Do clinical safety charts improve paramedic key performance indicator results? (A clinical improvement programme evaluation).

Science.gov (United States)

Ebbs, Phillip; Middleton, Paul M; Bonner, Ann; Loudfoot, Allan; Elliott, Peter

2012-07-01

Is the Clinical Safety Chart clinical improvement programme (CIP) effective at improving paramedic key performance indicator (KPI) results within the Ambulance Service of New South Wales? The CIP intervention area was compared with the non-intervention area in order to determine whether there was a statistically significant improvement in KPI results. The CIP was associated with a statistically significant improvement in paramedic KPI results within the intervention area. The strategies used within this CIP are recommended for further consideration.

Elements of safety and non proliferation

International Nuclear Information System (INIS)

Jalouneix, Jean; Aurelle, Jacques; Funk, Pierre; Ladsous, David; Bon Nguyen, Romuald; Goue, Georges; Lefevre, Odile

2015-01-01

This book on nuclear safety and non proliferation is based on knowledge and expertise of the IRSN. The first chapter addresses the safety of nuclear materials, of their installations and of their transportations. It proposes some contextual elements, presents the general guidelines of the French nuclear safety arrangement, the approach to take risks into account, the involved governmental and public bodies, the legal framework, and the protection and control arrangement (in terms of planning of safety-related activities, in terms of operator obligations, in terms of exercises and management crisis). The second part addresses the safety of radioactive sources: context (peculiarity, losses and thefts), international framework (source categories, Euratom directive), and the French organisation. The third chapter addresses nuclear non proliferation: historical background (creation and role of the IAEA and of the EAEC, definitions), principle of statements, inspection process, and French organisation (legal framework, governmental bodies, the IRSN). The last chapter addresses the issue of chemical non proliferation: historical background, international context (Convention on chemical weapons, organisation for their ban), and the French organisation

Clinical study of DMD gene point mutation causing Becker muscular dystrophy

Directory of Open Access Journals (Sweden)

Ji-qing CAO

2015-07-01

Full Text Available Background  DMD gene point mutation, mainly nonsense mutation, always cause the most severe Duchenne muscular dystrophy (DMD. However, we also observed some cases of Becker muscular dystrophy (BMD carrying DMD point mutation. This paper aims to explore the mechanism of DMD point mutation causing BMD, in order to enhance the understanding of mutation types of BMD.  Methods  Sequence analysis was performed in 11 cases of BMD confirmed by typical clinical manifestations and muscle biopsy. The exon of DMD gene was detected non-deletion or duplication by multiplex ligation-dependent probe amplification (MLPA.  Results  Eleven patients carried 10 mutation types without mutational hotspot. Six patients carried nonsense mutations [c.5002G>T, p.(Glu1668X; c.1615C > T, p.(Arg539X; c.7105G > T, p.(Glu2369X; c.5287C > T, p.(Arg1763X; c.9284T > G, p.(Leu3095X]. One patient carried missense mutation [c.5234G > A, p.(Arg1745His]. Two patients carried frameshift mutations (c.10231dupT, c.10491delC. Two patients carried splicing site mutations (c.4518 + 3A > T, c.649 + 2T > C.  Conclusions  DMD gene point mutation may result in BMD with mild clinical symptoms. When clinical manifestations suggest the possibility of BMD and MLPA reveals non?deletion or duplication mutation of DMD gene, BMD should be considered. Study on the mechanism of DMD point mutation causing BMD is very important for gene therapy of DMD. DOI: 10.3969/j.issn.1672-6731.2015.06.005

Procedures for conducting probabilistic safety assessment for non-reactor nuclear facilities

International Nuclear Information System (INIS)

2002-01-01

A well performed and adequately documented safety assessment of a nuclear facility will serve as a basis to determine whether the facility complies with the safety objectives, principles and criteria as stipulated by the national regulatory body of the country where the facility is in operation. International experience shows that the practices and methodologies used to perform safety assessments and periodic safety re-assessment for non-reactor nuclear facilities differ significantly from county to country. Most developing countries do not have methods and guidance for safety assessment that are prescribed by the regulatory body. Typically the safety evaluation for the facility is based on a case by case assessment. Whilst conservative deterministic analyses are predominantly used as a licensing basis in many countries, recently probabilistic safety assessment (PSA) techniques have been applied as a useful complementary tool to support safety decision making. The main benefit of PSA is to provide insights into the safety aspects of facility design and operation. PSA points up the potential environmental impacts of postulated accidents, including the dominant risk contributors, and enables safety analysts to compare options for reducing risk. In order to advise on how to apply PSA methodology for the safety assessment of non-reactor nuclear facilities, the IAEA organized several consultants meetings, which led to the preparation of this TECDOC. This document is intended as guidance for the conduct of PSA in non-nuclear facilities. The main emphasis here is on the general procedural steps of a PSA that is specific for a non-reactor nuclear facility, rather than the details of the specific methods. The report is directed at technical staff managing or performing such probabilistic assessments and to promote a standardized framework, terminology and form of documentation for these PSAs. It is understood that the level of detail implied in the tasks presented in this

Fast neutron reactors: the safety point of view

International Nuclear Information System (INIS)

Laverie, M.; Avenas, M.

1984-01-01

All versions of nuclear reactors present favourable and unfavourable characteristics from the point of view of safety. The safety of the installations is obtained by making efforts to utilize in the best possible way those which are favourable and by taking proper steps in the face of those which are unfavourable. The present article shows how this general principle has been applied as regards the fast neutron reactors of integrated design which have been developped in France, taking into account the specific features of this version. A qualitative method to compare the safety of this version with that of pressurized water reactors which has been widely put to the test commercially all over the world is presented. These analyses make, generally speaking, several positive characteristics stand out for these fast neutron reactors from the safety aspects [fr

Patient safety trilogy: perspectives from clinical engineering.

Science.gov (United States)

Gieras, Izabella; Sherman, Paul; Minsent, Dennis

2013-01-01

This article examines the role a clinical engineering or healthcare technology management (HTM) department can play in promoting patient safety from three different perspectives: a community hospital, a national government health system, and an academic medical center. After a general overview, Izabella Gieras from Huntington Hospital in Pasadena, CA, leads off by examining the growing role of human factors in healthcare technology, and describing how her facility uses clinical simulations in medical equipment evaluations. A section by Paul Sherman follows, examining patient safety initiatives from the perspective of the Veterans Health Administration with a focus on hazard alerts and recalls. Dennis Minsent from Oregon Health & Science University writes about patient safety from an academic healthcare perspective, and details how clinical engineers can engage in multidisciplinary safety opportunities.

Influence of Non-safety Important Component on Maintenance Rule

International Nuclear Information System (INIS)

Ju, Tae Young; Kim, Wang Bae

2016-01-01

The Maintenance Rule (MR) programs in KHNP have been implemented since Jan 2009. KHNP is currently developing MR program for new built plant which has been constructed from December 2011. It is required to utilize plant-specific probabilistic safety analysis (PSA) result as risk significant criteria to determine which components are significantly important to safety. The criteria consist of three PSA risk values which are risk reduction worth (RRW), risk achievement worth (RAW) and core damage frequency (CDF) contribution. Most safety related components are classified as high risk significant, and non-safety related components as low safety significant in MR program. This paper presents the influence of the non-safety related component which has high PSA risk value on MR program of new built plant. It is considered that safety related system has at least one or more safety functions and some non-safety functions, but non-safety system doesn't have any safety function. The safety functions are defined as three functions which are required to maintain 1) integrity of reactor coolant pressure boundary, 2) capability to shut-down the reactor and maintain it in a safe shutdown, and 3) capability to prevent or mitigate the accident that could result in potential offsite exposure. The Maintenance Rule program is developed based on PSA result. Safety functions have high risk value in PSA program and considered HSS function in MR program. On the contrary, non-safety functions are generally has low risk value in PSA program and they are determined as LSS function in MR program. The AAC DG and its supporting systems are designed as non-safety systems which mean they don't have any safety function. But, AAC DG is treated as an important measure to mitigate accident in PSA program. It is determined as HSS function in MR program because it has high risk value in PSA program. AAC DG supporting systems does not have high risk value in operating plant's PSA program

Clinical trial of non-ionic contrast media -comparison of efficacy and safety between non-ionic iopromide (Ultravist) and ionic contrast media-

International Nuclear Information System (INIS)

Lee, Ghi Jai; Kim, Seung Hyup; Park, Jae Hyung; Chang, Kee Hyun; Han, Man Chung; Kim, Chu Wan

1988-01-01

Non-ionic contrast media, iopromide (Ultravist) was compared with ioxitalamate (Telebrix) and/or ioxaglate (Hexabrix) for efficacy and safety in 203 patients undergoing cardiac angiography, neurovascular angiography, peripheral and visceral angiography and intravenous pyelography. In all patients, adverse symptoms and signs including heat sense, pain, nausea, vomiting, etc. were checked during and after the injection. In addition, EKG and LV pressure were monitored during the cardiac angiography. And also CBC, UA, BUN and creatinine were checked before and 24 hours after the cardiac angiography. Serious adverse effect did not occur in any case. Minor effects, such as nausea and abdominal pain, were less frequently caused by non-ionic contrast media than by ionic contrast media, especially in cardiac angiography and intravenous pyelography. There was no significant difference between ionic and non-ionic contrast media in regard to electrophysiologic parameters such as EKG and LV pressure. In case of intravenous pyelography, nonionic contrast media seemed to be superior to ionic contrast media in image quality. It is suggested that, in spite of higher cost, non-ionic contrast media be needed for the safety and image quality, particularly in those patients at high risk of adverse effects by ionic contrast media

Asymptotic safety of higher derivative quantum gravity non-minimally coupled with a matter system

Science.gov (United States)

Hamada, Yuta; Yamada, Masatoshi

2017-08-01

We study asymptotic safety of models of the higher derivative quantum gravity with and without matter. The beta functions are derived by utilizing the functional renormalization group, and non-trivial fixed points are found. It turns out that all couplings in gravity sector, namely the cosmological constant, the Newton constant, and the R 2 and R μν 2 coupling constants, are relevant in case of higher derivative pure gravity. For the Higgs-Yukawa model non-minimal coupled with higher derivative gravity, we find a stable fixed point at which the scalar-quartic and the Yukawa coupling constants become relevant. The relevant Yukawa coupling is crucial to realize the finite value of the Yukawa coupling constants in the standard model.

[A landscape ecological approach for urban non-point source pollution control].

Science.gov (United States)

Guo, Qinghai; Ma, Keming; Zhao, Jingzhu; Yang, Liu; Yin, Chengqing

2005-05-01

Urban non-point source pollution is a new problem appeared with the speeding development of urbanization. The particularity of urban land use and the increase of impervious surface area make urban non-point source pollution differ from agricultural non-point source pollution, and more difficult to control. Best Management Practices (BMPs) are the effective practices commonly applied in controlling urban non-point source pollution, mainly adopting local repairing practices to control the pollutants in surface runoff. Because of the close relationship between urban land use patterns and non-point source pollution, it would be rational to combine the landscape ecological planning with local BMPs to control the urban non-point source pollution, which needs, firstly, analyzing and evaluating the influence of landscape structure on water-bodies, pollution sources and pollutant removal processes to define the relationships between landscape spatial pattern and non-point source pollution and to decide the key polluted fields, and secondly, adjusting inherent landscape structures or/and joining new landscape factors to form new landscape pattern, and combining landscape planning and management through applying BMPs into planning to improve urban landscape heterogeneity and to control urban non-point source pollution.

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

Science.gov (United States)

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

A non-uniform expansion mechanical safety model of the stent.

Science.gov (United States)

Yang, J; Huang, N; Du, Q

2009-01-01

Stents have a serial unstable structure that readily leads to non-uniform expansion. Non-uniform expansion in turn creates a stent safety problem. We explain how a stent may be simplified to a serial unstable structure, and present a method to calculate the non-uniform expansion of the stent on the basis of the serial unstable structure. We propose a safety criterion based on the expansion displacement instead of the strain, and explain that the parameter Rd, the ratio of the maximum displacement of the elements to normal displacement, is meaningful to assess the safety level of the stent. We also examine how laser cutting influences non-uniform expansion. The examples illustrate how to calculate the parameter Rd to assess non-uniform expansion of the stent, and demonstrate how the laser cutting offset and strengthening coefficient of the material influence the stent expansion behaviour. The methods are valuable for assessing stent safety due to non-uniform expansion.

Analysis approach for common cause failure on non-safety digital control system

Energy Technology Data Exchange (ETDEWEB)

Kim, Yun Goo; Oh, Eungse [Korea Hydro and Nuclear Power Co. Ltd., Daejeon (Korea, Republic of)

2014-05-15

The effects of common cause failure (CCF) on safety digital instrumentation and control (I and C) system had been considered in defense in depth and diversity coping analysis with safety analysis method. For the non-safety system, single failure had been considered for safety analysis. IEEE Std. 603-1991, Clause 5.6.3.1(2), 'Isolation' states that no credible failure on the non-safety side of an isolation device shall prevent any portion of a safety system from meeting its minimum performance requirements during and following any design basis event requiring that safety function. The software CCF is one of the credible failure on the non-safety side. In advanced digital I and C system, same hardware component is used for different control system and the defect in manufacture or common external event can generate CCF. Moreover, the non-safety I and C system uses complex software for its various function and software quality assurance for the development process is less severe than safety software for the cost effective design. Therefore the potential defects in software cannot be ignored and the effect of software CCF on non-safety I and C system is needed to be evaluated. This paper proposes the general process and considerations for the analysis of CCF on non-safety I and C system.

Seismic qualification of non-safety class equipment whose failure would damage safety class equipment

International Nuclear Information System (INIS)

LaSalle, F.R.

1991-01-01

Both Code of Federal Regulations, Title 10, Part 50, and US Department of Energy Order 6340.1A have requirements to assess the interaction of non-safety and safety class structures and equipment during a seismic event to maintain the safety function. At the Hanford Site, a cost effective program has been developed to perform the evaluation of non-safety class equipment. Seismic qualification is performed by analysis, test, or upgrading of the equipment to ensure the integrity of safety class structures and equipment. This paper gives a brief overview and synopsis that address design analysis guidelines including applied loading, damping values, component anchorage, allowable loads, and stresses. Test qualification of equipment and walkdown acceptance criteria for heating ampersand ventilation (H ampersand V) ducting, conduit, cable tray, missile zone of influence, as well as energy criteria are presented

75 FR 55477 - Safety Zone; Revolution 3 Triathlon, Lake Erie & Sandusky Bay, Cedar Point, OH

Science.gov (United States)

2010-09-13

...-AA00 Safety Zone; Revolution 3 Triathlon, Lake Erie & Sandusky Bay, Cedar Point, OH AGENCY: Coast Guard... portions of the Lake Erie during the Revolution 3 Cedar Point Triathlon. The temporary safety zone is... 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have...

Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.

Science.gov (United States)

Hübner, N-O; Kramer, A

2010-01-01

Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications. Copyright © 2010 S. Karger AG, Basel.

[Efficacy and safety of levofloxacin to non-gonorrheal urethritis].

Science.gov (United States)

Onodera, Shoichi; Onoe, Yasuhiko; Hosobe, Takahide; Kato, Tetsuro; Yoshida, Masaki

2012-12-01

We investigated the efficacy and safety of levofloxacin (LVFX) 500mg once a day in patients with non-gonorrheal urethritis. Men, aged 20 years or older, with urethritis symptoms, and detection of Chlamydia trachomatis (C. trachomatis) or Mycoplasma genitalium (M. genitalium) by a microbiological examination were eligible for this study. Patients were administered LVFX 500mg, orally, once a day and the dosage period was seven days. We assumed 22 patients for a safety and efficacy analysis. In 22 patients, 17 patients had urethritis with C. trachomatis, 4 patients urethritis with M. genitalium, and one patient mixed infection of C. trachomatis and M. genitalium. In the clinial study, the primary endpoint was set as the bacteriological eradication rate at two to four weeks after completion of treatment. The bacterial eradication rate in the urethritis was 86.4% (19/22). The bacterial eradication rate in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 94.1% (16/17), 50.0% (2/4), 100% (1/1), respectively. A significant difference was not recognized among the three groups. The clinical efficacy at two to four weeks after completion of treatment was 90.9% (20/22). The clinical efficacy rates in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 100% (17/17), 50.0% (2/4), 100% (1/1), respectively. The efficacy rate of urethritis with M. genitalium was significantly low. No adverse drug reactions were observed. These results suggest that once-a-day levofloxacin (500mg) is effective and safe treatment for non-gonorrheal urethritis.

Health and safety in clinical laboratories in developing countries: safety considerations.

Science.gov (United States)

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

Advancement on safety management system of nuclear power for safety and non-anxiety of society

International Nuclear Information System (INIS)

Yoshikawa, Hidekazu

2004-01-01

Advancement on safety management system is investigated to improve safety and non-anxiety of society for nuclear power, from the standpoint of human machine system research. First, the recent progress of R and D works of human machine interface technologies since 1980 s are reviewed and then the necessity of introducing a new approach to promote technical risk communication activity to foster safety culture in nuclear industries. Finally, a new concept of Offsite Operation and Maintenance Support Center (OMSC) is proposed as the core facility to assemble human resources and their expertise in all organizations of nuclear power, for enhancing safety and non-anxiety of society for nuclear power. (author)

Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial

Science.gov (United States)

da Cruz, Lyndon; Dorn, Jessy D.; Humayun, Mark S.; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Ho, Allen C.; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V.; Arditi, Aries; Greenberg, Robert J.

2016-01-01

Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. PMID:27453256

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

Science.gov (United States)

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

Hinkley Point 'C' power station public inquiry: proof of evidence on design and safety

International Nuclear Information System (INIS)

George, B.V.

1988-09-01

A public inquiry has been set up to examine the planning application made by the Central Electricity Generating Board (CEGB) for the construction of a 1200 MW Pressurized Water Reactor power station at Hinkley Point (Hinkley Point ''C'') in the United Kingdom. The policy is to replicate the Sizewell ''B'' PWR design. The Hinkley Point ''C'' design is described indicating where changes in the Sizewell ''B'' design have been made to accommodate site differences. These are associated with the civil engineering construction and some of the electrical systems and do not affect the safety case. External hazards differ from site to site and the effect on the safety case of those specific to Hinkley Point are examined. The Chernobyl accident and the assessment of the United Kingdom PWR which was carried out subsequently are reviewed. The assessment indicated that no changes in the Sizewell ''B'' design and safety case were called for as a result of this accident; accident management developments are also reviewed, however. The CEGB's approach to minimizing occupational radiation doses is described. (UK)

Safety Culture and Senior Leadership Behavior: Using Negative Safety Ratings to Align Clinical Staff and Senior Leadership.

Science.gov (United States)

O'Connor, Shawn; Carlson, Elizabeth

2016-04-01

This report describes how staff-designed behavior changes among senior leaders can have a positive impact on clinical nursing staff and enhance the culture of safety in a community hospital. A positive culture of safety in a hospital improves outcomes for patients and staff. Senior leaders are accountable for developing an environment that supports a culture of safety. At 1 community hospital, surveys demonstrated that staff members did not view senior leaders as supportive of or competent in creating a culture of safety. After approval from the hospital's institutional review board was obtained, clinical nurses generated and selected ideas for senior leader behavior change. The new behaviors were assessed by a convenience sample survey of clinical nurses. In addition, culture of safety survey results were compared. Risk reports and harm events were also measured before and after behavior changes. The volume of risk and near-miss reports increased, showing that clinical staff were more inclined to report events after senior leader communication, access, and visibility increased. Harm events went down. The culture of safety survey demonstrated an improvement in the senior leadership domain in 4 of 6 units. The anonymous convenience survey demonstrated that staff members recognized changes that senior leaders had made and felt that these changes positively impacted the culture of safety. By developing skills in communication, advocacy, visibility, and access, senior leaders can enhance a hospital's culture of safety and create stronger ties with clinical staff.

Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study.

Science.gov (United States)

Crinò, Lucio; Dansin, Eric; Garrido, Pilar; Griesinger, Frank; Laskin, Janessa; Pavlakis, Nick; Stroiakovski, Daniel; Thatcher, Nick; Tsai, Chun-Ming; Wu, Yi-long; Zhou, Caicun

2010-08-01

Results of two phase 3 trials have shown first-line bevacizumab in combination with chemotherapy improves clinical outcomes in patients with advanced or recurrent non-squamous non-small-cell lung cancer (NSCLC). The SAiL (MO19390) study was undertaken to assess the safety and efficacy of first-line bevacizumab combined with standard chemotherapy regimens in clinical practice. Between August, 2006, and June, 2008, patients with untreated locally advanced, metastatic, or recurrent non-squamous NSCLC were recruited to this open-label, single group, phase 4 study from centres in 40 countries. Eligible patients had histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent disease (stage IIIB-IV); an Eastern Cooperative Oncology Group performance status of 0-2; and adequate haematological, hepatic, and renal function. Patients received bevacizumab (7.5 or 15 mg/kg every 3 weeks) plus standard chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety; analysis was by intention to treat (ITT). This study is registered with ClinicalTrials.gov, number NCT00451906. At the final data cutoff (July 24, 2009), an ITT population of 2212 patients was assessed. The incidence of clinically significant (grade > or = 3) adverse events of special interest was generally low; thromboembolism occurred in 172 (8%) patients, hypertension in 125 (6%), bleeding in 80 (4%), proteinuria in 67 (3%), and pulmonary haemorrhage in 15 (1%). 57 (3%) patients died because of these adverse events, with thromboembolism (26 patients, 1%) and bleeding (17, 1%) as the most common causes. The most common grade 3 or higher serious adverse events deemed by investigators to be associated with bevacizumab were pulmonary embolism (28 patients; 1%) and epistaxis, neutropenia, febrile neutropenia, and deep vein thrombosis (all of which occurred in 13 patients [1%]). Bevacizumab was temporarily

Rainfall Deduction Method for Estimating Non-Point Source Pollution Load for Watershed

OpenAIRE

Cai, Ming; Li, Huai-en; KAWAKAMI, Yoji

2004-01-01

The water pollution can be divided into point source pollution (PSP) and non-point source pollution (NSP). Since the point source pollution has been controlled, the non-point source pollution is becoming the main pollution source. The prediction of NSP load is being increasingly important in water pollution controlling and planning in watershed. Considering the monitoring data shortage of NPS in China, a practical estimation method of non-point source pollution load --- rainfall deduction met...

Non-point Source Pollutants Loss of Planting Industry in the Yunnan Plateau Lake Basin, China

Directory of Open Access Journals (Sweden)

ZHAO Zu-jun

2017-12-01

Full Text Available Non-point source pollution of planting has become a major factor affecting the quality and safety of water environment in our country. In recent years, some studies show that the loss of nitrogen and phosphorus in agricultural chemical fertilizers has led to more serious non-point source pollution. By means of the loss coefficient method and spatial overlay analysis, the loss amount, loss of strength and its spatial distribution characteristics of total nitrogen, total phosphorus, ammonium nitrogen and nitrate nitrogen were analyzed in the Fuxian Lake, Xingyun Lake and Qilu Lake Basin in 2015. The results showed that:The loss of total nitrogen was the highest in the three basins, following by ammonium nitrogen, nitrate nitrogen and total phosphorus, which the loss of intensity range were 2.73~22.07, 0.003~3.52, 0.01~2.25 kg·hm-2 and 0.05~1.36 kg·hm-2, respectively. Total nitrogen and total phosphorus loss were mainly concentrated in the southwest of Qilu Lake, west and south of Xingyun Lake. Ammonium nitrogen and nitrate nitrogen loss mainly concentrated in the south of Qilu Lake, south and north of Xingyun Lake. The loss of nitrogen and phosphorus was mainly derived from cash crops and rice. Therefore, zoning, grading and phased prevention and control schemes were proposed, in order to provide scientific basis for controlling non-point source pollution in the study area.

What is Clinical Safety in Electronic Health Care Record Systems?

Science.gov (United States)

Davies, George

There is mounting public awareness of an increasing number of adverse clinical incidents within the National Health Service (NHS), but at the same time, large health care projects like the National Programme for IT (NPFIT) are claiming that safer care is one of the benefits of the project and that health software systems in particular have the potential to reduce the likelihood of accidental or unintentional harm to patients. This paper outlines the approach to clinical safety management taken by CSC, a major supplier to NPFIT; discusses acceptable levels of risk and clinical safety as an end-to-end concept; and touches on the future for clinical safety in health systems software.

Interior-Point Method for Non-Linear Non-Convex Optimization

Czech Academy of Sciences Publication Activity Database

Lukšan, Ladislav; Matonoha, Ctirad; Vlček, Jan

2004-01-01

Roč. 11, č. 5-6 (2004), s. 431-453 ISSN 1070-5325 R&D Projects: GA AV ČR IAA1030103 Institutional research plan: CEZ:AV0Z1030915 Keywords : non-linear programming * interior point methods * indefinite systems * indefinite preconditioners * preconditioned conjugate gradient method * merit functions * algorithms * computational experiments Subject RIV: BA - General Mathematics Impact factor: 0.727, year: 2004

Clinical pharmacokinetics, safety, and preliminary efficacy evaluation of icotinib in patients with advanced non-small cell lung cancer.

Science.gov (United States)

Liu, Dongyang; Zhang, Li; Wu, Yiwen; Jiang, Ji; Tan, Fenlai; Wang, Yingxiang; Liu, Yong; Hu, Pei

2015-09-01

To receive pharmacokinetics, safety, and anti-tumor activity of icotinib, a novel epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), in patients with advanced non-small-cell lung cancer (NSCLC). Patients (n=40) with advanced NSCLC were enrolled to receive escalating doses of icotinib, which was administrated on Day 1 followed by 28-day continuous dosing starting from Day 4. Four dosing regimens, 100mg b.i.d., 150 mg b.i.d., 125 mg t.i.d., and 200mg b.i.d. were studied. Pharmacokinetics (PK), safety, and efficacy of icotinib were evaluated. Icotinib was well tolerated in Chinese patients with refractory NSCLC. No toxicity with >3 grades were reported in more than 2 patients under any dose levels. One complete response (3%) and 9 partial responses (23%) were received. Total disease control rate could reach at 73% and median progress-free survival (range) was 154 (17-462) days. PK exposure of icotinib increased with increase of dose in NSCLC patients. Food was suggested to increase PK exposure by ∼30%. Mean t1/2β was within 5.31-8.07 h. No major metabolite (>10% plasma exposure of icotinib) was found in NSCLC patients. Icotinib with up to 400 mg/day exhibited good tolerance and preliminary antitumor activity in Chinese NSCLC patients. Pharmacokinetics of icotinib and 5 major metabolites were fully investigated in NSCLC patients. Optimized biologic dose (OBD) was finally recommended to be 125 mg t.i.d. for the later clinical study. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Seafood safety: economics of hazard analysis and Critical Control Point (HACCP) programmes

National Research Council Canada - National Science Library

Cato, James C

1998-01-01

.... This document on economic issues associated with seafood safety was prepared to complement the work of the Service in seafood technology, plant sanitation and Hazard Analysis Critical Control Point (HACCP) implementation...

Pre-clinical efficacy and safety of experimental vaccines based on non-replicating vaccinia vectors against yellow fever.

Directory of Open Access Journals (Sweden)

Birgit Schäfer

Full Text Available BACKGROUND: Currently existing yellow fever (YF vaccines are based on the live attenuated yellow fever virus 17D strain (YFV-17D. Although, a good safety profile was historically attributed to the 17D vaccine, serious adverse events have been reported, making the development of a safer, more modern vaccine desirable. METHODOLOGY/PRINCIPAL FINDINGS: A gene encoding the precursor of the membrane and envelope (prME protein of the YFV-17D strain was inserted into the non-replicating modified vaccinia virus Ankara and into the D4R-defective vaccinia virus. Candidate vaccines based on the recombinant vaccinia viruses were assessed for immunogenicity and protection in a mouse model and compared to the commercial YFV-17D vaccine. The recombinant live vaccines induced γ-interferon-secreting CD4- and functionally active CD8-T cells, and conferred full protection against lethal challenge already after a single low immunization dose of 10(5 TCID(50. Surprisingly, pre-existing immunity against wild-type vaccinia virus did not negatively influence protection. Unlike the classical 17D vaccine, the vaccinia virus-based vaccines did not cause mortality following intracerebral administration in mice, demonstrating better safety profiles. CONCLUSIONS/SIGNIFICANCE: The non-replicating recombinant YF candidate live vaccines induced a broad immune response after single dose administration, were effective even in the presence of a pre-existing immunity against vaccinia virus and demonstrated an excellent safety profile in mice.

Pre-Clinical Efficacy and Safety of Experimental Vaccines Based on Non-Replicating Vaccinia Vectors against Yellow Fever

Science.gov (United States)

Schäfer, Birgit; Holzer, Georg W.; Joachimsthaler, Alexandra; Coulibaly, Sogue; Schwendinger, Michael; Crowe, Brian A.; Kreil, Thomas R.; Barrett, P. Noel; Falkner, Falko G.

2011-01-01

Background Currently existing yellow fever (YF) vaccines are based on the live attenuated yellow fever virus 17D strain (YFV-17D). Although, a good safety profile was historically attributed to the 17D vaccine, serious adverse events have been reported, making the development of a safer, more modern vaccine desirable. Methodology/Principal Findings A gene encoding the precursor of the membrane and envelope (prME) protein of the YFV-17D strain was inserted into the non-replicating modified vaccinia virus Ankara and into the D4R-defective vaccinia virus. Candidate vaccines based on the recombinant vaccinia viruses were assessed for immunogenicity and protection in a mouse model and compared to the commercial YFV-17D vaccine. The recombinant live vaccines induced γ-interferon-secreting CD4- and functionally active CD8-T cells, and conferred full protection against lethal challenge already after a single low immunization dose of 105 TCID50. Surprisingly, pre-existing immunity against wild-type vaccinia virus did not negatively influence protection. Unlike the classical 17D vaccine, the vaccinia virus-based vaccines did not cause mortality following intracerebral administration in mice, demonstrating better safety profiles. Conclusions/Significance The non-replicating recombinant YF candidate live vaccines induced a broad immune response after single dose administration, were effective even in the presence of a pre-existing immunity against vaccinia virus and demonstrated an excellent safety profile in mice. PMID:21931732

Tipping Point

Medline Plus

Full Text Available ... en español Blog About OnSafety CPSC Stands for Safety The Tipping Point Home > 60 Seconds of Safety (Videos) > The Tipping Point The Tipping Point by ... danger death electrical fall furniture head injury product safety television tipover tv Watch the video in Adobe ...

All-terrain vehicle dealership point-of-sale child safety compliance in Illinois.

Science.gov (United States)

Hafner, John W; Getz, Marjorie A; Begley, Brandon

2012-08-01

In 2008, an estimated 37,700 children younger than 16 were treated in US emergency departments for nonfatal all-terrain vehicle (ATV) injuries. This study identifies safety guidelines and recommendations dealers convey to consumers at the point of sale. A telephone survey of all 2004 licensed motorcycle dealers in Illinois was conducted. Trained investigators, using aliases and posing as a parent of a 13-year-old teenager, spoke with dealership personnel. Investigators indicated they wished to purchase an ATV with the dealership, but had no knowledge of ATV use or safety issues. The telephone call's true purpose was concealed during the survey. Specific responses from the salesperson, models and brands of ATVs, price quotes, engine sizes, and safety information/recommendations were recorded in a written survey instrument. One hundred twenty-seven ATV dealers completed the survey. A salesperson most often fielded the telephone interview (124/127). Telephone interviews by male investigators were longer than those by female interviewers (5 minutes 37 seconds vs 3 minutes 51 seconds; P = 0.001). Dealers recommended Consumer Product Safety Commission-based child-size ATVs (vehicles as "safe." Most dealers (83.5%) recommended some form of rider training, with half (49.6%) offered point-of-purchase training. All-terrain vehicle dealers in Illinois recommend child-size vehicles, safety training, and helmet use for the majority of telephone inquiries. Injury prevention efforts targeting ATV dealers may be less needed than those using other populations.

The zero-point field in non-inertial frames

International Nuclear Information System (INIS)

Hacyan, S.

1985-01-01

The energy spectrum of the zero-point field as seen in non-inertial frames is investigated. Uniformly accelerated frames and black holes are considered. It is suggested that the radiation produced by black holes or acceleration is a manifestation of the zero-point field and of the same nature (whether real or virtual)

7T: Physics, safety, and potential clinical applications.

Science.gov (United States)

Kraff, Oliver; Quick, Harald H

2017-12-01

With more than 60 installed magnetic resonance imaging (MRI) systems worldwide operating at a magnetic field strength of 7T or higher, ultrahigh-field (UHF) MRI has been established as a platform for clinically oriented research in recent years. Profound technical and methodological developments have helped overcome the inherent physical challenges of UHF radiofrequency (RF) signal homogenization in the human body. The ongoing development of dedicated RF coil arrays was pivotal in realizing UHF body MRI, beyond mere brain imaging applications. Another precondition to clinical application of 7T MRI is the safety testing of implants and the establishment of safety concepts. Against this backdrop, 7T MRI and MR spectroscopy (MRS) recently have demonstrated capabilities and potentials for clinical diagnostics in a variety of studies. This article provides an overview of the immanent physical challenges of 7T UHF MRI and discusses recent technical solutions and safety concepts. Furthermore, recent clinically oriented studies are highlighted that span a broad application spectrum from 7T UHF brain to body MRI. 4 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1573-1589. © 2017 International Society for Magnetic Resonance in Medicine.

Modeling hard clinical end-point data in economic analyses.

Science.gov (United States)

Kansal, Anuraag R; Zheng, Ying; Palencia, Roberto; Ruffolo, Antonio; Hass, Bastian; Sorensen, Sonja V

2013-11-01

The availability of hard clinical end-point data, such as that on cardiovascular (CV) events among patients with type 2 diabetes mellitus, is increasing, and as a result there is growing interest in using hard end-point data of this type in economic analyses. This study investigated published approaches for modeling hard end-points from clinical trials and evaluated their applicability in health economic models with different disease features. A review of cost-effectiveness models of interventions in clinically significant therapeutic areas (CV diseases, cancer, and chronic lower respiratory diseases) was conducted in PubMed and Embase using a defined search strategy. Only studies integrating hard end-point data from randomized clinical trials were considered. For each study included, clinical input characteristics and modeling approach were summarized and evaluated. A total of 33 articles (23 CV, eight cancer, two respiratory) were accepted for detailed analysis. Decision trees, Markov models, discrete event simulations, and hybrids were used. Event rates were incorporated either as constant rates, time-dependent risks, or risk equations based on patient characteristics. Risks dependent on time and/or patient characteristics were used where major event rates were >1%/year in models with fewer health states (Models of infrequent events or with numerous health states generally preferred constant event rates. The detailed modeling information and terminology varied, sometimes requiring interpretation. Key considerations for cost-effectiveness models incorporating hard end-point data include the frequency and characteristics of the relevant clinical events and how the trial data is reported. When event risk is low, simplification of both the model structure and event rate modeling is recommended. When event risk is common, such as in high risk populations, more detailed modeling approaches, including individual simulations or explicitly time-dependent event rates, are

On Safety Management. A Frame of Reference for Studies of Safety Management with Examples From Non-Nuclear Contexts of Relevance for Nuclear Safety

Energy Technology Data Exchange (ETDEWEB)

Svensson, Ola; Salo, Ilkka; Allwin, Pernilla (Risk Analysis, Social and Decision Research Unit, Dept. of Psychology, Stockholm Univ., Stockholm (Sweden))

2004-11-15

A good knowledge about safety management from risk technologies outside the area of nuclear power may contribute to both broaden the perspectives on safety management in general, and point at new opportunities for improving safety measures within the nuclear industry. First, a theoretical framework for the study of safety management in general is presented, followed by three case studies on safety management from different non-nuclear areas with potential relevance for nuclear safety. The chapters are written as separate reports and can be read independently of each other. The nuclear industry has a long experience about the management of risky activities, involving all the stages from planing to implementation, both on a more generalized level and in the specific branches of activities (management, administration, operation, maintenance, etc.). Here, safety management is a key concept related to these areas of activities. Outside the field of nuclear power there exist a number of different non-nuclear risk technologies, each one with their own specific needs and experiences about safety management. The differences between the areas consist partly of the different experiences caused by the different technologies. Besides using own experiences in safety practices within the own areas of activities, it may be profitable to take advantage in knowledge and experiences from one area and put it in practice in another area. In order to facilitate knowledge transfer from one technological area to another it may be possible to adapt a common theoretical model, for descriptions and explanations, to the different technologies. Such a model should admit that common denominators for safety management across the areas might be identified and described with common concepts. Systems theory gives the opportunity to not only create models that are descriptive for events within the limits of a given technology, but also to generate knowledge that can be transferred to other

The LVIS Jr. microstent to assist coil embolization of wide-neck intracranial aneurysms: clinical study to assess safety and efficacy

International Nuclear Information System (INIS)

Moehlenbruch, M.; Herweh, C.; Behrens, L.; Jestaedt, L.; Bendszus, M.; Pham, M.; Amiri, H.; Ringleb, P.A.

2014-01-01

This study was aimed to assess clinical safety and efficacy of the LVIS Jr. microstent in stent-assisted coil embolization of wide-neck intracranial aneurysms. IRB approved single-center interventional clinical study in 22 patients (10 females, 12 males, mean age 55, age range 33-74 years) for the endovascular treatment of wide-neck aneurysms. After obtaining informed consent, patients were included according to the following criteria: aneurysm fundus-to-neck ratio 4 mm, and a parent vessel diameter of ≤3.5 mm. Primary end point for clinical safety was absence of death, absence of major or minor stroke, and absence of transient ischemic attack. Primary end point for treatment efficacy was complete angiographic occlusion according to the Raymond-Roy Occlusion Classification (RROC) immediately after the procedure and at follow-up after 3 and 6 months on magnetic resonance imaging (MRI). In 20/22 (91 %) of patients, the primary end point of safety was reached; in the two remaining patients, transient ischemic attack, but no permanent deficit was observed; in 16/22 (73 %), efficient occlusion (RROC1) was reached, and in 6/22 (27 %), a residual neck remained (RROC2). Single [seven with antegrade, two in crossover configuration, and four with ''first-balloon-then-stent'' (FBTS) technique] or double-stent (eight patients with Y configuration and one patient with X configuration) deployment was technically successful in all cases. Deployment of the LVIS Jr. microstent in various single- or double-stent configurations is safe and effective to assist the treatment of intracranial wide-neck aneurysms. (orig.)

Point-of-care ultrasound education for non-physician clinicians in a resource-limited emergency department.

Science.gov (United States)

Stolz, Lori A; Muruganandan, Krithika M; Bisanzo, Mark C; Sebikali, Mugisha J; Dreifuss, Bradley A; Hammerstedt, Heather S; Nelson, Sara W; Nayabale, Irene; Adhikari, Srikar; Shah, Sachita P

2015-08-01

To describe the outcomes and curriculum components of an educational programme to train non-physician clinicians working in a rural, Ugandan emergency department in the use of POC ultrasound. The use of point-of-care ultrasound was taught to emergency care providers through lectures, bedsides teaching and hands-on practical sessions. Lectures were tailored to care providers' knowledge base and available therapeutic means. Every ultrasound examination performed by these providers was recorded over 4.5 years. Findings of these examinations were categorised as positive, negative, indeterminate or procedural. Other radiologic studies ordered over this same time period were also recorded. A total of 22,639 patients were evaluated in the emergency department by emergency care providers, and 2185 point-of-care ultrasound examinations were performed on 1886 patients. Most commonly used were the focused assessment with sonography in trauma examination (53.3%) and echocardiography (16.4%). Point-of-care ultrasound studies were performed more frequently than radiology department-performed studies. Positive findings were documented in 46% of all examinations. We describe a novel curriculum for point-of-care ultrasound education of non-physician emergency practitioners in a resource-limited setting. These non-physician clinicians integrated ultrasound into clinical practice and utilised this imaging modality more frequently than traditional radiology department imaging with a large proportion of positive findings. © 2015 John Wiley & Sons Ltd.

The registration of non-cooperative moving targets laser point cloud in different view point

Science.gov (United States)

Wang, Shuai; Sun, Huayan; Guo, Huichao

2018-01-01

Non-cooperative moving target multi-view cloud registration is the key technology of 3D reconstruction of laser threedimension imaging. The main problem is that the density changes greatly and noise exists under different acquisition conditions of point cloud. In this paper, firstly, the feature descriptor is used to find the most similar point cloud, and then based on the registration algorithm of region segmentation, the geometric structure of the point is extracted by the geometric similarity between point and point, The point cloud is divided into regions based on spectral clustering, feature descriptors are created for each region, searching to find the most similar regions in the most similar point of view cloud, and then aligning the pair of point clouds by aligning their minimum bounding boxes. Repeat the above steps again until registration of all point clouds is completed. Experiments show that this method is insensitive to the density of point clouds and performs well on the noise of laser three-dimension imaging.

Injection safety knowledge and practices among clinical health care ...

African Journals Online (AJOL)

Injection safety is therefore critical in preventing occupational exposure and infection from blood borne pathogens, hence prevention is a vital part of any ... safety among clinical healthcare workers at the Garissa Provincial General Hospital.

Regulatory aspects of the non-clinical researches in the Isotope Center

International Nuclear Information System (INIS)

Castro Alfonso, Yusniel

2017-01-01

For the quality control of radiopharmaceuticals produced by Centis and in pharmacokinetic studies carried out in this institution, scintigraphic images of animals are obtained. This allows the assessment of the distribution and behavior of these radiolabeled molecules inside the organism in order to use them in clinical trials in people having different pathologies. Besides following the CNSN regulations involving work with open radioactive sources, non-clinical research laboratory areas are subject to Biosafety Regulations particularly those established by Cecmed. The world trend to integrate the management systems in the organization processes requires the harmonization of Good Laboratory Practices, the compliance with Biosafety Regulations and International Standards concerning the ethics, when working with laboratory animals. This kind of laboratory coordinates its services directly with institutions developing drugs and with the Department of Quality Control for Products used in Nuclear Medicine in Centis. The present work is aimed at assessing the legislation and regulations related with non-clinical research area to take actions intended to improve the integrated management of biosafety for structuring a safety program. (author)

Cyber Security Test Strategy for Non-safety Display System

International Nuclear Information System (INIS)

Son, Han Seong; Kim, Hee Eun

2016-01-01

Cyber security has been a big issue since the instrumentation and control (I and C) system of nuclear power plant (NPP) is digitalized. A cyber-attack on NPP should be dealt with seriously because it might cause not only economic loss but also the radioactive material release. Researches on the consequences of cyber-attack onto NPP from a safety point of view have been conducted. A previous study shows the risk effect brought by initiation of event and deterioration of mitigation function by cyber terror. Although this study made conservative assumptions and simplifications, it gives an insight on the effect of cyber-attack. Another study shows that the error on a non-safety display system could cause wrong actions of operators. According to this previous study, the failure of the operator action caused by a cyber-attack on a display system might threaten the safety of the NPP by limiting appropriate mitigation actions. This study suggests a test strategy focusing on the cyber-attack on the information and display system, which might cause the failure of operator. The test strategy can be suggested to evaluate and complement security measures. Identifying whether a cyber-attack on the information and display system can affect the mitigation actions of operator, the strategy to obtain test scenarios is suggested. The failure of mitigation scenario is identified first. Then, for the test target in the scenario, software failure modes are applied to identify realistic failure scenarios. Testing should be performed for those scenarios to confirm the integrity of data and to assure effectiveness of security measures

Cyber Security Test Strategy for Non-safety Display System

Energy Technology Data Exchange (ETDEWEB)

Son, Han Seong [Joongbu University, Geumsan (Korea, Republic of); Kim, Hee Eun [KAIST, Daejeon (Korea, Republic of)

2016-10-15

Cyber security has been a big issue since the instrumentation and control (I and C) system of nuclear power plant (NPP) is digitalized. A cyber-attack on NPP should be dealt with seriously because it might cause not only economic loss but also the radioactive material release. Researches on the consequences of cyber-attack onto NPP from a safety point of view have been conducted. A previous study shows the risk effect brought by initiation of event and deterioration of mitigation function by cyber terror. Although this study made conservative assumptions and simplifications, it gives an insight on the effect of cyber-attack. Another study shows that the error on a non-safety display system could cause wrong actions of operators. According to this previous study, the failure of the operator action caused by a cyber-attack on a display system might threaten the safety of the NPP by limiting appropriate mitigation actions. This study suggests a test strategy focusing on the cyber-attack on the information and display system, which might cause the failure of operator. The test strategy can be suggested to evaluate and complement security measures. Identifying whether a cyber-attack on the information and display system can affect the mitigation actions of operator, the strategy to obtain test scenarios is suggested. The failure of mitigation scenario is identified first. Then, for the test target in the scenario, software failure modes are applied to identify realistic failure scenarios. Testing should be performed for those scenarios to confirm the integrity of data and to assure effectiveness of security measures.

On Safety Management. A Frame of Reference for Studies of Safety Management with Examples From Non-Nuclear Contexts of Relevance for Nuclear Safety

International Nuclear Information System (INIS)

Svensson, Ola; Salo, Ilkka; Allwin, Pernilla

2004-11-01

A good knowledge about safety management from risk technologies outside the area of nuclear power may contribute to both broaden the perspectives on safety management in general, and point at new opportunities for improving safety measures within the nuclear industry. First, a theoretical framework for the study of safety management in general is presented, followed by three case studies on safety management from different non-nuclear areas with potential relevance for nuclear safety. The chapters are written as separate reports and can be read independently of each other. The nuclear industry has a long experience about the management of risky activities, involving all the stages from planing to implementation, both on a more generalized level and in the specific branches of activities (management, administration, operation, maintenance, etc.). Here, safety management is a key concept related to these areas of activities. Outside the field of nuclear power there exist a number of different non-nuclear risk technologies, each one with their own specific needs and experiences about safety management. The differences between the areas consist partly of the different experiences caused by the different technologies. Besides using own experiences in safety practices within the own areas of activities, it may be profitable to take advantage in knowledge and experiences from one area and put it in practice in another area. In order to facilitate knowledge transfer from one technological area to another it may be possible to adapt a common theoretical model, for descriptions and explanations, to the different technologies. Such a model should admit that common denominators for safety management across the areas might be identified and described with common concepts. Systems theory gives the opportunity to not only create models that are descriptive for events within the limits of a given technology, but also to generate knowledge that can be transferred to other

Non-safety piping operability review case study -- Today and tomorrow

International Nuclear Information System (INIS)

Flensburg, W.C.; Adams, T.M.

1995-01-01

During a 1993 Outage at the Perry Nuclear Power Station, a condition report was issued which identified potential intersystem loss of water between the Emergency Closed Cooling Water System and the Nuclear Closed Cooling Water System during a design basis event. The review of this condition report indicated that if a SSE (safe shutdown earthquake) event were to occur during a design basis event components important to plant safety could potentially be adversely affected if non-seismic/non-safety portions of the Nuclear Closed Cooling Water System could not maintain pressure boundary integrity as a result of the seismic loadings. Presented in this paper are steps, criteria, and methodology used to demonstrate the seismic acceptability of the affected portion of the Nuclear Closed Cooling Water System Piping. Also discussed are the potential benefits and applicability of a recently developed EPRI non-safety, non-seismic operability procedure. This discussion includes the potential cost savings which could have arisen from application of this recently developed procedure

Safety and effectiveness considerations for clinical studies of visual prosthetic devices

Science.gov (United States)

Cohen, Ethan D.

2007-03-01

With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

Ab initio chemical safety assessment: A workflow based on exposure considerations and non-animal methods.

Science.gov (United States)

Berggren, Elisabet; White, Andrew; Ouedraogo, Gladys; Paini, Alicia; Richarz, Andrea-Nicole; Bois, Frederic Y; Exner, Thomas; Leite, Sofia; Grunsven, Leo A van; Worth, Andrew; Mahony, Catherine

2017-11-01

We describe and illustrate a workflow for chemical safety assessment that completely avoids animal testing. The workflow, which was developed within the SEURAT-1 initiative, is designed to be applicable to cosmetic ingredients as well as to other types of chemicals, e.g. active ingredients in plant protection products, biocides or pharmaceuticals. The aim of this work was to develop a workflow to assess chemical safety without relying on any animal testing, but instead constructing a hypothesis based on existing data, in silico modelling, biokinetic considerations and then by targeted non-animal testing. For illustrative purposes, we consider a hypothetical new ingredient x as a new component in a body lotion formulation. The workflow is divided into tiers in which points of departure are established through in vitro testing and in silico prediction, as the basis for estimating a safe external dose in a repeated use scenario. The workflow includes a series of possible exit (decision) points, with increasing levels of confidence, based on the sequential application of the Threshold of Toxicological (TTC) approach, read-across, followed by an "ab initio" assessment, in which chemical safety is determined entirely by new in vitro testing and in vitro to in vivo extrapolation by means of mathematical modelling. We believe that this workflow could be applied as a tool to inform targeted and toxicologically relevant in vitro testing, where necessary, and to gain confidence in safety decision making without the need for animal testing.

Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines.

Science.gov (United States)

Vannice, Kirsten S; Wilder-Smith, Annelies; Barrett, Alan D T; Carrijo, Kalinka; Cavaleri, Marco; de Silva, Aravinda; Durbin, Anna P; Endy, Tim; Harris, Eva; Innis, Bruce L; Katzelnick, Leah C; Smith, Peter G; Sun, Wellington; Thomas, Stephen J; Hombach, Joachim

2018-03-07

Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Non-monotonic Pre-fixed Points and Learning

Directory of Open Access Journals (Sweden)

Stefano Berardi

2013-08-01

Full Text Available We consider the problem of finding pre-fixed points of interactive realizers over arbitrary knowledge spaces, obtaining a relative recursive procedure. Knowledge spaces and interactive realizers are an abstract setting to represent learning processes, that can interpret non-constructive proofs. Atomic pieces of information of a knowledge space are stratified into levels, and evaluated into truth values depending on knowledge states. Realizers are then used to define operators that extend a given state by adding and possibly removing atoms: in a learning process states of knowledge change nonmonotonically. Existence of a pre-fixed point of a realizer is equivalent to the termination of the learning process with some state of knowledge which is free of patent contradictions and such that there is nothing to add. In this paper we generalize our previous results in the case of level 2 knowledge spaces and deterministic operators to the case of omega-level knowledge spaces and of non-deterministic operators.

Measures to Improve Diagnostic Safety in Clinical Practice.

Science.gov (United States)

Singh, Hardeep; Graber, Mark L; Hofer, Timothy P

2016-10-20

Timely and accurate diagnosis is foundational to good clinical practice and an essential first step to achieving optimal patient outcomes. However, a recent Institute of Medicine report concluded that most of us will experience at least one diagnostic error in our lifetime. The report argues for efforts to improve the reliability of the diagnostic process through better measurement of diagnostic performance. The diagnostic process is a dynamic team-based activity that involves uncertainty, plays out over time, and requires effective communication and collaboration among multiple clinicians, diagnostic services, and the patient. Thus, it poses special challenges for measurement. In this paper, we discuss how the need to develop measures to improve diagnostic performance could move forward at a time when the scientific foundation needed to inform measurement is still evolving. We highlight challenges and opportunities for developing potential measures of "diagnostic safety" related to clinical diagnostic errors and associated preventable diagnostic harm. In doing so, we propose a starter set of measurement concepts for initial consideration that seem reasonably related to diagnostic safety and call for these to be studied and further refined. This would enable safe diagnosis to become an organizational priority and facilitate quality improvement. Health-care systems should consider measurement and evaluation of diagnostic performance as essential to timely and accurate diagnosis and to the reduction of preventable diagnostic harm.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

ClinicalKey: a point-of-care search engine.

Science.gov (United States)

Vardell, Emily

2013-01-01

ClinicalKey is a new point-of-care resource for health care professionals. Through controlled vocabulary, ClinicalKey offers a cross section of resources on diseases and procedures, from journals to e-books and practice guidelines to patient education. A sample search was conducted to demonstrate the features of the database, and a comparison with similar tools is presented.

76 FR 55564 - Safety Zone; Revolution 3 Triathlon, Sandusky Bay, Lake Erie, Cedar Point, OH

Science.gov (United States)

2011-09-08

...-AA00 Safety Zone; Revolution 3 Triathlon, Sandusky Bay, Lake Erie, Cedar Point, OH AGENCY: Coast Guard... Erie during the Revolution 3 Triathlon. This temporary safety zone is necessary to protect participants..., between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT...

Electronic clinical safety reporting system: a benefits evaluation.

Science.gov (United States)

Elliott, Pamela; Martin, Desmond; Neville, Doreen

2014-06-11

Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

Tipping Point

Medline Plus

Full Text Available ... OnSafety CPSC Stands for Safety The Tipping Point Home > 60 Seconds of Safety (Videos) > The Tipping Point ... 24 hours a day. For young children whose home is a playground, it’s the best way to ...

A study on job satisfaction among clinical and non-clinical hospital ...

African Journals Online (AJOL)

Methods: Two hundred clinical and non-clinical hospital staff were invited to take part in the study. They completed a sociodemographic questionnaire and the Job Descriptive Index (JDI). Results: The results indicated that majority clinical and non-clinical staff were satisfied with their jobs as regards the parameters of the ...

GOLIMUMAB SAFETY ACCORDING TO CLINICAL FINDINGS

Directory of Open Access Journals (Sweden)

G. V. Lukina

2015-01-01

Full Text Available                                                      The review analyzes trials dealing with the safety of golimumab (GLM  used in rheumatology.  This drug was the latest Contact: Galina Lukina;gvl3@yandex.ru Поступила 12.05.14tumor necrosis factor α (TNF-α inhibitor introduced  into clinical practice and therefore the estimation of its tolerability is particularly relevant. The data obtained in large-scale clinical trials suggest that GLM has a good safety profile. The most common  adverse events (AE were infections, more often mild. The rate of infections was higher with the use of GLM 100 mg than with that of 50 mg. The overall cancer rate did not increase during a follow-up of less than 160 weeks. However, the rate of lymphomas in patients receiving GLM 100 mg proved to be higher than in those taking GLM 50 mg, in the general population, and in the placebo group in particular. AE were evenly distributed among patients with rheumatoid  arthritis, psoriatic arthritis, or ankylosing spondylitis. Overall, the findings are in agreement with the data on the safety of previously used TNF-α inhibitors. No fundamentally new AE have been encountered. It is necessary to accumulate  data on the use of GLM in real clinical practice, which will be able to more objectively define its place in the current therapy of rheumatic diseases.

33 CFR 165.502 - Safety and Security Zone; Cove Point Liquefied Natural Gas Terminal, Chesapeake Bay, Maryland.

Science.gov (United States)

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety and Security Zone; Cove... Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY... Areas Fifth Coast Guard District § 165.502 Safety and Security Zone; Cove Point Liquefied Natural Gas...

[Individualized clinical treatment from the prospective of hepatotoxicity of non-toxic traditional Chinese medicine].

Science.gov (United States)

Yang, Nan; Chen, Juan; Hou, Xue-Feng; Song, Jie; Feng, Liang; Jia, Xiao-Bin

2017-04-01

Traditional Chinese medicine has a long history in clinical application, and been proved to be safe and effective. In recent years, the toxicity and side-effects caused by the western medicine have been attracted much attention. As a result, increasing people have shifted their attention to traditional Chinese medicine. Nonetheless, due to the natural origin of traditional Chinese medicine and the lack of basic knowledge about them, many people mistakenly consider the absolute safety of traditional Chinese medicine, except for well-known toxic ones, such as arsenic. However, according to the clinical practices and recent studies, great importance shall be attached to the toxicity of non-toxic traditional Chinese medicine, in particular the hepatotoxicity. Relevant studies indicated that the toxicity of non-toxic traditional Chinese medicine is closely correlated with individual gene polymorphism and constitution. By discussing the causes and mechanisms of the hepatotoxicity induced by non-toxic traditional Chinese medicine in clinical practices, we wrote this article with the aim to provide new ideas for individualized clinical therapy of traditional Chinese medicine and give guidance for rational and safe use of traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

Non-Hodgkin's lymphomas: clinical governance issues.

Science.gov (United States)

Fields, P A; Goldstone, A H

2002-09-01

Every patient in every part of the world has the right to expect the best possible quality of care from health care providers. Non-Hodgkin's lymphomas (NHL) are an extremely heterogeneous group of conditions which require important decisions to be taken at many points along the treatment pathway. To get this right every time requires that high-quality standards are instituted and adhered to, so that the best possible outcome is achieved. In the past this has not always been the case because of the failure of clinicians sometimes to adhere to an optimal management plan. In 1995, the UK government commissioned an inquiry into the running of cancer services in the United Kingdom, which culminated in a series of recommendations to improve them. Subsequently, these recommendations were implemented as objectives of the NHS Cancer Plan which is the framework by which the UK government wishes to improve cancer services. Concurrently another general concept has emerged which is designed to ensure that the highest quality standards may be achieved for all patients across the whole National Health Service (NHS). This concept, termed 'clinical governance', brings together a corporate responsibility of all health care workers to deliver high quality standards, in the hope that this will translate into better long-term survival of patients with malignant disease. This chapter focuses on the issues surrounding clinical governance and how the principles of this concept relate to non-Hodgkin's lymphomas.

Trends in readmission rates for safety net hospitals and non-safety net hospitals in the era of the US Hospital Readmission Reduction Program: a retrospective time series analysis using Medicare administrative claims data from 2008 to 2015.

Science.gov (United States)

Salerno, Amy M; Horwitz, Leora I; Kwon, Ji Young; Herrin, Jeph; Grady, Jacqueline N; Lin, Zhenqiu; Ross, Joseph S; Bernheim, Susannah M

2017-07-13

To compare trends in readmission rates among safety net and non-safety net hospitals under the US Hospital Readmission Reduction Program (HRRP). A retrospective time series analysis using Medicare administrative claims data from January 2008 to June 2015. We examined 3254 US hospitals eligible for penalties under the HRRP, categorised as safety net or non-safety net hospitals based on the hospital's proportion of patients with low socioeconomic status. Admissions for Medicare fee-for-service patients, age ≥65 years, discharged alive, who had a valid five-digit zip code and did not have a principal discharge diagnosis of cancer or psychiatric illness were included, for a total of 52 516 213 index admissions. Mean hospital-level, all-condition, 30-day risk-adjusted standardised unplanned readmission rate, measured quarterly, along with quarterly rate of change, and an interrupted time series examining: April-June 2010, after HRRP was passed, and October-December 2012, after HRRP penalties were implemented. 58.0% (SD 15.3) of safety net hospitals and 17.1% (SD 10.4) of non-safety net hospitals' patients were in the lowest quartile of socioeconomic status. The mean safety net hospital standardised readmission rate declined from 17.0% (SD 3.7) to 13.6% (SD 3.6), whereas the mean non-safety net hospital declined from 15.4% (SD 3.0) to 12.7% (SD 2.5). The absolute difference in rates between safety net and non-safety net hospitals declined from 1.6% (95% CI 1.3 to 1.9) to 0.9% (0.7 to 1.2). The quarterly decline in standardised readmission rates was 0.03 percentage points (95% CI 0.03 to 0.02, preadmission rates for safety net hospitals have decreased more rapidly than those for non-safety net hospitals. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Robust non-rigid point set registration using student's-t mixture model.

Directory of Open Access Journals (Sweden)

Zhiyong Zhou

Full Text Available The Student's-t mixture model, which is heavily tailed and more robust than the Gaussian mixture model, has recently received great attention on image processing. In this paper, we propose a robust non-rigid point set registration algorithm using the Student's-t mixture model. Specifically, first, we consider the alignment of two point sets as a probability density estimation problem and treat one point set as Student's-t mixture model centroids. Then, we fit the Student's-t mixture model centroids to the other point set which is treated as data. Finally, we get the closed-form solutions of registration parameters, leading to a computationally efficient registration algorithm. The proposed algorithm is especially effective for addressing the non-rigid point set registration problem when significant amounts of noise and outliers are present. Moreover, less registration parameters have to be set manually for our algorithm compared to the popular coherent points drift (CPD algorithm. We have compared our algorithm with other state-of-the-art registration algorithms on both 2D and 3D data with noise and outliers, where our non-rigid registration algorithm showed accurate results and outperformed the other algorithms.

77 FR 51912 - Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY

Science.gov (United States)

2012-08-28

... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2012-0618] RIN 1625-AA00 Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY AGENCY.... 165.T01-0618 to read as follows: Sec. 165.T01-0618 Safety Zone; Tom Lyons Productions Fireworks, Long...

On the use of non-coherent fault trees in safety and security studies

International Nuclear Information System (INIS)

Contini, S.; Cojazzi, G.G.M.; Renda, G.

2008-01-01

This paper gives some insights on the usefulness of non-coherent fault trees in system modelling from both the point of view of safety and security. A safety-related system can evolve from the working states to failed states through degraded states, i.e. working state, but in a degraded mode. In practical applications the degraded states may be of particular interest due e.g. to the associated risk increase or the different types of consequent actions. The top events definitions of such states contain the working conditions of some sub-systems/components. How the use of non-coherent fault trees can greatly simplify both the modelling and quantification of these states is shown in this paper. Some considerations about the interpretation of the importance indexes of negated basic events are also briefly described. When dealing with security applications, there is a need to cope not only with stochastic events, such as component failures and human errors, but also with deliberate intentional actions, whose successes might be characterised by high probability values. Different mutually exclusive attack scenarios may be envisaged for a given system. Hence, the essential feature of a fault tree analyser is the capability to determine the exact value of the top event probability containing mutually exclusive events. It is also shown that in these cases the use of non-coherent fault trees allows solving the problem with limited effort

Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate.

Science.gov (United States)

Weng, Yanqiu; Palesch, Yuko Y; DeSantis, Stacia M; Zhao, Wenle

2016-01-01

In Phase III clinical trials for life-threatening conditions, some serious but expected adverse events, such as early deaths or congestive heart failure, are often treated as the secondary or co-primary endpoint, and are closely monitored by the Data and Safety Monitoring Committee (DSMC). A naïve group sequential design (GSD) for such a study is to specify univariate statistical boundaries for the efficacy and safety endpoints separately, and then implement the two boundaries during the study, even though the two endpoints are typically correlated. One problem with this naïve design, which has been noted in the statistical literature, is the potential loss of power. In this article, we develop an analytical tool to evaluate this negative impact for trials with non-trivial safety event rates, particularly when the safety monitoring is informal. Using a bivariate binary power function for the GSD with a random-effect component to account for subjective decision-making in safety monitoring, we demonstrate how, under common conditions, the power loss in the naïve design can be substantial. This tool may be helpful to entities such as the DSMCs when they wish to deviate from the prespecified stopping boundaries based on safety measures.

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire

Science.gov (United States)

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-01-01

Objective To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. Design A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). Setting 3 public hospitals and 27 health clinics. Participants 117 pharmacists. Main outcome measure(s) Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Results Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (psafety culture. As perceptions improved, the number of medication errors reported decreased. Group-specific interventions that target specific domains are necessary to improve the safety culture. PMID:26610761

Myocardial Contrast Agents – Safety Considerations and Clinical Efficacy in Stress Echocardiography

Directory of Open Access Journals (Sweden)

Maier Anca

2016-11-01

Full Text Available Transthoracic echocardiographic examination is known to be a safe, non-invasive and reproducible method, used in every day clinical practice to obtain important information about cardiac structure and function. Unfortunately, a significant proportion of studies have highlighted the considerable technically difficultly in producing diagnostic images due to a poor acoustic window and more than 33% of patients undergoing stress echocardiography have suboptimal echocardiographic images. All these limitations have led to the use of contrast agents to improve the quality of standard ultrasound examination to provide a better delineation of left ventricle endocardial borders or to obtain information that cannot be achieved by using standard echocardiography, such as assessing myocardial microcirculation and therefore perfusion. This paper sought to review the clinical efficacy and safety of ultrasound contrast agents focusing on stress echocardiography.

Non-technical issues in safety assessments for nuclear disposal facilities

International Nuclear Information System (INIS)

Kallenbach-Herbert, Beate; Brohmann, Bettina

2010-09-01

The paper highlights that a comprehensive approach to safety affords the consideration of technology, organisation, personnel and social environment. In several safety relevant contexts of nuclear waste disposal these fields are closely interrelated. The approach for the consideration of socio-scientific aspects which is sketched in this paper supports the systematic treatment of safety relevant non-technical issues in the safety case or in safety assessments for a disposal project. Furthermore it may foster the dialogue among specialists from the technical, the natural- and the socio-scientific field on questions of disposal safety. In this way it may contribute to a better understanding among the affected scientific disciplines in nuclear waste disposal.

Prediction of Clinically Relevant Safety Signals of Nephrotoxicity through Plasma Metabolite Profiling

Directory of Open Access Journals (Sweden)

W. B. Mattes

2013-01-01

Full Text Available Addressing safety concerns such as drug-induced kidney injury (DIKI early in the drug pharmaceutical development process ensures both patient safety and efficient clinical development. We describe a unique adjunct to standard safety assessment wherein the metabolite profile of treated animals is compared with the MetaMap Tox metabolomics database in order to predict the potential for a wide variety of adverse events, including DIKI. To examine this approach, a study of five compounds (phenytoin, cyclosporin A, doxorubicin, captopril, and lisinopril was initiated by the Technology Evaluation Consortium under the auspices of the Drug Safety Executive Council (DSEC. The metabolite profiles for rats treated with these compounds matched established reference patterns in the MetaMap Tox metabolomics database indicative of each compound’s well-described clinical toxicities. For example, the DIKI associated with cyclosporine A and doxorubicin was correctly predicted by metabolite profiling, while no evidence for DIKI was found for phenytoin, consistent with its clinical picture. In some cases the clinical toxicity (hepatotoxicity, not generally seen in animal studies, was detected with MetaMap Tox. Thus metabolite profiling coupled with the MetaMap Tox metabolomics database offers a unique and powerful approach for augmenting safety assessment and avoiding clinical adverse events such as DIKI.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

Science.gov (United States)

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

Overgeneral autobiographical memory bias in clinical and non-clinical voice hearers.

Science.gov (United States)

Jacobsen, Pamela; Peters, Emmanuelle; Ward, Thomas; Garety, Philippa A; Jackson, Mike; Chadwick, Paul

2018-03-14

Hearing voices can be a distressing and disabling experience for some, whilst it is a valued experience for others, so-called 'healthy voice-hearers'. Cognitive models of psychosis highlight the role of memory, appraisal and cognitive biases in determining emotional and behavioural responses to voices. A memory bias potentially associated with distressing voices is the overgeneral memory bias (OGM), namely the tendency to recall a summary of events rather than specific occasions. It may limit access to autobiographical information that could be helpful in re-appraising distressing experiences, including voices. We investigated the possible links between OGM and distressing voices in psychosis by comparing three groups: (1) clinical voice-hearers (N = 39), (2) non-clinical voice-hearers (N = 35) and (3) controls without voices (N = 77) on a standard version of the autobiographical memory test (AMT). Clinical and non-clinical voice-hearers also completed a newly adapted version of the task, designed to assess voices-related memories (vAMT). As hypothesised, the clinical group displayed an OGM bias by retrieving fewer specific autobiographical memories on the AMT compared with both the non-clinical and control groups, who did not differ from each other. The clinical group also showed an OGM bias in recall of voice-related memories on the vAMT, compared with the non-clinical group. Clinical voice-hearers display an OGM bias when compared with non-clinical voice-hearers on both general and voices-specific recall tasks. These findings have implications for the refinement and targeting of psychological interventions for psychosis.

Health IT for Patient Safety and Improving the Safety of Health IT.

Science.gov (United States)

Magrabi, Farah; Ong, Mei-Sing; Coiera, Enrico

2016-01-01

Alongside their benefits health IT applications can pose new risks to patient safety. Problems with IT have been linked to many different types of clinical errors including prescribing and administration of medications; as well as wrong-patient, wrong-site errors, and delays in procedures. There is also growing concern about the risks of data breach and cyber-security. IT-related clinical errors have their origins in processes undertaken to design, build, implement and use software systems in a broader sociotechnical context. Safety can be improved with greater standardization of clinical software and by improving the quality of processes at different points in the technology life cycle, spanning design, build, implementation and use in clinical settings. Oversight processes can be set up at a regional or national level to ensure that clinical software systems meet specific standards. Certification and regulation are two mechanisms to improve oversight. In the absence of clear standards, guidelines are useful to promote safe design and implementation practices. Processes to identify and mitigate hazards can be formalised via a safety management system. Minimizing new patient safety risks is critical to realizing the benefits of IT.

MR arthrography: pharmacology, efficacy and safety in clinical trials

International Nuclear Information System (INIS)

Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

2003-01-01

A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

Csf Based Non-Ground Points Extraction from LIDAR Data

Science.gov (United States)

Shen, A.; Zhang, W.; Shi, H.

2017-09-01

Region growing is a classical method of point cloud segmentation. Based on the idea of collecting the pixels with similar properties to form regions, region growing is widely used in many fields such as medicine, forestry and remote sensing. In this algorithm, there are two core problems. One is the selection of seed points, the other is the setting of the growth constraints, in which the selection of the seed points is the foundation. In this paper, we propose a CSF (Cloth Simulation Filtering) based method to extract the non-ground seed points effectively. The experiments have shown that this method can obtain a group of seed spots compared with the traditional methods. It is a new attempt to extract seed points

Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

Science.gov (United States)

Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

2017-06-01

The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Safety culture perceptions of pharmacists in Malaysian hospitals and health clinics: a multicentre assessment using the Safety Attitudes Questionnaire.

Science.gov (United States)

Samsuri, Srima Elina; Pei Lin, Lua; Fahrni, Mathumalar Loganathan

2015-11-26

To assess the safety attitudes of pharmacists, provide a profile of their domains of safety attitude and correlate their attitudes with self-reported rates of medication errors. A cross-sectional study utilising the Safety Attitudes Questionnaire (SAQ). 3 public hospitals and 27 health clinics. 117 pharmacists. Safety culture mean scores, variation in scores across working units and between hospitals versus health clinics, predictors of safety culture, and medication errors and their correlation. Response rate was 83.6% (117 valid questionnaires returned). Stress recognition (73.0±20.4) and working condition (54.8±17.4) received the highest and lowest mean scores, respectively. Pharmacists exhibited positive attitudes towards: stress recognition (58.1%), job satisfaction (46.2%), teamwork climate (38.5%), safety climate (33.3%), perception of management (29.9%) and working condition (15.4%). With the exception of stress recognition, those who worked in health clinics scored higher than those in hospitals (pculture. As perceptions improved, the number of medication errors reported decreased. Group-specific interventions that target specific domains are necessary to improve the safety culture. 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/

The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

International Nuclear Information System (INIS)

1992-01-01

The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

Marked point process framework for living probabilistic safety assessment and risk follow-up

International Nuclear Information System (INIS)

Arjas, Elja; Holmberg, Jan

1995-01-01

We construct a model for living probabilistic safety assessment (PSA) by applying the general framework of marked point processes. The framework provides a theoretically rigorous approach for considering risk follow-up of posterior hazards. In risk follow-up, the hazard of core damage is evaluated synthetically at time points in the past, by using some observed events as logged history and combining it with re-evaluated potential hazards. There are several alternatives for doing this, of which we consider three here, calling them initiating event approach, hazard rate approach, and safety system approach. In addition, for a comparison, we consider a core damage hazard arising in risk monitoring. Each of these four definitions draws attention to a particular aspect in risk assessment, and this is reflected in the behaviour of the consequent risk importance measures. Several alternative measures are again considered. The concepts and definitions are illustrated by a numerical example

Hinkley Point 'C' power station public inquiry: proof of evidence on safety criteria

International Nuclear Information System (INIS)

Taylor, R.H.

1988-09-01

A public inquiry has been set up to examine the planning application made by the Central Electricity Generating Board (CEGB) for the construction of a 1200 MW Pressurized Water Reactor power station at Hinkley Point (Hinkley Point ''C'') in the United Kingdom. The policy is to replicate the Sizewell ''B'' PWR design which was accepted as safe by an earlier enquiry. In this evidence to the Inquiry, subsequent developments are examined with a view to determining whether these would reverse the Sizewell decision. They are: the possible revision of radiation risk estimates upwards; whether cases of leukaemia occur with greater frequency around nuclear sites than elsewhere; publication of the Health and Safety Executive's consultative document ''The Tolerability of Risk from Nuclear Power Stations''. The overall conclusion is that these developments do not undermine the findings of the Sizewell ''B'' inquiry or the validity of the CEGB's safety criteria. (author)

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

Science.gov (United States)

Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

Non-Abelian monopole in the parameter space of point-like interactions

International Nuclear Information System (INIS)

Ohya, Satoshi

2014-01-01

We study non-Abelian geometric phase in N=2 supersymmetric quantum mechanics for a free particle on a circle with two point-like interactions at antipodal points. We show that non-Abelian Berry’s connection is that of SU(2) magnetic monopole discovered by Moody, Shapere and Wilczek in the context of adiabatic decoupling limit of diatomic molecule. - Highlights: • Supersymmetric quantum mechanics is an ideal playground for studying geometric phase. • We determine the parameter space of supersymmetric point-like interactions. • Berry’s connection is given by a Wu–Yang-like magnetic monopole in SU(2) Yang–Mills

Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults

DEFF Research Database (Denmark)

Hristovska, Ana-Marija; Duch, Patricia; Allingstrup, Mikkel

2017-01-01

, and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety......, reduced incidence of residual block on recovery, and more efficient use of healthcare resources. OBJECTIVES: The main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents......-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration. DATA...

SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

International Nuclear Information System (INIS)

Spraker, M; Nyflot, M; Ford, E; Kane, G; Zeng, J; Hendrickson, K

2016-01-01

Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposure to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing

SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

Energy Technology Data Exchange (ETDEWEB)

Spraker, M; Nyflot, M; Ford, E; Kane, G; Zeng, J; Hendrickson, K [University of Washington, Seattle, WA (United States)

2016-06-15

Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposure to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

Science.gov (United States)

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

Improving diabetic foot care in a nurse-managed safety-net clinic.

Science.gov (United States)

Peterson, Joann M; Virden, Mary D

2013-05-01

This article is a description of the development and implementation of a Comprehensive Diabetic Foot Care Program and assessment tool in an academically affiliated nurse-managed, multidisciplinary, safety-net clinic. The assessment tool parallels parameters identified in the Task Force Foot Care Interest Group of the American Diabetes Association's report published in 2008, "Comprehensive Foot Examination and Risk Assessment." Review of literature, Silver City Health Center's (SCHC) 2009 Annual Report, retrospective chart review. Since the full implementation of SCHC's Comprehensive Diabetic Foot Care Program, there have been no hospitalizations of clinic patients for foot-related complications. The development of the Comprehensive Diabetic Foot Assessment tool and the implementation of the Comprehensive Diabetic Foot Care Program have resulted in positive outcomes for the patients in a nurse-managed safety-net clinic. This article demonstrates that quality healthcare services can successfully be developed and implemented in a safety-net clinic setting. ©2012 The Author(s) Journal compilation ©2012 American Association of Nurse Practitioners.

Undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkship.

Science.gov (United States)

Lee, Hoo-Yeon; Hahm, Myung-Il; Lee, Sang Gyu

2018-04-04

The purpose of this study was to examine undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkships. Cross-sectional study administered in face-to-face interviews using modified the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS) from three colleges of medicine in Korea. We assessed medical students' perceptions of the cultures ('safety', 'teamwork', and 'error disclosure'), 'behavioural intentions' concerning patient safety issues and 'overall patient safety'. Confirmatory factor analysis and Spearman's correlation analyses was performed. In total, 194(91.9%) of the 211 third-year undergraduate students participated. 78% of medical students reported that the quality of care received by patients was impacted by teamwork during clinical rotations. Regarding error disclosure, positive scores ranged from 10% to 74%. Except for one question asking whether the disclosure of medical errors was an important component of patient safety (74%), the percentages of positive scores for all the other questions were below 20%. 41.2% of medical students have intention to disclose it when they saw a medical error committed by another team member. Many students had difficulty speaking up about medical errors. Error disclosure guidelines and educational efforts aimed at developing sophisticated communication skills are needed. This study may serve as a reference for other institutions planning patient safety education in their curricula. Assessing student perceptions of safety culture can provide clerkship directors and clinical service chiefs with information that enhances the educational environment and promotes patient safety.

Fractional CO2 laser resurfacing of photoaged facial and non-facial skin: histologic and clinical results and side effects.

Science.gov (United States)

Sasaki, Gordon H; Travis, Heather M; Tucker, Barbara

2009-12-01

CO(2) fractional ablation offers the potential for facial and non-facial skin resurfacing with minimal downtime and rapid recovery. The purpose of this study was (i) to document the average depths and density of adnexal structures in non-lasered facial and non-facial body skin; (ii) to determine injury in ex vivo human thigh skin with varying fractional laser modes; and (iii) to evaluate the clinical safety and efficacy of treatments. Histologies were obtained from non-lasered facial and non-facial skin from 121 patients and from 14 samples of excised lasered thigh skin. Seventy-one patients were evaluated after varying energy (mJ) and density settings by superficial ablation, deeper penetration, and combined treatment. Skin thickness and adnexal density in non-lasered skin exhibited variable ranges: epidermis (47-105 mum); papillary dermis (61-105 mum); reticular dermis (983-1986 mum); hair follicles (2-14/ HPF); sebaceous glands (2-23/HPF); sweat glands (2-7/HPF). Histological studies of samples from human thigh skin demonstrated that increased fluencies in the superficial, deep and combined mode resulted in predictable deeper levels of ablations and thermal injury. An increase in density settings results in total ablation of the epidermis. Clinical improvement of rhytids and pigmentations in facial and non-facial skin was proportional to increasing energy and density settings. Patient assessments and clinical gradings by the Wilcoxon's test of outcomes correlated with more aggressive settings. Prior knowledge of normal skin depths and adnexal densities, as well as ex vivo skin laser-injury profiles at varying fluencies and densities, improve the safety and efficiency of fractional CO(2) for photorejuvenation of facial and non-facial skin.

Non-Destructive Techniques in the Tacis and Phare Nuclear Safety Programmes

International Nuclear Information System (INIS)

Bieth, Michel

2002-01-01

Decisions regarding the verification of design plant lifetime and potential license renewal periods involve a determination of the component and circuit condition. In Service Inspection of key reactor components becomes a crucial consideration for continued safe plant operation. The determination of the equipment properties by Non Destructive Techniques during periodic intervals is an important aspect of the assessment of fitness-for-service and safe operation of nuclear power plants The Tacis and Phare were established since 1991 by the European Union as support mechanisms through which projects could be identified and addressed satisfactorily. In Nuclear Safety, the countries mainly concerned are Russia, Ukraine, Armenia, and Kazakhstan for the Tacis programme, and Bulgaria, Czech Republic, Hungary, Slovak Republic, Lithuania, Romania and Slovenia for the Phare programme. The Tacis and Phare programs concerning the Nuclear Power Plants consist of: - On Site Assistance and Operational Safety, - Design Safety, - Regulatory Authorities, - Waste management, and are focused on reactor safety issues, contributing to the improvement in the safety of East European reactors and providing technology and safety culture transfer. The main parts of these programmes are related to the On-Site Assistance and to the Design Safety of VVER and RBMK Nuclear power plants where Non Destructive Techniques for In Service Inspection of the primary circuit components are addressed. (authors)

Topical points of community policy concerning nuclear safety relevant to the Internal Market

International Nuclear Information System (INIS)

Schroeder, M.

1991-01-01

Starting with the Internal Market concept, the lecture describes general and specific expectations directed to the nuclear community from a point of view of nuclear safety, and analyzes those aspects of nuclear safety, EC policy focuses on. There are the following chapters: 1. Selection of sites for nuclear installations, 2. installation and reactor safety, 3. radioactive waste management, 4. decommissioning of nuclear installations, 5. radioactive waste storage, 6. coping with nuclear accidents and other radiological emergency situations. Sophistication of public health and environmental protection within the framework of the EURATOM Treaty is seen in connection with interim and final storage as well as reprocessing of radioactive waste, and with the decommissioning of nuclear facilities on the basis of section 30 ff., and installation and reactor safety on the basis of section 203 EURATOM Treaty. Improving the protection of public health in particular is possible and necessary in order to make the EURATOM community into a proper nuclear community of law. (orig./HSCH) [de

Introduction of the system of hazard analysis critical control point to ensure the safety of irradiated food

International Nuclear Information System (INIS)

Sajet, A.S.

2014-01-01

Hazard Analysis Critical Control Point (HACCP) is a preventive system for food safety. It identifies safety risks faced by food. Identified points are controlled ensuring product safety. Because of presence of many of the pathogenic microorganisms and parasites in food which caused cases of food poisoning and many diseases transmitted through food, the current methods of food production could not prevent food contamination or prevent the growth of these pathogens completely because of being a part of the normal flora in the environment. Irradiation technology helped to control diseases transmitted through food, caused by pathological microorganisms and parasites present in food. The application of a system based on risk analysis as a means of risk management in food chain, demonstrated the importance of food irradiation. (author)

75 FR 8239 - School Food Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP...

Science.gov (United States)

2010-02-24

... (HACCP); Approval of Information Collection Request AGENCY: Food and Nutrition Service, USDA. ACTION... Safety Program Based on Hazard Analysis and Critical Control Point Principles (HACCP) was published on... must be based on the (HACCP) system established by the Secretary of Agriculture. The food safety...

Dam safety review using non-destructive methods for reinforced concrete structure

Energy Technology Data Exchange (ETDEWEB)

Philibert, Alain; Saint-Pierre, Francois; Turcotte, Bernard [Le Groupe S.M. International Inc., Sherbrooke, (Canada)

2010-07-01

Dams built at the beginning of the twentieth century include concrete structures that were put in under rehabilitation works. In some cases, the details of the structures are not well documented. In other cases, concrete damage can be hidden under new layers of undamaged material. This requires that the dam safety review in a real investigation gather the information necessary for carrying out the hydraulic and stability studies required by the Dam Safety Act. This paper presented the process of dam safety review using non-destructive methods for reinforced concrete structures. Two reinforced concrete dams built in the 1900's, the Eustic dam on the Coaticook River and the Frontenac dam on the Magog River near Sherbrooke, were evaluated by S.M. International using non-destructive methods such as sonic and ground penetrating radar methods. The studies allowed mapping of concrete damage and provided geometric information on some non visible structure elements that were part of previous reinforcement operations.

A Randomized, Controlled, Multicenter Clinical Trial Comparing Pemetrexed/Cisplatin and Gemcitabine/Cisplatin as First-line Treatment for Advanced Nonsquamous Non-small Cell Lung Cancer

Directory of Open Access Journals (Sweden)

Yan HUANG

2012-10-01

Full Text Available Background and objective Platinum-based doublet chemotherapy is still the standard first-line treatment for non-small cell lung cancer (NSCLC. Previous studies have demonstrated that pemetrexed combined with platinum had promising efficacy and safety profile in NSCLC, especially in patients with nonsquamous NSCLC. This trial was conducted to evaluate the efficacy and safety of pemetrexed made in China as first-line treatment. Methods The present study was a randomized, controlled, multicenter clinical trial. Patients were randomly assigned (1:1 to receive cisplatin plus pemetrexed chemotherapy (PC group or gemcitabine plus cisplatin (GC group every 3 weeks. The primary end point was progression free survival (PFS and the secondary end points included 1 year survival rate, objective response rate (ORR, survival without grade 3/4 toxicity (SWT3/4 and safety profile. Results A total of 288 patients from 20 institutions across China were enrolled into the study. Based on the Full Analyses Set (FAS, the PFS was 168 days (5.6 months vs 140 days (4.7 months (P=0.16, one year survival rate was 50.0% vs 54.9% (P=0.47, ORR was 24.4% vs 14.2% (P=0.06 in the PC group and the GC group, respectively; Survival without grade 3/4 toxicity was 11.3 months in GC group vs 8.1 months in PC group (P=0.23. In terms of the safety, side effects were less observed on the PC group (81.95% vs 93.75%, P=0.003. The main side effects included leukopenia, neutropenia, emesis, anemia, thrombopenia. Conclusion The both regimens have similar efficacy as the treatment for advanced nonsquamous NSCLC, but pemetrexed plus cisplatin regimen has better safety profile and seems to have longer PFS, which makes it a new option as the first line setting.

Isolated left ventricular non-compaction cardiomyopathy associated with polymorphous ventricular tachycardia mimicking torsades de pointes

Directory of Open Access Journals (Sweden)

Oana Dickinson

2013-02-01

Full Text Available Left ventricular non-compaction (LVNC cardiomyopathy is a rare congenital disorder, classified by the American Heart Association as a primary genetic cardiomyopathy and characterized by multiple trabeculations within the left ventricle. LVNC cardiomyopathy has been associated with 3 major clinical manifestations: heart failure, atrial and ventricular arrhythmias and thromboembolic events, including stroke. In this case report, we describe a female patient with apparently isolated LVNC in whom pause-dependent polymorphic ventricular tachycardia suggesting torsades de pointes occurred in the presence of a normal QT interval.

Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations.

Science.gov (United States)

Anderson, Jocelyn C; Glass, Nancy E; Campbell, Jacquelyn C

Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence. The protocol presents the technological strategies to promote safety and allow autonomy in participant decision-making throughout the research process, including Voice over Internet Protocol telephone numbers, and tablet-based eligibility screening and data collection. Protocols for management of participants at risk for suicide and/or intimate partner homicide that included automated high-risk messaging to participants and research staff and facilitated disclosure of risk to clinical staff based on participant preferences are discussed. Use of technology and partnership with clinic staff helped to provide an environment where research regarding IPV could be conducted without undue burden or risk to participants. Utilizing tablet-based survey administration provided multiple practical and safety benefits for participants. Most women who screened into high-risk categories for suicide or intimate partner homicide did not choose to have their results shared with their healthcare providers, indicating the importance of allowing participants control over information sharing whenever possible.

Tipping Point

Medline Plus

Full Text Available ... 60 Seconds of Safety (Videos) > The Tipping Point The Tipping Point by CPSC Blogger September 22, 2009 appliance child Childproofing CPSC danger death electrical fall furniture head injury product safety television tipover tv Watch the video in Adobe Flash ...

Safety culture in the nuclear versus non-nuclear organization

International Nuclear Information System (INIS)

Haber, S.B.; Shurberg, D.A.

1996-01-01

The importance of safety culture in the safe and reliable operation of nuclear organizations is not a new concept. The greatest barriers to this area of research are twofold: (1) the definition and criteria of safety culture for a nuclear organization and (2) the measurement of those attributes in an objective and systematic fashion. This paper will discuss a proposed resolution of those barriers as demonstrated by the collection of data across nuclear and non-nuclear facilities over a two year period

HYGIENE PRACTICES IN URBAN RESTAURANTS AND CHALLENGES TO IMPLEMENTING FOOD SAFETY AND HAZARD ANALYSIS CRITICAL CONTROL POINTS (HACCP) PROGRAMMES IN THIKA TOWN, KENYA.

Science.gov (United States)

Muinde, R K; Kiinyukia, C; Rombo, G O; Muoki, M A

2012-12-01

To determine the microbial load in food, examination of safety measures and possibility of implementing an Hazard Analysis Critical Control Points (HACCP) system. The target population for this study consisted of restaurants owners in Thika. Municipality (n = 30). Simple randomsamples of restaurantswere selected on a systematic sampling method of microbial analysis in cooked, non-cooked, raw food and water sanitation in the selected restaurants. Two hundred and ninety eight restaurants within Thika Municipality were selected. Of these, 30 were sampled for microbiological testing. From the study, 221 (74%) of the restaurants were ready to eat establishments where food was prepared early enough to hold and only 77(26%) of the total restaurants, customers made an order of food they wanted. 118(63%) of the restaurant operators/staff had knowledge on quality control on food safety measures, 24 (8%) of the restaurants applied these knowledge while 256 (86%) of the restaurants staff showed that food contains ingredients that were hazard if poorly handled. 238 (80%) of the resultants used weighing and sorting of food materials, 45 (15%) used preservation methods and the rest used dry foods as critical control points on food safety measures. The study showed that there was need for implementation of Hazard Analysis Critical Control Points (HACCP) system to enhance food safety. Knowledge of HACCP was very low with 89 (30%) of the restaurants applying some of quality measures to the food production process systems. There was contamination with Coliforms, Escherichia coli and Staphylococcus aureus microbial though at very low level. The means of Coliforms, Escherichia coli and Staphylococcus aureas microbial in sampled food were 9.7 x 103CFU/gm, 8.2 x 103 CFU/gm and 5.4 x 103 CFU/gm respectively with Coliforms taking the highest mean.

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

Science.gov (United States)

Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

Clinical risk management and patient safety education for nurses: a critique.

Science.gov (United States)

Johnstone, Megan-Jane; Kanitsaki, Olga

2007-04-01

Nurses have a pivotal role to play in clinical risk management (CRM) and promoting patient safety in health care domains. Accordingly, nurses need to be prepared educationally to manage clinical risk effectively when delivering patient care. Just what form the CRM and safety education of nurses should take, however, remains an open question. A recent search of the literature has revealed a surprising lack of evidence substantiating models of effective CRM and safety education for nurses. In this paper, a critical discussion is advanced on the question of CRM and safety education for nurses and the need for nurse education in this area to be reviewed and systematically researched as a strategic priority, nationally and internationally. It is a key contention of this paper that without 'good' safety education research it will not be possible to ensure that the educational programs that are being offered to nurses in this area are evidence-based and designed in a manner that will enable nurses to develop the capabilities they need to respond effectively to the multifaceted and complex demands that are inherent in their ethical and professional responsibilities to promote and protect patient safety and quality care in health care domains.

77 FR 40515 - Safety Zone; Detroit Symphony Orchestra at Ford House Fireworks, Lake St. Clair, Grosse Pointe...

Science.gov (United States)

2012-07-10

...-AA00 Safety Zone; Detroit Symphony Orchestra at Ford House Fireworks, Lake St. Clair, Grosse Pointe... Detroit Symphony Orchestra at the Ford House Fireworks. This zone will be effective and enforced from 10.... 165.T09-0600 Safety Zone; Detroit Symphony Orchestra at Ford House Fireworks, Lake St. Clair, Grosse...

Non-compliance with agrochemical safety guides and associated ...

African Journals Online (AJOL)

Although several occupational health hazards are associated with farming, cocoa farmers could be exposed to more health hazards through use of agrochemicals. The objective of this study was to analyze the effect of non-compliance with agrochemical safety guides on health risks of farmers. The data were collected from ...

A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

Directory of Open Access Journals (Sweden)

Renata Mahfuz Daud-Gallotti

2011-01-01

Full Text Available INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59 ± 1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54 offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical

Hinkley Point 'C' power station public inquiry: proof of evidence on comparison of non-fossil options to Hinkley Point 'C'

International Nuclear Information System (INIS)

Goddard, S.C.

1988-09-01

A public inquiry has been set up to examine the planning application made by the Central Electricity Generating Board (CEGB) for the construction of a 1200 MW Pressurized Water Reactor power station at Hinkley Point (Hinkley Point ''C'') in the United Kingdom. This evidence to the Inquiry sets out and explains the non-fossil fuel options, with particular reference to renewable energy sources and other PWR locations; gives feasibility, capital cost, performance and total resource estimates for the renewable sources; and shows that no other non-fossil fuel source is to be preferred to Hinkley Point ''C''. (author)

Cognitive performance in both clinical and non-clinical burnout

NARCIS (Netherlands)

Oosterholt, B.G.; Maes, J.H.R.; Linden, D. van der; Verbraak, M.J.P.M.; Kompier, M.A.J.

2014-01-01

Relatively little is known about cognitive performance in burnout. The aim of the present study was to further our knowledge on this topic by examining, in one study, cognitive performance in both clinical and non-clinical burnout while focusing on three interrelated aspects of cognitive

Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease: A Randomized Clinical Trial.

Science.gov (United States)

Bond, Aaron E; Shah, Binit B; Huss, Diane S; Dallapiazza, Robert F; Warren, Amy; Harrison, Madaline B; Sperling, Scott A; Wang, Xin-Qun; Gwinn, Ryder; Witt, Jennie; Ro, Susie; Elias, W Jeffrey

2017-12-01

Clinical trials have confirmed the efficacy of focused ultrasound (FUS) thalamotomy in essential tremor, but its effectiveness and safety for managing tremor-dominant Parkinson disease (TDPD) is unknown. To assess safety and efficacy at 12-month follow-up, accounting for placebo response, of unilateral FUS thalamotomy for patients with TDPD. Of the 326 patients identified from an in-house database, 53 patients consented to be screened. Twenty-six were ineligible, and 27 were randomized (2:1) to FUS thalamotomy or a sham procedure at 2 centers from October18, 2012, to January 8, 2015. The most common reasons for disqualification were withdrawal (8 persons [31%]), and not being medication refractory (8 persons [31%]). Data were analyzed using intention-to-treat analysis, and assessments were double-blinded through the primary outcome. Twenty patients were randomized to unilateral FUS thalamotomy, and 7 to sham procedure. The sham group was offered open-label treatment after unblinding. The predefined primary outcomes were safety and difference in improvement between groups at 3 months in the on-medication treated hand tremor subscore from the Clinical Rating Scale for Tremor (CRST). Secondary outcomes included descriptive results of Unified Parkinson's Disease Rating Scale (UPDRS) scores and quality of life measures. Of the 27 patients, 26 (96%) were male and the median age was 67.8 years (interquartile range [IQR], 62.1-73.8 years). On-medication median tremor scores improved 62% (IQR, 22%-79%) from a baseline of 17 points (IQR, 10.5-27.5) following FUS thalamotomy and 22% (IQR, -11% to 29%) from a baseline of 23 points (IQR, 14.0-27.0) after sham procedures; the between-group difference was significant (Wilcoxon P = .04). On-medication median UPDRS motor scores improved 8 points (IQR, 0.5-11.0) from a baseline of 23 points (IQR, 15.5-34.0) following FUS thalamotomy and 1 point (IQR, -5.0 to 9.0) from a baseline of 25 points (IQR, 15.0-33.0) after sham

The body of nuclear safety rules in Germany. Tasks, problems, perspectives from the point of view of a manufacturer

International Nuclear Information System (INIS)

Orth, K.H.

1993-01-01

The paper discusses a manufacturer's point of view, industry's interests and aspects in connection with the evolution and definition of KTA safety rules, stating a certain field of tension between RSK recommendations and the KTA safety rules. Developments within the EU faster expectations for better harmonisation of safety guides and rules. (HP) [de

A patient safety objective structured clinical examination.

Science.gov (United States)

Singh, Ranjit; Singh, Ashok; Fish, Reva; McLean, Don; Anderson, Diana R; Singh, Gurdev

2009-06-01

There are international calls for improving education for health care workers around certain core competencies, of which patient safety and quality are integral and transcendent parts. Although relevant teaching programs have been developed, little is known about how best to assess their effectiveness. The objective of this work was to develop and implement an objective structured clinical examination (OSCE) to evaluate the impact of a patient safety curriculum. The curriculum was implemented in a family medicine residency program with 47 trainees. Two years after commencing the curriculum, a patient safety OSCE was developed and administered at this program and, for comparison purposes, to incoming residents at the same program and to residents at a neighboring residency program. All 47 residents exposed to the training, all 16 incoming residents, and 10 of 12 residents at the neighboring program participated in the OSCE. In a standardized patient case, error detection and error disclosure skills were better among trained residents. In a chart-based case, trained residents showed better performance in identifying deficiencies in care and described more appropriate means of addressing them. Third year residents exposed to a "Systems Approach" course performed better at system analysis and identifying system-based solutions after the course than before. Results suggest increased systems thinking and inculcation of a culture of safety among residents exposed to a patient safety curriculum. The main weaknesses of the study are its small size and suboptimal design. Much further investigation is needed into the effectiveness of patient safety curricula.

Preliminary investigation of interconnected systems interactions for the safety injection system of Indian Point-3

International Nuclear Information System (INIS)

Alesso, H.P.; Lappa, D.A.; Smith, C.F.; Sacks, I.J.

1983-01-01

The rich diversity of ideas and techniques for analyzing interconnected systems interaction has presented the NRC with the problem of identifying methods appropriate for their own review and audit. This report presents the findings of a preliminary study using the Digraph Matrix Analysis method to evaluate interconnected systems interactions for the safety injection system of Indian Point-3. The analysis effort in this study was subjected to NRC constraints regarding the use of Boolean logic, the construction of simplified plant representations or maps, and the development of heuristic measures as specified by the NRC. The map and heuristic measures were found to be an unsuccessful approach. However, from the effort to model and analyze the Indian Point-3 safety injection system, including Boolean logic in the model, singleton and doubleton cut-sets were identified. It is recommended that efforts excluding Boolean logic and utilizing the NRC heuristic measures not be pursed further and that the Digraph Matrix approach (or other comparable risk assessment technique) with Boolean logic included to conduct the audit of the Indian Point-3 systems interaction study

Patient safety and quality of care: how may clinical simulation contribute?

DEFF Research Database (Denmark)

Jensen, Sanne

2015-01-01

The usability of health information technology (IT) is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector...... influences the development and application of health IT. When health IT is introduced in local clinical work practices, potential patient safety hazards and insufficient support of work practices need to be examined. Qualitative methods, such as clinical simulation, may be used to evaluate new technology...

Clinical safety and professional liability claims in Ophthalmology.

Science.gov (United States)

Dolz-Güerri, F; Gómez-Durán, E L; Martínez-Palmer, A; Castilla Céspedes, M; Arimany-Manso, J

2017-11-01

Patient safety is an international public health priority. Ophthalmology scientific societies and organisations have intensified their efforts in this field. As a tool to learn from errors, these efforts have been linked to the management of medical professional liability insurance through the analysis of claims. A review is performed on the improvements in patient safety, as well as professional liability issues in Ophthalmology. There is a high frequency of claims and risk of economic reparation of damage in the event of a claim in Ophthalmology. Special complaints, such as wrong surgery or lack of information, have a high risk of financial compensation and need strong efforts to prevent these potentially avoidable events. Studies focused on pathologies or specific procedures provide information of special interest to sub-specialists. The specialist in Ophthalmology, like any other doctor, is subject to the current legal provisions and appropriate mandatory training in the medical-legal aspects of health care is essential. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career, and help in increasing patient safety. The aim of this review is to contribute to this training, for the benefit of professionals and patients. Copyright © 2017 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

International Nuclear Information System (INIS)

Endrikat, J.; Schwenke, C.; Prince, M.R.

2015-01-01

Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

Spallation Neutron Source Accelerator Facility Target Safety and Non-safety Control Systems

International Nuclear Information System (INIS)

Battle, Ronald E.; DeVan, B.; Munro, John K. Jr.

2006-01-01

The Spallation Neutron Source (SNS) is a proton accelerator facility that generates neutrons for scientific researchers by spallation of neutrons from a mercury target. The SNS became operational on April 28, 2006, with first beam on target at approximately 200 W. The SNS accelerator, target, and conventional facilities controls are integrated by standardized hardware and software throughout the facility and were designed and fabricated to SNS conventions to ensure compatibility of systems with Experimental Physics Integrated Control System (EPICS). ControlLogix Programmable Logic Controllers (PLCs) interface to instruments and actuators, and EPICS performs the high-level integration of the PLCs such that all operator control can be accomplished from the Central Control room using EPICS graphical screens that pass process variables to and from the PLCs. Three active safety systems were designed to industry standards ISA S84.01 and IEEE 603 to meet the desired reliability for these safety systems. The safety systems protect facility workers and the environment from mercury vapor, mercury radiation, and proton beam radiation. The facility operators operated many of the systems prior to beam on target and developed the operating procedures. The safety and non-safety control systems were tested extensively prior to beam on target. This testing was crucial to identify wiring and software errors and failed components, the result of which was few problems during operation with beam on target. The SNS has continued beam on target since April to increase beam power, check out the scientific instruments, and continue testing the operation of facility subsystems

Integrated plant safety assessment. Systematic evaluation program, Big Rock Point Plant (Docket No. 50-155). Final report

International Nuclear Information System (INIS)

1984-05-01

The Systematic Evaluation Program was initiated in February 1977 by the U.S. Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final Integrated Plant Safety Assessment Report has been issued. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

Science.gov (United States)

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

Modeling the contribution of point sources and non-point sources to Thachin River water pollution.

Science.gov (United States)

Schaffner, Monika; Bader, Hans-Peter; Scheidegger, Ruth

2009-08-15

Major rivers in developing and emerging countries suffer increasingly of severe degradation of water quality. The current study uses a mathematical Material Flow Analysis (MMFA) as a complementary approach to address the degradation of river water quality due to nutrient pollution in the Thachin River Basin in Central Thailand. This paper gives an overview of the origins and flow paths of the various point- and non-point pollution sources in the Thachin River Basin (in terms of nitrogen and phosphorus) and quantifies their relative importance within the system. The key parameters influencing the main nutrient flows are determined and possible mitigation measures discussed. The results show that aquaculture (as a point source) and rice farming (as a non-point source) are the key nutrient sources in the Thachin River Basin. Other point sources such as pig farms, households and industries, which were previously cited as the most relevant pollution sources in terms of organic pollution, play less significant roles in comparison. This order of importance shifts when considering the model results for the provincial level. Crosschecks with secondary data and field studies confirm the plausibility of our simulations. Specific nutrient loads for the pollution sources are derived; these can be used for a first broad quantification of nutrient pollution in comparable river basins. Based on an identification of the sensitive model parameters, possible mitigation scenarios are determined and their potential to reduce the nutrient load evaluated. A comparison of simulated nutrient loads with measured nutrient concentrations shows that nutrient retention in the river system may be significant. Sedimentation in the slow flowing surface water network as well as nitrogen emission to the air from the warm oxygen deficient waters are certainly partly responsible, but also wetlands along the river banks could play an important role as nutrient sinks.

Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group

NARCIS (Netherlands)

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

2016-01-01

PURPOSE: To provide recommendations on appropriate clinical trial designs in non-muscle-invasive bladder cancer (NMIBC) based on current literature and expert consensus of the International Bladder Cancer Group. METHODS: We reviewed published trials, guidelines, meta-analyses, and reviews and

Solutions to second order non-homogeneous multi-point BVPs using a fixed-point theorem

Directory of Open Access Journals (Sweden)

Yuji Liu

2008-07-01

Full Text Available In this article, we study five non-homogeneous multi-point boundary-value problems (BVPs of second order differential equations with the one-dimensional p-Laplacian. These problems have a common equation (in different function domains and different boundary conditions. We find conditions that guarantee the existence of at least three positive solutions. The results obtained generalize several known ones and are illustrated by examples. It is also shown that the approach for getting three positive solutions by using multi-fixed-point theorems can be extended to nonhomogeneous BVPs. The emphasis is on the nonhomogeneous boundary conditions and the nonlinear term involving first order derivative of the unknown. Some open problems are also proposed.

Clinical and non-clinical depressive symptoms and risk of long-term sickness absence among female employees in the Danish eldercare sector

DEFF Research Database (Denmark)

Hjarsbech, PU; Andersen, Rikke Voss; Christensen, Karl Bang

2011-01-01

was stronger for each subsequent group: MDI scores of 5–9: HR=1.07 (95% CI: 0.93–1.24); 10–14: 1.38 (1.15–1.66); 15–19: 1.54 (1.20–1.98); =20: 1.96 (1.45–2.64); clinical depression: 2.32 (1.59–3.38); after adjustment for previous LTSA, age, family status, smoking, leisure time physical activity, BMI......Background: Depression has a high point and life time prevalence and is a major cause of reduced work ability and long-term sickness absence (LTSA). Less is known of the extent to which non-clinical depressive symptoms are related to the risk of LTSA. The aim of this study was to investigate how...... non-clinical and clinical depressive symptoms are prospectively associated to subsequent LTSA. Methods: In a cohort study of 6985 femaleemployees fromthe Danish eldercare sector depressive symptoms were measured by the Major Depression Inventory (MDI) and scores (0–50) were divided into groups of 0...

Safety Management in Non-Nuclear Contexts. Examples from Swedish Railway Regulatory and Company Perspectives

Energy Technology Data Exchange (ETDEWEB)

Salo, Ilkka; Svensson, Ola (Risk Analysis, Social and Decision Research Unit, Dept. of Psychology, Stockholm Univ., Stockholm (Sweden))

2005-06-15

Nuclear power operations demand safe procedures. In the context of this report, safety management is considered as a key instrument to achieve safety in technology, organization and operations. Outside the area of nuclear operations there exist a number of other technological areas that also demand safe operations. From the perspective of knowledge management, there exists an enormous pool of safety experiences that may be possible to shear or reformulate from one context to another. From this point of view, it seems highly relevant to make efforts to utilize, and try to understand how safety in general is managed in other contexts. There is much to gain from such an approach, not at least from economical, societal, and systems points of views. Because of the vast diversity between technological areas and their operations, a common framework that allow elaboration with common concepts for understanding, must be generated. In preceding studies a number of steps have been taken towards finding such a general framework for modeling safety management. In an initial step a system theoretical framework was outlined. In subsequent steps central concepts from this framework has been applied and evaluated in relation to a number of non-nuclear organizations. The present report brings this intention one step further, and for the first time, a complete analysis of a system consisting of both the regulator and the licensee was carried out, in the above respects. This report focused the Swedish railway system, and the organizations studied were the Swedish Rail Agency (SRA) and SJ (the main rail traffic operator). The data used for this report consisted of various documents about the organizations, and interview data. This report is basically structured around three, more or less, independent studies that are presented in separate chapters. They are: the system theoretical framework that in the following chapters is applied to the two organizations, and one chapter each for the

Leveraging Trainees to Improve Quality and Safety at the Point of Care: Three Models for Engagement.

Science.gov (United States)

Johnson Faherty, Laura; Mate, Kedar S; Moses, James M

2016-04-01

Trainees, as frontline providers who are acutely aware of quality improvement (QI) opportunities and patient safety (PS) issues, are key partners in achieving institutional quality and safety goals. However, as academic medical centers accelerate their initiatives to prioritize QI and PS, trainees have not always been engaged in these efforts. This article describes the development of an organizing framework with three suggested models of varying scopes and time horizons to effectively involve trainees in the quality and safety work of their training institutions. The proposed models, which were developed through a literature review, expert interviews with key stakeholders, and iterative testing, are (1) short-term, team-based, rapid-cycle initiatives; (2) medium-term, unit-based initiatives; and (3) long-term, health-system-wide initiatives. For each, the authors describe the objective, scope, duration, role of faculty leaders, steps for implementation in the clinical setting, pros and cons, and examples in the clinical setting. There are many barriers to designing the ideal training environments that fully engage trainees in QI/PS efforts, including lack of protected time for faculty mentors, time restrictions due to rotation-based training, and structural challenges. However, one of the most promising strategies for overcoming these barriers is integrating QI/PS principles into routine clinical care. These models provide opportunities for trainees to successfully learn and apply quality and safety principles to routine clinical care at the team, unit, and system level.

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

Science.gov (United States)

Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

2008-08-06

Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

Ethics of safety reporting of a clinical trial

Directory of Open Access Journals (Sweden)

Amrita Sil

2017-01-01

Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

[Clinical safety audits for primary care centers. A pilot study].

Science.gov (United States)

Ruiz Sánchez, Míriam; Borrell-Carrió, Francisco; Ortodó Parra, Cristina; Fernàndez I Danés, Neus; Fité Gallego, Anna

2013-01-01

To identify organizational processes, violations of rules, or professional performances that pose clinical levels of insecurity. Descriptive cross-sectional survey with customized externally-behavioral verification and comparison of sources, conducted from June 2008 to February 2010. Thirteen of the 53 primary care teams (PCT) of the Catalonian Health Institute (ICS Costa de Ponent, Barcelona). Employees of 13 PCT classified into: director, nurse director, customer care administrators, and general practitioners. Non-random selection, teaching (TC)/non-teaching, urban (UC)/rural and small/large (LC) health care centers (HCC). A total of 33 indicators were evaluated; 15 of procedures, 9 of attitude, 3 of training, and 6 of communication. Level of uncertainty: <50% positive answers for each indicator. no collaboration. A total of 55 professionals participated (84.6% UC, 46.2% LC and 76.9% TC). Rank distribution: 13 customer care administrators, 13 nurse directors, 13 HCC directors, and 16 general practitioners. Levels of insecurity emerged from the following areas: reception of new medical professionals, injections administration, nursing weekend home calls, urgent consultations to specialists, aggressive patients, critical incidents over the agenda of the doctors, communication barriers with patients about treatment plans, and with immigrants. Clinical safety is on the agenda of the health centers. Identified areas of uncertainty are easily approachable, and are considered in the future system of accreditation of the Catalonian Government. General practitioners are more critical than directors, and teaching health care centers, rural and small HCC had a better sense of security. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Safety First: The Role of Trust and School Safety in Non-Suicidal Self-Injury

Science.gov (United States)

Noble, Rick Nelson; Sornberger, Michael J.; Toste, Jessica R.; Heath, Nancy L.; McLouth, Rusty

2011-01-01

Non-suicidal self-injury (NSSI) has become very prominent among adolescents in middle and high school settings. However, little research has evaluated the role of the school environment in the behaviour. This study examined whether indices of school trust and perceived safety were predictive of NSSI behaviour. Results indicate that these variables…

Safety culture in a Belgian nuclear research centre from a social science point of view

International Nuclear Information System (INIS)

Fucks, I.; Hardeman, F.

2002-01-01

This paper is the result of a reflection within the framework of a Ph.D. research at SCK-CEN (Belgian Nuclear Research Centre) in collaboration with the University of Liege. The starting point of the work was the 'safety culture' model presented in the IAEA report 75-INSAG-4. This model is applied to the working organization of the SCK-CEN, also considering the safety culture as an open concept given its multi dimensionality. The methodology is based on three methods: observations, focus groups and interviews. The fieldwork was limited to two main installations: a research reactor, and a dismantling site. The preliminary findings are based on the data resulting from 4 Focus Groups. The most prominent components of a safety culture and the multiplicity of safety cultures in a large organization such as SCK-CEN will be discussed. (author)

Technical evaluation of the susceptibility of safety-related systems to flooding caused by the failure of non-Category I systems for Turkey Point Nuclear Power Plant, Units 3 and 4

International Nuclear Information System (INIS)

Collins, E.K.

1979-08-01

Three separate reviews of the Turkey Point Units 3 and 4 were conducted by the FPLCO between 1972 and 1975. Initially, at the request of NBC in 1972, the FPLCO reviewed several water systems as sources of flooding. Subsequently, as a result of an abnormal occurrence, the drainage system was reviewed. Finally, the facilities were again reviewed at NRC's request and both the potential sources of flooding and safety-related equipment which could be damaged by flooding were identified. The sources of flooding and the appropriate safety equipment are discussed. An evaluation is presented of measures that were taken by FPLCO to minimize the danger of flooding and to protect safety-related equipment

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

Code of practice for safety in laboratory - non ionising radiation

International Nuclear Information System (INIS)

Ramli Jaya; Mohd Yusof Mohd Ali; Khoo Boo Huat; Khatijah Hashim

1995-01-01

The code identifies the non-ionizing radiation encountered in laboratories and the associated hazards. The code is intended as a laboratory standard reference document for general information on safety requirements relating to the usage of non-ionizing radiations in laboratories. The nonionizing radiations cover in this code, namely, are ultraviolet radiation, visible light, radio-frequency radiation, lasers, sound waves and ultrasonic radiation. (author)

Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation.

Science.gov (United States)

Nyong, Jonathan; Amit, Guy; Adler, Alma J; Owolabi, Onikepe O; Perel, Pablo; Prieto-Merino, David; Lambiase, Pier; Casas, Juan Pablo; Morillo, Carlos A

2016-11-22

The optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited. To determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions. We included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up. Two review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables. We included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non

Factors shaping effective utilization of health information technology in urban safety-net clinics.

Science.gov (United States)

George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

2013-09-01

Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

The succinonitrile triple-point standard: a fixed point to improve the accuracy of temperature measurements in the clinical laboratory.

Science.gov (United States)

Mangum, B W

1983-07-01

In an investigation of the melting and freezing behavior of succinonitrile, the triple-point temperature was determined to be 58.0805 degrees C, with an estimated uncertainty of +/- 0.0015 degrees C relative to the International Practical Temperature Scale of 1968 (IPTS-68). The triple-point temperature of this material is evaluated as a temperature-fixed point, and some clinical laboratory applications of this fixed point are proposed. In conjunction with the gallium and ice points, the availability of succinonitrile permits thermistor thermometers to be calibrated accurately and easily on the IPTS-68.

Analysis Method of Common Cause Failure on Non-safety Digital Control System

Energy Technology Data Exchange (ETDEWEB)

Kim, Yun Goo; Oh, Eun Gse [KHNP, Daejeon (Korea, Republic of)

2014-08-15

The effects of common cause failure on safety digital instrumentation and control system had been considered in defense in depth analysis with safety analysis method. However, the effects of common cause failure on non-safety digital instrumentation and control system also should be evaluated. The common cause failure can be included in credible failure on the non-safety system. In the I and C architecture of nuclear power plant, many design feature has been applied for the functional integrity of control system. One of that is segmentation. Segmentation defenses the propagation of faults in the I and C architecture. Some of effects from common cause failure also can be limited by segmentation. Therefore, in this paper there are two type of failure mode, one is failures in one control group which is segmented, and the other is failures in multiple control group because that the segmentation cannot defense all effects from common cause failure. For each type, the worst failure scenario is needed to be determined, so the analysis method has been proposed in this paper. The evaluation can be qualitative when there is sufficient justification that the effects are bounded in previous safety analysis. When it is not bounded in previous safety analysis, additional analysis should be done with conservative assumptions method of previous safety analysis or best estimation method with realistic assumptions.

Advancing medication infusion safety through the clinical integration of technology.

Science.gov (United States)

Gerhart, Donald; O'Shea, Kristen; Muller, Sharon

2013-01-01

Adverse drug events resulting from errors in prescribing or administering medications are preventable. Within a hospital system, numerous technologies are employed to address the common sources of medication error, including the use of electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. Infusion safety is inherently risky because of the high-risk medications administered and the lack of integration among the stand-alone systems in most institutions. Intravenous clinical integration (IVCI) is a technology that connects electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. It combines the safety features of an automatically programmed infusion pump (drug, concentration, infusion rate, and patient weight, all auto-programmed into the device) with software that provides visibility to real-time clinical infusion data. Our article describes the characteristics of IVCI at WellSpan Health and its impact on patient safety. The integrated infusion system has the capability of reducing medication errors, improving patient care, reducing in-facility costs, and supporting asset management. It can enhance continuous quality improvement efforts and efficiency of clinical work flow. After implementing IVCI, the institution realized a safer patient environment and a more streamlined work flow for pharmacy and nursing.

Performance of balanced bellows safety relief valves

International Nuclear Information System (INIS)

Lai, Y.S.

1992-01-01

By the nature of its design, the set point and lift of a conventional spring loaded safety relief valve are sensitive to back pressure. One way to reduce the adverse effects of the back pressure on the safety relief valve function is to install a balanced bellows in a safety relief valve. The metallic bellows has a rather wide range of manufacturing tolerance which makes the design of the bellows safety relief valve very complicated. The state-of-the-art balanced bellows safety relief valve can only substantially minimize, but cannot totally eliminate the back pressure effects on its set point and relieving capacity. Set point change is a linear function of the back pressure to the set pressure ratio. Depending on the valve design, the set point correction factor can be either greater or smaller than unity. There exists an allowable back pressure and critical back pressure for each safety relief valve. When total back pressure exceeds the R a , the relieving capacity will be reduced mainly resulting from the valve lift being reduced by the back pressure and the capacity reduction factor should be applied in valve sizing. Once the R c is exceeded, the safety relief valve becomes unstable and loses its over pressure protection capability. The capacity reduction factor is a function of system overpressure, but their relationship is non-linear in nature. (orig.)

Radiation safety considerations and compliance within equine veterinary clinics: Results of an Australian survey

International Nuclear Information System (INIS)

Surjan, Y.; Ostwald, P.; Milross, C.; Warren-Forward, H.

2015-01-01

Objective: To examine current knowledge and the level of compliance of radiation safety principles in equine veterinary clinics within Australia. Method: Surveys were sent to equine veterinary surgeons working in Australia. The survey was delivered both online and in hardcopy format; it comprised 49 questions, 15 of these directly related to radiation safety. The participants were asked about their current and previous use of radiation-producing equipment. Information regarding their level of knowledge and application of radiation safety principles and practice standards was collected and analysed. Results: The use of radiation-producing equipment was evident in 94% of responding clinics (a combination of X-ray, CT and/or Nuclear Medicine Cameras). Of those with radiation-producing equipment, 94% indicated that they hold a radiation licence, 78% had never completed a certified radiation safety course and 19% of participants did not use a personal radiation monitor. In 14% of cases, radiation safety manuals or protocols were not available within clinics. Conclusions: The study has shown that knowledge and application of guidelines as provided by the Code of Practice for Radiation Protection in Veterinary Medicine (2009) is poorly adhered to. The importance of compliance with regulatory requirements is pivotal in minimising occupational exposure to ionising radiation in veterinary medicine, thus there is a need for increased education and training in the area. - Highlights: • Application of the Code of Practice for Veterinary Medicine is poorly adhered to. • Majority of veterinary clinics had not completed certified radiation safety course. • One-fifth of participants did not use personal radiation monitoring. • Increased education and training in area of radiation safety and protection required to generate compliance in clinics

Optimal Power Flow by Interior Point and Non Interior Point Modern Optimization Algorithms

Directory of Open Access Journals (Sweden)

Marcin Połomski

2013-03-01

Full Text Available The idea of optimal power flow (OPF is to determine the optimal settings for control variables while respecting various constraints, and in general it is related to power system operational and planning optimization problems. A vast number of optimization methods have been applied to solve the OPF problem, but their performance is highly dependent on the size of a power system being optimized. The development of the OPF recently has tracked significant progress both in numerical optimization techniques and computer techniques application. In recent years, application of interior point methods to solve OPF problem has been paid great attention. This is due to the fact that IP methods are among the fastest algorithms, well suited to solve large-scale nonlinear optimization problems. This paper presents the primal-dual interior point method based optimal power flow algorithm and new variant of the non interior point method algorithm with application to optimal power flow problem. Described algorithms were implemented in custom software. The experiments show the usefulness of computational software and implemented algorithms for solving the optimal power flow problem, including the system model sizes comparable to the size of the National Power System.

The current CEA/DRN safety approach for the design and the assessment of non-electrical applications of nuclear heat

International Nuclear Information System (INIS)

Fiorini, G.L.; Costa, M.

2000-01-01

This paper presents the basis of the safety approach currently implemented by the Commissariat a l'Energie Atomique - Nuclear Reactor Directorate (CEA/DRN), both for the design and the assessment of innovative systems and future nuclear installations. It is considered that the described approach is applicable to the plants built for non-electrical applications of nuclear heat. This is typically the case of Nuclear Desalination Installations. This approach is the result of the experience maturated, within the context of the CEA/DRN Innovative Programme, through practical applications over several future concepts (both fission and fusion plants). The background of this experience is structured coherently with the European Safety Authorities recommendations, the European Utilities Requirements (EUR) and the ''fundamental safety objectives'' defined by the IAEA. The Defence In Depth principle and its application, by means, among others, of the barrier concept, remains the basis of the safety design process of future nuclear installations. Its adequacy is checked through the safety assessment. The methodology for Lines of Defence (LOD) implementation as well as the one for the LOD architecture assessment is shown and motivated. The document shows that the clear and unambiguous definition of the safety approach provides an essential base for the organisation of the design tasks, being sure that the safety aspects are correctly taken into account and implemented, and for an adequate safety assessment of the final design, both from qualitative point of view as well as for the quantitative safety analysis. (author)

Clinical Validation of Point-Source Corneal Topography in Keratoplasty

NARCIS (Netherlands)

Vrijling, A C L; Braaf, B.; Snellenburg, J.J.; de Lange, F.; Zaal, M.J.W.; van der Heijde, G.L.; Sicam, V.A.D.P.

2011-01-01

Purpose. To validate the clinical performance of point-source corneal topography (PCT) in postpenetrating keratoplasty (PKP) eyes and to compare it with conventional Placido-based topography. Methods. Corneal elevation maps of the anterior corneal surface were obtained from 20 post-PKP corneas using

ClinicalKey 2.0: Upgrades in a Point-of-Care Search Engine.

Science.gov (United States)

Huslig, Mary Ann; Vardell, Emily

2015-01-01

ClinicalKey 2.0, launched September 23, 2014, offers a mobile-friendly design with a search history feature for targeting point-of-care resources for health care professionals. Browsing is improved with searchable, filterable listings of sources highlighting new resources. ClinicalKey 2.0 improvements include more than 1,400 new Topic Pages for quick access to point-of-care content. A sample search details some of the upgrades and content options.

A Study of Time Response for Safety-Related Operator Actions in Non-LOCA Safety Analysis

Energy Technology Data Exchange (ETDEWEB)

Lee, Min Seok; Lee, Sang Seob; Park, Min Soo; Lee, Gyu Cheon; Kim, Shin Whan [KEPCO E and C Company, Daejeon (Korea, Republic of)

2014-10-15

The classification of initiating events for safety analysis report (SAR) chapter 15 is categorized into moderate frequency events (MF), infrequent events (IF), and limiting faults (LF) depending on the frequency of its occurrence. For the non-LOCA safety analysis with the purpose to get construction or operation license, however, it is assumed that the operator response action to mitigate the events starts at 30 minutes after the initiation of the transient regardless of the event categorization. Such an assumption of corresponding operator response time may have over conservatism with the MF and IF events and results in a decrease in the safety margin compared to its acceptance criteria. In this paper, the plant conditions (PC) are categorized with the definitions in SAR 15 and ANS 51.1. Then, the consequence of response for safety-related operator action time is determined based on the PC in ANSI 58.8. The operator response time for safety analysis regarding PC are reviewed and suggested. The clarifying alarm response procedure would be required for the guideline to reduce the operator response time when the alarms indicate the occurrence of the transient.

quasi hyperrigidity and weak peak points for non-commutative ...

Indian Academy of Sciences (India)

7

Abstract. In this article, we introduce the notions of weak boundary repre- sentation, quasi hyperrigidity and weak peak points in the non-commutative setting for operator systems in C∗-algebras. An analogue of Saskin's theorem relating quasi hyperrigidity and weak Choquet boundary for particular classes of C∗-algebras is ...

Safety controls according to the non-proliferation treaty in EC countries

International Nuclear Information System (INIS)

Pander, J. von.

1978-01-01

Above all, content and extent of the duty conferred upon the IAEA according to article III, paragraph 1 of the NP treaty which implies the conducting of safety controls and the consequences resulting here from are examined. Including the peaceful use of nuclear energy developing under international law the agreement on safety control signed on 5th April 1973 between IAEA and EURATOM as well as its seven non-nuclear-weapon member states is discussed, along with its technical and its implicit legal problems. In detail the manifold technical and judicial problems of IAEA safety controls are shown, their realization requiring a well-working cooperation between IAEA and the European Communities. As only the non-nuclear-weapon member states of the EC are subject to the IAEA safety control system within the frame of this agreement the following questions are discussed: 1. effects on the member status after the signing of the EURATOM contract and 2. granting the principle of equal treatment for all member states as against the nuclear-weapon member states of the EC, France and the United Kingdom. (orig./HP) [de

Microbiological performance of Hazard Analysis Critical Control Point (HACCP)-based food safety management systems: A case of Nile perch processing company

NARCIS (Netherlands)

Kussaga, J.B.; Luning, P.A.; Tiisekwa, B.P.M.; Jacxsens, L.

2017-01-01

This study aimed at giving insight into microbiological safety output of a Hazard Analysis Critical Control Point (HACCP)-based Food Safety Management System (FSMS) of a Nile perch exporting company by using a combined assessment, This study aimed at giving insight into microbiological safety output

Translating self-persuasion into an adolescent HPV vaccine promotion intervention for parents attending safety-net clinics.

Science.gov (United States)

Baldwin, Austin S; Denman, Deanna C; Sala, Margarita; Marks, Emily G; Shay, L Aubree; Fuller, Sobha; Persaud, Donna; Lee, Simon Craddock; Skinner, Celette Sugg; Wiebe, Deborah J; Tiro, Jasmin A

2017-04-01

Self-persuasion is an effective behavior change strategy, but has not been translated for low-income, less educated, uninsured populations attending safety-net clinics or to promote human papillomavirus (HPV) vaccination. We developed a tablet-based application (in English and Spanish) to elicit parental self-persuasion for adolescent HPV vaccination and evaluated its feasibility in a safety-net population. Parents (N=45) of age-eligible adolescents used the self-persuasion application. Then, during cognitive interviews, staff gathered quantitative and qualitative feedback on the self-persuasion tasks including parental decision stage. The self-persuasion tasks were rated as easy to complete and helpful. We identified six question prompts rated as uniformly helpful, not difficult to answer, and generated non-redundant responses from participants. Among the 33 parents with unvaccinated adolescents, 27 (81.8%) reported deciding to get their adolescent vaccinated after completing the self-persuasion tasks. The self-persuasion application was feasible and resulted in a change in parents' decision stage. Future studies can now test the efficacy of the tablet-based application on HPV vaccination. The self-persuasion application facilitates verbalization of reasons for HPV vaccination in low literacy, safety-net settings. This self-administered application has the potential to be more easily incorporated into clinical practice than other patient education approaches. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

MedAustron – Non-Clinical Research Opportunities

International Nuclear Information System (INIS)

Schreiner, T.

2013-01-01

MedAustron is a synchrotron based light-ion beam therapy centre for cancer treatment as well as for clinical and non-clinical research, currently in the construction phase in Wiener Neustadt. Whilst the choice of basic machine parameters was driven by medical requirements, the accelerator complex design was also optimised to offer flexibility for research operation. The potential of the synchrotron is being exploited to increase the maximum proton energy far beyond the medical needs to up to 800 MeV, for experimental physics applications, mainly in the areas of proton scattering and detector research. The accelerator layout allows for the installation of up to four ion source-spectrometer units, to provide various ion types besides the clinical used protons and carbon ions. To decouple research and medical operation, a dedicated irradiation room for non-clinical research was included providing two isocentres for the installation of different experiments. This presentation provides a status overview over the whole project and highlights the non-clinical research opportunities at MedAustron. (author)

Characterization of non point source pollutants and their dispersion ...

African Journals Online (AJOL)

EJIRO

landing site in Uganda. N. Banadda. Agricultural and Bio-Systems Engineering Department, Makerere University, P. O. Box 7062, Kampala, Uganda. E-mail: banadda@agric.mak.ac.ug. Fax: +256-414-53.16.41. Accepted 5 January, 2011. The aim of this research is to characterize non point pollutants and their dispersion in ...

Safety Management in Non-Nuclear Contexts. Examples from Swedish Railway Regulatory and Company Perspectives

International Nuclear Information System (INIS)

Salo, Ilkka; Svensson, Ola

2005-06-01

Nuclear power operations demand safe procedures. In the context of this report, safety management is considered as a key instrument to achieve safety in technology, organization and operations. Outside the area of nuclear operations there exist a number of other technological areas that also demand safe operations. From the perspective of knowledge management, there exists an enormous pool of safety experiences that may be possible to shear or reformulate from one context to another. From this point of view, it seems highly relevant to make efforts to utilize, and try to understand how safety in general is managed in other contexts. There is much to gain from such an approach, not at least from economical, societal, and systems points of views. Because of the vast diversity between technological areas and their operations, a common framework that allow elaboration with common concepts for understanding, must be generated. In preceding studies a number of steps have been taken towards finding such a general framework for modeling safety management. In an initial step a system theoretical framework was outlined. In subsequent steps central concepts from this framework has been applied and evaluated in relation to a number of non-nuclear organizations. The present report brings this intention one step further, and for the first time, a complete analysis of a system consisting of both the regulator and the licensee was carried out, in the above respects. This report focused the Swedish railway system, and the organizations studied were the Swedish Rail Agency (SRA) and SJ (the main rail traffic operator). The data used for this report consisted of various documents about the organizations, and interview data. This report is basically structured around three, more or less, independent studies that are presented in separate chapters. They are: the system theoretical framework that in the following chapters is applied to the two organizations, and one chapter each for the

Understanding of safety monitoring in clinical trials by individuals with CF or their parents: A qualitative analysis.

Science.gov (United States)

Kern-Goldberger, Andrew S; Hessels, Amanda J; Saiman, Lisa; Quittell, Lynne M

2018-03-14

Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials. Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., "pipeline"), abbreviations eliminated, and redundancy avoided. Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

Directory of Open Access Journals (Sweden)

Glastonbury Briony

2008-08-01

Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

Development of Non-safety System Architecture and Evaluation of Components/Systems

International Nuclear Information System (INIS)

Oh, I. S.; Lee, C. K.; Kim, D. H.; Lee, J. W.; Lee, D. Y.; Park, W. M.; Hwang, I. K.; Hur, S.; Kim, J. T.; Park, J. C.; Lee, J. W.

2007-10-01

We describe in this report the works performed for a technical evaluation of the non-safety digital control system of the KNICS, the non-safety process control system of the KNICS, a communication load analysis for the MMIS (including both the non-safety and the safety systems) of the KNICS, the development of MMI and an implementation of the logic for the CVCS, and the works performed to support writing a proposal needed for bidding an I and C system based on the KNICS. The technical evaluation results were aimed to be used by the designers to detect parts needed to be corrected or to be newly inserted, and also by the developers during the development phase. The requirement specifications and the data requirement characteristics have been identified for each subsystem of the determined KNICS structure. For each communication node, the specifications related to the data transfer including the data capacity for interfaces, delay time for the data transfer, and the marginal availability of its performance capabilities have been analyzed to identify the amount of data transfer and hence to verify that both of the designed structures for the safety related communications network and for the digital communications network are appropriate. The results of the supporting work performed for writing the technical specifications related to each subsystem of the KNICS structure, are expected to be useful in writing a proposal for the expected Uljin new units 1 and 2, and in the I and C upgrade for any of the existing nuclear power plants under operation. Also included in this report are the descriptions on a design of the chemical volume control system (CVCS), on the supporting work performed to draw the logic diagrams for CVCS using the tool ISaGRAF, and on the generation of a set of system displays to be used as references

Development of Non-safety System Architecture and Evaluation of Components/Systems

Energy Technology Data Exchange (ETDEWEB)

Oh, I. S.; Lee, C. K.; Kim, D. H.; Lee, J. W.; Lee, D. Y.; Park, W. M.; Hwang, I. K.; Hur, S.; Kim, J. T.; Park, J. C.; Lee, J. W

2007-10-15

We describe in this report the works performed for a technical evaluation of the non-safety digital control system of the KNICS, the non-safety process control system of the KNICS, a communication load analysis for the MMIS (including both the non-safety and the safety systems) of the KNICS, the development of MMI and an implementation of the logic for the CVCS, and the works performed to support writing a proposal needed for bidding an I and C system based on the KNICS. The technical evaluation results were aimed to be used by the designers to detect parts needed to be corrected or to be newly inserted, and also by the developers during the development phase. The requirement specifications and the data requirement characteristics have been identified for each subsystem of the determined KNICS structure. For each communication node, the specifications related to the data transfer including the data capacity for interfaces, delay time for the data transfer, and the marginal availability of its performance capabilities have been analyzed to identify the amount of data transfer and hence to verify that both of the designed structures for the safety related communications network and for the digital communications network are appropriate. The results of the supporting work performed for writing the technical specifications related to each subsystem of the KNICS structure, are expected to be useful in writing a proposal for the expected Uljin new units 1 and 2, and in the I and C upgrade for any of the existing nuclear power plants under operation. Also included in this report are the descriptions on a design of the chemical volume control system (CVCS), on the supporting work performed to draw the logic diagrams for CVCS using the tool ISaGRAF, and on the generation of a set of system displays to be used as references.

Non-equilibrium dynamics near a quantum multicritical point

International Nuclear Information System (INIS)

Patra, Ayoti; Mukherjee, Victor; Dutta, Amit

2011-01-01

We study the non-equilibrium dynamics of a quantum system close to a quantum multi-critical point (MCP) using the example of a one-dimensional spin-1/2 transverse XY spin chain. We summarize earlier results of defect generenation and fidelity susceptibility for quenching through MCP and close to the MCP, respectively. For a quenching scheme which enables the system to hit the MCP along different paths, we emphasize the role of path on exponents associated with quasicritical points which appear in the scaling relations. Finally, we explicitly derive the scaling of concurrence and negativity for two spin entanglement generated following a slow quenching across the MCP and enlist the results for different quenching schemes. We explicity show the dependence of the scaling on the quenching path and dicuss the limiting situations.

An investigation of safety climate in OHSAS 18001-certified and non-certified organizations.

Science.gov (United States)

Ghahramani, Abolfazl

2016-09-01

Many organizations worldwide have implemented Occupational Health and Safety Assessment Series (OHSAS) 18001 in their premises because of the assumed positive effects of this standard on safety. Few studies have analyzed the effect of the safety climate in OHSAS 18001-certified organizations. This case-control study used a new safety climate questionnaire to evaluate three OHSAS 18001-certified and three non-certified manufacturing companies in Iran. Hierarchical regression indicated that the safety climate was influenced by OHSAS implementation and by safety training. Employees who received safety training had better perceptions of the safety climate and its dimensions than other respondents within the certified companies. This study found that the implementation of OHSAS 18001 does not guarantee improvement of the safety climate. This study also emphasizes the need for high-quality safety training for employees of the certified companies to improve the safety climate.

Are HPV vaccination services accessible to high-risk communities? A spatial analysis of HPV-associated cancer and Chlamydia rates and safety-net clinics.

Science.gov (United States)

Tsui, Jennifer; Rodriguez, Hector P; Gee, Gilbert C; Escobedo, Loraine A; Kominski, Gerald F; Bastani, Roshan

2013-12-01

While HPV vaccines can greatly benefit adolescents and young women from high-risk areas, little is known about whether safety-net immunization services are geographically accessible to communities at greatest risk for HPV-associated diseases. We explore the spatial relationship between areas with high HPV risk and proximity to safety-net clinics from an ecologic perspective. We used cancer registry data and Chlamydia surveillance data to identify neighborhoods within Los Angeles County with high risk for HPV-associated cancers. We examined proximity to safety-net clinics among neighborhoods with the highest risk. Proximity was measured as the shortest distance between each neighborhood center and the nearest clinic and having a clinic within 3 miles of each neighborhood center. The average 5-year non-age-adjusted rates were 1,940 cases per 100,000 for Chlamydia and 60 per 100,000 for HPV-associated cancers. A large majority, 349 of 386 neighborhoods with high HPV-associated cancer rates and 532 of 537 neighborhoods with high Chlamydia rates, had a clinic within 3 miles of the neighborhood center. Clinics were more likely to be located within close proximity to high-risk neighborhoods in the inner city. High-risk neighborhoods outside of this urban core area were less likely to be near accessible clinics. The majority of high-risk neighborhoods were geographically near safety-net clinics with HPV vaccination services. Due to low rates of vaccination, these findings suggest that while services are geographically accessible, additional efforts are needed to improve uptake. Programs aimed to increase awareness about the vaccine and to link underserved groups to vaccination services are warranted.

Spatiotemporal patterns of non-point source nitrogen loss in an agricultural catchment

Directory of Open Access Journals (Sweden)

Jian-feng Xu

2016-04-01

Full Text Available Non-point source nitrogen loss poses a risk to sustainable aquatic ecosystems. However, non-point sources, as well as impaired river segments with high nitrogen concentrations, are difficult to monitor and regulate because of their diffusive nature, budget constraints, and resource deficiencies. For the purpose of catchment management, the Bayesian maximum entropy approach and spatial regression models have been used to explore the spatiotemporal patterns of non-point source nitrogen loss. In this study, a total of 18 sampling sites were selected along the river network in the Hujiashan Catchment. Over the time period of 2008–2012, water samples were collected 116 times at each site and analyzed for non-point source nitrogen loss. The morphometric variables and soil drainage of different land cover types were studied and considered potential factors affecting nitrogen loss. The results revealed that, compared with the approach using the Euclidean distance, the Bayesian maximum entropy approach using the river distance led to an appreciable 10.1% reduction in the estimation error, and more than 53.3% and 44.7% of the river network in the dry and wet seasons, respectively, had a probability of non-point source nitrogen impairment. The proportion of the impaired river segments exhibited an overall decreasing trend in the study catchment from 2008 to 2012, and the reduction in the wet seasons was greater than that in the dry seasons. High nitrogen concentrations were primarily found in the downstream reaches and river segments close to the residential lands. Croplands and residential lands were the dominant factors affecting non-point source nitrogen loss, and explained up to 70.7% of total nitrogen in the dry seasons and 54.7% in the wet seasons. A thorough understanding of the location of impaired river segments and the dominant factors affecting total nitrogen concentration would have considerable importance for catchment management.

Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study.

Directory of Open Access Journals (Sweden)

Laura K Erdman

Full Text Available Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance.We studied children with WHO-defined clinical pneumonia (n = 155 within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30, other infiltrates (n = 31, or normal chest x-ray (n = 94. Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis.Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5-98.8, 80.8% specificity (72.6-87.1, positive likelihood ratio 4.9 (3.4-7.1, negative likelihood ratio 0

Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study

Science.gov (United States)

Erdman, Laura K.; D’Acremont, Valérie; Hayford, Kyla; Kilowoko, Mary; Kyungu, Esther; Hongoa, Philipina; Alamo, Leonor; Streiner, David L.; Genton, Blaise; Kain, Kevin C.

2015-01-01

Background Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO) has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance. Methods We studied children with WHO-defined clinical pneumonia (n = 155) within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30), other infiltrates (n = 31), or normal chest x-ray (n = 94). Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis. Results Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5–98.8), 80.8% specificity (72.6–87.1), positive likelihood ratio 4.9 (3.4–7

[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

Science.gov (United States)

Benninger-Döring, G; Boos, J

2006-07-01

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

Directory of Open Access Journals (Sweden)

Girija Madhavanprabhakaran

2015-01-01

Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

Prevalence and determinants of non-standard motorcycle safety helmets amongst food delivery workers in Selangor and Kuala Lumpur.

Science.gov (United States)

Kulanthayan, S; See, Lai Git; Kaviyarasu, Y; Nor Afiah, M Z

2012-05-01

Almost half of the global traffic crashes involve vulnerable groups such as pedestrian, cyclists and two-wheeler users. The main objective of this study was to determine the factors that influence standard of the safety helmets used amongst food delivery workers by presence of Standard and Industrial Research Institute of Malaysia (SIRIM) certification label. A cross sectional study was conducted amongst 150 food delivery workers from fast food outlets in the vicinity of Selangor and Kuala Lumpur. During observation, safety helmets were classified as standard safety helmet in the presence of SIRIM label and non-standard in the absence of the label. They were approached for questionnaire participation once consent was obtained and were requested to exchange their safety helmet voluntarily with a new one after the interview. Data analysis was carried out using SPSS. Chi square and logistic regression analysis was applied to determine the significance and odds ratio of the variables studied, respectively (penetration test, age, education level, knowledge, crash history, types of safety helmet, marital status and years of riding experience) against the presence of SIRIM label. The response rate for this study was 85.2%. The prevalence of non-standard helmets use amongst fast food delivery workers was 55.3%. Safety helmets that failed the penetration test had higher odds of being non-standard helmets compared with safety helmets passing the test. Types of safety helmet indicated half-shell safety helmets had higher odds to be non-standard safety helmets compared to full-shell safety helmets. Riders with more years of riding experience were in high odds of wearing non-standard safety helmets compared to riders with less riding experience. Non-standard (non-SIRIM approved) helmets were more likely to be half-shell helmets, were more likely to fail the standards penetration test, and were more likely to be worn by older, more experienced riders. The implications of these

Patient safety and quality of care: How may clinical simulation contribute?

Directory of Open Access Journals (Sweden)

Sanne Jensen

2015-09-01

Full Text Available The usability of health information technology (IT is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector influences the development and application of health IT. When health IT is introduced in local clinical work practices, potential patient safety hazards and insufficient support of work practices need to be examined. Qualitative methods, such as clinical simulation, may be used to evaluate new technology in correlation with the clinical context and to study the interaction between users, technology and work practice. Compared with the “classic” methods, such as heuristic inspection and usability testing, clinical simulation takes the clinical context into account. Clinical simulation can be useful in many processes in the human-centred design cycle. In the requirement specification, clinical simulation can be useful to analyze user requirements and work practice as well to evaluate requirements. In the design of health IT, clinical simulation can be used to evaluate clinical information systems and serve as common ground to help to achieve a shared understanding between various communities of practice. In a public procurement process, a clinical simulation-based assessment can help give insight into different solutions and how they support work practice. Before organizational implementation, clinical simulation is a very suitable means, by which to assess an application in connection with work practice.

Internet access and online cancer information seeking among Latino immigrants from safety net clinics.

Science.gov (United States)

Selsky, Claire; Luta, George; Noone, Anne-Michelle; Huerta, Elmer E; Mandelblatt, Jeanne S

2013-01-01

Internet use is widespread, but little is known about Internet use for cancer information among Latinos, especially those who rely on safety net clinics. The authors investigated access to and intended use of the Internet for cancer information among low income, immigrant Latinos predominately from Central and South America. A cross-sectional study of 1,273 Latinos 21 years and older attending safety net clinics or health fairs was conducted from June 2007 to November 2008. The authors used logistic regression models to evaluate associations of age, acculturation, psychosocial factors and other covariates with Internet access and intended use of the Internet for cancer information among those with access. Of the sample, 44% reported Internet access. Higher information self-efficacy and greater trust in the Internet were independently associated with Internet access (p = .05 and p Internet use for cancer information, considering covariates. In addition, those with high (vs. low) perceived risk of cancer (OR = 1.76; 95% CI [1.14, 2.73]; p = .01) and higher levels of trust in online health information (OR = 1.47 per one-point increase; 95% [CI 1.19, 1.82]; p = .0004) were more likely to intend to seek cancer information online. These findings that Internet access is fairly high in the immigrant Latino population and that the Internet is a trusted source of cancer information suggest that the Internet may be a channel for cancer control interventions.

Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

Science.gov (United States)

Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

2017-01-28

Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be

Desonide: a review of formulations, efficacy and safety.

Science.gov (United States)

Kahanek, Nr; Gelbard, Cg; Hebert, Aa

2008-07-01

Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

Science.gov (United States)

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

Slope Safety Calculation With A Non-Linear Mohr Criterion Using Finite Element Method

DEFF Research Database (Denmark)

Clausen, Johan; Damkilde, Lars

2005-01-01

Safety factors for soil slopes are calculated using a non-linear Mohr envelope. The often used linear Mohr-Coulomb envelope tends to overestimate the safety as the material parameters are usually determined at much higher stress levels, than those present at slope failure. Experimental data...

Survey of Employees' Safety Attitude in a Teaching Hospital Tehran 2010

Directory of Open Access Journals (Sweden)

M. Mahmmoudi

2011-01-01

Full Text Available Background and aimsThe Medical Errors and the potential unsafe actions are always regarded as a serious trouble by the managers and health care providers. Using the employees' attitude data as a measurement criterion in the evaluation of the hospitals performance in the field of the “Safety” can improve the safety level among the personnel and patients . Survey of employees' attitude about safety and its comparison with different groups of offering health services in a teaching Hospital was the main objective of present study.   MethodsIn order to specify patient safety culture in Moddares hospital, all employees including physicians, nurses, managers and employees of Para-clinic, a volume sample consisting of 212 persons were selected. Then it was used from questionnaire of safety attitude within 6 dimensions including Teamwork climate, Safety climate, perceptions of Management , Job Satisfaction, Working Conditions and Stress Recognition. At first this questionnaire was gone under assessing validity and trust. The scale of measuring, Likert was 5 grades. In order to specify difference between groups under study it was used from ANOVA test.   Results Positive safety culture within 6 dimensions including Teamwork Climate, Safety climate, Job Satisfaction, Stress Recognition, Perception of Management , Working Conditions for doctors were 3, 4.13, 17.4, 0, 4.3, and 8.7 respectively; the aforesaid Dimensions for nurses were 19, 2.6, 10.3, 7.8, 2.6 and 15.5 respectively, the aforesaid Dimensions for managers were 30.3, 6.1, 33.3, 0, 18.2 and 21.2 respectively and the aforesaid Dimensions for employees of Para-clinic Were 50, 12.5, 25, 12.5, 10 and 37.5 respectively. There was Significant difference from View Point of statistics (p<0.5 from Dimensions of Job satisfaction among managers and nurses, employees of Para-clinic and nurses this difference Were zero and 0.001. From View Point of Stress recognition among managers and employees of Para-clinic

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

Science.gov (United States)

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

Safety measurement and monitoring in healthcare: a framework to guide clinical teams and healthcare organisations in maintaining safety

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Vincent, Charles; Burnett, Susan; Carthey, Jane

2014-01-01

Patients, clinicians and managers all want to be reassured that their healthcare organisation is safe. But there is no consensus about what we mean when we ask whether a healthcare organisation is safe or how this is achieved. In the UK, the measurement of harm, so important in the evolution of patient safety, has been neglected in favour of incident reporting. The use of softer intelligence for monitoring and anticipation of problems receives little mention in official policy. The Francis Inquiry report into patient treatment at the Mid Staffordshire NHS Foundation Trust set out 29 recommendations on measurement, more than on any other topic, and set the measurement of safety an absolute priority for healthcare organisations. The Berwick review found that most healthcare organisations at present have very little capacity to analyse, monitor or learn from safety and quality information. This paper summarises the findings of a more extensive report and proposes a framework which can guide clinical teams and healthcare organisations in the measurement and monitoring of safety and in reviewing progress against safety objectives. The framework has been used so far to promote self-reflection at both board and clinical team level, to stimulate an organisational check or analysis in the gaps of information and to promote discussion of ‘what could we do differently’. PMID:24764136

Prediction of Driving Safety in Individuals with Homonymous Hemianopia and Quadrantanopia from Clinical Neuroimaging

Directory of Open Access Journals (Sweden)

Michael S. Vaphiades

2014-01-01

Full Text Available Background. This study aimed to determine whether it is possible to predict driving safety of individuals with homonymous hemianopia or quadrantanopia based upon a clinical review of neuroimages that are routinely available in clinical practice. Methods. Two experienced neuroophthalmologists viewed a summary report of the CT/MRI scans of 16 participants with homonymous hemianopic or quadrantanopic field defects which indicated the site and extent of the lesion and they made predictions regarding whether participants would be safe/unsafe to drive. Driving safety was independently defined at the time of the study using state-recorded motor vehicle crashes (all crashes and at-fault for the previous 5 years and ratings of driving safety determined through a standardized on-road driving assessment by a certified driving rehabilitation specialist. Results. The ability to predict driving safety was highly variable regardless of the driving safety measure, ranging from 31% to 63% (kappa levels ranged from −0.29 to 0.04. The level of agreement between the neuroophthalmologists was only fair (kappa = 0.28. Conclusions. Clinical evaluation of summary reports of currently available neuroimages by neuroophthalmologists is not predictive of driving safety. Future research should be directed at identifying and/or developing alternative tests or strategies to better enable clinicians to make these predictions.

Prediction of driving safety in individuals with homonymous hemianopia and quadrantanopia from clinical neuroimaging.

Science.gov (United States)

Vaphiades, Michael S; Kline, Lanning B; McGwin, Gerald; Owsley, Cynthia; Shah, Ritu; Wood, Joanne M

2014-01-01

Background. This study aimed to determine whether it is possible to predict driving safety of individuals with homonymous hemianopia or quadrantanopia based upon a clinical review of neuroimages that are routinely available in clinical practice. Methods. Two experienced neuroophthalmologists viewed a summary report of the CT/MRI scans of 16 participants with homonymous hemianopic or quadrantanopic field defects which indicated the site and extent of the lesion and they made predictions regarding whether participants would be safe/unsafe to drive. Driving safety was independently defined at the time of the study using state-recorded motor vehicle crashes (all crashes and at-fault) for the previous 5 years and ratings of driving safety determined through a standardized on-road driving assessment by a certified driving rehabilitation specialist. Results. The ability to predict driving safety was highly variable regardless of the driving safety measure, ranging from 31% to 63% (kappa levels ranged from -0.29 to 0.04). The level of agreement between the neuroophthalmologists was only fair (kappa = 0.28). Conclusions. Clinical evaluation of summary reports of currently available neuroimages by neuroophthalmologists is not predictive of driving safety. Future research should be directed at identifying and/or developing alternative tests or strategies to better enable clinicians to make these predictions.

Understanding the digital divide in the clinical setting: the technology knowledge gap experienced by US safety net patients during teleretinal screening.

Science.gov (United States)

George, Sheba; Moran, Erin; Fish, Allison; Ogunyemi, Lola

2013-01-01

Differential access to everyday technology and healthcare amongst safety net patients is associated with low technological and health literacies, respectively. These low rates of literacy produce a complex patient "knowledge gap" that influences the effectiveness of telehealth technologies. To understand this "knowledge gap", six focus groups (2 African-American and 4 Latino) were conducted with patients who received teleretinal screenings in U.S. urban safety-net settings. Findings indicate that patients' "knowledge gap" is primarily produced at three points: (1) when patients' preexisting personal barriers to care became exacerbated in the clinical setting; (2) through encounters with technology during screening; and (3) in doctor-patient follow-up. This "knowledge gap" can produce confusion and fear, potentially affecting patients' confidence in quality of care and limiting their disease management ability. In rethinking the digital divide to include the consequences of this knowledge gap faced by patients in the clinical setting, we suggest that patient education focus on both their disease and specific telehealth technologies deployed in care delivery.

Evaluating the Clinical Learning Environment: Resident and Fellow Perceptions of Patient Safety Culture.

Science.gov (United States)

Bump, Gregory M; Calabria, Jaclyn; Gosman, Gabriella; Eckart, Catherine; Metro, David G; Jasti, Harish; McCausland, Julie B; Itri, Jason N; Patel, Rita M; Buchert, Andrew

2015-03-01

The Accreditation Council for Graduate Medical Education has begun to evaluate teaching institutions' learning environments with Clinical Learning Environment Review visits, including trainee involvement in institutions' patient safety and quality improvement efforts. We sought to address the dearth of metrics that assess trainee patient safety perceptions of the clinical environment. Using the Hospital Survey on Patient Safety Culture (HSOPSC), we measured resident and fellow perceptions of patient safety culture in 50 graduate medical education programs at 10 hospitals within an integrated health system. As institution-specific physician scores were not available, resident and fellow scores on the HSOPSC were compared with national data from 29 162 practicing providers at 543 hospitals. Of the 1337 residents and fellows surveyed, 955 (71.4%) responded. Compared with national practicing providers, trainees had lower perceptions of patient safety culture in 6 of 12 domains, including teamwork within units, organizational learning, management support for patient safety, overall perceptions of patient safety, feedback and communication about error, and communication openness. Higher perceptions were observed for manager/supervisor actions promoting patient safety and for staffing. Perceptions equaled national norms in 4 domains. Perceptions of patient safety culture did not improve with advancing postgraduate year. Trainees in a large integrated health system have variable perceptions of patient safety culture, as compared with national norms for some practicing providers. Administration of the HSOPSC was feasible and acceptable to trainees, and may be used to track perceptions over time.

Safety and usefulness of outreach clinic conducted by pediatric echosonographers

International Nuclear Information System (INIS)

Al Harbi, Badr; Al Akhfash, Ali A.; Al Ghamdi, Abdullah; Al-Mesned, Abdulrahman

2012-01-01

Outreach echocardiographic services led by cardiac sonographers may help district level hospitals in the management of patients suspected to have cardiac anomalies. However, the safety and utility of such an approach is not tested. We retrospectively reviewed our experience of patients seen in the outreach visits by the echocardiographers alone and subsequently reviewed in the pediatric cardiology clinic. Comparison between the diagnosis made by the echocardiographer and the consultant pediatric cardiologist were done. We defined safety as no change in patient management plan between the outreach evaluation and the pediatric cardiology clinic evaluation, and we defined usefulness as being beneficial, serviceable and of practical use. Two senior echocardiographic technicians did 41 clinic visits and over a period of 17 months, 623 patients were seen. Patients less than 3 months of age constitute 63% of the total patients seen. Normal echocardiographic examinations were found in 342 (55%) of patients. These patients were not seen in our cardiology clinic. Abnormal echocardiographic examinations were found in 281 (45%) of patients. Among the 281 patients with abnormal echos in the outreach visits, 251 patients (89.3%) were seen in the pediatric cardiology clinic. Comparing the results of the outreach clinic evaluation to that of the pediatric cardiology clinic, 73 patients (29%) diagnosed to have a minor CHD turned to have normal echocardiographic examinations. In all patients seen in both the outreach clinics and the pediatric tertiary cardiac clinics there was no change in patient's management plan. Outreach clinic conducted by pediatric echo sonographers could be useful and safe. It may help in reducing unnecessary visits to pediatric cardiology clinics, provide parental reassurance, and help in narrowing the differential diagnosis in critically ill patient unable to be transferred to tertiary cardiac centers provided it is done by experienced echosonographers

Modeling Staphylococcus epidermidis-Induced Non-Unions: Subclinical and Clinical Evidence in Rats.

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Arianna Barbara Lovati

Full Text Available S. epidermidis is one of the leading causes of orthopaedic infections associated with biofilm formation on implant devices. Open fractures are at risk of S. epidermidis transcutaneous contamination leading to higher non-union development compared to closed fractures. Although the role of infection in delaying fracture healing is well recognized, no in vivo models investigated the impact of subclinical low-grade infections on bone repair and non-union. We hypothesized that the non-union rate is directly related to the load of this commonly retrieved pathogen and that a low-grade contamination delays the fracture healing without clinically detectable infection. Rat femurs were osteotomized and stabilized with plates. Fractures were infected with a characterized clinical-derived methicillin-resistant S. epidermidis (10(3, 10(5, 10(8 colony forming units and compared to uninfected controls. After 56 days, bone healing and osteomyelitis were clinically assessed and further evaluated by micro-CT, microbiological and histological analyses. The biofilm formation was visualized by scanning electron microscopy. The control group showed no signs of infection and a complete bone healing. The 10(3 group displayed variable response to infection with a 67% of altered bone healing and positive bacterial cultures, despite no clinical signs of infection present. The 10(5 and 10(8 groups showed severe signs of osteomyelitis and a non-union rate of 83-100%, respectively. The cortical bone reaction related to the periosteal elevation in the control group and the metal scattering detected by micro-CT represented limitations of this study. Our model showed that an intra-operative low-grade S. epidermidis contamination might prevent the bone healing, even in the absence of infectious signs. Our findings also pointed out a dose-dependent effect between the S. epidermidis inoculum and non-union rate. This pilot study identifies a relevant preclinical model to assess the

Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

Science.gov (United States)

Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

2016-08-01

Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

Fixed-point theorems for families of weakly non-expansive maps

Science.gov (United States)

Mai, Jie-Hua; Liu, Xin-He

2007-10-01

In this paper, we present some fixed-point theorems for families of weakly non-expansive maps under some relatively weaker and more general conditions. Our results generalize and improve several results due to Jungck [G. Jungck, Fixed points via a generalized local commutativity, Int. J. Math. Math. Sci. 25 (8) (2001) 497-507], Jachymski [J. Jachymski, A generalization of the theorem by Rhoades and Watson for contractive type mappings, Math. Japon. 38 (6) (1993) 1095-1102], Guo [C. Guo, An extension of fixed point theorem of Krasnoselski, Chinese J. Math. (P.O.C.) 21 (1) (1993) 13-20], Rhoades [B.E. Rhoades, A comparison of various definitions of contractive mappings, Trans. Amer. Math. Soc. 226 (1977) 257-290], and others.

Death Anxiety in Clinical and Non-Clinical Groups

Science.gov (United States)

Abdel-Khalek, Ahmed M.

2005-01-01

The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N=765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The…

A feasibility study on the extended cycle from the point of view of Non-LOCA safety analysis

International Nuclear Information System (INIS)

Lee, Chul Sin; Kim, Hee Chul; Kim, Jeong Jin; Baek, Seung Su; Lee, Byung Il; Jeon, Tae Hyun; Lee, Jeong Chan

1996-06-01

Extended cycle operation has many advantages as compared with standard cycle operation (12 months) from the viewpoint of operators' exposure to radiation dose, man-power for maintenance and the production of nuclear waste. And it is more economic than the standard cycle operation. If the extended cycle operation is adopted in the CE type nuclear plant, the effective management and enhancement of operation capability could be expected. A feasibility study on the extended cycle operation should be performed. The purpose of this technical report is to perform safety analysis using the design data for Yonggwang Nuclear Plant (YGN) 3 and 4 extended cycle operation and to evaluate qualitatively and quantitatively the safety related design basis events to verify the satisfaction of the safety criteria. Boron dilution and steam line break accidents were found to be most influenced by the change of physics data due to the adaptation of the extended cycle operation. For boron dilution accident, source range monitor ratio of 3.07 for YGN 3 cycle 2 was decreased to 2.92. The 3D reactivity feedback effect due to the local heatup in the vicinity of stuck CEA was credited in the analysis of steam line break. No return-to-power occurred for the steam line break with offsite power available and return-to-power occurred for the steam line break with loss of offsite power. For the steam line break with loss of offsite power, the safety margin was preserved with respect to fuel performance (DNB and LHGR) despite the return-to-power. 6 tabs., 10 figs., 5 refs. (Author) .new

Guidelines for preparing criticality safety evaluations at Department of Energy non-reactor nuclear facilities

International Nuclear Information System (INIS)

1993-11-01

This document contains guidelines that should be followed when preparing Criticality Safety Evaluations that will be used to demonstrate the safety of operations performed at DOE non-reactor nuclear facilities. Adherence to these guidelines will provide consistency and uniformity in criticality safety evaluations (CSEs) across the complex and will document compliance with the requirements of DOE Order 5480.24

77 FR 22564 - Proposed Collection; Comment Request; Safety Standards for Full-Size Baby Cribs and Non-Full-Size...

Science.gov (United States)

2012-04-16

... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0019] Proposed Collection; Comment Request; Safety Standards for Full- Size Baby Cribs and Non-Full-Size Baby Cribs; Compliance Form AGENCY... safety standards for full-size and non-full-size baby cribs in response to the direction under section...

Evaluation of features to support safety and quality in general practice clinical software

Science.gov (United States)

2011-01-01

Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

A novel safety assessment strategy applied to non-selective extracts.

Science.gov (United States)

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Quality of care and safety indicators in anticoagulated patients with non-valvular auricular fibrillation and deep venous thromboembolic disease].

Science.gov (United States)

Ignacio, E; Mira, J J; Campos, F J; López de Sá, E; Lorenzo, A; Caballero, F

2018-03-19

To identify and prioritise indicators to assess the quality of care and safety of patients with non-valvular auricular fibrillation (NVAF) and deep vein thrombosis (DVT) treated with anticoagulants. Using the consensus conference technique, a group of professionals and clinical experts, the determining factors of the NVAF and DVT care process were identified, in order to define the quality and safety criteria. A proposal was made for indicators of quality and safety that were prioritised, taking into account a series of pre-established attributes. The selected indicators were classified into indicators of context, safety, action, and outcomes of the intervention in the patient. A set of 114 health care and safety quality indicators were identified, of which 35 were prioritised: 15 for NVAF and 20 for DVT. About half (49%) of the indicators (40% for NVAF and 55% for DVT) applied to patient safety, and 26% (33% for NVAF and 20% for DVT) to the outcomes of interventions in the patient. The present work presents a set of agreed indicators by a group of expert professionals that can contribute to the improvement of the quality of care of patients with NVAF and DVT treated with anticoagulants. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Basic researches on thermo-hydraulic non-equilibrium phenomena related to nuclear reactor safety

International Nuclear Information System (INIS)

Sakurai, Akira; Kataoka, Isao; Aritomi, Masanori.

1989-01-01

A review was made of recent developments of fundamental researches on thermo-hydraulic non-equilibrium phenomena related to light water reactor safety, in relation to problems to be solved for the improvement of safety analysis codes. As for the problems related to flow con ditions, fundamental researches on basic conservation equations and constitutive equations for transient two-phase flow were reviewed. Regarding to the problems related to thermal non-equilibrium phenomena, fundamental researches on film boiling in pool and forced convection, transient boiling heat transfer and flow behavior caused by pressure transients were reviewed. (author)

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

Science.gov (United States)

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical

Learning health 'safety' within non-technical skills interprofessional simulation education: a qualitative study.

Science.gov (United States)

Gordon, Morris; Fell, Christopher W R; Box, Helen; Farrell, Michael; Stewart, Alison

2017-01-01

Healthcare increasingly recognises and focusses on the phenomena of 'safe practice' and 'patient safety.' Success with non-technical skills (NTS) training in other industries has led to widespread transposition to healthcare education, with communication and teamwork skills central to NTS frameworks. This study set out to identify how the context of interprofessional simulation learning influences NTS acquisition and development of 'safety' amongst learners. Participants receiving a non-technical skills (NTS) safety focussed training package were invited to take part in a focus group interview which set out to explore communication, teamwork, and the phenomenon of safety in the context of the learning experiences they had within the training programme. The analysis was aligned with a constructivist paradigm and took an interactive methodological approach. The analysis proceeded through three stages, consisting of open, axial, and selective coding, with constant comparisons taking place throughout each phase. Each stage provided categories that could be used to explore the themes of the data. Additionally, to ensure thematic saturation, transcripts of observed simulated learning encounters were then analysed. Six themes were established at the axial coding level, i.e., analytical skills, personal behaviours, communication, teamwork, context, and pedagogy. Underlying these themes, two principal concepts emerged, namely: intergroup contact anxiety - as both a result of and determinant of communication - and teamwork, both of which must be considered in relation to context. These concepts have subsequently been used to propose a framework for NTS learning. This study highlights the role of intergroup contact anxiety and teamwork as factors in NTS behaviour and its dissipation through interprofessional simulation learning. Therefore, this should be a key consideration in NTS education. Future research is needed to consider the role of the affective non

Fire safety in dental clinics: Basics for dentists and dental students

Directory of Open Access Journals (Sweden)

Kalyana Chakravarthy Pentapati

2015-01-01

Full Text Available Fire safety is essential component and requirement in health care sector. It includes components like emergency exits, manual call outs, different types of fire extinguishers, safe assembly area, fire hydrant system with water sprinkler systems etc. We attempt to provide some basics about fire and fire safety that are prerequisite for safe working environment in dental clinics along with some recommendations that can be incorporated in the curriculum.

Variations in hospital worker perceptions of safety culture.

Science.gov (United States)

Listyowardojo, Tita Alissa; Nap, Raoul E; Johnson, Addie

2012-02-01

To compare the attitudes toward and perceptions of institutional practices that can influence patient safety between all professional groups at a university medical center. A questionnaire measuring nine dimensions of organizational and safety culture was distributed to all hospital workers. Each item was rated on a 1 ('strongly disagree') to 5 ('strongly agree') scale. Professionals (2995), grouped as 'physicians' (16.6%), 'nurses' (40.3%), 'clinical workers' (e.g. psychologists; 21.7%), 'laboratory workers' (e.g. technicians; 11%) and 'non-medical workers' (e.g. managers; 10.4%). One-way analysis of variances (ANOVAs) carried out separately on each dimension with professional group as the independent variable of interest. Differences in ratings of organizational and safety culture were found across professional groups. Physicians and non-medical workers tended to rate the dimensions of organizational and safety culture more positively than did nurses, clinical workers and laboratory workers. For example, physicians gave more positive ratings of 'institutional commitment to safety' than did nurses, clinical workers and laboratory workers (mean = 3.71 vs. 3.62, 3.61 and 3.58, respectively, P vs. 3.39, 3.36, 3.49 and 3.47, respectively, P culture should be tailored to the target group as attitudes and perceptions may differ among groups.

Evaluation of the Agricultural Non-point Source Pollution in Chongqing Based on PSR Model

Institute of Scientific and Technical Information of China (English)

Hanwen; ZHANG; Xinli; MOU; Hui; XIE; Hong; LU; Xingyun; YAN

2014-01-01

Through a series of exploration based on PSR framework model,for the purpose of building a suitable Chongqing agricultural nonpoint source pollution evaluation index system model framework,combined with the presence of Chongqing specific agro-environmental issues,we build a agricultural non-point source pollution assessment index system,and then study the agricultural system pressure,agro-environmental status and human response in total 3 major categories,develope an agricultural non-point source pollution evaluation index consisting of 3 criteria indicators and 19 indicators. As can be seen from the analysis,pressures and responses tend to increase and decrease linearly,state and complex have large fluctuations,and their fluctuations are similar mainly due to the elimination of pressures and impact,increasing the impact for agricultural non-point source pollution.

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study.

Science.gov (United States)

Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M

2016-08-19

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the study.

Simulated settings; powerful arenas for learning patient safety practices and facilitating transference to clinical practice. A mixed method study.

Science.gov (United States)

Reime, Marit Hegg; Johnsgaard, Tone; Kvam, Fred Ivan; Aarflot, Morten; Breivik, Marit; Engeberg, Janecke Merethe; Brattebø, Guttorm

2016-11-01

Poor teamwork is an important factor in the occurrence of critical incidents because of a lack of non-technical skills. Team training can be a key to prevent these incidents. The purpose of this study was to explore the experience of nursing and medical students after a simulation-based interprofessional team training (SBITT) course and its impact on professional and patient safety practices, using a concurrent mixed-method design. The participants (n = 262) were organized into 44 interprofessional teams. The results showed that two training sequences the same day improved overall team performance. Making mistakes during SBITT appeared to improve the quality of patient care once the students returned to clinical practice as it made the students more vigilant. Furthermore, the video-assisted oral debriefing provided an opportunity to strengthen interprofessional teamwork and share situational awareness. SBITT gave the students an opportunity to practice clinical reasoning skills and to share professional knowledge. The students conveyed the importance of learning to speak up to ensure safe patient practices. Simulated settings seem to be powerful arenas for learning patient safety practices and facilitating transference of this awareness to clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

Tackling non-point source water pollution in British Columbia: An action plan

Energy Technology Data Exchange (ETDEWEB)

1998-01-01

Efforts to protect British Columbia water quality by regulating point discharges from municipal and industrial sources have generally been successful, and it is recognized that the major remaining cause of water pollution in the province is from non-point sources. These sources are largely unregulated and associated with urbanization, agriculture, and other forms of land development. The first part of this report reviews the provincial commitment to clean water, the effects of non-point-source (NPS) pollution, and the management of NPS in the province. Part 2 describes the main causes of NPS in British Columbia: Land development, agriculture, stormwater runoff, on-site sewage systems, forestry and range activities, atmospheric deposition, and boating/marine activities. Finally, it presents key components of the province's NPS action plan: Education and training, prevention at site, land use planning and co-ordination, assessment and reporting, economic incentives, legislation and regulation, and implementation.

Non-English speakers attend gastroenterology clinic appointments at higher rates than English speakers in a vulnerable patient population

Science.gov (United States)

Sewell, Justin L.; Kushel, Margot B.; Inadomi, John M.; Yee, Hal F.

2009-01-01

Goals We sought to identify factors associated with gastroenterology clinic attendance in an urban safety net healthcare system. Background Missed clinic appointments reduce the efficiency and availability of healthcare, but subspecialty clinic attendance among patients with established healthcare access has not been studied. Study We performed an observational study using secondary data from administrative sources to study patients referred to, and scheduled for an appointment in, the adult gastroenterology clinic serving the safety net healthcare system of San Francisco, California. Our dependent variable was whether subjects attended or missed a scheduled appointment. Analysis included multivariable logistic regression and classification tree analysis. 1,833 patients were referred and scheduled for an appointment between 05/2005 and 08/2006. Prisoners were excluded. All patients had a primary care provider. Results 683 patients (37.3%) missed their appointment; 1,150 (62.7%) attended. Language was highly associated with attendance in the logistic regression; non-English speakers were less likely than English speakers to miss an appointment (adjusted odds ratio 0.42 [0.28,0.63] for Spanish, 0.56 [0.38,0.82] for Asian language, p gastroenterology clinic appointment, not speaking English was most strongly associated with higher attendance rates. Patient related factors associated with not speaking English likely influence subspecialty clinic attendance rates, and these factors may differ from those affecting general healthcare access. PMID:19169147

Study on personnel qualification for non-destructive tests in the field of reactor safety

International Nuclear Information System (INIS)

Trusch, K.; Wuestenberg, H.

1977-01-01

The training system for non-destructive testing is described, and the available and necessary personnel is analyzed; the personnel required for reactor safety problems is treated separately. On this basis, the subjects discussed in the study - available personnel, personnel requirements, training, training requirements, and suggestions for realisation - are treated in a general manner to begin with and afterwards with a view to specific problems of reactor safety. The methods employed are adapted to this situation. To obtain the necessary empirical data, questionnaires were set up and distributed, and experts in selected business companies and institutions were interviewed who work in the field of reactor safety or do same training in non-destructive testing. (orig.) [de

[Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

Science.gov (United States)

Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

2015-11-01

For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

Defining safety culture and the nexus between safety goals and safety culture. 1. An Investigation Study on Practical Points of Safety Management

International Nuclear Information System (INIS)

Hasegawa, Naoko; Takano, Kenichi; Hirose, Ayako

2001-01-01

In a report after the Chernobyl accident, the International Atomic Energy Agency indicated the definition and the importance of safety culture and the ideal organizational state where safety culture pervades. However, the report did not mention practical approaches to enhance safety culture. In Japan, although there had been investigations that clarified the consciousness of employees and the organizational climate in the nuclear power and railway industries, organizational factors that clarified the level of organization safety and practical methods that spread safety culture in an organization had not been studied. The Central Research Institute of the Electric Power Industry conducted surveys of organizational culture for the construction, chemical, and manufacturing industries. The aim of our study was to clarify the organizational factors that influence safety in an organization expressed in employee safety consciousness, commitment to safety activities, rate of accidents, etc. If these areas were clarified, the level of organization safety might be evaluated, and practical ways could be suggested to enhance the safety culture. Consequently, a series of investigations was conducted to clarify relationships among organizational climate, employee consciousness, safety management and activities, and rate of accidents. The questionnaire surveys were conducted in 1998-1999. The subjects were (a) managers of the safety management sections in the head offices of the construction, chemical, and manufacturing industries; (b) responsible persons in factories of the chemical and manufacturing industries; and (c) general workers in factories of the chemical and manufacturing industries. The number of collected data was (a) managers in the head office: 48 from the construction industry and 58 from the chemical and manufacturing industries, (b) responsible persons in factories: 567, and (c) general workers: from 29 factories. Items in the questionnaires were selected from

75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...

Meta-analysis of pemetrexed plus carboplatin doublet safety profile in first-line non-squamous non-small cell lung cancer studies.

Science.gov (United States)

Okamoto, Isamu; Schuette, Wolfgang H W; Stinchcombe, Thomas E; Rodrigues-Pereira, José; San Antonio, Belén; Chen, Jian; Liu, Jingyi; John, William J; Zinner, Ralph G

2017-05-01

This meta-analysis compared safety profiles (selected drug-related treatment-emergent adverse events [TEAEs]) of first-line pemetrexed plus carboplatin (PCb) area under the concentration-time curve 5 mg/min•mL (PCb5) or 6 mg/min•mL (PCb6), two widely used regimens in clinical practice for advanced non-squamous non-small cell lung cancer. All patients received pemetrexed 500 mg/m 2 every 21 days with either of two carboplatin doses for up to 4-6 cycles. Safety profiles of PCb doses were compared using three statistical analysis methods: frequency table analysis (FTA), generalized linear mixed effect model (GLMM), and the propensity score method. Efficacy outcomes of PCb5 and PCb6 regimens were summarized. A total of 486 patients mainly from the US, Europe, and East Asia were included in the analysis; 22% (n = 105) received PCb5 in one trial and 78% (n = 381) received PCb6 in four trials. The FTA comparison demonstrated that PCb5 vs PCb6 was associated with a statistically significantly lower incidence of TEAEs, including all-grade thrombocytopenia, anemia, fatigue, and vomiting, and grade 3/4 thrombocytopenia. In the GLMM analysis, PCb5 patients were numerically less likely to experience all-grade and grade 3/4 neutropenia, anemia, and thrombocytopenia. The propensity score regression analysis showed PCb5 group patients were significantly less likely than PCb6 group patients to experience all-grade hematologic TEAEs and grade 3/4 thrombocytopenia and anemia. After applying propensity score 1:1 matching, FTA analysis showed that the PCb5 group had significantly less all-grade and grade 3/4 hematologic toxicities. Overall efficacy outcomes, including overall survival, progression-free survival, and response rate, were similar between the two carboplatin doses. Acknowledging the limitations of this meta-analysis of five trials, heterogeneous in patient's characteristics and trial designs, the results show that the PCb5 regimen was generally associated

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

Science.gov (United States)

da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

2016-10-01

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

76 FR 21637 - Safety Zone; Ford Estate Wedding Fireworks, Lake St. Clair, Grosse Pointe Shores, MI

Science.gov (United States)

2011-04-18

...-AA00 Safety Zone; Ford Estate Wedding Fireworks, Lake St. Clair, Grosse Pointe Shores, MI AGENCY: Coast... portion of Lake St. Clair River during the Ford Estate Wedding Fireworks. DATES: This rule is effective... vessels during the setup, loading, and launching of the Ford Estate Wedding Fireworks Display. The...

Randomised clinical trial of five ear acupuncture points for the treatment of overweight people.

Science.gov (United States)

Yeo, Sujung; Kim, Kang Sik; Lim, Sabina

2014-04-01

To evaluate the efficacy of the five ear acupuncture points (Shen-men, Spleen, Stomach, Hunger, Endocrine), generally used in Korean clinics for treating obesity, and compare them with the Hunger acupuncture point. A randomised controlled clinical trial was conducted in 91 Koreans (16 male and 75 female, body mass index (BMI)≥23), who had not received any other weight control treatment within the past 6 months. Subjects were divided randomly into treatment I, treatment II or sham control groups and received unilateral auricular acupuncture with indwelling needles replaced weekly for 8 weeks. Treatment I group received acupuncture at the five ear acupuncture points, treatment II group at the Hunger acupuncture point only and the sham control group received acupuncture at the five ear acupuncture points used in treatment I, but the needles were removed immediately after insertion. BMI, waist circumference, weight, body fat mass (BFM), percentage body fat and blood pressure were measured at baseline and at 4 and 8 weeks after treatment. For the 58 participants who provided data at 8 weeks, significant differences in BMI, weight and BFM were found between the treatment and control groups. Treatment groups I and II showed 6.1% and 5.7% reduction in BMI, respectively (pfive ear acupuncture points, generally used in Korean clinics, and the Hunger point alone treatment are both effective for treating overweight people.

A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

Science.gov (United States)

Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

2015-01-01

The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.

Investigating antibiotic resistance in non-clinical environments

Directory of Open Access Journals (Sweden)

Fiona eWalsh

2013-02-01

Full Text Available There have been many calls for more information about the natural resistome and these have also highlighted the importance of understanding the soil resistome in the preservation of antibiotics for the treatment of infections. However, to date there have been few studies which have investigated the culturable soil resistome, which highlights the difficulties faced by microbiologists in designing these experiments to produce meaningful data. The World Health Organization definition of resistance is the most fitting to non-clinical environmental studies: Antimicrobial resistance is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. The ideal investigation of non-clinical environments for antibiotic resistance of clinical relevance would be using standardized guidelines and breakpoints. This review outlines different definitions and methodologies used to understand antibiotic resistance and suggests how this can be performed outside of the clinical environment.

Assessment of patient safety culture in clinical laboratories in the Spanish National Health System.

Science.gov (United States)

Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat

2015-01-01

There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.

[Exploratory study of road safety in Brazzaville and Pointe-Noire in Republic of the Congo].

Science.gov (United States)

Batala Mpondo, Georges; Bouanga, Marianne; Saya, Yvette Marie Clarisse; Maurice, Pierre; Burigusa, Guillaume

2014-01-01

Although road accidents in the Congo are reaching alarming levels (2,720 accidents in 2010 and 3,126 accidents in 2011), especially with the massive arrival of "Jakarta" mopeds, no evaluation has been conducted to identify and understand the factors responsible for this problem. This article reports the results of an exploratory study conducted in Brazzaville and Pointe-Noire based on information collected from existing documents and by semidirective questionnaire of people from various sectors able to elucidate the problem of road safety. Using William Haddon's matrix, the parameters investigated were : road user behaviour ; environmental and technological factors ; characteristics of road accident victims ; quality of care ; intervention times and organization of prevention. This study demonstrated the absence of a road safety policy in Congo. It also showed that the main factors responsible for road accidents are behavioural (failure to wear safety belts, failure to comply with road signs, fatigue, use of a telephone while driving, etc.), followed by environmental and technological factors (insufficient traffic lights, absence of sidewalks, disorganized occupation of roads, general state of vehicles). This study shows that, in order to improve road safety in the Congo, it is essential to promote the development of national road safety policies and an action plan, intervention on the determinants of road accidents, and a change of road user behaviours (compulsory use of safety belts, ban on the use of a telephone and smoking while driving, etc.). Effective organization of the management of road accident victims and allocation of a budget to implement a road safety policy are also necessary.

[Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

Science.gov (United States)

Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

2014-04-01

The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

Mochovce NPP safety measures evaluation from point of view of operational safety enhancement

International Nuclear Information System (INIS)

Cillik, I.; Vrtik, L.

2000-01-01

Mochovce NPP consists of four reactor units of WWER 440/V213 type and it is located in the south-middle part of Slovakia. At present first unit operated and the second one under the construction finishing. As these units represent second generation of WWER reactor design, the additional safety measures (SM) were implemented to enhance operational and nuclear safety according to the recommendations of performed international audits and operational experience based on exploitation of other similar units (as Dukovany and J. Bohunice NPPs). These requirements result into a number of SMs grouped according to their purpose to reach recent international requirements on nuclear and operational safety. The paper presents the bases used for safety measures establishing including their grouping into the comprehensive tasks covering different areas of safety goals as well as structural organization of a project management of including participating companies and work performance. More, results are given regarding contribution of selected SMs to the total core damage frequency decreasing. (author)

77 FR 43811 - Submission for OMB Review; Comment Request-Safety Standards for Full-Size Baby Cribs and Non-Full...

Science.gov (United States)

2012-07-26

... CONSUMER PRODUCT SAFETY COMMISSION Submission for OMB Review; Comment Request--Safety Standards for Full-Size Baby Cribs and Non-Full-Size Baby Cribs; Compliance Form AGENCY: Consumer Product Safety... standards for full-size and non-full-size baby cribs in response to the direction under section 104(b) of...

Clinical efficacy and safety of edaravone therapy in acute cerebral ...

African Journals Online (AJOL)

Purpose: To evaluate the clinical efficacy and safety of edaravone in the treatment of acute cerebral haemorrhage (ACH). Methods: This study recruited 120 patients who developed ACH. The patients were divided into control and treatment groups with 60 patients per group. The control group underwent conventional ...

Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.

Science.gov (United States)

Rosales, R; Abou Jaoude, E; Al-Arouj, M; Fawwad, A; Orabi, A; Shah, P; DiTommaso, S; Vaz, J; Latif, Z A

2015-06-01

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24 weeks of treatment with vildagliptin with or without metformin. Of 19 331 patients analysed, 3511 received vildagliptin and 15 820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice. © 2015 John Wiley & Sons Ltd.

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

Science.gov (United States)

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-05-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

HYDROLOGY AND SEDIMENT MODELING USING THE BASINS NON-POINT SOURCE MODEL

Science.gov (United States)

The Non-Point Source Model (Hydrologic Simulation Program-Fortran, or HSPF) within the EPA Office of Water's BASINS watershed modeling system was used to simulate streamflow and total suspended solids within Contentnea Creek, North Carolina, which is a tributary of the Neuse Rive...

78 FR 60290 - Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of...

Science.gov (United States)

2013-10-01

..., 2013, on the following topics: (1) What factors should be considered in masking study data (e.g., data...] Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of Comment Period... of Masked and De- identified Non-Summary Safety and Efficacy Data; Request for Comments,'' which...

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

Science.gov (United States)

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Guidelines for preparing criticality safety evaluations at Department of Energy non-reactor nuclear facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-09-01

This Department of Energy (DOE) is approved for use by all components of DOE. It contains guidelines that should be followed when preparing Criticality Safety Evaluations that will be used to demonstrate the safety of operations performed at DOE Non-Reactor Nuclear Facilities. Adherence with these guidelines will provide consistency and uniformity in Criticality Safety Evaluations (CSEs) across the complex and will document compliance with DOE Order 5480.24 requirements as they pertain to CSEs.

Guidelines for preparing criticality safety evaluations at Department of Energy non-reactor nuclear facilities

International Nuclear Information System (INIS)

1998-09-01

This Department of Energy (DOE) is approved for use by all components of DOE. It contains guidelines that should be followed when preparing Criticality Safety Evaluations that will be used to demonstrate the safety of operations performed at DOE Non-Reactor Nuclear Facilities. Adherence with these guidelines will provide consistency and uniformity in Criticality Safety Evaluations (CSEs) across the complex and will document compliance with DOE Order 5480.24 requirements as they pertain to CSEs

Reduction Assessment of Agricultural Non-Point Source Pollutant Loading

OpenAIRE

Fu, YiCheng; Zang, Wenbin; Zhang, Jian; Wang, Hongtao; Zhang, Chunling; Shi, Wanli

2018-01-01

NPS (Non-point source) pollution has become a key impact element to watershed environment at present. With the development of technology, application of models to control NPS pollution has become a very common practice for resource management and Pollutant reduction control in the watershed scale of China. The SWAT (Soil and Water Assessment Tool) model is a semi-conceptual model, which was put forward to estimate pollutant production & the influences on water quantity-quality under different...

Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory.

Science.gov (United States)

Miner, Michael H; Raymond, Nancy; Coleman, Eli; Swinburne Romine, Rebecca

2017-05-01

One of the major obstacles to conducting epidemiologic research and determining the incidence and prevalence of compulsive sexual behavior (CSB) has been the lack of relevant empirically derived cut points on the various instruments that have been used to measure the concept. To further develop the Compulsive Sexual Behavior Inventory (CSBI) through exploring predictive validity and developing an empirically determined and clinically useful cut point for defining CSB. A sample of 242 men who have sex with men was recruited from various sites in a moderate-size Midwestern city. Participants were assigned to a CSB group or a control group using an interview for the diagnosis that was patterned after the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition. The 22-item CSBI was administered as part of a larger battery of self-report inventories. Receiver operating characteristic analyses were used to compute area-under-the-curve measurements to ascertain the predictive validity of the total scale, the control subscale, and the violence subscale. Cut points were determined through consensus of experts balancing sensitivity and specificity as determined by receiver operating characteristic curves. Analyses indicated that the 22-item CSBI was a good predictor of group membership, as was the 13-item control subscale. The violence subscale added little to the predictive accuracy of the instrument; thus, it likely measures something other than CSB. Two relevant cut points were found, one that minimized false negatives and another, more conservative cut point that minimized false positives. The CSBI as currently configured measures two different constructions and only the control subscale is helpful in diagnosing CSB. Therefore, we decided to eliminate the violence subscale and move forward with a 13-item scale that we have named the CSBI-13. Two cut points were developed from this revised scale, one that is useful as a

Renormalization group fixed points of foliated gravity-matter systems

Energy Technology Data Exchange (ETDEWEB)

Biemans, Jorn [Institute for Mathematics, Astrophysics and Particle Physics (IMAPP),Radboud University Nijmegen,Heyendaalseweg 135, 6525 AJ Nijmegen (Netherlands); Platania, Alessia [Institute for Mathematics, Astrophysics and Particle Physics (IMAPP),Radboud University Nijmegen,Heyendaalseweg 135, 6525 AJ Nijmegen (Netherlands); Department of Physics and Astronomy, University of Catania,Via S. Sofia 63, 95123 Catania (Italy); INFN, Catania section,Via S. Sofia 64, 95123, Catania (Italy); INAF, Catania Astrophysical Observatory,Via S. Sofia 78, 95123, Catania (Italy); Saueressig, Frank [Institute for Mathematics, Astrophysics and Particle Physics (IMAPP),Radboud University Nijmegen,Heyendaalseweg 135, 6525 AJ Nijmegen (Netherlands)

2017-05-17

We employ the Arnowitt-Deser-Misner formalism to study the renormalization group flow of gravity minimally coupled to an arbitrary number of scalar, vector, and Dirac fields. The decomposition of the gravitational degrees of freedom into a lapse function, shift vector, and spatial metric equips spacetime with a preferred (Euclidean) “time”-direction. In this work, we provide a detailed derivation of the renormalization group flow of Newton’s constant and the cosmological constant on a flat Friedmann-Robertson-Walker background. Adding matter fields, it is shown that their contribution to the flow is the same as in the covariant formulation and can be captured by two parameters d{sub g}, d{sub λ}. We classify the resulting fixed point structure as a function of these parameters finding that the existence of non-Gaussian renormalization group fixed points is rather generic. In particular the matter content of the standard model and its most common extensions gives rise to one non-Gaussian fixed point with real critical exponents suitable for Asymptotic Safety. Moreover, we find non-Gaussian fixed points for any number of scalar matter fields, making the scenario attractive for cosmological model building.

Quality management and perceptions of teamwork and safety climate in European hospitals.

Science.gov (United States)

Kristensen, Solvejg; Hammer, Antje; Bartels, Paul; Suñol, Rosa; Groene, Oliver; Thompson, Caroline A; Arah, Onyebuchi A; Kutaj-Wasikowska, Halina; Michel, Philippe; Wagner, Cordula

2015-12-01

This study aimed to investigate the associations of quality management systems with teamwork and safety climate, and to describe and compare differences in perceptions of teamwork climate and safety climate among clinical leaders and frontline clinicians. We used a multi-method, cross-sectional approach to collect survey data of quality management systems and perceived teamwork and safety climate. Our data analyses included descriptive and multilevel regression methods. Data on implementation of quality management system from seven European countries were evaluated including patient safety culture surveys from 3622 clinical leaders and 4903 frontline clinicians. Perceived teamwork and safety climate. Teamwork climate was reported as positive by 67% of clinical leaders and 43% of frontline clinicians. Safety climate was perceived as positive by 54% of clinical leaders and 32% of frontline clinicians. We found positive associations between implementation of quality management systems and teamwork and safety climate. Our findings, which should be placed in a broader clinical quality improvement context, point to the importance of quality management systems as a supportive structural feature for promoting teamwork and safety climate. To gain a deeper understanding of this association, further qualitative and quantitative studies using longitudinally collected data are recommended. The study also confirms that more clinical leaders than frontline clinicians have a positive perception of teamwork and safety climate. Such differences should be accounted for in daily clinical practice and when tailoring initiatives to improve teamwork and safety climate. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Assessing and improving the safety culture of non-power nuclear installations

International Nuclear Information System (INIS)

Bastin, S.J.; Cameron, R.F.; McDonald, N.R.; Adams, A.; Williamson, A.

2000-01-01

The development and application of safety culture principles has understandably focused on nuclear power plant and fuel cycle facilities and has been based on studies in Europe, North America, Japan and Korea. However, most radiation injuries and deaths have resulted from the mishandling of radioactive sources, inadvertent over-exposure to X-rays and critically incidents, unrelated to nuclear power plant. Within the Forum on Nuclear Cooperation in Asia (FNCA), Australia has been promoting initiatives to apply safety culture principles across all nuclear and radiation application activities and in a manner that is culturally appropriate for Asian countries. ANSTO initiated a Safety Culture Project in 1996 to develop methods for assessing and improving safety culture at nuclear and radiation installations other than power reactors and to trial these at ANSTO and in the Asian region. The project has sensibly drawn on experience from the nuclear power industry, particularly in Japan and Korea. There has been a positive response in the participating countries to addressing safety culture issues in non-power nuclear facilities. This paper reports on the main achievements of the project. Further goals of the project are also identified. (author)

Non-reporting of work injuries and aspects of jobsite safety climate and behavioral-based safety elements among carpenters in Washington State.

Science.gov (United States)

Lipscomb, Hester J; Schoenfisch, Ashley L; Cameron, Wilfrid

2015-04-01

Declining work injury rates may reflect safer work conditions as well as under-reporting. Union carpenters were invited to participate in a mailed, cross-sectional survey designed to capture information about injury reporting practices. Prevalence of non-reporting and fear of repercussions for reporting were compared across exposure to behavioral-based safety elements and three domains of the Nordic Safety Climate Questionnaire (NOSACQ-50). The majority (>75%) of the 1,155 participants felt they could report work-related injuries to their supervisor without fear of retribution, and most felt that the majority of injuries on their jobsites got reported. However, nearly half indicated it was best not to report minor injuries, and felt pressures to use their private insurance for work injury care. The prevalence of non-reporting and fear of reporting increased markedly with poorer measures of management safety justice (NOSACQ-50). Formal and informal policies and practices on jobsites likely influence injury reporting. © 2015 Wiley Periodicals, Inc.

TH-C-18C-01: MRI Safety

Energy Technology Data Exchange (ETDEWEB)

Pooley, R [Mayo Clinic, Jacksonville, FL (United States); Bernstein, M; Shu, Y; Gorny, K; Felmlee, J [Mayo Clinic, Rochester, MN (United States); Panda, A [Mayo Clinic, Arizona, Scottsdale, AZ (United States)

2014-06-15

Clinical diagnostic medical physicists may be responsible for implementing and maintaining a comprehensive MR safety program. Accrediting bodies including the ACR, IAC, Radsite and The Joint Commission each include aspects of MR Safety into their imaging accreditation programs; MIPPA regulations further raise the significance of non-compliance. In addition, The Joint Commission recently announced New and Revised Diagnostic Imaging Standards for accredited health care organizations which include aspects of MR Safety. Hospitals and clinics look to the physicist to understand guidelines, regulations and accreditation requirements related to MR safety. The clinical medical physicist plays a significant role in a clinical practice by understanding the physical basis for the risks and acting as a facilitator to successfully implement a safety program that provides well-planned siting, allows for the safe scanning of certain implanted devices, and helps radiologists manage specific patient exams. The MRI scanning of specific devices will be discussed including cardiac pacemakers and neurostimulators such as deep brain stimulators. Furthermore for sites involved in MR guided interventional procedures, the MR physicist plays an essential role to establish safe practices. Creating a framework for a safe MRI practice includes the review of actual safety incidents or close calls to determine methods for prevention in the future. Learning Objectives: Understand the requirements and recommendations related to MR safety from accrediting bodies and federal regulations. Understand the Medical Physicist's roles to ensure MR Safety. Identify best practices for dealing with implanted devices, including pacemakers and deep brain stimulators. Review aspects of MR safety involved in an MR guided interventional environment. Understand the important MR safety aspects in actual safety incidents or near misses.

Nuclear medicine software: safety aspects

International Nuclear Information System (INIS)

Anon.

1989-01-01

A brief editorial discusses the safety aspects of nuclear medicine software. Topics covered include some specific features which should be incorporated into a well-written piece of software, some specific points regarding software testing and legal liability if inappropriate medical treatment was initiated as a result of information derived from a piece of clinical apparatus incorporating a malfunctioning computer program. (U.K.)

Integrated plant-safety assessment, Systematic Evaluation Program: Big Rock Point Plant (Docket No. 50-155)

International Nuclear Information System (INIS)

1983-09-01

The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

SAFETY: an integrated clinical reasoning and reflection framework for undergraduate nursing students.

Science.gov (United States)

Hicks Russell, Bedelia; Geist, Melissa J; House Maffett, Jenny

2013-01-01

Nurse educators can no longer focus on imparting to students knowledge that is merely factual and content specific. Activities that provide students with opportunities to apply concepts in real-world scenarios can be powerful tools. Nurse educators should take advantage of student-patient interactions to model clinical reasoning and allow students to practice complex decision making throughout the entire curriculum. In response to this change in nursing education, faculty in a pediatric course designed a reflective clinical reasoning activity based on the SAFETY template, which is derived from the National Council of State Boards of Nursing RN practice analysis. Students were able to prioritize key components of nursing care, as well as integrate practice issues such as delegation, Health Insurance Portability and Accountability Act violations, and questioning the accuracy of orders. SAFETY is proposed as a framework for integration of content knowledge, clinical reasoning, and reflection on authentic professional nursing concerns. Copyright 2012, SLACK Incorporated.

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

Science.gov (United States)

Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

2015-12-30

Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

Science.gov (United States)

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

Proceedings of the Seminar on Environmental and Radiation Safety Aspect at Non-nuclear Industry

International Nuclear Information System (INIS)

Mulyadi Rachmad; Muhammad Fathoni; Topo Suprihadi, PY.; Dumais, Johannes Robert; Eri Hiswara; Alatas, Zubaidah; Dahlan, Kgs.; Muhammad Isnaini

2003-03-01

The Seminar on Environmental and Radiation Safety Aspect at Non-nuclear Industry held on March 2003 in Jakarta. The purpose of this Seminar be able to information exchange among research workers in National Nuclear Energy Agency. The Seminar discussed about Science and Technology of Radiation Safety and Environment. There are 17 papers which have separated index. (PPIN)

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

Directory of Open Access Journals (Sweden)

Hengwei Jin

2017-09-01

Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

Double blind clinical trail comparing the safety and efficacy of ...

African Journals Online (AJOL)

Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews

Directory of Open Access Journals (Sweden)

Laura E. Chess

2016-02-01

Full Text Available Abstract Background Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. Methods The most recent 100 systematic reviews from the top five journals in medicine—JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine—and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. Results A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81 % of Cochrane reviews and 90 % of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1 % of non-Cochrane reviews and 8 % of Cochrane reviews explored the clinical

Neurologic Functional and Quality of Life Outcomes after TBI: Clinic Attendees versus Non-Attendees.

Science.gov (United States)

Patel, Mayur B; Wilson, Laura D; Bregman, Jana A; Leath, Taylor C; Humble, Stephen S; Davidson, Mario A; de Riesthal, Michael R; Guillamondegui, Oscar D

2015-07-01

This investigation describes the relationship between TBI patient demographics, quality of life outcome, and functional status outcome among clinic attendees and non-attendees. Of adult TBI survivors with intracranial hemorrhage, 63 attended our TBI clinic and 167 did not attend. All were telephone surveyed using the Extended-Glasgow Outcome Scale (GOSE), the Quality of Life after Brain Injury (QOLIBRI) scale, and a post-discharge therapy questionnaire. To determine risk factors for GOSE and QOLIBRI outcomes, we created multivariable regression models employing covariates of age, injury characteristics, clinic attendance, insurance status, post-discharge rehabilitation, and time from injury. Compared with those with severe TBI, higher GOSE scores were identified in individuals with both mild (odds ratio [OR]=2.0; 95% confidence interval [CI]: 1.1-3.6) and moderate (OR=4.7; 95% CI: 1.6-14.1) TBIs. In addition, survivors with private insurance had higher GOSE scores, compared with those with public insurance (OR=2.0; 95% CI: 1.1-3.6), workers' compensation (OR=8.4; 95% CI: 2.6-26.9), and no insurance (OR=3.1; 95% CI: 1.6-6.2). Compared with those with severe TBI, QOLIBRI scores were 11.7 points (95% CI: 3.7-19.7) higher in survivors with mild TBI and 17.3 points (95% CI: 3.2-31.5) higher in survivors with moderate TBI. In addition, survivors who received post-discharge rehabilitation had higher QOLIBRI scores by 11.4 points (95% CI: 3.7-19.1) than those who did not. Survivors with private insurance had QOLIBRI scores that were 25.5 points higher (95% CI: 11.3-39.7) than those with workers' compensation and 16.8 points higher (95% CI: 7.4-26.2) than those without insurance. Because neurologic injury severity, insurance status, and receipt of rehabilitation or therapy are independent risk factors for functional and quality of life outcomes, future directions will include improving earlier access to post-TBI rehabilitation, social work services, affordable insurance

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

Science.gov (United States)

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of

Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation.

Science.gov (United States)

Goebel, Carsten; Aeby, Pierre; Ade, Nadège; Alépée, Nathalie; Aptula, Aynur; Araki, Daisuke; Dufour, Eric; Gilmour, Nicola; Hibatallah, Jalila; Keller, Detlef; Kern, Petra; Kirst, Annette; Marrec-Fairley, Monique; Maxwell, Gavin; Rowland, Joanna; Safford, Bob; Schellauf, Florian; Schepky, Andreas; Seaman, Chris; Teichert, Thomas; Tessier, Nicolas; Teissier, Silvia; Weltzien, Hans Ulrich; Winkler, Petra; Scheel, Julia

2012-06-01

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. Copyright © 2012 Elsevier Inc. All rights reserved.

Demerit points systems.

NARCIS (Netherlands)

2006-01-01

In 2012, 21 of the 27 EU Member States had some form of demerit points system. In theory, demerit points systems contribute to road safety through three mechanisms: 1) prevention of unsafe behaviour through the risk of receiving penalty points, 2) selection and suspension of the most frequent

Regulatory Oversight of Safety Culture in Finland: A Systemic Approach to Safety

International Nuclear Information System (INIS)

Oedewald, P.; Väisäsvaara, J.

2016-01-01

In Finland the Radiation and Nuclear Safety Authority STUK specifies detailed regulatory requirements for good safety culture. Both the requirements and the practical safety culture oversight activities reflect a systemic approach to safety: the interconnections between the technical, human and organizational factors receive special attention. The conference paper aims to show how the oversight of safety culture can be integrated into everyday oversight activities. The paper also emphasises that the scope of the safety culture oversight is not specific safety culture activities of the licencees, but rather the overall functioning of the licence holder or the new build project organization from safety point of view. The regulatory approach towards human and organizational factors and safety culture has evolved throughout the years of nuclear energy production in Finland. Especially the recent new build projects have highlighted the need to systematically pay attention to the non-technical aspects of safety as it has become obvious how the HOF issues can affect the design processes and quality of construction work. Current regulatory guides include a set of safety culture related requirements. The requirements are binding to the licence holders and they set both generic and specific demands on the licencee to understand, monitor and to develop safety culture of their own organization but also that of their supplier network. The requirements set for the licence holders has facilitated the need to develop the regulator’s safety culture oversight practices towards a proactive and systemic approach.

Nuclear criticality safety handbook. Version 2

International Nuclear Information System (INIS)

1999-03-01

The Nuclear Criticality Safety Handbook, Version 2 essentially includes the description of the Supplement Report to the Nuclear Criticality Safety Handbook, released in 1995, into the first version of Nuclear Criticality Safety Handbook, published in 1988. The following two points are new: (1) exemplifying safety margins related to modelled dissolution and extraction processes, (2) describing evaluation methods and alarm system for criticality accidents. Revision is made based on previous studies for the chapter that treats modelling the fuel system: e.g., the fuel grain size that the system can be regarded as homogeneous, non-uniformity effect of fuel solution, and burnup credit. This revision solves the inconsistencies found in the first version between the evaluation of errors found in JACS code system and criticality condition data that were calculated based on the evaluation. (author)

Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

Directory of Open Access Journals (Sweden)

Mpimbaza Arthur

2008-06-01

Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

A Survey of the Non-clinical Benefits of EBVM

Directory of Open Access Journals (Sweden)

Sarah Hauser

2017-08-01

Full Text Available Objective: This study aims to add non-clinical benefits to the virtues for adopting Evidence-based Veterinary Medicine (EBVM. The objective is to quantify the commercial benefits of EBVM through an online survey of veterinary professionals, giving clear indications of the key areas of non-clinical benefits of EBVM. Further, the study aims to outline barriers to the wider implementation of EBVM and find preferred ways of overcoming those barriers.Background: A PICO-based literature review (Hauser and Jackson, 2016 found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted. This study builds on the findings of an exploratory study (Jackson and Hauser, 2017 outlining key areas of non-clinical benefits of EBVM: increased client satisfaction and retention, improved reputation, confidence, as well as employee engagement.Evidentiary value: This online survey of veterinary professionals (n=407 provides evidence for practitioners, universities and other veterinary staff regarding the non-clinical benefits of EBVM, the barriers to a wider adoption of the practice and ways of overcoming those barriers.Methods: The online survey of veterinary professionals was conducted during September – October 2016 and contained 23 questions. Survey participation was voluntary and the data used for analysis were de-identified.Results: The survey responses of 407 veterinary professionals provide quantitative evidence of how EBVM is put into practice, how EBVM is perceived to impact client behaviour and employee engagement, what the barriers are to practising EBVM and how these could be overcome. Key findings are that veterinary professionals are more likely to practise EBVM if they have been taught how to do so at vet school. EBVM is a way to provide value to and build trust with clients. Survey

Pharmacists' Perception of the Sale of Non-Clinically Proven Health ...

African Journals Online (AJOL)

Pharmacists' Perception of the Sale of Non-Clinically Proven Health Supplements in Penang, Malaysia. ... A total of 10.7 % respondents indicated that the sale of non-clinically proven products result in high profit. Only 25.0 % of the pharmacists ... Keywords: Perception, Health promotion, Urban poor, Health supplements.

Efficacy, safety and tolerability of rasagiline as adjunctive therapy in elderly patients with Parkinson's disease.

Science.gov (United States)

Tolosa, E; Stern, M B

2012-02-01

Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. Rasagiline decreased daily OFF time versus placebo (Prasagiline but were not significant. Between-group comparisons (≥70 vs. efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

Non-abelian gauge invariant classical Lagrangian formalism for point electric and magnetic charge

International Nuclear Information System (INIS)

Brandt, R.A.; Neri, F.

1978-01-01

The classical electrodynamics of electrically charged point particles has been generalized to include non-Abelian gauge groups and to include magnetically charged point particles. In this paper these two distinct generalizations are unified into a non-Abelian gauge theory of electric and magnetic charge. Just as the electrically charged particles constitute the generalized source of the gauge fields, the magnetically charged particles constitute the generalized source of the dual fields. The resultant equations of motion are invariant to the original 'electric' non-Abelian gauge group, but, because of the absence of a corresponding 'magnetic' gauge group, there is no 'duality' symmetry between electric and magnetic quantities. However, for a class of solutions to these equations, which includes all known point electric and magnetic monopole constructions, there is shown to exist an equivalent description based on a magnetic, rather than electric, gauge group. The gauge potentials in general are singular on strings extending from the particle position to infinity, but it is shown that the observables are without string singularities, and that the theory is Lorentz invariant, provided a charge quantization condition is satisfied. This condition, deduced from a stability analysis, is necessary for the consistency of the classical non-Abelian theory, in contrast to the Abelian case, where such a condition is necessary only for the consistency of the quantum theory. It is also shown that in the classical theory the strings cannot be removed by gauge transformations, as they sometimes can be in the quantum theory. (Auth.)

Evaluation of the dose uniformity for double-plane high dose rate interstitial breast implants with the use of dose reference points and dose non-uniformity ratio

International Nuclear Information System (INIS)

MAjor, T.; Polgar, C.; Somogyi, A.; Nemeth, G.

2000-01-01

also the high dose volume. The optimization on dose points and geometry provides the most uniform dose distribution. The dose non-uniformity ratio can be minimized by selecting the isodose line of the midpoints between the catheters in the whole volume for the dose prescription, but the dose coverage may not be adequate. For a clinically acceptable plan, a compromise should be made between dose non-uniformity and coverage. (author)

Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies.

Science.gov (United States)

Prior, Helen; Bottomley, Anna; Champéroux, Pascal; Cordes, Jason; Delpy, Eric; Dybdal, Noel; Edmunds, Nick; Engwall, Mike; Foley, Mike; Hoffmann, Michael; Kaiser, Robert; Meecham, Ken; Milano, Stéphane; Milne, Aileen; Nelson, Rick; Roche, Brian; Valentin, Jean-Pierre; Ward, Gemma; Chapman, Kathryn

2016-01-01

The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing. Thirty-nine sites, either running studies (Sponsors or Contract Research Organisations, CROs) and/or outsourcing work responded to the survey (51% from Europe; 41% from USA). During safety pharmacology studies, 84, 67 and 100% of respondents socially house dogs, minipigs and non-human primates (NHPs) respectively on non-recording days. However, on recording days 20, 20 and 33% of respondents socially house the animals, respectively. The main barriers for social housing were limitations in the recording equipment used, study design and animal temperament/activity. During toxicology studies, 94, 100 and 100% of respondents socially house dogs, minipigs and NHPs respectively on non-recording days. However, on recording days 31, 25 and 50% of respondents socially house the animals, respectively. The main barriers for social housing were risk of damage to and limitations in the recording equipment used, food consumption recording and temperament/activity of the animals. Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best practice and data from companies already socially housing, combined with technology improvements and investments in infrastructure are required to maintain the forward momentum of this refinement across the industry. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Real-time non-rigid target tracking for ultrasound-guided clinical interventions

Science.gov (United States)

Zachiu, C.; Ries, M.; Ramaekers, P.; Guey, J.-L.; Moonen, C. T. W.; de Senneville, B. Denis

2017-10-01

Biological motion is a problem for non- or mini-invasive interventions when conducted in mobile/deformable organs due to the targeted pathology moving/deforming with the organ. This may lead to high miss rates and/or incomplete treatment of the pathology. Therefore, real-time tracking of the target anatomy during the intervention would be beneficial for such applications. Since the aforementioned interventions are often conducted under B-mode ultrasound (US) guidance, target tracking can be achieved via image registration, by comparing the acquired US images to a separate image established as positional reference. However, such US images are intrinsically altered by speckle noise, introducing incoherent gray-level intensity variations. This may prove problematic for existing intensity-based registration methods. In the current study we address US-based target tracking by employing the recently proposed EVolution registration algorithm. The method is, by construction, robust to transient gray-level intensities. Instead of directly matching image intensities, EVolution aligns similar contrast patterns in the images. Moreover, the displacement is computed by evaluating a matching criterion for image sub-regions rather than on a point-by-point basis, which typically provides more robust motion estimates. However, unlike similar previously published approaches, which assume rigid displacements in the image sub-regions, the EVolution algorithm integrates the matching criterion in a global functional, allowing the estimation of an elastic dense deformation. The approach was validated for soft tissue tracking under free-breathing conditions on the abdomen of seven healthy volunteers. Contact echography was performed on all volunteers, while three of the volunteers also underwent standoff echography. Each of the two modalities is predominantly specific to a particular type of non- or mini-invasive clinical intervention. The method demonstrated on average an accuracy of�

Have the Findings from Clinical Risk Prediction and Trials Any Key Messages for Safety Pharmacology?

Directory of Open Access Journals (Sweden)

Jem D. Lane

2017-11-01

Full Text Available Anti-arrhythmic drugs are a mainstay in the management of symptoms related to arrhythmias, and are adjuncts in prevention and treatment of life-threatening ventricular arrhythmias. However, they also have the potential for pro-arrhythmia and thus the prediction of arrhythmia predisposition and drug response are critical issues. Clinical trials are the latter stages in the safety testing and efficacy process prior to market release, and as such serve as a critical safeguard. In this review, we look at some of the lessons to be learned from approaches to arrhythmia prediction in patients, clinical trials of drugs used in the treatment of arrhythmias, and the implications for the design of pre-clinical safety pharmacology testing.

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice

OpenAIRE

Hajjaj, FM; Salek, MS; Basra, MKA; Finlay, AY

2010-01-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional co...

Relevance of MICA and other non-HLA antibodies in clinical transplantation.

Science.gov (United States)

Sumitran-Holgersson, Suchitra

2008-10-01

The clinical importance of HLA-specific antibodies for organ allograft outcome is well established. In the past few years, there has been an increasing interest in non-HLA antigens as targets of injury in organ transplant recipients. This increased interest has been spurred by the fact that HLA-identical kidney transplants also undergo immunological rejections. Polymorphisms within non-HLA genes associated with evoking an immune response to alloantigens are currently being studied for their association with transplant outcome. Non-HLA antigens, such as the polymorphic MHC class I-related chain A (MICA), expressed on endothelial cells have been implicated in the pathogenesis of hyperacute, acute and chronic organ allograft rejections. Use of endothelial cells as targets may clarify the specificities of other clinically relevant non-HLA antibodies in graft rejections. This review summarizes past and current knowledge of the clinical importance and specificities of non-HLA antibodies, and mechanisms by which these antibodies may contribute to graft destruction in clinical transplantation. The aims of current research into the role of non-HLA antigens and their genetics in predicting outcome are to develop an improved insight into the basic science of transplantation and to develop a risk or prognostic index for use in the clinical setting. Non-HLA antibody responses are receiving increasing interest in acute and chronic rejection and specificity, affinity, and pathogenicity need to be investigated to estimate their contribution. Undoubtedly, this will continue to be an area of interest in terms of fully understanding the role of non-HLA antigens as targets of immune-mediated injury and the potential for clinical intervention.

The selection of probabilistic safety assessment techniques for non-reactor nuclear facilities

International Nuclear Information System (INIS)

Vail, J.

1992-01-01

Historically, the probabilistic safety assessment (PSA) methodology of choice is the well known event tree/fault tree inductive technique. For reactor facilities is has stood the test of time. Some non-reactor nuclear facilities have found inductive methodologies difficult to apply. The stand-alone fault tree deductive technique has been used effectively to analyze risk in nuclear chemical processing facilities and waste handling facilities. The selection between the two choices suggest benefits from use of the deductive method for non-reactor facilities

Clinical Trial of a Home Safety Toolkit for Alzheimer’s Disease

Directory of Open Access Journals (Sweden)

Kathy J. Horvath

2013-01-01

Full Text Available This randomized clinical trial tested a new self-directed educational intervention to improve caregiver competence to create a safer home environment for persons with dementia living in the community. The sample included 108 patient/caregiver dyads: the intervention group (n=60 received the Home Safety Toolkit (HST, including a new booklet based on health literacy principles, and sample safety items to enhance self-efficacy to make home safety modifications. The control group (n=48 received customary care. Participants completed measures at baseline and at twelve-week follow-up. Multivariate Analysis of Covariance (MANCOVA was used to test for significant group differences. All caregiver outcome variables improved in the intervention group more than in the control. Home safety was significant at P≤0.001, caregiver strain at P≤0.001, and caregiver self-efficacy at P=0.002. Similarly, the care receiver outcome of risky behaviors and accidents was lower in the intervention group (P≤0.001. The self-directed use of this Home Safety Toolkit activated the primary family caregiver to make the home safer for the person with dementia of Alzheimer's type (DAT or related disorder. Improving the competence of informal caregivers is especially important for patients with DAT in light of all stakeholders reliance on their unpaid care.

Perceptions of clinical safety climate of the multicultural nursing workforce in Saudi Arabia: a cross-sectional survey.

Science.gov (United States)

Almutairi, Adel F; Gardner, Glenn; McCarthy, Alexandra

2013-01-01

The purpose of this study is to explore the safety climate perceptions of the multicultural nursing workforce, and to investigate the influence of diversity of the multicultural nursing workforce on clinical safety in a large tertiary hospital in Saudi Arabia. Working in a multicultural environment is challenging. Each culture has its own unique characteristics and dimensions that shape the language, lifestyle, beliefs, values, customs, traditions, and patterns of behaviour, which expatriate nurses must come to terms with. However, cultural diversity in the health care environment can potentially affect the quality of care and patient safety. A mixed-method case study (survey, interview and document analysis) was employed. A primary study phase entailed the administration of the Safety Climate Survey (SCS). A population sampling strategy was used and 319 nurses participated, yielding a 76.8% response rate. Descriptive and inferential statistics (Kruskal-Wallis test) were used to analyse survey data. The data revealed the nurses' perceptions of the clinical safety climate in this multicultural environment was unsafe, with a mean score of 3.9 out of 5. No significant difference was found between the age groups, years of nursing experience and their perceptions of the safety climate in this context. A significant difference was observed between the national background categories of nurses and perceptions of safety climate. Cultural diversity within the nursing workforce could have a significant influence on perceptions of clinical safety. These findings have the potential to inform policy and practice related to cultural diversity in Saudi Arabia.

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

Directory of Open Access Journals (Sweden)

Huss M

2017-07-01

Full Text Available Michael Huss,1 Praveen Duhan,2 Preetam Gandhi,3 Chien-Wei Chen,4 Carsten Spannhuth,3 Vinod Kumar5 1Child and Adolescent Psychiatry, University Medicine, Mainz, Germany; 2Global Medical Affairs, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 3Development Franchise, Established Medicine Neuroscience, Novartis Pharma AG, Basel, Switzerland; 4Biostatistics Cardio-Metabolic & Established Medicine, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Established Medicines, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Abstract: Attention-deficit/hyperactivity disorder (ADHD is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH, a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. Keywords: methylphenidate, dose optimization, attention-deficit/hyperactivity disorder, ADHD

Thermodynamics of non-ionic surfactant Triton X-100-cationic surfactants mixtures at the cloud point

International Nuclear Information System (INIS)

Batigoec, Cigdem; Akbas, Halide; Boz, Mesut

2011-01-01

Highlights: → Non-ionic surfactants are used as emulsifier and solubilizate in such as textile, detergent and cosmetic. → Non-ionic surfactants occur phase separation at temperature as named the cloud point in solution. → Dimeric surfactants have attracted increasing attention due to their superior surface activity. → The positive values of ΔG cp 0 indicate that the process proceeds nonspontaneous. - Abstract: This study investigates the effects of gemini and conventional cationic surfactants on the cloud point (CP) of the non-ionic surfactant Triton X-100 (TX-100) in aqueous solutions. Instead of visual observation, a spectrophotometer was used for measurement of the cloud point temperatures. The thermodynamic parameters of these mixtures were calculated at different cationic surfactant concentrations. The gemini surfactants of the alkanediyl-α-ω-bis (alkyldimethylammonium) dibromide type, on the one hand, with different alkyl groups containing m carbon atoms and an ethanediyl spacer, referred to as 'm-2-m' (m = 10, 12, and 16) and, on the other hand, with -C 16 alkyl groups and different spacers containing s carbon atoms, referred to as '16-s-16' (s = 6 and 10) were synthesized, purified and characterized. Additions of the cationic surfactants to the TX-100 solution increased the cloud point temperature of the TX-100 solution. It was accepted that the solubility of non-ionic surfactant containing polyoxyethylene (POE) hydrophilic chain was a maximum at the cloud point so that the thermodynamic parameters were calculated at this temperature. The results showed that the standard Gibbs free energy (ΔG cp 0 ), the enthalpy (ΔH cp 0 ) and the entropy (ΔS cp 0 ) of the clouding phenomenon were found positive in all cases. The standard free energy (ΔG cp 0 ) increased with increasing hydrophobic alkyl chain for both gemini and conventional cationic surfactants; however, it decreased with increasing surfactant concentration.

More asymptotic safety guaranteed

Science.gov (United States)

Bond, Andrew D.; Litim, Daniel F.

2018-04-01

We study interacting fixed points and phase diagrams of simple and semisimple quantum field theories in four dimensions involving non-Abelian gauge fields, fermions and scalars in the Veneziano limit. Particular emphasis is put on new phenomena which arise due to the semisimple nature of the theory. Using matter field multiplicities as free parameters, we find a large variety of interacting conformal fixed points with stable vacua and crossovers inbetween. Highlights include semisimple gauge theories with exact asymptotic safety, theories with one or several interacting fixed points in the IR, theories where one of the gauge sectors is both UV free and IR free, and theories with weakly interacting fixed points in the UV and the IR limits. The phase diagrams for various simple and semisimple settings are also given. Further aspects such as perturbativity beyond the Veneziano limit, conformal windows, and implications for model building are discussed.

Non point source pollution modelling in the watershed managed by Integrated Conctructed Wetlands: A GIS approach.

OpenAIRE

Vyavahare, Nilesh

2008-01-01

The non-point source pollution has been recognised as main cause of eutrophication in Ireland (EPA Ireland, 2001). Integrated Constructed Wetland (ICW) is a management practice adopted in Annestown stream watershed, located in the south county of Waterford in Ireland, used to cleanse farmyard runoff. Present study forms the annual pollution budget for the Annestown stream watershed. The amount of pollution from non-point sources flowing into the stream was simulated by using GIS techniques; u...

A 3D printed smartphone optosensing platform for point-of-need food safety inspection.

Science.gov (United States)

Liu, Zhonggang; Zhang, Yali; Xu, Shujia; Zhang, Heng; Tan, Yixun; Ma, Chenming; Song, Rong; Jiang, Lelun; Yi, Changqing

2017-05-08

The deficiency in rapid and in-field detection methods and portable devices that are reliable, easy-to-use, and low cost, results in the difficulties to uphold the high safety standards in China. In this study, we introduce a rapid and cost-effective smartphone-based method for point-of-need food safety inspection, which employs aptamer-conjugated AuNPs as the colorimetric indicator, and a battery-powered optosensing accessory attached to the camera of a smartphone for transmission images capture. A user-friendly and easy-to-use Android application is developed for automatic digital image processing and result reporting. Streptomycin (STR) is selected as the proof-of-concept target, and its specific quantitation can be realized with a LOD of 12.3 nM (8.97 μg kg -1 ) using the reported smartphone-based method. The quantitation of STR in honey, milk and tap water confirm the reliability and applicability of the reported method. The extremely high acceptance of smartphone in remote and metropolitan areas of China and ease-of-use of the reported method facilitate active food contaminant and toxicant screening, thus making the implementation of the whole food supply chain monitoring and surveillance possible and hence significantly improving the current Chinese food safety control system. Copyright © 2017 Elsevier B.V. All rights reserved.

Using clinical supervision to improve the quality and safety of patient care: a response to Berwick and Francis.

Science.gov (United States)

Tomlinson, Jonathon

2015-06-11

After widely publicised investigations into excess patient deaths at Mid Staffordshire hospital the UK government commissioned reports from Robert Francis QC and Professor Don Berwick. Among their recommendations to improve the quality and safety of patient care were lifelong learning, professional support and 'just culture'. Clinical supervision is in an excellent position to support these activities but opportunities are in danger of being squeezed out by regulatory and managerial demands. Doctors who have completed their training are responsible for complex professional judgements for which narrative supervision is particularly helpful. With reference to the literature and my own practice I propose that all practicing clinicians should have regular clinical supervision. Clinical supervision has patient-safety and the quality of patient care as its primary purposes. After training is completed, doctors may practice for the rest of their career without any clinical supervision, the implication being that the difficulties dealt with in clinical supervision are no longer difficulties, or are better dealt with some other way. Clinical supervision is sufficiently flexible to be adapted to the needs of experienced clinicians as its forms can be varied, though its functions remain focused on patient safety, good quality clinical care and professional wellbeing. The evidence linking clinical supervision to the quality and safety of patient care reveals that supervision is most effective when its educational and supportive functions are separated from its managerial and evaluative functions. Among supervision's different forms, narrative-based-supervision is particularly useful as it has been developed for clinicians who have completed their training. It provides ways to explore the complexity of clinical judgements and encourages doctors to question one another's authority in a supportive culture. To be successful, supervision should also be professionally led and

Factors influencing non-attendance of clinic appointments in ...

African Journals Online (AJOL)

without an appointment, with an average of eight patients per day missing their appointment. The low rate of compliance with clinic appointments was of concern for the physicians at both the diabetes clinics. Prior to the current study, the reasons for non-attendance had not been examined. Materials and methods. A sample ...

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

Science.gov (United States)

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

Working and Non-Working University Students: Anxiety, Depression, and Grade Point Average

Science.gov (United States)

Mounsey, Rebecca; Vandehey, Michael A.; Diekhoff, George M.

2013-01-01

This study explored the differences between 110 working and non-working students in terms of mental health, academic achievement, and perceptions about student employment. Anxiety and depression were measured by the Beck Anxiety Inventory and the Beck Depression Inventory-II. Academic achievement was measured by grade point average. Perceptions of…

Slope Safety Factor Calculations With Non-Linear Yield Criterion Using Finite Elements

DEFF Research Database (Denmark)

Clausen, Johan; Damkilde, Lars

2006-01-01

The factor of safety for a slope is calculated with the finite element method using a non-linear yield criterion of the Hoek-Brown type. The parameters of the Hoek-Brown criterion are found from triaxial test data. Parameters of the linear Mohr-Coulomb criterion are calibrated to the same triaxial...... are carried out at much higher stress levels than present in a slope failure, this leads to the conclusion that the use of the non-linear criterion leads to a safer slope design...

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations

Science.gov (United States)

Kotrla Topić, Marina; Perković Kovačević, Marina; Mlačić, Boris

2012-01-01

Aim To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Methods Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N = 92) and non-clinical (high-school students, N = 87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Results Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior. PMID:23100207

Imitation learning of Non-Linear Point-to-Point Robot Motions using Dirichlet Processes

DEFF Research Database (Denmark)

Krüger, Volker; Tikhanoff, Vadim; Natale, Lorenzo

2012-01-01

In this paper we discuss the use of the infinite Gaussian mixture model and Dirichlet processes for learning robot movements from demonstrations. Starting point of this work is an earlier paper where the authors learn a non-linear dynamic robot movement model from a small number of observations....... The model in that work is learned using a classical finite Gaussian mixture model (FGMM) where the Gaussian mixtures are appropriately constrained. The problem with this approach is that one needs to make a good guess for how many mixtures the FGMM should use. In this work, we generalize this approach...... our algorithm on the same data that was used in [5], where the authors use motion capture devices to record the demonstrations. As further validation we test our approach on novel data acquired on our iCub in a different demonstration scenario in which the robot is physically driven by the human...

PSA analysis focused on Mochovce NPP safety measures evaluation from operational safety point of view

International Nuclear Information System (INIS)

Cillik, I.; Vrtik, L.

2001-01-01

Mochovce NPP consists of four reactor units of WWER 440/V213 type and it is located in the south-middle part of Slovakia. At present first unit operated and the second one under the construction finishing. As these units represent second generation of WWER reactor design, the additional safety measures (SM) were implemented to enhance operational and nuclear safety according to the recommendations of performed international audits and operational experience based on exploitation of other similar units (as Dukovany and J. Bohunice NPPs). These requirements result into a number of SMs grouped according to their purpose to reach recent international requirements on nuclear and operational safety. The paper presents the bases used for safety measures establishing including their grouping into the comprehensive tasks covering different areas of safety goals as well as structural organization of a project management of including participating companies and work performance. More, results are given regarding contribution of selected SMs to the total core damage frequency decreasing.(author)

Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice.

Science.gov (United States)

Calcagno, Fabien; Lenoble, Sabrina; Lakkis, Zaher; Nguyen, Thierry; Limat, Samuel; Borg, Christophe; Jary, Marine; Kim, Stefano; Nerich, Virginie

2016-01-01

Regorafenib is an orally administered multikinase inhibitor that has been approved for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Even though regorafenib significantly improved survival in two international phase 3 trials (CORRECT and CONCUR), a high rate of treatment-related toxic effects and dose modifications were observed with a modest benefit. The aim of this study was to provide information concerning the efficacy, safety, and cost of regorafenib in patients with mCRC in clinical practice. We retrospectively reviewed patients treated with regorafenib monotherapy for unresectable mCRC in five Franche-Comté cancer hospitals (France). The primary end point was overall survival. Secondary end points were safety and descriptive cost analyses of patients treated with regorafenib in clinical practice. Another aim of this study was to assess the impact of regorafenib prescription on the risk of hospitalization in real-life practice. From January 2014 to August 2014, 29 consecutive patients were enrolled. Patients were heavily pretreated and were refractory to standard chemotherapies. The primary tumor sites were the colon and the rectum for 55% and 45% of patients, respectively. Fifteen patients (51%) harbored an RAS mutation. Eastern Cooperative Oncology Group - Performance Status (PS) was 0-1 for 86% of patients and 2 for 14% of patients. Nineteen patients (66%) initially received reduced doses of 120 or 80 mg/day. The median duration of treatment was 2.5 months (range, 0.13-11.4 months). Treatment-related adverse events occurred in 86% of patients. The most frequent adverse events of any grade were fatigue (35%), diarrhea (20%), and hand-foot skin reaction (20%). Grade 3 or 4 treatment-related adverse events occurred in 10 patients (35%). Three patients (10%) were admitted to hospital due to drug-related severe adverse events. The mean cost of patient management with regorafenib for the duration of treatment was 9908 ± 8191�

Use of non-caloric edulcorants in children

OpenAIRE

Calzada León Raúl; Altamirano Bustamante Nelly

2014-01-01

We analyze the health normativity for the denomination of non caloric edulcorants in Mexico, and the authorization for the use of natural and synthetic non caloric edulcorants in newborn and until puberty. Special emphasis was given to the consecutive points of safety required in order to assure that they are free of secondary effects. For each non caloric edulcorant available in Mexico, we looked into the studies which mention their side effects in terms of growth and overall.

Evaluation of temporary non-code repairs in safety class 3 piping systems

International Nuclear Information System (INIS)

Godha, P.C.; Kupinski, M.; Azevedo, N.F.

1996-01-01

Temporary non-ASME Code repairs in safety class 3 pipe and piping components are permissible during plant operation in accordance with Nuclear Regulatory Commission Generic Letter 90-05. However, regulatory acceptance of such repairs requires the licensee to undertake several timely actions. Consistent with the requirements of GL 90-05, this paper presents an overview of the detailed evaluation and relief request process. The technical criteria encompasses both ductile and brittle piping materials. It also lists appropriate evaluation methods that a utility engineer can select to perform a structural integrity assessment for design basis loading conditions to support the use of temporary non-Code repair for degraded piping components. Most use of temporary non-code repairs at a nuclear generating station is in the service water system which is an essential safety related system providing the ultimate heat sink for various plant systems. Depending on the plant siting, the service water system may use fresh water or salt water as the cooling medium. Various degradation mechanisms including general corrosion, erosion/corrosion, pitting, microbiological corrosion, galvanic corrosion, under-deposit corrosion or a combination thereof continually challenge the pressure boundary structural integrity. A good source for description of corrosion degradation in cooling water systems is provided in a cited reference

Calculation and analysis of the non-point source pollution in the upstream watershed of the Panjiakou Reservoir, People's Republic of China

Science.gov (United States)

Zhang, S.; Tang, L.

2007-05-01

Panjiakou Reservoir is an important drinking water resource in Haihe River Basin, Hebei Province, People's Republic of China. The upstream watershed area is about 35,000 square kilometers. Recently, the water pollution in the reservoir is becoming more serious owing to the non-point pollution as well as point source pollution on the upstream watershed. To effectively manage the reservoir and watershed and develop a plan to reduce pollutant loads, the loading of non-point and point pollution and their distribution on the upstream watershed must be understood fully. The SWAT model is used to simulate the production and transportation of the non-point source pollutants in the upstream watershed of the Panjiakou Reservoir. The loadings of non-point source pollutants are calculated for different hydrologic years and the spatial and temporal characteristics of non-point source pollution are studied. The stream network and topographic characteristics of the stream network and sub-basins are all derived from the DEM by ArcGIS software. The soil and land use data are reclassified and the soil physical properties database file is created for the model. The SWAT model was calibrated with observed data of several hydrologic monitoring stations in the study area. The results of the calibration show that the model performs fairly well. Then the calibrated model was used to calculate the loadings of non-point source pollutants for a wet year, a normal year and a dry year respectively. The time and space distribution of flow, sediment and non-point source pollution were analyzed depending on the simulated results. The comparison of different hydrologic years on calculation results is dramatic. The loading of non-point source pollution in the wet year is relatively larger but smaller in the dry year since the non-point source pollutants are mainly transported through the runoff. The pollution loading within a year is mainly produced in the flood season. Because SWAT is a

Tipping Point

Science.gov (United States)

... Point by CPSC Blogger September 22, 2009 appliance child Childproofing CPSC danger death electrical fall furniture head injury product safety television tipover tv Watch the video in Adobe Flash ...

Safety and efficacy of first-line bevacizumab combination therapy in Chinese population with advanced non-squamous NSCLC: data of subgroup analyses from MO19390 (SAiL) study.

Science.gov (United States)

Zhou, C C; Bai, C X; Guan, Z Z; Jiang, G L; Shi, Y K; Wang, M Z; Wu, Y L; Zhang, Y P; Zhu, Y Z

2014-05-01

Bevacizumab is a monoclonal antibody with high antitumor activity against malignant diseases. Previous studies have demonstrated the efficacy of first-line bevacizumab combination therapy in advanced, non-squamous non-small cell lung cancer (NS-NSCLC). SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a subgroup analysis of Chinese patients enrolled in SAiL. Chemo-naive Chinese patients with locally advanced, metastatic or recurrent NSCLC were randomized to receive Bev 15 mg/kg every 3 weeks plus carboplatin + paclitaxel for maximum of six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety. Secondary endpoints included time to progression and overall survival. The Chinese intent-to-treat (ITT) population consists of 198 Chinese patients, among whom 107 (54 %) were non-smokers and 90 (45.5 %) were female. The median cycle of bevacizumab administration was 10 and median duration of bevacizumab treatment was 29.5 weeks. Only eight cases of severe adverse events were observed in the study, which were deemed to be related to bevacizumab. The incidence of AEs over grade 3 in Chinese ITT patients was generally low (SAiL study. No new safety signals were reported.

Safety and clinical efficacy of golimumab in the treatment of arthritides

Directory of Open Access Journals (Sweden)

Ismail Simsek

2010-09-01

Full Text Available Ismail Simsek, Yusuf YaziciNew York University School of Medicine, NYU Hospital for Joint Diseases, New York, USAAbstract: Golimumab is a human anti-tumor necrosis factor (TNF-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions.Keywords: arthritis, rheumatoid, psoriatic arthritis, ankylosing spondylitis

Developing non-technical ward-round skills.

Science.gov (United States)

Harvey, Rachel; Mellanby, Edward; Dearden, Effie; Medjoub, Karima; Edgar, Simon

2015-10-01

Conducting clinical 'rounds' is one of the most onerous and important duties that every junior doctor is expected to perform. There is evidence that newly qualified doctors are not adequately prepared by their undergraduate experiences for this task. The aim of this study was to analyse the challenges pertaining to non-technical skills that students would face during ward rounds, and to create a model that facilitates the transition from medical student to doctor. A total of 217 final-year medical students completed a simulated ward round. Free-text responses were analysed using template analysis applying an a priori template developed from the literature by the research team. This drew on the generic categories of non-technical skills suggested by Flin et al. Ninety-seven per cent of students agreed or strongly agreed that the simulated ward round improved their insight into the challenges of ward rounds and their perceived ability to work efficiently as an active member of the ward round. The responding students (206) submitted written feedback describing the learning that they planned to use: 800 learning points were recorded, and all could be categorised into one of seven non-technical skills. Conducting clinical 'rounds' is one of the most onerous and important duties that every junior doctor is expected to perform We believe that improved task efficiency and insight into the challenges of the ward round gained by medical students will lead to an enhancement in performance during clinical rounds, and will have a positive impact on patient safety. We would suggest that undergraduate medical schools consider this model in the preparation for the clinical practice element of the curriculum. © 2015 John Wiley & Sons Ltd.

Celiac disease in non-clinical populations of Japan.

Science.gov (United States)

Fukunaga, Mai; Ishimura, Norihisa; Fukuyama, Chika; Izumi, Daisuke; Ishikawa, Nahoko; Araki, Asuka; Oka, Akihiko; Mishiro, Tomoko; Ishihara, Shunji; Maruyama, Riruke; Adachi, Kyoichi; Kinoshita, Yoshikazu

2018-02-01

Celiac disease is a chronic autoimmune enteropathy caused by gluten ingestion. While its prevalence in Western countries is reported to be as high as 1%, the prevalence has not been evaluated in a large-scale study of a Japanese population. The aim of our study was to clarify the possible presence of celiac disease in a Japanese non-clinical population as well as in patients showing symptoms suggestive of the disease. Serum samples were collected from 2008 non-clinical adults and 47 patients with chronic unexplained abdominal symptoms between April 2014 and June 2016. The anti-tissue transglutaminase (TTG) immunoglobulin A antibody titer was determined as a screening test for celiac disease in all subjects, and individuals with a value of >2 U/mL subsequently underwent testing for the presence of serum endomysial IgA antibody (EMA) as confirmation. Those testing positive for EMA or with a high concentration (>10 U/mL) of TTG were further investigated by histopathological examinations of duodenal mucosal biopsy specimens and HLA typing tests. Of the 2008 non-clinical adults from whom serum samples were collected, 161 tested positive for TTG, and all tested negative for EMA. Four subjects who had a high TTG titer were invited to undergo confirmatory testing, and the histopathological results confirmed the presence of celiac disease in only a single case (0.05%). Of the 47 symptomatic patients, one (2.1%) was found to have a high TTG titer and was diagnosed with celiac disease based on duodenal histopathological findings. The presence of celiac disease in a non-clinical Japanese population was low at 0.05% and was rarely found in patients with unexplained chronic abdominal symptoms.

Clinical safety and efficacy of implantation of octacalcium phosphate collagen composites in tooth extraction sockets and cyst holes

Directory of Open Access Journals (Sweden)

Tadashi Kawai

2016-09-01

Full Text Available It was demonstrated that octacalcium phosphate collagen composite achieved notable bone regeneration in bone defects in preclinical studies. On the basis of the research results, an investigator-initiated exploratory clinical trial was conducted after approval from a local Institutional Review Board. This clinical study was performed as a single-arm non-randomized intervention study. Octacalcium phosphate collagen composite was implanted into a total of 10 cases of alveolar bone defects after tooth extractions and cystectomy. Safety assessment was performed in terms of the clinical course and several consecutive laboratory examinations, and sequential radiographs were used for efficacy assessment. All participants uneventfully completed the clinical trial without major problems in their general condition. Postoperative wound swelling was observed, as also commonly seen in tooth extraction or cystectomy. Although no serious liver dysfunction, renal dysfunction, electrolyte imbalance, or abnormal urinalysis results were recognized, the number of white blood cells and C-reactive protein level temporarily increased after the operation. An increase in radiopacity in the octacalcium phosphate collagen composite–implanted site was observed in all cases. Finally, the border between the original bone and the octacalcium phosphate collagen composite–implanted site became indistinguishable. These results suggest that octacalcium phosphate collagen composite could be utilized safely in clinical situations in the future.

Safety cost management in construction companies: A proposal classification.

Science.gov (United States)

López-Alonso, M; Ibarrondo-Dávila, M P; Rubio, M C

2016-06-16

Estimating health and safety costs in the construction industry presents various difficulties, including the complexity of cost allocation, the inadequacy of data available to managers and the absence of an accounting model designed specifically for safety cost management. Very often, the costs arising from accidents in the workplace are not fully identifiable due to the hidden costs involved. This paper reviews some studies of occupational health and safety cost management and proposes a means of classifying these costs. We conducted an empirical study in which the health and safety costs of 40 construction worksites are estimated. A new classification of the health and safety cost and its categories is proposed: Safety and non-safety costs. The costs of the company's health and safety policy should be included in the information provided by the accounting system, as a starting point for analysis and control. From this perspective, a classification of health and safety costs and its categories is put forward.

PSA methodology including new design, operational and safety factors, 'Level of recognition of phenomena with a presumed dominant influence upon operational safety' (failures of conventional as well as non-conventional passive components, dependent failures, influence of operator, fires and external threats, digital control, organizational factors)

International Nuclear Information System (INIS)

Jirsa, P.

2001-10-01

The document represents a specific type of discussion of existing methodologies for the creation and application of probabilistic safety assessment (PSA) in light of the EUR document summarizing requirements placed by Western European NPP operators on the future design of nuclear power plants. A partial goal of this discussion consists in mapping, from the PSA point of view, those selected design, operational and/or safety factors of future NPPs that may be entirely new or, at least, newly addressed. Therefore, the terms of reference for this stage were formulated as follows: Assess current level of knowledge and procedures in the analysis of factors and phenomena with a dominant influence upon operational safety of new generation reactors, especially in the following areas: (1) Phenomenology of failure types and mechanisms and reliability of conventional passive safety system components; (2) Phenomenology of failure types and mechanisms and reliability of non-conventional passive components of newly designed safety systems; (3) Phenomenology of types and mechanisms of dependent failures; (4) Human factor role in new generation reactors and its effect upon safety; (5) Fire safety and other external threats to new nuclear installations; (6) Reliability of the digital systems of the I and C system and their effect upon safety; and (7) Organizational factors in new nuclear installations. (P.A.)

Safety Work with an Ethnic Slant

Directory of Open Access Journals (Sweden)

David Wästerfors

2014-09-01

Full Text Available Ethnic discrimination in the criminal justice system is a well-researched topic, but the significance of ethnicity in policing activities at more mundane levels has attracted less attention. This article analyzes ethnographic data on municipal ‘safety work’ in a Swedish city troubled with robberies, vandalism, and violence. It shows how the efforts of different safety workers, operating to curb crime and promote security, came to focus on the ‘soft’ policing of young men with various immigrant backgrounds. A set of street-level safety practices, performed within spatial demarcations, was found to represent a more-or-less silent orientation towards local minorities; a focus on non-Swedish ethnicities was embedded in the policing activity. This article points out the importance of implied ethnicities in the contemporary landscape of plural policing.

A method to analyze “source–sink” structure of non-point source pollution based on remote sensing technology

International Nuclear Information System (INIS)

Jiang, Mengzhen; Chen, Haiying; Chen, Qinghui

2013-01-01

With the purpose of providing scientific basis for environmental planning about non-point source pollution prevention and control, and improving the pollution regulating efficiency, this paper established the Grid Landscape Contrast Index based on Location-weighted Landscape Contrast Index according to the “source–sink” theory. The spatial distribution of non-point source pollution caused by Jiulongjiang Estuary could be worked out by utilizing high resolution remote sensing images. The results showed that, the area of “source” of nitrogen and phosphorus in Jiulongjiang Estuary was 534.42 km 2 in 2008, and the “sink” was 172.06 km 2 . The “source” of non-point source pollution was distributed mainly over Xiamen island, most of Haicang, east of Jiaomei and river bank of Gangwei and Shima; and the “sink” was distributed over southwest of Xiamen island and west of Shima. Generally speaking, the intensity of “source” gets weaker along with the distance from the seas boundary increase, while “sink” gets stronger. -- Highlights: •We built an index to study the “source–sink” structure of NSP in a space scale. •The Index was applied in Jiulongjiang estuary and got a well result. •The study is beneficial to discern the high load area of non-point source pollution. -- “Source–Sink” Structure of non-point source nitrogen and phosphorus pollution in Jiulongjiang estuary in China was worked out by the Grid Landscape Contrast Index

Women's journey to safety - the Transtheoretical model in clinical practice when working with women experiencing Intimate Partner Violence: a scientific review and clinical guidance.

Science.gov (United States)

Reisenhofer, Sonia; Taft, Angela

2013-12-01

Review the applicability of the Transtheoretical model and provide updated guidance for clinicians working with women experiencing intimate partner violence. Critical review of related primary research conducted from 1990 to March 2013. Women's experiences of creating change within abusive relationships can be located within a stages of change continuum by identifying dominant behavioral clusters. The processes of change and constructs of decisional-balance and turning-points are evident in women's decision-making when they engage in change. Clinicians can use the stages of change to provide a means of assessing women's movement toward their nominated outcomes, and the processes of change, decisional-balance and turning-points, to enhance understanding of, and promote women's movement across stages in their journey to safety. Clinicians should assess women individually for immediate and ongoing safety and well-being, and identify their overarching stage of change. Clinicians can support women in identifying and implementing their personal objectives to enhance self-efficacy and create positive change movement across stages. The three primary objectives identified for clinician support are: 1. Minimizing harm and promoting well-being within an abusive relationship, 2. Achieving safety and well-being within the relationship; halting the abuse, or 3. Achieving safety by ending/leaving intimate relationships. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Tipping Point

Medline Plus

Full Text Available ... Point by CPSC Blogger September 22, 2009 appliance child Childproofing CPSC danger death electrical fall furniture head injury product safety television tipover tv Watch the video in Adobe Flash ...

Type A behavior pattern, accident optimism and fatalism: an investigation into non-compliance with safety work behaviors among hospital nurses.

Science.gov (United States)

Ugwu, Fabian O; Onyishi, Ike E; Ugwu, Chidi; Onyishi, Charity N

2015-01-01

Safety work behavior has continued to attract the interest of organizational researchers and practitioners especially in the health sector. The goal of the study was to investigate whether personality type A, accident optimism and fatalism could predict non-compliance with safety work behaviors among hospital nurses. One hundred and fifty-nine nursing staff sampled from three government-owned hospitals in a state in southeast Nigeria, participated in the study. Data were collected through Type A Behavior Scale (TABS), Accident Optimism, Fatalism and Compliance with Safety Behavior (CSB) Scales. Our results showed that personality type A, accident optimism and fatalism were all related to non-compliance with safety work behaviors. Personality type A individuals tend to comply less with safety work behaviors than personality type B individuals. In addition, optimistic and fatalistic views about accidents and existing safety rules also have implications for compliance with safety work behaviors.

Use of non-caloric edulcorants in children

Directory of Open Access Journals (Sweden)

Calzada León Raúl

2014-07-01

Full Text Available We analyze the health normativity for the denomination of non caloric edulcorants in Mexico, and the authorization for the use of natural and synthetic non caloric edulcorants in newborn and until puberty. Special emphasis was given to the consecutive points of safety required in order to assure that they are free of secondary effects. For each non caloric edulcorant available in Mexico, we looked into the studies which mention their side effects in terms of growth and overall.

The safety of nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

1988-01-01

Do nuclear power plants present an unjustifiable risk Can there be confidence in their safety The Uranium Institute invited a group of senior safety experts from eight different Western countries operating different types of reactors to provide an authoritative explanation for non-specialists of the basic principles of reactor safety, their application and their implications. The report presents the group's opinion on the level of safety achieved in the Western nuclear power plants with which the authors are directly familiar. Although many of the points made may well also be true for non-Western reactors, the report does not cover them except where specifically stated. It does describe and discuss the causes of the Chernobyl disaster. It does not compare nuclear power with other fuels, nor does it deal with its benefits, since however great the benefits from the peaceful use of nuclear power, and its own advantages over other fuels, they could not compensate for lack of safety. The conclusion reached is that the risk associated with electricity production at nuclear power plants can be kept very low. Proper use of the extensive knowledge available today can guarantee operation of nuclear power plants at very high safety levels, carrying very low risks, both to health and of contamination of the environment: risks that are continually lowered by upgrading existing plants and their operation, and by the design of future power plants. (author).

FDA drug safety communications: a narrative review and clinical considerations for older adults.

Science.gov (United States)

Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

2012-08-01

The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

A Comparative Study on Effective Factors in Patient Safety Culture from the Nursing Staff Points of View

Directory of Open Access Journals (Sweden)

Khalil Alimohammadzadeh

2017-04-01

Full Text Available Introduction: Patient safety and its requirements fulfillment are today one of the useful valuation indicators in healthcare organizations. Thus, patient safety culture and its promotion are referred to as one of the most important issues raised in the country. The present study aims to examine the effective factors (personal and organizational in patient safety culture from the point of view of nursing staff in Bahman and Parsian private hospitals. Method: The study has an analytical cross-sectional design and is an applied research. HSOPSC (with Cronbach’s alpha coefficient was 0.82 and researcher-devised questionnaires (with Cronbach’s Alpha equal to 0.912 were the only data collection tools. Statistical population includes nursing staff of Bahman and Parsian private hospitals in north-west Tehran. A sample consisting of 150 nurse shift supervisors and head nurses was selected from the population. Necessary data for completing questionnaires were collected by interview. Data were analyzed using SPSS16 software. Given the levels of measurement for the variables, valid measures of central tendency (mean, standard deviation, correlation tests, Chi-square, t- test, and ANOVA were used. Results: The findings showed us that such factors as organizational commitment, error reporting system, management support, reward system, and employee empowerment equipment distribution have important roles in patient safety. Their P-values are reported <0.001 for all of them. Patient safety was not significantly associated with age (P=0.964, educational level (P=0.154, and work experience (P=0.888 There is no low awareness about safety culture in any hospital and their mean awareness about patient safety culture was equal to 3.13 ±0.478 and 3.68 ±0.587 in Parsian and Bahman hospitals, respectively (P<0.001. Conclusion: Error reporting system and organizational commitment respectively have the most and the least effect on promoting patient safety culture

Safety of non-ionic contrast media during renal artery stenting

International Nuclear Information System (INIS)

Ni Jun; Shen Weifeng; Zhang Ruiyan; Zhang Qi; Zhang Xian; Zheng Aifang

2004-01-01

Objective: To evaluate the safety of non-ionic contras media during interventional treatment of renal artery stenosis (RAS). Methods: Fifty four coronary artery disease patients associated with RAS (luminal narrowing > 50%) underwent renal artery stent implantation and percutaneous coronary intervention, only 10 of them with merely renoarterial stenosis undergone renal artery stent implantation. The successful rates of the procedure and complication together with the volumes of contrast media were recorded respectively. And the serum creatine before and 12 hours after the successful procedure were also measured. Results: Both rates of procedural success and complication were similar among the three groups. The serum creatine levels, 12 hours after the procedure, showed no difference in comparing with the baseline. Conclusion: Non-ionic contrast media (Iopamiro 370) could be safely used in patients with RAS. (authors)

Application of non-dose/risk indicators for confidence-building in the H12 safety assessment

International Nuclear Information System (INIS)

Miyahara, K.; Makino, H.; Takasu, A.; Naito, M.; Umeke, H.; Wakasugi, K.; Ishiguro, K.

2002-01-01

In the H12 study, non-dose/risk safety indicators have also been considered with a view to increasing confidence in the safety assessment. The H12 safety assessment considers system evolution for a range of scenarios; not only normal groundwater scenarios but also isolation failure scenarios due to unlikely natural disruptive events. The calculated nuclide concentrations and fluxes in the surface environment for the reference groundwater scenario were compared with measurements of naturally occurring nuclides. This comparison indicated that the concentration and fluxes of radionuclides released from the repository would be several orders of magnitude lower than those of natural radionuclides. There may exist cases, such as some natural disruptive events, where the likelihood of occurrence is extremely low and the 'Reference Biosphere' approach is difficult to be applied for biosphere modelling. The use of qualitative assessment to allow comparison with naturally occurring nuclides based on observations of natural systems may play a role in supporting the robustness of the system concept. These examples suggest that relevant application of these non-dose/risk indicators supports a more robust case. An advantage to applying such indicators is that both technical and non-technical audiences can judge the relative, long-term impact of a deep geological repository. (author)

Validation of the Dutch language version of the Safety Attitudes Questionnaire (SAQ-NL).

Science.gov (United States)

Haerkens, Marck Htm; van Leeuwen, Wouter; Sexton, J Bryan; Pickkers, Peter; van der Hoeven, Johannes G

2016-08-15

As the first objective of caring for patients is to do no harm, patient safety is a priority in delivering clinical care. An essential component of safe care in a clinical department is its safety climate. Safety climate correlates with safety-specific behaviour, injury rates, and accidents. Safety climate in healthcare can be assessed by the Safety Attitudes Questionnaire (SAQ), which provides insight by scoring six dimensions: Teamwork Climate, Job Satisfaction, Safety Climate, Stress Recognition, Working Conditions and Perceptions of Management. The objective of this study was to assess the psychometric properties of the Dutch language version of the SAQ in a variety of clinical departments in Dutch hospitals. The Dutch version (SAQ-NL) of the SAQ was back translated, and analyzed for semantic characteristics and content. From October 2010 to November 2015 SAQ-NL surveys were carried out in 17 departments in two university and seven large non-university teaching hospitals in the Netherlands, prior to a Crew Resource Management human factors intervention. Statistical analyses were used to examine response patterns, mean scores, correlations, internal consistency reliability and model fit. Cronbach's α's and inter-item correlations were calculated to examine internal consistency reliability. One thousand three hundred fourteen completed questionnaires were returned from 2113 administered to health care workers, resulting in a response rate of 62 %. Confirmatory Factor Analysis revealed the 6-factor structure fit the data adequately. Response patterns were similar for professional positions, departments, physicians and nurses, and university and non-university teaching hospitals. The SAQ-NL showed strong internal consistency (α = .87). Exploratory analysis revealed differences in scores on the SAQ dimensions when comparing different professional positions, when comparing physicians to nurses and when comparing university to non-university hospitals. The SAQ

Safety pharmacology — Current and emerging concepts

International Nuclear Information System (INIS)

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad; Atkinson, Jeffrey; Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael; Delaunois, Annie; Dermody, Ailsa; Govindappa, Karthik; Guillon, Jean-Michel; Jenkins, Rosalind; Kenna, Gerry; Lemmer, Björn; Meecham, Ken; Olayanju, Adedamola; Pestel, Sabine; Rothfuss, Andreas

2013-01-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests

Safety pharmacology — Current and emerging concepts

Energy Technology Data Exchange (ETDEWEB)

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Atkinson, Jeffrey [Lorraine University Pharmacolor Consultants Nancy PCN (France); Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Delaunois, Annie [UCB Pharma (Belgium); Dermody, Ailsa; Govindappa, Karthik [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Guillon, Jean-Michel [Sanofi-aventis (France); Jenkins, Rosalind [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Kenna, Gerry [Astra-Zeneca (United Kingdom); Lemmer, Björn [Ruprecht-Karls-Universität Heidelberg (Germany); Meecham, Ken [Huntingdon Life Sciences (United Kingdom); Olayanju, Adedamola [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Pestel, Sabine [Boehringer-Ingelheim (Germany); Rothfuss, Andreas [Roche (Switzerland); and others

2013-12-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

Science.gov (United States)

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Hinkley Point 'C' power station public inquiry: proof of evidence on the need for Hinkley Point 'C' to help meet capacity requirement and the non-fossil-fuel proportion economically

International Nuclear Information System (INIS)

Jenkin, F.P.

1988-09-01

A public inquiry has been set up to examine the planning application made by the Central Electricity Generating Board (CEGB) for the construction of a 1200 MW Pressurized Water Reactor power station at Hinkley Point (Hinkley Point ''C'') in the United Kingdom. The purpose of this evidence to the Inquiry is to show why there is a need now to go ahead with the construction of Hinkley Point ''C'' generating station to help meet the non-fossil-fuel proportion of generation economically and also to help meet future generating capacity requirement. The CEGB submits that it is appropriate to compare Hinkley Point ''C'' with other non-fossil-fuel alternatives under various bases. Those dealt with by this proof of evidence are as follows: i) ability to contribute to capacity need and in assisting the distribution companies to meet their duty to supply electricity; ii) ability to contribute to the non-fossil-fuel proportion; iii) relative economic merit. (author)

Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410)

International Nuclear Information System (INIS)

1985-02-01

The Safety Evaluation Report for the application filed by the Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate the Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410), has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Subject to favorable resolution of the items discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

Energy Technology Data Exchange (ETDEWEB)

Ryan, Patricia C., E-mail: ryanp@medimmune.com [MedImmune, LLC, Gaithersburg, MD (United States); Sleeman, Matthew A. [MedImmune, LLC, Cambridge (United Kingdom); Rebelatto, Marlon [MedImmune, LLC, Gaithersburg, MD (United States); Wang, Bing; Lu, Hong [MedImmune, LLC, Moutain View, CA (United States); Chen, Xiaomin [Novartis, East Hanover, NJ (United States); Wu, Chi-Yuan [MedImmune, LLC, Moutain View, CA (United States); Hinrichs, Mary Jane; Roskos, Lorin [MedImmune, LLC, Gaithersburg, MD (United States); Towers, Heidi [MedImmune, LLC, Cambridge (United Kingdom); McKeever, Kathleen; Dixit, Rakesh [MedImmune, LLC, Gaithersburg, MD (United States)

2014-09-01

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters other than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. �

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

International Nuclear Information System (INIS)

Ryan, Patricia C.; Sleeman, Matthew A.; Rebelatto, Marlon; Wang, Bing; Lu, Hong; Chen, Xiaomin; Wu, Chi-Yuan; Hinrichs, Mary Jane; Roskos, Lorin; Towers, Heidi; McKeever, Kathleen; Dixit, Rakesh

2014-01-01

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters other than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. �

AMDIS Case Conference: Intrusive Medication Safety Alerts.

Science.gov (United States)

Graham, J; Levick, D; Schreiber, R

2010-01-01

Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center's dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.

AMDIS Case Conference: Intrusive Medication Safety Alerts

OpenAIRE

Graham, J.; Levick, D.; Schreiber, R.

2010-01-01

Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center’s dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.

Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

Science.gov (United States)

Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

Science.gov (United States)

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT: A randomized, controlled non-inferiority trial.

Directory of Open Access Journals (Sweden)

Kristina Keitel

2017-10-01

Full Text Available The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer. The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH, while reducing the proportion with antibiotic prescription.We performed a randomized (at patient level, blocks of 4, controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7 by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths. We enrolled 3

The algorithmic performance of J-Tpeak for drug safety clinical trial.

Science.gov (United States)

Chien, Simon C; Gregg, Richard E

The interval from J-point to T-wave peak (JTp) in ECG is a new biomarker able to identify drugs that prolong the QT interval but have different ion channel effects. If JTp is not prolonged, the prolonged QT may be associated with multi ion channel block that may have low torsade de pointes risk. From the automatic ECG measurement perspective, accurate and repeatable measurement of JTp involves different challenges than QT. We evaluated algorithm performance and JTp challenges using the Philips DXL diagnostic 12/16/18-lead algorithm. Measurement of JTp represents a different use model. Standard use of corrected QT interval is clinical risk assessment on patients with cardiac disease or suspicion of heart disease. Drug safety trials involve a very different population - young healthy subjects - who commonly have J-waves, notches and slurs. Drug effects include difficult and unusual morphology such as flat T-waves, gentle notches, and multiple T-wave peaks. The JTp initiative study provided ECGs collected from 22 young subjects (11 males and females) in randomized testing of dofetilide, quinidine, ranolazine, verapamil and placebo. We compare the JTp intervals between DXL algorithm and the FDA published measurements. The lead wise, vector-magnitude (VM), root-mean-square (RMS) and principal-component-analysis (PCA) representative beats were used to measure JTp and QT intervals. We also implemented four different methods for T peak detection for comparison. We found that JTp measurements were closer to the reference for combined leads RMS and PCA than individual leads. Differences in J-point location led to part of the JTp measurement difference because of the high prevalence of J-waves, notches and slurs. Larger differences were noted for drug effect causing multiple distinct T-wave peaks (Tp). The automated algorithm chooses the later peak while the reference was the earlier peak. Choosing among different algorithmic strategies in T peak measurement results in the

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations.

Science.gov (United States)

Kotrla Topic, Marina; Perkovic Kovacevic, Marina; Mlacic, Boris

2012-10-01

To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N=92) and non-clinical (high-school students, N=87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from 0.000 to 0.021) with Autodestructiveness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior.

Tackling non-point source water pollution in British Columbia : an action plan

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-03-01

British Columbia`s approach to water quality management is discussed. The BC efforts include regulating `end of pipe` point discharges from industrial and municipal outfalls. The major remaining cause of water pollution is from non-point sources (NPS). NPS water pollution is caused by the release of pollutants from different and diffuse sources, mostly unregulated and associated with urbanization, agriculture and other forms of land development. The importance of dealing with such problems on an immediate basis to avoid a decline in water quality in the province is emphasized. Major sources of water pollution in British Columbia include: land development, agriculture, storm water runoff, onsite sewage systems, forestry, atmospheric deposition, and marine activities. 3 tabs.

Duality of two-point functions for confined non-relativistic quark-antiquark systems

International Nuclear Information System (INIS)

Fishbane, P.M.; Gasiorowicz, S.G.; Kaus, P.

1985-01-01

An analog to the scattering matrix describes the spectrum and high-energy behavior of confined systems. We show that for non-relativistic systems this S-matrix is identical to a two-point function which transparently describes the bound states for all angular momenta. Confined systems can thus be described in a dual fashion. This result makes it possible to study the modification of linear trajectories (originating in a long-range confining potential) due to short range forces which are unknown except for the way in which they modify the asymptotic behavior of the two point function. A type of effective range expansion is one way to calculate the energy shifts. 9 refs

Safety of PEGylated recombinant human full-length coagulation factor VIII (BAX 855) in the overall context of PEG and PEG conjugates.

Science.gov (United States)

Stidl, R; Fuchs, S; Bossard, M; Siekmann, J; Turecek, P L; Putz, M

2016-01-01

BAX 855 is a PEGylated human full-length recombinant factor VIII (rFVIII) based on licensed rFVIII (ADVATE). The applied PEGylation technology has been optimized to retain functionality of the FVIII molecule, improve its pharmacokinetic properties and allow less frequent injections while maintaining efficacy. The aim of this study was to confirm that the excellent safety profile of ADVATE remains unchanged after PEGylation. Non-clinical safety studies with BAX 855 and its respective unbound polyethylene glycol (PEG) were conducted in several species. The distribution of a single dose of radiolabelled BAX 855 was further investigated in rats. Publically available safety data on PEG alone and PEGylated biomolecules were summarized and reviewed for specific safety findings attributable to PEG or PEGylated biopharmaceuticals. Safety pharmacology studies in rabbits and macaques and repeated dose toxicity studies in rats and macaques identified no safety issues. Results of a distribution study in rats administered radiolabelled BAX 855 showed that radioactivity was completely excreted; urine was the major elimination route. A 28-day study in rats dosed with the unbound PEG constituent (PEG2ru20KCOOH) of BAX 855 showed no adverse or non-adverse effects. Safety data for PEG and PEG-protein conjugates indicate no safety concerns associated with PEG at clinically relevant dose levels. Although vacuolation of certain cell types has been reported in mammals, no such vacuolation was observed with BAX 855 or with the unbound PEG constituent. Non-clinical safety evaluation of PEG and BAX 855 identified no safety signals; the compound is now in clinical development for the treatment of patients with haemophilia A. © 2015 Baxalta Innovations GmbH. Haemophilia Published by John Wiley & Sons Ltd.

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

Science.gov (United States)

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

MRI with cardiac pacing devices – Safety in clinical practice

Energy Technology Data Exchange (ETDEWEB)

Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)

2014-08-15

Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.

[Clinical key points. Gonioscopy].

Science.gov (United States)

Hamard, P

2007-05-01

Gonioscopy should be performed in all patients with glaucoma or suspected of having glaucoma. Four points are systematically evaluated: the width of the angle, the degree of trabecular pigmentation, the iridotrabecular appositions or synechia, and the level of iris insertion and the shape of the peripheral iris profile.

FOOD QUALITY MANAGEMENT AND SAFETY

OpenAIRE

Rizwana Khatoon; Debkumar Chakraborty; R.C. Chandni; Amar Sankar; A.V. Raghu

2017-01-01

Food safety system mainly focuses on identifying and preventing hazards that may lead product to deteriorate. The main important of manufacturing practice is a system that ensures that products meet food safety, quality and legal requirements. The hazard analysis and critical control point system, applies to food safety management, uses the approach of controlling critical points in food handling to prevent food safety problems. Besides enhancing food safety, other benefits of applying HACCP ...

Clinical aspects and therapy of non-Hodgkin lymphomas

International Nuclear Information System (INIS)

Meissner, K.; Jaenner, M.

1981-01-01

Definition, incidence and distribution of age and sex of cutaneous non-Hodgkin lymphomas are presented. Clinical appearance of cutaneous non-Hodgkin lymphomas may exhibit specific and unspecific cutaneous lesions. Histological examination is of greatest importance for subsequent diagnostic and therapeutic procedures. Topical treatment, X-ray- or photochemotherapy are performed in the early stages, in case of therapeutic resistance and in advanced disease systemical chemotherapy is indicated. (orig.) [de

[Analysis of patient complaints in Primary Care: An opportunity to improve clinical safety].

Science.gov (United States)

Añel-Rodríguez, R M; Cambero-Serrano, M I; Irurzun-Zuazabal, E

2015-01-01

To determine the prevalence and type of the clinical safety problems contained in the complaints made by patients and users in Primary Care. An observational, descriptive, cross-sectional study was conducted by analysing both the complaint forms and the responses given to them in the period of one year. At least 4.6% of all claims analysed in this study contained clinical safety problems. The family physician is the professional who received the majority of the complaints (53.6%), and the main reason was the problems related to diagnosis (43%), mainly the delay in diagnosis. Other variables analysed were the severity of adverse events experienced by patients (in 68% of cases the patient suffered some harm), the subsequent impact on patient care, which was affected in 39% of cases (7% of cases even requiring hospital admission), and the level of preventability of adverse events (96% avoidable) described in the claims. Finally the type of response issued to each complaint was analysed, being purely bureaucratic in 64% of all cases. Complaints are a valuable source of information about the deficiencies identified by patients and healthcare users. There is considerable scope for improvement in the analysis and management of claims in general, and those containing clinical safety issues in particular. To date, in our area, there is a lack of appropriate procedures for processing these claims. Likewise, we believe that other pathways or channels should be opened to enable communication by patients and healthcare users. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Adverse Outcome Pathways can drive non-animal approaches for safety assessment.

Science.gov (United States)

Burden, Natalie; Sewell, Fiona; Andersen, Melvin E; Boobis, Alan; Chipman, J Kevin; Cronin, Mark T D; Hutchinson, Thomas H; Kimber, Ian; Whelan, Maurice

2015-09-01

Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs and other chemicals, and may ultimately play an important role in regulatory decision making. Not only can the development and application of AOPs pave the way for the development of improved evidence-based approaches for hazard and risk assessment, there is also the promise of a significant impact on animal welfare, with a reduced reliance on animal-based methods. The establishment of a useable and coherent knowledge framework under which AOPs will be developed and applied has been a first critical step towards realizing this opportunity. This article explores how the development of AOPs under this framework, and their application in practice, could benefit the science and practice of safety assessment, while in parallel stimulating a move away from traditional methods towards an increased acceptance of non-animal approaches. We discuss here the key areas where current, and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd.

Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig

DEFF Research Database (Denmark)

Bjarkam, Carsten R; GLUD, AN; Margolin, Lee

2010-01-01

Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig......Safety and function of a new clinical intracerebral microinjection instrument for stem cells and therapeutics examined in the Göttingen minipig...

Safety Evaluation Report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410)

International Nuclear Information System (INIS)

1987-07-01

This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for the license to operate Nine Mile Point Nuclear Station, Unit 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. This report supports the issuance of the full-power license for Nine Mile Point Nuclear Station, Unit No. 2

Safety evaluation report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410)

International Nuclear Information System (INIS)

1986-07-01

This report supplements the Safety Evaluation Report (NUREG-1047, February 1985) for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate the Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). It has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located near Oswego, New York. Supplement 1 to the Safety Evaluation Report was published in June 1985 and contained the report from the Advisory Committee on Reactor Safeguards as well as the resolution to a number of outstanding issues from the Safety Evaluation Report. Supplement 2 was published in November 1985 and contained the resolution to a number of outstanding and confirmatory issues. Subject to favorable resolution of the issues discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public

Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

International Nuclear Information System (INIS)

Kulkarni, R.D.; Gopal, N.G.S.

1975-01-01

Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

A method to analyze "source-sink" structure of non-point source pollution based on remote sensing technology.

Science.gov (United States)

Jiang, Mengzhen; Chen, Haiying; Chen, Qinghui

2013-11-01

With the purpose of providing scientific basis for environmental planning about non-point source pollution prevention and control, and improving the pollution regulating efficiency, this paper established the Grid Landscape Contrast Index based on Location-weighted Landscape Contrast Index according to the "source-sink" theory. The spatial distribution of non-point source pollution caused by Jiulongjiang Estuary could be worked out by utilizing high resolution remote sensing images. The results showed that, the area of "source" of nitrogen and phosphorus in Jiulongjiang Estuary was 534.42 km(2) in 2008, and the "sink" was 172.06 km(2). The "source" of non-point source pollution was distributed mainly over Xiamen island, most of Haicang, east of Jiaomei and river bank of Gangwei and Shima; and the "sink" was distributed over southwest of Xiamen island and west of Shima. Generally speaking, the intensity of "source" gets weaker along with the distance from the seas boundary increase, while "sink" gets stronger. Copyright © 2013 Elsevier Ltd. All rights reserved.

Modeling the Non-functional Requirements in the Context of Usability, Performance, Safety and Security

OpenAIRE

Sadiq, Mazhar

2007-01-01

Requirement engineering is the most significant part of the software development life cycle. Until now great emphasis has been put on the maturity of the functional requirements. But with the passage of time it reveals that the success of software development does not only pertain to the functional requirements rather non-functional requirements should also be taken into consideration. Among the non-functional requirements usability, performance, safety and security are considered important. ...

Orbital classical solutions, non-perturbative phenomena and singularity at the zero coupling constant point

International Nuclear Information System (INIS)

Vourdas, A.

1982-01-01

We try to extend previous arguments on orbital classical solutions in non-relativistic quantum mechanics to the 1/4lambda vertical stroke phi vertical stroke 4 complex relativistic field theory. The single valuedness of the Green function in the semiclassical (Planksche Konstante → 0) limit leads to a Bohr-Sommerfeld quantization. A path integral formalism for the Green functions analogous to that in non-relativistic quantum mechanics is employed and a semiclassical approach which uses our classical solutions indicates non-perturbative effects. They reflect an esub(1/lambda) singularity at the zero coupling constant point. (orig.)

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

Directory of Open Access Journals (Sweden)

Xingsheng Hu

Full Text Available Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC previously treated with platinum-based chemotherapy.Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety.From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m and 5.4 months (95%CI 3.1-7.9 m, respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127, diarrhea (12.6%, 16/127 and elevation of transaminase (15.7%, 20/127.In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy.ClinicalTrials.gov NCT02486354.

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

Science.gov (United States)

Hu, Xingsheng; Zhang, Li; Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. ClinicalTrials.gov NCT02486354.

The effect of safety training involving non-destructive testing among students at specialized vocational high schools

Energy Technology Data Exchange (ETDEWEB)

Lim Young Khi [Dept. of Radiological Science, Gachon University, Inchon (Korea, Republic of); Han, Eun Ok; Choi, Yoon Seok [Dept. of Education amd Research, Korea Academy of Nuclear Safety, Seoul (Korea, Republic of)

2017-06-15

By examining the safety issues involved in on-site training sessions conducted at specialized vocational high schools, and by analyzing the effects of non-destructive testing (NDT) safety training, this study aims to contribute to ensuring the general safety of high school students. Students who expressed an interest in participation were surveyed regarding current NDT training practices, as well as NDT safety training. A total of 361 students from 4 schools participated in this study; 37.7% (136 students) were from the Seoul metropolitan area and 62.3% (225 students) were from other areas. Of the respondents, 2.2% (8 students) reported having engaged in NDT. As a result of safety training, statistically significant improvements were observed in most areas, except for individuals with previous NDT experience. The areas of improvement included safety awareness, acquisition of knowledge, subjective knowledge levels, objective knowledge levels, and adjustments to existing personal attitudes. Even at absolutely necessary observation-only training sessions, it is crucial that sufficient safety training and additional safety measures be adequately provided.

The effect of safety training involving non-destructive testing among students at specialized vocational high schools

International Nuclear Information System (INIS)

Lim Young Khi; Han, Eun Ok; Choi, Yoon Seok

2017-01-01

By examining the safety issues involved in on-site training sessions conducted at specialized vocational high schools, and by analyzing the effects of non-destructive testing (NDT) safety training, this study aims to contribute to ensuring the general safety of high school students. Students who expressed an interest in participation were surveyed regarding current NDT training practices, as well as NDT safety training. A total of 361 students from 4 schools participated in this study; 37.7% (136 students) were from the Seoul metropolitan area and 62.3% (225 students) were from other areas. Of the respondents, 2.2% (8 students) reported having engaged in NDT. As a result of safety training, statistically significant improvements were observed in most areas, except for individuals with previous NDT experience. The areas of improvement included safety awareness, acquisition of knowledge, subjective knowledge levels, objective knowledge levels, and adjustments to existing personal attitudes. Even at absolutely necessary observation-only training sessions, it is crucial that sufficient safety training and additional safety measures be adequately provided

Three-point phase correlations: A new measure of non-linear large-scale structure

CERN Document Server

Wolstenhulme, Richard; Obreschkow, Danail

2015-01-01

We derive an analytical expression for a novel large-scale structure observable: the line correlation function. The line correlation function, which is constructed from the three-point correlation function of the phase of the density field, is a robust statistical measure allowing the extraction of information in the non-linear and non-Gaussian regime. We show that, in perturbation theory, the line correlation is sensitive to the coupling kernel F_2, which governs the non-linear gravitational evolution of the density field. We compare our analytical expression with results from numerical simulations and find a very good agreement for separations r>20 Mpc/h. Fitting formulae for the power spectrum and the non-linear coupling kernel at small scales allow us to extend our prediction into the strongly non-linear regime. We discuss the advantages of the line correlation relative to standard statistical measures like the bispectrum. Unlike the latter, the line correlation is independent of the linear bias. Furtherm...

Effectiveness and safety of moxibustion treatment for non-specific lower back pain: protocol for a systematic review.

Science.gov (United States)

Leem, Jungtae; Lee, Seunghoon; Park, Yeoncheol; Seo, Byung-Kwan; Cho, Yeeun; Kang, Jung Won; Lee, Yoon Jae; Ha, In-Hyuk; Lee, Hyun-Jong; Kim, Eun-Jung; Lee, Sanghoon; Nam, Dongwoo

2017-06-23

Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients. We will conduct an electronic search of several databases from their inception to May 2017, including Embase, PubMed, Cochrane Central Register of Controlled Trial, Allied and Complementary Medicine Database, Wanfang Database, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure Database, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Oriental Medicine Advanced Searching Integrated System, the Korea Institute of Science and Technology, and KoreaMed. Randomised controlled trials investigating any type of moxibustion treatment will be included. The primary outcome will be pain intensity and functional status/disability due to lower back pain. The secondary outcome will be a global measurement of recovery or improvement, work-related outcomes, radiographic improvement of structure, quality of life, and adverse events (presence or absence). Risk ratio or mean differences with a 95% confidence interval will be used to show the effect of moxibustion therapy when it is possible to conduct a meta-analysis. This review will be published in a peer-reviewed journal and will be presented at an international academic conference for dissemination. Our results will provide current evidence of the effectiveness and safety of moxibustion treatment in non-specific lower back pain patients, and thus will be beneficial to patients, practitioners, and policymakers

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

Science.gov (United States)

Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

2017-08-01

Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

Safety, immune and clinical responses in metastatic melanoma patients vaccinated with a long peptide derived from indoleamine 2,3-dioxygenase in combination with ipilimumab

DEFF Research Database (Denmark)

Bjørn, Jon; Iversen, Trine Zeeberg; Nitschke, Nikolaj Juul

2016-01-01

antibody ipilimumab (ipi). METHODS: Ten patients with metastatic melanoma participated in a phase I first-in-human clinical study assessing safety of combining ipi with a 21-mer synthetic peptide vaccine from IDO denoted IDOlong. Secondary and tertiary end points included vaccine and clinical response......BACKGROUND AIM: Indoleamine 2,3-dioxygenase (IDO) is an emerging new target in cancer therapy that can be targeted with active immunotherapy (e.g. through peptide vaccination). Furthermore, IDO has been identified as a key mechanism underlying resistance to treatment with the checkpoint blocking....... RESULTS: Treatment was generally safe and well tolerated. Vaccine related adverse reactions included grade I and II erythema, oedema and pruritus at the vaccination site, which were manageable with mild topical corticosteroids. One patient developed presumed ipi-induced colitis. It initially responded...

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

Science.gov (United States)

Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Nuclear Safety. 1997

International Nuclear Information System (INIS)

1998-01-01

A quick review of the nuclear safety at EDF may be summarized as follows: - the nuclear safety at EDF maintains at a rather good standard; - none of the incidents that took place has had any direct impact upon safety; - the availability remained good; - initiation of the floor 4 reactor generation (N4 unit - 1450 MW) ensued without major difficulties (the Civaux 1 NPP has been coupled to the power network at 24 december 1997); - the analysis of the incidents interesting from the safety point of view presents many similarities with earlier ones. Significant progress has been recorded in promoting actively and directly a safe operation by making visible, evident and concrete the exertion of the nuclear operation responsibility and its control by the hierarchy. The report develops the following chapters and subjects: 1. An overview on 1997; 1.1. The technical issues of the nuclear sector; 1.2. General performances in safety; 1.3. The main incidents; 1.4. Wastes and radiation protection; 2. Nuclear safety management; 2.1. Dynamics and results; 2.2. Ameliorations to be consolidated; 3. Other important issues in safety; 3.1. Probabilistic safety studies; 3.2. Approach for safety re-evaluation; 3.3. The network safety; 3.4. Crisis management; 3.5. The Lifetime program; 3.6. PWR; 3.7. Documentation; 3.8. Competence; 4. Safety management in the future; 4.1. An open future; 4.2. The fast neutron NPP at Creys-Malville; 4.3. Stabilization of the PWR reference frame; 4.4. Implementing the EURATOM directive regarding the radiation protection standards; 4.5. Development of biomedical research and epidemiological studies; 4.6. New regulations concerning the liquid and gaseous effluents; 5. Visions of an open future; 5.1. Alternative views upon safety ay EDF; 5.2. Safety authority; 5.3. International considerations; 5.4. What happens abroad; 5.5. References from non-nuclear domain. Four appendices are added referring to policy of safety management, policy of human factors in NPPs

77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2012-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... per year. B. Research Objectives The goal of FDA's OPD grant program is to support the clinical... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of...

Non-Hematopoietic Essential Functions of Bone Marrow Cells: A Review of Scientific and Clinical Literature and Rationale for Treating Bone Defects.

Science.gov (United States)

Harrell, David B; Caradonna, Eugenio; Mazzucco, Laura; Gudenus, Rosmarie; Amann, Berthold; Prochazka, Vaclav; Giannoudis, Peter V; Hendrich, Christian; Jäger, Marcus; Krauspe, Rüdiger; Hernigou, Philippe

2015-12-28

Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo) and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angio-genesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA) has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG), or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP), but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT) has issued a reflection paper (20 June 2014) in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head) should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

Non-hematopoietic essential functions of bone marrow cells: a review of scientific and clinical literature and rationale for treating bone defects

Directory of Open Access Journals (Sweden)

David B. Harrell

2015-12-01

Full Text Available Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angiogenesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG, or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP, but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT has issued a reflection paper (20 June 2014 in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

A meta-model for computer executable dynamic clinical safety checklists.

Science.gov (United States)

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

Can non-point pollutions emissions from agriculture be regulated efficiently using input-output taxes?

DEFF Research Database (Denmark)

Hansen, Line Block; Gårn Hansen, Lars

2014-01-01

In many parts of Europe and North America, phosphorus loss from cultivated fields is threatening natural ecosystems. Though there are similarities to other non-point agricultural emissions like nitrogen that have been studied extensively, phosphorus is often characterized by the presence of large...

Current status of agricultural and rural non-point source Pollution assessment in China

International Nuclear Information System (INIS)

Ongley, Edwin D.; Zhang Xiaolan; Yu Tao

2010-01-01

Estimates of non-point source (NPS) contribution to total water pollution in China range up to 81% for nitrogen and to 93% for phosphorus. We believe these values are too high, reflecting (a) misuse of estimation techniques that were developed in America under very different conditions and (b) lack of specificity on what is included as NPS. We compare primary methods used for NPS estimation in China with their use in America. Two observations are especially notable: empirical research is limited and does not provide an adequate basis for calibrating models nor for deriving export coefficients; the Chinese agricultural situation is so different than that of the United States that empirical data produced in America, as a basis for applying estimation techniques to rural NPS in China, often do not apply. We propose a set of national research and policy initiatives for future NPS research in China. - Estimation techniques used in China for non-point source pollution are evaluated as a basis for recommending future policies and research in NPS studies in China.

A single-arm, multicenter, safety-monitoring, phase IV study of icotinib in treating advanced non-small cell lung cancer (NSCLC).

Science.gov (United States)

Hu, Xingsheng; Han, Baohui; Gu, Aiqin; Zhang, Yiping; Jiao, Shun Chang; Wang, Chang-Li; He, Jintao; Jia, Xueke; Zhang, Li; Peng, Jiewen; Wu, Meina; Ying, Kejing; Wang, Junye; Ma, Kewei; Zhang, Shucai; You, Changxuan; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2014-11-01

The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Safety and efficacy of first-line bevacizumab with chemotherapy in Asian patients with advanced nonsquamous NSCLC: results from the phase IV MO19390 (SAiL) study.

Science.gov (United States)

Tsai, Chun-Ming; Au, Joseph Siu-kie; Chang, Gee-Chen; Cheng, Ashley Chi-kin; Zhou, Caicun; Wu, Yi-long

2011-06-01

First-line treatment with bevacizumab combined with chemotherapy has been shown to improve outcomes in patients with advanced, nonsquamous non-small cell lung cancer (NSNSCLC) in phase III clinical trials. SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a preplanned subanalysis of Asian patients enrolled in SAiL. Patients with untreated, locally advanced, metastatic or recurrent NSNSCLC received bevacizumab 7.5 or 15 mg/kg every 3 weeks plus chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression. Eligibility criteria for SAiL permitted enrolment of a broad patient population. The primary end point was safety; secondary end points included time to disease progression and overall survival. The Asian intent-to-treat population comprised 314 of the 2212 patients enrolled in the SAiL trial. In the Asian subanalysis, patients received a median of nine cycles of bevacizumab, and the median follow-up was 16.4 months. The incidence of clinically significant adverse events (grade ≥3) of special interest was relatively low in this population (15.6% overall); proteinuria (7.6%), hypertension (4.8%), and bleeding (2.5%) were the most common. A total of five adverse events related to bevacizumab were reported as grade 5. Disease control rate was 94.1%, median time to disease progression was 8.3 months, and median overall survival was 18.9 months. The safety and efficacy of first-line bevacizumab-based treatment in Asian patients with advanced NSNSCLC is consistent with that demonstrated in phase III studies and in the overall SAiL population. There were no new safety signals.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies.

Science.gov (United States)

Biaoxue, Rong; Hua, Liu; Wenlong, Gao; Shuanying, Yang

2016-12-27

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC.

Nuclear Criticality Safety Handbook, Version 2. English translation

International Nuclear Information System (INIS)

2001-08-01

The Nuclear Criticality Safety Handbook, Version 2 essentially includes the description of the Supplement Report to the Nuclear Criticality Safety Handbook, released in 1995, into the first version of the Nuclear Criticality Safety Handbook, published in 1988. The following two points are new: (1) exemplifying safety margins related to modeled dissolution and extraction processes, (2) describing evaluation methods and alarm system for criticality accidents. Revision has been made based on previous studies for the chapter that treats modeling the fuel system: e.g., the fuel grain size that the system can be regarded as homogeneous, non-uniformity effect of fuel solution, an burnup credit. This revision has solved the inconsistencies found in the first version between the evaluation of errors found in JACS code system and the criticality condition data that were calculated based on the evaluation. This report is an English translation of the Nuclear Criticality Safety Handbook, Version 2, originally published in Japanese as JAERI 1340 in 1999. (author)

Execution of the Occupational Safety and Health Act (1994 in the Construction Industry from Contractors’ Point of View

Directory of Open Access Journals (Sweden)

Awang H.

2014-01-01

Full Text Available Construction is one of the highest contributing industries to occupational accidents by sector in Malaysia. Statistics have been drawn from year to year that show an increasing number of cases of accidents by industry sector. While it is impossible to completely eliminate all accidents, with a proper and effective safety and health policy or rules set by top management, especially contractors, the rate of accidents on construction sites can be reduced. The main objective of this study is to analyse the degree of application of the Occupational Safety and Health Act 1994 (OSHA 1994 in the construction industry and to identify the contributing factors leading to a lack of execution of OSHA 1994 on construction sites with a primary focus on contractors’ point of view. Five on-going construction projects in Perak were selected as case studies and site inspections were conducted. The results showed that none of the contractors have fully implemented the rules and regulations provided by the government. Within this report, some recommendations are made towards enhancing the safety and health issues on construction sites.

[Mindfulness-based stimulation in advanced Alzheimer's disease: A comparative, non-inferiority, clinical pilot study].

Science.gov (United States)

Quintana Hernández, Domingo Jesús; Miró Barrachina, María Teresa; Ibáñez Fernández, Ignacio; Santana del Pino, Angelo; Rojas Hernández, Jaime; Rodríguez García, Javier; Quintana Montesdeoca, María del Pino

2015-01-01

A longitudinal study was conducted in order to analyze the feasibility, safety, and effects of the practice of mindfulness, relaxation and cognitive stimulation on the evolution of Alzheimer's disease, with the aim of testing the equivalence of these interventions. There were a total of 168 participants with probable Alzheimer's disease (AD) treated with donepezil. In the present article, the 21 participants with advanced AD who completed a follow-up period of 24 months are presented. The participants were grouped into three experimental groups (mindfulness, relaxation, and cognitive stimulation) and one control group. Each group carried out three weekly sessions with bi-annual follow-up measurements (cognition: CAMCOG and MMSE; functionality: RDRS; psychopathology: NPI). Non-parametric analyses were performed. The cognitive function and functionality scores showed no significant differences between the groups. However, the scores in cognitive function of the mindfulness group and the cognitive stimulation group did not decrease in an intra-group analysis. In NPI, there were significant differences between the mindfulness group and the control group by the end of the study (P<.017). The data showed that the treatment with donepezil in combination with mindfulness or cognitive stimulation presented a better clinical evolution than the pharmacological treatment alone or combined with relaxation. These data suggest that these therapeutic alternatives should be investigated further, and that the non-pharmacological treatments should be recommended in clinical practice in order to control the evolution of AD in the long term. In order to confirm these findings, a larger study is necessary. Copyright © 2014 SEGG. Published by Elsevier Espana. All rights reserved.

PET and diagnostic technology evaluation in a global clinical process. DGN's point of view

International Nuclear Information System (INIS)

Kotzerke, J.; Dietlein, M.; Gruenwald, F.; Bockisch, A.

2010-01-01

malignancies will be improved continuously. It is the claim of the health insurances to implement innovative therapeutic approaches in controlled clinical trials with tools of quality control. The monitoring committee is responsible for the safety of the patients. PET is part of the health care. Internationally accepted rules for clinical trials stipulate that any interim analyses of those trials are confidential as long as recruitment is active. The delay until evidence is documented by the published final analysis is methodologically accepted and not a characteristic of PET. (7) Procedures in nuclear medicine without the use of PET-tracers with short half-life will increase the radiation exposure of the patients; the use of non-PET-tracers with longer half-life is in contravention of the German regulation of radiation protection. (orig.)

Clinical characteristics of catamenial and non-catamenial thoracic endometriosis-related pneumothorax.

Science.gov (United States)

Fukuoka, Mizuki; Kurihara, Masatoshi; Haga, Takahiro; Ebana, Hiroki; Kataoka, Hideyuki; Mizobuchi, Teruaki; Tatsumi, Koichiro

2015-11-01

A major pathogenic factor for catamenial pneumothorax is thoracic endometriosis. However, thoracic endometriosis-related pneumothorax (TERP) can develop as either catamenial or non-catamenial pneumothorax (CP). Therefore, the aim of this study was to elucidate the clinical differences between catamenial and non-catamenial TERP. The clinical and pathological data in female patients who underwent video-assisted thoracoscopic surgery at the Pneumothorax Research Center during an 8-year period were retrospectively reviewed. This study included 150 female patients with surgico-pathologically confirmed TERP. The subjects were divided into two groups, those having all of the pneumothorax episodes in the catamenial period (CP group) and those who did not (non-CP group). We compared the clinical characteristics and surgico-pathological findings between these two groups. Of the 150 TERP patients, 55 (36.7%) were classified in the CP group, and 95 (63.3%) in the non-CP group. In regard to the locations of endometriosis, all TERP patients had diaphragmatic endometriosis, while pleural implantation was recognized in 34 of the 55 (61.8%) patients in the CP group and 42 of the 95 (44.2%) patients in the non-CP group (P pneumothorax episodes. © 2015 Asian Pacific Society of Respirology.

Effects of an educational patient safety campaign on patients' safety behaviours and adverse events.

Science.gov (United States)

Schwappach, David L B; Frank, Olga; Buschmann, Ute; Babst, Reto

2013-04-01

Rationale, aims and objectives  The study aims to investigate the effects of a patient safety advisory on patients' risk perceptions, perceived behavioural control, performance of safety behaviours and experience of adverse incidents. Method  Quasi-experimental intervention study with non-equivalent group comparison was used. Patients admitted to the surgical department of a Swiss large non-university hospital were included. Patients in the intervention group received a safety advisory at their first clinical encounter. Outcomes were assessed using a questionnaire at discharge. Odds ratios for control versus intervention group were calculated. Regression analysis was used to model the effects of the intervention and safety behaviours on the experience of safety incidents. Results  Two hundred eighteen patients in the control and 202 in the intervention group completed the survey (75 and 77% response rates, respectively). Patients in the intervention group were less likely to feel poorly informed about medical errors (OR = 0.55, P = 0.043). There were 73.1% in the intervention and 84.3% in the control group who underestimated the risk for infection (OR = 0.51, CI 0.31-0.84, P = 0.009). Perceived behavioural control was lower in the control group (meanCon  = 3.2, meanInt  = 3.5, P = 0.010). Performance of safety-related behaviours was unaffected by the intervention. Patients in the intervention group were less likely to experience any safety-related incident or unsafe situation (OR for intervention group = 0.57, CI 0.38-0.87, P = 0.009). There were no differences in concerns for errors during hospitalization. There were 96% of patients (intervention) who would recommend other patients to read the advisory. Conclusions  The results suggest that the safety advisory decreases experiences of adverse events and unsafe situations. It renders awareness and perceived behavioural control without increasing concerns for safety and

Response surface use in safety analyses

International Nuclear Information System (INIS)

Prosek, A.

1999-01-01

When thousands of complex computer code runs related to nuclear safety are needed for statistical analysis, the response surface is used to replace the computer code. The main purpose of the study was to develop and demonstrate a tool called optimal statistical estimator (OSE) intended for response surface generation of complex and non-linear phenomena. The performance of optimal statistical estimator was tested by the results of 59 different RELAP5/MOD3.2 code calculations of the small-break loss-of-coolant accident in a two loop pressurized water reactor. The results showed that OSE adequately predicted the response surface for the peak cladding temperature. Some good characteristic of the OSE like monotonic function between two neighbor points and independence on the number of output parameters suggest that OSE can be used for response surface generation of any safety or system parameter in the thermal-hydraulic safety analyses.(author)

Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

Science.gov (United States)

Garcia-Garcia, Hector M; McFadden, Eugène P; Farb, Andrew; Mehran, Roxana; Stone, Gregg W; Spertus, John; Onuma, Yoshinobu; Morel, Marie-Angèle; van Es, Gerrit-Anne; Zuckerman, Bram; Fearon, William F; Taggart, David; Kappetein, Arie-Pieter; Krucoff, Mitchell W; Vranckx, Pascal; Windecker, Stephan; Cutlip, Donald; Serruys, Patrick W

2018-06-14

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

76 FR 38020 - Safety Zone; Bay Point Fireworks, Bay Point Marina; Marblehead, OH

Science.gov (United States)

2011-06-29

... environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal... Captain of the Port Detroit Zone on Lake Erie, Marblehead, Ohio. This Zone is intended to restrict vessels... interest because it would prevent the Captain of the Port Detroit from protecting the public from the...

Color-coding and human factors engineering to improve patient safety characteristics of paper-based emergency department clinical documentation.

Science.gov (United States)

Kobayashi, Leo; Boss, Robert M; Gibbs, Frantz J; Goldlust, Eric; Hennedy, Michelle M; Monti, James E; Siegel, Nathan A

2011-01-01

Investigators studied an emergency department (ED) physical chart system and identified inconsistent, small font labeling; a single-color scheme; and an absence of human factors engineering (HFE) cues. A case study and description of the methodology with which surrogate measures of chart-related patient safety were studied and subsequently used to reduce latent hazards are presented. Medical records present a challenge to patient safety in EDs. Application of HFE can improve specific aspects of existing medical chart organization systems as they pertain to patient safety in acute care environments. During 10 random audits over 5 consecutive days (573 data points), 56 (9.8%) chart binders (range 0.0-23%) were found to be either misplaced or improperly positioned relative to other chart binders; 12 (21%) were in the critical care area. HFE principles were applied to develop an experimental chart binder system with alternating color-based chart groupings, simple and prominent identifiers, and embedded visual cues. Post-intervention audits revealed significant reductions in chart binder location problems overall (p < 0.01), for Urgent Care A and B pods (6.4% to 1.2%; p < 0.05), Fast Track C pod (19.3% to 0.0%; p < 0.05) and Behavioral/Substance Abuse D pod (15.7% to 0.0%; p < 0.05) areas of the ED. The critical care room area did not display an improvement (11.4% to 13.2%; p = 0.40). Application of HFE methods may aid the development, assessment, and modification of acute care clinical environments through evidence-based design methodologies and contribute to safe patient care delivery.

An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

Directory of Open Access Journals (Sweden)

Elizabeth Jackson

2017-05-01

Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

Carbon-11 labeled diacylglycerol for signal transduction imaging by positron CT. Evaluation of the quality and safety for clinical use

Energy Technology Data Exchange (ETDEWEB)

Fujii, Ryou [Nishijin Hospital, Kyoto (Japan); Imahori, Yoshio; Ido, Tatsuo [and others

1995-02-01

To elucidate the synaptic transmission in the neural system, we have been developing fundamental studies for intracellular signaling. For clinical application of carbon-11 labeled diacylglycerol (1-[1-{sup 11}C]butyryl-2-palmitoyl-rac-glycerol: {sup 11}C-DAG) using positron emission computed tomography (PET), we evaluated the quality and the safety of {sup 11}C-DAG as the solution for injection. As a result, {sup 11}C-DAG was synthesized within 50 minutes, including the preparation step for injection. The half life time and energy spectrum of {sup 11}C-DAG were the same as the physical character of carbon-11, and other radioisotopes were not detected. In the quality control, {sup 11}C-DAG solution was negative in the examination of bacterial contamination and the pyrogen test in three successive synthesis procedures. In the acute toxicity test by administration of {sup 11}C-DAG and 100 {mu}mol/kg of non-radioactive DAG to the rat intravenously, the systemic condition of the rat was not changed and no abnormalities were found in any organ 24 hours after administration. These findings indicated the safety of {sup 11}C-DAG solution. Clinical application of {sup 11}C-DAG using positron emission tomography may be useful to elucidate the dysfunction of intracellular signaling in disorders of higher cortical function such as Alzheimer disease. (author).

Experience with nuclear safety standards development in non-governmental international organizations

International Nuclear Information System (INIS)

Becker, K.

1985-01-01

Besides the IAEA as a 'governmental' organization dealing with basic safety recommendations addressed primarily to the national regulatory bodies in developing countries, two closely related non-governmental international standards organizations have gained extensive experience in the field of nuclear standardization. Over more than 25 years since their formation, both (a) the International Organization for Standardization's (ISO) Technical Committee 85 'Nuclear Energy', in particular in its Sub-Committee 3 'Reactor Technology and Safety' and (b) the International Electrotechnical Commission's (IEC) Technical Committee 45 'Nuclear Instrumentation' have published numerous standards. A brief review is given of these, draft standards, and other documents planned to become international standards. Many of them deal with rather specialized topics typical for 'industrial' standards such as standardized procedures, instruments, methods, materials, test methods, terminology, and signs and symbols, but others are directly related to more basic safety issues. In some areas such as quality assurance, seismic aspects of siting and terminology, there has been in the past occasional overlap in the activities of the NUSS programme, IEC and ISO. Letters of Understanding have since 1981 contributed to clarifying the borderlines and to avoiding redundant efforts. Also, some experiences and problems are described arising, for example, from the harmonization of different national safety philosophies and traditions into universally accepted international standards, and the transfer of international standards into national standards systems. Finally, based on a recent comprehensive compilation of some 3300 nuclear standards and standards projects, an attempt is made to present a cost/benefit analysis and an outlook on future developments. (author)

Separation and recycling of nanoparticles using cloud point extraction with non-ionic surfactant mixtures.

Science.gov (United States)

Nazar, Muhammad Faizan; Shah, Syed Sakhawat; Eastoe, Julian; Khan, Asad Muhammad; Shah, Afzal

2011-11-15

A viable cost-effective approach employing mixtures of non-ionic surfactants Triton X-114/Triton X-100 (TX-114/TX-100), and subsequent cloud point extraction (CPE), has been utilized to concentrate and recycle inorganic nanoparticles (NPs) in aqueous media. Gold Au- and palladium Pd-NPs have been pre-synthesized in aqueous phases and stabilized by sodium 2-mercaptoethanesulfonate (MES) ligands, then dispersed in aqueous non-ionic surfactant mixtures. Heating the NP-micellar systems induced cloud point phase separations, resulting in concentration of the NPs in lower phases after the transition. For the Au-NPs UV/vis absorption has been used to quantify the recovery and recycle efficiency after five repeated CPE cycles. Transmission electron microscopy (TEM) was used to investigate NP size, shape, and stability. The results showed that NPs are preserved after the recovery processes, but highlight a potential limitation, in that further particle growth can occur in the condensed phases. Copyright © 2011 Elsevier Inc. All rights reserved.

Drug Safety

Science.gov (United States)

... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

Clinical application and side effects of non-ionic, low-osmolar contrast media: Iopromide (Ultavist)

International Nuclear Information System (INIS)

Lee, Jong Tae; Suh, Jung Ho; Suh, Jin Suk; Lee, Yeon Hee

1988-01-01

Generally non-ionic, water-soluble contrast media has been known to be considerably better than the conventional ionic contrast agents, because of its physiochemical properties which are more hydrophilic, lower in osmolality than the ionic agents of equivalent iodine concentration. It means that the non-ionic agent has less side reaction and better general tolerance. Iopromide (Ultavist) is a newly developed non-ionic contrast media that is suitable for angiography. Some non-ionic contrast media such as Metrizamide and lopamidol were clinically introduced and proved tobe the most compromising agents for neuroradiographic study, but lopromide is not yet freely available in the vascular study. In order to evaluate the clinical fitness and its side effects of lopromide for angiography various type of angiography were done in 136 patients using lopromide and 51 received Diatrizoate meglumine (DTM). Similar volumes of the contrast media was administered at similar rate to both groups. The results were as the follows: 1. In celiac angiography of 31 patients with lopromide (Ultravist 370) and 18 with DTM 60, there were observed 9.7% mild pain and 25.8% mild heat sensation in lopromide. In DTM 60 mild pain was approximately 3 times more frequently observed than lopromide. Heat sensation is mild and similar in frequency of both groups. There was no clinically significant side effects related to the osmolality and its difference between two groups. 2. In peripheral angiography of 47 patients with lopromide 300 and 24 with DTM 60, there were observed 19.1% mild, 6.4 moderate in pain and 46.8% mild, 1% moderate heat sensation in lopromide. But in DTM there were 33.3% mild, 58.3% moderate and 8.3% severe pain, and also 70.8% mild and 16.7% moderate heat sensation in DTM were observed. lopromide is more advantageous and better contrast agents than the DTM for peripheral vascular study on the point of low side effect related to osmolality. 3. In renal angiography, there was no

The Perception of Patient Safety in Medical Students

Directory of Open Access Journals (Sweden)

Unal Demirtas

2014-08-01

CONCLUSION:It is seen that effects that increase the awareness such as more intense clinical studies, having knowledge about the subject, getting harmed from malpractice increase the perception of malpractice. Particularly the practices and studies of patient safety done in university hospitals have some benefits on the approach and point of views of medical school students, taking these benefits into account, we consider that taking active role in these studies for students and including patient safety classes into the medical school programs would be useful in increasing the awareness and in being more cautious against malpractice [TAF Prev Med Bull 2014; 13(4.000: 315-320

Safety syringes and anti-needlestick devices in orthopaedic surgery.

Science.gov (United States)

Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D

2011-09-07

The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting

Safety evaluation report related to the operation of Nine Mile Point Nuclear Station, Unit No. 2 (Docket No. 50-410). Supplement No. 1

International Nuclear Information System (INIS)

1985-06-01

This report supplements the Safety Evaluation Report for the application filed by Niagara Mohawk Power Corporation, as applicant and co-owner, for a license to operate the Nine Mile Point Nuclear Station Unit 2. The facility is located near Oswego, New York. Subject to favorable resolution of the issues discussed in this report, the NRC staff concludes that the facility can be operated by the applicant without endangering the health and safety of the public. 1 fig., 3 tabs

Innovative Patient Safety Curriculum Using iPAD Game (PASSED) Improved Patient Safety Concepts in Undergraduate Medical Students.

Science.gov (United States)

Kow, A W C; Ang, B L S; Chong, C S; Tan, W B; Menon, K R

2016-11-01

While healthcare outcomes have improved significantly, the complex management of diseases in the hospitals has also escalated the risks in patient safety. Therefore, in the process of training medical students to be proficient in medical knowledge and skills, the importance of patient safety cannot be neglected. A new innovation using mobile apps gaming system (PAtient Safety in Surgical EDucation-PASSED) to teach medical students on patient safety was created. Students were taught concepts of patient safety followed by a gaming session using iPad games created by us. This study aims to evaluate the outcome of patient safety perception using the PASSED games created. An interactive iPad game focusing on patient safety issues was created by the undergraduate education team in the Department of Surgery, Yong Loo Lin School of Medicine at the National University of Singapore. The game employed the unique touched-screen feature with clinical scenarios extracted from the hospital sentinel events. Some of the questions were time sensitive, with extra bonus marks awarded if the student provided the correct answer within 10 s. Students could reattempt the questions if the initial answer was wrong. However, this entailed demerit points. Third-year medical students posted to the Department of Surgery experienced this gaming system in a cohort of 55-60 students. Baseline understanding of the students on patient safety was evaluated using Attitudes to Patient Safety Questionnaire III (APSQ-III) prior to the game. A 20 min talk on concept of patient safety using the WHO Patient Safety Guidelines was conducted. Following this, students downloaded the apps from ITune store and played with the game for 20-30 min. The session ended with the students completing the postintervention questionnaire. A total of 221 3rd year medical students responded to the survey during the PASSED session. Majority of the students felt that the PASSED game had trained them to understand the

Factors Enhancing Manpower Efficiency from the Viewpoint of Clinical and Non-clinical Faculty Members at Guilan University of Medical Sciences in 2011

Directory of Open Access Journals (Sweden)

Fardin Mehrabian

2012-11-01

Full Text Available Introduction: There are various factors that affect manpower efficiency. Identification of the most important and influential factors on efficiency is quite essential. Analysis of factors affecting manpower efficiency from the viewpoint of clinical and non-clinical faculty members at Guilan University of Medical Sciences in 2011.Methods: This descriptive, analytical, cross-sectional study was performed in October and November in 2011. The study sample consisted of 186 faculty members, including 128 clinical and 58 non-clinical. Instruments used to collect library data were questionnaire and field studies. Exploratory factor analysis with Varimax rotation was utilized to determine the factors influencing manpower efficiency as well as loading level of each of the variables. Results: Among clinical faculty members, 70.66% of changes in manpower efficiency, and among non-clinical faculty members, 79.57% of changes in manpower efficiency were explained by 9 and 8 factors, respectivelyConclusion: Staff empowerment and organizational culture were recognized as the most important factors enhancing manpower efficiency from the viewpoint of clinical and non-clinical faculty members, respectively.

Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

Directory of Open Access Journals (Sweden)

Yo Han Ahn

2014-06-01

Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

Assessment of Groundwater Susceptibility to Non-Point Source Contaminants Using Three-Dimensional Transient Indexes.

Science.gov (United States)

Zhang, Yong; Weissmann, Gary S; Fogg, Graham E; Lu, Bingqing; Sun, HongGuang; Zheng, Chunmiao

2018-06-05

Groundwater susceptibility to non-point source contamination is typically quantified by stable indexes, while groundwater quality evolution (or deterioration globally) can be a long-term process that may last for decades and exhibit strong temporal variations. This study proposes a three-dimensional (3- d ), transient index map built upon physical models to characterize the complete temporal evolution of deep aquifer susceptibility. For illustration purposes, the previous travel time probability density (BTTPD) approach is extended to assess the 3- d deep groundwater susceptibility to non-point source contamination within a sequence stratigraphic framework observed in the Kings River fluvial fan (KRFF) aquifer. The BTTPD, which represents complete age distributions underlying a single groundwater sample in a regional-scale aquifer, is used as a quantitative, transient measure of aquifer susceptibility. The resultant 3- d imaging of susceptibility using the simulated BTTPDs in KRFF reveals the strong influence of regional-scale heterogeneity on susceptibility. The regional-scale incised-valley fill deposits increase the susceptibility of aquifers by enhancing rapid downward solute movement and displaying relatively narrow and young age distributions. In contrast, the regional-scale sequence-boundary paleosols within the open-fan deposits "protect" deep aquifers by slowing downward solute movement and displaying a relatively broad and old age distribution. Further comparison of the simulated susceptibility index maps to known contaminant distributions shows that these maps are generally consistent with the high concentration and quick evolution of 1,2-dibromo-3-chloropropane (DBCP) in groundwater around the incised-valley fill since the 1970s'. This application demonstrates that the BTTPDs can be used as quantitative and transient measures of deep aquifer susceptibility to non-point source contamination.

Towards the certification of non-deterministic control systems for safety-critical applications: analysing aviation analogies for possible certification strategies

CSIR Research Space (South Africa)

Burger, CR

2011-11-01

Full Text Available Current certification criteria for safety-critical systems exclude non-deterministic control systems. This paper investigates the feasibility of using human-like monitoring strategies to achieve safe non-deterministic control using multiple...

Multi point of care instrument evaluation for use in anti-retroviral clinics in South Africa.

Science.gov (United States)

Gounden, Verena; George, Jaya

2012-01-01

South Africa has the largest prevalence of HIV infected individuals in the world. The introduction of point of care testing to anti-retroviral (ARV) clinic sites is hoped to fast track initiation of patients on ARVs and to allow for earlier recognition of adverse effects such as dyslipidaemia, renal and hepatic dysfunction. We evaluated six instruments for the following analytes: glucose, lactate, creatinine, cholesterol, triglycerides, HDL-cholesterol, alanine transaminase (ALT), and glycated haemoglobin. Comparisons with the central laboratory analyser were performed as well as precision studies. A scoring system was developed by the authors to evaluate the instruments in terms of analytical performance, cost, ease of use, and other operational characteristics. As one of the goals of the placement of these instruments was that their operation was simple enough to be used by non-laboratory staff, ease of use contributed a large proportion to the final scoring. Analytical performance of the POC analysers were generally similar, however, there were significant differences in operational characteristics and ease of use. Bias for the different analytes when compared to the laboratory analyser ranged from -27% to 14%. Calculated total errors for all analytes except for HDL cholesterol were within total allowable error recommendations. The two instruments (Roche Reflotron and Cholestech LDX) with the highest overall total points achieved the highest scores for ease of use. This pilot study has led to the development of a scoring system for the evaluation of POC instruments.

Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

Science.gov (United States)

Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

2006-11-01

Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

Traditional clinical risk factors predict clopidogrel hypo-responsiveness in unselected patients undergoing non-emergent percutaneous coronary intervention

DEFF Research Database (Denmark)

Ratcovich, Hanna; Holmvang, Lene; Johansson, Pär Inge

2016-01-01

patients with HPR and LPR. Nine hundred and twenty-three consecutive patients undergoing non-emergent PCI were enrolled. Platelet reactivity (PR) was determined using Multiplate assays. Patients were grouped into quintiles based on their PR values. Upper and lower quintiles defined HPR and LPR......, respectively, whereas quintiles 2-4 defined normal responders. All patients were assigned PREDICT score points in clinical categories (age > 65, reduced left ventricular function, reduced kidney function, acute coronary syndrome (ACS) and diabetes). We found an association between the cumulative number...... of PREDICT score variables and the incidence of HPR for clopidogrel (HPR (ADP)) (p 

Clinical and bacteriological characteristics of pyogenic liver abscess in non-diabetic patients.

Science.gov (United States)

Chuang, Han-Chuan; Chen, Te-Li; Chiang, Dung-Hung; Lee, Yi-Tzu; Huang, Ling-Ju; Wang, Fu-Der; Fung, Chang-Phone; Liu, Cheng-Yi

2009-10-01

Diabetes mellitus is an important risk factor for Klebsiella pneumoniae liver abscess, but many patients with pyogenic liver abscess (PLA) do not have diabetes. This study was conducted to compare the clinical characteristics and prognostic factors of K. pneumoniae PLA with that caused by other organisms in non-diabetic patients. The medical charts of patients with a diagnosis of PLA were retrospectively reviewed from January 2005 to December 2007. The clinical symptoms and signs, laboratory data, and risk factors were analyzed. There were 50 patients in the K. pneumoniae group and 34 patients in the non-K. pneumoniae group. The clinical presentations did not differ between the 2 groups. The patients in the non-K. pneumoniae group had a higher prevalence of malignant disease than those in the K. pneumoniae group (58.8% vs 6.0%; p factors included chronic renal failure (p = 0.005), abscess rupture (p = 0.036), and right lower lung infiltration (p = 0.049). Hepatobiliary malignancy and newly diagnosed malignancy were risk factors for non-K. pneumoniae liver abscess in non-diabetic patients. Physicians should ascertain the presence of underlying malignancy in patients with non-K. pneumoniae PLA.

Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents

DEFF Research Database (Denmark)

Kaiser, Christoph; Galatius, Søren; Jeger, Raban

2015-01-01

-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined...... secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute...

Ethical and Safety Issues of Stem Cell-Based Therapy.

Science.gov (United States)

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

Everything safe? – Risk situations in advanced home care from the point of view of ventilated patients and their relatives

Science.gov (United States)

Ewers, Michael; Schaepe, Christiane; Lehmann, Yvonne

2017-01-01

Background: The number of home mechanically ventilated (HMV) patients has been growing for years. However, little is known about requirements, processes and effects of advanced home care, provided in distance from clinics and doctors. To date, safety related aspects of the above mentioned issues have scarcely been examined. Aim: Users of advanced home care were asked about their experiences and about situations in which they felt safe or unsafe. The aim was to gain insights into the daily care provision, explore safety risks from the users’ point of view, and to develop new approaches to enhance patient safety in home care for the severely ill. Method: A qualitative explorative study has been carried out, based on semi-structured interviews (ventilated patients N = 21; relatives N = 15). Sampling, data collecting and data analysis were guided by principles of Grounded Theory. Results: Risk situations occur when (non-)verbal communication offers of HMV patients are overseen or misunderstood, patient- or technology related monitoring tasks are neglected, if coordination and collaboration requirements are undervalued and if negotiation processes as well as education and supervision needs are disregarded. Furthermore, nurses’ lack of competence, self-confidence and professionalism may produce risk situations. Conclusion: Listen carefully to patients and relatives can help to identify quality shortcomings in advanced home care, to prevent risk situations and to develop patient-centered safety concepts for this particular setting.

Non tumoral intracranial expansive processes: clinical tomographic correlation

International Nuclear Information System (INIS)

Campos, P.; Herrera, G.; Valneica, F.

1991-01-01

Presentation of clinical-tomographic correlation in 111 cases of non tumoral intracranial expansive processes seen between 1984-1988 in the Hospital Cayetano Heredia (Lima, Peru). Emphasis is given fundamentally to: the importance of establishing the organicity of partial and late epilepsy; the high incidence rate of inflammatory infectious processes with CNS compromise in under developing countries; the necessity of making public the importance of two parasitic diseases in the differential diagnosis of non tumoral intracranial expansive processes: free living amebiasis, and toxoplasmosis (especially in association with AIDS). (author)

Application of catastrophe theory to a point model for bumpy torus with neoclassical non-resonant electrons

Energy Technology Data Exchange (ETDEWEB)

Punjabi, A; Vahala, G [College of William and Mary, Williamsburg, VA (USA). Dept. of Physics

1983-12-01

The point model for the toroidal core plasma in the ELMO Bumpy Torus (with neoclassical non-resonant electrons) is examined in the light of catastrophe theory. Even though the point model equations do not constitute a gradient dynamic system, the equilibrium surfaces are similar to those of the canonical cusp catastrophe. The point model is then extended to incorporate ion cyclotron resonance heating. A detailed parametric study of the equilibria is presented. Further, the nonlinear time evolution of these equilibria is studied, and it is observed that the point model obeys the delay convention (and hence hysteresis) and shows catastrophes at the fold edges of the equilibrium surfaces. Tentative applications are made to experimental results.

Telephone reminders reduced the non-attendance rate in a gastroenterology outpatient clinic.

Science.gov (United States)

Jeppesen, Maja Haunstrup; Ainsworth, Mark Andrew

2015-06-01

Non-attendance is a global health-care problem. The aim of the present study was 1) to investigate if a telephone reminder could reduce the non-attendance rate, 2) to study reasons for non-attendance and 3) to evaluate if a permanent implementation would be economically advantageous in a gastroenterology outpatient clinic like ours. This was a comparative intervention study with a historical control group in a gastroenterology outpatient clinic. The study lasted six months. Patients with a scheduled appointment in the first three-month period received no reminder (control group, n = 2,705). Patients in the following three-month period were reminded by telephone one weekday in advance of their appointment, when possible (intervention group, n = 2,479). Non-attending patients in the intervention group received a questionnaire. Based on the results, a financial cost-benefit analysis was made. In the intervention group, 1,577 (64%) patients answered the reminder telephone call. The non-attendance rate was significantly lower in the intervention group (6.1%) than in the control group (10.5%) (p < 0.00001). Only 1.3% of the patients who answered the reminder turned out to be non-attendees. The most common explanation for non-attendance in the intervention group was forgetfulness (39%). The reminder telephone call was cost-effective. In this outpatient clinic, telephone reminders were cost-effective and significantly reduced the non-attendance rate by 43%.

77 FR 14963 - Special Local Regulation; Moss Point Rockin' the Riverfront Festival; O'Leary Lake; Moss Point, MS

Science.gov (United States)

2012-03-14

...-AA08 Special Local Regulation; Moss Point Rockin' the Riverfront Festival; O'Leary Lake; Moss Point, MS..., and persons on navigable waters during the Moss Point Rockin' the Riverfront Festival high speed boat... and vessels from safety hazards associated with the Moss Point Rockin' the Riverfront Festival high...

Clinical observation on the treatment of acute liver failure by combined non-biological artificial liver.

Science.gov (United States)

Li, Maoqin; Sun, Jingxi; Li, Jiaqiong; Shi, Zaixiang; Xu, Jiyuan; Lu, Bo; Cheng, Shuli; Xu, Yanjun; Wang, Xiaomeng; Zhang, Xianjiang

2016-12-01

The clinical efficacy and safety of different combinations of non-bio artificial liver in the treatment of acute liver failure was examined. A total of 61 cases were selected under blood purification treatment from the patients with severe acute liver failure admitted to the severe disease department of the hospital from December, 2010 to December, 2015. Three types of artificial liver combinations were observed, i.e., plasma exchange plus hemoperfusion plus continuous venovenous hemodiafiltration (PE+HP+CVVHDF), PE+CVVHDF and HP+CVVHDF. The heart rate (HR), mean arterial pressure (MAP), respiratory index (PaO 2 /FiO 2 ), liver and kidney function indicator, as well as platelet and coagulation function were compared. A comparison before and after the treatment using the three methods, showed improvement in the HRs, MAPs, PaO 2 /FiO 2 , total bilirubins (TBIL) and alanine aminotransferases (ALT) (Prate of 62.3% (38/61), and a viral survival rate of 35.0% (7/20); with the non-viral survival rate being 75.6% (31/41). In conclusion, following the treatment of three types of artificial livers, the function was improved to varying degrees, with the PE+HP+CVVHDF and the PE+CVVHDF method being better. By contrast, after the treatment of non-viral liver failure, the survival rate was significantly higher than the patients with viral liver failure.

Points to consider for prioritizing clinical genetic testing services

DEFF Research Database (Denmark)

Severin, Franziska; Borry, Pascal; Cornel, Martina C

2015-01-01

Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set...... testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit......, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.European Journal of Human Genetics advance online publication, 24 September 2014; doi:10.1038/ejhg.2014.190....

English language proficiency and the accommodations for language non-concordance amongst patients utilizing chiropractic college teaching clinics.

Science.gov (United States)

Saporito, Richard P

2013-02-01

The number of households in the United States that are not proficient in the English language is growing and presenting a challenge to the health care system. Over nineteen percent of the US population speak a language other than English in the home. This increase in language discordance generates a greater need to find and implement accommodations in the clinical setting to insure accurate and efficient diagnosis and treatment as well as provide for patient safety. The purpose of this study is to determine the percentage of patients accessing the chiropractic college teaching clinics who are not proficient in the English language and to what extent the colleges provide accommodations for that language disparity. The clinic directors and deans of the Association of Chiropractic Colleges were surveyed via an on-line survey engine. The survey queried the percentage of the patient population that is not English language proficient, the accommodations the college currently has in place, if the college has a language specific consent to treat document and if the college has a written policy concerning patients without English proficiency. Fifty percent of the contacted chiropractic colleges responded to the survey. In the respondent college clinics 16.5% of the patient population is not proficient in English, with over 75% speaking Spanish. All but one of the respondents provide some level of accommodation for the language non-concordance. Forty five percent of the responding colleges employ a language specific consent to treat form. The implementation of accommodations and the use of a language specific consent to treat form is more prevalent at colleges with a higher percentage of non-English speaking patients. The percentage of patients with limited English proficiency accessing services at the teaching clinics of the chiropractic colleges mirrors the numbers in the general population. There is a wide disparity in the accommodations that the individual colleges make

A General Factor of Death Distress in Seven Clinical and Non-Clinical Groups

Science.gov (United States)

Abdel-Khalek, Ahmed M.

2004-01-01

The Arabic Scale of Death anxiety (ASDA), the Death Depression Scale (DDS), and the Death Obsession Scale (DOS) were administered, individually, to 7 groups (n = 765) of Egyptian normal participants (non-clinical), anxiety disorder patients, patients suffering from schizophrenia (males and females), and addicts (males only). They were generally…

The Comparison of Early Maladaptive Schema’s Domains Between Successful And Non-Successful Opiate Addicts and Non-Clinical Persons

Directory of Open Access Journals (Sweden)

Bahram Sahand

2009-10-01

Full Text Available Introduction: The current research was done in order to compare the early maladaptive schema’s domains between successful and non-successful opiate addicts and non-clinical persons in Tehran. Method: The research design was causal effect method. In this purpose 90 men (include successful and non-successful opiate addicts, and non-clinical persons (30 for each group, were selected by the available sampling method. Young Schema Questionnaire (YSQ-RE2R, General Health Questionnaire (GHQ, and Personal Characteristic Questionnaire were administered among selected sample. The results were analyzed by ANOVA, chi square, MANOVA, and tukey test. Results: The findings of this research indicated that there was a significant difference on “Early Maladaptive Schema’s domains” between these three groups. Conclusion: The results have important clinical interpretations. It is assumed that medical interference with the aim of modifying and correcting the “Early Maladaptive Schema’s domains” can be effective on the level of success for opiate addicts to give up their addiction.

Viewing behaviour of spider phobics and non-phobics in the presence of threat and safety stimuli.

Science.gov (United States)

Lange, W G T; Tierney, K J; Reinhardt-Rutland, A H; Vivekananda-Schmidt, P

2004-09-01

To determine whether spider phobics and spider non-phobics differ in attending to threat and safety stimuli in close proximity, or spatially separated. A sample group of 16 spider-phobic and 16 spider-non-phobic volunteers were drawn from a student population on the basis of their scores on Watts and Sharrock's Spider Phobia Questionnaire. Attention was assessed by way of participants' viewing behaviour using an ASL 501 head-mounted eye-tracking system. In a control condition, participants viewed a neutral stimulus (a TV video) in the absence of the threat stimulus. In two experimental conditions, the threat stimulus (a live Chilean rose tarantula) was introduced (a) immediately beside the safety stimulus (the only exit of the experimental room), or (b) away from the safety stimulus. In the experimental conditions, phobics reduced their viewing of the TV and increased their viewing of the tarantula and of the exit; the biggest changes occurred when tarantula and exit were together. Phobics also made more eye motions across the experimental room. Our results are consistent with previous research employing reaction time to a neutral stimulus as dependent measure. In addition, our results suggest that phobics scan the environment as part of safety behaviour. We suggest that exposure treatments to reduce spider phobia may be facilitated by encouraging patients to stop environmental scanning. Copyright 2004 The British Psychological Society

Clinical Utility and Safety of a Model-Based Patient-Tailored Dose of Vancomycin in Neonates.

Science.gov (United States)

Leroux, Stéphanie; Jacqz-Aigrain, Evelyne; Biran, Valérie; Lopez, Emmanuel; Madeleneau, Doriane; Wallon, Camille; Zana-Taïeb, Elodie; Virlouvet, Anne-Laure; Rioualen, Stéphane; Zhao, Wei

2016-04-01

Pharmacokinetic modeling has often been applied to evaluate vancomycin pharmacokinetics in neonates. However, clinical application of the model-based personalized vancomycin therapy is still limited. The objective of the present study was to evaluate the clinical utility and safety of a model-based patient-tailored dose of vancomycin in neonates. A model-based vancomycin dosing calculator, developed from a population pharmacokinetic study, has been integrated into the routine clinical care in 3 neonatal intensive care units (Robert Debré, Cochin Port Royal, and Clocheville hospitals) between 2012 and 2014. The target attainment rate, defined as the percentage of patients with a first therapeutic drug monitoring serum vancomycin concentration achieving the target window of 15 to 25 mg/liter, was selected as an endpoint for evaluating the clinical utility. The safety evaluation was focused on nephrotoxicity. The clinical application of the model-based patient-tailored dose of vancomycin has been demonstrated in 190 neonates. The mean (standard deviation) gestational and postnatal ages of the study population were 31.1 (4.9) weeks and 16.7 (21.7) days, respectively. The target attainment rate increased from 41% to 72% without any case of vancomycin-related nephrotoxicity. This proof-of-concept study provides evidence for integrating model-based antimicrobial therapy in neonatal routine care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

A business planning model to identify new safety net clinic locations.