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...

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.

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.

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.

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...

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...

[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.

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.

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

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.

[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.

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.

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)

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.

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

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.

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).

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

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.

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

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.

[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-

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.

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.

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.

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.

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 ...

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

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.

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

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.

"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.

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

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.

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.

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.

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.

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.

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).

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...

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

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

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

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

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)

[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.

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

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

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.

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.

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.

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

“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

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.

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.

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.

Stemless shoulder arthroplasty: current status.

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Churchill, R Sean

2014-09-01

Since the original Neer humeral replacement in the 1950s, the standard primary anatomic total shoulder arthroplasty design has slowly evolved. Most recently, the humeral stem has become progressively shorter to help combat stem-related complications. Currently, there are several companies who have developed and marketed a stemless humeral arthroplasty component. Manufacturers' data for 5 stemless shoulder arthroplasty components currently on the market were analyzed and reviewed. A literature review of short-term results for stemless shoulder arthroplasty was completed. Of the stemless shoulder arthroplasty systems available on the market, 3 are currently undergoing clinical trials in the United States. The Tornier Simpliciti (Tornier, Edina, MN, USA) clinical trial began in 2011. The study with 2-year minimum follow-up results is scheduled for completion in November 2014. The Arthrex Eclipse (Arthrex, Naples, FL, USA) clinical trial was started in January 2013. The tentative study completion date is 2017. The Biomet Nano (Biomet, Warsaw, IN, USA) clinical trial began in October 2013 and also has a tentative completion date of 2017. No other clinical trial is currently under way in the United States. Early results for stemless shoulder arthroplasty indicate clinical results similar to standard stemmed shoulder arthroplasty. Radiographic analysis indicates implant stability without migration or subsidence at 2- to 3-year minimum follow-up.. Several stemless shoulder arthroplasty implants are available outside the United States. Early clinical and radiographic results are promising, but well-designed clinical studies and midterm results are lacking. Three clinical trials are currently under way in the United States with initial availability for use anticipated in 2015. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

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

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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

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

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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

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.

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

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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.

[Current clinical significance of anaerobic bacteremia].

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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.

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

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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.

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

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

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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…

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

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.

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

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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.

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

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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.

Current clinical evidence on pioglitazone pharmacogenomics

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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

Is current clinical practice modified about intraoperative breast irradiation?

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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.

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.'

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

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.

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.

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.

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.

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

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

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...

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.

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.

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.

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...

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."

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

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.

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.

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

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.

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

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.

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

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.

[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.

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.

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.

Visualizing and Validating Metadata Traceability within the CDISC Standards.

Science.gov (United States)

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

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

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

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.

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…

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.

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.

Standard effective doses for proliferative tumours

International Nuclear Information System (INIS)

Jones, L.C.; Hoban, P.

1999-01-01

This study was undertaken to investigate the treatment schedules used clinically for highly proliferative tumours, particularly with reference to the effects of fraction size, fraction number and treatment duration. The linear quadratic model (with time component) is used here to compare non-standard treatment regimens (e.g. accelerated and hyperfractionated schedules), currently the focus of randomized trials, with each other and some common 'standard regimens'. To ensure easy interpretation of results, two parameters known as proliferative standard effective dose one (PSED 1 ) and proliferative standard effective dose two (PSED 2 ) have been calculated for each regimen. Graphs of PSED 1 and PSED 2 versus potential doubling time (T p ) have been generated for a range of fractionation regimens which are currently under trial in various randomized studies. From these graphs it can be seen that the highly accelerated schedules (such as CHART) only show advantages for tumours with very short potential doubling times. Calculations for most of the schedules considered showed at least equivalent tumour control expected for the trial schedule compared with the control arm used and these values agree quite well with clinical results. These calculations are in good agreement with clinical results available at present. The greater the PSED 1 or PSED 2 for the schedule considered the greater the tumour control, which can be expected. However, as has been seen with clinical trials, this higher cell kill also results in higher acute effects which have proved too great for some accelerated schedules to continue. (author)

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

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.

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/.

Clopidogrel Resistance: Current Issues

Directory of Open Access Journals (Sweden)

NS Neki

2016-05-01

Full Text Available Antiplatelet agents are mainly used in the prevention and management of atherothrombotic complications. Dual antiplatelet therapy, combining aspirin and clopidogrel, is the standard care for patients having acute coronary syndromes or undergoing percutaneous coronary intervention according to the current ACC/AHA and ESC guidelines. But in spite of administration of dual antiplatelet therapy, some patients develop recurrent cardiovascular ischemic events especially stent thrombosis which is a serious clinical problem. Antiplatelet response to clopidogrel varies widely among patients based on ex vivo platelet function measurements. Clopidogrel is an effective inhibitor of platelet activation and aggregation due to its selective and irreversible blockade of the P2Y12 receptor. Patients who display little attenuation of platelet reactivity with clopidogrel therapy are labeled as low or nonresponders or clopidogrel resistant. The mechanism of clopidogrel resistance remains incompletely defined but there are certain clinical, cellular and genetic factors including polymorphisms responsible for therapeutic failure. Currently there is no standardized or widely accepted definition of clopidogrel resistance. The future may soon be realised in the routine measurement of platelet activity in the same way that blood pressure, cholesterol and blood sugar are followed to help guide the therapy, thus improving the care for millions of people. This review focuses on the methods used to identify patients with clopidogrel resistance, the underlying mechanisms, metabolism, clinical significance and current therapeutic strategies to overcome clopidogrel resistance. J Enam Med Col 2016; 6(1: 38-46

Quality standards for bone conduction implants.

Science.gov (United States)

Gavilan, Javier; Adunka, Oliver; Agrawal, Sumit; Atlas, Marcus; Baumgartner, Wolf-Dieter; Brill, Stefan; Bruce, Iain; Buchman, Craig; Caversaccio, Marco; De Bodt, Marc T; Dillon, Meg; Godey, Benoit; Green, Kevin; Gstoettner, Wolfgang; Hagen, Rudolf; Hagr, Abdulrahman; Han, Demin; Kameswaran, Mohan; Karltorp, Eva; Kompis, Martin; Kuzovkov, Vlad; Lassaletta, Luis; Li, Yongxin; Lorens, Artur; Martin, Jane; Manoj, Manikoth; Mertens, Griet; Mlynski, Robert; Mueller, Joachim; O'Driscoll, Martin; Parnes, Lorne; Pulibalathingal, Sasidharan; Radeloff, Andreas; Raine, Christopher H; Rajan, Gunesh; Rajeswaran, Ranjith; Schmutzhard, Joachim; Skarzynski, Henryk; Skarzynski, Piotr; Sprinzl, Georg; Staecker, Hinrich; Stephan, Kurt; Sugarova, Serafima; Tavora, Dayse; Usami, Shin-Ichi; Yanov, Yuri; Zernotti, Mario; Zorowka, Patrick; de Heyning, Paul Van

2015-01-01

Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

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)

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.

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

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

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

[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".

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.

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.

[Current overview of cartilage regeneration procedures].

Science.gov (United States)

Schenker, H; Wild, M; Rath, B; Tingart, M; Driessen, A; Quack, V; Betsch, M

2017-11-01

Cartilage is an avascular, alymphatic and non-innervated tissue with limited intrinsic repair potential. The high prevalence of cartilage defects and their tremendous clinical importance are a challenge for all treating physicians. This article provides the reader with an overview about current cartilage treatment options and their clinical outcome. Microfracture is still considered the gold standard in the treatment of small cartilage lesions. Small osteochondral defects can be effectively treated with the autologous osteochondral transplantation system. Larger cartilage defects are successfully treated by autologous membrane-induced chondrogenesis (AMIC) or by membrane-assisted autologous chondrocyte implantation (MACI). Despite limitations of current cartilage repair strategies, such procedures can result in short- and mid-term clinical improvement of the patients. Further developments and clinical studies are necessary to improve the long-term outcome following cartilage repair.

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)

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

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

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.

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.

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.

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.

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.

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

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

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

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.

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.

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...

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.)

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.

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.

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

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.

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.

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

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.

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.

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.

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.

Practical Considerations for Clinical PET/MR Imaging.

Science.gov (United States)

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2018-01-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

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...

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.

Bench-to-bedside review: human subjects research--are more standards needed?

Science.gov (United States)

Huang, David T; Hadian, Mehrnaz

2006-01-01

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine.

Current concepts of severe asthma

Science.gov (United States)

Raundhal, Mahesh; Oriss, Timothy B.; Ray, Prabir; Wenzel, Sally E.

2016-01-01

The term asthma encompasses a disease spectrum with mild to very severe disease phenotypes whose traditional common characteristic is reversible airflow limitation. Unlike milder disease, severe asthma is poorly controlled by the current standard of care. Ongoing studies using advanced molecular and immunological tools along with improved clinical classification show that severe asthma does not identify a specific patient phenotype, but rather includes patients with constant medical needs, whose pathobiologic and clinical characteristics vary widely. Accordingly, in recent clinical trials, therapies guided by specific patient characteristics have had better outcomes than previous therapies directed to any subject with a diagnosis of severe asthma. However, there are still significant gaps in our understanding of the full scope of this disease that hinder the development of effective treatments for all severe asthmatics. In this Review, we discuss our current state of knowledge regarding severe asthma, highlighting different molecular and immunological pathways that can be targeted for future therapeutic development. PMID:27367183

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

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...

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.

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.

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.

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.

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.

['Gold standard', not 'golden standard'

NARCIS (Netherlands)

Claassen, J.A.H.R.

2005-01-01

In medical literature, both 'gold standard' and 'golden standard' are employed to describe a reference test used for comparison with a novel method. The term 'gold standard' in its current sense in medical research was coined by Rudd in 1979, in reference to the monetary gold standard. In the same

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.

The uses and implications of standards in general practice consultations

DEFF Research Database (Denmark)

Lippert, Maria Laura; Reventlow, Susanne; Kousgaard, Marius Brostrøm

2017-01-01

Quality standards play an increasingly important role in primary care through their inscription in various technologies for improving professional practice. While ‘hard’ biomedical standards have been the most common and debated, current quality development initiatives increasingly seek to include...... as manifestations of an inherent conflict between principles of patient-centredness and formal biomedical quality standards. However, this study suggests that standards on the ‘softer’ aspects of care may just as well interfere with a clinical approach relying on situated and attentive interactions with patients....

Bench-to-bedside review: Human subjects research – are more standards needed?

Science.gov (United States)

Huang, David T; Hadian, Mehrnaz

2006-01-01

There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine. PMID:17184560

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

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.

Novel methods to optimize the effects of transcranial direct current stimulation: a systematic review of transcranial direct current stimulation patents.

Science.gov (United States)

Malavera, Alejandra; Vasquez, Alejandra; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that has been extensively studied. While there have been initial positive results in some clinical trials, there is still variability in tDCS results. The aim of this article is to review and discuss patents assessing novel methods to optimize the use of tDCS. A systematic review was performed using Google patents database with tDCS as the main technique, with patents filling date between 2010 and 2015. Twenty-two patents met our inclusion criteria. These patents attempt to address current tDCS limitations. Only a few of them have been investigated in clinical trials (i.e., high-definition tDCS), and indeed most of them have not been tested before in human trials. Further clinical testing is required to assess which patents are more likely to optimize the effects of tDCS. We discuss the potential optimization of tDCS based on these patents and the current experience with standard tDCS.

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.

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

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

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

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.

Development of clinical practice guidelines.

Science.gov (United States)

Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

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.

Clinical proton dosimetry. Part 1: Beam production, beam delivery and measurement of absorbed dose

International Nuclear Information System (INIS)

1998-01-01

The development of accurate and uniform standards for radiation treatment dosimetry has been a continuing effort since the earliest days of radiotherapy. This ICRU Report is intended to promote uniformity of standards that will provide a basis for world-wide comparison of clinical results and allow the development of meaningful clinical trials. This Report describes current practice in proton therapy and recommends standards for the dosimetry of proton treatments. Established proton treatment facilities might use this Report as a source of information for the maintenance of accurate standards. New facilities may build their procedures from recommendations found in this Report and planners of new facilities may examine alternatives within current practice for the production and monitoring of treatment beams. This Report includes a description of the interaction of protons with matter, various methods of beam production, the characteristics of proton beams in clinical use, current methods for beam monitoring and specific recommendations for dose calibration

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.

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.

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.

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

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.

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, ...

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.

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

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

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.

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.

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

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.

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.

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.

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.

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.

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

DOE technical standards list: Department of Energy standards index

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-05-01

This Department of Energy (DOE) technical standards list (TSL) has been prepared by the Office of Nuclear Safety Policy and Standards (EH-31) on the basis of currently available technical information. Periodic updates of this TSL will be issued as additional information is received on standardization documents being issued, adopted, or canceled by DOE. This document was prepared for use by personnel involved in the selection and use of DOE technical standards and other Government and non-Government standards. This TSL provides listings of current DOE technical standards, non-Government standards that have been adopted by DOE, other standards-related documents in which DOE has a recorded interest, and canceled DOE technical standards. Information on new DOE technical standards projects, technical standards released for coordination, recently published DOE technical standards, and activities of non-Government standards bodies that may be of interest to DOE is published monthly in Standards Actions.

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

Science.gov (United States)

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

2015-01-01

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

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.

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.

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

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)

[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.

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.

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.

Defining progression in nonmuscle invasive bladder cancer: it is time for a new, standard definition

NARCIS (Netherlands)

Lamm, D.; Persad, R.; Brausi, M.; Buckley, R.; Witjes, J.A.; Palou, J.; Bohle, A.; Kamat, A.M.; Colombel, M.; Soloway, M.

2014-01-01

PURPOSE: Despite being one of the most important clinical outcomes in nonmuscle invasive bladder cancer, there is currently no standard definition of disease progression. Major clinical trials and meta-analyses have used varying definitions or have failed to define this end point altogether. A

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...

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.

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.

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.

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.

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.

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.

Standard lymphadenectomy technique in the gastric adenocarcinoma

International Nuclear Information System (INIS)

Aguirre Fernandez, Roberto Eduardo; Fernandez Vazquez, Pedro Ivan; LLera Dominguez, Gerardo de la

2012-01-01

The surgical technique used from 1990 in the 'Celia Sanchez Manduley' Clinical Surgical Teaching Provincial Hospital in Manzanillo, Granma province to carry out the gastrectomy together with the standard lymphadenectomy in patients carriers of a gastric adenocarcinoma, allowing application of the current oncologic and surgical concepts of the Japanese Society for Research of Gastric Cancer, essential to obtain a better prognosis in these patients

Chemoradiotherapy for esophageal cancer. Current status and perspectives

International Nuclear Information System (INIS)

Ohtsu, Atsushi

2004-01-01

The optimal role of chemoradiotherapy in the multimodality treatment of esophageal cancer is still controversial. According to a series of clinical trials, definitive chemoradiotherapy is considered the standard of care for patients with medically inoperable or surgically unresectable esophageal cancer. This modality provides survivals comparable to those in Western series of surgery alone and is one of the standards of care even for resectable-stage disease. Recent reports of primary chemoradiotherapy from Japan suggest survival comparable to that of surgery in Japanese patients with stage I disease, but radical surgery is still the standard treatment for T2-3NanyM0 disease in Japan. However, it is clear that this approach has limitations in treatment outcomes. Trimodality therapy, i.e., preoperative chemoradiotherapy followed by surgery, is more favored than surgery alone in clinical practice, particularly in patients with adenocarcinoma, although current data from randomized trials are insufficient to support this approach. To improve the local control rate of chemoradiotherapy, intensification of the radiation dose has been attempted, but this has failed to demonstrate any superiority in terms of local control or survival. The addition of new agents, including molecular targeting agents, to the current standard chemoradiotherapy has shown more promising results and warrants further investigations in future studies. Salvage treatment for patients who do not achieve a complete response (CR) is necessary to improve the overall treatment results. Salvage surgery, as well as endoscopic resection, in selected patients, may provide an improvement in survival. Until high rates of local control can be consistently achieved with chemoradiotherapy alone, these salvage treatments will be an integral component of multimodality treatment for esophageal cancer, and should be active areas for clinical investigations. (author)

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

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.

[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

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.

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.

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

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

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)

Perspectives on Clinical Informatics: Integrating Large-Scale Clinical, Genomic, and Health Information for Clinical Care

Directory of Open Access Journals (Sweden)

In Young Choi

2013-12-01

Full Text Available The advances in electronic medical records (EMRs and bioinformatics (BI represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.

Description and status update on GELLO: a proposed standardized object-oriented expression language for clinical decision support.

Science.gov (United States)

Sordo, Margarita; Boxwala, Aziz A; Ogunyemi, Omolola; Greenes, Robert A

2004-01-01

A major obstacle to sharing computable clinical knowledge is the lack of a common language for specifying expressions and criteria. Such a language could be used to specify decision criteria, formulae, and constraints on data and action. Al-though the Arden Syntax addresses this problem for clinical rules, its generalization to HL7's object-oriented data model is limited. The GELLO Expression language is an object-oriented language used for expressing logical conditions and computations in the GLIF3 (GuideLine Interchange Format, v. 3) guideline modeling language. It has been further developed under the auspices of the HL7 Clinical Decision Support Technical Committee, as a proposed HL7 standard., GELLO is based on the Object Constraint Language (OCL), because it is vendor-independent, object-oriented, and side-effect-free. GELLO expects an object-oriented data model. Although choice of model is arbitrary, standardization is facilitated by ensuring that the data model is compatible with the HL7 Reference Information Model (RIM).

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.

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.

Antibacterial activity of amino- and amido- terminated poly (amidoamine)-G6 dendrimer on isolated bacteria from clinical specimens and standard strains

Science.gov (United States)

Rastegar, Ayoob; Nazari, Shahram; Allahabadi, Ahmad; Falanji, Farahnaz; Akbari Dourbash, Fakhreddin Akbari Dourbash; Rezai, Zahra; Alizadeh Matboo, Soudabeh; Hekmat-Shoar, Reza; Mohseni, Seyed Mohsen; Majidi, Gharib

2017-01-01

Background: Nanoscale poly (amidoamine) dendrimers have been investigated for their biological demands, but their antibacterial activity has not been widely discovered. Thus, the sixth generation of poly (amidoamine) dendrimer (PAMAM-G6) was synthesized and its antibacterial activities were evaluated on Gram-negative bacteria; P. aeruginosa, E. coli, A. baumannii, S. typhimurium, S. dysenteriae, K. pneumoniae, P. mirabilis, and Gram-positive bacteria, and S.aureus and B. subtilis, which were isolated from different clinical specimens and standard strains of these bacteria. Methods: In this study, 980 specimens including urine (47%), blood (27%), sputum (13%), wounds (8%), and burns (5%) were collected from clinical specimens of 16 hospitals and clinics in city of Sabzevar, Iran. Then, the target bacteria were isolated and identified using standard methods. Minimum inhibitory concentration and minimum bactericidal concentrations against Gram-positive and Gram-negative bacteria were determined according to guidelines described by clinical and laboratory standards institute (CLSI). Standard discs were prepared using 0.025, 0.25, 2.5, and 25 μg/mL concentrations of PAMAM-G6 on Mueller-Hinton agar plates to determinate the zone of inhibition. The cytotoxicity of PAMAM-G6 dendrimer was evaluated in HCT116 cells by MTT assay. Results: The most important isolated bacteria were E. coli (23.65%), S. aureus (24.7%), P. aeruginosa (10.49%), B. subtilis (7.7%), S. typhimurium (8.87%), A. baumannii (7.02%), K. pneumoniae (7.1%), P. mirabilis (6.46%), and S. dysenteriae (3.6%). Moreover, it was found that poly (amidoamine)–G6 exhibited more antibacterial efficacy on standard strains than isolated bacteria from clinical samples (p<0.05). The cytotoxicity of PAMAM-G6 to the cells showed that cytotoxicity depended on the concentration level and exposure time. Conclusion: The PAMAM-G6 dendrimer showed a positive impact on the removal of dominant bacterial isolated from clinical

[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.

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

Guidelines for the Standardization of Genital Photography.

Science.gov (United States)

Joumblat, Natalie R; Chim, Jimmy; Sanchez Aguirre, Priscila Gisselle; Bedolla, Edgar; Salgado, Christopher J

2018-02-06

Plastic surgery relies on photography for both clinical practice and research. The Photographic Standards in Plastic Surgery laid the foundation for standardized photography in plastic surgery. Despite these advancements, the current literature lacks guidelines for genital photography, thus resulting in a discordance of documentation. The authors propose photographic standards for the male and female genitalia to establish homogeneity in which information can be accurately exchanged. All medical photographs include a sky-blue background, proper lighting, removal of distractors, consistent camera framing, and standard camera angles. We propose the following guidelines to standardize genital photography. In the anterior upright position, feet are shoulder-width apart and arms are placed posteriorly. The frame is bounded superiorly by the xiphoid-umbilicus midpoint and inferiorly by the patella. For circumferential documentation, frontal 180 degree capture via 45 degree intervals is often sufficient. Images in standard lithotomy position should be captured at both parallel and 45 degrees above the horizontal. Images of the phallus should include both the flaccid and erect states. Despite the increasing incidence of genital procedures, there lacks a standardized methodology in which to document the genitalia, resulting in a substantial heterogeneity in the current literature. Our standardized techniques for genital photography set forth to establish a uniform language that promotes more effective communication with both the patient as well as with colleagues. The proposed photography guidelines provide optimal visualization and standard documentation of the genitalia, allowing for accurate education, meaningful collaborations, and advancement in genital surgery. © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

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

Instant standard concept for data standards development

NARCIS (Netherlands)

Folmer, Erwin Johan Albert; Kulcsor, Istvan Zsolt; Roes, Jasper

2013-01-01

This paper presents the current results of an ongoing research about a new data standards development concept. The concept is called Instant Standard referring to the pressure that is generated by shrinking the length of the standardization process. Based on this concept it is estimated that the

[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.

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.

Current status of quantum electrical metrology

International Nuclear Information System (INIS)

Urano, Chiharu; Kaneko, Nobuhisa; Kiryu, Shogo

2005-01-01

Physical background, current status of proof systems and researches of the next generation standards of Josephson voltage and Quantized Hall Resistance (QHR) standard system are described. Josephson effect, the principle and theory of quantized hall effect, usual voltage standard system, standard feed of direct current resistance, and researches of voltage standard and direct current resistance standard are explained. The current-voltage of Josephson element in the usual voltage standard proof system and bias method, outline of typical Josephson voltage standard proof system and GaAs/AlGaAs heterostructure used as resistance standard are stated. Cryogenic Current Comparator (CCC) and Direct Current Comparator (DCC) proofread usual resistor. New Quantum Hall Array Resistance Standard (QHARS) is studied by BNM-LNE group in French, and the other new AC Quantized Hall Resistance (AC-QHR) by the European ACQHE Project. (S.Y.)

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

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...

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.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

Science.gov (United States)

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

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.

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

Science.gov (United States)

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

2015-11-04

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

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.

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.…

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

Science.gov (United States)

Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

2018-04-30

FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

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

Clinical Trials

Medline Plus

Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

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

Science.gov (United States)

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

2013-04-02

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

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.

Translating state-of-the-art spinal cord MRI techniques to clinical use: A systematic review of clinical studies utilizing DTI, MT, MWF, MRS, and fMRI

Directory of Open Access Journals (Sweden)

Allan R. Martin

2016-01-01

Conclusions: State-of-the-art spinal cord MRI techniques are emerging with great potential to improve the diagnosis and management of various spinal pathologies, but the current body of evidence has only showed limited clinical utility to date. Among these imaging tools DTI is the most mature, but further work is necessary to standardize and validate its use before it will be adopted in the clinical realm. Large, well-designed studies with a priori hypotheses, standardized acquisition methods, detailed clinical data collection, and robust automated analysis techniques are needed to fully demonstrate the potential of these rapidly evolving techniques.

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

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

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.

A SOA-Based Platform to Support Clinical Data Sharing

Directory of Open Access Journals (Sweden)

R. Gazzarata

2017-01-01

Full Text Available The eSource Data Interchange Group, part of the Clinical Data Interchange Standards Consortium, proposed five scenarios to guide stakeholders in the development of solutions for the capture of eSource data. The fifth scenario was subdivided into four tiers to adapt the functionality of electronic health records to support clinical research. In order to develop a system belonging to the “Interoperable” Tier, the authors decided to adopt the service-oriented architecture paradigm to support technical interoperability, Health Level Seven Version 3 messages combined with LOINC (Logical Observation Identifiers Names and Codes vocabulary to ensure semantic interoperability, and Healthcare Services Specification Project standards to provide process interoperability. The developed architecture enhances the integration between patient-care practice and medical research, allowing clinical data sharing between two hospital information systems and four clinical data management systems/clinical registries. The core is formed by a set of standardized cloud services connected through standardized interfaces, involving client applications. The system was approved by a medical staff, since it reduces the workload for the management of clinical trials. Although this architecture can realize the “Interoperable” Tier, the current solution actually covers the “Connected” Tier, due to local hospital policy restrictions.

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.

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

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

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

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.

Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder

DEFF Research Database (Denmark)

Kessing, Lars Vedel; Hansen, Hanne Vibe; Hvenegaard, Anne

2013-01-01

BACKGROUND: Little is known about whether treatment in a specialised out-patient mood disorder clinic improves long-term prognosis for patients discharged from initial psychiatric hospital admissions for bipolar disorder. AIMS: To assess the effect of treatment in a specialised out-patient mood...... disorder clinic v. standard decentralised psychiatric treatment among patients discharged from one of their first three psychiatric hospital admissions for bipolar disorder. METHOD: Patients discharged from their first, second or third hospital admission with a single manic episode or bipolar disorder were...... randomised to treatment in a specialised out-patient mood disorder clinic or standard care (ClinicalTrials.gov: NCT00253071). The primary outcome measure was readmission to hospital, which was obtained from the Danish Psychiatric Central Register. RESULTS: A total of 158 patients with mania/bipolar disorder...

Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

Science.gov (United States)

Ramos, Nestor R.; Mo, Clifton C.; Karp, Judith E.; Hourigan, Christopher S.

2015-01-01

The limited sensitivity of the historical treatment response criteria for acute myeloid leukemia (AML) has resulted in a different paradigm for treatment compared with most other cancers presenting with widely disseminated disease. Initial cytotoxic induction chemotherapy is often able to reduce tumor burden to a level sufficient to meet the current criteria for “complete” remission. Nevertheless, most AML patients ultimately die from their disease, most commonly as clinically evident relapsed AML. Despite a variety of available salvage therapy options, prognosis in patients with relapsed or refractory AML is generally poor. In this review, we outline the commonly utilized salvage cytotoxic therapy interventions and then highlight novel investigational efforts currently in clinical trials using both pathway-targeted agents and immunotherapy based approaches. We conclude that there is no current standard of care for adult relapsed or refractory AML other than offering referral to an appropriate clinical trial. PMID:25932335

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.

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.

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.

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.

DOE technical standards list. Department of Energy standards index

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-08-01

This document was prepared for use by personnel involved in the selection and use of DOE technical standards and other Government and non-Government standards. This TSL provides listing of current DOE technical standards, non-Government standards that have been adopted by DOE, other Government documents in which DOE has a recorded interest, and canceled DOE technical standards. Information on new DOE technical standards projects, technical standards released for coordination, recently published DOE technical standards, and activities of non-Government standards bodies that may be of interest to DOE is published monthly in Standards Actions.

Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation

NARCIS (Netherlands)

Schmitt, Jochen; Langan, Sinéad; Deckert, Stefanie; Svensson, Ake; von Kobyletzki, Laura; Thomas, Kim; Spuls, Phyllis

2013-01-01

Clinical signs are a core outcome domain for atopic dermatitis (AD) trials. The current lack of standardization of outcome measures in AD trials hampers evidence-based communication. We sought to provide evidence-based recommendations for the measurement of clinical signs in AD trials and to inform

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.

Role of the clinical microbiology laboratory in infection control - a Danish perspective

DEFF Research Database (Denmark)

Kolmos, H J

2001-01-01

for standardization and documentation of quality. Currently a national standard for infection control is being prepared. It consists of a main standard defining requirements for the management system and 12 subsidiary standards defining requirements for specific areas of infection control. Adoption of the standard...... will undoubtedly require additional resources for infection control at a local level, and some organizational changes may also be needed. Infection control should be maintained as an integrated part of clinical microbiology....

Review and comparison of quality standards, guidelines and regulations for laboratories

Directory of Open Access Journals (Sweden)

Tjeerd A.M. Datema

2011-12-01

Full Text Available Background: The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. Objectives: There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. Method: We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services. Results: Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Conclusion: Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory

Perception matters for clinical perfectionism and social anxiety.

Science.gov (United States)

Levinson, Cheri A; Rodebaugh, Thomas L; Shumaker, Erik A; Menatti, Andrew R; Weeks, Justin W; White, Emily K; Heimberg, Richard G; Warren, Cortney S; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R

2015-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N=602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N=180), and by using a variance decomposition model of self- and informant-report of perfectionism (N=134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants' perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

Science.gov (United States)

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

DOE technical standards list: Department of Energy standards index

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-06-01

This technical standards list (TSL) was prepared for use by personnel involved in the selection and use of US DOE technical standards and other government and non-government standards. This TSL provides listings of current DOE technical standards, non-government standards that have been adopted by DOE, other government documents in which DOE has a recorded interest, and cancelled DOE technical standards. Standards are indexed by type in the appendices to this document. Definitions of and general guidance for the use of standards are also provided.

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.

QUALITY MANAGEMENT SYSTEM IN CLINICAL LABORATORIES ACCORDING TO THE ISO 15189:2007 STANDARD - EVALUATION OF THE BENEFITS OF IMPLEMENTATION IN AN ASSISTED REPRODUCTION LABORATORY

Directory of Open Access Journals (Sweden)

A.D. Sialakouma

2011-03-01

Full Text Available Biomedical science is a sensitive discipline and presents unique challenges due to its social character, continuous development and competitiveness. The issue of quality management systems and accreditation is gaining increasing interest in this sector. All over Europe, Health Services Units have started to introduce quality management systems and harmonization of criteria for accreditation is of increasing importance. Moreover, clinical laboratories, like the Assisted Reproduction laboratories and biochemical laboratories are required to apply a Quality Management System in order to ensure their correct, scientific and effective operation. Ultimately, it is a moral obligation for every health care organisation to supply the best possible care for the patient. The specific features and the diversity of clinical laboratories led to the introduction (2003 and, recently to the revision (2007 of the international standard ISO 15189, which is the first international standard developed specifically to address the requirements for accreditation of this type of laboratory. The basic principles for the quality assurance in the clinical laboratories are: x Complete and unambiguous standardized operating procedures. x Complete and unambiguous directives of operation. x Obligatory detailed written documentation, i.e., how each action is done, who will do it, where will this action take place and when. x Suitable scheduling of calibration/control/preventive maintenance of laboratory equipment and recording of each activity. x Distribution of responsibilities among the staff and continuous education and briefing according to current scientific data. x Complete and informed record file keeping. x Continuous improvement which is monitored with the adoption of quantified indicators. x Internal and external audit of all activities. x Troubleshooting. All these principles should be supported by the Management in order that the necessary adaptations should be made

Environmental radiation standards

International Nuclear Information System (INIS)

Kocher, D.C.

1987-01-01

This document contains an outline of an oral presentation on environmental radiation standards presented to the American Nuclear Societies' Topical Conference on Population Exposure from the Nuclear Fuel Cycle. The paper contains several definitions, a summary of current radiation exposure limits; and numerous proposed changes to current standards. 7 figs

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.

SU-E-P-22: AAPM Task Group 263 Tackling Standardization of Nomenclature for Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

Matuszak, M; Feng, M [University of Michigan, Ann Arbor, MI (United States); Moran, J [Univ Michigan Medical Center, Ann Arbor, MI (United States); Xiao, Y [Thomas Jefferson University, Philadelphia, PA (United States); Mayo, C; Miller, R [Mayo Clinic, Rochester, MN (United States); Bosch, W [Washington Univ, Saint Louis, MO (United States); Popple, R [Univ Alabama Birmingham, Birmingham, AL (United States); Marks, L [UNC School of Medicine, Chapel Hill, NC (United States); Wu, Q [Duke University Medical Center, Durham, NC (United States); Molineu, A; Martel, M [UT MD Anderson Cancer Center, Houston, TX (United States); Yock, T [Massachusetts General Hospital, Boston, MA (United States); McNutt, T [Johns Hopkins University, Severna Park, MD (United States); Brown, N [Baptist Medical Center, Jacksonville, FL (United States); Purdie, T [Princess Margaret Hospital, Toronto, ON (Canada); Yorke, E [Memorial Sloan-Kettering Cancer Center, New York, NY (United States); Santanam, L [Washington University School of Medicine, St.louis, MO (United States); Gabriel, P [University of Pennsylvania, Philadelphia, PA (United States); Michalski, J [Washington University, Saint Louis, MO (United States); and others

2015-06-15

Purpose: There is growing recognition of need for increased clarity and consistency in the nomenclatures used for body and organ structures, DVH metrics, toxicity, dose and volume units, etc. Standardization has multiple benefits; e.g. facilitating data collection for clinical trials, enabling the pooling of data between institutions, making transfers (i.e. hand-offs) between centers safer, and enabling vendors to define “default” settings. Towards this goal, the American Association of Physicists in Medicine (AAPM) formed a task group (TG263) in July of 2014, operating under the Work Group on Clinical Trials to develop consensus statements. Guiding principles derived from the investigation and example nomenclatures will be presented for public feedback. Methods: We formed a multi-institutional and multi-vendor collaborative group of 39 physicists, physicians and others involved in clinical use and electronic transfer of information. Members include individuals from IROC, NRG, IHE-RO, DICOM WG-7, ASTRO and EORTC groups with overlapping interests to maximize the quality of the consensus and increase the likelihood of adoption. Surveys of group and NRG members were used to define current nomenclatures and requirements. Technical requirements of vendor systems and the proposed DICOM standards were examined. Results: There is a marked degree of inter and intra institutional variation in current approaches, resulting from inter-vendor differences in capabilities, clinic specific conceptualizations and inconsistencies. Using a consensus approach, the group defined optimal formats for the naming of targets and normal structures. A formal objective assessment of 13 existing clinically-used software packages show that all had capabilities to accommodate these recommended nomenclatures. Conclusions: A multi-stakeholder effort is making significant steps forward in developing a standard nomenclature that will work across platforms. Our current working list includes > 550

Vorapaxar: The Current Role and Future Directions of a Novel Protease-Activated Receptor Antagonist for Risk Reduction in Atherosclerotic Disease

OpenAIRE

Gryka, Rebecca J.; Buckley, Leo F.; Anderson, Sarah M.

2017-01-01

Introduction Despite the current standard of care, patients with cardiovascular disease remain at a high risk for recurrent events. Inhibition of thrombin-mediated platelet activation through protease-activated receptor-1 antagonism may provide reductions in atherosclerotic disease beyond those achievable with the current standard of care. Objective Our primary objective is to evaluate the clinical literature regarding the role of vorapaxar (Zontivity?) in the reduction of cardiovascular even...

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.

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.

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.

Our Approach to Toxic Epidermal Necrolysis and Review of Current Treatment Alternatives

Directory of Open Access Journals (Sweden)

Fatih Uygur

2008-09-01

Full Text Available Toxic epidermal necrolysis (TEN is a clinical entity which has a 30 to 40 % mortality rate, with necrolysis affecting the entire epidermis. Antibiotics, nonsteroidal anti-inflammatory drugs and anticonvulsants are offender drugs in TEN etiology. A standard treatment protocol with proven efficacy is still lacking. In this study, current treatment practice and our treatment strategy for TEN is discussed and eight patients treated in our clinic between the years 2001 and 2008 are reviewed.

Clinical practice guidelines: 2004 standards, options and recommendations for the management of patient with adenocarcinoma of the stomach - radiotherapy

International Nuclear Information System (INIS)

Ychou, M.; Duffour, J.; Lemanski, C.; Masson, B.; Gory-Delabaere, G.; Bosquet, L.; Blanc, P.; Giovannini, M.; Monge, G.; Guillemin, F.; Marchal, F.; Conroy, T.; Merrouche, Y.; Adenis, A.; Bosset, J.F.; Bouche, O.; Pezet, D.; Triboulet, J.P.

2004-01-01

Context. - The 'Standards, Options and Recommendations' (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. Objectives. - To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors. Methods. - The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement. Results. - Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with D1 or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without de-nutrition with a lymphadenectomy < D1 (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without de-nutrition with D1 or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3). (authors)

77 FR 69637 - Development of Prioritized Therapeutic Area Data Standards; Request for Comments

Science.gov (United States)

2012-11-20

... regulatory information. FDA has developed a roadmap that provides its current thinking on therapeutic area... Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute, Health Level 7's (HL7... 20993-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics...

Space Life Sciences at NASA: Spaceflight Health Policy and Standards

Science.gov (United States)

Davis, Jeffrey R.; House, Nancy G.

2006-01-01

In January 2005, the President proposed a new initiative, the Vision for Space Exploration. To accomplish the goals within the vision for space exploration, physicians and researchers at Johnson Space Center are establishing spaceflight health standards. These standards include fitness for duty criteria (FFD), permissible exposure limits (PELs), and permissible outcome limits (POLs). POLs delineate an acceptable maximum decrement or change in a physiological or behavioral parameter, as the result of exposure to the space environment. For example cardiovascular fitness for duty standards might be a measurable clinical parameter minimum that allows successful performance of all required duties. An example of a permissible exposure limit for radiation might be the quantifiable limit of exposure over a given length of time (e.g. life time radiation exposure). An example of a permissible outcome limit might be the length of microgravity exposure that would minimize bone loss. The purpose of spaceflight health standards is to promote operational and vehicle design requirements, aid in medical decision making during space missions, and guide the development of countermeasures. Standards will be based on scientific and clinical evidence including research findings, lessons learned from previous space missions, studies conducted in space analog environments, current standards of medical practices, risk management data, and expert recommendations. To focus the research community on the needs for exploration missions, NASA has developed the Bioastronautics Roadmap. The Bioastronautics Roadmap, NASA's approach to identification of risks to human space flight, revised baseline was released in February 2005. This document was reviewed by the Institute of Medicine in November 2004 and the final report was received in October 2005. The roadmap defines the most important research and operational needs that will be used to set policy, standards (define acceptable risk), and

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.

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.

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.

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.

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.

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.

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.

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.

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.

Current status and installation of dental PACS

International Nuclear Information System (INIS)

Park, Chang Seo; Kim, Kee Deog; Park, Hyok; Jeong, Ho Gul

2004-01-01

Picture Archiving and Communication System (PACS) is difficult to implement in the best of situations, but evidence is growing that the benefits are significant. The aims of this study are to analyze the current status of full PACS and establish successful installation standard of dental PACS. Materials and Methods were based on the investigation of current working status and installation standard of PACS, and observation of variable issues to installation of dental PACS. By September 30, 2004, full PACS implementations in their facilities were 88.1% in specialized general hospitals (37 installations out of total 42 hospitals), 59.8% in general hospitals (144 installations out of total 241 hospitals), 12.3% in medical hospitals (116 installations out of total 941 hospitals) and 3.6% in dental hospitals (4 installations out of total 110 hospitals). Only 4 university dental hospitals currently have installed and are operating full PACS. Major obstacle to wide spread of dental PACS is initial high investments. Clinical environments of dental PACS differed from medical situation. Because of characteristic dental practice, the initial investments for dental PACS are generally much greater than those of medical PACS. Also new economic crisis makes users scruple. The best way to overcome these limitations is to establish an economic installation standard for dental PACS. Also the clear technical communication between the customer and the supplier before both sides are committed to the obstacles are critical to its success.

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

Science.gov (United States)

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

2016-01-01

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

76 FR 28990 - Ultra High Throughput Sequencing for Clinical Diagnostic Applications-Approaches To Assess...

Science.gov (United States)

2011-05-19

... Web cast of the public meeting, you must register online at http://www.fda.gov/MedicalDevices/News... technologies are currently extensively used in research and are entering clinical diagnostic use; they are... technologies for clinical applications, appropriate evaluation tools (e.g., standards, well established...

The Future of Glioblastoma Therapy: Synergism of Standard of Care and Immunotherapy

Energy Technology Data Exchange (ETDEWEB)

Patel, Mira A.; Kim, Jennifer E.; Ruzevick, Jacob [Department of Neurosurgery, The Johns Hopkins University School of Medicine, 600 N. Wolfe St., Phipps Building Rm 123, Baltimore, MD 21287 (United States); Li, Gordon [Department of Neurosurgery, Stanford University Medical Center, 1201 Welch Rd., P309 MSLS, Stanford, CA 94305 (United States); Lim, Michael, E-mail: mlim3@jhmi.edu [Department of Neurosurgery, The Johns Hopkins University School of Medicine, 600 N. Wolfe St., Phipps Building Rm 123, Baltimore, MD 21287 (United States)

2014-09-29

The current standard of care for glioblastoma (GBM) is maximal surgical resection with adjuvant radiotherapy and temozolomide (TMZ). As the 5-year survival with GBM remains at a dismal <10%, novel therapies are needed. Immunotherapies such as the dendritic cell (DC) vaccine, heat shock protein vaccines, and epidermal growth factor receptor (EGFRvIII) vaccines have shown encouraging results in clinical trials, and have demonstrated synergistic effects with conventional therapeutics resulting in ongoing phase III trials. Chemoradiation has been shown to have synergistic effects when used in combination with immunotherapy. Cytotoxic ionizing radiation is known to trigger pro-inflammatory signaling cascades and immune activation secondary to cell death, which can then be exploited by immunotherapies. The future of GBM therapeutics will involve finding the place for immunotherapy in the current treatment regimen with a focus on developing strategies. Here, we review current GBM therapy and the evidence for combination of immune checkpoint inhibitors, DC and peptide vaccines with the current standard of care.

The Future of Glioblastoma Therapy: Synergism of Standard of Care and Immunotherapy

International Nuclear Information System (INIS)

Patel, Mira A.; Kim, Jennifer E.; Ruzevick, Jacob; Li, Gordon; Lim, Michael

2014-01-01

The current standard of care for glioblastoma (GBM) is maximal surgical resection with adjuvant radiotherapy and temozolomide (TMZ). As the 5-year survival with GBM remains at a dismal <10%, novel therapies are needed. Immunotherapies such as the dendritic cell (DC) vaccine, heat shock protein vaccines, and epidermal growth factor receptor (EGFRvIII) vaccines have shown encouraging results in clinical trials, and have demonstrated synergistic effects with conventional therapeutics resulting in ongoing phase III trials. Chemoradiation has been shown to have synergistic effects when used in combination with immunotherapy. Cytotoxic ionizing radiation is known to trigger pro-inflammatory signaling cascades and immune activation secondary to cell death, which can then be exploited by immunotherapies. The future of GBM therapeutics will involve finding the place for immunotherapy in the current treatment regimen with a focus on developing strategies. Here, we review current GBM therapy and the evidence for combination of immune checkpoint inhibitors, DC and peptide vaccines with the current standard of care

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.

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.

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.

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

Current Research Studies

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... Success Home > Explore Research > Current Research Studies Current Research Studies Email Print + Share The Crohn’s & Colitis Foundation ... conducted online. Learn more about IBD Partners. Clinical Research Alliance The Clinical Research Alliance is a network ...

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.

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.

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.

MREIT experiments with 200 µA injected currents: a feasibility study using two reconstruction algorithms, SMM and harmonic BZ

International Nuclear Information System (INIS)

Arpinar, V E; Muftuler, L T; Hamamura, M J; Degirmenci, E

2012-01-01

Magnetic resonance electrical impedance tomography (MREIT) is a technique that produces images of conductivity in tissues and phantoms. In this technique, electrical currents are applied to an object and the resulting magnetic flux density is measured using magnetic resonance imaging (MRI) and the conductivity distribution is reconstructed using these MRI data. Currently, the technique is used in research environments, primarily studying phantoms and animals. In order to translate MREIT to clinical applications, strict safety standards need to be established, especially for safe current limits. However, there are currently no standards for safe current limits specific to MREIT. Until such standards are established, human MREIT applications need to conform to existing electrical safety standards in medical instrumentation, such as IEC601. This protocol limits patient auxiliary currents to 100 µA for low frequencies. However, published MREIT studies have utilized currents 10–400 times larger than this limit, bringing into question whether the clinical applications of MREIT are attainable under current standards. In this study, we investigated the feasibility of MREIT to accurately reconstruct the relative conductivity of a simple agarose phantom using 200 µA total injected current and tested the performance of two MREIT reconstruction algorithms. These reconstruction algorithms used are the iterative sensitivity matrix method (SMM) by Ider and Birgul (1998 Elektrik 6 215–25) with Tikhonov regularization and the harmonic B Z proposed by Oh et al (2003 Magn. Reason. Med. 50 875–8). The reconstruction techniques were tested at both 200 µA and 5 mA injected currents to investigate their noise sensitivity at low and high current conditions. It should be noted that 200 µA total injected current into a cylindrical phantom generates only 14.7 µA current in imaging slice. Similarly, 5 mA total injected current results in 367 µA in imaging slice. Total acquisition

A standardized model for predicting flap failure using indocyanine green dye

Science.gov (United States)

Zimmermann, Terence M.; Moore, Lindsay S.; Warram, Jason M.; Greene, Benjamin J.; Nakhmani, Arie; Korb, Melissa L.; Rosenthal, Eben L.

2016-03-01

Techniques that provide a non-invasive method for evaluation of intraoperative skin flap perfusion are currently available but underutilized. We hypothesize that intraoperative vascular imaging can be used to reliably assess skin flap perfusion and elucidate areas of future necrosis by means of a standardized critical perfusion threshold. Five animal groups (negative controls, n=4; positive controls, n=5; chemotherapy group, n=5; radiation group, n=5; chemoradiation group, n=5) underwent pre-flap treatments two weeks prior to undergoing random pattern dorsal fasciocutaneous flaps with a length to width ratio of 2:1 (3 x 1.5 cm). Flap perfusion was assessed via laser-assisted indocyanine green dye angiography and compared to standard clinical assessment for predictive accuracy of flap necrosis. For estimating flap-failure, clinical prediction achieved a sensitivity of 79.3% and a specificity of 90.5%. When average flap perfusion was more than three standard deviations below the average flap perfusion for the negative control group at the time of the flap procedure (144.3+/-17.05 absolute perfusion units), laser-assisted indocyanine green dye angiography achieved a sensitivity of 81.1% and a specificity of 97.3%. When absolute perfusion units were seven standard deviations below the average flap perfusion for the negative control group, specificity of necrosis prediction was 100%. Quantitative absolute perfusion units can improve specificity for intraoperative prediction of viable tissue. Using this strategy, a positive predictive threshold of flap failure can be standardized for clinical use.

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

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

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.

Role of imaging in testicular cancer: current and future practice.

Science.gov (United States)

Barrisford, Glen W; Kreydin, Evgeniy I; Preston, Mark A; Rodriguez, Dayron; Harisighani, Mukesh G; Feldman, Adam S

2015-09-01

The article provides a summary of the epidemiologic and clinical aspects of testicular malignancy. Current standard imaging and novel techniques are reviewed. Present data and clinical treatment trends have favored surveillance protocols over adjuvant radiation or chemotherapy for low-stage testicular malignancy. This has resulted in increasing numbers of imaging studies and the potential for increased long-term exposure risks. Understanding imaging associated risks as well as strategies to minimize these risks is of increasing importance. The development, validation and incorporation of alternative lower risk highly efficacious and cost-effective imaging techniques is essential.

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.

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

Science.gov (United States)

Davis, Drew; Lee, Gordon

2011-07-01

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

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.

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.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

Science.gov (United States)

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project

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...

Finite element model predicts current density distribution for clinical applications of tDCS and tACS

Directory of Open Access Journals (Sweden)

Toralf eNeuling

2012-09-01

Full Text Available Transcranial direct current stimulation (tDCS has been applied in numerous scientific studies over the past decade. However, the possibility to apply tDCS in therapy of neuropsychiatric disorders is still debated. While transcranial magnetic stimulation (TMS has been approved for treatment of major depression in the United States by the Food and Drug Administration (FDA, tDCS is not as widely accepted. One of the criticisms against tDCS is the lack of spatial specificity. Focality is limited by the electrode size (35 cm2 are commonly used and the bipolar arrangement. However, a current flow through the head directly from anode to cathode is an outdated view. Finite element (FE models have recently been used to predict the exact current flow during tDCS. These simulations have demonstrated that the current flow depends on tissue shape and conductivity. Toface the challenge to predict the location, magnitude and direction of the current flow induced by tDCS and transcranial alternating current stimulation (tACS, we used a refined realistic FE modeling approach. With respect to the literature on clinical tDCS and tACS, we analyzed two common setups for the location of the stimulation electrodes which target the frontal lobe and the occipital lobe, respectively. We compared lateral and medial electrode configuration with regard to theirusability. We were able to demonstrate that the lateral configurations yielded more focused stimulation areas as well as higher current intensities in the target areas. The high resolution of our simulation allows one to combine the modeled current flow with the knowledge of neuronal orientation to predict the consequences of tDCS and tACS. Our results not only offer a basis for a deeper understanding of the stimulation sites currently in use for clinical applications but also offer a better interpretation of observed effects.

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.

Adolescent health care maintenance in a teen-friendly clinic.

Science.gov (United States)

Chaisson, Nicole; Shore, William B

2014-09-01

Adolescence is marked by complex physical, cognitive, social, and emotional development, which can be stressful for families and adolescents. Before the onset of puberty, providers should clearly lay the groundwork for clinical care and office visits during the adolescent years. This article addresses the guidelines and current legal standards for confidentiality in adolescent care, the most frequently used psychosocial screening tools, and current recommendations for preventive health services and immunizations. Through the creation of teen-friendly clinics, primary care providers are well positioned to offer guidance and support to teens and their parents during this time of transition and growth. Copyright © 2014 Elsevier Inc. All rights reserved.

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

A taxonomy of psychology standards and training, and their relevance for psychiatrists.

Science.gov (United States)

Hunt, Caroline; Hyde, Judy

2013-04-01

The aim of the article is to describe the current standards for psychology registration and pathways to training that operate in Australia today, to compare these with international requirements, and to discuss how they relate to the work and training of psychiatrists. The standards and training for practice in psychology involve multiple pathways that are not straightforward for the public or other health practitioners to understand. Most developed nations other than Australia require higher entry requirements into the profession. New national standards set by the Psychology Board of Australia, such as endorsed areas of practice, will lead to greater consistency in standards and make the task of referring to psychologists with the appropriate competencies more straightforward, allowing for greater collaboration between clinical psychology and psychiatry practitioners.

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.)

Comparative study among calibration methods of clinical applicators of beta radiation

International Nuclear Information System (INIS)

Antonio, Patricia de Lara

2009-01-01

90 Sr+ 90 Y clinical applicators are instruments used in brachytherapy procedures and they have to be periodically calibrated, according to international standards and recommendations. In this work, four calibration methods of dermatological and ophthalmic applicators were studied, comparing the results with those given by the calibration certificates of the manufacturers. The methods included the use of the standard applicator of the Calibration Laboratory (LCI), calibrated by the National Institute of Standards and Technology; an Amersham applicator (LCI) as reference; a mini-extrapolation chamber developed at LCI as an absolute standard; and thermoluminescent dosimetry. The mini-extrapolation chamber and a PTW commercial extrapolation chamber were studied in relation to their performance through quality control tests of their response, as leakage current, repeatability and reproducibility. The distribution of the depth dose in water, that presents high importance in dosimetry of clinical applicators, was determined using the mini extrapolation chamber and the thermoluminescent dosimeters. The results obtained were considered satisfactory for the both cases, and comparable to the data of the IAEA (2002) standard. Furthermore, a dosimetry postal kit was developed for the calibration of clinical applicators using the thermoluminescent technique, to be sent to clinics and hospitals, without the need of the transport of the sources to IPEN for calibration. (author)

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

The first clinical implementation of real-time image-guided adaptive radiotherapy using a standard linear accelerator.

Science.gov (United States)

Keall, Paul J; Nguyen, Doan Trang; O'Brien, Ricky; Caillet, Vincent; Hewson, Emily; Poulsen, Per Rugaard; Bromley, Regina; Bell, Linda; Eade, Thomas; Kneebone, Andrew; Martin, Jarad; Booth, Jeremy T

2018-04-01

Until now, real-time image guided adaptive radiation therapy (IGART) has been the domain of dedicated cancer radiotherapy systems. The purpose of this study was to clinically implement and investigate real-time IGART using a standard linear accelerator. We developed and implemented two real-time technologies for standard linear accelerators: (1) Kilovoltage Intrafraction Monitoring (KIM) that finds the target and (2) multileaf collimator (MLC) tracking that aligns the radiation beam to the target. Eight prostate SABR patients were treated with this real-time IGART technology. The feasibility, geometric accuracy and the dosimetric fidelity were measured. Thirty-nine out of forty fractions with real-time IGART were successful (95% confidence interval 87-100%). The geometric accuracy of the KIM system was -0.1 ± 0.4, 0.2 ± 0.2 and -0.1 ± 0.6 mm in the LR, SI and AP directions, respectively. The dose reconstruction showed that real-time IGART more closely reproduced the planned dose than that without IGART. For the largest motion fraction, with real-time IGART 100% of the CTV received the prescribed dose; without real-time IGART only 95% of the CTV would have received the prescribed dose. The clinical implementation of real-time image-guided adaptive radiotherapy on a standard linear accelerator using KIM and MLC tracking is feasible. This achievement paves the way for real-time IGART to be a mainstream treatment option. Copyright © 2018 Elsevier B.V. All rights reserved.

Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

Directory of Open Access Journals (Sweden)

Sandra Álvarez Guerra

2005-12-01

Full Text Available La calidad en los ensayos clínicos conducidos por los centros de investigación por contrato , constituye un factor de suma importancia. En la actualidad estas instituciones usan como estándar de calidad la Buena Práctica Clínica. Sin embargo, su combinación con la Norma ISO 9001:2000, estándar de calidad, internacionalmente utilizado, no se ha generalizado. Para demostrar la factibilidad que el uso conjunto de estas normas brindan a las organizaciones se decidió establecer reflexiones para demostrar cómo se complementan ambos estándares de calidad en la realización de ensayos clínicos. Para esto se revisó bibliografía actualizada en dichos temas. Se valoraron aspectos en común como: clientes, responsabilidad, tratamiento de datos generados, estadística, control de la calidad y documentos esenciales. Por medio de estos aspectos ambas normas tributan a la calidad del ensayo clínico, para una mejor protección al paciente, resultados confiables, satisfacción de los clientes, internos y externos, que garanticen la mejora continua, y establecer planes de contingencia y medidas preventivas. Se concluye que ambas normativas no están en contraposición y pueden ser utilizadas como vía capaz de garantizar excelencia en el servicio brindado.The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were

'Muscle-sparing' statins: preclinical profiles and future clinical use.

Science.gov (United States)

Pfefferkorn, Jeffrey A

2009-03-01

Coronary heart disease (CHD) is a leading cause of death in the US, and hypercholesterolemia is a key risk factor for this disease. The current standard of care for treating hypercholesterolemia is the use of HMG-CoA reductase inhibitors, also known as statins, which block the rate-limiting step of cholesterol biosynthesis. In widespread clinical use, statins have proven safe and effective for both primary prevention of CHD and secondary prevention of coronary events. Results from several recent clinical trials have demonstrated that increasingly aggressive cholesterol-lowering therapy might offer additional protection against CHD compared with less aggressive treatment standards. While higher doses of current statin therapies are capable of achieving these more aggressive treatment goals, in certain cases statin-induced myalgia, the muscle pain or weakness that sometimes accompanies high-dose statin therapy, limits patient compliance with a treatment regimen. To address this limitation, efforts have been undertaken to develop highly hepatoselective statins that are capable of delivering best-in-class efficacy with minimized risk of dose-limiting myalgia. In this review, the preclinical and early clinical data for these next generation statins are discussed.

Clinical grade adult stem cell banking.

Science.gov (United States)

Thirumala, Sreedhar; Goebel, W Scott; Woods, Erik J

2009-07-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed.

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.

Step Up-Not On-The Step 2 Clinical Skills Exam: Directors of Clinical Skills Courses (DOCS) Oppose Ending Step 2 CS.

Science.gov (United States)

Ecker, David J; Milan, Felise B; Cassese, Todd; Farnan, Jeanne M; Madigosky, Wendy S; Massie, F Stanford; Mendez, Paul; Obadia, Sharon; Ovitsh, Robin K; Silvestri, Ronald; Uchida, Toshiko; Daniel, Michelle

2018-05-01

Recently, a student-initiated movement to end the United States Medical Licensing Examination Step 2 Clinical Skills and the Comprehensive Osteopathic Medical Licensing Examination Level 2-Performance Evaluation has gained momentum. These are the only national licensing examinations designed to assess clinical skills competence in the stepwise process through which physicians gain licensure and certification. Therefore, the movement to end these examinations and the ensuing debate merit careful consideration. The authors, elected representatives of the Directors of Clinical Skills Courses, an organization comprising clinical skills educators in the United States and beyond, believe abolishing the national clinical skills examinations would have a major negative impact on the clinical skills training of medical students, and that forfeiting a national clinical skills competency standard has the potential to diminish the quality of care provided to patients. In this Perspective, the authors offer important additional background information, outline key concerns regarding the consequences of ending these national clinical skills examinations, and provide recommendations for moving forward: reducing the costs for students, exploring alternatives, increasing the value and transparency of the current examinations, recognizing and enhancing the strengths of the current examinations, and engaging in a national dialogue about the issue.

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.)

MR imaging of the articular cartilage of the knee with arthroscopy as gold standard: assessment of methodological quality of clinical studies

International Nuclear Information System (INIS)

Duchateau, Florence; Berg, Bruno C. vande

2002-01-01

The purpose of this study was to assess the methodological quality of articles addressing the value of MR imaging of the knee cartilage with arthroscopy as a standard. Relevant papers were selected after Medline review (MEDLINE database search including the terms ''cartilage'' ''knee'', ''MR'' and ''arthroscopy''). Two observers reviewed independently 29 selected articles to determine how each study had met 15 individual standards that had been previously developed to assess the methodological quality of clinical investigations. The following criteria were met in variable percentage of articles including adequate definition of purpose (100%), statistical analysis (90%), avoidance of verification bias (86%), patient population description (83%), reference standard (79%), review bias (79%), study design (66%), inclusion criteria (41%) and method of analysis (41.5%), avoidance of diagnostic-review bias (24%), exclusion criteria (21%), indeterminate examination results (17%), analysis criteria (14%), interobserver reliability (14%) and intraobserver reliability (7%). The assessment of the methodological quality of clinical investigations addressing the value of MR imaging in the evaluation of the articular cartilage of the knee with arthroscopy as the standard of reference demonstrated that several standards were rarely met in the literature. Efforts should be made to rely on clearly defined lesion criteria and to determine reliability of the observations. (orig.)

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.)

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.)

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.

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.

Neuropsychology in Japan: history, current challenges, and future prospects.

Science.gov (United States)

Sakamoto, Maiko

2016-11-01

The purpose of this special issue was to describe the cross-cultural differences in neuropsychology throughout the world. The current state of neuropsychology in Japan is discussed in this manuscript. Information on six topics, including (1) the history of Japanese neuropsychology, (2) licensure system, (3) job opportunities, (4) neuropsychological clinical services, (5) neuropsychological tests, and (6) neuropsychological research, was gathered via literature searches, official organization websites, and personal communication with clinical psychologists and other professionals in Japan. Neuropsychology reached Japan from the west in the late 1800s, a period of rapid political and social modernization. Professional associations were founded in the 1960s and 1970s and continued to grow. The need for neuropsychological assessment in Japan is growing; however, credential requirements for neuropsychologists have not yet been established. To practice clinical psychology in Japan, one must obtain a Master's degree and pass a licensure examination that is administered by a private professional foundation. Clinical psychologists often conduct neuropsychological tests; however, they have little training in neuropsychological assessment. While many western neuropsychological tests have been translated into Japanese and are used in clinical settings, the majority of translated tests have not been standardized and their psychometric properties remain poorly understood. Standardization and development of normative data in Japan is warranted. Given that needs for neuropsychological services are increasing, it is essential for clinical psychologists in Japan to improve their skills in neuropsychological evaluations. Japanese graduate schools must work to establish neuropsychology programs to educate and train clinical neuropsychologists.

[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.

Malaysian NDT standards

International Nuclear Information System (INIS)

Khazali Mohd Zin

2001-01-01

In order to become a developed country, Malaysia needs to develop her own national standards. It has been projected that by the year 2020, Malaysia requires about 8,000 standards (Department of Standard Malaysia). Currently more than 2,000 Malaysian Standards have been gazette by the government which considerably too low before tire year 2020. NDT standards have been identified by the standard working group as one of the areas to promote our national standards. In this paper the author describes the steps taken to establish the Malaysian very own NDT standards. The project starts with the establishment of radiographic standards. (Author)

[Thinking on designation of sham acupuncture in clinical research].

Science.gov (United States)

Pan, Li-Jia; Chen, Bo; Zhao, Xue; Guo, Yi

2014-01-01

Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.

Defining progression in nonmuscle invasive bladder cancer: it is time for a new, standard definition.

Science.gov (United States)

Lamm, Donald; Persad, Raj; Brausi, Maurizio; Buckley, Roger; Witjes, J Alfred; Palou, Joan; Böhle, Andreas; Kamat, Ashish M; Colombel, Marc; Soloway, Mark

2014-01-01

Despite being one of the most important clinical outcomes in nonmuscle invasive bladder cancer, there is currently no standard definition of disease progression. Major clinical trials and meta-analyses have used varying definitions or have failed to define this end point altogether. A standard definition of nonmuscle invasive bladder cancer progression as determined by reproducible and reliable procedures is needed. We examine current definitions of nonmuscle invasive bladder cancer progression, and propose a new definition that will be more clinically useful in determining patient prognosis and comparing treatment options. The IBCG (International Bladder Cancer Group) analyzed published clinical trials and meta-analyses that examined nonmuscle invasive bladder cancer progression as of December 2012. The limitations of the definitions of progression used in these trials were considered, as were additional parameters associated with the advancement of nonmuscle invasive bladder cancer. The most commonly used definition of nonmuscle invasive bladder cancer progression is an increase in stage from nonmuscle invasive to muscle invasive disease. Although this definition is clinically important, it fails to include other important parameters of advancing disease such as progression to lamina propria invasion and increase in grade. The IBCG proposes the definition of nonmuscle invasive bladder cancer progression as an increase in T stage from CIS or Ta to T1 (lamina propria invasion), development of T2 or greater or lymph node (N+) disease or distant metastasis (M1), or an increase in grade from low to high. Investigators should consider the use of this new definition to help standardize protocols and improve the reporting of progression. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Simulation with standardized patients to prepare undergraduate nursing students for mental health clinical practice: An integrative literature review.

Science.gov (United States)

Øgård-Repål, Anita; De Presno, Åsne Knutson; Fossum, Mariann

2018-04-22

To evaluate the available evidence supporting the efficacy of using simulation with standardized patients to prepare nursing students for mental health clinical practice. Integrative literature review. A systematic search of the electronic databases CINAHL (EBSCOhost), Embase, MEDLINE, PsycINFO, and SveMed+ was conducted to identify empirical studies published until November 2016. Multiple search terms were used. Original empirical studies published in English and exploring undergraduate nursing students' experiences of simulation with standardized patients as preparation for mental health nursing practice were included. A search of reference lists and gray literature was also conducted. In total, 1677 studies were retrieved; the full texts of 78 were screened by 2 of the authors, and 6 studies reminded in the review. The authors independently reviewed the studies in three stages by screening the titles, abstracts, and full texts, and the quality of the included studies was assessed in the final stage. Design-specific checklists were used for quality appraisal. The thematic synthesizing method was used to summarize the findings of the included studies. The studies used four different research designs, both qualitative and quantitative. All studies scored fairly low in the quality appraisal. The five themes identified were enhanced confidence, clinical skills, anxiety regarding the unknown, demystification, and self-awareness. The findings of this study indicate that simulation with standardized patients could decrease students' anxiety level, shatter pre-assumptions, and increase self-confidence and self-awareness before entering clinical practice in mental health. More high-quality studies with larger sample sizes are required because of the limited evidence provided by the six studies in the present review. Copyright © 2018 Elsevier Ltd. All rights reserved.

An intensive nurse-led, multi-interventional clinic is more successful in achieving vascular risk reduction targets than standard diabetes care.

LENUS (Irish Health Repository)

MacMahon Tone, J

2009-06-01

The aim of this research was to determine whether an intensive, nurse-led clinic could achieve recommended vascular risk reduction targets in patients with type 2 diabetes as compared to standard diabetes management.

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.

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.

[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.

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.

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.

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.

Standardizing Umbilical Cord Mesenchymal Stromal Cells for Translation to Clinical Use: Selection of GMP-Compliant Medium and a Simplified Isolation Method

Directory of Open Access Journals (Sweden)

J. Robert Smith

2016-01-01

Full Text Available Umbilical cord derived mesenchymal stromal cells (UC-MSCs are a focus for clinical translation but standardized methods for isolation and expansion are lacking. Previously we published isolation and expansion methods for UC-MSCs which presented challenges when considering good manufacturing practices (GMP for clinical translation. Here, a new and more standardized method for isolation and expansion of UC-MSCs is described. The new method eliminates dissection of blood vessels and uses a closed-vessel dissociation following enzymatic digestion which reduces contamination risk and manipulation time. The new method produced >10 times more cells per cm of UC than our previous method. When biographical variables were compared, more UC-MSCs per gram were isolated after vaginal birth compared to Caesarian-section births, an unexpected result. UC-MSCs were expanded in medium enriched with 2%, 5%, or 10% pooled human platelet lysate (HPL eliminating the xenogeneic serum components. When the HPL concentrations were compared, media supplemented with 10% HPL had the highest growth rate, smallest cells, and the most viable cells at passage. UC-MSCs grown in 10% HPL had surface marker expression typical of MSCs, high colony forming efficiency, and could undergo trilineage differentiation. The new protocol standardizes manufacturing of UC-MSCs and enables clinical translation.

Optometry Australia Entry-level Competency Standards for Optometry 2014.

Science.gov (United States)

Kiely, Patricia M; Slater, Jared

2015-01-01

Competency standards for entry-level to the profession of optometry in Australia were first developed in 1993, revised in 1997 and 2000, and again in 2008, when therapeutic competency standards were introduced but differentiated from the entry-level competencies. Therapeutic competencies were an additional requirement for the purpose of endorsing optometric registration to allow prescription of medicines for conditions of the eye. Recent changes to educational and registration requirements mean that therapeutic competencies are now required at entry-level. To address this and to ensure the standards reflect current best practice, a full revision of the standards was undertaken. A steering committee oversaw the review of the standards, which involved a literature review, workshops with optometrists and broad consultation with stakeholders, including the Optometry Board of Australia, individual optometrists and employers of optometrists, to identify changes needed. Representatives of the profession from Australia and New Zealand and from academia in Australia were involved. A modified document based on the feedback received was circulated to the State Divisions and the National Board of the then Optometrists Association Australia. The updated standards reflect the state of entry to the optometric profession in 2014; competencies for prescribing of scheduled medicines are included, new material has been added, other areas have been modified. The updated entry-level competency standards were adopted on behalf of the profession by the National Board of the then Optometrists Association Australia in March 2014. Competency standards have been updated so that they continue to be current and useful for the profession, individual optometrists and Australian and New Zealand registration authorities for the purposes of accreditation of optometric programs and assessment of overseas-trained optometrists. This paper details the revision process and presents the 2014 version of

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

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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.

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.

Coaching individuals with perfectionistic tendencies When high standards help and hinder

Directory of Open Access Journals (Sweden)

Sarah Corrie

2014-07-01

Full Text Available Perfectionism has been widely recognised in the clinical field but has received less attention in the coaching psychology literature. Referring to overly high and unforgiving personal standards of performance that are accompanied by harsh self-evaluation when self-imposed standards are not met, perfectionism has the potential to undermine the coachee’s ability to achieve their goals as well as the coaching process itself. In consequence, it is important for practitioners to be able to identify and work effectively with those coachees whose perfectionistic tendencies represent an obstacle to progress. This paper discusses the current literature on perfectionism and provides recommendations on how to work effectively with coachees for whom unremittingly high personal standards are an impediment to personal growth and development.

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

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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.

ISO radiation sterilization standards

International Nuclear Information System (INIS)

Lambert, Byron J.; Hansen, Joyce M.

1998-01-01

This presentation provides an overview of the current status of the ISO radiation sterilization standards. The ISO standards are voluntary standards which detail both the validation and routine control of the sterilization process. ISO 11137 was approved in 1994 and published in 1995. When reviewing the standard you will note that less than 20% of the standard is devoted to requirements and the remainder is guidance on how to comply with the requirements. Future standards developments in radiation sterilization are being focused on providing additional guidance. The guidance that is currently provided in informative annexes of ISO 11137 includes: device/packaging materials, dose setting methods, and dosimeters and dose measurement, currently, there are four Technical Reports being developed to provide additional guidance: 1. AAMI Draft TIR, 'Radiation Sterilization Material Qualification' 2. ISO TR 13409-1996, 'Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches' 3. ISO Draft TR, 'Sterilization of health care products - Radiation sterilization Selection of a sterilization dose for a single production batch' 4. ISO Draft TR, 'Sterilization of health care products - Radiation sterilization-Product Families, Plans for Sampling and Frequency of Dose Audits'

Misophonia: current perspectives

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Cavanna AE

2015-08-01

Full Text Available Andrea E Cavanna,1–3 Stefano Seri3,4 1Department of Neuropsychiatry, Birmingham and Solihull Mental Health NHS Foundation Trust and University of Birmingham, Birmingham, 2Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology, University College London, London, 3School of Life and Health Sciences, Aston Brain Centre, Wellcome Trust Laboratory for MEG Studies, Aston University, 4Children’s Epilepsy Surgery Programme, The Birmingham Children’s Hospital NHS Foundation Trust, Birmingham, UK Abstract: Misophonia is characterized by a negative reaction to a sound with a specific pattern and meaning to a given individual. In this paper, we review the clinical features of this relatively common yet underinvestigated condition, with focus on co-occurring neurodevelopmental disorders. Currently available data on the putative pathophysiology of the condition can inform our understanding and guide the diagnostic process and treatment approach. Tinnitus retraining therapy and cognitive behavior therapy have been proposed as the most effective treatment strategies for reducing symptoms; however, current treatment algorithms should be validated in large population studies. At the present stage, competing paradigms see misophonia as a physiological state potentially inducible in any subject, an idiopathic condition (which can present with comorbid psychiatric disorders, or a symptomatic manifestation of an underlying psychiatric disorder. Agreement on the use of standardized diagnostic criteria would be an important step forward in terms of both clinical practice and scientific inquiry. Areas for future research include phenomenology, epidemiology, modulating factors, neurophysiological underpinnings, and treatment trials. Keywords: misophonia, selective sound sensitivity syndrome, hyperacusis, neurodevelopmental disorders, Tourette syndrome, obsessive-compulsive spectrum

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.

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

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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.

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

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Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal

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

Study of Grants, new Mexico, uranium miners: current status

International Nuclear Information System (INIS)

Samet, J.M.; Morgan, M.V.; Buechley, R.W.; Key, C.R.; Valdivia, A.A.

1981-01-01

The Uranium Epidemiology Study at the University of New Mexico was initiated in 1977 with the objective of assessing health effects of uranium mining in the Grants, New Mexico, area. The planned approach was a cohort study of mortality that would capitalize on the availability of health records at the Grants Clinic. The first year's work confirmed the study's feasibility (Buechley, 1979). Subsequent efforts have focused on the health and exposure data base and comprehensive follow-up. A retrospective cohort study of early miners is in progress; a prospective cohort study of miners who began working under the current federal standard is planned. This report will summarize the current status of the Uranium Epidemiology Study

Surgical management of morbidity due to lymphatic filariasis: the usefulness of a standardized international clinical classification of hydroceles.

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Capuano, G P; Capuano, C

2012-03-01

The objective of this work is to evaluate the usefulness of a standardized clinical classification of hydroceles in lymphatic filariasis endemic countries to guide their surgical management. 64 patients with hydroceles were operated in 2009-2010, in Level II hospitals (WHO classification), during two visits to Fiji, by the same mobile surgical team. The number of hydroceles treated was 83. We developed and evaluated a much needed clinical classification of hydroceles based on four criteria: Type (uni/bilateral); Side (left/right); Stage of enlargement of the scrotum rated from I to VI; Grade of burial of the penis rated from 0 to 4. It lead to the conclusion that 1) A Stage I or II hydrocele, associated with Grade 0 or 1 penis burial could be considered a "Simple Hydrocele". The surgical treatment is simple with no anticipated early complication. WHO Level II of health care structure seems adapted. 2) A Stage III or IV hydrocele associated with Grade 2, 3 or 4 penis burial could be considered a "Complicated Hydrocele". The operation is longer, more complicated and the possibility of occurrence of complications seems greater. A level III health care facility would be more adapted under the normal functioning of the health system. We conclude that a standardized clinical classification of hydroceles based on the Stage of enlargement of the scrotum and the Grade of burial of the penis appears to be a useful tool to guide the decision about the level of care and the surgical technique required. We use the same classification for penoscrotal lymphoedema. A decision tree is presented for the management of hydroceles in lymphatic filariasis endemic countries which could usefully complement the "Algorithm for management of scrotal swelling" proposed by WHO in 2002. An international classification system of hydroceles would also allow standardization and facilitate study design and comparisons of their results.

Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.

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Schnyer, Rosa N; Allen, John J B

2002-10-01

An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments. To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization. A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given. A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.

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

Treatment of cutaneous melanoma: current approaches and future prospects

International Nuclear Information System (INIS)

Algazi, Alain P; Soon, Christopher W; Daud, Adil I

2010-01-01

Melanoma is the most aggressive and deadly type of skin cancer. Surgical resection with or without lymph node sampling is the standard of care for primary cutaneous melanoma. Adjuvant therapy decisions may be informed by careful consideration of prognostic factors. High-dose adjuvant interferon alpha-2b increases disease-free survival and may modestly improve overall survival. Less toxic alternatives for adjuvant therapy are currently under study. External beam radiation therapy is an option for nodal beds where the risk of local recurrence is very high. In-transit melanoma metastases may be treated locally with surgery, immunotherapy, radiation, or heated limb perfusion. For metastatic melanoma, the options include chemotherapy or immunotherapy; targeted anti-BRAF and anti-KIT therapy is under active investigation. Standard chemotherapy yields objective tumor responses in approximately 10%–20% of patients, and sustained remissions are uncommon. Immunotherapy with high-dose interleukin-2 yields objective tumor responses in a minority of patients; however, some of these responses may be durable. Identification of activating mutations of BRAF, NRAS, c-KIT, and GNAQ in distinct clinical subtypes of melanoma suggest that these are molecularly distinct. Emerging data from clinical trials suggest that substantial improvements in the standard of care for melanoma may be possible

Partial Thickness Rotator Cuff Tears: Current Concepts

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Matthewson, Graeme; Beach, Cara J.; Nelson, Atiba A.; Woodmass, Jarret M.; Ono, Yohei; Boorman, Richard S.; Lo, Ian K. Y.; Thornton, Gail M.

2015-01-01

Partial thickness rotator cuff tears are a common cause of pain in the adult shoulder. Despite their high prevalence, the diagnosis and treatment of partial thickness rotator cuff tears remains controversial. While recent studies have helped to elucidate the anatomy and natural history of disease progression, the optimal treatment, both nonoperative and operative, is unclear. Although the advent of arthroscopy has improved the accuracy of the diagnosis of partial thickness rotator cuff tears, the number of surgical techniques used to repair these tears has also increased. While multiple repair techniques have been described, there is currently no significant clinical evidence supporting more complex surgical techniques over standard rotator cuff repair. Further research is required to determine the clinical indications for surgical and nonsurgical management, when formal rotator cuff repair is specifically indicated and when biologic adjunctive therapy may be utilized. PMID:26171251

Partial Thickness Rotator Cuff Tears: Current Concepts

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Graeme Matthewson

2015-01-01

Full Text Available Partial thickness rotator cuff tears are a common cause of pain in the adult shoulder. Despite their high prevalence, the diagnosis and treatment of partial thickness rotator cuff tears remains controversial. While recent studies have helped to elucidate the anatomy and natural history of disease progression, the optimal treatment, both nonoperative and operative, is unclear. Although the advent of arthroscopy has improved the accuracy of the diagnosis of partial thickness rotator cuff tears, the number of surgical techniques used to repair these tears has also increased. While multiple repair techniques have been described, there is currently no significant clinical evidence supporting more complex surgical techniques over standard rotator cuff repair. Further research is required to determine the clinical indications for surgical and nonsurgical management, when formal rotator cuff repair is specifically indicated and when biologic adjunctive therapy may be utilized.

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

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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

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…

Esophageal tissue engineering: Current status and perspectives.

Science.gov (United States)

Poghosyan, T; Catry, J; Luong-Nguyen, M; Bruneval, P; Domet, T; Arakelian, L; Sfeir, R; Michaud, L; Vanneaux, V; Gottrand, F; Larghero, J; Cattan, P

2016-02-01

Tissue engineering, which consists of the combination and in vivo implantation of elements required for tissue remodeling toward a specific organ phenotype, could be an alternative for classical techniques of esophageal replacement. The current hybrid approach entails creation of an esophageal substitute composed of an acellular matrix and autologous epithelial and muscle cells provides the most successful results. Current research is based on the use of mesenchymal stem cells, whose potential for differentiation and proangioogenic, immune-modulator and anti-inflammatory properties are important assets. In the near future, esophageal substitutes could be constructed from acellular "intelligent matrices" that contain the molecules necessary for tissue regeneration; this should allow circumvention of the implantation step and still obtain standardized in vivo biological responses. At present, tissue engineering applications to esophageal replacement are limited to enlargement plasties with absorbable, non-cellular matrices. Nevertheless, the application of existing clinical techniques for replacement of other organs by tissue engineering in combination with a multiplication of translational research protocols for esophageal replacement in large animals should soon pave the way for health agencies to authorize clinical trials. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns

Science.gov (United States)

Zhao, Haichao; Qiao, Lei; Fan, Dongqiong; Zhang, Shuyue; Turel, Ofir; Li, Yonghui; Li, Jun; Xue, Gui; Chen, Antao; He, Qinghua

2017-01-01

Transcranial direct current stimulation (tDCS) is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation. PMID:28539894

Minimum Information about T Regulatory Cells: A Step toward Reproducibility and Standardization

Directory of Open Access Journals (Sweden)

Anke Fuchs

2018-01-01

Full Text Available Cellular therapies with CD4+ T regulatory cells (Tregs hold promise of efficacious treatment for the variety of autoimmune and allergic diseases as well as posttransplant complications. Nevertheless, current manufacturing of Tregs as a cellular medicinal product varies between different laboratories, which in turn hampers precise comparisons of the results between the studies performed. While the number of clinical trials testing Tregs is already substantial, it seems to be crucial to provide some standardized characteristics of Treg products in order to minimize the problem. We have previously developed reporting guidelines called minimum information about tolerogenic antigen-presenting cells, which allows the comparison between different preparations of tolerance-inducing antigen-presenting cells. Having this experience, here we describe another minimum information about Tregs (MITREG. It is important to note that MITREG does not dictate how investigators should generate or characterize Tregs, but it does require investigators to report their Treg data in a consistent and transparent manner. We hope this will, therefore, be a useful tool facilitating standardized reporting on the manufacturing of Tregs, either for research purposes or for clinical application. This way MITREG might also be an important step toward more standardized and reproducible testing of the Tregs preparations in clinical applications.

[Team approaches to critical bleeding (massive bleeding and transfusion) - chairmen's introductory remarks. Questionnaire survey on current status of hospital clinical laboratories evaluating critical hemorrhage].

Science.gov (United States)

Kino, Shuichi; Suwabe, Akira

2014-12-01

In 2007, "the Guidelines for Actions against Intraoperative Critical Hemorrhage" were established by the Japanese Society of Anaesthesiologists and the Japanese Society of Blood transfusion and Cell Therapy. The documentation of in-hospital procedures for critical hemorrhage, especially about how to select RBC units, has widely standardized hospital practice. Patients with intraoperative critical hemorrhage sometimes suffer from massive blood loss. In this situation, some patients develop coagulopathy. To treat them, we need to evaluate their coagulation status based on laboratory test results. So, we performed a nationwide questionnaire survey on the current status of hospital clinical laboratories evaluating critical hemorrhage. From the results of this survey, it was recommended that central hospital laboratories should try to reduce the turn-around time required to test for coagulation parameters as much as possible for appropriate substitution therapy. (Review).

Armonización de estándares de calidad para ensayos clínicos. Norma ISO 9001-Guía de Buena Práctica Clínica Harmonization of quality standards for clinical trials. ISO-9001 standard and Guide of Good Clinical Practice

Directory of Open Access Journals (Sweden)

Sandra Álvarez Guerra

2011-09-01

Full Text Available El proceso de ensayo clínico necesario para autorizar el uso de nuevos medicamentos en humanos es extenso y complejo. Para garantizar la calidad y estandarizar este proceso, la Conferencia Internacional de Armonización ha establecido la Guía E6 para la Buena Práctica Clínica, la cual ha sido asumida y adaptada por las agencias reguladoras nacionales para estandarizar este proceso en sus países. Otra norma que permite garantizar calidad es la ISO 9001:2008, que establece requisitos para implementar Sistema de Gestión de Calidad. El objetivo de este trabajo consistió en establecer elementos comunes que demuestren la armonización entre la Buena Práctica Clínica de la Conferencia Internacional de Armonización, la Buena Práctica Clínica cubana y la ISO 9001:2008 para su implementación en sistemas de calidad para los ensayos clínicos. Para ello se realizó el estudio de estos estándares analizando qué tienen en común en su aplicación para el proceso de ensayo clínico. Se determinó que el cliente, los proveedores, el enfoque de proceso, la documentación, la dirección, las revisiones, la forma de realización de la investigación y la mejora de la calidad son puntos comunes para los cuales se establecen requisitos a cumplir. Esto permitió afirmar que los estándares estudiados al ser usados de conjunto en el proceso de ensayo clínico, contribuyen a elevar la calidad, pues no existe ningún aspecto contemplado en ellos que refleje contradicción sino aspectos comunes que permiten su armonización y uso.A clinical trial is an extensive, complex and necessary process to authorize the use of new medications in humans. For the purpose of assuring the quality and the standardization of this process, the International Conference of Harmonization (ICH set the Guideline E6 for Good Clinical Practice, which has been adopted and adapted by the national regulatory agencies. There also exists another standard to guarantee quality in the

Clinical professional governance for detailed clinical models.

Science.gov (United States)

Goossen, William; Goossen-Baremans, Anneke

2013-01-01

This chapter describes the need for Detailed Clinical Models for contemporary Electronic Health Systems, data exchange and data reuse. It starts with an explanation of the components related to Detailed Clinical Models with a brief summary of knowledge representation, including terminologies representing clinic relevant "things" in the real world, and information models that abstract these in order to let computers process data about these things. Next, Detailed Clinical Models are defined and their purpose is described. It builds on existing developments around the world and accumulates in current work to create a technical specification at the level of the International Standards Organization. The core components of properly expressed Detailed Clinical Models are illustrated, including clinical knowledge and context, data element specification, code bindings to terminologies and meta-information about authors, versioning among others. Detailed Clinical Models to date are heavily based on user requirements and specify the conceptual and logical levels of modelling. It is not precise enough for specific implementations, which requires an additional step. However, this allows Detailed Clinical Models to serve as specifications for many different kinds of implementations. Examples of Detailed Clinical Models are presented both in text and in Unified Modelling Language. Detailed Clinical Models can be positioned in health information architectures, where they serve at the most detailed granular level. The chapter ends with examples of projects that create and deploy Detailed Clinical Models. All have in common that they can often reuse materials from earlier projects, and that strict governance of these models is essential to use them safely in health care information and communication technology. Clinical validation is one point of such governance, and model testing another. The Plan Do Check Act cycle can be applied for governance of Detailed Clinical Models

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

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

Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

Directory of Open Access Journals (Sweden)

de Bie Rob A

2010-06-01

Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

Department of Energy Standards Index

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-08-01

This TSL, intended for use in selecting and using DOE technical standards and other Government and non-Government standards, provides listing of current and inactive DOE technical standards, non-Government standards adopted by DOE, other Government documents in which DOE has a recorded interest, and cancelled DOE technical standards.

[Modularization by the open standard. (I)].

Science.gov (United States)

Hirano, H

2000-10-01

We are proceeding with the project called "Open LA21 Project" in the course of the clinical laboratory automation toward the 21st century. With the modular system that realizes integration, downsizing, a reasonable price, and is the future course in the clinical testing automation system as well, we aim to establish common standards among manufacturers as the only way to create user friendly market environments where the proper competition exists among the manufacturers. The common standards which are in preparation by the participating companies as "Open module system standards" are the standards which are going to be made public. They are intended to guarantee connection, compatibility of the products in conformity with the standards. In this project, we intend to realize the modular system that integrates each field, such as chemistry, hematology, coagulation/fibrinolysis, immunology, urinalysis in an early stage, and contribute positively to restructuring and upgrading the "raison d'etre" of the 21st century clinical testing.

Standard procedures for adults in accredited sleep medicine centres in Europe

DEFF Research Database (Denmark)

Fischer, Jürgen; Dogas, Zoran; Bassetti, Claudio L

2012-01-01

The present paper describes standardized procedures within clinical sleep medicine. As such, it is a continuation of the previously published European guidelines for the accreditation of sleep medicine centres and European guidelines for the certification of professionals in sleep medicine, aimed...... at creating standards of practice in European sleep medicine. It is also part of a broader action plan of the European Sleep Research Society, including the process of accreditation of sleep medicine centres and certification of sleep medicine experts, as well as publishing the Catalogue of Knowledge...... and Skills for sleep medicine experts (physicians, non-medical health care providers, nurses and technologists), which will be a basis for the development of relevant educational curricula. In the current paper, the standard operational procedures sleep medicine centres regarding the diagnostic...

The Management of Dental Waste in Dental Offices and Clinics in Shiraz, Southern Iran

Directory of Open Access Journals (Sweden)

M Danaei

2014-01-01

Full Text Available Background: Dental waste can be hazardous to humans and the environment. Objective: To determine the current status of dental waste management in private and public dental clinics and private dental offices in Shiraz, southern Iran. Methods: This cross-sectional study was conducted at the Shiraz University of Medical Sciences from February through June 2013. A stratified random sampling method was used to study 86 private offices, 14 private clinics and 10 public clinics. Types of waste studied included mercury and amalgam, lead foil packets, sharps, infectious tissues and fluids, pharmaceuticals and domestic waste materials. Compliance with established standards by the monitored dental offices and clinics and public clinics were compared. Results: 89.1% of dental offices and clinics disposed their infectious waste with domestic waste. Only 60% of centers used standard method for sharps disposal. None of the dental centers disposed their pharmaceutical waste and x-ray fixer waste by standard methods. Less than 10% of centers recycled the amalgam and lead foil pockets waste to the manufacture. Conclusion: Government agencies should establish monitoring programs for all dental offices and clinics to identify noncompliant activity and enforce recommended regulations.

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. 

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective.

Directory of Open Access Journals (Sweden)

Kim P C Kuypers

Full Text Available Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT. The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user was predictive of having clinically deficient memory performance compared to a healthy control group.WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions.Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired.The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective.

Science.gov (United States)

Kuypers, Kim P C; Theunissen, Eef L; van Wel, Janelle H P; de Sousa Fernandes Perna, Elizabeth B; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G; Ramaekers, Johannes G

2016-01-01

Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse

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

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.

PRESCRIBING OF ANTIHYPERTENSIVE AGENTS IN PUBLIC PRIMARY CARE CLINICS – IS IT IN ACCORDANCE WITH CURRENT EVIDENCE?

Directory of Open Access Journals (Sweden)

SAJARI J

2010-01-01

Full Text Available Background: Large population surveys in Malaysia have consistently shown minimal improvement of blood pressure control rates over the last 10 years. Poor adherence to antihypertensive medication has been recognized as a major reason for poor control of hypertension. This study aimed to describe the prescribing pattern of antihypertensive agents in 2 public primary care clinics and assess its appropriateness in relation to current evidence and guidelines. Methods: A cross-sectional survey to describe the prescribing pattern of antihypertensive agents was carried out in 2 publicprimary care clinics in Selangor from May to June 2009. Hypertensive patients on pharmacological treatment for ≥1 year who attended the clinics within the study period of 7 weeks were selected. Appropriate use of antihypertensive agents was defined based on current evidence and the recommendations by the Malaysian Clinical Practice Guidelines (CPG on the Management of Hypertension, 2008. Data were obtained from patients’ medical records and were analysed using the SPSS software version 16.0. Results: A total of 400 hypertensive patients on treatment were included. Mean age was 59.5 years (SD ±10.9, range 28 to91 years, of which 52.8% were females and 47.2% were males. With regards to pharmacotherapy, 45.7% were on monotherapy,43.3% were on 2 agents and 11.0% were on ≥3 agents. Target blood pressure of <140/90mmHg was achieved in 51.4% of patients on monotherapy, and 33.2% of patients on combination of ≥2 agents. The commonest monotherapy agents being prescribed were β-blockers (atenolol or propranolol, followed by the short-acting calcium channel blocker (nifedipine. The commonest combination of 2-drug therapy prescribed was β-blockers and short-acting calcium channel blocker. Conclusion: This study shows that the prescribing pattern of antihypertensive agents in the 2 primary care clinics was not in accordance with current evidence and guidelines. �

Current and emerging treatment options for nasopharyngeal carcinoma

Directory of Open Access Journals (Sweden)

Spratt DE

2012-10-01

Full Text Available Daniel E Spratt, Nancy LeeDepartment of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USAAbstract: In this article, we focus on the current and emerging treatments in nasopharyngeal cancer (NPC. A detailed evolution of the current standard of care, and new techniques and treatment options will be reviewed. Intergroup 0099 established the role for chemoradiotherapy (chemo-RT in the treatment of nasopharyngeal carcinoma. Multiple randomized Phase III trials have shown the benefit of chemo-RT; however, none of these studies utilized modern radiotherapy (RT techniques of intensity-modulated radiation therapy (IMRT. IMRT has the ability to deliver high doses of radiation to the target structures while sparing adjacent bystander healthy tissues, and has now become the preferred RT treatment modality. Chemotherapy also has had a shifting paradigm of induction and/or adjuvant chemotherapy combined with RT alone, to the investigation with concurrent chemo-RT. New treatment options including targeted monoclonal antibodies and small molecule tyrosine kinase inhibitors are being studied in NPC. These new biologic therapies have promising in vitro activity for NPC, and emerging clinical studies are beginning to define their role. RT continues to expand its capabilities, and since IMRT and particle therapy, specifically intensity-modulated proton therapy (IMPT, has reports of impressive dosimetric efficacy in-silica. Adaptive RT is attempting to reduce toxicity while maintaining treatment efficacy, and the clinical results are still in their youth. Lastly, Epstein–Barr virus (EBV DNA has recently been studied for prediction of tumor response and its use as a biomarker is increasingly promising to aid in early detection as well as supplementing the current staging system. RT with or without chemotherapy remains the standard of care for nasopharyngeal carcinoma. Advances in RT technique, timing of chemotherapy, biologically

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.

Current irritability robustly related to current and prior anxiety in bipolar disorder.

Science.gov (United States)

Yuen, Laura D; Miller, Shefali; Wang, Po W; Hooshmand, Farnaz; Holtzman, Jessica N; Goffin, Kathryn C; Shah, Saloni; Ketter, Terence A

2016-08-01

Although current irritability and current/prior anxiety have been associated in unipolar depression, these relationships are less well understood in bipolar disorder (BD). We investigated relationships between current irritability and current/prior anxiety as well as other current emotions and BD illness characteristics. Outpatients referred to the Stanford Bipolar Disorders Clinic during 2000-2011 were assessed with the Systematic Treatment Enhancement Program for BD (STEP-BD) Affective Disorders Evaluation. Prevalence and clinical correlates of current irritability and current/prior anxiety and other illness characteristics were examined. Among 497 BD outpatients (239 Type I, 258 Type II; 58.1% female; mean ± SD age 35.6 ± 13.1 years), 301 (60.6%) had baseline current irritability. Patients with versus without current irritability had significantly higher rates of current anxiety (77.1% versus 42.9%, p anxiety disorder (73.1% versus 52.6%, p anxiety than to current anhedonia, sadness, or euphoria (all p anxiety associations persisted across current predominant mood states. Current irritability was more robustly related to past anxiety than to all other assessed illness characteristics, including 1° family history of mood disorder, history of alcohol/substance use disorder, bipolar subtype, and current syndromal/subsyndromal depression (all p anxiety. Further studies are warranted to assess longitudinal clinical implications of relationships between irritability and anxiety in BD. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinical Trials

Medline Plus

Full Text Available ... strategies. For example, one group may get the current standard treatment for a condition, while another group ... new strategy being tested, you may receive the current standard care for your condition. This treatment might ...

Topography-modified refraction (TMR): adjustment of treated cylinder amount and axis to the topography versus standard clinical refraction in myopic topography-guided LASIK.

Science.gov (United States)

Kanellopoulos, Anastasios John

2016-01-01

To evaluate the safety, efficacy, and contralateral eye comparison of topography-guided myopic LASIK with two different refraction treatment strategies. Private clinical ophthalmology practice. A total of 100 eyes (50 patients) in consecutive cases of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond and EX500 excimer lasers) were randomized for treatment as follows: one eye with the standard clinical refraction (group A) and the contralateral eye with the topographic astigmatic power and axis (topography-modified treatment refraction; group B). All cases were evaluated pre- and post-operatively for the following parameters: refractive error, best corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), topography (Placido-disk based) and tomography (Scheimpflug-image based), wavefront analysis, pupillometry, and contrast sensitivity. Follow-up visits were conducted for at least 12 months. Mean refractive error was -5.5 D of myopia and -1.75 D of astigmatism. In group A versus group B, respectively, the average UDVA improved from 20/200 to 20/20 versus 20/16; post-operative CDVA was 20/20 and 20/13.5; 1 line of vision gained was 27.8% and 55.6%; and 2 lines of vision gained was 5.6% and 11.1%. In group A, 27.8% of eyes had over -0.50 diopters of residual refractive astigmatism, in comparison to 11.7% in group B ( P Topography-modified refraction (TMR): topographic adjustment of the amount and axis of astigmatism treated, when different from the clinical refraction, may offer superior outcomes in topography-guided myopic LASIK. These findings may change the current clinical paradigm of the optimal subjective refraction utilized in laser vision correction.

XML Syntax for Clinical Laboratory Procedure Manuals

OpenAIRE

Saadawi, Gilan; Harrison, James H.

2003-01-01

We have developed a document type description (DTD) in Extensable Markup Language (XML)1 for clinical laboratory procedures. Our XML syntax can adequately structure a variety of procedure types across different laboratories and is compatible with current procedure standards. The combination of this format with an XML content management system and appropriate style sheets will allow efficient procedure maintenance, distributed access, customized display and effective searching across a large b...

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

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.

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.