WorldWideScience

Sample records for standard clinical approaches

  1. 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.

  2. 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.

  3. 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.

  4. Objective structured clinical examination for undergraduates: Is it a feasible approach to standardized assessment in India?

    Directory of Open Access Journals (Sweden)

    Kavita R Bhatnagar

    2011-01-01

    Full Text Available Background: There has been a growing concern among medical educators about the quality of medical graduates trained in various medical colleges in our country. Data based on the faculty and student perceptions of undergraduate curriculum indicate a need for laying more stress on practical skills during their training and assessment. The Objective Structured Clinical Examination (OSCE is a reliable and an established and effective multistation test for the assessment of practical skills in an objective and a transparent manner. The aim of this article is to sensitize universities, examiners, organizers, faculty, and students across India to OSCE. Materials and Methods: We designed an assessment based on 22-station OSCE and administered it to 67 students during their final year, integrating all the domains of learning, that is higher order cognitive domain, psychomotor domain, and affective domain. Data analysis was done using SPSS version 15. Results: The OSCE was feasible to conduct and had high perceived construct validity. There was a significant correlation between the station score and total examination score for 19 stations. The reliability of this OSCE was 0.778. Both students and faculty members expressed a high degree of satisfaction with the format. Conclusion: Integrating a range of modalities into an OSCE in ophthalmology appears to represent a valid and reliable method of examination. The biggest limitation with this format was the direct expenditure of time and energy of those organizing an OSCE; therefore, sustaining the motivation of faculty might pose a challenge.

  5. 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.

    Science.gov (United States)

    Fedorov, Andriy; Clunie, David; Ulrich, Ethan; Bauer, Christian; Wahle, Andreas; Brown, Bartley; Onken, Michael; Riesmeier, Jörg; Pieper, Steve; Kikinis, Ron; Buatti, John; Beichel, Reinhard R

    2016-01-01

    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 abstractions

  6. 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

  7. Nuclear security standard: Argentina approach

    International Nuclear Information System (INIS)

    Bonet Duran, Stella M.; Rodriguez, Carlos E.; Menossi, Sergio A.; Serdeiro, Nelida H.

    2007-01-01

    Argentina has a comprehensive regulatory system designed to assure the security and safety of radioactive sources, which has been in place for more than fifty years. In 1989 the Radiation Protection and Nuclear Safety branch of the National Atomic Energy Commission created the 'Council of Physical Protection of Nuclear Materials and Installations' (CAPFMIN). This Council published in 1992 a Physical Protection Standard based on a deep and careful analysis of INFCIRC 225/Rev.2 including topics like 'sabotage scenario'. Since then, the world's scenario has changed, and some concepts like 'design basis threat', 'detection, delay and response', 'performance approach and prescriptive approach', have been applied to the design of physical protection systems in facilities other than nuclear installations. In Argentina, radioactive sources are widely used in medical and industrial applications with more than 1,600 facilities controlled by the Nuclear Regulatory Authority (in spanish ARN). During 2005, measures like 'access control', 'timely detection of intruder', 'background checks', and 'security plan', were required by ARN for implementation in facilities with radioactive sources. To 'close the cycle' the next step is to produce a regulatory standard based on the operational experience acquired during 2005. ARN has developed a set of criteria for including them in a new standard on security of radioactive materials. Besides, a specific Regulatory Guide is being prepared to help licensees of facilities in design a security system and to fulfill the 'Design of Security System Questionnaire'. The present paper describes the proposed Standard on Security of Radioactive Sources and the draft of the Nuclear Security Regulatory Guidance, based on our regulatory experience and the latest international recommendations. (author)

  8. 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...

  9. Implementing Home Health Standards in Clinical Practice.

    Science.gov (United States)

    Gorski, Lisa A

    2016-02-01

    In 1986, the American Nurses Association (ANA) published the first Standards of Home Health Practice. Revised in 1992 and expanded in 1999 to become Home Health Nursing: Scope and Standards of Practice, it was revised in 2008 and again in 2014. In the 2014 edition, there are 6 standards of home healthcare nursing practice and 10 standards of professional performance for home healthcare nursing. The focus of this article is to describe the home healthcare standards and to provide guidance for implementation in clinical practice. It is strongly encouraged that home healthcare administrators, educators, and staff obtain a copy of the standards and fully read this essential home healthcare resource.

  10. Clinical approach to dyslipidaemia

    African Journals Online (AJOL)

    Repro

    ment and management right can pro- foundly influence ... Depending on the clinical context, a lipid value that .... tree, to which as much information as possible is .... Further useful laboratory investiga- tions at the ... on the system. If triglyceride ...

  11. Standard approach to plant modifications

    International Nuclear Information System (INIS)

    Mecredy, R.C.

    1988-01-01

    Organizational and management approaches to the design, installation, and turnover of nuclear plant modifications have changed dramatically in the last 10 to 15 yr. In response to these changes, organizational and individual responsibilities have been defined and management systems have been established at Rochester Gas and Electric (RG and E) Corporation to ensure that high-quality plant modifications are installed in a timely manner that satisfies user needs at minimal cost

  12. 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.

  13. 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

  14. 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...

  15. The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation - Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and Donor Bone Marrow Cells

    Science.gov (United States)

    2014-10-01

    Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and...Translational Science and Standardize Clinical Monitoring of Restorative Transplantation – Immunomodulation and Tolerance Induction after VCA using Biologic...wider application. Thus the purpose of this project is to develop novel clinically relevant regimens for immunomodulation and tolerance induction after

  16. Risk approaches in setting radiation standards

    International Nuclear Information System (INIS)

    Whipple, C.

    1984-01-01

    This paper discusses efforts to increase the similarity of risk regulation approaches for radiation and chemical carcinogens. The risk assessment process in both cases involves the same controversy over the extrapolation from high to low doses and dose rates, and in both cases the boundaries between science and policy in risk assessment are indistinct. Three basic considerations are presented to approach policy questions: the economic efficiency of the regulatory approach, the degree of residual risk, and the technical opportunities for risk control. It is the author's opinion that if an agency can show that its standard-setting policies are consistent with those which have achieved political and judicial acceptance in other contexts, the greater the predictability of the regulatory process and the stability of this process

  17. Natural background approach to setting radiation standards

    International Nuclear Information System (INIS)

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

    1979-01-01

    The suggestion has often been made that an additional radiation exposure imposed on humanity as a result of some important activity such as electricity generation would be acceptable if the exposure was small compared to the natural background. In order to make this concept quantitative and objective, we propose that small compared with the natural background be interpreted as the standard deviation (weighted with the exposed population) of the natural background. 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. When this method is applied to the population of the United States, it suggests that a dose of 20 mrem/year would be an acceptable standard. This is comparable to the 25 mrem/year suggested as the maximum allowable exposure to an individual from the complete uranium fuel cycle

  18. A review of the literature and discussion: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach.

    Science.gov (United States)

    Brackstone, Murial

    2016-09-01

    Chronic pain presents a management challenge for physicians and patients alike, and post-mastectomy pain is no exception. In this issue, Waltho and Rockwell present a review of post-mastectomy pain syndrome (PMPS) and propose a standard definition that should allow future studies to be comparable. The proposed definition of "post-breast surgery pain syndrome" includes pain after any type of breast surgery that is of at least moderate intensity and comprises neuropathic qualities, that is present in the ipsilateral breast/chest/arm, that lasts longer than 6 months and is present at least half the time. Further work is needed to clarify whether this pain syndrome is in fact driven by neuralgia resulting from the axillary dissection component of breast cancer surgery.

  19. 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.)

  20. 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...

  1. Standard plants, standard outages: the EdF approach

    International Nuclear Information System (INIS)

    Miron, J.L.

    1991-01-01

    At the end of 1990 Electricite de France had carried out a total of 350 PWR refuelling outages. Although the French units are standardized the routine of the outages are not all the same. The major influences on outages were: setting up new organizations to apply quality assurance regulations; improving systematic experience feedback; incorporating modifications in the outage schedules; assumilation of computerized maintenance management by the sites. (author)

  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 493.1276 - Standard: Clinical cytogenetics.

    Science.gov (United States)

    2010-10-01

    ... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process...

  4. 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

  5. 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, and...

  6. The STEP standard as an approach for design and prototyping

    OpenAIRE

    Plantec , Alain; Ribaud , Vincent

    1998-01-01

    International audience; STEP is an ISO standard (ISO-10303) for the computer-interpretable representation and exchange of product data. Parts of STEP standardize conceptual structures and usage of information in generic or specific domains. The standardization process of these constructs is an evolutionary approach , which uses generated prototypes at different phases of the process. This paper presents a method for the building of prototype generators, inspired by this standardization proces...

  7. [Possible relation between clinical guidelines and legal standard of medicine].

    Science.gov (United States)

    Furukawa, Toshiharu; Kitagawa, Yuko

    2010-10-01

    Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

  8. The development of clinical document standards for semantic interoperability in china.

    Science.gov (United States)

    Yang, Peng; Pan, Feng; Liu, Danhong; Xu, Yongyong; Wan, Yi; Tu, Haibo; Tang, Xuejun; Hu, Jianping

    2011-12-01

    This study is aimed at developing a set of data groups (DGs) to be employed as reusable building blocks for the construction of the eight most common clinical documents used in China's general hospitals in order to achieve their structural and semantic standardization. The Diagnostics knowledge framework, the related approaches taken from the Health Level Seven (HL7), the Integrating the Healthcare Enterprise (IHE), and the Healthcare Information Technology Standards Panel (HITSP) and 1,487 original clinical records were considered together to form the DG architecture and data sets. The internal structure, content, and semantics of each DG were then defined by mapping each DG data set to a corresponding Clinical Document Architecture data element and matching each DG data set to the metadata in the Chinese National Health Data Dictionary. By using the DGs as reusable building blocks, standardized structures and semantics regarding the clinical documents for semantic interoperability were able to be constructed. Altogether, 5 header DGs, 48 section DGs, and 17 entry DGs were developed. Several issues regarding the DGs, including their internal structure, identifiers, data set names, definitions, length and format, data types, and value sets, were further defined. Standardized structures and semantics regarding the eight clinical documents were structured by the DGs. This approach of constructing clinical document standards using DGs is a feasible standard-driven solution useful in preparing documents possessing semantic interoperability among the disparate information systems in China. These standards need to be validated and refined through further study.

  9. 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.

  10. 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

  11. 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

  12. [Accreditation of clinical laboratories based on ISO standards].

    Science.gov (United States)

    Kawai, Tadashi

    2004-11-01

    International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

  13. The clinical approach to movement disorders.

    NARCIS (Netherlands)

    Abdo, W.F.; Warrenburg, B.P.C. van de; Burn, D.J.; Quinn, N.P.; Bloem, B.R.

    2010-01-01

    Movement disorders are commonly encountered in the clinic. In this Review, aimed at trainees and general neurologists, we provide a practical step-by-step approach to help clinicians in their 'pattern recognition' of movement disorders, as part of a process that ultimately leads to the diagnosis.

  14. A Clinical Approach to Vulvar Ulcers.

    Science.gov (United States)

    Stewart, Kristen M A

    2017-09-01

    This article discusses the differential diagnosis of vulvar ulcers and describes a general clinical approach to this common but nonspecific examination finding. The differential diagnosis includes sexually and nonsexually transmitted infections, dermatitides, trauma, neoplasms, hormonally induced ulcers, and drug reactions. Patient history and physical examination provide important clues to the cause of a vulvar ulcer. However, laboratory testing is usually required for accurate diagnosis because the clinical presentation is often nonspecific and may be atypical due to secondary conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

    Science.gov (United States)

    Binkley, Neil; Carter, Graham D

    2017-12-01

    Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    DEFF Research Database (Denmark)

    Aslak, Katrine Kanstrup; Bulut, Orhan

    2012-01-01

    BACKGROUND AND OBJECTIVES: The purpose of this study was to audit our results after implementation of a standardized operative approach to laparoscopic surgery for rectal cancer within a fast-track recovery program. METHODS: From January 2009 to February 2011, 100 consecutive patients underwent...... 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...

  17. 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.

  18. The evolution of a clinical database: from local to standardized clinical languages.

    OpenAIRE

    Prophet, C. M.

    2000-01-01

    For more than twenty years, the University of Iowa Hospitals and Clinics Nursing Informatics (UIHC NI) has been developing a clinical database to support patient care planning and documentation in the INFORMM NIS (Information Network for Online Retrieval & Medical Management Nursing Information System). Beginning in 1992, the database content was revised to standardize orders and to incorporate the Standardized Nursing Languages (SNLs) of the North American Nursing Diagnosis Association (NAND...

  19. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion.

    Science.gov (United States)

    Waltho, Daniel; Rockwell, Gloria

    2016-09-01

    Post-mastectomy pain syndrome (PMPS) is a frequent complication of breast surgery. There is currently no standard definition for this chronic pain syndrome. The purpose of this review was to establish a consensus for defining PMPS by identifying the various elements included in the definitions and how they vary across the literature, determining how these definitions affect the methodological components therein, and proposing a definition that appropriately encompasses all of the appropriate elements. We searched PubMed to retrieve all studies and case reports on PMPS, and we analyzed definitions of PMPS, inclusion/exclusion criteria, and methods of measuring PMPS. Twenty-three studies were included in this review. We identified 7 independent domains for defining PMPS: surgical breast procedure, neuropathic nature, pain of at least moderate intensity, protracted duration, frequent symptoms, appropriate location of the symptoms and exacerbation with movement. These domains were used with varying frequency. Inclusion/exclusion criteria and methods for assessing PMPS also varied markedly. To prevent future discrepancies in both the clinical and research settings, we propose a new and complete definition based on the results of our review: PMPS is pain that occurs after any breast surgery; is of at least moderate severity; possesses neuropathic qualities; is located in the ipsilateral breast/chest wall, axilla, and/or arm; lasts at least 6 months; occurs at least 50% of the time; and may be exacerbated by movements of the shoulder girdle.

  20. 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.

  1. 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.

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

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    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.

  3. 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.

  4. A clinical approach to Lyme disease.

    Science.gov (United States)

    Nadelman, R B; Wormser, G P

    1990-05-01

    Lyme disease (also known as Lyme borreliosis) is an emerging, newly described infectious disease with diverse clinical manifestations. The disease is caused by the spirochetal agent Borrelia burgdorferi, which is transmitted to humans by the bite of certain species of Ixodes ticks harboring the organism. The most readily identifiable clinical feature is the distinctive skin lesion, erythema migrans. If recently infected patients go untreated, approximately 15% will develop neurologic conditions (most commonly facial nerve palsy), 8% will develop myocarditis (typically with heart block), and 60% will develop migratory mono- or pauci-articular arthritis. Diagnosis depends on clinical suspicion, recognition of the characteristic signs and symptoms, and appropriate testing for antibody to B. burgdorferi. Serology for Lyme disease, although in need of better standardization, is most useful in diagnosing patients with manifestations of Lyme disease other than erythema migrans. All manifestations of Lyme disease are potentially treatable with either a beta-lactam antibiotic (for instance penicillin, amoxicillin, or ceftriaxone) or a tetracycline preparation. However, the optimal antimicrobial regimen, including choice of drug, drug dose, route of administration, and length of therapy, is unknown. Other important areas for future research include Ixodes biology and control, improved laboratory tests for diagnosis and for assessing response to therapy, and vaccine development.

  5. Quality assurance in clinical trials : a multi-disciplinary approach

    International Nuclear Information System (INIS)

    Cornes, D.

    2001-01-01

    Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  6. 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

  7. A neurophysiological approach to tinnitus: clinical implications.

    Science.gov (United States)

    Jastreboff, P J; Hazell, J W

    1993-02-01

    This paper presents a neurophysiological approach to tinnitus and discusses its clinical implications. A hypothesis of discordant damage of inner and outer hair cells systems in tinnitus generation is outlined. A recent animal model has facilitated the investigation of the mechanisms of tinnitus and has been further refined to allow for the measurement of tinnitus pitch and loudness. The analysis of the processes involved in tinnitus detection postulates the involvement of an abnormal increase of gain within the auditory system. Moreover, it provides a basis for treating patients with hyperacusis, which we are considering to be a pre-tinnitus state. Analysis of the process of tinnitus perception allows for the possibility of facilitating the process of tinnitus habituation for the purpose of its alleviation. The combining of theoretical analysis with clinical findings has resulted in the creation of a multidisciplinary Tinnitus Centre. The foundation of the Centre focuses on two goals: the clinical goal is to remove tinnitus perception from the patient's consciousness, while directing research toward finding a mechanism-based method for the suppression of tinnitus generators and processes responsible for enhancement of tinnitus-related neuronal activity.

  8. Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-01-01

    Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

  9. Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-07-01

    Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

  10. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

    Science.gov (United States)

    Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

    2005-09-01

    To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

  11. European standards and approaches to EMC in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Bardsley, D.J.; Dillingham, S.R.; McMinn, K. [AEA Technology, Dorset (United Kingdom)

    1995-04-01

    Electromagnetic Interference (EMI) arising from a wide range of sources can threaten nuclear power plant operation. The need for measures to mitigate its effects have long been recognised although there are difference in approaches worldwide. The US industry approaches the problem by comprehensive site surveys defining an envelope of emissions for the environmental whilst the UK nuclear industry defined many years ago generic levels which cover power station environments. Moves to standardisation within the European community have led to slight changes in UK approach, in particular how large systems can be tested. The tests undertaken on UK nuclear plant include tests for immunity to conducted as well as radiated interference. Similar tests are also performed elsewhere in Europe but are not, to the authors` knowledge, commonly undertaken in the USA. Currently work is proceeding on draft international standards under the auspices of the IEC.

  12. 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)

  13. 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.

  14. Approaches for protection standards for ionizing radiation and combustion pollutants

    International Nuclear Information System (INIS)

    Butler, G.C.

    1978-01-01

    The question ''can the approach used for radiation protection standards, i.e., to extrapolate dose--response relationships to low doses, be applied to combustion pollutants'' provided a basis for discussion. The linear, nonthreshold model postulated by ICRP and UNSCEAR for late effects of ionizing radiation is described and discussed. The utility and problems of applying this model to the effects of air pollutants constitute the focus of this paper. The conclusion is that, in the absence of evidence to the contrary, one should assume the same type of dose--effect relation for chemical air pollutants as for ionizing radiation

  15. The natural background approach to setting radiation standards

    International Nuclear Information System (INIS)

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

    1979-01-01

    The suggestion has often been made that an additional radiation exposure imposed on humanity as a result of some important activity such as electricity generation would be acceptable if the exposure was 'small' compared to the natural background. In order to make this concept quantitative and objective, we propose that 'small compared with the natural background' be interpreted as the standard deviation (weighted with the exposed population) of the natural background. We believe 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. When this method is applied to the population of the USA, it implies that a dose of 20 mrem/year would be an acceptable standard. This is closely comparable to the 25 mrem/year suggested by the Environmental Protection Agency as the maximum allowable exposure to an individual in the general population as a result of the operation of the complete uranium fuel cycle. Other agents for which a natural background exists can be treated in the same way as radiation. In addition, a second method for determining permissible exposure levels for agents other than radiation is presented. This method makes use of the natural background radiation data as a primary standard. Some observations on benzo(a)pyrene, using this latter method, are presented. (author)

  16. Sacroiliac Pain: A Clinical Approach for the Neurosurgeon

    Science.gov (United States)

    Moscote-Salazar, Luis Rafael; Alvis-Miranda, Hernando Raphael; Joaquim, Andrei Fernandes; Amaya-Quintero, Jessica; Padilla-Zambrano, Huber S.; Agrawal, Amit

    2017-01-01

    Pain originating from sacroiliac joint may also cause pain in the lumbar and gluteal region in 15% of the population. The clinical manifestation represents a public health problem due to the great implications on the quality of life and health-related costs. However, this is a diagnosis that is usually ignored in the general clinical practice; probably because of the unknown etiology, making harder to rule out the potential etiologies of this pathology, or maybe because the clinical criteria that support this pathology are unknown. By describing several diagnostic techniques, many authors have studied the prevalence of this pathology, finding more positive data than expected; coming to the conclusion that even though there is no diagnostic gold standard yet, an important amount of cases might be detected by properly applying several tests at the physical examination. Thus, it is necessary to have knowledge of the physiopathology and clinical presentation so that diagnosis can be made to those patients that manifest this problem. We present a clinical approach for the neurosurgeon. PMID:29204025

  17. Sacroiliac pain: A clinical approach for the neurosurgeon

    Directory of Open Access Journals (Sweden)

    Luis Rafael Moscote-Salazar

    2017-01-01

    Full Text Available Pain originating from sacroiliac joint may also cause pain in the lumbar and gluteal region in 15% of the population. The clinical manifestation represents a public health problem due to the great implications on the quality of life and health-related costs. However, this is a diagnosis that is usually ignored in the general clinical practice; probably because of the unknown etiology, making harder to rule out the potential etiologies of this pathology, or maybe because the clinical criteria that support this pathology are unknown. By describing several diagnostic techniques, many authors have studied the prevalence of this pathology, finding more positive data than expected; coming to the conclusion that even though there is no diagnostic gold standard yet, an important amount of cases might be detected by properly applying several tests at the physical examination. Thus, it is necessary to have knowledge of the physiopathology and clinical presentation so that diagnosis can be made to those patients that manifest this problem. We present a clinical approach for the neurosurgeon.

  18. 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.

  19. 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.

  20. Clinical and radiological instability following standard fenestration discectomy

    Directory of Open Access Journals (Sweden)

    Mascarenhas Amrithlal

    2009-01-01

    signs of instability are seen even in asymptomatic patients and so are not as reliable as clinical signs of instability. Standard fenestration discectomy does not destabilize the spine more than microdiscectomy.

  1. 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...

  2. 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.

  3. A standardized approach for determining radiological sabotage targets

    International Nuclear Information System (INIS)

    Gardner, B.H.; Snell, M.K.

    1993-01-01

    The US Department of Energy has required radiological sabotage vulnerability assessments to be conducted for years. However, the exact methodology to be used in this type of analysis still remains somewhat elusive. Therefore, there is tremendous variation in the methodologies and assumptions used to determine release levels and doses potentially affecting the health and safety of the public. In some cases, there are three orders of magnitude difference in results for dispersal of similar materials under similar meteorological conditions. To address this issue, the authors have developed an approach to standardizing radiological sabotage target analysis that starts by addressing basic assumptions and then directs the user to some recommended computerized analytical tools. Results from different dispersal codes are also compared in this analysis

  4. The need for European professional standards and the challenges facing clinical microbiology.

    Science.gov (United States)

    Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

    2010-06-01

    Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

  5. 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.

  6. 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.)

  7. Nuclear medical approaches to clinical research

    International Nuclear Information System (INIS)

    Otte, Andreas; Nguyen, Tristan

    2009-01-01

    In the frame of the master course Clinical research management at the scientific college Lahr in cooperation with the Albert-Ludwigs-University Freiburg three contributions are presented: Functional imaging - supported clinical studies in the sleep research. A comparison of NMR imaging versus SPECT and PET (advantages and disadvantages). Clinical studies with ionizing radiation and the radiation fear of the public. The new radioimmunotherapeutic agent Zevalin and the challenges at the market.

  8. 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

  9. 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...

  10. CLINICAL APPROACH TO THE FLOPPY CHILD

    African Journals Online (AJOL)

    Enrique

    There are two approaches to the diagnostic problem. The first is ... Ability to cough and clear airway secretions ('cough test'). Apply pressure to ... the tongue may suggest a storage dis- ... Toxic: drugs, heavy metals ... Urine oligosaccharides.

  11. Clinical pharmacogenetics implementation: approaches, successes, and challenges.

    Science.gov (United States)

    Weitzel, Kristin W; Elsey, Amanda R; Langaee, Taimour Y; Burkley, Benjamin; Nessl, David R; Obeng, Aniwaa Owusu; Staley, Benjamin J; Dong, Hui-Jia; Allan, Robert W; Liu, J Felix; Cooper-Dehoff, Rhonda M; Anderson, R David; Conlon, Michael; Clare-Salzler, Michael J; Nelson, David R; Johnson, Julie A

    2014-03-01

    Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. © 2014 Wiley Periodicals, Inc.

  12. 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

  13. Cow-specific treatment of clinical mastitis: an economic approach

    NARCIS (Netherlands)

    Steeneveld, W.; Werven, van T.; Barkema, H.W.; Hogeveen, H.

    2011-01-01

    Under Dutch circumstances, most clinical mastitis (CM) cases of cows on dairy farms are treated with a standard intramammary antimicrobial treatment. Several antimicrobial treatments are available for CM, differing in antimicrobial compound, route of application, duration, and cost. Because cow

  14. [Clinical laboratory approaches to parodontitis treatment optimization].

    Science.gov (United States)

    Soboleva, L A; Shul'diakov, A A; Oseeva, A O; Aleksandrova, E A

    2010-01-01

    In order to determine cycloferon liniment clinical-pathogenetic efficacy in comprehensive parodontitis therapy examination and treatment of 80 patients was done. It was determined that the cycloferon liniment use in comprehensive treatment of patients with parodontitis let to reduce infectious load in parodontal pockets and local inflammation intensity, to normalize the secretory immunoglobulin level and immune status indices that provided speed up of healing process and reduction relapse frequency.

  15. 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…

  16. 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.

  17. 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

  18. A Generalizability Theory Approach to Standard Error Estimates for Bookmark Standard Settings

    Science.gov (United States)

    Lee, Guemin; Lewis, Daniel M.

    2008-01-01

    The bookmark standard-setting procedure is an item response theory-based method that is widely implemented in state testing programs. This study estimates standard errors for cut scores resulting from bookmark standard settings under a generalizability theory model and investigates the effects of different universes of generalization and error…

  19. 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.

  20. 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.

  1. An approach to meeting the spent fuel standard

    Energy Technology Data Exchange (ETDEWEB)

    Makhijani, A. [Institute for Energy and Environmental Research, Takoma Park, MD (United States)

    1996-05-01

    The idea of the spent fuel standard is that there should be a high surface gamma radiation to prevent theft. For purposes of preventing theft, containers should be massive, and the plutonium should be difficult to extract. This report discusses issues associated with the spent fuel standard.

  2. 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

  3. 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

  4. An approach to meeting the spent fuel standard

    International Nuclear Information System (INIS)

    Makhijani, A.

    1996-01-01

    The idea of the spent fuel standard is that there should be a high surface gamma radiation to prevent theft. For purposes of preventing theft, containers should be massive, and the plutonium should be difficult to extract. This report discusses issues associated with the spent fuel standard

  5. 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.

  6. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

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

    NARCIS (Netherlands)

    Mingo, J.; Erramuzpe, A.; Luna, S.; Aurtenetxe, O.; Amo, L.; Diez, I.; Schepens, J.T.G.; Hendriks, W.J.A.J.; Cortes, J.M.; Pulido, R.

    2016-01-01

    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

  8. Making the Case for Standards of Conduct in Clinical Training

    Science.gov (United States)

    Homrich, Alicia M.; DeLorenzi, Leigh D.; Bloom, Zachary D.; Godbee, Brandi

    2014-01-01

    The authors examined a proposed set of standards for the personal and professional conduct of counseling trainees. Eighty-two counselor educators and supervisors from programs accredited by the Council for Accreditation of Counseling and Related Educational Programs ranked 55 behaviors divided across 3 categories (i.e., professional,…

  9. CLINICAL APPROACH TO HEREDITARY HEMORRHAGIC TELANGIECTASIA

    Directory of Open Access Journals (Sweden)

    Mary Hachmeriyan

    2013-11-01

    Full Text Available Background: Hereditary hemorrhagic telangiectasia (HHT or Rendu-Osler-Weber disease is a rare syndrome, inherited as an autosomal dominant trait with incidence of 1/10000. The clinical manifestations are due to vascular malformations and predisposition to hemorrhages in different organs, the leading symptom being recurrent epistaxis. If diagnosed with HHT, the patient and his relatives and especially children have to be screened for occult vascular malformations.Case report: A 30 years old woman was treated for cerebral stroke, epistaxis, anemia, arterio-venous malformations for over 6 months. Only at this point she was diagnosed with HHT, after noticing the typical mucosal changes. Focused family history revealed symptoms of HHT in her only child, her father, aunt and two cousins The child was screened for occult vascular malformations – attainment of the nasal mucosa, lungs, gastrointestinal system, liver and brain. Pulmonary and gastrointestinal arterio-venous malformations were proven.Conclusion: Any case of recurrent epistaxis should be evaluated for HHT. After confirmation of the diagnosis every patient and close relatives have to be screened for attainment of other organs and followed up in order to prevent severe life threatening complications.

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

    DEFF Research Database (Denmark)

    Rosenberg, Jacob

    2016-01-01

    . 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......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...... 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...

  11. 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)

  12. 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

  13. The place of clinical features and standard chest radiography in ...

    African Journals Online (AJOL)

    One hundred and five primary mediastinal masses were seen between 1975 and 1998, at the Cardiothoracic surgical Unit of the University College Hospital Ibadan. These were studied to establish the importance of clinical features and plain chest radiography in preoperative evaluation of these masses. The sources of ...

  14. The Clinical and Client-Centered Approach to Counseling.

    Science.gov (United States)

    Rivas, Richard G.

    This review analyzes the clinical and client-centered approaches to counseling. Clinical counseling separated from vocational counseling in the third decade of this century. A split took place between guidance and discipline. The mental hygiene movement facilitated this split. In 1942 Carl Rogers made an impact on counseling theory with the…

  15. Quality control with R an ISO standards approach

    CERN Document Server

    Cano, Emilio L; Prieto Corcoba, Mariano

    2015-01-01

    Presenting a practitioner's guide to capabilities and best practices of quality control systems using the R programming language, this volume emphasizes accessibility and ease-of-use through detailed explanations of R code as well as standard statistical methodologies. In the interest of reaching the widest possible audience of quality-control professionals and statisticians, examples throughout are structured to simplify complex equations and data structures, and to demonstrate their applications to quality control processes, such as ISO standards. The volume balances its treatment of key aspects of quality control, statistics, and programming in R, making the text accessible to beginners and expert quality control professionals alike. Several appendices serve as useful references for ISO standards and common tasks performed while applying quality control with R.

  16. 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

  17. 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.

  18. 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 ...

  19. 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.

  20. "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.

  1. Machine Learning Approaches for Clinical Psychology and Psychiatry.

    Science.gov (United States)

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

    2018-05-07

    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 given 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 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.

  2. Development of job standards for clinical nutrition therapy for dyslipidemia patients.

    Science.gov (United States)

    Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

    2015-04-01

    Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

  3. 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

  4. Development of Standard Approach for Sickle Blade Manufacturing

    OpenAIRE

    Noordin, M. N. A; Hudzari, R. M; Azuan, H. N; Zainon, M. S; Mohamed, S. B; Wafi, S. A

    2016-01-01

    The sickle blade used in the motorised palm cutter known as “CANTAS” provides fast, easy and safe pruning and harvesting for those hard to reach applications. Jariz Technologies Company is experiencing problem in the consistency of sickle blade which was supplied by various blade manufacturers. Identifying the proper blade material with a certain hardness value would produce a consistent as well as long lasting sickle blade. A Standard Operating Procedure (SOP) in the manufacturing of the sic...

  5. 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…

  6. 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

  7. A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

    Science.gov (United States)

    Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

    2013-10-01

    Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

  8. 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

  9. Clinical Significance: a Therapeutic Approach Topsychological Assessment in Treatment Planning

    Directory of Open Access Journals (Sweden)

    Afolabi Olusegun Emmanuel

    2015-06-01

    Full Text Available Psychological assessment has long been reported as a key component of clinical psychology. This paper examines the complexities surrounding the clinical significance of therapeutic approach to treatment planning. To achieve this objective, the paper searched and used the PsycINFO and PubMed databases and the reference sections of chapters and journal articles to analysed, 1 a strong basis for the usage of therapeutic approach to psychological assessment in treatment plans, 2 explained the conceptual meaning of clinical significant change in therapeutic assessment, 3 answered some of the questions regarding practicability and the clinical significance of therapeutic approach to treatment plans, particularly during or before treatment, 4 linked therapeutic assessment to change in clients’ clinical impression, functioning and therapeutic needs 5 analysed the empirically documenting clinically significant change in therapeutic assessment. Finally, the study suggested that though therapeutic assessment is not sufficient for the systematic study of psychotherapy outcome and process, it is still consistent with both the layman and professional expectations regarding treatment outcome and also provides a precise method for classifying clients as ‘changed’ or ‘unchanged’ on the basis of clinical significance criteria.

  10. 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

  11. 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…

  12. 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.

  13. Are industry codes and standards a valid cost containment approach

    International Nuclear Information System (INIS)

    Rowley, C.W.; Simpson, G.T.; Young, R.K.

    1990-01-01

    The nuclear industry has historically concentrated on safety design features for many years, but recently has been shifting to the reliability of the operating systems and components. The Navy has already gone through this transition and has found that Reliability Centered Maintenance (RCM) is an invaluable tool to improve the reliability of components, systems, ships, and classes of ships. There is a close correlation of Navy ships and equipment to commercial nuclear power plants and equipment. The Navy has a central engineering and configuration management organization (Naval Sea Systems Command) for over 500 ships, where as the over 100 commercial nuclear power plants and 52 nuclear utilities represent a fragmented owner/management structure. This paper suggests that the results of the application of RCM in the Navy can be duplicated to a large degree in the commercial nuclear power industry by the development and utilization of nuclear codes and standards

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

    2018-06-01

    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.

  1. Validation by simulation of a clinical trial model using the standardized mean and variance criteria.

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2006-12-01

    To develop and validate a model of a clinical trial that evaluates the changes in cholesterol level as a surrogate marker for lipodystrophy in HIV subjects under alternative antiretroviral regimes, i.e., treatment with Protease Inhibitors vs. a combination of nevirapine and other antiretroviral drugs. Five simulation models were developed based on different assumptions, on treatment variability and pattern of cholesterol reduction over time. The last recorded cholesterol level, the difference from the baseline, the average difference from the baseline and level evolution, are the considered endpoints. Specific validation criteria based on a 10% minus or plus standardized distance in means and variances were used to compare the real and the simulated data. The validity criterion was met by all models for considered endpoints. However, only two models met the validity criterion when all endpoints were considered. The model based on the assumption that within-subjects variability of cholesterol levels changes over time is the one that minimizes the validity criterion, standardized distance equal to or less than 1% minus or plus. Simulation is a useful technique for calibration, estimation, and evaluation of models, which allows us to relax the often overly restrictive assumptions regarding parameters required by analytical approaches. The validity criterion can also be used to select the preferred model for design optimization, until additional data are obtained allowing an external validation of the model.

  2. Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.

    Science.gov (United States)

    Bamford, K B; Wood, S; Shaw, R J

    2005-02-01

    Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.

  3. Whole-genome-based Mycobacterium tuberculosis surveillance: a standardized, portable, and expandable approach.

    Science.gov (United States)

    Kohl, Thomas A; Diel, Roland; Harmsen, Dag; Rothgänger, Jörg; Walter, Karen Meywald; Merker, Matthias; Weniger, Thomas; Niemann, Stefan

    2014-07-01

    Whole-genome sequencing (WGS) allows for effective tracing of Mycobacterium tuberculosis complex (MTBC) (tuberculosis pathogens) transmission. However, it is difficult to standardize and, therefore, is not yet employed for interlaboratory prospective surveillance. To allow its widespread application, solutions for data standardization and storage in an easily expandable database are urgently needed. To address this question, we developed a core genome multilocus sequence typing (cgMLST) scheme for clinical MTBC isolates using the Ridom SeqSphere(+) software, which transfers the genome-wide single nucleotide polymorphism (SNP) diversity into an allele numbering system that is standardized, portable, and not computationally intensive. To test its performance, we performed WGS analysis of 26 isolates with identical IS6110 DNA fingerprints and spoligotyping patterns from a longitudinal outbreak in the federal state of Hamburg, Germany (notified between 2001 and 2010). The cgMLST approach (3,041 genes) discriminated the 26 strains with a resolution comparable to that of SNP-based WGS typing (one major cluster of 22 identical or closely related and four outlier isolates with at least 97 distinct SNPs or 63 allelic variants). Resulting tree topologies are highly congruent and grouped the isolates in both cases analogously. Our data show that SNP- and cgMLST-based WGS analyses facilitate high-resolution discrimination of longitudinal MTBC outbreaks. cgMLST allows for a meaningful epidemiological interpretation of the WGS genotyping data. It enables standardized WGS genotyping for epidemiological investigations, e.g., on the regional public health office level, and the creation of web-accessible databases for global TB surveillance with an integrated early warning system. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

  4. 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

  5. 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…

  6. 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 ...

  7. 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 ...

  8. Neurological gait disorders in elderly people: clinical approach and classification.

    NARCIS (Netherlands)

    Snijders, A.H.; Warrenburg, B.P.C. van de; Giladi, N.; Bloem, B.R.

    2007-01-01

    Gait disorders are common and often devastating companions of ageing, leading to reductions in quality of life and increased mortality. Here, we present a clinically oriented approach to neurological gait disorders in the elderly population. We also draw attention to several exciting scientific

  9. 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.

  10. Understanding clinical reasoning in osteopathy: a qualitative research approach.

    Science.gov (United States)

    Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

    2016-01-01

    Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it was similar or different from clinical reasoning in other health professions. This study was informed by constructivist grounded theory. Participants were clinical educators in osteopathic teaching institutions in Australia, New Zealand and the UK. Focus groups and written critical reflections provided a rich data set. Data were analysed using constant comparison to develop inductive categories. According to participants, clinical reasoning in osteopathy is different from clinical reasoning in other health professions. Osteopaths use a two-phase approach: an initial biomedical screen for serious pathology, followed by use of osteopathic reasoning models that are based on the relationship between structure and function in the human body. Clinical reasoning in osteopathy was also described as occurring in a number of contexts (e.g. patient, practitioner and community) and drawing on a range of metaskills (e.g. hypothesis generation and reflexivity) that have been described in other health professions. The use of diagnostic reasoning models that are based on the relationship between structure and function in the human body differentiated clinical reasoning in osteopathy. These models were not used to name a medical condition but rather to guide the selection of treatment approaches. If confirmed by further research that clinical reasoning in osteopathy is distinct from clinical reasoning in other health professions, then osteopaths may have a unique perspective to bring to multidisciplinary

  11. Personalized-Detailed Clinical Model for Data Interoperability Among Clinical Standards

    OpenAIRE

    Khan, Wajahat Ali; Hussain, Maqbool; Afzal, Muhammad; Amin, Muhammad Bilal; Saleem, Muhammad Aamir; Lee, Sungyoung

    2013-01-01

    Objective: Data interoperability among health information exchange (HIE) systems is a major concern for healthcare practitioners to enable provisioning of telemedicine-related services. Heterogeneity exists in these systems not only at the data level but also among different heterogeneous healthcare standards with which these are compliant. The relationship between healthcare organization data and different heterogeneous standards is necessary to achieve the goal of data level interoperabi...

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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....

  17. 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

  18. A System Approach to Advanced Practice Clinician Standardization and High Reliability.

    Science.gov (United States)

    Okuno-Jones, Susan; Siehoff, Alice; Law, Jennifer; Juarez, Patricia

    Advanced practice clinicians (APCs) are an integral part of the health care team. Opportunities exist within Advocate Health Care to standardize and optimize APC practice across the system. To enhance the role and talents of APCs, an approach to role definition and optimization of practice and a structured approach to orientation and evaluation are shared. Although in the early stages of development, definition and standardization of accountabilities in a framework to support system changes are transforming the practice of APCs.

  19. 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 ...... sophisticated definitions, terminology and tools....

  20. 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.

  1. 77 FR 63763 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-10-17

    ... BCBS in 2006 and 2009, as well as other proposals set forth in consultative papers of the BCBS. Section... provided in this Federal Register document, which describes the economic impact of the Standardized... in recent consultative papers of the BCBS.\\2\\ In the Standardized Approach NPR, the agencies also...

  2. 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…

  3. 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…

  4. 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)

  5. Using Narratives to Develop Standards for Leaders: Applying an Innovative Approach in Western Australia

    Science.gov (United States)

    Wildy, Helen; Pepper, Coral

    2005-01-01

    Dissatisfaction with long lists of duties as substitutes for standards led to the innovative application of narratives as an alternative approach to the generation and use of standards for school leaders. This paper describes research conducted over nearly a decade in collaboration with the state education authority in Western Australia,…

  6. 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

  7. 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

  8. 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.

  9. Oral Pathology in Clinical Dentistry: A systematic approach

    Directory of Open Access Journals (Sweden)

    R V Subramanyam

    2014-01-01

    Full Text Available The dental clinician frequently comes across lesions that involve the hard and soft tissues of the oral cavity. Most of these conditions do not pose a diagnostic problem for the dental surgeon. However, the clinical dentist is sometimes accosted with a lesion, the diagnosis of which is not only challenging, but influencing the choice of treatment. This review article provides a systematic and logical approach for diagnosing common lesions encountered in the dental practice.

  10. Systemic Sclerosis and the Gastrointestinal Tract-Clinical Approach.

    Science.gov (United States)

    Braun-Moscovici, Yolanda; Brun, Rita; Braun, Marius

    2016-10-31

    Systemic sclerosis (SSc) is a multisystem disease characterized by functional and structural abnormalities of small blood vessels, fibrosis of the skin and internal organs, immune system activation, and autoimmunity. The gastrointestinal tract is involved in nearly all patients and is a source of significant morbidity and even mortality. The aim of this review is to summarize the pathogenesis and to provide a clinical approach to these patients.

  11. 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.

  12. 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

    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...... 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...

  13. Combining clinical judgment with guidelines for the management of type 2 diabetes: overall standards of comprehensive care.

    Science.gov (United States)

    Yacoub, Tamer G

    2014-05-01

    The rising toll of type 2 diabetes mellitus (T2DM) on patients and society has resulted in a wide variety of guidelines and therapies to address the need to combat this trend. Given the heterogeneity of T2DM and the different responses patients have to therapies, as well as the continued need for patients to institute lifestyle changes, guidelines published by the American Diabetes Association/European Association for the Study of Diabetes and the American Association of Clinical Endocrinologists/American College of Endocrinology have in recent years increased the focus on personalized and patient-centered care. How to best assimilate the overall standards of care for T2DM into clinical practice remains a challenge. The 4 pillars of effective diabetes management are a unifying framework and approach to clinical practice that can be integrated with the latest diabetes guidelines. These 4 pillars are lifestyle modifications involving (1) diet, (2) exercise, (3) a system to monitor preprandial and postprandial blood glucose and glycated hemoglobin levels, and (4) pharmacologic intervention when required. This article reviews the overall standards of care for T2DM, focusing on the first 3 nonpharmacologic pillars, and provides suggestions for integrating this approach with the current American Diabetes Association and American Association of Clinical Endocrinologists/American College of Endocrinology guidelines. Barriers to effective implementation of exercise programs, diets, and monitoring of blood glucose levels are discussed along with clinical strategies to overcome these barriers and achieve effective glycemic control and lifestyle changes for patients with T2DM. Personalized approaches to the management of T2DM are also reviewed.

  14. A review of standardized patients in clinical education: Implications for speech-language pathology programs.

    Science.gov (United States)

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

    2010-06-01

    The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

  15. Development of Canadian seismic design approach and overview of seismic standards

    Energy Technology Data Exchange (ETDEWEB)

    Usmani, A. [Amec Foster Wheeler, Toronto, ON (Canada); Aziz, T. [TSAziz Consulting Inc., Mississauga, ON (Canada)

    2015-07-01

    Historically the Canadian seismic design approaches have evolved for CANDU® nuclear power plants to ensure that they are designed to withstand a design basis earthquake (DBE) and have margins to meet the safety requirements of beyond DBE (BDBE). While the Canadian approach differs from others, it is comparable and in some cases more conservative. The seismic requirements are captured in five CSA nuclear standards which are kept up to date and incorporate lessons learnt from recent seismic events. This paper describes the evolution of Canadian approach, comparison with others and provides an overview and salient features of CSA seismic standards. (author)

  16. 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.

  17. 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

  18. [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.

  19. Incorporating Standardized Colleague Simulations in a Clinical Assessment Course and Evaluating the Impact on Interprofessional Communication.

    Science.gov (United States)

    Shrader, Sarah; Dunn, Brianne; Blake, Elizabeth; Phillips, Cynthia

    2015-05-25

    To determine the impact of incorporating standardized colleague simulations on pharmacy students' confidence and interprofessional communication skills. Four simulations using standardized colleagues portraying attending physicians in inpatient and outpatient settings were integrated into a required course. Pharmacy students interacted with the standardized colleagues using the Situation, Background, Assessment, Request/Recommendation (SBAR) communication technique and were evaluated on providing recommendations while on simulated inpatient rounds and in an outpatient clinic. Additionally, changes in student attitudes and confidence toward interprofessional communication were assessed with a survey before and after the standardized colleague simulations. One hundred seventy-one pharmacy students participated in the simulations. Student interprofessional communication skills improved after each simulation. Student confidence with interprofessional communication in both inpatient and outpatient settings significantly improved. Incorporation of simulations using standardized colleagues improves interprofessional communication skills and self-confidence of pharmacy students.

  20. Liver involvement in Gaucher disease - Review and clinical approach.

    Science.gov (United States)

    Adar, Tomer; Ilan, Yaron; Elstein, Deborah; Zimran, Ari

    2018-02-01

    Gaucher disease (GD), one of the most prevalent lysosomal storage diseases, is associated with glucocerebroside accumulation in cells of the monocyte-macrophage system in various organs, including the liver. Evaluating and managing liver disease in patients with Gaucher disease may be challenging. While hepatic involvement is common in Gaucher disease, its severity, and clinical significance span a wide spectrum, ranging from sub-clinical involvement to liver cirrhosis with its associated complications including portal hypertension. Apart from liver involvement in Gaucher disease, patients with may also suffer from other comorbidities involving the liver. That Gaucher disease itself can mimic hepatic lesions, affect laboratory tests used to characterize liver disease, and may be associated with non-cirrhotic portal hypertension, complicates the diagnostic approach even more. Better understanding of liver involvement in Gaucher disease can spare patients unnecessary invasive testing, and assist physicians in decision making when evaluating patients with Gaucher disease suspected for significant liver disease. This review describes the various clinical manifestations, laboratory and imaging abnormalities that may be encountered when following patients with Gaucher disease for liver involvement. The mechanism for liver disease are discussed, as well as the possible hepato-protective effect of glucocerebroside, and the a diagnostic and treatment approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

    Directory of Open Access Journals (Sweden)

    Xiao J

    2017-09-01

    Full Text Available Juan Xiao,1,2 Lin Chen,3 Gengsheng Mao,1 Wenyong Gao,1,2 Ming Lu,4 Xijing He,5 Hongyun Huang1,2 On behalf of the Neurorestoratology Professional Committee of Chinese Medical Doctors Association (Chinese Association of Neurorestoratology 1Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China; 2Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China; 3Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China; 4Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University, Changsha, Hunan Province, People’s Republic of China; 5Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China Abstract: Olfactory ensheathing cells (OECs are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis. To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for

  2. An outcome-based approach for the creation of fetal growth standards: do singletons and twins need separate standards?

    Science.gov (United States)

    Joseph, K S; Fahey, John; Platt, Robert W; Liston, Robert M; Lee, Shoo K; Sauve, Reg; Liu, Shiliang; Allen, Alexander C; Kramer, Michael S

    2009-03-01

    Contemporary fetal growth standards are created by using theoretical properties (percentiles) of birth weight (for gestational age) distributions. The authors used a clinically relevant, outcome-based methodology to determine if separate fetal growth standards are required for singletons and twins. All singleton and twin livebirths between 36 and 42 weeks' gestation in the United States (1995-2002) were included, after exclusions for missing information and other factors (n = 17,811,922). A birth weight range was identified, at each gestational age, over which serious neonatal morbidity and neonatal mortality rates were lowest. Among singleton males at 40 weeks, serious neonatal morbidity/mortality rates were lowest between 3,012 g (95% confidence interval (CI): 3,008, 3,018) and 3,978 g (95% CI: 3,976, 3,980). The low end of this optimal birth weight range for females was 37 g (95% CI: 21, 53) less. The low optimal birth weight was 152 g (95% CI: 121, 183) less for twins compared with singletons. No differences were observed in low optimal birth weight by period (1999-2002 vs. 1995-1998), but small differences were observed for maternal education, race, parity, age, and smoking status. Patterns of birth weight-specific serious neonatal morbidity/neonatal mortality support the need for plurality-specific fetal growth standards.

  3. 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

  4. A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

    Science.gov (United States)

    Spiegelhalter, D J; Freedman, L S

    1986-01-01

    The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

  5. 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

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

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    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.

  7. 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.

  8. 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.

  9. 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, ...

  10. Enhancing translation: guidelines for standard pre-clinical experiments in mdx mice.

    Science.gov (United States)

    Willmann, Raffaella; De Luca, Annamaria; Benatar, Michael; Grounds, Miranda; Dubach, Judith; Raymackers, Jean-Marc; Nagaraju, Kanneboyina

    2012-01-01

    Duchenne Muscular Dystrophy is an X-linked disorder that affects boys and leads to muscle wasting and death due to cardiac involvement and respiratory complications. The cause is the absence of dystrophin, a large structural protein indispensable for muscle cell function and viability. The mdx mouse has become the standard animal model for pre-clinical evaluation of potential therapeutic treatments. Recent years have seen a rapid increase in the number of experimental compounds being evaluated in the mdx mouse. There is, however, much variability in the design of these pre-clinical experimental studies. This has made it difficult to interpret and compare published data from different laboratories and to evaluate the potential of a treatment for application to patients. The authors therefore propose the introduction of a standard study design for the mdx mouse model. Several aspects, including animal care, sampling times and choice of tissues, as well as recommended endpoints and methodologies are addressed and, for each aspect, a standard procedure is proposed. Testing of all new molecules/drugs using a widely accepted and agreed upon standard experimental protocol would greatly improve the power of pre-clinical experimentations and help identifying promising therapies for the translation into clinical trials for boys with Duchenne Muscular Dystrophy. Copyright © 2011 Elsevier B.V. All rights reserved.

  11. Narrative Interest Standard: A Novel Approach to Surrogate Decision-Making for People With Dementia.

    Science.gov (United States)

    Wilkins, James M

    2017-06-17

    Dementia is a common neurodegenerative process that can significantly impair decision-making capacity as the disease progresses. When a person is found to lack capacity to make a decision, a surrogate decision-maker is generally sought to aid in decision-making. Typical bases for surrogate decision-making include the substituted judgment standard and the best interest standard. Given the heterogeneous and progressive course of dementia, however, these standards for surrogate decision-making are often insufficient in providing guidance for the decision-making for a person with dementia, escalating the likelihood of conflict in these decisions. In this article, the narrative interest standard is presented as a novel and more appropriate approach to surrogate decision-making for people with dementia. Through case presentation and ethical analysis, the standard mechanisms for surrogate decision-making for people with dementia are reviewed and critiqued. The narrative interest standard is then introduced and discussed as a dementia-specific model for surrogate decision-making. Through incorporation of elements of a best interest standard in focusing on the current benefit-burden ratio and elements of narrative to provide context, history, and flexibility for values and preferences that may change over time, the narrative interest standard allows for elaboration of an enriched context for surrogate decision-making for people with dementia. More importantly, however, a narrative approach encourages the direct contribution from people with dementia in authoring the story of what matters to them in their lives.

  12. The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

    Science.gov (United States)

    Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

    2017-06-20

    Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. AN EVALUATION OF SELECTED MOROCCAN ELT TEXTBOOKS: A STANDARDS-BASED APPROACH PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Hassan Ait Bouzid

    2017-05-01

    Full Text Available Standards-Based Approach to textbook evaluation has been blooming in recent decades. Nevertheless, this practice has received very little attention in Morocco.  The present study aims to bridge a gap in the literature of the Moroccan context by investigating the extent to which three locally designed ELT textbooks conform to the theoretical principles of the Standards-Based Approach which defines the teaching of English as a foreign language in the country (Ministry of National Education, 2007. Its objective is to examine whether and how these textbooks present contents that enable learners to meet the content standards included in the goal areas of Communications, Cultures, Connections and Comparisons. The study is informed by the theoretical framework of the Standards-Based Approach. It adopts a mixed-methods design that uses content analysis as a mixed data analysis method combining both quantitative and qualitative techniques. The findings reveal a number of shortcomings relevant to the representation of the content standards as several standards are not sufficiently addressed in the activities included in these textbooks. Eventually, some suggestions are addressed to policy makers, textbook designers and teachers to overcome the identified problems in current and future textbooks. The study is expected to sensitize ELT practitioners about the viability of using textbook evaluation in boosting both the quality of ELT textbooks and the quality of the teaching learning outcomes.

  18. Analysis of approaches to classification of forms of non-standard employment

    Directory of Open Access Journals (Sweden)

    N. V. Dorokhova

    2017-01-01

    Full Text Available Currently becoming more widespread non-standard forms of employment. If this is not clear approach to the definition and maintenance of non-standard employment. In the article the analysis of diverse interpretations of the concept, on what basis, the author makes a conclusion about the complexity and contradictory nature of precarious employment as an economic category. It examines different approaches to classification of forms of precarious employment. The main forms of precarious employment such as flexible working year, flexible working week, flexible working hours, remote work, employees on call, shift forwarding; Agency employment, self-employment, negotiator, underemployment, over employment, employment on the basis of fixed-term contracts employment based on contract of civil-legal nature, one-time employment, casual employment, temporary employment, secondary employment and part-time. The author’s approach to classification of non-standard forms of employment, based on identifying the impact of atypical employment on the development of human potential. For the purpose of classification of non-standard employment forms from the standpoint of their impact on human development as the criteria of classification proposed in the following: working conditions, wages and social guarantees, possibility of workers ' participation in management, personal development and self-employment stability. Depending on what value each of these criteria, some form of non-standard employment can be attributed to the progressive or regressive. Classification of non-standard forms of employment should be the basis of the state policy of employment management.

  19. 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.

  20. Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

    Science.gov (United States)

    Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

    2013-05-07

    Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

  1. 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.

  2. 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

  3. 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

  4. Diagnosis of flexible flatfoot in children: a systematic clinical approach.

    Science.gov (United States)

    Benedetti, Maria Grazia; Ceccarelli, Francesco; Berti, Lisa; Luciani, Deianira; Catani, Fabio; Boschi, Marco; Giannini, Sandro

    2011-01-01

    The goal of this study was to provide measures of symptoms and signs in a consecutive case series of children with flexible flatfoot based on a systematic clinical approach. Fifty-three children (age range, 10-14 years) previously diagnosed with flexible flatfoot were evaluated by a structured interview and clinical assessment. Most patients had foot symptoms (65.3% of feet) and functional limitation (68.3%). Symptoms included a sensation of discomfort (11.3%), such as early tiredness or difficulties during prolonged standing or walking, and pain (54%), mostly located in the plantar aspect of the foot (28.7%) and the medial hindfoot (18.8%). Body mass index was positively correlated to the presence of symptoms and their severity. Even if an enlarged footprint was present in 93.1% of feet, objective assessment evidenced the presence of heel valgus only in 83% of feet. Forefoot adduction was present in 22% of feet. Jack's test provided varus correction in only 54% of feet. Internal knee rotation was the most common associated disalignment, present in 43.6% of limbs. Symptoms were significantly correlated to knee alignment, and functional limitation was correlated to heel valgus. Standing balance on 1 leg was significantly correlated to footprint grading severity. A systematic clinical approach to assess children with flexible flatfoot should always be recommended for the correct diagnosis and the associated treatment management based on symptoms, functional limitation, and foot dysfunction. Functional assessment by specific tests should be included in the examination, as evidence exists that morphology and function are not necessarily related. Copyright 2011, SLACK Incorporated.

  5. Clinical transfusion practice update: haemovigilance, complications, patient blood management and national standards.

    Science.gov (United States)

    Engelbrecht, Sunelle; Wood, Erica M; Cole-Sinclair, Merrole F

    2013-09-16

    Blood transfusion is not without risk. Although the risks of HIV and hepatitis transmission have diminished, haemovigilance programs highlight that other significant transfusion hazards remain. Sepsis from bacterial contamination is the most common residual infectious hazard in developed countries, and events due to clerical error are problematic. Unnecessary transfusions should be avoided. New national guidelines on patient blood management (PBM) emphasise holistic approaches, including strategies to reduce transfusion requirements. Perioperative PBM should incorporate preoperative haemoglobin and medication optimisation, intraoperative blood conservation, and consideration of restrictive postoperative transfusion and cell-salvage techniques. When massive transfusion is required, hospitals should implement massive transfusion protocols. These protocols reduce mortality, improve communication and facilitate adequate provision of blood products. They should include multidisciplinary team involvement and guidelines for use of blood components and adjunctive agents. Although fresh frozen plasma to red blood cell and platelet to red blood cell ratios of ≥ 1 : 2 appear to reduce mortality in trauma patients who receive massive transfusion, there is insufficient evidence to recommend specific ratios. Systematic reviews have found no significant benefit of recombinant activated factor VII in critical bleeding, and an increase in thromboembolic events; specialist haematology advice is therefore recommended when considering use of this agent. The National Safety and Quality Health Service Standards address use of blood and blood products, and provide important transfusion principles for adoption by all clinicians. Storage of red cells in additive solution results in changes, known as the "storage lesion", and studies to determine the clinical effect of the age of blood at transfusion are ongoing.

  6. 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...

  7. 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

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

    Science.gov (United States)

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

    2017-04-01

    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 dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

  9. 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.

  10. 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

  11. 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...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  12. 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)

  13. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    Science.gov (United States)

    Men'shikov, V V

    2012-12-01

    The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

  14. Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data

    Science.gov (United States)

    Walther, Brigitte; Hossin, Safayet; Townend, John; Abernethy, Neil; Parker, David; Jeffries, David

    2011-01-01

    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-associated costs

  15. 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

  16. 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...

  17. 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 As a result of successful initiatives in Australia, New Zealand and Canada, the introduction of a performance-based standards (PBS) approach in the heavy vehicle sector in South Africa was identified by the Council for Scientific and Industrial...

  18. 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.…

  19. 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.

  20. Extracting business vocabularies from business process models: SBVR and BPMN standards-based approach

    Science.gov (United States)

    Skersys, Tomas; Butleris, Rimantas; Kapocius, Kestutis

    2013-10-01

    Approaches for the analysis and specification of business vocabularies and rules are very relevant topics in both Business Process Management and Information Systems Development disciplines. However, in common practice of Information Systems Development, the Business modeling activities still are of mostly empiric nature. In this paper, basic aspects of the approach for business vocabularies' semi-automated extraction from business process models are presented. The approach is based on novel business modeling-level OMG standards "Business Process Model and Notation" (BPMN) and "Semantics for Business Vocabularies and Business Rules" (SBVR), thus contributing to OMG's vision about Model-Driven Architecture (MDA) and to model-driven development in general.

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. A targeted metabolomics approach for clinical diagnosis of inborn errors of metabolism.

    Science.gov (United States)

    Jacob, Minnie; Malkawi, Abeer; Albast, Nour; Al Bougha, Salam; Lopata, Andreas; Dasouki, Majed; Abdel Rahman, Anas M

    2018-09-26

    Metabolome, the ultimate functional product of the genome, can be studied through identification and quantification of small molecules. The global metabolome influences the individual phenotype through clinical and environmental interventions. Metabolomics has become an integral part of clinical research and allowed for another dimension of better understanding of disease pathophysiology and mechanism. More than 95% of the clinical biochemistry laboratory routine workload is based on small molecular identification, which can potentially be analyzed through metabolomics. However, multiple challenges in clinical metabolomics impact the entire workflow and data quality, thus the biological interpretation needs to be standardized for a reproducible outcome. Herein, we introduce the establishment of a comprehensive targeted metabolomics method for a panel of 220 clinically relevant metabolites using Liquid chromatography-tandem mass spectrometry (LC-MS/MS) standardized for clinical research. The sensitivity, reproducibility and molecular stability of each targeted metabolite (amino acids, organic acids, acylcarnitines, sugars, bile acids, neurotransmitters, polyamines, and hormones) were assessed under multiple experimental conditions. The metabolic tissue distribution was determined in various rat organs. Furthermore, the method was validated in dry blood spot (DBS) samples collected from patients known to have various inborn errors of metabolism (IEMs). Using this approach, our panel appears to be sensitive and robust as it demonstrated differential and unique metabolic profiles in various rat tissues. Also, as a prospective screening method, this panel of diverse metabolites has the ability to identify patients with a wide range of IEMs who otherwise may need multiple, time-consuming and expensive biochemical assays causing a delay in clinical management. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. 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.

  7. 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.

  8. Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

    Science.gov (United States)

    Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

    2014-02-01

    Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

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

    Energy Technology Data Exchange (ETDEWEB)

    Gabriel, P. [University of Pennsylvania (United States)

    2015-06-15

    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.

  10. 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

  11. 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...

  12. 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.

  13. 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.

  14. 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.

  15. A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

    Science.gov (United States)

    de la Iglesia, Diana; García-Remesal, Miguel; Anguita, Alberto; Muñoz-Mármol, Miguel; Kulikowski, Casimir; Maojo, Víctor

    2014-01-01

    Clinical Trials (CTs) are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano), and CTs that do not involve nanotechnology (non-nano). Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results. We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i) extraction and manual annotation of CTs as nano vs. non-nano, ii) pre-processing and automatic classification, and iii) performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset. The performance of the best automated classifier closely matches that of experts (AUC over 0.95), suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice, which is

  16. 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.

  17. Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments.

    Science.gov (United States)

    Maccall, Steven L

    2006-04-01

    The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log "hit" during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non-North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of Web server data warrant an exploratory assessment. This

  18. Clinical Digital Libraries Project: design approach and exploratory assessment of timely use in clinical environments*

    Science.gov (United States)

    MacCall, Steven L.

    2006-01-01

    Objective: The paper describes and evaluates the use of Clinical Digital Libraries Project (CDLP) digital library collections in terms of their facilitation of timely clinical information seeking. Design: A convenience sample of CDLP Web server log activity over a twelve-month period (7/2002 to 6/2003) was analyzed for evidence of timely information seeking after users were referred to digital library clinical topic pages from Web search engines. Sample searches were limited to those originating from medical schools (26% North American and 19% non-North American) and from hospitals or clinics (51% North American and 4% non-North American). Measurement: Timeliness was determined based on a calculation of the difference between the timestamps of the first and last Web server log “hit” during each search in the sample. The calculated differences were mapped into one of three ranges: less than one minute, one to three minutes, and three to five minutes. Results: Of the 864 searches analyzed, 48% were less than 1 minute, 41% were 1 to 3 minutes, and 11% were 3 to 5 minutes. These results were further analyzed by environment (medical schools versus hospitals or clinics) and by geographic location (North America versus non-North American). Searches reflected a consistent pattern of less than 1 minute in these environments. Though the results were not consistent on a month-by-month basis over the entire time period, data for 8 of 12 months showed that searches shorter than 1 minute predominated and data for 1 month showed an equal number of less than 1 minute and 1 to 3 minute searches. Conclusions: The CDLP digital library collections provided timely access to high-quality Web clinical resources when used for information seeking in medical education and hospital or clinic environments from North American and non–North American locations and consistently provided access to the sought information within the documented two-minute standard. The limitations of the use of

  19. 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

  20. Cow-specific treatment of clinical mastitis: an economic approach.

    Science.gov (United States)

    Steeneveld, W; van Werven, T; Barkema, H W; Hogeveen, H

    2011-01-01

    Under Dutch circumstances, most clinical mastitis (CM) cases of cows on dairy farms are treated with a standard intramammary antimicrobial treatment. Several antimicrobial treatments are available for CM, differing in antimicrobial compound, route of application, duration, and cost. Because cow factors (e.g., parity, stage of lactation, and somatic cell count history) and the causal pathogen influence the probability of cure, cow-specific treatment of CM is often recommended. The objective of this study was to determine if cow-specific treatment of CM is economically beneficial. Using a stochastic Monte Carlo simulation model, 20,000 CM cases were simulated. These CM cases were caused by Streptococcus uberis and Streptococcus dysgalactiae (40%), Staphylococcus aureus (30%), or Escherichia coli (30%). For each simulated CM case, the consequences of using different antimicrobial treatment regimens (standard 3-d intramammary, extended 5-d intramammary, combination 3-d intramammary+systemic, combination 3-d intramammary+systemic+1-d nonsteroidal antiinflammatory drugs, and combination extended 5-d intramammary+systemic) were simulated simultaneously. Finally, total costs of the 5 antimicrobial treatment regimens were compared. Some inputs for the model were based on literature information and assumptions made by the authors were used if no information was available. Bacteriological cure for each individual cow depended on the antimicrobial treatment regimen, the causal pathogen, and the cow factors parity, stage of lactation, somatic cell count history, CM history, and whether the cow was systemically ill. Total costs for each case depended on treatment costs for the initial CM case (including costs for antibiotics, milk withdrawal, and labor), treatment costs for follow-up CM cases, costs for milk production losses, and costs for culling. Average total costs for CM using the 5 treatments were (US) $224, $247, $253, $260, and $275, respectively. Average probabilities

  1. 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 .

  2. 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.

  3. Towards clinical prostate ultrasound elastography using full inversion approach.

    Science.gov (United States)

    Mousavi, Seyed Reza; Sadeghi-Naini, Ali; Czarnota, Gregory J; Samani, Abbas

    2014-03-01

    Various types of cancers including prostate cancer are known to be associated with biological changes that lead to tissue stiffening. Digital rectal examination is based on manually palpating the prostate tissue via the rectum. This test lacks sufficient accuracy required for early diagnosis which is necessary for effective management of prostate cancer. To develop an effective prostate cancer diagnostic technique, the authors propose an imaging technique that maps the distribution of the relative prostate tissue's elasticity modulus. Unlike digital rectal examination, this technique is quantitative, capable of accurately detecting small prostate lesions that cannot be sensed by manual palpation, and its accuracy is independent of the physician's experience. The proposed technique is a quasistatic elastography technique which uses ultrasound imaging to acquire tissue displacements resulting from transrectal ultrasound mechanical stimulation. The system involves a standard ultrasound imaging unit with accessibility to its radiofrequency data. The displacements are used as data for the tissue elasticity reconstruction. This reconstruction does not require tissue segmentation and is based on physics governing tissue mechanics. It is formulated using an inverse problem framework where elastic tissue deformation equations are fully inverted using an iterative scheme where each iteration involves stress calculation followed by elastic modulus updating until convergence is achieved.In silico and tissue mimicking phantom studies were conducted to validate the proposed technique, followed by a clinical pilot study involving two prostate cancer patients with whole-mount histopathology analysis on prostatectomy specimens to confirm a cancer location. The phantom studies demonstrated robustness and reasonably high accuracy of the proposed method. Obtained Young's modulus ratios indicated reconstruction errors of less than 12%. Reconstructed elastic modulus images of the two

  4. MASTER: a model to improve and standardize clinical breakpoints for antimicrobial susceptibility testing using forecast probabilities.

    Science.gov (United States)

    Blöchliger, Nicolas; Keller, Peter M; Böttger, Erik C; Hombach, Michael

    2017-09-01

    The procedure for setting clinical breakpoints (CBPs) for antimicrobial susceptibility has been poorly standardized with respect to population data, pharmacokinetic parameters and clinical outcome. Tools to standardize CBP setting could result in improved antibiogram forecast probabilities. We propose a model to estimate probabilities for methodological categorization errors and defined zones of methodological uncertainty (ZMUs), i.e. ranges of zone diameters that cannot reliably be classified. The impact of ZMUs on methodological error rates was used for CBP optimization. The model distinguishes theoretical true inhibition zone diameters from observed diameters, which suffer from methodological variation. True diameter distributions are described with a normal mixture model. The model was fitted to observed inhibition zone diameters of clinical Escherichia coli strains. Repeated measurements for a quality control strain were used to quantify methodological variation. For 9 of 13 antibiotics analysed, our model predicted error rates of  0.1% for ampicillin, cefoxitin, cefuroxime and amoxicillin/clavulanic acid. Increasing the susceptible CBP (cefoxitin) and introducing ZMUs (ampicillin, cefuroxime, amoxicillin/clavulanic acid) decreased error rates to < 0.1%. ZMUs contained low numbers of isolates for ampicillin and cefuroxime (3% and 6%), whereas the ZMU for amoxicillin/clavulanic acid contained 41% of all isolates and was considered not practical. We demonstrate that CBPs can be improved and standardized by minimizing methodological categorization error rates. ZMUs may be introduced if an intermediate zone is not appropriate for pharmacokinetic/pharmacodynamic or drug dosing reasons. Optimized CBPs will provide a standardized antibiotic susceptibility testing interpretation at a defined level of probability. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For

  5. 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.

  6. A modified artificial immune system based pattern recognition approach -- an application to clinic diagnostics

    Science.gov (United States)

    Zhao, Weixiang; Davis, Cristina E.

    2011-01-01

    Objective This paper introduces a modified artificial immune system (AIS)-based pattern recognition method to enhance the recognition ability of the existing conventional AIS-based classification approach and demonstrates the superiority of the proposed new AIS-based method via two case studies of breast cancer diagnosis. Methods and materials Conventionally, the AIS approach is often coupled with the k nearest neighbor (k-NN) algorithm to form a classification method called AIS-kNN. In this paper we discuss the basic principle and possible problems of this conventional approach, and propose a new approach where AIS is integrated with the radial basis function – partial least square regression (AIS-RBFPLS). Additionally, both the two AIS-based approaches are compared with two classical and powerful machine learning methods, back-propagation neural network (BPNN) and orthogonal radial basis function network (Ortho-RBF network). Results The diagnosis results show that: (1) both the AIS-kNN and the AIS-RBFPLS proved to be a good machine leaning method for clinical diagnosis, but the proposed AIS-RBFPLS generated an even lower misclassification ratio, especially in the cases where the conventional AIS-kNN approach generated poor classification results because of possible improper AIS parameters. For example, based upon the AIS memory cells of “replacement threshold = 0.3”, the average misclassification ratios of two approaches for study 1 are 3.36% (AIS-RBFPLS) and 9.07% (AIS-kNN), and the misclassification ratios for study 2 are 19.18% (AIS-RBFPLS) and 28.36% (AIS-kNN); (2) the proposed AIS-RBFPLS presented its robustness in terms of the AIS-created memory cells, showing a smaller standard deviation of the results from the multiple trials than AIS-kNN. For example, using the result from the first set of AIS memory cells as an example, the standard deviations of the misclassification ratios for study 1 are 0.45% (AIS-RBFPLS) and 8.71% (AIS-kNN) and those for

  7. The development of an efficient mass balance approach for the purity assignment of organic calibration standards.

    Science.gov (United States)

    Davies, Stephen R; Alamgir, Mahiuddin; Chan, Benjamin K H; Dang, Thao; Jones, Kai; Krishnaswami, Maya; Luo, Yawen; Mitchell, Peter S R; Moawad, Michael; Swan, Hilton; Tarrant, Greg J

    2015-10-01

    The purity determination of organic calibration standards using the traditional mass balance approach is described. Demonstrated examples highlight the potential for bias in each measurement and the need to implement an approach that provides a cross-check for each result, affording fit for purpose purity values in a timely and cost-effective manner. Chromatographic techniques such as gas chromatography with flame ionisation detection (GC-FID) and high-performance liquid chromatography with UV detection (HPLC-UV), combined with mass and NMR spectroscopy, provide a detailed impurity profile allowing an efficient conversion of chromatographic peak areas into relative mass fractions, generally avoiding the need to calibrate each impurity present. For samples analysed by GC-FID, a conservative measurement uncertainty budget is described, including a component to cover potential variations in the response of each unidentified impurity. An alternative approach is also detailed in which extensive purification eliminates the detector response factor issue, facilitating the certification of a super-pure calibration standard which can be used to quantify the main component in less-pure candidate materials. This latter approach is particularly useful when applying HPLC analysis with UV detection. Key to the success of this approach is the application of both qualitative and quantitative (1)H NMR spectroscopy.

  8. 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.)

  9. 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.

  10. 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.

  11. 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

  12. Exploring Chinese cultural standards through the lens of German managers: A case study approach

    Directory of Open Access Journals (Sweden)

    Roger Moser

    2011-06-01

    Full Text Available The ability to understand one’s own culture and to deal with specificities of foreign cultures is one of the core requirements in today’s international business. Management skills are partially culture specific and a management approach that is appropriate in one cultural context may not be appropriate in another. Several business activities of companies nowadays take place abroad, which requires managers to interact with different cultures. This paper aims to analyse cultural characteristics, especially in a Sino-German business context. Based on literature analysis and case study research, relevant cultural standards in China were identified from the German perspective. The result differentiates three superordinate cultural areas and five specific cultural standards and analyses different influence factors on the dimensions of the identified Chinese cultural standards.

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

    Directory of Open Access Journals (Sweden)

    Scott Okuno

    2011-08-01

    Full Text Available 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.

  14. 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.

  15. Crises in clinical care: an approach to management.

    Science.gov (United States)

    Runciman, W B; Merry, A F

    2005-06-01

    A "crisis" in health care is "the point in the course of a disease at which a decisive change occurs, leading either to recovery or to death". The daunting challenges faced by clinicians when confronted with a crisis are illustrated by a tragic case in which a teenage boy died after a minor surgical procedure. Crises are challenging for reasons which include: presentation with non-specific signs or symptoms, interaction of complex factors, progressive evolution, new situations, "revenge effects", inadequate assistance, and time constraints. In crises, clinicians often experience anxiety- and overload-induced performance degradation, tend to use "frequency gambling", run out of "rules" and have to work from first principles, and are prone to "confirmation bias". The effective management of crises requires formal training, usually simulator-based, and ideally in the inter-professional groups who will need to function as a team. "COVER ABCD-A SWIFT CHECK" is a pre-compiled algorithm which can be applied quickly and effectively to facilitate a systematic and effective response to the wide range of potentially lethal problems which may occur suddenly in anaesthesia. A set of 25 articles describing additional pre-compiled responses collated into a manual for the management of any crisis under anaesthesia has been published electronically as companion papers to this article. This approach to crisis management should be applied to other areas of clinical medicine as well as anaesthesia.

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

    International Nuclear Information System (INIS)

    Joglekar, Siddharth B.; Rose, Peter S.; Sim, Franklin; Okuno, Scott; Petersen, Ivy

    2011-01-01

    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

  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. Can context justify an ethical double standard for clinical research in developing countries?

    Directory of Open Access Journals (Sweden)

    Landes Megan

    2005-07-01

    Full Text Available Abstract Background The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. Discussion These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. Conclusion Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries.

  19. Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty.

    Science.gov (United States)

    Tanner, J M; Whitehouse, R H

    1976-01-01

    New charts for height, weight, height velocity, and weight velocity are presented for clinical (as opposed to population survey) use. They are based on longitudinal-type growth curves, using the same data as in the British 1965 growth standards. In the velocity standards centiles are given for children who are early- and late-maturing as well as for those who mature at the average age (thus extending the use of the previous charts). Limits of normality for the age of occurrence of the adolescent growth spurt are given and also for the successive stages of penis, testes, and pubic hair development in boys, and for stages of breast and pubic hair development in girls. PMID:952550

  20. 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.

  1. Thermafil: A New Clinical Approach Due to New Dimensional Evaluations

    Science.gov (United States)

    Vittoria, G.; Pantaleo, G.; Blasi, A.; Spagnuolo, G.; Iandolo, A.; Amato, M.

    2018-01-01

    Background: There are a lot of techniques to obturate the root canals, but lateral condensation of gutta-percha is the most used one. An important aspect of thermafil is the error margin tolerated by the manufacturer in the production of plastic carriers. In literature, there is no evidence about discrepancy percentage between different carriers. It is demonstrated that the error margin of gutta-percha is 0.5% and is 0.2% for metal files (ISO standards). Objective: The aim of this study was to evaluate the real dimensions of thermafil plastic carriers observed by the stereo microscope measuring the dimensional discrepancy between them. Methods: For this study, 80 new thermafil (Dentsply Maillefer) have been selected. 40 thermafil 0.25 and 40 thermafil 0.30. Through 60X stereo microscope, the dimensions of the plastic carrier tips have been measured. The dimensions of the plastic carrier were also measured after a heating cycle. ZL GAL 11TUSM (Zetaline stereo evolution) microscope was used to observe the samples. Measurements were made through a dedicated software (Image Focus). All samples were analysed at 60X. Results: A non-parametric paired test (Wilcoxon test) was used to compare baseline and after heating values; p-values ≤ 0.05 were assumed to be statistically significant. Conclusion: The samples we measured showed a mean value of the diameters in Thermafil 25 that was 0.27 mm, for Thermafil 30 the mean value was 0.33 mm. We have measured a dimensional variable of 8% in the 25 group while in group 30 the maximum possible variation found was 4%, that’s why we propose a new protocol of obturation with thermafil. We can also conclude that a single heating process does not affect clinically the plastic carrier dimensions. PMID:29541263

  2. 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) 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.

  3. Standardized terminology for clinical trial protocols based on top-level ontological categories.

    Science.gov (United States)

    Heller, B; Herre, H; Lippoldt, K; Loeffler, M

    2004-01-01

    This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.

  4. 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

  5. Comparisons of non-destructive examination standards in the framework of fracture mechanics approach

    International Nuclear Information System (INIS)

    Reale, S.; Corvi, A.

    1993-01-01

    One of the aims of the various Engineering Standards related to Non-destructive Examination (NDE) is to identify and limit some characteristics of defects in a structure, since the degree of damage of a structure can be associated with these defect characteristics. One way that the damage level can be evaluated is by means of Fracture Mechanics. The objective of the present paper is to compare and identify the differences in the flaw acceptance criteria of national NDE Standards so as to suggest some guidelines for a future common European Standard. This paper examines the Standards adopted in France (RCC-MR), Germany (DIN), Italy (ASME) and the UK (BSI). It concentrates on both ultrasonic and radiographic inspection methods. The flaw acceptance criteria in these standards relating to non-destructive tests performed on a component during manufacturing are compared and evaluated by the Fracture Mechanics CEGB R6 procedure. General guidelines and results supporting the significance of the Fracture Mechanics approach are given. (Author)

  6. 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)

  7. 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.

  8. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

    Science.gov (United States)

    Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

    2011-01-01

    Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada. Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the

  9. ORAL CLINICAL LONG CASE PRESENTATION, THE NEED FOR STANDARDIZATION AND DOCUMENTATION.

    Science.gov (United States)

    Agodirin, S O; Olatoke, S A; Rahman, G A; Agbakwuru, E A; Kolawole, O A

    2015-01-01

    The oral presentation of the clinical long case is commonly an implied knowledge. The challenge of the presentation is compounded by the examiners' preferences and sometimes inadequate understanding of what should be assessed. To highlight the different opinions and misconceptions of trainers as the basis for improving our understanding and assessment of oral presentation of the clinical long case. Questionnaire was administered during the West African College of Surgeons fellowship clinical examinations and at their workplaces. Eligibility criteria included being a surgeon, a trainer and responding to all questions. Of the 72 questionnaires that were returned, 36(50%) were eligible for the analysis. The 36 respondents were from 14 centers in Nigeria and Ghana. Fifty-two percent were examiners at the postgraduate medical colleges and 9(25%) were professors. Eight(22.2%) indicated they were unaware of the separate methods of oral presentation for different occasions while 21( 58.3%) respondents were aware that candidate used the "5Cs" method and the traditional compartmentalized method in long case oral presentation. Eleven(30.6%) wanted postgraduates to present differently on a much higher level than undergraduate despite not encountering same in literature and 21(58.3%) indicated it was an unwritten rule. Seventeen (47.2%) had not previously encountered the "5Cs" of history of presenting complaint in literature also 17(47.2%) teach it to medical students and their junior residents. This study has shown that examiners definitely have varying opinions on what form the oral presentation of the clinical long case at surgery fellowship/professional examination should be and it translates to their expectations of the residents or clinical students. This highlights the need for standardization and consensus of what is expected at a formal oral presentation during the clinical long case examination in order to avoid subjectivity and bias.

  10. Understanding clinical reasoning in osteopathy: a qualitative research approach

    OpenAIRE

    Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

    2016-01-01

    Background Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it wa...

  11. 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

  12. Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017

    Directory of Open Access Journals (Sweden)

    Ao Q

    2017-12-01

    Full Text Available Qiang Ao,1,* Juan Xiao,2,3,* Yanqiu Yu,4 Gengsheng Mao,2 Qingyan Zou,5 Wenyong Gao,2,3 Hongyun Huang2,3 On behalf of Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology 1Department of Tissue Engineering, China Medical University, Shen Yang, 2Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, 3Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, 4Department of Pathophysiology, China Medical University, Shen Yang, 5Guangdong 999 Brain Hospital, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Formulating common standards for the culture and quality control of umbilical cord mesenchymal stromal cells (MSCs is crucial for the standardization of clinical neurorestorative therapy. But to date, there have been no standardized guidelines for the culture and quality control of MSCs in neurorestorative clinical application. Based on a relatively comprehensive review of published clinical studies as well as the existing methods of MSC culture and quality control, the Chinese Association of Neurorestoratology has developed standards for the culture and quality control of umbilical cord MSCs which possess the potential in neurorestorative clinical application. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture and proliferation of umbilical cord MSCs; standardized management for cell preservation, transport and related safeguard measures; as well as standardization of a clean environment, routine maintenance and related tests and examinations and so on. These guidelines represent the minimum required standards for the culture and quality control of umbilical cord MSCs for potential use in current neurorestorative clinical therapy, and will be further

  13. Cardiopulmonary resuscitation standards for clinical practice and training in the UK.

    Science.gov (United States)

    Gabbott, David; Smith, Gary; Mitchell, Sarah; Colquhoun, Michael; Nolan, Jerry; Soar, Jasmeet; Pitcher, David; Perkins, Gavin; Phillips, Barbara; King, Ben; Spearpoint, Ken

    2005-07-01

    The Royal College of Anaesthetists, the Royal College of Physicians, the Intensive Care Society and the Resuscitation Council (UK) have published new resuscitation standards. The document provides advice to UK healthcare organisations, resuscitation committees and resuscitation officers on all aspects of the resuscitation service. It includes sections on resuscitation training, resuscitation equipment, the cardiac arrest team, cardiac arrest prevention, patient transfer, post-resuscitation care, audit and research. The document makes several recommendations. Healthcare institutions should have, or be represented on, a resuscitation committee that is responsible for all resuscitation issues. Every institution should have at least one resuscitation officer responsible for teaching and conducting training in resuscitation techniques. Staff with patient contact should be given regular resuscitation training appropriate to their expected abilities and roles. Clinical staff should receive regular training in the recognition of patients at risk of cardiopulmonary arrest and the measures required for the prevention of cardiopulmonary arrest. Healthcare institutions admitting acutely ill patients should have a resuscitation team, or its equivalent, available at all times. Clear guidelines should be available indicating how and when to call for the resuscitation team. Cardiopulmonary arrest should be managed according to current national guidelines. Resuscitation equipment should be available throughout the institution for clinical use and for training. The practice of resuscitation should be audited to maintain and improve standards of care. A do not attempt resuscitation (DNAR) policy should be compiled, communicated to relevant members of staff, used and audited regularly. Funding must be provided to support an effective resuscitation service.

  14. A standardized multidisciplinary approach reduces the use of allogeneic blood products in patients undergoing cardiac surgery.

    Science.gov (United States)

    Van der Linden, P; De Hert, S; Daper, A; Trenchant, A; Jacobs, D; De Boelpaepe, C; Kimbimbi, P; Defrance, P; Simoens, G

    2001-10-01

    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. This prospective non randomized observational study evaluated the effects of a standardized multidisciplinary transfusion strategy on allogeneic blood products exposure in patients undergoing non-emergent cardiac surgery. The developed strategy involved a standardized blood conservation program and a multidisciplinary allogeneic blood transfusion policy based mainly on clinical judgement, not only on a specific hemoglobin concentration. Data obtained in a first group including patients operated from September 1997 to August 1998 (Group pre: n=321), when the transfusion strategy was progressively developed, were compared to those obtained in a second group, including patients operated from September 1998 to August 1999 (Group post: n=315) when the transfusion strategy was applied uniformly. Patient populations and surgical procedures were similar. Patients in Group post underwent acute normovolemic hemodilution more frequently, had a higher core temperature at arrival in the intensive care unit and presented lower postoperative blood losses at day one. Three hundred forty units of packed red blood cells were transfused in 33% of the patients in Group pre whereas 161 units were transfused in 18% of the patients in Group post (P <0.001). Pre- and postoperative hemoglobin concentrations, mortality and morbidity were not different among groups. Development of a standardized multidisciplinary transfusion strategy markedly reduced the exposure of cardiac surgery patients to allogeneic blood.

  15. A new approach to preparation of standard LEDs for luminous intensity and flux measurement of LEDs

    Science.gov (United States)

    Park, Seung-Nam; Park, Seongchong; Lee, Dong-Hoon

    2006-09-01

    This work presents an alternative approach for preparing photometric standard LEDs, which is based on a novel functional seasoning method. The main idea of our seasoning method is simultaneously monitoring the light output and the junction voltage to obtain quantitative information on the temperature dependence and the aging effect of the LED emission. We suggested a general model describing the seasoning process by taking junction temperature variation and aging effect into account and implemented a fully automated seasoning facility, which is capable of seasoning 12 LEDs at the same time. By independent measurements of the temperature dependence, we confirmed the discrepancy of the theoretical model to be less than 0.5 % and evaluate the uncertainty contribution of the functional seasoning to be less than 0.5 % for all the seasoned samples. To demonstrate assigning the reference value to a standard LED, the CIE averaged LED intensity (ALI) of the seasoned LEDs was measured with a spectroradiometer-based instrument and the measurement uncertainty was analyzed. The expanded uncertainty of the standard LED prepared by the new approach amounts to be 4 % ~ 5 % (k=2) depending on color without correction of spectral stray light in the spectroradiometer.

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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

  1. A new approach for heparin standardization: combination of scanning UV spectroscopy, nuclear magnetic resonance and principal component analysis.

    Directory of Open Access Journals (Sweden)

    Marcelo A Lima

    Full Text Available 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.

  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 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

  4. 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

  5. Conceptual Explanation for the Algebra in the Noncommutative Approach to the Standard Model

    International Nuclear Information System (INIS)

    Chamseddine, Ali H.; Connes, Alain

    2007-01-01

    The purpose of this Letter is to remove the arbitrariness of the ad hoc choice of the algebra and its representation in the noncommutative approach to the standard model, which was begging for a conceptual explanation. We assume as before that space-time is the product of a four-dimensional manifold by a finite noncommmutative space F. The spectral action is the pure gravitational action for the product space. To remove the above arbitrariness, we classify the irreducible geometries F consistent with imposing reality and chiral conditions on spinors, to avoid the fermion doubling problem, which amounts to have total dimension 10 (in the K-theoretic sense). It gives, almost uniquely, the standard model with all its details, predicting the number of fermions per generation to be 16, their representations and the Higgs breaking mechanism, with very little input

  6. Caution regarding the choice of standard deviations to guide sample size calculations in clinical trials.

    Science.gov (United States)

    Chen, Henian; Zhang, Nanhua; Lu, Xiaosun; Chen, Sophie

    2013-08-01

    The method used to determine choice of standard deviation (SD) is inadequately reported in clinical trials. Underestimations of the population SD may result in underpowered clinical trials. This study demonstrates how using the wrong method to determine population SD can lead to inaccurate sample sizes and underpowered studies, and offers recommendations to maximize the likelihood of achieving adequate statistical power. We review the practice of reporting sample size and its effect on the power of trials published in major journals. Simulated clinical trials were used to compare the effects of different methods of determining SD on power and sample size calculations. Prior to 1996, sample size calculations were reported in just 1%-42% of clinical trials. This proportion increased from 38% to 54% after the initial Consolidated Standards of Reporting Trials (CONSORT) was published in 1996, and from 64% to 95% after the revised CONSORT was published in 2001. Nevertheless, underpowered clinical trials are still common. Our simulated data showed that all minimal and 25th-percentile SDs fell below 44 (the population SD), regardless of sample size (from 5 to 50). For sample sizes 5 and 50, the minimum sample SDs underestimated the population SD by 90.7% and 29.3%, respectively. If only one sample was available, there was less than 50% chance that the actual power equaled or exceeded the planned power of 80% for detecting a median effect size (Cohen's d = 0.5) when using the sample SD to calculate the sample size. The proportions of studies with actual power of at least 80% were about 95%, 90%, 85%, and 80% when we used the larger SD, 80% upper confidence limit (UCL) of SD, 70% UCL of SD, and 60% UCL of SD to calculate the sample size, respectively. When more than one sample was available, the weighted average SD resulted in about 50% of trials being underpowered; the proportion of trials with power of 80% increased from 90% to 100% when the 75th percentile and the

  7. 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

  8. 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.

  9. Web-based objective structured clinical examination with remote standardized patients and Skype: resident experience.

    Science.gov (United States)

    Langenau, Erik; Kachur, Elizabeth; Horber, Dot

    2014-07-01

    Using Skype and remote standardized patients (RSPs), investigators sought to evaluate user acceptance of a web-based objective structured clinical examination (OSCE) among resident physicians. After participating in four web-based clinical encounters addressing pain with RSPs, 59 residents from different training programs, disciplines and geographic locations completed a 52-item questionnaire regarding their experience with Skype and RSPs. Open-ended responses were solicited as well. The majority of participants (97%) agreed or strongly agreed the web-based format was convenient and a practical learning exercise, and 90% agreed or strongly agreed the format was effective in teaching communication skills. Although 93% agreed or strongly agreed they could communicate easily with RSPs using Skype, 80% preferred traditional face-to-face clinical encounters, and 58% reported technical difficulties during the encounters. Open-ended written responses supported survey results. Findings from this study expose challenges with technology and human factors, but positive experiences support the continued investigation of web-based OSCEs as a synchronous e-learning initiative for teaching and assessing doctor-patient communication. Such educational programs are valuable but unlikely to replace face-to-face encounters with patients. This web-based OSCE program provides physician learners with additional opportunity to improve doctor-patient communication. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  10. Current clinical approach to patients with disorders of consciousness

    Directory of Open Access Journals (Sweden)

    Robson Luis Oliveira de Amorim

    Full Text Available Summary In clinical practice, hospital admission of patients with altered level of consciousness, sleepy or in a non-responsive state is extremely common. This clinical condition requires an effective investigation and early treatment. Performing a focused and objective evaluation is critical, with quality history taking and physical examination capable to locate the lesion and define conducts. Imaging and laboratory exams have played an increasingly important role in supporting clinical research. In this review, the main types of changes in consciousness are discussed as well as the essential points that should be evaluated in the clinical management of these patients.

  11. A standardized approach to study human variability in isometric thermogenesis during low-intensity physical activity

    Directory of Open Access Journals (Sweden)

    Delphine eSarafian

    2013-07-01

    Full Text Available Limitations of current methods: The assessment of human variability in various compartments of daily energy expenditure (EE under standardized conditions is well defined at rest (as basal metabolic rate and thermic effect of feeding, and currently under validation for assessing the energy cost of low-intensity dynamic work. However, because physical activities of daily life consist of a combination of both dynamic and isometric work, there is also a need to develop standardized tests for assessing human variability in the energy cost of low-intensity isometric work.Experimental objectives: Development of an approach to study human variability in isometric thermogenesis by incorporating a protocol of intermittent leg press exercise of varying low-intensity isometric loads with measurements of EE by indirect calorimetry. Results: EE was measured in the seated position with the subject at rest or while intermittently pressing both legs against a press-platform at 5 low-intensity isometric loads (+5, +10, + 15, +20 and +25 kg force, each consisting of a succession of 8 cycles of press (30 s and rest (30 s. EE, integrated over each 8-min period of the intermittent leg press exercise, was found to increase linearly across the 5 isometric loads with a correlation coefficient (r > 0.9 for each individual. The slope of this EE-Load relationship, which provides the energy cost of this standardized isometric exercise expressed per kg force applied intermittently (30 s in every min, was found to show good repeatability when assessed in subjects who repeated the same experimental protocol on 3 separate days: its low intra-individual coefficient of variation (CV of ~ 10% contrasted with its much higher inter-individual CV of 35%; the latter being mass-independent but partly explained by height. Conclusion: This standardized approach to study isometric thermogenesis opens up a new avenue for research in EE phenotyping and metabolic predisposition to obesity

  12. A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

    Directory of Open Access Journals (Sweden)

    Diana de la Iglesia

    Full Text Available Clinical Trials (CTs are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano, and CTs that do not involve nanotechnology (non-nano. Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results.We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i extraction and manual annotation of CTs as nano vs. non-nano, ii pre-processing and automatic classification, and iii performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset.The performance of the best automated classifier closely matches that of experts (AUC over 0.95, suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice

  13. 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

  14. 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

  15. Current Methods Applied to Biomaterials - Characterization Approaches, Safety Assessment and Biological International Standards.

    Science.gov (United States)

    Oliveira, Justine P R; Ortiz, H Ivan Melendez; Bucio, Emilio; Alves, Patricia Terra; Lima, Mayara Ingrid Sousa; Goulart, Luiz Ricardo; Mathor, Monica B; Varca, Gustavo H C; Lugao, Ademar B

    2018-04-10

    Safety and biocompatibility assessment of biomaterials are themes of constant concern as advanced materials enter the market as well as products manufactured by new techniques emerge. Within this context, this review provides an up-to-date approach on current methods for the characterization and safety assessment of biomaterials and biomedical devices from a physicalchemical to a biological perspective, including a description of the alternative methods in accordance with current and established international standards. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  16. 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...

  17. 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.

  18. 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....

  19. 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 ...

  20. Lateral Load Capacity of Piles: A Comparative Study Between Indian Standards and Theoretical Approach

    Science.gov (United States)

    Jayasree, P. K.; Arun, K. V.; Oormila, R.; Sreelakshmi, H.

    2018-05-01

    As per Indian Standards, laterally loaded piles are usually analysed using the method adopted by IS 2911-2010 (Part 1/Section 2). But the practising engineers are of the opinion that the IS method is very conservative in design. This work aims at determining the extent to which the conventional IS design approach is conservative. This is done through a comparative study between IS approach and the theoretical model based on Vesic's equation. Bore log details for six different bridges were collected from the Kerala Public Works Department. Cast in situ fixed head piles embedded in three soil conditions both end bearing as well as friction piles were considered and analyzed separately. Piles were also modelled in STAAD.Pro software based on IS approach and the results were validated using Matlock and Reese (In Proceedings of fifth international conference on soil mechanics and foundation engineering, 1961) equation. The results were presented as the percentage variation in values of bending moment and deflection obtained by different methods. The results obtained from the mathematical model based on Vesic's equation and that obtained as per the IS approach were compared and the IS method was found to be uneconomical and conservative.

  1. 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.

  2. 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...... – “mpDCs”, containing MPL, IFN-γ and PGE2. αDC1s and mDCs secreted IL-12 directly and following re-stimulation with CD40L-expressing cells and they mainly secreted the T effector cell attracting chemokines CXCL10 and CCL5 as opposed to sDCs that mainly secreted CCL22, known to attract regulatory T cells...

  3. A Practical Approach to Tumor Heterogeneity in Clinical Research and Diagnostics.

    Science.gov (United States)

    Stanta, Giorgio; Bonin, Serena

    2018-01-01

    This Pathobiology issue tries to better define the complex phenomenon of intratumor heterogeneity (ITH), mostly from a practical point of view. This topic has been chosen because ITH is a central issue in tumor development and has to be investigated directly in patient tissue and immediately applied in the treatment of the presenting patient. Different types of ITH should be considered: clonal genetic and epigenetic evolution, morphological heterogeneity, and tumor sampling, heterogeneity resulting from microenvironmental autocrine and paracrine interaction, and stochastic plasticity related to different functional cell efficiencies. For a higher level of reproducibility in clinical research and diagnostics, it is necessary to establish standardized analytical methods, including microdissection. In situ techniques can be pivotal to explore tumor microenvironment and can be improved with associated digital analysis. Liquid biopsies for plasma DNA analysis are at present the best method to study recurrent tumors with treatment adaptation, and widespread clinical use could be beneficial. The different types of tumor genomic instabilities could have pragmatic applications to rank ITH for clinical applications: treatment approaches differ in patients with a high nucleotide mutation rate and patients with high copy number alterations. © 2017 S. Karger AG, Basel.

  4. An oral clinical approach to Gorlin-Goltz syndrome.

    Science.gov (United States)

    Abreu, Lucas Guimaraes; Paiva, Saul Martins; Pretti, Henrique; Bastos Lages, Elizabeth Maria; Castro, Wagner Henriques

    2015-01-01

    Gorlin-Goltz syndrome is a rare hereditary disease that can have negative effects on one's quality of life. The main clinical features are multiple nevoid basal cell carcinomas, odontogenic keratocysts, congenital skeletal abnormalities, calcification of the falx cerebri, facial dysmorphism, and skin depressions (pits) on the palms and soles. Diagnosis is based on major and minor clinical and radiological criteria and can be confirmed by DNA analysis. This article describes the case of a child with Gorlin-Goltz syndrome and outlines the clinical manifestations of the disease.

  5. 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)

  6. A new approach to the determination of air kerma using primary-standard cavity ionization chambers

    International Nuclear Information System (INIS)

    Burns, D T

    2006-01-01

    A consistent formalism is presented using Monte Carlo calculations to determine the reference air kerma from the measured energy deposition in a primary-standard cavity ionization chamber. A global approach avoiding the use of cavity ionization theory is discussed and its limitations shown in relation to the use of the recommended value for W. The role of charged-particle equilibrium is outlined and the consequent requirements placed on the calculations are detailed. Values for correction factors are presented for the BIPM air-kerma standard for 60 Co, making use of the Monte Carlo code PENELOPE, a detailed geometrical model of the BIPM 60 Co source and event-by-event electron transport. While the wall correction factor k wall = 1.0012(2) is somewhat lower than the existing value, the axial non-uniformity correction k an = 1.0027(3) is significantly higher. The use of a point source in the evaluation of k an is discussed. A comparison is made of the calculated dose ratio with the Bragg-Gray and Spencer-Attix stopping-power ratios, the results indicating a preference for the Bragg-Gray approach in this particular case. A change to the recommended value for W of up to 2 parts in 10 3 is discussed. The uncertainties arising from the geometrical models, the use of phase-space files, the radiation transport algorithms and the underlying radiation interaction coefficients are estimated

  7. Parallelism measurement for base plate of standard artifact with multiple tactile approaches

    Science.gov (United States)

    Ye, Xiuling; Zhao, Yan; Wang, Yiwen; Wang, Zhong; Fu, Luhua; Liu, Changjie

    2018-01-01

    Nowadays, as workpieces become more precise and more specialized which results in more sophisticated structures and higher accuracy for the artifacts, higher requirements have been put forward for measuring accuracy and measuring methods. As an important method to obtain the size of workpieces, coordinate measuring machine (CMM) has been widely used in many industries. In order to achieve the calibration of a self-developed CMM, it is found that the parallelism of the base plate used for fixing the standard artifact is an important factor which affects the measurement accuracy in the process of studying self-made high-precision standard artifact. And aimed to measure the parallelism of the base plate, by using the existing high-precision CMM, gauge blocks, dial gauge and marble platform with the tactile approach, three methods for parallelism measurement of workpieces are employed, and comparisons are made within the measurement results. The results of experiments show that the final accuracy of all the three methods is able to reach micron level and meets the measurement requirements. Simultaneously, these three approaches are suitable for different measurement conditions which provide a basis for rapid and high-precision measurement under different equipment conditions.

  8. A new approach for modeling the peak utility impacts from a proposed CUAC standard

    Energy Technology Data Exchange (ETDEWEB)

    LaCommare, Kristina Hamachi; Gumerman, Etan; Marnay, Chris; Chan, Peter; Coughlin, Katie

    2004-08-01

    This report describes a new Berkeley Lab approach for modeling the likely peak electricity load reductions from proposed energy efficiency programs in the National Energy Modeling System (NEMS). This method is presented in the context of the commercial unitary air conditioning (CUAC) energy efficiency standards. A previous report investigating the residential central air conditioning (RCAC) load shapes in NEMS revealed that the peak reduction results were lower than expected. This effect was believed to be due in part to the presence of the squelch, a program algorithm designed to ensure changes in the system load over time are consistent with the input historic trend. The squelch applies a system load-scaling factor that scales any differences between the end-use bottom-up and system loads to maintain consistency with historic trends. To obtain more accurate peak reduction estimates, a new approach for modeling the impact of peaky end uses in NEMS-BT has been developed. The new approach decrements the system load directly, reducing the impact of the squelch on the final results. This report also discusses a number of additional factors, in particular non-coincidence between end-use loads and system loads as represented within NEMS, and their impacts on the peak reductions calculated by NEMS. Using Berkeley Lab's new double-decrement approach reduces the conservation load factor (CLF) on an input load decrement from 25% down to 19% for a SEER 13 CUAC trial standard level, as seen in NEMS-BT output. About 4 GW more in peak capacity reduction results from this new approach as compared to Berkeley Lab's traditional end-use decrement approach, which relied solely on lowering end use energy consumption. The new method has been fully implemented and tested in the Annual Energy Outlook 2003 (AEO2003) version of NEMS and will routinely be applied to future versions. This capability is now available for use in future end-use efficiency or other policy analysis

  9. Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation.

    Science.gov (United States)

    van Es, Suzanne C; Venema, Clasina M; Glaudemans, Andor W J M; Lub-de Hooge, Marjolijn N; Elias, Sjoerd G; Boellaard, Ronald; Hospers, Geke A P; Schröder, Carolina P; de Vries, Elisabeth G E

    2016-02-01

    Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. With a good rationale, after development of the tracer and proven feasibility, it is of interest to evaluate whether there is a potential meaningful role for the tracer in the clinical setting-such as in staging, in the (early) prediction of a treatment response, or in supporting drug choices. So far, only (18)F-FDG PET has been incorporated into breast cancer guidelines. For proof of the clinical relevance of tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. However, resources for PET implementation research are limited. Therefore, next to randomized studies, novel approaches are required for proving the clinical value of PET tracers with the smallest possible number of patients. The aim of this review is to describe the process of the development of PET tracers and the level of evidence needed for the use of these tracers in breast cancer. Several breast cancer trials have been performed with the PET tracers (18)F-FDG, 3'-deoxy-3'-(18)F-fluorothymidine ((18)F-FLT), and (18)F-fluoroestradiol ((18)F-FES). We studied them to learn lessons for the implementation of novel tracers. After defining the gap between a good rationale for a tracer and implementation in the clinical setting, we propose solutions to fill the gap to try to bring more PET tracers to daily clinical practice. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

  10. Measuring the nose in septorhinoplasty patients: ultrasonographic standard values and clinical correlations.

    Science.gov (United States)

    Stenner, Markus; Koopmann, Mario; Rudack, Claudia

    2017-02-01

    Although septorhinoplasty is the most commonly performed operation in plastic surgery, and the surgical plan as well as its outcome is directly related to the configuration of the anatomical structures in the nose, these are not routinely assessed preoperatively. The aim of our study was to evaluate the nasal soft tissue and cartilaginous structures by means of high-resolution ultrasonography to set up clinical correlations and standard values. We examined 44 patients before septorhinoplasty by high-resolution ultrasonography in noncontact mode. All pictures were quantitatively evaluated by measuring 13 lengths and 4 ratios. All patients underwent a rhinomanometry measuring the nasal air flow. Besides others, men as well as older patients have a significantly thicker alar cartilage. Patients with thinner alar cartilages have a significantly smaller interdomal distance as well as significantly thinner upper lateral cartilages. The soft tissue above the bony dorsum was significantly thicker in older patients. Younger patients have significantly thicker soft tissue in relation to their cartilage. Patients with thicker soft tissue and thinner cartilage have a smaller tip. The interdomal distance and the thickness of the cartilaginous septum significantly correlated with the nasal air flow. We set up standard values of nasal structures in septorhinoplasty patients which can be used as reference values. By judging cartilage and soft tissue characteristics preoperatively, relevant factors for distinct procedures could be analyzed and the surgical steps can be better planned. Visualization by ultrasonography enables the surgeon to achieve treatment goals in a more predictable fashion.

  11. 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.

  12. 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.

  13. Standard Operating Procedures for PET/CT: A Practical Approach for Use in Adult Oncology

    International Nuclear Information System (INIS)

    2013-01-01

    of operating procedures for FDG-PET/CT imaging in adult oncology patients. The text is based on consensus and agreement among the authors, following a systematic approach of relying on personal experience and the available scientific evidence on all the subjects included. Due to the evolving nature of PET/CT imaging, which is a rapidly growing technology, this publication will undoubtedly need to be updated on a regular basis. It may well be that each PET/CT centre will have to modify the recommendations provided here to suit its own particular circumstances, according to, inter alia, the type of scanner, patient population, use of intravenous contrast, availability of FDG, professional staff experience, local regulations and preferences of referring physicians. The information provided here is felt to be important in the light of the growing need to standardize and optimize the way PET/CT scans are performed, not only to enable trials using FDG-PET/CT in different institutions to be compared and correlated, but also to allow for more accurate comparisons of scans performed on the same patient at different points in time at a single institution. This is important when assessing the response to cancer therapy, and especially so when this evaluation is performed early and after using novel targeted treatments that very often only produce changes in metabolic activity and not in lesion/tumour size. This is the reason why strictly following a correct imaging protocol is crucial. The reliability of the PET/CT imaging information in cancer patients depends on trustworthy and consistently applied protocols. This issue has current relevance in drug discovery and development, where PET/CT imaging with FDG and other radiotracers is viewed by the pharmaceutical industry as potentially useful for shortening the process of clinical validation of new drugs

  14. A survey of UK fertility clinics' approach to surrogacy arrangements.

    Science.gov (United States)

    Norton, Wendy; Crawshaw, Marilyn; Hudson, Nicky; Culley, Lorraine; Law, Caroline

    2015-09-01

    This paper draws on the findings of the first survey of surrogacy arrangements in Human Fertilisation and Embryology Authority (HFEA) licensed fertility clinics since 1998. Given the complex social, ethical and legal issues involved, surrogacy continues to raise debate worldwide and fuel calls for increased domestic provision in developed countries. However, little is known about how recent changes have affected HFEA licensed clinics. A 24-item online survey was undertaken between August and October 2013, designed to improve understanding of recent trends and current practices associated with UK-based surrogacy, and consider the implications for future policy and practice in UK and cross-border surrogacy arrangements. The response rate was 51.4%, comprising 54 clinics. Quantitative data were analysed using descriptive statistics, and open-ended qualitative responses analysed for extending understanding. Of the participating clinics, 42.6% offered surrogacy (mostly gestational surrogacy). Heterosexual couples using gestational surrogacy were the largest group currently using services followed by male same-sex couples. Most clinics reported having encountered problems with surrogacy treatments, suggesting barriers still exist to expanding the UK provision of surrogacy arrangements. It is important that professionals are well informed about the legal implications of surrogacy and that clinics have consistent and appropriate operational protocols for surrogacy arrangements. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  15. Preclinical and clinical experience in vascular gene therapy: advantages over conservative/standard therapy.

    Science.gov (United States)

    Nikol, S; Huehns, T Y

    2001-04-01

    No systemic pharmacological treatment has been shown to convincingly reduce the incidence of restenosis after angioplasty or increase the formation of collaterals in ischemic tissue in patients. The lack of success of many pharmaceutical agents in reducing restenosis rates or in inducing angiogenesis post-angioplasty and following stent implantation has encouraged the development of new technological treatment approaches. Gene therapy is a novel strategy with the potential to prevent some of the sequelae after arterial injury, particularly cell proliferation, and to induce growth of new vessels or remodeling of pre-existing vessel branches, which may help patients with critical ischemia. Gene therapy strategies have the advantage of minimizing systemic side effects and may have a long-term effect as the encoded protein is released. Most clinical trials investigating gene therapy for vascular disease have been uncontrolled phase I and IIa trials. Gene therapy into vessels with the genes for growth factors has been demonstrated to be feasible and efficient. Local drug delivery devices have been used in combination with gene therapy in several trials to maximize safety and efficiency. Data from experimental animal work indicates that gene therapy may modify intimal hyperplasia after arterial injury, but there are few clinical trials on restenosis in patients. Preliminary clinical results show only limited success in altering restenosis rates. In vitro and experimental in vivo investigations into gene therapy for angiogenesis demonstrate increased formation of collaterals and functional improvement of limb ischemia. There is some evidence of increased collateral formation and clinical improvement in patients with critical limb ischemia. Results of placebo-controlled and double-blind trials of gene therapy for vascular disease are awaited.

  16. 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.

  17. 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.

  18. 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.

  19. Development of Australian clinical practice outcome standards for graduates of critical care nurse education.

    Science.gov (United States)

    Gill, Fenella J; Leslie, Gavin D; Grech, Carol; Boldy, Duncan; Latour, Jos M

    2015-02-01

    To develop critical care nurse education practice standards. Critical care specialist education for registered nurses in Australia is provided at graduate level. Considerable variation exists across courses with no framework to guide practice outcomes or evidence supporting the level of qualification. An eDelphi technique involved the iterative process of a national expert panel responding to three survey rounds. For the first round, 84 statements, organised within six domains, were developed from earlier phases of the study that included a literature review, analysis of critical care courses and input from health consumers. The panel, which represented the perspectives of four stakeholder groups, responded to two rating scales: level of importance and level of practice. Of 105 experts who agreed to participate, 92 (88%) completed survey round I; 85 (92%) round II; and 73 (86%) round III. Of the 98 statements, 75 were rated as having a high level of importance - median 7 (IQR 6-7); 14 were rated as having a moderate level of importance - median 6 (IQR 5-7); and nine were rated as having a low level of importance - median 4 (IQR 4-6)-6 (IQR 4-6). The majority of the panel rated graduate level of practice as 'demonstrates independently' or 'teaches or supervises others' for 80 statements. For 18 statements, there was no category selected by 50% or more of the panel. The process resulted in the development of 98 practice standards, categorised into three levels, indicating a practice outcome level by the practitioner who can independently provide nursing care for a variety of critically ill patients in most contexts, using a patient- and family-focused approach. The graduate practice outcomes provide a critical care qualification definition for nursing workforce standards and can be used by course providers to achieve consistent practice outcomes. © 2014 John Wiley & Sons Ltd.

  20. 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

  1. Clinical Performance of a Combined Approach for the Esthetic ...

    African Journals Online (AJOL)

    2017-09-14

    Sep 14, 2017 ... leads to mild to severe esthetic problems requiring esthetic ... esthetic management of dental fluorosis, ranging from bleaching ... approaches such involving the use of composite or ceramic .... smoking or poor dental health.

  2. 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.

  3. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement

    Science.gov (United States)

    MacPherson, Hugh; Altman, Douglas G; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

    2010-01-01

    The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. PMID:20615861

  4. 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.

  5. Syndromic classification of rickettsioses: an approach for clinical practice

    Directory of Open Access Journals (Sweden)

    Álvaro A. Faccini-Martínez

    2014-11-01

    Full Text Available Rickettsioses share common clinical manifestations, such as fever, malaise, exanthema, the presence or absence of an inoculation eschar, and lymphadenopathy. Some of these manifestations can be suggestive of certain species of Rickettsia infection. Nevertheless none of these manifestations are pathognomonic, and direct diagnostic methods to confirm the involved species are always required. A syndrome is a set of signs and symptoms that characterizes a disease with many etiologies or causes. This situation is applicable to rickettsioses, where different species can cause similar clinical presentations. We propose a syndromic classification for these diseases: exanthematic rickettsiosis syndrome with a low probability of inoculation eschar and rickettsiosis syndrome with a probability of inoculation eschar and their variants. In doing so, we take into account the clinical manifestations, the geographic origin, and the possible vector involved, in order to provide a guide for physicians of the most probable etiological agent.

  6. 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 ...

  7. 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

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

    African Journals Online (AJOL)

    Syncope refers to a brief loss of consciousness. (LOC) due to an abrupt fall in cerebral perfusion. It remains a frequent reason for medical presentation and accounts for a large proportion of emergency department and outpatient clinic visits. While there are no population-based epidemiological studies of syncope in South.

  9. Community-acquired pneumonia - a clinical approach to ...

    African Journals Online (AJOL)

    to pneumonia acquired within the general community. CAP remains a common and ... patients.2 The exact incidence of atypical pathogens as a cause of CAP in South Africa is ... nor specific enough to use in clinical practice. There is a ..... resolve within 14 days but non-respiratory symptoms such as fatigue may persist for ...

  10. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

    Directory of Open Access Journals (Sweden)

    Tropp Hans

    2005-06-01

    Full Text Available Abstract Background The tissue origin of low back pain (LBP or referred lower extremity symptoms (LES may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216 with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement

  11. Answering PICO Clinical Questions: a Semantic Graph-Based Approach

    OpenAIRE

    Znaidi , Eya; Tamine , Lynda; Latiri , Chiraz

    2015-01-01

    International audience; In this paper, we tackle the issue related to the retrieval of the best evidence that fits with a PICO (Population, Intervention, Comparison and Outcome) question. We propose a new document ranking algorithm that relies on semantic based query expansion bounded by the local search context to better discard irrelevant documents. Experiments using a standard dataset including 423 PICO questions and more than 1,2 million of documents, show that our aproach is promising.

  12. [Changes in clinical standards and the need for adjusting legal standards of care from the point of view of civil law].

    Science.gov (United States)

    Rosenberger, Rainer

    2007-01-01

    The legal standard of medical care is laid down in Sect. 276 of the German Civil Code (principle of due diligence). It applies to both contractual and tortious liability and likewise to the treatment of patients insured under the statutory health insurance scheme and self-payers. The legal standard of care conforms to the clinical standards because medical liability means medical professional liability. Liability law does not distinguish between different standards of care in the treatment of patients insured under the statutory health insurance scheme on the one hand and privately insured patients on the other. Changes in clinical standards immediately affect liability law without the need for formal adaptation of the legal standard of care. Liability law cannot claim more diligence than that owed from a medical point of view. Legislative changes that result in a lowering of medical standards (reduction in the quality of treatment) will have to be accepted by liability law, even if these are regulations pertaining to Social Law (SGB V, Book 5 of the German Social Code). In this respect, the principle of legal unity applies. In consideration of this kind of changes the due diligence requirements for the treatment of patients insured under the statutory health insurance scheme and privately insured patients remain basically equal. If these changes lead to an increase of risk for the patient, the resulting liabilities are not to be attributed to the therapist. What remains to be seen is whether there will be an increased attempt to minimise risk by "additionally purchasing health care services".

  13. Standardized patients in audiology: a proposal for a new method of evaluating clinical competence.

    Science.gov (United States)

    Dinsmore, Brooke Freeman; Bohnert, Carrie; Preminger, Jill E

    2013-05-01

    While accrediting organizations require AuD programs to provide evidence that their students are able to demonstrate knowledge and competencies in specific content areas, there are no generally accepted mechanisms for the assessment and the measurement of these proficiencies. We propose that AuD programs consider developing standardized patient (SP) cases in order to develop consistent summative assessment programs within and across universities. The purpose of this article is to provide a framework for establishing SP programs to evaluate competencies in AuD students by detailing the history of SP cases and their use, developing a rationale for this method of assessment, and outlining the steps for writing and implementing SP cases. Literature review. SPs have been used to assess clinical competence in medical students for over 50 yr. The prevalence of SP assessment in allied health professions (e.g., dentistry, psychology, pharmacy) has increased over the last two decades but has only gained a limited following in audiology. SP assessment has been implemented in medical education using the Objective Structured Clinical Examination, a multistation, timed exam that uses fictional cases to assess students' clinical abilities. To date, only one published report has been completed that evaluates the use of SPs to assess clinical abilities in audiology students. This article expands upon the work of English et al (2007) and their efforts to use SPs to evaluate counseling abilities. To this end, we describe the steps necessary to write a case, procedures to determine performance requirements, and the need to develop remediation plans. As an example, we include a case that we have developed in order to evaluate vestibular assessment and patient communication skills. Utilizing SP assessment in audiology education would provide useful means to evaluate competence in a uniform way. Future research is necessary to develop reliable and valid cases that may be implemented

  14. 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.

  15. Standard and biological treatment in large vessel vasculitis: guidelines and current approaches.

    Science.gov (United States)

    Muratore, Francesco; Pipitone, Nicolò; Salvarani, Carlo

    2017-04-01

    Giant cell arteritis and Takayasu arteritis are the two major forms of idiopathic large vessel vasculitis. High doses of glucocorticoids are effective in inducing remission in both conditions, but relapses and recurrences are common, requiring prolonged glucocorticoid treatment with the risk of the related adverse events. Areas covered: In this article, we will review the standard and biological treatment strategies in large vessel vasculitis, and we will focus on the current approaches to these diseases. Expert commentary: The results of treatment trials with conventional immunosuppressive agents such as methotrexate, azathioprine, mycophenolate mofetil, and cyclophosphamide have overall been disappointing. TNF-α blockers are ineffective in giant cell arteritis, while observational evidence and a phase 2 randomized trial support the use of tocilizumab in relapsing giant cell arteritis. Observational evidence strongly supports the use of anti-TNF-α agents and tocilizumab in Takayasu patients with relapsing disease. However biological agents are not curative, and relapses remain common.

  16. 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

  17. Voluntary pulmonary function screening with GOLD standard: an effective and simple approach to detect lung obstruction.

    Science.gov (United States)

    Wang, Shengyu; Gong, Wei; Tian, Yao; Yang, Min

    2015-11-01

    The prevalence of lung obstruction is probably underestimated. Early detection and screening may alter the course and prognosis associated with lung disease. We investigated the effectiveness of voluntary lung function screening program and the agreement between the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the lower limit of normal (LLN) standard for public screening in Xi'an China. Pulmonary function testing was conducted on volunteers recruited from eight community centers in Xi'an, China between July and August 2012. Participants underwent three forced vital capacity (FVC) maneuvers. The maneuver with the best FEV1 was retained. Participants filled out a medical history survey before undergoing pulmonary function testing. Patients that self-reported lung disease on the health survey were excluded from the analysis. A total of 803 volunteers participated in this study. And 722 participants (93.8%) did not self-report chronic lung disease and were analyzed. Of these participants, 143 subjects (19.8%) were diagnosed by GOLD standard and 134 subjects (18.6%) had obstruction with LLN definition. GOLD definition can identify more asymptomatic subjects (19.1%) with respect to LLN. GOLD definition can detect more lung obstruction in elder subjects compared with young people, the difference is significant (P=0.0007). The overall agreement between the 2 methods was good: the kappa estimate was 0.822. The agreement in subjects aged 40-49, 50-59 and 60-69 years was good: the kappa estimate was 0.82, 0.936 and 0.907 respectively and the agreement in subjects aged 18-29 was inferior: the kappa estimate was only 0.555. Voluntary lung function screening program with GOLD standard may be a simple and effective approach to ensuring high yield detection of lung obstruction in subjects aged 40-69.

  18. Improving the road wear performance of heavy vehicles in South Africa using a performance-based standards approach

    CSIR Research Space (South Africa)

    Nordengen, Paul A

    2010-05-01

    Full Text Available of the world to achieve regional harmonisation and effective road use have had limited success. Another approach is to consider performance-based standards (PBS); in this case standards specify the performance required from the operation of a vehicle on a...

  19. “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. PMID:27579354

  20. 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.

  1. Clinical Approach to Supranuclear Brainstem Saccadic Gaze Palsies

    Directory of Open Access Journals (Sweden)

    Alexandra Lloyd-Smith Sequeira

    2017-08-01

    Full Text Available Failure of brainstem supranuclear centers for saccadic eye movements results in the clinical presence of a brainstem-mediated supranuclear saccadic gaze palsy (SGP, which is manifested as slowing of saccades with or without range of motion limitation of eye movements and as loss of quick phases of optokinetic nystagmus. Limitation in the range of motion of eye movements is typically worse with saccades than with smooth pursuit and is overcome with vestibular–ocular reflexive eye movements. The differential diagnosis of SGPs is broad, although acute-onset SGP is most often from brainstem infarction and chronic vertical SGP is most commonly caused by the neurodegenerative condition progressive supranuclear palsy. In this review, we discuss the brainstem anatomy and physiology of the brainstem saccade-generating network; we discuss the clinical features of SGPs, with an emphasis on insights from quantitative ocular motor recordings; and we consider the broad differential diagnosis of SGPs.

  2. 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

  3. Possession States: Approaches to Clinical Evaluation and Classification

    Directory of Open Access Journals (Sweden)

    S. McCormick

    1992-01-01

    Full Text Available The fields of anthropology and sociology have produced a large quantity of literature on possession states, physicians however rarely report on such phenomena. As a result clinical description of possession states has suffered, even though these states may be more common and less deviant than supposed. Both ICD-10 and DSM-IV may include specific criteria for possession disorders. The authors briefly review Western notions about possession and kindred states and present guidelines for evaluation and classification.

  4. 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...

  5. [New trends in neuropathy practice: clinical approach to CIDP].

    Science.gov (United States)

    Baba, M

    2001-12-01

    Our recent study showed that the overall prevalence of CIDP was estimated as 2.2 per 100,000 population in Aomori Prefecture, in Northan Honshu of Japan. In our series of more than 80 cases with CIDP, a chronic acquired inflammatory demyelinating polyneuropathy, nearly 30% showed clear laterality of weakness, and electrophysiologic laterality or multifocality was apparent in almost all cases. Nearly 90% of patients were able to walk without walking aids or other assistance. Sixty% showed distal dominant muscular weakness. In 12 patients with age of onset under 15, pes cavus deformity was seen in 5. Two thirds complained numbness in the extremities during progressive phase. Four cases initially showed severe sensory ataxia associated with motor conduction block. It should be, thus, reminded that clinical spectrum of CIDP is enormously wide: chronic acquired demyelinating multiple mononeuropathy showing asymmetric involvement (Lewis-Summer syndrome) should be put on one side of the clinical presentation of CIDP. Multifocal motor neuropathy (MMN) is, on the other hand, an unique syndrome mimicking amyotrophic lateral sclerosis (ALS). There may be, however, true association syndrome of CIDP and ALS presenting both peripheral nerve demyelination and pyramidal sign with progressive bulbar involvement. Recently, several atypical varieties of CIDP showing only one-limb involvement, upper limb weakness rather than lower limb power loss, or proximal weakness, etc ... have been reported in the literature. To realize such clinical variations of chronic acquired demyelinating neuropathy is important for early diagnosis and commencement of treatment of CIDP. Clinical guideline for suspicion of CIDP could be useful for general physicians and neurologists unfamiliar to peripheral neuropathies.

  6. Clinical correlation of radiological spinal stenosis after standardization for vertebral body size

    International Nuclear Information System (INIS)

    Athiviraham, A.; Yen, D.; Scott, C.; Soboleski, D.

    2007-01-01

    Aim: To determine the relationship between the degree of radiographic lumbar spinal stenosis, adjusted with an internal control for vertebral body size, and disability from lumbar stenosis. Materials and methods: one hundred and twenty-three consecutive patients with clinical and radiological confirmation of neural impingement secondary to lumbar stenosis were enrolled prospectively. Thecal sac anteroposterior (AP) diameter (TSD) and cross-sectional area (CSA), and vertebral body AP dimension (VBD) were determined. These parameters were then correlated with patients' symptoms using the modified Roland-Morris questionnaire (RMQ) disability score. Results: No statistically significant inverse correlation was found between the TSD and RMQ score (p = 0.433), between the CSA and RMQ score (p = 0.124), or between the TSD:VBD ratio and RMQ score (p = 0.109). There was a significant positive correlation between the CSA:VBD ratio and RMQ score (p = .036), and therefore, there was no statistical support for an inverse relationship between the two. There was a significant difference in mean RMQ scores when the patients were divided into those with CSA greater than or equal to 70 mm 2 and those less than 70 mm 2 , with T = -2.104 and p = 0.038. Conclusion: The degree of radiographic lumbar spinal stenosis, even with the use of an internal control of vertebral body size and standardized disability questionnaires, does not correlate with clinical symptoms. However, patients with more severe stenosis below a CSA critical threshold of 70 mm 2 , have significantly greater functional disability

  7. 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.

  8. 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.

  9. Genetic testing in congenital heart disease:A clinical approach

    Institute of Scientific and Technical Information of China (English)

    Marie A Chaix; Gregor Andelfinger; Paul Khairy

    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 followup. 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.

  10. Approach to pharmacological and clinical applications of Anisi aetheroleum

    Directory of Open Access Journals (Sweden)

    Khaled Mohamed Mohamed Koriem

    2015-01-01

    Full Text Available Anisi aetheroleum is the oil obtained from Pimpinella anisum L. (P. anisum by steam distillation. P. anisum seeds were air-dried, and then the dry seeds were crushed, pulverized, and weighed in sequence for anise oil preparation. P. anisum is one of the oldest medicinal plants that belong to family Apiaceae. The fruit of P. anisum is harvested in August and September. P. anisum is widespread in Asia, Africa and Europe. Local names of P. anisum include anise, anisoon, roomy, saunf, sweet cumin and yansoon. The anise oil odour is aromatic while the oil tastes sweet. The average daily dose of Anisi aetheroleum is 0.3 g. trans-Anethole is the major ingredient of the anise oil. Anisi aetheroleum also displays a protective action against neurotoxicity. In addition, Anisi aetheroleum increases glucose absorption and reduces urine output in the rat. The plant oil have pharmacological (antimicrobial, hepatoprotective, anticonvulsant, anti-inflammatory, antispasmodic, bronchodilator, estrogenic, expectorant and insecticidal effects and clinical effects on nausea, constipation, menopausal period, virus, diabetes, obesity and sedative action. Owing to the wide application of Anisi aetheroleum in pharmacological and clinical fields, it is recommended for more clinical trails to discover a new medication from the active constituents of the plant oil in the future to treat human diseases especially chronic ones.

  11. 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

  12. 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

  13. An integrated approach towards the nutritional assessment of the Sardinian donkey: a tool for clinical nutritionists

    Directory of Open Access Journals (Sweden)

    Maria Grazia Cappai

    2013-05-01

    Full Text Available The aims of the current study were to establish: i a species-specific approach for nutritional assessment during clinical checks on Sarda breed adult donkeys, and ii a suitable equation for body weight prediction, which at present is lacking. A total of 18 adult donkeys were sampled and the following criteria were recorded: body weight (BW, body condition score (BCS, muscular mass index (MMI, along with somatometric measures (height at withers; chest girth and metabolic profiles of each individual. The species-specific nutritional assessment based on the integrated approach turned out to correlate significantly (P<0.05 with the body condition score and levels of Na, P and cholesterol in blood. The parametric equation for predicting the BW (y=0.353a+0.443b-7.62, where a= height at withers in cm; b= chest girth in cm closely fit the determined BW, with a standard error of SE=±5 kg BW.

  14. Review of clinically accessible methods to determine lean body mass for normalization of standardized uptake values

    International Nuclear Information System (INIS)

    DEVRIESE, Joke; POTTEL, Hans; BEELS, Laurence; MAES, Alex; VAN DE WIELE, Christophe; GHEYSENS, Olivier

    2016-01-01

    With the routine use of 2-deoxy-2-[ 18 F]-fluoro-D-glucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) scans, metabolic activity of tumors can be quantitatively assessed through calculation of SUVs. One possible normalization parameter for the standardized uptake value (SUV) is lean body mass (LBM), which is generally calculated through predictive equations based on height and body weight. (Semi-)direct measurements of LBM could provide more accurate results in cancer populations than predictive equations based on healthy populations. In this context, four methods to determine LBM are reviewed: bioelectrical impedance analysis, dual-energy X-ray absorptiometry. CT, and magnetic resonance imaging. These methods were selected based on clinical accessibility and are compared in terms of methodology, precision and accuracy. By assessing each method’s specific advantages and limitations, a well-considered choice of method can hopefully lead to more accurate SUVLBM values, hence more accurate quantitative assessment of 18F-FDG PET images.

  15. 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.

  16. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. Acid-base equilibrium: The best clinical approach

    OpenAIRE

    Aristizábal-Salazar, Raúl E; Calvo-Torres, L. Felipe; Valencia-Arango, Luis Alfonso; Montoya-Canon, Mauricio; Barbosa-Gantiva, Oscar; Hincapié-Baena, Vanessa

    2015-01-01

    Acid-base balance disorders can be found in a primary or secondary form in patients with a disease process such as Diabetes Mellitus or acute renal failure, among others. The objective of this article is to explain and guide the correlation ship between the clinical findings in the patient and the parameters of arterial blood gases in a simple and precise manner, in order to make the correct acid-base balance diagnosis and adequate therapeutic interventions. A non-systematic review of the sci...

  2. 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

  3. 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...

  4. Short Shrift to Long Lists: An Alternative Approach to the Development of Performance Standards for School Principals.

    Science.gov (United States)

    Louden, William; Wildy, Helen

    1999-01-01

    Describes examples of standards frameworks for principals' work operant in three countries and describes an alternative approach based on interviewing 40 Australian principals. By combining qualitative case studies with probabilistic measurement techniques, the alternative approach provides contextually rich descriptions of growth in performance…

  5. 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.

  6. 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.

  7. Clinical decision-making and therapeutic approaches in osteopathy - a qualitative grounded theory study.

    Science.gov (United States)

    Thomson, Oliver P; Petty, Nicola J; Moore, Ann P

    2014-02-01

    There is limited understanding of how osteopaths make decisions in relation to clinical practice. The aim of this research was to construct an explanatory theory of the clinical decision-making and therapeutic approaches of experienced osteopaths in the UK. Twelve UK registered osteopaths participated in this constructivist grounded theory qualitative study. Purposive and theoretical sampling was used to select participants. Data was collected using semi-structured interviews which were audio-recorded and transcribed. As the study approached theoretical sufficiency, participants were observed and video-recorded during a patient appointment, which was followed by a video-prompted interview. Constant comparative analysis was used to analyse and code data. Data analysis resulted in the construction of three qualitatively different therapeutic approaches which characterised participants and their clinical practice, termed; Treater, Communicator and Educator. Participants' therapeutic approach influenced their approach to clinical decision-making, the level of patient involvement, their interaction with patients, and therapeutic goals. Participants' overall conception of practice lay on a continuum ranging from technical rationality to professional artistry, and contributed to their therapeutic approach. A range of factors were identified which influenced participants' conception of practice. The findings indicate that there is variation in osteopaths' therapeutic approaches to practice and clinical decision-making, which are influenced by their overall conception of practice. This study provides the first explanatory theory of the clinical decision-making and therapeutic approaches of osteopaths. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. 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

  9. 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

  10. Systems medicine: a new approach to clinical practice.

    Science.gov (United States)

    Cardinal-Fernández, Pablo; Nin, Nicolás; Ruíz-Cabello, Jesús; Lorente, José A

    2014-10-01

    Most respiratory diseases are considered complex diseases as their susceptibility and outcomes are determined by the interaction between host-dependent factors (genetic factors, comorbidities, etc.) and environmental factors (exposure to microorganisms or allergens, treatments received, etc.) The reductionist approach in the study of diseases has been of fundamental importance for the understanding of the different components of a system. Systems biology or systems medicine is a complementary approach aimed at analyzing the interactions between the different components within one organizational level (genome, transcriptome, proteome), and then between the different levels. Systems medicine is currently used for the interpretation and understanding of the pathogenesis and pathophysiology of different diseases, biomarker discovery, design of innovative therapeutic targets, and the drawing up of computational models for different biological processes. In this review we discuss the most relevant concepts of the theory underlying systems medicine, as well as its applications in the various biological processes in humans. Copyright © 2013 SEPAR. Published by Elsevier Espana. All rights reserved.

  11. 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.

  12. Hyperthyroidism in adults: variable clinical presentations and approaches to diagnosis.

    Science.gov (United States)

    Knudson, P B

    1995-01-01

    Hyperthyroidism is a disease that has various symptoms and can present in many ways. In the elderly patient hyperthyroidism often is not expressed in the classical manner. A case report of a middle-aged man who had hyperthyroidism with only one symptom is detailed. A literature review utilizing MEDLINE files from 1988 to the present, as well as current textbooks of medicine and endocrinology, was used to prepare this report. Keywords for the search were "hyperthyroidism," "symptoms," "unintentional weight loss," and "differential diagnosis." The clinical presentation of hyperthyroidism can vary from almost asymptomatic to apathetic in appearance to a marked hyperdynamic physiologic response. Family physicians must be well informed of this variation in disease expression. Overlooking the diagnosis of this relatively easily treated condition can be detrimental to patient care and expensive.

  13. Evidence-based emergency medicine. Creating a system to facilitate translation of evidence into standardized clinical practice: a preliminary report.

    Science.gov (United States)

    Wright, Stewart W; Trott, Alexander; Lindsell, Christopher J; Smith, Carol; Gibler, W Brian

    2008-01-01

    The Institute of Medicine, through its landmark report concerning errors in medicine, suggests that standardization of practice through systematic development and implementation of evidence-based clinical pathways is an effective way of reducing errors in emergency systems. The specialty of emergency medicine is well positioned to develop a complete system of innovative quality improvement, incorporating best practice guidelines with performance measures and practitioner feedback mechanisms to reduce errors and therefore improve quality of care. This article reviews the construction, ongoing development, and initial impact of such a system at a large, urban, university teaching hospital and at 2 affiliated community hospitals. The Committee for Procedural Quality and Evidence-Based Practice was formed within the Department of Emergency Medicine to establish evidence-based guidelines for nursing and provider care. The committee measures the effect of such guidelines, along with other quality measures, through pre- and postguideline patient care medical record audits. These measures are fed back to the providers in a provider-specific, peer-matched "scorecard." The Committee for Procedural Quality and Evidence-Based Practice affects practice and performance within our department. Multiple physician and nursing guidelines have been developed and put into use. Using asthma as an example, time to first nebulizer treatment and time to disposition from the emergency department decreased. Initial therapeutic agent changed and documentation improved. A comprehensive, guideline-driven, evidence-based approach to clinical practice is feasible within the structure of a department of emergency medicine. High-level departmental support with dedicated personnel is necessary for the success of such a system. Internet site development (available at http://www.CPQE.com) for product storage has proven valuable. Patient care has been improved in several ways; however, consistent and

  14. Standardized 15N tracer method for the determination of parameters of the whole-body protein metabolism in clinical practice

    International Nuclear Information System (INIS)

    Junghans, P.; Jung, K.; Matkowitz, R.

    1984-01-01

    A standardized 15 N tracer method is described for the assessment of nitrogen and protein metabolism in healthy and pathological changed organisms. The method represents an isotope technical procedure for the application in clinical research and practice. The clinical preparation of the patient/proband by means of a standardized nutritional regime, the tracer administration (single dose) and the sampling (urine, blood), the 15 N tracer technique (sample chemistry, emissionsspectrometric isotope analysis) and the mathematical evaluation of 15 N tracer data are described. (author)

  15. From computer-assisted intervention research to clinical impact: The need for a holistic approach.

    Science.gov (United States)

    Ourselin, Sébastien; Emberton, Mark; Vercauteren, Tom

    2016-10-01

    The early days of the field of medical image computing (MIC) and computer-assisted intervention (CAI), when publishing a strong self-contained methodological algorithm was enough to produce impact, are over. As a community, we now have substantial responsibility to translate our scientific progresses into improved patient care. In the field of computer-assisted interventions, the emphasis is also shifting from the mere use of well-known established imaging modalities and position trackers to the design and combination of innovative sensing, elaborate computational models and fine-grained clinical workflow analysis to create devices with unprecedented capabilities. The barriers to translating such devices in the complex and understandably heavily regulated surgical and interventional environment can seem daunting. Whether we leave the translation task mostly to our industrial partners or welcome, as researchers, an important share of it is up to us. We argue that embracing the complexity of surgical and interventional sciences is mandatory to the evolution of the field. Being able to do so requires large-scale infrastructure and a critical mass of expertise that very few research centres have. In this paper, we emphasise the need for a holistic approach to computer-assisted interventions where clinical, scientific, engineering and regulatory expertise are combined as a means of moving towards clinical impact. To ensure that the breadth of infrastructure and expertise required for translational computer-assisted intervention research does not lead to a situation where the field advances only thanks to a handful of exceptionally large research centres, we also advocate that solutions need to be designed to lower the barriers to entry. Inspired by fields such as particle physics and astronomy, we claim that centralised very large innovation centres with state of the art technology and health technology assessment capabilities backed by core support staff and open

  16. 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.

  17. 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.

  18. Fatigue in Parkinson's disease: concepts and clinical approach.

    Science.gov (United States)

    Nassif, Daniel V; Pereira, João S

    2018-03-01

    Parkinson's disease (PD) is a progressive neurological disorder characterized by a large number of motor and non-motor features. Fatigue is one of the most common and most disabling symptoms among patients with PD, and it has a significant impact on their quality of life. Although fatigue has been recognized for a long time, its pathophysiology remains poorly understood, and there is no evidence to support any therapeutic approach in PD patients. Expert consensus on case definition and diagnostic criteria for PD-related fatigue have been recently published, and although they still need to be adequately validated, they provide a great step forward in the study of fatigue. The goal of this article is to provide relevant information for the identification and management of patients with fatigue. © 2018 Japanese Psychogeriatric Society.

  19. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Science.gov (United States)

    Mosolov, Sergey N; Potapov, Andrey V; Ushakov, Uriy V; Shafarenko, Aleksey A; Kostyukova, Anastasiya B

    2014-01-01

    Background 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 data revealed that 65.5% of the patients met the SCFRC. In the controlled trial, 70% of patients in the RLAI group met the SCFRC and only 19% the IRC. In the routine treatment group, 55.9% met the SCFRC and only 5.7% the IRC. Results of the further independent

  20. 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

  1. Adaptive Optical System for Retina Imaging Approaches Clinic Applications

    Science.gov (United States)

    Ling, N.; Zhang, Y.; Rao, X.; Wang, C.; Hu, Y.; Jiang, W.; Jiang, C.

    We presented "A small adaptive optical system on table for human retinal imaging" at the 3rd Workshop on Adaptive Optics for Industry and Medicine. In this system, a 19 element small deformable mirror was used as wavefront correction element. High resolution images of photo receptors and capillaries of human retina were obtained. In recent two years, at the base of this system a new adaptive optical system for human retina imaging has been developed. The wavefront correction element is a newly developed 37 element deformable mirror. Some modifications have been adopted for easy operation. Experiments for different imaging wavelengths and axial positions were conducted. Mosaic pictures of photoreceptors and capillaries were obtained. 100 normal and abnormal eyes of different ages have been inspected.The first report in the world concerning the most detailed capillary distribution images cover ±3° by ± 3° field around the fovea has been demonstrated. Some preliminary very early diagnosis experiment has been tried in laboratory. This system is being planned to move to the hospital for clinic experiments.

  2. Promoting a Strategic Approach to Clinical Nurse Leader Practice Integration.

    Science.gov (United States)

    Williams, Marjory; Avolio, Alice E; Ott, Karen M; Miltner, Rebecca S

    2016-01-01

    The Office of Nursing Services of the Department of Veterans Affairs (VA) piloted implementation of the clinical nurse leader (CNL) into the care delivery model and established a strategic goal in 2011 to implement the CNL role across the VA health care system. The VA Office of Nursing Services CNL Implementation and Evaluation (CNL I&E) Service was created as one mechanism to facilitate that goal in response to a need identified by facility nurse executives for consultative support for CNL practice integration. This article discusses strategies employed by the CNL I&E consultative team to help facility-level nursing leadership integrate CNLs into practice. Measures of success include steady growth in CNL practice capacity as well as positive feedback from nurse executives about the value of consultative engagement. Future steps to better integrate CNL practice into the VA include consolidation of lessons learned, collaboration to strengthen the evidence base for CNL practice, and further exploration of the transformational potential of CNL practice across the care continuum.

  3. A Modern Clinical Approach of the Traditional Korean Saam Acupuncture

    Directory of Open Access Journals (Sweden)

    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.

  4. Heart failure in sub-Saharan Africa: A clinical approach.

    Science.gov (United States)

    Kraus, S; Ogunbanjo, G; Sliwa, K; Ntusi, N A B

    2016-01-01

    Despite medical advances, heart failure (HF) remains a global health problem and sub-Saharan Africa (SSA) is no exception, with decompensated HF being the most common primary diagnosis for patients admitted to hospital with heart disease. In SSA the in-hospital mortality rate of decompensated HF is up to 8.3%. HF is a clinical syndrome that is caused by a diverse group of aetiologies, each requiring unique management strategies, highlighting the need for diagnostic certainty and a broad understanding of the complex pathophysiology of this condition. While there are a number of advanced medical, device and surgical interventions being tailored for HF internationally, the fundamental basic principles of HF management, such as patient education, effective management of congestion and initiation of disease-modifying medical therapies, remain a challenge on our continent. This review addresses both the epidemiology of HF in SSA and principles of management that focus specifically on symptom relief, prevention of hospitalisation and improving survival in this population.

  5. A Triadic Neurocognitive Approach to Addiction for Clinical Interventions

    Science.gov (United States)

    Noël, Xavier; Brevers, Damien; Bechara, Antoine

    2013-01-01

    According to the triadic neurocognitive model of addiction to drugs (e.g., cocaine) and non-drugs (e.g., gambling), weakened “willpower” associated with these behaviors 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 behaviors; (2) a prefrontal cortex dependent system important for self-regulation and forecasting the future consequences of a behavior; 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 signaling, and supervisory function aimed at helping individuals become less governed by immediate situations and automatic pre-potent responses, and more influenced by systems involved in the pursuit of future valued goals. PMID:24409155

  6. Quality assurance in ultrasound screening for hepatocellular carcinoma using a standardized phantom and standard clinical images: a 3-year national investigation in Korea.

    Science.gov (United States)

    Choi, Joon-Il; Jung, Seung Eun; Kim, Pyo Nyun; Cha, Sang Hoon; Jun, Jae Kwan; Lee, Hoo-Yeon; Park, Eun-Cheol

    2014-06-01

    The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P quality of the clinical images obtained by radiologists was the best. © 2014 by the American Institute of Ultrasound in Medicine.

  7. 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

    2017-02-01

    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. 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. 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. 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.

  8. Primary repair of colon injuries: clinical study of nonselective approach.

    Science.gov (United States)

    Lazovic, Ranko G; Barisic, Goran I; Krivokapic, Zoran V

    2010-12-02

    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. 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. 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. Results of this study justify more liberal use of primary repair in early management of colon injuries. Current Controlled Trials ISRCTN94682396.

  9. 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

  10. 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

  11. Factors influencing the approaches to studying of preclinical and clinical students and postgraduate trainees

    Directory of Open Access Journals (Sweden)

    Samarasekera Dharmabandu N

    2011-05-01

    Full Text Available Abstract Background Students can be classified into three categories depending on their approaches to studying; namely, deep approach (DA, strategic approach (SA and surface apathetic or superficial approach (SAA. The aim of this study was to identify factors affecting the approaches to studying among Sri Lankan medical undergraduates and post graduate trainees and to analyze the change in the pattern of study skills with time and experience. Method Pre-clinical and clinical students of the Faculty of Medicine, University of Colombo and postgraduate trainees in Surgery at the National Hospital of Sri Lanka were invited to complete the Approaches and Study Skills Inventory for Students (ASSIST questionnaire. Results A total of 187 pre clinical (M: F = 96:91, 124 clinical (M: F = 61:63 and 53 post graduate trainees (M: F = 50:3 participated in the study. Approaches of male and female students were similar. SA was significantly affected by age among the preclinical students (p = 0.01, but not in other groups. Among pre-clinical students, males preferred a teacher who supported understanding (p = 0.04 but females preferred a passive transmission of information (p Conclusion Different factors affect the approach to studying in different groups but these explain only a small fraction of the variance observed.

  12. The clinical utility of a adding lateral approach to conventional vertical approach for prone stereotactic vacuum-assisted breast biopsy

    International Nuclear Information System (INIS)

    Myong, Joo Hwa; Kang, Bong Joo; Yoon, Soo Kyung; Kim, Sung Hun; An, Yeong Yi

    2013-01-01

    The purpose of this study is to evaluate the clinical utility of adding lateral approach to conventional vertical approach for prone stereotactic vacuum-assisted breast biopsies. From April 2010 to May 2012, 130 vacuum-assisted stereotactic biopsies were attempted in 127 patients. While a vertical approach was preferred, a lateral approach was used if the vertical approach failed. The success rate of biopsies utilizing only a vertical approach was compared with that using both vertical and lateral approaches and the breast thickness for both procedures was measured and compared with that for vertical approach. In addition, pathology results were evaluated and the causes of the failed biopsies were analyzed. Of the 130 cases, 127 biopsies were performed and 3 biopsies failed. The success rate of the vertical approach was 83.8% (109/130); however, when the lateral approach was also used, the success rate increased to 97.7% (127/130) (p = 0.0004). The mean breast thickness was 2.7 ± 1 cm for the lateral approach and 4 ± 1.2 cm for the vertical approach (p < 0.0001). The histopathologic results in 76 (59.8%) of the biopsies were benign, 23 (18.1%) were high-risk lesions, and 28 (22.0%) were malignant. The causes of biopsy failure were thin breasts (n = 2) and undetected difficult lesion location (n = 1). The addition of lateral approach to conventional vertical approach in prone stereotactic vacuum-assisted breast biopsy improved the success rate of stereotactic biopsy, especially in patients with thin breasts.

  13. 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

    2018-05-01

    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.

  14. 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.

  15. 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.

  16. Approach to the problem of combined radiation and environmental effect standardization

    International Nuclear Information System (INIS)

    Burykina, L.N.; Ajzina, N.L.; Vasil'eva, L.A.; Veselovskaya, K.A.; Likhachev, Yu.P.; Ponomareva, V.L.; Satarina, S.M.; Shmeleva, E.V.

    1978-01-01

    Rats were used to study combined forms of damage caused by radioactive substances with varioUs types of distribution ( 131 I and 147 Pm) and by external radiation sources (γ, X). Damage caused by radiation and dust factors was also studied. Synergism of the combined effect of the tolerance dose of 147 Pm introduced and preceding external general γ-irradiation was determined. The combined action of 131 I and external γ- and X-ray radiation exhibited an additional effect on rat thyroid glands. The combined action of dust and radiation factors showed that the biological effect depended on the dose abs.orbed in a critical organ (lungs). The results of the investigations point to an important role of critical organs (systems) and the degree of their radiosensitivity in response of body to combined internal and external irradiations. The facts presented show that the approach to standardizing radiation factors from the position of partial summation should be changed. This may be accomplished by using a combination factor which is determined experimentally and reflects a relative biological efficiency of the combined effects as compared to separate ones

  17. 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.

  18. A standardized approach to verification and validation to assist in expert system development

    International Nuclear Information System (INIS)

    Hines, J.W.; Hajek, B.K.; Miller, D.W.; Haas, M.A.

    1992-01-01

    For the past six years, the Nuclear Engineering Program's Artificial Intelligence (AI) Group at The Ohio State University has been developing an integration of expert systems to act as an aid to nuclear power plant operators. This Operator Advisor consists of four modules that monitor plant parameters, detect deviations from normality, diagnose the root cause of the abnormality, manage procedures to effectively respond to the abnormality, and mitigate its consequences. To aid in the development of this new system, a standardized Verification and Validation (V and V) approach is being implemented. The primary functions are to guide the development of the expert system and to ensure that the end product fulfills the initial objectives. The development process has been divided into eight life-cycle V and V phases from concept to operation and maintenance. Each phase has specific V and V tasks to be performed to ensure a quality end product. Four documents are being used to guide development. The Software Verification and Validation Plan (SVVP) outlines the V and V tasks necessary to verify the product at the end of each software development phase, and to validate that the end product complies with the established software and system requirements and meets the needs of the user. The Software Requirements Specification (SRS) documents the essential requirements of the system. The Software Design Description (SDD) represents these requirements with a specific design. And lastly, the Software Test Document establishes a testing methodology to be used throughout the development life-cycle

  19. In-silico approach to the development of a prototype clinical ...

    African Journals Online (AJOL)

    International Journal of Natural and Applied Sciences ... In-silico approaches to information management of pediatrics sections of hospitals could ... This study was aimed at developing a prototype clinic information system for keeping track of ...

  20. Vision Restoration in Glaucoma by Activating Residual Vision with a Holistic, Clinical Approach: A Review.

    Science.gov (United States)

    Sabel, Bernhard A; Cárdenas-Morales, Lizbeth; Gao, Ying

    2018-01-01

    How to cite this article: Sabel BA, Cárdenas-Morales L, Gao Y. Vision Restoration in Glaucoma by activating Residual Vision with a Holistic, Clinical Approach: A Review. J Curr Glaucoma Pract 2018;12(1):1-9.

  1. 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

  2. A new fracture mechanics approach for defining defect acceptance standards for inservice inspection

    Energy Technology Data Exchange (ETDEWEB)

    Heliot, J [Societe Franco-Americaine de Constructions Atomiques (FRAMATOME), 92 - Paris-La-Defense (France); Chevanne, H; Grandemange, J; Barthelet, B [Electricite de France (EDF), 75 - Paris (France). Service de la Production Thermique

    1988-12-31

    This document presents several standards and methods defined by the french national utility Electricite De France (EDF). Methods to predict crack propagation and crack stability in ductile materials are presented together with standards of allowable defects. (TEC).

  3. A new fracture mechanics approach for defining defect acceptance standards for inservice inspection

    International Nuclear Information System (INIS)

    Heliot, J.; Chevanne, H.; Grandemange, J.; Barthelet, B.

    1988-01-01

    This document presents several standards and methods defined by the french national utility Electricite De France (EDF). Methods to predict crack propagation and crack stability in ductile materials are presented together with standards of allowable defects. (TEC)

  4. 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

  5. Improving the efficiency of quantitative (1)H NMR: an innovative external standard-internal reference approach.

    Science.gov (United States)

    Huang, Yande; Su, Bao-Ning; Ye, Qingmei; Palaniswamy, Venkatapuram A; Bolgar, Mark S; Raglione, Thomas V

    2014-01-01

    The classical internal standard quantitative NMR (qNMR) method determines the purity of an analyte by the determination of a solution containing the analyte and a standard. Therefore, the standard must meet the requirements of chemical compatibility and lack of resonance interference with the analyte as well as a known purity. The identification of such a standard can be time consuming and must be repeated for each analyte. In contrast, the external standard qNMR method utilizes a standard with a known purity to calibrate the NMR instrument. The external standard and the analyte are measured separately, thereby eliminating the matter of chemical compatibility and resonance interference between the standard and the analyte. However, the instrumental factors, including the quality of NMR tubes, must be kept the same. Any deviations will compromise the accuracy of the results. An innovative qNMR method reported herein utilizes an internal reference substance along with an external standard to assume the role of the standard used in the traditional internal standard qNMR method. In this new method, the internal reference substance must only be chemically compatible and be free of resonance-interference with the analyte or external standard whereas the external standard must only be of a known purity. The exact purity or concentration of the internal reference substance is not required as long as the same quantity is added to the external standard and the analyte. The new method reduces the burden of searching for an appropriate standard for each analyte significantly. Therefore the efficiency of the qNMR purity assay increases while the precision of the internal standard method is retained. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. 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

  7. 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

  8. A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research.

    Science.gov (United States)

    Cofiel, Luciana; Zammar, Guilherme R; Zaveri, Amrapali J; Shah, Jatin Y; Carvalho, Elias; Nahm, Meredith; Kesselring, Gustavo; Pietrobon, Ricardo

    2010-12-31

    Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Future studies should explore ways of creating mechanisms which decrease the time and cost

  9. A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research

    Science.gov (United States)

    2010-01-01

    Background Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Methods Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. Results A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Conclusions Future studies should explore ways of creating

  10. A service oriented approach for guidelines-based clinical decision support using BPMN.

    Science.gov (United States)

    Rodriguez-Loya, Salvador; Aziz, Ayesha; Chatwin, Chris

    2014-01-01

    Evidence-based medical practice requires that clinical guidelines need to be documented in such a way that they represent a clinical workflow in its most accessible form. In order to optimize clinical processes to improve clinical outcomes, we propose a Service Oriented Architecture (SOA) based approach for implementing clinical guidelines that can be accessed from an Electronic Health Record (EHR) application with a Web Services enabled communication mechanism with the Enterprise Service Bus. We have used Business Process Modelling Notation (BPMN) for modelling and presenting the clinical pathway in the form of a workflow. The aim of this study is to produce spontaneous alerts in the healthcare workflow in the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The use of BPMN as a tool to automate clinical guidelines has not been previously employed for providing Clinical Decision Support (CDS).

  11. 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…

  12. 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.

  13. Effects of adding Braun jejunojejunostomy to standard Whipple procedure on reduction of afferent loop syndrome - a randomized clinical trial.

    Science.gov (United States)

    Kakaei, Farzad; Beheshtirouy, Samad; Nejatollahi, Seyed Moahammad Reza; Rashidi, Iqbal; Asvadi, Touraj; Habibzadeh, Afshin; Oliaei-Motlagh, Mohammad

    2015-12-01

    Whipple surgery (pancreaticodeudenectomy) has a high complication rate. We aimed to evaluate whether adding Braun jejunojejunostomy (side-to-side anastomosis of afferent and efferent loops distal to the gastrojejunostomy site) to a standard Whipple procedure would reduce postoperative complications. We conducted a randomized clinical trial comparing patients who underwent standard Whipple surgery (standard group) and patients who underwent standard Whipple surgery with Braun jejunojejunostomy (Braun group). Patients were followed for 1 month after the procedure and postoperative complications were recorded. Our study included 30 patients: 15 in the Braun and 15 in the standard group. In the Braun group, 4 (26.7%) patients experienced 6 complications, whereas in the standard group, 7 (46.7%) patients experienced 11 complications (p = 0.14). Complications in the Braun group were gastrointestinal bleeding and wound infection (n = 1 each) and delayed gastric emptying and pulmonary infection (n = 2 each). Complications in the standard group were death, pancreatic anastomosis leak and biliary anastomosis leak (n = 1 each); gastrointestinal bleeding (n = 2); and afferent loop syndrome and delayed gastric emptying (n = 3 each). There was no significant difference between groups in the subtypes of complications. Our results showed that adding Braun jejunojejunostomy to standard Whipple procedure was associated with lower rates of afferent loop syndrome and delayed gastric emptying. However, more studies are needed to define the role of Braun jejunojejunostomy in this regard. IRCT2014020316473N1 (www.irct.ir).

  14. Effect of International Standards Certification on Firm-Level Exports: An Application of the Control Function Approach

    OpenAIRE

    Tsunehiro Otsuki

    2011-01-01

    Growing number of firms in developing countries have earned certifications such as International Standards Organization (ISO) as it enhances reputation of their company or brand and attract buyers particularly in export market. This study evaluates the effect of international standards certification on firm's export performance in Europe and Central Asia by applying the control function approach with endogenous treatment effect to firm-level data. Certification is found to increase export sha...

  15. Evaluation of linear accelerator performance standards using an outcome oriented approach

    International Nuclear Information System (INIS)

    Rangel, Alejandra; Ploquin, Nicolas; Kay, Ian; Dunscombe, Peter

    2008-01-01

    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

  16. An analysis of clinical transition stresses experienced by dental students: A qualitative methods approach.

    Science.gov (United States)

    Botelho, M; Gao, X; Bhuyan, S Y

    2018-04-17

    Stress in dental students is well established with potential psychological distress, emotional exhaustion and burnout-related symptoms. Little attention has been given to the problems encountered by dental students during the transition from theoretical or paraclinical training to the clinical environment. The aim of this study was to adopt a qualitative research methods approach to understand the perceived stressors during students' clinical transition and provide insights for curriculum planners to enhance learning. This study analysed four groups of 2nd- and 3rd-year BDS students' experiences in focus group interviews relating to their pre-clinical and clinical transitions. The interviews were recorded and transcribed verbatim, and a thematic analysis was performed using an inductive qualitative approach. Key overlapping domains identified were the transition gap and stresses. The transition gap was subclassified into knowledge and skill (hard and soft), and stresses was subcategorised into internal and external stresses. On first coming to clinics, students experienced knowledge gaps of unfamiliar clinical treatments with mismatches between knowledge acquisition and clinical exposure. Students felt incompetent owing to the stresses attributable to curriculum design, staff and the patient. This negatively affected their confidence and clinical performance. A range of challenges have been identified that will allow curriculum designer's to plan a more supportive learning experience to help students during their transition to clinical practice giving them timely knowledge, confidence and clinical performance to better prepare them for entering clinics. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. 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

  18. Using a business model approach and marketing techniques for recruitment to clinical trials

    Science.gov (United States)

    2011-01-01

    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. PMID:21396088

  19. Clinical roundtable monograph: unmet needs in the treatment of chronic lymphocytic leukemia: integrating a targeted approach.

    Science.gov (United States)

    O'Brien, Susan M; Furman, Richard R; Byrd, John C; Smith, Ashbel

    2014-01-01

    Chronic lymphocytic leukemia (CLL) is the most frequently diagnosed hematologic malignancy in the United States. Although several features can be useful in the diagnosis of CLL, the most important is the immunophenotype.Two staging systems--the Binet system and the Rai classification--are used to assess risk. After diagnosis, the first major therapeutic decision is when to initiate therapy, as a watchful waiting approach is often appropriate for patients with asymptomatic disease. Once a patient has met the criteria for treatment, the choice of therapy is the next major decision. Younger patients (<65 years) often receive more aggressive treatment that typically consists of cytotoxic chemotherapy. There is a great unmet need concerning treatment of older patients with CLL, who often present with more comorbid conditions that can decrease their ability to tolerate particular regimens. The current standard of care for older patients with CLL is rituximab plus chlorambucil. The concept of targeted agents is currently an area of intense interest in CLL. The Bruton’s tyrosine kinase inhibitor ibrutinib is the targeted agent that is furthest along in clinical development. It is associated with an overall survival rate of 83%. Idelalisib targets the phosphatidyl inositol 3-kinase and is under evaluation in pivotal trials. Targeted agents offer much promise in terms of efficacy, toxicity, and oral availability. They will change the management of patients with CLL.

  20. Using a business model approach and marketing techniques for recruitment to clinical trials

    Directory of Open Access Journals (Sweden)

    Knight Rosemary

    2011-03-01

    Full Text Available Abstract 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.

  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. A standardized approach to verification and validation to assist in expert system development

    International Nuclear Information System (INIS)

    Hines, J.W.; Hajek, B.K.; Miller, D.W.; Haas, M.A.

    1992-01-01

    For the past six years, the Nuclear Engineering Program's Artificial Intelligence (AI) Group at The Ohio State University has been developing an integration of expert systems to act as an aid to nuclear power plant operators. This Operator Advisor consists of four modules that monitor plant parameters, detect deviations from normality, diagnose the root cause of the abnormality, manage procedures to effectively respond to the abnormality, and mitigate its consequences. Recently Ohio State University received a grant from the Department of Energy's Special Research Grant Program to utilize the methodologies developed for the Operator Advisor for Heavy Water Reactor (HWR) malfunction root cause diagnosis. To aid in the development of this new system, a standardized Verification and Validation (V ampersand V) approach is being implemented. Its primary functions are to guide the development of the expert system and to ensure that the end product fulfills the initial objectives. The development process has been divided into eight life-cycle V ampersand V phases from concept to operation and maintenance. Each phase has specific V ampersand V tasks to be performed to ensure a quality end product. Four documents are being used to guide development. The Software Verification and Validation Plan (SVVP) outlines the V ampersand V tasks necessary to verify the product at the end of each software development phase, and to validate that the end product complies with the established software and system requirements and meets the needs of the user. The Software Requirements Specification (SRS) documents the essential requirements of the system. The Software Design Description (SDD) represents these requirements with a specific design. And lastly, the Software Test Document establishes a testing methodology to be used throughout the development life-cycle. 10 refs., 1 fig

  3. A standards-based approach to quality improvement for HIV services at Zambia Defence Force facilities: results and lessons learned.

    Science.gov (United States)

    Kols, Adrienne; Kim, Young-Mi; Bazant, Eva; Necochea, Edgar; Banda, Joseph; Stender, Stacie

    2015-07-01

    The Zambia Defence Force adopted the Standards-Based Management and Recognition approach to improve the quality of the HIV-related services at its health facilities. This quality improvement intervention relies on comprehensive, detailed assessment tools to communicate and verify adherence to national standards of care, and to test and implement changes to improve performance. A quasi-experimental evaluation of the intervention was conducted at eight Zambia Defence Force primary health facilities (four facilities implemented the intervention and four did not). Data from three previous analyses are combined to assess the effect of Standards-Based Management and Recognition on three domains: facility readiness to provide services; observed provider performance during antiretroviral therapy (ART) and antenatal care consultations; and provider perceptions of the work environment. Facility readiness scores for ART improved on four of the eight standards at intervention sites, and one standard at comparison sites. Facility readiness scores for prevention of mother-to-child transmission (PMTCT) of HIV increased by 15 percentage points at intervention sites and 7 percentage points at comparison sites. Provider performance improved significantly at intervention sites for both ART services (from 58 to 84%; P improved at intervention sites and declined at comparison sites; differences in trends between study groups were significant for eight items. A standards-based approach to quality improvement proved effective in supporting healthcare managers and providers to deliver ART and PMTCT services in accordance with evidence-based standards in a health system suffering from staff shortages.

  4. Evidence-based health care: development and audit of a clinical standard for research and its impact on an NHS trust.

    Science.gov (United States)

    Parkin, Claire; Bullock, Ian

    2005-04-01

    Working within a modern National Health Service in the United Kingdom, the place for research and its dissemination is increasingly important. The organization of this within each National Health Service (NHS) Trust is challenging but nevertheless essential. If health care professionals are to be empowered to adopt an evidence-based approach in both the planning and delivery of care, research aware employees are crucial. This paper highlights the importance of NHS hospital trusts implementing initiatives that will facilitate this process. One such initiative has been the development and survey of a clinical standard for research. The primary development aim was to provide a benchmark standard for all nursing research. The standard was developed to fit within the current dynamic quality improvement (DQI) programme and has directly contributed to an evolving culture of research by shaping nurses' awareness, and offering a support and consultancy network within the Trust. The standard is one aspect of a research awareness programme, with the primary objective of providing guidance and education whilst developing nurses throughout the research process. The planned strategic outcome is to see a positive outcome on the quality of research in the Trust. A baseline survey was conducted to provide a definitive snap shot of research understanding and practice within the Trust following the introduction of the research standard. The standard was developed by a team of clinicians led by a member of the quality team, to ensure that it fitted the DQI structure, and a member of the Nursing Research Unit (NRU). The standard was distributed to every clinical area and 192 nurses were surveyed to evaluate its impact on their awareness of educational opportunities, their use of the consultancy and support service, their use of other support services, their research utilization and research quality. The survey demonstrated that the implementation of the standard had increased awareness

  5. Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding.

    Directory of Open Access Journals (Sweden)

    Zbyněk Straňák

    Full Text Available Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age.We randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation or control group (standard approach, SA. Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing.Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively, 3 months (p-value 0.12 and 0.10 and 6 months of infants' age (p-value 0.45 and 0.34 respectively. The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002.The study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall.ISRCTN registry ISRCTN61915183.

  6. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss

  7. A novel approach to generating CER hypotheses based on mining clinical data.

    Science.gov (United States)

    Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

    2013-01-01

    Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

  8. 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.

  9. 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…

  10. 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

  11. 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

    Introduction In patients with symptomatic hip dysplasia soft-tissue pain may be a prevalent condition that might affect the outcome of periacetabular osteotomy (PAO). However, the distribution of soft-tissue pain in hip dysplasia has never been examined systematically using a standardised...... 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...... prevalence in the iliopsoas and the hip abductors. This indicates that patients with hip dysplasia also experience pain related to the surrounding soft-tissues, and not only from the hip joint. References (1) Holmich P, Holmich LR, Bjerg AM. Clinical examination of athletes with groin pain: an intraobserver...

  12. 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.

  13. Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

    Directory of Open Access Journals (Sweden)

    Anne Korir

    Full Text Available Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis.The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1 documentation of positive HIV serology; 2 antiretroviral drug prescription; 3 CD4+ lymphocyte count; and 4 WHO HIV clinical stage or immune suppression syndrome (ISS, which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3% met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma and 31% (53 were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27% cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria.This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease

  14. Developing clinical strength-of-evidence approach to define HIV-associated malignancies for cancer registration in Kenya.

    Science.gov (United States)

    Korir, Anne; Mauti, Nathan; Moats, Pamela; Gurka, Matthew J; Mutuma, Geoffrey; Metheny, Christine; Mwamba, Peter M; Oyiro, Peter O; Fisher, Melanie; Ayers, Leona W; Rochford, Rosemary; Mwanda, Walter O; Remick, Scot C

    2014-01-01

    Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a "strength-of-evidence" approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis. The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1) documentation of positive HIV serology; 2) antiretroviral drug prescription; 3) CD4+ lymphocyte count; and 4) WHO HIV clinical stage or immune suppression syndrome (ISS), which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3%) met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association - Kaposi's sarcoma, cervical cancer, non-Hodgkin's and Hodgkin's lymphoma, and conjunctiva carcinoma) and 31% (53) were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27%) cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria. This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease in the

  15. 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.

  16. 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.

  17. 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

  18. Students' approaches to learning in a clinical practicum: A psychometric evaluation based on item response theory.

    Science.gov (United States)

    Zhao, Yue; Kuan, Hoi Kei; Chung, Joyce O K; Chan, Cecilia K Y; Li, William H C

    2018-07-01

    The investigation of learning approaches in the clinical workplace context has remained an under-researched area. Despite the validation of learning approach instruments and their applications in various clinical contexts, little is known about the extent to which an individual item, that reflects a specific learning strategy and motive, effectively contributes to characterizing students' learning approaches. This study aimed to measure nursing students' approaches to learning in a clinical practicum using the Approaches to Learning at Work Questionnaire (ALWQ). Survey research design was used in the study. A sample of year 3 nursing students (n = 208) who undertook a 6-week clinical practicum course participated in the study. Factor analyses were conducted, followed by an item response theory analysis, including model assumption evaluation (unidimensionality and local independence), item calibration and goodness-of-fit assessment. Two subscales, deep and surface, were derived. Findings suggested that: (a) items measuring the deep motive from intrinsic interest and deep strategies of relating new ideas to similar situations, and that of concept mapping served as the strongest discriminating indicators; (b) the surface strategy of memorizing facts and details without an overall picture exhibited the highest discriminating power among all surface items; and, (c) both subscales appeared to be informative in assessing a broad range of the corresponding latent trait. The 21-item ALWQ derived from this study presented an efficient, internally consistent and precise measure. Findings provided a useful psychometric evaluation of the ALWQ in the clinical practicum context, added evidence to the utility of the ALWQ for nursing education practice and research, and echoed the discussions from previous studies on the role of the contextual factors in influencing student choices of different learning strategies. They provided insights for clinical educators to measure

  19. 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...

  20. 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.

  1. 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.

  2. Impact of the site specialty of a continuity practice on students' clinical skills: performance with standardized patients.

    Science.gov (United States)

    Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L

    2010-07-01

    The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.

  3. 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

  4. EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos).

    Science.gov (United States)

    Khashab, Mouen A; Valeshabad, Ali Kord; Modayil, Rani; Widmer, Jessica; Saxena, Payal; Idrees, Mehak; Iqbal, Shahzad; Kalloo, Anthony N; Stavropoulos, Stavros N

    2013-11-01

    EUS-guided biliary drainage (EGBD) can be performed via direct transluminal or rendezvous techniques. It is unknown how both techniques compare in terms of efficacy and adverse events. To describe outcomes of EGBD performed by using a standardized approach and compare outcomes of rendezvous and transluminal techniques. Retrospective analysis of prospectively collected data. Two tertiary-care centers. Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EGBD after failed ERCP between July 2006 and December 2012 were included. EGBD by using a standardized algorithm. Technical success, clinical success, and adverse events. During the study period, 35 patients underwent EGBD (rendezvous n = 13, transluminal n = 20). Technical success was achieved in 33 patients (94%), and clinical success was attained in 32 of 33 patients (97.0%). The mean postprocedure bilirubin level was 1.38 mg/dL in the rendezvous group and 1.33 mg/dL in the transluminal group (P = .88). Similarly, length of hospital stay was not different between groups (P = .23). There was no significant difference in adverse event rate between rendezvous and transluminal groups (15.4% vs 10%; P = .64). Long-term outcomes were comparable between groups, with 1 stent migration in the rendezvous group at 62 days and 1 stent occlusion in the transluminal group at 42 days after EGBD. Retrospective analysis, small number of patients, and selection bias. EGBD is safe and effective when the described standardized approach is used. Stent occlusion is not common during long-term follow-up. Both rendezvous and direct transluminal techniques seem to be equally effective and safe. The latter approach is a reasonable alternative to rendezvous EGBD. Copyright © 2013. Published by Mosby, Inc.

  5. A gold standard method for the evaluation of antibody-based materials functionality: Approach to forced degradation studies.

    Science.gov (United States)

    Coussot, Gaëlle; Le Postollec, Aurélie; Faye, Clément; Dobrijevic, Michel

    2018-04-15

    The scope of this paper is to present a gold standard method to evaluate functional activity of antibody (Ab)-based materials during the different phases of their development, after their exposure to forced degradations or even during routine quality control. Ab-based materials play a central role in the development of diagnostic devices, for example, for screening or therapeutic target characterization, in formulation development, and in novel micro(nano)technology approaches to develop immunosensors useful for the analysis of trace substances in pharmaceutical and food industries, clinical and environmental fields. A very important aspect in diagnostic device development is the construction of its biofunctional surfaces. These Ab surfaces require biocompatibility, homogeneity, stability, specificity and functionality. Thus, this work describes the validation and applications of a unique ligand binding assay to directly perform the quantitative measurement of functional Ab binding sites immobilized on the solid surfaces. The method called Antibody Anti-HorseRadish Peroxidase (A2HRP) method, uses a covalently coated anti-HRP antibody (anti-HRP Ab) and does not need for a secondary Ab during the detection step. The A2HRP method was validated and gave reliable results over a wide range of absorbance values. Analyzed validation criteria were fulfilled as requested by the food and drug administration (FDA) and European Medicines Agency (EMA) guidance for the validation of bioanalytical methods with 1) an accuracy mean value within +15% of the nominal value; 2) the within-assay precision less than 7.1%, and 3) the inter-day variability under 12.1%. With the A2HRP method, it is then possible to quantify from 0.04 × 10 12 to 2.98 × 10 12 functional Ab binding sites immobilized on the solid surfaces. A2HRP method was validated according to FDA and EMA guidance, allowing the creation of a gold standard method to evaluate Ab surfaces for their resistance under

  6. Updating contextualized clinical practice guidelines on stroke rehabilitation and low back pain management using a novel assessment framework that standardizes decisions.

    Science.gov (United States)

    Gambito, Ephraim D V; Gonzalez-Suarez, Consuelo B; Grimmer, Karen A; Valdecañas, Carolina M; Dizon, Janine Margarita R; Beredo, Ma Eulalia J; Zamora, Marcelle Theresa G

    2015-11-04

    Clinical practice guidelines need to be regularly updated with current literature in order to remain relevant. This paper reports on the approach taken by the Philippine Academy of Rehabilitation Medicine (PARM). This dovetails with its writing guide, which underpinned its foundational work in contextualizing guidelines for stroke and low back pain (LBP) in 2011. Working groups of Filipino rehabilitation physicians and allied health practitioners met to reconsider and modify, where indicated, the 'typical' Filipino patient care pathways established in the foundation guidelines. New clinical guidelines on stroke and low back pain which had been published internationally in the last 3 years were identified using a search of electronic databases. The methodological quality of each guideline was assessed using the iCAHE Guideline Quality Checklist, and only those guidelines which provided full text references, evidence hierarchy and quality appraisal of the included literature, were included in the PARM update. Each of the PARM-endorsed recommendations was then reviewed, in light of new literature presented in the included clinical guidelines. A novel standard updating approach was developed based on the criteria reported by Johnston et al. (Int J Technol Assess Health Care 19(4):646-655, 2003) and then modified to incorporate wording from the foundational PARM writing guide. The new updating tool was debated, pilot-tested and agreed upon by the PARM working groups, before being applied to the guideline updating process. Ten new guidelines on stroke and eleven for low back pain were identified. Guideline quality scores were moderate to good, however not all guidelines comprehensively linked the evidence body underpinning recommendations with the literature. Consequently only five stroke and four low back pain guidelines were included. The modified PARM updating guide was applied by all working groups to ensure standardization of the wording of updated recommendations

  7. 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

  8. 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.

  9. Independent Auditor's Approach to the Concept of Fraud in Accounting Standards

    Directory of Open Access Journals (Sweden)

    Handan Bulca

    2015-07-01

    Full Text Available Control in the field of standards, quality and safety can be increased fraud and error reduction is envisaged. In parallel with these changes, the conditions in the Official Gazette dated 14 March 2014 to companies that provide audit is mandatory. With the implementation of auditing standards and corporate companies will become more transparent. Information users more secure thanks to the information reaching these standards will be able to make healthy decisions. The study also has redefined the concept of independent auditors and the audit process should follow an independent auditor, is also indicated. The focus of the study of the risk of fraud and cheating, Independent Auditing Standards Number 240 constitutes in terms of views.

  10. 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

  11. Bridging the Nomothetic and Idiographic Approaches to the Analysis of Clinical Data.

    Science.gov (United States)

    Beltz, Adriene M; Wright, Aidan G C; Sprague, Briana N; Molenaar, Peter C M

    2016-08-01

    The nomothetic approach (i.e., the study of interindividual variation) dominates analyses of clinical data, even though its assumption of homogeneity across people and time is often violated. The idiographic approach (i.e., the study of intraindividual variation) is best suited for analyses of heterogeneous clinical data, but its person-specific methods and results have been criticized as unwieldy. Group iterative multiple model estimation (GIMME) combines the assets of the nomothetic and idiographic approaches by creating person-specific maps that contain a group-level structure. The maps show how intensively measured variables predict and are predicted by each other at different time scales. In this article, GIMME is introduced conceptually and mathematically, and then applied to an empirical data set containing the negative affect, detachment, disinhibition, and hostility composite ratings from the daily diaries of 25 individuals with personality pathology. Results are discussed with the aim of elucidating GIMME's potential for clinical research and practice.

  12. 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.

  13. Clinical outcome after standardized versus dosimetric radioiodine treatment of hyperthyroidism: an equivalence study

    NARCIS (Netherlands)

    Kok, S. W.; Smit, J. W.; de Craen, A. J.; Goslings, B. M.; van Eck-Smit, B. L.; Romijn, J. A.

    2000-01-01

    The aim of this study was to investigate the equivalence in outcome of standardized versus uptake-adjusted dosing of radioactive iodine (131I) for hyperthyroidism. We performed a 1-year follow-up study of two patient cohorts: 326 patients referred for 131I treatment of hyperthyroidism in Graves'

  14. 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.

  15. Approaches to the international standards application in healthcare and public health in different countries

    Directory of Open Access Journals (Sweden)

    Vitaliy Sarancha

    2017-06-01

    Full Text Available As a result of consequent development, and guided by an increasing demand of different types of the organizations regarding structured management, the system of standardization has been established. The idea behind standardization is adjusting the characteristics of a product, process or a production cycle to make them consistent and in line with the rules regarding what is proper and acceptable. The “standard” is a document that specifies such established set of criteria covering a broad range of topics and applicable to commissioners of health, specialists in primary care, public health staff, and social care providers, as well as the local authorities and service users. Health products, ranging from medical devices and health informatics to traditional medicines and unconventional healing tools are all in the focus of standards’ application. Different countries have their own quality management traditions based on their history, mentality, socio-economic environment and the local regulations. Taking into consideration that community social system organization and the quality of social infrastructure are the main foundations of social relations and future prosperity, here we review the existing standardization environment in the health sector in different countries, both developed and those on a convergence path. We focused on standardization environment in the United States of America, Great Britain, Germany, Ukraine, Russian Federation, Croatia and Albania. In order to simplify comprehension, we also demonstrate the algorithm of standardization, as well as the opportunities for application of the international standards in healthcare and public health.

  16. 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.)

  17. Promoting Clinical Reasoning in Undergraduate Physical Therapy Education: A Review of Strategies and Approaches

    DEFF Research Database (Denmark)

    Brekke, Anders Falk

    2015-01-01

    Title: Promoting Clinical Reasoning in Undergraduate Physical Therapy Education: A Review of Strategies and Approaches Juneja H1, Brekke A F2 1,2 Physical Therapy Education, University College Zealand, Denmark Background: Clinical reasoning (CR) also referred to as “critical thinking” or “decision....... It is imperative that physical therapy educators utilize innovative pedagogical methods to facilitate learning of reasoning skills in students. Purpose: The review is an attempt to highlight and discuss selected pedagogical strategies and approaches to enhance clinical reasoning skills in undergraduate physical...... programs was shortlisted for the review. References of pertinent literature were scanned to identify further relevant citations. Results: The review provides a detailed insight into the interwoven nature of pedagogical techniques to promote clinical reasoning being used by different physical therapy...

  18. An analysis of clinical reasoning through a recent and comprehensive approach: the dual-process theory

    OpenAIRE

    Pelaccia, Thierry; Tardif, Jacques; Triby, Emmanuel; Charlin, Bernard

    2011-01-01

    Context: Clinical reasoning plays a major role in the ability of doctors to make diagnoses and decisions. It is considered as the physician’s most critical competence, and has been widely studied by physicians, educationalists, psychologists and sociologists. Since the 1970s, many theories about clinical reasoning in medicine have been put forward. Purpose: This paper aims at exploring a comprehensive approach: the ‘‘dual-process theory’’, a model developed by co...

  19. On the applicability of the standard approaches for evaluating a neoclassical radial electric field in a tokamak edge region

    Energy Technology Data Exchange (ETDEWEB)

    Dorf, M. A.; Cohen, R. H.; Joseph, I. [Lawrence Livermore National Laboratory, Livermore, California 94550 (United States); Simakov, A. N. [Los Alamos National Laboratory, Los Alamos, New Mexico 87544 (United States)

    2013-08-15

    The use of the standard approaches for evaluating a neoclassical radial electric field E{sub r}, i.e., the Ampere (or gyro-Poisson) equation, requires accurate calculation of the difference between the gyroaveraged electron and ion particle fluxes (or densities). In the core of a tokamak, the nontrivial difference appears only in high-order corrections to a local Maxwellian distribution due to the intrinsic ambipolarity of particle transport. The evaluation of such high-order corrections may be inconsistent with the accuracy of the standard long wavelength gyrokinetic equation (GKE), thus imposing limitations on the applicability of the standard approaches. However, in the edge of a tokamak, charge-exchange collisions with neutrals and prompt ion orbit losses can drive non-intrinsically ambipolar particle fluxes for which a nontrivial (E{sub r}-dependent) difference between the electron and ion fluxes appears already in a low order and can be accurately predicted by the long wavelength GKE. The parameter regimes, where the radial electric field dynamics in the tokamak edge region is dominated by the non-intrinsically ambipolar processes, thus allowing for the use of the standard approaches, are discussed.

  20. Microbial environmental contamination in Italian dental clinics: A multicenter study yielding recommendations for standardized sampling methods and threshold values.

    Science.gov (United States)

    Pasquarella, Cesira; Veronesi, Licia; Napoli, Christian; Castiglia, Paolo; Liguori, Giorgio; Rizzetto, Rolando; Torre, Ida; Righi, Elena; Farruggia, Patrizia; Tesauro, Marina; Torregrossa, Maria V; Montagna, Maria T; Colucci, Maria E; Gallè, Francesca; Masia, Maria D; Strohmenger, Laura; Bergomi, Margherita; Tinteri, Carola; Panico, Manuela; Pennino, Francesca; Cannova, Lucia; Tanzi, Marialuisa

    2012-03-15

    A microbiological environmental investigation was carried out in ten dental clinics in Italy. Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days, for one week per month, for a three-month period. Water and surfaces were sampled before and after clinical activity; air was sampled before, after, and during clinical activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and for the different sampling times. Before clinical activity, microbial water contamination in tap water reached 51,200cfu/mL (colony forming units per milliliter), and that in Dental Unit Water Systems (DUWSs) reached 872,000cfu/mL. After clinical activity, there was a significant decrease in the Total Viable Count (TVC) in tap water and in DUWSs. Pseudomonas aeruginosa was found in 2.38% (7/294) of tap water samples and in 20.06% (59/294) of DUWS samples; Legionella spp. was found in 29.96% (89/297) of tap water samples and 15.82% (47/297) of DUWS samples, with no significant difference between pre- and post-clinical activity. Microbial air contamination was highest during dental treatments, and decreased significantly at the end of the working activity (p<0.05). The microbial buildup on surfaces increased significantly during the working hours. This study provides data for the establishment of standardized sampling methods, and threshold values for contamination monitoring in dentistry. Some very critical situations have been observed which require urgent intervention. Furthermore, the study emphasizes the need for research aimed at defining effective managing strategies for dental clinics. Copyright © 2012 Elsevier B.V. All rights reserved.

  1. Traceable working standards with SI units of radiance for characterizing the measurement performance of investigational clinical NIRF imaging devices

    Science.gov (United States)

    Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni; Sevick-Muraca, Eva M.

    2017-03-01

    All medical devices for Food and Drug market approval require specifications of performance based upon International System of Units (SI) or units derived from SI for reasons of traceability. Recently, near-infrared fluorescence (NIRF) imaging devices of a variety of designs have emerged on the market and in investigational clinical studies. Yet the design of devices used in the clinical studies vary widely, suggesting variable device performance. Device performance depends upon optimal excitation of NIRF imaging agents, rejection of backscattered excitation and ambient light, and selective collection of fluorescence emanating from the fluorophore. There remains no traceable working standards with SI units of radiance to enable prediction that a given molecular imaging agent can be detected in humans by a given NIRF imaging device. Furthermore, as technologies evolve and as NIRF imaging device components change, there remains no standardized means to track device improvements over time and establish clinical performance without involving clinical trials, often costly. In this study, we deployed a methodology to calibrate luminescent radiance of a stable, solid phantom in SI units of mW/cm2/sr for characterizing the measurement performance of ICCD and IsCMOS camera based NIRF imaging devices, such as signal-to-noise ratio (SNR) and contrast. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS system; comparable contrast of ICCD and IsCMOS depending upon binning strategies.

  2. 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.

  3. 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.

  4. Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

    Science.gov (United States)

    Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

    2015-07-01

    To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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...

  10. 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.

  11. 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

  12. 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.…

  13. Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials

    OpenAIRE

    Clark, Catharine H; Aird, Edwin GA; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia AD; Thomas, Russell AS; Venables, Karen; Thwaites, David I

    2015-01-01

    Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK...

  14. Microbleed detection using automated segmentation (MIDAS): a new method applicable to standard clinical MR images.

    Science.gov (United States)

    Seghier, Mohamed L; Kolanko, Magdalena A; Leff, Alexander P; Jäger, Hans R; Gregoire, Simone M; Werring, David J

    2011-03-23

    Cerebral microbleeds, visible on gradient-recalled echo (GRE) T2* MRI, have generated increasing interest as an imaging marker of small vessel diseases, with relevance for intracerebral bleeding risk or brain dysfunction. Manual rating methods have limited reliability and are time-consuming. We developed a new method for microbleed detection using automated segmentation (MIDAS) and compared it with a validated visual rating system. In thirty consecutive stroke service patients, standard GRE T2* images were acquired and manually rated for microbleeds by a trained observer. After spatially normalizing each patient's GRE T2* images into a standard stereotaxic space, the automated microbleed detection algorithm (MIDAS) identified cerebral microbleeds by explicitly incorporating an "extra" tissue class for abnormal voxels within a unified segmentation-normalization model. The agreement between manual and automated methods was assessed using the intraclass correlation coefficient (ICC) and Kappa statistic. We found that MIDAS had generally moderate to good agreement with the manual reference method for the presence of lobar microbleeds (Kappa = 0.43, improved to 0.65 after manual exclusion of obvious artefacts). Agreement for the number of microbleeds was very good for lobar regions: (ICC = 0.71, improved to ICC = 0.87). MIDAS successfully detected all patients with multiple (≥2) lobar microbleeds. MIDAS can identify microbleeds on standard MR datasets, and with an additional rapid editing step shows good agreement with a validated visual rating system. MIDAS may be useful in screening for multiple lobar microbleeds.

  15. Post-standardization of routine creatinine assays: are they suitable for clinical applications.

    Science.gov (United States)

    Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

    2017-05-01

    Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility

  16. 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.

  17. Mid-level healthcare personnel training: an evaluation of the revised, nationally-standardized, pre-service curriculum for clinical officers in Mozambique.

    Science.gov (United States)

    Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Augusto, Gerito; Cesar, Freide; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

    2014-01-01

    Mozambique suffers from a critical shortage of healthcare workers. Mid-level healthcare workers, (Tecnicos de Medicina Geral (TMG)), in Mozambique require less money and time to train than physicians. From 2009-2010, the Mozambique Ministry of Health (MoH) and the International Training and Education Center for Health (I-TECH), University of Washington, Seattle, revised the TMG curriculum. To evaluate the effect of the curriculum revision, we used mixed methods to determine: 1) if TMGs meet the MoH's basic standards of clinical competency; and 2) do scores on measurements of clinical knowledge, physical exam, and clinical case scenarios differ by curriculum? T-tests of differences in means examined differences in continuous score variables between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related and demographic factors associated with assessment scores on each of the three evaluation methods at the pTMG scores on both the clinical cases and physical exam. TMGs trained in either curriculum may be inadequately prepared to provide quality care. Curriculum changes are a necessary, but insufficient, part of improving TMG knowledge and skills overall. A more comprehensive, multi-level approach to improving TMG training that includes post-graduation mentoring, strengthening the pre-service internship training, and greater resources for training institute faculty may result in improvements in TMG capacity and patient care over time.

  18. 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)

  19. 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

    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...

  20. 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.

  1. 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).

  2. The use of standardized patients in the plastic surgery residency curriculum: teaching core competencies with objective structured clinical examinations.

    Science.gov (United States)

    Davis, Drew; Lee, Gordon

    2011-07-01

    As of 2006, the Accreditation Council for Graduate Medical Education had defined six "core competencies" of residency education: interpersonal communication skills, medical knowledge, patient care, professionalism, practice-based learning and improvement, and systems-based practice. Objective structured clinical examinations using standardized patients are becoming effective educational tools, and the authors developed a novel use of the examinations in plastic surgery residency education that assesses all six competencies. Six plastic surgery residents, two each from postgraduate years 4, 5, and 6, participated in the plastic surgery-specific objective structured clinical examination that focused on melanoma. The examination included a 30-minute videotaped encounter with a standardized patient actor and a postencounter written exercise. The residents were scored on their performance in all six core competencies by the standardized patients and faculty experts on a three-point scale (1 = novice, 2 = moderately skilled, and 3 = proficient). Resident performance was averaged for each postgraduate year, stratified according to core competency, and scored from a total of 100 percent. Residents overall scored well in interpersonal communications skills (84 percent), patient care (83 percent), professionalism (86 percent), and practice-based learning (84 percent). Scores in medical knowledge showed a positive correlation with level of training (86 percent). All residents scored comparatively lower in systems-based practice (65 percent). The residents reported unanimously that the objective structured clinical examination was realistic and educational. The objective structured clinical examination provided comprehensive and meaningful feedback and identified areas of strengths and weakness for the residents and for the teaching program. The examination is an effective assessment tool for the core competencies and a valuable adjunct to residency training.

  3. Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

    Science.gov (United States)

    Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

    2016-04-01

    The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

  4. Faculty Development for Fostering Clinical Reasoning Skills in Early Medical Students Using a Modified Bayesian Approach.

    Science.gov (United States)

    Addy, Tracie Marcella; Hafler, Janet; Galerneau, France

    2016-01-01

    Clinical reasoning is a necessary skill for medical students to acquire in the course of their education, and there is evidence that they can start this process at the undergraduate level. However, physician educators who are experts in their given fields may have difficulty conveying their complex thought processes to students. Providing faculty development that equips educators with tools to teach clinical reasoning may support skill development in early medical students. We provided faculty development on a modified Bayesian method of teaching clinical reasoning to clinician educators who facilitated small-group, case-based workshops with 2nd-year medical students. We interviewed them before and after the module regarding their perceptions on teaching clinical reasoning. We solicited feedback from the students about the effectiveness of the method in developing their clinical reasoning skills. We carried out this project during an institutional curriculum rebuild where clinical reasoning was a defined goal. At the time of the intervention, there was also increased involvement of the Teaching and Learning Center in elevating the status of teaching and learning. There was high overall satisfaction with the faculty development program. Both the faculty and the students described the modified Bayesian approach as effective in fostering the development of clinical reasoning skills. Through this work, we learned how to form a beneficial partnership between a clinician educator and Teaching and Learning Center to promote faculty development on a clinical reasoning teaching method for early medical students. We uncovered challenges faced by both faculty and early learners in this study. We observed that our faculty chose to utilize the method of teaching clinical reasoning in a variety of manners in the classroom. Despite obstacles and differing approaches utilized, we believe that this model can be emulated at other institutions to foster the development of clinical

  5. 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 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.

  6. 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 programme is to gain practical experience in the PBS approach and to quantify and evaluate the potential infrastructure preservation, safety and productivity benefits for road freight transport. The Smart Truck demonstration vehicles have been designed...

  7. Magnetic Resonance Fingerprinting - a promising new approach to obtain standardized imaging biomarkers from MRI

    OpenAIRE

    2015-01-01

    Current routine MRI examinations rely on the acquisition of qualitative images that have a contrast ?weighted? for a mixture of (magnetic) tissue properties. Recently, a novel approach was introduced, namely MR Fingerprinting (MRF) with a completely different approach to data acquisition, post-processing and visualization. Instead of using a repeated, serial acquisition of data for the characterization of individual parameters of interest, MRF uses a pseudo randomized acquisition that causes ...

  8. How Well Can We Learn With Standard BCI Training Approaches? A Pilot Study.

    OpenAIRE

    Jeunet , Camille; Cellard , Alison; Subramanian , Sriram; Hachet , Martin; N'Kaoua , Bernard; Lotte , Fabien

    2014-01-01

    International audience; While being very promising, brain-computer interfaces (BCI) remain barely used outside laboratories because they are not reliable enough. It has been suggested that current training approaches may be partly responsible for the poor reliability of BCIs as they do not satisfy recommendations from psychology and are thus inadequate. To determine to which extent such BCI training approaches (i.e., feedback and training tasks) are suitable to learn a skill, we used them in ...

  9. A new approach to the Darboux-Baecklund transformation versus the standard dressing method

    International Nuclear Information System (INIS)

    Cieslinski, Jan L; Biernacki, Waldemar

    2005-01-01

    We present a new approach to the construction of the Darboux matrix. This is a generalization of a recently formulated method based on the assumption that the square of the Darboux matrix vanishes for some values of the spectral parameter. We consider the multisoliton case, the reduction problem and the discrete case. The relationships between our approach, the Zakharov-Shabat dressing method and the Neugebauer-Meinel method are discussed in detail

  10. 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…

  11. Comparison of NDE standards in the frame of fracture mechanics approach

    International Nuclear Information System (INIS)

    Reale, S.; Capurro, E.; Corvi, A.

    1991-01-01

    The Design and Construction Codes are a set of rules which were set together because they were the best ones when the Codes were issued. A permanent objective must be to complete and improve these rules. This objective can be attained as the result of industrial experiences and by means of research and development activities. Until recently, high risk plants like nuclear plants were designed and built on the basis of the codes and standards of the country where the plant was to be built and operated, and this caused many disadvantages. On the contrary, the use of common codes and standards offers many advantages. A general objective is to compare codes in order to identify the differences in national rules and standards. The acceptance criteria based on nondestructive testing to reject dangerous defects are discussed. In this paper, the standards adopted in France, Germany, Italy and the United Kingdom are taken in consideration, and ultrasonic and radiographic inspections are selected. The methodology of this activity and the results of comparison are reported. (K.I.)

  12. Standard Chinese: A Modular Approach. Resource Modules: Pronunciation and Romanization, Numbers, Classroom Expressions, Time and Dates.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    Texts in spoken Standard Chinese were developed to improve and update Chinese materials to reflect current usage in Beijing and Taipei. The focus is on communicating in Chinese in practical situations. The overall course is organized into 10 situational modules, student workbooks for each module, and resource modules. This text contains resource…

  13. Standard Chinese: A Modular Approach. Student Workbook. Module 1: Orientation; Module 2: Biographic Information.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    Texts in spoken Standard Chinese were developed to improve and update Chinese materials to reflect current usage in Beijing and Taipei. The focus is on communicating in Chinese in practical situations. The overall course is organized into 10 modules, student workbooks, and resource modules. This workbook covers the orientation and biographic…

  14. Standard Chinese: A Modular Approach. Student Workbook. Module 3: Money; Module 4: Directions.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    Texts in spoken Standard Chinese were developed to improve and update Chinese materials and to reflect current usage in Beijing and Taipei. The focus is on communicating in Chinese in practical situations. The overall course is organized into 10 situational modules, student workbooks, and resource modules. This workbook covers the money and…

  15. Standard Chinese: A Modular Approach. Student Text. Module 1: Orientation; Module 2: Biographic Information.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    Texts in spoken Standard Chinese were developed to improve and update Chinese materials to reflect current usage in Beijing and Taipei. The focus is on communicating in Chinese in practical situations, and the texts summarize and supplement tapes. The overall course is organized into 10 situational modules, student workbooks, and resource modules.…

  16. Standard Chinese: A Modular Approach. Student Text. Module 3: Money; Module 4: Directions.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    Texts in spoken Standard Chinese were developed to improve and update Chinese materials to reflect current usage in Beijing and Taipei. The focus is on communicating in practical situations, and the texts summarize and supplement tapes. The overall course is organized into 10 situational modules, student workbooks, and resource modules. This text…

  17. 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...

  18. 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

    DC and AC Microgrids are key elements to integrate renewable and distributed energy resources as well as distributed energy storage systems. In the last years, efforts toward the standardization of these Microgrids have been made. In this sense, this paper present the hierarchical control derived...

  19. A Novel Instructional Approach to the Design of Standard Controllers: Using Inversion Formulae

    Science.gov (United States)

    Ntogramatzidis, Lorenzo; Zanasi, Roberto; Cuoghi, Stefania

    2014-01-01

    This paper describes a range of design techniques for standard compensators (Lead-Lag networks and PID controllers) that have been applied to the teaching of many undergraduate control courses throughout Italy over the last twenty years, but that have received little attention elsewhere. These techniques hinge upon a set of simple formulas--herein…

  20. 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.

  1. Can a Competence or Standards Model Facilitate an Inclusive Approach to Teacher Education?

    Science.gov (United States)

    Moran, Anne

    2009-01-01

    The paper seeks to determine whether programmes of initial teacher education (ITE) can contribute to the development of beginning teachers' inclusive attitudes, values and practices. The majority of ITE programmes are based on government prescribed competence or standards frameworks, which are underpinned by Codes of Professional Values. It is…

  2. Standardization of calibration of clinic dosemeters using electric currents and charges

    International Nuclear Information System (INIS)

    Peres, Marcos Antonio de Lima

    1999-09-01

    Clinical dosimeters used in radiotherapy are calibrated in Latin American countries, including Brazil, as a complete 'system, i.e., ionization chamber and electrometer together. Some countries, as European ones, and USA calibrate them by component, i.e., ionisation chamber apart from electrometer. This method is more advantageous than the previous one, since it makes possible the automation of the calibration process, allowing the acquisition of data related to the chamber and the electrometer measurements independently, as well as the