the standard approach. Substantial agreement was found between each pilot's judgment of his performance and his actual performance.

  16. The Cardiology Audit and Registration Data Standards (CARDS), European data standards for clinical cardiology practice

    NARCIS (Netherlands)

    M.R. Flynn (Rachel); C. Barrett (Conor); F.G. Cosio (Francisco); A.K. Gitt (Anselm); L.C. Wallentin (Lars); P. Kearney (Peter); M. Lonergan (Moira); E. Shelley (Emer); M.L. Simoons (Maarten)

    2005-01-01

    textabstractAIMS: Systematic registration of data from clinical practice is important for clinical care, local, national and international registries, and audit. Data to be collected for these different purposes should be harmonized. Therefore, during Ireland's Presidency of the European Union (EU)

  17. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1996-01-01

    Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. Tumor type and clinical course are often correlated with age at presentation and anatomic site. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon age at presentation, tumor type, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of 'standard' radiation therapy and evolving chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of precision radiation techniques. Modifications in radiation delivery are fundamental to current investigations in medulloblastoma; the rationale for contemporary and projected

  18. The Efficacy of Standardized Patient Feedback in Clinical Teaching: A Mixed Methods Analysis

    Directory of Open Access Journals (Sweden)

    Lisa Doyle Howley, PhD

    2004-01-01

    Full Text Available Introduction. The purpose of the current study was to investigate the effects of oral feedback from standardized patients on medical students’ overall perceptions of an educational exercise. We chose a mixed-methods approach to better understand the following research questions: Does satisfaction with the standardized patient exercise differ among those students who receive oral feedback and those who do not? What is the quality of oral feedback provided by standardized patients? Procedures. In order to address the first question, a basic randomized design comparing treatment (or those receiving SP feedback to control (those not receiving SP feedback was conducted. To address the second question, students in the treatment group were surveyed about their impressions of the quality of the feedback provided to them by their SP. One hundred and thirty six first year medical students were divided into treatment and control groups and interviewed one standardized patient during a single 20-minute encounter. Standardized patients were trained to simulate one of two outpatient cases and provide feedback using standard training materials. Both treatment and control groups completed a rating scale and questionnaire regarding their satisfaction with the encounter and students in the treatment group responded to additional questions regarding the quality of the SP feedback. Results. A one-way multivariate analysis of variance (MANOVA revealed significant differences among control and treatment groups on the seven combined dependent variables, Wilks’ =.890, F(7, 127=2.25, p<.034, ?2=.110. Students reported that the quality of SP feedback was very strong and additional qualitative analysis revealed further evidence to support the efficacy of providing oral SP feedback in a formative pre-clinical educational activity.

  19. Standardization for climate change. Approaches and perspectives. Final report

    International Nuclear Information System (INIS)

    Weterings, R.

    1995-01-01

    The results of a project, aimed at support of the environmental quality target for climate policy on a national level (Follow-up Memorandum Climatic Change of the Dutch government) and on an international level (elaboration of the UN Framework Convention on Climate Change). In order to generate ideas for standards of the climate policy a workshop was held on Environmental Quality and Climate. During the workshop standards of climatic change were highlighted from different points of view. Those views and perspectives are analyzed and the results are presented in this report. 4 figs., 31 refs

  20. The implementation of a standardized approach to laparoscopic rectal surgery

    DEFF Research Database (Denmark)

    Aslak, Katrine Kanstrup; Bulut, Orhan

    2012-01-01

    laparoscopic surgery on an intention-to-treat basis for rectal cancer. The results were retrospectively reviewed from a prospectively collected database. Operative steps and instrumentation for the procedure were standardized. A standard perioperative care plan was used. RESULTS: The following procedures were...... performed: low anterior resection (n = 26), low anterior resection with loop-ileostomy (n = 39), Hartmann's operation (n = 14), and abdominoperineal resection (n = 21). The median length of hospital stay was 7 days; 9 patients were readmitted There were 9 cases of conversion to open surgery. The overall...

  1. Standard setting and quality of assessment: A conceptual approach ...

    African Journals Online (AJOL)

    Quality performance standards and the effect of assessment outcomes are important in the educational milieu, as assessment remains the representative ... not be seen as a methodological process of setting pass/fail cut-off points only, but as a powerful catalyst for quality improvements in HPE by promoting excellence in ...

  2. An approach to establishing international quality standards for medical travel

    NARCIS (Netherlands)

    Lácha, O.; Kovács, B.E.; McCarthy, C.; Schuurmans, A.T.; Dobyns, C.; Haller, E.; Hinrichs, S.; Ruggeri, K.

    2016-01-01

    Traveling abroad to receive a non-elective treatment is expanding each year. Such rising popularity of medical travel and the absence of clear minimum quality requirements in this area urgently calls for setting international standards to ensure good practice and patient safety. The aim of this

  3. Next Generation Space Interconnect Standard (NGSIS): a modular open standards approach for high performance interconnects for space

    Science.gov (United States)

    Collier, Charles Patrick

    2017-04-01

    The Next Generation Space Interconnect Standard (NGSIS) effort is a Government-Industry collaboration effort to define a set of standards for interconnects between space system components with the goal of cost effectively removing bandwidth as a constraint for future space systems. The NGSIS team has selected the ANSI/VITA 65 OpenVPXTM standard family for the physical baseline. The RapidIO protocol has been selected as the basis for the digital data transport. The NGSIS standards are developed to provide sufficient flexibility to enable users to implement a variety of system configurations, while meeting goals for interoperability and robustness for space. The NGSIS approach and effort represents a radical departure from past approaches to achieve a Modular Open System Architecture (MOSA) for space systems and serves as an exemplar for the civil, commercial, and military Space communities as well as a broader high reliability terrestrial market.

  4. Is the Standard Monte Carlo Power Iteration Approach the Wrong Approach?

    Energy Technology Data Exchange (ETDEWEB)

    Booth, Thomas E [Los Alamos National Laboratory

    2012-06-05

    The power iteration method is the standard Monte Carlo approach for obtaining the eigenfunctions of a nuclear system, but the power method sometimes converges very slowly. Most discussions give a mathematical reason for the slow convergence of the Monte Carlo power method using the same concepts and terminology as when the power method is applied to a deterministic problem. This note first looks at why the convergence is slow from an intuitive Monte Carlo neutron perspective. Second, this note proposes building an eigenfunction intuitively in a cumulative (and noniterative) neutron by neutron manner that tends to better direct neutrons to where the neutrons need to be. Third, a very similar method for building the second eigenfunction is speculatively proposed.

  5. Looking beyond RtI Standard Treatment Approach: It's Not Too Late to Embrace the Problem-Solving Approach

    Science.gov (United States)

    King, Diane; Coughlin, Patricia Kathleen

    2016-01-01

    There are two approaches for providing Tier 2 interventions within Response to Intervention (RtI): standard treatment protocol (STP) and the problem-solving approach (PSA). This article describes the multi-tiered RtI prevention model being implemented across the United States through an analysis of these two approaches in reading instruction. It…

  6. The role of the standard EEG in clinical psychiatry.

    LENUS (Irish Health Repository)

    O'Sullivan, S S

    2012-02-03

    BACKGROUND: The EEG is a commonly requested test on patients attending psychiatric services, predominantly to investigate for a possible organic brain syndrome causing behavioural changes. AIMS: To assess referrals for EEG from psychiatric services in comparison with those from other sources. We determine which clinical factors were associated with an abnormal EEG in patients referred from psychiatric sources. METHODS: A retrospective review of EEG requests in a 1-year period was performed. Analysis of referral reasons for psychiatric patients was undertaken, and outcome of patients referred from psychiatric services post-EEG was reviewed. RESULTS: One thousand four hundred and seventy EEGs were reviewed, of which 91 (6.2%) were referred from psychiatry. Neurology service referrals had detection rates of abnormal EEGs of 27%, with psychiatric referrals having the lowest abnormality detection rate of 17.6% (p < 0.1). In psychiatric-referred patients the only significant predictors found of an abnormal EEG were a known history of epilepsy (p < 0.001), being on clozapine (p < 0.05), and a possible convulsive seizure (RR = 6.51). Follow-up data of 53 patients did not reveal a significant clinical impact of EEG results on patient management. CONCLUSIONS: Many patients are referred for EEG from psychiatric sources despite a relatively low index of suspicion of an organic brain disorders, based on reasons for referral documented, with an unsurprising low clinical yield.

  7. [Discussion on the standard of clinical genetic testing report and the consensus of gene testing industry].

    Science.gov (United States)

    Huang, Hui; Shen, Yiping; Gu, Weihong; Wang, Wei; Wang, Yiming; Qi, Ming; Shen, Jun; Qiu, Zhengqing; Yu, Shihui; Zhou, Zaiwei; Chen, Baixue; Chen, Lei; Chen, Yundi; Cui, Huanhuan; Du, Juan; Gao, Yong; Guo, Yiran; Hu, Chanjuan; Hu, Liang; Huang, Yi; Li, Peipei; Li, Xiaorong; Li, Xiurong; Liu, Yaping; Lu, Jie; Ma, Duan; Ma, Yongyi; Peng, Mei; Song, Fang; Sun, Hongye; Wang, Liang; Wang, Dawei; Wang, Jingmin; Wang, Ling; Wang, Zhengyuan; Wang, Zhinong; Wu, Jihong; Wu, Jing; Wu, Jian; Xu, Yimin; Yao, Hong; Yang, Dongsheng; Yang, Xu; Yang, Yanling; Zhang, Ying; Zhou, Yulin; Zhu, Baosheng; Zeng, Sicong; Peng, Zhiyu; Huang, Shangzhi

    2018-02-10

    The widespread application of next generation sequencing (NGS) in clinical settings has enabled testing, diagnosis, treatment and prevention of genetic diseases. However, many issues have arisen in the meanwhile. One of the most pressing issues is the lack of standards for reporting genetic test results across different service providers. The First Forum on Standards and Specifications for Clinical Genetic Testing was held to address the issue in Shenzhen, China, on October 28, 2017. Participants, including geneticists, clinicians, and representatives of genetic testing service providers, discussed problems of clinical genetic testing services across in China and shared opinions on principles, challenges, and standards for reporting clinical genetic test results. Here we summarize expert opinions presented at the seminar and report the consensus, which will serve as a basis for the development of standards and guidelines for reporting of clinical genetic testing results, in order to promote the standardization and regulation of genetic testing services in China.

  8. "Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

    Science.gov (United States)

    Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

  9. Approaching standard by designing a basic safety function

    OpenAIRE

    Baudoin , James; Bello , Jean-Paul

    2014-01-01

    This document is intended to guide designers to perform machinery control systems with only one or a few "basic safety functions such as emergency stop or movable guard.Among the available standards for machinery design, EN ISO 13849-1 is the one providing recommendations to design safety related parts of control systems (SRP/CS) implementing different types of energy such as electric, hydraulic or pneumatic.This document is based on the implementation of the simplified method of EN ISO 13849...

  10. Coset Space Dimensional Reduction approach to the Standard Model

    International Nuclear Information System (INIS)

    Farakos, K.; Kapetanakis, D.; Koutsoumbas, G.; Zoupanos, G.

    1988-01-01

    We present a unified theory in ten dimensions based on the gauge group E 8 , which is dimensionally reduced to the Standard Mode SU 3c xSU 2 -LxU 1 , which breaks further spontaneously to SU 3L xU 1em . The model gives similar predictions for sin 2 θ w and proton decay as the minimal SU 5 G.U.T., while a natural choice of the coset space radii predicts light Higgs masses a la Coleman-Weinberg

  11. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2011-06-01

    If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

  12. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  13. A Risk and Standards Based Approach to Quality Assurance in Australia's Diverse Higher Education Sector

    Science.gov (United States)

    Australian Government Tertiary Education Quality and Standards Agency, 2015

    2015-01-01

    The Australian Government Tertiary Education Quality and Standards Agency's (TEQSA's) role is to assure that quality standards are being met by all registered higher education providers. This paper explains how TEQSA's risk-based approach to assuring higher education standards is applied in broad terms to a diverse sector. This explanation is…

  14. Standardized Patients Provide a Reliable Assessment of Athletic Training Students' Clinical Skills

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2016-01-01

    Context: Providing students reliable objective feedback regarding their clinical performance is of great value for ongoing clinical skill assessment. Since a standardized patient (SP) is trained to consistently portray the case, students can be assessed and receive immediate feedback within the same clinical encounter; however, no research, to our…

  15. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  16. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.

    Science.gov (United States)

    Rapport, Frances; Storey, Mel; Porter, Alison; Snooks, Helen; Jones, Kerina; Peconi, Julie; Sánchez, Antonio; Siebert, Stefan; Thorne, Kym; Clement, Clare; Russell, Ian

    2013-02-21

    Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.

  17. Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

    Science.gov (United States)

    Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

    2017-04-18

    Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality

  18. Comprehensive Shoulder US Examination: A Standardized Approach with Multimodality Correlation for Common Shoulder Disease

    Science.gov (United States)

    Sheehan, Scott E.; Orwin, John F.; Lee, Kenneth S.

    2016-01-01

    Shoulder pain is one of the most common musculoskeletal conditions encountered in primary care and specialty orthopedic clinic settings. Although magnetic resonance (MR) imaging is typically the modality of choice for evaluating the soft-tissue structures of the shoulder, ultrasonography (US) is becoming an important complementary imaging tool in the evaluation of superficial soft-tissue structures such as the rotator cuff, subacromial-subdeltoid bursa, and biceps tendon. The advantages of US driving its recent increased use include low cost, accessibility, and capability for real-time high-resolution imaging that enables dynamic assessment and needle guidance. As more radiologists are considering incorporating shoulder US into their practices, the development of a standardized approach to performing shoulder US should be a priority to facilitate the delivery of high-quality patient care. Familiarity with and comfort in performing a standardized shoulder US examination, as well as knowledge of the types of anomalies that can be evaluated well with US, will enhance the expertise of those working in musculoskeletal radiology practices and add value in the form of increased patient and health care provider satisfaction. This review describes the utility and benefits of shoulder US as a tool that complements MR imaging in the assessment of shoulder pain. A standardized approach to the shoulder US examination is also described, with a review of the basic technique of this examination, normal anatomy of the shoulder, common indications for shoulder US, and characteristic US findings of common shoulder diseases—with select MR imaging and arthroscopic correlation. Online supplemental material is available for this article. ©RSNA, 2016 PMID:27726738

  19. Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard

    International Nuclear Information System (INIS)

    Gwak, Yeon Joo; Kim, Hye Jung; Kwak, Jin Young; Son, Eun Ju; Ko, Kyung Hee; Lee, Jin Hwa; Lim, Hyo Soon; Lee, You Jin; Park, Ji Won; Shin, Kyung Min; Jang, Yun-Jin

    2013-01-01

    The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea

  20. Peer Review of Clinical Information Models: A Web 2.0 Crowdsourced Approach.

    Science.gov (United States)

    Leslie, Heather; Ljosland Bakke, Silje

    2017-01-01

    Over the past 8 years the openEHR Clinical Model program has been developing a Web 2.0 approach and tooling to support the development, review and governance of atomic clincial information models, known as archetypes. This paper describes the background and review process, and provides a practical example where cross standards organisation collaboration resulted in jointly agreed clinical content which was subsequently represented in different implementation formalisms that were effectively semantically aligned. The discussion and conclusions highlight some of the socio-technical benefits and challenges facing organisations who seek to govern automic clinical information models in a global and collaborative online community.

  1. Experimental and clinical standards, and evolution of lasers in neurosurgery.

    Science.gov (United States)

    Devaux, B C; Roux, F X

    1996-01-01

    From initial experiments of ruby, argon and CO2 lasers on the nervous system so far, dramatic progress was made in delivery systems technology as well as in knowledge of laser-tissue interaction effects and hazards through various animal experiments and clinical experience. Most surgical effects of laser light on neural tissue and the central nervous system (CNS) are thermal lesions. Haemostasis, cutting and vaporization depend on laser emission parameters--wavelength, fluence and mode--and on the exposed tissues optical and thermal properties--water and haemoglobin content, thermal conductivity and specific heat. CO2 and Nd-YAG lasers have today a large place in the neurosurgical armamentarium, while new laser sources such as high power diode lasers will have one in the near future. Current applications of these lasers derive from their respective characteristics, and include CNS tumour and vascular malformation surgery, and stereotactic neurosurgery. Intracranial, spinal cord and intra-orbital meningiomas are the best lesions for laser use for haemostasis, dissection and tissue vaporization. Resection of acoustic neuromas, pituitary tumours, spinal cord neuromas, intracerebral gliomas and metastases may also benefit from lasers as accurate, haemostatic, non-contact instruments which reduce surgical trauma to the brain and eloquent structures such as brain stem and cranial nerves. Coagulative lasers (1.06 microns and 1.32 microns Nd-YAG, argon, or diode laser) will find an application for arteriovenous malformations and cavernomas. Any fiberoptic-guided laser will find a use during stereotactic neurosurgical procedures, including image-guided resection of tumours and vascular malformations and endoscopic tumour resection and cysts or entry into a ventricle. Besides these routine applications of lasers, laser interstitial thermotherapy (LITT) and photodynamic therapy (PDT) of brain tumours are still in the experimental stage. The choice of a laser in a

  2. a Standardized Approach to Topographic Data Processing and Workflow Management

    Science.gov (United States)

    Wheaton, J. M.; Bailey, P.; Glenn, N. F.; Hensleigh, J.; Hudak, A. T.; Shrestha, R.; Spaete, L.

    2013-12-01

    An ever-increasing list of options exist for collecting high resolution topographic data, including airborne LIDAR, terrestrial laser scanners, bathymetric SONAR and structure-from-motion. An equally rich, arguably overwhelming, variety of tools exists with which to organize, quality control, filter, analyze and summarize these data. However, scientists are often left to cobble together their analysis as a series of ad hoc steps, often using custom scripts and one-time processes that are poorly documented and rarely shared with the community. Even when literature-cited software tools are used, the input and output parameters differ from tool to tool. These parameters are rarely archived and the steps performed lost, making the analysis virtually impossible to replicate precisely. What is missing is a coherent, robust, framework for combining reliable, well-documented topographic data-processing steps into a workflow that can be repeated and even shared with others. We have taken several popular topographic data processing tools - including point cloud filtering and decimation as well as DEM differencing - and defined a common protocol for passing inputs and outputs between them. This presentation describes a free, public online portal that enables scientists to create custom workflows for processing topographic data using a number of popular topographic processing tools. Users provide the inputs required for each tool and in what sequence they want to combine them. This information is then stored for future reuse (and optionally sharing with others) before the user then downloads a single package that contains all the input and output specifications together with the software tools themselves. The user then launches the included batch file that executes the workflow on their local computer against their topographic data. This ZCloudTools architecture helps standardize, automate and archive topographic data processing. It also represents a forum for discovering and

  3. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1997-01-01

    Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon tumor type and site, age at presentation, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of radiation therapy and chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of 3-dimensional radiation techniques. Modifications in radiation delivery are important components of current investigations in medulloblastoma; the rationale for contemporary cooperative group trials will be presented as well as the background data re surgical, radiotherapeutic, and

  4. Regional Implementation of a Pediatric Cardiology Syncope Algorithm Using Standardized Clinical Assessment and Management Plans (SCAMPS) Methodology

    OpenAIRE

    Paris, Yvonne; Toro?Salazar, Olga H.; Gauthier, Naomi S.; Rotondo, Kathleen M.; Arnold, Lucy; Hamershock, Rose; Saudek, David E.; Fulton, David R.; Renaud, Ashley; Alexander, Mark E.

    2016-01-01

    Background: Pediatric syncope is common. Cardiac causes are rarely found. We describe and assess a pragmatic approach to these patients first seen by a pediatric cardiologist in the New England region, using Standardized Clinical Assessment and Management Plans (SCAMPs). Methods and Results: Ambulatory patients aged 7 to 21 years initially seen for syncope at participating New England Congenital Cardiology Association practices over a 2.5‐year period were evaluated using a SCAMP. Findings wer...

  5. Proposal for a collaborative approach to clinical teaching.

    Science.gov (United States)

    Beckman, Thomas J; Lee, Mark C

    2009-04-01

    Evidence suggests that inexperienced clinical teachers are often controlling and noninteractive. Adult learning theory states that mature students prefer shared and self-directed learning and that skillful teachers favor facilitating discussions over transmitting knowledge. Similarly, education research shows that effective clinical teachers invest in relationships with learners, ask questions to diagnose learners, communicate complex information clearly, and provide meaningful feedback. On the basis of these principles, we propose a collaborative approach to clinical teaching that has 4 essential components: (1) establish a relationship with the learner, (2) diagnose the learner, (3) use teaching frameworks that engage learners, and (4) develop teaching scripts and a personal philosophy. This article includes suggestions for creating a positive learning climate, asking higher-order questions, providing meaningful feedback, and developing teaching scripts. We believe that practicing this approach, which emphasizes respectful teacher-learner relationships, improves the quality of every clinical teaching encounter.

  6. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

    Science.gov (United States)

    Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

    2015-06-03

    A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

  7. THE DECOMPOSITION OF POVERTY: A DISTRIBUTIVE APPROACH TO LIVING STANDARDS

    Directory of Open Access Journals (Sweden)

    Mbu Daniel Tambi

    2012-04-01

    Full Text Available This study attempts to carry out a comprehensive analysis of the evolution of poverty trends using national household consumption survey I and II collected in 1996 and 2001 respectively. The theoretical decomposition frameworks propelling the study are motivated mainly by the Shapley value while empirical estimates are obtained from DAD 4.4. From our findings, we observe that Rural forest and Rural highlands regions were hardest hit by poverty and inequality trends in Cameroon. The result shows that the within-regions effects were found to be more instrumental in accounting for changes in all the classes of poverty measures than the inter-sector population shift effects in the period under review. While the between-region effects were systematically contributing in alleviating poverty in the Rural forest and Rural highlands and at the same time aggravating poverty in Yaounde, Douala. Based on our result, we suggest that policies and strategies for reducing poverty/inequality should place particular emphasis on the countryside and on a region-by-region approach such as decentralization, increase provision of rural extension services (roads, electricity, markets, portable water.

  8. Approaches for optimizing the calibration standard of Tewameter TM 300.

    Science.gov (United States)

    Miteva, Maria; Richter, Stefan; Elsner, Peter; Fluhr, Joachim W

    2006-11-01

    Calibration of devices measuring transepidermal water loss (TEWL) is in intensive discussion. Comparative studies revealed that comparable measuring systems, e.g. open and closed chamber systems, do not always deliver the same results, even when expressing the measured values in SI units, namely in g/m(2)/h. Therefore, adequate and reliable calibration procedures need to be established. We were able to test the reliability of a multi-step calibration algorithm for an open chamber system such as Tewameter TM 300. In order to achieve reliable measurements, the maintenance of stable microclimate conditions without air turbulences is mandatory. The TEWL values should be compared with those determined gravimetrically on heated skin simulators. The reproducibility of the results is warranted by consecutive measurements on different adjacent spots of a defined area. Preheating of the probe sensors is an effective approach for shortening the measuring time and gaining a rapid steady-state. The accurate calibration of the probe can be checked under laboratory conditions any time. The critical point of the calibration and ultimately the accuracy of in vivo measurements maintain the steady functional capacity of the probes during the entire duration of continuous studies. The studied calibration procedure ensures these requirements.

  9. Multiple, sclerosis: clinical feature, pathogenesis and current therapeutical approaches

    International Nuclear Information System (INIS)

    Merkelbach, S.; Koelmel, C.; Schimrigk, K.

    2000-01-01

    Multiple sclerosis (MS) is considered as a T-cell mediated autoimmune disease. Caused by central nervous system demyelination and axonal damage varying clinical signs do occur either with relapsing-remitting or with chronic progressive course. Based on pathogenetic considerations immunomodulative and immunosuppressive therapeutical approaches are used to limit the disease progression. Clinical symptoms, diagnostic criteria, pathogenetical considerations, and consecutive therapeutical interventions are summarized. (orig.) [de

  10. The dimensional approach to clinical psychopharmacology: a polysemous concept.

    OpenAIRE

    Baruch, P; Filteau, M J; Bouchard, R H; Pourcher, E; Vincent, P; Jouvent, R

    1992-01-01

    The last decade has seen significant progress in the development and specific clinical application of selective psychotropes. The dimensional approach to clinical psychopharmacology views the behavioral targets of psychotropes as phenomena existing on a continuum and as components, in varying degrees, of most psychopathologies. The modern concept of dimension has been used in different contexts. In psychology it has a mathematical sense, whereas in biological psychiatry it is associated more ...

  11. Sequential boundaries approach in clinical trials with unequal allocation ratios

    Directory of Open Access Journals (Sweden)

    Ayatollahi Seyyed

    2006-01-01

    Full Text Available Abstract Background In clinical trials, both unequal randomization design and sequential analyses have ethical and economic advantages. In the single-stage-design (SSD, however, if the sample size is not adjusted based on unequal randomization, the power of the trial will decrease, whereas with sequential analysis the power will always remain constant. Our aim was to compare sequential boundaries approach with the SSD when the allocation ratio (R was not equal. Methods We evaluated the influence of R, the ratio of the patients in experimental group to the standard group, on the statistical properties of two-sided tests, including the two-sided single triangular test (TT, double triangular test (DTT and SSD by multiple simulations. The average sample size numbers (ASNs and power (1-β were evaluated for all tests. Results Our simulation study showed that choosing R = 2 instead of R = 1 increases the sample size of SSD by 12% and the ASN of the TT and DTT by the same proportion. Moreover, when R = 2, compared to the adjusted SSD, using the TT or DTT allows to retrieve the well known reductions of ASN observed when R = 1, compared to SSD. In addition, when R = 2, compared to SSD, using the TT and DTT allows to obtain smaller reductions of ASN than when R = 1, but maintains the power of the test to its planned value. Conclusion This study indicates that when the allocation ratio is not equal among the treatment groups, sequential analysis could indeed serve as a compromise between ethicists, economists and statisticians.

  12. Standardizing clinical trials workflow representation in UML for international site comparison.

    Science.gov (United States)

    de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia M O; Rodrigues, Maria J; Shah, Jatin; Loures, Marco R; Patil, Sunita; Payne, Philip; Pietrobon, Ricardo

    2010-11-09

    With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials

  13. Childhood obesity treatment and prevention. Psychological perspectives of clinical approaches

    Directory of Open Access Journals (Sweden)

    Maria Catena Quattropani

    2013-05-01

    Full Text Available Objective: This work focuses on clinical psychologist’ presence within childhood obesity prevention programmes in several countries. Method: The Authors collected articles considering psychological, biological and social aspects linked to childhood obesity. Results: Studies reveal that childhood obesity prevention programmes are based on biological, medical and educational aspects; clinical psychologists up until now have been engaged almost exclusively in the treatment of obesity. Conclusions: There is a clear need to consider psychological aspects (emotional, cognitive and relational related to the childhood obesity’s causes and involve psychologists in its prevention projects. Keywords: childhood obesity, overweight, multidisciplinary approach, clinical psychology, prevention, treatment

  14. Integrity, standards, and QC-related issues with big data in pre-clinical drug discovery.

    Science.gov (United States)

    Brothers, John F; Ung, Matthew; Escalante-Chong, Renan; Ross, Jermaine; Zhang, Jenny; Cha, Yoonjeong; Lysaght, Andrew; Funt, Jason; Kusko, Rebecca

    2018-03-15

    The tremendous expansion of data analytics and public and private big datasets presents an important opportunity for pre-clinical drug discovery and development. In the field of life sciences, the growth of genetic, genomic, transcriptomic and proteomic data is partly driven by a rapid decline in experimental costs as biotechnology improves throughput, scalability, and speed. Yet far too many researchers tend to underestimate the challenges and consequences involving data integrity and quality standards. Given the effect of data integrity on scientific interpretation, these issues have significant implications during preclinical drug development. We describe standardized approaches for maximizing the utility of publicly available or privately generated biological data and address some of the common pitfalls. We also discuss the increasing interest to integrate and interpret cross-platform data. Principles outlined here should serve as a useful broad guide for existing analytical practices and pipelines and as a tool for developing additional insights into therapeutics using big data. Copyright © 2018 Elsevier Inc. All rights reserved.

  15. A semantic interoperability approach to support integration of gene expression and clinical data in breast cancer.

    Science.gov (United States)

    Alonso-Calvo, Raul; Paraiso-Medina, Sergio; Perez-Rey, David; Alonso-Oset, Enrique; van Stiphout, Ruud; Yu, Sheng; Taylor, Marian; Buffa, Francesca; Fernandez-Lozano, Carlos; Pazos, Alejandro; Maojo, Victor

    2017-08-01

    The introduction of omics data and advances in technologies involved in clinical treatment has led to a broad range of approaches to represent clinical information. Within this context, patient stratification across health institutions due to omic profiling presents a complex scenario to carry out multi-center clinical trials. This paper presents a standards-based approach to ensure semantic integration required to facilitate the analysis of clinico-genomic clinical trials. To ensure interoperability across different institutions, we have developed a Semantic Interoperability Layer (SIL) to facilitate homogeneous access to clinical and genetic information, based on different well-established biomedical standards and following International Health (IHE) recommendations. The SIL has shown suitability for integrating biomedical knowledge and technologies to match the latest clinical advances in healthcare and the use of genomic information. This genomic data integration in the SIL has been tested with a diagnostic classifier tool that takes advantage of harmonized multi-center clinico-genomic data for training statistical predictive models. The SIL has been adopted in national and international research initiatives, such as the EURECA-EU research project and the CIMED collaborative Spanish project, where the proposed solution has been applied and evaluated by clinical experts focused on clinico-genomic studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. A Swarm Optimization approach for clinical knowledge mining.

    Science.gov (United States)

    Christopher, J Jabez; Nehemiah, H Khanna; Kannan, A

    2015-10-01

    Rule-based classification is a typical data mining task that is being used in several medical diagnosis and decision support systems. The rules stored in the rule base have an impact on classification efficiency. Rule sets that are extracted with data mining tools and techniques are optimized using heuristic or meta-heuristic approaches in order to improve the quality of the rule base. In this work, a meta-heuristic approach called Wind-driven Swarm Optimization (WSO) is used. The uniqueness of this work lies in the biological inspiration that underlies the algorithm. WSO uses Jval, a new metric, to evaluate the efficiency of a rule-based classifier. Rules are extracted from decision trees. WSO is used to obtain different permutations and combinations of rules whereby the optimal ruleset that satisfies the requirement of the developer is used for predicting the test data. The performance of various extensions of decision trees, namely, RIPPER, PART, FURIA and Decision Tables are analyzed. The efficiency of WSO is also compared with the traditional Particle Swarm Optimization. Experiments were carried out with six benchmark medical datasets. The traditional C4.5 algorithm yields 62.89% accuracy with 43 rules for liver disorders dataset where as WSO yields 64.60% with 19 rules. For Heart disease dataset, C4.5 is 68.64% accurate with 98 rules where as WSO is 77.8% accurate with 34 rules. The normalized standard deviation for accuracy of PSO and WSO are 0.5921 and 0.5846 respectively. WSO provides accurate and concise rulesets. PSO yields results similar to that of WSO but the novelty of WSO lies in its biological motivation and it is customization for rule base optimization. The trade-off between the prediction accuracy and the size of the rule base is optimized during the design and development of rule-based clinical decision support system. The efficiency of a decision support system relies on the content of the rule base and classification accuracy. Copyright

  17. Standardizing Clinical Document Names Using the HL7/LOINC Document Ontology and LOINC Codes.

    Science.gov (United States)

    Chen, Elizabeth S; Melton, Genevieve B; Engelstad, Mark E; Sarkar, Indra Neil

    2010-11-13

    The standardization of clinical document names is an essential first step towards the optimal use, management, and exchange of documents within and across institutions. The HL7/LOINC Document Ontology (DO) is an existing and evolving document standard developed to provide consistent naming of clinical documents and to guide the creation of LOINC codes for clinical notes. The goal of this study was to explore the feasibility and challenges of mapping local clinical document names from two institutions into the five axes of the DO and then to leverage this mapping for identifying specific LOINC codes. The results indicate that the DO is either adequate or too broad for representing a majority of the document names and that there are LOINC codes available for one- to two-thirds of the names. Through this mapping process, granularity and other issues were revealed that will be valuable for guiding next steps towards effective standardization of clinical document names.

  18. The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

    Science.gov (United States)

    Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

    2013-01-01

    Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…

  19. The Electronic Patient Record and Second Generation Clinical Databases: Problems of Standards and Nomenclature.

    Science.gov (United States)

    Monteith, Brian D.

    1991-01-01

    Three principles of classification are stressed in the development of electronic dental patient records and clinical databases: (1) the classification must have a suitable organizing principle; (2) use must be made of standard terminology; and (3) there must be standard operational criteria. (DB)

  20. Performance of physician-certified verbal autopsies: multisite validation study using clinical diagnostic gold standards

    Directory of Open Access Journals (Sweden)

    Flaxman Abraham D

    2011-08-01

    Full Text Available Abstract Background Physician review of a verbal autopsy (VA and completion of a death certificate remains the most widely used approach for VA analysis. This study provides new evidence about the performance of physician-certified verbal autopsy (PCVA using defined clinical diagnostic criteria as a gold standard for a multisite sample of 12,542 VAs. The study was also designed to analyze issues related to PCVA, such as the impact of a second physician reader on the cause of death assigned, the variation in performance with and without household recall of health care experience (HCE, and the importance of local information for physicians reading VAs. Methods The certification was performed by 24 physicians. The assignment of VA was random and blinded. Each VA was certified by one physician. Half of the VAs were reviewed by a different physician with household recall of health care experience included. The completed death certificate was processed for automated ICD-10 coding of the underlying cause of death. PCVA was compared to gold standard cause of death assignment based on strictly defined clinical diagnostic criteria that are part of the Population Health Metrics Research Consortium (PHMRC gold standard verbal autopsy study. Results For individual cause assignment, the overall chance-corrected concordance for PCVA against the gold standard cause of death is less than 50%, with substantial variability by cause and physician. Physicians assign the correct cause around 30% of the time without HCE, and addition of HCE improves performance in adults to 45% and slightly higher in children to 48%. Physicians estimate cause-specific mortality fractions (CSMFs with considerable error for adults, children, and neonates. Only for neonates for a cause list of six causes with HCE is accuracy above 0.7. In all three age groups, CSMF accuracy improves when household recall of health care experience is available. Conclusions Results show that physician

  1. Addiction and psychopathology: a multidimensional approach to clinical practice

    NARCIS (Netherlands)

    V. Hendriks (Vincent)

    1990-01-01

    textabstractThe etiology of addiction has a long history of clinical and scientific interest, which is characterized by differences in conceptual approach, conflicting data and public controversy. There have been numerous attempts to describe the antecedents and consequences of addiction in

  2. Do diabetes-specialty clinics differ in management approach and ...

    African Journals Online (AJOL)

    Objectives: To evaluate management approach and outcome in two endocrinologist-managed clinics using data on treatment adherence, diabetes specific parameters, prescribed medications and self-management practices among ambulatory type 2 diabetes patients. Opinion on cause(s) and perceived fear about ...

  3. Clinical approach to a patient with abnormal uterine bleeding

    African Journals Online (AJOL)

    bleeding, type, appearance, duration, cyclicity and associated ... Clinical approach. In all cases where the main complaint is that of excessive menstrual bleeding, an immediate differentiation must be made between acute severe blood loss and chronic excessive ... management rules can be implemented. In such patients ...

  4. Enhancing Critical Thinking Via a Clinical Scholar Approach.

    Science.gov (United States)

    Simpson, Vicki; McComb, Sara A; Kirkpatrick, Jane M

    2017-11-01

    Safety, quality improvement, and a systems perspective are vital for nurses to provide quality evidence-based care. Responding to the call to prepare nurses with these perspectives, one school of nursing used a clinical scholar approach, enhanced by systems engineering to more intentionally develop the ability to clinically reason and apply evidence-based practice. A two-group, repeated-measures control trial was used to determine the effects of systems engineering content and support on nursing students' clinical judgment and critical thinking skills. Findings indicated this approach had a positive effects on student's clinical judgment and clinical reasoning skills. This approach helped students view health care issues from a broader perspective and use evidence to guide solution development, enhancing the focus on evidence-based practice, and quality improvement. Intentional integration of an evidence-based, systems perspective by nursing faculty supports development of nurses who can function safely and effectively in the current health care system. [J Nurs Educ. 2017;56(11):679-682.]. Copyright 2017, SLACK Incorporated.

  5. Machine Learning Approaches for Clinical Psychology and Psychiatry.

    Science.gov (United States)

    Dwyer, Dominic B; Falkai, Peter; Koutsouleris, Nikolaos

    2018-01-29

    Machine learning approaches for clinical psychology and psychiatry explicitly focus on learning statistical functions from multidimensional data sets to make generalizable predictions about individuals. The goal of this review is to provide an accessible understanding of why this approach is important for future practice because of its potential to augment decisions associated with the diagnosis, prognosis, and treatment of people suffering from mental illness using clinical and biological data. To this end, the limitations of current statistical paradigms in mental health research are critiqued, and an introduction is provided to the critical machine learning methods used in clinical studies. A selective literature review is then presented aiming to reinforce the usefulness of machine learning methods and provide evidence of their potential. In the context of promising initial results, the current limitations of machine learning approaches are addressed, and considerations for future clinical translation are outlined. Expected final online publication date for the Annual Review of Clinical Psychology Volume 14 is May 7, 2018. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

  6. 77 FR 63763 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-10-17

    ... 324 RIN 3064-AD96 Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and Disclosure Requirements; Initial Regulatory Flexibility Analysis AGENCY: Federal Deposit Insurance Corporation. ACTION: Initial regulatory flexibility analysis. SUMMARY: On August 30, 2012, the...

  7. 77 FR 12454 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2012-03-01

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30829; Amdt. No. 3467] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule...

  8. Video-assisted thoracoscopic surgery (VATS) lobectomy using a standardized anterior approach

    DEFF Research Database (Denmark)

    Hansen, Henrik Jessen; Petersen, René Horsleben; Christensen, Merete

    2011-01-01

    Lobectomy using video-assisted thoracoscopic surgery (VATS) still is a controversial operation despite its many observed benefits. The controversy may be due to difficulties performing the procedure. This study addresses a standardized anterior approach facilitating the operation.......Lobectomy using video-assisted thoracoscopic surgery (VATS) still is a controversial operation despite its many observed benefits. The controversy may be due to difficulties performing the procedure. This study addresses a standardized anterior approach facilitating the operation....

  9. Sunscreen compliance with regional clinical practice guidelines and product labeling standards in New Zealand.

    Science.gov (United States)

    Sporer, Matthias E; Mathy, Joanna E; Kenealy, John; Mathy, Jon A

    2016-03-01

    INTRODUCTION For general practitioners, practice nurses and community pharmacists in New Zealand, a core duty is to educate patients about sun protection. We aimed to evaluate compliance of locally available sunscreens with regional clinical practice guidelines and sunscreen labelling standards, to assist clinicians in advising consumers on sunscreen selection. METHODS We audited all sunscreens available at two Auckland stores for three New Zealand sunscreen retailers. We then assessed compliance with accepted regional clinical practice guidelines for sun protection from the New Zealand Guidelines Group. We further assessed compliance with regional Australia/New Zealand consumer standards for sunscreen labelling. RESULTS All sunscreens satisfied clinical guidelines for broad-spectrum protection, and 99% of sunscreens met or exceeded clinical guidelines for minimal Sun Protection Factor. Compliance with regional standardized labelling guidelines is voluntary in New Zealand and 27% of audited sunscreens were not fully compliant with SPF labelling standards. DISCUSSION Sunscreens were generally compliant with clinical guidelines for minimal sun protection. However there was substantial noncompliance with regional recommendations for standardized sunscreen labelling. Primary health care clinicians should be aware that this labelling noncompliance may mislead patients into thinking some sunscreens offer more sun protection than they do. Mandatory compliance with the latest regional labelling standards would simplify sunscreen selection by New Zealand consumers. KEYWORDS Sunscreen; Sun Protection Factor; SPF; Skin Neoplasms; Melanoma; Skin Cancer Prevention.

  10. A Creative Approach to the Common Core Standards: The Da Vinci Curriculum

    Science.gov (United States)

    Chaucer, Harry

    2012-01-01

    "A Creative Approach to the Common Core Standards: The Da Vinci Curriculum" challenges educators to design programs that boldly embrace the Common Core State Standards by imaginatively drawing from the genius of great men and women such as Leonardo da Vinci. A central figure in the High Renaissance, Leonardo made extraordinary contributions as a…

  11. External Peer Review of Assessment: An Effective Approach to Verifying Standards?

    Science.gov (United States)

    Bloxham, Sue; Hudson, Jane; den Outer, Birgit; Price, Margaret

    2015-01-01

    There is growing international concern to regulate and assure standards in higher education. External peer review of assessment, often called external examining, is a well-established approach to assuring standards. Australian higher education is one of several systems without a history of external examining for undergraduate programmes that is…

  12. Integrated management system - management standards evolution and the IAEA new approach

    International Nuclear Information System (INIS)

    Oliveira, Dirceu Paulo de; Zouain, Desiree Moraes

    2007-01-01

    The management standards application began in military and nuclear areas towards the end of Second World War, when some westerns countries developed quality standards to improve their means to assess suppliers' conditions to assure their products conformance, which was increasingly complex and required a higher degree of reliability. Afterwards, the quality standards application was extended to the consumer market focused on consumers' requirements satisfaction. Coming along the society crescent concern about quality of life, other management standards were developed, such as those dealing with environmental and sustainable development, occupational health and safety, social accountability and so on. As a consequence, the management process became complex. The management system integrated form approach makes possible the compatibility of distinct and complementary interests from several functions and disciplines involved and supply the absence of the organizations' holistic approach. According to this integrated management approach, the Agency - 'International Atomic Energy Agency' (IAEA) - decided to review the structure of the 50-C-Q standard - 'Quality Assurance for Safety in Nuclear Power Plants and Other Nuclear Installations', from 1996, publishing in 2006 the new GS-R-3 standard - 'The Management System for Facilities and Activities - Safety Requirements'. This work presents a brief evolution of management standards and integrated management approach, showing the Agency's new vision concerning this issue with the GS-R-3 standard publication. (author)

  13. To Teach Standard English or World Englishes? A Balanced Approach to Instruction

    Science.gov (United States)

    Farrell, Thomas S. C.; Martin, Sonia

    2009-01-01

    This article suggests that English language teachers should consider all varieties of English, not just British Standard English or American Standard English. In order to better prepare students for the global world, and to show them that their own English is valued, teachers can implement a balanced approach that incorporates the teaching and…

  14. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  15. Standard requirements for GCP-compliant data management in multinational clinical trials

    DEFF Research Database (Denmark)

    Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve

    2011-01-01

    A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre......). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed...... a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials....

  16. Using Semantic Web technologies for the generation of domain-specific templates to support clinical study metadata standards.

    Science.gov (United States)

    Jiang, Guoqian; Evans, Julie; Endle, Cory M; Solbrig, Harold R; Chute, Christopher G

    2016-01-01

    The Biomedical Research Integrated Domain Group (BRIDG) model is a formal domain analysis model for protocol-driven biomedical research, and serves as a semantic foundation for application and message development in the standards developing organizations (SDOs). The increasing sophistication and complexity of the BRIDG model requires new approaches to the management and utilization of the underlying semantics to harmonize domain-specific standards. The objective of this study is to develop and evaluate a Semantic Web-based approach that integrates the BRIDG model with ISO 21090 data types to generate domain-specific templates to support clinical study metadata standards development. We developed a template generation and visualization system based on an open source Resource Description Framework (RDF) store backend, a SmartGWT-based web user interface, and a "mind map" based tool for the visualization of generated domain-specific templates. We also developed a RESTful Web Service informed by the Clinical Information Modeling Initiative (CIMI) reference model for access to the generated domain-specific templates. A preliminary usability study is performed and all reviewers (n = 3) had very positive responses for the evaluation questions in terms of the usability and the capability of meeting the system requirements (with the average score of 4.6). Semantic Web technologies provide a scalable infrastructure and have great potential to enable computable semantic interoperability of models in the intersection of health care and clinical research.

  17. Developing a Clinical Approach to Air Pollution and Cardiovascular Health.

    Science.gov (United States)

    Hadley, Michael B; Baumgartner, Jill; Vedanthan, Rajesh

    2018-02-13

    Nearly 3 billion people are exposed to household air pollution emitted from inefficient cooking and heating stoves, and almost the entire global population is exposed to detectable levels of outdoor air pollution from traffic, industry, and other sources. Over 3 million people die annually of ischemic heart disease or stroke attributed to air pollution, more than from traditional cardiac risk factors such as obesity, diabetes mellitus, or smoking. Clinicians have a role to play in reducing the burden of pollution-attributable cardiovascular disease. However, there currently exists no clear clinical approach to this problem. Here, we provide a blueprint for an evidence-based clinical approach to assessing and mitigating cardiovascular risk from exposure to air pollution. We begin with a discussion of the global burden of pollution-attributable cardiovascular disease, including a review of the mechanisms by which particulate matter air pollution leads to cardiovascular outcomes. Next, we offer a simple patient-screening tool using known risk factors for pollution exposure. We then discuss approaches to quantifying air pollution exposures and cardiovascular risk, including the development of risk maps for clinical catchment areas. We review a collection of interventions for household and outdoor air pollution, which clinicians can tailor to patients and populations at risk. Finally, we identify future research needed to quantify pollution exposures and validate clinical interventions. Overall, we demonstrate that clinicians can be empowered to mitigate the global burden of cardiovascular disease attributable to air pollution. © 2018 American Heart Association, Inc.

  18. Epileptic Seizures Versus Syncope: Pathophysiology and Clinical Approach

    Directory of Open Access Journals (Sweden)

    Marios Charalambous

    2017-02-01

    Full Text Available Generalised epileptic seizures and syncope are two syndromes with similar clinical manifestation and their differentiation can be quite challenging. The aim of this review is to use an evidence-based approach in differentiating these two syndromes through the comprehension of the pathophysiological mechanisms involved and their clinical signs. Both syndromes affect regions of the forebrain and consciousness level, although, different mechanisms are involved. Syncope is a paroxysmal event secondary to a short-term decrease in cerebral perfusion, oxygenation or essential nutrients delivery. Generalised epileptic seizure activity is defined as the clinical manifestation of transient paroxysmal disturbances in brain function secondary to an imbalance between excitatory and inhibitory neurotransmitters. Clinical criteria, including precipitating events, clinical signs preceding, during and following the episodes and event duration, can be used to differentiate the two syndromes. Although these criteria might be useful for the practitioner, definite conclusions should be precluded due to the lack of original research articles and weak evidence on this specific field.Application: The review might be a useful tool for the general practitioner and clinical scientist as it will aid towards the differentiation of two syndromes, i.e. generalised epileptic seizures and syncope, with similar clinical presentation.

  19. Establishment of quality assessment standard for mammographic equipment: evaluation of phantom and clinical images

    International Nuclear Information System (INIS)

    Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young

    2005-01-01

    The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government

  20. Validation of standardized and structured EHR data in the dual model approach.

    Science.gov (United States)

    Rinner, Christoph; Duftschmid, Georg

    2009-01-01

    We present a W3C XML Schema-based method to validate standardized EHR data against semantic constraints that build the knowledge layer within the dual model approach. The approach was tested with three EN/ISO13606 archetypes and an HL7 CDA implementation guide for diabetes therapies.

  1. Exploring the feasibility and synergistic value of the One Health approach in clinical research

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Sørensen, Tina Møller; Holm, Anne

    2015-01-01

    diagnostic pathways (i.e., 16 possiblecombinations of diagnostic tools) to gold standard in human and veterinary primary care practice in Denmark.Fifty primary care practices and 100 veterinary clinics will each consecutively include 20 human patients or 8–10dogs, respectively. Data will be collected......Background: The One Health approach is emerging in response to the development of bacterial resistance. To thebest of our knowledge, the possibility to use this approach in a clinical context has not yet been explored. Thus, inthis paper, we report the procedures to implement a prospective...... observational study of diagnostic pathways in humanand canine patients with suspected urinary tract infection as a means to assess the feasibility and synergistic value ofsetting up One Health clinical research projects and interventions. Methods/design: A prospective observational study will compare different...

  2. A model-driven approach for representing clinical archetypes for Semantic Web environments.

    Science.gov (United States)

    Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Maldonado, José Alberto

    2009-02-01

    The life-long clinical information of any person supported by electronic means configures his Electronic Health Record (EHR). This information is usually distributed among several independent and heterogeneous systems that may be syntactically or semantically incompatible. There are currently different standards for representing and exchanging EHR information among different systems. In advanced EHR approaches, clinical information is represented by means of archetypes. Most of these approaches use the Archetype Definition Language (ADL) to specify archetypes. However, ADL has some drawbacks when attempting to perform semantic activities in Semantic Web environments. In this work, Semantic Web technologies are used to specify clinical archetypes for advanced EHR architectures. The advantages of using the Ontology Web Language (OWL) instead of ADL are described and discussed in this work. Moreover, a solution combining Semantic Web and Model-driven Engineering technologies is proposed to transform ADL into OWL for the CEN EN13606 EHR architecture.

  3. A Network Approach to Hypersexuality: Insights and Clinical Implications.

    Science.gov (United States)

    Werner, Marlene; Štulhofer, Aleksandar; Waldorp, Lourens; Jurin, Tanja

    2018-03-01

    In spite of a growing interest in research on hypersexuality, consensus about its etiology and best treatment strategy has not been achieved. To further the empirical and clinical understanding of hypersexuality by exploring the structure of its symptoms using a network analytic approach. In 2014, an online survey advertised as focusing on Internet pornography, sexual health, and relationships was carried out among Croatian men and women aged 18-60 years (M age  = 31.1 years, SD = 9.67). In a sample of 3,028 participants, we applied a network analytic approach to explore the structure of hypersexuality symptoms. In the network, nodes represented hypersexuality symptoms and associated sexual behaviors, while their connections were operationalized as partial correlations. 4 Research questions were addressed: (1) does the hypersexuality network differ between genders; (2) which symptoms are centrally positioned; (3) what is the topological location of pornography use; and (4) are there distinct clusters ("communities") of symptoms in the network? We estimated and plotted hypersexuality networks by gender using items from the Hypersexual Disorder Screening Inventory and the Hypersexual Behavioral Consequences Scale, as well as indicators of sexual desire, pornography use, sexual intercourse, and masturbation frequency. The structure of the hypersexuality network was surprisingly similar in women and men, both in terms of symptom centrality and the clustering of symptoms. Psychological distress and negative emotions triggered by sexual fantasies and/or behaviors, together with a loss of control over sexual feelings, occupied central positions in the networks. Pornography use was located peripherally in both the men's and women's hypersexuality networks. Psychological distress and negative emotions triggered by sexual fantasies and/or behaviors constituted the core of the hypersexuality network, which makes them potential prime targets for clinical intervention and

  4. A clinical approach to the diagnosis of retinal vasculitis.

    Science.gov (United States)

    El-Asrar, Ahmed M Abu; Herbort, Carl P; Tabbara, Khalid F

    2010-04-01

    Retinal vasculitis is a sight-threatening inflammatory eye condition that involves the retinal vessels. Detection of retinal vasculitis is made clinically, and is confirmed with the help of fundus fluorescein angiography. Active vascular disease is characterized by exudates around retinal vessels resulting in white sheathing or cuffing of the affected vessels. In this review, a practical approach to the diagnosis of retinal vasculitis is discussed based on ophthalmoscopic and fundus fluorescein angiographic findings.

  5. Standardized exchange of clinical documents--towards a shared care paradigm in glaucoma treatment.

    Science.gov (United States)

    Gerdsen, F; Müller, S; Jablonski, S; Prokosch, H-U

    2006-01-01

    The exchange of medical data from research and clinical routine across institutional borders is essential to establish an integrated healthcare platform. In this project we want to realize the standardized exchange of medical data between different healthcare institutions to implement an integrated and interoperable information system supporting clinical treatment and research of glaucoma. The central point of our concept is a standardized communication model based on the Clinical Document Architecture (CDA). Further, a communication concept between different health care institutions applying the developed document model has been defined. With our project we have been able to prove that standardized communication between an Electronic Medical Record (EMR), an Electronic Health Record (EHR) and the Erlanger Glaucoma Register (EGR) based on the established conceptual models, which rely on CDA rel.1 level 1 and SCIPHOX, could be implemented. The HL7-tool-based deduction of a suitable CDA rel.2 compliant schema showed significant differences when compared with the manually created schema. Finally fundamental requirements, which have to be implemented for an integrated health care platform, have been identified. An interoperable information system can enhance both clinical treatment and research projects. By automatically transferring screening findings from a glaucoma research project to the electronic medical record of our ophthalmology clinic, clinicians could benefit from the availability of a longitudinal patient record. The CDA as a standard for exchanging clinical documents has demonstrated its potential to enhance interoperability within a future shared care paradigm.

  6. A clinical audit programme for diagnostic radiology: the approach adopted by the International Atomic Energy Agency.

    Science.gov (United States)

    Faulkner, K; Järvinen, H; Butler, P; McLean, I D; Pentecost, M; Rickard, M; Abdullah, B

    2010-01-01

    The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to

  7. A clinical audit programme for diagnostic radiology: The Approach adopted by the international atomic energy agency

    International Nuclear Information System (INIS)

    Faulkner, K.; Jaervinen, H.; Butler, P.; McLean, I. D.; Pentecost, M.; Rickard, M.; Abdullah, B.

    2010-01-01

    The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to

  8. Secondary use of clinical data: the Vanderbilt approach.

    Science.gov (United States)

    Danciu, Ioana; Cowan, James D; Basford, Melissa; Wang, Xiaoming; Saip, Alexander; Osgood, Susan; Shirey-Rice, Jana; Kirby, Jacqueline; Harris, Paul A

    2014-12-01

    The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools built atop the data layer to assist researchers across the enterprise. Providing resources dedicated to research initiatives benefits not only the research community, but also clinicians, patients and institutional leadership. This work provides a summary of our approach in the secondary use of clinical data for research domain, including a description of key components and a list of lessons learned, designed to assist others assembling similar services and infrastructure. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Minimum reporting standards for clinical research on groin pain in athletes

    DEFF Research Database (Denmark)

    Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

    2015-01-01

    are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes......Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...

  10. Clinical evaluation in advanced practice nursing education: using standardized patients in Health Assessment.

    Science.gov (United States)

    Gibbons, Susanne W; Adamo, Graceanne; Padden, Diane; Ricciardi, Richard; Graziano, Marjorie; Levine, Eugene; Hawkins, Richard

    2002-05-01

    Clinical education is critically important because competency in practice ultimately will determine the future of advanced practice nursing. Skills taught in Health Assessment, the first in a series of clinical courses, exposed students to tools that form the basis on which other competencies are built. The availability of standardized patients, people who participate in enacting a simulated but seemingly "real life" clinical encounter in a realistic clinical setting for the benefit of student learning and/or evaluation, made this instructional development project possible. The underlying assumption of this project was that clinical advanced practice nursing student education is enhanced by using an authentic clinical environment, known as a simulation center, with standardized patients and by using one or more evaluation techniques with multiple evaluators (i.e., peer, self, faculty, standardized patient). The student clinical experience was expected to improve and overall learning to increase by this method. This improvement was reflected at the end-of-course evaluations and in the quality of the final videotaped physical examination, which was superior to previous years. Student and faculty satisfaction with this teaching-learning process exceeded all expectations.

  11. A practical approach to clinical and research biobanking.

    Science.gov (United States)

    Yong, William H; Dry, Sarah M; Shabihkhani, Maryam

    2014-01-01

    Powerful technologies critical to personalized medicine and targeted therapeutics require the analysis of carefully validated, procured, stored, and managed biospecimens. Reflecting advancements in biospecimen science, the National Cancer Institute and the International Society for Biological and Environmental Repositories are periodically publishing best practices that can guide the biobanker. The modern biobank will operate more like a clinical laboratory with formal accreditation, standard operating procedures, and quality assurance protocols. This chapter highlights practical issues of consent, procurement, storage, quality assurance, disbursement, funding, and space. Common topics of concern are discussed including the differences between clinical and research biospecimens, stabilization of biospecimens during procurement, optimal storage temperatures, and technical validation of biospecimen content and quality. With quickly expanding biospecimen needs and limited healthcare budgets, biobanks may need to be selective as to what is stored. Furthermore, a shift to room-temperature storage modalities where possible can reduce long-term space and fiscal requirements.

  12. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  13. Providing support to nursing students in the clinical environment: a nursing standard requirement.

    Science.gov (United States)

    Anderson, Carina; Moxham, Lorna; Broadbent, Marc

    2016-10-01

    This discussion paper poses the question 'What enables or deters Registered Nurses to take up their professional responsibility to support undergraduate nursing students through the provision of clinical education?'. Embedded within many nursing standards are expectations that Registered Nurses provide support and professional development to undergraduate nursing students undertaking clinical placements. Expectations within nursing standards that Registered Nurses provide support and professional development to nursing students are important because nursing students depend on Registered Nurses to help them to become competent practitioners. Contributing factors that enable and deter Registered Nurses from fulfilling this expectation to support nursing students in their clinical learning include; workloads, preparedness for the teaching role, confidence in teaching and awareness of the competency requirement to support students. Factors exist which can enable or deter Registered Nurses from carrying out the licence requirement to provide clinical education and support to nursing students.

  14. [The challenges of standardization in clinical diagnostic laboratories of medical organizations].

    Science.gov (United States)

    Men'shikov, V V

    2013-04-01

    The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

  15. Authoring and verification of clinical guidelines: a model driven approach.

    Science.gov (United States)

    Pérez, Beatriz; Porres, Ivan

    2010-08-01

    The goal of this research is to provide a framework to enable authoring and verification of clinical guidelines. The framework is part of a larger research project aimed at improving the representation, quality and application of clinical guidelines in daily clinical practice. The verification process of a guideline is based on (1) model checking techniques to verify guidelines against semantic errors and inconsistencies in their definition, (2) combined with Model Driven Development (MDD) techniques, which enable us to automatically process manually created guideline specifications and temporal-logic statements to be checked and verified regarding these specifications, making the verification process faster and cost-effective. Particularly, we use UML statecharts to represent the dynamics of guidelines and, based on this manually defined guideline specifications, we use a MDD-based tool chain to automatically process them to generate the input model of a model checker. The model checker takes the resulted model together with the specific guideline requirements, and verifies whether the guideline fulfils such properties. The overall framework has been implemented as an Eclipse plug-in named GBDSSGenerator which, particularly, starting from the UML statechart representing a guideline, allows the verification of the guideline against specific requirements. Additionally, we have established a pattern-based approach for defining commonly occurring types of requirements in guidelines. We have successfully validated our overall approach by verifying properties in different clinical guidelines resulting in the detection of some inconsistencies in their definition. The proposed framework allows (1) the authoring and (2) the verification of clinical guidelines against specific requirements defined based on a set of property specification patterns, enabling non-experts to easily write formal specifications and thus easing the verification process. Copyright 2010 Elsevier Inc

  16. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2......) To stimulate establishment of ROAD (Risk of OA Development) and ROAP (Risk of OA Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages - REDI...... (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more...

  17. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use.

    Science.gov (United States)

    Kraus, V B; Blanco, F J; Englund, M; Karsdal, M A; Lohmander, L S

    2015-08-01

    Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2) To stimulate establishment of ROAD (Risk of OA Development) and ROAP (Risk of OA Progression) tools analogous to the FRAX™ instrument for predicting risk of fracture in osteoporosis; and (3) To stimulate formulation of tools for identifying disease in its early preradiographic and/or molecular stages - REDI (Reliable Early Disease Identification). Consensus around more sensitive and specific diagnostic criteria for OA could spur development of disease modifying therapies for this entity that has proved so recalcitrant to date. We fully acknowledge that as we move forward, we expect to develop more sophisticated definitions, terminology and tools. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  18. Clinical features and multidisciplinary approaches to dementia care

    Directory of Open Access Journals (Sweden)

    Gr

    2011-05-01

    Full Text Available Jacob HG Grand¹, Sienna Caspar², Stuart WS MacDonald11Department of Psychology, University of Victoria, Victoria, BC, Canada; 2Interdisciplinary Graduate Studies, University of British Columbia, Vancouver, BC, CanadaAbstract: Dementia is a clinical syndrome of widespread progressive deterioration of cognitive abilities and normal daily functioning. These cognitive and behavioral impairments pose considerable challenges to individuals with dementia, along with their family members and caregivers. Four primary dementia classifications have been defined according to clinical and research criteria: 1 Alzheimer’s disease; 2 vascular dementias; 3 frontotemporal dementias; and 4 dementia with Lewy bodies/Parkinson’s disease dementia. The cumulative efforts of multidisciplinary healthcare teams have advanced our understanding of dementia beyond basic descriptions, towards a more complete elucidation of risk factors, clinical symptoms, and neuropathological correlates. The characterization of disease subtypes has facilitated targeted management strategies, advanced treatments, and symptomatic care for individuals affected by dementia. This review briefly summarizes the current state of knowledge and directions of dementia research and clinical practice. We provide a description of the risk factors, clinical presentation, and differential diagnosis of dementia. A summary of multidisciplinary team approaches to dementia care is outlined, including management strategies for the treatment of cognitive impairments, functional deficits, and behavioral and psychological symptoms of dementia. The needs of individuals with dementia are extensive, often requiring care beyond traditional bounds of medical practice, including pharmacologic and non-pharmacologic management interventions. Finally, advanced research on the early prodromal phase of dementia is reviewed, with a focus on change-point models, trajectories of cognitive change, and threshold models of

  19. Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy

    Directory of Open Access Journals (Sweden)

    Kjersti Marie Blytt

    2017-10-01

    Full Text Available Abstract Background Sleep disturbances are widespread among nursing home (NH patients and associated with numerous negative consequences. Identifying and treating them should therefore be of high clinical priority. No prior studies have investigated the degree to which sleep disturbances as detected by actigraphy and by the sleep-related items in the Cornell Scale for Depression in Dementia (CSDD and the Neuropsychiatric Inventory – Nursing Home version (NPI-NH provide comparable results. Such knowledge is highly needed, since both questionnaires are used in clinical settings and studies use the NPI-NH sleep item to measure sleep disturbances. For this reason, insight into their relative (disadvantages is valuable. Method Cross-sectional study of 83 NH patients. Sleep was objectively measured with actigraphy for 7 days, and rated by NH staff with the sleep items in the CSDD and the NPI-NH, and results were compared. McNemar's tests were conducted to investigate whether there were significant differences between the pairs of relevant measures. Cohen's Kappa tests were used to investigate the degree of agreement between the pairs of relevant actigraphy, NPI-NH and CSDD measures. Sensitivity and specificity analyses were conducted for each of the pairs, and receiver operating characteristics (ROC curves were designed as a plot of the true positive rate against the false positive rate for the diagnostic test. Results Proxy-raters reported sleep disturbances in 20.5% of patients assessed with NPI-NH and 18.1% (difficulty falling asleep, 43.4% (multiple awakenings and 3.6% (early morning awakenings of patients had sleep disturbances assessed with CSDD. Our results showed significant differences (p<0.001 between actigraphy measures and proxy-rated sleep by the NPI-NH and CSDD. Sensitivity and specificity analyses supported these results. Conclusions Compared to actigraphy, proxy-raters clearly underreported NH patients' sleep disturbances as assessed

  20. Quality standards for DNA sequence variation databases to improve clinical management under development in Australia

    Directory of Open Access Journals (Sweden)

    B. Bennetts

    2014-09-01

    Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.

  1. Teaching emergent bilingual students flexible approaches in an era of new standards

    CERN Document Server

    Proctor, C Patrick; Hiebert, Elfrieda H

    2016-01-01

    Recent educational reform initiatives such as the Common Core State Standards (CCSS) largely fail to address the needs--or tap into the unique resources--of students who are developing literacy skills in both English and a home language. This book discusses ways to meet the challenges that current standards pose for teaching emergent bilingual students in grades K-8. Leading experts describe effective, standards-aligned instructional approaches and programs expressly developed to promote bilingual learners' academic vocabulary, comprehension, speaking, writing, and content learning. Innovative

  2. OSTEOARTHRITIS: CURRENT CLINICAL CONCEPT AND SOME PROMISING THERAPEUTIC APPROACHES

    Directory of Open Access Journals (Sweden)

    A. E. Karateev

    2018-01-01

    Full Text Available In recent years, there has been a trend toward changing the clinical concept of osteoarthritis (OA. This disease has been considered as an age-related disease and the long-term result of a current pathological process for a very long time. However, many experts are now inclined to consider it necessary to identify the early, pre-X-ray stage of OA, when adequate treatment may not only halt the progression, but also achieve the regression of joint structural changes. This review deals with a number of pathogenetic and clinical aspects of the early stages of OA, which are important for timely diagnosis and pathogenetic therapy choice. It also considers some therapeutic approaches, both a "classic" and recently actively discussed methods for using platelet-rich plasma and autologous chondrocyte transplantation.

  3. Cavitary Lung Diseases-A Clinical-Radiological Algorithmic Approach.

    Science.gov (United States)

    Gafoor, Khalid; Patel, Shalin; Girvin, Francis; Gupta, Nishant; Naidich, David; Machnicki, Stephen; Brown, Kevin K; Mehta, Atul; Husta, Bryan; Ryu, Jay; Sarosi, George; Franquet, Tomas; Verschakelen, Johny; Johkoh, Takeshi; Travis, William; Raoof, Suhail

    2018-03-05

    Cavities are occasionally encountered on thoracic imaging. Their differential diagnosis is large and includes, among others, various infections, autoimmune conditions and primary and metastatic malignancies. We offer an algorithmic approach to their evaluation by initially excluding mimics of cavities then broadly classifying them according to the duration of clinical symptoms and radiological abnormalities.. An acute or subacute process (12 weeks) suggests mycobacterial, fungal, viral, or parasitic infections; malignancy (primary lung or metastases); or autoimmune disorders (rheumatoid arthritis and granulomatosis with polyangiitis). While a number of radiographic features can suggest a diagnosis, their lack of specificity requires that imaging findings be combined with the clinical context in order to make a confident diagnosis. Copyright © 2018. Published by Elsevier Inc.

  4. Clinical practice guidelines: potential misconceptions of the GRADE approach.

    Science.gov (United States)

    Watine, Joseph; Wils, Julien; Augereau, Christine

    2014-01-01

    To challenge the Grading of Recommendations Assessment, Development and Evaluation (GRADE) group to address the potential misconceptions about their approach to grading the strength of recommendations in clinical practice guidelines. Based on our own expertise of health care professionals trying to think in depth about, and using, guidelines, we have identified four such misconceptions. These potential misconceptions are: (1) evidence in medicine means factual or scientific evidence; (2) opinions are a subcategory of evidence; (3) the most important evidence is related to clinical benefits and harms; (4) being virtuous, and principled, does not particularly help in developing the best possible guidelines. We call on the GRADE leadership to address all the above-mentioned misconceptions. These need explicit answers in their manuscript series. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Teamwork approach to clinical hypnosis at a pediatric pulmonary center.

    Science.gov (United States)

    Anbar, Ran D; Hummell, Kim E

    2005-07-01

    The aim of this report is to demonstrate the success of a teamwork approach for providing instruction in self-hypnosis at a Pediatric Pulmonary Center. In order to add to the hypnosis service provided by a pulmonologist at the Center, the Center social worker learned how to use clinical hypnosis. During a 3-year period, she instructed 72 patients (average age 11.6 years) in self-hypnosis. Eighty-two percent of the patients reported improvement or resolution of the primary symptoms, which included anxiety, asthma, chest pain, dyspnea, habit cough, hyperventilation, sighing, and vocal cord dysfunction. The social worker and pulmonologist consulted with each other on a regular basis regarding their hypnosis work, and achieved similar successful results following their hypnosis interventions. Thus, clinical hypnosis at a Pediatric Pulmonary Center can be provided by a team of varied professionals. As a team, these professionals can support each other in their on-going development of hypnosis skills.

  6. Mild obstructive sleep apnoea: clinical relevance and approaches to management.

    Science.gov (United States)

    McNicholas, Walter T; Bonsignore, Maria R; Lévy, Patrick; Ryan, Silke

    2016-10-01

    Obstructive sleep apnoea is highly prevalent in the general population worldwide, especially in its mild form. Clinical manifestations correlate poorly with disease severity measured by the apnoea-hypopnoea index (AHI), which complicates diagnosis. Full polysomnography might be more appropriate to assess suspected mild cases because limited ambulatory diagnostic systems are least accurate in mild disease. Treatment options in mild obstructive sleep apnoea include continuous positive airway pressure (CPAP) and oral appliance therapy, in addition to positional therapy and weight reduction when appropriate. The superior efficacy of CPAP in reducing AHI is offset by greater tolerance of oral appliances, especially in mild disease. Although severe obstructive sleep apnoea is associated with adverse health consequences, including cardiometabolic comorbidities, the association with mild disease is unclear, and reports differ regarding the clinical relevance of mild obstructive sleep apnoea. Improved diagnostic techniques and evidence-based approaches to management in mild obstructive sleep apnoea require further research. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. An automated standardized system for managing adverse events in clinical research networks.

    Science.gov (United States)

    Richesson, Rachel L; Malloy, Jamie F; Paulus, Kathleen; Cuthbertson, David; Krischer, Jeffrey P

    2008-01-01

    Multi-site clinical protocols and clinical research networks require tools to manage and monitor adverse events (AEs). To be successful, these tools must be designed to comply with applicable regulatory requirements, reflect current data standards, international directives and advances in pharmacovigilance, and be convenient and adaptable to multiple needs. We describe an Adverse Event Data Management System (AEDAMS) that is used across multiple study designs in the various clinical research networks and multi-site studies for which we provide data and technological support. Investigators enter AE data using a standardized and structured web-based data collection form. The automated AEDAMS forwards the AE information to individuals in designated roles (investigators, sponsors, Data Safety and Monitoring Boards) and manages subsequent communications in real time, as the entire reporting, review and notification is done by automatically generated emails. The system was designed to adhere to timelines and data requirements in compliance with Good Clinical Practice (International Conference on Harmonisation E6) reporting standards and US federal regulations, and can be configured to support AE management for many types of study designs and adhere to various domestic or international reporting requirements. This tool allows AEs to be collected in a standard way by multiple distributed users, facilitates accurate and timely AE reporting and reviews, and allows the centralized management of AEs. Our design justification and experience with the system are described.

  8. European AIDS Clinical Society Standard of Care meeting on HIV and related coinfections: The Rome Statements

    NARCIS (Netherlands)

    Mussini, C.; Antinori, A.; Bhagani, S.; Branco, T.; Brostrom, M.; Dedes, N.; Bereczky, T.; Girardi, E.; Gökengin, D.; Horban, A.; Lacombe, K.; Lundgren, J. D.; Mendao, L.; Mocroft, A.; Oprea, C.; Porter, K.; Podlekareva, D.; Battegay, M.; d'Arminio Monforte, A.; Mulcahy, Fiona; Geretti, Anna Maria; Clumeck, Nathan; Reiss, Peter; Arribas, Jose; Gatell, Jose; Katlama, Christine; Pozniak, Anton; Rockstroh, Jürgen; Youle, Mike; Friis-Møller, Nina; Rusconi, Stefano; Behrens, Georg; de Wit, Stéphane; Furrer, Hansjakob; Wensing, Annemarie; John Gill, M.; Letendre, Scott

    2016-01-01

    The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. Data-driven presentations were given on specific topics followed by interactive panel

  9. European AIDS Clinical Society Standard of Care meeting on HIV and related coinfections : The Rome Statements

    NARCIS (Netherlands)

    Mussini, C.; Antinori, A.; Bhagani, S.; Branco, T.; Brostrom, M.; Dedes, N.; Bereczky, T.; Girardi, E.; Gökengin, D.; Horban, A.; Lacombe, K.; Lundgren, J. D.; Mendao, L.; Mocroft, A.; Oprea, C.; Porter, K.; Podlekareva, D.; Battegay, M.; d'Arminio Monforte, A.; Mulcahy, Fiona; Geretti, Anna Maria; Clumeck, Nathan; Reiss, Peter; Arribas, Jose; Gatell, Jose; Katlama, Christine; Pozniak, Anton; Rockstroh, Jürgen; Youle, Mike; Friis-Møller, Nina; Rusconi, Stefano; Behrens, Georg; De Wit, Stéphane; Furrer, Hansjakob; Wensing, Annemarie|info:eu-repo/dai/nl/30817724X; John Gill, M.; Letendre, Scott

    2016-01-01

    Objectives: The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. Methods: Data-driven presentations were given on specific topics followed

  10. Standardized Patient Encounters Improved Athletic Training Students' Confidence in Clinical Evaluations

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2015-01-01

    Context: Researchers have reported that interacting with standardized patients (SPs) is a worthwhile and realistic experience for athletic training (AT) students. These encounters enhance students' interviewing skills, confidence as a clinician, clinical skill development, and interpersonal communication. Objective: To determine how SP encounters…

  11. European AIDS Clinical Society Second Standard of Care Meeting, Brussels 16-17 November 2016

    DEFF Research Database (Denmark)

    De Wit, S; Battegay, M; D'Arminio Monforte, A

    2018-01-01

    The European AIDS Clinical Society (EACS) organized a second meeting on Standard of Care in Europe on November 16-17 th, 2016. The aims of the meeting were to discuss and propose actions on three topics, namely: Adherence to guidelines for treatment initiation, treatment monitoring and outcomes, ...

  12. Designing a New Model for Clinical Education: An Innovative Approach.

    Science.gov (United States)

    Shaffer, Kathryn; Swan, Beth Ann; Bouchaud, Mary

    2017-12-01

    To keep pace with the ever-changing health care delivery system, it is important to transform the way future nurses are educated, both in classroom and in clinical settings, to care for people along the life and care continuum, not only in acute-care settings. The purpose of this article is to describe a new approach to educating baccalaureate nursing students using immersion practicums that expose students to population health, transitions of care, care coordination, and the multiple roles a nurse engages in along the continuum. The curriculum includes 5 immersions, each with a specific life and care continuum focus to develop anticipatory thinkers.

  13. Risk Management Standards: Towards a contemporary, organisation-wide management approach

    OpenAIRE

    Koutsoukis, Nikitas-Spiros

    2010-01-01

    Risk management has been progressively evolving into a systemic approach for organisational decision making in today’s dynamic economic environment of the global era. In this context, risk management is reaching beyond its traditional finance and insurance application context and is entering the sphere of generic, organisation-wide management approaches. In support of this argument we consider four generic risk management standards issued at the institutional, national or international level...

  14. College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

    Science.gov (United States)

    Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

    2015-04-01

    The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

  15. Certifying a university ENT clinic using the ISO 9001:2000 international standard.

    Science.gov (United States)

    Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika

    2010-01-01

    Against statutory duties to introduce quality management systems, the increased importance of this subject has led to numerous activities in various public health institutions. Following the International Standardization Organization (ISO 9001:2000) prerequisites, Frankfurt Goethe University Hospital ENT clinic staff introduced a quality management system. This paper aims to investigate this process. Designing, planning and implementing the quality management system is described. Under the supervision of an executive quality management board, clinic quality goals were defined. Thereafter, several quality management teams performed an actual state analysis as well as developing and realising improvement proposals. Finally a quality management manual containing binding standards and working instructions concerning all patient care, research and teaching aspects was written. Successful certification by a neutral body ascertained that the clinic's quality management system conformed to current national and international standards while restructuring and reform improved procedural efficiency. The paper shows that mplementing the quality management system requires considerable effort but patients as well as staff profit considerably from the innovation. On the whole, the positive impact on structure and workflow in a specialist clinic predominates. Therefore, implementing a quality management system in all the clinic's wards and departments is recommended.

  16. A scheme for the audit of scientific and technological standards in clinical nuclear medicine

    International Nuclear Information System (INIS)

    Perkins, A.C.; Jarritt, P.H.

    2002-01-01

    Aim: Audit is the process whereby the quality of a service is monitored and optimised. It forms an essential component of the quality assurance process, whether by self-assessment or by external peer review. In the UK the British Nuclear Medicine Society (BNMS) has undertaken external organisational audit of departments providing clinical nuclear medicine services. This work aimed to develop a more thorough and service specific process for the audit of scientific and technological standards in nuclear medicine. Materials and Methods: The audit process has been implemented using written audit documents to facilitate the audit procedure. A questionnaire forms part of the formal documentation for audit of the scientific and technical standards of a clinical service. Scientific and technical standards were derived from a number of sources including legal requirements, regulatory obligations, notes for guidance, peer reviewed publications and accepted good clinical practice (GCP). Results: The audit process graded the standards of an individual department according to legal or safety requirements (Grade A), good practice (Grade B) and desirable aspects of service delivery (Grade C). The standards have been allocated into eight main categories. These are: Instrumentation; Software and data protection; Electrical Safety; Mechanical Safety; Workstation Safety; The Control of Substances Hazardous to Health (COSHH); Radiation Protection; Scientific and Technical staffing levels. During the audit visit a detailed inspection of clinical and laboratory areas and department written documentation is also necessary to validate the data obtained. Conclusion: The printed scheme now provides a means for external audit or self-assessment. There should be evidence of a well-organised and safe environment for both patients and staff. Health and Safety legislation requires written local rules and these records should be available to demonstrate the standard of service provision. Other

  17. The need for international standardization in clinical beta dosimetry for brachytherapy

    International Nuclear Information System (INIS)

    Quast, U.; Boehm, J.; Kaulich, T.W.

    2002-01-01

    Beta radiation has found increasing interest in radiotherapy. Besides the curative treatment of small and medium-sized intraocular tumors by means of ophthalmic beta radiation plaques, intravascular brachytherapy has proven to successfully overcome the severe problem of restenosis after interventional treatment of arterial stenosis in coronaries and peripheral vessels in many clinical trials with a large number of patients. Prior to initiating procedures applying beta radiation in radiotherapy, however, there is a common need to specify methods for the determination and specification of the absorbed dose to water or tissue and their spatial distributions. The IAEA-TECDOC-1274 Calibration of photon and beta ray sources used in brachytherapy (2002) is a help for photon brachytherapy calibration. But, for beta seed and line sources, IAEA recommends well type ionization chambers as working standards which are far from measuring absorbed dose to water of the radiation clinically used. Although the application of such working standards seems to be more precise, large errors can occur when the medical physicist has to convert the calibration data to absorbed dose to water of the beta radiation emitted. The user must believe that the source is equally activated and that the manufacturer did not change the design and construction of the source encapsulation. With the DGMP Report 16 (2001) Guidelines for medical physical aspects of intravascular brachytherapy a very detailed code of practice is given, especially for the calibration and clinical dosimetry of intravascular beta radiation sources. As there is a global need for standardization in clinical dosimetry for intravascular brachytherapy utilizing beta radiation, the DIN-NAR, the German committee on standardization in radiology, task group dosimetry, has initiated an international adhoc working group for a new ISO work item proposal on the standardization of procedures in clinical dosimetry to guarantee reliable

  18. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    Science.gov (United States)

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  19. Headache after traumatic brain injury: a national survey of clinical practices and treatment approaches.

    Science.gov (United States)

    Brown, Allen W; Watanabe, Thomas K; Hoffman, Jeanne M; Bell, Kathleen R; Lucas, Sylvia; Dikmen, Sureyya

    2015-01-01

    Individuals with headache after traumatic brain injury (TBI) receive care in a wide variety of clinical locations by physicians trained in multiple specialties. To understand current practice patterns and perceptions of treatment issues among clinicians managing headache after TBI. National survey of current clinical practice using a 20-item questionnaire developed by the authors. Survey respondents were members of the Central Nervous System Council list survey of the American Academy of Physical Medicine and Rehabilitation (N = 1782) and the American Headache Society membership (N = 1260). The survey was sent electronically to potential participants and was followed by 2 biweekly reminders. The survey queried the physicians' clinical setting; their use of headache classification systems, headache diaries, checklists, and diagnostic procedures; the pharmacologic and nonpharmacologic treatments prescribed; and headache chronicity and associated symptoms and disorders among their patients with TBI. Completed surveys were received from 193 respondents. The use of standardized classification systems and checklists was commonly reported. Respondents used nonpharmacologic and pharmacologic treatment approaches with similar frequency and modest perceived success rates. A high frequency of headache-associated new sleep and mood disorders was reported. When response differences occurred between practice settings, they reflected a focus on headache diagnosis, classification, and pharmacologic treatment among neurology and specialty headache clinics, whereas a nonpharmacologic approach to management among TBI specialty and general rehabilitation clinicians was more commonly reported. Management strategies for treating headache after TBI vary widely among general and specialty clinical practices. This suggests that additional research is needed that would lead to an increase in the use of established headache classification and the development of standardized management

  20. The role of pharmacokinetics/pharmacodynamics in setting clinical MIC breakpoints: the EUCAST approach.

    NARCIS (Netherlands)

    Mouton, J.W.; Brown, D.F.; Apfalter, P.; Canton, R.; Giske, C.G.; Ivanova, M.; MacGowan, A.P.; Rodloff, A.; Soussy, C.J.; Steinbakk, M.; Kahlmeter, G.

    2012-01-01

    Clinical breakpoints are used in clinical microbiology laboratories to categorize microorganisms as clinically susceptible (S), intermediate (I) or resistant (R) dependent on the quantitative antimicrobial susceptibility as indicated by the MIC value determined in a well-defined standard test

  1. A Novel Approach to Simulation-Based Education for Veterinary Medical Communication Training Over Eight Consecutive Pre-Clinical Quarters.

    Science.gov (United States)

    Englar, Ryane E

    Experiential learning through the use of standardized patients (SPs) is the primary way by which human medical schools teach clinical communication. The profession of veterinary medicine has followed suit in response to new graduates' and their employers' concerns that veterinary interpersonal skills are weak and unsatisfactory. As a result, standardized clients (SCs) are increasingly relied upon as invaluable teaching tools within veterinary curricula to advance relationship-centered care in the context of a clinical scenario. However, there is little to no uniformity in the approach that various colleges of veterinary medicine take when designing simulation-based education (SBE). A further complication is that programs with pre-conceived curricula must now make room for training in clinical communication. Curricular time constraints challenge veterinary colleges to individually decide how best to utilize SCs in what time is available. Because it is a new program, Midwestern University College of Veterinary Medicine (MWU CVM) has had the flexibility and the freedom to prioritize an innovative approach to SBE. The author discusses the SBE that is currently underway at MWU CVM, which incorporates 27 standardized client encounters over eight consecutive pre-clinical quarters. Prior to entering clinical rotations, MWU CVM students are exposed to a variety of simulation formats, species, clients, settings, presenting complaints, and communication tasks. These represent key learning opportunities for students to practice clinical communication, develop self-awareness, and strategize their approach to future clinical experiences.

  2. Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland.

    Science.gov (United States)

    Glier, Hana; Heijnen, Ingmar; Hauwel, Mathieu; Dirks, Jan; Quarroz, Stéphane; Lehmann, Thomas; Rovo, Alicia; Arn, Kornelius; Matthes, Thomas; Hogan, Cassandra; Keller, Peter; Dudkiewicz, Ewa; Stüssi, Georg; Fernandez, Paula

    2017-07-29

    The EuroFlow Consortium developed a fully standardized flow cytometric approach from instrument settings, through antibody panel, reagents and sample preparation protocols, to data acquisition and analysis. The Swiss Cytometry Society (SCS) promoted a study to evaluate the feasibility of using such standardized measurements of 8-color data across two different flow cytometry platforms - Becton Dickinson (BD) FACSCanto II and Beckman Coulter (BC) Navios, aiming at increasing reproducibility and inter-laboratory comparability of immunophenotypic data in clinical laboratories in Switzerland. The study was performed in two phases, i.e. a learning phase (round 1) and an analytical phase (rounds 2 and 3) consisting of a total of three rounds. Overall, 10 laboratories using BD FACSCanto II (n=6) or BC Navios (n=4) flow cytometers participated. Each laboratory measured peripheral blood samples from healthy donors stained with a uniform antibody panel of reagents - EuroFlow Lymphoid Screening Tube (LST) - applying the EuroFlow standardized protocols for instrument setup and sample preparation (www.EuroFlow.org). All data files were analyzed centrally and median fluorescence intensity (MedFI) values for individual markers on defined lymphocyte subsets were recorded; variability from reference MedFI values was assessed using performance scores. Data troubleshooting and discussion of the results with the participants followed after each round at SCS meetings. The results of the learning phase demonstrated that standardized instrument setup and data acquisition are feasible in routine clinical laboratories without previous experience with EuroFlow. During the analytical phase, highly comparable data were obtained at the different laboratories using either BD FACSCanto II or BC Navios. The coefficient of variation of MedFI for 7 of 11 markers performed repeatedly below 30%. In the last study round, 89% of participants scored over 90% MedFI values within the acceptance criteria

  3. A Gold Standards Approach to Training Instructors to Evaluate Crew Performance

    Science.gov (United States)

    Baker, David P.; Dismukes, R. Key

    2003-01-01

    The Advanced Qualification Program requires that airlines evaluate crew performance in Line Oriented Simulation. For this evaluation to be meaningful, instructors must observe relevant crew behaviors and evaluate those behaviors consistently and accurately against standards established by the airline. The airline industry has largely settled on an approach in which instructors evaluate crew performance on a series of event sets, using standardized grade sheets on which behaviors specific to event set are listed. Typically, new instructors are given a class in which they learn to use the grade sheets and practice evaluating crew performance observed on videotapes. These classes emphasize reliability, providing detailed instruction and practice in scoring so that all instructors within a given class will give similar scores to similar performance. This approach has value but also has important limitations; (1) ratings within one class of new instructors may differ from those of other classes; (2) ratings may not be driven primarily by the specific behaviors on which the company wanted the crews to be scored; and (3) ratings may not be calibrated to company standards for level of performance skill required. In this paper we provide a method to extend the existing method of training instructors to address these three limitations. We call this method the "gold standards" approach because it uses ratings from the company's most experienced instructors as the basis for training rater accuracy. This approach ties the training to the specific behaviors on which the experienced instructors based their ratings.

  4. An alternative to the standard spatial econometric approaches in hedonic house price models

    DEFF Research Database (Denmark)

    von Graevenitz, Kathrine; Panduro, Toke Emil

    2015-01-01

    Omitted, misspecified, or mismeasured spatially varying characteristics are a cause for concern in hedonic house price models. Spatial econometrics or spatial fixed effects have become popular ways of addressing these concerns. We discuss the limitations of standard spatial approaches to hedonic...

  5. A Principles-Based Approach to Teaching International Financial Reporting Standards (IFRS)

    Science.gov (United States)

    Persons, Obeua

    2014-01-01

    This article discusses the principles-based approach that emphasizes a "why" question by using the International Accounting Standards Board (IASB) "Conceptual Framework for Financial Reporting" to question and understand the basis for specific differences between IFRS and U.S. generally accepted accounting principles (U.S.…

  6. Do Energy Efficiency Standards Improve Quality? Evidence from a Revealed Preference Approach

    Energy Technology Data Exchange (ETDEWEB)

    Houde, Sebastien [Univ. of Maryland, College Park, MD (United States); Spurlock, C. Anna [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    Minimum energy efficiency standards have occupied a central role in U.S. energy policy for more than three decades, but little is known about their welfare effects. In this paper, we employ a revealed preference approach to quantify the impact of past revisions in energy efficiency standards on product quality. The micro-foundation of our approach is a discrete choice model that allows us to compute a price-adjusted index of vertical quality. Focusing on the appliance market, we show that several standard revisions during the period 2001-2011 have led to an increase in quality. We also show that these standards have had a modest effect on prices, and in some cases they even led to decreases in prices. For revision events where overall quality increases and prices decrease, the consumer welfare effect of tightening the standards is unambiguously positive. Finally, we show that after controlling for the effect of improvement in energy efficiency, standards have induced an expansion of quality in the non-energy dimension. We discuss how imperfect competition can rationalize these results.

  7. 466 Bee venom Immunotherapy with Standardized Extract, Two Case Comunication and Clinical Progress

    Science.gov (United States)

    Cardona, Aristoteles Alvarez; Nieto, Leticia Hernandez; Melendez, Alvaro Pedroza

    2012-01-01

    Background Bee venom immunotherapy is a safe and effective treatment, indicated in patients with previous history of severe systemic reactions to bee venom, demonstrating succesful desensitization in more than 90% of cases with standardized extract. Currently in Mexico there is no standardized extract commercially available for treatment, despite of having high activity of beekeeping and occupational exposure with at least 17,478 registered stings per year and an annually honey production of nearly 70 tons. Methods We present the clinical progress of 2 patients with history of severe systemic reactions to bee venom and occupational exposure, both with demonstrated sensitization by specific IgE and who underwent specific immunotherapy with standardized extract (Alk-US) reaching a maintenance weekly dose of 100 mcg (PLA2) for the last 4 years. Results Both patients sufered of accidental stings after reached the maintenance dose presenting mild local reactions to stings. Both patients had very different clinical course presenting a wide variety of adverse reactions during desensitization protocol; from mild local to generalized reactions all generally well tolerated allowed to reach the maintenance dose with succesful desensitization proved by accidental exposure without severe systemic reactions. Conclusions Bee venom specific immunotherapy with standardized extract is a well tolerated and efective treatment preventing the development of life threathening reactions in sensitized patients. It is important to promote the use and availability of standardized extract in developing countries with poor safety measures and high occupational exposure.

  8. Current National Approach to Healthcare ICT Standardization: Focus on Progress in New Zealand.

    Science.gov (United States)

    Park, Young-Taek; Atalag, Koray

    2015-07-01

    Many countries try to efficiently deliver high quality healthcare services at lower and manageable costs where healthcare information and communication technologies (ICT) standardisation may play an important role. New Zealand provides a good model of healthcare ICT standardisation. The purpose of this study was to review the current healthcare ICT standardisation and progress in New Zealand. This study reviewed the reports regarding the healthcare ICT standardisation in New Zealand. We also investigated relevant websites related with the healthcare ICT standards, most of which were run by the government. Then, we summarised the governance structure, standardisation processes, and their output regarding the current healthcare ICT standards status of New Zealand. New Zealand government bodies have established a set of healthcare ICT standards and clear guidelines and procedures for healthcare ICT standardisation. Government has actively participated in various enactments of healthcare ICT standards from the inception of ideas to their eventual retirement. Great achievements in eHealth have already been realized, and various standards are currently utilised at all levels of healthcare regionally and nationally. Standard clinical terminologies, such as International Classification of Diseases (ICD) and Systematized Nomenclature of Medicine - Clinical Terms (SNOMED-CT) have been adopted and Health Level Seven (HL7) standards are actively used in health information exchanges. The government to New Zealand has well organised ICT institutions, guidelines, and regulations, as well as various programs, such as e-Medications and integrated care services. Local district health boards directly running hospitals have effectively adopted various new ICT standards. They might already be benefiting from improved efficiency resulting from healthcare ICT standardisation.

  9. The Programmatic Approach; a Flexible and Complex Tool to Achieve Environmental Quality Standards

    Directory of Open Access Journals (Sweden)

    M.N. Boeve

    2012-11-01

    Full Text Available This contribution focuses on the integrated or programmatic approaches at both the European and national level, which are used as a tool to attain environmental quality standards. These approaches leave much room for flexibility with respect to the choice of measures to be adopted in order to achieve the quality standards. However, difficulties can arise while implementing the integrated or programmatic approach. Instruments or measures which are laid down in other relevant EU legislation can for instance restrict flexibility in the choice of measures. Furthermore, the polluter pays principle requires a fair allocation of costs in situations where multiple polluters have contributed to the pollution. In the Netherlands the principle of égalité devant les charges publiques applies. In principle, polluters will not have a right to compensation for the costs of environmental measures. However, in special circumstances, liability in damages based on a breach of égalité could be an issue.

  10. Postimplant Dosimetry Using a Monte Carlo Dose Calculation Engine: A New Clinical Standard

    International Nuclear Information System (INIS)

    Carrier, Jean-Francois; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, Andre-Guy; Vigneault, Eric; Beaulieu, Luc

    2007-01-01

    Purpose: To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. Methods and Materials: An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. Results: For the clinical target volume (CTV) D 90 parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. Conclusions: The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future

  11. Transformation of standardized clinical models based on OWL technologies: from CEM to OpenEHR archetypes.

    Science.gov (United States)

    Legaz-García, María del Carmen; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Chute, Christopher G; Tao, Cui

    2015-05-01

    The semantic interoperability of electronic healthcare records (EHRs) systems is a major challenge in the medical informatics area. International initiatives pursue the use of semantically interoperable clinical models, and ontologies have frequently been used in semantic interoperability efforts. The objective of this paper is to propose a generic, ontology-based, flexible approach for supporting the automatic transformation of clinical models, which is illustrated for the transformation of Clinical Element Models (CEMs) into openEHR archetypes. Our transformation method exploits the fact that the information models of the most relevant EHR specifications are available in the Web Ontology Language (OWL). The transformation approach is based on defining mappings between those ontological structures. We propose a way in which CEM entities can be transformed into openEHR by using transformation templates and OWL as common representation formalism. The transformation architecture exploits the reasoning and inferencing capabilities of OWL technologies. We have devised a generic, flexible approach for the transformation of clinical models, implemented for the unidirectional transformation from CEM to openEHR, a series of reusable transformation templates, a proof-of-concept implementation, and a set of openEHR archetypes that validate the methodological approach. We have been able to transform CEM into archetypes in an automatic, flexible, reusable transformation approach that could be extended to other clinical model specifications. We exploit the potential of OWL technologies for supporting the transformation process. We believe that our approach could be useful for international efforts in the area of semantic interoperability of EHR systems. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Standard requirements for GCP-compliant data management in multinational clinical trials

    LENUS (Irish Health Repository)

    Ohmann, Christian

    2011-03-22

    Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit

  13. Comparison of electronic data capture (EDC with the standard data capture method for clinical trial data.

    Directory of Open Access Journals (Sweden)

    Brigitte Walther

    Full Text Available BACKGROUND: Traditionally, clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records. Although well established, this method is time-consuming and error-prone. This study compares four electronic data capture (EDC methods with the conventional approach with respect to duration of data capture and accuracy. It was performed in a West African setting, where clinical trials involve data collection from urban, rural and often remote locations. METHODOLOGY/PRINCIPAL FINDINGS: Three types of commonly available EDC tools were assessed in face-to-face interviews; netbook, PDA, and tablet PC. EDC performance during telephone interviews via mobile phone was evaluated as a fourth method. The Graeco Latin square study design allowed comparison of all four methods to standard paper-based recording followed by data double entry while controlling simultaneously for possible confounding factors such as interview order, interviewer and interviewee. Over a study period of three weeks the error rates decreased considerably for all EDC methods. In the last week of the study the data accuracy for the netbook (5.1%, CI95%: 3.5-7.2% and the tablet PC (5.2%, CI95%: 3.7-7.4% was not significantly different from the accuracy of the conventional paper-based method (3.6%, CI95%: 2.2-5.5%, but error rates for the PDA (7.9%, CI95%: 6.0-10.5% and telephone (6.3%, CI95% 4.6-8.6% remained significantly higher. While EDC-interviews take slightly longer, data become readily available after download, making EDC more time effective. Free text and date fields were associated with higher error rates than numerical, single select and skip fields. CONCLUSIONS: EDC solutions have the potential to produce similar data accuracy compared to paper-based methods. Given the considerable reduction in the time from data collection to database lock, EDC holds the promise to reduce research

  14. Novel electrophysiological approaches to clinical epilepsy. Diagnosis and treatment

    International Nuclear Information System (INIS)

    Kanazawa, Kyoko; Matsumoto, Riki; Ikeda, Akio; Kinoshita, Masako

    2011-01-01

    Seizure onset zone (SOZ) is currently defined by ictal epileptiform discharges, which are most commonly recorded as regional low-voltage fast waves or repetitive spikes. Interictal epileptiform discharges, on the other hand, are not specific enough for SOZ as they are recorded at zones other than the SOZ; they are also recorded from areas that do not generate the ictal pattern and from areas to which ictal discharges propagate. Besides spikes and sharp waves, a novel index of human epileptogenicity has been investigated in association with wide-band electroencephalography (EEG) analysis. We primarily noted the following during clinical neurophysiological analysis for clinical epilepsy. Recent development of digital EEG technology enabled us to record wide-band EEG in a clinical setting. Thus, high frequency (>200 Hz) and low frequency (<1 Hz) components can be reliably recorded using subdural electrodes. Direct current shift, slow shift, ripple, and fast ripple can be well delineated, and they will be potentially useful in the diagnosis and management of epileptic patients. Fiber tractography (morphological parameter) and cortico-cortical-evoked potentials with single cortical stimulation (electrophysiological parameter) elucidated cortico-cortical connections in human brain. The data thus obtained can help us understand the mechanism of seizure propagation and normal cortical functional connectivity. Non-invasive simultaneous recording of EEG and functional magnetic resonance imaging (fMRI) provided information on the roles of deep brain structures associated with scalp-recorded epileptiform discharges. Interventional neurophysiology can shed light on the non-pharmacological treatment of epilepsy. In this report, we discuss these novel electrophysiological approaches to the diagnosis and treatment of clinical epilepsy. (author)

  15. Representation of Time-Relevant Common Data Elements in the Cancer Data Standards Repository: Statistical Evaluation of an Ontological Approach.

    Science.gov (United States)

    Chen, Henry W; Du, Jingcheng; Song, Hsing-Yi; Liu, Xiangyu; Jiang, Guoqian; Tao, Cui

    2018-02-22

    Today, there is an increasing need to centralize and standardize electronic health data within clinical research as the volume of data continues to balloon. Domain-specific common data elements (CDEs) are emerging as a standard approach to clinical research data capturing and reporting. Recent efforts to standardize clinical study CDEs have been of great benefit in facilitating data integration and data sharing. The importance of the temporal dimension of clinical research studies has been well recognized; however, very few studies have focused on the formal representation of temporal constraints and temporal relationships within clinical research data in the biomedical research community. In particular, temporal information can be extremely powerful to enable high-quality cancer research. The objective of the study was to develop and evaluate an ontological approach to represent the temporal aspects of cancer study CDEs. We used CDEs recorded in the National Cancer Institute (NCI) Cancer Data Standards Repository (caDSR) and created a CDE parser to extract time-relevant CDEs from the caDSR. Using the Web Ontology Language (OWL)-based Time Event Ontology (TEO), we manually derived representative patterns to semantically model the temporal components of the CDEs using an observing set of randomly selected time-related CDEs (n=600) to create a set of TEO ontological representation patterns. In evaluating TEO's ability to represent the temporal components of the CDEs, this set of representation patterns was tested against two test sets of randomly selected time-related CDEs (n=425). It was found that 94.2% (801/850) of the CDEs in the test sets could be represented by the TEO representation patterns. In conclusion, TEO is a good ontological model for representing the temporal components of the CDEs recorded in caDSR. Our representative model can harness the Semantic Web reasoning and inferencing functionalities and present a means for temporal CDEs to be machine

  16. International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

    Science.gov (United States)

    Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

    2015-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

  17. International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium.

    Science.gov (United States)

    Harris, Andrew C; Young, Rachel; Devine, Steven; Hogan, William J; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L M; Levine, John E

    2016-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed on by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multicenter clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance followed discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture, which may improve the reproducibility of GVHD clinical trials after further prospective validation. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  18. [Standardized management of acupuncture-moxibustion clinic in Singapore General Hospital].

    Science.gov (United States)

    Cui, Shu-Li; Tan, Kian Hian; Ong, Biauw Chi; Lim, Shih hui; Yong, Yang; Seah, Cheng Ngee; Huang, Youyi; Han, Seong Ng

    2014-02-01

    The standardized management of acupuncture-moxibustion in Singapore General Hospital is introduced. With gradual improvement of outpatient infrastructure, re-training of medical staff, strict disinfection of manipulation, periodical inspection of medical instruments, unified management of writing, saving and processing in medical records and public education of TCM knowledge, a standardized management system in accordance with modernized hospital is gradually established. As a result, efficiency and quality of clinical treatment is continuously increasing. From April of 1998 to December of 2012, a total of 74 654 times of treatment were performed, and treatment amount per day is gradually increased. The unusual condition of acupuncture is avoided. Periodical strict inspection of joint committee authenticated by domestic and overseas medical health organization is repeatedly passed and accepted. Additionally, three clinical researches funded by Singapore Health-care Company are still in progress in acupuncture-moxibustion department.

  19. [Effect of standardized PICC training and management on the clinical effect and complication of catheterization].

    Science.gov (United States)

    Zhang, Jinghui; Tang, Siyuan; He, Lianxiang; Chen, Wenfeng; Jiang, Pinglan; Hu, Yuanping; Chen, Hua

    2014-06-01

    To determine the clinical effect of standardized training and management of peripherally inserted central catheter (PICC) and catheter-related complications. A total of 610 patients were divided into a control group and an observation group, the control group (n=300) were catheterized by trainees who received "short-term intensive training", the observation group (n=310) by "system standardized training and management". The clinical efficacy of catheterization and the rate of catheter-related complications were compared. There was significant difference in the one-time puncture success rate, one-time cannulation success rate, the time for operation and the pain score between the 2 groups (all PPICC training and management can improve the effect of catheterization and reduce the incidence of PICC-related complication.

  20. Gamification of Clinical Routine: The Dr. Fill Approach.

    Science.gov (United States)

    Bukowski, Mark; Kühn, Martin; Zhao, Xiaoqing; Bettermann, Ralf; Jonas, Stephan

    2016-01-01

    Gamification is used in clinical context in the health care education. Furthermore, it has shown great promises to improve the performance of the health care staff in their daily routine. In this work we focus on the medication sorting task, which is performed manually in hospitals. This task is very error prone and needs to be performed daily. Nevertheless, errors in the medication are crucial and lead to serious complications. In this work we present a real world gamification approach of the medication sorting task in a patient's daily pill organizer. The player of the game needs to sort the correct medication into the correct dispenser slots and is rewarded or punished in real time. At the end of the game, a score is given and the user can register in a leaderboard.

  1. A review of clinical approaches to gender dysphoria.

    Science.gov (United States)

    Brown, G R

    1990-02-01

    Gender dysphoric patients are not infrequently encountered in the clinical practice of psychiatry. A comprehensive review of the world literature reveals that the systematic study of severe gender disorders--as exemplified by transsexualism--is relatively new, consisting of just over 25 years of collective experience. While the formal diagnosis of transsexualism is rare, this disorder represents the most severe form of the gender dysphoric conditions. Many nontranssexual patients with a variety of other psychiatric disorders present to psychiatrists desperately requesting somatic treatments (cross-gender hormones, sex reassignment surgery, and other cosmetic surgical procedures). A lengthy differential diagnosis needs to be considered, and a specialized approach to interviewing gender dysphoric patients is highly recommended. Available treatments and their efficacy are discussed. Large prospective controlled studies of treatments for gender dysphoria, such as sex reassignment surgery and psychotherapy, are lacking. Countertransference issues are noted to be particularly relevant in the care of gender dysphoric individuals.

  2. Standardized approaches to the investigation of syncope: Canadian Cardiovascular Society position paper.

    Science.gov (United States)

    Sheldon, Robert S; Morillo, Carlos A; Krahn, Andrew D; O'Neill, Blair; Thiruganasambandamoorthy, Venkatesh; Parkash, Ratika; Talajic, Mario; Tu, Jack V; Seifer, Colette; Johnstone, David; Leather, Richard

    2011-01-01

    Syncope is a very common presentation in the emergency department, and the combination of a wide differential diagnosis, a range of prognoses, and infrequent documentation of the faint leads to a high proportion of patients being admitted. These problems are mirrored in the investigation of inpatients with syncope, for which the high proportion of patients with benign outcomes and the profound risk aversion of health care providers make for expensive and inefficient assessment. Difficulties such as this in health services delivery can be improved by standardized approaches, such as guidelines, pathways, and checklists. Accordingly, emergency department decision rules, specialized syncope-monitoring units, and formal diagnostic algorithms have been developed to provide standardized approaches to the investigation of syncope. To provide guidance in the management of syncope, the Canadian Cardiovascular Society commissioned a position paper on standardized approaches to syncope investigation in adults. A primary panel first reviewed the literature systematically, then undertook iterative syntheses of data, and finally took positions with specific recommendations according to the GRADE framework. This paper summarizes the evidence and its quality and makes recommendations on the specific approaches meriting adoption. The position paper was then reviewed by a secondary panel, which provided suggestions for revisions leading to the final document as presented here. Overall, the position group concluded that there is little persuasive evidence that emergency department syncope rules and diagnostic syncope units provide efficient care and improved outcomes but that formal diagnostic algorithms with specialist support show promise. Copyright © 2011. Published by Elsevier Inc.

  3. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... Analyzing field notes: • How to write useful field notes? • How to analyze field notes systematically? • Using Nvivo when analyzing field notes and interviews?...

  4. Clinical Features of Herniated Disc at Cervicothoracic Junction Level Treated by Anterior Approach.

    Science.gov (United States)

    Lee, Jun Gue; Kim, Hyeun Sung; Ju, Chang Il; Kim, Seok Won

    2016-06-01

    The anterior approach for C7-T1 disc herniation may be challenging because of obstruction by the manubrium and the narrow operative field. This study aimed to investigate the clinical and neurological outcomes of anterior approach for C7-T1 disc herniation. We retrospectively evaluated 13 patients who underwent the anterior approach for C7-T1 disc herniation by a single surgeon within a period of 11 years (2003-2014). The minimum follow-up duration was 6 months. We describe the clinical presentation, radiographic findings, neurological outcome, and related complications. Of 372 patients with single-level anterior discectomy and fusion or artificial disc replacement for cervical disc herniation, 13 (3.5%) had C7-T1 disc herniation. The main clinical presentation was unilateral motor weakness in intrinsic hand muscles (11 patients), along with numbness, pain, and tingling sensation that radiate down the arm to the little finger. Most of the patients improved after surgery via the anterior approach. Ten patients underwent successful anterior discectomy and fusion by the standard supramanubrial Smith-Robinson approach, but 2 needed additional manubriotomy and sternotomy. In 1 patient, we performed surgery at a wrong level because the correct level was difficult to identify intraoperatively. Two patients had transient vocal dysfunction, but none had major complications related to injuries of the great vessels such as the thoracic duct or esophagus. For patients who require direct anterior decompression for C7-T1 disc herniation, the anterior approach is relatively feasible. However, care should be taken to overcome physical constraints by the manubrium and slope.

  5. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    DEFF Research Database (Denmark)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-01-01

    for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements......Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able...

  6. WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

    International Nuclear Information System (INIS)

    Gabriel, P.

    2015-01-01

    Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented

  7. Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies.

    Science.gov (United States)

    VanDevanter, Donald R; Mayer-Hamblett, Nicole

    2017-11-01

    Evolving cystic fibrosis 'standards of care' have influenced recent cystic fibrosis clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Three cystic fibrosis therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced cystic fibrosis transmembrane conductance regulator [CFTR] protein function) differ with respect to the duration for which recognized 'standards of care' have been available. However, developers of new therapies in all the three areas are affected by similar challenges: standards of care have become so strongly entrenched that traditional placebo-controlled studies in cystic fibrosis populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active-comparator trial designs, that have substantial challenges of their own. Foremost among these are the selection of 'valid' active comparator(s), estimation of a comparator's current clinical efficacy (required for testing noninferiority hypotheses), and effective blinding of commercially available comparators. Recent and future cystic fibrosis clinical trial designs will have to creatively address this collateral result of successful past development of effective cystic fibrosis therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.

  8. Innovative approaches to clinical development and trial design

    Directory of Open Access Journals (Sweden)

    John J Orloff

    2011-01-01

    Full Text Available Pharmaceutical innovation is increasingly risky, costly and at times inefficient, which has led to a decline in industry productivity. Despite the increased investment in R&D by the industry, the number of new molecular entities achieving marketing authorization is not increasing. Novel approaches to clinical development and trial design could have a key role in overcoming some of these challenges by improving efficiency and reducing attrition rates. The effectiveness of clinical development can be improved by adopting a more integrated model that increases flexibility and maximizes the use of accumulated knowledge. Central to this model of drug development are novel tools, including modelling and simulation, Bayesian methodologies, and adaptive designs, such as seamless adaptive designs and sample-size re-estimation methods. Applications of these methodologies to early- and late-stage drug development are described with some specific examples, along with advantages, challenges, and barriers to implementation. Because they are so flexible, these new trial designs require significant statistical analyses, simulations and logistical considerations to verify their operating characteristics, and therefore tend to require more time for the planning and protocol development phase. Greater awareness of the distinct advantages of innovative designs by regulators and sponsors are crucial to increasing the adoption of these modern tools.

  9. One-Tube-Only Standardized Site-Directed Mutagenesis: An Alternative Approach to Generate Amino Acid Substitution Collections.

    Directory of Open Access Journals (Sweden)

    Janire Mingo

    Full Text Available Site-directed mutagenesis (SDM is a powerful tool to create defined collections of protein variants for experimental and clinical purposes, but effectiveness is compromised when a large number of mutations is required. We present here a one-tube-only standardized SDM approach that generates comprehensive collections of amino acid substitution variants, including scanning- and single site-multiple mutations. The approach combines unified mutagenic primer design with the mixing of multiple distinct primer pairs and/or plasmid templates to increase the yield of a single inverse-PCR mutagenesis reaction. Also, a user-friendly program for automatic design of standardized primers for Ala-scanning mutagenesis is made available. Experimental results were compared with a modeling approach together with stochastic simulation data. For single site-multiple mutagenesis purposes and for simultaneous mutagenesis in different plasmid backgrounds, combination of primer sets and/or plasmid templates in a single reaction tube yielded the distinct mutations in a stochastic fashion. For scanning mutagenesis, we found that a combination of overlapping primer sets in a single PCR reaction allowed the yield of different individual mutations, although this yield did not necessarily follow a stochastic trend. Double mutants were generated when the overlap of primer pairs was below 60%. Our results illustrate that one-tube-only SDM effectively reduces the number of reactions required in large-scale mutagenesis strategies, facilitating the generation of comprehensive collections of protein variants suitable for functional analysis.

  10. A clinical approach to complex regional pain syndrome.

    Science.gov (United States)

    Harden, R N

    2000-06-01

    The clinical approach to complex regional pain syndrome (CRPS) is complicated by a lack of precision diagnostically, and a lack of evidence-based information for treatment. The vagaries of diagnosis were somewhat improved by the Orlando Conference (1993), where a consensus panel of experts developed a new taxonomy and criteria. Unfortunately the criteria can be based entirely on subjective grounds (patient history), and as such provides a very sensitive but not very specific device. There is some effort in the research community to amend these criteria to make them more specific. We encourage the practicing physician to include as much objective data along with the quasi-objective and subjective information currently used in formulating the diagnosis. This imprecision in diagnostic issues has significantly hampered treatment because it has not led to solid, generalizable, randomized controlled trials. To date there are no substantial scientific trials of any particular therapy or medication in the specific diagnosis of CRPS. Much can be inferred from the work with peripheral neuropathy and central pain. However, it is unlikely that this will be a perfect concordance with best therapy for CRPS. It remains our responsibility to diagnose each patient as best we can, supported by the best possible objective signs and testing. Once the diagnosis is made it is necessary to proceed in a pragmatic empirical way, following the best guidelines available. The guidelines should be considered a "rough sketch" and the key to clinical success will be flexibility, a vast fund of the available knowledge, patience, and compassion. To allow the deficiencies in the science to paralyze the clinical process is therapeutic nihilism, and not acceptable.

  11. [Psychometric approach of metacognition: Pilot study in clinical population].

    Science.gov (United States)

    Visinet, A; Soumet-Leman, C; Baptista, A; Bungener, C; Jouvent, R

    2017-04-01

    Metacognition describes the process of thinking about one's own thought processes. This concept was introduced by Flavell in 1979 and has since been widely developed in the cognitive approach to mood and anxiety disorders. As it happens, many recent studies have underlined the links between metacognition and anxio-depressive symptoms, pointing out the interest of assessing its various dimensions. The short form of the Metacognitions Questionnaire is a brief multidimensional measure of a range of metacognitive processes and metacognitive beliefs about worry and cognition relevant to the vulnerability to and the maintenance of emotional disorders. The aim of this study was twofold: firstly to adapt and validate a French version of the short form of the Metacognitions Questionnaire (MCQ-30) and to assess its psychometric properties in a clinical sample, and secondly to investigate metacognitive predictors of anxiety and depression in this sample. The sample included 55 clinical participants (24 men, 31 women, mean age=51.33±14.62) with DSM-IV-TR psychiatric disorders (major depression, bipolar disorder and obsessive-compulsive disorder). Instrument reliability (internal consistency), construct validity (confirmatory factor analysis), and convergent validity were measured. The total score and the five subscale scores were also compared with previous results in non-clinical samples. Reliability analyses indicated that the French version of the MCQ-30 possessed satisfactory internal consistency (Cronbach α=0.84), and confirmatory factor analysis supported the MCQ's original five-factor structure. Correlation with measurements of depression, anxiety and pathological worry demonstrated convergent validity (r=0.62, Pmetacognition, in relation to the anxio-depressive symptomatology and the subsequent management of patients. Copyright © 2016 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  12. Targeting NK cells for anti-cancer immunotherapy: clinical and pre-clinical approaches

    Directory of Open Access Journals (Sweden)

    Sebastian eCarotta

    2016-04-01

    Full Text Available The recent success of checkpoint blockade has highlighted the potential of immunotherapy approaches for cancer treatment. While the majority of approved immunotherapy drugs target T cell subsets, it is appreciated that other components of the immune system have important roles in tumor immune-surveillance as well and thus represent promising additional targets for immunotherapy. Natural killer cells are the body’s first line of defense against infected or transformed cells as they kill target cells in an antigen-independent manner. Although several studies have clearly demonstrated the active role of NK cells in cancer-immune surveillance, only few clinically approved therapies currently exist that harness their potential. Our increased understanding of NK cell biology over the past few years has renewed the interest in NK cell based anti-cancer therapies, which has lead to a steady increase of NK cell based clinical and pre-clinical trials. Here, the role of NK cells in cancer immunesurveillance is summarized and several novel approaches to enhance NK cell cytotoxicity against cancer are discussed.

  13. Standardized, App-based disinfection of iPads in a clinical and nonclinical setting: comparative analysis.

    Science.gov (United States)

    Albrecht, Urs-Vito; von Jan, Ute; Sedlacek, Ludwig; Groos, Stephanie; Suerbaum, Sebastian; Vonberg, Ralf-Peter

    2013-08-14

    With the use of highly mobile tools like tablet PCs in clinical settings, an effective disinfection method is a necessity. Since manufacturers do not allow cleaning methods that make use of anything but a dry fleece, other approaches have to be established to ensure patient safety and to minimize risks posed by microbiological contamination. The ability of isopropanol wipes to decontaminate iPads was evaluated prospectively in a observer blinded, comparative analysis of devices used in a clinical and a nonclinical setting. 10 new iPads were randomly deployed to members of the nursing staff of 10 clinical wards, to be used in a clinical setting over a period of 4 weeks. A pre-installed interactive disinfection application (deBac-app, PLRI MedAppLab, Germany) was used on a daily basis. Thereafter, the number and species of remaining microorganisms on the surface of the devices (13 locations; front and back) was evaluated using contact agar plates. Following this, the 10 iPads were disinfected and randomly deployed to medical informatics professionals who also used the devices for 4 weeks but were forbidden to use disinfecting agents. The quality of a single, standardized disinfection process was then determined by a final surface disinfection process of all devices in the infection control laboratory. No personal data were logged with the devices. The evaluation was performed observer blinded with respect to the clinical setting they were deployed in and personnel that used the devices. We discovered a 2.7-fold (Mann-Whitney U test, z=-3.402, P=.000670) lower bacterial load on the devices used in the clinical environment that underwent a standardized daily disinfection routine with isopropanol wipes following the instructions provided by "deBac-app". Under controlled conditions, an average reduction of the mainly Gram-positive normal skin microbiological load of 99.4% (Mann-Whitney U test, z=-3.1798, P=.001474) for the nonclinical group and 98.1% (Mann-Whitney U test

  14. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Van Heertum RL

    2015-09-01

    Full Text Available Ronald L Van Heertum, Robert Scarimbolo, Robert Ford, Eli Berdougo, Michael O’Neal BioClinica Inc, Princeton, PA, USA Abstract: In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes. Keywords: companion diagnostics, molecular imaging, oncology trials, personalized medicine, diagnostic assays

  15. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

    Science.gov (United States)

    Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

    2015-01-01

    In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

  16. Personalized translational epilepsy research - Novel approaches and future perspectives: Part I: Clinical and network analysis approaches.

    Science.gov (United States)

    Rosenow, Felix; van Alphen, Natascha; Becker, Albert; Chiocchetti, Andreas; Deichmann, Ralf; Deller, Thomas; Freiman, Thomas; Freitag, Christine M; Gehrig, Johannes; Hermsen, Anke M; Jedlicka, Peter; Kell, Christian; Klein, Karl Martin; Knake, Susanne; Kullmann, Dimitri M; Liebner, Stefan; Norwood, Braxton A; Omigie, Diana; Plate, Karlheinz; Reif, Andreas; Reif, Philipp S; Reiss, Yvonne; Roeper, Jochen; Ronellenfitsch, Michael W; Schorge, Stephanie; Schratt, Gerhard; Schwarzacher, Stephan W; Steinbach, Joachim P; Strzelczyk, Adam; Triesch, Jochen; Wagner, Marlies; Walker, Matthew C; von Wegner, Frederic; Bauer, Sebastian

    2017-11-01

    Despite the availability of more than 15 new "antiepileptic drugs", the proportion of patients with pharmacoresistant epilepsy has remained constant at about 20-30%. Furthermore, no disease-modifying treatments shown to prevent the development of epilepsy following an initial precipitating brain injury or to reverse established epilepsy have been identified to date. This is likely in part due to the polyetiologic nature of epilepsy, which in turn requires personalized medicine approaches. Recent advances in imaging, pathology, genetics and epigenetics have led to new pathophysiological concepts and the identification of monogenic causes of epilepsy. In the context of these advances, the First International Symposium on Personalized Translational Epilepsy Research (1st ISymPTER) was held in Frankfurt on September 8, 2016, to discuss novel approaches and future perspectives for personalized translational research. These included new developments and ideas in a range of experimental and clinical areas such as deep phenotyping, quantitative brain imaging, EEG/MEG-based analysis of network dysfunction, tissue-based translational studies, innate immunity mechanisms, microRNA as treatment targets, functional characterization of genetic variants in human cell models and rodent organotypic slice cultures, personalized treatment approaches for monogenic epilepsies, blood-brain barrier dysfunction, therapeutic focal tissue modification, computational modeling for target and biomarker identification, and cost analysis in (monogenic) disease and its treatment. This report on the meeting proceedings is aimed at stimulating much needed investments of time and resources in personalized translational epilepsy research. Part I includes the clinical phenotyping and diagnostic methods, EEG network-analysis, biomarkers, and personalized treatment approaches. In Part II, experimental and translational approaches will be discussed (Bauer et al., 2017) [1]. Copyright © 2017 Elsevier Inc

  17. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    Science.gov (United States)

    Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

    2016-12-01

    Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

  18. A Pilot Curriculum to Integrate Standardized Patient Simulation into Clinical Pastoral Education.

    Science.gov (United States)

    Ahmed, Rami A; Damore, Deborah R; Viti, Joseph F; Hughes, Patrick G; Miesle, Rebecca; Ataya, Ramsey; Atkinson, S Scott; Gable, Brad

    2016-06-01

    We describe a novel means of experiential learning for clinical pastoral care residents using standardized patient (SP) simulations. A prospective cohort study involving 7 clinical pastoral care residents was performed. All residents underwent 2 verbatim SP sessions and 2 simulation sessions. After all sessions, residents completed a self-evaluation. Faculty completed an evaluation and then provided a debriefing session to all residents. Performance ratings were globally higher on simulated scenarios when compared to the verbatim sessions. More research in the field of pastoral care is needed to validate the learned professional skills that enhance a comprehensive training program through the use of medical simulation, verbatim reports, and clinical pastoral education (CPE) competencies. Medical simulation provides a promising teaching methodology for the training of CPE residents. © The Author(s) 2015.

  19. A Model Driven Approach to domain standard specifications examplified by Finance Accounts receivable/ Accounts payable

    OpenAIRE

    Khan, Bahadar

    2005-01-01

    This thesis was written as a part of a master degree at the University of Oslo. The thesis work was conducted at SINTEF. The work has been carried out in the period November 2002 and April 2005. This thesis might be interesting to anyone interested in Domain Standard Specification Language developed by using the MDA approach to software development. The Model Driven Architecture (MDA) allows to separate the system functionality specification from its implementation on any specific technolo...

  20. Standardized patients' preferences for pharmacist interactive communication style: A mixed method approach.

    Science.gov (United States)

    Guirguis, Lisa M; Nusair, Mohammad B

    2016-01-01

    Interactive communication approaches may help to shift pharmacy practice toward more patient-centered care. One example of such an approach is the 3 prime questions (3PQs). Patients' preferences for pharmacists' interactive communication styles were not identified in the literature. The purpose of this paper was to explore standardized patient (SP) preferences, satisfaction, and perceptions of pharmacists' communication style and changes in pharmacist to standardized patient talk-time ratio. Mixed methods, before and after evaluation. SPs were hired from the University of Alberta's Standardized Patient Program, Canada. Twelve SPs and 10 pharmacists. SPs were video recorded interacting with the same pharmacists before and after pharmacist training on the 3PQs. SPs participated in an open-ended interview using stimulated recall on videos of their pharmacist encounters. Explore SP preferences, satisfaction, and perceptions of pharmacists' communication style, in addition to changes in pharmacist to standardized patient talk-time ratio before and after the intervention Generally SPs were satisfied with pharmacists' interactive communication style post training. Qualitative themes varied with SPs' preference for an interactive approach (58%, i.e., Conversation with Equals, Double Check, and Manageable Information) or traditional approach (33%, i.e., Expected Information, Shouldn't the Pharmacist Know, and Feels Uncomfortable) and improvements in item scores varied by type of prescription. Pharmacists' use of the 3PQs increased patient talk time for scenarios with new chronic and acute medication, though pharmacists still dominated the conversation. Just over half of SPs preferred an interactive communication style, although a third of SPs preferred a communication style that focused on information provision. Patients had more time to talk in some interactive encounters. Pharmacists may need to be aware of patient expectations when using the 3PQs. Copyright © 2016

  1. Resource utilization after introduction of a standardized clinical assessment and management plan.

    Science.gov (United States)

    Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E

    2010-01-01

    A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.

  2. Microbial air quality and standard precaution practice in a hospital dental clinic.

    Science.gov (United States)

    Luksamijarulkul, Pipat; Panya, Navapan; Sujirarat, Dusit; Thaweboon, Sroisiri

    2009-12-01

    A cross-sectional study was carried out to assess standard precaution practices among dental personnel and to investigate microbial counts in indoor air samples collected from a hospital dental clinic before and during dental works. Thirty dental personnel who voluntarily participated were interviewed using a questionnaire towards demographic information and standard precaution practices between May and August 2007. Additionally, 138 indoor air samples (72 from dental treatment units, 48 from dental supporting units and offices and 18 from patient waiting area) were collected before and during dental works for 6 days (Monday to Saturday) to investigate bacterial and fungal counts. Data were analyzed by using descriptive statistics. Paired t-test was used for analyzing the difference of mean + standard deviation between microbial counts before and during dental procedures. The statistical significance was expressed in term of p-value and the critical level was set at alpha = 0.05. The results revealed that standard precaution practices towards wearing personal protective equipments regularly during dental procedures ranged from 50% to 100%, whereas, cleaning and disinfecting dental unit after each patient treatment and cleaning dental unit water lines with antiseptics every week were done regularly only 36.7%. The mean score of standard precaution was 8.4 +/- 2.5 (moderate level, total score of 13). The means of bacterial and fungal counts in air samples collected from dental treatment units significantly increased during dental procedures when compared with those collected before dental works (p 0.05. This study demonstrated the moderate level of standard precaution practice score among studied dental personnel and significantly higher microbial counts (bacterial and fungal counts) in air samples collected from dental treatment units during dental procedures were demonstrated. To reduce the occupational risk among this group, standard precaution practices should be

  3. Standardized Ki67 Diagnostics Using Automated Scoring--Clinical Validation in the GeparTrio Breast Cancer Study.

    Science.gov (United States)

    Klauschen, Frederick; Wienert, Stephan; Schmitt, Wolfgang D; Loibl, Sibylle; Gerber, Bernd; Blohmer, Jens-Uwe; Huober, Jens; Rüdiger, Thomas; Erbstößer, Erhard; Mehta, Keyur; Lederer, Bianca; Dietel, Manfred; Denkert, Carsten; von Minckwitz, Gunter

    2015-08-15

    Scoring proliferation through Ki67 immunohistochemistry is an important component in predicting therapy response to chemotherapy in patients with breast cancer. However, recent studies have cast doubt on the reliability of "visual" Ki67 scoring in the multicenter setting, particularly in the lower, yet clinically important, proliferation range. Therefore, an accurate and standardized Ki67 scoring is pivotal both in routine diagnostics and larger multicenter studies. We validated a novel fully automated Ki67 scoring approach that relies on only minimal a priori knowledge on cell properties and requires no training data for calibration. We applied our approach to 1,082 breast cancer samples from the neoadjuvant GeparTrio trial and compared the performance of automated and manual Ki67 scoring. The three groups of autoKi67 as defined by low (≤ 15%), medium (15.1%-35%), and high (>35%) automated scores showed pCR rates of 5.8%, 16.9%, and 29.5%, respectively. AutoKi67 was significantly linked to prognosis with overall and progression-free survival P values P(OS) Ki67 scoring. Moreover, automated Ki67 scoring was an independent prognosticator in the multivariate analysis with P(OS) = 0.002, P(PFS) = 0.009 (autoKi67) versus P(OS) = 0.007, PPFS = 0.004 (manual Ki67). The computer-assisted Ki67 scoring approach presented here offers a standardized means of tumor cell proliferation assessment in breast cancer that correlated with clinical endpoints and is deployable in routine diagnostics. It may thus help to solve recently reported reliability concerns in Ki67 diagnostics. ©2014 American Association for Cancer Research.

  4. Peculiarities of Professional Training Standards Development and Implementation within Competency-Based Approach: Foreign Experience

    Directory of Open Access Journals (Sweden)

    Desyatov Tymofiy

    2015-12-01

    Full Text Available The article analyzes the development of competency-based professional training standards and their implementation into educational process in foreign countries. It determines that the main idea of competency-based approach is competency-and-active learning, which aims at complex acquirement of diverse skills and ways of practice activities via mastering respective competences. The article states that competency is the product of competence due to which a person successfully realizes themselves in different spheres of their professional engagement, gains social independence and becomes mobile and qualified. The article also dwells on the international experience of professional and training standards development, it analyses specific internal national, as well as external all-European and worldwide conceptions of professional and training standards development, conceptual foundations of competency-based approach in national higher education within the framework of global information society formation. It highlights specific aspects of standards development based on activity-oriented technologies and professional competence assessment. The article states that within the framework of competency-based teaching and training, quality-assuring actions have to ensure the correspondence of standards and learning outcomes. It informs that the labour market is represented by employers, trade unions and the government. The article explores the fact that in Russia, Ukraine and many other countries the employers and the trade unions do not collaborate to formulate their needs with regard to professional training standards, that is why the government and its administration bodies have to do the task of predicting labour market needs on their own.

  5. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial.

    Science.gov (United States)

    Phonghanyudh, A; Phantumvanit, P; Songpaisan, Y; Petersen, P E

    2012-06-01

    To evaluate the clinical performance and radiographic outcome of glass ionomer cement (GIC) restoration in primary molars using three caries removal techniques. Randomised clinical controlled trial. Two standard dental clinics in 2 hospitals near Bangkok. A total of 276 children, aged 6-11, having dentinal caries on the occlusal and/or proximal surface extending at least one-third of dentine without signs and/or symptoms of irreversible pulpitis. Children were randomly allocated into 3 study groups with different caries removal techniques: Group 1, partial soft caries removal at enamel-dentine junction (EDJ) by spoon excavation; Group 2, complete soft caries removal by spoon excavation; and Group 3, conventional caries removal by steel burs. All cavity preparations were restored with GIC (Fuji IX, GC Corp., Japan). Clinical and radiographic evaluations were carried out at 6 and 12 months after restoration. After 12 months, 89, 89, and 88 restorations in Groups 1, 2 and 3 were evaluated. The cumulative survival rates of GIC restorations in Groups 1, 2 and 3 were 83%, 83%, and 89% while the cumulative survival rates of pulp were 99%, 100% and 98% respectively. There were no statistically significant differences in the survival of GIC restorations or pulp in the three groups (p > 0.05). The clinical and radiographic evaluations after 12 months indicated that partial soft caries removal at EDJ followed by GIC restoration was comparable to that of ART and conventional approaches.

  6. A standards-based clinical information system for HIV/AIDS.

    Science.gov (United States)

    Stitt, F W

    1995-01-01

    To create a clinical data repository to interface the Veteran's Administration (VA) Decentralized Hospital Computer Program (DHCP) and a departmental clinical information system for the management of HIV patients. This system supports record-keeping, decision-making, reporting, and analysis. The database development was designed to overcome two impediments to successful implementations of clinical databases: (i) lack of a standard reference data model, and; (ii) lack of a universal standard for medical concept representation. Health Level Seven (HL7) is a standard protocol that specifies the implementation of interfaces between two computer applications (sender and receiver) from different vendors or sources of electronic data exchange in the health care environment. This eliminates or substantially reduces the custom interface programming and program maintenance that would otherwise be required. HL7 defines the data to be exchanged, the timing of the interchange, and the communication of errors to the application. The formats are generic in nature and must be configured to meet the needs of the two applications involved. The standard conceptually operates at the seventh level of the ISO model for Open Systems Interconnection (OSI). The OSI simply defines the data elements that are exchanged as abstract messages, and does not prescribe the exact bit stream of the messages that flow over the network. Lower level network software developed according to the OSI model may be used to encode and decode the actual bit stream. The OSI protocols are not universally implemented and, therefore, a set of encoding rules for defining the exact representation of a message must be specified. The VA has created an HL7 module to assist DHCP applications in exchanging health care information with other applications using the HL7 protocol. The DHCP HL7 module consists of a set of utility routines and files that provide a generic interface to the HL7 protocol for all DHCP applications

  7. Standard donor lung procurement with normothermic ex vivo lung perfusion: A prospective randomized clinical trial.

    Science.gov (United States)

    Slama, Alexis; Schillab, Lukas; Barta, Maximilian; Benedek, Aris; Mitterbauer, Andreas; Hoetzenecker, Konrad; Taghavi, Shahrokh; Lang, Gyoergy; Matilla, Jose; Ankersmit, Hendrik; Hager, Helmut; Roth, Georg; Klepetko, Walter; Aigner, Clemens

    2017-07-01

    Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx). This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP. From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p 1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients remained intubated (1.6 days vs 1.6 days, p = 0.67), in the intensive care unit (6 days vs 6 days, p = 0.76), and in the hospital (23 days vs 19 days, p = 0.42) for a comparable period of time. The 30-day survival was 97.1% vs 100% (p = 0.46). This study provides evidence that EVLP can safely be used in standard donor lungs. Functional results and perioperative

  8. The k0-based neutron activation analysis: a mono standard to standardless approach of NAA

    International Nuclear Information System (INIS)

    Acharya, R.; Nair, A.G.C.; Sudarshan, K.; Goswami, A.; Reddy, A.V.R.

    2006-01-01

    The k 0 -based neutron activation analysis (k 0 -NAA) uses neutron flux parameters, detection efficiency and nuclear constants namely k 0 and Q 0 for the determination of concentration of elements. Gold ( 197 Au) or any other element having suitable nuclear properties is used as external or internal single comparator. This article describes the principle of k 0 -NAA and standardization of method by characterization of reactor irradiation sites and calibration of efficiency of the detector and applications. The method was validated using CRMs obtained from USGS, IAEA and NIST. The applications of method includes samples like gemstones (ruby, beryl and emerald), sediments, manganese nodules and encrustations, cereals, and medicinal and edible leaves. Recently, a k-o-based internal mono standard INAA (IM-NAA) method using in-situ relative efficiency has been standardized by us for the analysis of small and large samples of different shapes and sizes. The method was applied to a new meteorite sample and large size wheat samples. Non-standard size and shape samples of nuclear cladding materials namely zircaloy 2 and 4, stainless steels (SS 316M and D9) and 1S aluminium were analysed. Standard-less analysis of these cladding materials was possible by mass balance approach since all the major and minor elements were amenable to NAA. (author)

  9. Scientific Approaches | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    CPTAC employs two complementary scientific approaches, a "Targeting Genome to Proteome" (Targeting G2P) approach and a "Mapping Proteome to Genome" (Mapping P2G) approach, in order to address biological questions from data generated on a sample.

  10. Deep round window insertion versus standard approach in cochlear implant surgery.

    Science.gov (United States)

    Nordfalk, Karl Fredrik; Rasmussen, Kjell; Bunne, Marie; Jablonski, Greg Eigner

    2016-01-01

    The aim of this study was to compare the outcomes of vestibular tests and the residual hearing of patients who have undergone full insertion cochlear implant surgery using the round window approach with a hearing preservation protocol (RW-HP) or the standard cochleostomy approach (SCA) without hearing preservation. A prospective study of 34 adults who underwent unilateral cochlear implantation was carried out. One group was operated using the RW-HP (n = 17) approach with Med-El +Flex(SOFT) electrode array with full insertion, while the control group underwent a more conventional SCA surgery (n = 17) with shorter perimodiolar electrodes. Assessments of residual hearing, cervical vestibular-evoked myogenic potentials (cVEMP), videonystagmography, subjective visual vertical/horizontal (SVH/SVV) were performed before and after surgery. There was a significantly (p < 0.05) greater number of subjects who exhibited complete or partial hearing preservation in the deep insertion RW-HP group (9/17) compared to the SCA group (2/15). A higher degree of vestibular loss but a lower degree of vertigo symptoms could be seen in the RW-HP group, but the differences were not statistically significant. It is possible to preserve residual hearing to a certain extent also with deep insertion. Full insertion with hearing preservation was less harmful to residual hearing particularly at 125 Hz (p < 0.05), than was the standard cochleostomy approach.

  11. Whole-body magnetic resonance angiography of patients using a standard clinical scanner

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)

    2006-01-01

    The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)

  12. Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

    Science.gov (United States)

    Currie, Colin T; Hutchison, James D

    To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

  13. Web 2.0-based crowdsourcing for high-quality gold standard development in clinical natural language processing.

    Science.gov (United States)

    Zhai, Haijun; Lingren, Todd; Deleger, Louise; Li, Qi; Kaiser, Megan; Stoutenborough, Laura; Solti, Imre

    2013-04-02

    A high-quality gold standard is vital for supervised, machine learning-based, clinical natural language processing (NLP) systems. In clinical NLP projects, expert annotators traditionally create the gold standard. However, traditional annotation is expensive and time-consuming. To reduce the cost of annotation, general NLP projects have turned to crowdsourcing based on Web 2.0 technology, which involves submitting smaller subtasks to a coordinated marketplace of workers on the Internet. Many studies have been conducted in the area of crowdsourcing, but only a few have focused on tasks in the general NLP field and only a handful in the biomedical domain, usually based upon very small pilot sample sizes. In addition, the quality of the crowdsourced biomedical NLP corpora were never exceptional when compared to traditionally-developed gold standards. The previously reported results on medical named entity annotation task showed a 0.68 F-measure based agreement between crowdsourced and traditionally-developed corpora. Building upon previous work from the general crowdsourcing research, this study investigated the usability of crowdsourcing in the clinical NLP domain with special emphasis on achieving high agreement between crowdsourced and traditionally-developed corpora. To build the gold standard for evaluating the crowdsourcing workers' performance, 1042 clinical trial announcements (CTAs) from the ClinicalTrials.gov website were randomly selected and double annotated for medication names, medication types, and linked attributes. For the experiments, we used CrowdFlower, an Amazon Mechanical Turk-based crowdsourcing platform. We calculated sensitivity, precision, and F-measure to evaluate the quality of the crowd's work and tested the statistical significance (Pcrowdsourced and traditionally-developed annotations. The agreement between the crowd's annotations and the traditionally-generated corpora was high for: (1) annotations (0.87, F-measure for medication names

  14. A Standardized Narrative Profile Approach to Self-Reflection and Assessment of Cross-Cultural Communication

    Directory of Open Access Journals (Sweden)

    Kyle J Wilby

    2017-03-01

    Full Text Available Objectives: 1 to explore clinical assessor’s values regarding behaviours related to cultural aspects of care, 2 to generate standardized narrative profiles regarding cultural behavioural outcomes within clinical teaching settings, and 3 to rank order standardized narrative profiles according to performance expectations. Methods: Ten interviews were completed with clinicians to determine values and performance expectations for culturally competent behaviours. Transcripts were produced and coded. Six narrative profiles were developed based on data obtained. Twenty clinicians categorized profiles according to performance expectations and rank ordered. Intraclass correlation coefficients (ICCs determined inter-rater reliability. Clinicians rated usability of profiles in clinical training settings. Results: Eighteen categories were coded with communication, awareness and ability most frequently reported with each ranging from 9.6-11.5% of the utterances. Consensus for categorization of all profiles was achieved at a level of 70% (ICC = 0.837, 95% CI 0.654-0.969. High inter-rater reliability was achieved for rank ordering (ICC = 0.815, 95% CI 0.561 to 0.984. Seventeen (85% clinicians agreed that the profiles would be usable in clinical training settings. Conclusions: Standardized narrative profiles may aid assessment and self-reflection for student performance within culturally diverse interactions. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

  15. Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

    Science.gov (United States)

    McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

    2017-10-01

    The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

  16. Clinical approach to kidney disease in kidney recipients in Spain.

    Science.gov (United States)

    Campistol, Josep M; Gutiérrez-Dalmau, Alex; Crespo, Josep; Saval, Núria; Grinyó, Josep Maria

    2015-01-01

    In the present study, clinical criteria used by Spanish nephrologists when approaching chronic kidney disease (CKD) in kidney recipients, as well as their level of maintenance and control of renal function, were evaluated. An epidemiological, observational, multicenter, nation-wide, prospective study was carried out, with a 6-month follow-up period. Three hundred and sixty-eight adult patients with stage3 kidney disease after a 24-month or longer post-transplantation follow-up period were included. Visits schedule included a retrospective visit, a baseline visit, an optional mid-term visit, and a final visit at month6. Mean time since kidney transplantation was 8.2±5.4years. Most common pre-transplant cardiovascular risk factors were high blood pressure (80.2%), followed by high cholesterol levels (61.7%). Serum creatinine levels showed a statistically significant decrease from baseline visit to 6-month visit (0.06±0.22; P<.0001), and glomerular filtration rate (GFR) reduction was -1.03±6.14 (P=0.0014). Significant independent prognostic factors for GFR worsening were: higher 24-hour proteinuria (OR=1.001 per mg; P=.020), longer time since transplantation (OR=1.009 per month; P=.017), and lower hemoglobin levels (OR=1.261 per g/dl; P=.038). Donor age also had some negative influence (OR=1.021 per year; P=.106). Biopsies were obtained in only 8% of kidney transplant recipients with stage 3 CKD with an intervention being carried out in 25.4% of cases. Secondary markers and factors resulting in CKD progression, particularly anemia, are still frequently uncontrolled after kidney transplantation. Only about 2% of patients benefit from a therapeutic intervention based on a biopsy. Clinical perception differs from objective measures, which results in an obvious clinical inertia regarding risk factor control in such patients. Copyright © 2015 The Authors. Published by Elsevier España, S.L.U. All rights reserved.

  17. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    Science.gov (United States)

    Biering-Sørensen, Fin; Noonan, Vanessa K.

    2016-01-01

    Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society’s International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities. PMID:27529284

  18. Setting a Minimum Standard of Care in Clinical Trials: Human Rights and Bioethics as Complementary Frameworks.

    Science.gov (United States)

    Marouf, Fatma E; Esplin, Bryn S

    2015-06-11

    For the past few decades, there has been intense debate in bioethics about the standard of care that should be provided in clinical trials conducted in developing countries. Some interpret the Declaration of Helsinki to mean that control groups should receive the best intervention available worldwide, while others interpret this and other international guidelines to mean the best local standard of care. Questions of justice are particularly relevant where limited resources mean that the local standard of care is no care at all. Introducing human rights law into this complex and longstanding debate adds a new and important perspective. Through non-derogable rights, including the core obligations of the right to health, human rights law can help set a minimum standard of care. Copyright 2015 Marouf and Esplin. This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited.

  19. A standardized methodology for the surveillance of antimicrobial prescribing linked to clinical indications in primary care.

    Science.gov (United States)

    Smith, Sue; Hawker, Jeremy I; Smith, Gillian E; Morbey, Roger; Johnson, Alan P; Fleming, Douglas M; Shallcross, Laura; Hayward, Andrew C

    2017-09-11

    A key component of strategies to reduce antimicrobial resistance is better antimicrobial prescribing. The majority of antibiotics are prescribed in primary care. While many existing surveillance systems can monitor trends in the quantities of antibiotics prescribed in this setting, it can be difficult to monitor the quality of prescribing as data on the condition for which prescriptions are issued are often not available. We devised a standardized methodology to facilitate the monitoring of condition-specific antibiotic prescribing in primary care. We used a large computerized general practitioner database to develop a standardized methodology for routine monitoring of antimicrobial prescribing linked to clinical indications in primary care in the UK. Outputs included prescribing rate by syndrome and percentages of consultations with antibiotic prescription, for recommended antibiotic, and of recommended treatment length. The standardized methodology can monitor trends in proportions of common infections for which antibiotics were prescribed, the specific drugs prescribed and duration of treatment. These data can be used to help assess the appropriateness of antibiotic prescribing and to assess the impact of prescribing guidelines. We present a standardized methodology that could be applied to any suitable national or local database and adapted for use in other countries. © Crown copyright 2017.

  20. Operationalizing trance II: clinical application using a psychophenomenological approach.

    Science.gov (United States)

    Pekala, Ronald J

    2002-01-01

    Although many clinicians use the word "trance" to describe the subjective effects associated with being hypnotized, heretofore there has been no means to operationalize that concept. In a prior paper (Pekala & Kumar, 2000) the authors operationalized the notion of trance by using a retrospective, self-report instrument, the Phenomenology of Consciousness Inventory (PCI), to quantify the subjective experience of being hypnotized. Trance was operationalized in terms of: hypnotic depth via a pHGS (predicted Harvard Group Scale) score (derived from regression analysis using subdimensions of the PCI) that gives a quantitative measure of subjective trance depth; and trance typology profiles (derived from cluster and discriminant analyses of the PCI dimensions and subdimensions) that give a qualitative measure of empirically derived clusters of subjective trance experiences. These measures, when used in conjunction with data on the individual PCI dimensions and subdimensions, provide the clinician with specific information on phenomenological events experienced by the client during hypnosis which can be used in better adapting hypnotic suggestions to the client's phenomenological world. Two clinical cases are presented in which use of the above approach has been helpful in facilitating treatment planning.

  1. Hypertensive crisis: an update on clinical approach and management.

    Science.gov (United States)

    Ipek, Emrah; Oktay, Ahmet Afşin; Krim, Selim R

    2017-07-01

    Here, we review current concepts on hypertensive crisis (HTN-C) with a focus on epidemiology, causes, pathophysiology and prognosis. We also offer a practical approach to the management of HTN-C. HTN-C is characterized by a severe and abrupt increase in blood pressure (BP) with impending or progressive acute end-organ damage (EOD). HTN-C can be divided into hypertensive emergency (HTN-E) and hypertensive urgency (HTN-U) based on the presence or absence of acute EOD, respectively. Recent retrospective studies have demonstrated that emergency department (ED) referrals from an outpatient clinic or rapid BP-lowering strategies in the ED do not lead to improved outcomes in patients with HTN-U. HTN-C can be a de-novo manifestation or a complication of essential or secondary HTN. The presence of acute EOD is a major poor prognostic indicator in HTN-C. The main objectives of the management of HTN-C are distinction of HTN-E from HTN-U and appropriate risk stratification, prevention or regression of acute EOD due to severely elevated BP, prevention of recurrence of HTN-C with an effective long-term management plan and avoidance of rapid lowering of BP except in some special circumstances. The majority of patients with asymptomatic HTN-U can be safely managed in the outpatient setting without exposing them to the risks of aggressive BP lowering. However, patients with HTN-E require hospitalization, prompt treatment and close monitoring.

  2. Gummy smile: clinical parameters useful for diagnosis and therapeutical approach.

    Science.gov (United States)

    Monaco, Annalisa; Streni, Oriana; Marci, Maria Chiara; Marzo, Giuseppe; Gatto, Roberto; Giannoni, Mario

    2004-01-01

    In the analysis of the characteristics of a pleasant smile, a gummy smile has negative components, which most affect the esthetics of non-verbal communication. For this purpose a proposed classification based upon etiopathogenetic criteria as useful indications for a therapeutical approach is given. The nature of a high smile line can be: dento-gingival, connected to an abnormal dental eruption, which is revealed by a short clinic crown; muscular, caused by an hyperactivity of the elevator muscle of the upper lip; dento-alveolar (skeletal), due to an excessive protuberance or vertical growth of the jawbone (maxillary); lastly, a mixed nature, in the presence of more than one of the above described factors The diagnosis of gummy smile must be precocious and based, with reference to specific parameters, upon a careful analysis of the etiopathogenetic factors and the degree of seriousness of the alteration. A correct treatment plan must contemplate the possibility of an orthognatodontic, orthopedic and/or surgical therapeutic resolution considering the seriousness and complexity of the gums exposures (high smile line) in connection with the age of the subject.

  3. Current Perspectives on Desmoid Tumors: The Mayo Clinic Approach

    Energy Technology Data Exchange (ETDEWEB)

    Joglekar, Siddharth B. [Musculoskeletal Oncology, Mayo Clinic, Rochester, MN55905 (United States); Rose, Peter S.; Sim, Franklin, E-mail: sim.franklin@mayo.edu [Department of Orthopedics, Mayo Clinic, 200 1st ST SW, Rochester, MN 55905 (United States); Okuno, Scott [Department of Oncology, Mayo Clinic, Rochester, MN55905 (United States); Petersen, Ivy [Department of Radiation Oncology, Mayo Clinic, Rochester, MN55905 (United States)

    2011-08-08

    Desmoid tumors are a rare group of locally aggressive, non malignant tumors of fibroblastic origin that can lead to significant morbidity due to local invasion. Despite advances in the understanding of these tumors, their natural history is incompletely understood and the optimal treatment is still a matter of debate. Local control is the main goal of treatment and there has been a change in philosophy regarding the management of these tumors from aggressive surgical resection to function preservation. A multidisciplinary approach is essential to plan local control with acceptable morbidity. The current Mayo Clinic algorithm for the treatment of these tumors is based on institutional experience and the available evidence in the literature: asymptomatic/non progressive lesions away from vital structures are managed with observation and regular imaging; primary or recurrent desmoid tumors which are symptomatic or progressive or near vital structures are managed with wide surgical resection when wide surgical margins are possible with minimal functional and cosmetic loss. When positive or close surgical margins are likely, surgical resection with adjuvant radiotherapy or definitive radiotherapy is preferred. If likely functional or cosmetic deficit is unacceptable, radiotherapy is the treatment of choice. Unresectable lesions are considered for radiotherapy, chemotherapy or newer modalities however an unresectable lesion associated with a painful, functionless, infected extremity is managed with an amputation.

  4. Standardization and classification of In vitro biofilm formation by clinical isolates of Staphylococcus aureus

    Directory of Open Access Journals (Sweden)

    Ashish Kumar Singh

    2017-01-01

    Full Text Available Background: Staphylococcus aureus is Gram-positive bacterium commonly associated with nosocomial infections. The development of biofilm exhibiting drug resistance especially in foreign body associated infections has enabled the bacterium to draw considerable attention. However, till date, consensus guidelines for in vitro biofilm quantitation and categorization criterion for the bacterial isolates based on biofilm-forming capacity are lacking. Therefore, it was intended to standardize in vitro biofilm formation by clinical isolates of S. aureus and then to classify them on the basis of their biofilm-forming capacity. Materials and Methods: A study was conducted for biofilm quantitation by tissue culture plate (TCP assay employing 61 strains of S. aureus isolated from clinical samples during May 2015– December 2015 wherein several factors influencing the biofilm formation were optimized. Therefore, it was intended to propose a biofilm classification criteria based on the standard deviation multiples of the control differentiating them into non, low, medium, and high biofilm formers. Results: Brain-heart infusion broth was found to be more effective in biofilm formation compared to trypticase soy broth. Heat fixation was more effective than chemical fixation. Although, individually, glucose, sucrose, and sodium chloride (NaCl had no significant effect on biofilm formation, a statistically significant increase in absorbance was observed after using the supplement mix consisting of 222.2 mM glucose, 116.9 mM sucrose, and 1000 mM NaCl (P = 0.037. Conclusions: The present study puts forth a standardized in vitro TCP assay for biofilm biomass quantitation and categorization criteria for clinical isolates of S. aureus based on their biofilm-forming capacity. The proposed in vitro technique may be further evaluated for its usefulness in the management of persistent infections caused by the bacterium.

  5. Process-outcome interrelationship and standard setting in medical education: the need for a comprehensive approach.

    Science.gov (United States)

    Christensen, Leif; Karle, Hans; Nystrup, Jørgen

    2007-09-01

    An outcome-based approach to medical education compared to a process/content orientation is currently being discussed intensively. In this article, the process and outcome interrelationship in medical education is discussed, with specific emphasis on the relation to the definition of standards in basic medical education. Perceptions of outcome have always been an integrated element of curricular planning. The present debate underlines the need for stronger focus on learning objectives and outcome assessment in many medical schools around the world. The need to maintain an integrated approach of process/content and outcome is underlined in this paper. A worry is expressed about the taxonomy of learning in pure outcome-based medical education, in which student assessment can be a major determinant for the learning process, leaving the control of the medical curriculum to medical examiners. Moreover, curricula which favour reductionism by stating everything in terms of instrumental outcomes or competences, do face a risk of lowering quality and do become a prey for political interference. Standards based on outcome alone rise unclarified problems in relationship to licensure requirements of medical doctors. It is argued that the alleged dichotomy between process/content and outcome seems artificial, and that formulation of standards in medical education must follow a comprehensive line in curricular planning.

  6. A systematic approach to the training in the nuclear power industry: The need for standard

    International Nuclear Information System (INIS)

    Wilkinson, J.D.

    1995-01-01

    The five elements of a open-quotes Systematic Approach to Trainingclose quotes (SAT) are analysis, design, development, implementation and evaluation. These elements are also present in the effective application of basic process control. The fundamental negative feedback process control loop is therefore an excellent model for a successful, systematic approach to training in the nuclear power industry. Just as standards are required in today's manufacturing and service industries, eg ISO 9000, so too are control standards needed in the training industry and in particular in the training of nuclear power plant staff. The International Atomic Energy Agency (IAEA) produced its TECDOC 525 on open-quotes Training to Establish and Maintain the Qualification and Competence of Nuclear Power Plant Operations Personnelclose quotes in 1989 and the American Nuclear Society published its open-quotes Selection, Qualification, and Training of Personnel for Nuclear Power Plants, an American National Standardclose quotes in 1993. It is important that community colleges, training vendors and organizations such as the Instrument Society of America (ISA), who may be supplying basic or prerequisite training to the nuclear power industry, become aware of these and other standards relating to training in the nuclear power industry

  7. [Nomenclature and classification of complications. Standard procedure at the Heidelberg University Orthopedic Clinic].

    Science.gov (United States)

    Krämer, K L; Clauss, M

    1999-03-01

    In order to get a better data management of complications in orthopedic surgery and in order to get comparable statistics a standardisation of nomenclature and classification of complications is demanded since 1.1.1997. The Orthopedic University Clinic of Heidelberg started with a register of all early complications of all inpatients. According to a standardized nomenclature all occurred complications the doctors put in the data of complications in a database. These data were controlled, complemented and classified by members of the quality management group. This guideline consists of five parts: catalogue of diagnoses, general and special definitions, classification and an allocation table of diagnoses to grades of severity.

  8. Longitudinal analysis of standardized test scores of students in the Science Writing Heuristic approach

    Science.gov (United States)

    Chanlen, Niphon

    The purpose of this study was to examine the longitudinal impacts of the Science Writing Heuristic (SWH) approach on student science achievement measured by the Iowa Test of Basic Skills (ITBS). A number of studies have reported positive impact of an inquiry-based instruction on student achievement, critical thinking skills, reasoning skills, attitude toward science, etc. So far, studies have focused on exploring how an intervention affects student achievement using teacher/researcher-generated measurement. Only a few studies have attempted to explore the long-term impacts of an intervention on student science achievement measured by standardized tests. The students' science and reading ITBS data was collected from 2000 to 2011 from a school district which had adopted the SWH approach as the main approach in science classrooms since 2002. The data consisted of 12,350 data points from 3,039 students. The multilevel model for change with discontinuity in elevation and slope technique was used to analyze changes in student science achievement growth trajectories prior and after adopting the SWH approach. The results showed that the SWH approach positively impacted students by initially raising science achievement scores. The initial impact was maintained and gradually increased when students were continuously exposed to the SWH approach. Disadvantaged students who were at risk of having low science achievement had bigger benefits from experience with the SWH approach. As a result, existing problematic achievement gaps were narrowed down. Moreover, students who started experience with the SWH approach as early as elementary school seemed to have better science achievement growth compared to students who started experiencing with the SWH approach only in high school. The results found in this study not only confirmed the positive impacts of the SWH approach on student achievement, but also demonstrated additive impacts found when students had longitudinal experiences

  9. Standardization in clinical enzymology: a challenge for the theory of metrological traceability.

    Science.gov (United States)

    Infusino, Ilenia; Schumann, Gerhard; Ceriotti, Ferruccio; Panteghini, Mauro

    2010-03-01

    The goal of standardization for measurement of the catalytic concentration of enzymes is to achieve comparable results in human samples, independent of the reagent kits, instruments, and laboratory where the assay is performed. To pursue this objective, the IFCC has established reference systems for the most important clinical enzymes. These systems are based on the following requirements: a) reference methods, well described and evaluated extensively; b) suitable reference materials; and c) reference laboratories operating in a highly controlled manner. When these reference systems are used appropriately, the diagnostic industry can assign traceable values to commercial calibrators. Clinical laboratories that use procedures with validated calibrators to measure human specimens can now obtain values that are traceable to higher-order reference procedures. These reference systems constitute the structure of the traceability chain to which the routine methods can be linked via an appropriate calibration process, provided that they have a comparable specificity (i.e., they are measuring the same catalytic quantity).

  10. Representation of Functional Status Concepts from Clinical Documents and Social Media Sources by Standard Terminologies.

    Science.gov (United States)

    Kuang, Jinqiu; Mohanty, April F; Rashmi, V H; Weir, Charlene R; Bray, Bruce E; Zeng-Treitler, Qing

    2015-01-01

    Patient-reported functional status is widely recognized as an important patient-centered outcome that adds value to medical care, research, and quality improvement. Functional status outcomes are, however, not routinely or uniformly collected in the medical record, except in certain small patient populations (e.g. geriatrics, nursing home residents). To utilize patient reported functional status for clinical research and practice, we manually collected 2,763 terms from clinical records and social media sites and modeled them on the widely used Short Form-36 Health Survey. We then examined the coverage of the Unified Medical Language System (UMLS) for these functional status terms through automated mapping. Most terms (85.9%) did not have exact matches in the UMLS. The partial matches were prevalent, however, they typically did not capture the terms' exact semantics. Our study suggests that there is a need to extend existing standard terminologies to incorporate functional status terms used by patients and clinicians.

  11. In search of standards to support circularity in product policies: A systematic approach.

    Science.gov (United States)

    Tecchio, Paolo; McAlister, Catriona; Mathieux, Fabrice; Ardente, Fulvio

    2017-12-01

    The aspiration of a circular economy is to shift material flows toward a zero waste and pollution production system. The process of shifting to a circular economy has been initiated by the European Commission in their action plan for the circular economy. The EU Ecodesign Directive is a key policy in this transition. However, to date the focus of access to market requirements on products has primarily been upon energy efficiency. The absence of adequate metrics and standards has been a key barrier to the inclusion of resource efficiency requirements. This paper proposes a framework to boost sustainable engineering and resource use by systematically identifying standardization needs and features. Standards can then support the setting of appropriate material efficiency requirements in EU product policy. Three high-level policy goals concerning material efficiency of products were identified: embodied impact reduction, lifetime extension and residual waste reduction. Through a lifecycle perspective, a matrix of interactions among material efficiency topics (recycled content, re-used content, relevant material content, durability, upgradability, reparability, re-manufacturability, reusability, recyclability, recoverability, relevant material separability) and policy goals was created. The framework was tested on case studies for electronic displays and washing machines. For potential material efficiency requirements, specific standardization needs were identified, such as adequate metrics for performance measurements, reliable and repeatable tests, and calculation procedures. The proposed novel framework aims to provide a method by which to identify key material efficiency considerations within the policy context, and to map out the generic and product-specific standardisation needs to support ecodesign. Via such an approach, many different stakeholders (industry, academics, policy makers, non-governmental organizations etc.) can be involved in material efficiency

  12. A Lifecycle Approach to Brokered Data Management for Hydrologic Modeling Data Using Open Standards.

    Science.gov (United States)

    Blodgett, D. L.; Booth, N.; Kunicki, T.; Walker, J.

    2012-12-01

    The U.S. Geological Survey Center for Integrated Data Analytics has formalized an information management-architecture to facilitate hydrologic modeling and subsequent decision support throughout a project's lifecycle. The architecture is based on open standards and open source software to decrease the adoption barrier and to build on existing, community supported software. The components of this system have been developed and evaluated to support data management activities of the interagency Great Lakes Restoration Initiative, Department of Interior's Climate Science Centers and WaterSmart National Water Census. Much of the research and development of this system has been in cooperation with international interoperability experiments conducted within the Open Geospatial Consortium. Community-developed standards and software, implemented to meet the unique requirements of specific disciplines, are used as a system of interoperable, discipline specific, data types and interfaces. This approach has allowed adoption of existing software that satisfies the majority of system requirements. Four major features of the system include: 1) assistance in model parameter and forcing creation from large enterprise data sources; 2) conversion of model results and calibrated parameters to standard formats, making them available via standard web services; 3) tracking a model's processes, inputs, and outputs as a cohesive metadata record, allowing provenance tracking via reference to web services; and 4) generalized decision support tools which rely on a suite of standard data types and interfaces, rather than particular manually curated model-derived datasets. Recent progress made in data and web service standards related to sensor and/or model derived station time series, dynamic web processing, and metadata management are central to this system's function and will be presented briefly along with a functional overview of the applications that make up the system. As the separate

  13. Pilot workload during approaches: comparison of simulated standard and noise-abatement profiles.

    Science.gov (United States)

    Elmenhorst, Eva-Maria; Vejvoda, Martin; Maass, Hartmut; Wenzel, Jürgen; Plath, Gernot; Schubert, Ekkehart; Basner, Mathias

    2009-04-01

    A new noise-reduced landing approach was tested--a Segmented Continuous Descent Approach (SCDA)-with regard to the resulting workload on pilots. Workload of 40 pilots was measured using physiological (heart rate, blood pressure, blink frequency, saliva cortisol concentration) and psychological (fatigue, sleepiness, tension, and task load) parameters. Approaches were conducted in A320 and A330 full-flight simulators during night shift. SCDA was compared to the standard Low Drag Low Power (LDLP) procedure as reference. Mean heart rate and blood pressure during the SCDA were not elevated, but were partly, even significantly, reduced (on average by 5 bpm and 4 mmHg from the flying captain). Cortisol levels did not change significantly with mean values of 0.9 to 1.2 ng ml(-1). Landing was the most demanding segment of both approaches as indicated by significant increases in heart rate and decreases in blink frequency. Subjective task load was low. Both approach procedures caused a similar workload level. Interpreting the results, methodological limitations have to be considered, e.g., the artificial and controlled airspace situation in the flight simulator. Nevertheless, it can be concluded that under these ideal conditions, the SCDA is operable without a higher workload for pilots compared to the common LDLP.

  14. Implementation of a Standardized Clinical Assessment and Management Plan (SCAMP) for Food Challenges.

    Science.gov (United States)

    Simberloff, Tander; Parambi, Ron; Bartnikas, Lisa M; Broyles, Ana Dioun; Hamel, Victoria; Timmons, Karol G; Miller, D Marlowe; Graham, Dionne A; Schneider, Lynda C; MacGinnitie, Andrew J

    Oral food challenges (OFCs) are routinely used to confirm ongoing food allergy. Serum-specific IgE (sIgE) and skin prick testing (SPT) are imperfect predictors of which patients will pass OFCs. The objective of this study was to describe the design and implementation of a Standardized Clinical Assessment and Management Plan (SCAMP) to study and iteratively improve sIgE and SPT thresholds to determine when and where to conduct OFCs for patients. Allergists consulted recommended sIgE and SPT thresholds when ordering challenges although diversions were permitted. Criteria were iteratively improved after periodic analyses of challenge outcome and diversions. Over 3 years, allergists ordered 2368 food challenges for 1580 patients with histories of IgE-mediated reactions to food: 1386 in an outpatient clinic and 945 in a higher resource infusion center. Reactions to challenge were observed in 13% of clinic and 23% of infusion center challenges. Six patients challenged in clinic required treatment with epinephrine compared with 22 in the infusion center. The need for epinephrine was more common in patients with asthma-5% of asthmatic patients required epinephrine compared with 1% of nonasthmatic patients (P challenges ordered in the higher resource location. By setting and continually refining sIgE and SPT recommendations using the SCAMP method, allergists can better determine the risk of severe reaction and triage patients to the appropriate setting for an OFC. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  15. A New Approach for Heparin Standardization: Combination of Scanning UV Spectroscopy, Nuclear Magnetic Resonance and Principal Component Analysis

    Science.gov (United States)

    Lima, Marcelo A.; Rudd, Timothy R.; de Farias, Eduardo H. C.; Ebner, Lyvia F.; Gesteira, Tarsis F.; de Souza, Lauro M.; Mendes, Aline; Córdula, Carolina R.; Martins, João R. M.; Hoppensteadt, Debra; Fareed, Jawed; Sassaki, Guilherme L.; Yates, Edwin A.; Tersariol, Ivarne L. S.; Nader, Helena B.

    2011-01-01

    The year 2007 was marked by widespread adverse clinical responses to heparin use, leading to a global recall of potentially affected heparin batches in 2008. Several analytical methods have since been developed to detect impurities in heparin preparations; however, many are costly and dependent on instrumentation with only limited accessibility. A method based on a simple UV-scanning assay, combined with principal component analysis (PCA), was developed to detect impurities, such as glycosaminoglycans, other complex polysaccharides and aromatic compounds, in heparin preparations. Results were confirmed by NMR spectroscopy. This approach provides an additional, sensitive tool to determine heparin purity and safety, even when NMR spectroscopy failed, requiring only standard laboratory equipment and computing facilities. PMID:21267460

  16. Systematic Approach to Design Tailor Made Fuel Blends That Meets ASTM Standards

    DEFF Research Database (Denmark)

    Intikhab, S.; Kalakul, Sawitree; H., Choudhury

    2015-01-01

    blends [1]. The main architecture in MINLP has four structures viz., (i) problem definition (ii) property model identification (iii) mixture blend design and (iv) model-based verification. These structures are further subdivided in to sub-problems and a decomposition based solution approach was adopted...... point, vapor pressure, and heat content were determined using analytical instruments according to their respective American Society for Testing and Materials (ASTM) standards. Most of the properties complied well with the industry standards. However, model gasoline had a comparatively low RVP....... On the other hand, model diesel had a significantly higher cloud point and pour point than what is recommended. This deviation will have an impact on the cold flow properties of the fuels. For both fuels, different additives along with their composition have also been determined using the same computational...

  17. Development and implementation of a clinical pathway approach to simulation-based training for foregut surgery.

    Science.gov (United States)

    Miyasaka, Kiyoyuki W; Buchholz, Joseph; LaMarra, Denise; Karakousis, Giorgos C; Aggarwal, Rajesh

    2015-01-01

    Contemporary demands on resident education call for integration of simulation. We designed and implemented a simulation-based curriculum for Post Graduate Year 1 surgery residents to teach technical and nontechnical skills within a clinical pathway approach for a foregut surgery patient, from outpatient visit through surgery and postoperative follow-up. The 3-day curriculum for groups of 6 residents comprises a combination of standardized patient encounters, didactic sessions, and hands-on training. The curriculum is underpinned by a summative simulation "pathway" repeated on days 1 and 3. The "pathway" is a series of simulated preoperative, intraoperative, and postoperative encounters in following up a single patient through a disease process. The resident sees a standardized patient in the clinic presenting with distal gastric cancer and then enters an operating room to perform a gastrojejunostomy on a porcine tissue model. Finally, the resident engages in a simulated postoperative visit. All encounters are rated by faculty members and the residents themselves, using standardized assessment forms endorsed by the American Board of Surgery. A total of 18 first-year residents underwent this curriculum. Faculty ratings of overall operative performance significantly improved following the 3-day module. Ratings of preoperative and postoperative performance were not significantly changed in 3 days. Resident self-ratings significantly improved for all encounters assessed, as did reported confidence in meeting the defined learning objectives. Conventional surgical simulation training focuses on technical skills in isolation. Our novel "pathway" curriculum targets an important gap in training methodologies by placing both technical and nontechnical skills in their clinical context as part of managing a surgical patient. Results indicate consistent improvements in assessments of performance as well as confidence and support its continued usage to educate surgery residents

  18. Performance analysis of air-standard Diesel cycle using an alternative irreversible heat transfer approach

    International Nuclear Information System (INIS)

    Al-Hinti, I.; Akash, B.; Abu-Nada, E.; Al-Sarkhi, A.

    2008-01-01

    This study presents the investigation of air-standard Diesel cycle under irreversible heat transfer conditions. The effects of various engine parameters are presented. An alternative approach is used to evaluate net power output and cycle thermal efficiency from more realistic parameters such as air-fuel ratio, fuel mass flow rate, intake temperature, engine design parameters, etc. It is shown that for a given fuel flow rate, thermal efficiency and maximum power output increase with decreasing air-fuel ratio. Also, for a given air-fuel ratio, the maximum power output increases with increasing fuel rate. However, the effect of the thermal efficiency is limited

  19. Extracting and standardizing medication information in clinical text - the MedEx-UIMA system.

    Science.gov (United States)

    Jiang, Min; Wu, Yonghui; Shah, Anushi; Priyanka, Priyanka; Denny, Joshua C; Xu, Hua

    2014-01-01

    Extraction of medication information embedded in clinical text is important for research using electronic health records (EHRs). However, most of current medication information extraction systems identify drug and signature entities without mapping them to standard representation. In this study, we introduced the open source Java implementation of MedEx, an existing high-performance medication information extraction system, based on the Unstructured Information Management Architecture (UIMA) framework. In addition, we developed new encoding modules in the MedEx-UIMA system, which mapped an extracted drug name/dose/form to both generalized and specific RxNorm concepts and translated drug frequency information to ISO standard. We processed 826 documents by both systems and verified that MedEx-UIMA and MedEx (the Python version) performed similarly by comparing both results. Using two manually annotated test sets that contained 300 drug entries from medication list and 300 drug entries from narrative reports, the MedEx-UIMA system achieved F-measures of 98.5% and 97.5% respectively for encoding drug names to corresponding RxNorm generic drug ingredients, and F-measures of 85.4% and 88.1% respectively for mapping drug names/dose/form to the most specific RxNorm concepts. It also achieved an F-measure of 90.4% for normalizing frequency information to ISO standard. The open source MedEx-UIMA system is freely available online at http://code.google.com/p/medex-uima/.

  20. Comparison of different segmentation approaches without using gold standard. Application to the estimation of the left ventricle ejection fraction from cardiac cine MRI sequences

    Science.gov (United States)

    Lebenberg, Jessica; Buvat, Irène; Garreau, Mireille; Casta, Christopher; Constantinidès, Constantin; Cousty, Jean; Cochet, Alexandre; Jehan-Besson, Stéphanie; Tilmant, Christophe; Lefort, Muriel; Roullot, Elodie; Najman, Laurent; Sarry, Laurent; Clarysse, Patrick; De Cesare, Alain; Lalande, Alain; Frouin, Frédérique

    2011-01-01

    A statistical method is proposed to compare several estimates of a relevant clinical parameter when no gold standard is available. The method is illustrated by considering the left ventricle ejection fraction derived from cardiac magnetic resonance images and computed using seven approaches with different degrees of automation. The proposed method did not use any a priori regarding with the reliability of each method and its degree of automation. The results showed that the most accurate estimates of the ejection fraction were obtained using manual segmentations, followed by the semi-automatic methods, while the methods with the least user input yielded the least accurate ejection fraction estimates. These results were consistent with the expected performance of the estimation methods, suggesting that the proposed statistical approach might be helpful to assess the performance of estimation methods on clinical data for which no gold standard is available. PMID:22254889

  1. National Mesothelioma Virtual Bank: a standard based biospecimen and clinical data resource to enhance translational research.

    Science.gov (United States)

    Amin, Waqas; Parwani, Anil V; Schmandt, Linda; Mohanty, Sambit K; Farhat, Ghada; Pople, Andrew K; Winters, Sharon B; Whelan, Nancy B; Schneider, Althea M; Milnes, John T; Valdivieso, Federico A; Feldman, Michael; Pass, Harvey I; Dhir, Rajiv; Melamed, Jonathan; Becich, Michael J

    2008-08-13

    Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. The National Mesothelioma Virtual Bank architecture is based on three major components: (a) common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards), (b) clinical and epidemiologic data annotation, and (c) data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid (caBIG, see http://cabig.nci.nih.gov). This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational research. Furthermore, it protects patient privacy by disclosing only

  2. National Mesothelioma Virtual Bank: A standard based biospecimen and clinical data resource to enhance translational research

    Directory of Open Access Journals (Sweden)

    Valdivieso Federico A

    2008-08-01

    Full Text Available Abstract Background Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. Methods The National Mesothelioma Virtual Bank architecture is based on three major components: (a common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards, (b clinical and epidemiologic data annotation, and (c data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid™ (caBIG™, see http://cabig.nci.nih.gov. This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. Result The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. Conclusion The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational

  3. Revisiting photodynamic therapy dosimetry: reductionist & surrogate approaches to facilitate clinical success

    Science.gov (United States)

    Pogue, Brian W.; Elliott, Jonathan T.; Kanick, Stephen C.; Davis, Scott C.; Samkoe, Kimberley S.; Maytin, Edward V.; Pereira, Stephen P.; Hasan, Tayyaba

    2016-04-01

    Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

  4. Revisiting photodynamic therapy dosimetry: reductionist and surrogate approaches to facilitate clinical success

    International Nuclear Information System (INIS)

    Pogue, Brian W; Elliott, Jonathan T; Kanick, Stephen C; Davis, Scott C; Samkoe, Kimberley S; Maytin, Edward V; Pereira, Stephen P; Hasan, Tayyaba

    2016-01-01

    Photodynamic therapy (PDT) can be a highly complex treatment, with many parameters influencing treatment efficacy. The extent to which dosimetry is used to monitor and standardize treatment delivery varies widely, ranging from measurement of a single surrogate marker to comprehensive approaches that aim to measure or estimate as many relevant parameters as possible. Today, most clinical PDT treatments are still administered with little more than application of a prescribed drug dose and timed light delivery, and thus the role of patient-specific dosimetry has not reached widespread clinical adoption. This disconnect is at least partly due to the inherent conflict between the need to measure and understand multiple parameters in vivo in order to optimize treatment, and the need for expedience in the clinic and in the regulatory and commercialization process. Thus, a methodical approach to selecting primary dosimetry metrics is required at each stage of translation of a treatment procedure, moving from complex measurements to understand PDT mechanisms in pre-clinical and early phase I trials, towards the identification and application of essential dose-limiting and/or surrogate measurements in phase II/III trials. If successful, identifying the essential and/or reliable surrogate dosimetry measurements should help facilitate increased adoption of clinical PDT. In this paper, examples of essential dosimetry points and surrogate dosimetry tools that may be implemented in phase II/III trials are discussed. For example, the treatment efficacy as limited by light penetration in interstitial PDT may be predicted by the amount of contrast uptake in CT, and so this could be utilized as a surrogate dosimetry measurement to prescribe light doses based upon pre-treatment contrast. Success of clinical ALA-based skin lesion treatment is predicted almost uniquely by the explicit or implicit measurements of photosensitizer and photobleaching, yet the individualization of treatment

  5. Influenza and other respiratory viruses: standardizing disease severity in surveillance and clinical trials.

    Science.gov (United States)

    Rath, Barbara; Conrad, Tim; Myles, Puja; Alchikh, Maren; Ma, Xiaolin; Hoppe, Christian; Tief, Franziska; Chen, Xi; Obermeier, Patrick; Kisler, Bron; Schweiger, Brunhilde

    2017-06-01

    Influenza-Like Illness is a leading cause of hospitalization in children. Disease burden due to influenza and other respiratory viral infections is reported on a population level, but clinical scores measuring individual changes in disease severity are urgently needed. Areas covered: We present a composite clinical score allowing individual patient data analyses of disease severity based on systematic literature review and WHO-criteria for uncomplicated and complicated disease. The 22-item ViVI Disease Severity Score showed a normal distribution in a pediatric cohort of 6073 children aged 0-18 years (mean age 3.13; S.D. 3.89; range: 0 to 18.79). Expert commentary: The ViVI Score was correlated with risk of antibiotic use as well as need for hospitalization and intensive care. The ViVI Score was used to track children with influenza, respiratory syncytial virus, human metapneumovirus, human rhinovirus, and adenovirus infections and is fully compliant with regulatory data standards. The ViVI Disease Severity Score mobile application allows physicians to measure disease severity at the point-of care thereby taking clinical trials to the next level.

  6. Practical Approach for the Clinical Use of Dopamine Transporter Imaging

    International Nuclear Information System (INIS)

    Kim, Jae Seung

    2008-01-01

    Dopamine transporter imaging is useful in the diagnosis of Parkinson's disease and the most successful technique in the clinical use of neuroreceptor imaging. Recently, several radiopharmaceuticals including I-123 FP-CIT, Tc-99m TRODAT, and F-18 FP-CIT for dopamine transporter imaging have been approved for the routine clinical use in several European countries, Taiwan and Korea, respectively. This review summarized the practical issue for the routine clinical examination of dopamine transporter imaging

  7. National Cancer Institute Biospecimen Evidence-Based Practices: a novel approach to pre-analytical standardization.

    Science.gov (United States)

    Engel, Kelly B; Vaught, Jim; Moore, Helen M

    2014-04-01

    Variable biospecimen collection, processing, and storage practices may introduce variability in biospecimen quality and analytical results. This risk can be minimized within a facility through the use of standardized procedures; however, analysis of biospecimens from different facilities may be confounded by differences in procedures and inferred biospecimen quality. Thus, a global approach to standardization of biospecimen handling procedures and their validation is needed. Here we present the first in a series of procedural guidelines that were developed and annotated with published findings in the field of human biospecimen science. The series of documents will be known as NCI Biospecimen Evidence-Based Practices, or BEBPs. Pertinent literature was identified via the National Cancer Institute (NCI) Biospecimen Research Database ( brd.nci.nih.gov ) and findings were organized by specific biospecimen pre-analytical factors and analytes of interest (DNA, RNA, protein, morphology). Meta-analysis results were presented as annotated summaries, which highlight concordant and discordant findings and the threshold and magnitude of effects when applicable. The detailed and adaptable format of the document is intended to support the development and execution of evidence-based standard operating procedures (SOPs) for human biospecimen collection, processing, and storage operations.

  8. Time transfer capability of standard small form factor pluggable laser modules based on photon counting approach

    Science.gov (United States)

    Trojanek, Pavel; Prochazka, Ivan; Blazej, Josef

    2017-05-01

    We are reporting on timing parameters of commonly used standard Small Form Factor Pluggable (SFP) laser modules using single photon counting method. Photon counting is a promising approach for laser time transfer via optical fiber communication hardware. The sub-picosecond precision and stability may be achieved. We have performed several experiments with the aim to measure main parameters of the modules, such as time delay precision, time stability and temperature stability, all being critical for optical time transfer applications. Two standard 16 and 10 Gbit/s at 850 nm SFP modules were examined. The ultimate precision of possible time transfer of 800 fs for averaging times of hours was achieved. The modules together with their driving circuits exhibited very good temperature stability. The temperature drift as low as 300+/-200 fs/K was measured. The achieved timing parameters will enable to use the standard SFP modules for a new method of two way time transfer where the time differences between two distant time scales are measured in parallel to data transfer on existing optical data links without any communication interference.

  9. Formalizalization of clinical trial eligibility criteria: Evaluation of a pattern-based approach

    NARCIS (Netherlands)

    Milian, K.; Bucur, A.; ten Teije, A.C.M.; Gao, J.; Alhaij, R.; Dubitzky, W.; Ungar, L.; Wu, C.; Christianson, A,; Liebman, M.; Hu, X.

    2012-01-01

    The semi-automatic evaluation of eligibility criteria can facilitate the recruitment for clinical trials, timely completion of studies and generation of clinical evidence about new approaches to treatment, prevention and diagnosis. Because eligibility criteria are represented as free text,

  10. Clinical evaluation of guidelines and two-test approach for lyme disease

    NARCIS (Netherlands)

    Blaauw, A. A.; van Loon, A. M.; Schellekens, J. F.; Bijlsma, J. W.

    1999-01-01

    The diagnosis of Lyme disease should be based on objective clinical signs and symptoms. In a clinical study, we have evaluated whether the recommended two-step approach for serodiagnosis of Lyme disease is useful in daily clinical practice and can influence clinical decision making. The signs and

  11. Standardized Approaches to Syncope Evaluation for Reducing Hospital Admissions and Costs in Overcrowded Emergency Departments

    Science.gov (United States)

    Shin, Tae Gun; Jo, Ik Joon; Sim, Min Seob; Park, Seung-Jung

    2013-01-01

    Purpose The evaluation of syncope is often disorganized and ineffective. The objective of this study was to examine whether implementation of a standardized emergency department (ED) protocol improves the quality of syncope evaluation. Materials and Methods This study was a prospective, non-randomized study conducted at a 1900-bed, tertiary teaching hospital in South Korea. We compared two specific periods, including a 12-month observation period (control group, January-December 2009) and a 10-month intervention period after the implementation of standardized approaches, comprising risk stratification, hospital order sets and establishment of a syncope observational unit (intervention group, March-December 2010). Primary end points were hospital admission rates and medical costs related to syncope evaluation. Results A total of 244 patients were enrolled in this study (116 patients in the control group and 128 patients in the intervention group). The admission rate decreased by 8.3% in the intervention group (adjusted odds ratio 0.31, 95% confidence interval 0.13-0.70, p=0.005). There was a cost reduction of about 30% during the intervention period [369000 Korean won (KRW), interquartile range (IQR) 240000-602000 KRW], compared with the control period (542000 KRW, IQR 316000-1185000 KRW). The length of stay in the ED was also reduced in the intervention group (median: 4.6 hours vs. 3.4 hours). Conclusion Standardized approaches to syncope evaluation reduced hospital admissions, medical costs and length of stay in the overcrowded emergency department of a tertiary teaching hospital in South Korea. PMID:23918559

  12. Clinical evaluation of three caries removal approaches in primary teeth

    DEFF Research Database (Denmark)

    Phonghanyudh, A; Phantumvanit, P; Songpaisan, Y

    2012-01-01

    To evaluate the clinical performance and radiographic outcome of glass ionomer cement (GIC) restoration in primary molars using three caries removal techniques.......To evaluate the clinical performance and radiographic outcome of glass ionomer cement (GIC) restoration in primary molars using three caries removal techniques....

  13. Zellweger spectrum disorders: clinical overview and management approach

    NARCIS (Netherlands)

    Klouwer, Femke C. C.; Berendse, Kevin; Ferdinandusse, Sacha; Wanders, Ronald J. A.; Engelen, Marc; Poll-The, Bwee Tien

    2015-01-01

    Zellweger spectrum disorders (ZSDs) represent the major subgroup within the peroxisomal biogenesis disorders caused by defects in PEX genes. The Zellweger spectrum is a clinical and biochemical continuum which can roughly be divided into three clinical phenotypes. Patients can present in the

  14. Childhood obesity treatment and prevention. Psychological perspectives of clinical approaches

    OpenAIRE

    Maria Catena Quattropani; Teresa Buccheri

    2013-01-01

    Objective: This work focuses on clinical psychologist’ presence within childhood obesity prevention programmes in several countries. Method: The Authors collected articles considering psychological, biological and social aspects linked to childhood obesity. Results: Studies reveal that childhood obesity prevention programmes are based on biological, medical and educational aspects; clinical psychologists up until now have been engaged almost exclusively in the treatment of obesity. Conclusion...

  15. Parkinsonism and tremor disorders: A clinical approach | Benamer ...

    African Journals Online (AJOL)

    Differentiation of idiopathic Parkinson's disease from other causes of Parkinsonism, such as Multiple System Atrophy, Progressive Supranuclar Palsy and Vascular Parkinsonism can be difficult. Clinicopathological studies suggest that the clinical diagnosis of idiopathic Parkinson's disease is 76% reliable. Also, clinical ...

  16. Clinical approach to kidney disease in kidney recipients in Spain

    Directory of Open Access Journals (Sweden)

    Josep M. Campistol

    2015-05-01

    Conclusions: Secondary markers and factors resulting in CKD progression, particularly anemia, are still frequently uncontrolled after kidney transplantation. Only about 2% of patients benefit from a therapeutic intervention based on a biopsy. Clinical perception differs from objective measures, which results in an obvious clinical inertia regarding risk factor control in such patients.

  17. Novel femoral artery terminology: integrating anatomy and clinical procedures leading to standardized intuitive nomenclature.

    Science.gov (United States)

    Benninger, Brion

    2014-10-01

    The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower

  18. Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

    Science.gov (United States)

    Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

    2002-01-01

    For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified

  19. Elevated mortality amongst weekend hospital admissions is not associated with adoption of seven-day clinical standards

    OpenAIRE

    Meacock, Rachel; Sutton, Matt

    2017-01-01

    IntroductionPatients admitted to hospital in an emergency at weekends have been found to experience higher mortality rates than those admitted during the week. The NHS in England has introduced four priority clinical standards for emergency hospital care with the objective of reducing the deaths associated with this ‘weekend effect’. This study aimed to determine whether adoption of these clinical standards is associated with the extent to which weekend mortality is elevated. MethodsWe utilis...

  20. Clinically significant cardiopulmonary events and the effect of definition standardization on apnea of prematurity management.

    Science.gov (United States)

    Powell, M B F; Ahlers-Schmidt, C R; Engel, M; Bloom, B T

    2017-01-01

    To define the impact of care standardization on caffeine and cardiorespiratory monitoring at neonatal intensive care unit (NICU) discharge. Electronic records were abstracted for infants aged 24-36 weeks gestation with birth weights appropriate for gestational age. Infants who died, transferred prior to discharge, had major pulmonary anomalies, required a home monitor for mechanical ventilation or had a family history of sudden infant death syndrome were excluded. Data and records were used to indicate when the new definition of clinically significant cardiopulmonary events (CSCPEs) and concurrent education was implemented. Preimplementation and postimplementation cohorts were compared. Incidence fell from 74% diagnosed with apnea of prematurity at baseline to 49% diagnosed with CSCPE postimplementation (Pdefinitions and treatments reduced the use of caffeine and cardiorespiratory monitors upon NICU dismissal.

  1. European AIDS Clinical Society Standard of Care meeting on HIV and related coinfections

    DEFF Research Database (Denmark)

    Mussini, C; Antinori, A; Bhagani, S

    2016-01-01

    OBJECTIVES: The objective of the 1st European AIDS Clinical Society meeting on Standard of Care in Europe was to raise awareness of the European scenario and come to an agreement on actions that could be taken in the future. METHODS: Data-driven presentations were given on specific topics followed...... by interactive panel discussions. RESULTS: In Eastern European countries, the epidemic is largely driven by injecting drug use, in contrast with Western Europe where the infection mainly occurs through heterosexual contact. A high proportion of people living with HIV remain unaware of their infection...... diagnosed multi-drug-resistant cases. Hepatitis C is widespread in selected geographical areas and risk groups. CONCLUSIONS: The key conclusion from the meeting was that a high-priority group of actions could be identified, including: increasing HIV awareness and testing, improving training for health care...

  2. Inconsistent detection of changes in cerebral blood volume by near infrared spectroscopy in standard clinical tests.

    Science.gov (United States)

    Canova, D; Roatta, S; Bosone, D; Micieli, G

    2011-06-01

    The attractive possibility of near infrared spectroscopy (NIRS) to noninvasively assess cerebral blood volume and oxygenation is challenged by the possible interference from extracranial tissues. However, to what extent this may affect cerebral NIRS monitoring during standard clinical tests is ignored. To address this issue, 29 healthy subjects underwent a randomized sequence of three maneuvers that differently affect intra- and extracranial circulation: Valsalva maneuver (VM), hyperventilation (HV), and head-up tilt (HUT). Putative intracranial ("i") and extracranial ("e") NIRS signals were collected from the forehead and from the cheek, respectively, and acquired together with cutaneous plethysmography at the forehead (PPG), cerebral blood velocity from the middle cerebral artery, and arterial blood pressure. Extracranial contribution to cerebral NIRS monitoring was investigated by comparing Beer-Lambert (BL) and spatially resolved spectroscopy (SRS) blood volume indicators [the total hemoglobin concentration (tHb) and the total hemoglobin index, (THI)] and by correlating their changes with changes in extracranial circulation. While THIe and tHbe generally provided concordant indications, tHbi and THIi exhibited opposite-sign changes in a high percentage of cases (VM: 46%; HV: 31%; HUT: 40%). Moreover, tHbi was correlated with THIi only during HV (P < 0.05), not during VM and HUT, while it correlated with PPG in all three maneuvers (P < 0.01). These results evidence that extracranial circulation may markedly affect BL parameters in a high percentage of cases, even during standard clinical tests. Surface plethysmography at the forehead is suggested as complementary monitoring helpful in the interpretation of cerebral NIRS parameters.

  3. Cervicogenic headache: pathogenesis, clinical features, diagnosis, therapeutic approaches

    Directory of Open Access Journals (Sweden)

    M V Putilina

    2011-01-01

    Full Text Available The concept of cervicogenic headache (CGH comprises the types of headaches having different origins, which are associated with pathology in the cervical spine and its other structural areas. CGH is induced by diverse pathogenetic mechanisms and has different clinical manifestations so it is referred to different classification categories. The anatomic and pathophysiological causes of CGH, its clinical picture, and therapeutic principles are discussed. In clinical practice, more and more preference has been recently given to combined analgesics, ketorolac and nimesulide in particular.

  4. Study of the behavior of radiation detectors for mammography in standard beams using a clinical system

    International Nuclear Information System (INIS)

    Barreira, Jacqueline Sales

    2014-01-01

    A mammogram is the x-ray of the breast that allows early detection of cancer, by being able to show lesions in very small early stage. But to get an early and reliable diagnosis is necessary that the mammography unit is calibrated and working properly, otherwise there may be a loss in image produced, may lead to a false diagnosis, and possible harm to the patient. So it is important to control these devices, especially in relation to the radiation produced by them. In this project, we propose a study of the behavior of ionization chambers for mammography calibrated beam patterns in a clinical system (Philips-VMI mammography, Graph Mammo AF, which operates a range of 20 to 35 kV) from Instruments Calibration Laboratory at IPEN-CNEN/SP, with the aim of determining parameters correction approaching conditions calibration conditions for clinical use. Measurements of the parameters of the beams set in mammography using simulators acrylic specially developed for these measurements were performed in order to establish a new protocol for calibration of the ionization chambers in a clinical system rather than the industrial system, or as a complement to this. (author)

  5. 2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy.

    Science.gov (United States)

    Neuss, Michael N; Polovich, Martha; McNiff, Kristen; Esper, Peg; Gilmore, Terry R; LeFebvre, Kristine B; Schulmeister, Lisa; Jacobson, Joseph O

    2013-05-01

    In 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards.

  6. Antimicrobial Potential of Momordica charantia L. against Multiresistant Standard Species and Clinical Isolates.

    Science.gov (United States)

    Lucena Filho, José Hardman Sátiro de; Lima, Rennaly de Freitas; Medeiros, Ana Claudia Dantas de; Pereira, Jozinete Vieira; Granville-Garcia, Ana Flávia; Costa, Edja Maria Melo de Brito

    2015-11-01

    The aim of the present study was to evaluate the antibacterial and antifungal potential in vitro of Momordica charantia L. against the microorganisms of clinical interest (standard strains and multiresistant isolates) in order to aggregate scientific information in relation to its use as a therapeutic product. M. charantia L. plant material was acquired in municipality of Malta, Paraiba, Brazil. The extract was obtained through maceration, filtration and then concentrated under reduced pressure in a rotary evaporator, resulting in a dough, and was then dried in an oven for 72 hours at 40°C. Antimicrobial action of ethanolic extract of seed M. charantia L. was evaluated based on the minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC) and minimum fungicidal concentration (MFC) against standard strains of bacteria, isolates multiresistant bacteria and Candida species, by microdilution in broth method. All organisms were sensitive to the extract, being considered strong antimicrobial activity (MIC and MBC/MFC charantia L. showed strong antimicrobial potential, with bactericidal and fungicidal profile, there is the prospect to constitute a new therapeutic strategy for the control of infections, particularly in multiresistant strains. The use of medicinal plants in treatment of infectious processes have an important function nowadays, due to the limitations of the use of synthetic antibiotics available, related specifically to the microbial resistance emergence.

  7. Comparison study of judged clinical skills competence from standard setting ratings generated under different administration conditions.

    Science.gov (United States)

    Roberts, William L; Boulet, John; Sandella, Jeanne

    2017-12-01

    When the safety of the public is at stake, it is particularly relevant for licensing and credentialing exam agencies to use defensible standard setting methods to categorize candidates into competence categories (e.g., pass/fail). The aim of this study was to gather evidence to support change to the Comprehensive Osteopathic Medical Licensing-USA Level 2-Performance Evaluation standard setting design and administrative process. Twenty-two video recordings of candidates assessed for clinical competence were randomly selected from the 2014-2015 Humanistic domain test score distribution ranging from the highest to lowest quintile of performance. Nineteen panelists convened at the same site to receive training and practice prior to generating judgments of qualified or not qualified performance to each of the twenty videos. At the end of training, one panel remained onsite to complete their judgments and the second panel was released and given 1 week to observe the same twenty videos and complete their judgments offsite. The two one-sided test procedure established equivalence between panel group means at the 0.05 confidence level, controlling for rater errors within each panel group. From a practical cost-effective and administrative resource perspective, results from this study suggest it is possible to diverge from typical panel groups, who are sequestered the entire time onsite, to larger numbers of panelists who can make their judgments offsite with little impact on judged samples of qualified performance. Standard setting designs having panelists train together and then allowing those to provide judgments yields equivalent ratings and, ultimately, similar cut scores.

  8. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  9. Comparative analysis of photograph-based clinical goniometry to standard techniques.

    Science.gov (United States)

    Crasto, Jared A; Sayari, Arash J; Gray, Robert R-L; Askari, Morad

    2015-06-01

    Assessment of joint range of motion (ROM) is an accepted evaluation of disability as well as an indicator of recovery from musculoskeletal injuries. Many goniometric techniques have been described to measure ROM, with variable validity due to inter-rater reliability. In this report, we assessed the validity of photograph-based goniometry in measurement of ROM and its inter-rater reliability and compared it to two other commonly used techniques. We examined three methods for measuring ROM in the upper extremity: manual goniometry (MG), visual estimations (VE), and photograph-based goniometry (PBG). Eight motions of the upper extremity were measured in 69 participants at an academic medical center. We found visual estimations and photograph-based goniometry to be clinically valid when tested against manual goniometry (r avg. 0.58, range 0.28 to 0.87). Photograph-based measurements afforded a satisfactory degree of inter-rater reliability (ICC avg. 0.77, range 0.28 to 0.96). Our study supports photograph-based goniometry as the new standard goniometric technique, as it has been clinically validated, is performed with greater consistency and better inter-rater reliability when compared with manual goniometry. It also allows for better documentation of measurements and potential incorporation into medical records in direct contrast to visual estimation.

  10. Resource reduction in pediatric chest pain: Standardized clinical assessment and management plan.

    Science.gov (United States)

    Saleeb, Susan F; McLaughlin, Sarah R; Graham, Dionne A; Friedman, Kevin G; Fulton, David R

    2018-01-01

    Using a Standardized Clinical Assessment and Management Plan (SCAMP) for pediatric patients presenting to clinic with chest pain, we evaluated the cost impact associated with implementation of the care algorithm. Prior to introduction of the SCAMP, we analyzed charges for 406 patients with chest pain, seen in 2009, and predicted 21% reduction of overall charges had the SCAMP methodology been used. The SCAMP recommended an echocardiogram for history, examination, or ECG findings suggestive of a cardiac etiology for chest pain. Resource utilization was reviewed for 1517 patients (7-21 years) enrolled in the SCAMP from July 2010 to April 2014. Compared to the 2009 historic cohort, patients evaluated by the SCAMP had higher rates of exertional chest pain (45% vs 37%) and positive family history (5% vs 1%). The SCAMP cohort had fewer abnormal physical examination findings (1% vs 6%) and abnormal electrocardiograms (3% vs 5%). Echocardiogram use increased in the SCAMP cohort compared to the 2009 historic cohort (45% vs 41%), whereas all other ancillary testing was reduced: exercise stress testing (4% SCAMP vs 28% historic), Holter (4% vs 7%), event monitors (3% vs 10%), and MRI (1% vs 2%). Total charges were reduced by 22% ($822 625) by use of the Chest Pain SCAMP, despite a higher percentage of patients for whom echocardiogram was recommended compared to the historic cohort. The Chest Pain SCAMP effectively streamlines cardiac testing and reduces resource utilization. Further reductions can be made by algorithm refinement regarding echocardiograms for exertional symptoms. © 2017 Wiley Periodicals, Inc.

  11. Using standardized patients versus video cases for representing clinical problems in problem-based learning

    Directory of Open Access Journals (Sweden)

    Bo Young Yoon

    2016-06-01

    Full Text Available Purpose: The quality of problem representation is critical for developing students’ problem-solving abilities in problem-based learning (PBL. This study investigates preclinical students’ experience with standardized patients (SPs as a problem representation method compared to using video cases in PBL. Methods: A cohort of 99 second-year preclinical students from Inje University College of Medicine (IUCM responded to a Likert scale questionnaire on their learning experiences after they had experienced both video cases and SPs in PBL. The questionnaire consisted of 14 items with eight subcategories: problem identification, hypothesis generation, motivation, collaborative learning, reflective thinking, authenticity, patient-doctor communication, and attitude toward patients. Results: The results reveal that using SPs led to the preclinical students having significantly positive experiences in boosting patient-doctor communication skills; the perceived authenticity of their clinical situations; development of proper attitudes toward patients; and motivation, reflective thinking, and collaborative learning when compared to using video cases. The SPs also provided more challenges than the video cases during problem identification and hypotheses generation. Conclusion: SPs are more effective than video cases in delivering higher levels of authenticity in clinical problems for PBL. The interaction with SPs engages preclinical students in deeper thinking and discussion; growth of communication skills; development of proper attitudes toward patients; and motivation. Considering the higher cost of SPs compared with video cases, SPs could be used most advantageously during the preclinical period in the IUCM curriculum.

  12. Using standardized patients versus video cases for representing clinical problems in problem-based learning.

    Science.gov (United States)

    Yoon, Bo Young; Choi, Ikseon; Choi, Seokjin; Kim, Tae-Hee; Roh, Hyerin; Rhee, Byoung Doo; Lee, Jong-Tae

    2016-06-01

    The quality of problem representation is critical for developing students' problem-solving abilities in problem-based learning (PBL). This study investigates preclinical students' experience with standardized patients (SPs) as a problem representation method compared to using video cases in PBL. A cohort of 99 second-year preclinical students from Inje University College of Medicine (IUCM) responded to a Likert scale questionnaire on their learning experiences after they had experienced both video cases and SPs in PBL. The questionnaire consisted of 14 items with eight subcategories: problem identification, hypothesis generation, motivation, collaborative learning, reflective thinking, authenticity, patient-doctor communication, and attitude toward patients. The results reveal that using SPs led to the preclinical students having significantly positive experiences in boosting patient-doctor communication skills; the perceived authenticity of their clinical situations; development of proper attitudes toward patients; and motivation, reflective thinking, and collaborative learning when compared to using video cases. The SPs also provided more challenges than the video cases during problem identification and hypotheses generation. SPs are more effective than video cases in delivering higher levels of authenticity in clinical problems for PBL. The interaction with SPs engages preclinical students in deeper thinking and discussion; growth of communication skills; development of proper attitudes toward patients; and motivation. Considering the higher cost of SPs compared with video cases, SPs could be used most advantageously during the preclinical period in the IUCM curriculum.

  13. Clinical standardized fMRI reveals altered language lateralization in patients with brain tumor.

    Science.gov (United States)

    Partovi, S; Jacobi, B; Rapps, N; Zipp, L; Karimi, S; Rengier, F; Lyo, J K; Stippich, C

    2012-12-01

    Brain tumors affecting language-relevant areas may influence language lateralization. The purpose of this study was to systematically investigate language lateralization in brain tumor patients using clinical language fMRI, comparing the results with a group of healthy volunteers. Fifty-seven strictly right-handed patients with left-hemispheric-space intracranial masses (mainly neoplastic) affecting either the Broca area (n = 19) or Wernicke area (n = 38) were prospectively enrolled in this study. Fourteen healthy volunteers served as a control group. Standardized clinical language fMRI, using visually triggered sentence- and word-generation paradigms, was performed on a 1.5T MR scanner. Semiautomated analyses of all functional data were conducted on an individual basis using BrainVoyager. A regional lateralization index was calculated for Broca and Wernicke areas separately versus their corresponding right-hemisphere homologs. In masses affecting the Broca area, a significant decrease in the lateralization index was found when performing word generation (P = .0017), whereas when applying sentence generation, the decrease did not reach statistical significance (P = .851). Masses affecting the Wernicke area induced a significant decrease of the lateralization index when performing sentence generation (P = .0007), whereas when applying word generation, the decrease was not statistically significant (P = .310). Clinical language fMRI was feasible for patients with brain tumors and provided relevant presurgical information by localizing essential language areas and determining language dominance. A significant effect of the brain masses on language lateralization was observed, with a shift toward the contralesional, nondominant hemisphere. This may reflect compensatory mechanisms of the brain to maintain communicative abilities.

  14. Adjunctive nutraceuticals with standard pharmacotherapies in bipolar disorder: a systematic review of clinical trials.

    Science.gov (United States)

    Sarris, Jerome; Mischoulon, David; Schweitzer, Isaac

    2011-01-01

      Studies using augmentation of pharmacotherapies with nutraceuticals in bipolar disorder (BD) have been conducted and preliminary evidence in many cases appears positive. To date, however, no specialized systematic review of this area has been conducted. We present the first systematic review of clinical trials using nutrient-based nutraceuticals in combination with standard pharmacotherapies to treat BD. A subsequent aim of this report was to discuss posited underlying mechanisms of action.   PubMed, CINAHL, Web of Science, and Cochrane Library databases, and grey literature were searched during mid-2010 for human clinical trials in English using nutraceuticals such as omega-3, N-acetyl cysteine (NAC), inositol, and vitamins and minerals, in combination with pharmacotherapies to treat bipolar mania and bipolar depression. A review of the results including an effect size analysis (Cohen's d) was subsequently conducted.   In treating bipolar depression, positive evidence with large effect sizes were found for NAC (d=1.04) and a chelated mineral and vitamin formula (d=1.70). On the outcome of bipolar mania, several nutraceuticals reduced mania with strong clinical effects: a chelated mineral formula (d=0.83), L-tryptophan (d=1.47), magnesium (d=1.44), folic acid (d=0.40), and branched-chain amino acids (d=1.60). Mixed, but mainly positive, evidence was found for omega-3 for bipolar depression, while no evidentiary support was found for use in mania. No significant effect on BD outcome scales was found for inositol (possibly due to small samples).   BD treatment outcomes may potentially be improved by additional use of certain nutraceuticals with conventional pharmacotherapies. However, caution should be extended in interpreting the large effects of several isolated studies, as they have not yet been replicated in larger trials. © 2011 John Wiley and Sons A/S.

  15. Comparison of anthropometry with photogrammetry based on a standardized clinical photographic technique using a cephalostat and chair.

    Science.gov (United States)

    Han, Kihwan; Kwon, Hyuk Joon; Choi, Tae Hyun; Kim, Jun Hyung; Son, Daegu

    2010-03-01

    The aim of this study was to standardize clinical photogrammetric techniques, and to compare anthropometry with photogrammetry. To standardize clinical photography, we have developed a photographic cephalostat and chair. We investigated the repeatability of the standardized clinical photogrammetric technique. Then, with 40 landmarks, a total of 96 anthropometric measurement items was obtained from 100 Koreans. Ninety six photogrammetric measurements from the same subjects were also obtained from standardized clinical photographs using Adobe Photoshop version 7.0 (Adobe Systems Corporation, San Jose, CA, USA). The photogrammetric and anthropometric measurement data (mm, degree) were then compared. A coefficient was obtained by dividing the anthropometric measurements by the photogrammetric measurements. The repeatability of the standardized photography was statistically significantly high (p=0.463). Among the 96 measurement items, 44 items were reliable; for these items the photogrammetric measurements were not different to the anthropometric measurements. The remaining 52 items must be classified as unreliable. By developing a photographic cephalostat and chair, we have standardized clinical photogrammetric techniques. The reliable set of measurement items can be used as anthropometric measurements. For unreliable measurement items, applying a suitable coefficient to the photogrammetric measurement allows the anthropometric measurement to be obtained indirectly.

  16. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Safety Standards

    OpenAIRE

    Gullatte, Mary

    2013-01-01

    Oncology nurses have used chemotherapy standards to develop educational materials and guidelines for standardization and safety and anticipate future opportunities to partner in translating evidence into practice.

  17. Nutritional interventions for Alzheimer's prevention: a clinical precision medicine approach.

    Science.gov (United States)

    Schelke, Matthew W; Hackett, Katherine; Chen, Jaclyn L; Shih, Chiashin; Shum, Jessica; Montgomery, Mary E; Chiang, Gloria C; Berkowitz, Cara; Seifan, Alon; Krikorian, Robert; Isaacson, Richard Scott

    2016-03-01

    Alzheimer's disease (AD) is a major source of morbidity and mortality, with the disease burden expected to rise as the population ages. No disease-modifying agent is currently available, but recent research suggests that nutritional and lifestyle modifications can delay or prevent the onset of AD. However, preventive nutritional interventions are not universally applicable and depend on the clinical profile of the individual patient. This article reviews existing nutritional modalities for AD prevention that act through improvement of insulin resistance, correction of dyslipidemia, and reduction of oxidative stress, and discusses how they may be modified on the basis of individual biomarkers, genetics, and behavior. In addition, we report preliminary results of clinical application of these personalized interventions at the first AD prevention clinic in the United States. The use of these personalized interventions represents an important application of precision medicine techniques for the prevention of AD that can be adopted by clinicians across disciplines. © 2016 New York Academy of Sciences.

  18. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

    Science.gov (United States)

    Ferrando, Carlos; Soro, Marina; Unzueta, Carmen; Suarez-Sipmann, Fernando; Canet, Jaume; Librero, Julián; Pozo, Natividad; Peiró, Salvador; Llombart, Alicia; León, Irene; India, Inmaculada; Aldecoa, Cesar; Díaz-Cambronero, Oscar; Pestaña, David; Redondo, Francisco J; Garutti, Ignacio; Balust, Jaume; García, Jose I; Ibáñez, Maite; Granell, Manuel; Rodríguez, Aurelio; Gallego, Lucía; de la Matta, Manuel; Gonzalez, Rafael; Brunelli, Andrea; García, Javier; Rovira, Lucas; Barrios, Francisco; Torres, Vicente; Hernández, Samuel; Gracia, Estefanía; Giné, Marta; García, María; García, Nuria; Miguel, Lisset; Sánchez, Sergio; Piñeiro, Patricia; Pujol, Roger; García-Del-Valle, Santiago; Valdivia, José; Hernández, María J; Padrón, Oto; Colás, Ana; Puig, Jaume; Azparren, Gonzalo; Tusman, Gerardo; Villar, Jesús; Belda, Javier

    2018-03-01

    The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m 2 . Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O 2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic

  19. Anterolateral approach with tibial tubercle osteotomy versus standard medial approach for primary total knee arthroplasty: does it matter?

    Directory of Open Access Journals (Sweden)

    Jenabzadeh Reza-Amir

    2010-07-01

    Full Text Available Abstract Background The purpose of this prospective consecutive multicenter study was to investigate whether the type of surgical approach (medial parapatellar (MPA or lateral parapatellar with tibial tubercle osteotomy (TubOT influences the early clinical and radiological outcomes of primary total knee arthroplasty (TKA. Methods Ligament balancing primary TKA with a rotating platform was performed in 143 knees (m:w = 1:1.6; mean age 69 ± 8 years. The TKA was done by a lateral parapatellar subvastus approach with stepcut osteotomy of the tibial tubercle (53%; n = 76, group A or medial parapatellar approach (47%; n = 67, group B. The outcome was assessed at 1 and 2 years postoperatively by the American Knee Society score (KSS and the knee society total knee arthroplasty roentgenographic evaluation and scoring system (TKA-RESS. The patient's pain level and satisfaction was noted by a visual analogue scale (VAS. Data were analyzed by an independent statistician with a level of significance of p 2-test was performed. Results Although having a lower degree of preoperative flexion (112° ± 15° versus 115° ± 15° patients in group A showed a significantly (p = 0.027 higher degree of flexion (118° ± 10° at their last follow-up than patients in group B (114° ± 10°. Patients in group A showed a significantly better mean VAS pain (p = 0.0001 and satisfaction (p = 0.0058 at 2 years follow-up. The pain free walking distance was significantly (p = 0.036 longer for group A than group B. Patients treated with a lateral approach were significantly more stable in terms of valgus stress (p = 0.049. The Knee society score was significantly (p = 0.0009 higher at two years follow up in group A compared to group B. The postoperative mechanical alignment and positioning of the prosthesis were not significantly different. Patients in group B presented with significantly (p = 0.0017 more tibial radiolucencies (> 2 mm at their last follow-up than patients in

  20. A clinical approach to diagnosis of autoimmune encephalitis

    Science.gov (United States)

    Graus, Francesc; Titulaer, Maarten J; Balu, Ramani; Benseler, Susanne; Bien, Christian G; Cellucci, Tania; Cortese, Irene; Dale, Russell C; Gelfand, Jeffrey M; Geschwind, Michael; Glaser, Carol A; Honnorat, Jerome; Höftberger, Romana; Iizuka, Takahiro; Irani, Sarosh R; Lancaster, Eric; Leypoldt, Frank; Prüss, Harald; Rae-Grant, Alexander; Reindl, Markus; Rosenfeld, Myrna R; Rostásy, Kevin; Saiz, Albert; Venkatesan, Arun; Vincent, Angela; Wandinger, Klaus-Peter; Waters, Patrick; Dalmau, Josep

    2016-01-01

    Encephalitis is a severe inflammatory disorder of the brain with many possible causes and a complex differential diagnosis. Advances in autoimmune encephalitis research in the past 10 years have led to the identification of new syndromes and biomarkers that have transformed the diagnostic approach to these disorders. However, existing criteria for autoimmune encephalitis are too reliant on antibody testing and response to immunotherapy, which might delay the diagnosis. We reviewed the literature and gathered the experience of a team of experts with the aims of developing a practical, syndrome-based diagnostic approach to autoimmune encephalitis and providing guidelines to navigate through the differential diagnosis. Because autoantibody test results and response to therapy are not available at disease onset, we based the initial diagnostic approach on neurological assessment and conventional tests that are accessible to most clinicians. Through logical differential diagnosis, levels of evidence for autoimmune encephalitis (possible, probable, or definite) are achieved, which can lead to prompt immunotherapy. PMID:26906964

  1. Clinical approach to inherited metabolic disorders in neonates

    NARCIS (Netherlands)

    Saudubray, J. M.; Narcy, C.; Lyonnet, L.; Bonnefont, J. P.; Poll The, B. T.; Munnich, A.

    1990-01-01

    Most inborn errors of intermediary metabolism presenting in the neonatal period fall schematically into three clinical categories: (1) those which lead to a neurological distress 'intoxication type' with a symptom-free interval, vomiting, comas, hypertonia, abnormal movements and frequent humoral

  2. An approach to the clinical assessment and management of ...

    African Journals Online (AJOL)

    Syncope, defined as a brief loss of consciousness due to an abrupt fall in cerebral perfusion, remains a frequent reason for medical presentation. The goals of the clinical assessment of a patient with syncope are twofold: (i) to identify the precise cause in order to implement a mechanism-specific and effective therapeutic ...

  3. Behavioural variant frontotemporal dementia: clinical and therapeutic approaches.

    Science.gov (United States)

    Fernández-Matarrubia, M; Matías-Guiu, J A; Moreno-Ramos, T; Matías-Guiu, J

    2014-10-01

    Behavioural variant frontotemporal dementia (bvFTD) is the most frequent presentation in the clinical spectrum of frontotemporal dementia (FTD) and it is characterised by progressive changes in personality and conduct. Major breakthroughs in molecular biology and genetics made during the last two decades have lent us a better understanding of this syndrome, which may be the first manifestation in many different neurodegenerative diseases. We reviewed the main epidemiological, clinical, diagnostic and therapeutic aspects of bvFTD. Most cases manifest sporadically and the average age of onset is 58 years. Current criteria for bvFTD propose three levels of diagnostic certainty: possible, probable, and definite. Clinical diagnosis is based on a detailed medical history provided by family members and caregivers, in conjunction with neuropsychological testing. Treatments which have been used in bvFDT to date are all symptomatic and their effectiveness is debatable. New drugs designed for specific molecular targets that are implicated in frontotemporal lobar degeneration are being developed. BvFDT is a frequent cause of dementia. It is a non-specific syndrome associated with heterogeneous histopathological and biomolecular findings. The definition of clinical subtypes complemented by biomarker identification may help predict the underlying pathology. This knowledge, along with the development of drugs designed for molecular targets, will offer new treatment possibilities. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

  4. An Interactive Diagnosis Approach for Supporting Clinical Nursing Courses

    Science.gov (United States)

    Wei, Chun-Wang; Lin, Yi-Chun; Lin, Yen-Ting

    2016-01-01

    Clinical resources in nursing schools are always insufficient for satisfying the practice requirements of each student at the same time during a formal course session. Although several studies have applied information and communication technology to develop computer-based learning tools for addressing this problem, most of these developments lack…

  5. Current approach to masked hypertension: From diagnosis to clinical management.

    LENUS (Irish Health Repository)

    Dolan, Eamon

    2013-11-28

    The term masked hypertension phenomenon was first described by the late Professor Thomas Pickering and is commonly defined as having a normal clinic blood pressure (BP) but an elevated "out of office" reading. In the main these elevated readings have been provided through ambulatory blood pressure monitoring (ABPM) but sometimes home BP monitoring is used. It is now largely accepted that ABPM gives a better classification of risk than clinic BP. Thus the elevated ABPM levels should relate to higher cardiovascular risk and it follows that these people might be regarded as being genuinely hypertensive and at higher cardiovascular risk. The problem for clinical practice is how to identify and manage these subjects. The phenomenon should be suspected in subjects who have had an elevated clinic BP at some time, in young subjects with normal or normal-high clinic BP who have early left ventricular hypertrophy, in subjects with a family history of hypertension in both parents, patients with multiple risks for cardiovascular disease and perhaps diabetic patients. It appears to be more prevalent in subjects of male gender, with younger age, higher heart rate, obesity or high cholesterol levels and in smokers. Those with masked hypertension are at higher risk of events such as stroke and have a higher prevalence of target organ damage, for example, nephropathy. In conclusion most of the debate around this topic relates to its reliable identification. Given the higher ambulatory readings there is an increases cardiovascular risk making this diagnosis important. This article is protected by copyright. All rights reserved.

  6. Rule-based Approach on Extraction of Malay Compound Nouns in Standard Malay Document

    Science.gov (United States)

    Abu Bakar, Zamri; Kamal Ismail, Normaly; Rawi, Mohd Izani Mohamed

    2017-08-01

    Malay compound noun is defined as a form of words that exists when two or more words are combined into a single syntax and it gives a specific meaning. Compound noun acts as one unit and it is spelled separately unless an established compound noun is written closely from two words. The basic characteristics of compound noun can be seen in the Malay sentences which are the frequency of that word in the text itself. Thus, this extraction of compound nouns is significant for the following research which is text summarization, grammar checker, sentiments analysis, machine translation and word categorization. There are many research efforts that have been proposed in extracting Malay compound noun using linguistic approaches. Most of the existing methods were done on the extraction of bi-gram noun+noun compound. However, the result still produces some problems as to give a better result. This paper explores a linguistic method for extracting compound Noun from stand Malay corpus. A standard dataset are used to provide a common platform for evaluating research on the recognition of compound Nouns in Malay sentences. Therefore, an improvement for the effectiveness of the compound noun extraction is needed because the result can be compromised. Thus, this study proposed a modification of linguistic approach in order to enhance the extraction of compound nouns processing. Several pre-processing steps are involved including normalization, tokenization and tagging. The first step that uses the linguistic approach in this study is Part-of-Speech (POS) tagging. Finally, we describe several rules-based and modify the rules to get the most relevant relation between the first word and the second word in order to assist us in solving of the problems. The effectiveness of the relations used in our study can be measured using recall, precision and F1-score techniques. The comparison of the baseline values is very essential because it can provide whether there has been an improvement

  7. Comparison of Standard and Novel Signal Analysis Approaches to Obstructive Sleep Apnoea Classification

    Directory of Open Access Journals (Sweden)

    Aoife eRoebuck

    2015-08-01

    Full Text Available Obstructive sleep apnoea (OSA is a disorder characterised by repeated pauses in breathing during sleep, which leads to deoxygenation and voiced chokes at the end of each episode. OSA is associated by daytime sleepiness and an increased risk of serious conditions such as cardiovascular disease, diabetes and stroke. Between 2-7% of the adult population globally has OSA, but it is estimated that up to 90% of those are undiagnosed and untreated. Diagnosis of OSA requires expensive and cumbersome screening. Audio offers a potential non-contact alternative, particularly with the ubiquity of excellent signal processing on every phone.Previous studies have focused on the classification of snoring and apnoeic chokes. However, such approaches require accurate identification of events. This leads to limited accuracy and small study populations. In this work we propose an alternative approach which uses multiscale entropy (MSE coefficients presented to a classifier to identify disorder in vocal patterns indicative of sleep apnoea. A database of 858 patients was used, the largest reported in this domain. Apnoeic choke, snore, and noise events encoded with speech analysis features were input into a linear classifier. Coefficients of MSE derived from the first 4 hours of each recording were used to train and test a random forest to classify patients as apnoeic or not.Standard speech analysis approaches for event classification achieved an out of sample accuracy (Ac of 76.9% with a sensitivity (Se of 29.2% and a specificity (Sp of 88.7% but high variance. For OSA severity classification, MSE provided an out of sample Ac of 79.9%, Se of 66.0% and Sp = 88.8%. Including demographic information improved the MSE-based classification performance to Ac = 80.5%, Se = 69.2%, Sp = 87.9%. These results indicate that audio recordings could be used in screening for OSA, but are generally under-sensitive.

  8. Population-genetic approach to standardization of radiation and non-radiation factors

    International Nuclear Information System (INIS)

    Telnov, I.

    2006-01-01

    population level. Of 65 analyses of association between diseases and unfavorable effects and various genetic polymorphic systems, 27 had negative results. Other 38 had significant, i.e. positive results. Respective G.S.R.R. varied accordingly in the range from 1.2 to 2.5. Averaged G.S.R.R. for some genetic systems ranged from 1.4 to 1.9. More stable and closer values of averaged G.S.R.R. calculated for various categories of effects: pathologies due to radiation and non-radiation factors - 1.51; non-tumor (1,47) and tumor (1,54) diseases; average life expectancy - 1.34. Population-averaged or integral value of G.S.R.R. was about 1.5. This value can be used as genetic predisposition coefficient (C.G.P.) for correction in averaging of environmental population level factors. Such correction can be done by decreasing of permissible standard value by the value of C.G.P. to calculate population-genetic standard. It should be noted that population-genetic standards decrease risk of development of unfavorable consequences due to effect of environmental factors in individuals with genetic predisposition to the general population level. An important advantage of this approach is that there is no need to account for all existing variations of genetic predisposition to multiform unfavorable environmental factors

  9. Population-genetic approach to standardization of radiation and non-radiation factors

    Energy Technology Data Exchange (ETDEWEB)

    Telnov, I. [Southern Urals Biophysics Institute, Ozersk (Russian Federation)

    2006-07-01

    characteristics on population level. Of 65 analyses of association between diseases and unfavorable effects and various genetic polymorphic systems, 27 had negative results. Other 38 had significant, i.e. positive results. Respective G.S.R.R. varied accordingly in the range from 1.2 to 2.5. Averaged G.S.R.R. for some genetic systems ranged from 1.4 to 1.9. More stable and closer values of averaged G.S.R.R. calculated for various categories of effects: pathologies due to radiation and non-radiation factors - 1.51; non-tumor (1,47) and tumor (1,54) diseases; average life expectancy - 1.34. Population-averaged or integral value of G.S.R.R. was about 1.5. This value can be used as genetic predisposition coefficient (C.G.P.) for correction in averaging of environmental population level factors. Such correction can be done by decreasing of permissible standard value by the value of C.G.P. to calculate population-genetic standard. It should be noted that population-genetic standards decrease risk of development of unfavorable consequences due to effect of environmental factors in individuals with genetic predisposition to the general population level. An important advantage of this approach is that there is no need to account for all existing variations of genetic predisposition to multiform unfavorable environmental factors.

  10. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    Full Text Available Sayeeda Rahman1, Md Anwarul Azim Majumder1, Sami F Shaban2, Nuzhat Rahman3, Moslehuddin Ahmed4, Khalid Bin Abdulrahman5, Urban JA D’Souza61Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK; 2Department of Medical Education, Faculty of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates; 3Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA; 4Department of Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh; 5Department of Family Medicine and Medical Education, College of Medicine, Al-Imam University, Riyadh, Saudi Arabia; 6Department of Post Graduate Studies, School of Medicine, University Malaysia Sabah, Kota Kinabalu, Sabah, MalaysiaAbstract: The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system- or organization-related as well as research- and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and

  11. Mental Illness and Firearms: Legal Context and Clinical Approaches.

    Science.gov (United States)

    Pinals, Debra A; Anacker, Lisa

    2016-12-01

    Gun violence and mental illness is a major area of media attention, especially because highly publicized mass shootings seem to have become more commonly reported in the press. Gun access also is undergoing a highly politicized debate in the United States. It is important for mental health practitioners to understand the background and context of laws related to firearms access, and to understand data related to risk of suicide and violence toward others caused by gun violence among persons with mental illness. In addition, clinically driven risk assessments with specific inquiry related to firearms can be important for identifying individuals for whom firearm-focused clinical risk mitigation may be warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Zellweger spectrum disorders: clinical overview and management approach.

    Science.gov (United States)

    Klouwer, Femke C C; Berendse, Kevin; Ferdinandusse, Sacha; Wanders, Ronald J A; Engelen, Marc; Poll-The, Bwee Tien

    2015-12-01

    Zellweger spectrum disorders (ZSDs) represent the major subgroup within the peroxisomal biogenesis disorders caused by defects in PEX genes. The Zellweger spectrum is a clinical and biochemical continuum which can roughly be divided into three clinical phenotypes. Patients can present in the neonatal period with severe symptoms or later in life during adolescence or adulthood with only minor features. A defect of functional peroxisomes results in several metabolic abnormalities, which in most cases can be detected in blood and urine. There is currently no curative therapy, but supportive care is available. This review focuses on the management of patients with a ZSD and provides recommendations for supportive therapeutic options for all those involved in the care for ZSD patients.

  13. Identification of dementia using standard clinical assessments by primary care physicians in Japan.

    Science.gov (United States)

    Noda, Hiroyuki; Yamagishi, Kazumasa; Ikeda, Ai; Asada, Takashi; Iso, Hiroyasu

    2018-01-16

    The aim of the present study was to develop a way of identifying dementia using clinical assessments made by primary care physicians under the existing medical care system in Japan. A total of 623 people aged ≥65 years underwent standard clinical assessments by primary care physicians under the long-term-care insurance program to determine their grade of activities of daily living related to dementia. To examine the validity of the diagnosis, neuropsychiatrists carried out further diagnosis of dementia for all the participants. We regarded the dementia patients who received care for disability under the long-term care insurance program as having disabling dementia. Multivariable odds ratio (95% confidence interval) in single-grade increments of the activity was 2.1 (1.7-2.5) for dementia and 2.8 (2.2-3.4) for disabling dementia. The grades ≥I and ≥IIa were near the upper-left corner in the receiver operating characteristic curves. Setting the cut-off point at grades ≥I or ≥IIa yielded a higher integrated discrimination improvement, suggesting a major improvement in reducing misclassification by using these cut-off points. When we used grades ≥I as the cut-off point, the sensitivity (95% confidence limits) was 65% (58-72%) and the specificity was 93% (91-96%) for dementia, and the corresponding values in grades ≥IIa were 54% (47-62%) and 96% (94-97%). The corresponding values for disabling dementia were 83% (76-90%), 92% (90-95%), 73% (65-80%) and 96% (94-97%). Our findings suggest that selection of grades ≥I or ≥IIa as the cut-off point would reduce instances of misclassification in the identification of dementia and disabling dementia. Geriatr Gerontol Int 2018; ••: ••-••. © 2018 Japan Geriatrics Society.

  14. Standardized Patients in Clinical Psychology and Psychotherapy: a Scoping Review of Barriers and Facilitators for Implementation.

    Science.gov (United States)

    Kühne, Franziska; Ay, Destina Sevde; Otterbeck, Mara Jasmin; Weck, Florian

    2018-02-08

    The use of simulated and standardized patients (SP) is widely accepted in the medical field and, from there, is beginning to disseminate into clinical psychology and psychotherapy. The purpose of this study was therefore to systematically review barriers and facilitators that should be considered in the implementation of SP interventions specific to clinical psychology and psychotherapy. Following current guidelines, a scoping review was conducted. The literature search focused on the MEDLINE, PsycINFO and Web of Science databases, including Dissertation Abstracts International. After screening for titles and abstracts, full texts were screened independently and in duplicate according to our inclusion criteria. For data extraction, a pre-defined form was piloted and used. Units of meaning with respect to barriers and facilitators were extracted and categorized inductively using content-analysis techniques. From the results, a matrix of interconnections and a network graph were compiled. The 41 included publications were mainly in the fields of psychiatry and mental health nursing, as well as in training and education. The detailed category system contrasts four supercategories, i.e., which organizational and economic aspects to consider, which persons to include as eligible SPs, how to develop adequate scenarios, and how to authentically and consistently portray mental health patients. Publications focused especially on the interrelation between authenticity and consistency of portrayals, on how to evoke empathy in learners, and on economic and training aspects. A variety of recommendations for implementing SP programs, from planning to training, monitoring, and debriefing, is provided, for example, ethical screening of and ongoing support for SPs.

  15. BETA-THALASSEMIA SYNDROMES, CLINICAL AND LABORATORY APPROACH

    OpenAIRE

    Türkkan, Emine; Berrak, Su Gülsün; Canpolat, Cengiz

    2016-01-01

    The Beta ((3) thalassemia syndromes are a heterogeneous group of genetic disorders. The frequency of thalassemia is dependent on the ethnic origins of the patient population. Turkey is located in a geographic area of the world where thalassemia syndromes are common. The incidence rate of (3-thalassemia carriers was stated to be 2 per cent in Turkey. Clinical manifestations are diverse and range from asymptomatic hypochromia and microcytosis to profound anemia leading to death in early childho...

  16. Assessment of Thyroid Function: Towards an Integrated Laboratory - Clinical Approach

    OpenAIRE

    Stockigt, Jim

    2003-01-01

    Laboratory assessment of thyroid function is now often initiated with a low pre-test probability, by clinicians who may not have a detailed knowledge of current methodology or testing strategies. Skilled laboratory staff can significantly enhance the choice of appropriate tests and the accuracy of clinical response; such involvement requires both appropriate training and relevant information from the clinician. Measurement of the serum thyroid stimulating hormone (TSH) concentration with an a...

  17. Clinical approach to splanchnic vein thrombosis: risk factors and treatment.

    Science.gov (United States)

    Riva, Nicoletta; Donadini, Marco P; Dentali, Francesco; Squizzato, Alessandro; Ageno, Walter

    2012-10-01

    Splanchnic vein thrombosis (SVT) is an unusual manifestation of venous thromboembolism which involves one or more abdominal veins (portal, splenic, mesenteric and supra-hepatic veins). SVT may be associated with different underlying disorders, either local (abdominal cancer, liver cirrhosis, intra-abdominal inflammation or surgery) or systemic (hormonal treatment, thrombophilic conditions). In the last decades, myeloproliferative neoplasm (MPN) emerged as the leading systemic cause of SVT. JAK2 mutation, even in the absence of known MPN, showed a strong association with the development of SVT, and SVT was suggested to be the first clinical manifestation of MPN. Recently, an association between SVT, in particular supra-hepatic vein thrombosis, and paroxysmal nocturnal hemoglobinuria has also been reported. SVT occurs with heterogeneous clinical presentations, ranging from incidentally detected events to extensive thrombosis associated with overt gastrointestinal bleeding, thus representing a clinical challenge for treatment decisions. In the absence of major contraindications, anticoagulant therapy is generally recommended for all patients presenting with acute symptomatic SVT, but there is no consensus about the use of anticoagulant drugs in chronic or incidentally detected SVT. High quality evidence on the acute and long-term management is substantially lacking and the risk to benefit-ratio of anticoagulant therapy in SVT still needs to be better assessed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  18. Systematic Approach toward the Clinical Diagnosis of Functional Dyspepsia

    Directory of Open Access Journals (Sweden)

    Pierre Paré

    1999-01-01

    Full Text Available Functional dyspepsia (FD is the most common condition in patients consulting with upper gastrointestinal tract symptoms, resulting in up to 5% of visits to family physicians. By definition, patients with FD have no clinical, biochemical or endoscopic evidence of an organic disease that is likely to explain their symptoms. The process to be used in a structured interview for establishing a clinical diagnosis of FD is presented. The steps are as follows: determine the duration and the course of the disease; characterize the current syndrome and review the alarm symptoms; elicit the patient-perceived dominant symptom and/or condition; and identify the patient’s reason for consulting and address the psychosocial factors. According to the clinical characteristics of the three most frequent causes of dyspepsia (peptic ulcer, gastroesophageal reflux and FD and acknowledging that these conditions may coexist rather than overlap in some patients, an algorithm is suggested for establishing a working diagnosis of FD and indications for investigation, and initiating a management strategy.

  19. Genetic testing in congenital heart disease: A clinical approach

    Science.gov (United States)

    Chaix, Marie A; Andelfinger, Gregor; Khairy, Paul

    2016-01-01

    Congenital heart disease (CHD) is the most common type of birth defect. Traditionally, a polygenic model defined by the interaction of multiple genes and environmental factors was hypothesized to account for different forms of CHD. It is now understood that the contribution of genetics to CHD extends beyond a single unified paradigm. For example, monogenic models and chromosomal abnormalities have been associated with various syndromic and non-syndromic forms of CHD. In such instances, genetic investigation and testing may potentially play an important role in clinical care. A family tree with a detailed phenotypic description serves as the initial screening tool to identify potentially inherited defects and to guide further genetic investigation. The selection of a genetic test is contingent upon the particular diagnostic hypothesis generated by clinical examination. Genetic investigation in CHD may carry the potential to improve prognosis by yielding valuable information with regards to personalized medical care, confidence in the clinical diagnosis, and/or targeted patient follow-up. Moreover, genetic assessment may serve as a tool to predict recurrence risk, define the pattern of inheritance within a family, and evaluate the need for further family screening. In some circumstances, prenatal or preimplantation genetic screening could identify fetuses or embryos at high risk for CHD. Although genetics may appear to constitute a highly specialized sector of cardiology, basic knowledge regarding inheritance patterns, recurrence risks, and available screening and diagnostic tools, including their strengths and limitations, could assist the treating physician in providing sound counsel. PMID:26981213

  20. Hypohidrotic ectodermal dysplasia: a clinical case with a longitudinal approach.

    Science.gov (United States)

    Fraiz, Fabian Calixto; Gugisch, Renato Cordeiro; Cavalcante-Leão, Bianca Lopes; Macedo, Liliane Moreira

    2014-11-01

    This paper describes a clinical case of a male with hypohidrotic ectodermal dysplasia submitted to rehabilitation and occlusal dental interventions with follow-up from 3 to 14 years of age. Due to the severe effects on function and esthetics, the clinical manifestations of ectodermal dysplasia exert a negative impact on quality of life. However, oral rehabilitation in childhood poses a challenge due to growth and development. A male with hypohidrotic ectodermal dysplasia began dental intervention at the age of 3 years. The clinical and radiographic exams revealed the absence of several primary and permanent teeth and abnormal shape of the primary maxillary incisors. The facial characteristics were compatible with hypohidrotic ectodermal dysplasia, such as a prominent brow, everted lips, fattened bridge of the nose and small vertical facial height. The treatment proposed involved rehabilitation through successive temporary partial dentures, functional orthopedics of the jaws, esthetic reconstruction of the anterior teeth, timely occlusal intervention and preventive actions for the control of dental caries and plaque. The present case demonstrates that early care plays a fundamental role in minimizing the biopsychosocial consequences of hypohidrotic ectodermal dysplasia and preparing the patient for future oral rehabilitation. Although, the literature offers a number of papers describing dental treatment for ectodermal dysplasia, few cases include long-term follow-up and the use of a functional orthopedic appliance in combination with removable dentures in such patients.

  1. Development of Standardized Mobile Tracer Correlation Approach for Large Area Emission Measurements (DRAFT UNDER EPA REVIEW)

    Science.gov (United States)

    Foster-wittig, T. A.; Thoma, E.; Green, R.; Hater, G.; Swan, N.; Chanton, J.

    2013-12-01

    Improved understanding of air emissions from large area sources such as landfills, waste water ponds, open-source processing, and agricultural operations is a topic of increasing environmental importance. In many cases, the size of the area source, coupled with spatial-heterogeneity, make direct (on-site) emission assessment difficult; methane emissions, from landfills for example, can be particularly complex [Thoma et al, 2009]. Recently, whole-facility (remote) measurement approaches based on tracer correlation have been utilized [Scheutz et al, 2011]. The approach uses a mobile platform to simultaneously measure a metered-release of a conservative gas (the tracer) along with the target compound (methane in the case of landfills). The known-rate tracer release provides a measure of atmospheric dispersion at the downwind observing location allowing the area source emission to be determined by a ratio calculation [Green et al, 2010]. Although powerful in concept, the approach has been somewhat limited to research applications due to the complexities and cost of the high-sensitivity measurement equipment required to quantify the part-per billion levels of tracer and target gas at kilometer-scale distances. The advent of compact, robust, and easy to use near-infrared optical measurement systems (such as cavity ring down spectroscopy) allow the tracer correlation approach to be investigated for wider use. Over the last several years, Waste Management Inc., the U.S. EPA, and collaborators have conducted method evaluation activities to determine the viability of a standardized approach through execution of a large number of field measurement trials at U.S. landfills. As opposed to previous studies [Scheutz et al, 2011] conducted at night (optimal plume transport conditions), the current work evaluated realistic use-scenarios; these scenarios include execution by non-scientist personnel, daylight operation, and full range of atmospheric condition (all plume transport

  2. Simplified Symptom Pattern Method for verbal autopsy analysis: multisite validation study using clinical diagnostic gold standards

    Directory of Open Access Journals (Sweden)

    Lozano Rafael

    2011-08-01

    Full Text Available Abstract Background Verbal autopsy can be a useful tool for generating cause of death data in data-sparse regions around the world. The Symptom Pattern (SP Method is one promising approach to analyzing verbal autopsy data, but it has not been tested rigorously with gold standard diagnostic criteria. We propose a simplified version of SP and evaluate its performance using verbal autopsy data with accompanying true cause of death. Methods We investigated specific parameters in SP's Bayesian framework that allow for its optimal performance in both assigning individual cause of death and in determining cause-specific mortality fractions. We evaluated these outcomes of the method separately for adult, child, and neonatal verbal autopsies in 500 different population constructs of verbal autopsy data to analyze its ability in various settings. Results We determined that a modified, simpler version of Symptom Pattern (termed Simplified Symptom Pattern, or SSP performs better than the previously-developed approach. Across 500 samples of verbal autopsy testing data, SSP achieves a median cause-specific mortality fraction accuracy of 0.710 for adults, 0.739 for children, and 0.751 for neonates. In individual cause of death assignment in the same testing environment, SSP achieves 45.8% chance-corrected concordance for adults, 51.5% for children, and 32.5% for neonates. Conclusions The Simplified Symptom Pattern Method for verbal autopsy can yield reliable and reasonably accurate results for both individual cause of death assignment and for determining cause-specific mortality fractions. The method demonstrates that verbal autopsies coupled with SSP can be a useful tool for analyzing mortality patterns and determining individual cause of death from verbal autopsy data.

  3. Clinical trial for detection of dental caries using laser-induced fluorescence ratio reference standard

    Science.gov (United States)

    Thomas, Shiny Sara; Mohanty, Soumyakant; Jayanthi, J. L.; Varughese, Jolly Mary; Balan, Anitha; Subhash, Narayanan

    2010-03-01

    We present the clinical applicability of fluorescence ratio reference standard (FRRS) to discriminate different stages of dental caries. Toward this, laser-induced autofluorescence emission spectra are recorded in vivo in the 400- to 800-nm spectral range on a miniature fiber optic spectrometer from 65 patients, with a 404-nm diode laser as the excitation source. Autofluorescence spectra of sound teeth consist of a broad emission at 500 nm that is typical of natural enamel, whereas in caries teeth additional peaks are seen at 635 and 680 nm due to emission from porphyrin compounds in oral bacteria. Scatter plots are developed to differentiate sound teeth from enamel caries, sound teeth from dentinal caries, and enamel caries from dentinal caries using the mean fluorescence intensity (FI) and ratios F500/F635 and F500/F680 measured from 25 sites of sound teeth and 65 sites of carious teeth. The sensitivity and specificity of both the FI and FRRS are determined. It is observed that a diagnostic algorithm based on FRRS scatter plots is able to discriminate enamel caries from sound teeth, dentinal caries from sound teeth, and enamel from dentinal caries with overall sensitivities of 85, 100, and 88% and specificities of 90, 100, and 77%, respectively.

  4. Mental health legislation in Lebanon: Nonconformity to international standards and clinical dilemmas in psychiatric practice.

    Science.gov (United States)

    Kerbage, Hala; El Chammay, Rabih; Richa, Sami

    2016-01-01

    Mental health legislation represents an important mean of protecting the rights of persons with mental disabilities by preventing human rights violations and discrimination and by legally reinforcing the objectives of a mental health policy. The last decade has seen significant changes in the laws relating to psychiatric practice all over the world, especially with the implementation of the Convention for the Rights of People with Disabilities (CRPD). In this paper, we review the existing legislation in Lebanon concerning the following areas in mental health: treatment and legal protection of persons with mental disabilities, criminal laws in relation to offenders with mental disorders, and laws regulating incapacity. We will discuss these texts in comparison with international recommendations and standards on the rights of persons with disabilities, showing the recurrent contradiction between them. Throughout our article, we will address the clinical dilemmas that Lebanese psychiatrists encounter in practice, in the absence of a clear legislation that can orient their decisions and protect their patients from abuse. Copyright © 2015. Published by Elsevier Ltd.

  5. On the creation of a clinical gold standard corpus in Spanish: Mining adverse drug reactions.

    Science.gov (United States)

    Oronoz, Maite; Gojenola, Koldo; Pérez, Alicia; de Ilarraza, Arantza Díaz; Casillas, Arantza

    2015-08-01

    The advances achieved in Natural Language Processing make it possible to automatically mine information from electronically created documents. Many Natural Language Processing methods that extract information from texts make use of annotated corpora, but these are scarce in the clinical domain due to legal and ethical issues. In this paper we present the creation of the IxaMed-GS gold standard composed of real electronic health records written in Spanish and manually annotated by experts in pharmacology and pharmacovigilance. The experts mainly annotated entities related to diseases and drugs, but also relationships between entities indicating adverse drug reaction events. To help the experts in the annotation task, we adapted a general corpus linguistic analyzer to the medical domain. The quality of the annotation process in the IxaMed-GS corpus has been assessed by measuring the inter-annotator agreement, which was 90.53% for entities and 82.86% for events. In addition, the corpus has been used for the automatic extraction of adverse drug reaction events using machine learning. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Comparison between Clinically Used Irregular Fields Shielded by Cerrobend and Standard Lead Blocks

    Directory of Open Access Journals (Sweden)

    Farajollahi A. R.

    2015-06-01

    Full Text Available Introduction: In radiation therapy centers across Iran, protection of normal tissues is usually accomplished by either Cerrobend or lead block shielding. In this study, the influence of these two shielding methods on central axis dose distribution of photon beam a Cobalt unit was investigated in clinical conditions. Materials and Methods: All measurements were performed for 60Co γ-ray beams and the Cerrobend blocks were fabricated by commercial Cerrobend materials. Standard lead block shields belonged to Cobalt unit. Data was collected through a calibrated ionization chamber, relative dosimetry systems and a TLD dosimetery. Results: Results of the percent depth dose (PDD measurements at depths of 0.5, 1, 5, 10, 15 and 20 cm for 23 different field sizes of patients with head and neck cancer showed no significant differences between lead and Cerrobend shielding methods. Measurement results of absolute dosimetry in depths of 1.5, 3, 5, 7, 10 and 12 cm also showed no significant differences between these two shielding methods. The same results were obtained by TLD dosimetry on patient skin. Conclusion: Use of melt shielding methods is a very easy and fast shield-making technique with no differences in PDD, absolute and skin dose between lead and Cerrobend block shielding methods.

  7. Comparison of clinical grade type 1 polarized and standard matured dendritic cells for cancer immunotherapy

    DEFF Research Database (Denmark)

    Hansen, Morten; Hjortø, Gertrud Malene; Donia, Marco

    2013-01-01

    induction of type 1 effector T cells. Standard matured clinical grade DCs “sDCs” were compared with DCs matured with either of two type 1 polarizing maturation cocktails; the alpha-type-1 DCs “αDC1s” (TNF-α, IL-1β, IFN-γ, IFN-α, Poly(I:C)) and “mDCs” (monophosphoryl lipid A (MPL), IFN-γ) or a mixed cocktail....... αDC1s and mDCs were functionally superior to sDCs as they polarized naïve CD4+ T cells most efficiently into T helper type 1 effector cells and primed more functional MART-1 specific CD8+ T cells although with variation between donors. αDC1s and mDCs were transiently less capable of CCL21-directed......DCs and strikingly had the highest expression of the inhibitory molecules PD-L1 and CD25. Thus, further studies with type 1 polarized DCs are warranted for use in immunotherapy, but when combined with PGE2 as in mpDCs, they seems to be less optimal for maturation of DCs....

  8. Characteristics of student preparedness for clinical learning: clinical educator perspectives using the Delphi approach

    Directory of Open Access Journals (Sweden)

    Chipchase Lucinda S

    2012-11-01

    Full Text Available Abstract Background During clinical placements, clinical educators facilitate student learning. Previous research has defined the skills, attitudes and practices that pertain to an ideal clinical educator. However, less attention has been paid to the role of student readiness in terms of foundational knowledge and attitudes at the commencement of practice education. Therefore, the aim of this study was to ascertain clinical educators’ views on the characteristics that they perceive demonstrate that a student is well prepared for clinical learning. Methods A two round on-line Delphi study was conducted. The first questionnaire was emailed to a total of 636 expert clinical educators from the disciplines of occupational therapy, physiotherapy and speech pathology. Expert clinical educators were asked to describe the key characteristics that indicate a student is prepared for a clinical placement and ready to learn. Open-ended responses received from the first round were subject to a thematic analysis and resulted in six themes with 62 characteristics. In the second round, participants were asked to rate each characteristic on a 7 point Likert Scale. Results A total of 258 (40.56% responded to the first round of the Delphi survey while 161 clinical educators completed the second (62.40% retention rate. Consensus was reached on 57 characteristics (six themes using a cut off of greater than 70% positive respondents and an interquartile deviation IQD of equal or less than 1. Conclusions This study identified 57 characteristics (six themes perceived by clinical educators as indicators of a student who is prepared and ready for clinical learning. A list of characteristics relating to behaviours has been compiled and could be provided to students to aid their preparation for clinical learning and to universities to incorporate within curricula. In addition, the list provides a platform for discussions by professional bodies about the role of placement

  9. Approach to Clinical Syndrome of Jaundice and Encephalopathy in Tropics

    Science.gov (United States)

    Anand, Anil C.; Garg, Hitendra K.

    2015-01-01

    A large number of patients present with jaundice and encephalopathy in tropical country like India and acute liver failure is the usual cause. Clinical presentation like ALF is also a complication of many tropical infections, and these conditions may mimic ALF but may have subtle differences from ALF. Moreover, what hepatologists see as acute liver failure in tropics is different from what is commonly described in Western Textbooks. Paracetamol overdose, which is possibly the commonest cause of ALF in UK and USA, is hardly ever seen in India. Most common etiology here is viral hepatitis (hepatitis E > hepatitis B> hepatitis A). Apart from ALF, one may also come across subacute hepatic failure (SAHF) as well as acute-on-chronic liver failure (ACLF) due to viral hepatitis. Interestingly, a host of other conditions can mimic ALF because clinical presentation in these conditions can be dominated by jaundice and encephalopathy. Malarial hepatopathy is possibly the best-known condition out of these and is not an uncommon manifestation of severe malaria. A similar presentation can also be seen in other common infections in tropics such as dengue fever, typhoid fever, leptospirosis, scrub typhus, amoebic liver abscesses, tuberculosis and other bacterial and fungal infections with or without human immunodeficiency virus (HIV) related disease. In many of these conditions, liver failure may not be underlying pathophysiology. Some pregnancy related liver diseases could also present with jaundice and encephalopathy. This review summarizes the commonly seen presentations in tropical country like India, where jaundice and encephalopathy dominate the clinical picture. PMID:26041951

  10. Endoscope-assisted frenotomy approach to median upper neck masses: clinical outcomes and safety (from a phase II clinical trial).

    Science.gov (United States)

    Woo, Seung Hoon; Jeong, Han-Sin; Kim, Jin Pyeong; Park, Jung Je; Baek, Chung-Hwan

    2014-07-01

    An endoscope-assisted frenotomy approach (EFA) to resection of the median upper neck mass has been introduced to clinical practice. However, its technical feasibility, indications, and safety have not been fully studied. Here, we report the results of a prospective phase II clinical trial to evaluate the clinical outcomes. Twenty patients were enrolled in this trial. The masses were divided into 3 subtypes. We implemented EFA to remove the masses after receiving informed patient consent. We evaluated the clinical outcomes and complications related to this procedure for more than a 2-year period. EFA successfully removed the masses in all cases without any injuries to adjacent nerves or ducts. During the more than 2-year follow-up period, recurrence or revision surgeries were not required. EFA can be a very effective and safe approach for median upper neck masses, and can also lead to excellent cosmetic and functional results. Copyright © 2013 Wiley Periodicals, Inc.

  11. A rational clinical approach to suspected insulin allergy

    DEFF Research Database (Denmark)

    Bødtger, Uffe; Wittrup, M

    2005-01-01

    AIMS: Allergy to recombinant human (rDNA) insulin preparations is a rare complication of insulin therapy. However, insulin preparations contain several allergens, and several disorders can resemble insulin allergy. Studies evaluating the diagnostic procedures on suspected insulin allergy...... technique (n = 5), skin disease (n = 3) and other systemic allergy (n = 1). Nine other patients were found to be allergic to protamine (n = 3) or rDNA insulin (n = 6), and specific treatment was associated with relief in 8 patients (89%). Four patients had local reactions of unknown causes but symptom...... relief was obtained in three cases by unspecific therapy. Overall, 20 (91%) reported relief of symptoms. CONCLUSION: Our standardized investigative procedure of suspected insulin preparation (IP) allergy was associated with relief of symptoms in > 90% of patients. IP allergy was diagnosed in 41...

  12. 76 FR 28990 - Ultra High Throughput Sequencing for Clinical Diagnostic Applications-Approaches To Assess...

    Science.gov (United States)

    2011-05-19

    ... Web cast of the public meeting, you must register online at http://www.fda.gov/MedicalDevices/News... technologies are currently extensively used in research and are entering clinical diagnostic use; they are... technologies for clinical applications, appropriate evaluation tools (e.g., standards, well established...

  13. Lower Face: Clinical Anatomy and Regional Approaches with Injectable Fillers.

    Science.gov (United States)

    Braz, André; Humphrey, Shannon; Weinkle, Susan; Yee, G Jackie; Remington, B Kent; Lorenc, Z Paul; Yoelin, Steve; Waldorf, Heidi A; Azizzadeh, Babak; Butterwick, Kimberly J; de Maio, Mauricio; Sadick, Neil; Trevidic, Patrick; Criollo-Lamilla, Gisella; Garcia, Philippe

    2015-11-01

    The use of injectable fillers enables facial sculpting through treatment of volume depletion and modeling of facial contours. Injectable fillers are among the most frequently performed minimally invasive cosmetic procedures.However, treatment of the lower third of the face can be challenging and requires expertise in facial anatomy. In this article, the authors provide a comprehensive review of the anatomy of the lower third of the face, highlighting danger zones. In addition, the authors describe their preferred approach and detailed technique used in the treatment of each specific area, namely the jawline, prejowl sulcus, melomental folds, and lips.

  14. Australian elapid snake envenomation in cats: Clinical priorities and approach.

    Science.gov (United States)

    Mcalees, Trudi J; Abraham, Linda A

    2017-11-01

    Practical relevance: No fewer than 140 species of terrestrial snakes reside in Australia, 92 of which possess venom glands. With the exception of the brown tree snake, the venom-producing snakes belong to the family Elapidae. The venom of a number of elapid species is more toxic than that of the Indian cobra and eastern diamondback rattle snake, which has earned Australia its reputation for being home to the world's most venomous snakes. Clinical challenges: The diagnosis of elapid snake envenomation is not always easy. Identification of Australian snakes is not straightforward and there are no pathognomonic clinical signs. In cats, diagnosis of envenomation is confounded by the fact that, in most cases, there is a delay in seeking veterinary attention, probably because snake encounters are not usually witnessed by owners, and also because of the tendency of cats to hide and seek seclusion when unwell. Although the administration of antivenom is associated with improved outcomes, the snake venom detection kit and antivenom are expensive and so their use may be precluded if there are financial constraints. Evidence base: In providing comprehensive guidance on the diagnosis and treatment of Australian elapid snake envenomation in cats, the authors of this review draw on the published veterinary, medical and toxicology literature, as well as their professional experience as specialists in medicine, and emergency medicine and critical care.

  15. Verbal communication of students with high patient-physician interaction scores in a clinical performance examination assessed by standardized patients.

    Science.gov (United States)

    Roh, HyeRin; Park, Kyung Hye; Park, Song Yi

    2017-12-01

    Standardized patients (SPs) tend to rate medical students' communication skills subjectively and comprehensively, in contrast to such objective skill set defined in the clinical performance examination (CPX). Meanwhile, medical school instructors have a different approach in their evaluation of students' communication skills. We aim to analyze medical students' verbal communication skills using objective methods, and to determine the contributing factors of a patient-physician interaction (PPI) score. Students with high- and low-ranking scores for PPI in CPX were selected. The Roter interaction analysis system was used to compare verbal communication behaviors of the students and SPs. Patient-centeredness scores (PCSs), physician's verbal dominance, and number of utterances were compared between the two groups. PCSs and physician's verbal dominance had no difference between the groups. The number of utterances during the limited time of 5 minutes of CPX was higher for the high-ranking students. They tended to employ more paraphrase/check for understanding, and closed questions for psychosocial state and open questions for medical condition. The SPs interviewed by high-ranking students gave more medical information and requested for more services. In the case of the routine checkup, smooth conversations with more frequent utterances were detected in the high-ranking students. More medical information exchange and requests for services by SPs were higher for the high-ranking students. Medical communication instructors should keep in mind that our results could be indicators of a high PPI score.

  16. A work-based learning approach for clinical support workers on mental health inpatient wards.

    Science.gov (United States)

    Kemp, Philip; Gilding, Moorene; Seewooruttun, Khooseal; Walsh, Hannah

    2016-09-14

    Background With a rise in the number of unqualified staff providing health and social care, and reports raising concerns about the quality of care provided, there is a need to address the learning needs of clinical support workers. This article describes a qualitative evaluation of a service improvement project that involved a work-based learning approach for clinical support workers on mental health inpatient wards. Aim To investigate and identify insights in relation to the content and process of learning using a work-based learning approach for clinical support workers. Method This was a qualitative evaluation of a service improvement project involving 25 clinical support workers at the seven mental health inpatient units in South London and Maudsley NHS Foundation Trust. Three clinical skills tutors were appointed to develop, implement and evaluate the work-based learning approach. Four sources of data were used to evaluate this approach, including reflective journals, qualitative responses to questionnaires, three focus groups involving the clinical support workers and a group interview involving the clinical skills tutors. Data were analysed using thematic analysis. Findings The work-based learning approach was highly valued by the clinical support workers and enhanced learning in practice. Face-to-face learning in practice helped the clinical support workers to develop practice skills and reflective learning skills. Insights relating to the role of clinical support workers were also identified, including the benefits of face-to-face supervision in practice, particularly in relation to the interpersonal aspects of care. Conclusion A work-based learning approach has the potential to enhance care delivery by meeting the learning needs of clinical support workers and enabling them to apply learning to practice. Care providers should consider how the work-based learning approach can be used on a systematic, organisation-wide basis in the context of budgetary

  17. A collaborative comparison of objective structured clinical examination (OSCE) standard setting methods at Australian medical schools

    NARCIS (Netherlands)

    Malau-Aduli, B.S.; Teague, P.A.; D'Souza, K.; Heal, C.; Turner, R.; Garne, D.L.; Vleuten, C. van der

    2017-01-01

    BACKGROUND: A key issue underpinning the usefulness of the OSCE assessment to medical education is standard setting, but the majority of standard-setting methods remain challenging for performance assessment because they produce varying passing marks. Several studies have compared standard-setting

  18. Clinical approach to obscure GI bleeding - Diagnostic testing and management

    Directory of Open Access Journals (Sweden)

    Prashanth Prabakaran

    2013-01-01

    Full Text Available Obscure gastrointestinal bleeding (OGIB can present as a diagnostic dilemma and management can be challenging. The search for causes of OGIB is usually centered on visualizing the small bowel, and in the past decade, the technology to visualize the entire small bowel has significantly advanced. Moreover, small bowel endoscopic imaging has replaced, in many instances, prior radiographic evaluation for obscure GI bleeding. These new modalities, such as small bowel capsule endoscopy (CE, balloon-assisted deep enteroscopy [double balloon enteroscopy (DBE and single balloon enteroscopy (SBE], and overtube-assisted deep enteroscopy (spiral enteroscopy, are paving the way toward more accurately identifying and treating patients with OGIB. We will review the diagnostic modalities available in evaluating a patient with OGIB and also propose the management based on clinical and endoscopic findings.

  19. Standardization of Unani polyherbal formulation, Qurse-e-Hummaz: A comprehensive approach

    Directory of Open Access Journals (Sweden)

    Y T Kamal

    2016-01-01

    Full Text Available Background: An increase in the awareness about the advantages of the traditional system of medicines has led to the commercialization of the formulations used for the treatments. Manufacture of these medicines to meet this increasing demand has resulted in a decline in their quality, primarily due to a lack of adequate regulations pertaining to this sector of medicine. Hence, it is necessary to come up with a systematic approach to develop well-designed methodologies for the standardization of polyherbal formulations which are used in traditional systems of medicine. Materials and Methods: Qurs-e-Hummaz formulations were prepared by a qualified “Hakim” (Unani medical practitioner of Faculty of Unani Medicine, Hamdard University, as per the formula and instruction given in National Formulary of Unani Medicine. Results: Various quality control parameters such as organoleptic evaluations (color, odor, taste, and consistency, physicochemical evaluations (loss on drying, disintegration time, moisture content, total ash, acid insoluble ash, water soluble ash, pH of 1 and 10% solution, extractive values, water soluble matter, alcohol-soluble matter, and total phenolic content and thin layer chromatography fingerprint profiling have been carried out in triplicate. The evaluation of contaminants such as heavy metals, aflatoxins, pesticide residues, and microbial contamination has also been carried out in the formulation. Conclusion: Help in maintaining the quality and batch to batch consistency of many important polyherbal formulations.

  20. A perturbative approach to the redshift space correlation function: beyond the Standard Model

    Energy Technology Data Exchange (ETDEWEB)

    Bose, Benjamin; Koyama, Kazuya, E-mail: benjamin.bose@port.ac.uk, E-mail: kazuya.koyama@port.ac.uk [Institute of Cosmology and Gravitation, University of Portsmouth, Burnaby Road, Portsmouth, Hampshire, PO1 3FX (United Kingdom)

    2017-08-01

    We extend our previous redshift space power spectrum code to the redshift space correlation function. Here we focus on the Gaussian Streaming Model (GSM). Again, the code accommodates a wide range of modified gravity and dark energy models. For the non-linear real space correlation function used in the GSM we use the Fourier transform of the RegPT 1-loop matter power spectrum. We compare predictions of the GSM for a Vainshtein screened and Chameleon screened model as well as GR. These predictions are compared to the Fourier transform of the Taruya, Nishimichi and Saito (TNS) redshift space power spectrum model which is fit to N-body data. We find very good agreement between the Fourier transform of the TNS model and the GSM predictions, with ≤ 6% deviations in the first two correlation function multipoles for all models for redshift space separations in 50Mpc h ≤ s ≤ 180Mpc/ h . Excellent agreement is found in the differences between the modified gravity and GR multipole predictions for both approaches to the redshift space correlation function, highlighting their matched ability in picking up deviations from GR. We elucidate the timeliness of such non-standard templates at the dawn of stage-IV surveys and discuss necessary preparations and extensions needed for upcoming high quality data.

  1. A perturbative approach to the redshift space correlation function: beyond the Standard Model

    Science.gov (United States)

    Bose, Benjamin; Koyama, Kazuya

    2017-08-01

    We extend our previous redshift space power spectrum code to the redshift space correlation function. Here we focus on the Gaussian Streaming Model (GSM). Again, the code accommodates a wide range of modified gravity and dark energy models. For the non-linear real space correlation function used in the GSM we use the Fourier transform of the RegPT 1-loop matter power spectrum. We compare predictions of the GSM for a Vainshtein screened and Chameleon screened model as well as GR. These predictions are compared to the Fourier transform of the Taruya, Nishimichi and Saito (TNS) redshift space power spectrum model which is fit to N-body data. We find very good agreement between the Fourier transform of the TNS model and the GSM predictions, with <= 6% deviations in the first two correlation function multipoles for all models for redshift space separations in 50Mpch <= s <= 180Mpc/h. Excellent agreement is found in the differences between the modified gravity and GR multipole predictions for both approaches to the redshift space correlation function, highlighting their matched ability in picking up deviations from GR. We elucidate the timeliness of such non-standard templates at the dawn of stage-IV surveys and discuss necessary preparations and extensions needed for upcoming high quality data.

  2. Regional Implementation of a Pediatric Cardiology Syncope Algorithm Using Standardized Clinical Assessment and Management Plans (SCAMPS) Methodology.

    Science.gov (United States)

    Paris, Yvonne; Toro-Salazar, Olga H; Gauthier, Naomi S; Rotondo, Kathleen M; Arnold, Lucy; Hamershock, Rose; Saudek, David E; Fulton, David R; Renaud, Ashley; Alexander, Mark E

    2016-02-19

    Pediatric syncope is common. Cardiac causes are rarely found. We describe and assess a pragmatic approach to these patients first seen by a pediatric cardiologist in the New England region, using Standardized Clinical Assessment and Management Plans (SCAMPs). Ambulatory patients aged 7 to 21 years initially seen for syncope at participating New England Congenital Cardiology Association practices over a 2.5-year period were evaluated using a SCAMP. Findings were iteratively analyzed and the care pathway was revised. The vast majority (85%) of the 1254 patients had typical syncope. A minority had exercise-related or more problematic symptoms. Guideline-defined testing identified one patient with cardiac syncope. Syncope Severity Scores correlated well between physician and patient perceived symptoms. Orthostatic vital signs were of limited use. Largely incidental findings were seen in 10% of ECGs and 11% of echocardiograms. The 10% returning for follow-up, by design, reported more significant symptoms, but did not have newly recognized cardiac disease. Iterative analysis helped refine the approach. SCAMP methodology confirmed that the vast majority of children referred to the outpatient pediatric cardiology setting had typical low-severity neurally mediated syncope that could be effectively evaluated in a single visit using minimal resources. A simple scoring system can help triage patients into treatment categories. Prespecified criteria permitted the effective diagnosis of the single patient with a clear cardiac etiology. Patients with higher syncope scores still have a very low risk of cardiac disease, but may warrant attention. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  3. The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

    Science.gov (United States)

    Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

    2017-06-01

    The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

  4. “Which Box Should I Check?”: Examining Standard Check Box Approaches to Measuring Race and Ethnicity

    Science.gov (United States)

    Eisenhower, Abbey; Suyemoto, Karen; Lucchese, Fernanda; Canenguez, Katia

    2014-01-01

    Objective This study examined methodological concerns with standard approaches to measuring race and ethnicity using the federally defined race and ethnicity categories, as utilized in National Institutes of Health (NIH) funded research. Data Sources/Study Setting Surveys were administered to 219 economically disadvantaged, racially and ethnically diverse participants at Boston Women Infants and Children (WIC) clinics during 2010. Study Design We examined missingness and misclassification in responses to the closed-ended NIH measure of race and ethnicity compared with open-ended measures of self-identified race and ethnicity. Principal Findings Rates of missingness were 26 and 43 percent for NIH race and ethnicity items, respectively, compared with 11 and 18 percent for open-ended responses. NIH race responses matched racial self-identification in only 44 percent of cases. Missingness and misclassification were disproportionately higher for self-identified Latina(o)s, African-Americans, and Cape Verdeans. Race, but not ethnicity, was more often missing for immigrant versus mainland U.S.-born respondents. Results also indicated that ethnicity for Hispanic/Latina(o)s is more complex than captured in this measure. Conclusions The NIH's current race and ethnicity measure demonstrated poor differentiation of race and ethnicity, restricted response options, and lack of an inclusive ethnicity question. Separating race and ethnicity and providing respondents with adequate flexibility to identify themselves both racially and ethnically may improve valid operationalization. PMID:24298894

  5. Clinically relevant anatomy of high anterior cervical approach.

    Science.gov (United States)

    Haller, Justin M; Iwanik, Michael; Shen, Francis H

    2011-12-01

    An anatomic study of anterior cervical dissection of 11 embalmed cadavers and measurement of structures relative to cervical spine. To determine the anatomic relationship of the hypoglossal nerve (HN), internal and external superior laryngeal nerves (ESLNs), superior thyroid artery (STA), and superior laryngeal artery (SLA) to cervical spine and demonstrate any vulnerability. The anterior approach is a common approach to the cervical spine. Much of the operative morbidity in high cervical region is related to neurovascular injury leading to dysphagia, dysphonia, impaired high-pitch phonation, and impaired cough reflex. Eleven adult cadavers (5 male/6 female) were dissected bilaterally to expose structures of the high anterior cervical region. The HN consistently traveled toward the midline at C2-3 and was safe caudal to C3-4. In 95% of dissections, the internal superior laryngeal nerve (ISLN) was exposed within 1 cm of C3-4. The path of the ESLN was variable, but it was safe above C3-4 and below C6-7. The ESLN was deep to the STA, and it was less bulky and tauter than the ISLN in all dissections. The origin of the STA was quite variable along the carotid artery, but it was most commonly located at C4. Two anatomic variants of the SLA were observed. In 15 dissections, the SLA branched off the superior thyroid. In six dissections, the SLA branched directly from external carotid artery. There was no appreciable side-to-side variation in the neurovascular structures studied. On the basis this study, spine surgeons can have enhanced knowledge of high anterior cervical anatomy. The neurovascular structures in this study did not demonstrate side-to-side anatomic variation; therefore, patient pathology and surgeon preference should dictate the operative side.

  6. Clinical supervision in the palliative care team setting: a concrete approach to team wellness.

    Science.gov (United States)

    Edmonds, Kyle P; Yeung, Heidi N; Onderdonk, Christopher; Mitchell, William; Thornberry, Kathryn

    2015-03-01

    Clinical supervision is a structured, case-based approach to learning that is used most often in the mental health field. An established palliative care consultation service at a large, academic medical center implemented a modified clinical supervision model in an effort to improve team members' awareness of their own emotions and the way those emotions impact behavior during, primarily, clinical encounters. This report discusses clinical supervision in detail and, by way of a case, illustrates the power of this intervention as a source of self-care and a concrete approach to managing palliative care team well-being.

  7. A risk-based approach for developing standards for irrigation with reclaimed water.

    Science.gov (United States)

    Troldborg, Mads; Duckett, Dominic; Allan, Richard; Hastings, Emily; Hough, Rupert L

    2017-12-01

    A generalised quantitative risk assessment (QRA) is developed to assess the potential harm to human health resulting from irrigation with reclaimed water. The QRA is conducted as a backward calculation starting from a pre-defined acceptable risk level at the receptor point (defined as an annual infection risk of 10 -4 for pathogens and by reference doses (RfD) for chemical hazards) and results in an estimate of the corresponding acceptable concentration levels of the given hazards in the effluent. In this way the QRA is designed to inform the level of water treatment required to achieve an acceptable risk level and help establish reclaimed water quality standards. The QRA considers the exposure of human receptors to microbial and chemical hazards in the effluent through various exposure pathways and routes depending on the specific irrigation scenario. By considering multiple pathways and routes, a number of key aspects relevant to estimating human exposure to recycled water can be accounted for, including irrigation and crop handling practices (e.g., non-edible vs edible, spray vs. drip, withholding time) and volumes consumed (directly vs indirectly). The QRA relies on a large number of inputs, many of which were found to be highly uncertain. A possibilistic approach, based on fuzzy set theory, was used to propagate the uncertain input values through the QRA model to estimate the possible range of hazard concentrations that are deemed acceptable/safe for reclaimed water irrigation. Two scenarios were considered: amenity irrigation and irrigation of ready-to-eat food crops, and calculations were carried out for six example hazards (norovirus, Cryptosporidium, cadmium, lead, PCB118 and naphthalene) and using UK-specific input values. The human health risks associated with using reclaimed water for amenity irrigation were overall deemed low, i.e. the calculated acceptable concentration levels for most of the selected hazards were generally far greater than levels

  8. STANDARDISED CLINICAL EXAMINATION OF SOFT-TISSUE PAIN IN PATIENTS WITH HIP DYSPLASIA USING THE CLINICAL ENTITIES APPROACH

    DEFF Research Database (Denmark)

    Jacobsen, Julie Sandell; Hölmich, Per; Thorborg, Kristian

    2016-01-01

    ) and 12% (n=6) in the hip adductors. Hamstrings and rectus abdominis entities were less common with a prevalence of 4% (n=2) and 0% (n=0), respectively. The clinical entities are reported in Table 3. Conclusion Clinical entities suggestive of soft-tissue pathology in the hip region are common with a high...... and reliable protocol. The aim of this study was to investigate five clinical entities in 100 patients with hip dysplasia using the clinical entities approach identifying the anatomic location of soft-tissue pain. The first 50 patients are presented in this paper. Material and Methods Fifty patients (10 males......, 40 females), with a median age of 26 (15-49) years were included (Table 1). The standardised examination protocol included evaluation of “known” pain in the muscles, tendons and at their insertion point provoked by palpation, contraction or stretching (Figure 1-5). Clinical entities were predefined...

  9. Irritable bowel syndrome: diagnostic approaches in clinical practice

    Directory of Open Access Journals (Sweden)

    Eugene J Burbige

    2010-09-01

    Full Text Available Eugene J BurbigeDivision of Gastroenterology, Gastrointestinal and Liver Research, John Muir Medical Center, Concord, CA, USABackground: Irritable bowel syndrome (IBS, a functional gastrointestinal disorder long considered a diagnosis of exclusion, has chronic symptoms that vary over time and overlap with those of non-IBS disorders. Traditional symptom-based criteria effectively identify IBS patients but are not easily applied in clinical practice, leaving >40% of patients to experience symptoms up to 5 years before diagnosis.Objective: To review the diagnostic evaluation of patients with suspected IBS, strengths and weaknesses of current methodologies, and newer diagnostic tools that can augment current symptom-based criteria.Methods: The peer-reviewed literature (PubMed was searched for primary reports and reviews using the limiters of date (1999–2009 and English language and the search terms irritable bowel syndrome, diagnosis, gastrointestinal disease, symptom-based criteria, outcome, serology, and fecal markers. Abstracts from Digestive Disease Week 2008–2009 and reference lists of identified articles were reviewed.Results: A disconnect is apparent between practice guidelines and clinical practice. The American Gastroenterological Association and American College of Gastroenterology recommend diagnosing IBS in patients without alarm features of organic disease using symptom-based criteria (eg, Rome. However, physicians report confidence in a symptom-based diagnosis without further testing only up to 42% of the time; many order laboratory tests and perform sigmoidoscopies or colonoscopies despite good evidence showing no utility for this work-up in uncomplicated cases. In the absence of diagnostic criteria easily usable in a busy practice, newer diagnostic methods, such as stool-form examination, fecal inflammatory markers, and serum biomarkers, have been proposed as adjunctive tools to aid in an IBS diagnosis by increasing physicians

  10. MicroRNA profiling of patient plasma for clinical trials using bioinformatics and biostatistical approaches

    Directory of Open Access Journals (Sweden)

    Markowitz J

    2016-09-01

    Full Text Available Joseph Markowitz,1–4 Zachary Abrams,2,5 Naduparambil K Jacob,2,6 Xiaoli Zhang,2,7 John N Hassani,1 Nicholas Latchana,8 Lai Wei,2,7 Kelly E Regan,2,5 Taylor R Brooks,2 Sarvani R Uppati,2 Kala M Levine,2 Tanios Bekaii-Saab,2,4 Kari L Kendra,2,4 Gregory B Lesinski,2,4 J Harrison Howard,2,8 Thomas Olencki,2,4 Philip R Payne,2,5 William E Carson III2,8 1Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL, 2Comprehensive Cancer Center, The Ohio State University, Columbus, OH, 3Department of Oncologic Sciences, USF Morsani School of Medicine, Tampa, FL, 4Division of Medical Oncology, The Ohio State University Wexner Medical Center, 5Department of Biomedical Informatics, 6Department of Radiation Oncology, 7Center for Biostatistics, 8Department of Surgery, The Ohio State University, Columbus, OH, USA Background: MicroRNAs (miRNAs are short noncoding RNAs that function to repress translation of mRNA transcripts and contribute to the development of cancer. We hypothesized that miRNA array-based technologies work best for miRNA profiling of patient-derived plasma samples when the techniques and patient populations are precisely defined.Methods: Plasma samples were obtained from five sources: melanoma clinical trial of interferon and bortezomib (12, purchased normal donor plasma samples (four, gastrointestinal tumor bank (nine, melanoma tumor bank (ten, or aged-matched normal donors (eight for the tumor bank samples. Plasma samples were purified for miRNAs and quantified using NanoString® arrays or by the company Exiqon. Standard biostatistical array approaches were utilized for data analysis and compared to a rank-based analytical approach.Results: With the prospectively collected samples, fewer plasma samples demonstrated visible hemolysis due to increased attention to eliminating factors, such as increased pressure during phlebotomy, small gauge needles, and multiple punctures. Cancer patients enrolled in a melanoma clinical study

  11. Clinical Approach in Orbital Cellulitis Cases: Case Series

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    Altan Atakan Özcan

    2012-07-01

    Full Text Available Pur po se: To evaluate the etiological factors, diagnosis, follow-up and treatment procedures in cases of orbital cellulitis. Ma te ri al and Met hod: A retrospective review was performed on medical records of patients with orbital cellulitis treated between 2009 and 2011 in our clinic. The patients were studied for age, ophthalmologic examination features, laboratory and radiology results, treatment modalities and the response to these treatments. Re sults: Eleven patients (7 male, 4 female having an average age of 9.7 years (6 months-25 years participated in the study. All patients had eyelid oedema, hyperemia and ocular pain; with chemosis in 3, gaze restriction in 6, relative afferent pupillary defect and proptosis in 4 cases. Orbital cellulitis was observed to occur secondary to paranasal sinusitis in 10 patients (90.9% and 1 patient had only history of superior respiratory tract infection. Sinus infection was localized in ethmoid and maxillary sinuses in all except one case. Laboratory tests showed leukocytosis in 8 patients. Surgical drainage was performed in 7 of 8 patients with abscess formation observed with radiological imaging. The remainder of the patients were followed with sole medical treatment. All patients recovered without any vision loss or life-threatening complication. Dis cus si on: Orbital cellulitis cases must be followed with radiologic imaging for any complication that may occur and patients with abscess should be evaluated for surgical drainage besides antimicrobial treatment.(Turk J Ophthalmol 2012; 42: 284-7

  12. A triadic approach to addiction for clinical interventions

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    Xavier eNoel

    2013-12-01

    Full Text Available According to the triadic neurocognitive model of addiction to drugs (e.g., cocaine and non-drugs (e.g., gambling, weakened willpower associated with these behaviours is the product of an abnormal functioning in one or more of three key neural and cognitive systems: (1 an amygdala-striatum dependent system mediating automatic, habitual, and salient behaviours; (2 a prefrontal cortex dependent system important for self-regulation and forecasting the future consequences of a behaviour and (3 an insula dependent system for the reception of interoceptive signals and their translation into feeling states (such as urge and craving, which in turn plays a strong influential role in decision-making and impulse control processes related to uncertainty, risk, and reward. The described three-systems account for poor decision-making (i.e., prioritizing short-term consequences of a decisional option and stimulus-driven actions, thus leading to a more elevated risk for relapse. Finally, this article elaborates on the need for personalized clinical model-based interventions targeting interactions between implicit processes, interoceptive signalling, and supervisory function aimed at helping individuals become less governed by immediate situations and automatic prepotent responses, and more influenced by systems involved in the pursuit of future valued goals.

  13. Applying artificial intelligence to clinical guidelines: the GLARE approach.

    Science.gov (United States)

    Terenziani, Paolo; Montani, Stefania; Bottrighi, Alessio; Molino, Gianpaolo; Torchio, Mauro

    2008-01-01

    We present GLARE, a domain-independent system for acquiring, representing and executing clinical guidelines (GL). GLARE is characterized by the adoption of Artificial Intelligence (AI) techniques in the definition and implementation of the system. First of all, a high-level and user-friendly knowledge representation language has been designed. Second, a user-friendly acquisition tool, which provides expert physicians with various forms of help, has been implemented. Third, a tool for executing GL on a specific patient has been made available. At all the levels above, advanced AI techniques have been exploited, in order to enhance flexibility and user-friendliness and to provide decision support. Specifically, this chapter focuses on the methods we have developed in order to cope with (i) automatic resource-based adaptation of GL, (ii) representation and reasoning about temporal constraints in GL, (iii) decision making support, and (iv) model-based verification. We stress that, although we have devised such techniques within the GLARE project, they are mostly system-independent, so that they might be applied to other guideline management systems.

  14. A Modern Clinical Approach of the Traditional Korean Saam Acupuncture

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    Manyong Park

    2015-01-01

    Full Text Available Saam acupuncture is one of the original therapeutic modalities representing traditional Korean medicine. It was originally described in a manuscript that is estimated to be published at some point between 1644 and 1742, in the middle of the Cho Sun dynasty, by a Korean Buddhist monk whose name is unknown. The principle of combining five shu points is based on the theory of Nan-jing. The treatment and diagnosis concepts in Saam acupuncture were mainly influenced by Dongeuibogam and Chimgoogyeong-heombang. The basic characteristic of combining five shu points in Saam acupuncture is the selection of the tonification and sedation points along the self-meridian and other meridians based on creation and governor relationships. Saam acupuncture clinical studies have mainly focused on musculoskeletal pain and autonomic nervous system regulation. From a neurophysiological perspective, Saam acupuncture, which involves five shu points as the main treatment aspect, has the advantage of increasing parasympathetic nerve activation and adjusting the balance of the autonomic nervous system. Inserting a needle into the skin layer while considering the respiratory phase and stimulating the needle gently and lightly could maximize the effect of Saam acupuncture. The specific Saam acupuncture prescribed should be identified on the basis of the neurobiological perspective.

  15. Robotic positioning of standard electrophysiology catheters: a novel approach to catheter robotics.

    Science.gov (United States)

    Knight, Bradley; Ayers, Gregory M; Cohen, Todd J

    2008-05-01

    Robotic systems have been developed to manipulate and position electrophysiology (EP) catheters remotely. One limitation of existing systems is their requirement for specialized catheters or sheaths. We evaluated a system (Catheter Robotics Remote Catheter Manipulation System [RCMS], Catheter Robotics, Inc., Budd Lake, New Jersey) that manipulates conventional EP catheters placed through standard introducer sheaths. The remote controller functions much like the EP catheter handle, and the system permits repeated catheter disengagement for manual manipulation without requiring removal of the catheter from the body. This study tested the hypothesis that the RCMS would be able to safely and effectively position catheters at various intracardiac sites and obtain thresholds and electrograms similar to those obtained with manual catheter manipulation. Two identical 7 Fr catheters (Blazer II; Boston Scientific Corp., Natick, Massachusetts) were inserted into the right femoral veins of 6 mongrel dogs through separate, standard 7 Fr sheaths. The first catheter was manually placed at a right ventricular endocardial site. The second catheter handle was placed in the mating holder of the RCMS and moved to approximately the same site as the first catheter using the Catheter Robotics RCMS. The pacing threshold was determined for each catheter. This sequence was performed at 2 right atrial and 2 right ventricular sites. The distance between the manually and robotically placed catheters tips was measured, and pacing thresholds and His-bundle recordings were compared. The heart was inspected at necropsy for signs of cardiac perforation or injury. Compared to manual positioning, remote catheter placement produced the same pacing threshold at 7/24 sites, a lower threshold at 11/24 sites, and a higher threshold at only 6/24 sites (p > 0.05). The average distance between catheter tips was 0.46 +/- 0.32 cm (median 0.32, range 0.13-1.16 cm). There was no difference between right atrial

  16. Proximity of the Lateral Calcaneal Artery With a Modified Extensile Lateral Approach Compared to Standard Extensile Approach.

    Science.gov (United States)

    Kwon, John Y; Gonzalez, Tyler; Riedel, Matthew D; Nazarian, Ara; Ghorbanhoseini, Mohammad

    2017-03-01

    The extensile lateral approach (EL) has been associated with increased wound complications such as apical necrosis which may be due partially from violation of the lateral calcaneal artery (LCA). Traditionally, the vertical limb has been placed half-way between the fibula and Achilles tendon, which may be suboptimal given the proximity to the LCA. We hypothesized that placing the vertical limb further posterior (ie, modified EL [MEL]) would increase the distance from the LCA. The purposes of this study were to quantify the location of the LCA in relation to the vertical limb of the traditional EL approach and to determine if utilizing the MEL approach endangered the LCA to a lesser extent. 20 cadavers were used. For the EL approach, the fibula and Achilles tendon were palpated and a line parallel to the plantar foot was drawn between the two. A vertical line (VL), representing the vertical limb of the approach, was drawn at the midway point as a perpendicular extending proximally from the junction of the glabrous/non-glabrous skin (JGNG). For the MEL approach, the anterior border of the Achilles tendon was palpated and a similar vertical line (MVL) was drawn 0.75 cm anterior. Dissection was performed and if the LCA was identified crossing the line VL/MVL, the distance from the JGNG was documented. For the EL approach, the LCA was identified in 17/20 (85%) cadavers at an average distance of 5.0 cm (range 3-7 cm, SD = 1.3 cm) from JGNG. For the ML approach, the LCA was identified in 4/20 (20%) cadavers at an average distance of 5.9 cm (range 3-6.5 cm, SD = 1.7 cm) from the JGNG ( P LCA was encountered 4 times more often during the EL approach as compared to the MEL approach. A modification of the EL approach may decrease iatrogenic injury to the LCA and may decrease wound complications.

  17. Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education -Effects of Introduction of an Education System Using OSCE-.

    Science.gov (United States)

    Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo

    2013-09-01

    [Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE.

  18. Clinical presentation and diagnostic approach in cases of genitourinary tuberculosis

    Directory of Open Access Journals (Sweden)

    Rakesh Kapoor

    2008-01-01

    Full Text Available Objective: We herein describe the various modes of presentation in genitourinary tuberculosis (GUTB and a simple diagnostic approach to it. Materials and Methods: We made a literature search through Medline database and various other peer-reviewed online journals to study the various modes of presentation in GUTB. We reviewed over 100 articles published in the last 10 years (1998 -- 2007, which were tracked through the key words like GUTB and extrapulmonary tuberculosis. Results: GUTB has varied presentation and the most common way of presentation is in the form of irritative voiding symptoms, which are found in more than 50% of the patients. The usual frequency of organ involvement is: kidney, bladder, fallopian tube, and scrotum. The usual tests used to diagnose GUTB are the demonstration of mycobacterium in urine or body fluid and radiographic examination. Intravenous urography (IVU has been considered to be one of the most useful tests for the anatomical as well as the functional details of kidneys and ureters. In cases of renal failure, MRI can be used. Newer examinations such as radiometric liquid culture systems (i.e., BACTEC ® , Becton Dickinson,USA and polymerase chain reaction (PCR give rapid results and are highly sensitive in the identification of mycobacterium. Conclusion: GUTB can involve any part of the genitourinary system and presentation may vary from vague urinary symptoms to chronic kidney disease. Newer tests like radiometric liquid culture systems and polymerase chain reaction give rapid results and carry high diagnostic value.

  19. Primary repair of colon injuries: clinical study of nonselective approach

    Directory of Open Access Journals (Sweden)

    Krivokapic Zoran V

    2010-12-01

    Full Text Available Abstract Background This study was designed to determine the role of primary repair and to investigate the possibility of expanding indications for primary repair of colon injuries using nonselective approach. Methods Two groups of patients were analyzed. Retrospective (RS group included 30 patients managed by primary repair or two stage surgical procedure according to criteria published by Stone (S/F and Flint (Fl. In this group 18 patients were managed by primary repair. Prospective (PR group included 33 patients with primary repair as a first choice procedure. In this group, primary repair was performed in 30 cases. Results Groups were comparable regarding age, sex, and indexes of trauma severity. Time between injury and surgery was shorter in PR group, (1.3 vs. 3.1 hours. Stab wounds were more frequent in PR group (9:2, and iatrogenic lesions in RS group (6:2. Associated injuries were similar, as well as segmental distribution of colon injuries. S/F criteria and Flint grading were similar. In RS group 15 primary repairs were successful, while in two cases relaparotomy and colostomy was performed due to anastomotic leakage. One patient died. In PR group, 25 primary repairs were successful, with 2 immediate and 3 postoperative (7-10 days deaths, with no evidence of anastomotic leakage. Conclusions Results of this study justify more liberal use of primary repair in early management of colon injuries. Trial registration Current Controlled Trials ISRCTN94682396

  20. Residents’ perceptions of simulation as a clinical learning approach

    Science.gov (United States)

    Walsh, Catharine M.; Garg, Ankit; Ng, Stella L.; Goyal, Fenny; Grover, Samir C.

    2017-01-01

    Background Simulation is increasingly being integrated into medical education; however, there is little research into trainees’ perceptions of this learning modality. We elicited trainees’ perceptions of simulation-based learning, to inform how simulation is developed and applied to support training. Methods We conducted an instrumental qualitative case study entailing 36 semi-structured one-hour interviews with 12 residents enrolled in an introductory simulation-based course. Trainees were interviewed at three time points: pre-course, post-course, and 4–6 weeks later. Interview transcripts were analyzed using a qualitative descriptive analytic approach. Results Residents’ perceptions of simulation included: 1) simulation serves pragmatic purposes; 2) simulation provides a safe space; 3) simulation presents perils and pitfalls; and 4) optimal design for simulation: integration and tension. Key findings included residents’ markedly narrow perception of simulation’s capacity to support non-technical skills development or its use beyond introductory learning. Conclusion Trainees’ learning expectations of simulation were restricted. Educators should critically attend to the way they present simulation to learners as, based on theories of problem-framing, trainees’ a priori perceptions may delimit the focus of their learning experiences. If they view simulation as merely a replica of real cases for the purpose of practicing basic skills, they may fail to benefit from the full scope of learning opportunities afforded by simulation. PMID:28344719

  1. One-step (standard) versus two-step surgical approach in adolescent idiopathic scoliosis posterior spinal fusion: Which is better?

    Science.gov (United States)

    Ramirez, Norman; Valentin, Pablo; García-Cartagena, Manuel; Samalot, Solais; Iriarte, Ivan

    2016-07-01

    A retrospective cohort study with IRB approval. Significant blood loss remains an important concern in terms of the performance of the posterior spinal fusion in adolescent idiopathic scoliosis. Several strategies have been reported to minimize blood loss during surgery. In order to address the need to minimize blood loss without sacrificing the quality of the fusion, in our hospital, we adopted a two-step surgical approach. This surgical approach consist of the exposure and instrumentation of the lumbar region prior to and followed by an extension of the surgical incision to the thoracic region for its subsequent instrumentation. The main purpose of this study was to compare a two-step surgical approach with the one-step (standard) approach. This study was a review of all the data on consecutive posterior spinal fusion surgeries performed by a specific two-surgeon team during 2004-2013. Demographics, surgical variables, radiographic findings, and outcomes regarding blood loss, morbidity, and the duration of the procedure were evaluated. Eighty-five patients underwent the standard surgical exposure, and 41 patients underwent the two-step surgical technique. With the exception of BMI, neither group showed any statistically preoperative variable significant differences. None of the postoperative outcome variables were statistically significant between both surgical approaches. No differences were detected in terms of using a two-step surgical approach versus the one-step standard surgical approach regarding perioperative blood loss, surgical time, or complications. Level of evidence III.

  2. How Wood Fuels’ Quality Relates to the Standards: A Class-Modelling Approach

    Directory of Open Access Journals (Sweden)

    Michela Zanetti

    2017-09-01

    Full Text Available The quality requirements of wood biofuels are regulated by a series of harmonized international standards. These standards define the technical parameter limits that influence the quality of solid biomass as a fuel. In 2014 the European reference standard for solid biofuel was replaced by the International ISO standard. In the case of wood chips, the main difference between the European and International standards is the definition of particle size distribution classes. In this context, this study analyses the quality of wood chips and its variation over the years according to the “former” (EN 14691-4 and “in force” (ISO 17225-4 standards. A Soft Independent Modelling of Class Analogy (SIMCA model was built to predict the best quality of wood chips and to clarify the relationship between quality and standard parameters, time and changes in the standard regulations. The results show that, compared to the EN standards, classification with the ISO standards increases the samples belonging to the best quality classes and decreases the not classified samples. Furthermore, all the SIMCA models have a high sensitivity (>90%, reflect the differences introduced to the quality standards and are therefore suitable for monitoring the quality of wood chips and their changes.

  3. Autoverification process improvement by Six Sigma approach: Clinical chemistry & immunoassay.

    Science.gov (United States)

    Randell, Edward W; Short, Garry; Lee, Natasha; Beresford, Allison; Spencer, Margaret; Kennell, Marina; Moores, Zoë; Parry, David

    2018-03-05

    This study examines effectiveness of a project to enhance an autoverification (AV) system through application of Six Sigma (DMAIC) process improvement strategies. Similar AV systems set up at three sites underwent examination and modification to produce improved systems while monitoring proportions of samples autoverified, the time required for manual review and verification, sample processing time, and examining characteristics of tests not autoverified. This information was used to identify areas for improvement and monitor the impact of changes. Use of reference range based criteria had the greatest impact on the proportion of tests autoverified. To improve AV process, reference range based criteria was replaced with extreme value limits based on a 99.5% test result interval, delta check criteria were broadened, and new specimen consistency rules were implemented. Decision guidance tools were also developed to assist staff using the AV system. The mean proportion of tests and samples autoverified improved from 90% for samples and >95% for tests across all three sites. The new AV system significantly decreased turn-around time and total sample review time (to about a third), however, time spent for manual review of held samples almost tripled. There was no evidence of compromise to the quality of testing process and process improvement methodology was successfully applied to AV systems resulting in an increase in overall test and sample AV by >90%, improved turn-around time, reduced time for manual verification, and with no obvious compromise to quality or error detection. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  4. Evaluation of linear accelerator performance standards using an outcome oriented approach.

    Science.gov (United States)

    Rangel, Alejandra; Ploquin, Nicolas; Kay, Ian; Dunscombe, Peter

    2008-06-01

    Radiation therapy, along with other branches of medicine, is moving towards a firmer basis in evidence to optimally utilize resources. As new treatment technology and strategies place greater demands on quality assurance resources, the need to objectively evaluate equipment and process performance standards from the perspective of predicted clinical impact becomes more urgent. This study evaluates the appropriateness of recommended quality control tolerance and action levels for linear accelerators based on the calculated dosimetric impact of suboptimal equipment performance. A method is described to quantify the dosimetric changes, as reflected by the changes in the outcome surrogate, equivalent uniform dose (EUD), of machine performance deviations from the optimal, specifically in the range of tolerance and action levels promulgated by the Canadian Association of Provincial Cancer Agencies (CAPCA). Linear accelerator performance deviations were simulated for the treatment of prostate, breast, lung, and brain using 3D conformal techniques, and the impact evaluated in terms of the changes in the EUD of the target volumes and two principal organs at risk (OARs) per site. The eight key performance characteristics examined are: Output constancy, beam flatness, gantry angle, collimator angle, field size indicator, laser alignment (three directions) and, by inference, the optical distance indicator. Currently accepted CAPCA tolerance levels for these eight performance characteristics are shown to maintain average EUD deviations to within 2% for the targets and 2 Gy for the OARs. However, within the 2% or 2 Gy range, the recommended tolerance levels are found to have markedly different effects on the EUDs of the structures of interest.

  5. Professional approaches in clinical judgements among senior and junior doctors: implications for medical education

    Directory of Open Access Journals (Sweden)

    Pilhammar Ewa

    2009-05-01

    Full Text Available Abstract Background Clinical experience has traditionally been highly valued in medical education and clinical healthcare. On account of its multi-faceted nature, clinical experience is mostly difficult to articulate, and is mainly expressed in clinical situations as professional approaches. Due to retirement, hospitals in Scandinavia will soon face a substantial decrease in the number of senior specialist doctors, and it has been discussed whether healthcare will suffer an immense loss of experienced-based knowledge when this senior group leaves the organization. Both senior specialists and junior colleagues are often involved in clinical education, but the way in which these two groups vary in professional approaches and contributions to clinical education has not been so well described. Cognitive psychology has contributed to the understanding of how experience may influence professional approaches, but such studies have not included the effect of differences in position and responsibilities that junior and senior doctors hold in clinical healthcare. In the light of the discussion above, it is essential to describe the professional approaches of senior doctors in relation to those of their junior colleagues. This study therefore aims to describe and compare the professional approaches of junior and senior doctors when making clinical judgements. Methods Critical incident technique was used in interviews with nine senior doctors and nine junior doctors in internal medicine. The interviews were subjected to qualitative content analysis. Result Senior and junior doctors expressed a variety of professional approaches in clinical judgement as follows: use of theoretical knowledge, use of prior experience of cases and courses of events, use of ethical and moral values, meeting and communicating with the patient, focusing on available information, relying on their own ability, getting support and guidance from others and being directed by the

  6. Development of Best practices document for Peptide Standards | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The Assay Development Working Group (ADWG) of the CPTAC Program is currently drafting a document to propose best practices for generation, quantification, storage, and handling of peptide standards used for mass spectrometry-based assays, as well as interpretation of quantitative proteomic data based on peptide standards. The ADWG is seeking input from commercial entities that provide peptide standards for mass spectrometry-based assays or that perform amino acid analysis.

  7. Thermal analysis of a solar collector with a standard approach and software used to study windows

    Energy Technology Data Exchange (ETDEWEB)

    Simko, T.; Harrison, S.J. [Queen' s Univ., Kingston, ON (Canada). Dept. of Mechanical and Materials Engineering

    2007-07-01

    A method of calculating the overall heat loss coefficient of a solar collector was presented. The method was based on a standard approach used to obtain total window U-values. A model of the solar collector was developed with a finite element analysis (FEA) program. Heat loss from the solar collector was represented as the gross collector area; the overall heat loss coefficient; and the difference between the assumed mean absorber plate temperature and ambient temperature. The edge heat loss coefficient was approximated by assuming that there was a 1-D sideways heat flow through the edge area of the collector. Regional heat loss coefficients obtained with the model were then used to calculate the overall heat loss coefficient. Equations used for parallel tube type collectors were applied to the serpentine tube collector. The sightline of the solar collector was defined as being the position along the top cover below absorber plate. The same definitions for the extents of the frame, edge and center-of-glass regions for a window were applied to the collector. Multiple U-values were defined to account for heat flows outward across the top, bottom, and side surfaces of the collector. The absorber plate was simulated as being isothermal. Results were then compared with an experimental study in order to validate the method. The method was also compared with results obtained from a conventional analysis for estimating heat loss coefficients. It was concluded that the new method provided more accurate results than those obtained using the conventional method. 16 refs., 1 tab., 5 figs.

  8. Clinical trials information in drug development and regulation : existing systems and standards

    NARCIS (Netherlands)

    Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans

    2012-01-01

    Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and

  9. Initial flight and simulator evaluation of a head up display for standard and noise abatement visual approaches

    Science.gov (United States)

    Bourquin, K.; Palmer, E. A.; Cooper, G.; Gerdes, R. M.

    1973-01-01

    A preliminary assessment was made of the adequacy of a simple head up display (HUD) for providing vertical guidance for flying noise abatement and standard visual approaches in a jet transport. The HUD featured gyro-stabilized approach angle scales which display the angle of declination to any point on the ground and a horizontal flight path bar which aids the pilot in his control of the aircraft flight path angle. Thirty-three standard and noise abatement approaches were flown in a Boeing 747 aircraft equipped with a head up display. The HUD was also simulated in a research simulator. The simulator was used to familiarize the pilots with the display and to determine the most suitable way to use the HUD for making high capture noise abatement approaches. Preliminary flight and simulator data are presented and problem areas that require further investigation are identified.

  10. Photodynamic action of LED-light on standard and clinical strains of Staphylococci processed by Brilliant Green and Titanium Dioxide

    Science.gov (United States)

    Tuchina, Elena S.; Tuchin, Valery V.

    2011-03-01

    We assume that the effectiveness of phototherapy against microorganisms may be increased if together with the photosensitizer a photocatalyst will be used. It was found that the combination of TiO2-nanoparticles and Brilliant Green at two-wavelength irradiation with blue (405 nm) and red (625 nm) light provides a strong antimicrobial effect on standard and clinical strains of Staphylococci.

  11. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

    DEFF Research Database (Denmark)

    Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio

    2007-01-01

    OBJECTIVE: To conduct a cross-sectional review of non-selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. METHODS: The review included current disease activity using data from...

  12. Offering pre-exposure prophylaxis for HIV prevention to pregnant and postpartum women: a clinical approach.

    Science.gov (United States)

    Seidman, Dominika L; Weber, Shannon; Cohan, Deborah

    2017-03-08

    HIV prevention during pregnancy and lactation is critical for both maternal and child health. Pregnancy provides a critical opportunity for clinicians to elicit women's vulnerabilities to HIV and offer HIV testing, treatment and referral and/or comprehensive HIV prevention options for the current pregnancy, the postpartum period and safer conception options for future pregnancies. In this commentary, we review the safety of oral pre-exposure prophylaxis with tenofovir/emtricitabine in pregnant and lactating women and suggest opportunities to identify pregnant and postpartum women at substantial risk of HIV. We then describe a clinical approach to caring for women who both choose and decline pre-exposure prophylaxis during pregnancy and postpartum, highlighting areas for future research. Evidence suggests that pre-exposure prophylaxis with tenofovir/emtricitabine is safe in pregnancy and lactation. Identifying women vulnerable to HIV and eligible for pre-exposure prophylaxis is challenging in light of the myriad of individual, community, and structural forces impacting HIV acquisition. Validated risk calculators exist for specific populations but have not been used to screen and offer HIV prevention methods. Partner testing and engagement of men living with HIV are additional means of reaching at-risk women. However, women's vulnerabilities to HIV change over time. Combining screening for HIV vulnerability with HIV and/or STI testing at standard intervals during pregnancy is a practical way to prompt providers to incorporate HIV screening and prevention counselling. We suggest using shared decision-making to offer women pre-exposure prophylaxis as one of multiple HIV prevention strategies during pregnancy and postpartum, facilitating open conversations about HIV vulnerabilities, preferences about HIV prevention strategies, and choosing a method that best meets the needs of each woman. Growing evidence suggests that pre-exposure prophylaxis with tenofovir

  13. Radiotherapy for pediatric brain tumors: Standards of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Goldwein, Joel W.

    1995-01-01

    The objectives of the course are to evaluate the role of radiation therapy in the treatment of pediatric brain tumors. Areas where the role is evolving will be identified, and the results of clinical trials which been mounted to clarify radiotherapy's role will be reviewed. Brain tumors are the second most common malignancy of childhood after leukemias and lymphomas. However, they remain the most common group of childhood tumors to require radiation therapy. Therefore, a thorough understanding of these tumors, and the appropriate role of surgery, radiation and chemotherapy is critical. Issues surrounding the management of sequelae are no less important. The role of radiotherapy for the treatment of these tumors is far different from that for adults. These differences relate to the profound potential for sequelae from therapy, the higher overall cure rates, and the utility of multimodality therapies. In addition, the rarity of childhood brain tumors compared with adults' makes them more difficult to study. In this session, the following issues will be reviewed; 1. Incidence of pediatric brain tumors, 2. General issues regarding symptoms, diagnosis, diagnostic tests and evaluation, 3. Importance of a team approach, 4. General issues regarding treatment sequelae, 5. Specific tumor types/entities; a. Cerebellar Astrocytomas b. Benign and malignant Gliomas including brainstem and chiasmatic lesions c. Primitive Neuroectodermal Tumors (PNET) and Medulloblastoma d. Ependymomas e. Craniopharyngiomas f. Germ cell tumors g. Miscellaneous and rare pediatric brain tumors 6. Management of sequelae 7. New and future directions a. Treatment of infants b. The expanding role of chemotherapy c. Advances in radiotherapy. The attendees will complete the course with a better understanding of the role that radiation therapy plays in the treatment of pediatric brain tumors. They will be knowledgeable in the foundation for that role, and the changes which are likely to take place in the

  14. Assessing the reliability of the borderline regression method as a standard setting procedure for objective structured clinical examination

    Directory of Open Access Journals (Sweden)

    Sara Mortaz Hejri

    2013-01-01

    Full Text Available Background: One of the methods used for standard setting is the borderline regression method (BRM. This study aims to assess the reliability of BRM when the pass-fail standard in an objective structured clinical examination (OSCE was calculated by averaging the BRM standards obtained for each station separately. Materials and Methods: In nine stations of the OSCE with direct observation the examiners gave each student a checklist score and a global score. Using a linear regression model for each station, we calculated the checklist score cut-off on the regression equation for the global scale cut-off set at 2. The OSCE pass-fail standard was defined as the average of all station′s standard. To determine the reliability, the root mean square error (RMSE was calculated. The R2 coefficient and the inter-grade discrimination were calculated to assess the quality of OSCE. Results: The mean total test score was 60.78. The OSCE pass-fail standard and its RMSE were 47.37 and 0.55, respectively. The R2 coefficients ranged from 0.44 to 0.79. The inter-grade discrimination score varied greatly among stations. Conclusion: The RMSE of the standard was very small indicating that BRM is a reliable method of setting standard for OSCE, which has the advantage of providing data for quality assurance.

  15. Hemodynamic function of the standard St. Jude bileaflet disc valve has no clinical impact 10 years after aortic valve replacement

    DEFF Research Database (Denmark)

    Lund, Ole; Dorup, Inge; Emmertsen, Kristian

    2005-01-01

    OBJECTIVES: Size mismatch and impaired left ventricular function have been shown to determine the hemodynamic function of the standard St. Jude bileaflet disc valve early after aortic valve replacement (AVR). We aimed to analyse St. Jude valve hemodynamic function and its clinical impact in the s......OBJECTIVES: Size mismatch and impaired left ventricular function have been shown to determine the hemodynamic function of the standard St. Jude bileaflet disc valve early after aortic valve replacement (AVR). We aimed to analyse St. Jude valve hemodynamic function and its clinical impact......Hg. In a multilinear regression analysis GOA indexed for LVEDD, hypertension, and LVEF were independently related to peak gradient. CONCLUSION: High gradients of the standard St. Jude bileaflet disc valve 10 years after AVR was primarily related to systemic hypertension and mismatch between valve and left ventricular...

  16. Translating Basic Behavioral and Social Science Research to Clinical Application: The EVOLVE Mixed Methods Approach

    Science.gov (United States)

    Peterson, Janey C.; Czajkowski, Susan; Charlson, Mary E.; Link, Alissa R.; Wells, Martin T.; Isen, Alice M.; Mancuso, Carol A.; Allegrante, John P.; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B.

    2013-01-01

    Objective: To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease…

  17. Facilitating Consumer Clinical Information Seeking by Maintaining Referential Context: Evaluation of a Prototypic Approach

    Science.gov (United States)

    Lobach, David F.; Waters, Andrew; Silvey, Garry M.; Clark, Shelly J.; Kalyanaraman, Sri; Kawamoto, Kensaku; Lipkus, Isaac

    2009-01-01

    Millions of consumers seek health information on the Internet. Unfortunately, this searching often falls short because of design limitations of many consumer-oriented Web sites. In this paper, we describe an approach that addresses several known barriers to consumer health information seeking. This approach primarily involves maintaining the referential context throughout a consumer’s search for information. To maintain referential context, this approach uses multiple levels of hierarchical constructs to organize complex information, and data elements are toggled to minimize the need for scrolling. An information resource based on this approach was implemented for information about smoking using standard Web technologies. The resource was evaluated by 31 diverse consumers through standardized usability instruments. Consumers found the resource to be easy to navigate and to use. We conclude that the approach described in this manuscript could be applied more broadly to facilitate the organization and presentation of consumer health information. PMID:20351884

  18. 77 FR 13513 - Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public...

    Science.gov (United States)

    2012-03-07

    ... at the public hearing must register on or before close of business on April 2, 2012. To register for...., participation of vulnerable populations, increased frequency of outsourcing) and globalization are posing... from increased clinical trial complexity and globalization? For each of the suggested efforts...

  19. Distribution-based estimates of clinically significant changes in the International Standards for Neurological Classification of Spinal Cord Injury motor and sensory scores.

    Science.gov (United States)

    Scivoletto, G; Tamburella, F; Laurenza, L; Molinari, M

    2013-06-01

    Although the psychometric properties and statistical significance of the International Standards for Neurological Classification of Spinal Cord Injury Patients (ISNCSCI) have been widely examined, the clinical significance of motor and sensory scores (i.e., the improvement in score that has a meaningful impact on patients) is unknown. To calculate the clinical significance of the International Standards for Neurological Classification of Spinal Cord Injury Patients (ISNCSCI). Analysis of prospectively collected data. Spinal Cord Unit of a rehabilitation hospital in the centre of Italy. Analysis of the data of 600 patients with registration of the ISNCSCI Motor scores (total score and separately upper and lower extremity scores) and ISNCSCI Sensory scores. Clinical significance was calculated per several distribution-based approaches: minimal important differences, effect size-based estimates for small and substantial changes, standard error of measurement, and minimal detectable change. The calculated clinical significance was compared with improvements by the patients to determine the percentage of patients who achieved significant improvement. Furthermore, the functional status (as evaluated by the Spinal Cord Independence measure [SCIM III]) was studied in patients who achieved significant improvement compared to those who did not achieve them. The results of the study showed that motor scores were more amenable to change than sensory scores. A 5-point change in motor score resulted in a clinically significant improvement of 0.2 standard deviation units, and an 11-point change in motor score was associated with an improvement of 0.5 standard deviation units. The percentages of patients with a significant improvement varied from 8 to 80% according to the level and severity of the lesion. In some AIS grade/level of lesion groups, patients who achieved clinical significant scores also showed a better functional status with significantly higher SCIM III scores than

  20. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Directory of Open Access Journals (Sweden)

    Mosolov SN

    2014-01-01

    Full Text Available Sergey N Mosolov,1 Andrey V Potapov,1 Uriy V Ushakov,2 Aleksey A Shafarenko,1 Anastasiya B Kostyukova11Department of Mental Disorders Therapy, Moscow Research Institute of Psychiatry, Moscow, Russia; 2Moscow Psychiatric Outpatient Services #21, Moscow, RussiaBackground: International Remission Criteria (IRC for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC.Methods: We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10 criteria and the Mini-International Neuropsychiatric Interview (MINI. Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP. The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI versus olanzapine.Results: Only 64 of the 203 outpatients (31.5% initially met the IRC, and 53 patients (26.1% met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%, or remittent (15% paranoid schizophrenia, or schizoaffective disorder (17%. In addition, 105 patients of 139 (51.7%, who did not meet symptomatic IRC, remained stable within the period. Reanalysis of

  1. Using a business model approach and marketing techniques for recruitment to clinical trials.

    Science.gov (United States)

    McDonald, Alison M; Treweek, Shaun; Shakur, Haleema; Free, Caroline; Knight, Rosemary; Speed, Chris; Campbell, Marion K

    2011-03-11

    Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.

  2. Beyond Ockham's razor: redefining problem-solving in clinical sleep medicine using a "five-finger" approach.

    Science.gov (United States)

    McCarty, David E

    2010-06-15

    The rule of diagnostic parsimony--otherwise known as "Ockham's Razor"--teaches students of medicine to find a single unifying diagnosis to explain a given patient's symptoms. While this approach has merits in some settings, a more comprehensive approach is often needed for patients with chronic, nonspecific presentations for which there is a broad differential diagnosis. The cardinal manifestations of sleep disorders--daytime neurocognitive impairment and subjective sleep disturbances-are examples of such presentations. Successful sleep medicine clinicians therefore approach every patient with the knowledge that multiple diagnoses-rather than simply one-are likely to be found. Teaching an integrated and comprehensive approach to other clinicians in an organized and reproducible fashion is challenging, and the evaluation of effectiveness of such teaching is even more so. As a practical aid for teaching the approach to--and evaluation of--a comprehensive sleep medicine encounter, five functional domains of sleep medicine clinical problem-solving are presented as potential sources for sleep/wake disruption: (1) circadian misalignment, (2) pharmacologic factors, (3) medical factors, (4) psychiatric/psychosocial factors, and (5) primary sleep medicine diagnoses. These domains are presented and explained in an easy-to-remember "five finger" format. The five finger format can be used in real time to evaluate the completeness of a clinical encounter, or can be used in the design of standardized patients to identify areas of strength and potential weakness. A score sheet based upon this approach is offered as an alternative to commonly used Likert scales as a potentially more objective and practical measure of clinical problem-solving competence, making it useful for training programs striving to achieve or maintain fellowship accreditation.

  3. The negotiation of quality standards: A social interactionists approach to fruit and vegetable distribution in Argentina

    NARCIS (Netherlands)

    Arce, A.M.G.; Viteri, M.L.

    2013-01-01

    This article addresses food quality standards. It suggests that writing on standards creates a flat view of the subject, failing to grasp the richness of the multiple self-organizing practices that shape quality within functioning markets. The article documents the social dimension of quality and

  4. Discourse Surrounding the International Education Standards for Professional Accountants (IES): A Content Analysis Approach

    Science.gov (United States)

    Sugahara, Satoshi; Wilson, Rachel

    2013-01-01

    The development and implementation of the International Education Standards (IES) for professional accountants is currently an important issue in accounting education and for educators interested in a shift toward international education standards more broadly. The purpose of this study is to investigate professional and research discourse…

  5. Evaluation of a performance-based standards approach to heavy vehicle design to reduce pavement wear

    CSIR Research Space (South Africa)

    Nordengen, Paul A

    2013-11-01

    Full Text Available of the Australian PBS system while the infrastructure performance standards are based on South African bridge and pavement design standards. In order to optimise road wear per ton of payload, the South African Mechanistic-Empirical Design Method, which is the basis...

  6. An Approach to Improve the Negative Predictive Value and Clinical Utility of Transthoracic Echocardiography in Suspected Native Valve Infective Endocarditis.

    Science.gov (United States)

    Sivak, Joseph A; Vora, Amit N; Navar, Ann Marie; Schulte, Phillip J; Crowley, Anna Lisa; Kisslo, Joseph; Corey, G Ralph; Liao, Lawrence; Wang, Andrew; Velazquez, Eric J; Samad, Zainab

    2016-04-01

    In patients with suspected native valve infective endocarditis, current guidelines recommend initial transthoracic echocardiography (TTE) followed by transesophageal echocardiography (TEE) if clinical suspicion remains. The guidelines do not account for the quality of initial TTE or other findings that may alter the study's diagnostic characteristics. This may lead to unnecessary TEE when initial TTE was sufficient to rule out vegetation. The objective of this study was to determine if the use of a strict definition of negative results on TTE would improve the performance characteristics of TTE sufficiently to exclude vegetation. A retrospective analysis of patients at a single institution with suspected native valve endocarditis who underwent TTE followed by TEE within 7 days between January 1, 2007, and February 28, 2014, was performed. Negative results on TTE for vegetation were defined by either the standard approach (no evidence of vegetation seen on TTE) or by applying a set of strict negative criteria incorporating other findings on TTE. Using TEE as the gold standard for the presence of vegetation, the diagnostic performance of the two transthoracic approaches was compared. In total, 790 pairs of TTE and TEE were identified. With the standard approach, 661 of the transthoracic studies had negative findings (no vegetation seen), compared with 104 studies with negative findings using the strict negative approach (meeting all strict negative criteria). The sensitivity and negative predictive value of TTE for detecting vegetation were substantially improved using the strict negative approach (sensitivity, 98% [95% CI, 95%-99%] vs 43% [95% CI, 36%-51%]; negative predictive value, 97% [95% CI, 92%-99%] vs 87% [95% CI, 84%-89%]). The ability of TTE to exclude vegetation in patients is excellent when strict criteria for negative results are applied. In patients at low to intermediate risk with strict negative results on TTE, follow-up TEE may be unnecessary

  7. A strategic approach for managing conflict in hospitals: responding to the Joint Commission leadership standard, Part 1.

    Science.gov (United States)

    Scott, Charity; Gerardi, Debra

    2011-02-01

    The Joint Commission's leadership standard for conflict management in hospitals, LD.02.04.01, states, "The hospital manages conflict between leadership groups to protect the quality and safety of care." This standard is one of numerous standards and alerts issued by The Joint Commission that address conflict and communication. They underscore the significant impact of relational dynamics on patient safety and quality of care and the critical need for a strategic approach to conflict in health care organizations. Whether leadership conflicts openly threaten a major disruption of hospital operations or whether unresolved conflicts lurk beneath the surface of daily interactions, unaddressed conflict can undermine a hospital's efforts to ensure safe, high-quality patient care. How leaders manage organizational conflict has a significant impact on achieving strategic objectives. Aligning conflict management approaches with quality and safety goals is the first step in adopting a strategic approach to conflict management. A strategic approach goes beyond reducing costs of litigation or improving grievance processes--it integrates a collaborative mind-set and individual conflict competency with nonadversarial processes. Conflict assessment should determine how conflicts are handled among the leaders at the hospital, the degree of conflict competence already present among the leaders, where the most significant conflicts occur, and how leaders think a conflict management system might work for them. Strategically aligning a conflict management approach that addresses conflict among leadership groups as a means of protecting the quality and safety of patient care is at the heart of LD.02.04.01.

  8. Low-dose versus standard-dose CT protocol in patients with clinically suspected renal colic.

    Science.gov (United States)

    Poletti, Pierre-Alexandre; Platon, Alexandra; Rutschmann, Olivier T; Schmidlin, Franz R; Iselin, Christophe E; Becker, Christoph D

    2007-04-01

    The purpose of our study was to compare a low-dose abdominal CT protocol, delivering a dose of radiation close to the dose delivered by abdominal radiography, with standard-dose unenhanced CT in patients with suspected renal colic. One hundred twenty-five patients (87 men, 38 women; mean age, 45 years) who were admitted with suspected renal colic underwent both abdominal low-dose CT (30 mAs) and standard-dose CT (180 mAs). Low-dose CT and standard-dose CT were independently reviewed, in a delayed fashion, by two radiologists for the characterization of renal and ureteral calculi (location, size) and for indirect signs of renal colic (renal enlargement, pyeloureteral dilatation, periureteral or renal stranding). Results reported for low-dose CT, with regard to the patients' body mass indexes (BMIs), were compared with those obtained with standard-dose CT (reference standard). The presence of non-urinary tract-related disorders was also assessed. Informed consent was obtained from all patients. In patients with a BMI 3 mm. Low-dose CT was 100% sensitive and specific for depicting non-urinary tract-related disorders (n = 6). Low-dose CT achieves sensitivities and specificities close to those of standard-dose CT in assessing the diagnosis of renal colic, depicting ureteral calculi > 3 mm in patients with a BMI < 30, and correctly identifying alternative diagnoses.

  9. Household energy consumption versus income and relative standard of living: A panel approach

    International Nuclear Information System (INIS)

    Joyeux, Roselyne; Ripple, Ronald D.

    2007-01-01

    Our fundamental premise is that energy consumption at the household level is a key indicator of standard of living. We employ state-of-the-art panel cointegration techniques to evaluate the nature of the relationship between income measures and energy consumption measures for seven East Indian Ocean countries. The general finding is that income and household electricity consumption are not cointegrated. Given this finding, we conclude that standard of living measures that rely on income measures and do not include household-level energy consumption information will necessarily miss important indications of both levels and changes of standard of living

  10. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    Science.gov (United States)

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  11. Static X-ray diffraction study of cerium: The standard approach and the magic-angle approach

    International Nuclear Information System (INIS)

    Chesnut, Gary N.; Streetman, Becky D.; Schiferl, David; Anderson, William W.; Nicol, Malcolm; Meng Yue

    2004-01-01

    Cerium, a member of the rare earth metals, has been studied up to 300 kilobars in a diamond-anvil cell using energy- and angular-dispersive x-ray diffraction with a synchrotron source. The purpose of this experiment was to examine the electronic and structural behavior of cerium and to examine the effects of deviatoric stress due to non-hydrostatic conditions within the sample environment. Using the standard sample orientation and data from various orientations, the effects of deviatoric stress are shown

  12. A direct sensitivity approach to predict hourly ozone resulting from compliance with the National Ambient Air Quality Standard.

    Science.gov (United States)

    Simon, Heather; Baker, Kirk R; Akhtar, Farhan; Napelenok, Sergey L; Possiel, Norm; Wells, Benjamin; Timin, Brian

    2013-03-05

    In setting primary ambient air quality standards, the EPA's responsibility under the law is to establish standards that protect public health. As part of the current review of the ozone National Ambient Air Quality Standard (NAAQS), the US EPA evaluated the health exposure and risks associated with ambient ozone pollution using a statistical approach to adjust recent air quality to simulate just meeting the current standard level, without specifying emission control strategies. One drawback of this purely statistical concentration rollback approach is that it does not take into account spatial and temporal heterogeneity of ozone response to emissions changes. The application of the higher-order decoupled direct method (HDDM) in the community multiscale air quality (CMAQ) model is discussed here to provide an example of a methodology that could incorporate this variability into the risk assessment analyses. Because this approach includes a full representation of the chemical production and physical transport of ozone in the atmosphere, it does not require assumed background concentrations, which have been applied to constrain estimates from past statistical techniques. The CMAQ-HDDM adjustment approach is extended to measured ozone concentrations by determining typical sensitivities at each monitor location and hour of the day based on a linear relationship between first-order sensitivities and hourly ozone values. This approach is demonstrated by modeling ozone responses for monitor locations in Detroit and Charlotte to domain-wide reductions in anthropogenic NOx and VOCs emissions. As seen in previous studies, ozone response calculated using HDDM compared well to brute-force emissions changes up to approximately a 50% reduction in emissions. A new stepwise approach is developed here to apply this method to emissions reductions beyond 50% allowing for the simulation of more stringent reductions in ozone concentrations. Compared to previous rollback methods, this

  13. OSCE vs. TEM: Different Approaches to Assess Clinical Skills of Nursing Students.

    Science.gov (United States)

    Jelly, Prasuna; Sharma, Rakesh

    2017-01-01

    Nurses are trained with specific clinical skills, and objective structured clinical examination (OSCE) could be a better approach to assess clinical skills of nursing students. A comparative study was conducted by observational checklist regarding antenatal care and opinionnaire on the usefulness of OSCE and tradition evaluation method (TEM) was used to assess the clinical skills and to get opinion. The mean score of OSCE was more than TEM and the difference was statistically significant ( P OSCE was higher than TEM. The study concluded that implementing OSCE will overweigh the advantages of the TEM.

  14. OSCE vs. TEM: Different approaches to assess clinical skills of nursing students

    Directory of Open Access Journals (Sweden)

    Prasuna Jelly

    2017-01-01

    Full Text Available Introduction: Nurses are trained with specific clinical skills, and objective structured clinical examination (OSCE could be a better approach to assess clinical skills of nursing students. Materials and Methods: A comparative study was conducted by observational checklist regarding antenatal care and opinionnaire on the usefulness of OSCE and tradition evaluation method (TEM was used to assess the clinical skills and to get opinion. Results: The mean score of OSCE was more than TEM and the difference was statistically significant (P < 0.001. The opinion of students regarding the usefulness of OSCE was higher than TEM. Conclusions: The study concluded that implementing OSCE will overweigh the advantages of the TEM.

  15. OSCE vs. TEM: Different Approaches to Assess Clinical Skills of Nursing Students

    Science.gov (United States)

    Jelly, Prasuna; Sharma, Rakesh

    2017-01-01

    Introduction: Nurses are trained with specific clinical skills, and objective structured clinical examination (OSCE) could be a better approach to assess clinical skills of nursing students. Materials and Methods: A comparative study was conducted by observational checklist regarding antenatal care and opinionnaire on the usefulness of OSCE and tradition evaluation method (TEM) was used to assess the clinical skills and to get opinion. Results: The mean score of OSCE was more than TEM and the difference was statistically significant (P < 0.001). The opinion of students regarding the usefulness of OSCE was higher than TEM. Conclusions: The study concluded that implementing OSCE will overweigh the advantages of the TEM. PMID:28382064

  16. Analyzing Statistical Mediation with Multiple Informants: A New Approach with an Application in Clinical Psychology.

    Science.gov (United States)

    Papa, Lesther A; Litson, Kaylee; Lockhart, Ginger; Chassin, Laurie; Geiser, Christian

    2015-01-01

    Testing mediation models is critical for identifying potential variables that need to be targeted to effectively change one or more outcome variables. In addition, it is now common practice for clinicians to use multiple informant (MI) data in studies of statistical mediation. By coupling the use of MI data with statistical mediation analysis, clinical researchers can combine the benefits of both techniques. Integrating the information from MIs into a statistical mediation model creates various methodological and practical challenges. The authors review prior methodological approaches to MI mediation analysis in clinical research and propose a new latent variable approach that overcomes some limitations of prior approaches. An application of the new approach to mother, father, and child reports of impulsivity, frustration tolerance, and externalizing problems (N = 454) is presented. The results showed that frustration tolerance mediated the relationship between impulsivity and externalizing problems. The new approach allows for a more comprehensive and effective use of MI data when testing mediation models.

  17. 78 FR 14010 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2013-03-04

    ...). Issued in Washington, DC, on February 15, 2013. John M. Allen, Director, Flight Standards Service..., RNAV (GPS) RWY 36, Orig Siren, WI, Burnett County, Takeoff Minimums and Obstacle DP, Orig BILLING CODE...

  18. 75 FR 63712 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-10-18

    ... 1, 2010. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly..., Takeoff Minimums and Obstacle DP, Amdt 3 Siren, WI, Burnett County, VOR OR GPS RWY 5, Amdt 2B Solon...

  19. 76 FR 40600 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2011-07-11

    ... Navigation (air). Issued in Washington, DC, on June 24, 2011. John M. Allen, Director, Flight Standards... Corinth, MS, Roscoe Turner, RNAV (GPS) RWY 36, Amdt 1 Harvey, ND, Harvey Muni, RNAV (GPS) RWY 29, Orig-A...

  20. A standardized multidisciplinary approach reduces the use of allogeneic blood products in patients undergoing cardiac surgery

    NARCIS (Netherlands)

    van der Linden, P.; de Hert, S.; Daper, A.; Trenchant, A.; Jacobs, D.; de Boelpaepe, C.; Kimbimbi, P.; Defrance, P.; Simoens, G.

    2001-01-01

    PURPOSE: Individual and institutional practices remain an independent predictor factor for allogeneic blood transfusion. Application of a standardized multidisciplinary transfusion strategy should reduce the use of allogeneic blood transfusion in major surgical patients. METHODS: This prospective

  1. 75 FR 25760 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-05-10

    .... John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly, pursuant to... Muni, Takeoff Minimums and Obstacle DP, Amdt 3 Galliano, LA, South Lafourche Leonard Miller Jr, LOC/DME...

  2. 75 FR 9098 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-03-01

    ... 19, 2010. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment 0 Accordingly... GALLIANO SOUTH LAFOURCHE 0/3269 2/3/10 RNAV (GPS) RWY 18, AMDT 1. LEONARD MILLER JR. 8-Apr-10 LA JENNINGS...

  3. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    idea of selecting the subset with minimal p-value when testing the subset-specific treatment effects. We present a framework to compare this approach with other approaches to select subsets by introducing three performance measures. The results of a comprehensive simulation study are presented...

  4. Accounting Education Approach in the Context of New Turkish Commercial Code and Turkish Accounting Standards

    Directory of Open Access Journals (Sweden)

    Cevdet Kızıl

    2014-08-01

    Full Text Available The aim of this article is to investigate the impact of new Turkish commercial code and Turkish accounting standards on accounting education. This study takes advantage of the survey method for gathering information and running the research analysis. For this purpose, questionnaire forms are distributed to university students personally and via the internet.This paper includes significant research questions such as “Are accounting academicians informed and knowledgeable on new Turkish commercial code and Turkish accounting standards?”, “Do accounting academicians integrate new Turkish commercial code and Turkish accounting standards to their lectures?”, “How does modern accounting education methodology and technology coincides with the teaching of new Turkish commercial code and Turkish accounting standards?”, “Do universities offer mandatory and elective courses which cover the new Turkish commercial code and Turkish accounting standards?” and “If such courses are offered, what are their names, percentage in the curriculum and degree of coverage?”Research contributes to the literature in several ways. Firstly, new Turkish commercial code and Turkish accounting standards are current significant topics for the accounting profession. Furthermore, the accounting education provides a basis for the implementations in public and private sector. Besides, one of the intentions of new Turkish commercial code and Turkish accounting standards is to foster transparency. That is definitely a critical concept also in terms of mergers, acquisitions and investments. Stakeholders of today’s business world such as investors, shareholders, entrepreneurs, auditors and government are in need of more standardized global accounting principles Thus, revision and redesigning of accounting educations plays an important role. Emphasized points also clearly prove the necessity and functionality of this research.

  5. Towards the standardization of stem cell therapy studies for ischemic heart diseases: Bridging the gap between animal models and the clinical setting.

    Science.gov (United States)

    Trindade, Fábio; Leite-Moreira, Adelino; Ferreira-Martins, João; Ferreira, Rita; Falcão-Pires, Inês; Vitorino, Rui

    2017-02-01

    Today there is an increasing demand for heart transplantations for patients diagnosed with heart failure. Though, shortage of donors as well as the large number of ineligible patients hurdle such treatment option. This, in addition to the considerable number of transplant rejections, has driven the clinical research towards the field of regenerative medicine. Nonetheless, to date, several stem cell therapies tested in animal models fall by the wayside and when they meet the criteria to clinical trials, subjects often exhibit modest improvements. A main issue slowing down the admission of such therapies in the domain of human trials is the lack of protocol standardization between research groups, which hampers comparison between different approaches as well as the lack of thought regarding the clinical translation. In this sense, given the large amount of reports on stem cell therapy studies in animal models reported in the last 3years, we sought to evaluate their advantages and limitations towards the clinical setting and provide some suggestions for the forthcoming investigations. We expect, with this review, to start a new paradigm on regenerative medicine, by evoking the debate on how to plan novel stem cell therapy studies with animal models in order to achieve more consistent scientific production and accelerate the admission of stem cell therapies in the clinical setting. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Detection of High Frequency Oscillations by Hybrid Depth Electrodes in Standard Clinical Intracranial EEG Recordings

    Directory of Open Access Journals (Sweden)

    Efstathios D Kondylis

    2014-08-01

    Full Text Available High frequency oscillations (HFOs have been proposed as a novel marker for epileptogenic tissue, spurring tremendous research interest into the characterization of these transient events. A wealth of continuously recorded intracranial electroencephalographic (iEEG data is currently available from patients undergoing invasive monitoring for the surgical treatment of epilepsy. In contrast to data recorded on research-customized recording systems, data from clinical acquisition systems remain an underutilized resource for HFO detection in most centers. The effective and reliable use of this clinically obtained data would be an important advance in the ongoing study of HFOs and their relationship to ictogenesis. The diagnostic utility of HFOs ultimately will be limited by the ability of clinicians to detect these brief, sporadic, and low amplitude events in an electrically noisy clinical environment. Indeed, one of the most significant factors limiting the use of such clinical recordings for research purposes is their low signal to noise ratio, especially in the higher frequency bands. In order to investigate the presence of HFOs in clinical data, we first obtained continuous intracranial recordings in a typical clinical environment using a commercially available, commonly utilized data acquisition system and off the shelf hybrid macro/micro depth electrodes. This data was then inspected for the presence of HFOs using semi-automated methods and expert manual review. With targeted removal of noise frequency content, HFOs were detected on both macro- and micro-contacts, and preferentially localized to seizure onset zones. HFOs detected by the offline, semi-automated method were also validated in the clinical viewer, demonstrating that 1 this clinical system allows for the visualization of HFOs, and 2 with effective signal processing, clinical recordings can yield valuable information for offline analysis.

  7. A collaborative comparison of objective structured clinical examination (OSCE) standard setting methods at Australian medical schools.

    Science.gov (United States)

    Malau-Aduli, Bunmi Sherifat; Teague, Peta-Ann; D'Souza, Karen; Heal, Clare; Turner, Richard; Garne, David L; van der Vleuten, Cees

    2017-12-01

    A key issue underpinning the usefulness of the OSCE assessment to medical education is standard setting, but the majority of standard-setting methods remain challenging for performance assessment because they produce varying passing marks. Several studies have compared standard-setting methods; however, most of these studies are limited by their experimental scope, or use data on examinee performance at a single OSCE station or from a single medical school. This collaborative study between 10 Australian medical schools investigated the effect of standard-setting methods on OSCE cut scores and failure rates. This research used 5256 examinee scores from seven shared OSCE stations to calculate cut scores and failure rates using two different compromise standard-setting methods, namely the Borderline Regression and Cohen's methods. The results of this study indicate that Cohen's method yields similar outcomes to the Borderline Regression method, particularly for large examinee cohort sizes. However, with lower examinee numbers on a station, the Borderline Regression method resulted in higher cut scores and larger difference margins in the failure rates. Cohen's method yields similar outcomes as the Borderline Regression method and its application for benchmarking purposes and in resource-limited settings is justifiable, particularly with large examinee numbers.

  8. Short Implants Versus Standard Implants: Midterm Outcomes of a Clinical Study.

    Science.gov (United States)

    Benlidayi, M Emre; Ucar, Yurdanur; Tatli, Ufuk; Ekren, Orhun; Evlice, Burcu; Kisa, Halil Ibrahim; Baksi, Uygar

    2018-02-01

    The aim of this study was to evaluate the midterm survival rate, marginal bone resorption (MBR), and stability of short implants and to compare the results with standard length implants. A total of 38 patients were included. In total, 147 implants (Nucleoss Implants, Izmir, Turkey) were placed (86 short implants and 61 standard implants). Cement-retained metal-ceramic prostheses were fabricated. MBR was evaluated on periapical radiographs taken at implant placement, at the time of crown insertion and annually thereafter. The stability of the implants was evaluated by resonance frequency analysis. The 3- and 5-year cumulative survival rates for standard implants was 98.4% and for short implants was 96.5% (P = 0.644). The MBR of the short implants was significantly lower than that of the standard implants after 1, 2, and 3 years of loading (P implant stability (implant stability quotient values) (P > 0.05). Within the limits of this study, it is concluded that short implants achieved similar results as standard implants after 3 to 5 years of loading.

  9. The stakeholder approach: a new perspective on developing and marketing clinical trials.

    Science.gov (United States)

    Droms, Courtney M; Ferguson, Michael; Giuliano, Karen

    2014-01-01

    The use of evidence-based medical practice has become the standard for health care decision-making. Thus, it has become increasingly important for medical device manufactures to provide evidence for the efficacy of their products. As new products, services, and solutions are developed, it is important to perform a stakeholder analysis to assess clinical evidence needs. As evidenced by the variety of stakeholders in clinical trials, we expect that each has different interests in how clinical trials are developed, conducted, and promoted to the general public. This analysis of the stakeholders' concerns provides recommendations for marketing professionals on meeting the needs of these stakeholders.

  10. Planned change or emergent change implementation approach and nurses' professional clinical autonomy.

    Science.gov (United States)

    Luiking, Marie-Louise; Aarts, Leon; Bras, Leo; Grypdonck, Maria; van Linge, Roland

    2017-11-01

    Nurses' clinical autonomy is considered important for patients' outcome and influenced by the implementation approach of innovations. Emergent change approach with participation in the implementation process is thought to increase clinical autonomy. Planned change approach without this participation is thought not to increase clinical autonomy. Evidence of these effects on clinical autonomy is however limited. To examine the changes in clinical autonomy and in personal norms and values for a planned change and emergent change implementation of an innovation, e.g. intensive insulin therapy. Prospective comparative study with two geographically separated nurses' teams on one intensive care unit (ICU), randomly assigned to the experimental conditions. Data were collected from March 2008 to January 2009. Pre-existing differences in perception of team and innovation characteristics were excluded using instruments based on the innovation contingency model. The Nursing Activity Scale was used to measure clinical autonomy. The Personal Values and Norms instrument was used to assess orientation towards nursing activities and the Team Learning Processes instrument to assess learning as a team. Pre-implementation the measurements did not differ. Post-implementation, clinical autonomy was increased in the emergent change team and decreased in the planned change team. The Personal Values and Norms instrument showed in the emergent change team a decreased hierarchic score and increased developmental and rational scores. In the planned change team the hierarchical and group scores were increased. Learning as a team did not differ between the teams. In both teams there was a change in clinical autonomy and orientation towards nursing activities, in line with the experimental conditions. Emergent change implementation resulted in more clinical autonomy than planned change implementation. If an innovation requires the nurses to make their own clinical decisions, an emergent change

  11. Addiction Competencies in the 2009 CACREP Clinical Mental Health Counseling Program Standards

    Science.gov (United States)

    Lee, Tiffany K.; Craig, Stephen E.; Fetherson, Bianca T. L.; Simpson, C. Dennis

    2013-01-01

    The Council for Accreditation of Counseling and Related Educational Programs developed addiction competencies for clinical mental health counseling students. This article highlights these competencies, provides an overview of current addiction training, and describes methods to integrate addiction education into curricula.

  12. The inter-examiner reliability of standardized manual palpation for the identification of clinically relevant myofascial triggerpoints

    DEFF Research Database (Denmark)

    Myburgh, Corrie; Lauridsen, Henrik Hein; Larsen, Anders Holsgaard

    -observer agreement of TP examination among four examiners and whether reproducibility is influenced by examiner clinical experience. Two experienced and two inexperienced clinicians each performed a standardized palpation of the upper Trapezius musculature. Each observer was asked to judge the presents....../absence of clinically relevant TP(s) using clinician global assessment (GA). A random case mix of 81 female participants was examined, 14 being asymptomatic and the remainder suffering from neck/shoulder pain. Examiners received psychomotor training and video analysis feedback provided prior to and during the study...... in order to improve protocol standardization. Kappa co-efficients were calculated for all possible examiner pairings. Good agreement was noted between the experienced pairing (κ= 0.63). Moderate levels of agreement were observed among the two mixed pairings (κ=0.35 and 0.47 respectively). However, poor...

  13. Differences in Approach between Nuclear and Conventional Seismic Standards with regard to Hazard Definition - CSNI Integrity And Ageing Working Group

    International Nuclear Information System (INIS)

    Djaoudi, Ali; Labbe, Pierre; Murphy, Andrew; Kitada, Yoshio

    2008-01-01

    The Committee on the safety of Nuclear Installations (CSNI) of the OECD-NEA co-ordinates the NEA activities related to maintaining and advancing the scientific and technological knowledge base of the safety of nuclear installations. The Integrity and Ageing of Components and Structures Working Group of the CSNI is responsible for work related to the development and use of methods, data and information to assess the behaviour of materials and structures. It has three sub-groups, dealing with the integrity of metal components and structures, ageing of concrete structures, and the seismic behaviour of structures. The CSNI, at its meeting in June 2003, agreed to initiate an activity aimed to identify any difference between nuclear and non-nuclear conventional standards and their potential significance with regard to seismic hazards and design methods. There was a perception, mainly in some of the European countries that nuclear seismic hazard and design standards may be lagging behind developments in similar standards for conventional facilities. Adequate answer to such perception, need the examination of the following aspects and their significance on the seismic assessment of structures and components: - The safety philosophy behind the seismic nuclear and conventional standards. - The differences in approach regarding the seismic hazard definition. - The difference in approach regarding the design and the methods of analysis. These topics are examined in this report. Appendices A to H of this report contain a brief description of the conventional and the nuclear approaches in the NEA member countries: Belgium, Canada, Czech Republic, Germany, Japan, South Korea, Spain,and USA. The following general conclusions can be drawn: - The approach adopted by the nuclear seismic standards is more conservative and more reliable (in particular for meeting the continued operation criteria) than the recommended by the currently applicable force based conventional seismic codes

  14. Standardized serum GM-CSF autoantibody testing for the routine clinical diagnosis of autoimmune pulmonary alveolar proteinosis.

    Science.gov (United States)

    Uchida, Kanji; Nakata, Koh; Carey, Brenna; Chalk, Claudia; Suzuki, Takuji; Sakagami, Takuro; Koch, Diana E; Stevens, Carrie; Inoue, Yoshikazu; Yamada, Yoshitsugu; Trapnell, Bruce C

    2014-01-15

    Autoantibodies against granulocyte/macrophage colony-stimulating factor (GMAbs) cause autoimmune pulmonary alveolar proteinosis (PAP) and measurement of the GMAb level in serum is now commonly used to identify this disease, albeit, in a clinical research setting. The present study was undertaken to optimize and standardize serum GMAb concentration testing using a GMAb enzyme-linked immunosorbent assay (GMAb ELISA) to prepare for its introduction into routine clinical use. The GMAb ELISA was evaluated using serum specimens from autoimmune PAP patients, healthy people, and GMAb-spiked serum from healthy people. After optimizing assay components and procedures, its accuracy, precision, reliability, sensitivity, specificity, and ruggedness were evaluated. The coefficient of variation in repeated measurements was acceptable (standards, or by storage of serum samples at -80°C. The lower limit of quantification (LLOQ) of the PAP patient-derived polyclonal GMAb reference standard (PCRS) was 0.78ng/ml. Receiver operating characteristic curve analysis identified a serum GMAb level of 5μg/ml (based on PCRS) as the optimal cut off value for distinguishing autoimmune PAP serum from normal serum. A pharmaceutical-grade, monoclonal GMAb reference standard (MCRS) was developed as the basis of a new unit of measure for GMAb concentration: one International Unit (IU) of GMAb is equivalent to 1μg/ml of MCRS. The median [interquartile range] serum GMAb level was markedly higher in autoimmune PAP patients than in healthy people (21.54 [12.83-36.38] versus 0.08 [0.05-0.14] IU; n=56, 38; respectively; Pstandardized units. These findings support the use of this GMAb ELISA for the routine clinical diagnosis of autoimmune PAP and introduce a new unit of measure to enable standardized reporting of serum GMAb data from different laboratories. Copyright © 2013. Published by Elsevier B.V.

  15. An ontology-based hierarchical semantic modeling approach to clinical pathway workflows.

    Science.gov (United States)

    Ye, Yan; Jiang, Zhibin; Diao, Xiaodi; Yang, Dong; Du, Gang

    2009-08-01

    This paper proposes an ontology-based approach of modeling clinical pathway workflows at the semantic level for facilitating computerized clinical pathway implementation and efficient delivery of high-quality healthcare services. A clinical pathway ontology (CPO) is formally defined in OWL web ontology language (OWL) to provide common semantic foundation for meaningful representation and exchange of pathway-related knowledge. A CPO-based semantic modeling method is then presented to describe clinical pathways as interconnected hierarchical models including the top-level outcome flow and intervention workflow level along a care timeline. Furthermore, relevant temporal knowledge can be fully represented by combing temporal entities in CPO and temporal rules based on semantic web rule language (SWRL). An illustrative example about a clinical pathway for cesarean section shows the applicability of the proposed methodology in enabling structured semantic descriptions of any real clinical pathway.

  16. Development of a document management system for the standardization of clinical laboratory documents.

    Science.gov (United States)

    Hwang, Sang-Hyun; Jung, Seon-Kyung; Kang, Soo-Jin; Cha, Hyo Soung; Chung, Seung Hyun; Lee, Do-Hoon

    2013-11-01

    Documentation is very important; a considerable number of documents exist for use in accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system. A document code formatting system was modified by comparing the document list data received from 3 major university hospitals. In addition, a questionnaire regarding document code standardization was created and sent to 268 institutes to establish document classifications and generate a standard coding scheme. A computerized document management system was developed. Only 32% (8 out of 25 institutes) answered that they were able to identify all of the document types and their numbers. In total, 76% of institutes (19 out of 25) answered that a systematic document management system was necessary. Disorganized document files were systemized by classifying them into 8 major groups according to their characteristics: patient test records (T), test quality control (Q), manuals (M), equipment and environment management (E), statistics (S), division administration (A), department administration (R), and others (X). Our documentation system may serve as a basis for the standardization of documents and the creation of a document management system for all hospital laboratories.

  17. The Development of a New Medical Device for Standardized Episiotomy: A Pre-Clinical Validation Study

    NARCIS (Netherlands)

    Mulder, Femke; Piersma, Dorine; Veersema, Sebastiaan; van der Post, Joris; Roovers, Jan-Paul

    2016-01-01

    The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. We performed a preclinical validation study. This study was performed at the University hospital. Animal, cadaver. Together with technical engineers,

  18. The Right "Fit": Exploring Science Teacher Candidates' Approaches to Natural Selection Within a Clinical Simulation

    Science.gov (United States)

    Dotger, Benjamin; Dotger, Sharon; Masingila, Joanna; Rozelle, Jeffrey; Bearkland, Mary; Binnert, Ashley

    2017-04-01

    Teachers and students struggle with the complexities surrounding the evolution of species and the process of natural selection. This article examines how science teacher candidates (STCs) engage in a clinical simulation that foregrounds two common challenges associated with natural selection—students' understanding of "survival of the fittest" and the variation of species over time. We outline the medical education pedagogy of clinical simulations and its recent diffusion to teacher education. Then, we outline the study that situates each STC in a one-to-one interaction with a standardized student who is struggling to accurately interpret natural selection concepts. In simulation with the standardized student, each STC is challenged to recognize content misconceptions and respond with appropriate instructional strategies and accurate explanations. Findings and implications center on the STCs' instructional practices in the simulation and the use of clinical learning environments to foster science teacher learning.

  19. A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials.

    Science.gov (United States)

    Odani, Motoi; Fukimbara, Satoru; Sato, Tosiya

    2017-04-01

    Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Comparison of the results from the Bayesian meta-analysis model with those from Fisher's exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher's exact test under the body system "Musculoskeletal and connective tissue disorders." Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher's exact test. For example, when the threshold value of the posterior probability for

  20. What do standard radiography and clinical examination tell about the shoulder with cuff tear arthropathy?

    Directory of Open Access Journals (Sweden)

    Favard Luc

    2011-01-01

    Full Text Available Abstract Background This study evaluates the preoperative conventional anteroposterior radiography and clinical testing in non-operated patients with cuff tear arthropathy. It analyses the radiological findings in relation to the status of the rotator cuff and clinical status as also the clinical testing in relation to the rotator cuff quality. The aim of the study is to define the usefulness of radiography and clinical examination in cuff tear arthropathy. Methods This study analyses the preoperative radiological (AP-view, (Artro-CT-scan or MRI-scan and clinical characteristics (Constant-Murley-score plus active and passive mobility testing and the peroperative findings in a cohort of 307 patients. These patients were part of a multicenter, retrospective, consecutive study of the French Orthopaedic Society (SOFCOT-2006. All patients had no surgical antecedents and were all treated with prosthetic shoulder surgery for a painful irreparable cuff tear arthropathy (reverse-(84% or hemi-(8% or double cup-bipolar prosthesis (8%. Results A positive significancy could be found for the relationship between clinical testing and the rotator cuff quality; between acromiohumeral distance and posterior rotator cuff quality; between femoralization and posterior rotator cuff quality. Conclusion A conventional antero-posterior radiograph can not provide any predictive information on the clinical status of the patient. The subscapular muscle can be well tested by the press belly test and the teres minor muscle can be well tested by the hornblower' sign and by the exorotation lag signs. The upward migration index and the presence of femoralization are good indicators for the evaluation of the posterior rotator cuff. An inferior coracoid tip positioning suggests rotator cuff disease.

  1. Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

    Science.gov (United States)

    Cunningham, S G; Carinci, F; Brillante, M; Leese, G P; McAlpine, R R; Azzopardi, J; Beck, P; Bratina, N; Bocquet, V; Doggen, K; Jarosz-Chobot, P K; Jecht, M; Lindblad, U; Moulton, T; Metelko, Ž; Nagy, A; Olympios, G; Pruna, S; Skeie, S; Storms, F; Di Iorio, C T; Massi Benedetti, M

    2016-01-01

    A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.

  2. QCM-D surpassing clinical standard for the dose administration of new oral anticoagulant in the patient of coagulation disorders.

    Science.gov (United States)

    Hussain, Munawar; Wendel, Hans Peter; Schmidt, Katrin; Langer, Elisabeth; Körber, Mareike Kristina; Faul, Oksana; Northoff, Hinnak; von Heymann, Christian; Gehring, Frank K

    2018-05-01

    The study focuses the dose administration of dabigatran to avoid the deaths due to hemorrhagic complications and thromboembolic stroke in clinics worldwide. To target the issue, a novel emerging acoustic technology, namely ''Quartz Crystal Microbalance with Dissipation'' (QCM-D) has been applied, while the acoustic assays namely ''activated Partial Thromboplastin Time'' (aPTT) and ''Prothrombinase complex-induced Clotting Test'' (PiCT) have been compared with the standard methods in parallel. Both techniques have been applied to 300 samples, including 220 plasma samples of patients suffering coagulation disorders and 80 plasma samples of non-patients. In comparison, the coagulation times of the acoustic aPTT and PiCT yielded an excellent correlation with the standard methods with in analytical standard deviation limits. Finally, the acoustic aPTT assay is the ''gold standard'' for a dose administration of the new oral anticoagulant, where the Δf/ΔΓ ratio of the acoustic assay demonstrates that dabigatran with FEIBA 50 combination could be a safe remedy to avoid the deaths in clinics. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Clinical evaluation of further-developed MRCP sequences in comparison with standard MRCP sequences

    International Nuclear Information System (INIS)

    Hundt, W.; Scheidler, J.; Reiser, M.; Petsch, R.

    2002-01-01

    The purpose of this study was the comparison of technically improved single-shot magnetic resonance cholangiopancreatography (MRCP) sequences with standard single-shot rapid acquisition with relaxation enhancement (RARE) and half-Fourier acquired single-shot turbo spin-echo (HASTE) sequences in evaluating the normal and abnormal biliary duct system. The bile duct system of 45 patients was prospectively investigated on a 1.5-T MRI system. The investigation was performed with RARE and HASTE MR cholangiography sequences with standard and high spatial resolutions, and with a delayed-echo half-Fourier RARE (HASTE) sequence. Findings of the improved MRCP sequences were compared with the standard MRCP sequences. The level of confidence in assessing the diagnosis was divided into five groups. The Wilcoxon signed-rank test at a level of p<0.05 was applied. In 15 patients no pathology was found. The MRCP showed stenoses of the bile duct system in 10 patients and choledocholithiasis and cholecystolithiasis in 16 patients. In 12 patients a dilatation of the bile duct system was found. Comparison of the low- and high spatial resolution sequences and the short and long TE times of the half-Fourier RARE (HASTE) sequence revealed no statistically significant differences regarding accuracy of the examination. The diagnostic confidence level in assessing normal or pathological findings for the high-resolution RARE and half-Fourier RARE (HASTE) was significantly better than for the standard sequences. For the delayed-echo half-Fourier RARE (HASTE) sequence no statistically significant difference was seen. The high-resolution RARE and half-Fourier RARE (HASTE) sequences had a higher confidence level, but there was no significant difference in diagnosis in terms of detection and assessment of pathological changes in the biliary duct system compared with standard sequences. (orig.)

  4. Clinical evaluation of further-developed MRCP sequences in comparison with standard MRCP sequences

    Energy Technology Data Exchange (ETDEWEB)

    Hundt, W.; Scheidler, J.; Reiser, M. [Department of Clinical Radiology, Klinikum Grosshadern, Ludwig-Maximilians University of Munich (Germany); Petsch, R. [Department of MRI, Siemens Medizintechnik, Erlangen (Germany)

    2002-07-01

    The purpose of this study was the comparison of technically improved single-shot magnetic resonance cholangiopancreatography (MRCP) sequences with standard single-shot rapid acquisition with relaxation enhancement (RARE) and half-Fourier acquired single-shot turbo spin-echo (HASTE) sequences in evaluating the normal and abnormal biliary duct system. The bile duct system of 45 patients was prospectively investigated on a 1.5-T MRI system. The investigation was performed with RARE and HASTE MR cholangiography sequences with standard and high spatial resolutions, and with a delayed-echo half-Fourier RARE (HASTE) sequence. Findings of the improved MRCP sequences were compared with the standard MRCP sequences. The level of confidence in assessing the diagnosis was divided into five groups. The Wilcoxon signed-rank test at a level of p<0.05 was applied. In 15 patients no pathology was found. The MRCP showed stenoses of the bile duct system in 10 patients and choledocholithiasis and cholecystolithiasis in 16 patients. In 12 patients a dilatation of the bile duct system was found. Comparison of the low- and high spatial resolution sequences and the short and long TE times of the half-Fourier RARE (HASTE) sequence revealed no statistically significant differences regarding accuracy of the examination. The diagnostic confidence level in assessing normal or pathological findings for the high-resolution RARE and half-Fourier RARE (HASTE) was significantly better than for the standard sequences. For the delayed-echo half-Fourier RARE (HASTE) sequence no statistically significant difference was seen. The high-resolution RARE and half-Fourier RARE (HASTE) sequences had a higher confidence level, but there was no significant difference in diagnosis in terms of detection and assessment of pathological changes in the biliary duct system compared with standard sequences. (orig.)

  5. The development of an ICF-based clinical guideline and screening tool for the standardized assessment and evaluation of functioning after head and neck cancer treatment.

    Science.gov (United States)

    Kisser, Ulrich; Adderson-Kisser, Christine; Coenen, Michaela; Stier-Jarmer, Marita; Becker, Sven; Sabariego, Carla; Harréus, Ulrich

    2017-02-01

    The assessment and evaluation of functioning and quality of life after tumor treatment in head and neck cancer (HNC) are considered as essential aspects of clinical routine and studies. A huge number of instruments are available that have been designed to evaluate functioning and quality of life after HNC treatment. The diversity of these instruments in terms of content, response options and administration hinders the comparability of available studies and the performance of meta-analyses. The objective of this paper is to inform about the development of a screening tool for the standardized assessment and evaluation of functioning based on the International Classification of Functioning, Disability and Health (ICF) Core Set for HNC. We followed a multi-step approach including (1) preparatory studies to identify and preselect suitable instruments for the assessment of functioning, (2) a decision-making process to agree on an ICF-based clinical guideline including instruments assessing functioning and (3) the development of a computer-based standardized screening tool to assess and evaluate functioning based on this guideline in clinical routine. Twenty-one experts participated in a consensus meeting and decided on instruments to be included in an ICF-based clinical guideline and screening tool for the assessment and evaluation of functioning in HNC patients in cancer treatment. The chosen instruments cover all aspects of the ICF Core Set for HNC addressing therapy control, pain, food intake/swallowing, voice/speech/breathing, other somatic complaints and psychosocial aspects. The screening tool contains patient-reported outcome measures and a clinician's checklist. It has to be further tested in clinical practice.

  6. Standardization for climate change. Approaches and perspectives. Final report; Normstelling voor klimaatverandering. Invalshoeken en perspectieven. Eindrapport

    Energy Technology Data Exchange (ETDEWEB)

    Weterings, R.

    1995-01-01

    The results of a project, aimed at support of the environmental quality target for climate policy on a national level (Follow-up Memorandum Climatic Change of the Dutch government) and on an international level (elaboration of the UN Framework Convention on Climate Change). In order to generate ideas for standards of the climate policy a workshop was held on Environmental Quality and Climate. During the workshop standards of climatic change were highlighted from different points of view. Those views and perspectives are analyzed and the results are presented in this report. 4 figs., 31 refs.

  7. Learning curve for a modified Watson-Jones minimally invasive approach in primary total hip replacement: analysis of complications and early results versus the standard-incision posterior approach.

    Science.gov (United States)

    Laffosse, Jean-Michel; Chiron, Philippe; Accadbled, Franck; Molinier, François; Tricoire, Jean-Louis; Puget, Jean

    2006-12-01

    We analysed the learning curve of an anterolateral minimally invasive (ALMI) approach for primary total hip replacement (THR). The first 42 THR's with large-diameter heads implanted through this approach (group 1) were compared to a cohort of 58 THR's with a 28-mm head performed through a standard-incision posterior approach (group 2). No selection was made and the groups were comparable. Implant positioning as well as early clinical results were satisfactory and were comparable in the two groups. In group 1, the rate of intraoperative complications was significantly higher (greater trochanter fracture in 4 cases, cortical perforation in 3 cases, calcar fracture in one case, nerve palsy in one case, secondary tilting of the metal back in 2 cases) than in group 2 (one nerve palsy and one calcar crack). At 6 months, one revision of the acetabular cup was performed in group 1 for persistent pain, whereas in group 2, we noted 3 dislocations (2 were revised) and 2 periprosthetic femoral fractures. Our study showed a high rate of intra- and perioperative complications during the learning curve for an ALMI approach. These are more likely to occur in obese or osteoporotic patients, and in those with bulky muscles or very stiff hips. Postoperative complications were rare. The early clinical results are excellent and we may expect to achieve better results with a more standardised procedure. During the initial period of the learning curve, it would be preferable to select patients with an appropriate morphology.

  8. A clinical pathway including psychotherapy approaches for managing emotional difficulties after acquired brain injury.

    Science.gov (United States)

    Coetzer, Rudi

    2009-11-01

    Emotional difficulties, such as anxiety and depression, are common after acquired brain injury in adults and can influence long-term outcome. Diagnosis in a brain injury context can be difficult. Ideally, rehabilitation approaches should consider the specific treatment of anxiety and depression as well and may include pharmacotherapy, individual psychotherapy, and family interventions. Psychotherapy, especially in regards to longer-term adjustment to brain injury, may have an important adjunctive role in treatment approaches, but adaptations of techniques may be needed. A clinical pathway is described which can help to raise clinicians awareness, as well as increase detection rates and consideration of the specific role of individual psychotherapy in this clinical population. However, an important caveat is that clinical pathways should not serve as a substitute, but rather a facilitator, for the process of reasoning about individual patients in everyday clinical practice.

  9. Multigrid method based on a space-time approach with standard coarsening for parabolic problems

    NARCIS (Netherlands)

    S.R. Franco (Sebastião Romero); F.J. Gaspar Lorenz (Franscisco); M.A. Villela Pinto (Marcio Augusto); C. Rodrigo (Carmen)

    2018-01-01

    textabstractIn this work, a space-time multigrid method which uses standard coarsening in both temporal and spatial domains and combines the use of different smoothers is proposed for the solution of the heat equation in one and two space dimensions. In particular, an adaptive smoothing strategy,

  10. Vehicle safety performance improvements using a performance-based standards approach: four case studies

    CSIR Research Space (South Africa)

    Nordengen, Paul A

    2014-01-01

    Full Text Available As part of a performance-based standards (PBS) research programme for heavy vehicles in South Africa, a need was identified to design, manufacture and operate a number of PBS or Smart Truck demonstration vehicles. The purpose of the demonstration...

  11. 78 FR 37452 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2013-06-21

    ..., 2013. John M. Allen, Director, Flight Standards Service. Adoption of the Amendment Accordingly..., Amdt 1. 7/25/13 FL Tampa Tampa Executive. 3/0405 6/6/13 ILS OR LOC RWY 23, Amdt 1. 7/25/13 FL Milton...

  12. Bootstrap Approach To Compare the Slopes of Two Calibrations When Few Standards Are Available.

    Science.gov (United States)

    Estévez-Pérez, Graciela; Andrade, Jose M; Wilcox, Rand R

    2016-02-16

    Comparing the slopes of aqueous-based and standard addition calibration procedures is almost a daily task in analytical laboratories. As usual protocols imply very few standards, sound statistical inference and conclusions are hard to obtain for current classical tests (e.g., the t-test), which may greatly affect decision-making. Thus, there is a need for robust statistics that are not distorted by small samples of experimental values obtained from analytical studies. Several promising alternatives based on bootstrapping are studied in this paper under the typical constraints common in laboratory work. The impact of number of standards, homoscedasticity or heteroscedasticity, three variance patterns, and three error distributions on least-squares fits were considered (in total, 144 simulation scenarios). The Student's t-test is the most valuable procedure when the normality assumption is true and homoscedasticity is present, although it can be highly affected by outliers. A wild bootstrap method leads to average rejection percentages that are closer to the nominal level in almost every situation, and it is recommended for laboratories working with a small number of standards. Finally, it was seen that the Theil-Sen percentile bootstrap statistic is very robust but its rejection percentages depart from the nominal ones (bootstrap principles to compare the slopes of two calibration lines.

  13. Hierarchical Control of Droop-Controlled DC and AC Microgrids - A General Approach Towards Standardization

    DEFF Research Database (Denmark)

    Guerrero, Josep M.; Vásquez, Juan V.; Teodorescu, Remus

    2009-01-01

    from ISA-95 and electrical dispatching standards to endow smartness and flexibility to microgrids. The hierarchical control proposed consist of three levels: i) the primary control is based on the droop method, including an output impedance virtual loop; ii) the secondary control allows restoring...

  14. Sustainability in Science Education? How the Next Generation Science Standards Approach Sustainability, and Why It Matters

    Science.gov (United States)

    Feinstein, Noah Weeth; Kirchgasler, Kathryn L.

    2015-01-01

    In this essay, we explore how sustainability is embodied in the Next Generation Science Standards (NGSS), analyzing how the NGSS explicitly define and implicitly characterize sustainability. We identify three themes (universalism, scientism, and technocentrism) that are common in scientific discourse around sustainability and show how they appear…

  15. 75 FR 72942 - Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures...

    Science.gov (United States)

    2010-11-29

    ...: Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions..., SD, Rapid City Rgnl, ILS OR LOC RWY 32, Amdt 19 Newport News, VA, Newport News/Williamsburg Intl, ILS OR LOC RWY 7, Amdt 33 Newport News, VA, Newport News/Williamsburg Intl, ILS OR LOC RWY 25, Amdt 1...

  16. Methodology of synchronization among strategy and operation. A standards-based modeling approach

    Directory of Open Access Journals (Sweden)

    VICTOR EDWIN COLLAZOS

    2017-05-01

    Full Text Available Enterprise Architecture (EA has gained importance in recent years, mainly for its concept of “alignment” between the strategic and operational levels of organizations. Such alignment occurs when Information Technology (IT is applied correctly and timely, working in synergy and harmony with strategy and the operation to achieve mutually their own goals and satisfy the organizational needs.Both the strategic and operational levels have standards that help model elements necessary to obtain desired results. In this sense, BMM and BPMN were selected because both have the support of OMG and they are fairly well known for modelling the strategic level and operational level, respectively. In addition, i* modeling goal can be used for reducing the gap between these two standards. This proposal may help both the high-level design of the information system and to the appropriate identification of the business processes that will support it.This paper presents a methodology for aligning strategy and the operation based on standards and heuristics. We have made a classification for elements of the models and, for some specific cases, an extension of the heuristics associated between them. This allows us to propose methodology, which uses above-mentioned standards and combines mappings, transformations and actions to be considered in the alignment process.

  17. A confirmatory factor analysis of the WMS-III in a clinical sample with crossvalidation in the standardization sample.

    Science.gov (United States)

    Bradley Burton, D; Ryan, Joseph J; Axelrod, Bradley N; Schellenberger, Tony; Richards, Heather M

    2003-08-01

    A maximum likelihood confirmatory factor analysis (CFA) of the Wechsler Memory Scale-III (WMS-III) was performed by applying LISREL 8 to a general clinical sample (n=281). Analyses were designed to determine which of seven hypothesized oblique factor solutions could best explain memory as measured by the WMS-III. Competing latent variable models were identified in previous studies. Results in the clinical sample were crossvalidated by testing all models in the WMS-III standardization samples (combined n=1,250). Findings in both the clinical and standardization samples supported a four-factor model containing auditory memory, visual memory, working memory, and learning factors. Our analysis differed from that presented in the WMS-III manual and by other authors. We tested our models in a clinical sample and included selected word list subtests in order to test the viability of a learning dimension. Consistent with prior research, we were also unable to empirically support the viability of the immediate and delayed memory indices, despite allowing the error terms between the immediate and delayed memory subtests to correlate.

  18. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study.

    Science.gov (United States)

    Wittenmeier, Eva; Bellosevich, Sophia; Mauff, Susanne; Schmidtmann, Irene; Eli, Michael; Pestel, Gunther; Noppens, Ruediger R

    2015-10-01

    Collecting a blood sample is usually necessary to measure hemoglobin levels in children. Especially in small children, noninvasively measuring the hemoglobin level could be extraordinarily helpful, but its precision and accuracy in the clinical environment remain unclear. In this study, noninvasive hemoglobin measurement and blood gas analysis were compared to hemoglobin measurement in a clinical laboratory. In 60 healthy preoperative children (0.2-7.6 years old), hemoglobin was measured using a noninvasive method (SpHb; Radical-7 Pulse Co-Oximeter), a blood gas analyzer (clinical standard, BGAHb; ABL 800 Flex), and a laboratory hematology analyzer (reference method, labHb; Siemens Advia). Agreement between the results was assessed by Bland-Altman analysis and by determining the percentage of outliers. Sixty SpHb measurements, 60 labHb measurements, and 59 BGAHb measurements were evaluated. In 38% of the children, the location of the SpHb sensor had to be changed more than twice for the signal quality to be sufficient. The bias/limits of agreement between SpHb and labHb were -0.65/-3.4 to 2.1 g·dl(-1) . Forty-four percent of the SpHb values differed from the reference value by more than 1 g·dl(-1) . Age, difficulty of measurement, and the perfusion index (PI) had no influence on the accuracy of SpHb. The bias/limits of agreement between BGAHb and labHb were 1.14/-1.6 to 3.9 g·dl(-1) . Furthermore, 66% of the BGAHb values differed from the reference values by more than 1 g·dl(-1) . The absolute mean difference between SpHb and labHb (1.1 g·dl(-1) ) was smaller than the absolute mean difference between BGAHb and labHb (1.5 g·dl(-1) /P = 0.024). Noninvasive measurement of hemoglobin agrees more with the reference method than the measurement of hemoglobin using a blood gas analyzer. However, both methods can show clinically relevant differences from the reference method (ClinicalTrials.gov: NCT01693016). © 2015 John Wiley & Sons Ltd.

  19. Total-body photography in skin cancer screening: the clinical utility of standardized imaging.

    Science.gov (United States)

    Rosenberg, Alexandra; Meyerle, Jon H

    2017-05-01

    Early detection of skin cancer is essential to reducing morbidity and mortality from both melanoma and nonmelanoma skin cancers. Total-body skin examinations (TBSEs) may improve early detection of malignant melanomas (MMs) but are controversial due to the poor quality of data available to establish a mortality benefit from skin cancer screening. Total-body photography (TBP) promises to provide a way forward by lowering the costs of dermatologic screening while simultaneously leveraging technology to increase patient access to dermatologic care. Standardized TBP also offers the ability for dermatologists to work synergistically with modern computer technology involving algorithms capable of analyzing high-quality images to flag concerning lesions that may require closer evaluation. On a population level, inexpensive TBP has the potential to increase access to skin cancer screening and it has several specific applications in a military population. The utility of standardized TBP is reviewed in the context of skin cancer screening and teledermatology.

  20. Machine Learning Approaches for Detecting Diabetic Retinopathy from Clinical and Public Health Records.

    Science.gov (United States)

    Ogunyemi, Omolola; Kermah, Dulcie

    2015-01-01

    Annual eye examinations are recommended for diabetic patients in order to detect diabetic retinopathy and other eye conditions that arise from diabetes. Medically underserved urban communities in the US have annual screening rates that are much lower than the national average and could benefit from informatics approaches to identify unscreened patients most at risk of developing retinopathy. Using clinical data from urban safety net clinics as well as public health data from the CDC's National Health and Nutrition Examination Survey, we examined different machine learning approaches for predicting retinopathy from clinical or public health data. All datasets utilized exhibited a class imbalance. Classifiers learned on the clinical data were modestly predictive of retinopathy with the best model having an AUC of 0.72, sensitivity of 69.2% and specificity of 55.9%. Classifiers learned on public health data were not predictive of retinopathy. Successful approaches to detecting latent retinopathy using machine learning could help safety net and other clinics identify unscreened patients who are most at risk of developing retinopathy and the use of ensemble classifiers on clinical data shows promise for this purpose.

  1. Predicting failing performance on a standardized patient clinical performance examination: the importance of communication and professionalism skills deficits.

    Science.gov (United States)

    Chang, Anna; Boscardin, Christy; Chou, Calvin L; Loeser, Helen; Hauer, Karen E

    2009-10-01

    The purpose is to determine which assessment measures identify medical students at risk of failing a clinical performance examination (CPX). Retrospective case-control, multiyear design, contingency table analysis, n = 149. We identified two predictors of CPX failure in patient-physician interaction skills: low clerkship ratings (odds ratio 1.79, P = .008) and student progress review for communication or professionalism concerns (odds ratio 2.64, P = .002). No assessments predicted CPX failure in clinical skills. Performance concerns in communication and professionalism identify students at risk of failing the patient-physician interaction portion of a CPX. This correlation suggests that both faculty and standardized patients can detect noncognitive traits predictive of failing performance. Early identification of these students may allow for development of a structured supplemental curriculum with increased opportunities for practice and feedback. The lack of predictors in the clinical skills portion suggests limited faculty observation or feedback.

  2. Guidelines for defining and implementing standard episode of care for hematopoietic stem cell transplantation within the context of clinical trials.

    Science.gov (United States)

    Majhail, Navneet S; Giralt, Sergio; Bonagura, Anthony; Crawford, Stephen; Farnia, Stephanie; Omel, James L; Pasquini, Marcelo; Saber, Wael; LeMaistre, Charles F

    2015-04-01

    The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  3. Assessment of Measurement Tools of Observation Rate of Nursing Handover Standards in Clinical Wards of Hospital

    Directory of Open Access Journals (Sweden)

    Saadi Amini

    2015-08-01

    Full Text Available Background and objectives : In health centers, clinical information of patient is transferred among care staffs regularly. One of the common cases in information transferring is during the time of nurses’ handover in hospital which performing it correctly will help schedule patient care, providing safety and facilitating exact transferring of information. The aim of this study is investigating validity and reliability of assessment of observance rate of shift handover in clinical wards checklist. Material and Methods : In order to determine the reliability of checklist, two experts panel meetings were held with the presence of 10 experts in clinical field that in those meetings the reliability was investigated with discussion and consensus of participants. Checklist validity was investigated through pilot study in 4 wards of 4 hospitals and calculated by Kronbach- alpha method with 28 cases of shifts handover in morning, noon, and night shift. Results : In studying reliability, the primary checklist was divided into two checklists: patient handover, equipments and ward handover that included 27 and 72 items, respectively. The reliability of patient handover checklist was verified with 0.9155 Kronbach-alpha and that of equipments and ward handover was verified with 0.8779 Kronbach-alpha. Conclusion : Verifying checklists by mentioned scientific and statistical methods showed that these are very powerful instruments that can be used as one of the assessment tools of shift handover in clinical wards to be used towards promoting received services by customers of healthcare system.

  4. Setting global standards for stem cell research and clinical translation : The 2016 ISSCR guidelines

    NARCIS (Netherlands)

    Daley, George Q.; Hyun, Insoo; Apperley, Jane F.; Barker, Roger A.; Benvenisty, Nissim; Bredenoord, Annelien L.; Breuer, Christopher K.; Caulfield, Timothy; Cedars, Marcelle I.; Frey-Vasconcells, Joyce; Heslop, Helen E.; Jin, Ying; Lee, Richard T.; McCabe, Christopher; Munsie, Megan; Murry, Charles E.; Piantadosi, Steven; Rao, Mahendra; Rooke, Heather M.; Sipp, Douglas; Studer, Lorenz; Sugarman, Jeremy; Takahashi, Masayo; Zimmerman, Mark; Kimmelman, Jonathan

    2016-01-01

    The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of

  5. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and biological... therapeutic drug or biological product, especially for an efficacy endpoint. As part of the reauthorization of... from the Secretary of Health and Human Services to the Chairman of ] the Committee on Health, Education...

  6. Generalizability of Standardized Patients' Satisfaction Ratings of Their Clinical Encounter with Fourth-Year Medical Students.

    Science.gov (United States)

    Vu, Nu Viet; And Others

    1990-01-01

    At the end of their clinical clerkship rotations, all students in one medical school's classes of 1988 (N=69), 1989 (N=63), 1990 (N=66) took the Post-Clerkship Examination. This study examined the nature of the patients' satisfaction ratings; reliability of patient satisfaction ratings and number of patients needed to derive reliable ratings; etc.…

  7. Analyzing Statistical Mediation with Multiple Informants: A New Approach with an Application in Clinical Psychology

    Directory of Open Access Journals (Sweden)

    Lesther ePapa

    2015-11-01

    Full Text Available Testing mediation models is critical for identifying potential variables that need to be targeted to effectively change one or more outcome variables. In addition, it is now common practice for clinicians to use multiple informant (MI data in studies of statistical mediation. By coupling the use of MI data with statistical mediation analysis, clinical researchers can combine the benefits of both techniques. Integrating the information from MIs into a statistical mediation model creates various methodological and practical challenges. The authors review prior methodological approaches to MI mediation analysis in clinical research and propose a new latent variable approach that overcomes some limitations of prior approaches. An application of the new approach to mother, father, and child reports of impulsivity, frustration tolerance, and externalizing problems (N = 454 is presented. The results showed that frustration tolerance mediated the relationship between impulsivity and externalizing problems. Advantages and limitations of the new approach are discussed. The new approach can help clinical researchers overcome limitations of prior techniques. It allows for a more comprehensive and effective use of MI data when testing mediation models.

  8. Clinical practice guidelines: 2004 standards, options and recommendations for the management of patient with adenocarcinoma of the stomach - radiotherapy

    International Nuclear Information System (INIS)

    Ychou, M.; Duffour, J.; Lemanski, C.; Masson, B.; Gory-Delabaere, G.; Bosquet, L.; Blanc, P.; Giovannini, M.; Monge, G.; Guillemin, F.; Marchal, F.; Conroy, T.; Merrouche, Y.; Adenis, A.; Bosset, J.F.; Bouche, O.; Pezet, D.; Triboulet, J.P.

    2004-01-01

    Context. - The 'Standards, Options and Recommendations' (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. Objectives. - To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors. Methods. - The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement. Results. - Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with D1 or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without de-nutrition with a lymphadenectomy < D1 (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without de-nutrition with D1 or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3). (authors)

  9. Clinical Outcomes and Survivorship of Lateral Unicompartmental Knee Arthroplasty: Does Surgical Approach Matter?

    Science.gov (United States)

    Edmiston, Tori A; Manista, Gregory C; Courtney, P Maxwell; Sporer, Scott M; Della Valle, Craig J; Levine, Brett R

    2018-02-01

    Lateral unicompartmental knee arthroplasty (UKA) has been shown to be an effective procedure to treat isolated lateral compartment osteoarthritis with excellent long-term survivorship. Whether a medial parapatellar approach or a lateral parapatellar approach is superior in lateral UKA is unknown. The purpose of this study was to determine if there is a difference in intermediate-term clinical outcomes in patients undergoing lateral UKA through a lateral vs medial parapatellar approach. We retrospectively reviewed a consecutive series of 65 patients who underwent lateral UKA with a minimum of 2-year follow-up. Fifty-two patients (80%) had a lateral approach and 13 (20%) a medial parapatellar approach. Patient demographics, preoperative and postoperative radiographic findings, need for revision surgery, Knee Society Score, and range of motion were assessed. Overall survivorship was 94% at a mean of 82 months; with the sample size available for study, there was no difference in survivorship between the groups. There was no difference in Knee Society Score or revision to total knee arthroplasty (5% vs 7%, P = 1.000) between the medial and lateral approach groups. Comparatively, the lateral approach group did have significantly greater postoperative flexion (123.6° vs 116.5°, P = .006) and greater improvement in flexion from preoperative measurements (3.0 vs -8.0°, P = .010). Although our sample size was small, we could not demonstrate a difference in revision rates or clinical outcome scores when comparing a lateral or a medial approach with lateral UKA at intermediate-term follow-up. A lateral approach did have greater postoperative flexion, but its clinical significance remains undetermined. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. The standard laboratory module approach to automation of the chemical laboratory

    International Nuclear Information System (INIS)

    Hollen, R.M.; Erkkila, T.H.

    1993-01-01

    Automation of the technology and practice of environmental laboratory automation has not been as rapid or complete as one might expect. Confined to autosamplers and limited robotic systems, our ability to apply production concepts to environmental analytical analysis is not great. With the impending remediation of our hazardous waste sites in the US, only the application of production chemistry techniques will even begin to provide those responsible with the necessary knowledge to accomplish the cleanup expeditiously and safely. Tightening regulatory requirements have already mandated staggering increases in sampling and characterization needs with the future only guaranteeing greater demands. The Contaminant Analysis Automation Program has been initiated by our government to address these current and future characterization by application of a new robotic paradigm for analytical chemistry. By using standardized modular instruments, named Standard Laboratory Modules, flexible automation systems can rapidly be configured to apply production techniques to our nations environmental problems at-site

  11. Approach for domestic preparation of standard material (LSD spike) for isotope dilution mass spectrometry

    International Nuclear Information System (INIS)

    Ishikawa, Fumitaka; Sumi, Mika; Chiba, Masahiko; Suzuki, Toru; Abe, Tomoyuki; Kuno, Yusuke

    2008-01-01

    The accountancy analysis of the nuclear fuel material at Plutonium Fuel Development Center of JAEA is performed by isotope dilution mass spectrometry (IDMS; Isotope Dilution Mass Spectrometry). IDMS requires the standard material called LSD spike (Large Size Dried spike) which is indispensable for the accountancy in the facilities where the nuclear fuel materials are handled. Although the LSD spike and Pu source material have been supplied from foreign countries, the transportation for such materials has been getting more difficult recently. This difficulty may affect the operation of nuclear facilities in the future. Therefore, research and development of the domestic LSD spike and base material has been performed at JAEA. Certification for such standard nuclear materials including spikes produced in Japan is being studied. This report presents the current status and the future plan for the technological development. (author)

  12. Computational Approach to Annotating Variants of Unknown Significance in Clinical Next Generation Sequencing.

    Science.gov (United States)

    Schulz, Wade L; Tormey, Christopher A; Torres, Richard

    2015-01-01

    Next generation sequencing (NGS) has become a common technology in the clinical laboratory, particularly for the analysis of malignant neoplasms. However, most mutations identified by NGS are variants of unknown clinical significance (VOUS). Although the approach to define these variants differs by institution, software algorithms that predict variant effect on protein function may be used. However, these algorithms commonly generate conflicting results, potentially adding uncertainty to interpretation. In this review, we examine several computational tools used to predict whether a variant has clinical significance. In addition to describing the role of these tools in clinical diagnostics, we assess their efficacy in analyzing known pathogenic and benign variants in hematologic malignancies. Copyright© by the American Society for Clinical Pathology (ASCP).

  13. STANDARDIZING THE STRUCTURE OF STROKE CLINICAL AND EPIDEMIOLOGIC RESEARCH DATA: THE NINDS STROKE COMMON DATA ELEMENT (CDE) PROJECT

    Science.gov (United States)

    Saver, Jeffrey L.; Warach, Steven; Janis, Scott; Odenkirchen, Joanne; Becker, Kyra; Benavente, Oscar; Broderick, Joseph; Dromerick, Alexander W.; Duncan, Pamela; Elkind, Mitchell S. V.; Johnston, Karen; Kidwell, Chelsea S.; Meschia, James F.; Schwamm, Lee

    2012-01-01

    Background and Purpose The National Institute of Neurological Disorders and Stroke initiated development of stroke-specific Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research in all fields of neuroscience. Standardizing data elements in translational, clinical and population research in cerebrovascular disease could decrease study start-up time, facilitate data sharing, and promote well-informed clinical practice guidelines. Methods A Working Group of diverse experts in cerebrovascular clinical trials, epidemiology, and biostatistics met regularly to develop a set of Stroke CDEs, selecting among, refining, and adding to existing, field-tested data elements from national registries and funded trials and studies. Candidate elements were revised based on comments from leading national and international neurovascular research organizations and the public. Results The first iteration of the NINDS stroke-specific CDEs comprises 980 data elements spanning nine content areas: 1) Biospecimens and Biomarkers; 2) Hospital Course and Acute Therapies; 3) Imaging; 4) Laboratory Tests and Vital Signs; 5) Long Term Therapies; 6) Medical History and Prior Health Status; 7) Outcomes and Endpoints; 8) Stroke Presentation; 9) Stroke Types and Subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms (CRFs) using the CDEs. Conclusion Stroke-specific CDEs are now available as standardized, scientifically-vetted variable structures to facilitate data collection and data sharing in cerebrovascular patient-oriented research. The CDEs are an evolving resource that will be iteratively improved based on investigator use, new technologies, and emerging concepts and research findings. PMID:22308239

  14. Accounting Education Approach in the Context of New Turkish Commercial Code and Turkish Accounting Standards

    OpenAIRE

    Cevdet Kızıl; Ayşe Tansel Çetin; Ahmed Bulunmaz

    2014-01-01

    The aim of this article is to investigate the impact of new Turkish commercial code and Turkish accounting standards on accounting education. This study takes advantage of the survey method for gathering information and running the research analysis. For this purpose, questionnaire forms are distributed to university students personally and via the internet.This paper includes significant research questions such as “Are accounting academicians informed and knowledgeable on new Turkish commerc...

  15. DBKM Issues, Approaches and Challenges for new build: Harmonization, standardization, certification, peer review

    International Nuclear Information System (INIS)

    Omoto, A.

    2013-01-01

    Among issues when discussing DBKM: ⇒ What to preserve throughout plant lifetime? ⇒ Who manages (Design Authority)? ⇒ How best it is managed? ⇒ What are the threats of degradation? ⇒ What are the practical adverse effects on safety by inappropriate DBKM? ⇒ What about the future of licensing, harmonization, standardization, certification, peer review? … to be discussed in the context of new builds including those in new entrants

  16. Orientation and mobility training for adults with low vision: a new standardized approach.

    Science.gov (United States)

    Zijlstra, G A Rixt; Ballemans, Judith; Kempen, Gertrudis I J M

    2013-01-01

    Orientation and mobility training aims to facilitate independent functioning and participation in the community of people with low vision. (1) To gain insight into current practice regarding orientation and mobility training, and (2) to develop a theory-driven standardized version of this training to teach people with low vision how to orientate and be safe in terms of mobility. STUDY OF CURRENT PRACTICE: Insight into current practice and its strengths and weaknesses was obtained via reviewing the literature, observing orientation and mobility training sessions (n = 5) and interviewing Dutch mobility trainers (n = 18). Current practice was mainly characterized by an individual, face-to-face orientation and mobility training session concerning three components: crystallizing client's needs, providing information and training skills. A weakness was the lack of a (structured) protocol based on evidence or theory. NEW THEORY-DRIVEN TRAINING: A new training protocol comprising two face-to-face sessions and one telephone follow-up was developed. Its content is partly based on the components of current practice, yet techniques from theoretical frameworks (e.g. social-cognitive theory and self-management) are incorporated. A standardized, tailor-made orientation and mobility training for using the identification cane is available. The new theory-driven standardized training is generally applicable for teaching the use of every low-vision device. Its acceptability and effectiveness are currently being evaluated in a randomized controlled trial.

  17. Approach toward development of release standards for D and D cleanup

    International Nuclear Information System (INIS)

    Chen, S. Y.

    1999-01-01

    The release of materials containing residual radioactivity from a controlled environment in decontamination and decommissioning (D and D) activities has been problematic. The primary impediment to such a release is the lack of a suitable framework within which release standards can be developed. The concept of clearance for radioactive materials was recently introduced by the International Atomic Energy Agency (IAEA) (l). This concept is being evaluated by the international regulatory communities as a basis for setting standards for releasing from control solid materials containing residual radioactivity. Accordingly, both the IAEA (2) and the European Commission (EC) (3) have recently proposed clearance standards. In the US, the Nuclear Regulatory Commission (USNRC) has just begun its rule-making process on clearance. The term ''clearance'' was introduced as a regulatory process for releasing radioactive materials posing negligible risks. A trivial risk level has been determined to be a 10 -6 to 10 -7 annual risk to an exposed individual, and a population risk of no more than 0.1 for an annual practice. Under these strict constraints, exposure scenarios would be developed to estimate potential doses to affected individuals. Such scenarios may account for processing, disposal, and product end-use of materials. This paper discusses these scenarios and also describes the technical basis for deriving release levels under the suggested risk for dose constraints

  18. The O'Neill grading system for evaluation of the tympanic membrane: A practical approach for clinical hyperbaric patients.

    Science.gov (United States)

    O'Neill, Owen J; Weitzner, Erica D

    2015-01-01

    Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are the two most common complications of clinical hyperbaric oxygen (HBO2) treatment. The current grading system, the Teed's Classification, was first described in 1944 with modifications to this system over the years, but none are specific for the evaluation and treatment of patients undergoing clinical HBO2 therapy. Currently, the standard of care is a baseline otoscopic examination performed prior to starting HBO2 therapy. Repeat otoscopy is required for patients having ETD, pain or other symptoms during the compression and/or decompression phase of the treatment. Results from these examinations are used to determine the proper course of treatment for the ETD or MEB. The Teed's classification was not intended to correlate with the consistency of diagnosis, the clinical approach to relieving symptoms or the treatment of the inflicted trauma. It is not a practical tool for the modern hyperbaric team. We describe a newer grading system, the O'Neill Grading System (OGS), which allows simple, practical and consistent classification of ETD and MEB by all members of the clinical hyperbaric medicine team. Based on the O'Neill Grade assigned, evidence supported suggestions for appropriate actions and medical interventions are offered.

  19. Standardization of the radioimmunoassay technique for the determination of human gastrin and its clinical application

    International Nuclear Information System (INIS)

    Peig Ginabredra, M.G.

    1989-01-01

    It was developed and standardized a system of radioimmunoassay for the determination of gastrin, employing synthetic human gastrin for radioiodination and preparation of standard as well as specific antibody raised rabbits. The hormone was labeled with 125 I by the Cloramine T techique and purified by anion exchange chromatography in QAE-Sephadex A-25, being determined its specific activity. The tracer thus obtained was submitted to analysis of purity by poliacrilamide gel eletrophoresis and precipitation of proteins by trichloroacetic acid. Its stability evaluated according to the time of storage, being its purity and adequation for the use in radioimmunoassay also compared to a tracer obtained from a commercial diagnosis kit. The assays were performed by incubation of radioiodinated gastrin, standard gastrin prepared in plasma free from this hormone (from zero to 500 pmol/l) or samples to be assayed with the antiserum for 4 days at 4 0 C. The separation between the free gastrin and the gastrin bound to the antibody was carried out by adsorption of the free hormone to the charcoal, whose ideal concentration was previously determined. Plasma free from gastrin was obtained from time-expired blood bank plasma submitted to extraction with charcoal. When performed the quality control, this radioimmunoassay was shown specific, accurate, precise and sensitive, allowing the performance of valid assays. Its validation was even confirmed by clear discrimination not only of the gastrin concentration in subjects with very low levels (gastrectomized) and extremely high levels (Zollinger-Ellison syndrome) as well as gastrin concentrations in subjects with other diseases, such as Chagas disease, pernicious anemia and chronic renal failure. (author) [pt

  20. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.

    Science.gov (United States)

    Daley, George Q; Hyun, Insoo; Apperley, Jane F; Barker, Roger A; Benvenisty, Nissim; Bredenoord, Annelien L; Breuer, Christopher K; Caulfield, Timothy; Cedars, Marcelle I; Frey-Vasconcells, Joyce; Heslop, Helen E; Jin, Ying; Lee, Richard T; McCabe, Christopher; Munsie, Megan; Murry, Charles E; Piantadosi, Steven; Rao, Mahendra; Rooke, Heather M; Sipp, Douglas; Studer, Lorenz; Sugarman, Jeremy; Takahashi, Masayo; Zimmerman, Mark; Kimmelman, Jonathan

    2016-06-14

    The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  1. Molecular identification of mumps virus genotypes from clinical samples: standardized method of analysis.

    Science.gov (United States)

    Palacios, G; Jabado, O; Cisterna, D; de Ory, F; Renwick, N; Echevarria, J E; Castellanos, A; Mosquera, M; Freire, M C; Campos, R H; Lipkin, W I

    2005-04-01

    A sensitive nested reverse transcription-PCR assay, targeting a short fragment of the gene encoding the small hydrophobic protein (SH gene), was developed to allow rapid characterization of mumps virus in clinical samples. The sensitivity and specificity of the assay were established using representative genotypes A, B, C, D, E, and F. Mumps virus RNA was characterized directly from cerebrospinal fluid (CSF) samples and in extracts of mumps virus isolates from patients with various clinical syndromes. Direct sequencing of products and subsequent phylogenetic analysis enabled genetic classification. A simple web-based system of sequence analysis was established. The study also allowed characterization of mumps virus strains from Argentina as part of a new subgenotype. This PCR assay for characterization of mumps infections coupled to a web-based analytical program provides a rapid method for identification of known and novel strains.

  2. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

    Directory of Open Access Journals (Sweden)

    George Q. Daley

    2016-06-01

    Full Text Available The International Society for Stem Cell Research (ISSCR presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016. The 2016 guidelines reflect the revision and extension of two past sets o