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Sample records for current clinical standard

  1. 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

  2. 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

  3. 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 substitution of one of the components, in case of failure. This work proposes a method for standardisation of low intensity electric charge and currents in order to implement electric calibration of electrometers. This will make possible the implementation of a by components calibration technique, by components, of clinical dosimeters in Brazil. The results obtained with the calibration by components prove that the proposed method of standardisation of low electric charges and currents is viable. The difficulties found for the generation and measurement of low intensity electric charges and currents and the procedures adopted for the calibration by components are presented. Additionally, a current source was built to yield reference electric charges that will make possible the quality control clinical dosimeters. This source will also allow the user to identify the defective components of the dosimeters, through a simple verification test. (author)

  4. 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

  5. Clinical balance assessment: perceptions of commonly-used standardized measures and current practices among physiotherapists in Ontario, Canada.

    Science.gov (United States)

    Sibley, Kathryn M; Straus, Sharon E; Inness, Elizabeth L; Salbach, Nancy M; Jaglal, Susan B

    2013-03-20

    Balance impairment is common in multiple clinical populations, and comprehensive assessment is important for identifying impairments, planning individualized treatment programs, and evaluating change over time. However, little information is available regarding whether clinicians who treat balance are satisfied with existing assessment tools. In 2010 we conducted a cross-sectional survey of balance assessment practices among physiotherapists in Ontario, Canada, and reported on the use of standardized balance measures (Sibley et al. 2011 Physical Therapy; 91: 1583-91). The purpose of this study was to analyse additional survey data and i) evaluate satisfaction with current balance assessment practices and standardized measures among physiotherapists who treat adult or geriatric populations with balance impairment, and ii) identify factors associated with satisfaction. The questionnaire was distributed to 1000 practicing physiotherapists. This analysis focuses on questions in which respondents were asked to rate their general perceptions about balance assessment, the perceived utility of individual standardized balance measures, whether they wanted to improve balance assessment practices, and why. Data were summarized with descriptive statistics and utility of individual measures was compared across clinical practice areas (orthopaedic, neurological, geriatric or general rehabilitation). The questionnaire was completed by 369 respondents, of which 43.4% of respondents agreed that existing standardized measures of balance meet their needs. In ratings of individual measures, the Single Leg Stance test and Berg Balance Scale were perceived as useful for clinical decision-making and evaluating change over time by over 70% of respondents, and the Timed Up-and-Go test was perceived as useful for decision-making by 56.9% of respondents and useful for evaluating change over time by 62.9% of respondents, but there were significant differences across practice groups. Seventy

  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 standards: current issues and future trends

    International Nuclear Information System (INIS)

    Landis, J.W.

    1985-01-01

    A summary of the important issues that currently face the nuclear standards field is presented and a discussion of how each of these issues is being resolved is given. The economic benefits that properly developed standards produce are listed

  8. A review of the quantum current standard

    International Nuclear Information System (INIS)

    Kaneko, Nobu-Hisa; Nakamura, Shuji; Okazaki, Yuma

    2016-01-01

    The electric current, voltage, and resistance standards are the most important standards related to electricity and magnetism. Of these three standards, only the ampere, which is the unit of electric current, is an International System of Units (SI) base unit. However, even with modern technology, relatively large uncertainty exists regarding the generation and measurement of current. As a result of various innovative techniques based on nanotechnology and novel materials, new types of junctions for quantum current generation and single-electron current sources have recently been proposed. These newly developed methods are also being used to investigate the consistency of the three quantum electrical effects, i.e. the Josephson, quantum Hall, and single-electron tunneling effects, which are also known as ‘the quantum metrology triangle’. This article describes recent research and related developments regarding current standards and quantum-metrology-triangle experiments. (topical review)

  9. Current and future neutron radiography standards

    International Nuclear Information System (INIS)

    Brenizer, J.S.

    1999-01-01

    Only two organizations are actively producing standards which are used in neutron radiology (NR): the American Society of Testing and Materials (ASTM) and the International Organization for Standardization (ISO). Six ASTM standards exist that address the neutron radiography method. Two of the ASTM standards have been extensively used world-wide. ISO has a working group which is developing three standards that also address the neutron radiography method. Two of these are currently making their way through the ISO approval system. No ASTM or ISO standards exist for the neutron radioscopic method. Future ASTM standards will address the neutron radioscopic method and neutron radiologic system characterization. It is expected that similar efforts will be undertaken in ISO. Given the relatively small community providing neutron radiologic services, international cooperation and the need for ISO standards will most likely continue to grow.(author)

  10. Current standard treatment for pediatric glioma patients

    International Nuclear Information System (INIS)

    Sonoda, Yukihiko; Kumabe, Toshihiro; Saito, Ryuta; Kanamori, Masayuki; Yamashita, Yoji; Tominaga, Teiji

    2012-01-01

    In this paper, we selected three representative disorders among pediatric gliomas and reviewed standard treatments for these diseases. The formation of this rare disease is involved with BRAF mutation as well as cerebellar pilocytic astrocytoma. Radical resection is not recommended as initial therapy due to high morbidity. Despite its good tumor control, radiotherapy is not a standard therapy due to neuroendocrine and neurocognitive dysfunction. Several papers have reported the effectiveness of platinum-based chemotherapy, which is a useful for induction therapy. Recent progress in molecular analyses has suggested that some markers might be used for staging ependymoma. While total resection is considered to be strongly correlated with patients' survival, the majority of recurrence occurs in the primary site. Despite many clinical trials, chemotherapeutic agents were not found to be effective for this disease. Since whole brain radiation cannot prevent dissemination, local radiation is recommended for adjuvant therapy. The prognosis of this disease is still dismal, and median survival time is within 1 year. Although clinical trials have been conducted to assess the efficacy of chemotherapy prior to, concomitantly with, or after radiotherapy, an effective regimen has not yet been established. Therefore, only conventional local radiotherapy is the standard regimen for this disease. A new therapeutic approach, such as convection-enhanced drug delivery, would be required for improved outcomes in patients with this disease. (author)

  11. Cranial MRI: Current clinical applications

    International Nuclear Information System (INIS)

    Bradley, W.G. Jr.; Kortman, K.E.

    1987-01-01

    Human MR images were first published by the Nottingham group in 1980. Since that time, there have been steady improvements in image quality and significant reductions in imaging time. After initial studies by the Hammersmith group in London, investigators at UCSF published studies comparing CT with MR, clearly demonstrating the higher sensitivity of MR to pathologic intracranial processes. Since that time, several investigators have demonstrated the efficacy of MR in the evaluation of a wide range of intracranial pathologic processes, including neoplasms, demyelinating disease, trauma, and congenital abnormalities. In the authors' studies comparing MR with CT in 400 consecutive cases of suspected CNS pathology, MR detected abnormalities which were not seen on CT in 30 percent of these cases. MR has become established as the imaging modality of choice in the evaluation of a broad range of CNS abnormalities and is rapidly being implemented not only at university medical centers but also in community hospitals and free-standing clinics. This chapter deals with fundamental principles of MR image interpretation and provides insight into current clinical indications for MR in intracranial disorders

  12. 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...

  13. Current state of clinical lithotripsy

    Science.gov (United States)

    Lingeman, James E.

    2003-10-01

    Extracorporeal shock wave lithotripsy (ESWL) has revolutionized the treatment of urolithiasis. Because of the clinical success of the original lithotriptor, the Dornier HM3, numerous manufacturers introduced different approaches to lithotripsy based on empiricism rather than an understanding of the fundamental mechanisms of this new technology. Our understanding of shock wave physics and the physiologic effects of shock waves has progressed greatly over the last decade resulting in insights that hopefully will be reflected favorably in future lithotriptor designs and lithotripsy techniques.

  14. 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.

  15. Eddy current standards - Cracks versus notches

    Science.gov (United States)

    Hagemaier, D. J.; Collingwood, M. R.; Nguyen, K. H.

    1992-10-01

    Eddy current tests aimed at evaluating cracks and electron-discharge machined (EDM) notches in 7075-T6 aluminum specimens are described. A comparison of the shape and amplitude of recordings made from both transverse and longitudinal scans of small EDM notches and fatigue cracks showd almost identical results. The signal amplitude and phase angle increased with an increase of EDM notch and crak size. It is concluded that equivalent eddy current results obtained from similar-size surface cracks and notches in aluminum can be used to establish a desired sensitivity level for inspection.

  16. Pharmacotherapy of erectile dysfunction: Current standards

    Directory of Open Access Journals (Sweden)

    Kew-Kim Chew

    2006-01-01

    Full Text Available Pharmacotherapy is currently the therapeutic option of choice for erectile dysfunction. Comprising mainly intracavernosal injection therapy using alprostadil or alprostadil combined with phentolamine and/or papaverine and oral phosphodiesterase-5 inhibitors, it is safe and effective if appropriately prescribed and administered. The medications in current use produce satisfactory erectile responses by enhancing cavernosal vasodilatation mainly through their ability to promote relaxation of the smooth muscle cells in the corpora cavernosa involving the synthesis and activity of nitric oxide via the cyclic guanosine monophosphate and cyclic adenosine monophosphate biochemical pathways. The main side-effects and complications of intracavernosal injections are postinjection pain, prolonged erections, priapism and penile fibrosis. There may be a variety of side-effects with phosphodiesterase-5 inhibition but these are usually inconsequential. Recent serious ill health and the need for ongoing long-acting nitrate therapy or frequent use of short-acting nitrates for angina are absolute contraindications to the use of phosphodiesterase-5 inhibitors. Caution has to be exercised in prescribing phosphodiesterase-5 inhibitors for patients with impaired renal or hepatic functions or receiving multi-drug therapy for any systemic disease. All patients presenting with erectile dysfunction should be investigated and treated for cardiovascular risk factors. They should also be counseled regarding lifestyle factors particularly healthy balanced diet, regular physical exercise and inappropriate social habits.

  17. Standard guidelines for electrosurgery with radiofrequency current

    Directory of Open Access Journals (Sweden)

    Mutalik Sharad

    2009-08-01

    Full Text Available Definition: Radiofrequency (RF induces thermal destruction of the targeted tissue by an electrical current at a frequency of 0.5 MHz (RF. As the electrode tip is not heated, there is minimal thermal damage to the surrounding tissues, producing good esthetic results. Therefore, RF ablation is also known as cold ablation or "coblation." Modality: It has three modes of operation: (a Cut, (b cut and coagulate and (c coagulate. Therefore, it can be used for various purposes like incision, ablation, fulguration, shave excision and coagulation. Because of the coagulation facility, hemostasis can be achieved and operation becomes easier and faster. Indications: It is effective in treating various skin conditions like dermatosis papulosa nigra, warts, molluscum contagiosum, colloid milia, acquired junctional, compound and dermal melanocytic nevi, seborrheic keratosis, skin tags, granuloma pyogenicum, verrucous epidermal nevi, xanthelesma, rhinophyma, superficial basal cell carcinoma and telangiectasia. It can also be used for cosmetic indications such as resurfacing, earlobe repair and blepharoplasty. Anesthesia: The procedure is accomplished either under topical anesthesia eutactic mixture of local anesthetics or local injectable anesthesia, under all aseptic precautions. Procedure: While operating, only the tip of the electrode should come in contact with the tissue. Actual contact of the electrode with the tissue should be very brief in order to prevent excessive damage to the deeper tissues. This can be accomplished by moving the electrode quickly. Complications: Complications are uncommon and mainly occur due to an improper technique. The treating physician should be aware of the contraindications of the procedure as listed in these guidelines. Physician qualification: RF surgery may be performed by a dermatologist who has acquired adequate training during post-graduation or through recognized fellowships and workshops dedicated to RF surgery. He

  18. 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

  19. 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

  20. Current standards for infection control: audit assures compliance.

    Science.gov (United States)

    Flanagan, Pauline

    Having robust policies and procedures in place for infection control is fundamentally important. However, each organization has to go a step beyond this; evidence has to be provided that these policies and procedures are followed. As of 1 April 2009, with the introduction of the Care Quality Commission and The Health and Social Care Act 2008 Code of Practice for the NHS on the Prevention and Control of Healthcare-Associated Infections and Related Guidance, the assurance of robust infection control measures within any UK provider of health care became an even higher priority. Also, the commissioning of any service by the NHS must provide evidence that the provider has in place robust procedures for infection control. This article demonstrates how the clinical audit team at the Douglas Macmillan Hospice in North Staffordshire, UK, have used audit to assure high rates of compliance with the current national standards for infection control. Prior to the audit, hospice staff had assumed that the rates of compliance for infection control approached 100%. This article shows that a good quality audit tool can be used to identify areas of shortfall in infection control and the effectiveness of putting in place an action plan followed by re-audit.

  1. Current educational issues in the clinical neurosciences.

    Science.gov (United States)

    Desbiens, R; Elleker, M G; Goldsand, G; Hugenholtz, H; Puddester, D; Toyota, B; Findlay, J M

    2001-11-01

    Canadian training in the clinical neurosciences, neurology and neurosurgery, faces significant challenges. New balances are being set by residents, their associations and the Royal College of Physicians and Surgeons of Canada between clinical service, education and personal time. The nature of hospital-provided medical service has changed significantly over the past decade, impacting importantly on resident training. Finally, future manpower needs are of concern, especially in the field of neurosurgery, where it appears that soon more specialists will be trained than can be absorbed into the Canadian health care system. A special symposium on current challenges in clinical neuroscience training was held at the Canadian Congress of Neurological Sciences in June 2000. Representatives from the Canadian Association of Interns and Residents, the Royal College of Physicians and Surgeons of Canada and English and French neurology and neurosurgery training programs made presentations, which are summarized in this report. Residency training has become less service-oriented, and this trend will continue. In order to manage the increasingly sophisticated hospital services of neurology and neurosurgery, resident-alternatives in the form of physician "moonlighters" or more permanent hospital-based clinicians or "hospitalists" will be necessary in order to operate major neuroclinical units. Health authorities and hospitals will need to recognize and assume this responsibility. As clinical experience diminishes during residency training, inevitably so will the concept of the fully competent "generalist" at the end of specialty training. Additional subspecialty training is being increasingly sought by graduates, particularly in neurosurgery. Training in neurology and neurosurgery, as in all medical specialties, has changed significantly in recent years and continues to change. Programs and hospitals need to adapt to these changes in order to ensure the production of fully

  2. [Current clinical significance of anaerobic bacteremia].

    Science.gov (United States)

    Jirsa, Roman; Marešová, Veronika; Brož, Zdeněk

    2010-10-01

    to estimate tje current clinical significance of anaerobic bacteremia in a group of Czech hospitals. this retrospective analysis comprised 8 444 anaerobic blood cultures in patients admitted to four Czech hospitals between 2004 and 2007. in 16 patients, blood cultures yielded significant anaerobic bacteria. Thus, anaerobic bacteremia accounted for less than 2 % of clinically significant bacteremia. Four patients (18 %) died but none of the deaths could be clearly attributable to anaerobic bacteria in the bloodstream. The most common comorbidities predisposing to anaerobic bacteremia and the most frequent sources of infection were similar to those reported by other authors. The majority of anaerobic bacteremia cases were due to gram-negative bacteria, followed by Clostridium perfringens and, surprisingly, Eubacterium spp. (particularly Eubacterium lentum). anaerobic bacteremia remains rare. The comparison of our data with those by other authors suggests that (despite the reported high mortality) the actual clinical significance of anaerobic bacteremia is rather controversial and that the anaerobic bacteremia might not correspond to more serious pathogenic role of the anaerobic bacteria as the source of infection.

  3. Current clinical evidence on pioglitazone pharmacogenomics

    Directory of Open Access Journals (Sweden)

    Marina eKawaguchi-Suzuki

    2013-11-01

    Full Text Available Pioglitazone is the most widely used thiazolidinedione and acts as an insulin-sensitizer through activation of the Peroxisome Proliferator-Activated Receptor-γ (PPARγ. Pioglitazone is approved for use in the management of type 2 diabetes mellitus, but its use in other therapeutic areas is increasing due to pleiotropic effects. In this hypothesis article, the current clinical evidence on pioglitazone pharmacogenomics is summarized and related to variability in pioglitazone response. How genetic variation in the human genome affects the pharmacokinetics and pharmacodynamics of pioglitazone was examined. For pharmacodynamic effects, hypoglycemic and anti-atherosclerotic effects, risks of fracture or edema, and the increase in body mass index in response to pioglitazone based on genotype were examined. The genes CYP2C8 and PPARG are the most extensively studied to date and selected polymorphisms contribute to respective variability in pioglitazone pharmacokinetics and pharmacodynamics. We hypothesized that genetic variation in pioglitazone pathway genes contributes meaningfully to the clinically observed variability in drug response. To test the hypothesis that genetic variation in PPARG associates with variability in pioglitazone response, we conducted a meta-analysis to synthesize the currently available data on the PPARG p.Pro12Ala polymorphism. The results showed that PPARG 12Ala carriers had a more favorable change in fasting blood glucose from baseline as compared to patients with the wild-type Pro12Pro genotype (p=0.018. Unfortunately, findings for many other genes lack replication in independent cohorts to confirm association; further studies are needed. Also, the biological functionality of these polymorphisms is unknown. Based on current evidence, we propose that pharmacogenomics may provide an important tool to individualize pioglitazone therapy and better optimize therapy in patients with T2DM or other conditions for which pioglitazone

  4. Xpand chest drain: assessing equivalence to current standard ...

    African Journals Online (AJOL)

    leakage from 'open to air' system or breakage of glass bottle (with associated risk to ... and an air-leak detection system. It is connected to a ... need to add water. Xpand chest drain: assessing equivalence to current standard therapy – a randomised controlled trial. CHARL COOPER, M.B. CH.B. TIMOTHY HARDCASTLE ...

  5. Topical steroids in the current clinical practice

    Directory of Open Access Journals (Sweden)

    T. A. Belousova

    2014-01-01

    Full Text Available The article discusses issues related to current criteria for selection of glucocorticosteroids for external use as the basic therapy for a great number of allergic and inflammatory skin diseases. The authors emphasize that non-fluorinated GCSs having the best efficacy-to-safety ratio must be the drugs of first choice. The article provides data on a positive clinical experience of using a non-halogenated glucocorticosteroid for external use - hydrocortisone 17-butyrate (Laticort - for treatment of steroid-sensitive dermatoses in children and adults. The drug has a high anti-inflammatory action and minimum risk of the development of side effects, which is sufficient for using it in sensitive areas of skin (face, neck, folds, genitals both in children and in adults. The availability of three forms of the drug (solution, cream and ointment ensures the expedience and convenience of its application at any stage of the inflammatory process and for any localization.

  6. 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.

  7. Current issues on a standard for surrogate pregnancy procedures

    OpenAIRE

    Ha, Jung-Ok

    2012-01-01

    While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

  8. Current issues on a standard for surrogate pregnancy procedures.

    Science.gov (United States)

    Ha, Jung-Ok

    2012-12-01

    While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

  9. Islet cell transplant: Update on current clinical trials

    Science.gov (United States)

    Schuetz, Christian; Markmann, James F.

    2016-01-01

    In the last 15 years clinical islet transplantation has made the leap from experimental procedure to standard of care for a highly selective group of patients. Due to a risk-benefit calculation involving the required systemic immunosuppression the procedure is only considered in patients with type 1 diabetes, complicated by severe hypoglycemia or end stage renal disease. In this review we summarize current outcomes of the procedure and take a look at ongoing and future improvements and refinements of beta cell therapy. PMID:28451515

  10. 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...

  11. 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...

  12. 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...

  13. UV dose-effect relationships and current protection exposure standards

    International Nuclear Information System (INIS)

    Singh, M.S.; Campbell, G.W.

    1982-04-01

    In this paper we have attempted to quantify the health effects in man of uv-radiation exposure of wavelengths from 240 nm to 320 nm. Exposure to uv in this region could result in the formation of skin cancer or premature aging in man. The induction of cancer by uv radiation results from changes in genetic material. We have used the DNA action spectrum coupled with the uv skin cancer data available in the literature to derive the dose-effect relationships. The results are compared against the current uv protection standards

  14. 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.

  15. Hyperthermia: Clinical promise and current challenges

    International Nuclear Information System (INIS)

    Kapp, D.S.

    1987-01-01

    Local-regional hyperthermia (HT) when used in conjunction with radiation therapy (XRT), has been shown in numerous clinical trials to result in considerable improvement in response rates and local tumor control rates when compared with treatment by XRT alone. Although considerable progress has been made in understanding the biological basis for hyperthermia induced cytotoxicity and radiosensitization, additional research remains in establishing the optimal treatment schedules for the clinical utilization of HT-XRT. The number of HT treatments; the sequencing of HT and XRT; the frequency of administration of HT; and the ideal temperature-time parameters all remain to be better defined for the clinical setting. The role of tumor blood flow on the thermal distributions also warrants further investigation. In addition, considerable effort is needed to improve hyperthermia equipment in order to provide more uniform therapeutic temperature distributions (temperatures ≥42.5%C). Better heating equipment is particularly needed for the treatment of deep seeted tumors. Pertinent clinical literature will be presented summarizing the clinical promise of hyperthermia and the above mentioned clinical challenges

  16. International comparison of AC-DC current transfer standards

    Science.gov (United States)

    Heine, G.; Garcocz, M.; Waldmann, W.

    2017-01-01

    The measurements of the international comparison of ac-dc current transfer standards identified as EURAMET.EM-K12 started in June 2012 and were completed in December 2014. Twenty NMIs in the EURAMET region and one NMI in the AFRIMET region took part: BEV (Austria), CMI (Czech Republic), PTB (Germany), METAS (Switzerland), JV (Norway), UME (Turkey), GUM (Poland), IPQ (Portugal), CEM (Spain), INRIM (Italy), SP (Sweden), DANIAmet-MI-Trescal (Denmark), BIM (Bulgaria), MKEH (Hungary), SIQ (Slovenia), LNE (France), NSAI NML (Ireland), VSL (The Netherlands), NPL (United Kingdom), Metrosert (Estonia), NIS (Egypt). The comparison was proposed to link the National Metrology Institutes organised in EURAMET to the key comparison CCEM-K12. The ac-dc current transfer difference of each travelling standard had been measured at its nominal current 10 mA and 5 A at the following frequencies: 10 Hz, 55 Hz, 1 kHz, 10 kHz, 20 kHz, 50 kHz, 100 kHz. The test points were selected to link the results with the equivalent CCEM Key Comparison (CCEM-K12), through five NMIs participating in both EURAMET and CCEM key comparisons (PTB, JV, NPL, SP and BEV). The report shows the degree of equivalence in the EURAMET region and also the degree of equivalence with the corresponding CCEM reference value. Main text To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/. The final report has been peer-reviewed and approved for publication by the CCEM, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

  17. Views of surgery program directors on the current ACGME and proposed IOM duty-hour standards.

    Science.gov (United States)

    Willis, Ross E; Coverdill, James E; Mellinger, John D; Collins, J Craig; Potts, John R; Dent, Daniel L

    2009-01-01

    The purpose of this study was to survey the experiences of surgery program directors with the current Accreditation Council for Graduate Medical Education (ACGME) duty-hour standards and views of the Institute of Medicine (IOM) proposed duty-hour recommendations. A total of 118 program directors (47.6% of all surgery programs in the US) responded to the survey. Results showed that the current duty-hour standards have hindered clinical education opportunities by reducing or eliminating rotations on many services, didactic teaching conferences, and clinical bedside teaching opportunities. Additionally, patient safety has been compromised by frequent hand offs of care. Most IOM recommendations were perceived as extremely difficult or impossible to implement, with the exception of the moonlighting recommendation. The results indicated that adopting the IOM recommendations is not feasible given current workforce limitations, and most program directors supported maintaining the current duty-hour standards until such time as there is evidence-based outcomes research to direct change. The conclusion was that the current ACGME duty-hour standards have reduced teaching opportunities and narrowed the scope of training.

  18. Addressing unwarranted clinical variation: A rapid review of current evidence.

    Science.gov (United States)

    Harrison, Reema; Manias, Elizabeth; Mears, Stephen; Heslop, David; Hinchcliff, Reece; Hay, Liz

    2018-05-15

    Unwarranted clinical variation (UCV) can be described as variation that can only be explained by differences in health system performance. There is a lack of clarity regarding how to define and identify UCV and, once identified, to determine whether it is sufficiently problematic to warrant action. As such, the implementation of systemic approaches to reducing UCV is challenging. A review of approaches to understand, identify, and address UCV was undertaken to determine how conceptual and theoretical frameworks currently attempt to define UCV, the approaches used to identify UCV, and the evidence of their effectiveness. Rapid evidence assessment (REA) methodology was used. A range of text words, synonyms, and subject headings were developed for the major concepts of unwarranted clinical variation, standards (and deviation from these standards), and health care environment. Two electronic databases (Medline and Pubmed) were searched from January 2006 to April 2017, in addition to hand searching of relevant journals, reference lists, and grey literature. Results were merged using reference-management software (Endnote) and duplicates removed. Inclusion criteria were independently applied to potentially relevant articles by 3 reviewers. Findings were presented in a narrative synthesis to highlight key concepts addressed in the published literature. A total of 48 relevant publications were included in the review; 21 articles were identified as eligible from the database search, 4 from hand searching published work and 23 from the grey literature. The search process highlighted the voluminous literature reporting clinical variation internationally; yet, there is a dearth of evidence regarding systematic approaches to identifying or addressing UCV. Wennberg's classification framework is commonly cited in relation to classifying variation, but no single approach is agreed upon to systematically explore and address UCV. The instances of UCV that warrant investigation and

  19. Evaluation of leak current of clinical electrometers

    International Nuclear Information System (INIS)

    Lopez G, W.; Campos, X.

    2002-01-01

    The present work shows the evaluation of two electrometers model Victoreen used in radiotherapy. The performance of the electrometers was proven using a source of current, built inside the work frame arcal 34, and using like reference the norm iec 60371. The results of the tests of leakage, displacement of the zero and linealty of the electrometers are presented

  20. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  1. Current and future perspectives in clinical management

    International Nuclear Information System (INIS)

    Willett, Christopher

    1996-01-01

    In the past several years, there has been significant progress and controversy in the clinical management of patients with rectal cancer as well as important advances in the understanding the biology of these tumors. The panel will highlight relevant biologic and clinical developments. One of major advances has been in the understanding of the molecular basis for the development of colon and rectal cancer with many of the events leading to cancer development having been determined. Although there is much to be learned, there is now a much improved understanding of colon and rectal carcinogenesis with the prospect of being able to define high risk patient populations and the possibility of early detection (before cancer formation) now a real possibility. In addition, the identification of favorable or unfavorable subsets of patients wit rectal cancer based on molecular markers is under active investigation. These exciting developments will be summarized. In the clinical arena, there are a number of controversial issues in the management of patients with rectal cancer. For patients with distal rectal cancer, the goals of therapy have evolved from cure to cure with sphincter preservation. The role of resection with coloanal anastomosis as an alternative to an abdominoperineal resection is also being defined. A wide array of treatment programs of radiation therapy and chemotherapy and sphincter sparing surgery are under active investigation. The relative merits of preoperative chemo-irradiation versus postoperative chemo-irradiation continues to be debated. The utility of total mesorectal excision is being evaluated and the need for adjuvant therapy is being questioned. These clinical issues will be highlighted

  2. Current developments in clinical multiphoton tomography

    Science.gov (United States)

    König, Karsten; Weinigel, Martin; Breunig, Hans Georg; Gregory, Axel; Fischer, Peter; Kellner-Höfer, Marcel; Bückle, Rainer

    2010-02-01

    Two-photon microscopy has been introduced in 1990 [1]. 13 years later, CE-marked clinical multiphoton systems for 3D imaging of human skin with subcellular resolution have been launched by the JenLab company with the tomograph DermaInspectTM. In 2010, the second generation of clinical multiphoton tomographs was introduced. The novel mobile multiphoton tomograph MPTflexTM, equipped with a flexible articulated optical arm, provides an increased flexibility and accessibility especially for clinical and cosmetical examinations. The multiphoton excitation of fluorescent biomolecules like NAD(P)H, flavins, porphyrins, elastin, and melanin as well as the second harmonic generation of collagen is induced by picojoule femtosecond laser pulses from an tunable turn-key near infrared laser system. The ability for rapid highquality image acquisition, the user-friendly operation of the system, and the compact and flexible design qualifies this system to be used for melanoma detection, diagnostics of dermatological disorders, cosmetic research, and skin aging measurements as well as in situ drug monitoring and animal research. So far, more than 1,000 patients and volunteers have been investigated with the multiphoton tomographs in Europe, Asia, and Australia.

  3. Small Bowel Transplantation: Current Clinical Status

    Directory of Open Access Journals (Sweden)

    David Sigalet

    1991-01-01

    Full Text Available With recent refinements in immunosuppression techniques, the first successful reports of small bowel transplantation in humans have now been made, increasing interest in bowel transplantation among clinicians and patients alike. This article reviews recent developments in understanding of the functional capabilities and requirements for effective immune suppression in bowel transplantation. Both experimental and clinical experience with transplantation are discussed, as are the areas which appear to offer the most promise for future developments. Finally guidelines for consideration of patient selection for this procedure are reviewed.

  4. Ketamine use in current clinical practice

    Science.gov (United States)

    Gao, Mei; Rejaei, Damoon; Liu, Hong

    2016-01-01

    After nearly half a century on the market, ketamine still occupies a unique corner in the medical armamentarium of anesthesiologists or clinicians treating pain. Over the last two decades, much research has been conducted highlighting the drug's mechanisms of action, specifically those of its enantiomers. Nowadays, ketamine is also being utilized for pediatric pain control in emergency department, with its anti-hyperalgesic and anti-inflammatory effects being revealed in acute and chronic pain management. Recently, new insights have been gained on ketamine's potential anti-depressive and antisuicidal effects. This article provides an overview of the drug's pharmacokinetics and pharmacodynamics while also discussing the potential benefits and risks of ketamine administration in various clinical settings. PMID:27018176

  5. Syncope: causes, clinical evaluation, and current therapy.

    Science.gov (United States)

    Benditt, D G; Remole, S; Milstein, S; Bailin, S

    1992-01-01

    Syncope is a common clinical problem comprising the sudden loss of both consciousness and postural tone, with a subsequent spontaneous and relatively prompt recovery. Often it is difficult to differentiate a true syncopal spell from other conditions, such as seizure disorders, or from some simple accidents. Even more difficult is the identification of the cause of syncopal episodes. Nonetheless, establishing a definitive diagnosis ia an important task given the high risk of recurrent symptoms. Careful use of noninvasive and invasive cardiovascular studies (including electrophysiologic testing and tilt-table testing) along with selected hematologic, biochemical, and neurologic studies provides, in the majority of cases, the most effective strategy for obtaining a specific diagnosis and for directing therapy.

  6. 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.

  7. Standardized high current solid targets for cyclotron production of radionuclides

    International Nuclear Information System (INIS)

    Al-Jammaz, Ibrahim

    2000-01-01

    The Cyclotron and Radiopharmaceuticals Department (CRP) is an advanced and modern facility that encompasses two essential components: radioisotope research, and radiopharmaceuticals manufacturing. Radiopharmaceuticals manufacturing program is not only quite unique, but also an essential component of King Faisal Specialist Hospital and Research Center (KFSH and RC) in providing quality patient care for the population of the Kingdom. Accurate diagnosis and therapy with medical imaging equipment requires quality radiopharmaceuticals that are available readily and with reliability. The CRP Department provides that quality and reliability. Research activities of the CRP Department are focused on developing new radiotracers with potential usefulness in biomedical research and clinical applications. Research projects consist of: developing cyclotron targetry for radioisotope production; developing synthesis methods for radiolabeling biomolecules; and developing analytical methods for quality control. The CRP Department operates a semi-commercial radiopharmaceuticals manufacturing program that supplies the diagnostic radioactive products to several hospitals in the Kingdom and neighboring countries. These products for clinical applications are produced according to the international standards of Good Manufacturing Practices of quality and efficacy. At the heart of the radioisotope program is a medium energy cyclotron capable of accelerating a number of particles for transformation of non-radioactive atoms into radionuclides that are the primary sources for research and development activities, and for preparing radiopharmaceuticals. In addition to having the only cyclotron facility in the region, KFSH and RC also has the only Positron Emission Tomography Center (PET) in this part of the world. This combination of cyclotron and the ultra modern PET facility translates into advanced and specialized care for the patients at KFSH and RC

  8. Current Standards of Care and Long Term Outcomes for Thalassemia and Sickle Cell Disease.

    Science.gov (United States)

    Chonat, Satheesh; Quinn, Charles T

    2017-01-01

    Thalassemia and sickle cell disease (SCD) are disorders of hemoglobin that affect millions of people worldwide. The carrier states for these diseases arose as common, balanced polymorphisms during human history because they afforded protection against severe forms of malaria. These complex, multisystem diseases are reviewed here with a focus on current standards of clinical management and recent research findings. The importance of a comprehensive, multidisciplinary and lifelong system of care is also emphasized.

  9. Current Status of Standardization of Traditional Chinese Medicine in China

    Science.gov (United States)

    Guo, Yi; Li, Gui Lan

    2016-01-01

    As an important component of traditional medicine, Traditional Chinese Medicine (TCM) is widely spread and applied in more than 100 countries across the world. The standardization of TCM is very important for the international application of Chinese medicine. In this paper, we have explained and analyzed the standardization situations of TCM in China with the purpose of providing reference for standardization and international development of TCM. PMID:27110268

  10. Current Status of Standardization of Traditional Chinese Medicine in China

    Directory of Open Access Journals (Sweden)

    Juan Wang

    2016-01-01

    Full Text Available As an important component of traditional medicine, Traditional Chinese Medicine (TCM is widely spread and applied in more than 100 countries across the world. The standardization of TCM is very important for the international application of Chinese medicine. In this paper, we have explained and analyzed the standardization situations of TCM in China with the purpose of providing reference for standardization and international development of TCM.

  11. Fibrinolysis standards: a review of the current status.

    Science.gov (United States)

    Thelwell, C

    2010-07-01

    Biological standards are used to calibrate measurements of components of the fibrinolytic system, either for assigning potency values to therapeutic products, or to determine levels in human plasma as an indicator of thrombotic risk. Traditionally WHO International Standards are calibrated in International Units based on consensus values from collaborative studies. The International Unit is defined by the response activity of a given amount of the standard in a bioassay, independent of the method used. Assay validity is based on the assumption that both standard and test preparation contain the same analyte, and the response in an assay is a true function of this analyte. This principle is reflected in the diversity of source materials used to prepare fibrinolysis standards, which has depended on the contemporary preparations they were employed to measure. With advancing recombinant technology, and improved analytical techniques, a reference system based on reference materials and associated reference methods has been recommended for future fibrinolysis standards. Careful consideration and scientific judgement must however be applied when deciding on an approach to develop a new standard, with decisions based on the suitability of a standard to serve its purpose, and not just to satisfy a metrological ideal. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

  12. [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-

  13. 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.

  14. ANS-10 standards - current status and future direction

    International Nuclear Information System (INIS)

    Poetschat, G.R.

    1988-01-01

    The ANS-10 Standards Subcommittee is sponsored by the Mathematics and Computation Division of the American Nuclear Society (ANS). The scope of ANS-10 activities includes the development of standards that will promote effective utilization of and enhance the reliability of computer programs throughout the nuclear community. The application of ANS-10 standards during the computer program development process creates coding and documentation for the program product that promotes effective use and enhances reliability. The end product is a program package that contains adequate documentation, includes verification and validation results, is easy to use and maintain, and is easy to transfer from one hardware-software system to another

  15. Technical standardization of oil well abandonment: a review of current standards and technologies

    Energy Technology Data Exchange (ETDEWEB)

    Suzart, J. Walter P.; Pessoa, Laudemar; Paiva, Maria [Halliburton Energy Services (HES), Duncan, OK (United States)

    2008-07-01

    The objective of this study is to provide a new methodology for well abandonment. This practice is becoming more and more important because of the increasing number of production fields being abandoned. We strongly recommend a study of cement slurries properties for specific use in temporary and permanent abandonment plugs based on the estimation of the cement slurry hardened when placed in the well. By using specific additives, it is possible to achieve very stable slurries. For example, when permeability is reduced, formation fluid migration can be blocked and chemical reactions between the fluid and the slurry may be inhibited. With this objective, we present a laboratory investigation model and an example of slurry testing recommendation. During the abandonment operation, all records of the well characteristics should be maintained to include the reason for the abandonment, and location of fresh water, brine, and hydrocarbon zones that may exist. This documentation will also allow the analysis of solutions for the problems that originally caused the abandonment of the well. This data could be important for future use by environmental protection commissions to reopen or to drill an adjacent well. Given the high price of oil, it may now be economically feasible to reopen the well, if the reason for abandonment was low productivity. This way, a critical analysis of the current conditions of well and field abandonment in the country is presented. Based on this information, a review of the current standards is suggested. (author)

  16. Current status of the MPEG-4 standardization effort

    Science.gov (United States)

    Anastassiou, Dimitris

    1994-09-01

    The Moving Pictures Experts Group (MPEG) of the International Standardization Organization has initiated a standardization effort, known as MPEG-4, addressing generic audiovisual coding at very low bit-rates (up to 64 kbits/s) with applications in videotelephony, mobile audiovisual communications, video database retrieval, computer games, video over Internet, remote sensing, etc. This paper gives a survey of the status of MPEG-4, including its planned schedule, and initial ideas about requirements and applications. A significant part of this paper is summarizing an incomplete draft version of a `requirements document' which presents specifications of desirable features on the video, audio, and system level of the forthcoming standard. Very low bit-rate coding algorithms are not described, because no endorsement of any particular algorithm, or class of algorithms, has yet been made by MPEG-4, and several seminars held concurrently with MPEG-4 meetings have not so far provided evidence that such high performance coding schemes are achievable.

  17. [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.

  18. [The costs of new drugs compared to current standard treatment].

    Science.gov (United States)

    Ujeyl, Mariam; Schlegel, Claudia; Gundert-Remy, Ursula

    2013-01-01

    Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions. Copyright © 2013. Published by Elsevier GmbH.

  19. Review of Current Standard Model Results in ATLAS

    CERN Document Server

    Brandt, Gerhard; The ATLAS collaboration

    2018-01-01

    This talk highlights results selected from the Standard Model research programme of the ATLAS Collaboration at the Large Hadron Collider. Results using data from $p-p$ collisions at $\\sqrt{s}=7,8$~TeV in LHC Run-1 as well as results using data at $\\sqrt{s}=13$~TeV in LHC Run-2 are covered. The status of cross section measurements from soft QCD processes and jet production as well as photon production are presented. The presentation extends to vector boson production with associated jets. Precision measurements of the production of $W$ and $Z$ bosons, including a first measurement of the mass of the $W$ bosons, $m_W$, are discussed. The programme to measure electroweak processes with di-boson and tri-boson final states is outlined. All presented measurements are compatible with Standard Model descriptions and allow to further constrain it. In addition they allow to probe new physics which would manifest through extra gauge couplings, or Standard Model gauge couplings deviating from their predicted value.

  20. Informatics in clinical research in oncology: current state, challenges, and a future perspective.

    Science.gov (United States)

    Chahal, Amar P S

    2011-01-01

    The informatics landscape of clinical trials in oncology has changed significantly in the last 10 years. The current state of the infrastructure for clinical trial management, execution, and data management is reviewed. The systems, their functionality, the users, and the standards available to researchers are discussed from the perspective of the oncologist-researcher. Challenges in complexity and in the processing of information are outlined. These challenges include the lack of communication and information-interchange between systems, the lack of simplified standards, and the lack of implementation and adherence to the standards that are available. The clinical toxicology criteria from the National Cancer Institute (CTCAE) are cited as a successful standard in oncology, and HTTP on the Internet is referenced for its simplicity. Differences in the management of information standards between industries are discussed. Possible future advances in oncology clinical research informatics are addressed. These advances include strategic policy review of standards and the implementation of actions to make standards free, ubiquitous, simple, and easily interpretable; the need to change from a local data-capture- or transaction-driven model to a large-scale data-interpretation model that provides higher value to the oncologist and the patient; and the need for information technology investment in a readily available digital educational model for clinical research in oncology that is customizable for individual studies. These new approaches, with changes in information delivery to mobile platforms, will set the stage for the next decade in clinical research informatics.

  1. Current Status of Operation and Management of Dental School Clinics.

    Science.gov (United States)

    Reinhardt, John W

    2017-08-01

    This article summarizes the current status of the operation and management of dental school clinics as schools strive to provide excellent patient-centered care in an environment that is educationally sound, efficient, and financially strong. Clinical education is a large component of dental education and an area in which many dental schools have an opportunity to enhance revenue. Clinical efficiencies and alternative models of clinical education are evolving in U.S. dental schools, and this article describes some of those evolutionary changes. This article was written as part of the project "Advancing Dental Education in the 21 st Century."

  2. Current Standards in the Management of Cerebral Metastases

    Directory of Open Access Journals (Sweden)

    Pablo Goetz

    2012-01-01

    Full Text Available The last 30 years have seen major changes in attitude toward patients with cerebral metastases. This paper aims to outline the major landmarks in this transition and the therapeutic strategies currently used. The controversies surrounding control of brain disease are discussed, and two emerging management trends are reviewed: tumor bed radiosurgery and salvage radiation.

  3. Radiation cancer, safety standards and current levels of exposure

    International Nuclear Information System (INIS)

    Mole, R.H.

    1976-01-01

    Cancer can be induced by radiation in any tissue where cancer occurs naturally. The observation that antenatal diagnostic radiography causes a small but definite increase in childhood cancer is as good evidence as could be expected in support of the scientific expectation that there would be no threshold of dose for carcinogenesis. A linear relation between radiation dose and frequency of induced cancer is a necessary assumption for a system of radiological protection but is not necessarily a reasonable basis for realistic assessments of cancer risk. Indeed there are radiobiological and epidemiological reasons to the contrary. If the linear hypothesis is accepted then at the present time in the UK the routine practice of medicine is of about 2 orders of magnitude more important in causing cancer than environmental pollution by discharge of radio-activity. The acceptability of radiation safety standards for occupational exposure may be justified by comparison of radiation cancer risks with risks from fatal accidents in the safer industries. The acceptability of the corresponding standards for members of the public seems to require more public discussion of the concept of negligible risk. Emotional reactions to uncontrolled releases of radio-activity are based at least in part on a failure to appreciate the hypothesis of linearity

  4. Clinical pharmacology in Russia-historical development and current state.

    Science.gov (United States)

    Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

    2015-02-01

    Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

  5. Current situation of International Organization for Standardization/Technical Committee 249 international standards of traditional Chinese medicine.

    Science.gov (United States)

    Liu, Yu-Qi; Wang, Yue-Xi; Shi, Nan-Nan; Han, Xue-Jie; Lu, Ai-Ping

    2017-05-01

    To review the current situation and progress of traditional Chinese medicine (TCM) international standards, standard projects and proposals in International Organization for Standardization (ISO)/ technical committee (TC) 249. ISO/TC 249 standards and standard projects on the ISO website were searched and new standard proposals information were collected from ISO/TC 249 National Mirror Committee in China. Then all the available data were summarized in 5 closely related items, including proposed time, proposed country, assigned working group (WG), current stage and classifification. In ISO/TC 249, there were 2 international standards, 18 standard projects and 24 new standard proposals proposed in 2014. These 44 standard subjects increased year by year since 2011. Twenty-nine of them were proposed by China, 15 were assigned to WG 4, 36 were in preliminary and preparatory stage and 8 were categorized into 4 fifields, 7 groups and sub-groups based on International Classifification Standards. A rapid and steady development of international standardization in TCM can be observed in ISO/TC 249.

  6. [Current standards in the treatment of gastric cancer].

    Science.gov (United States)

    Hacker, Ulrich; Lordick, Florian

    2015-08-01

    Endoscopic resection is established in the treatment of early gastric cancer. More advanced gastric cancer requires gastrectomy and D2 lymphadenectomy. Perioperative chemotherapy improves overall survival in locally advanced gastric cancer representing a standard of care. Locally advanced adenocarcinomas of the esophago-gastric junction can alternatively be treated with concurrent radiochemotherapy. In metastatic disease, systemic chemotherapy improves survival, quality of life and symptom control. Trastuzumab plus chemotherapy should be used together with first-line chemotherapy in HER2 positive gastric cancer patients. Second- and third-line therapy is now well established. The anti-VEGFR2 antibody Ramucirumab improves survival in second line treatment both as a monotherapy and in combination with paclitaxel and represents a novel treatment option. © Georg Thieme Verlag KG Stuttgart · New York.

  7. Clinical exome sequencing reports: current informatics practice and future opportunities.

    Science.gov (United States)

    Swaminathan, Rajeswari; Huang, Yungui; Astbury, Caroline; Fitzgerald-Butt, Sara; Miller, Katherine; Cole, Justin; Bartlett, Christopher; Lin, Simon

    2017-11-01

    The increased adoption of clinical whole exome sequencing (WES) has improved the diagnostic yield for patients with complex genetic conditions. However, the informatics practice for handling information contained in whole exome reports is still in its infancy, as evidenced by the lack of a common vocabulary within clinical sequencing reports generated across genetic laboratories. Genetic testing results are mostly transmitted using portable document format, which can make secondary analysis and data extraction challenging. This paper reviews a sample of clinical exome reports generated by Clinical Laboratory Improvement Amendments-certified genetic testing laboratories at tertiary-care facilities to assess and identify common data elements. Like structured radiology reports, which enable faster information retrieval and reuse, structuring genetic information within clinical WES reports would help facilitate integration of genetic information into electronic health records and enable retrospective research on the clinical utility of WES. We identify elements listed as mandatory according to practice guidelines but are currently missing from some of the clinical reports, which might help to organize the data when stored within structured databases. We also highlight elements, such as patient consent, that, although they do not appear within any of the current reports, may help in interpreting some of the information within the reports. Integrating genetic and clinical information would assist the adoption of personalized medicine for improved patient care and outcomes. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. 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.

  9. [Current situation of the standardization of acupuncture and moxibustion in Taiwan].

    Science.gov (United States)

    Pan, Li-Jia; Cui, Rui; Zhan, Bi-Yu; Liao, Cai-Yan; Cao, Qi-Hua; Li, Gui-Lan; Guo, Yi

    2012-09-01

    The current situation of the standardization of acupuncture and moxibustion in the Taiwan region is introduced in this paper from the three aspects, named the development state of standard of acupuncture and moxibustion in Taiwan, the implementation of Taiwan district standard and the standardization of acupuncture and moxibustion in Taiwan. At present, the relevant standards of acupuncture and moxibustion in Taiwan just include the standard operation procedure of acupuncture and moxibustion, the reference guideline of the safe operation in the medical service centers of traditional Chinese medicine, and the faculty standard of Chinese medicine hospital, etc. It is concluded that the current situation of the standardization of acupuncture and moxibusiton presented the weak awareness of the standardization of acupuncture and moxibustion in the industry, insufficient enterprise standard, less-quantity of the implemented standards and narrow coverage.

  10. Current and future standards in evaluation of erectile dysfunction

    Directory of Open Access Journals (Sweden)

    Raymond W Pak

    2006-01-01

    Full Text Available Sexual dysfunction and more specifically erectile dysfunction (ED can be a harbinger of serious occult medical conditions. ED can be considered a clinical manifestation of generalized vascular disease and therefore shares similar risk factors: aging, hypertension, diabetes mellitus, hypercholesterolemia and smoking. The initial evaluation of men with ED should be thorough. Studies of normal and abnormal penile tumescence have led to the discovery of many important pathways. The greatest medical advance in the management of male sexual dysfunction since the identification of androgens have been the discoveries that nitric oxide (NO is the primary neuro-modulator of penile smooth muscle relaxation and that oral phosphodiesterase type 5 inhibitors enhance erection quality through the NO mechanism. As a consequence of oral pharmacotherapies, the role of invasive diagnostics has diminished. Most guidelines recommend only history, physical exam and limited laboratory testing prior to instituting oral therapies for ED. In 2006 we still have unanswered questions about ED and these will frame the role of future diagnosis and therapy: can lifestyle changes alone improve erectile function; is ED a marker for the development of atherosclerotic heart disease, do lower urinary tract symptoms of benign prostatic hypertrophy and ED share a common pathway?

  11. 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...

  12. 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.

  13. Mineralized Collagen: Rationale, Current Status, and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Zhi-Ye Qiu

    2015-07-01

    Full Text Available This paper presents a review of the rationale for the in vitro mineralization process, preparation methods, and clinical applications of mineralized collagen. The rationale for natural mineralized collagen and the related mineralization process has been investigated for decades. Based on the understanding of natural mineralized collagen and its formation process, many attempts have been made to prepare biomimetic materials that resemble natural mineralized collagen in both composition and structure. To date, a number of bone substitute materials have been developed based on the principles of mineralized collagen, and some of them have been commercialized and approved by regulatory agencies. The clinical outcomes of mineralized collagen are of significance to advance the evaluation and improvement of related medical device products. Some representative clinical cases have been reported, and there are more clinical applications and long-term follow-ups that currently being performed by many research groups.

  14. 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.

  15. Bimodal Programming: A Survey of Current Clinical Practice.

    Science.gov (United States)

    Siburt, Hannah W; Holmes, Alice E

    2015-06-01

    The purpose of this study was to determine the current clinical practice in approaches to bimodal programming in the United States. To be specific, if clinicians are recommending bimodal stimulation, who programs the hearing aid in the bimodal condition, and what method is used for programming the hearing aid? An 11-question online survey was created and sent via email to a comprehensive list of cochlear implant programming centers in the United States. The survey was sent to 360 recipients. Respondents in this study represented a diverse group of clinical settings (response rate: 26%). Results indicate little agreement about who programs the hearing aids, when they are programmed, and how they are programmed in the bimodal condition. Analysis of small versus large implant centers indicated small centers are less likely to add a device to the contralateral ear. Although a growing number of cochlear implant recipients choose to wear a hearing aid on the contralateral ear, there is inconsistency in the current clinical approach to bimodal programming. These survey results provide evidence of large variability in the current bimodal programming practices and indicate a need for more structured clinical recommendations and programming approaches.

  16. Challenges of implementing fibromyalgia treatment guidelines in current clinical practice.

    Science.gov (United States)

    Arnold, Lesley M; Clauw, Daniel J

    2017-09-01

    The current diagnostic and treatment pathway for patients with fibromyalgia (FM) is lengthy, complex, and characterized by multiple physician visits with an average 2-year wait until diagnosis. It is clear that effective identification and appropriate treatment of FM remain a challenge in current clinical practice. Ideally, FM management involves a multidisciplinary approach with the preferable patient pathway originating in primary care but supported by a range of health care providers, including referral to specialist care when necessary. After the publication of individual clinical studies, high-quality reviews, and meta-analyses, recently published FM treatment guidelines have transitioned from an expert consensus to an evidence-based approach. Evidence-based guidelines provide a framework for ensuring early diagnosis and timely adoption of appropriate treatment. However, for successful outcomes, FM treatments must adopt a more holistic approach, which addresses more than just pain. Impact on the associated symptoms of fatigue and cognitive problems, sleep and mood disturbances, and lowered functional status are also important in judging the success of FM therapy. Recently published guidelines recommend the adoption of a symptom-based approach to guide pharmacologic treatment. Emerging treatment options for FM may be best differentiated on the basis of their effect on comorbid symptoms that are often associated with pain (e.g. sleep disturbance, mood, fatigue). The current review discusses the most recently published Canadian guidelines and the implications of the recent European League Against Rheumatism (EULAR) recommendations, with a focus on the challenges of implementing these guidelines in current clinical practice.

  17. 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.

  18. Application of radiotherapy for hepatocellular carcinoma in current clinical practice guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Rim, Chai Hong; Seong, Jin Sil [Dept. of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2016-09-15

    In oncologic practice, treatment guidelines provide appropriate treatment strategies based on evidence. Currently, many guidelines are used, including those of the European Association for the Study of the Liver and European Organization for Research and Treatment of Cancer (EASL-EORTC), National Comprehensive Cancer Network (NCCN), Asia-Pacific Primary Liver Cancer Expert (APPLE), and Korean Liver Cancer Study Group and National Cancer Centre (KLCSG-NCC). Although radiotherapy is commonly used in clinical practice, some guidelines do not accept it as a standard treatment modality. In this review, we will investigate the clinical practice guidelines currently used, and discuss the application of radiotherapy.

  19. Application of radiotherapy for hepatocellular carcinoma in current clinical practice guidelines

    International Nuclear Information System (INIS)

    Rim, Chai Hong; Seong, Jin Sil

    2016-01-01

    In oncologic practice, treatment guidelines provide appropriate treatment strategies based on evidence. Currently, many guidelines are used, including those of the European Association for the Study of the Liver and European Organization for Research and Treatment of Cancer (EASL-EORTC), National Comprehensive Cancer Network (NCCN), Asia-Pacific Primary Liver Cancer Expert (APPLE), and Korean Liver Cancer Study Group and National Cancer Centre (KLCSG-NCC). Although radiotherapy is commonly used in clinical practice, some guidelines do not accept it as a standard treatment modality. In this review, we will investigate the clinical practice guidelines currently used, and discuss the application of radiotherapy

  20. Is current clinical practice modified about intraoperative breast irradiation?

    Science.gov (United States)

    Massa, Michela; Franchelli, Simonetta; Panizza, Renzo; Massa, Tiberio

    2016-04-01

    After the results obtained in the two randomized clinical trial, the ELIOT trial and the TARGIT-A trial, a heated debate is going on concerning the question of applying intraoperative radiotherapy (IORT) instead of postoperative whole breast irradiation (WBI) after breast conservative treatment. Currently, many centers are applying the IORT following the strict selection criteria dictated by the working groups American Society for Radiation Oncology (ASTRO) and Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) and monitoring the oncological outcome together with radiation toxicity on breast tissue. The clinical experience of the Geneva University Hospital regarding the use of the Intrabeam system is evaluated and compared with current evidences.

  1. Rectocele repair using biomaterial augmentation: current documentation and clinical experience.

    Science.gov (United States)

    Altman, Daniel; Mellgren, Anders; Zetterström, Jan

    2005-11-01

    Although the etiology of rectocele remains debated, surgical innovations are currently promoted to improve anatomic outcome while avoiding dyspareunia and alleviating rectal emptying difficulties following rectocele surgery. Use of biomaterials in rectocele repair has become widespread in a short time, but the clinical documentation of their effectiveness and complications is limited. Medline and the Cochrane database were searched electronically from 1964 to May 2005 using the Pubmed and Ovid search engines. All English language publications including any of the search terms "rectocele," "implant," "mesh," "biomaterial," "prolapse," "synthetical," "pelvic floor," "biological," and "compatibility" were reviewed. This review outlines the basic principles for use of biomaterials in pelvic reconstructive surgery and provides a condensation of peer-reviewed articles describing clinical use of biomaterials in rectocele surgery. Historical and new concepts in rectocele surgery are discussed. Factors of importance for human in vivo biomaterial compatibility are presented together with current knowledge from clinical studies. Potential risks and problems associated with the use of biomaterials in rectocele and pelvic reconstructive surgery in general are described. Although use of biomaterials in rectocele and other pelvic organ prolapse surgery offers exciting possibilities, it raises treatment costs and may be associated with unknown and potentially severe complications at short and long term. Clinical benefits are currently unknown and need to be proven in clinical studies. Obstetricians & Gynecologists, Family Physicians After completion of this article, the reader should be able to explain that the objective of surgical treatment is to improve anatomic outcome and alleviate rectal emptying difficulties, describe the efficacy of biomaterials in rectocele repair, and summarize the potential risks and problems associated with use of biomaterials in rectocele and pelvic

  2. Treatment of sepsis: current status of clinical immunotherapy.

    LENUS (Irish Health Repository)

    O'Callaghan, A

    2012-02-03

    While antibiotics address the root cause of sepsis--that of pathogen infection--they fail to provide an adequate cure for the condition. Currently, 30% to 50% of septic patients die, and this figure is likely to increase in line with the proliferation of multi-drug resistant bacteria. With an increased understanding of the immune response, it has been proposed that modulation of this defence mechanism offers the best hope of cure. Many entry-points in the immune system have been identified and targeted therapies have been developed,but why are these not in routine clinical practice? This review examines the latest evidence for the use of immuno-modulating drugs, obtained from human clinical trials. We discuss cytokine-based therapies, steroids and anti-coagulants. Finally, consideration is given as to why successful therapies in the laboratory, and in vivo models, do not automatically translate into clinical benefit

  3. Design and evaluation of a 10-mA DC current reference standard

    CERN Document Server

    Fernqvist, G; Pickering, J; Power, F

    2003-01-01

    A new DC current reference standard has been developed for high- current power converter calibration in the large hadron collider (LHC) project at the European Organization for Nuclear Research (CERN). This standard provides a near ideal 10-mA DC current with long-term drift of one part in 10/sup 6/ per year. The paper describes the requirements and the detailed design and evaluation of the unit. Since similar 10-V standards are commercially available, the paper concentrates on the unique current output capability of this device. (4 refs).

  4. Evaluation of a new 10 mA DC current reference standard

    CERN Document Server

    Fernqvist, G; Power, F

    2002-01-01

    A new DC current reference standard has been developed as a component in a Current calibration hierarchy in the LHC project at CERN. The standard provides 10 mA DC current with an accuracy less than 0.5 ppm, drift less than 2 ppm/year and compliance error less than 0.1 ppm for 0-10 V. The paper gives the results from two years evaluation of a series of 5 units.

  5. A programmable quantum current standard from the Josephson and the quantum Hall effects

    Energy Technology Data Exchange (ETDEWEB)

    Poirier, W., E-mail: wilfrid.poirier@lne.fr; Lafont, F.; Djordjevic, S.; Schopfer, F.; Devoille, L. [Quantum metrology group, Laboratoire National de métrologie et d' Essais, 29 avenue Roger Hennequin, 78197 Trappes (France)

    2014-01-28

    We propose a way to realize a programmable quantum current standard (PQCS) from the Josephson voltage standard and the quantum Hall resistance standard (QHR) exploiting the multiple connection technique provided by the quantum Hall effect (QHE) and the exactness of the cryogenic current comparator. The PQCS could lead to breakthroughs in electrical metrology like the realization of a programmable quantum current source, a quantum ampere-meter, and a simplified closure of the quantum metrological triangle. Moreover, very accurate universality tests of the QHE could be performed by comparing PQCS based on different QHRs.

  6. 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.

  7. Current status of verification practices in clinical biochemistry in Spain.

    Science.gov (United States)

    Gómez-Rioja, Rubén; Alvarez, Virtudes; Ventura, Montserrat; Alsina, M Jesús; Barba, Núria; Cortés, Mariano; Llopis, María Antonia; Martínez, Cecilia; Ibarz, Mercè

    2013-09-01

    Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification. Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase). Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size. A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.

  8. Current Status of the IAU Working Group for Numerical Standards of Fundamental Astronomy

    National Research Council Canada - National Science Library

    Luzum, B; Capitaine, N; Fienga, A; Folkner, W; Fukushima, T; Hilton, J; Hohenkerk, C; Krasinsky, G; Petit, G; Pitjeva, E; Soffel, M; Wallace, P

    2007-01-01

    ...) for Numerical Standards of Fundamental Astronomy. The goal of the WG are to update "IAU Current Best Estimates" conforming with IAU Resolutions, the International Earth Rotation and Reference System Service (IERS...

  9. Evaluation of uncertainties in femtoampere current measurement for the number concentration standard of aerosol nanoparticles

    International Nuclear Information System (INIS)

    Sakurai, Hiromu; Ehara, Kensei

    2011-01-01

    We evaluated uncertainties in current measurement by the electrometer at the current level on the order of femtoamperes. The electrometer was the one used in the Faraday-cup aerosol electrometer of the Japanese national standard for number concentration of aerosol nanoparticles in which the accuracy of the absolute current is not required, but the net current which is obtained as the difference in currents under two different conditions must be measured accurately. The evaluation was done experimentally at the current level of 20 fA, which was much smaller than the intervals between the electrometer's calibration points at +1, +0.5, −0.5 and −1 pA. The slope of the response curve for the relationship between the 'true' and measured current, which is crucial in the above measurement, was evaluated locally at many different points within the ±1 pA range for deviation from the slope determined by a linear regression of the calibration data. The sum of the current induced by a flow of charged particles and a bias current from a current-source instrument was measured by the electrometer while the particle current was toggled on and off. The net particle current was obtained as the difference in the measured currents between the toggling, while at the same time the current was estimated from the particle concentration read by a condensation particle counter. The local slope was calculated as the ratio of the measured to estimated currents at each bias current setting. The standard deviation of the local slope values observed at varied bias currents was about 0.003, which was calculated by analysis of variance (ANOVA) for the treatment of the bias current. The combined standard uncertainty of the slope, which was calculated from the uncertainty of the slope by linear regression and the variability of the slope, was calculated to be about 0.004

  10. Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play.

    Science.gov (United States)

    Savitz, J B; Rauch, S L; Drevets, W C

    2013-05-01

    In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders.

  11. Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play

    Science.gov (United States)

    Savitz, J B; Rauch, S L; Drevets, W C

    2013-01-01

    In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders. PMID:23546169

  12. Comparison of the Standard of Air Leakage in Current Metal Duct Systems in the World

    Science.gov (United States)

    Di, Yuhui; Wang, Jiqian; Feng, Lu; Li, Xingwu; Hu, Chunlin; Shi, Junshe; Xu, Qingsong; Qiao, Leilei

    2018-01-01

    Based on the requirements of air leakage of metal ducts in Chinese design standards, technical measures and construction standards, this paper compares the development history, the classification of air pressure levels and the air tightness levels of air leakage standards of current Chinese and international metal ducts, sums up the differences, finds shortage by investigating the design and construction status and access to information, and makes recommendations, hoping to help the majority of engineering and technical personnel.

  13. Risk assessment based on current release standards for radioactive surface contamination

    International Nuclear Information System (INIS)

    Chen, S.Y.

    1993-09-01

    Standards for uncontrolled releases of radioactive surface contamination have been in existence in the United States for about two decades. Such standards have been issued by various agencies, including the US Department of Energy. This paper reviews the technical basis of published standards, identifies areas in need of revision, provides risk interpretations based on current technical knowledge and the regulatory environment, and offers suggestions for improvements

  14. Biomarkers in prostate cancer - Current clinical utility and future perspectives.

    Science.gov (United States)

    Kretschmer, Alexander; Tilki, Derya

    2017-12-01

    Current tendencies in the treatment course of prostate cancer patients increase the need for reliable biomarkers that help in decision-making in a challenging clinical setting. Within the last decade, several novel biomarkers have been introduced. In the following comprehensive review article, we focus on diagnostic (PHI ® , 4K score, SelectMDx ® , ConfirmMDx ® , PCA3, MiPS, ExoDX ® , mpMRI) and prognostic (OncotypeDX GPS ® , Prolaris ® , ProMark ® , DNA-ploidy, Decipher ® ) biomarkers that are in widespread clinical use and are supported by evidence. Hereby, we focus on multiple clinical situations in which innovative biomarkers may guide decision-making in prostate cancer therapy. In addition, we describe novel liquid biopsy approaches (circulating tumor cells, cell-free DNA) that have been described as predictive biomarkers in metastatic castration-resistant prostate cancer and might support an individual patient-centred oncological approach in the nearer future. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Perceptions of dry eye disease management in current clinical practice.

    Science.gov (United States)

    Williamson, Jennifer F; Huynh, Kyle; Weaver, Mark A; Davis, Richard M

    2014-03-01

    To assess the perceptions of eye care providers regarding the clinical management of dry eye. Invitations to complete a 17-question online survey were mailed to 400 members of the North Carolina Ophthalmology and Optometry Associations including community optometrists, comprehensive ophthalmologists, and cornea specialists. The survey was completed by 100 eye care providers (25% response rate). Providers reported burning (46.5%) as the most frequent symptom described by patients, followed by foreign body sensation (30.3%) and tearing (17.2%). Most respondents (80.8%) listed artificial tears as the recommended first-line treatment, even though providers reported high failure rates for both artificial tears and cyclosporine A (Restasis). Rheumatoid arthritis, Sjögren syndrome, affective disorders such as anxiety and depression, history of photorefractive surgery, smoking, and thyroid disease were acknowledged as common comorbid conditions. The survey provided an informative snapshot into the preferences of eye care providers concerning the diagnosis and management of dry eye disease. Overall, burning was the most common symptom reported by patients. Providers relied more on patient history in guiding their clinical decisions than objective signs. The survey underscores the incongruence when comparing subjective symptoms with objective signs, thereby highlighting the urgent need for the development of reliable metrics to better quantify dry eye symptoms and also the development of a more sensitive and specific test that can be used as the gold standard to diagnose dry eye.

  16. 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.

  17. 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

  18. Endoscopic Ultrasound Elastography: Current Clinical Use in Pancreas.

    Science.gov (United States)

    Mondal, Utpal; Henkes, Nichole; Patel, Sandeep; Rosenkranz, Laura

    2016-08-01

    Elastography is a newer technique for the assessment of tissue elasticity using ultrasound. Cancerous tissue is known to be stiffer (hence, less elastic) than corresponding healthy tissue, and as a result, could be identified in an elasticity-based imaging. Ultrasound elastography has been used in the breast, thyroid, and cervix to differentiate malignant from benign neoplasms and to guide or avoid unnecessary biopsies. In the liver, elastography has enabled a noninvasive and reliable estimate of fibrosis. Endoscopic ultrasound has become a robust diagnostic and therapeutic tool for the management of pancreatic diseases. The addition of elastography to endoscopic ultrasound enabled further characterization of pancreas lesions, and several European and Asian studies have reported encouraging results. The current clinical role of endoscopic ultrasound elastography in the management of pancreas disorders and related literature are reviewed.

  19. 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.

  20. Figures in clinical trial reports: current practice & scope for improvement.

    Science.gov (United States)

    Pocock, Stuart J; Travison, Thomas G; Wruck, Lisa M

    2007-11-19

    Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses) and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

  1. Figures in clinical trial reports: current practice & scope for improvement

    Directory of Open Access Journals (Sweden)

    Travison Thomas G

    2007-11-01

    Full Text Available Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Results Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. Conclusion There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

  2. Neoplastic stem cells: current concepts and clinical perspectives.

    Science.gov (United States)

    Schulenburg, Axel; Brämswig, Kira; Herrmann, Harald; Karlic, Heidrun; Mirkina, Irina; Hubmann, Rainer; Laffer, Sylvia; Marian, Brigitte; Shehata, Medhat; Krepler, Clemens; Pehamberger, Hubert; Grunt, Thomas; Jäger, Ulrich; Zielinski, Christoph C; Valent, Peter

    2010-11-01

    Neoplastic stem cells have initially been characterized in myeloid leukemias where NOD/SCID mouse-repopulating progenitors supposedly reside within a CD34+/Lin- subset of the malignant clone. These progenitors are considered to be self-renewing cells responsible for the in vivo long-term growth of neoplastic cells in leukemic patients. Therefore, these cells represent an attractive target of therapy. In some lymphoid leukemias, NOD/SCID mouse-repopulating cells were also reported to reside within the CD34+/Lin- subfraction of the clone. More recently, several attempts have been made to transfer the cancer stem cell concept to solid tumors and other non-hematopoietic neoplasms. In several of these tumors, the cell surface antigens AC133 (CD133) and CD44 are considered to indicate the potential of a cell to initiate permanent tumor formation in vivo. However, several questions concerning the phenotype, self-renewal capacity, stroma-dependence, and other properties of cancer- or leukemia-initiating cells remain to be solved. The current article provides a summary of our current knowledge on neoplastic (cancer) stem cells, with special emphasis on clinical implications and therapeutic options as well as a discussion about conceptual and technical limitations. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  3. Cognition in epilepsy: current clinical issues of interest.

    Science.gov (United States)

    Witt, Juri-Alexander; Helmstaedter, Christoph

    2017-04-01

    This review provides an update and summary of recent neuropsychological findings in epilepsy focusing on three major clinical topics among the many developments in the field. We will critically outline the current state with regard to cognition in new-onset epilepsies, social cognition in epilepsy, and the long-term outcome of epilepsy surgery and the cognitive outcomes of superselective surgical procedures. Current studies indicate that neuropsychological impairments are prevalent already at the onset of epilepsy and even before, social cognition (i.e., emotion recognition and theory of mind) is impaired in different epilepsy populations, the long-term outcome of epilepsy surgery is mostly characterized by a stable or even improved cognitive status, and superselective epilepsy surgeries are associated with a promising neuropsychological outcome. The high prevalence of cognitive deficits around epilepsy onset challenges the assumption that epilepsy is the major cause of cognitive problems and calls for early neuropsychological diagnostics. Social cognition seems to be a relevant domain that is not yet routinely considered in epilepsy. The cognitive long-term outcome of epilepsy surgery is mostly positive. Stereotactic thermocoagulation and gamma knife surgery appear to be cognitively safe procedures.

  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. The use of psychometrists in clinical neuropsychology: history, current status, and future directions.

    Science.gov (United States)

    Malek-Ahmadi, Michael; Erickson, Tom; Puente, Antonio E; Pliskin, Neil; Rock, Rachel

    2012-01-01

    In recent years, the National Academy of Neuropsychology and other professional neuropsychological organizations have published a number of articles and position papers regarding the use, education, and training of psychometrists ("technicians"). Although these documents provide guidelines for the suggested qualifications and training procedures of psychometrists, none make any mention of the need for a standardized credentialing process, which is commonly required of technicians in similar fields, especially in medical settings. Given the recent changes in current procedural Terminology codes used to bill for neuropsychological services and the interpretation of legislation disallowing the use of psychometrists in New York, the need for a standard credential for psychometrists is apparent. This article will review the history and current use of psychometrists in clinical neuropsychology and highlight the need and rationale for the credentialing of psychometrists.

  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. Transresistance calibrations and temperature dependence evaluation of a magnetic bridge current sensor with shunt standards

    International Nuclear Information System (INIS)

    Yamada, T; Kon, S; Tadatsu, T

    2011-01-01

    This paper deals with a magnetic bridge current sensor for dc current measurements and a calibration system developed for the current sensor. The current sensor forms a magnetic bridge structure with a magnetic fluid core. The calibration system has been developed by using standard shunts for a test current range of 1 mA to 100 A and establishing a comparison method with a switching/sampling system. In the calibration system, the transresistances of the current sensor are measured and the uncertainties of the system are estimated for the input test current range. Also, the temperature dependence on the transresistances is investigated for temperatures ranging from −40 to 100 °C

  8. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  9. Constraints on Non-Standard Contributions to the Charged-Current Interactions

    CERN Document Server

    Hagiwara, K; Hagiwara, Kaoru; Matsumoto, Seiji

    1998-01-01

    The success of the quantum level predictions of the Standard Model on the $Z$ boson properties, on $\\mw$ and on $\\mt$, which makes use of the muon lifetime as an input, implies a stringent constraint on new physics contributions to the $V-A$ charged-current interactions among leptons. Observed unitarity of the CKM matrix elements then implies constraints on non-standard contributions to the lepton-quark charged-current interactions. By using the recent electroweak data as inputs, we find the 95% CL limits for the corresponding contact interactions: $\\Lambda_{CC,+}^{\\ell\\ell}>7.5$ TeV and the lepton-quark contact interactions.

  10. A New International Standard for "Actions from Waves and Currents on Coastal Structures"

    DEFF Research Database (Denmark)

    Tørum, Alf; Burcharth, Hans F.; Goda, Yoshimi

    2007-01-01

    The International Organization for Standardization (ISO) is going to issue a new standard concerning "Actions from Waves and Currents on Coastal Structures," which becomes the first international standard in coastal engineering. It is composed of a normative part (29 pages), an informative part (80...... pages) and Bibliography ( 17 pages). The normative part describes what is considered as the norm of the matters in concern, while the informative part provides the information on recommended practice. The paper introduces the main points of the normative part and discusses the influence of the new...

  11. 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

  12. 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.

  13. Clinical proteomics: Current status, challenges, and future perspectives

    Directory of Open Access Journals (Sweden)

    Shyh-Horng Chiou

    2011-01-01

    Full Text Available This account will give an overview and evaluation of the current advances in mass spectrometry (MS-based proteomics platforms and technology. A general review of some background information concerning the application of these methods in the characterization of molecular sizes and related protein expression profiles associated with different types of cells under varied experimental conditions will be presented. It is intended to provide a concise and succinct overview to those clinical researchers first exposed to this foremost powerful methodology in modern life sciences of postgenomic era. Proteomic characterization using highly sophisticated and expensive instrumentation of MS has been used to characterize biological samples of complex protein mixtures with vastly different protein structure and composition. These systems are then used to highlight the versatility and potential of the MS-based proteomic strategies for facilitating protein expression analysis of various disease-related organisms or tissues of interest. Major MS-based strategies reviewed herein include (1 matrix-assisted laser desorption ionization-MS and electron-spray ionization proteomics; (2 one-dimensional or two-dimensional gel-based proteomics; (3 gel-free shotgun proteomics in conjunction with liquid chromatography/tandem MS; (4 Multiple reaction monitoring coupled tandem MS quantitative proteomics and; (5 Phosphoproteomics based on immobilized metal affinity chromatography and liquid chromatography-MS/MS.

  14. 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

  15. HYPOPARATHYROIDISM: ETIOLOGY, CLINICAL MANIFESTATION, CURRENT DIAGNOSTICS AND TREATMENT

    Directory of Open Access Journals (Sweden)

    N. G. Mokrysheva

    2016-01-01

    Full Text Available Parathyroid hormone (PTH is the main regulator of calcium and phosphorus metabolism. PTH deficiency or tissue resistance to its effects results in hypoparathyroidism characterized by low serum calcium and elevated serum phosphate levels. The most common is post-operative hypoparathyroidism caused by an inadvertent damage or removal of the parathyroid glands, deterioration of blood supply to the neck region, most often during thyroid surgery. The second common form of the disease is the autoimmune one related with immune destruction of parathyroid cells. Less frequent causes of hypoparathyroidism include a variety of genetic syndromes, mitochondrial genome defects, and hypomagnesemia. The main signs and symptoms of hypoparathyroidism are related to hypocalcaemia and hyperphosphatemia land result in increased neuromuscular irritability and general autonomic reactivity, with finger and toe tingling, muscle cramps, tonic seizures, laryngo- and bronchospasm, and neurosis. These symptoms are closely associated with serum calcium levels; their severity depends on the degree of hypocalcaemia. Laboratory parameters confirming the diagnosis of hypoparathyroidism are hypocalcaemia, hyperphosphatemia, and reduced serum PTH. Treatment of hypoparathyroidism involves management of hypocalcaemic crisis and maintenance therapy. Acute hypocalcaemia, a  potentially life-threatening condition, is treated as an emergency with intravenous calcium combined with oral calcium and active vitamin D. Standard chronic treatment for hypoparathyroidism is based on oral calcium and active metabolites of vitamin  D / vitamin  D analogs and is aimed at the balance between optimal low-normal serum calcium concentrations and normocalciuria. Worsening hypercalciuria is often underestimated by specialists, although it can cause severe renal problems, such as nephrocalcinosis and neprolithiasis. Hypoparathyroidism is one of the few endocrine deficiencies for which replacement

  16. 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.

  17. 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.

  18. Current referral practices and adolescent transition to Adult clinic ...

    African Journals Online (AJOL)

    2016-02-02

    Feb 2, 2016 ... of adolescent transition from child to adult care ... from paediatric to adult clinics. Adolescent ... The fate of older adolescent patients in paediatric clinics is either one of ..... fer depends on physical and psychological factors and.

  19. Study of the leakage current of clinical dosimeters for teletherapy

    International Nuclear Information System (INIS)

    Damatto, Willian B.; Santos, Gelson P.; Potiens, Maria da Penha A.; Caldas, Linda V.E.; Vivolo, Vitor

    2009-01-01

    This work demonstrates the importance of quality control of clinical dosemeters and therefore the equipment for radiotherapy treatment, exhibiting the necessary care related to answers and sensibilities and the possible defects of the clinical assembly

  20. Evaluation of 2 new optical biometry devices and comparison with the current gold standard biometer.

    Science.gov (United States)

    Chen, Yen-An; Hirnschall, Nino; Findl, Oliver

    2011-03-01

    To compare 2 new optical biometry devices with the present gold standard biometer. Vienna Institute for Research in Ocular Surgery, Department of Ophthalmology, Hanusch Hospital, Vienna, Austria. Evaluation of diagnostic test or technology. In patients scheduled for cataract surgery, measurements performed with the current gold standard optical biometer (IOLMaster) were compared with those of 2 new optical biometers, the Lenstar LS 900 (optical low-coherence reflectometry [OLCR] device; substudy 1) and the IOLMaster 500 (partial coherence interferometry [PCI] device; substudy 2). The duration of patient data entry and of the actual measurement process and the time from intraocular lens power calculation to printout were calculated. The mean difference in axial length measurements was 0.01 mm ± 0.05 (SD) between the gold standard device and the new OLCR device and 0.01 ± 0.02 mm between the gold standard device and the new PCI device (P=.12 and P gold standard device (mean difference 209 ± 127 seconds), and measurements with the gold standard device took significantly longer than with the new PCI device (mean difference 82 ± 46 seconds) (both P gold standard device. Measurements with the new OLCR device took twice as long as those with the gold standard device. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  1. Current status on performance of CT colonography and clinical indications

    International Nuclear Information System (INIS)

    Laghi, Andrea; Rengo, Marco; Graser, Anno; Iafrate, Franco

    2013-01-01

    CT colonography (CTC) is a robust and reliable imaging test of the colon. Accuracy for the detection of colorectal cancer (CRC) is as high as conventional colonoscopy (CC). Identification of polyp is size dependent, with large lesions (≥10 mm) accurately detected and small lesions (6–9 mm) identified with moderate to good sensitivity. Recent studies show good sensitivity for the identification of nonpolypoid (flat) lesions as well. Current CTC indications include the evaluation of patients who had undergone a previous incomplete CC or those who are unfit for CC (elderly and frail individuals, patients with underlying severe clinical conditions, or with contraindication to sedation). CTC can also be efficiently used in the assessment of diverticular disease (excluding patients with acute diverticulitis, where the exam should be postponed), before laparoscopic surgery for CRC (to have an accurate localization of the lesion), in the evaluation of colonic involvement in the case of deep pelvic endometriosis (replacing barium enema). CTC is also a safe procedure in patients with colostomy. For CRC screening, CTC should be considered an opportunistic screening test (not available for population, or mass screening) to be offered to asymptomatic average-risk individuals, of both genders, starting at age 50. The use in individuals with positive family history should be discussed with the patient first. Absolute contraindication is to propose CTC for surveillance of genetic syndromes and chronic inflammatory bowel diseases (in particular, ulcerative colitis). The use of CTC in the follow-up after surgery for CRC is achieving interesting evidences despite the fact that literature data are still relatively weak in terms of numerosity of the studied populations. In patients who underwent previous polypectomy CTC cannot be recommended as first test because debate is still open. It is desirable that in the future CTC would be the first-line and only diagnostic test for

  2. Current status on performance of CT colonography and clinical indications

    Energy Technology Data Exchange (ETDEWEB)

    Laghi, Andrea, E-mail: andrea.laghi@uniroma1.it [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Polo Pontino, I.C.O.T. Hospital, Via Franco Faggiana 43, 04100 Latina (Italy); Rengo, Marco [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Polo Pontino, I.C.O.T. Hospital, Via Franco Faggiana 43, 04100 Latina (Italy); Graser, Anno [InstitutfürKlinische Radiologie, Klinikumder Ludwig-Maximilians-Universität München, Campus Großhadern, Marchioninistr. 15, 81377 München (Germany); Iafrate, Franco [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Policlinico Umberto I, Viale Regina Elena 324, 00161 Rome (Italy)

    2013-08-15

    CT colonography (CTC) is a robust and reliable imaging test of the colon. Accuracy for the detection of colorectal cancer (CRC) is as high as conventional colonoscopy (CC). Identification of polyp is size dependent, with large lesions (≥10 mm) accurately detected and small lesions (6–9 mm) identified with moderate to good sensitivity. Recent studies show good sensitivity for the identification of nonpolypoid (flat) lesions as well. Current CTC indications include the evaluation of patients who had undergone a previous incomplete CC or those who are unfit for CC (elderly and frail individuals, patients with underlying severe clinical conditions, or with contraindication to sedation). CTC can also be efficiently used in the assessment of diverticular disease (excluding patients with acute diverticulitis, where the exam should be postponed), before laparoscopic surgery for CRC (to have an accurate localization of the lesion), in the evaluation of colonic involvement in the case of deep pelvic endometriosis (replacing barium enema). CTC is also a safe procedure in patients with colostomy. For CRC screening, CTC should be considered an opportunistic screening test (not available for population, or mass screening) to be offered to asymptomatic average-risk individuals, of both genders, starting at age 50. The use in individuals with positive family history should be discussed with the patient first. Absolute contraindication is to propose CTC for surveillance of genetic syndromes and chronic inflammatory bowel diseases (in particular, ulcerative colitis). The use of CTC in the follow-up after surgery for CRC is achieving interesting evidences despite the fact that literature data are still relatively weak in terms of numerosity of the studied populations. In patients who underwent previous polypectomy CTC cannot be recommended as first test because debate is still open. It is desirable that in the future CTC would be the first-line and only diagnostic test for

  3. Current standards of neuropsychological assessment in epilepsy surgery centers across Europe.

    Science.gov (United States)

    Vogt, Viola Lara; Äikiä, Marja; Del Barrio, Antonio; Boon, Paul; Borbély, Csaba; Bran, Ema; Braun, Kees; Carette, Evelien; Clark, Maria; Cross, Judith Helen; Dimova, Petia; Fabo, Daniel; Foroglou, Nikolaos; Francione, Stefano; Gersamia, Anna; Gil-Nagel, Antonio; Guekht, Alla; Harrison, Sue; Hecimovic, Hrvoje; Heminghyt, Einar; Hirsch, Edouard; Javurkova, Alena; Kälviäinen, Reetta; Kavan, Nicole; Kelemen, Anna; Kimiskidis, Vasilios K; Kirschner, Margarita; Kleitz, Catherine; Kobulashvili, Teia; Kosmidis, Mary H; Kurtish, Selin Yagci; Lesourd, Mathieu; Ljunggren, Sofia; Lossius, Morten Ingvar; Malmgren, Kristina; Mameniskiené, Ruta; Martin-Sanfilippo, Patricia; Marusic, Petr; Miatton, Marijke; Özkara, Çiğdem; Pelle, Federica; Rubboli, Guido; Rudebeck, Sarah; Ryvlin, Philippe; van Schooneveld, Monique; Schmid, Elisabeth; Schmidt, Pia-Magdalena; Seeck, Margitta; Steinhoff, Bernhard J; Shavel-Jessop, Sara; Tarta-Arsene, Oana; Trinka, Eugen; Viggedal, Gerd; Wendling, Anne-Sophie; Witt, Juri-Alexander; Helmstaedter, Christoph

    2017-03-01

    We explored the current practice with respect to the neuropsychological assessment of surgical epilepsy patients in European epilepsy centers, with the aim of harmonizing and establishing common standards. Twenty-six epilepsy centers and members of "E-PILEPSY" (a European pilot network of reference centers in refractory epilepsy and epilepsy surgery), were asked to report the status of neuropsychological assessment in adults and children via two different surveys. There was a consensus among these centers regarding the role of neuropsychology in the presurgical workup. Strong agreement was found on indications (localization, epileptic dysfunctions, adverse drugs effects, and postoperative monitoring) and the domains to be evaluated (memory, attention, executive functions, language, visuospatial skills, intelligence, depression, anxiety, and quality of life). Although 186 different tests are in use throughout these European centers, a core group of tests reflecting a moderate level of agreement could be discerned. Variability exists with regard to indications, protocols, and paradigms for the assessment of hemispheric language dominance. For the tests in use, little published evidence of clinical validity in epilepsy was provided. Participants in the survey reported a need for improvement concerning the validity of the tests, tools for the assessment of everyday functioning and accelerated forgetting, national norms, and test co-normalization. Based on the present survey, we documented a consensus regarding the indications and principles of neuropsychological testing. Despite the variety of tests in use, the survey indicated that there may be a core set of tests chosen based on experience, as well as on published evidence. By combining these findings with the results of an ongoing systematic literature review, we aim for a battery that can be recommended for the use across epilepsy surgical centers in Europe. Wiley Periodicals, Inc. © 2017 International League

  4. Clinical data management: Current status, challenges, and future directions from industry perspectives

    Directory of Open Access Journals (Sweden)

    Zhengwu Lu

    2010-06-01

    Full Text Available Zhengwu Lu1, Jing Su21Smith Hanley Consulting, Houston, Texas; 2Department of Chemical Engineering, University of Massachusetts, Amherst, MA, USAAbstract: To maintain a competitive position, the biopharmaceutical industry has been facing the challenge of increasing productivity both internally and externally. As the product of the clinical development process, clinical data are recognized to be the key corporate asset and provide critical evidence of a medicine’s efficacy and safety and of its potential economic value to the market. It is also well recognized that using effective technology-enabled methods to manage clinical data can enhance the speed with which the drug is developed and commercialized, hence enhancing the competitive advantage. The effective use of data-capture tools may ensure that high-quality data are available for early review and rapid decision-making. A well-designed, protocol-driven, standardized, site workflow-oriented and documented database, populated via efficient data feed mechanisms, will ensure regulatory and commercial questions receive rapid responses. When information from a sponsor’s clinical database or data warehouse develops into corporate knowledge, the value of the medicine can be realized. Moreover, regulators, payer groups, patients, activist groups, patient advocacy groups, and employers are becoming more educated consumers of medicine, requiring monetary value and quality, and seeking out up-todate medical information supplied by biopharmaceutical companies. All these developments in the current biopharmaceutical arena demand that clinical data management (CDM is at the forefront, leading change, influencing direction, and providing objective evidence. Sustaining an integrated database or data repository for initial product registration and subsequent postmarketing uses is a long-term process to maximize return on investment for organizations. CDM should be the owner of driving clinical data

  5. Electromagnetic field standards in Central and Eastern European countries: current state and stipulations for international harmonization.

    Science.gov (United States)

    Gajsek, P; Pakhomov, A G; Klauenberg, B J

    2002-04-01

    Electromagnetic field standards in the West are based on well-established acute biological effects that could be considered as signaling a potentially adverse health effect. The specific absorption rate, which is proportional to the tissue heating (thermal effects), represents the basic restriction of exposure to Radio-Frequency (RF) fields. On the other hand, Eastern European standards are designed to protect from potential non-thermal effects that might be caused by chronic exposure to very low intensities, where a so-called "power load" (a product of field intensity and duration of exposure) represents the basic limitation. Thus, electromagnetic field standards in Eastern European countries differ considerably from those which are proposed by the International Commission of Non-ionizing Radiation Protection and the Standards Coordinating Committee 28 of the Institute of Electrical and Electronics Engineers, Inc. In the present paper, the strategies for development of exposure limit values in electromagnetic fields standards currently in force in Eastern and Central European countries are discussed. Some differences as well as similarities of the national health and safety standards and the main obstacles to harmonization of these standards with those being established by Western national and international organizations and agencies are presented.

  6. A survey of current and anticipated use of standard and specialist equipment by UK optometrists.

    Science.gov (United States)

    Dabasia, Priya L; Edgar, David F; Garway-Heath, David F; Lawrenson, John G

    2014-09-01

    To investigate current and anticipated use of equipment and information technology (IT) in community optometric practice in the UK, and to elicit optometrists' views on adoption of specialist equipment and IT. An anonymous online questionnaire was developed, covering use of standard and specialist diagnostic equipment, and IT. The survey was distributed to a random sample of 1300 UK College of Optometrists members. Four hundred and thirty-two responses were received (response rate = 35%). Enhanced (locally commissioned) or additional/separately contracted services were provided by 73% of respondents. Services included glaucoma repeat measures (30% of respondents), glaucoma referral refinement (22%), fast-track referral for wet age-related macular degeneration (48%), and direct cataract referral (40%). Most respondents (88%) reported using non-contact/pneumo tonometry for intra-ocular pressure measurement, with 81% using Goldmann or Perkins tonometry. The most widely used item of specialist equipment was the fundus camera (74% of respondents). Optical Coherence Tomography (OCT) was used by 15% of respondents, up from 2% in 2007. Notably, 43% of those anticipating purchasing specialist equipment in the next 12 months planned to buy an OCT. 'Paperless' records were used by 39% of respondents, and almost 80% of practices used an electronic patient record/practice management system. Variations in responses between parts of the UK reflect differences in the provision of the General Ophthalmic Services contract or community enhanced services. There was general agreement that specialised equipment enhances clinical care, permits increased involvement in enhanced services, promotes the practice and can be used as a defence in clinico-legal cases, but initial costs and ongoing maintenance can be a financial burden. Respondents generally agreed that IT facilitates administrative flow and secure exchange of health information, and promotes a state-of-the-art practice image

  7. 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.

  8. Current state of standardization in the field of dimensional computed tomography

    International Nuclear Information System (INIS)

    Bartscher, Markus; Härtig, Frank; Neuschaefer-Rube, Ulrich; Sato, Osamu

    2014-01-01

    Industrial x-ray computed tomography (CT) is a well-established non-destructive testing (NDT) technology and has been in use for decades. Moreover, CT has also started to become an important technology for dimensional metrology. But the requirements on dimensional CTs, i.e., on performing coordinate measurements with CT, are different from NDT. For dimensional measurements, the position of interfaces or surfaces is of importance, while this is often less critical in NDT. Standardization plays an important role here as it can create trust in new measurement technologies as is the case for dimensional CT. At the international standardization level, the ISO TC 213 WG 10 is working on specifications for dimensional CT. This paper highlights the demands on international standards in the field of dimensional CT and describes the current developments from the viewpoint of representatives of national and international standardization committees. Key aspects of the discussion are the material influence on the length measurement error E and how E can best be measured. A respective study was performed on hole plates as new reference standards for error testing of length measurements incorporating the material influence. We performed corresponding measurement data analysis and present a further elaborated hole plate design. The authors also comment on different approaches currently pursued and give an outlook on upcoming developments as far as they can be foreseen. (paper)

  9. 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…

  10. submitter Flavour-changing neutral currents making and breaking the standard model

    CERN Document Server

    Archilli, F; Owen, P; Petridis, K A

    2017-01-01

    The standard model of particle physics is our best description yet of fundamental particles and their interactions, but it is known to be incomplete. As yet undiscovered particles and interactions might exist. One of the most powerful ways to search for new particles is by studying processes known as flavour-changing neutral current decays, whereby a quark changes its flavour without altering its electric charge. One example of such a transition is the decay of a beauty quark into a strange quark. Here we review some intriguing anomalies in these decays, which have revealed potential cracks in the standard model—hinting at the existence of new phenomena.

  11. Implementing the psychosocial standards in pediatric cancer: Current staffing and services available.

    Science.gov (United States)

    Scialla, Michele A; Canter, Kimberly S; Chen, Fang Fang; Kolb, E Anders; Sandler, Eric; Wiener, Lori; Kazak, Anne E

    2017-11-01

    Fifteen evidence-based Standards for Psychosocial Care for Children with Cancer and Their Families (Standards) were published in 2015. The Standards cover a broad range of topics and circumstances and require qualified multidisciplinary staff to be implemented. This paper presents data on the availability of psychosocial staff and existing practices at pediatric oncology programs in the United States, providing data that can be used to advocate for expanded services and prepare for implementation of the Standards. Up to three healthcare professionals from 144 programs (72% response rate) participated in an online survey conducted June-December 2016. There were 99 pediatric oncologists with clinical leadership responsibility (Medical Director/Clinical Director), 132 psychosocial leaders in pediatric oncology (Director of Psychosocial Services/Manager/most senior staff member), and 58 administrators in pediatric oncology (Administrative Director/Business Administrator/Director of Operations). The primary outcomes were number and type of psychosocial staff, psychosocial practices, and identified challenges in the delivery of psychosocial care. Over 90% of programs have social workers and child life specialists who provide care to children with cancer and their families. Fewer programs have psychologists (60%), neuropsychologists (31%), or psychiatrists (19%). Challenges in psychosocial care are primarily based on pragmatic issues related to funding and reimbursement. Most participating pediatric oncology programs appear to have at least the basic level of staffing necessary to implement of some of the Standards. However, the lack of a more comprehensive multidisciplinary team is a likely barrier in the implementation of the full set of Standards. © 2017 Wiley Periodicals, Inc.

  12. 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

  13. Analysis of the Current Technical Issues on ASME Code and Standard for Nuclear Mechanical Design(2009)

    International Nuclear Information System (INIS)

    Koo, Gyeong Hoi; Lee, B. S.; Yoo, S. H.

    2009-11-01

    This report describes the analysis on the current revision movement related to the mechanical design issues of the U.S ASME nuclear code and standard. ASME nuclear mechanical design in this report is composed of the nuclear material, primary system, secondary system and high temperature reactor. This report includes the countermeasures based on the ASME Code meeting for current issues of each major field. KAMC(ASME Mirror Committee) of this project is willing to reflect a standpoint of the domestic nuclear industry on ASME nuclear mechanical design and play a technical bridge role for the domestic nuclear industry in ASME Codes application

  14. 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.

  15. Report on the Current Technical Issues on ASME Nuclear Code and Standard

    International Nuclear Information System (INIS)

    Koo, Gyeong Hoi; Lee, B. S.; Yoo, S. H.

    2008-11-01

    This report describes the analysis on the current revision movement related to the mechanical design issues of the U.S ASME nuclear code and standard. ASME nuclear mechanical design in this report is composed of the nuclear material, primary system, secondary system and high temperature reactor. This report includes the countermeasures based on the ASME Code meeting for current issues of each major field. KAMC(ASME Mirror Committee) of this project is willing to reflect a standpoint of the domestic nuclear industry on ASME nuclear mechanical design and play a technical bridge role for the domestic nuclear industry in ASME Codes application

  16. Analysis of the Current Technical Issues on ASME Code and Standard for Nuclear Mechanical Design(2009)

    Energy Technology Data Exchange (ETDEWEB)

    Koo, Gyeong Hoi; Lee, B. S.; Yoo, S. H.

    2009-11-15

    This report describes the analysis on the current revision movement related to the mechanical design issues of the U.S ASME nuclear code and standard. ASME nuclear mechanical design in this report is composed of the nuclear material, primary system, secondary system and high temperature reactor. This report includes the countermeasures based on the ASME Code meeting for current issues of each major field. KAMC(ASME Mirror Committee) of this project is willing to reflect a standpoint of the domestic nuclear industry on ASME nuclear mechanical design and play a technical bridge role for the domestic nuclear industry in ASME Codes application

  17. Standard practice for examination of welds using the alternating current field measurement technique

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2007-01-01

    1.1 This practice describes procedures to be followed during alternating current field measurement examination of welds for baseline and service-induced surface breaking discontinuities. 1.2 This practice is intended for use on welds in any metallic material. 1.3 This practice does not establish weld acceptance criteria. 1.4 The values stated in either inch-pound units or SI units are to be regarded separately as standard. The values stated in each system might not be exact equivalents; therefore, each system shall be used independently of the other. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  18. Measurement of the depth of narrow slotted sections in eddy current reference standards

    Science.gov (United States)

    Kim, Young-Joo; Kim, Young-gil; Ahn, Bongyoung; Yoon, Dong-Jin

    2007-02-01

    The dimensions of the slots in eddy current (EC) reference standards are too narrow to be measured by general depth measurement methods such as the optical (laser) or stylus methods. However, measurement of the dimensions of the machined slots is a prerequisite to using the blocks as references. The present paper suggests a measurement method for the slotted section using an ultrasonic test. The width and depth of the slots measured in our study are roughly 0.1 mm and 0.5 mm, respectively. The time of flight (TOF) of the ultrasonic wave was measured precisely. The ultrasonic velocity in the material of the EC reference standard was calculated with the measured values of the TOF and its thickness. Reflected waves from the tip of the slot and the bottom surface of the EC standard were successfully classified. Using this method we have successfully determined the depth of the slotted section.

  19. Current applications and future directions for the CDISC Operational Data Model standard: A methodological review.

    Science.gov (United States)

    Hume, Sam; Aerts, Jozef; Sarnikar, Surendra; Huser, Vojtech

    2016-04-01

    In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM's limitations and capitalize on its strengths to support new trends in clinical research informatics. A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was "CDISC ODM." The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2686 articles identified, 266 were included in a title level review, resulting in 183 articles. An abstract review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria. As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM's original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record

  20. 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.

  1. 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,…

  2. 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)

  3. ANTIFUNGAL SUSCEPTIBILITY TESTING: CURRENT ROLE FROM THE CLINICAL LABORATORY PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Brunella Posteraro

    2014-04-01

    Full Text Available Despite availability of many antifungal agents, antifungal clinical resistance occurs, perhaps as a result of an infecting organism found to be resistant in vitro to one or more antifungals tested. Thus, antifungal susceptibility testing (AFST results, if timely generated by the clinical microbiology and communicated to clinicians, can aid them in the therapeutic decision making, especially for difficult-to-treat invasive candidiasis and aspergillosis. Although recently refined AFST methods are commercially available to allow a close antifungal resistance surveillance in many clinical setting, novel assays, relying on short-time antifungal drug exposure of fungal isolates, are upcoming tools for AFST. Based on emerging technologies such as flow cytometry, MALDI-TOF mass spectrometry, and isothermal microcalorimetry, these assays could provide a reliable means for quicker and sensitive assessment of AFST.

  4. 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 ...

  5. Clinical knowledge management: an overview of current understanding.

    Science.gov (United States)

    Bali, Rajeev K; Dwivedi, Ashish

    2005-01-01

    This chapter outlines contributions to a workshop for ICMCC 2005. We details some of the central issues surrounding the incorporation of the Knowledge Management (KM) paradigm for the healthcare and clinical sectors. The complex nature of KM is discussed, together with some essential theories and some contemporary applications of the tools and techniques are presented.

  6. The current status of oral contraceptive clinical development in Japan.

    Science.gov (United States)

    Kuwabara, Y

    1989-01-01

    Since the oral contraceptive guideline was issued in April 1987, Japanese pharmaceutical firms have been asking physicians to perform clinical studies of the low-dose OCs. At present, eight products from six companies are under clinical development. Ethinyl estradiol (30-35 micrograms per tablet) as an estrogen component is common to all the test drugs. The progestin component in each OC is norethindrone, levonorgestrel, or desogestrel. Phase I clinical studies on small numbers of healthy volunteers showed that they could tolerate the test drugs without any serious complaints. The effects on endocrine systems, including the inhibition of ovulation, were also examined. Pharmacokinetic parameters of active ingredients were comparable to those of Western women, and no substantial difference seemed to exist between Japanese and Western women. As an example, the results of phase I studies of OJK-777 (Ortho-Novum 7/7/7) are mentioned. Phase III clinical studies, which are "open studies," are now under progress with more than 3,000 women. The major objectives are to examine (1) how well the drugs are tolerated, and the dropout rates; (2) the effects on cycle control, especially bleeding patterns; (3) effects on the cardiovascular system, including coagulation and lipid metabolism; (4) effects on hormone secretions. Although some women have been taking the test drugs for more than 12 cycles, overall statistics are not yet available, because the guideline requires long-term administration (for more than 24 cycles). However, some characteristic features observed thus far are discussed.

  7. Abnormal Uterine Bleeding: Current Classification and Clinical Management.

    Science.gov (United States)

    Bacon, Janice L

    2017-06-01

    Abnormal uterine bleeding is now classified and categorized according to the International Federation of Gynecology and Obstetrics classification system: PALM-COEIN. This applies to nongravid women during their reproductive years and allows more clear designation of causes, thus aiding clinical care and future research. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Current clinical trials testing combinations of immunotherapy and radiation.

    Science.gov (United States)

    Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

    2015-01-01

    Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. 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.

  10. Clinical Supervision of Substance Abuse Counselors: Current and Preferred Practices.

    Science.gov (United States)

    Culbreth, John R.

    1999-01-01

    Reports on a national survey of substance abuse counselors (N=134) to learn their current and preferred supervision practices. Results suggests that substance abuse counselor are receiving supervision similar to other counselors. No preference was indicated for the sex of the supervisor, nor for the 12-step recovery experience. Counselors did…

  11. CSF-1R Inhibitor Development: Current Clinical Status.

    Science.gov (United States)

    Peyraud, Florent; Cousin, Sophie; Italiano, Antoine

    2017-09-05

    Colony-stimulating factor 1 receptor (CSF-1R) and its ligands, CSF-1 and interleukin 34 (IL-34), regulate the function and survival of tumor-associated macrophages, which are involved in tumorigenesis and in the suppression of antitumor immunity. Moreover, the CSF-1R/CSF-1 axis has been implicated in the pathogenesis of pigmented villonodular synovitis (PVNS), a benign tumor of the synovium. As advanced or metastatic malignant solid tumors and relapsed/refractory PVNS remain unresolved therapeutic problems, new approaches are needed to improve the outcome of patients with these conditions. In solid tumors, targeting CSF-1R via either small molecules or antibodies has shown interesting results in vitro but limited antitumor activity in vivo. Concerning PVNS, clinical trials assessing CSF-1R inhibitors have revealed promising initial outcomes. Blocking CSF-1/CSF-1R signaling represents a promising immunotherapy approach and several new potential combination therapies for future clinical testing.

  12. Current clinical research of immunoglobulin G4-related orbital disease

    Directory of Open Access Journals (Sweden)

    Yang Wang

    2016-05-01

    Full Text Available Immunoglobulin G4-related disease(IgG4-related diseasehas received lots of attention in medical community as a recently recognized fibro-inflammatory condition. It is characterized by infiltration of IgG4-immunopositive plasmacytes and concentration of elevated serum IgG4. IgG4-related disease shows organ enlargement or nodular/hyperplastic lesions in various organs including the pancreas, hepatobiliary tract and orbit, which is called IgG4-related orbital disease. The diagnostic criteria for IgG4-related disease and IgG4-related orbital disease has recently been established, which is based on clinical, imaging and histopathologic features of the orbital lesions. Besides, attention should be drawn to the differentiation from other diseases. The treatment is empirical including corticosteroids, immunosuppressive drugs, radiotherapy, and rituximab. This article reviews clinical progression of IgG4-related orbital disease.

  13. Clinical observation of cerebrovascular diseases current in Chernobyl accident liquidators

    International Nuclear Information System (INIS)

    Golovchenko, Yu.Yi.; Usatenko, O.G.; Romanenko, N.Yi.

    1999-01-01

    The results of the clinical follow up study (1993-1997) of cerebrovascular diseases development in the Chernobyl accident liquidators are presented. The syndrome of autonomous nervous system dysfunction following to an exposure to the Chernobyl accident consequences factors promotes to fast development of atherosclerosis and arterial hypertension. On the base of an analysis of the data obtained it was established that the primary diencephalic structures damage resulted in severe changes of different metabolic system, particularly in the cerebrovascular disorders development

  14. Current challenges for clinical trials of cardiovascular medical devices.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

    2014-07-15

    Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. 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.

  16. Quantification of the islet product: presentation of a standardized current good manufacturing practices compliant system with minimal variability.

    Science.gov (United States)

    Friberg, Andrew S; Brandhorst, Heide; Buchwald, Peter; Goto, Masafumi; Ricordi, Camillo; Brandhorst, Daniel; Korsgren, Olle

    2011-03-27

    Accurate islet quantification has proven difficult to standardize in a good manufacturing practices (GMP) approved manner. The influence of assessment variables from both manual and computer-assisted digital image analysis (DIA) methods were compared using calibrated, standardized microspheres or islets alone. Additionally, a mixture of microspheres and exocrine tissue was used to evaluate the variability of both the current, internationally recognized, manual method and a novel GMP-friendly purity- and volume-based method (PV) evaluated by DIA in a semiclosed, culture bag system. Computer-assisted DIA recorded known microsphere size distribution and quantities accurately. By using DIA to evaluate islets, the interindividual manually evaluated percent coefficients of variation (CV%; n=14) were reduced by almost half for both islet equivalents (IEs; 31% vs. 17%, P=0.002) and purity (20% vs. 13%, P=0.033). The microsphere pool mixed with exocrine tissue did not differ from expected IE with either method. However, manual IE resulted in a total CV% of 44.3% and a range spanning 258 k IE, whereas PV resulted in CV% of 10.7% and range of 60 k IE. Purity CV% for each method were similar approximating 10.5% and differed from expected by +7% for the manual method and +3% for PV. The variability of standard counting methods for islet samples and clinical quantities of microspheres mixed with exocrine tissue were reduced with DIA. They were reduced even further by use of a semiclosed bag system compared with standard manual counting, thereby facilitating the standardization of islet evaluation according to GMP standards.

  17. Current status, opportunities and problems in clinical combined chemoradiotherapy

    International Nuclear Information System (INIS)

    Phillips, T.L.

    1979-01-01

    The clinical experience with combined radiation and chemotherapy has been positive in a number of situations. The enhanced local tumor control and patient cure due to the sterilization of distant metastases have been observed. More widespread clinical applications have been limited by the enhanced effects in normal tissues, necessitating radiation dose reduction which in some situations may be counterproductive. The limitations have been caused by the lack of a wide range of active anti-tumor compounds, particularly for most common solid tumors. The very active combinations of cyclophosphamide and adriamycin or cyclophosphamide and cis-Pt, as well as of the 3 agents, caused the response of a number of the solid tumors previously found to be drug resistant. The introduction of these compounds and a number of others active in slowly proliferating solid tumors will allow new look for improved survival in the tumors not yet amenable to combined radiation and chemotherapy. The experiments designed to elucidate the nature of the interaction of radiation and chemotherapy and in particular the nature of normal tissue response should allow for the safer employment of 2 modalities and should help in the design of prospective clinical trials on a more rational basis. (Yamashita, S.)

  18. Pleiotropic effects of niacin: Current possibilities for its clinical use

    Directory of Open Access Journals (Sweden)

    Zeman Miroslav

    2016-12-01

    Full Text Available Niacin was the first hypolipidemic drug to significantly reduce both major cardiovascular events and mortality in patients with cardiovascular disease. Niacin favorably influences all lipoprotein classes, including lipoprotein[a],and belongs to the most potent hypolipidemic drugs for increasing HDL-C. Moreover, niacin causes favorable changes to the qualitative composition of lipoprotein HDL. In addition to its pronounced hypolipidemic action, niacin exerts many other, non-hypolipidemic effects (e.g., antioxidative, anti-inflammatory, antithrombotic, which favorably influence the development and progression of atherosclerosis. These effects are dependent on activation of the specific receptor HCA2. Recent results published by the two large clinical studies, AIM-HIGH and HPS2-THRIVE, have led to the impugnation of niacin’s role in future clinical practice. However, due to several methodological flaws in the AIM-HIGH and HPS2-THRIVE studies, the pleiotropic effects of niacin now deserve thorough evaluation. This review summarizes the present and possible future use of niacin in clinical practice in light of its newly recognized pleiotropic effects.

  19. Clinical review: Current state and future perspectives in the diagnosis of diabetes insipidus: a clinical review.

    Science.gov (United States)

    Fenske, Wiebke; Allolio, Bruno

    2012-10-01

    The differential diagnosis of diabetes insipidus (DI) is often challenging but essential, because treatment may vary substantially. This article analyzes the database and performance of currently used differential diagnostic tests for DI and discusses future perspectives for diagnostic improvement. A review of electronic and print data comprising original and review articles retrieved from the PubMed or Cochrane Library database up to January 2012 was conducted. The search term "polyuria polydipsia syndrome" was cross-referenced with underlying forms of disease and associated clinical, diagnostic, and therapeutic MeSH terms. In addition, references from review articles and textbook chapters were screened for papers containing original data. Search results were narrowed to articles containing primary data with a description of criteria for the differential diagnosis of DI. Fifteen articles on differential diagnosis of DI were identified, mainly consisting of small series of patients, and mostly covering only part of the differential diagnostic spectrum of DI. Test protocols differed, and prospective validation of diagnostic criteria was consistently missing. Inconsistent data were reported on the diagnostic superiority of direct plasma arginine vasopressin determination over the indirect water deprivation test. Both test methods revealed limitations, especially in the differentiation of disorders with a milder phenotype. The available data demonstrate limitations of current biochemical tests for the differential diagnosis of DI, potentially leading to incorrect diagnosis and treatment. The newly available assay for copeptin, the C terminus of the vasopressin precursor, holds promise for a higher diagnostic specificity and simplification of the differential diagnostic protocol in DI.

  20. Extracorporeal membrane oxygenation: current clinical practice, coding, and reimbursement.

    Science.gov (United States)

    Schuerer, Douglas J E; Kolovos, Nikoleta S; Boyd, Kayla V; Coopersmith, Craig M

    2008-07-01

    Extracorporeal membrane oxygenation (ECMO) is a technique for providing life support for patients experiencing both pulmonary and cardiac failure by maintaining oxygenation and perfusion until native organ function is restored. ECMO is used routinely at many specialized hospitals for infants and less commonly for children with respiratory or cardiac failure from a variety of causes. Its usage is more controversial in adults, but select medical centers have reported favorable findings in patients with ARDS and other causes of severe pulmonary failure. ECMO is also rarely used as a rescue therapy in a small subset of adult patients with cardiac failure. This article will review the current uses and techniques of ECMO in the critical care setting as well as the evidence supporting its usage. In addition, current practice management related to coding and reimbursement for this intensive therapy will be discussed.

  1. Ion transport and loss in the earth's quiet ring current. I - Data and standard model

    Science.gov (United States)

    Sheldon, R. B.; Hamilton, D. C.

    1993-01-01

    A study of the transport and loss of ions in the earth's quiet time ring current, in which the standard radial diffusion model developed for the high-energy radiation belt particles is compared with the measurements of the lower-energy ring current ions, is presented. The data set provides ionic composition information in an energy range that includes the bulk of the ring current energy density, 1-300 keV/e. Protons are found to dominate the quiet time energy density at all altitudes, peaking near L of about 4 at 60 keV/cu cm, with much smaller contributions from O(+) (1-10 percent), He(+) (1-5 percent), and He(2+) (less than 1 percent). A minimization procedure is used to fit the amplitudes of the standard electric radial diffusion coefficient, yielding 5.8 x 10 exp -11 R(E-squared)/s. Fluctuation ionospheric electric fields are suggested as the source of the additional diffusion detected.

  2. Is it time to reassess current safety standards for glyphosate-based herbicides?

    Science.gov (United States)

    Vandenberg, Laura N; Blumberg, Bruce; Antoniou, Michael N; Benbrook, Charles M; Carroll, Lynn; Colborn, Theo; Everett, Lorne G; Hansen, Michael; Landrigan, Philip J; Lanphear, Bruce P; Mesnage, Robin; Vom Saal, Frederick S; Welshons, Wade V; Myers, John Peterson

    2017-06-01

    Use of glyphosate-based herbicides (GBHs) increased ∼100-fold from 1974 to 2014. Additional increases are expected due to widespread emergence of glyphosate-resistant weeds, increased application of GBHs, and preharvest uses of GBHs as desiccants. Current safety assessments rely heavily on studies conducted over 30 years ago. We have considered information on GBH use, exposures, mechanisms of action, toxicity and epidemiology. Human exposures to glyphosate are rising, and a number of in vitro and in vivo studies challenge the basis for the current safety assessment of glyphosate and GBHs. We conclude that current safety standards for GBHs are outdated and may fail to protect public health or the environment. To improve safety standards, the following are urgently needed: (1) human biomonitoring for glyphosate and its metabolites; (2) prioritisation of glyphosate and GBHs for hazard assessments, including toxicological studies that use state-of-the-art approaches; (3) epidemiological studies, especially of occupationally exposed agricultural workers, pregnant women and their children and (4) evaluations of GBHs in commercially used formulations, recognising that herbicide mixtures likely have effects that are not predicted by studying glyphosate alone. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. 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.

  4. Including Alternative Resources in State Renewable Portfolio Standards: Current Design and Implementation Experience

    Energy Technology Data Exchange (ETDEWEB)

    Heeter, J.; Bird, L.

    2012-11-01

    Currently, 29 states, the District of Columbia, and Puerto Rico have instituted a renewable portfolio standard (RPS). An RPS sets a minimum threshold for how much renewable energy must be generated in a given year. Each state policy is unique, varying in percentage targets, timetables, and eligible resources. This paper examines state experience with implementing renewable portfolio standards that include energy efficiency, thermal resources, and non-renewable energy and explores compliance experience, costs, and how states evaluate, measure, and verify energy efficiency and convert thermal energy. It aims to gain insights from the experience of states for possible federal clean energy policy as well as to share experience and lessons for state RPS implementation.

  5. "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.

  6. Fundamentals of functional imaging I: current clinical techniques.

    Science.gov (United States)

    Luna, A; Martín Noguerol, T; Mata, L Alcalá

    2018-05-01

    Imaging techniques can establish a structural, physiological, and molecular phenotype for cancer, which helps enable accurate diagnosis and personalized treatment. In recent years, various imaging techniques that make it possible to study the functional characteristics of tumors quantitatively and reproducibly have been introduced and have become established in routine clinical practice. Perfusion studies enable us to estimate the microcirculation as well as tumor angiogenesis and permeability using ultrafast dynamic acquisitions with ultrasound, computed tomography, or magnetic resonance (MR) imaging. Diffusion-weighted sequences now form part of state-of-the-art MR imaging protocols to evaluate oncologic lesions in any anatomic location. Diffusion-weighted imaging provides information about the occupation of the extracellular and extravascular space and indirectly estimates the cellularity and apoptosis of tumors, having demonstrated its relation with biologic aggressiveness in various tumor lines and its usefulness in the evaluation of the early response to systemic and local targeted therapies. Another tool is hydrogen proton MR spectroscopy, which is used mainly in the study of the metabolic characteristics of brain tumors. However, the complexity of the technique and its lack of reproducibility have limited its clinical use in other anatomic areas, although much experience with the use of this technique in the assessment of prostate and breast cancers as well as liver lesions has also accumulated. This review analyzes the imaging techniques that make it possible to evaluate the physiological and molecular characteristics of cancer that have already been introduced into clinical practice, such as techniques that evaluate angiogenesis through dynamic acquisitions after the administration of contrast material, diffusion-weighted imaging, or hydrogen proton MR spectroscopy, as well as their principal applications in oncology. Copyright © 2018 SERAM. Publicado

  7. [Current situation of clinical research on impacted premolars].

    Science.gov (United States)

    Liu, Ran-Ran; Tian, Jun

    2018-04-01

    Teeth impaction is a common developmental malformation in oral diseases. Impacted teeth are usually the canines, third molar, central incisors, premolars, and second molars. The prevalence of impaction of maxillary canines and mandibular wisdom teeth is higher than that of other teeth. Most recent studies have focused on the canines and third molars, but research on impacted premolars is limited. In clinical practice, the majority of orthodontic patients require premolar extraction. Thus, impacted premolars play important roles in orthodontic design and prognosis. This article provides an overview of recent research on impacted premolars and summarizes epidemiological features, localizations, and treatments, with the aim of guiding practitioners on orthodontic design and therapy.

  8. ASME nuclear codes and standards: Scope of coverage and current initiatives

    International Nuclear Information System (INIS)

    Eisenberg, G. M.

    1995-01-01

    The objective of this paper is to address the broad scope of coverage of nuclear codes, standards and guides produced and administered by the American Society of Mechanical Engineers (ASME). Background information is provided regarding the evolution of the present activities. Details are provided on current initiatives intended to permit ASME to meet the needs of a changing nuclear industry on a worldwide scale. During the early years of commercial nuclear power, ASME produced a code for the construction of nuclear vessels used in the reactor coolant pressure boundary, containment and auxiliary systems. In response to industry growth, ASME Code coverage soon broadened to include rules for construction of other nuclear components, and inservice inspection of nuclear reactor coolant systems. In the years following this, the scope of ASME nuclear codes, standards and guides has been broadened significantly to include air cleaning activities for nuclear power reactors, operation and maintenance of nuclear power plants, quality assurance programs, cranes for nuclear facilities, qualification of mechanical equipment, and concrete reactor vessels and containments. ASME focuses on globalization of its codes, standards and guides by encouraging and promoting their use in the international community and by actively seeking participation of international members on its technical and supervisory committees and in accreditation activities. Details are provided on current international representation. Initiatives are underway to separate the technical requirements from administrative and enforcement requirements, to convert to hard metric units, to provide for non-U. S. materials, and to provide for translations into non-English languages. ASME activity as an accredited ISO 9000 registrar for suppliers of mechanical equipment is described. Rules are being developed for construction of containment systems for nuclear spent fuel and high-level waste transport packagings. Intensive

  9. Development of a CT simulator and its current clinical status

    International Nuclear Information System (INIS)

    Nagata, Yasushi; Hiraoka, Masahiro; Nishidai, Takehiro

    2000-01-01

    A computed tomography (CT) simulator is defined as a radiotherapy treatment planning (RTP) system which consists of an X-ray CT scanner, a treatment planning computer, and a marking projector. The developmental process from the introduction of an X-ray CT to a CT simulator is described in this article. After the development of the first CT simulator, several new developments in CT scanners, marking projector, and data transfer networks were introduced. CT simulator systems have recently become more widely available and are produced by more than 8 commercial companies. The advantages of a CT simulator are a shortening of overall RTP time, increased accuracy of RTP, and the possibility of 3-D conformal therapy. Clinical experience with CT simulators has accumulated over the past 10 years. Site-specific trials have been undertaken, and the clinical usefulness of CT simulators for breast cancer, maxillary cancer, nasopharyngeal cancer, orbital tumor, lung cancer and other tumors has been demonstrated. The use of CT simulators has resulted in a decrease in the complications of radiotherapy. It also appears to be an essential tool for dose escalation studies, which may permit increased local control of certain tumors. In Japan, CT simulators were in use at more than 134 (20%) of 682 radiotherapy institutions as of the end of 1998. In the USA, CT simulators were present in more than 12% of 1,542 radiotherapy centers in 1994. The CT simulator is now an essential RTP system for advanced radiotherapy. (author)

  10. [Clinical neuropsychology in perspective: future challenges based on current developments].

    Science.gov (United States)

    Verdejo-García, Antonio; Tirapu-Ustárroz, Javier

    2012-02-01

    New lines of translational, interdisciplinary research are emerging among different fields of the neurosciences, which often point at clinical neuropsychology as the hinge discipline capable of linking the basic findings with their clinical implications and thereby endow them with some meaning for phenomenological experience. To establish the great lines of progress made in the fields of neuroscience and neuropsychology in recent years, so as to be able to foresee the strategic lines and priorities of neuroscience in the near future. To achieve this aim, the first step will be to identify the changes of paradigm that have taken place in the areas of neuroscience and psychology in the last two decades. The next step will be to propose new topics and fields of application that these changes in paradigm offer and demand from neuroscience. The false dichotomies of genes versus environment, mind versus brain, and reason versus emotion are considered, as are the new applications of neuropsychology to the understanding of psychopathological disorders, from the neurodegenerative to neurodevelopment, from 'dirty' drugs to cognitive and affective enhancers.

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

    Science.gov (United States)

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

    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

  12. [Current status and clinical application prospect of Akabane's test].

    Science.gov (United States)

    Wang, Wenjie; Du, Yanjun

    2016-06-12

    The Akabane's test is one of the meridian diagnostic methods. Compared with the current meridian diagnostic methods, it has the advantages of convenience and efficiency, but it also has several disadvantages such as the accuracy is difficult to control, the outcome interpretation is limited, etc. In this paper, the influence factors of Akabane's test were analyzed one by one, especially proposed personal opinion on outcome interpretation, which could ascertain the location and nature of disease, leading to disease syndrome. With accurate syndrome, the treatment plan could be established. The application prospect of Akabane's test was initially explored, and it was proposed that wearable automation equipment could be one of the development directions.

  13. Technological advances in perioperative monitoring: Current concepts and clinical perspectives.

    Science.gov (United States)

    Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

    2015-01-01

    Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any.

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

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2016-01-01

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

  15. Clinical management of achalasia: current state of the art

    Directory of Open Access Journals (Sweden)

    Krill JT

    2016-04-01

    Full Text Available Joseph T Krill, Rishi D Naik, Michael F Vaezi Division of Gastroenterology, Hepatology, and Nutrition, Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, TN, USA Abstract: Achalasia is a primary disorder of esophageal motility. It classically presents with dysphagia to both solids and liquids but may be accompanied by regurgitation and chest pain. The gold standard for the diagnosis of achalasia is esophageal motility testing with manometry, which often reveals aperistalsis of the esophageal body and incomplete lower esophageal sphincter relaxation. The diagnosis is aided by complimentary tests, such as esophagogastroduodenoscopy and contrast radiography. Esophagogastroduodenoscopy is indicated to rule out mimickers of the disease known as “pseudoachalasia” (eg, malignancy. Endoscopic appearance of a dilated esophagus with retained food or saliva and a puckered lower esophageal sphincter should raise suspicion for achalasia. Additionally, barium esophagography may reveal a dilated esophagus with a distal tapering giving it a “bird’s beak” appearance. Multiple therapeutic modalities aid in the management of achalasia, the decision of which depends on operative risk factors. Conventional treatments include medical therapy, botulinum toxin injection, pneumatic dilation, and Heller myotomy. The last two are defined as the most definitive treatment options. New emerging therapies include peroral endoscopic myotomy, placement of self-expanding metallic stents, and endoscopic sclerotherapy. Keywords: achalasia, pseudoachalasia, pneumatic dilation, Heller myotomy, botulinum toxin injection, peroral endoscopic myotomy

  16. Clinical management of achalasia: current state of the art

    Science.gov (United States)

    Krill, Joseph T; Naik, Rishi D; Vaezi, Michael F

    2016-01-01

    Achalasia is a primary disorder of esophageal motility. It classically presents with dysphagia to both solids and liquids but may be accompanied by regurgitation and chest pain. The gold standard for the diagnosis of achalasia is esophageal motility testing with manometry, which often reveals aperistalsis of the esophageal body and incomplete lower esophageal sphincter relaxation. The diagnosis is aided by complimentary tests, such as esophagogastroduodenoscopy and contrast radiography. Esophagogastroduodenoscopy is indicated to rule out mimickers of the disease known as “pseudoachalasia” (eg, malignancy). Endoscopic appearance of a dilated esophagus with retained food or saliva and a puckered lower esophageal sphincter should raise suspicion for achalasia. Additionally, barium esophagography may reveal a dilated esophagus with a distal tapering giving it a “bird’s beak” appearance. Multiple therapeutic modalities aid in the management of achalasia, the decision of which depends on operative risk factors. Conventional treatments include medical therapy, botulinum toxin injection, pneumatic dilation, and Heller myotomy. The last two are defined as the most definitive treatment options. New emerging therapies include peroral endoscopic myotomy, placement of self-expanding metallic stents, and endoscopic sclerotherapy. PMID:27110134

  17. 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.

  18. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues.

    Directory of Open Access Journals (Sweden)

    Ethan Budd Russo

    2016-09-01

    Full Text Available This overview covers a wide range of cannabis topics, initially examining issue in dispensaries and self-administration, plus regulatory requirement for production of cannabis-based medicines, particularly the Food and Drug Administration Botanical Guidance. The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety and public health issues remain.

  19. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    Science.gov (United States)

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

  20. Current and past strategies for bacterial culture in clinical microbiology.

    Science.gov (United States)

    Lagier, Jean-Christophe; Edouard, Sophie; Pagnier, Isabelle; Mediannikov, Oleg; Drancourt, Michel; Raoult, Didier

    2015-01-01

    A pure bacterial culture remains essential for the study of its virulence, its antibiotic susceptibility, and its genome sequence in order to facilitate the understanding and treatment of caused diseases. The first culture conditions empirically varied incubation time, nutrients, atmosphere, and temperature; culture was then gradually abandoned in favor of molecular methods. The rebirth of culture in clinical microbiology was prompted by microbiologists specializing in intracellular bacteria. The shell vial procedure allowed the culture of new species of Rickettsia. The design of axenic media for growing fastidious bacteria such as Tropheryma whipplei and Coxiella burnetii and the ability of amoebal coculture to discover new bacteria constituted major advances. Strong efforts associating optimized culture media, detection methods, and a microaerophilic atmosphere allowed a dramatic decrease of the time of Mycobacterium tuberculosis culture. The use of a new versatile medium allowed an extension of the repertoire of archaea. Finally, to optimize the culture of anaerobes in routine bacteriology laboratories, the addition of antioxidants in culture media under an aerobic atmosphere allowed the growth of strictly anaerobic species. Nevertheless, among usual bacterial pathogens, the development of axenic media for the culture of Treponema pallidum or Mycobacterium leprae remains an important challenge that the patience and innovations of cultivators will enable them to overcome. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  1. Clinical Characteristics and Current Therapies for Inherited Retinal Degenerations

    Science.gov (United States)

    Sahel, José-Alain; Marazova, Katia; Audo, Isabelle

    2015-01-01

    Inherited retinal degenerations (IRDs) encompass a large group of clinically and genetically heterogeneous diseases that affect approximately 1 in 3000 people (>2 million people worldwide) (Bessant DA, Ali RR, Bhattacharya SS. 2001. Molecular genetics and prospects for therapy of the inherited retinal dystrophies. Curr Opin Genet Dev 11: 307–316.). IRDs may be inherited as Mendelian traits or through mitochondrial DNA, and may affect the entire retina (e.g., rod–cone dystrophy, also known as retinitis pigmentosa, cone dystrophy, cone–rod dystrophy, choroideremia, Usher syndrome, and Bardet-Bidel syndrome) or be restricted to the macula (e.g., Stargardt disease, Best disease, and Sorsby fundus dystrophy), ultimately leading to blindness. IRDs are a major cause of severe vision loss, with profound impact on patients and society. Although IRDs remain untreatable today, significant progress toward therapeutic strategies for IRDs has marked the past two decades. This progress has been based on better understanding of the pathophysiological pathways of these diseases and on technological advances. PMID:25324231

  2. 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

  3. 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

  4. Current trends in the cardiovascular clinical trial arena (I

    Directory of Open Access Journals (Sweden)

    Pater Cornel

    2004-06-01

    Full Text Available Abstract The existence of effective therapies for most cardiovascular disease states, coupled with increased requirements that potential benefits of new drugs be evaluated on clinical rather than surrogate endpoints, makes it increasingly difficult to substantiate any incremental improvements in efficacy that these new drugs might offer. Compounding the problem is the highly controversial issue of comparing new agents with placebos rather than active pharmaceuticals in drug efficacy trials. Despite the recent consensus that placebos may be used ethically in well-defined, justifiable circumstances, the problem persists, in part because of increased scrutiny by ethics committees but also because of considerable lingering disagreement regarding the propriety and scientific value of placebo-controlled trials (and trials of antihypertensive drugs in particular. The disagreement also substantially affects the most viable alternative to placebo-controlled trials: actively controlled equivalence/noninferiority trials. To a great extent, this situation was prompted by numerous previous trials of this type that were marked by fundamental methodological flaws and consequent false claims, inconsistencies, and potential harm to patients. As the development and use of generic drugs continue to escalate, along with concurrent pressure to control medical costs by substituting less-expensive therapies for established ones, any claim that a new drug, intervention, or therapy is "equivalent" to another should not be accepted without close scrutiny. Adherence to proper methods in conducting studies of equivalence will help investigators to avoid false claims and inconsistencies. These matters will be addressed in the third article of this three-part series.

  5. Autoimmune liver serology: current diagnostic and clinical challenges.

    Science.gov (United States)

    Bogdanos, Dimitrios-P; Invernizzi, Pietro; Mackay, Ian-R; Vergani, Diego

    2008-06-07

    Liver-related autoantibodies are crucial for the correct diagnosis and classification of autoimmune liver diseases (AiLD), namely autoimmune hepatitis types 1 and 2 (AIH-1 and 2), primary biliary cirrhosis (PBC), and the sclerosing cholangitis variants in adults and children. AIH-1 is specified by anti-nuclear antibody (ANA) and smooth muscle antibody (SMA). AIH-2 is specified by antibody to liver kidney microsomal antigen type-1 (anti-LKM1) and anti-liver cytosol type 1 (anti-LC1). SMA, ANA and anti-LKM antibodies can be present in de-novo AIH following liver transplantation. PBC is specified by antimitochondrial antibodies (AMA) reacting with enzymes of the 2-oxo-acid dehydrogenase complexes (chiefly pyruvate dehydrogenase complex E2 subunit) and disease-specific ANA mainly reacting with nuclear pore gp210 and nuclear body sp100. Sclerosing cholangitis presents as at least two variants, first the classical primary sclerosing cholangitis (PSC) mostly affecting adult men wherein the only (and non-specific) reactivity is an atypical perinuclear antineutrophil cytoplasmic antibody (p-ANCA), also termed perinuclear anti-neutrophil nuclear antibodies (p-ANNA) and second the childhood disease called autoimmune sclerosing cholangitis (ASC) with serological features resembling those of type 1 AIH. Liver diagnostic serology is a fast-expanding area of investigation as new purified and recombinant autoantigens, and automated technologies such as ELISAs and bead assays, become available to complement (or even compete with) traditional immunofluorescence procedures. We survey for the first time global trends in quality assurance impacting as it does on (1) manufacturers/purveyors of kits and reagents, (2) diagnostic service laboratories that fulfill clinicians' requirements, and (3) the end-user, the physician providing patient care, who must properly interpret test results in the overall clinical context.

  6. Indian Adolescent Living with HIV-AIDS: Current Clinical Scenario.

    Science.gov (United States)

    Joshi, Kavita S; Bhaware, Bhushan D; Pazare, Amar R

    2017-07-01

    Statistics suggest that, HIV has now largely become the disease of young patients. Hence, the adolescent HIV/AIDS needs to be handled and managed separately from adult HIV. Relatively fewer Indian data exist to characterize the associations in adolescents and young adults infected with HIV disease. The present study explores the current challenges in the management of HIV infected adolescents. The study was aimed at evaluating, relationship between CD4 count and duration of antiretroviral therapy (ART), effects of ART on body mass index and the adverse effects of antiretroviral drugs in adolescent HIV positive patients. This was a cross-sectional study involving 60 HIV positive adolescent patients attending tertiary care Institute KEM Hospital, Parel over duration of one year conducted at Mumbai. Patients on ART between age group 12 to 19 years. ART naïve patients were excluded from the study. 60 adolescent HIV positive patients attended our OPD including 37 males (61.67%) and 23 females (38.33%).The most common mode of transmission was vertical (80%). Education level was: school dropouts - 15%, primary education - 30%, Completed SSC - 31.7%, higher secondary - 23%. Among ADRs were 12 (63.15%) cases of anaemia due to Zidovudine, 4 (21.05%) hepatitis due to Nevirapine, 2 (10.52%) Tenofovir induced AKI and 1 (5.26%) Nevirapine rash. Wilcoxon matched pairs test showed a highly significant increase in the BMI (p ART under government programme has increased the duration of survival of the adolescent population with HIV. Treatment with HAART showed a favourable response with a statistical significant increase in CD4 count. Longer the duration of HAART, higher was the gain in CD4 count. Indian adolescent receiving long term ART, Lipodystrophy is not a troubling issue. Indian adolescent seems to be more tolerance of ART than the other parts of world.

  7. 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

  8. Current standard rules of combined anteversion prevent prosthetic impingement but ignore osseous contact in total hip arthroplasty.

    Science.gov (United States)

    Weber, Markus; Woerner, Michael; Craiovan, Benjamin; Voellner, Florian; Worlicek, Michael; Springorum, Hans-Robert; Grifka, Joachim; Renkawitz, Tobias

    2016-12-01

    In this prospective study of 135 patients undergoing cementless total hip arthroplasty (THA) we asked whether six current definitions of combined anteversion prevent impingement and increase postoperative patient individual impingement-free range-of-motion (ROM). Implant position was measured by an independent, external institute on 3D-CT performed six weeks post-operatively. Post-operative ROM was calculated using a CT-based algorithm detecting osseous and/or prosthetic impingement by virtual hip movement. Additionally, clinical ROM was evaluated pre-operatively and one-year post-operatively by a blinded observer. Combined component position of cup and stem according to the definitions of Ranawat, Widmer, Dorr, Hisatome and Yoshimine inhibited prosthetic impingement in over 90 %, while combined osseous and prosthetic impingement still occurred in over 40 % of the cases. The recommendations by Jolles, Widmer, Dorr, Yoshimine and Hisatome enabled higher flexion (p ≤ 0.001) and internal rotation (p ≤ 0.006). Clinically, anteversion rules of Widmer and Yoshimine provided one-year post-operatively statistically but not clinically relevant higher internal rotation (p ≤0.034). Standard rules of combined anteversion detect prosthetic but fail to prevent combined osseous and prosthetic impingement in THA. Future models will have to account for the patient-individual anatomic situation to ensure impingement-free ROM.

  9. 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.

  10. Ectopic pregnancy: current clinical trends, a fifteen year study.

    Science.gov (United States)

    Weekes, L R

    1981-09-01

    This paper reviews the clinical recognition, diagnosis, and management of ectopic pregnancy at the Queen of Angels Hospital for the past 15 years. The incidence of ectopic pregnancy to deliveries is 1:195. Pain is the cardinal symptom of ectopic pregnancy, and amenorrhea of some degree was present in all cases. Pelvic inflammatory disease is a factor in the development of tubal pregnancy in some women. A careful history and thorough physical examination are important in making a careful diagnosis. The only laboratory procedures which are of any value are the blood type and the Rh determination. While examination of endometrial tissue obtained by biopsy or curettage has proved useful in ectopic pregnancy diagnosis, it is not totally decisive. Culdocentesis has proved to be the diagnostic procedure of the greatest value in recognizing intraperitoneal hemorrhage and it increases the correct preoperative diagnosis from 65-70% to 95%. Laparoscopy is useful when the physician is in doubt about the nature of the problem and it has produced an increase in the number of ectopic pregnancies diagnosed. Ultrasound is another useful tool in confirming a diagnosis of ectopic pregnancy; its accuracy ranges from 70-92%. A newly developed pregnancy test is more sensitive than conventional pregnancy tests and would be positive for pregnancy. Women who have had a previous ectopic pregnancy have a higher subsequent incidence of persistent infertility, recurrent ectopic pregnancy, and pregnancy wastage; the risk of another ectopic pregnancy increases 30-50 fold. While extopic pregnancy does recur, it is true that about 1/3 of those women do have successful pregnancies. Where previous induced abortion has occurred, there is a 10-fold increased risk of ectopic pregnancy. Women who become pregnant accidentally with an IUD in place have a greater likelihood of experiencing an extrauterine pregnancy. Abdominal pregnancy is often encountered as an aborting ectopic pregnancy during the 1st

  11. 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.

  12. 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

  13. Low power fast settling multi-standard current reusing CMOS fractional-N frequency synthesizer

    Institute of Scientific and Technical Information of China (English)

    Lou Wenfeng; Feng Peng; Wang Haiyong; Wu Nanjian

    2012-01-01

    A low power fast settling multi-standard CMOS fractional-N frequency synthesizer is proposed.The current reusing and frequency presetting techniques are adopted to realize the low power fast settling multi-standard fractional-N frequency synthesizer.An auxiliary non-volatile memory (NVM) is embedded to avoid the repetitive calibration process and to save power in practical application.This PLL is implemented in a 0.18μm technology.The frequency range is 0.3 to 2.54 GHz and the settling time is less than 5μs over the entire frequency range.The LC-VCO with the stacked divide-by-2 has a good figure of merit of-193.5 dBc/Hz.The measured phase noise of frequency synthesizer is about -115 dBc/Hz at 1 MHz offset when the carrier frequency is 2.4 GHz and the reference spurs are less than -52 dBc.The whole frequency synthesizer consumes only 4.35 mA @ 1.8 V.

  14. Low power fast settling multi-standard current reusing CMOS fractional-N frequency synthesizer

    International Nuclear Information System (INIS)

    Lou Wenfeng; Feng Peng; Wang Haiyong; Wu Nanjian

    2012-01-01

    A low power fast settling multi-standard CMOS fractional-N frequency synthesizer is proposed. The current reusing and frequency presetting techniques are adopted to realize the low power fast settling multi-standard fractional-N frequency synthesizer. An auxiliary non-volatile memory (NVM) is embedded to avoid the repetitive calibration process and to save power in practical application. This PLL is implemented in a 0.18 μm technology. The frequency range is 0.3 to 2.54 GHz and the settling time is less than 5 μs over the entire frequency range. The LC-VCO with the stacked divide-by-2 has a good figure of merit of −193.5 dBc/Hz. The measured phase noise of frequency synthesizer is about −115 dBc/Hz at 1 MHz offset when the carrier frequency is 2.4 GHz and the reference spurs are less than −52 dBc. The whole frequency synthesizer consumes only 4.35 mA and 1.8 V. (semiconductor integrated circuits)

  15. 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…

  16. Air Emissions Damages from Municipal Drinking Water Treatment Under Current and Proposed Regulatory Standards.

    Science.gov (United States)

    Gingerich, Daniel B; Mauter, Meagan S

    2017-09-19

    Water treatment processes present intersectoral and cross-media risk trade-offs that are not presently considered in Safe Drinking Water Act regulatory analyses. This paper develops a method for assessing the air emission implications of common municipal water treatment processes used to comply with recently promulgated and proposed regulatory standards, including concentration limits for, lead and copper, disinfection byproducts, chromium(VI), strontium, and PFOA/PFOS. Life-cycle models of electricity and chemical consumption for individual drinking water unit processes are used to estimate embedded NO x , SO 2 , PM 2.5 , and CO 2 emissions on a cubic meter basis. We estimate air emission damages from currently installed treatment processes at U.S. drinking water facilities to be on the order of $500 million USD annually. Fully complying with six promulgated and proposed rules would increase baseline air emission damages by approximately 50%, with three-quarters of these damages originating from chemical manufacturing. Despite the magnitude of these air emission damages, the net benefit of currently implemented rules remains positive. For some proposed rules, however, the promise of net benefits remains contingent on technology choice.

  17. 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...

  18. 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.

  19. Non-destructive testing. The current state of standards and qualification and certification for leak testing

    International Nuclear Information System (INIS)

    Tamura, Yoshikazu

    2011-01-01

    Domestic standards of the leak testing are enacted as one of Japan Industrial Standards. The conformity is advanced between these domestic standards and ISO (International Organization for Standardization) standard. ISO9712 (Non-destructive testing-Qualification and certification of personnel) was revised to include the leak testing of qualification and certification in 2005. The preparation working group of qualification and certification for leak testing is planning start aiming at the system in one and a half years. (author)

  20. Wireless networking for the dental office: current wireless standards and security protocols.

    Science.gov (United States)

    Mupparapu, Muralidhar; Arora, Sarika

    2004-11-15

    Digital radiography has gained immense popularity in dentistry today in spite of the early difficulty for the profession to embrace the technology. The transition from film to digital has been happening at a faster pace in the fields of Orthodontics, Oral Surgery, Endodontics, Periodontics, and other specialties where the radiographic images (periapical, bitewing, panoramic, cephalometric, and skull radiographs) are being acquired digitally, stored within a server locally, and eventually accessed for diagnostic purposes, along with the rest of the patient data via the patient management software (PMS). A review of the literature shows the diagnostic performance of digital radiography is at least comparable to or even better than that of conventional radiography. Similarly, other digital diagnostic tools like caries detectors, cephalometric analysis software, and digital scanners were used for many years for the diagnosis and treatment planning purposes. The introduction of wireless charged-coupled device (CCD) sensors in early 2004 (Schick Technologies, Long Island City, NY) has moved digital radiography a step further into the wireless era. As with any emerging technology, there are concerns that should be looked into before adapting to the wireless environment. Foremost is the network security involved in the installation and usage of these wireless networks. This article deals with the existing standards and choices in wireless technologies that are available for implementation within a contemporary dental office. The network security protocols that protect the patient data and boost the efficiency of modern day dental clinics are enumerated.

  1. Revision of the Euratom basic safety standards directive-current status

    International Nuclear Information System (INIS)

    Mundig, S.

    2011-01-01

    The European Commission is currently developing a revised Euratom Basic Safety Standards (BSS) Directive covering two major objectives: the consolidation of existing Euratom Radiation Protection legislation and the revision of the Euratom BSS. The consolidation will merge the following five Directives into one single Directive: the BSS Directive, the Medical Exposures Directive, the Public Information Directive, the Outside Workers Directive and the Directive on the Control of high-activity sealed radioactive sources and orphan sources. The revision of the Euratom BSS will take account of the latest recommendations by the International Commission on Radiological Protection and shall improve clarity of the requirements where appropriate. It is planned to introduce more binding requirements on natural radiation sources, on criteria for exemption and clearance, and on the cooperation between Member States for emergency planning and response. The provisions for regulatory control of planned exposure situations foresee a graded approach commensurate to the magnitude and likelihood of exposures from a practice. Finally, the new BSS shall take account of recent scientific developments. One additional goal is to achieve greater harmonisation between the Euratom BSS and the international BSS. While the requirements on the protection of workers, apprentices and students remain nearly unchanged, the revised BSS will clarify the roles and responsibilities of services and experts involved in technical and practical aspects of radiation protection, such as the occupational health services, the dosimetry services, the radiation protection expert and the medical physics expert. The requirements in the BSS on individual monitoring of category A workers remain unchanged, but the existing guidance on individual monitoring was revised and updated-the technical recommendations for monitoring individuals occupationally exposed to external radiation are published by the European

  2. 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

  3. 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....

  4. Treatment Options for Paediatric Anaplastic Large Cell Lymphoma (ALCL: Current Standard and beyond

    Directory of Open Access Journals (Sweden)

    Nina Prokoph

    2018-03-01

    Full Text Available Anaplastic Lymphoma Kinase (ALK-positive Anaplastic Large Cell Lymphoma (ALCL, remains one of the most curable cancers in the paediatric setting; multi-agent chemotherapy cures approximately 65–90% of patients. Over the last two decades, major efforts have focused on improving the survival rate by intensification of combination chemotherapy regimens and employing stem cell transplantation for chemotherapy-resistant patients. More recently, several new and ‘renewed’ agents have offered the opportunity for a change in the paradigm for the management of both chemo-sensitive and chemo-resistant forms of ALCL. The development of ALK inhibitors following the identification of the EML4-ALK fusion gene in Non-Small Cell Lung Cancer (NSCLC has opened new possibilities for ALK-positive ALCL. The uniform expression of CD30 on the cell surface of ALCL has given the opportunity for anti-CD30 antibody therapy. The re-evaluation of vinblastine, which has shown remarkable activity as a single agent even in the face of relapsed disease, has led to the consideration of a revised approach to frontline therapy. The advent of immune therapies such as checkpoint inhibition has provided another option for the treatment of ALCL. In fact, the number of potential new agents now presents a real challenge to the clinical community that must prioritise those thought to offer the most promise for the future. In this review, we will focus on the current status of paediatric ALCL therapy, explore how new and ‘renewed’ agents are re-shaping the therapeutic landscape for ALCL, and identify the strategies being employed in the next generation of clinical trials.

  5. 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.

  6. Advanced practice registered nurses and physician assistants in sleep centers and clinics: a survey of current roles and educational background.

    Science.gov (United States)

    Colvin, Loretta; Cartwright, Ann; Collop, Nancy; Freedman, Neil; McLeod, Don; Weaver, Terri E; Rogers, Ann E

    2014-05-15

    To survey Advanced Practice Registered Nurse (APRN) and Physician Assistant (PA) utilization, roles and educational background within the field of sleep medicine. Electronic surveys distributed to American Academy of Sleep Medicine (AASM) member centers and APRNs and PAs working within sleep centers and clinics. Approximately 40% of responding AASM sleep centers reported utilizing APRNs or PAs in predominantly clinical roles. Of the APRNs and PAs surveyed, 95% reported responsibilities in sleep disordered breathing and more than 50% in insomnia and movement disorders. Most APRNs and PAs were prepared at the graduate level (89%), with sleep-specific education primarily through "on the job" training (86%). All APRNs surveyed were Nurse Practitioners (NPs), with approximately double the number of NPs compared to PAs. APRNs and PAs were reported in sleep centers at proportions similar to national estimates of NPs and PAs in physicians' offices. They report predominantly clinical roles, involving common sleep disorders. Given current predictions that the outpatient healthcare structure will change and the number of APRNs and PAs will increase, understanding the role and utilization of these professionals is necessary to plan for the future care of patients with sleep disorders. Surveyed APRNs and PAs reported a significant deficiency in formal and standardized sleep-specific education. Efforts to provide formal and standardized educational opportunities for APRNs and PAs that focus on their clinical roles within sleep centers could help fill a current educational gap.

  7. Military Housing: Status of the Services' Implementation of the Current Barracks Design Standard

    National Research Council Canada - National Science Library

    1999-01-01

    .... In November 1995, DOD adopted a new barracks construction standard, referred to as the 1+1 design standard, that called for more space and increased privacy in new barracks for service members permanently assigned to an installation...

  8. A Survey of the Current Situation of Clinical Biobanks in China.

    Science.gov (United States)

    Li, Haiyan; Ni, Mingyu; Wang, Peng; Wang, Xiaomin

    2017-06-01

    The development of biomedical research urgently needs the support of a large number of high-quality clinical biospecimens. Therefore, human biobanks at different levels have been established successively in China and other countries at a significantly increasing pace in recent years. To better understand the general current state of clinical biobanks in China, we surveyed 42 clinical biobanks based in hospitals and collected information involving their management systems, sharing mechanisms, quality control systems, and informational management systems using closed questionnaire methods. Based on our current information, there has not been such a large-scale survey in China. An understanding of the status and challenges current clinical biobanks face will provide valuable insights for the construction and sustainable development of higher quality clinical biobanks.

  9. XBRL Standard for Financial Reporting in Croatia: Current State and Perspectives

    Directory of Open Access Journals (Sweden)

    Gostimir Dejan

    2015-09-01

    Full Text Available Background: Harmonization and standardization is becoming important among regulators and business community. XBRL has entered the global stage as a financial reporting standard. Its mission was to standardize the financial reporting, lower the reporting costs and make the reporting as transparent as possible.

  10. [Is the structure of surgical clinics in Germany changing? A current investigation into the structure of surgical clinics in the Federal Republic of Germany].

    Science.gov (United States)

    Lob, G; Lob, T; Bauer, H; Niethard, F; Polonius, J; Siebert, H

    2009-04-01

    Medical developments have led to extensive specialization in the field of surgery. This has already been reflected for many years in altered structure and organization forms of surgical clinics. Indispensable quality standards, statutory general conditions, increasing competition in service providers and health insurance with transparency of the service procedure all intensify this trend. The aim of this investigation was, therefore, to determine how far this differentiation of service supply in the field of surgery is also reflected in the area and in surgical departments and clinics of basic and routine supply. To achieve this, all available published information on the structure and organization of surgical clinics in the Federal Republic of Germany was classified according to current departmentalization into "undivided" or general/visceral surgery facilities compared to orthopedic/trauma surgery departments.

  11. NODC Standard Format Current Meter (Components) (F015) Data (1962-1992) (NODC Accession 0066358)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This data set contains time series measurements of ocean currents. These data are obtained from current meter moorings and represent the Eulerian method of current...

  12. 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.

  13. 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...

  14. Radiotherapy in the management of non-metastatic prostate cancer: Current standards and future opportunities

    International Nuclear Information System (INIS)

    Forman, Jeffrey D.

    1997-01-01

    Objectives: The intent of this course is to review issues involved in the management of non-metastatic prostate cancer and to clarify the role of external beam radiotherapy, the use of neo-adjuvant and adjuvant hormonal therapy in conjunction with the radiation, the management of patients with regional metastases and recurrent disease following surgery and radiation. At the end of this course, participants should be able to fluently discuss management issues and strategies across the entire spectrum of non-metastatic prostate cancer. - Pre-treatment prognostic factors including clinical stage, grade, and pre-treatment PSA, will be presented and their relative value in determining therapeutic strategies will be discussed. Strategies to be discussed include standard dose radiation, escalated dose radiation, particle radiation and the use of adjuvant and neo-adjuvant hormonal therapy. - The process of simulation and field design will be presented, the value of CT-based treatment planning, beams-eye view design and the relative value of three-dimensional treatment planning will be discussed. - The significance of prostate and patient movement and strategies for dealing with this will also be presented so that what constitutes an adequate simulation and margin of treatment can be clarified. - The management of newly diagnosed patients, covering the range of low stage/low grade to locally advanced prostate cancer will be discussed. - The relative value of increasing dose, the relative value of using neo-adjuvant and/or adjuvant hormone therapy and the indications for escalated dose will be presented. - Strategies for managing post-prostatectomy patients will be reviewed. Data on adjuvant and therapeutic irradiation for biochemical failure will be presented and a strategy for management will be discussed. - How to deal with patients with residual disease post radiation will be discussed and the relative value of cryotherapy, salvage prostatectomy or hormonal therapy will

  15. Current challenges in adherence to clinical guidelines for antibiotic prophylaxis in surgery.

    Science.gov (United States)

    Khan, Sohail Ahmad; Rodrigues, Gabrial; Kumar, Pramod; Rao, Padma G M

    2006-06-01

    To study the impact of guidelines on surgical antibiotic prophylaxis in clinical practice, barriers involved in adherence to guidelines and how to overcome the same. Literature pertaining to prophylactic antibiotic usage was searched. Medscape, Medline, Cochrane, Surgical Infection Prevention (SIP) project databases were reviewed. Recent articles from relevant journals, texts, and standard guidelines were also studied. Local guidelines seem more likely to be accepted and followed than those developed nationally. Major barriers involved in adherence to guidelines include lack of awareness about the guidelines, general perception of guideline as a bureaucratic rather than educational tool. Some practitioners perceive guidelines as "cookbook medicine" that does not permit them to make their own medical decisions. Other barriers are complex, multi-step systems that create confusion, decrease accountability. Methods for guideline adherence include surveillance and data analysis, new systems to facilitate documentation and improving workflow, education regarding current evidence-based guidelines and promoting the development of local guidelines or protocol, development and implementation of reminders to facilitate adherence to the local guidelines. A multidisciplinary steering team of surgeons, infectious disease specialists, pharmacists, anesthesiologists, microbiologists and nurses should develop local guidelines suitable to their institution and methods for adherence to prevent the surgical site infections. The gap between evidence-based guidelines and practice must be addressed in order to achieve optimal practice in this domain.

  16. A survey of current clinical practice in permanent and temporary prostate brachytherapy: 2010 update.

    Science.gov (United States)

    Buyyounouski, Mark K; Davis, Brian J; Prestidge, Bradley R; Shanahan, Thomas G; Stock, Richard G; Grimm, Peter D; Demanes, D Jeffrey; Zaider, Marco; Horwitz, Eric M

    2012-01-01

    To help establish patterns of care and standards of care of interstitial permanent low-dose-rate (LDR) and temporary high-dose-rate brachytherapy for prostate cancer and to compare the results with a similar 1998 American Brachytherapy Society (ABS) survey. A comprehensive questionnaire intended to survey specific details of current clinical brachytherapy practice was provided to the participants of the seventh ABS Prostate Brachytherapy School. Responses were tabulated and descriptive statistics are reported. Sixty-five brachytherapy practitioners responded to the survey. Eighty-nine percent (89%) of respondents performed LDR and 49% perform high-dose-rate brachytherapy. The median number of years of experience for LDR brachytherapists increased from 5 to 10 years over the course of the 12 years since the preceding survey. Compared with the first ABS, a smaller proportion of respondents received formal brachytherapy residency training (43% vs. 56%) or formal "hands-on" brachytherapy training (15% vs. 63%). There has been a marked decline in the utilization of the Mick applicator (Mick Radio-Nuclear Instruments, Inc., Mount Vernon, NY, USA) (60% vs. 28%) and an increase in the use of stranded seeds (40% vs. 11%). Compliance with postimplant dosimetry was higher in the 2010 survey. This survey does suggest an evolution in the practice of LDR brachytherapy since 1998 and aids in identifying aspects that require further progress or investigation. ABS guidelines and other practice recommendations appear to impact the practice of brachytherapy. Copyright © 2012 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

  17. 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.

  18. A survey of current clinical practice of permanent prostate brachytherapy in the United States

    International Nuclear Information System (INIS)

    Prestidge, Bradley R.; Prete, James J.; Buchholz, Thomas A.; Friedland, Jay L.; Stock, Richard G.; Grimm, Peter D.; Bice, William S.

    1998-01-01

    Purpose: To help establish standards of care for transperineal interstitial permanent prostate brachytherapy (TIPPB) by obtaining data regarding current clinical practice among the most experienced TIPPB brachytherapists in the United States. Methods and Materials: The 70 brachytherapists who performed the greatest number of TIPPB cases in 1995 in the U.S. were surveyed. Each received a comprehensive four page questionnaire that included sections on training and experience, patient and isotope selection criteria, manpower, technique, and follow-up. Thirty-five (50%) surveys were ultimately returned after three mailings and follow-up phone calls. The cumulative experience of the 35 respondents represented approximately 45% of the total TIPPB volume in the U.S. for 1995. Respondents included 29 from the private sector and six from academic programs. Results: The median physician experience with TIPPB was reported as 4.9 years. Each performed an average of 73 TIPPB procedures in 1995 (range 40-300). This represented an increase in volume for most (74%) of the respondents. Sixty-three percent of the respondents attended a formal training course, 54% had TIPPB-specific residency training, and 31% had been proctored (16 had received two or more types of training experience). The most commonly reported selection criteria for implant alone was on Gleason score ≤7, PSA 125 I prescribed to 120 Gy (75%) or 103 Pd to 90 Gy (50%). Sixty percent reported using a Mick applicator, 46% prefer using preloaded needles, and (11%) use both techniques. Real-time imaging was usually performed with ultrasound (94%); most included fluoroscopy (60%). Definitions of PSA control varied widely. Conclusions: TIPPB clinical practice in the U.S. demonstrates similarities in technique, but differences in patient selection and definitions of biochemical control. It is, therefore, incumbent on those beginning TIPPB programs to carefully review the specific practice details of those institutions

  19. 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.

  20. 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

  1. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder.

    Science.gov (United States)

    Kalsi-Ryan, Sukhvinder; Karadimas, Spyridon K; Fehlings, Michael G

    2013-08-01

    Cervical spondylotic myelopathy (CSM) is a common disorder involving chronic progressive compression of the cervical spinal cord due to degenerative disc disease, spondylosis, or other degenerative pathology. CSM is the most common form of spinal cord impairment and causes functional decline leading to reduced independence and quality of life. Despite a sound understanding of the disease process, clinical presentation and management, a universal definition of CSM and a standardized index of severity are not currently used universally. Work is required to develop a definition and establish clinical predictors of progression to improve management of CSM. Despite advances in decompressive and reconstructive surgery, patients are often left with residual disability. Gaps in knowledge of the pathobiology of CSM have limited therapeutic advances to complement surgery. Although the histopathologic and pathophysiologic similarities between CSM and traumatic spinal cord injury have long been acknowledged, the unique pathomechanisms of CSM remain unexplored. Increased efforts to elucidate CSM pathobiology could lead to the discovery of novel therapeutic targets for human CSM and other spinal cord diseases. Here, the natural history of CSM, epidemiology, clinical presentation, and current methods of clinical management are reported, along with the current state of basic scientific research in the field.

  2. [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.

  3. 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.

  4. Clinical proteomics-driven precision medicine for targeted cancer therapy: current overview and future perspectives.

    Science.gov (United States)

    Zhou, Li; Wang, Kui; Li, Qifu; Nice, Edouard C; Zhang, Haiyuan; Huang, Canhua

    2016-01-01

    Cancer is a common disease that is a leading cause of death worldwide. Currently, early detection and novel therapeutic strategies are urgently needed for more effective management of cancer. Importantly, protein profiling using clinical proteomic strategies, with spectacular sensitivity and precision, offer excellent promise for the identification of potential biomarkers that would direct the development of targeted therapeutic anticancer drugs for precision medicine. In particular, clinical sample sources, including tumor tissues and body fluids (blood, feces, urine and saliva), have been widely investigated using modern high-throughput mass spectrometry-based proteomic approaches combined with bioinformatic analysis, to pursue the possibilities of precision medicine for targeted cancer therapy. Discussed in this review are the current advantages and limitations of clinical proteomics, the available strategies of clinical proteomics for the management of precision medicine, as well as the challenges and future perspectives of clinical proteomics-driven precision medicine for targeted cancer therapy.

  5. 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.

  6. NODC Standard Product: Ocean current drifter data (2 disc set) (NODC Accession 0098060)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — These CD-ROMs hold over 4 million surface current observations, almost all obtained by the ship drift method. Date, data source, position, and current direction and...

  7. Delivery of care consistent with the psychosocial standards in pediatric cancer: Current practices in the United States.

    Science.gov (United States)

    Scialla, Michele A; Canter, Kimberly S; Chen, Fang Fang; Kolb, E Anders; Sandler, Eric; Wiener, Lori; Kazak, Anne E

    2018-03-01

    With published evidence-based Standards for Psychosocial Care for Children with Cancer and their Families, it is important to know the current status of their implementation. This paper presents data on delivery of psychosocial care related to the Standards in the United States. Pediatric oncologists, psychosocial leaders, and administrators in pediatric oncology from 144 programs completed an online survey. Participants reported on the extent to which psychosocial care consistent with the Standards was implemented and was comprehensive and state of the art. They also reported on specific practices and services for each Standard and the extent to which psychosocial care was integrated into broader medical care. Participants indicated that psychosocial care consistent with the Standards was usually or always provided at their center for most of the Standards. However, only half of the oncologists (55.6%) and psychosocial leaders (45.6%) agreed or strongly agreed that their psychosocial care was comprehensive and state of the art. Types of psychosocial care provided included evidence-based and less established approaches but were most often provided when problems were identified, rather than proactively. The perception of state of the art care was associated with practices indicative of integrated psychosocial care and the extent to which the Standards are currently implemented. Many oncologists and psychosocial leaders perceive that the delivery of psychosocial care at their center is consistent with the Standards. However, care is quite variable, with evidence for the value of more integrated models of psychosocial services. © 2017 Wiley Periodicals, Inc.

  8. 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

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

    Directory of Open Access Journals (Sweden)

    B. Bennetts

    2014-09-01

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

  10. Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

    Science.gov (United States)

    Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

    2015-10-01

    Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia. © The Author(s) 2015.

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

    DEFF Research Database (Denmark)

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

    2018-01-01

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

  12. 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.

  13. Optical coherence tomography—current technology and applications in clinical and biomedical research

    DEFF Research Database (Denmark)

    Marschall, Sebastian; Sander, Birgit; Mogensen, Mette

    2011-01-01

    such as birefringence, motion, or the distributions of certain substances can be detected with high spatial resolution. Its main field of application is biomedical imaging and diagnostics. In ophthalmology, OCT is accepted as a clinical standard for diagnosing and monitoring the treatment of a number of retinal...

  14. A standardized procedure for eddy-current testing of stainless steel, thin-walled nuclear fuel element cladding tubes

    International Nuclear Information System (INIS)

    Barat, P.; Raj, B.; Bhattacharya, D.K.

    1982-01-01

    Thin-walled nuclear fuel cladding tubes made of AISI 316 stainless steel have been examined by eddy-current testing. Standardization of the procedures has required investigations on optimizing the test frequency, finding a method to locate a defect with respect to the probe reference end, and the use of standard defects and sequential metallography of natural defects detected by eddy-current testing, to understand the influence of the nature of defects on the impedance output signals. Test frequency and method of locating the defect were optimized by the use of standard defects made by machining in reference cladding tubes. Subsequent metallography of natural defects detected by eddy-current testing revealed mainly clusters of inclusions but also other types of defects. The effect of the distribution of inclusions along the length of the tube on the impedance output is discussed. (author)

  15. Standardized procedure for eddy-current testing of stainless steel, thin-walled nuclear fuel element cladding tubes

    Energy Technology Data Exchange (ETDEWEB)

    Barat, P; Raj, B; Bhattacharya, D K [Reactor Research Centre, Kalpakkam (India)

    1982-10-01

    Thin-walled nuclear fuel cladding tubes made of AISI 316 stainless steel have been examined by eddy-current testing. Standardization of the procedures has required investigations on optimizing the test frequency, finding a method to locate a defect with respect to the probe reference end, and the use of standard defects and sequential metallography of natural defects detected by eddy-current testing, to understand the influence of the nature of defects on the impedance output signals. Test frequency and method of locating the defect were optimized by the use of standard defects made by machining in reference cladding tubes. Subsequent metallography of natural defects detected by eddy-current testing revealed mainly clusters of inclusions but also other types of defects. The effect of the distribution of inclusions along the length of the tube on the impedance output is discussed.

  16. 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.

  17. Smartphone use in dermatology for clinical photography and consultation: Current practice and the law.

    Science.gov (United States)

    Abbott, Lisa M; Magnusson, Roger S; Gibbs, Emma; Smith, Saxon D

    2018-05-01

    Smartphones are rapidly changing the way doctors capture and communicate clinical information, particularly in highly visual specialties such as dermatology. An understanding of how and why smartphones are currently used in clinical practice is critical in order to evaluate professional and legal risks, and to formulate policies that enable safe use of mobile technologies for the maximal benefit of practitioners and patients. Australian dermatologists and dermatology trainees were surveyed on their current practices relating to clinical smartphone use. Of the 105 respondents, 101 provided useable results. The data show clinical smartphone use is common and frequent, with more than 50% of respondents sending and receiving images on their smartphones at least weekly. Clinical photographs were usually sent via multimedia message or email and were commonly stored on smartphones (46%). Security measures adopted to protect data were limited. There was inadequate documentation of consent for transmission of photographs and advice provided. Only 22% of respondents were aware of clear policies in their workplace regarding smartphone use, and a majority desired further education on digital image management. Given the frequency of use and the degree of importance placed on the ability to send and receive clinical images, clinical smartphone use will persist and will likely increase over time. Current practices are insufficient to comply with professional and legal obligations, and increase practitioners' vulnerability to civil and disciplinary proceedings. Further education, realistic policies and adequate software resources are critical to ensure protection of patients, practitioners and the reputation of the dermatological profession. © 2017 The Australasian College of Dermatologists.

  18. 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

  19. Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

    Science.gov (United States)

    Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

    2016-03-01

    In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

  20. 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

  1. 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

  2. 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.

  3. STATEWIDE DATA STANDARDS TO SUPPORT CURRENT AND FUTURE STRATEGIC PUBLIC TRANSIT INVESTMENT

    Science.gov (United States)

    2018-04-01

    Significant progress has been made in recent years in reporting and using public transit service data. With the creation and widespread use of the General Transit Feed Specification (GTFS) data standard, there has been a significant increase in the f...

  4. 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

  5. Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards

    Directory of Open Access Journals (Sweden)

    Valkenhoef Gert

    2012-09-01

    Full Text Available Abstract Background Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making. Methods We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making. Results The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making. Conclusions The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.

  6. Current therapeutic interventions in the glycation pathway: evidence from clinical studies.

    Science.gov (United States)

    Engelen, L; Stehouwer, C D A; Schalkwijk, C G

    2013-08-01

    The increased formation of advanced glycation endproducts (AGEs) constitutes a potential mechanism of hyperglycaemia-induced micro- and macrovascular disease in diabetes. In vitro and animal experiments have shown that various interventions can inhibit formation and/or actions of AGEs, in particular the specific AGE inhibitor aminoguanidine and the AGEs crosslink breaker alagebrium, and the B vitamins pyridoxamine and thiamine, and the latter's synthetic derivative, benfotiamine. The potential clinical value of these interventions, however, remains to be established. The present review provides, from the clinical point of view, an overview of current evidence on interventions in the glycation pathway relating to (i) the clinical benefits of specific AGE inhibitors and AGE breakers and (ii) the potential AGE-inhibiting effects of therapies developed for purposes unrelated to the glycation pathway. We found that safety and/or efficacy in clinical studies with the specific AGE inhibitor, aminoguanidine and the AGE breaker, alagebrium, appeared to be a concern. The clinical evidence on the potential AGE-inhibiting effects of B vitamins is still limited. Finally, current evidence for AGE inhibition by therapies developed for purposes unrelated to glycation is limited due to a large heterogeneity in study designs and/or measurement techniques, which have often been sub-optimal. We conclude that, clinical evidence on interventions to inhibit formation and/or action of AGEs is currently weak and unconvincing. © 2012 Blackwell Publishing Ltd.

  7. THE CURRENT STATE OF APPLICATION OF INTERNATIONAL FINANCIAL REPORTING STANDARDS IN UKRAINE.

    Directory of Open Access Journals (Sweden)

    B. Zasadnyi

    2016-09-01

    Full Text Available The article analyzed the process of reforming the system of accounting and reporting in Ukraine in accordance with International Financial Reporting Standards. The main results of the tasks of the Strategy of application IFRS in Ukraine approved by the Cabinet of Ministers of Ukraine in 2007 are identified. The results of analysis showed that only 1% of the total number of enterprises form the financial statements in accordance with IFRS, the others apply national standards of accounting. The proportion of small enterprises is 95% that do not have the financial capacity, qualified staff and the necessary motivation for the formation of financial statements in accordance with IFRS. As a result, one of the main objectives of the reform of the accounting and reporting is to improve the legislation on accounting for small enterprises and develop national accounting standards of the simplified procedure for accounting of assets, liabilities, equity and financial results of the calculation for small enterprises.

  8. 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

  9. 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.'

  10. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  11. 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

  12. Historical Development of NATO Stanag 6001 Language Standards and Common European Framework (CEF) and the Comparison of Their Current Status

    Science.gov (United States)

    Solak, Ekrem

    2011-01-01

    The aim of the article is to shed light on the historical development of language studies in military and social context and to compare the current status of NATO Stanag (Standard Agreement) 6001 language scale with Common European Framework (CEF). Language studies in military context date back to World War II and the emergence of Army Specialized…

  13. 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...

  14. [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.

  15. Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

    Science.gov (United States)

    Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni

    2017-06-21

    Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.

  16. Sulfur Dioxide (SO2) Primary Standards Documents from Current Review - Federal Register Notices

    Science.gov (United States)

    EPA develops and publishes a notice of proposed rulemaking regarding the review of the SO2 national ambient air quality standards (NAAQS). A public comment period follows. Taking into account comments received on the proposed rule, EPA issues a final rule.

  17. Standard Terminology for Phenotypic Variations: The Elements of Morphology Project, Its Current Progress, and Future Directions

    NARCIS (Netherlands)

    Carey, John C.; Allanson, Judith E.; Hennekam, Raoul C. M.; Biesecker, Leslie G.

    2012-01-01

    In 2005, the authors of this article formed an international working group to develop standardized definitions and terms to describe the physical variations used in human phenotypic analyses. This project, which came to be known as the Elements of Morphology, resulted in six articles proposing

  18. A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining

    NARCIS (Netherlands)

    den Uyl, T.E.; Gladwin, T.E.; Rinck, M.; Lindenmeyer, J.; Wiers, R.W.

    2017-01-01

    Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase

  19. Delivering Communication Strategy Training for People with Aphasia: What Is Current Clinical Practice?

    Science.gov (United States)

    Beckley, Firle; Best, Wendy; Beeke, Suzanne

    2017-01-01

    Background: Communication strategy training (CST) is a recognized part of UK speech and language therapists' (SLTs) role when working with a person with aphasia. Multiple CST interventions have been published but, to date, there are no published studies exploring clinical practice in this area. Aims: To investigate UK SLTs' current CST practices.…

  20. Current clinical magnetoencephalography practice across Europe: Are we closer to use MEG as an established clinical tool?

    Science.gov (United States)

    De Tiège, Xavier; Lundqvist, Daniel; Beniczky, Sándor; Seri, Stefano; Paetau, Ritva

    2017-08-01

    This comprehensive survey aims at characterizing the current clinical use of magnetoencephalography (MEG) across European MEG centres. Forty-four MEG centres across Europe were contacted in May 2015 via personalized e-mail to contribute to survey. The web-based survey was available on-line for 1 month and the MEG centres that did not respond were further contacted to maximize participation. Among the 57% of responders, 12 centres from 10 different countries reported to use MEG for clinical applications. A total of 524 MEG investigations were performed in 2014 for the pre-surgical evaluation of epilepsy, while in the same period 244 MEG investigations were performed for pre-surgical functional brain mapping. Seven MEG centres located in different European countries performed ≥50 MEG investigations for epilepsy mapping in 2014, both in children and adults. In those centres, time from patient preparation to MEG data reporting tends to be lower than those investigating a lower annual number of patients. This survey demonstrates that there is in Europe an increasing and widespread expertise in the field of clinical MEG. These findings should serve as a basis to harmonize clinical MEG procedures and promote the clinical added value of MEG across Europe. MEG should now be considered in Europe as a mature clinical neurophysiological technique that should be used routinely in two specific clinical indications, i.e, the pre-surgical evaluation of refractory focal epilepsy and functional brain mapping. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  1. Comparison of current practices of cardiopulmonary perfusion technology in Iran with American Society of Extracorporeal Technology's standards.

    Science.gov (United States)

    Faravan, Amir; Mohammadi, Nooredin; Alizadeh Ghavidel, Alireza; Toutounchi, Mohammad Zia; Ghanbari, Ameneh; Mazloomi, Mehran

    2016-01-01

    Standards have a significant role in showing the minimum level of optimal optimum and the expected performance. Since the perfusion technology staffs play an the leading role in providing the quality services to the patients undergoing open heart surgery with cardiopulmonary bypass machine, this study aimed to assess the standards on how Iranian perfusion technology staffs evaluate and manage the patients during the cardiopulmonary bypass process and compare their practice with the recommended standards by American Society of Extracorporeal Technology. In this descriptive study, data was collected from 48 Iranian public hospitals and educational health centers through a researcher-created questionnaire. The data collection questionnaire assessed the standards which are recommended by American Society of Extracorporeal Technology. Findings showed that appropriate measurements were carried out by the perfusion technology staffs to prevent the hemodilution and avoid the blood transfusion and unnecessary blood products, determine the initial dose of heparin based on one of the proposed methods, monitor the anticoagulants based on ACT measurement, and determine the additional doses of heparin during the cardiopulmonary bypass based on ACT or protamine titration. It was done only in 4.2% of hospitals and health centers. Current practices of cardiopulmonary perfusion technology in Iran are inappropriate based on the standards of American Society of Cardiovascular Perfusion. This represents the necessity of authorities' attention to the validation programs and development of the caring standards on one hand and continuous assessment of using these standards on the other hand.

  2. 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.

  3. 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

  4. 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...

  5. 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.

  6. Labeling programs and efficiency standards to control the energy consumption of household appliances: current situation, main results and recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Menanteau, Ph.

    2000-09-01

    To control the rise in electricity consumption for specific uses, the industrialized countries started by introducing special programs aimed at improving energy efficiency. Among the different instruments available, labeling programs and minimum energy performance standards (MEPS) have proved to be very effective. The first part of this document presents the current situation, the main results and recommendations concerning the labeling programs and efficiency standards to control the energy consumption of household appliances. This analyze is done for each country in details providing the name of the program or measure, the date of implementation, the objective and the main characteristics of the program, the impacts and evaluation. (A.L.B.)

  7. 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.

  8. 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 .

  9. New clinical validation method for automated sphygmomanometer: a proposal by Japan ISO-WG for sphygmomanometer standard.

    Science.gov (United States)

    Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

    2007-12-01

    Owing to fast or stepwise cuff deflation, or measuring at places other than the upper arm, the clinical accuracy of most recent automated sphygmomanometers (auto-BPMs) cannot be validated by one-arm simultaneous comparison, which would be the only accurate validation method based on auscultation. Two main alternative methods are provided by current standards, that is, two-arm simultaneous comparison (method 1) and one-arm sequential comparison (method 2); however, the accuracy of these validation methods might not be sufficient to compensate for the suspicious accuracy in lateral blood pressure (BP) differences (LD) and/or BP variations (BPV) between the device and reference readings. Thus, the Japan ISO-WG for sphygmomanometer standards has been studying a new method that might improve validation accuracy (method 3). The purpose of this study is to determine the appropriateness of method 3 by comparing immunity to LD and BPV with those of the current validation methods (methods 1 and 2). The validation accuracy of the above three methods was assessed in human participants [N=120, 45+/-15.3 years (mean+/-SD)]. An oscillometric automated monitor, Omron HEM-762, was used as the tested device. When compared with the others, methods 1 and 3 showed a smaller intra-individual standard deviation of device error (SD1), suggesting their higher reproducibility of validation. The SD1 by method 2 (P=0.004) significantly correlated with the participant's BP, supporting our hypothesis that the increased SD of device error by method 2 is at least partially caused by essential BPV. Method 3 showed a significantly (P=0.0044) smaller interparticipant SD of device error (SD2), suggesting its higher interparticipant consistency of validation. Among the methods of validation of the clinical accuracy of auto-BPMs, method 3, which showed the highest reproducibility and highest interparticipant consistency, can be proposed as being the most appropriate.

  10. Establishment of the European College of Veterinary Clinical Pathology (ECVCP) and the current status of veterinary clinical pathology in Europe

    DEFF Research Database (Denmark)

    O'Brien, P.J.; Fournel-Fleury, C.; Bolliger, Adrian Marc

    2007-01-01

    congresses and a joint journal (with the American Society for Veterinary Clinical Pathology) for communication of scientific research and information; the College also maintains a website, a joint listserv, and a newsletter; 6) collaboration in training and continuing education with relevant colleges......After 5 years of development, the European College of Veterinary Clinical Pathology (ECVCP)was formally recognized and approved on July 4, 2007 by the European Board of Veterinary Specialisation (EBVS), the European regulatory body that oversees specialization in veterinary medicine and which has......; currently there are 18 resident trainingprograms inEurope; 3) administration of 3 annual board-certifying examinations thus far,with an overall pass rate of 70%; 4) European consensus criteria for assessing the continuing education of specialists every 5 ears; 5) organization of 8 annual scientific...

  11. 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.

  12. Current Role for Biomarkers in Clinical Diagnosis of Alzheimer Disease and Frontotemporal Dementia.

    Science.gov (United States)

    Sheikh-Bahaei, Nasim; Sajjadi, Seyed Ahmad; Pierce, Aimee L

    2017-11-14

    Purpose of review Alzheimer's disease (AD) and frontotemporal dementia can often be diagnosed accurately with careful clinical history, cognitive testing, neurological examination, and structural brain MRI. However, there are certain circumstances wherein detection of specific biomarkers of neurodegeneration or underlying AD pathology will impact the clinical diagnosis or treatment plan. We will review the currently available biomarkers for AD and frontotemporal dementia (FTD) and discuss their clinical importance. Recent findings With the advent of 18 F-labeled tracers that bind amyloid plaques, amyloid PET is now clinically available for the detection of amyloid pathology and to aid in a biomarker-supported diagnosis of AD or mild cognitive impairment (MCI) due to AD. It is not yet possible to test for the specific FTD pathologies (tau or TDP-43); however, a diagnosis of FTD may be "imaging supported" based upon specific MRI or FDG-PET findings. Cerebrospinal fluid measures of amyloid-beta, total-tau, and phospho-tau are clinically available and allow detection of both of the cardinal pathologies of AD: amyloid and tau pathology. Summary It is appropriate to pursue biomarker testing in cases of MCI and dementia when there remains diagnostic uncertainty and the result will impact diagnosis or treatment. Practically speaking, due to the rising prevalence of amyloid positivity with advancing age, measurement of biomarkers in cases of MCI and dementia is most helpful in early-onset patients, patients with atypical clinical presentations, or when considering referral for AD clinical trials.

  13. Including alternative resources in state renewable portfolio standards: Current design and implementation experience

    International Nuclear Information System (INIS)

    Heeter, Jenny; Bird, Lori

    2013-01-01

    As of October 2012, 29 states, the District of Columbia, and Puerto Rico have instituted a renewable portfolio standard (RPS). Each state policy is unique, varying in percentage targets, timetables, and eligible resources. Increasingly, new RPS polices have included alternative resources. Alternative resources have included energy efficiency, thermal resources, and, to a lesser extent, non-renewables. This paper examines state experience with implementing renewable portfolio standards that include energy efficiency, thermal resources, and non-renewable energy and explores compliance experience, costs, and how states evaluate, measure, and verify energy efficiency and convert thermal energy. It aims to gain insights from the experience of states for possible federal clean energy policy as well as to share experience and lessons for state RPS implementation. - Highlights: • Increasingly, new RPS policies have included alternative resources. • Nearly all states provide a separate tier or cap on the quantity of eligible alternative resources. • Where allowed, non-renewables and energy efficiency are being heavily utilized

  14. The Social and Consumer Standards and Guarantees in Ukraine: the Current Structural and Dynamic Characteristics

    Directory of Open Access Journals (Sweden)

    Kolesov Oleksandr S.

    2017-04-01

    Full Text Available The article attempts to generalize the theoretical approaches to the social guarantees and standards as economic categories. The classification of social guarantees is provided. The dynamic parameters for development of the social and consumer standards adopted in Ukraine were considered. An evaluation of the real poverty level under the system of criteria was carried out. The inconsistency of methods for the poverty evaluation adopted by the Ministry of Social Policy of Ukraine and contradiction of its individual indicators has been indicated. The structural characteristics of the population’s income have been determined. The relevance of the existing social guarantees to their real value in today’s economic conditions have been analyzed. Tendencies of falling of the welfare level of population, resulting in a decline in the consumer demand and a narrowing of the domestic market for goods and services, have been identified. The need to take measures to stimulate small businesses, to overcome corruption, and to deregulate the economy has been indicated.

  15. Clinical Research with Transcranial Direct Current Stimulation (tDCS): Challenges and Future Directions

    Science.gov (United States)

    Brunoni, Andre Russowsky; Nitsche, Michael A.; Bolognini, Nadia; Bikson, Marom; Wagner, Tim; Merabet, Lotfi; Edwards, Dylan J.; Valero-Cabre, Antoni; Rotenberg, Alexander; Pascual-Leone, Alvaro; Ferrucci, Roberta; Priori, Alberto; Boggio, Paulo; Fregni, Felipe

    2011-01-01

    Background Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past ten years, tDCS physiological mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodological, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. Methods We convened a workgroup of researchers in the field to review, discuss and provide updates and key challenges of neuromodulation use for clinical research. Main Findings/Discussion We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (i) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (ii) methodological aspects related to the clinical research of tDCS as divided according to study phase (i.e., preclinical, phase I, phase II and phase III studies); (iii) ethical and regulatory concerns; (iv) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS. PMID:22037126

  16. 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

  17. CpG Methylation Analysis—Current Status of Clinical Assays and Potential Applications in Molecular Diagnostics

    Science.gov (United States)

    Sepulveda, Antonia R.; Jones, Dan; Ogino, Shuji; Samowitz, Wade; Gulley, Margaret L.; Edwards, Robin; Levenson, Victor; Pratt, Victoria M.; Yang, Bin; Nafa, Khedoudja; Yan, Liying; Vitazka, Patrick

    2009-01-01

    Methylation of CpG islands in gene promoter regions is a major molecular mechanism of gene silencing and underlies both cancer development and progression. In molecular oncology, testing for the CpG methylation of tissue DNA has emerged as a clinically useful tool for tumor detection, outcome prediction, and treatment selection, as well as for assessing the efficacy of treatment with the use of demethylating agents and monitoring for tumor recurrence. In addition, because CpG methylation occurs early in pre-neoplastic tissues, methylation tests may be useful as markers of cancer risk in patients with either infectious or inflammatory conditions. The Methylation Working Group of the Clinical Practice Committee of the Association of Molecular Pathology has reviewed the current state of clinical testing in this area. We report here our summary of both the advantages and disadvantages of various methods, as well as the needs for standardization and reporting. We then conclude by summarizing the most promising areas for future clinical testing in cancer molecular diagnostics. PMID:19541921

  18. Effects of ionizing radiation on plants and animals at levels implied by current radiation protection standards

    International Nuclear Information System (INIS)

    1992-01-01

    The 1977 Recommendations of the International Commission on Radiological Protection stated that the commission believes that if man is adequately protected from radiation, other organisms are also likely to be sufficiently protected. The present report examines this statement by considering the effects of ionizing radiation on animals and plants in both terrestrial and aquatic ecosystems. The conclusions are that chronic dose rates of IMGy.d -1 or less are unlikely to cause measurable deleterious effects in terrestrial populations, and that in the aquatic environment limiting chronic dose rates to 10MGy.d -1 to the maximally exposed individuals would provide adequate protection for the population. Thus specific radiation protection standards for non-human organisms are not needed. 193 refs, 2 figs, 7 tabs

  19. Current medical treatment of lower urinary tract symptoms/BPH: do we have a standard?

    Science.gov (United States)

    Silva, João; Silva, Carlos Martins; Cruz, Francisco

    2014-01-01

    The pharmacological treatment of lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) is based on alpha-blockers and 5α-reductase inhibitors isolated or in combination. Silodosin, an alpha-1A specific alpha-blocker is the only innovation in these groups of agents. This classical paradigm is being challenged by antimuscarinics, 5-phosphodiesterase inhibitors (PDE5i) and β3-adrenoreceptor agonists. Silodosin is effective in reducing BPH/LUTS, including nocturia and shows little cardiovascular adverse events. Antimuscarinic drugs isolated or in combination with alpha-blockers improve storage symptoms without any harmful effect to the voiding function. PDE5i alone improve BPH/LUTS. Combination of PDE5i with alpha-blockers provides better symptomatic control than alpha-blockers alone. A recent head-to-head comparison of tadalafil 5 mg/day with tamsulosin 0.4 mg/day showed that these agents provided the same improvement in BPH/LUTS and, surprisingly, the same improvement in the urinary flow. In fact, previous studies with tadalafil had not shown any effect of tadalafil on flow. In addition, tadalafil but not tamsulosin improved sexual function. Mirabegron, the first β3-adrenoreceptor agonist, while improving BPH/LUTS in men with bladder outlet obstruction, do not decrease urinary flow or detrusor pressure. The standard medical treatment for BPH/LUTS is still based on alpha-blockers, 5ARIs or its combination. In the future, it is expected that BPH/LUTS treatment will become individualized, according to the type of symptoms, presence of sexual dysfunction and risk of BPH progression. This will challenge our concept of standard treatment for BPH/LUTS.

  20. Atopic Dermatitis in Children: Current Clinical Guidelines for Diagnosis and Therapy

    Directory of Open Access Journals (Sweden)

    Leyla S. Namazova-Baranova

    2016-01-01

    Full Text Available Atopic dermatitis is a chronic multifactorial skin disease that is common enough in childhood. The article presents the current data on epidemiology and dynamics of incidence of pathological symptoms, pathogenesis basics, and key factors of the disease development, shows the current classification of the disease. The authors consider in detail the key principles of the diagnosis and peculiarities of a clinical aspect depending on age. Algorithms of a therapeutic approach, as well as basics of an individual hypoallergenic diet are proposed. General recommendations and possible prognosis for pediatric patients with atopic dermatitis are given.

  1. 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.

  2. Online purchases of an expanded range of condom sizes in comparison to current dimensional requirements allowable by US national standards.

    Science.gov (United States)

    Cecil, Michael; Warner, Lee; Siegler, Aaron J

    2013-11-01

    Across studies, 35-50% of men describe condoms as fitting poorly. Rates of condom use may be inhibited in part due to the inaccessibility of appropriately sized condoms. As regulated medical devices, condom sizes conform to national standards such as those developed by the American Society for Testing and Materials (ASTM) or international standards such as those developed by the International Organisation for Standardisation (ISO). We describe the initial online sales experience of an expanded range of condom sizes and assess uptake in relation to the current required standard dimensions of condoms. Data regarding the initial 1000 sales of an expanded range of condom sizes in the United Kingdom were collected from late 2011 through to early 2012. Ninety-five condom sizes, comprising 14 lengths (83-238mm) and 12 widths (41-69mm), were available. For the first 1000 condom six-pack units that were sold, a total of 83 of the 95 unique sizes were purchased, including all 14 lengths and 12 widths, and both the smallest and largest condoms. Initial condom purchases were made by 572 individuals from 26 countries. Only 13.4% of consumer sales were in the ASTM's allowable range of sizes. These initial sales data suggest consumer interest in an expanded choice of condom sizes that fall outside the range currently allowable by national and international standards organisations.

  3. International pressure vessels and piping codes and standards. Volume 2: Current perspectives; PVP-Volume 313-2

    International Nuclear Information System (INIS)

    Rao, K.R.; Asada, Yasuhide; Adams, T.M.

    1995-01-01

    The topics in this volume include: (1) Recent or imminent changes to Section 3 design sections; (2) Select perspectives of ASME Codes -- Section 3; (3) Select perspectives of Boiler and Pressure Vessel Codes -- an international outlook; (4) Select perspectives of Boiler and Pressure Vessel Codes -- ASME Code Sections 3, 8 and 11; (5) Codes and Standards Perspectives for Analysis; (6) Selected design perspectives on flow-accelerated corrosion and pressure vessel design and qualification; (7) Select Codes and Standards perspectives for design and operability; (8) Codes and Standards perspectives for operability; (9) What's new in the ASME Boiler and Pressure Vessel Code?; (10) A look at ongoing activities of ASME Sections 2 and 3; (11) A look at current activities of ASME Section 11; (12) A look at current activities of ASME Codes and Standards; (13) Simplified design methodology and design allowable stresses -- 1 and 2; (14) Introduction to Power Boilers, Section 1 of the ASME Code -- Part 1 and 2. Separate abstracts were prepared for most of the individual papers

  4. 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.)

  5. 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.

  6. Imaging in syndrome complex diabetes mellitus. Current standards and future perspectives

    International Nuclear Information System (INIS)

    Hetterich, H.; Schafnitzel, A.; Bamberg, F.

    2015-01-01

    Diabetes mellitus is a highly prevalent multisystemic disorder with numerous potential complications and substantial socioeconomic consequences. In many cases, the patient history, physical examination and laboratory tests are not sufficient for a comprehensive evaluation of complicating disorders. Imaging modalities, such as sonography, computed tomography (CT) and magnetic resonance imaging (MRI) are of major significance in the evaluation of complicating disorders of diabetes according to current guidelines. Examples include assessment of coronary artery disease, peripheral artery disease, stroke and diabetic foot syndrome. Technical developments allow a substantial reduction in radiation dose and scan time in CT and MRI, respectively and could therefore justify a broader application in this patient population. In the future CT and MRI could also be used for the early detection of diabetic complications. Furthermore, they could also be used for risk stratification, e.g. measurement of hepatic fat content and evaluation of atherosclerosis in whole body MRI. Prior to widespread application of advanced imaging techniques in this patient population, improved outcomes with respect to survival, quality of life and cost-effectiveness need to be demonstrated. Diagnostic imaging modalities for the evaluation of the syndrome complex of diabetic disorders should be used according to the current guidelines but the use is predicted to increase given the high potential in this population. (orig.) [de

  7. A Review of Current Clinical Applications of Three-Dimensional Printing in Spine Surgery.

    Science.gov (United States)

    Cho, Woojin; Job, Alan Varkey; Chen, Jing; Baek, Jung Hwan

    2018-02-01

    Three-dimensional (3D) printing is a transformative technology with a potentially wide range of applications in the field of orthopaedic spine surgery. This article aims to review the current applications, limitations, and future developments of 3D printing technology in orthopaedic spine surgery. Current preoperative applications of 3D printing include construction of complex 3D anatomic models for improved visual understanding, preoperative surgical planning, and surgical simulations for resident education. Intraoperatively, 3D printers have been successfully used in surgical guidance systems and in the creation of patient specific implantable devices. Furthermore, 3D printing is revolutionizing the field of regenerative medicine and tissue engineering, allowing construction of biocompatible scaffolds suitable for cell growth and vasculature. Advances in printing technology and evidence of positive clinical outcomes are needed before there is an expansion of 3D printing applied to the clinical setting.

  8. Clinical effectiveness of primary and secondary headache treatment by transcranial direct current stimulation

    Directory of Open Access Journals (Sweden)

    Dmitry ePinchuk

    2013-03-01

    Full Text Available The clinical effectiveness of headache treatment by transcranial direct current stimulation with various locations of stimulating electrodes on the scalp was analyzed retrospectively. The results of the treatment were analyzed in 90 patients aged from 19 to 54 years (48 patients had migraine without aura, 32 – frequent episodic tension-type headaches, 10 – chronic tension-type headaches and in 44 adolescents aged 11 – 16 years with chronic posttraumatic headaches after a mild head injury. Clinical effectiveness of tDCS with 70 – 150 µA current for 30 – 45 minutes via 6.25 cm2 stimulating electrodes is comparable to that of modern pharmacological drugs, with no negative side effects. The obtained result has been maintained on average from 5 to 9 months. It has been demonstrated that effectiveness depends on localization of stimulating electrodes used for different types of headaches.

  9. 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.

  10. Prehospital Ultrasound in Trauma: A Review of Current and Potential Future Clinical Applications

    Directory of Open Access Journals (Sweden)

    Tharwat El Zahran

    2018-01-01

    Full Text Available Ultrasound (US is an essential tool for evaluating trauma patients in the hospital setting. Many previous in-hospital studies have been extrapolated to out of hospital setting to improve diagnostic accuracy in prehospital and austere environments. This review article presents the role of prehospital US in blunt and penetrating trauma management with emphasis on its current clinical applications, challenges, and future implications of such use.

  11. Laboratory Diagnosis and Characterization of Fungal Disease in Patients with Cystic Fibrosis (CF): A Survey of Current UK Practice in a Cohort of Clinical Microbiology Laboratories.

    Science.gov (United States)

    Boyle, Maeve; Moore, John E; Whitehouse, Joanna L; Bilton, Diana; Downey, Damian G

    2018-03-02

    There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of 'old' fungal pathogens, as well as 'emerging' fungal pathogens.

  12. Limiting the costs of renewable portfolio standards: A review and critique of current methods

    International Nuclear Information System (INIS)

    Stockmayer, Gabriella; Finch, Vanessa; Komor, Paul; Mignogna, Rich

    2012-01-01

    Over half of U.S. states have renewable portfolio standards (RPSs) mandating that a minimum percentage of electricity sold derives from renewable sources. State RPSs vary widely in how they attempt to control or limit the costs of these RPSs. Approaches utilized include alternative compliance payments, direct rate caps, and cost caps on resource acquisitions, while some states employ no specific limitation at all. This paper describes how states attempt to control RPS costs and discusses the strengths and weaknesses of these various cost controls. There is no one best method; however the experience to date suggests that the most important factors in implementing an effective mechanism to curtail costs are clarity of the rule, consistency in application, and transparency for customers. - Highlights: ▶ We review states' RPS statutes and regulations for mechanisms that attempt to control overall compliance costs. ▶ We categorize the major cost curtailment mechanisms. ▶ For each mechanism, we describe policy designs that are or could be implemented by states. ▶ We identify strengths and weaknesses of the various designs for consideration by policymakers.

  13. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng

    2011-01-01

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  14. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

    2011-08-15

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  15. The role of hybrid SPECT-CT in oncology: current and emerging clinical applications

    International Nuclear Information System (INIS)

    Chowdhury, F.U.; Scarsbrook, A.F.

    2008-01-01

    Single photon emission computed tomography - computed tomography (SPECT-CT) is an emerging dual-modality imaging technique with many established and potential clinical applications in the field of oncology. To date, there has been a considerable emphasis on the benefits of integrated positron emission tomography - computed tomography (PET-CT) in oncology, but relatively little focus on the clinical utility of SPECT-CT. As with PET-CT, accurate co-registration of anatomical and functional data from a combined SPECT-CT camera often provides complementary diagnostic information. Both sensitivity (superior disease localization) and specificity (exclusion of false-positives due to physiological tracer uptake) are improved, and the functional significance of indeterminate lesions detected on cross-sectional imaging can be defined. This article will review the scope of hybrid SPECT-CT in oncology and illustrate both current and emerging clinical applications

  16. Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers.

    Science.gov (United States)

    Dunnenberger, Henry M; Crews, Kristine R; Hoffman, James M; Caudle, Kelly E; Broeckel, Ulrich; Howard, Scott C; Hunkler, Robert J; Klein, Teri E; Evans, William E; Relling, Mary V

    2015-01-01

    Although the field of pharmacogenetics has existed for decades, practioners have been slow to implement pharmacogenetic testing in clinical care. Numerous publications describe the barriers to clinical implementation of pharmacogenetics. Recently, several freely available resources have been developed to help address these barriers. In this review, we discuss current programs that use preemptive genotyping to optimize the pharmacotherapy of patients. Array-based preemptive testing includes a large number of relevant pharmacogenes that impact multiple high-risk drugs. Using a preemptive approach allows genotyping results to be available prior to any prescribing decision so that genomic variation may be considered as an inherent patient characteristic in the planning of therapy. This review describes the common elements among programs that have implemented preemptive genotyping and highlights key processes for implementation, including clinical decision support.

  17. Preemptive Clinical Pharmacogenetics Implementation: Current programs in five United States medical centers

    Science.gov (United States)

    Dunnenberger, Henry M.; Crews, Kristine R.; Hoffman, James M.; Caudle, Kelly E.; Broeckel, Ulrich; Howard, Scott C.; Hunkler, Robert J.; Klein, Teri E.; Evans, William E.; Relling, Mary V.

    2015-01-01

    Although the field of pharmacogenetics has existed for decades, the implementation of, pharmacogenetic testing in clinical care has been slow. There are numerous publications, describing the barriers to clinical implementation of pharmacogenetics. Recently, several freely, available resources have been developed to help address these barriers. In this review we, discuss current programs that use preemptive genotyping to optimize the pharmacotherapy of, patients. Array-based preemptive testing includes a large number of relevant pharmacogenes, that impact multiple high-risk drugs. Using a preemptive approach allows genotyping results to, be available prior to any prescribing decision so that genomic variation may be considered as, an inherent patient characteristic in the planning of therapy. This review describes the common, elements among programs that have implemented preemptive genotyping and highlights key, processes for implementation, including clinical decision support. PMID:25292429

  18. Hypertrophic pachymeningitis: Current criteria for diagnosis and differentiation (Clinical case and review of literature

    Directory of Open Access Journals (Sweden)

    E. G. Mendelevich

    2015-01-01

    Full Text Available The paper describes a 44-year-old male patient with an about 6-year history of hypertrophic pachymeningitis. The major clinical symptoms were characterized by headache, exophthalmos, and blindness in one eye. The data for differential diagnosis of the disease are given. The current literature on the clinical manifestations of hypertrophic pachymeningitis, its differential diagnosis, and the results of magnetic resonance imaging (MRI is reviewed. Diagnostic difficulties at the stage of a clinical observation are due to the nonspecificity of neurological manifestations and the need for a comprehensive examination to detect a somatic disease. MRI can diagnose the disease-specific phenomenon of damage to the meninges, which calls for further careful differentiation. Clinicians must be familiar with alternative differential diagnosis, as a rapid specific therapeutic approach will help avoid long-term or irreversible neurological complications.

  19. Developing genomic knowledge bases and databases to support clinical management: current perspectives.

    Science.gov (United States)

    Huser, Vojtech; Sincan, Murat; Cimino, James J

    2014-01-01

    Personalized medicine, the ability to tailor diagnostic and treatment decisions for individual patients, is seen as the evolution of modern medicine. We characterize here the informatics resources available today or envisioned in the near future that can support clinical interpretation of genomic test results. We assume a clinical sequencing scenario (germline whole-exome sequencing) in which a clinical specialist, such as an endocrinologist, needs to tailor patient management decisions within his or her specialty (targeted findings) but relies on a genetic counselor to interpret off-target incidental findings. We characterize the genomic input data and list various types of knowledge bases that provide genomic knowledge for generating clinical decision support. We highlight the need for patient-level databases with detailed lifelong phenotype content in addition to genotype data and provide a list of recommendations for personalized medicine knowledge bases and databases. We conclude that no single knowledge base can currently support all aspects of personalized recommendations and that consolidation of several current resources into larger, more dynamic and collaborative knowledge bases may offer a future path forward.

  20. Clinical and Laboratory Features of the Nocardia spp. Based on Current Molecular Taxonomy

    Science.gov (United States)

    Brown-Elliott, Barbara A.; Brown, June M.; Conville, Patricia S.; Wallace, Richard J.

    2006-01-01

    The recent explosion of newly described species of Nocardia results from the impact in the last decade of newer molecular technology, including PCR restriction enzyme analysis and 16S rRNA sequencing. These molecular techniques have revolutionized the identification of the nocardiae by providing rapid and accurate identification of recognized nocardiae and, at the same time, revealing new species and a number of yet-to-be-described species. There are currently more than 30 species of nocardiae of human clinical significance, with the majority of isolates being N. nova complex, N. abscessus, N. transvalensis complex, N. farcinica, N. asteroides type VI (N. cyriacigeorgica), and N. brasiliensis. These species cause a wide variety of diseases and have variable drug susceptibilities. Accurate identification often requires referral to a reference laboratory with molecular capabilities, as many newer species are genetically distinct from established species yet have few or no distinguishing phenotypic characteristics. Correct identification is important in deciding the clinical relevance of a species and in the clinical management and treatment of patients with nocardial disease. This review characterizes the currently known pathogenic species of Nocardia, including clinical disease, drug susceptibility, and methods of identification. PMID:16614249

  1. 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

  2. [Clinical research outside of teaching hospitals: Current situation in north-eastern France].

    Science.gov (United States)

    Goetz, C; Dupoux, A; Déloy, L; Hertz, C; Jeanmaire, T; Parneix, N

    2015-04-01

    Most clinical research in France takes place in teaching hospitals. There are, however, many advantages to developing it in other hospitals: access to innovative treatments, improvement in healthcare quality, attractiveness of hospitals, increased trial inclusion rates and reduced selection bias. The objectives of our study were to report on the current situation of clinical research outside teaching hospitals. A three-stage survey was conducted between January 2012 and May 2013 in non-teaching hospitals of north-eastern France. First, questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with members of 20 selected hospitals. The administrative and medical boards of 85 hospitals participated in the first stage of the survey; half of these hospitals were engaged in clinical research activities and for 10 the internal structuring was cross-disciplinary. Answers from 178 departments were obtained during the second stage; 47% reported a clinical research activity. Meetings with research teams in 20 hospitals allowed us to identify difficulties concerning research funding, transversal organization and sponsoring. Clinical research existed in more than half of the respondent non-teaching hospitals. Obstacles to its development can be grouped in three categories: 1) internal structuring of clinical research, 2) access to information and knowledge of how clinical research functions and to interlocutors outside the hospital and 3) access to skills necessary to sponsor clinical research. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Proposal on ''standardized high current solid targets for cyclotron production of diagnostic and therapeutic radionuclides''

    International Nuclear Information System (INIS)

    Suparman, Ibon

    2000-01-01

    The Center for the Development of Radioisotopes and Radiopharmaceuticals - National Nuclear Energy Agency (P2RR-BATAN) has one Cyclotron type CS-30 with maximum 30 MeV proton energy. It is used since 1990 for 201 Tl production. The main use of 201 Tl in Indonesia is for diagnosis and assessment of myocardial ischaemia, especially diagnosis of coronary artery disease, viability of the heart muscle and forecasting the outcome for patients with coronary disease. The Cyclotron facility is supported with a solid target station, two hot cells and the chemical equipment for electroplating. The yield of 201 Tl production currently achieved around 40-50%. The irradiation technique and chemical separation should be improved. We are also very interested in the development of the production of 103 Pd via 103 Rh (p,n) 103 Pd reaction. The objective of this proposal will support the main program of the National Nuclear Energy Agency (BATAN) in enhancement of health care and in providing Cyclotron produced radiopharmaceuticals for hospitals

  8. 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.

  9. Nicotine at clinically relevant concentrations affects atrial inward rectifier potassium current sensitive to acetylcholine.

    Science.gov (United States)

    Bébarová, Markéta; Matejovič, Peter; Švecová, Olga; Kula, Roman; Šimurdová, Milena; Šimurda, Jiří

    2017-05-01

    Nicotine abuse is associated with variety of diseases including arrhythmias, most often atrial fibrillation (AF). Altered inward rectifier potassium currents including acetylcholine-sensitive current I K(Ach) are known to be related to AF pathogenesis. Since relevant data are missing, we aimed to investigate I K(Ach) changes at clinically relevant concentrations of nicotine. Experiments were performed by the whole cell patch clamp technique at 23 ± 1 °C on isolated rat atrial myocytes. Nicotine was applied at following concentrations: 4, 40 and 400 nM; ethanol at 20 mM (∼0.09%). Nicotine at 40 and 400 nM significantly activated constitutively active component of I K(Ach) with the maximum effect at 40 nM (an increase by ∼100%); similar effect was observed at -110 and -50 mV. Changes at 4 nM nicotine were negligible on average. Coapplication of 40 nM nicotine and 20 mM ethanol (which is also known to activate this current) did not show cumulative effect. In the case of acetylcholine-induced component of I K(Ach) , a dual effect of nicotine and its correlation with the current magnitude in control were apparent: the current was increased by nicotine in the cells showing small current in control and vice versa. The effect of 40 and 400 nM nicotine on acetylcholine-induced component of I K(Ach) was significantly different at -110 and -50 mV. We conclude that nicotine at clinically relevant concentrations significantly increased constitutively active component of I K(Ach) and showed a dual effect on its acetylcholine-induced component, similarly as ethanol. Synchronous application of nicotine and ethanol did not cause additive effect.

  10. 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

  11. 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.

  12. Current status of epilepsy treatment and efficacy of standard phenobarbital therapy in rural areas of Northern China.

    Science.gov (United States)

    Yu, Jinbei; Luo, Nan; Wang, Zan; Lin, Weihong

    2017-08-01

    To investigate the current status of epilepsy treatment and the efficacy and adverse effects of phenobarbital therapy in rural areas of Northern China. A total of 2192 patients diagnosed with convulsive epilepsy were recruited from seven different rural regions in Jilin Province, China to investigate the current status of epilepsy treatment, and 1379 of them were enrolled in a standard phenobarbital therapy trial. Patients were selected according to strict inclusion and exclusion criteria, and medical records for all patients were collected and analyzed before the standard treatment was started. Patients were followed up monthly, and efficacy in 1218 patients was analyzed at 1, 3, 6 and 12 months of treatment. More patients had the initial seizure in juveniles than in adults, and 40.72% of the 2192 patients were not receiving any treatment before the treatment trial. The efficacy of phenobarbital increased and adverse effects decreased within the treatment period. Among the 349 patients who were followed up for 12 months from the beginning of the phenobarbital treatment, seizures were decreased by more than 75% in 71.3% of patients using a low-to-medium dose of phenobarbital. Major adverse effects of phenobarbital included mild exhaustion, drowsiness, dizziness and headache. Standardized long-term and regular administration of phenobarbital at a low-to-medium dose can be used as an effective, economic and safe treatment against epilepsy in rural areas.

  13. HYDROXYCARBAMINE: FROM AN OLD DRUG USED IN MALIGNANT HEMOPATHIES TO A CURRENT STANDARD IN SICKLE CELL DISEASE

    Directory of Open Access Journals (Sweden)

    Giovanna Cannas

    2017-02-01

    Full Text Available While hydroxycarbamine (hydroxyurea, HU has less and less indications in malignant hemopathies, it represents the only widely used drug which modifies sickle cell disease pathogenesis. Clinical experience with HU for patients with sickle cell disease has been accumulated over the past 25 years in Western countries. The review of the literature provides increasing support of safety and efficacy in both children and adults for reducing acute vaso-occlusive events including pain episodes and acute chest syndrome. HU has become the standard-of-care for sickle cell anemia, but remains underused. Barriers to its use should be identified and overcome.

  14. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    Science.gov (United States)

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  15. Current Status and Future Suggestions for Improving the Pharm. D Curriculum towards Clinical Pharmacy Practice in Pakistan

    Science.gov (United States)

    Malhi, Saima Mahmood; Ajmal, Kiran; Shamim, Sumbul; Ata, Saniya; Farooq, Salman; Sharib, Syed Muhammad; Muntaha, Sidrat-ul

    2017-01-01

    Objectives & Background: Good curriculum is reflected as the backbone for standard universities to develop competitive professionals having great potential. Pharmacy education in Pakistan has gone through the same developmental stages as in other countries, but is still striving for improvement. In the present study, we want (i) to know the opinion on whether the current pharmacy curriculum requires any improvement in order to meet the training needs of pharmacy professionals regarding clinical knowledge and pharmacy practice; and (ii) to present some humble suggestions to decision-making authorities in order to improve it with respect to patient-focused programs (PFP). Methods: The study was conducted in two sessions. In first session, a questionnaire was distributed to pharmacy students of eight public/private sector universities of Karachi (N = 354) offering Pharm. D degrees. The second session dealt with the pharmacy teachers, deans, and practicing pharmacists in health care facilities (who are in any ways also related to academia), in order to take their opinions on and suggestions for the development of a better Pharm. D curriculum (N = 135). Results: Our results showed that 75.2% of respondents agree that the Pharm. D curriculum does not meet the international standards of practice, and 88.4% of respondents support the addition of more clinical aspects than industrial ones, as Pharm. D could be both clinically and industrially oriented, according to the needs of the Pakistani people. Furthermore, 80.2% of respondents are of the view that an apprenticeship should be included in last two years, while 88.4% demand a ‘paid residency program’ to facilitate the hospital, clinical and compounding areas of pharmacy. In addition, we also received a number of verbal suggestions for improving the Pharm. D curriculum being followed in Pakistan. Discussion & Conclusions: We conclude that our Pharm. D curriculum needs additions in terms of clinical practice by

  16. A Summary of Proposed Changes to the Current ICARTT Format Standards and their Implications to Future Airborne Studies

    Science.gov (United States)

    Northup, E. A.; Kusterer, J.; Quam, B.; Chen, G.; Early, A. B.; Beach, A. L., III

    2015-12-01

    The current ICARTT file format standards were developed for the purpose of fulfilling the data management needs for the International Consortium for Atmospheric Research on Transport and Transformation (ICARTT) campaign in 2004. The goal of the ICARTT file format was to establish a common and simple to use data file format to promote data exchange and collaboration among science teams with similar science objectives. ICARTT has been the NASA standard since 2010, and is widely used by NOAA, NSF, and international partners (DLR, FAAM). Despite its level of acceptance, there are a number of issues with the current ICARTT format, especially concerning the machine readability. To enhance usability, the ICARTT Refresh Earth Science Data Systems Working Group (ESDSWG) was established to enable a platform for atmospheric science data producers, users (e.g. modelers) and data managers to collaborate on developing criteria for this file format. Ultimately, this is a cross agency effort to improve and aggregate the metadata records being produced. After conducting a survey to identify deficiencies in the current format, we determined which are considered most important to the various communities. Numerous recommendations were made to improve upon the file format while maintaining backward compatibility. The recommendations made to date and their advantages and limitations will be discussed.

  17. Current computational modelling trends in craniomandibular biomechanics and their clinical implications.

    Science.gov (United States)

    Hannam, A G

    2011-03-01

    Computational models of interactions in the craniomandibular apparatus are used with increasing frequency to study biomechanics in normal and abnormal masticatory systems. Methods and assumptions in these models can be difficult to assess by those unfamiliar with current practices in this field; health professionals are often faced with evaluating the appropriateness, validity and significance of models which are perhaps more familiar to the engineering community. This selective review offers a foundation for assessing the strength and implications of a craniomandibular modelling study. It explores different models used in general science and engineering and focuses on current best practices in biomechanics. The problem of validation is considered at some length, because this is not always fully realisable in living subjects. Rigid-body, finite element and combined approaches are discussed, with examples of their application to basic and clinically relevant problems. Some advanced software platforms currently available for modelling craniomandibular systems are mentioned. Recent studies of the face, masticatory muscles, tongue, craniomandibular skeleton, temporomandibular joint, dentition and dental implants are reviewed, and the significance of non-linear and non-isotropic material properties is emphasised. The unique challenges in clinical application are discussed, and the review concludes by posing some questions which one might reasonably expect to find answered in plausible modelling studies of the masticatory apparatus. © 2010 Blackwell Publishing Ltd.

  18. 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.

  19. Evaluation of current operating standards for chlorine dioxide in disinfection of dump tank and flume for fresh tomatoes.

    Science.gov (United States)

    Tomás-Callejas, Alejandro; López-Velasco, Gabriela; Valadez, Angela M; Sbodio, Adrian; Artés-Hernández, Francisco; Danyluk, Michelle D; Suslow, Trevor V

    2012-02-01

    Standard postharvest unit operations that rely on copious water contact, such as fruit unloading and washing, approach the criteria for a true critical control point in fresh tomato production. Performance data for approved sanitizers that reflect commercial systems are needed to set standards for audit compliance. This study was conducted to evaluate the efficacy of chlorine dioxide (ClO(2)) for water disinfection as an objective assessment of recent industry-adopted standards for dump tank and flume management in fresh tomato packing operations. On-site assessments were conducted during eight temporally distinct shifts in two Florida packinghouses and one California packinghouse. Microbiological analyses of incoming and washed fruit and dump and flume system water were evaluated. Water temperature, pH, turbidity, conductivity, and oxidation-reduction potential (ORP) were monitored. Reduction in populations of mesophilic and coliform bacteria on fruit was not significant, and populations were significantly higher (P Turbidity and conductivity increased with loads of incoming tomatoes. Water temperature varied during daily operations, but pH and ORP mostly remained constant. The industry standard positive temperature differential of 5.5°C between water and fruit pulp was not maintained in tanks during the full daily operation. ORP values were significantly higher in the flume than in the dump tank. A positive correlation was found between ORP and temperature, and negative correlations were found between ORP and turbidity, total mesophilic bacteria, and coliforms. This study provides in-plant data indicating that ClO(2) can be an effective sanitizer in flume and spray-wash systems, but current operational limitations restrict its performance in dump tanks. Under current conditions, ClO(2) alone is unlikely to allow the fresh tomato industry to meet its microbiological quality goals under typical commercial conditions.

  20. Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations.

    Science.gov (United States)

    Kelly, A S; Fox, C K; Rudser, K D; Gross, A C; Ryder, J R

    2016-07-01

    Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial end-point selection, trial duration, implementation of lifestyle modification therapy and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity.

  1. Clinical Risk Assessment in the Antiphospholipid Syndrome: Current Landscape and Emerging Biomarkers.

    Science.gov (United States)

    Chaturvedi, Shruti; McCrae, Keith R

    2017-07-01

    Laboratory criteria for the classification of antiphospholipid syndrome include the detection of a lupus anticoagulant and/or anticardiolipin and anti-β2-glycoprotein I antibodies. However, the majority of patients who test positive in these assays do not have thrombosis. Current risk-stratification tools are largely limited to the antiphospholipid antibody profile and traditional thrombotic risk factors. Novel biomarkers that correlate with disease activity and potentially provide insight into future clinical events include domain 1 specific anti-β 2 GPI antibodies, antibodies to other phospholipids or phospholipid/protein antigens (such as anti-PS/PT), and functional/biological assays such as thrombin generation, complement activation, levels of circulating microparticles, and annexin A5 resistance. Clinical risk scores may also have value in predicting clinical events. Biomarkers that predict thrombosis risk in patients with antiphospholipid antibodies have been long sought, and several biomarkers have been proposed. Ultimately, integration of biomarkers with established assays and clinical characteristics may offer the best chance of identifying patients at highest risk of APS-related complications.

  2. The current role of on-line extraction approaches in clinical and forensic toxicology.

    Science.gov (United States)

    Mueller, Daniel M

    2014-08-01

    In today's clinical and forensic toxicological laboratories, automation is of interest because of its ability to optimize processes, to reduce manual workload and handling errors and to minimize exposition to potentially infectious samples. Extraction is usually the most time-consuming step; therefore, automation of this step is reasonable. Currently, from the field of clinical and forensic toxicology, methods using the following on-line extraction techniques have been published: on-line solid-phase extraction, turbulent flow chromatography, solid-phase microextraction, microextraction by packed sorbent, single-drop microextraction and on-line desorption of dried blood spots. Most of these published methods are either single-analyte or multicomponent procedures; methods intended for systematic toxicological analysis are relatively scarce. However, the use of on-line extraction will certainly increase in the near future.

  3. Current Status of Immunomodulatory and Cellular Therapies in Preclinical and Clinical Islet Transplantation

    Science.gov (United States)

    Chhabra, Preeti; Brayman, Kenneth L.

    2011-01-01

    Clinical islet transplantation is a β-cell replacement strategy that represents a possible definitive intervention for patients with type 1 diabetes, offering substantial benefits in terms of lowering daily insulin requirements and reducing incidences of debilitating hypoglycemic episodes and unawareness. Despite impressive advances in this field, a limiting supply of islets, inadequate means for preventing islet rejection, and the deleterious diabetogenic and nephrotoxic side effects associated with chronic immunosuppressive therapy preclude its wide-spread applicability. Islet transplantation however allows a window of opportunity for attempting various therapeutic manipulations of islets prior to transplantation aimed at achieving superior transplant outcomes. In this paper, we will focus on the current status of various immunosuppressive and cellular therapies that promote graft function and survival in preclinical and clinical islet transplantation with special emphasis on the tolerance-inducing capacity of regulatory T cells as well as the β-cells regenerative capacity of stem cells. PMID:22046502

  4. Current Status of Immunomodulatory and Cellular Therapies in Preclinical and Clinical Islet Transplantation

    Directory of Open Access Journals (Sweden)

    Preeti Chhabra

    2011-01-01

    Full Text Available Clinical islet transplantation is a -cell replacement strategy that represents a possible definitive intervention for patients with type 1 diabetes, offering substantial benefits in terms of lowering daily insulin requirements and reducing incidences of debilitating hypoglycemic episodes and unawareness. Despite impressive advances in this field, a limiting supply of islets, inadequate means for preventing islet rejection, and the deleterious diabetogenic and nephrotoxic side effects associated with chronic immunosuppressive therapy preclude its wide-spread applicability. Islet transplantation however allows a window of opportunity for attempting various therapeutic manipulations of islets prior to transplantation aimed at achieving superior transplant outcomes. In this paper, we will focus on the current status of various immunosuppressive and cellular therapies that promote graft function and survival in preclinical and clinical islet transplantation with special emphasis on the tolerance-inducing capacity of regulatory T cells as well as the -cells regenerative capacity of stem cells.

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. Molecular subtyping of cancer: current status and moving toward clinical applications.

    Science.gov (United States)

    Zhao, Lan; Lee, Victor H F; Ng, Michael K; Yan, Hong; Bijlsma, Maarten F

    2018-04-12

    Cancer is a collection of genetic diseases, with large phenotypic differences and genetic heterogeneity between different types of cancers and even within the same cancer type. Recent advances in genome-wide profiling provide an opportunity to investigate global molecular changes during the development and progression of cancer. Meanwhile, numerous statistical and machine learning algorithms have been designed for the processing and interpretation of high-throughput molecular data. Molecular subtyping studies have allowed the allocation of cancer into homogeneous groups that are considered to harbor similar molecular and clinical characteristics. Furthermore, this has helped researchers to identify both actionable targets for drug design as well as biomarkers for response prediction. In this review, we introduce five frequently applied techniques for generating molecular data, which are microarray, RNA sequencing, quantitative polymerase chain reaction, NanoString and tissue microarray. Commonly used molecular data for cancer subtyping and clinical applications are discussed. Next, we summarize a workflow for molecular subtyping of cancer, including data preprocessing, cluster analysis, supervised classification and subtype characterizations. Finally, we identify and describe four major challenges in the molecular subtyping of cancer that may preclude clinical implementation. We suggest that standardized methods should be established to help identify intrinsic subgroup signatures and build robust classifiers that pave the way toward stratified treatment of cancer patients.

  10. American Clinical Neurophysiology Society Guideline 2: Guidelines for Standard Electrode Position Nomenclature.

    Science.gov (United States)

    Acharya, Jayant N; Hani, Abeer; Cheek, Janna; Thirumala, Partha; Tsuchida, Tammy N

    2016-08-01

    This revision to the EEG Guidelines is an update incorporating current electroencephalography technology and practice and was previously published as Guideline 5. While the 10-10 system of electrode position nomenclature has been accepted internationally for almost two decades, it has not been used universally. The reasons for this and clinical scenarios when the 10-10 system provides additional localizing information are discussed in this revision. In addition, situations in which AF1/2, AF5/6, PO1/2 and PO5/6 electrode positions may be utilized for EEG recording are discussed.

  11. Patient centric approach for clinical trials: Current trend and new opportunities.

    Science.gov (United States)

    Sharma, Neha Shankar

    2015-01-01

    The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.

  12. Patient centric approach for clinical trials: Current trend and new opportunities

    Directory of Open Access Journals (Sweden)

    Neha Shankar Sharma

    2015-01-01

    Full Text Available The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.

  13. A review of the current state of digital plate reading of cultures in clinical microbiology.

    Science.gov (United States)

    Rhoads, Daniel D; Novak, Susan M; Pantanowitz, Liron

    2015-01-01

    Digital plate reading (DPR) is increasingly being adopted as a means to facilitate the analysis and improve the quality and efficiency within the clinical microbiology laboratory. This review discusses the role of DPR in the context of total laboratory automation and explores some of the platforms currently available or in development for digital image capturing of microbial growth on media. The review focuses on the advantages and challenges of DPR. Peer-reviewed studies describing the utility and quality of these novel DPR systems are largely lacking, and professional guidelines for DPR implementation and quality management are needed. Further development and more widespread adoption of DPR is anticipated.

  14. National turnaround time survey: professional consensus standards for optimal performance and thresholds considered to compromise efficient and effective clinical management.

    Science.gov (United States)

    McKillop, Derek J; Auld, Peter

    2017-01-01

    Background Turnaround time can be defined as the time from receipt of a sample by the laboratory to the validation of the result. The Royal College of Pathologists recommends that a number of performance indicators for turnaround time should be agreed with stakeholders. The difficulty is in arriving at a goal which has some evidence base to support it other than what may simply be currently achievable technically. This survey sought to establish a professional consensus on the goals and meaning of targets for laboratory turnaround time. Methods A questionnaire was circulated by the National Audit Committee to 173 lead consultants for biochemistry in the UK. The survey asked each participant to state their current target turnaround time for core investigations in a broad group of clinical settings. Each participant was also asked to provide a professional opinion on what turnaround time would pose an unacceptable risk to patient safety for each departmental category. A super majority (2/3) was selected as the threshold for consensus. Results The overall response rate was 58% ( n = 100) with a range of 49-72% across the individual Association for Clinical Biochemistry and Laboratory Medicine regions. The consensus optimal turnaround time for the emergency department was 2 h considered unacceptable. The times for general practice and outpatient department were 48 h and for Wards 12 h, respectively. Conclusions We consider that the figures provide a useful benchmark of current opinion, but clearly more empirical standards will have to develop alongside other aspects of healthcare delivery.

  15. [Current state of training in pharmacy education using a problem-based learning/tutorial model with simulated patients and standardized patients at National University Corporation].

    Science.gov (United States)

    Irie, Tetsumi; Nitta, Atsumi; Akaike, Akinori

    2012-01-01

    Simulated/standardized patient-based (SP) education and problem-based learning (PBL) tutorial education become a powerful tool to heighten the pharmacy students' will to learn in order to cultivate the responsibility to contribute to public health and welfare as a clinical professional and to facilitate students' competences to solve problems by themselves. What this program is trying to do is: 1) to establish the system to train, educate and supply SP who are effective in the training and education of pharmacy students in close cooperation with the medical schools and their affiliated hospitals; 2) to improve the quality of the current PBL tutorial education and thereby establish it as an advanced education program in the education of senior students. We carried out the questionnaire to National University Corporation which establishes a school of pharmacy, as to the training and education of SP. The analysis of the answers to the questionnaire revealed the present status of SP in the Pharmaceutical Objective Structured Clinical Examination (OSCE) in the Pharmaceutical Common Achievement Test, and the existence of the problems on how to standardize SP as well as how to cover such expenses. Furthermore, the activity of the first year consisted of the exchange and sharing of information regarding the existing method of training and education of SP and PBL tutorial education and the identification of the problems to be solved in order to improve the quality of the educational program.

  16. The clinical endocrinology workforce: current status and future projections of supply and demand.

    Science.gov (United States)

    Vigersky, Robert A; Fish, Lisa; Hogan, Paul; Stewart, Andrew; Kutler, Stephanie; Ladenson, Paul W; McDermott, Michael; Hupart, Kenneth H

    2014-09-01

    Many changes in health care delivery, health legislation, and the physician workforce that affect the supply and demand for endocrinology services have occurred since the first published workforce study of adult endocrinologists in 2003. The objective of the study was to assess the current adult endocrinology workforce data and provide the first analysis of the pediatric endocrinology workforce and to project the supply of and demand for endocrinologists through 2025. A workforce model was developed from an analysis of proprietary and publicly available databases, consultation with a technical expert panel, and the results of an online survey of board-certified endocrinologists. The Endocrine Society commissioned The Lewin Group to estimate current supply and to project gaps between supply and demand for endocrinologists. A technical expert panel of senior endocrinologists provided context, clinical information, and direction. The following were measured: 1) the current adult and pediatric endocrinology workforce and the supply of and demand for endocrinologists through 2025 and 2) the number of additional entrants into the endocrinology work pool that would be required to close the gap between supply and demand. Currently there is a shortage of approximately 1500 adult and 100 pediatric full-time equivalent endocrinologists. The gap for adult endocrinologists will expand to 2700 without an increase in the number of fellows trained. An increase in the prevalence of diabetes mellitus further expands the demand for adult endocrinologists. The gap can be closed in 5 and 10 years by increasing the number of fellowship positions by 14.4% and 5.5% per year, respectively. The gap between supply and demand for pediatric endocrinologists will close by 2016, and thereafter an excess supply over demand will develop at the current rate of new entrants into the work force. There are insufficient adult endocrinologists to satisfy current and future demand. A number of proactive

  17. Effect of ethanol at clinically relevant concentrations on atrial inward rectifier potassium current sensitive to acetylcholine.

    Science.gov (United States)

    Bébarová, Markéta; Matejovič, Peter; Pásek, Michal; Hořáková, Zuzana; Hošek, Jan; Šimurdová, Milena; Šimurda, Jiří

    2016-10-01

    Alcohol intoxication tends to induce arrhythmias, most often the atrial fibrillation. To elucidate arrhythmogenic mechanisms related to alcohol consumption, the effect of ethanol on main components of the ionic membrane current is investigated step by step. Considering limited knowledge, we aimed to examine the effect of clinically relevant concentrations of ethanol (0.8-80 mM) on acetylcholine-sensitive inward rectifier potassium current I K(Ach). Experiments were performed by the whole-cell patch clamp technique at 23 ± 1 °C on isolated rat and guinea-pig atrial myocytes, and on expressed human Kir3.1/3.4 channels. Ethanol induced changes of I K(Ach) in the whole range of concentrations applied; the effect was not voltage dependent. The constitutively active component of I K(Ach) was significantly increased by ethanol with the maximum effect (an increase by ∼100 %) between 8 and 20 mM. The changes were comparable in rat and guinea-pig atrial myocytes and also in expressed human Kir3.1/3.4 channels (i.e., structural correlate of I K(Ach)). In the case of the acetylcholine-induced component of I K(Ach), a dual ethanol effect was apparent with a striking heterogeneity of changes in individual cells. The effect correlated with the current magnitude in control: the current was increased by eth-anol in the cells showing small current in control and vice versa. The average effect peaked at 20 mM ethanol (an increase of the current by ∼20 %). Observed changes of action potential duration agreed well with the voltage clamp data. Ethanol significantly affected both components of I K(Ach) even in concentrations corresponding to light alcohol consumption.

  18. 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

  19. Clinical predictors of acute response to transcranial direct current stimulation (tDCS) in major depression.

    Science.gov (United States)

    D'Urso, Giordano; Dell'Osso, Bernardo; Rossi, Rodolfo; Brunoni, Andre Russowsky; Bortolomasi, Marco; Ferrucci, Roberta; Priori, Alberto; de Bartolomeis, Andrea; Altamura, Alfredo Carlo

    2017-09-01

    Transcranial direct current stimulation (tDCS) is a promising neuromodulation intervention for poor-responding or refractory depressed patients. However, little is known about predictors of response to this therapy. The present study aimed to analyze clinical predictors of response to tDCS in depressed patients. Clinical data from 3 independent tDCS trials on 171 depressed patients (including unipolar and bipolar depression), were pooled and analyzed to assess predictors of response. Depression severity and the underlying clinical dimensions were measured using the Hamilton Depression Rating Scale (HDRS) at baseline and after the tDCS treatment. Age, gender and diagnosis (bipolar/unipolar depression) were also investigated as predictors of response. Linear mixed models were fitted in order to ascertain which HDRS factors were associated with response to tDCS. Age, gender and diagnosis did not show any association with response to treatment. The reduction in HDRS scores after tDCS was strongly associated with the baseline values of "Cognitive Disturbances" and "Retardation" factors, whilst the "Anxiety/Somatization" factor showed a mild association with the response. Open-label design, the lack of control group, and minor differences in stimulation protocols. No differences in response to tDCS were found between unipolar and bipolar patients, suggesting that tDCS is effective for both conditions. "Cognitive disturbance", "Retardation", and "Anxiety/Somatization", were identified as potential clinical predictors of response to tDCS. These findings point to the pre-selection of the potential responders to tDCS, therefore optimizing the clinical use of this technique and the overall cost-effectiveness of the psychiatric intervention for depressed patients. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. The emergence of international food safety standards and guidelines: understanding the current landscape through a historical approach.

    Science.gov (United States)

    Ramsingh, Brigit

    2014-07-01

    Following the Second World War, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) teamed up to construct an International Codex Alimentarius (or 'food code') which emerged in 1963. The Codex Committee on Food Hygiene (CCFH) was charged with the task of developing microbial hygiene standards, although it found itself embroiled in debate with the WHO over the nature these standards should take. The WHO was increasingly relying upon the input of biometricians and especially the International Commission on Microbial Specifications for Foods (ICMSF) which had developed statistical sampling plans for determining the microbial counts in the final end products. The CCFH, however, was initially more focused on a qualitative approach which looked at the entire food production system and developed codes of practice as well as more descriptive end-product specifications which the WHO argued were 'not scientifically correct'. Drawing upon historical archival material (correspondence and reports) from the WHO and FAO, this article examines this debate over microbial hygiene standards and suggests that there are many lessons from history which could shed light upon current debates and efforts in international food safety management systems and approaches.

  1. The Immunology of Neuromyelitis Optica-Current Knowledge, Clinical Implications, Controversies and Future Perspectives.

    Science.gov (United States)

    Jasiak-Zatonska, Michalina; Kalinowska-Lyszczarz, Alicja; Michalak, Slawomir; Kozubski, Wojciech

    2016-03-02

    Neuromyelitis optica (NMO) is an autoimmune, demyelinating disorder of the central nervous system (CNS) with typical clinical manifestations of optic neuritis and acute transverse myelitis attacks. Previously believed to be a variant of multiple sclerosis (MS), it is now considered an independent disorder which needs to be differentiated from MS. The discovery of autoantibodies against aquaporin-4 (AQP4-IgGs) changed our understanding of NMO immunopathogenesis and revolutionized the diagnostic process. AQP4-IgG is currently regarded as a specific biomarker of NMO and NMO spectrum disorders (NMOsd) and a key factor in its pathogenesis. Nevertheless, AQP4-IgG seronegativity in 10%-25% of NMO patients suggests that there are several other factors involved in NMO immunopathogenesis, i.e., autoantibodies against aquaporin-1 (AQP1-Abs) and antibodies against myelin oligodendrocyte glycoprotein (MOG-IgGs). This manuscript reviews current knowledge about NMO immunopathogenesis, pointing out the controversial issues and showing potential directions for future research. Further efforts should be made to broaden our knowledge of NMO immunology which could have important implications for clinical practice, including the use of potential novel biomarkers to facilitate an early and accurate diagnosis, and modern treatment strategies improving long-term outcome of NMO patients.

  2. The Immunology of Neuromyelitis Optica—Current Knowledge, Clinical Implications, Controversies and Future Perspectives

    Science.gov (United States)

    Jasiak-Zatonska, Michalina; Kalinowska-Lyszczarz, Alicja; Michalak, Slawomir; Kozubski, Wojciech

    2016-01-01

    Neuromyelitis optica (NMO) is an autoimmune, demyelinating disorder of the central nervous system (CNS) with typical clinical manifestations of optic neuritis and acute transverse myelitis attacks. Previously believed to be a variant of multiple sclerosis (MS), it is now considered an independent disorder which needs to be differentiated from MS. The discovery of autoantibodies against aquaporin-4 (AQP4-IgGs) changed our understanding of NMO immunopathogenesis and revolutionized the diagnostic process. AQP4-IgG is currently regarded as a specific biomarker of NMO and NMO spectrum disorders (NMOsd) and a key factor in its pathogenesis. Nevertheless, AQP4-IgG seronegativity in 10%–25% of NMO patients suggests that there are several other factors involved in NMO immunopathogenesis, i.e., autoantibodies against aquaporin-1 (AQP1-Abs) and antibodies against myelin oligodendrocyte glycoprotein (MOG-IgGs). This manuscript reviews current knowledge about NMO immunopathogenesis, pointing out the controversial issues and showing potential directions for future research. Further efforts should be made to broaden our knowledge of NMO immunology which could have important implications for clinical practice, including the use of potential novel biomarkers to facilitate an early and accurate diagnosis, and modern treatment strategies improving long-term outcome of NMO patients. PMID:26950113

  3. Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods.

    Science.gov (United States)

    Viette, Véronique; Fathi, Marc; Rudaz, Serge; Hochstrasser, Denis; Veuthey, Jean-Luc

    2011-07-01

    Abstract Toxicological screening is the analysis of a biological specimen to detect and identify compounds in patients admitted to the hospital with acute intoxication of unknown origin. The screening of a wide range of toxicologically relevant compounds in biological samples is a serious challenge for clinical laboratories. The high selectivity and sensitivity of liquid chromatography coupled to mass spectrometry or tandem mass spectrometry technology provides an attractive alternative to the current methods. For these reasons, an increasing number of applications for multi-target screening or general screening of unknown compounds in biological matrices are being published. This paper is an overview of sample clean-up, chromatographic separation and mass spectrometry detection procedures which can be combined to obtain screening methods adapted to the constraints and needs of various laboratories, and none specifically in clinical toxicology. Currently the techniques are in the hands of specialists, principally in academic institutes. However, the evolution in technology should allow application of the techniques as a tool in toxicology laboratories and thus more widespread exploitation of their potential.

  4. Clinical decision support systems in hospital care using ubiquitous devices: Current issues and challenges.

    Science.gov (United States)

    Baig, Mirza Mansoor; GholamHosseini, Hamid; Moqeem, Aasia A; Mirza, Farhaan; Lindén, Maria

    2017-11-01

    Supporting clinicians in decision making using advanced technologies has been an active research area in biomedical engineering during the past years. Among a wide range of ubiquitous systems, smartphone applications have been increasingly developed in healthcare settings to help clinicians as well as patients. Today, many smartphone applications, from basic data analysis to advanced patient monitoring, are available to clinicians and patients. Such applications are now increasingly integrating into healthcare for clinical decision support, and therefore, concerns around accuracy, stability, and dependency of these applications are rising. In addition, lack of attention to the clinicians' acceptability, as well as the low impact on the medical professionals' decision making, are posing more serious issues on the acceptability of smartphone applications. This article reviews smartphone-based decision support applications, focusing on hospital care settings and their overall impact of these applications on the wider clinical workflow. Additionally, key challenges and barriers of the current ubiquitous device-based healthcare applications are identified. Finally, this article addresses current challenges, future directions, and the adoption of mobile healthcare applications.

  5. Inhaled therapies in patients with moderate COPD in clinical practice: current thinking

    Science.gov (United States)

    Ariel, Amnon; Altraja, Alan; Belevskiy, Andrey; Boros, Piotr W; Danila, Edvardas; Fležar, Matjaz; Koblizek, Vladimir; Fridlender, Zvi G; Kostov, Kosta; Krams, Alvils; Milenkovic, Branislava; Somfay, Attila; Tkacova, Ruzena; Tudoric, Neven; Ulmeanu, Ruxandra; Valipour, Arschang

    2018-01-01

    COPD is a complex, heterogeneous condition. Even in the early clinical stages, COPD carries a significant burden, with breathlessness frequently leading to a reduction in exercise capacity and changes that correlate with long-term patient outcomes and mortality. Implementation of an effective management strategy is required to reduce symptoms, preserve lung function, quality of life, and exercise capacity, and prevent exacerbations. However, current clinical practice frequently differs from published guidelines on the management of COPD. This review focuses on the current scientific evidence and expert opinion on the management of moderate COPD: the symptoms arising from moderate airflow obstruction and the burden these symptoms impose, how physical activity can improve disease outcomes, the benefits of dual bronchodilation in COPD, and the limited evidence for the benefits of inhaled corticosteroids in this disease. We emphasize the importance of maximizing bronchodilation in COPD with inhaled dual-bronchodilator treatment, enhancing patient-related outcomes, and enabling the withdrawal of inhaled corticosteroids in COPD in well-defined patient groups. PMID:29317810

  6. A Systematic Review of Wearable Patient Monitoring Systems - Current Challenges and Opportunities for Clinical Adoption.

    Science.gov (United States)

    Baig, Mirza Mansoor; GholamHosseini, Hamid; Moqeem, Aasia A; Mirza, Farhaan; Lindén, Maria

    2017-07-01

    The aim of this review is to investigate barriers and challenges of wearable patient monitoring (WPM) solutions adopted by clinicians in acute, as well as in community, care settings. Currently, healthcare providers are coping with ever-growing healthcare challenges including an ageing population, chronic diseases, the cost of hospitalization, and the risk of medical errors. WPM systems are a potential solution for addressing some of these challenges by enabling advanced sensors, wearable technology, and secure and effective communication platforms between the clinicians and patients. A total of 791 articles were screened and 20 were selected for this review. The most common publication venue was conference proceedings (13, 54%). This review only considered recent studies published between 2015 and 2017. The identified studies involved chronic conditions (6, 30%), rehabilitation (7, 35%), cardiovascular diseases (4, 20%), falls (2, 10%) and mental health (1, 5%). Most studies focussed on the system aspects of WPM solutions including advanced sensors, wireless data collection, communication platform and clinical usability based on a specific area or disease. The current studies are progressing with localized sensor-software integration to solve a specific use-case/health area using non-scalable and 'silo' solutions. There is further work required regarding interoperability and clinical acceptance challenges. The advancement of wearable technology and possibilities of using machine learning and artificial intelligence in healthcare is a concept that has been investigated by many studies. We believe future patient monitoring and medical treatments will build upon efficient and affordable solutions of wearable technology.

  7. 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.

  8. 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...

  9. The association between current unemployment and clinically determined poor oral health.

    Science.gov (United States)

    Al-Sudani, Fouad Y H; Vehkalahti, Miira M; Suominen, Anna L

    2015-08-01

    The aim of this study was to assess whether current unemployment was associated with poor oral health and whether there was a difference in oral health according to the duration of the current unemployment. As part of the Health 2000 Survey in Finland (a nationwide comprehensive health examination survey), we used its data based on interviews, questionnaires, and clinical oral examinations of the 30- to 63-year-old respondents (n = 4773). Current employment status was measured in its dichotomous form, employed versus unemployed, and length of current unemployment was classified into four categories. We measured oral health in terms of numbers of missing teeth, of sound teeth, of filled teeth, of decayed teeth, and of teeth with deepened periodontal pockets (≥4 mm, ≥6 mm). Poisson regression models were fitted for all oral health outcomes except number of decayed teeth, for which negative binomial regression model was used. Oral health-related behaviors and sociodemographic and socioeconomic factors were added to the analyses. The unemployed subjects had higher numbers of missing teeth, of decayed teeth, and of teeth with periodontal pockets than the employed ones. The association remained consistent even after adjustments. Oral health-related behaviors seemed to mediate the association. We found no association between unemployment and number of sound teeth. Current long-term unemployment showed stronger association with poor oral health than short-term among women. The unemployed can be considered as a risk group for poor oral health. Oral healthcare should be reoriented toward those who are unemployed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Cutaneous leishmaniasis in Syria: clinical features, current status and the effects of war.

    Science.gov (United States)

    Hayani, Kinan; Dandashli, Anwar; Weisshaar, Elke

    2015-01-01

    Cutaneous leishmaniasis (CL) is a worldwide disease caused by an infection with the protozoan parasite Leishmania transmitted via sand flies. It is endemic in many of the poorest countries of all continents. "Aleppo boil" is one of the recognised names given to this disease in the medical literature. Although CL used to be well-controlled and well-documented in Syria, its incidence has dramatically increased since the beginning of the war; however, there is lack of documentation. Here, we present the past and current epidemiological situation of the disease in Syria. We also draw attention to gross and highly unusual clinical variants of CL presented to the Department of Dermatology in Aleppo covering the important differential clinical diagnoses, since this disease is already known to mimic other conditions. Diagnostic procedures and treatment as well as prevention are summarised. Due to the increased ability to travel, and especially the flight of Syrians to neighbouring countries, as well as to Europe, CL may become a new threat in formerly unaffected regions. Through this account, we hope to give weight to the aspiration that CL does not remain a neglected and often clinically overlooked tropical dermatosis.

  11. [Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

    Science.gov (United States)

    Ishida, Haku; Nakamura, Junji; Yoshida, Hiroshi; Koike, Masaru; Inoue, Yuji

    2014-11-01

    We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.

  12. Imaging of Mucosal Inflammation: Current Technological Developments, Clinical Implications, and Future Perspectives

    Directory of Open Access Journals (Sweden)

    Maximilian J. Waldner

    2017-10-01

    Full Text Available In recent years, various technological developments markedly improved imaging of mucosal inflammation in patients with inflammatory bowel diseases. Although technological developments such as high-definition-, chromo-, and autofluorescence-endoscopy led to a more precise and detailed assessment of mucosal inflammation during wide-field endoscopy, probe-based and stationary confocal laser microscopy enabled in vivo real-time microscopic imaging of mucosal surfaces within the gastrointestinal tract. Through the use of fluorochromes with specificity against a defined molecular target combined with endoscopic techniques that allow ultrastructural resolution, molecular imaging enables in vivo visualization of single molecules or receptors during endoscopy. Molecular imaging has therefore greatly expanded the clinical utility and applications of modern innovative endoscopy, which include the diagnosis, surveillance, and treatment of disease as well as the prediction of the therapeutic response of individual patients. Furthermore, non-invasive imaging techniques such as computed tomography, magnetic resonance imaging, scintigraphy, and ultrasound provide helpful information as supplement to invasive endoscopic procedures. In this review, we provide an overview on the current status of advanced imaging technologies for the clinical non-invasive and endoscopic evaluation of mucosal inflammation. Furthermore, the value of novel methods such as multiphoton microscopy, optoacoustics, and optical coherence tomography and their possible future implementation into clinical diagnosis and evaluation of mucosal inflammation will be discussed.

  13. Current status and clinical association of beta-catenin with juvenile nasopharyngeal angiofibroma.

    Science.gov (United States)

    Mishra, A; Singh, V; Verma, V; Pandey, S; Trivedi, R; Singh, H P; Kumar, S; Dwivedi, R C; Mishra, S C

    2016-10-01

    A possible role of the APC/beta-catenin pathway in the pathogenesis of sporadic juvenile nasopharyngeal angiofibroma has been suggested. This paper presents its current status and clinical association in our patients. A prospective observational study was conducted at King George Medical University and Central Drug Research Institute, in Lucknow, India. Western blot analysis was undertaken in 16 cases to examine beta-catenin expression. The clinical details were recorded along with follow up observations, to determine associations. Up-regulation of beta-catenin expression was seen in 69 per cent of cases. The clinical variables did not reveal significant differences between patients with extremes of expression (extreme under- vs over-expression). However, absent expression was shown exclusively in young adults aged over 18 years, while enhanced expression was associated with an altered facial profile. Although a beta-catenin association was seen in a subset of our sporadic juvenile nasopharyngeal angiofibroma cases, its expression was not homogeneous. This is in contrast to the Western literature that suggests a universal (homogenous) enhanced expression in the majority. Hence, further research is required to better define its molecular cascade.

  14. Current status and future prospects of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) clinical trials in ovarian cancer.

    Science.gov (United States)

    Cowan, Renee A; O'Cearbhaill, Roisin E; Zivanovic, Oliver; Chi, Dennis S

    2017-08-01

    The natural history of advanced-stage epithelial ovarian cancer is one of clinical remission after surgery and platinum/taxane-based intravenous (IV) and/or intraperitoneal (IP) chemotherapy followed by early or late recurrence in the majority of patients. Prevention of progression and recurrence remains a major hurdle in the management of ovarian cancer. Recently, many investigators have evaluated the use of normothermic and hyperthermic intraoperative IP drug delivery as a management strategy. This is a narrative review of the current status of clinical trials of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in ovarian cancer and the future directions for this treatment strategy. The existing studies on HIPEC in patients with epithelial ovarian cancer are mostly retrospective in nature, are heterogeneous with regards to combined inclusion of primary and recurrent disease and lack unbiased data. Until data are available from evidence-based trials, it is reasonable to conclude that surgical cytoreduction and HIPEC is a rational and interesting, though still investigative, approach in the management of epithelial ovarian cancer, whose use should be employed within prospective clinical trials.

  15. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review

    Directory of Open Access Journals (Sweden)

    Patrícia do Carmo Silva Parreira

    2014-03-01

    Full Text Available Questions: Is Kinesio Taping more effective than a sham taping/placebo, no treatment or other interventions in people with musculoskeletal conditions? Is the addition of Kinesio Taping to other interventions more effective than other interventions alone in people with musculoskeletal conditions? Design: Systematic review of randomised trials. Participants: People with musculoskeletal conditions. Intervention: Kinesio Taping was compared with sham taping/placebo, no treatment, exercises, manual therapy and conventional physiotherapy. Outcome measures: Pain intensity, disability, quality of life, return to work, and global impression of recovery. Results: Twelve randomised trials involving 495 participants were included in the review. The effectiveness of the Kinesio Taping was tested in participants with: shoulder pain in two trials; knee pain in three trials; chronic low back pain in two trials; neck pain in three trials; plantar fasciitis in one trial; and multiple musculoskeletal conditions in one trial. The methodological quality of eligible trials was moderate, with a mean of 6.1 points on the 10-point PEDro Scale score. Overall, Kinesio Taping was no better than sham taping/placebo and active comparison groups. In all comparisons where Kinesio Taping was better than an active or a sham control group, the effect sizes were small and probably not clinically significant or the trials were of low quality. Conclusion: This review provides the most updated evidence on the effectiveness of the Kinesio Taping for musculoskeletal conditions. The current evidence does not support the use of this intervention in these clinical populations. PROSPERO registration: CRD42012003436. [Parreira PdCS, Costa LdCM, Hespanhol Junior LC, Lopes AD, Costa LOP (2014 Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. Journal of Physiotherapy 60: 31–39

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Customized oligonucleotide microarray gene expression-based classification of neuroblastoma patients outperforms current clinical risk stratification.

    Science.gov (United States)

    Oberthuer, André; Berthold, Frank; Warnat, Patrick; Hero, Barbara; Kahlert, Yvonne; Spitz, Rüdiger; Ernestus, Karen; König, Rainer; Haas, Stefan; Eils, Roland; Schwab, Manfred; Brors, Benedikt; Westermann, Frank; Fischer, Matthias

    2006-11-01

    To develop a gene expression-based classifier for neuroblastoma patients that reliably predicts courses of the disease. Two hundred fifty-one neuroblastoma specimens were analyzed using a customized oligonucleotide microarray comprising 10,163 probes for transcripts with differential expression in clinical subgroups of the disease. Subsequently, the prediction analysis for microarrays (PAM) was applied to a first set of patients with maximally divergent clinical courses (n = 77). The classification accuracy was estimated by a complete 10-times-repeated 10-fold cross validation, and a 144-gene predictor was constructed from this set. This classifier's predictive power was evaluated in an independent second set (n = 174) by comparing results of the gene expression-based classification with those of risk stratification systems of current trials from Germany, Japan, and the United States. The first set of patients was accurately predicted by PAM (cross-validated accuracy, 99%). Within the second set, the PAM classifier significantly separated cohorts with distinct courses (3-year event-free survival [EFS] 0.86 +/- 0.03 [favorable; n = 115] v 0.52 +/- 0.07 [unfavorable; n = 59] and 3-year overall survival 0.99 +/- 0.01 v 0.84 +/- 0.05; both P model, the PAM predictor classified patients of the second set more accurately than risk stratification of current trials from Germany, Japan, and the United States (P < .001; hazard ratio, 4.756 [95% CI, 2.544 to 8.893]). Integration of gene expression-based class prediction of neuroblastoma patients may improve risk estimation of current neuroblastoma trials.

  1. Current role of liquid chromatography-mass spectrometry in clinical and forensic toxicology.

    Science.gov (United States)

    Maurer, Hans H

    2007-08-01

    This paper reviews multi-analyte single-stage and tandem liquid chromatography-mass spectrometry (LC-MS) procedures using different mass analyzers (quadrupole, ion trap, time-of-flight) for screening, identification, and/or quantification of drugs, poisons, and/or their metabolites in blood, plasma, serum, or urine published after 2004. Basic information about the biosample assayed, work-up, LC column, mobile phase, ionization type, mass spectral detection mode, and validation data of each procedure is summarized in tables. The following analytes are covered: drugs of abuse, analgesics, opioids, sedative-hypnotics, benzodiazepines, antidepressants including selective-serotonin reuptake inhibitors (SSRIs), herbal phenalkylamines (ephedrines), oral antidiabetics, antiarrhythmics and other cardiovascular drugs, antiretroviral drugs, toxic alkaloids, quaternary ammonium drugs and herbicides, and dialkylphosphate pesticides. The pros and cons of the reviewed procedures are critically discussed, particularly, the need for studies on matrix effects, selectivity, analyte stability, and the use of stable-isotope labeled internal standards instead of unlabeled therapeutic drugs. In conclusion, LC-MS will probably become a gold standard for detection of very low concentrations particularly in alternative matrices and for quantification in clinical and forensic toxicology. However, some drawbacks still need to be addressed and finally overcome.

  2. 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.

  3. Consensus of best current management: the starting point for clinical quality assessment

    International Nuclear Information System (INIS)

    Hanks, G.E.; Kramer, S.

    1984-01-01

    Consensus of best current management developed by a rational and deliberative process can provide the basis for clinical quality assessment. When it is possible to arrive at consensus in a specific disease, this consensus should detail appropriate pretreatment evaluation and the details of the treatment. Committees of experts for each specific disease site can formulate the consensus and must document their decision based on information from the current world literature. The authors have observed that individuals formulating consensus of best current management do not strictly follow their own criteria, and that compliance in various strata of practice throughout the United States shows a greater deviation from consensus than anticipated and indeed this deviation crosses all types of practice. The authors have observed quite different outcomes for two groups of patients with Hodgkin's disease treated with the same processes (i.e., mantle field technology and adequate radiation dose, etc.). They were unable to identify the reason for an increased failure rate in one group of these patients until they looked at each individual mantle port film from the two groups of patients. They identified that one facility was not including the Hodgkin's disease in the treatment portal due to poor technical performance. This program of process verification may be important in evaluating quality for any disease site

  4. 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.

  5. 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.

  6. 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.

  7. Policies for patient access to clinical data via PHRs: current state and recommendations.

    Science.gov (United States)

    Collins, Sarah A; Vawdrey, David K; Kukafka, Rita; Kuperman, Gilad J

    2011-12-01

    Healthcare delivery organizations are increasingly using online personal health records (PHRs) to provide patients with direct access to their clinical information; however, there may be a lack of consistency in the data made available. We aimed to understand the general use and functionality of PHRs and the organizational policies and decision-making structures for making data available to patients. A cross-sectional survey was administered by telephone structured interview to 21 organizations to determine the types of data made available to patients through PHRs and the presence of explicit governance for PHR data release. Organizations were identified based on a review of the literature, PHR experts, and snowball sampling. Organizations that did not provide patients with electronic access to their data via a PHR were excluded. Interviews were conducted with 17 organizations for a response rate of 81%. Half of the organizations had explicit governance in the form of a written policy that outlined the data types made available to patients. Overall, 88% of the organizations used a committee structure for the decision-making process and included senior management and information services. All organizations sought input from clinicians. Discussion There was considerable variability in the types of clinical data and the time frame for releasing these data to patients. Variability in data release policies may have implications for PHR use and adoption. Future policy activities, such as requirement specification for the latter stages of Meaningful Use, should be leveraged as an opportunity to encourage standardization of functionality and broad deployment of PHRs.

  8. Optical coherence tomography-current technology and applications in clinical and biomedical research.

    Science.gov (United States)

    Marschall, Sebastian; Sander, Birgit; Mogensen, Mette; Jørgensen, Thomas M; Andersen, Peter E

    2011-07-01

    Optical coherence tomography (OCT) is a noninvasive imaging technique that provides real-time two- and three-dimensional images of scattering samples with micrometer resolution. By mapping the local reflectivity, OCT visualizes the morphology of the sample. In addition, functional properties such as birefringence, motion, or the distributions of certain substances can be detected with high spatial resolution. Its main field of application is biomedical imaging and diagnostics. In ophthalmology, OCT is accepted as a clinical standard for diagnosing and monitoring the treatment of a number of retinal diseases, and OCT is becoming an important instrument for clinical cardiology. New applications are emerging in various medical fields, such as early-stage cancer detection, surgical guidance, and the early diagnosis of musculoskeletal diseases. OCT has also proven its value as a tool for developmental biology. The number of companies involved in manufacturing OCT systems has increased substantially during the last few years (especially due to its success in opthalmology), and this technology can be expected to continue to spread into various fields of application.

  9. 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.

  10. 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

  11. 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.

  12. MO-D-213-08: Remote Dosimetric Credentialing for Clinical Trials with the Virtual EPID Standard Phantom Audit (VESPA)

    International Nuclear Information System (INIS)

    Lehmann, J; Miri, N; Vial, P; Hatton, J; Zwan, B; Sloan, K; Craig, A; Beenstock, V; Molloy, T; Greer, P

    2015-01-01

    Purpose: Report on implementation of a Virtual EPID Standard Phantom Audit (VESPA) for IMRT to support credentialing of facilities for clinical trials. Data is acquired by local facility staff and transferred electronically. Analysis is performed centrally. Methods: VESPA is based on published methods and a clinically established IMRT QA procedure, here extended to multi-vendor equipment. Facilities, provided with web-based comprehensive instructions and CT datasets, create IMRT treatment plans. They deliver the treatments directly to their EPID without phantom or couch in the beam. They also deliver a set of simple calibration fields. Collected EPID images are uploaded electronically. In the analysis, the dose is projected back into a virtual phantom and 3D gamma analysis is performed. 2D dose planes and linear dose profiles can be analysed when needed for clarification. Results: Pilot facilities covering a range of planning and delivery systems have performed data acquisition and upload successfully. Analysis showed agreement comparable to local experience with the method. Advantages of VESPA are (1) fast turnaround mainly driven by the facility’s capability to provide the requested EPID images, (2) the possibility for facilities performing the audit in parallel, as there is no need to wait for a phantom, (3) simple and efficient credentialing for international facilities, (4) a large set of data points, and (5) a reduced impact on resources and environment as there is no need to transport heavy phantoms or audit staff. Limitations of the current implementation of VESPA for trials credentialing are that it does not provide absolute dosimetry, therefore a Level 1 audit still required, and that it relies on correctly delivered open calibration fields, which are used for system calibration. Conclusion: The implemented EPID based IMRT audit system promises to dramatically improve credentialing efficiency for clinical trials and wider applications. VESPA for VMAT

  13. MO-D-213-08: Remote Dosimetric Credentialing for Clinical Trials with the Virtual EPID Standard Phantom Audit (VESPA)

    Energy Technology Data Exchange (ETDEWEB)

    Lehmann, J [Calvary Mater Newcastle, Newcastle, NSW (Australia); University of Sydney, Sydney, NSW (Australia); Miri, N [University of Newcastle, Newcastle, NSW (Australia); Vial, P [Liverpool Hospital, Liverpool, NSW (Australia); Hatton, J [Trans Tasman Radiation Oncology Group (TROG), Newcastle, NSW (Australia); Zwan, B; Sloan, K [Gosford Hospital, Gosford, NSW (Australia); Craig, A; Beenstock, V [Canterbury Regional Cancer and Haematology Service, Christchurch (New Zealand); Molloy, T [Orange Hospital, Orange, NSW (Australia); Greer, P [Calvary Mater Newcastle, Newcastle, NSW (Australia); University of Newcastle, Newcastle, NSW (Australia)

    2015-06-15

    Purpose: Report on implementation of a Virtual EPID Standard Phantom Audit (VESPA) for IMRT to support credentialing of facilities for clinical trials. Data is acquired by local facility staff and transferred electronically. Analysis is performed centrally. Methods: VESPA is based on published methods and a clinically established IMRT QA procedure, here extended to multi-vendor equipment. Facilities, provided with web-based comprehensive instructions and CT datasets, create IMRT treatment plans. They deliver the treatments directly to their EPID without phantom or couch in the beam. They also deliver a set of simple calibration fields. Collected EPID images are uploaded electronically. In the analysis, the dose is projected back into a virtual phantom and 3D gamma analysis is performed. 2D dose planes and linear dose profiles can be analysed when needed for clarification. Results: Pilot facilities covering a range of planning and delivery systems have performed data acquisition and upload successfully. Analysis showed agreement comparable to local experience with the method. Advantages of VESPA are (1) fast turnaround mainly driven by the facility’s capability to provide the requested EPID images, (2) the possibility for facilities performing the audit in parallel, as there is no need to wait for a phantom, (3) simple and efficient credentialing for international facilities, (4) a large set of data points, and (5) a reduced impact on resources and environment as there is no need to transport heavy phantoms or audit staff. Limitations of the current implementation of VESPA for trials credentialing are that it does not provide absolute dosimetry, therefore a Level 1 audit still required, and that it relies on correctly delivered open calibration fields, which are used for system calibration. Conclusion: The implemented EPID based IMRT audit system promises to dramatically improve credentialing efficiency for clinical trials and wider applications. VESPA for VMAT

  14. [Materials/Biomaterials in Clinical Practice - a Short Review and Current Trends].

    Science.gov (United States)

    Bolle, T; Meyer, F; Walcher, F; Lohmann, C; Jockenhövel, S; Gries, T; Hoffmann, W

    2017-04-01

    Biomaterials play a major role in interventional medicine and surgery. However, the development of biomaterials is still in its early phases in spite of the huge progress made within the last decades. On the one hand, this is because our knowledge of the molecular and cellular processes associated with biomaterials is still increasing exponentially. On the other hand, a wide variety of advanced materials with highly interesting properties is being developed currently. This review provides a short introduction into the variety of materials in use as well as their application in interventional medicine and surgery. Also the importance of biomaterials for tissue engineering in the field of regenerative medicine and the functionalisation of biomaterials, including sterilisation methods are discussed. For the future, an even broader interdisciplinary scientific collaboration is necessary in order to develop novel biomaterials and facilitate their translation into clinical practice. Georg Thieme Verlag KG Stuttgart · New York.

  15. Tissue engineered vascular grafts: Origins, development, and current strategies for clinical application.

    Science.gov (United States)

    Benrashid, Ehsan; McCoy, Christopher C; Youngwirth, Linda M; Kim, Jina; Manson, Roberto J; Otto, James C; Lawson, Jeffrey H

    2016-04-15

    Since the development of a dependable and durable synthetic non-autogenous vascular conduit in the mid-twentieth century, the field of vascular surgery has experienced tremendous growth. Concomitant with this growth, development in the field of bioengineering and the development of different tissue engineering techniques have expanded the armamentarium of the surgeon for treating a variety of complex cardiovascular diseases. The recent development of completely tissue engineered vascular conduits that can be implanted for clinical application is a particularly exciting development in this field. With the rapid advances in the field of tissue engineering, the great hope of the surgeon remains that this conduit will function like a true blood vessel with an intact endothelial layer, with the ability to respond to endogenous vasoactive compounds. Eventually, these engineered tissues may have the potential to supplant older organic but not truly biologic technologies, which are used currently. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Improving performance in golf: current research and implications from a clinical perspective.

    Science.gov (United States)

    Evans, Kerrie; Tuttle, Neil

    2015-01-01

    Golf, a global sport enjoyed by people of all ages and abilities, involves relatively long periods of low intensity exercise interspersed with short bursts of high intensity activity. To meet the physical demands of full swing shots and the mental and physical demands of putting and walking the course, it is frequently recommended that golfers undertake golf-specific exercise programs. Biomechanics, motor learning, and motor control research has increased the understanding of the physical requirements of the game, and using this knowledge, exercise programs aimed at improving golf performance have been developed. However, while it is generally accepted that an exercise program can improve a golfer's physical measurements and some golf performance variables, translating the findings from research into clinical practice to optimise an individual golfer's performance remains challenging. This paper discusses how biomechanical and motor control research has informed current practice and discusses how emerging sophisticated tools and research designs may better assist golfers improve their performance.

  17. SHORT OVERVIEW OF CLINICAL TRIALS WITH CURRENT IMMUNOTHERAPEUTIC TOOLS FOR CANCER TREATMENT

    Directory of Open Access Journals (Sweden)

    T. S. Nepomnyashchikh

    2017-01-01

    Full Text Available Over last decade, a substantial progress has been made, with respect to understanding of cancer biology and its interplay with the host immune system. Different immunotherapeutic drugs based on recombinant cytokines and monoclonal antibodies are widely used in cancer therapy, and a large number of experimental cancer treatments have been developed, many of which are currently undergoing various stages of clinical trials. Recent endorsement of a recombinant oncolytic herpesvirus T-VEC for the treatment of melanoma was an important step towards a more safe and efficient anticancer therapeutics. In this review, we shall mention only some of the most promising cancer immunotherapy strategies, namely, immune checkpoint inhibitors, cellular therapy and oncolytic viruses. 

  18. 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

  19. [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".

  20. Current Evidence for Clinical Efficacy of Platelet Rich Plasma in Aesthetic Surgery: A Systematic Review.

    Science.gov (United States)

    Frautschi, Russell S; Hashem, Ahmed M; Halasa, Brianna; Cakmakoglu, Cagri; Zins, James E

    2017-03-01

    Platelet rich plasma (PRP) has attracted attention in a number of surgical fields due to a wide variety of potential clinical benefits. Yet PRP has not gained wide popularity in aesthetic surgery as a result of uncertainty surrounding objective clinical evidence. We aim to describe the current applications, define preparation and activation, explore effectiveness, and propose a classification system to facilitate comparisons across studies. A comprehensive review of the literature regarding the use of platelet rich plasma in aesthetic surgery was performed. Data gathered included: PRP application, study type, subject number, centrifugation, anticoagulation, activation, PRP composition, and outcomes. Thirty-eight reports were identified. Applications included injection into aging skin (29%), scalp alopecia (26%), lipofilling (21%), fractional laser (13%), and facial surgery (11%). The majority of studies (53%) were case series without controls. Leucocytes were sparsely defined (32%). The concentration of injected and/or baseline platelets was rarely clarified (18%). The mechanism of activation was described in 27 studies (71%), while anticoagulation was uncommonly elucidated (47%). While most studies (95%) claim effectiveness, objective measures were only utilized in 17 studies (47%). Current studies produce context-dependent results with a lack of consistent reporting of PRP preparation, composition, and activation in aesthetic applications, making meaningful meta-analysis unrealistic. Thus the method of PRP preparation warrants increased attention. We recommend a set of descriptors, FIT PAAW (described below), to produce scientifically grounded conclusions, facilitating a clearer understanding of the situations in which PRP is effective. 4 © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com

  1. 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

  2. A review of multidisciplinary clinical practice guidelines in suicide prevention: toward an emerging standard in suicide risk assessment and management, training and practice.

    Science.gov (United States)

    Bernert, Rebecca A; Hom, Melanie A; Roberts, Laura Weiss

    2014-10-01

    The current paper aims to: (1) examine clinical practice guidelines in suicide prevention across fields, organizations, and clinical specialties and (2) inform emerging standards in clinical practice, research, and training. The authors conducted a systematic literature review to identify clinical practice guidelines and resource documents in suicide prevention and risk management. The authors used PubMed, Google Scholar, and Google Search, and keywords included: clinical practice guideline, practice guideline, practice parameters, suicide, suicidality, suicidal behaviors, assessment, and management. To assess for commonalities, the authors reviewed guidelines and resource documents across 13 key content categories and assessed whether each document suggested validated assessment measures. The search generated 101 source documents, which included N = 10 clinical practice guidelines and N = 12 additional resource documents (e.g., non-formalized guidelines, tool-kits). All guidelines (100 %) provided detailed recommendations for the use of evidence-based risk factors and protective factors, 80 % provided brief (but not detailed) recommendations for the assessment of suicidal intent, and 70 % recommended risk management strategies. By comparison, only 30 % discussed standardization of risk-level categorizations and other content areas considered central to best practices in suicide prevention (e.g., restricting access to means, ethical considerations, confidentiality/legal issues, training, and postvention practices). Resource documents were largely consistent with these findings. Current guidelines address similar aspects of suicide risk assessment and management, but significant discrepancies exist. A lack of consensus was evident in recommendations across core competencies, which may be improved by increased standardization in practice and training. Additional resources appear useful for supplemental use.

  3. Prognostic Modeling in Pathologic N1 Breast Cancer Without Elective Nodal Irradiation After Current Standard Systemic Management.

    Science.gov (United States)

    Yu, Jeong Il; Park, Won; Choi, Doo Ho; Huh, Seung Jae; Nam, Seok Jin; Kim, Seok Won; Lee, Jeong Eon; Kil, Won Ho; Im, Young-Hyuck; Ahn, Jin Seok; Park, Yeon Hee; Cho, Eun Yoon

    2015-08-01

    This study was conducted to establish a prognostic model in patients with pathologic N1 (pN1) breast cancer who have not undergone elective nodal irradiation (ENI) under the current standard management and to suggest possible indications for ENI. We performed a retrospective study with patients with pN1 breast cancer who received the standard local and preferred adjuvant chemotherapy treatment without neoadjuvant chemotherapy and ENI from January 2005 to June 2011. Most of the indicated patients received endocrine and trastuzumab therapy. In 735 enrolled patients, the median follow-up period was 58.4 months (range, 7.2-111.3 months). Overall, 55 recurrences (7.4%) developed, and locoregional recurrence was present in 27 patients (3.8%). Recurrence-free survival was significantly related to lymphovascular invasion (P = .04, hazard ratio [HR], 1.83; 95% confidence interval [CI], 1.03-2.88), histologic grade (P = .03, HR, 2.57; 95% CI, 1.05-6.26), and nonluminal A subtype (P = .02, HR, 3.04; 95% CI, 1.23-7.49) in multivariate analysis. The prognostic model was established by these 3 prognostic factors. Recurrence-free survival was less than 90% at 5 years in cases with 2 or 3 factors. The prognostic model has stratified risk groups in pN1 breast cancer without ENI. Patients with 2 or more factors should be considered for ENI. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Utilization study of antidiabetic agents in a teaching hospital of Sikkim and adherence to current standard treatment guidelines.

    Science.gov (United States)

    Satpathy, Sushrut Varun; Datta, Supratim; Upreti, Binu

    2016-01-01

    Diabetes has gradually emerged as one of the most serious public health problems in our country. This underlines the need for timely disease detection and decisive therapeutic intervention. This prospective cross-sectional observational study aims at analyzing the utilization pattern of antidiabetic agents in a remote North-East Indian tertiary care teaching hospital in the perspective of current standard treatment guidelines. Diabetic patients receiving antidiabetic medication, both as outpatients and inpatients in our hospital over a period of 12 months (May 2013-May 2014), were included in this study. The data obtained were sorted and analyzed on the basis of gender, type of therapy, and hospital setting. A total of 310 patients were included in the study. Metformin was the single most frequently prescribed antidiabetic agent (66.8%) followed by the sulfonylureas group (37.4%). Insulin was prescribed in 23.2% of the patients. Combination antidiabetic drug therapy (65.1%) was used more frequently than monotherapy (34.8%). The use of biguanides (P standard treatment guidelines. Increased use of generic drugs is an area with scope for improvement.

  5. Human iPS Cell-Derived Germ Cells: Current Status and Clinical Potential

    Directory of Open Access Journals (Sweden)

    Tetsuya Ishii

    2014-10-01

    Full Text Available Recently, fertile spermatozoa and oocytes were generated from mouse induced pluripotent (iPS cells using a combined in vitro and in vivo induction system. With regard to germ cell induction from human iPS cells, progress has been made particularly in the male germline, demonstrating in vitro generation of haploid, round spermatids. Although iPS-derived germ cells are expected to be developed to yield a form of assisted reproductive technology (ART that can address unmet reproductive needs, genetic and/or epigenetic instabilities abound in iPS cell generation and germ cell induction. In addition, there is still room to improve the induction protocol in the female germline. However, rapid advances in stem cell research are likely to make such obstacles surmountable, potentially translating induced germ cells into the clinical setting in the immediate future. This review examines the current status of the induction of germ cells from human iPS cells and discusses the clinical potential, as well as future directions.

  6. The Current Status of The Clinical Application of Radioisotope in Korea

    International Nuclear Information System (INIS)

    Lee, Myung Chul

    1987-01-01

    The medical application of radioisotope started in the western countries in the 1920's but the first successful clinical use of Nuclear Medicine in Korea was made in June, 1959, through the treatment of a patient with hyperthyroidism using radioactive iodine. However, keeping pace with the brilliant international development of nuclear medicine, nuclear medicine in Korea has remarkably grown scientifically; The Korean Society of Nuclear Medicine was organized in 1961, The Radiology Science Institute attached to the Korea Atomic Energy Research Institute, the predecessor of the Korea Cancer Center Hospital, was established in 1963, and The Korean Journal of Nuclear Medicine published its first issue in 1967. Furthermore, the active studies using radioisotopes and the vigorous interchanges of information with foreign countries had increased so steadily and remarkably that we could hold the 3rd Asia and Oceania Congress of Nuclear Medicine in 1984. In Korea, Nuclear Medicine has now settled as a field of a science which interests lots of medical doctors and scientists. However, I cannot deny the fact that the progress of the development of Nuclear Medicine in Korea tends to defer relatively to that of the western countries, which is naturally a very active one, in many respects. I here would like to analyze the current status of clinical application of radioisotope in Korea, find the problems and present their solutions

  7. Bipolar disorder and complementary medicine: current evidence, safety issues, and clinical considerations.

    Science.gov (United States)

    Sarris, Jerome; Lake, James; Hoenders, Rogier

    2011-10-01

    Bipolar disorder (BD) is a debilitating syndrome that is often undiagnosed and undertreated. Population surveys show that persons with BD often self-medicate with complementary and alternative medicine (CAM) or integrative therapies in spite of limited research evidence supporting their use. To date, no review has focused specifically on nonconventional treatments of BD. The study objectives were to present a review of nonconventional (complementary and integrative) interventions examined in clinical trials on BD, and to offer provisional guidelines for the judicious integrative use of CAM in the management of BD. PubMed, CINAHL,(®) Web of Science, and Cochrane Library databases were searched for human clinical trials in English during mid-2010 using Bipolar Disorder and CAM therapy and CAM medicine search terms. Effect sizes (Cohen's d) were also calculated where data were available. Several positive high-quality studies on nutrients in combination with conventional mood stabilizers and antipsychotic medications in BD depression were identified, while branched-chain amino acids and magnesium were effective (small studies) in attenuating mania in BD. In the treatment of bipolar depression, evidence was mixed regarding omega-3, while isolated studies provide provisional support for a multinutrient formula, n-acetylcysteine, and l-tryptophan. In one study, acupuncture was found to have favorable but nonsignificant effects on mania and depression outcomes. Current evidence supports the integrative treatment of BD using combinations of mood stabilizers and select nutrients. Other CAM or integrative modalities used to treat BD have not been adequately explored to date; however, some early findings are promising. Select CAM and integrative interventions add to established conventional treatment of BD and may be considered when formulating a treatment plan. It is hoped that the safety issues and clinical considerations addressed in this article may encourage the practice

  8. Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

    Directory of Open Access Journals (Sweden)

    Natesan SK

    2016-12-01

    Full Text Available Suganthini Krishnan Natesan,1,2 Pranatharthi H Chandrasekar1 1Division of Infectious Diseases, Department of Internal Medicine, Wayne State University, 2John D Dingell VA Medical Center, Detroit, MI, USA Abstract: The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. Keywords: isavuconazole, aspergillosis, mucormycosis, efficacy, antifungal therapy, novel azole, tolerability, drug interactions

  9. Lymphoma: current status of clinical and preclinical imaging with radiolabeled antibodies

    Energy Technology Data Exchange (ETDEWEB)

    England, Christopher G. [University of Wisconsin School of Medicine and Public Health, Department of Medical Physics, Madison, WI (United States); Rui, Lixin [University of Wisconsin School of Medicine and Public Health, Department of Medicine, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Carbone Cancer Center, Madison, WI (United States); Cai, Weibo [University of Wisconsin School of Medicine and Public Health, Department of Medical Physics, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Carbone Cancer Center, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Department of Radiology, Madison, WI (United States)

    2017-03-15

    Lymphoma is a complex disease that arises from cells of the immune system with an intricate pathology. While lymphoma may be classified as Hodgkin or non-Hodgkin, each type of tumor is genetically and phenotypically different and highly invasive tissue biopsies are the only method to investigate these differences. Noninvasive imaging strategies, such as immunoPET, can provide a vital insight into disease staging, monitoring treatment response in patients, and dose planning in radioimmunotherapy. ImmunoPET imaging with radiolabeled antibody-based tracers may also assist physicians in optimizing treatment strategies and enhancing patient stratification. Currently, there are two common biomarkers for molecular imaging of lymphoma, CD20 and CD30, both of which have been considered for investigation in preclinical imaging studies. In this review, we examine the current status of both preclinical and clinical imaging of lymphoma using radiolabeled antibodies. Additionally, we briefly investigate the role of radiolabeled antibodies in lymphoma therapy. As radiolabeled antibodies play critical roles in both imaging and therapy of lymphoma, the development of novel antibodies and the discovery of new biomarkers may greatly affect lymphoma imaging and therapy in the future. (orig.)

  10. Lymphoma: current status of clinical and preclinical imaging with radiolabeled antibodies

    International Nuclear Information System (INIS)

    England, Christopher G.; Rui, Lixin; Cai, Weibo

    2017-01-01

    Lymphoma is a complex disease that arises from cells of the immune system with an intricate pathology. While lymphoma may be classified as Hodgkin or non-Hodgkin, each type of tumor is genetically and phenotypically different and highly invasive tissue biopsies are the only method to investigate these differences. Noninvasive imaging strategies, such as immunoPET, can provide a vital insight into disease staging, monitoring treatment response in patients, and dose planning in radioimmunotherapy. ImmunoPET imaging with radiolabeled antibody-based tracers may also assist physicians in optimizing treatment strategies and enhancing patient stratification. Currently, there are two common biomarkers for molecular imaging of lymphoma, CD20 and CD30, both of which have been considered for investigation in preclinical imaging studies. In this review, we examine the current status of both preclinical and clinical imaging of lymphoma using radiolabeled antibodies. Additionally, we briefly investigate the role of radiolabeled antibodies in lymphoma therapy. As radiolabeled antibodies play critical roles in both imaging and therapy of lymphoma, the development of novel antibodies and the discovery of new biomarkers may greatly affect lymphoma imaging and therapy in the future. (orig.)

  11. Achieving transparency in carbon labelling for construction materials – Lessons from current assessment standards and carbon labels

    International Nuclear Information System (INIS)

    Wu, Peng; Low, Sui Pheng; Xia, Bo; Zuo, Jian

    2014-01-01

    Highlights: • The evolution of international GHG standards is reviewed. • The evolution of international carbon labelling schemes is reviewed. • The transparency requirements in carbon labelling schemes are revealed. • Key recommendations are provided to improve transparency in carbon labelling. - Abstract: The construction industry is one of the largest sources of carbon emissions. Manufacturing of raw materials, such as cement, steel and aluminium, is energy intensive and has considerable impact on carbon emissions level. Due to the rising recognition of global climate change, the industry is under pressure to reduce carbon emissions. Carbon labelling schemes are therefore developed as meaningful yardsticks to measure and compare carbon emissions. Carbon labelling schemes can help switch consumer-purchasing habits to low-carbon alternatives. However, such switch is dependent on a transparent scheme. The principle of transparency is highlighted in all international greenhouse gas (GHG) standards, including the newly published ISO 14067: Carbon footprint of products – requirements and guidelines for quantification and communication. However, there are few studies which systematically investigate the transparency requirements in carbon labelling schemes. A comparison of five established carbon labelling schemes, namely the Singapore Green Labelling Scheme, the CarbonFree (the U.S.), the CO 2 Measured Label and the Reducing CO 2 Label (UK), the CarbonCounted (Canada), and the Hong Kong Carbon Labelling Scheme is therefore conducted to identify and investigate the transparency requirements. The results suggest that the design of current carbon labels have transparency issues relating but not limited to the use of a single sign to represent the comprehensiveness of the carbon footprint. These transparency issues are partially caused by the flexibility given to select system boundary in the life cycle assessment (LCA) methodology to measure GHG emissions. The

  12. “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

  13. 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

  14. Alternatives to current flow cytometry data analysis for clinical and research studies.

    Science.gov (United States)

    Gondhalekar, Carmen; Rajwa, Bartek; Patsekin, Valery; Ragheb, Kathy; Sturgis, Jennifer; Robinson, J Paul

    2018-02-01

    Flow cytometry has well-established methods for data analysis based on traditional data collection techniques. These techniques typically involved manual insertion of tube samples into an instrument that, historically, could only measure 1-3 colors. The field has since evolved to incorporate new technologies for faster and highly automated sample preparation and data collection. For example, the use of microwell plates on benchtop instruments is now a standard on virtually every new instrument, and so users can easily accumulate multiple data sets quickly. Further, because the user must carefully define the layout of the plate, this information is already defined when considering the analytical process, expanding the opportunities for automated analysis. Advances in multi-parametric data collection, as demonstrated by the development of hyperspectral flow-cytometry, 20-40 color polychromatic flow cytometry, and mass cytometry (CyTOF), are game-changing. As data and assay complexity increase, so too does the complexity of data analysis. Complex data analysis is already a challenge to traditional flow cytometry software. New methods for reviewing large and complex data sets can provide rapid insight into processes difficult to define without more advanced analytical tools. In settings such as clinical labs where rapid and accurate data analysis is a priority, rapid, efficient and intuitive software is needed. This paper outlines opportunities for analysis of complex data sets using examples of multiplexed bead-based assays, drug screens and cell cycle analysis - any of which could become integrated into the clinical environment. Copyright © 2017. Published by Elsevier Inc.

  15. Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

    Science.gov (United States)

    Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

    2011-03-01

    Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  16. How to use current practice, risk analysis and standards to define hospital-wide policies on the safe use of infusion technology.

    Science.gov (United States)

    Timmerman, Annemoon M; Oliveira-Martens, Suzanne M; Snijder, Roland A; Nieman, Anders K; Egberts, Toine C

    2015-08-01

    Infusion therapy is widely used in hospitals. It is well known that medication errors constitute one of the highest risks to patient safety, leading to numerous adverse events concerning incorrect application of infusion technology. Both clinical practice and in vitro studies show that infusion of multiple medications via one access point induces unwanted phenomena such as backflow and an incorrect system response to interventions. Within the Metrology for Drug Delivery project, we addressed the role of infusion devices in drug delivery. We surveyed current practices for application in hospitals to provide input to standards and quality norms for the materials used in infusion technology. Furthermore, we organized meetings with clinicians and other relevant stakeholders to set up a risk analysis-based infusion policy, accompanied by easy to access operating procedures on infusion technology. It was found difficult to establish clear-cut infusion safety guidelines based on quantitative data because of the many different application areas and stakeholders. However, both the expert team and the survey indicated the value of multidisciplinary qualitative discussion for defining best practices. We advise to incorporate specific requirements on infusion devices in protocols and standards, adjusted to specific applications, to ensure safe use of infusion technology.

  17. CLAIM (CLinical Accounting InforMation)--an XML-based data exchange standard for connecting electronic medical record systems to patient accounting systems.

    Science.gov (United States)

    Guo, Jinqiu; Takada, Akira; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Takahashi, Kiwamu; Daimon, Hiroyuki; Suzuki, Toshiaki; Nakashima, Yusei; Araki, Kenji; Yoshihara, Hiroyuki

    2005-08-01

    With the evolving and diverse electronic medical record (EMR) systems, there appears to be an ever greater need to link EMR systems and patient accounting systems with a standardized data exchange format. To this end, the CLinical Accounting InforMation (CLAIM) data exchange standard was developed. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data among different medical institutions. CLAIM uses eXtensible Markup Language (XML) as a meta-language. The current version, 2.1, inherited the basic structure of MML 2.x and contains two modules including information related to registration, appointment, procedure and charging. CLAIM 2.1 was implemented successfully in Japan in 2001. Consequently, it was confirmed that CLAIM could be used as an effective data exchange format between EMR systems and patient accounting systems.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Pioneering a new role: the beginning, current practice and future of the Clinical Nurse Leader.

    Science.gov (United States)

    Poulin-Tabor, Danielle; Quirk, Rebecca L; Wilson, Lauri; Orff, Sonja; Gallant, Paulette; Swan, Nina; Manchester, Nicole

    2008-07-01

    To discuss the development of a new nursing role in response to the health care crisis in the United States. The nursing shortage and fragmentation of care has contributed to the need for nurses who are prepared to laterally integrate care, bring evidence-based practice to the bedside and provide continuity of care to patients and families. The CNLs review the literature, share their experiences, and discuss outcomes related to improved quality of care. Having clinical nurses with a global perspective acting as facilitators and integrators of care is essential to maintaining a high standard of care. Organizational and management support is critical. The more CNLs that can be embedded in an institution, the more successful the role can be. The varied utilization of the CNLs in this practice setting has proven its value in a short period of time and facilitated better communication and collaboration among patients and their health care team. The flexibility and broad scope of this role allows for its use in any practice setting to realize gains in quality outcomes, cost savings, improved patient flow, increased safety, nurse satisfaction and increasing organizational capacity.

  4. Echocardiographic assessment of the right ventricle in the current era: Application in clinical practice.

    Science.gov (United States)

    Venkatachalam, Sridhar; Wu, Geru; Ahmad, Masood

    2017-12-01

    The right ventricle has unique structural and functional characteristics. It is now well recognized that the so-called forgotten ventricle is a key player in cardiovascular physiology. Furthermore, there is accumulating evidence that demonstrates right ventricular dysfunction as an important marker of morbidity and mortality in several commonly encountered clinical situations such as heart failure, pulmonary hypertension, pulmonary embolism, right ventricular myocardial infarction, and adult congenital heart disease. In contrast to the left ventricle, echocardiographic assessment of right ventricular function is more challenging as volume estimations are not possible without the use of three-dimensional (3D) echocardiography. Guidelines on chamber quantification provide a standardized approach to assessment of the right ventricle. The technique and limitations of each of the parameters for RV size and function need to be fully understood. In this era of multimodality imaging, echocardiography continues to remain a useful tool for the initial assessment and follow-up of patients with right heart pathology. Several novel approaches such as 3D and strain imaging of the right ventricle have expanded the usefulness of this indispensable modality. © 2017, Wiley Periodicals, Inc.

  5. Global women's health: current clinical trials in low- and middle-income countries.

    Science.gov (United States)

    Merriel, A; Harb, H M; Williams, H; Lilford, R; Coomarasamy, A

    2015-01-01

    Clinical trials in low- and middle-income countries (LMICs) are necessary to develop evidence-based approaches to improve women's health. Understanding what research is currently being conducted will allow the identification of research gaps, avoidance of duplication, planning of future studies, collaboration amongst research groups, and geographical targeting for research investments. To provide an overview of active women's health trials in LMICs. The World Health Organization's International Clinical Trials Registry Platform was searched for trials registered between 1 April 2012 and 31 March 2014. Selected trials were randomised, conducted in LMICs, active, and with a women's health intervention or a significant outcome for the woman. Two reviewers extracted data. Analysis included geographical spread, speciality areas, pre-enrolment registration, study size, and funders. Of the 8966 records, 509 were eligible for inclusion. Gynaecology trials made up 57% of the research, whereas the remaining 43% of trials were in obstetrics. Research activity focused on fertility (17%), the antenatal period (15%), benign gynaecology (14%), intrapartum care (9%), and pre-invasive disease and cancers (8%). The majority of trials (84%) took place in middle-income countries (MICs). In low-income countries (LICs) 83% of research investigated obstetrics, and in MICs 60% of research investigated gynaecology. Most trials (80%) had a sample size of 500 or fewer participants. The median size of trials in LICs was 815 compared with 128 in MICs. Pre-enrolment registration occurred in 54% of trials. The majority (62%) of trials were funded locally. Many LMICs are active in women's health research. The majority of registered trials are located in MICs; however, the trials in LICs are often larger. The focus of research in MICs may be driven by local priorities and funding, with fertility being highly researched. In LICs, pregnancy is the focus, perhaps reflecting the international

  6. Clinical experimentation with aerosol antibiotics: current and future methods of administration

    Directory of Open Access Journals (Sweden)

    Zarogoulidis P

    2013-10-01

    Full Text Available Paul Zarogoulidis,1,2 Ioannis Kioumis,1 Konstantinos Porpodis,1 Dionysios Spyratos,1 Kosmas Tsakiridis,3 Haidong Huang,4 Qiang Li,4 J Francis Turner,5 Robert Browning,6 Wolfgang Hohenforst-Schmidt,7 Konstantinos Zarogoulidis1 1Pulmonary Department, G Papanikolaou General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; 2Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Hospital, University Duisburg-Essen, Essen, Germany; 3Cardiothoracic Surgery Department, Saint Luke Private Hospital of Health Excellence, Thessaloniki, Greece; 4Department of Respiratory Diseases, Shanghai Hospital/First Affiliated Hospital of the Second Military Medical University, Shanghai, People’s Republic of China; 5Pulmonary Medicine, University of Nevada School of Medicine, National Supercomputing Center for Energy and the Environment University of Nevada, Las Vegas, NV, USA; 6Pulmonary and Critical Care Medicine, Interventional Pulmonology, National Naval Medical Center, Walter Reed Army Medical Center, Bethesda, MD, USA; 7II Medical Department, Regional Clinic of Coburg, University of Wuerzburg, Coburg, Germany Abstract: Currently almost all antibiotics are administered by the intravenous route. Since several systems and situations require more efficient methods of administration, investigation and experimentation in drug design has produced local treatment modalities. Administration of antibiotics in aerosol form is one of the treatment methods of increasing interest. As the field of drug nanotechnology grows, new molecules have been produced and combined with aerosol production systems. In the current review, we discuss the efficiency of aerosol antibiotic studies along with aerosol production systems. The different parts of the aerosol antibiotic methodology are presented. Additionally, information regarding the drug molecules used is presented and future applications of this method are discussed

  7. Current practices in clinical neurofeedback with functional MRI-Analysis of a survey using the TIDieR checklist.

    Science.gov (United States)

    Randell, Elizabeth; McNamara, Rachel; Subramanian, Leena; Hood, Kerenza; Linden, David

    2018-04-01

    A core principle of creating a scientific evidence base is that results can be replicated in independent experiments and in health intervention research. The TIDieR (Template for Intervention Description and Replication) checklist has been developed to aid in summarising key items needed when reporting clinical trials and other well designed evaluations of complex interventions in order that findings can be replicated or built on reliably. Neurofeedback (NF) using functional MRI (fMRI) is a multicomponent intervention that should be considered a complex intervention. The TIDieR checklist (with minor modification to increase applicability in this context) was distributed to NF researchers as a survey of current practice in the design and conduct of clinical studies. The aim was to document practice and convergence between research groups, highlighting areas for discussion and providing a basis for recommendations for harmonisation and standardisation. The TIDieR checklist was interpreted and expanded (21 questions) to make it applicable to neurofeedback research studies. Using the web-based Bristol Online Survey (BOS) tool, the revised checklist was disseminated to researchers in the BRAINTRAIN European research collaborative network (supported by the European Commission) and others in the fMRI-neurofeedback community. There were 16 responses to the survey. Responses were reported under eight main headings which covered the six domains of the TIDieR checklist: What, Why, When, How, Where and Who. This piece of work provides encouraging insight into the ability to be able to map neuroimaging interventions to a structured framework for reporting purposes. Regardless of the considerable variability of design components, all studies could be described in standard terms of diagnostic groups, dose/duration, targeted areas/signals, and psychological strategies and learning models. Recommendations are made which include providing detailed rationale of intervention design in

  8. 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)

  9. Clinical symptoms, signs and tests for identification of impending and current water-loss dehydration in older people.

    Science.gov (United States)

    Hooper, Lee; Abdelhamid, Asmaa; Attreed, Natalie J; Campbell, Wayne W; Channell, Adam M; Chassagne, Philippe; Culp, Kennith R; Fletcher, Stephen J; Fortes, Matthew B; Fuller, Nigel; Gaspar, Phyllis M; Gilbert, Daniel J; Heathcote, Adam C; Kafri, Mohannad W; Kajii, Fumiko; Lindner, Gregor; Mack, Gary W; Mentes, Janet C; Merlani, Paolo; Needham, Rowan A; Olde Rikkert, Marcel G M; Perren, Andreas; Powers, James; Ranson, Sheila C; Ritz, Patrick; Rowat, Anne M; Sjöstrand, Fredrik; Smith, Alexandra C; Stookey, Jodi J D; Stotts, Nancy A; Thomas, David R; Vivanti, Angela; Wakefield, Bonnie J; Waldréus, Nana; Walsh, Neil P; Ward, Sean; Potter, John F; Hunter, Paul

    2015-04-30

    There is evidence that water-loss dehydration is common in older people and associated with many causes of morbidity and mortality. However, it is unclear what clinical symptoms, signs and tests may be used to identify early dehydration in older people, so that support can be mobilised to improve hydration before health and well-being are compromised. To determine the diagnostic accuracy of state (one time), minimally invasive clinical symptoms, signs and tests to be used as screening tests for detecting water-loss dehydration in older people by systematically reviewing studies that have measured a reference standard and at least one index test in people aged 65 years and over. Water-loss dehydration was defined primarily as including everyone with either impending or current water-loss dehydration (including all those with serum osmolality ≥ 295 mOsm/kg as being dehydrated). Structured search strategies were developed for MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL, LILACS, DARE and HTA databases (The Cochrane Library), and the International Clinical Trials Registry Platform (ICTRP). Reference lists of included studies and identified relevant reviews were checked. Authors of included studies were contacted for details of further studies. Titles and abstracts were scanned and all potentially relevant studies obtained in full text. Inclusion of full text studies was assessed independently in duplicate, and disagreements resolved by a third author. We wrote to authors of all studies that appeared to have collected data on at least one reference standard and at least one index test, and in at least 10 people aged ≥ 65 years, even where no comparative analysis has been published, requesting original dataset so we could create 2 x 2 tables. Diagnostic accuracy of each test was assessed against the best available reference standard for water-loss dehydration (serum or plasma osmolality cut-off ≥ 295 mOsm/kg, serum osmolarity or weight change) within each study. For

  10. 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.

  11. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study.

    Science.gov (United States)

    Vallejo, Karin Papapietro; Martínez, Carolina Méndez; Matos Adames, Alfredo A; Fuchs-Tarlovsky, Vanessa; Nogales, Guillermo Carlos Contreras; Paz, Roger Enrique Riofrio; Perman, Mario Ignacio; Correia, Maria Isabel Toulson Davisson; Waitzberg, Dan Linetzky

    2017-08-25

    Malnutrition in critically ill adults in the intensive care unit (ICU) is associated with a significantly elevated risk of mortality. Adequate nutrition therapy is crucial to optimise outcomes. Currently, there is a paucity of such data in Latin America. Our aims were to characterise current clinical nutrition practices in the ICU setting in Latin America and evaluate whether current practices meet caloric and protein requirements in critically ill patients receiving nutrition therapy. We conducted a cross-sectional, retrospective, observational study in eight Latin American countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, and Peru). Eligible patients were critically ill adults hospitalised in the ICU and receiving enteral nutrition (EN) and/or parenteral nutrition (PN) on the Screening Day and the previous day (day -1). Caloric and protein balance on day -1, nutritional status, and prescribed nutrition therapy were recorded. Multivariable logistic regression analysis was performed to identify independent predictors of reaching daily caloric and protein targets. The analysis included 1053 patients from 116 hospitals. Evaluation of nutritional status showed that 74.1% of patients had suspected/moderate or severe malnutrition according to the Subjective Global Assessment. Prescribed nutrition therapy included EN alone (79.9%), PN alone (9.4%), and EN + PN (10.7%). Caloric intake met >90% of the daily target in 59.7% of patients on day -1; a caloric deficit was present in 40.3%, with a mean (±SD) daily caloric deficit of -688.8 ± 455.2 kcal. Multivariable logistic regression analysis showed that combined administration of EN + PN was associated with a statistically significant increase in the probability of meeting >90% of daily caloric and protein targets compared with EN alone (odds ratio, 1.56; 95% confidence interval, 1.02-2.39; p = 0.038). In the ICU setting in Latin America, malnutrition was highly prevalent and caloric

  12. 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

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

    Directory of Open Access Journals (Sweden)

    Brigitte Walther

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

  14. 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

  15. HIV Surveillance Among Pregnant Women Attending Antenatal Clinics: Evolution and Current Direction.

    Science.gov (United States)

    Dee, Jacob; Garcia Calleja, Jesus M; Marsh, Kimberly; Zaidi, Irum; Murrill, Christopher; Swaminathan, Mahesh

    2017-12-05

    Since the late 1980s, human immunodeficiency virus (HIV) sentinel serosurveillance among pregnant women attending select antenatal clinics (ANCs) based on unlinked anonymous testing (UAT) has provided invaluable information for tracking HIV prevalence and trends and informing global and national HIV models in most countries with generalized HIV epidemics. However, increased coverage of HIV testing, prevention of mother-to-child transmission (PMTCT), and antiretroviral therapy has heightened ethical concerns about UAT. PMTCT programs now routinely collect demographic and HIV testing information from the same pregnant women as serosurveillance and therefore present an alternative to UAT-based ANC serosurveillance. This paper reports on the evolution and current direction of the global approach to HIV surveillance among pregnant women attending ANCs, including the transition away from traditional UAT-based serosurveillance and toward new guidance from the World Health Organization and the Joint United Nations Programme on HIV/AIDS on the implementation of surveillance among pregnant women attending ANCs based on routine PMTCT program data. ©Jacob Dee, Jesus M Garcia Calleja, Kimberly Marsh, Irum Zaidi, Christopher Murrill, Mahesh Swaminathan. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 05.12.2017.

  16. Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis.

    Science.gov (United States)

    Barra, Fabio; Scala, Carolina; Ferrero, Simone

    2018-04-01

    Endometriosis is a chronic estrogen and progestogen responsive inflammatory disease associated with pain symptoms and infertility. The medical therapy of endometriosis aims to induce decidualization within the hormonally dependent ectopic endometrium, and it is often administered to ameliorate women' pain symptoms or to prevent post-surgical disease recurrence. A variety of progestins have been used in monotherapy for the medical management of women with endometriosis. Areas covered: This review aims to offer the reader a complete overview of pharmacokinetic (PK) and clinical efficacy of progestins for the treatment of endometriosis. Expert opinion: Each progestin has a distinct PK parameters and pharmacodynamics affinity not only for progesterone receptor, but also for other steroid receptors, such as estrogen, androgen, and glucocorticoid. Moreover, progestins can also be delivered in different formulations. All these characteristics influence their final biological effect. Randomized, controlled, non-blinded studies support the use of oral progestin-only treatment for pelvic pain associated with endometriosis. Currently, the only two progestins approved by Food and Drug Administration (FDA) for the treatment of endometriosis are norethindrone acetate (NETA) and depot medroxyprogesterone acetate (DMPA).

  17. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  18. 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

  19. 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.

  20. 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.

  1. Landscape of current and emerging cell therapy clinical trials in the UK: current status, comparison to global trends and future perspectives.

    Science.gov (United States)

    Bisson, Isabelle; Green, Emma; Sharpe, Michaela; Herbert, Chris; Hyllner, Johan; Mount, Natalie

    2015-01-01

    Cell Therapy Clinical Trial and Preclinical Research databases have been established by the Cell Therapy Catapult to document current and future cell therapy clinical trials in the UK. We identified 41 ongoing trials in April 2014, an increase of seven trials from April 2013. In addition, we identified 45 late-stage preclinical research projects. The majority of the clinical trials are early phase, primarily led by academic groups. The leading therapeutic areas are cancer, cardiology and neurology. The trends in the UK are also seen globally. As the field matures, more later phase and commercial studies will emerge and the challenges will likely evolve into how to manufacture sufficient cell quantities, manage complex logistics for multi-center trials and control cost.

  2. Lung scintigraphy in the diagnosis of pulmonary embolism: current methods and interpretation criteria in clinical practice

    International Nuclear Information System (INIS)

    Skarlovnik, Ajda; Hrastnik, Damjana; Fettich, Jure; Grmek, Marko

    2014-01-01

    In current clinical practice lung scintigraphy is mainly used to exclude pulmonary embolism (PE). Modified diagnostic criteria for planar lung scintigraphy are considered, as newer scitigraphic methods, especially single photon emission computed tomography (SPECT) are becoming more popular. Data of 98 outpatients who underwent planar ventilation/perfusion (V/Q) scintigraphy and 49 outpatients who underwent V/Q SPECT from the emergency department (ED) were retrospectively collected. Planar V/Q images were interpreted according to 0.5 segment mismatch criteria and revised PIOPED II criteria and perfusion scans according to PISA-PED criteria. V/Q SPECT images were interpreted according to the criteria suggested in EANM guidelines. Final diagnosis of PE was based on the clinical decision of an attending physician and evaluation of a 12 months follow-up period. Using 0.5 segment mismatch criteria and revised PIOPED II, planar V/Q scans were diagnostic in 93% and 84% of cases, respectively. Among the diagnostic planar scans readings specificity for 0.5 segment mismatch criteria was 98%, and 99% for revised PIOPED II criteria. V/Q SPECT showed a sensitivity of 100% and a specificity of 98%, without any non-diagnostic cases. In patients with low pretest probability for PE, planar V/Q scans assessed by 0.5 segment mismatch criteria were diagnostic in 92%, and in 85% using revised PIOPED II criteria, while perfusion scintigraphy without ventilation scans was diagnostic in 80%. Lung scintigraphy yielded diagnostically definitive results and is reliable in ruling out PE in patients from ED. V/Q SPECT has excellent specificity and sensitivity without any non-diagnostic results. Percentage of non-diagnostic results in planar lung scintigraphy is considerably smaller when 0.5 segment mismatch criteria instead of revised PIOPED II criteria are used. Diagnostic value of perfusion scintigraphy according to PISA-PED criteria is inferior to combined V/Q scintigraphy; the difference is

  3. Current status of clinical education in paramedic programs: a descriptive research project.

    Science.gov (United States)

    Grubbs, K C

    1997-01-01

    Development of competence in exercising therapeutic judgment skills represents the goal of clinical education. Time (clock hours) is not a valid predictor of attainment of competence in paramedic clinical education. Quantity of patient contact experiences facilitates development of judgment skills, and offers a valid measure of progress toward competence. This project uses national survey data from accredited programs to describe the availability and accessibility of patient contact experiences within paramedic clinical education. Data from this local program supplements the national survey results. The components of clinical judgment are enumerated, and strategies to teach and evaluate clinical judgment skills are discussed.

  4. 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

  5. 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

  6. Comparison of liberal and restrictive blood transfusion: current insights into clinical outcomes

    Directory of Open Access Journals (Sweden)

    Gregersen M

    2016-10-01

    Full Text Available Merete Gregersen, Else Marie Damsgaard Department of Geriatrics, Aarhus University Hospital, Aarhus, Denmark Abstract: The aim of this review is to evaluate the evidence of randomized controlled trials and meta-analyses that the current blood transfusion guidelines are based upon. These studies examine the administration of blood to patients where benefits outweigh risks according to the hemoglobin (Hb level. The guidelines for transfusion policies are based on studies published up to the year 2014 and recommend the restrictive Hb thresholds as applicable to all care environments compared to a more liberal one. Within the past 2 years, the published studies are more targeted on specific settings and disease groups who can tolerate anemia and who cannot. The recent findings raise the possibility that patient outcome is better using a more liberal transfusion policy in patients with cardiovascular disease and in perioperative patients (surgery for abdominal cancer, cardiac surgery, and frail older patients with hip fracture. There are still many ongoing studies reflecting, what this review also suggests, that the evidence of the restrictive limits used on all patients across the board is not usable for clinicians. In the clinic (as in research, it is crucial to have the opportunity to deviate from the guidelines if signs of anemia are present in the patients and to tailor the transfusion strategy to each patient. There is also a lack of evidence on the most optimal transfusion threshold in other cancer categories than abdominal and in the nonoperative old and frail patients. This should be studied in future experimental studies. Keywords: literature review, hemoglobin thresholds, guidelines, acute anemia, chronic anemia, tailored intervention

  7. FDG PET/CT in infection and inflammation—current and emerging clinical applications

    International Nuclear Information System (INIS)

    Vaidyanathan, S.; Patel, C.N.; Scarsbrook, A.F.; Chowdhury, F.U.

    2015-01-01

    Integrated positron emission tomography/computed tomography (PET/CT) with the glucose analogue, 2-[ 18 F]-fluoro-2-deoxy-D-glucose (FDG), is an evolving hybrid imaging technique in the evaluation of an important and diverse group of pathological conditions, which are characterised by infection and aseptic inflammation. With a rapidly expanding body of evidence, it is being increasingly recognised that, in addition to its established role in oncological imaging, FDG PET/CT also has clinical utility in suspected infection and inflammation. The technique can identify the source of infection or inflammation in a timely fashion ahead of morphological changes on conventional anatomical imaging techniques, such as computed tomography (CT) and magnetic resonance imaging (MRI), map the extent and severity of disease, identify sites for tissue sampling, and assess therapy response. FDG PET/CT exhibits distinct advantages over traditional radionuclide imaging techniques in terms of shorter duration of examination, higher spatial resolution, non-invasive nature of acquisition, ability to perform quantitative analyses, and the provision of a synergistic combination of functional and anatomical imaging. With the use of illustrative clinico-radiological cases, this article discusses the current and emerging evidence for the use of FDG PET/CT in a broad spectrum of disorders, such as fever of unknown origin, sarcoidosis, large vessel vasculitis, musculoskeletal infections, joint prosthesis or implant-related complications, human immunodeficiency virus (HIV)-related infections, and miscellaneous indications, such as IgG4-related systemic disease. It will also briefly summarise the role of more novel tracers such as FDG-labelled leukocytes and gallium-68 PET tracers in this arena

  8. 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.

  9. 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).

  10. First Results of the “Carbonaceous Aerosol in Rome and Environs (CARE” Experiment: Beyond Current Standards for PM10

    Directory of Open Access Journals (Sweden)

    Francesca Costabile

    2017-12-01

    future research directions. First, we found that BC and EC mass concentration in Rome are larger than those measured in similar urban areas across Europe (the urban background mass concentration of eBC in Rome in winter being on average 2.6 ± 2.5 μ g · m − 3 , mean eBC at the peak level hour being 5.2 (95% CI = 5.0–5.5 μ g · m − 3 . Then, we discussed significant variations of carbonaceous aerosol properties occurring with time scales of minutes, and questioned on the data averaging period used in current air quality standard for PM 10 (24-h. Third, we showed that the oxidative potential induced by aerosol depends on particle size and composition, the effects of toxicity being higher with lower mass concentrations and smaller particle size. Albeit this is a preliminary analysis, findings reinforce the need for an urgent update of existing air quality standards for PM 10 and PM 2.5 with regard to particle composition and size distribution, and data averaging period. Our results reinforce existing concerns about the toxicity of carbonaceous aerosols, support the existing evidence indicating that particle size distribution and composition may play a role in the generation of this toxicity, and remark the need to consider a shorter averaging period (<1 h in these new standards.

  11. Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

    Science.gov (United States)

    Dreischulte, Tobias; Fernandez-Llimos, Fernando

    2016-12-01

    Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists accepting responsibility for drug therapy outcomes.

  12. 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

  13. 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.

  14. Clinical pathways for primary care: current use, interest and perceived usability.

    Science.gov (United States)

    Waters, Richard C; Toy, Jennifer M; Drechsler, Adam

    2018-02-26

    Translating clinical evidence to daily practice remains a challenge and may improve with clinical pathways. We assessed interest in and usability of clinical pathways by primary care professionals. An online survey was created. Interest in pathways for patient care and learning was assessed at start and finish. Participants completed baseline questions then pathway-associated question sets related to management of 2 chronic diseases. Perceived pathway usability was assessed using the system usability scale. Accuracy and confidence of answers was compared for baseline and pathway-assisted questions. Of 115 participants, 17.4% had used clinical pathways, the lowest of decision support tool types surveyed. Accuracy and confidence in answers significantly improved for all pathways. Interest in using pathways daily or weekly was above 75% for the respondents. There is low utilization of, but high interest in, clinical pathways by primary care clinicians. Pathways improve accuracy and confidence in answering written clinical questions.

  15. Periodic Epileptiform Discharges Clarified for the Nonneurologist Intensivist: Clinical Implications and Current Management.

    Science.gov (United States)

    Lahiri, Shouri; Boro, Alexis D; Shiloh, Ariel L; Milstein, Mark J; Savel, Richard H

    2015-10-01

    Periodic epileptiform discharges (PEDs) are frequently encountered during continuous electroencephalography monitoring in the intensive care unit. Their implications and management are variable and highly dependent on the clinical context. This article is intended for the nonneurologist intensivist, reviews basic terminology and clinical implications (including causes, prognosis, and association with seizures), and suggests an approach to management. Several case vignettes are included to illustrate the clinical variability associated with PEDs. © The Author(s) 2013.

  16. Current clinical practice: differential management of uveal melanoma in the era of molecular tumor analyses

    Directory of Open Access Journals (Sweden)

    Aaberg Jr TM

    2014-12-01

    Full Text Available Thomas M Aaberg Jr,1 Robert W Cook,2 Kristen Oelschlager,2 Derek Maetzold,2 P Kumar Rao,3 John O Mason III41Michigan State University Medical School and Retina Specialists of Michigan, Grand Rapids, MI, 2Castle Biosciences, Friendswood, TX, 3Washington University School of Medicine in St Louis, St Louis, MO, 4Retina Consultants of Alabama and University of Alabama Birmingham, Birmingham, AL, USA Objective: Assess current clinical practices for uveal melanoma (UM and the impact of molecular prognostic testing on treatment decisions.Design: Cross-sectional survey and sequential medical records review.Participants: Ophthalmologists who treat UM.Methods: (A Medical records review of all Medicare beneficiaries tested by UM gene expression profile in 2012, conducted under an institutional review board-approved protocol. (B 109 ophthalmologists specializing in the treatment of UM were invited to participate in 24-question survey in 2012; 72 were invited to participate in a 23-question survey in 2014.Main outcome measures: Responses analyzed by descriptive statistics, frequency analyses (percentages, Tukey, histograms, and Fisher’s exact test. Descriptive presentation of essay answers.Results: The review of Medicare medical records included 191 evaluable patients, 88 (46% with documented medical treatment actions or institutional policies related to surveillance plans. Of these 88, all gene expression profiling (GEP Class 1 UM patients were treated with low-intensity surveillance. All GEP Class 2 UM patients were treated with high-intensity surveillance (P<0.0001 versus Class 1. There were 36 (19% with information concerning referrals after initial diagnosis. Of these 36, all 23 Class 2 patients were referred to medical oncology; however, none of the 13 Class 1 patients were referred (P<0.0001 versus Class 1. Only Class 2 patients were recommended for adjunctive treatment regimens. 2012 survey: 50 respondents with an annual median of 35 new UM

  17. Significance of breast boost volume changes during radiotherapy in relation to current clinical interobserver variations

    International Nuclear Information System (INIS)

    Hurkmans, Coen; Admiraal, Marjan; Sangen, Maurice van der; Dijkmans, Ingrid

    2009-01-01

    Background and purpose: Nowadays, many departments introduce CT images for breast irradiation techniques, aiming to obtain a better accuracy in the definition of the relevant target volumes. However, the definition of the breast boost volume based on CT images requires further investigation, because it may not only vary between observers, but it may also change during the course of treatment. This study aims to quantify the variability of the CT based visible boost volume (VBV) during the course of treatment in relation to the variability between observers. Materials and methods: Ten patients with stage T1-2 invasive breast cancer treated with breast conservative surgery and post surgical radiotherapy were included in this study. In addition to the regular planning CT which is obtained several days prior to radiotherapy, three additional CT scans were acquired 3, 5 and 7 weeks after the planning CT scan. Four radiation oncologists delineated the VBV in all scans. Conformity of the delineations was analysed both between observers, and between scans taken at different periods of the radiotherapy treatment. Results: The VBV averaged over all patients decreased during the course of the treatment from an initial 40 cm 3 to 28 cm 3 , 27 cm 3 and 25 cm 3 after 3, 5 and 7 weeks, respectively. Assuming the VBV to be spherical, this corresponds to a reduction in diameter of 5-6 mm. More detailed analysis revealed that this reduction was more pronounced when radiotherapy started within 30 days after surgery. These boost volume changes over time were found to be significant (p = 0.02) even in the presence of interobserver variations. Moreover, the conformity index (CI) for the volume changes was of the same magnitude as the conformity index for the interobserver variation (0.25 and 0.31, respectively). Conclusions: Breast boost volume variations during a course of radiotherapy are significant in relation to current clinical interobserver variations. This is an important

  18. Robotic surgery for rectal cancer: current immediate clinical and oncological outcomes.

    Science.gov (United States)

    Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

    2014-10-21

    Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be

  19. 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

  20. [Pain care in Austrian health care centers: Questionnaire study on the current status of Austrian pain clinics].

    Science.gov (United States)

    Szilagyi, I-S; Bornemann-Cimenti, H; Messerer, B; Vittinghoff, M; Sandner-Kiesling, A

    2015-12-01

    Pain clinics provide interdisciplinary therapy to treat chronic pain patients and to increase the return-to-work rate. In recent years and due to increased economic pressure in health care, a change in the management of pain in Austrian health care centers has been observed. For the analysis of the current situation, two surveys addressing all Austrian pain clinics were performed. In total, 133 heads of Austrian Anesthesia Departments were interviewed online and personally. The data from the first interview were confirmed by an additional telephone survey that was performed by one anesthetist per Austrian state (n = 9). Currently, 44 Austrian pain clinics are active. During the last 5 years, 9 pain clinics closed. Adding the current active pain clinics together, they represent a total of 17.5 full-time-operated clinics. The most common reasons for closing the pain clinics were lack of personnel (47%), lack of time resources (26%), lack of space resources (11%), and financial difficulties (11%). A reduction of >50% of operating hours during the last 3 years was reported by 9 hospitals. The reasons for not running a pain clinic were lack of personnel (36%), lack of time (25%) and department too small (16%). Estimates between actual and required clinics indicate that 49.5 full-time-operating pain clinics are lacking in Austria, resulting in 74% of the Austrian chronic pain patients not receiving interdisciplinary pain management. Our survey confirmed the closure of 9 pain clinics during the last 5 years due to lack of personnel and time. Pain clinics appear to provide the simplest economic saving potential. This development is a major concern. Although running a pain clinic seems to be expensive at the first sight, it reduces pain, sick leave, complications, and potential legal issues against health care centers, while simultaneously increasing the hospital's competitiveness. Our results show that 74% of Austrian chronic pain patients do not have access to an

  1. A Review of Clinical Data for Currently Approved Hysteroscopic Sterilization Procedures

    Science.gov (United States)

    Basinski, Cindy M

    2010-01-01

    Two hysteroscopic permanent sterilization procedures are approved for use in the United States: Essure® Permanent Birth Control System (Conceptus Incorporated, Mountain View, CA) and Adiana® Permanent Contraception (Hologic, Inc., Bedford, MA). This review compares the clinical trial data for these procedures. A notable difference is the resultant clinical pregnancy risk. The clinical trials for the Essure procedure have reported no pregnancies in 643 relying women in the 9 years since initiation of the studies. The clinical trial for the Adiana procedure has reported 12 pregnancies in 570 relying women in nearly 5 years of collected data. Other clinical outcome parameters concerning Essure and Adiana are examined in this review. PMID:21364861

  2. The Database of the Catalogue of Clinical Practice Guidelines Published via Internet in the Czech Language -The Current State

    Czech Academy of Sciences Publication Activity Database

    Zvolský, Miroslav

    2010-01-01

    Roč. 6, č. 1 (2010), s. 83-89 ISSN 1801-5603 R&D Projects: GA MŠk(CZ) 1M06014 Institutional research plan: CEZ:AV0Z10300504 Keywords : internet * World Wide Web * database * clinical practice guideline * clinical practice * evidence-based medicine * formalisation * GLIF (Guideline Inerchange Format) * doctor of medicine, * decision support systems Subject RIV: IN - Informatics, Computer Science http://www.ejbi.org/en/ejbi/article/63-en-the-database-of-the-catalogue-of-clinical- practice -guidelines-published-via-internet-in-the-czech-language-the-current-state.html

  3. Early diagnosis of amyotrophic lateral sclerosis mimic syndromes: pros and cons of current clinical diagnostic criteria.

    Science.gov (United States)

    Cortés-Vicente, Elena; Pradas, Jesús; Marín-Lahoz, Juan; De Luna, Noemi; Clarimón, Jordi; Turon-Sans, Janina; Gelpí, Ellen; Díaz-Manera, Jordi; Illa, Isabel; Rojas-Garcia, Ricard

    2017-08-01

    To describe the frequency and clinical characteristics of patients referred to a tertiary neuromuscular clinic as having amyotrophic lateral sclerosis (ALS) but who were re-diagnosed as having an ALS mimic syndrome, and to identify the reasons that led to the revision of the diagnosis. We reviewed the final diagnosis of all patients prospectively registered in the Sant Pau-MND register from 1 January 2004 to 31 December 2015. A detailed clinical evaluation and a clinically-guided electrophysiological study were performed at first evaluation. Twenty of 314 (6.4%) patients included were re-diagnosed as having a condition other than ALS, in 18 cases already at first evaluation. An alternative specific diagnosis was identified in 17 of those 20, consisting of a wide range of conditions. The main finding leading to an alternative diagnosis was the result of the electrophysiological study. Fifty per cent did not fulfil the El Escorial revised criteria (EECr) for ALS. The most common clinical phenotype at onset in patients with ALS mimic syndromes was progressive muscular atrophy (PMA). Misdiagnosing ALS is still a common problem. Early identification of ALS mimic syndromes is possible based on atypical clinical features and a clinically-guided electrophysiological study. Patients should be attended in specialised centres. The application of EECr helps to identify ALS misdiagnoses.

  4. Current status of psychology and clinical psychology in India - an appraisal.

    Science.gov (United States)

    Virudhagirinathan, Baboo Sankar; Karunanidhi, Subbiah

    2014-10-01

    This paper provides an overview of the social and cultural context for the emergence and development of psychology in India and also more specifically of the development of clinical psychology. It details the range of universities offering psychology programmes and the various bodies involved in supporting the development of the psychology. The paper also describes the development of clinical psychology in India and the variety of roles undertaken by clinical psychologists. Finally, it raises a number of issues facing the development of Indian psychology into the future.

  5. Current management strategies and long-term clinical outcomes of upper extremity venous thrombosis

    NARCIS (Netherlands)

    Bleker, S. M.; van Es, N.; Kleinjan, A.; Buller, H. R.; Kamphuisen, P. W.; Aggarwal, A.; Beyer-Westendorf, J.; Camporese, G.; Cosmi, B.; Gary, T.; Ghirarduzzi, A.; Kaasjager, K.; Lerede, T.; Marschang, P.; Meijer, Karina; Otten, H. -M.; Porreca, E.; Righini, M.; Verhamme, P.; van Wissen, S.; Di Nisio, M.

    Background: There is scant information on the optimal management and clinical outcome of deep and superficial vein thrombosis of the upper extremity (UEDVT and UESVT). Objectives: To explore treatment strategies and the incidence of recurrent venous thromboembolism (VTE), mortality, postthrombotic

  6. Current technological clinical practice in breast radiotherapy; results of a survey in EORTC-Radiation Oncology Group affiliated institutions

    NARCIS (Netherlands)

    van der Laan, Hans Paul; Hurkmans, Coen W; Kuten, Abraham; Westenberg, Helen A

    PURPOSE: To evaluate the current technological clinical practice of radiation therapy of the breast in institutions participating in the EORTC-Radiation Oncology Group (EORTC-ROG). MATERIALS AND METHODS: A survey was conducted between August 2008 and January 2009 on behalf of the Breast Working

  7. The current situation and related problems of percutaneous vertebroplasty in clinical treatment of osteoporosis vertebral compression fracture

    International Nuclear Information System (INIS)

    Wang Luchang; Wu Chungen; Cheng Yongde

    2011-01-01

    As an effective, safe and less-invasive technique in interventional radiology, percutaneous vertebroplasty has satisfactory therapeutic results with fewer complications in treating osteoporosis vertebral compression fracture. This paper aims to make a comprehensive review of the current situation and related problems of percutaneous vertebroplasty in clinical treatment of osteoporosis vertebral compression fracture. (authors)

  8. Distinguishing between Unipolar Depression and Bipolar Depression: Current and Future Clinical and Neuroimaging Perspectives

    OpenAIRE

    de Almeida, Jorge Renner Cardoso; Phillips, Mary Louise

    2012-01-01

    Differentiating bipolar disorder (BD) from recurrent unipolar depression (UD) is a major clinical challenge. Main reasons for this include the higher prevalence of depressive relative to hypo/manic symptoms during the course of BD illness and the high prevalence of subthreshold manic symptoms in both BD and UD depression. Identifying objective markers of BD might help improve accuracy in differentiating between BD and UD depression, to ultimately optimize clinical and functional outcome for a...

  9. 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.

  10. Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

    Science.gov (United States)

    Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

    2017-11-01

    The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. 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.

  12. Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Mishra, Mark V., E-mail: mmishra@umm.edu [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Aggarwal, Sameer [Department of Internal Medicine, University of Maryland School of Medicine, Baltimore, Maryland (United States); Bentzen, Soren M. [Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland (United States); Knight, Nancy [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Mehta, Minesh P. [Miami Cancer Institute at Baptist Health South Florida, Miami, Florida (United States); Regine, William F. [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States)

    2017-02-01

    Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% of trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.

  13. 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

  14. Discharge communication from inpatient care: an audit of written medical discharge summary procedure against the new National Health Service Standard for clinical handover.

    Science.gov (United States)

    Reid, Daniel Brooks; Parsons, Shaun R; Gill, Stephen D; Hughes, Andrew J

    2015-04-01

    To audit written medical discharge summary procedure and practice against Standard Six (clinical handover) of the Australian National Safety and Quality Health Service Standards at a major regional Victorian health service. Department heads were invited to complete a questionnaire about departmental discharge summary practices. Twenty-seven (82%) department heads completed the questionnaire. Seven (26%) departments had a documented discharge summary procedure. Fourteen (52%) departments monitored discharge summary completion and 13 (48%) departments monitored the timeliness of completion. Seven (26%) departments informed the patient of the content of the discharge summary and six (22%) departments provided the patient with a copy. Seven (26%) departments provided training for staff members on how to complete discharge summaries. Completing discharge summaries was usually delegated to the medical intern. The introduction of the National Service Standards prompted an organisation-wide audit of discharge summary practices against the external criterion. There was substantial variation in the organisation's practices. The Standards and the current audit results highlight an opportunity for the organisation to enhance and standardise discharge summary practices and improve communication with general practice.

  15. 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'

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

    Science.gov (United States)

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

    2016-01-01

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

  17. Current status, challenges and the way forward for clinical pharmacy service in Ethiopian public hospitals.

    Science.gov (United States)

    Bilal, Arebu Issa; Tilahun, Zelalem; Gebretekle, Gebremedhin Beedemariam; Ayalneh, Belete; Hailemeskel, Bisrat; Engidawork, Ephrem

    2017-05-19

    Clinical pharmacy service has evolved steadily over the past few decades and is now contributing to the 'patient care journey' at all stages. It is improving the safety and effectiveness of medicines and has made a significant contribution to the avoidance of medication errors. In Ethiopia, clinical pharmacy service is in its initial phase, being started in July 2013. This study therefore aimed at assessing the status, challenges and way forward of clinical pharmacy service in the country. A cross-sectional survey was conducted in six regional states and one city- administration in September 2014. A total of 51 hospitals were included in the study. Both qualitative and quantitative methods were employed for data collection. A total of 160 pharmacy graduates, and 51 pharmacy heads participated in the study. Internal Medicine and Pediatric wards were the major wards where the graduates provide clinical pharmacy service. Almost 94% of the new graduates were found to be involved in clinical pharmacy service, but 47% of them rated their service as poor. The overall satisfaction of the graduates was close to 36%. Thirteen hospitals discontinued and two hospitals not even initiated the service largely due to shortage of pharmacists and lack of management support. About 44% of the surveyed hospitals documented the clinical pharmacy service provided using either developed or adopted formats. Lack of awareness by the medical fraternity, high attrition rate, lack of support from the management as well as from the health care team, readiness of the graduates to deliver the service, and shortage of pharmacists were identified by the key informants as the major stumbling block to deliver clinical pharmacy service. Clinical pharmacy service is initiated in most of the surveyed hospitals and a large proportion of the graduates were involved in the service. Although there is a great enthusiasm to promote clinical pharmacy service in the surveyed hospitals, efforts made to

  18. Doctors currently in jobs with academic content and their future intentions to pursue clinical academic careers: questionnaire surveys.

    Science.gov (United States)

    Lambert, Trevor W; Smith, Fay; Goldacre, Michael J

    2015-02-01

    Our aim was to report on doctors' descriptions of their current post at about 12 years after qualification, in respect of academic content, and to compare this with their long-term intentions. By academic content, we mean posts that are designated as clinical academic posts or clinical service posts that include research and/or teaching commitments. Questionnaire survey. All UK medical graduates of 1996 contacted in 2007, graduates of 1999 in 2012, and graduates of 2000 in 2012. UK. Responses about current posts and future intentions. Postal and email questionnaires. The response rate was 61.9% (6713/10844). Twenty eight per cent were working in posts with academic content (3.3% as clinical academics, 25% in clinical posts with some academic content). Seventeen per cent of women were working in clinical posts with some teaching and research, compared with 29% of men. A higher percentage of men than women intended to be clinical academics as their eventual career choice (3.9% overall, 5.4% of men, 2.7% of women). More doctors wished to move to a job with an academic component than away from one (N = 824 compared with 236). This was true for both men (433 compared with 118) and women (391 compared with 118). Women are under-represented both in holding posts with academic content and in aspirations to do so. It is noteworthy that many more doctors hoped to move into an academic role than to move out of one. Policy should facilitate this wish in order to address current shortfalls in clinical academic medicine.

  19. 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.)

  20. The Role of Clinical Cardiac Magnetic Resonance Imaging in China: Current Status and the Future

    Directory of Open Access Journals (Sweden)

    Shi Chen, MD

    2016-12-01

    Full Text Available Cardiac magnetic resonance (CMR imaging plays an important role in the diagnosis and management of cardiovascular diseases. The state-of-the-art CMR imaging has many advantages in cardiac imaging, including excellent spatial and temporal resolution, unrestricted imaging field, no exposure to ionizing radiation, excellent tissue contrast, and unique myocardial tissue characterization. Clinical CMR imaging is used during the cardiovascular diagnostic workup in the United States and some European countries. Use of CMR imaging is emerging in hospitals in China and has a promising future. This review briefly describes the real-world clinical application of CMR imaging in China and discuss obstacles for its future development.

  1. Clinical features and pathophysiology of Complex Regional Pain Syndrome – current state of the art

    Science.gov (United States)

    Marinus, Johan; Moseley, G. Lorimer; Birklein, Frank; Baron, Ralf; Maihöfner, Christian; Kingery, Wade S.; van Hilten, Jacobus J.

    2017-01-01

    That a minor injury can trigger a complex regional pain syndrome (CRPS) - multiple system dysfunction, severe and often chronic pain and disability - has fascinated scientists and perplexed clinicians for decades. However, substantial advances across several medical disciplines have recently increased our understanding of CRPS. Compelling evidence implicates biological pathways that underlie aberrant inflammation, vasomotor dysfunction, and maladaptive neuroplasticity in the clinical features of CRPS. Collectively, the evidence points to CRPS being a multifactorial disorder that is associated with an aberrant host response to tissue injury. Varying susceptibility to perturbed regulation of any of the underlying biological pathways probably accounts for the clinical heterogeneity of CRPS. PMID:21683929

  2. Current situation of hospital-based endocrinology and clinical nutrition in Spain.

    Science.gov (United States)

    Angeles Gálvez Moreno, M

    2008-01-01

    In 2006, the Healthcare Commission of Spanish Society of Endocrinology and Nutrition did a survey in order to know the actual situation of endocrinology and clinical nutrition healthcare in Public Sanitary Systems in Spain. The survey has been more extensive than the last and it has taken up number and geographical distribution of specialists in Spain in addition to data about clinical assistance. The mean of public hospitals with endocrinologist participation has been 50%. Copyright © 2008 Sociedad Española de Endocrinología y Nutrición. Published by Elsevier Espana. All rights reserved.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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