WorldWideScience

Sample records for term safety review

  1. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review

    OpenAIRE

    Marasinghe, Keshini Madara

    2015-01-01

    Objectives Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LT...

  2. Short-term efficacy and safety of three novel sphincter-sparing techniques for anal fistulae: a systematic review.

    Science.gov (United States)

    Adegbola, S O; Sahnan, K; Pellino, G; Tozer, P J; Hart, A; Phillips, R K S; Warusavitarne, J; Faiz, O D

    2017-10-01

    The surgical treatment of complex anal fistulae, particularly those involving a significant portion of the anal sphincter in which fistulotomy would compromise continence, is challenging. Video-assisted anal fistula treatment (VAAFT), fistula tract laser closure (FiLaC™) and over-the-scope clip (OTSC®) proctology system are all novel sphincter-sparing techniques targeted at healing anal fistulae. In this study, all published articles on these techniques were reviewed to determine efficacy, feasibility and safety. A systematic search of major databases was performed using defined terms. All studies reporting on experience of these techniques were included and outcomes (fistula healing and safety) evaluated. Eighteen studies (VAAFT-12, FiLaC™-3, OTSC®-3) including 1245 patients were analysed. All were case series, and outcomes were heterogeneous with follow-up ranging from 6 to 69 months and short-term (anal fistulae, and short-term healing rates are acceptable with no sustained effect on continence. There is, however, a paucity of robust data with long-term outcomes. These techniques are thus welcome additions; however, their long-term place in the colorectal surgeon's armamentarium, whether diagnostic or therapeutic, remains uncertain.

  3. Microvascular decompression for hemifacial spasm: A systematic review of vascular pathology, long term treatment efficacy and safety.

    Science.gov (United States)

    Sharma, Ravi; Garg, Kanwaljeet; Agarwal, Samagra; Agarwal, Deepak; Chandra, P Sarat; Kale, Shashank S; Sharma, Bhawani S; Mahapatra, Ashok K

    2017-01-01

    Hemifacial spasm (HS) is a rare disorder caused by the compression of facial nerve root exit zone (REZ) at the brainstem by a vascular loop. Microvascular decompression (MVD) is a popular treatment modality for HS. The purpose of this study was to determine the long-term efficacy and safety of MVD for HS by assessing the effect of the procedure from the literature published over the last 25 years. A systematic data review from 1992 to 2015 using specific eligibility criteria yielded 27 studies on MVD for HS, the data of which were pooled and subjected to a meta-analysis. The pooled odds ratio (OR) revealed by the meta-analysis showed that anterior inferior cerebellar artery was the most common offending vessel in 37.8% (95% confidence interval [CI]: 27.8-47.7%) of the patients. Complete resolution of HS was seen in 88.5% (95% CI: 86.7-90.4%) of the patients after a long-term follow up. The complication rate was low following MVD, the most common being temporary facial paresis in 5.9% (95% CI: 4.3-7.5%) of patients. MVD is a safe and effective treatment for HS with long-term benefits and a low complication rate.

  4. Ustekinumab in chronic immune-mediated diseases: a review of long term safety and patient improvement

    Directory of Open Access Journals (Sweden)

    Toussirot E

    2013-04-01

    clinical trial data indicated no specific patterns of infection or malignancy under long-term ustekinumab administration. Ustekinumab is easy to use, has a comfortable therapeutic regimen, improves quality of life in patients, and thus appears to be an attractive biological treatment that is adapted and accepted by patients with moderate to severe psoriasis. Keywords: IL-23, psoriasis, autoimmune diseases, quality of life

  5. Lift truck safety review

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

  6. The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review.

    Science.gov (United States)

    Dewa, Carolyn S; Loong, Desmond; Bonato, Sarah; Trojanowski, Lucy

    2017-06-21

    This study reviews the current state of the published peer-reviewed literature related to physician burnout and two quality of care dimensions. The purpose of this systematic literature review is to address the question, 'How does physician burnout affect the quality of healthcare related to the dimensions of acceptability and safety?' Using a multiphase screening process, this systematic literature review is based on publically available peer-reviewed studies published between 2002 and 2017. Six electronic databases were searched: (1) MEDLINE Current, (2) MEDLINE In-process, (3) MEDLINE Epub Ahead of Print, (4) PsycINFO, (5) Embase and (6) Web of Science. Physicians practicing in civilian settings. Practicing physicians who have completed training. Quality of healthcare related to acceptability (ie, patient satisfaction, physician communication and physician attitudes) and safety (ie, minimising risks or harm to patients). 4114 unique citations were identified. Of these, 12 articles were included in the review. Two studies were rated as having high risk of bias and 10 as having moderate risk. Four studies were conducted in North America, four in Europe, one in the Middle East and three in East Asia. Results of this systematic literature review suggest there is moderate evidence that burnout is associated with safety-related quality of care. Because of the variability in the way patient acceptability-related quality of care was measured and the inconsistency in study findings, the evidence supporting the relationship between burnout and patient acceptability-related quality of care is less strong. The focus on direct care-related quality highlights additional ways that physician burnout affects the healthcare system. These studies can help to inform decisions about how to improve patient care by addressing physician burnout. Continued work looking at the relationship between dimensions of acceptability-related quality of care measures and burnout is needed to

  7. Safety analysis SFR 1. Long-term safety

    Energy Technology Data Exchange (ETDEWEB)

    2008-12-15

    regulatory authorities' previous review comments. Furthermore, definitions are given of terms and abbreviations used in SAR- 08, General Part 2, 'Long-term safety'. Chapter 2 Method. The chapter provides an overall description of the method used for the safety assessment and some aspects of the methodology are presented, such as time periods, safety principles, management of uncertainties, quality assurance and risk management. Chapter 3 Identification, ranking and handling of FEPs. The chapter systematically describes the factors to be taken into account in the assessment in the form of features, events and processes (FEPs). Interaction matrices are used to structure the information. Chapter 4 Initial state in the repository and its environs. The chapter describes the initial state, defined as the expected state of the repository and its environs, at closure in 2040. The description of the initial state is based on the technical design of the repository, present-day knowledge concerning conditions in the repository and its environs, and the expected evolution of the repository up until 2040. Chapter 5 Safety functions and safety performance indicators. Safety functions and safety performance indicators are identified and described in this chapter. A safety function is a role by means of which a repository component contributes to safety. Chapter 6 Reference evolution for the repository and its environs. This chapter describes the reference evolution of the repository and its environs and how the safety functions of the repository can be affected by this evolution up until 100,000 years after closure. Chapter 7 Selection of scenarios. This chapter describes how scenarios are selected based on safety performance indicators and interaction matrices. The selected scenarios illustrate the most important processes leading to the migration of radionuclides in the repository and to exposure of man and environment. The description of the processes is based on the

  8. Long-term efficacy and safety of otilonium bromide in the management of irritable bowel syndrome: a literature review.

    Science.gov (United States)

    Triantafillidis, John K; Malgarinos, George

    2014-01-01

    Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits. The disease affects a large part of the world population. The clinical course is mostly characterized by a cyclic recurrence of symptoms. Therefore, IBS patients should receive, as an initial therapeutic approach, a short course of treatment, and long-term treatment should be reserved for those patients with recurrent symptoms. The available clinical trials show that significant improvement of the symptoms over placebo could be achieved with various drugs, although this improvement is frequently time dependent and with high relapse rates after the cessation of the treatment. In a proportion of patients, clinically obvious relapse could appear long after stopping the treatment. Some of the available pharmacologic agents, including otilonium bromide (OB), are able to significantly prolong the time to the appearance of relapse, compared with placebo. As a consequence, some authors suggest that a cyclic treatment could be of benefit. Antispasmodic drugs have been used for many years in an effort to control the symptoms of IBS. OB is a poorly absorbed spasmolytic drug, exerting significantly greater control of the symptoms of IBS compared with placebo. Recent data suggest that the drug could effectively be used for the long-term management of patients with IBS. The aim of this review is to provide the reader with an evidence-based overview of the efficacy and tolerability of OB in the long-term management of IBS patients, based on the results of the clinical trials published so far.

  9. Efficacy and Safety of Acupuncture in Preterm and Term Infants

    OpenAIRE

    Wolfgang Raith; Berndt Urlesberger; Georg M Schmölzer

    2013-01-01

    The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants. We searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials using a predefined algorithm, reviewed abstracts from the Pediatric Academic Society annual meetings (2000–2012), and performed a manual search of references in narrative and systematic reviews. A total of 26 studies identified met our search criteria. Only 6 of these studies met our in...

  10. TOY SAFETY SURVEILLANCE FROM ONLINE REVIEWS.

    Science.gov (United States)

    Winkler, Matt; Abrahams, Alan S; Gruss, Richard; Ehsani, Johnathan P

    2016-10-01

    Toy-related injuries account for a significant number of childhood injuries and the prevention of these injuries remains a goal for regulatory agencies and manufacturers. Text-mining is an increasingly prevalent method for uncovering the significance of words using big data. This research sets out to determine the effectiveness of text-mining in uncovering potentially dangerous children's toys. We develop a danger word list, also known as a 'smoke word' list, from injury and recall text narratives. We then use the smoke word lists to score over one million Amazon reviews, with the top scores denoting potential safety concerns. We compare the smoke word list to conventional sentiment analysis techniques, in terms of both word overlap and effectiveness. We find that smoke word lists are highly distinct from conventional sentiment dictionaries and provide a statistically significant method for identifying safety concerns in children's toy reviews. Our findings indicate that text-mining is, in fact, an effective method for the surveillance of safety concerns in children's toys and could be a gateway to effective prevention of toy-product-related injuries.

  11. Internet Safety and Security Surveys - A Review

    DEFF Research Database (Denmark)

    Sharp, Robin

    This report gives a review of investigations into Internet safety and security over the last 10 years. The review covers a number of surveys of Internet usage, of Internet security in general, and of Internet users' awareness of issues related to safety and security. The focus and approach...

  12. A literature review of safety culture.

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

    2013-03-01

    Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavor was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of

  13. Occupational Safety Review of High Technology Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Lee Cadwallader

    2005-01-31

    This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

  14. Efficacy and Safety of Acupuncture in Preterm and Term Infants

    Directory of Open Access Journals (Sweden)

    Wolfgang Raith

    2013-01-01

    Full Text Available The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants. We searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials using a predefined algorithm, reviewed abstracts from the Pediatric Academic Society annual meetings (2000–2012, and performed a manual search of references in narrative and systematic reviews. A total of 26 studies identified met our search criteria. Only 6 of these studies met our inclusion criteria; however, two studies had to be excluded because the manuscripts were published in Chinese. Hence, only four studies were included in our analysis. Three of the four studies evaluated the effects of acupuncture on infantile colic, and one assessed pain reduction during minor painful procedures in preterm babies. The limited data available suggests that acupuncture could be a safe nonpharmacologic treatment option for pain reduction in term and preterm infants and could also be a non-pharmacologic treatment option to treat infantile colic. Currently acupuncture in infants should be limited to clinical trials and studies evaluating short- and long-term effects and should be performed only by practitioners with adequate training and experience in neonatal/pediatric acupuncture.

  15. Efficacy and safety of acupuncture in preterm and term infants.

    Science.gov (United States)

    Raith, Wolfgang; Urlesberger, Berndt; Schmölzer, Georg M

    2013-01-01

    The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants. We searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials using a predefined algorithm, reviewed abstracts from the Pediatric Academic Society annual meetings (2000-2012), and performed a manual search of references in narrative and systematic reviews. A total of 26 studies identified met our search criteria. Only 6 of these studies met our inclusion criteria; however, two studies had to be excluded because the manuscripts were published in Chinese. Hence, only four studies were included in our analysis. Three of the four studies evaluated the effects of acupuncture on infantile colic, and one assessed pain reduction during minor painful procedures in preterm babies. The limited data available suggests that acupuncture could be a safe nonpharmacologic treatment option for pain reduction in term and preterm infants and could also be a non-pharmacologic treatment option to treat infantile colic. Currently acupuncture in infants should be limited to clinical trials and studies evaluating short- and long-term effects and should be performed only by practitioners with adequate training and experience in neonatal/pediatric acupuncture.

  16. Testosterone Replacement Therapy: Long-Term Safety and Efficacy

    Directory of Open Access Journals (Sweden)

    Giovanni Corona

    2017-08-01

    Full Text Available Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG or late-onset hypogonadism (LOH. The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T therapy (TTh. In addition, concerns related to cardiovascular (CV safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented.

  17. Improving Patient Safety Culture in Primary Care: A Systematic Review.

    Science.gov (United States)

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2016-09-01

    Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which effect interventions have on the safety culture. To review literature on the use of interventions that effect patient safety culture in primary care. Searches were performed in PubMed, EMBASE, CINAHL, and PsychINFO on March 4, 2013. Terms defining safety culture were combined with terms identifying intervention and terms indicating primary care. Inclusion followed if the intervention effected patient safety culture, and effect measures were reported. The search yielded 214 articles from which two were eligible for inclusion. Both studies were heterogeneous in their interventions and outcome; we present a qualitative summary. One study described the implementation of an electronic medical record system in general practices as part of patient safety improvements. The other study facilitated 2 workshops for general practices, one on risk management and another on significant event audit. Results showed signs of improvement, but the level of evidence was low because of the design and methodological problems. These studies in general practice provide a first understanding of improvement strategies and their effect in primary care. As the level of evidence was low, no clear preference can be determined. Further research is needed to help practices make an informed choice for an intervention.

  18. Long-term efficacy and safety of human papillomavirus vaccination

    Directory of Open Access Journals (Sweden)

    De Vincenzo R

    2014-12-01

    Full Text Available Rosa De Vincenzo,1 Carmine Conte,1 Caterina Ricci,1 Giovanni Scambia,1 Giovanni Capelli2 1Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, 2Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio, Cassino, Italy Abstract: In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV vaccines and their safety profile. Two prophylactic HPV vaccines – bivalent (bHPV and quadrivalent (qHPV – are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman’s sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs, serious

  19. Temsirolimus: a safety and efficacy review.

    Science.gov (United States)

    Bukowski, Ronald M

    2012-09-01

    The vascular endothelial growth factor (VEGF) pathway and the mammalian Target of Rapamycin (mTOR) represent the most frequently exploited targets in renal cell carcinoma (RCC). Temsirolimus is an inhibitor of mTOR, and is a unique ester derivative of sirolimus, a macrocyclic lactone, with improved pharmaceutical properties, including stability and solubility. Temsirolimus binds to the cytoplasmic protein FKBP-12, and the complex binds and inhibits mTOR. This review summarizes the clinical findings and safety of temsirolimus in RCC patients. A Phase III clinical trial has demonstrated that temsirolimus has statistically significant advantages over treatment with IFN-α in RCC patients with poor prognosis, in terms of OS (overall survival), PFS (progression-free survival), and tumor response. Median OS was improved 49% compared to IFN-α, and median PFS was approximately doubled. It is now considered the standard for RCC patients with poor prognostic features. The possibility that this agent is useful in metastatic non-clear cell carcinoma patients has also been suggested by a subset analysis of the pivotal Phase III trial. Studies in untreated favorable and intermediate risk clear cell and refractory mRCC patients are required.

  20. Safety of long-term PPI therapy

    DEFF Research Database (Denmark)

    Reimer, Christina

    2013-01-01

    in the past decade and are critically reviewed in this article and the existing evidence is evaluated and translated into possible clinical consequences. Based on the existing evidence the benefits of PPI treatment seem to outweigh potential risks in the large majority of patients especially if PPI use...

  1. REVIEW OF SAFETY AND TOLERANCE OF OMALIZUMAB

    Directory of Open Access Journals (Sweden)

    A.V. Emel'yanov

    2008-01-01

    Full Text Available The review of safety of monoclonal anti-ige-antibodies (xolair — a new medication for the treatment of severe allergic bronchial asthma is presented. Local and system adverse events, originating after injection of medicament in clinical studies and following administration in patients are discussed.Key words: children, bronchial asthma, monoclonal anti Ige antibodies.

  2. Literature review regarding patient safety culture.

    Science.gov (United States)

    Xuanyue, Mao; Yanli, Nie; Hao, Cui; Pengli, Jia; Mingming, Zhang

    2013-02-01

    Quite a number of articles on patient safety culture have been published in recent 10 years to assess the safety culture in hospitals using the Hospital Survey on Patient Safety Culture in many countries. However, until now there have been no relevant studies to investigate the quality of these, and their contribution to present-day thinking. The aim of this study was to explore the areas of theme, and the study design of published research on patient safety culture in literature published in English and Chinese language journals. We searched the major databases, including MEDLINE, EMbase, Chinese Biomedical Literature Database, Chinese Journals Full-text Database, and to analyze the publication years, research themes, authors' affiliations and methodologies of articles published from January 2001 to December 2011. Quality and statistical method were only appraised by classification of study designs. The annual number of published articles on patient safety culture was increasing in the last decade, and the number of articles published in 2010 and 2011 reached its peak with 86 articles accounting for 44.6% of the decade's publication; patient safety culture scale dominated the included literature, accounting for 67.8% of all studies. Cross-sectional studies and commentary reviews were the most popular study designs which took up approximately 95.9% of the included studies with 66.9% (129 articles) and 29.0% (56 articles), respectively. All the included studies on patient safety culture were conducted in the following four institutions: hospitals, geracomium, Veterans Health Administration hospitals, and medical schools. There is a growing change trend in the number of articles on patient safety culture research in recent 10 years, most of which are non-comparative studies. More methodologically rigorous designs are needed to improve research quality on patient safety culture. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of

  3. Safety review of conceptual fusion power plants

    Energy Technology Data Exchange (ETDEWEB)

    Clark, R.G.

    1976-11-01

    The potential public safety impacts from accidents in conceptual fusion power plants were investigated. Fusion was found to have some potential for accidents, as does any energy generating system. Functions of fusion power plants were identified that possess sufficient potential for an accidental release of toxic materials to the environment. An assessment was made of the impact of the potential accidents and recommendations are included for R and D that will allow incorporation of safety concerns in fusion power plant design. This work was based on a review of information available in conceptual design documents of fusion reactor systems.

  4. Safety of human papillomavirus vaccines: a review

    Science.gov (United States)

    Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

    2015-01-01

    Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence. PMID:25689872

  5. Translation and review on the IAEA safety standards and guides

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hoon; Lee, Yeong Hwan; Moon, Seok Hyeong; Sohn, Moon Kyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    2000-12-15

    Translation and review of five IAEA safety guides as follows : staffing of Nuclear Power Plants and the recruitment, training and authorization of operating personnel (safety series No. 50-SG-01), in-service inspection for Nuclear Power Plants (safety series No. 50-SG-02), operating limits and conditions for Nuclear Power Plants (safety series No. 50-SG-03), commissioning procedures for Nuclear Power Plants (safety series No. 50-SG-04), maintenance of Nuclear Power Plants (safety series No. 50-SG-07)

  6. [Safety of long-term nicotine use: An ongoing debate].

    Science.gov (United States)

    Dupont, P; Benyamina, A; Aubin, H-J

    2016-12-01

    Long-term nicotine use has been proposed as a risk-reduction strategy in smokers unwilling or unable to quit. However, its safety remains debated. Analysis of publications identified in PubMed, Toxibase, Google Scholar and in the Food and Drug Administration, and French National Authority for Health websites. Nicotine seems to be implicated in the genesis of atherosclerosis. It could be a cancer precursor, could be implicated in cancer proliferation and angiogenesis, in apoptosis reduction, and may be genotoxic. New studies are warranted for more complete assessment of the risk-benefit balance. It is difficult to affirm the safety of long term nicotine use. The risk-benefit balance should be assessed in terms of a risk-reduction strategy, as in other domains, notably illicit drug use. Copyright © 2016 SPLF. Published by Elsevier Masson SAS. All rights reserved.

  7. [Long-term opioid therapy in chronic noncancer pain. A systematic review and meta-analysis of efficacy, tolerability and safety in open-label extension trials with study duration of at least 26 weeks].

    Science.gov (United States)

    Häuser, W; Bernardy, K; Maier, C

    2015-02-01

    The efficacy and safety of long-term (≥ 6 months) opioid therapy (LtOT) in chronic noncancer pain (CNCP) is under debate. A systematic review with meta-analysis of the efficacy and harms of opioids in open-label extension studies of randomized controlled trials (RCTs) has not been conducted until now. We screened MEDLINE and clinicaltrials.gov (through to December 2013), as well as reference sections of systematic reviews of long-term RCTs of opioids in CNCP. We included open-label extension trials with a study duration ≥ 26 weeks of RCTs of ≥ 2 weeks duration. Using a random effects model, pooled estimates of event rates for categorical data and standardized mean differences (SMD) for continuous variables were calculated. We included 11 open-label extension studies with 2445 participants with nociceptive (low back, osteoarthritis) and neuropathic (radicular, polyneuropathy) pain. Median study duration was 26 (range 26-108) weeks. Four studies tested oxycodone, two studies tramadol and buprenorphine; hydromorphone, morphine, oxymorphone and tapentadol were each tested in one study. Of the patients randomized at baseline, 28.5 % (95 % confidence interval, CI, 17.9-39.2 %) finished the open-label period; 53.5 % (95 % CI 38.1-68.2 %) of patients entering the open-label period finished the open-label period. In sum, the total loss was 71.5 % (95 % CI 60.9-83.1 %) of all patients primarily included into the RCT. A total of 4.9 % (95 % CI 2.9-8.2 %) of patients dropped out due lack of efficacy; 16.8 % (95 % CI 11.0-24.8 %) dropped out to due adverse events (AE) in the open-label period and 0.08 % (95 % CI 0.001-0.05 %) of patients died during the open-label period. Only one study systematically assessed aberrant drug behavior of the patients: 5.7 % (95 % CI 3.4-9.6 %) showed aberrant drug behavior in the opinion of the investigators and 2.6 % (95 % CI 1.2-5.8 %) were judged to show

  8. Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

    Energy Technology Data Exchange (ETDEWEB)

    DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

    2007-04-12

    This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

  9. Patient safety education for undergraduate medical students: a systematic review

    Directory of Open Access Journals (Sweden)

    Zhang Mingming

    2011-06-01

    Full Text Available Abstract Background To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients. Incorporating the knowledge of how to do this into the medical student curriculum is an urgent necessity. This paper aims to systematically review the literature about patient safety education for undergraduate medical students in terms of its content, teaching strategies, faculty availability and resources provided so as to identify evidence on how to promote patient safety in the curriculum for medical schools. This paper includes a perspective from the faculty of a medical school, a major hospital and an Evidence Based Medicine Centre in Sichuan Province, China. Methods We searched MEDLINE, ERIC, Academic Source Premier(ASP, EMBASE and three Chinese Databases (Chinese Biomedical Literature Database, CBM; China National Knowledge Infrastructure, CNKI; Wangfang Data from 1980 to Dec. 2009. The pre-specified form of inclusion and exclusion criteria were developed for literature screening. The quality of included studies was assessed using Darcy Reed and Gemma Flores-Mateo criteria. Two reviewers selected the studies, undertook quality assessment, and data extraction independently. Differing opinions were resolved by consensus or with help from the third person. Results This was a descriptive study of a total of seven studies that met the selection criteria. There were no relevant Chinese studies to be included. Only one study included patient safety education in the medical curriculum and the remaining studies integrated patient safety into clinical rotations or medical clerkships. Seven studies were of a pre and post study design, of which there was only one controlled study. There was considerable variation in relation to contents

  10. Patient safety and electromagnetic protection: a review.

    Science.gov (United States)

    Carranza, Noemí; Febles, Víctor; Hernández, José A; Bardasano, José L; Monteagudo, José L; Fernández de Aldecoa, José C; Ramos, Victoria

    2011-05-01

    A systematic literature review was carried out to study patient security and possible harmful effects, immunity and interferences on medical devices, and effectiveness and transmission problems in healthcare and hospital environments due to electromagnetic interferences. The objective was to determine already-reported cases of patient security, immunity of medical devices, and transmission/reception failure in order to evaluate safety and security of patients. Literature published in the last 10 years has been reviewed by searching in bibliographic databases, journals, and proceedings of conferences. Search strategies developed in electronic databases identified a total of 820 references, with 50 finally being included. The study reveals the existence of numerous publications on interferences in medical devices due to radiofrequency fields. However, literature on effectiveness, transmission problems and measurements of electromagnetic fields is limited. From the studies collected, it can be concluded that several cases of serious interferences in medical instruments have been reported. Measures of electromagnetic fields in healthcare environments have been also reported, concluding that special protective measures should be taken against electromagnetic interferences by incoming radio waves.

  11. Long-term efficacy and safety of iloperidone: an update.

    Science.gov (United States)

    Rado, Jeffrey T; Janicak, Philip G

    2014-01-01

    Schizophrenia is a devastating neuropsychiatric disease with a worldwide prevalence of approximately 0.5%-1%. Since many patients do not achieve adequate symptom relief from available agents, alternate pharmacotherapeutic approaches are needed. In this context, iloperidone was recently approved by the US Food and Drug Administration for the treatment of schizophrenia. This paper first reviews its pharmacodynamic and pharmacokinetic profiles, emphasizing their clinical relevance. Next, it summarizes the literature on its acute and maintenance efficacy, safety, and tolerability. It then considers pharmacogenetic data which may help to predict response and risk of cardiac arrhythmias with this agent. Finally, it critically positions iloperidone relative to other first- and second-generation antipsychotics.

  12. Safety Education Impact and Good Practice: A Review

    Science.gov (United States)

    Mulvaney, Caroline A.; Watson, Michael C.; Errington, Gail

    2012-01-01

    Purpose: The aim of this literature review was to examine recent evidence of the impact of safety education for children and young people on unintentional injury rates and to update an earlier review. Evidence was sought that linked safety education for children and young people in schools, centres and other settings with changes in knowledge,…

  13. Conducting organizational safety reviews - requirements, methods and experience

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, T.; Oedewald, P.; Wahlstroem, B. [Technical Research Centre of Finland, VTT (Finland); Rollenhagen, C. [Royal Institute of Technology, KTH, (Sweden); Kahlbom, U. [RiskPilot (Sweden)

    2008-03-15

    Organizational safety reviews are part of the safety management process of power plants. They are typically performed after major reorganizations, significant incidents or according to specified review programs. Organizational reviews can also be a part of a benchmarking between organizations that aims to improve work practices. Thus, they are important instruments in proactive safety management and safety culture. Most methods that have been used for organizational reviews are based more on practical considerations than a sound scientific theory of how various organizational or technical issues influence safety. Review practices and methods also vary considerably. The objective of this research is to promote understanding on approaches used in organizational safety reviews as well as to initiate discussion on criteria and methods of organizational assessment. The research identified a set of issues that need to be taken into account when planning and conducting organizational safety reviews. Examples of the issues are definition of appropriate criteria for evaluation, the expertise needed in the assessment and the organizational motivation for conducting the assessment. The study indicates that organizational safety assessments involve plenty of issues and situations where choices have to be made regarding what is considered valid information and a balance has to be struck between focus on various organizational phenomena. It is very important that these choices are based on a sound theoretical framework and that these choices can later be evaluated together with the assessment findings. The research concludes that at its best, the organizational safety reviews can be utilised as a source of information concerning the changing vulnerabilities and the actual safety performance of the organization. In order to do this, certain basic organizational phenomena and assessment issues have to be acknowledged and considered. The research concludes with recommendations on

  14. CCAA Mid Term Review | IDRC - International Development ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2011-01-07

    Jan 7, 2011 ... This report presents the findings of the mid term review (MTR) of the Canadian International Development Research Centre (IDRC) and the UK Department for International Development (DFID) Climate Change Adaptation in Africa research and capacity development programme (CCAA). It aims to inform ...

  15. The Safety of Orthokeratology--A Systematic Review.

    Science.gov (United States)

    Liu, Yue M; Xie, Peiying

    2016-01-01

    The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Relevant clinical studies including case series, case reports, patient/practitioner surveys, retrospective and prospective cohort studies, and clinical trials were all included in the review. The material of OrthoK lenses was limited to gas-permeable lens. This review incorporated a total of 170 publications, including 58 English and 112 Chinese literature. The risk of microbial keratitis in overnight OrthoK was similar to that of other overnight modality. The most common complication was corneal staining. Other clinically insignificant side effects included epithelial iron deposit, prominent fribrillary lines, and transient changes of corneal biomechanical properties. There was no long-term effect of OrthoK on corneal endothelium. There is sufficient evidence to suggest that OrthoK is a safe option for myopia correction and retardation. Long-term success of OrthoK treatment requires a combination of proper lens fitting, rigorous compliance to lens care regimen, good adherence to routine follow-ups, and timely treatment of complications.

  16. The Safety of Orthokeratology—A Systematic Review

    Science.gov (United States)

    Xie, Peiying

    2016-01-01

    Objectives: The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Data Sources: Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Selection Criteria: Relevant clinical studies including case series, case reports, patient/practitioner surveys, retrospective and prospective cohort studies, and clinical trials were all included in the review. The material of OrthoK lenses was limited to gas-permeable lens. Main Results: This review incorporated a total of 170 publications, including 58 English and 112 Chinese literature. The risk of microbial keratitis in overnight OrthoK was similar to that of other overnight modality. The most common complication was corneal staining. Other clinically insignificant side effects included epithelial iron deposit, prominent fribrillary lines, and transient changes of corneal biomechanical properties. There was no long-term effect of OrthoK on corneal endothelium. Conclusions: There is sufficient evidence to suggest that OrthoK is a safe option for myopia correction and retardation. Long-term success of OrthoK treatment requires a combination of proper lens fitting, rigorous compliance to lens care regimen, good adherence to routine follow-ups, and timely treatment of complications. PMID:26704136

  17. Design review report for modifications to RMCS safety class equipment

    Energy Technology Data Exchange (ETDEWEB)

    Corbett, J.E.

    1997-05-30

    This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable.

  18. Long-term efficacy and safety of iloperidone: an update

    Directory of Open Access Journals (Sweden)

    Rado JT

    2014-02-01

    Full Text Available Jeffrey T Rado, Philip G JanicakRush University Medical Center, Chicago, IL, USAAbstract: Schizophrenia is a devastating neuropsychiatric disease with a worldwide prevalence of approximately 0.5%–1%. Since many patients do not achieve adequate symptom relief from available agents, alternate pharmacotherapeutic approaches are needed. In this context, iloperidone was recently approved by the US Food and Drug Administration for the treatment of schizophrenia. This paper first reviews its pharmacodynamic and pharmacokinetic profiles, emphasizing their clinical relevance. Next, it summarizes the literature on its acute and maintenance efficacy, safety, and tolerability. It then considers pharmacogenetic data which may help to predict response and risk of cardiac arrhythmias with this agent. Finally, it critically positions iloperidone relative to other first- and second-generation antipsychotics.Keywords: schizophrenia, iloperidone, antipsychotic

  19. Long-term safety and efficacy of teriflunomide

    Science.gov (United States)

    Comi, Giancarlo; Freedman, Mark S.; Miller, Aaron E.; Kappos, Ludwig; Bouchard, Jean-Pierre; Lebrun-Frenay, Christine; Mares, Jan; Benamor, Myriam; Thangavelu, Karthinathan; Liang, Jinjun; Truffinet, Philippe; Lawson, Victoria J.; Wolinsky, Jerry S.

    2016-01-01

    Objective: To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). Methods: A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg. Results: By June 2013, median (maximum) teriflunomide exposure exceeded 190 (325) weeks per patient; 468 patients (63%) remained on treatment. Teriflunomide was well-tolerated with continued exposure. The most common adverse events (AEs) matched those in the core study. In extension year 1, first AEs of transient liver enzyme increases or reversible hair thinning were generally attributable to patients switching from placebo to teriflunomide. Approximately 11% of patients discontinued treatment owing to AEs. Twenty percent of patients experienced serious AEs. There were 3 deaths unrelated to teriflunomide. Soon after the extension started, annualized relapse rates and gadolinium-enhancing T1 lesion counts fell in patients switching from placebo to teriflunomide, remaining low thereafter. Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48). Conclusions: In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years. Disease activity decreased in patients switching from placebo and remained low in patients continuing on teriflunomide. Classification of evidence: This study provides Class III evidence that long-term treatment with teriflunomide is well-tolerated and efficacy of teriflunomide is maintained long-term. PMID:26865517

  20. Tank waste remediation system nuclear criticality safety program management review

    Energy Technology Data Exchange (ETDEWEB)

    BRADY RAAP, M.C.

    1999-06-24

    This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

  1. Nuclear Safety: Technical progress review, January--March 1989

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E. G. [ed.

    1989-01-01

    This review journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  2. Patient safety in otolaryngology: a descriptive review.

    Science.gov (United States)

    Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

    2017-03-01

    Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within

  3. 78 FR 11902 - Review of Gun Safety Technologies

    Science.gov (United States)

    2013-02-20

    ... an interest in gun safety. Representative stakeholders include, but are not limited to, law... of Justice Programs Review of Gun Safety Technologies AGENCY: National Institute of Justice, JPO, DOJ. ACTION: Notice. SUMMARY: Following the President's Plan to reduce gun violence released on January 16...

  4. Long term operation of nuclear power plants – IAEA SALTO peer review service and its results

    Energy Technology Data Exchange (ETDEWEB)

    Krivanek, Robert, E-mail: r.krivanek@iaea.org

    2014-12-15

    Highlights: • SALTO peer review service is designed for reviewing of ageing management and NPPs’ preparedness LTO. • It has been established as an effective tool to review the compliance with IAEA safety standards. • The important issues for safe LTO are being identified by SALTO missions. • Analysis of those issues is provided in the paper. • This peer review service is strongly recommended for NPPs prior to entering LTO period. - Abstract: This paper presents main IAEA activities for safe long term operation (LTO) which includes establishment of IAEA Safety Standards and other LTO related documents, fostering information exchange and establishing databases and provision of SALTO (Safety Aspects of Long Term Operation) peer review service. This paper provides insights into IAEA SALTO peer review service objectives, scope and methodology. The SALTO peer review service was designed to assist nuclear power plant (NPP) operators in adopting a proper approach to LTO of their plants and in implementing complete and appropriate activities to ensure that plant safety will be maintained during the LTO period. The SALTO peer review service can also support regulators in establishing or improving regulatory and licensing strategies for LTO of NPPs. Issues derived from 19 SALTO missions and 2 LTO modules of OSART (Operational Safety Review Team) missions conducted during the period of 2005 to March 2014 are also analyzed in this paper.

  5. Nulcear Safety: Technical progress review, October--December 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    Nuclear Safety is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  6. Nuclear Safety: Volume 29, No. 3: Technical progress review

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-07-01

    Nuclear Safety is a review journal that covers significant development in the field of nuclear safety. Its scope included the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated. Individual papers have been cataloged separately.

  7. Patient participation in patient safety and nursing input - a systematic review.

    Science.gov (United States)

    Vaismoradi, Mojtaba; Jordan, Sue; Kangasniemi, Mari

    2015-03-01

    This systematic review aims to synthesise the existing research on how patients participate in patient safety initiatives. Ambiguities remain about how patients participate in routine measures designed to promote patient safety. Systematic review using integrative methods. Electronic databases were searched using keywords describing patient involvement, nursing input and patient safety initiatives to retrieve empirical research published between 2007 and 2013. Findings were synthesized using the theoretical domains of Vincent's framework for analysing risk and safety in clinical practice: "patient", "healthcare provider", "task", "work environment", "organisation & management". We identified 17 empirical research papers: four qualitative, one mixed-method and 12 quantitative designs. All 17 papers indicated that patients can participate in safety initiatives. Improving patient participation in patient safety necessitates considering the patient as a person, the nurse as healthcare provider, the task of participation and the clinical environment. Patients' knowledge, health conditions, beliefs and experiences influence their decisions to engage in patient safety initiatives. An important component of the management of long-term conditions is to ensure that patients have sufficient knowledge to participate. Healthcare providers may need further professional development in patient education and patient care management to promote patient involvement in patient safety, and ensure that patients understand that they are 'allowed' to inform nurses of adverse events or errors. A healthcare system characterised by patient-centredness and mutual acknowledgement will support patient participation in safety practices. Further research is required to improve international knowledge of patient participation in patient safety in different disciplines, contexts and cultures. Patients have a significant role to play in enhancing their own safety while receiving hospital care. This

  8. [Should we establish patient safety leadership walkrounds? A systematic review].

    Science.gov (United States)

    Girerd-Genessay, I; Michel, P

    2015-10-01

    Used for over a decade, patient safety leadership walkrounds (PSLWs) is a managerial method designed to enhance the implementation of safety measures in hospitals. In order to determine the effect of PSLWs in French hospitals, we reviewed the literature on participant perceptions and the impact of PSLW on the overall culture of safety. We conducted a systematic review of articles assessing the impact of PSLWs on the culture of safety (comparative studies) or the perceptions of caregivers and managers (qualitative studies). Five studies investigating safety culture and three studies investigating participant perception were identified. PSLWs were associated with an improvement in safety culture and the overall safety climate. The presence of caregivers during the PSLWs was important to achieve improvement. PSLWs improved the dialogue between caregivers and managers, and improved knowledge on care safety. Some problems concerning managerial PSLW attendance and counter-productive attitudes have occasionally been reported. PSLWs improve safety culture. Their effectiveness depends on the way they are implemented. They should initially be tested in France to ensure their feasibility and acceptability in our healthcare system. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  9. Demonstrating the Safety of Long-Term Dry Storage - 13468

    Energy Technology Data Exchange (ETDEWEB)

    McCullum, Rod [Nuclear Energy Institute, 1201 F St. NW, Washington, DC, 20004 (United States); Brookmire, Tom [Dominion Energy, 5000 Dominion Boulevard Glen Allen, VA 23060 (United States); Kessler, John [Electric Power Research Institute, 1300 West W.T. Harris Boulevard, Charlotte, NC 28262 (United States); Leblang, Suzanne [Entergy, 1340 Echelon Parkway, Jackson, MS 39211 (United States); Levin, Adam [Exelon, 4300 Winfield Road, Warrenville, IL 60555 (United States); Martin, Zita [Tennessee Valley Authority, 1101 Market Street, Chattanooga, TN 37402 (United States); Nesbit, Steve [Duke Energy, 550 South Tryon Street, Charlotte, NC 28202 (United States); Nichol, Marc [Nuclear Energy Institute, 1201 F St. NW Washington DC, 2004 (United States); Pickens, Terry [Xcel Energy, 414 Nicollet Mall, Minneapolis, MN 55401 (United States)

    2013-07-01

    Commercial nuclear plants in the United States were originally designed with the expectation that used nuclear fuel would be moved directly from the reactor pools and transported off site for either reprocessing or direct geologic disposal. However, Federal programs intended to meet this expectation were never able to develop the capability to remove used fuel from reactor sites - and these programs remain stalled to this day. Therefore, in the 1980's, with reactor pools reaching capacity limits, industry began developing dry cask storage technology to provide for additional on-site storage. Use of this technology has expanded significantly since then, and has today become a standard part of plant operations at most US nuclear sites. As this expansion was underway, Federal programs remained stalled, and it became evident that dry cask systems would be in use longer than originally envisioned. In response to this challenge, a strong technical basis supporting the long term dry storage safety has been developed. However, this is not a static situation. The technical basis must be able to address future challenges. Industry is responding to one such challenge - the increasing prevalence of high burnup (HBU) used fuel and the need to provide long term storage assurance for these fuels equivalent to that which has existed for lower burnup fuels over the past 25 years. This response includes a confirmatory demonstration program designed to address the aging characteristics of HBU fuel and set a precedent for a learning approach to aging management that will have broad applicability across the used fuel storage landscape. (authors)

  10. Data from Telecommunication Networks for Incident Management: An Exploratory Review on Transport Safety and Security

    NARCIS (Netherlands)

    Steenbruggen, J.G.M.; Borzacchiello, M.T.; Nijkamp, P.; Scholten, H.J.

    2013-01-01

    Problems such as traffic congestion and environmental sustainability are forcing us to review our long-term plans for transport, whose aim should be to develop and improve safety, security and effectiveness of the transportation systems. The consequences of traffic accidents are not only limited to

  11. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    kim

    2Pesticide Action Network (PAN) Nexus, Ethiopia;. 3Department of Preventive Medicine, Keck School of Medicine, University of Southern California, USA;. 4Ministry of Labour and Social Affairs, Ethiopia. Review Article. Occupational Health and Safety in Ethiopia: A review of. Situational Analysis and Needs Assessment.

  12. Long-term safety of aromatase inhibitors in the treatment of breast cancer

    Directory of Open Access Journals (Sweden)

    Jean-Marc A Nabholtz

    2008-03-01

    Full Text Available Jean-Marc A NabholtzBreast Cancer Research Institute La Prandie, Valojoulx, FranceAbstract: Following promising data for metastatic breast cancer in terms of efficacy and safety profile, third-generation aromatase inhibitors (AI, anastrozole, letrozole, and exemestane, underwent a full development in early setting. If recent results consistently show the superiority of these agents over tamoxifen, the therapeutic strategies of AIs in adjuvant setting are still debated. Beyond the choice of clinical strategy, the long duration of exposure to AI in adjuvant setting required a full determination of the long-term toxicity profile of these agents. While all three AIs have either favorable (decreased incidence of hot flashes, gynecologic and thromboembolic side-effects or unfavorable (skeletal complications, arthralgia, musculoskeletal pain, sexual dysfunction class adverse events, some variability between AIs has been reported in side-effects as well as gastrointestinal, urogenital, neurologic, and visual disturbances, confirming the lack of interchangeability between the three AIs. The overall therapeutic index of AIs appears today superior to that of tamoxifen with proven improved efficacy and better toxicity profile. This review will explore the results from the available adjuvant AIs trials with a particular emphasis on safety profiles, quality of life, and therapeutic index, helping to define the present role of AIs in the adjuvant management of postmenopausal patients with breast cancer.Keywords: breast cancer, aromatase inhibitors, adjuvant, safety profile

  13. Lithium safety and tolerability in mood disorders: a critical review

    Directory of Open Access Journals (Sweden)

    Ivan Aprahamian

    2014-04-01

    Full Text Available Background : Lithium is a first-line treatment for bipolar disorder in all phases, also indicated as add-on drug for unipolar depression and suicide prevention. This study encompasses a broad critical review on the safety and tolerability of lithium for mood disorders. Methods : A computerized search for English written human studies was made in MEDLINE, using the keywords “lithium” and “mood disorders”, starting from July 1993 through July 2013 (n = 416. This initial search aimed to select clinical trials, prospective data, and controlled design studies of lithium treatment for mood disorders reporting adverse effects (n = 36. The final selection yielded 91 studies. Results : The most common general side effects in patients on lithium treatment were thirst, frequent urination, dry mouth, weight gain, fatigue and cognitive complaints. Lithium users showed a high prevalence of hypothyroidism, hyperparathyroidism, and decrease in urinary concentration ability. Reduction of glomerular filtration rate in patients using lithium was also observed, but in a lesser extent. The evidence of teratogenicity associated with lithium use is not well established. Anti-inflammatory non-steroidal drugs, thiazide diuretics, angiotensin-converting enzyme inhibitors, and alprazolam may increase serum lithium and the consequent risk for intoxication. Discussion : Short-term lithium treatment is associated with mild side effects. Medium and long-term lithium treatment, however, might have effects on target organs which may be prevented by periodical monitoring. Overall, lithium is still a safe option for the treatment of mood disorders.

  14. A review of microwave oven safety.

    Science.gov (United States)

    Osepchuk, J M

    1978-03-01

    The microwave leakage from current microwave ovens, which are manufactured to meet government emission standards, is reviewed. Typical leakage values imply exposure values well below the most conservative exposure standards in the world. A review of recent developments discloses increasingly stringent government regulation along with advances in techniques for suppression of microwave leakage. The nature of the leakage field is described and studies relating emission to exposure are reviewed. Field survey data are reviewed and it is found that the overwhelming majority of certified ovens in the field show leakage well below permissible limits with an increasing degree of certainty as time goes on. The conclusion is that microwave ovens are not only just as safe as they were in 1973 but they are being accepted as safe under essentially equivalent emission regulations in various countries including those in Eastern Europe.

  15. Achievements and challenges of Space Station Freedom's safety review process

    Science.gov (United States)

    Robinson, David W.

    1993-01-01

    The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

  16. Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis.

    Science.gov (United States)

    Hoefnagel, J J; Thio, H B; Willemze, R; Bouwes Bavinck, J N

    2003-08-01

    Therapy with fumaric acid esters (FAE) has been shown to be safe and effective in patients with severe psoriasis in several clinical studies with limited follow-up periods. In view of the chronic character of psoriasis, long-term safety aspects are of major importance in determining the suitability of a drug during prolonged periods of treatment. To investigate adverse events of therapy with systemic FAE with follow-up periods of up to 14 years, in order to determine safety aspects of their long-term use in patients with severe psoriasis. Current and/or past therapeutic use of FAE was reviewed in 66 patients with severe psoriasis. Forty-one of 66 patients had received FAE for at least 1 year, and 12 of these 41 patients had received FAE for between 10 and 14 years. Adverse events were reported in 73% of the patients. These were usually mild and mainly consisting of flushing (55%), diarrhoea (42%), nausea (14%), tiredness (14%) and stomach complaints (12%). A relative lymphocytopenia was observed in 76% of patients during therapy with FAE, resulting in a permanent discontinuation of therapy with FAE in four patients. A transient eosinophilia and moderate liver enzyme elevations were observed in 14% and 25% of patients, respectively. The present study indicates that FAE can be considered as a safe long-term treatment in patients with severe psoriasis.

  17. Safety of doxycycline and minocycline: a systematic review.

    Science.gov (United States)

    Smith, Kelly; Leyden, James J

    2005-09-01

    The goal of this review was to summarize the available literature covering the safety profiles of oral doxycycline and minocycline. Scientific literature published between 1966 and August 2003 was searched using the MEDLINE, EMBASE, and Biosis databases (search terms: minocycline or doxycycline, each paired with adverse reaction, adverse event, and side effect, and doxycycline or minocycline with the limits English language, human, and clinical trials). Safety information was collected from case reports and clinical trials. Adverse event (AE) rates in the United States were calculated by comparing data from the MedWatch AE reporting program used by the US Food and Drug Administration (FDA) with the number of new prescriptions dispensed for each drug from January 1998 to August 2003. Between 1966 and 2003, a total of 130 and 333 AEs were published in case reports of doxycycline and minocycline, respectively. In 24 doxycycline clinical trials (n = 3833) and 11 minocycline trials (n = 788), the ranges in incidence of AEs were 0% to 61% and 11.7% to 83.3%, respectively. Gastrointestinal AEs were most common with doxycycline; central nervous system and gastrointestinal AEs were most common with minocycline. From January 1998 to August 2003, the FDA MedWatch data contained 628 events for doxycycline and 1099 events for minocycline reported in the United States. Approximately 47,630,000 doxycycline and 15,234,000 minocycline new prescriptions were dispensed in the United States during that period, yielding event rates of 13 per million for doxycycline and 72 per million for minocycline, based on FDA data. Between 1998 and 2003, doxycycline was prescribed 3 times as often as minocycline. The incidence of AEs with either drug is very low, but doxycycline had fewer reported AEs. Although more head-to-head clinical trials are needed for a direct comparison of AE frequency, these preliminary data from separate reports suggest the possibility that AEs may be less likely with

  18. Review of actinide nitride properties with focus on safety aspects

    Energy Technology Data Exchange (ETDEWEB)

    Albiol, Thierry [CEA Cadarache, St Paul Lez Durance Cedex (France); Arai, Yasuo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    This report provides a review of the potential advantages of using actinide nitrides as fuels and/or targets for nuclear waste transmutation. Then a summary of available properties of actinide nitrides is given. Results from irradiation experiments are reviewed and safety relevant aspects of nitride fuels are discussed, including design basis accidents (transients) and severe (core disruptive) accidents. Anyway, as rather few safety studies are currently available and as many basic physical data are still missing for some actinide nitrides, complementary studies are proposed. (author)

  19. 78 FR 4477 - Review of Safety Analysis Reports for Nuclear Power Plants, Introduction

    Science.gov (United States)

    2013-01-22

    ... COMMISSION Review of Safety Analysis Reports for Nuclear Power Plants, Introduction AGENCY: Nuclear... subsection to NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power..., Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: Integral...

  20. Book review: Safety of Biologics Therapy

    Directory of Open Access Journals (Sweden)

    Robak T

    2017-01-01

    Full Text Available Tadeusz Robak Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, PolandSafety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins (Cham, Switzerland: Springer International Publishing; 2016 by Brian A Baldo from the Molecular Immunology Unit, Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney, and the Department of Medicine, University of Sydney, Australia, is a book that belongs on the shelf of everyone in the field of biologic therapies research and clinical practice. In writing this book, the author’s intention was to produce an up-to-date text book on approved biologic therapies, as far as that is possible in this time of rapidly evolving developments in biotherapeutic research and the introduction of new and novel agents for clinical use.The monograph comprises 610 pages in 13 chapters, each including a summary and further reading suggestions. All chapters include a discussion of basic and clinical material. Well-designed, comprehensive tables and color figures are present throughout the book. The book itself examines the biologic products that have regulatory approval in the USA and/or European Union and that show every indication of remaining important therapies. It covers in great detail all the latest work on peptide hormones and enzymes, monoclonal antibodies, fusion proteins, and cytokine therapies. Beyond that, it also presents the latest information on blood coagulation proteins, vaccines, botulinum neurotoxins, and biosimilars. 

  1. Ways of ensuring short/long term safety

    Energy Technology Data Exchange (ETDEWEB)

    Boeck, B. de [AVN / Association Vincotte Nucleaire, Bruxelles (Belgium); Baltes, B. [GRS - Gesellschaft fur Anlagen and Reaktosieherheit mbH, Koln (Germany); Besnus, F. [Institut de Radioprotection et de Surete Nucleaire, 92 - Fontenay-aux-Roses (France)

    2006-07-01

    Various strategies have been adopted among countries to manage radioactive waste. The present publication gives to this respect a broad overview of the policies and strategies adopted by Germany, Belgium and France. It appears that these may show remarkable differences, but motivated mainly by political and societal considerations. With regard to safety, practices for waste management are consistent and reflect the broad international consensus that has been progressively established. As an illustration, safety practices and possible specificities for the storage and geological disposal of spent fuel and high level radioactive waste from reprocessing are shortly described. (authors)

  2. Review Article: Socio-Economic Implications of Poor Safety Practices

    African Journals Online (AJOL)

    Review Article: Socio-Economic Implications of Poor Safety Practices. LC Okoro. Abstract. No abstract. Journal of Medical Laboratory Science Vol.12(2) 2003: 28 - 32. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · http://dx.doi.org/10.4314/jmls.v12i2.35284.

  3. Immunization Safety Review: Thimerosal - Containing Vaccines and Neurodevelopmental Disorders

    National Research Council Canada - National Science Library

    Stratton, Kathleen; Gable, Alicia; McCormick, Marie C

    2001-01-01

    ..., and Marie C.McCormick, Editors Immunization Safety Review Committee Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. Copyrightoriginal retained, the be not from cannot book, paper original however, for version formatting, authoritative the typesetting-specific created from the as publ...

  4. Agricultural Media Coverage of Farm Safety: Review of the Literature.

    Science.gov (United States)

    Evans, Jim; Heiberger, Scott

    2016-01-01

    Agricultural media merit increased attention in addressing dynamic changes in safety aspects of one of the nation's most hazardous industries. Changes in farming, such as larger-scale, new "niche" enterprises and new technologies, bring new forms of risk to the safety of those who live and work on farms and ranches. At the same time, traditional agricultural media--commercial firms that publish farm periodicals and commercial radio/television stations and networks that provide farm programming--are changing dramatically. In the face of media convergence, these enterprises provide an increasing menu of agricultural information services delivered by print, radio, and television, plus a host of new electronic media. This review of literature addressed the role and importance of commercial agricultural media in the United States, the scope and pattern of their safety coverage, and the opportunities they represent. The review involved searches of 14 bibliographic databases, as well as reference lists of relevant studies and contacts with farm safety experts. Analysis of 122 documents suggested that limited focus has been directed to the role of commercial agricultural media in safety decisions on US farms. Findings revealed that they continue to serve an efficient, early-stage role in creating awareness and interest, providing information, forming attitudes, and stirring consideration of farm safety. Potentials are seen as expanding through the interactive features of social media and other new services offered by these media firms. Findings also identified research needs, 100 farm safety topics for reporting, and opportunities for strengthening safety coverage by commercial agricultural media.

  5. Long-term safety and efficacy of teriflunomide

    DEFF Research Database (Denmark)

    O'Connor, Paul; Comi, Giancarlo; Freedman, Mark S

    2016-01-01

    OBJECTIVE: To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). METHODS: A total of 742 patients entered the extension. Teriflunomide-treate...

  6. Review article: olestra and its gastrointestinal safety.

    Science.gov (United States)

    Thomson, A B; Hunt, R H; Zorich, N L

    1998-12-01

    Olestra is a fat substitute made from sucrose and vegetable oil. Olestra is neither digested nor absorbed, and therefore adds no calories or fat to the diet. Because the gut is the only organ that is exposed to olestra, the potential for olestra to affect gastrointestinal structure and function, and the absorption of nutrients from the gut, has been investigated. Histological evaluations performed after long-term feeding studies have shown no indications that olestra causes injury to the gastrointestinal mucosa. Olestra is not metabolized by the colonic microflora, and has no meaningful effects on the metabolic function of these organisms. Studies of gastrointestinal transit have shown that the consumption of olestra with food does not affect gastric emptying, or small or large bowel transit times. Olestra does not affect the absorption of macronutrients, water-soluble vitamins or minerals. It causes a dose-responsive decrease in the availability of the fat-soluble vitamins A, D, E and K; however, this potentially adverse effect is offset by the addition of vitamins to olestra-containing foods. Olestra has no consistent effect on the amount of total bile acids excreted in the faeces, and therefore probably has no significant effect on bile acid absorption. The occurrence of gastrointestinal symptoms, including diarrhoea, loose stools, gas and abdominal cramping, after consumption of olestra under ordinary snacking conditions is comparable to that following consumption of triglyceride-containing snacks.

  7. Trials of bevacizumab in breast cancer - a safety review

    DEFF Research Database (Denmark)

    Kümler, Iben; Nielsen, Dorte Lisbet

    2012-01-01

    enables the reader to overview current knowledge on the efficacy and safety of bevacizumab in breast cancer. Expert opinion: Insight into complex risk-benefit calculations for bevacizumab is missing. In unselected patients with HER2-negative metastatic breast cancer, the risk of serious side effects...... for continued gains in therapy efficacy. Areas covered: The authors review Phase III data concerning the safety of bevacizumab in breast cancer, summarize data on efficacy and discuss the risk:benefit ratio of the drug. The data for this review were obtained by searching in the PubMed database. This review...... of bevacizumab overshadows the benefit of the drug. However, increased response rates and progression-free survival in the majority of Phase III trials suggest that the drug is of benefit in a subgroup of patients. Although requiring close monitoring, most side effects are manageable. Reliable, validated...

  8. Patient involvement in the safety of care: an integrative review

    Directory of Open Access Journals (Sweden)

    Thaynara de Oliveira Silva

    2016-06-01

    Full Text Available The aim of this integrative review was to survey the strategies adopted by health institutions that involve patients in care as a barrier to prevent incidents. A search was conducted in MEDLINE, LILACS, CINAHL and PubMed databases using the descriptors ‘patient safety’, ‘iatrogenic’, ‘medical error’ and ‘involvement’. The review included studies in full text published between 2003 and March 2016 in English, Spanish or Portuguese. It was found that the effective communication and the development of patients’ autonomy are the most advocated strategies. The level of evidence of studies was limited to four and six. The assessment or description of institutional practices involving patients in their safety emerged as a gap in scientific knowledge. The impact of this review is to demonstrate the need for randomized studies to identify effective interventions, directing health institutions towards change in the organizational culture, focusing on safety and patient-centered care.

  9. Safety analysis and review system (SARS) assessment report

    Energy Technology Data Exchange (ETDEWEB)

    Browne, E.T.

    1981-03-01

    Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. As part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.

  10. Safety signal detection: the relevance of literature review.

    Science.gov (United States)

    Pontes, Helena; Clément, Mallorie; Rollason, Victoria

    2014-07-01

    Adverse drug reactions (ADRs) represent an important risk for patients and have a significant economic impact on health systems. ADRs are the fifth most common cause of hospital death, with a burden estimated at 197,000 deaths per year in the EU. This has a societal cost of 79 billion per year. Because of this strong impact in public health, regulatory authorities (RAs) worldwide are implementing new pharmacovigilance legislation to promote and protect public health by reducing the burden of ADRs through the detection of safety signals. Although, traditionally, signal detection activities have mainly been performed based on spontaneous reporting from healthcare professionals and national health RAs, the new pharmacovigilance legislation underlines the relevance of other sources of information (such as scientific literature) for the evaluation of the benefit-risk balance of a certain product. This review aims to highlight the relevance of periodic scientific literature screening in the safety signal detection process. The authors present four practical examples where a safety signal that was detected from a literature report had an impact on the lifecycle of a drug. In addition, based on practical experience of the screening of medical and scientific literature for safety purposes, this article analyses the requirements of the new pharmacovigilance guidelines on literature screening and highlights the need for the implementation of a literature review procedure and the main challenges encountered when performing literature screening for safety aspects.

  11. Safety of long-term use of linezolid: results of an open-label study

    Directory of Open Access Journals (Sweden)

    Vazquez JA

    2016-09-01

    Full Text Available Jose A Vazquez,1 Anthony C Arnold,2 Robert N Swanson,3 Pinaki Biswas,3 Matteo Bassetti4 1Section of Infectious Diseases, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA; 2UCLA Department of Ophthalmology, Jules Stein Eye Institute, Los Angeles, CA, USA; 3Clinical Research, Global Innovative Pharmaceutical, Pfizer Inc., New York, NY, USA; 4Infectious Diseases Division, Santa Maria della Misericordia University Hospital, Udine, Italy Objective: The objective of this study was to assess the long-term safety of linezolid in patients with chronic infections requiring treatment for ≥6 weeks. Enhanced monitoring for optic neuropathy was included to characterize the early development of this side effect and to identify ophthalmologic tests that might be valuable in early detection of this event. Methods: This was a multicenter, open-label, pilot study of patients aged ≥18 years on long-term linezolid therapy. Matched control patients were included for baseline assessment comparison. Patients were assessed at study entry, monthly while on treatment, at the end of treatment, and 30 days following the last dose. Aggregate ocular safety data were reviewed. Response to treatment was reported. Results: The study was terminated owing to slow enrollment. Twenty-four patients received linezolid; nine patients were included as matched controls. Linezolid was prescribed for a median of 80.5 days (range, 50–254 days. In patients with a reported clinical outcome, the majority were considered improved or cured. Common treatment-related adverse events (AEs included anemia, peripheral neuropathy, polyneuropathy, vomiting, and asthenia, and were consistent with the known safety profile. Most AEs resolved or stabilized with discontinuation of treatment. Results of ophthalmologic tests in the one case adjudicated as probable linezolid-associated optic neuropathy revealed abnormal color vision, characteristic changes in the optic disk

  12. Patient safety culture in hospitals of Iran: a systematic review and meta-analysis.

    Science.gov (United States)

    Azami-Aghdash, Saber; Ebadifard Azar, Farbod; Rezapour, Aziz; Azami, Akbar; Rasi, Vahid; Klvany, Khalil

    2015-01-01

    Nowadays, for quality improvement, measuring patient safety culture (PSC) in healthcare organizations is being increasingly used. The aim of this study was to clarify PSC status in Iranian hospitals using a meta-analysis method. Six databases were searched: PubMed, Scopus, Google Scholar, Cochrane Library, Magiran, SID and IranMedex using the search terms including patient safety, patient safety culture, patient safety climate and combined with hospital (such as "hospital survey on patient safety culture"), measurement, assessment, survey and Iran. A total of 11 articles which conducted using Hospital Survey on Patient Safety Culture (HSOPSC) questionnaire initially were reviewed. To estimate overall PSC status and perform the meta-analyses, Comprehensive Meta-Analysis (CMA) software v. 2 was employed. The overall PSC score based on the random model was 50.1%. "Teamwork within hospital units" dimension received the highest score of PSC (67.4%) and "Non-punitive response to error" the lowest score (32.4%). About 41% of participants in reviewed articles evaluate their hospitals' performance in PSC as 'excellent/very good'. Approximately %52.7 of participants did not report any adverse event in the past 12 months. The results of this study show that Iranian hospitals' performances in PSC were poor. Among the 12 dimensions of HSOPSC questionnaire, the "Non-punitive response to error" achieved the lowest score and could be a priority for future interventions. In this regard, hospitals staff should be encouraged to report adverse event without fear of punitive action.

  13. Effect of electronic device use on pedestrian safety : a literature review.

    Science.gov (United States)

    2016-04-01

    This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...

  14. Understanding safety culture in long-term care: a case study.

    Science.gov (United States)

    Halligan, Michelle H; Zecevic, Aleksandra; Kothari, Anita R; Salmoni, Alan W; Orchard, Treena

    2014-12-01

    This case study aimed to understand safety culture in a high-risk secured unit for cognitively impaired residents in a long-term care (LTC) facility. Specific objectives included the following: diagnosing the present level of safety culture maturity using the Patient Safety Culture Improvement Tool (PSCIT), examining the barriers to a positive safety culture, and identifying actions for improvement. A mixed methods design was used within a secured unit for cognitively impaired residents in a Canadian nonprofit LTC facility. Semistructured interviews, a focus group, and the Modified Stanford Patient Safety Culture Survey Instrument were used to explore this topic. Data were synthesized to situate safety maturity of the unit within the PSCIT adapted for LTC. Results indicated a reactive culture, where safety systems were piecemeal and developed only in response to adverse events and/or regulatory requirements. A punitive regulatory environment, inadequate resources, heavy workloads, poor interdisciplinary collaboration, and resident safety training capacity were major barriers to improving safety. This study highlights the importance of understanding a unit's safety culture and identifies the PSCIT as a useful framework for planning future improvements to safety culture maturity. Incorporating mixed methods in the study of health care safety culture provided a good model that can be recommended for future use in research and LTC practice.

  15. Treating osteoarthrosis in terms of the safety of pharmacotherapy

    Directory of Open Access Journals (Sweden)

    A E Karateyev

    2009-01-01

    Full Text Available It is shown that of great importance in osteoarthrosis (OA is the use of hyaluronic acid preparations and oral chondroprotectors that produce not only symptomatic, but also structurally modifying effects. Combined therapy using these agents makes it possible to enhance the efficiency of the therapy for OA and to reduce a risk of drug-induced complications due to the decreased requirements for nonsteroidal anti-inflammatory drugs. The data showing the benefits of a low molecular-weight hyaluronic acid preparation (Hyalgan® and an agent based on the unsaponifiable compounds of avocado and soybean (Piascledine® and evidence for their efficacy and safety are given.

  16. ENHANCING FOOD SAFETY AND STABILITY THROUGH IRRADIATION: A REVIEW

    Directory of Open Access Journals (Sweden)

    Manzoor Ahmad Shah

    2014-04-01

    Full Text Available Food irradiation is one of the non thermal food processing methods. It is the process of exposing food materials to the controlled amounts of ionizing radiations such as gamma rays, X-rays and accelerated electrons, to improve microbiological safety and stability. Irradiation disrupts the biological processes that lead to decay of food quality. It is an effective tool to reduce food-borne pathogens, spoilage microorganisms and parasites; to extend shelf-life and for insect disinfection. The safety and consumption of irradiated foods have been extensively studied at national levels and in international cooperations and have concluded that foods irradiated under appropriate technologies are both safe and nutritionally adequate. Specific applications of food irradiation have been approved by national legislations of more than 55 countries worldwide. This review aims to discuss the applications of irradiation in food processing with the emphasis on food safety and stability.

  17. Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

    Science.gov (United States)

    2017-01-01

    A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes

  18. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    DEFF Research Database (Denmark)

    Thomson, Neil C; Rubin, Adalberto S; Niven, Robert M

    2011-01-01

    Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure....

  19. A critical review on toxicological safety of 2-alkylcyclobutanones

    Science.gov (United States)

    Song, Beom-Seok; Choi, Soo-Jeong; Jin, Young-Bae; Park, Jong-Heum; Kim, Jae-Kyung; Byun, Eui-Baek; Kim, Jae-Hun; Lee, Ju-Woon; Kim, Gang-Sung; Marchioni, Eric

    2014-10-01

    2-Alkylcyclobutanones (2-ACBs) are known as unique radiolytic products generated from the major fatty acids and triglycerides in food through only irradiation. Since 1990, studies on the toxicological safety of 2-ACBs have been conducted extensively with synthetic compounds. Mutagenicity tests of 2-ACBs on the microorganisms reviewed in this study clearly indicate that no evidence was observed, while several in vitro studies demonstrated the cytotoxicity of 2-ACBs through cell death. Moreover, the genotoxicity of 2-ACBs was suggested as DNA strand breaks were observed. However, these findings should be interpreted with caution because genotoxicity may result from cytotoxicity, which causes DNA damage or from cell membrane destruction and indirect oxidative DNA damage. Therefore, elucidation of the mechanism of genotoxic effects is needed. With regards to the suggestion of Raul et al. (2002) who showed the promoting effect of colon cancer by the administration of 2-ACBs, further studies are needed to correct some experimental design errors. Moreover, an in-vivo experiment that evaluated the metabolism of 2-ACBs has revealed that 2-dDCB was metabolized into cyclic alcohol and excreted through fecal discharge. In conclusion, it is considered that the ingestion of 2-ACBs through irradiated foods is unlikely to affect the human health. However, more specific studies are required to identify the fate of 2-ACBs in body and the LD50 values. The determination of chronic toxicity by long-term exposure to low concentrations of 2-ACBs has to be evaluated more clearly to determine if these compounds are safe to human.

  20. Identifying nontechnical skills associated with safety in the emergency department: a scoping review of the literature.

    Science.gov (United States)

    Flowerdew, Lynsey; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

    2012-05-01

    Understanding the nontechnical skills specifically applicable to the emergency department (ED) is essential to facilitate training and more broadly consider interventions to reduce error. The aim of this scoping review is to first identify and then explore in depth the nontechnical skills linked to safety in the ED. The review was conducted in 2 stages. In stage 1, online databases were searched for published empirical studies linking nontechnical skills to safety and performance in the ED. Articles were analyzed to identify key ED nontechnical skills. In stage 2, these key skills were used to generate additional key words, which enabled a second search of the literature to be undertaken and expand on the evidence available for review. In stage 1, 11 articles were retrieved for data analysis and 9 core emergency medicine nontechnical skills were identified. These were communicating, managing workload, anticipating, situational awareness, supervising and providing feedback, leadership, maintaining standards, using assertiveness, and decisionmaking. In stage 2, a secondary search, using these 9 skills and related terms, uncovered a further 21 relevant articles. Therefore, 32 articles were used to describe the main nontechnical skills linked to safety in the ED. This article highlights the challenges of reviewing a topic for which the terms are not clearly defined in the literature. A novel methodological approach is described that provides a structured and transparent process for reviewing the literature in emerging areas of interest. A series of literature reviews focusing on individual nontechnical skills will provide a clearer understanding of how the skills identified contribute to safety in the ED. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  1. A safety review of medications used for labour induction.

    Science.gov (United States)

    Sheibani, Lili; Wing, Deborah A

    2018-02-01

    Induction of labour is a commonly performed procedure around the world. There are various medications used for induction including those commonly used for cervical ripening (prostaglandins) and oxytocin. The ideal agent is one that decreases the time to achieving delivery without compromising maternal or neonatal safety. The 'optimal safe agent' remains undetermined. Areas covered: This article reviews the safety of currently used induction agents. Prostaglandins and oxytocin have proven to be effective in labour induction, and their profiles will be reviewed in this article. We discuss the data that supports combining some of the agents. We also cover the safety of medications used for labour induction in setting of a scarred uterus. Expert Opinion: There is continuous debate about the ideal induction agent: one that balances safety with efficacy. We recommend the practice that there is not one perfect agent for all, and that the clinical scenario and previous obstetric history should be considered before choosing an agent. In the future, pharmacogenomics may show that genetics may affect the individual response and adverse reactions to the various agents.

  2. Approaches to advancing blood safety through haemovigilance: a review.

    Science.gov (United States)

    Mwangi, J W; Kimani, D; Oduor, M

    2009-12-01

    Blood transfusion is always associated with some level of risk. Haemovigilance is a risk monitoring system integral to the practice of transfusion medicine whose ultimate purpose is to improve the quality and safety of transfusion therapy. To examine the contribution of haemovigilance to blood safety, including the approaches that some countries have taken to institute haemovigilance, and explore routes through which countries without such systems can achieve them. The internet and journals on the topic of haemovigilance and development of haemovigilance systems in the English language. Reputable journals on the topic of haemovigilance were examined for abstracts and papers. Abstracts based on known credible and distinguished sources were selected. Information on haemovigilance and the processes of developing haemovigilance in various countries was reviewed. The information from selected papers and abstracts was used for writing this paper. Varying processes for haemovigilance have been adopted by different countries. The more advanced systems have national/regional coordinating mechanisms. Availability of haemovigilance data has given transfusion services a clear understanding of problems associated with transfusion that need to be solved so as to improve transfusion safety. Although countries in sub-Saharan Africa have made considerable progress in enhancing blood safety in the recent past, nationally coordinated haemovigilance systems are lacking. Focus on haemovigilance systems is considered the next frontier to be conquered in enhancing blood safety in the region.

  3. Unmanned Aerial Vehicle Mishap Taxonomy for Range Safety Reviews

    Science.gov (United States)

    2016-02-01

    failures. 2 Robert E. Ball . The Fundamentals of Aircraft Combat Survivability Analysis and Design...for Range Safety Reviews, RCC 326-16, February 2016 2-9  Encounter with lightning , lost aileron control Scenario: Failure of a vehicle’s ground...A vehicle operator attempted to find a route between thunderstorms. The vehicle was lost after a lightning strike and apparent encounter with icing

  4. The Safety of Orthokeratology?A Systematic Review

    OpenAIRE

    Liu, Yue M.; Xie, Peiying

    2015-01-01

    Objectives: The aim of this review is to evaluate the ocular safety of orthokeratology (OrthoK) treatment of myopia correction and retardation. Data Sources: Clinical studies published in English and Chinese were identified from MEDLINE, EMBASE CNKI, CQVIP, and WANFANG DATA (all from 1980 to April 2015). The reference lists of the studies and the Science Citation Index were also searched. Selection Criteria: Relevant clinical studies including case series, case reports, patient/practitioner s...

  5. Home safety education and provision of safety equipment for injury prevention (Review).

    Science.gov (United States)

    Kendrick, Denise; Young, Ben; Mason-Jones, Amanda J; Ilyas, Nohaid; Achana, Felix A; Cooper, Nicola J; Hubbard, Stephanie J; Sutton, Alex J; Smith, Sherie; Wynn, Persephone; Mulvaney, Caroline; Watson, Michael C; Coupland, Carol

    2013-05-01

    In industrialised countries injuries (including burns, poisoning or drowning) are the leading cause of childhood death and steep social gradients exist in child injury mortality and morbidity. The majority of injuries in pre-school children occur at home but there is little meta-analytic evidence that child home safety interventions reduce injury rates or improve a range of safety practices, and little evidence on their effect by social group. We evaluated the effectiveness of home safety education, with or without the provision of low cost, discounted or free equipment (hereafter referred to as home safety interventions), in reducing child injury rates or increasing home safety practices and whether the effect varied by social group. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2009, Issue 2) in The Cochrane Library, MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED), ISI Web of Science: Social Sciences Citation Index (SSCI), ISI Web of Science: Conference Proceedings Citation Index- Science (CPCI-S), CINAHL (EBSCO) and DARE (2009, Issue 2) in The Cochrane Library. We also searched websites and conference proceedings and searched the bibliographies of relevant studies and previously published reviews. We contacted authors of included studies as well as relevant organisations. The most recent search for trials was May 2009. Randomised controlled trials (RCTs), non-randomised controlled trials and controlled before and after (CBA) studies where home safety education with or without the provision of safety equipment was provided to those aged 19 years and under, and which reported injury, safety practices or possession of safety equipment. Two authors independently assessed study quality and extracted data. We attempted to obtain individual participant level data (IPD) for all included studies and summary data and IPD were simultaneously combined in meta-regressions by social

  6. A Review of General Aviation Safety (1984-2017).

    Science.gov (United States)

    Boyd, Douglas D

    2017-07-01

    General aviation includes all civilian aviation apart from operations involving paid passenger transport. Unfortunately, this category of aviation holds a lackluster safety record, accounting for 94% of civil aviation fatalities. In 2014, of 1143 general aviation accidents, 20% were fatal compared with 0 of 29 airline mishaps in the United States. Herein, research findings over the past 30 yr will be reviewed. Accident risk factors (e.g., adverse weather, geographical region, post-impact fire, gender differences) will be discussed. The review will also summarize the development and implementation of stringent crashworthiness designs with multi-axis dynamic testing and head-injury protection and its impact on mitigating occupant injury severity. The benefits and drawbacks of new technology and human factor considerations associated with increased general aviation automation will be debated. Data on the safety of the aging general aviation population and increased drug usage will also be described. Finally, areas in which general aviation occupant survival could be improved and injury severity mitigated will be discussed with the view of equipping aircraft with 1) crash-resistant fuel tanks to reduce post-impact conflagration; 2) after-market ballistic parachutes for older aircraft; and 3) current generation electronic locator beacons to hasten site access by first responders.Boyd DD. A review of general aviation safety (1984-2017). Aerosp Med Hum Perform. 2017; 88(7):657-664.

  7. 77 FR 26790 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2012-05-07

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... Safety Officer Medal of Valor Review Board (``Board'') to vote on the position of Board Chairperson... Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C...

  8. 75 FR 30859 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2010-06-02

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting via conference call of the Public Safety Officer Medal of Valor Review Board to vote on the... . ] SUPPLEMENTARY INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory...

  9. 76 FR 56226 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2011-09-12

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting via conference call of the Public Safety Officer Medal of Valor Review Board to vote of the... Public Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U...

  10. 49 CFR 209.501 - Review of rail transportation safety and security route analysis.

    Science.gov (United States)

    2010-10-01

    ....820 § 209.501 Review of rail transportation safety and security route analysis. (a) Review of route... analysis does not support the railroad carrier's original selected route, that safety and security... 49 Transportation 4 2010-10-01 2010-10-01 false Review of rail transportation safety and security...

  11. Simulation of safety: a review of the state of the art in road safety simulation modelling.

    Science.gov (United States)

    Young, William; Sobhani, Amir; Lenné, Michael G; Sarvi, Majid

    2014-05-01

    Recent decades have seen considerable growth in computer capabilities, data collection technology and communication mediums. This growth has had considerable impact on our ability to replicate driver behaviour and understand the processes involved in failures in the traffic system. From time to time it is necessary to assess the level of development as a basis of determining how far we have come. This paper sets out to assess the state of the art in the use of computer models to simulate and assess the level of safety in existing and future traffic systems. It reviews developments in the area of road safety simulation models. In particular, it reviews computer models of driver and vehicle behaviour within a road context. It focuses on stochastic numerical models of traffic behaviour and how reliable these are in estimating levels of safety on the traffic network. Models of this type are commonly used in the assessment of traffic systems for capacity, delay and general performance. Adding safety to this assessment regime may allow more comprehensive assessment of future traffic systems. To date the models have focused primarily on vehicular traffic that is, cars and heavy vehicles. It has been shown that these models have potential in measuring the level of conflict on parts of the network and the measure of conflict correlated well with crash statistics. Interest in the prediction of crashes and crash severity is growing and new models are focusing on the continuum of general traffic conditions, conflict, severe conflict, crash and severe crashes. The paper also explores the general data types used to develop, calibrate and validate these models. Recent technological development in in-vehicle data collection, driver simulators and machine learning offers considerable potential for improving the behavioural base, rigour and application of road safety simulation models. The paper closes with some indication of areas of future development. Copyright © 2014. Published

  12. Eurosafe 2006 radioactive waste management: long term safety requirements and societal expectations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    The EUROSAFE Forum is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety, to share experiences, exchange technical and scientific opinions, and conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum 2006 focuses on 'Radioactive Waste Management: Long Term Safety Requirements and Societal Expectations' from the point of view of the authorities, TSOs and industry and presents the latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe. A high level of nuclear safety is a priority for Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining increasing recognition

  13. Towards an International Classification for Patient Safety: key concepts and terms.

    Science.gov (United States)

    Runciman, William; Hibbert, Peter; Thomson, Richard; Van Der Schaaf, Tjerk; Sherman, Heather; Lewalle, Pierre

    2009-02-01

    Understanding the patient safety literature has been compromised by the inconsistent use of language. To identify key concepts of relevance to the International Patient Safety Classification (ICPS) proposed by the World Alliance For Patient Safety of the World Health Organization (WHO), and agree on definitions and preferred terms. Six principles were agreed upon-that the concepts and terms should: be applicable across the full spectrum of healthcare; be consistent with concepts from other WHO Classifications; have meanings as close as possible to those in colloquial use; convey the appropriate meanings with respect to patient safety; be brief and clear, without unnecessary or redundant qualifiers; be fit-for-purpose for the ICPS. Definitions and preferred terms were agreed for 48 concepts of relevance to the ICPS; these were described and the relationships between them and the ICPS were outlined. The consistent use of key concepts, definitions and preferred terms should pave the way for better understanding, for comparisons between facilities and jurisdictions, and for trends to be tracked over time. Changes and improvements, translation into other languages and alignment with other sets of patient safety definitions will be necessary. This work represents the start of an ongoing process of progressively improving a common international understanding of terms and concepts relevant to patient safety.

  14. Patient safety in out-of-hours primary care: a review of patient records

    Directory of Open Access Journals (Sweden)

    Wensing Michel

    2010-12-01

    Full Text Available Abstract Background Most patients receive healthcare in primary care settings, but relatively little is known about patient safety. Out-of-hours contacts are of particular importance to patient safety. Our aim was to examine the incidence, types, causes, and consequences of patient safety incidents at general practice cooperatives for out-of-hours primary care and to examine which factors were associated with the occurrence of patient safety incidents. Methods A retrospective study of 1,145 medical records concerning patient contacts with four general practice cooperatives. Reviewers identified records with evidence of a potential patient safety incident; a physician panel determined whether a patient safety incident had indeed occurred. In addition, the panel determined the type, causes, and consequences of the incidents. Factors associated with incidents were examined in a random coefficient logistic regression analysis. Results In 1,145 patient records, 27 patient safety incidents were identified, an incident rate of 2.4% (95% CI: 1.5% to 3.2%. The most frequent incident type was treatment (56%. All incidents had at least partly been caused by failures in clinical reasoning. The majority of incidents did not result in patient harm (70%. Eight incidents had consequences for the patient, such as additional interventions or hospitalisation. The panel assessed that most incidents were unlikely to result in patient harm in the long term (89%. Logistic regression analysis showed that age was significantly related to incident occurrence: the likelihood of an incident increased with 1.03 for each year increase in age (95% CI: 1.01 to 1.04. Conclusion Patient safety incidents occur in out-of-hours primary care, but most do not result in harm to patients. As clinical reasoning played an important part in these incidents, a better understanding of clinical reasoning and guideline adherence at GP cooperatives could contribute to patient safety.

  15. Current Status of Periodic Safety Review of HANARO Research Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Minjin; Ahn, Guk-Hoon; Lee, Choong Sung [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    A PSR for a research reactor became a legal requirement as the Nuclear Safety Act was amended and came into effect in 2014. This paper describes the current status and methodology of the first Periodic Safety Review (PSR) of HANARO that is being performed. The legal requirements, work plan, and process of implementing a PSR are described. Because this is the first PSR for a research reactor, it is our understating that the operating organization and regulatory body should communicate well with each other to complete the PSR in a timely manner. The first PSR of HANARO is under way. In order to achieve a successful result, activities of the operation organization such as scheduling, maintaining consistency in input data for review, and reviewing the PSR reports that will require intensive resources should be well planned. This means the operating organization needs to incorporate appropriate measures to ensure the transfer of knowledge and expertise arising from the PSR via a contractor to the operation organization. It is desirable for the Regulatory Body to be involved in all stage of the PSR to prevent any waste of resources and minimize the potential for a reworking of the PSR and the need for an additional assessment and review as recommended by foreign experts.

  16. Safety as a management concept in the air transport sector: A systematic literature review

    Directory of Open Access Journals (Sweden)

    Fernando Campa-Planas

    2017-01-01

    Full Text Available Purpose: The main purpose of the present study is to conduct a literature review of the contribution made by safety in air transport, based on the existing international academic literature in the field of the social sciences. It primarily attempts to examine and verify the relationship between safety-related concepts (co-occurrence, the link between the different authors (co-authorship and the corresponding citations (co-citations. Methodology: To achieve the established objectives, a systematic literature review (SLR has been conducted using the Scopus database between the years 1990 and 2016, identifying international academic papers related to the research topic of the present study. Findings: It has been verified, on the one hand, that safety in the air transport sector is a field of growing interest, as the number of papers has increased considerably in recent years, thus demonstrating the importance that this topic has acquired over time. On the other hand, however, it must be mentioned that the total quantity of papers related to the topic is low in terms of absolute numbers. The results of the co-occurrence analysis show that the most important aspect of safety is safety management, while the strongest link is between safety management and aircraft accidents, a fact that is foreseeable a priori.  Originality/value: The approach used allows a better view of the academic contribution made in relation to safety; this serves as the link among the different elements of the concept studied, and it demonstrates the growing interest in this area.

  17. Modern diaper performance: construction, materials, and safety review.

    Science.gov (United States)

    Dey, Swatee; Kenneally, Dianna; Odio, Mauricio; Hatzopoulos, Ioannis

    2016-07-01

    A review of the literature on diapers and diaper rash reveals that many clinicians are unfamiliar with modern diaper construction and materials as well as diaper safety testing methods. Typical modern diapers do not contain ingredients of concern such as latex and disperse dyes, but use ingredients such as spandex and pigments with a favorable safety profile. Today's disposable diaper is a high performance product whose carefully designed layers and liners provide optimal urine and feces absorption and an ever more clothing-like and comfortable fit. This is possible due to a variety of specialized polymer materials that provide optimal absorption of urine and feces, thereby minimizing skin exposure. © 2016 The International Society of Dermatology.

  18. 75 FR 54915 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2010-09-09

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office... meeting/conference call of the Public Safety Officer Medal of Valor Review Board to vote on recommendations for the 2009-2010 Medal of Valor nominations, review issues relevant to the nomination review...

  19. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence.

    Science.gov (United States)

    Mellgren, Anders; Wexner, Steven D; Coller, John A; Devroede, Ghislain; Lerew, Darin R; Madoff, Robert D; Hull, Tracy

    2011-09-01

    Sacral nerve stimulation is effective in the treatment of urinary incontinence and is currently under Food and Drug Administration review in the United States for fecal incontinence. Previous reports have focused primarily on short-term results of sacral nerve stimulation for fecal incontinence. The present study reports the long-term effectiveness and safety of sacral nerve stimulation for fecal incontinence in a large prospective multicenter study. Patients with fecal incontinent episodes more than twice per week were offered participation in this multicentered prospective trial. Patients showing ≥ 50% improvement during test stimulation were offered chronic implantation of the InterStim Therapy system (Medtronic; Minneapolis, MN). The aims of the current report were to provide 3-year follow-up data on patients from that study who underwent sacral nerve stimulation and were monitored under the rigors of an Food and Drug Administration-approved investigational protocol. One hundred thirty-three patients underwent test stimulation with a 90% success rate, of whom 120 (110 females) with a mean age of 60.5 years and a mean duration of fecal incontinence of 7 years received chronic implantation. Mean length of follow-up was 3.1 (range, 0.2-6.1) years, with 83 patients completing all or part of the 3-year follow-up assessment. At 3 years follow-up, 86% of patients (P < .0001) reported ≥ 50% reduction in the number of incontinent episodes per week compared with baseline and the number of incontinent episodes per week decreased from a mean of 9.4 at baseline to 1.7. Perfect continence was achieved in 40% of subjects. The therapy also improved the fecal incontinence severity index. Sacral nerve stimulation had a positive impact on the quality of life, as evidenced by significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument at 12, 24, and 36 months of follow-up. The most common device- or therapy-related adverse events through the

  20. Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature.

    Science.gov (United States)

    Crespin, Oscar M; Liu, Louis W C; Parmar, Ambica; Jackson, Timothy D; Hamid, Jemila; Shlomovitz, Eran; Okrainec, Allan

    2017-05-01

    Peroral endoscopic myotomy (POEM) is a novel intervention for the treatment of achalasia, which combines the advantages of endoscopic access and myotomy. The purpose of this study was to perform a systematic review of the literature to evaluate the efficacy and safety of POEM. The systematic review was conducted following the PRISMA guidelines. Evidence-Based Medicine Reviews, Cochrane Central Register of Controlled Trials, Ovid MEDLINE (R) including in-process and non-indexed citations were searched for POEM studies using the keywords: esophageal achalasia, POEM, endoscopy, natural orifice surgery, laparoscopic Heller myotomy (LHM), and related terms. Eckardt score, lower esophageal sphincter (LES) pressure, and reported complications were the main outcomes. Two authors reviewed the search result independently. A third reviewer resolved all disagreements. Data abstraction was pilot-tested and approved by all authors. Data were examined for clinical, methodological, and statistical heterogeneity with the aim of determining whether evidence synthesis using meta- analysis was possible. The search strategy retrieved 2894 citations. After removing duplicates and applying the exclusion criteria, 54 studies were selected for full-text review of which a total of 19 studies were considered eligible for further analysis. There were 10 retrospective and 9 prospective studies, including 1299 POEM procedures. No randomized control trial (RCT) was identified. Overall, the pre- and post-POEM Eckardt scores and LES pressure were significantly different. The most frequently reported complications were mucosal perforation, subcutaneous emphysema, pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion, and pneumonia. The median follow-up was 13 months (range 3-24). POEM is a safe and effective alternative for the treatment of achalasia. However, only short-term follow-up data compared with LHM are available. RCTs and long-term follow-up studies are needed to establish

  1. The economic burden of patient safety targets in acute care: a systematic review

    Directory of Open Access Journals (Sweden)

    Mittmann N

    2012-10-01

    Full Text Available Nicole Mittmann,1 Marika Koo,1 Nick Daneman,2 Andrew McDonald,3 Michael Baker,4 Anne Matlow,5 Murray Krahn,6 Kaveh Shojania,7 Edward Etchells71Health Outcomes and Pharmaco Economics (HOPE Research Centre, Division of Clinical Pharmacology, 2Division of Infectious Diseases, 3Quality and Patient Safety, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; 4Patient Safety in Ontario, University Health Network, Toronto, ON, Canada; 5Infection Prevention and Control and Patient Safety, Hospital for Sick Children, Toronto, ON, Canada; 6Toronto Health Economics and Technology Assessment (THETA Collaborative, University of Toronto, Toronto, ON, Canada; 7University of Toronto Centre for Patient Safety, Sunnybrook Health Sciences Centre, Toronto, ON, CanadaBackground: Our objective was to determine the quality of literature in costing of the economic burden of patient safety.Methods: We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76. The quality of each costing study per patient safety target was also evaluated.Results: We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39% reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22

  2. A Systematic Review of Occupational Health and Safety Business Cases.

    Science.gov (United States)

    Lee, Geunjae

    2018-02-01

    Business cases are arguments developed to secure management commitment and approval for investment in an intervention. This systematic review evaluated 12 experimental and quasi-experimental studies on occupational health and safety interventions (OHSI) in various settings. The search engines used in this systematic review include PubMed, CINAHL, and Scopus. A cost and benefit analysis of OHSI was completed at the organizational level in these studies. The focus of this analysis included sample, design, theoretical framework, interventional strategies, and threats to validity and outcomes. Positive returns on investment of OHSI outcomes were shown in 10 of the studies. The other two studies concluded that their chosen OHSI were not cost-effective.

  3. The economic burden of patient safety targets in acute care: a systematic review.

    Science.gov (United States)

    Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

    2012-01-01

    Our objective was to determine the quality of literature in costing of the economic burden of patient safety. We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: "costs and cost analysis," "cost-effectiveness," "cost," and "financial management, hospital." We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed.

  4. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  5. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Review of the efficacy and safety of over-the-counter medicine

    Directory of Open Access Journals (Sweden)

    Gerusa Clazer Halila

    2015-06-01

    Full Text Available Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups.

  7. The mid-term efficacy and safety of a permanent nitinol IVC filter (TrapEase)

    Energy Technology Data Exchange (ETDEWEB)

    Liu, Wei Chiang [Sungae General Hospital, Seoul (Korea, Republic of); Do, Young Soo; Choo, Sung Wook; Kim, Dong Ik; Kim, Young Wook; Kim, Duk Kyung; Shin, Sung Wook; Park, Kwang Bo; Jeon, Yong Hwan; Choo, In Wook [Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of)

    2005-06-15

    1) To evaluate the mid-term efficacy and safety of a permanent nitinol inferior vena cava (IVC) filter; 2) to evaluate filter effectiveness, filter stability and caval occlusion. A prospective evaluation of the TrapEase IVC filter was performed on 42 patients (eight men, 34 women) ranging in age from 22 to 78 years (mean age 66 years). All patients were ill with a high risk of pulmonary embolism (PE). Indications for filter placement were: 1) deep vein thrombosis with recurrent thromboembolism; 2) and/or free-floating thrombus with contraindication to anticoagulation; and 3) complications in achieving adequate anticoagulation. Follow-up evaluations (mean: 15.4 months, range: 2 to 28 months) were performed at 6- and 12-month intervals after the procedure and included clinical histories, chart reviews, plain film, Doppler ultrasounds, and contrasted abdominal CT scans. In follow-up evaluations, the data analysis revealed no cases of symptomatic PE. There were no cases of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study, there was one case of filter thrombosis; early symptomatic thrombosis that was successfully treated in the hospital. Of the 42 subjects, eight dead. These deaths were not related to the filter device or the implantation procedure, but to the underlying disease. This study demonstrates that the TrapEase permanent IVC filter is a safe and an effective device with low complication rates and is best used in patients with thromboembolic disease with a high risk of PE.

  8. Safety and Efficacy of Gliclazide as Treatment for Type 2 Diabetes : A Systematic Review and Meta-Analysis of Randomized Trials

    NARCIS (Netherlands)

    Landman, Gijs W D; de Bock, Geertruide H; van Hateren, Kornelis J J; van Dijk, Peter R; Groenier, Klaas H; Gans, Rijk O B; Houweling, Sebastiaan T; Bilo, Henk J G; Kleefstra, Nanne

    2014-01-01

    Objective and Design: Gliclazide has been associated with a low risk of hypoglycemic episodes and beneficial long-term cardiovascular safety in observational cohorts. The aim of this study was to assess in a systematic review and meta-analysis of randomized controlled trials the safety and efficacy

  9. Can patients report patient safety incidents in a hospital setting? A systematic review.

    Science.gov (United States)

    Ward, Jane K; Armitage, Gerry

    2012-08-01

    Patients are increasingly being thought of as central to patient safety. A small but growing body of work suggests that patients may have a role in reporting patient safety problems within a hospital setting. This review considers this disparate body of work, aiming to establish a collective view on hospital-based patient reporting. This review asks: (a) What can patients report? (b) In what settings can they report? (c) At what times have patients been asked to report? (d) How have patients been asked to report? 5 databases (MEDLINE, EMBASE, CINAHL, (Kings Fund) HMIC and PsycINFO) were searched for published literature on patient reporting of patient safety 'problems' (a number of search terms were utilised) within a hospital setting. In addition, reference lists of all included papers were checked for relevant literature. 13 papers were included within this review. All included papers were quality assessed using a framework for comparing both qualitative and quantitative designs, and reviewed in line with the study objectives. Patients are clearly in a position to report on patient safety, but included papers varied considerably in focus, design and analysis, with all papers lacking a theoretical underpinning. In all papers, reports were actively solicited from patients, with no evidence currently supporting spontaneous reporting. The impact of timing upon accuracy of information has yet to be established, and many vulnerable patients are not currently being included in patient reporting studies, potentially introducing bias and underestimating the scale of patient reporting. The future of patient reporting may well be as part of an 'error detection jigsaw' used alongside other methods as part of a quality improvement toolkit.

  10. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report. Revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1993-11-01

    Westinghouse Hanford Company (WHC) is the Integrating Contractor for the Hanford Waste Vitrification Plant (HWVP) Project, and as such is responsible for preparation of the HWVP Preliminary Safety Analysis Report (PSAR). The HWVP PSAR was prepared pursuant to the requirements for safety analyses contained in US Department of Energy (DOE) Orders 4700.1, Project Management System (DOE 1987); 5480.5, Safety of Nuclear Facilities (DOE 1986a); 5481.lB, Safety Analysis and Review System (DOE 1986b) which was superseded by DOE order 5480-23, Nuclear Safety Analysis Reports, for nuclear facilities effective April 30, 1992 (DOE 1992); and 6430.lA, General Design Criteria (DOE 1989). The WHC procedures that, in large part, implement these DOE requirements are contained in WHC-CM-4-46, Nonreactor Facility Safety Analysis Manual. This manual describes the overall WHC safety analysis process in terms of requirements for safety analyses, responsibilities of the various contributing organizations, and required reviews and approvals.

  11. Short-term initiatives for enhancing cyber-safety within South African schools

    Directory of Open Access Journals (Sweden)

    Elmarie Kritzinger

    2016-07-01

    Full Text Available The rate of technological development across the globe is dramatic. The decreasing cost and increasing availability of ICT devices means that its users are no longer exclusively industry or government employees – they are now also home users. Home users integrate ICT in their daily lives for education, socialising and information gathering. However, using ICT is associated with risks and threats, such as identity theft and phishing scams. Most home users of ICT do not have the necessary information technology and Internet skills to protect themselves and their information. School learners, in particular, are not sufficiently educated on how to use technological devices safely, especially in developing countries such as South Africa. The national school curriculum in South Africa currently does not make provision for cyber-safety education, and the availability of supporting material and training for ICT teachers in South Africa is limited, resulting in a lack of knowledge and skills regarding cyber-safety. The research in hand focuses on the situation concerning cyber-safety awareness in schools and has adopted a short-term approach towards cyber-safety among teachers and school learners in South Africa until a formal long-term national approach has been implemented. This study takes a quantitative approach to investigating the current options of teachers to enhance cyber-safety among learners in their schools. The research proposes that short-term initiatives (i.e. posters can increase learners’ awareness of cyber-safety until formal cyber-safety awareness methods have been introduced.

  12. 78 FR 25476 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2013-05-01

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Bureau... announcement of a meeting (via conference call-in) of the Public Safety Officer Medal of Valor Review Board to... Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C. 15202. Pursuant...

  13. 77 FR 51826 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2012-08-27

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Bureau.... SUMMARY: This is an announcement of a meeting of the Public Safety Officer Medal of Valor Review Board to review and vote on recommendations for the 2011-2012 Medal of Valor nominations, consider issues relevant...

  14. 78 FR 43227 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2013-07-19

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office.... SUMMARY: This is an announcement of a meeting of the Public Safety Officer Medal of Valor Review Board to review and vote on recommendations for the 2012-2013 Medal of Valor nominations, consider issues relevant...

  15. 29 CFR 2200.108 - Official Seal of the Occupational Safety and Health Review Commission.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Official Seal of the Occupational Safety and Health Review... HEALTH REVIEW COMMISSION RULES OF PROCEDURE Miscellaneous Provisions § 2200.108 Official Seal of the Occupational Safety and Health Review Commission. The seal of the Commission shall consist of: A gold eagle...

  16. A mathematical theory for related long term developments of road traffic and safety.

    NARCIS (Netherlands)

    Oppe, S. & Koornstra, M. J.

    1990-01-01

    This article presents and discusses an adoptive evolution model for forecasting long term developments in road safety. It takes into account both traffic growth and human adaptation. Earlier parsimonious models such as those used here are also discussed, and shown to predict trends in accident rates

  17. Long-term efficacy and safety of sustained-release diltiazem in the ...

    African Journals Online (AJOL)

    A.C.P., F.A.C.C.. Accepted 30 Mar 1990. Reprint requests [0: Dr D. P. Myburgh, Dept of Cardiology, Institute for Aviation Medicine,. Private Bag lG, Verwoerdbwg, 0140 RSA. diltiazem (Tilazem; Parke-Davis) was compared with that of atenolol.' The study was extended in order to evaluate the long-term efficacy and safety of ...

  18. Efficacy, safety and immunogenicity of biosimilars in inflammatory bowel diseases: A systematic review.

    Science.gov (United States)

    Martelli, Laura; Peyrin-Biroulet, Laurent

    2016-10-14

    Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD. A PubMed literature search was performed using the following terms until May 2016: 'biosimilars', 'CT-P13', 'infliximab', 'Crohn's disease', 'ulcerative colitis', 'inflammatory bowel diseases', 'efficacy', 'safety', 'immunogenicity'. Additionally, abstracts from international meetings were also reviewed. A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator. The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

  19. Westinghouse independent safety review of Savannah River production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Leggett, W.D.; McShane, W.J. (Westinghouse Hanford Co., Richland, WA (USA)); Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear and Advanced Technology Div.); Toto, G. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear Services Div.); Fauske, H.K. (Fauske and Associates, Inc., Burr Ridge, IL (USA)); Call, D.W. (Westinghouse Savannah R

    1989-04-01

    Westinghouse Electric Corporation has performed a safety assessment of the Savannah River production reactors (K,L, and P) as requested by the US Department of Energy. This assessment was performed between November 1, 1988, and April 1, 1989, under the transition contract for the Westinghouse Savannah River Company's preparations to succeed E.I. du Pont de Nemours Company as the US Department of Energy contractor for the Savannah River Project. The reviewers were drawn from several Westinghouse nuclear energy organizations, embody a combination of commercial and government reactor experience, and have backgrounds covering the range of technologies relevant to assessing nuclear safety. The report presents the rationale from which the overall judgment was drawn and the basis for the committee's opinion on the phased restart strategy proposed by E.I. du Pont de Nemours Company, Westinghouse, and the US Department of Energy-Savannah River. The committee concluded that it could recommend restart of one reactor at partial power upon completion of a list of recommended upgrades both to systems and their supporting analyses and after demonstration that the organization had assimilated the massive changes it will have undergone.

  20. Safety and tolerability review of lorcaserin in clinical trials.

    Science.gov (United States)

    Greenway, F L; Shanahan, W; Fain, R; Ma, T; Rubino, D

    2016-10-01

    Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations. © 2016 World Obesity.

  1. Reviewing real-time performance of nuclear reactor safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Preckshot, G.G. [Lawrence Livermore National Lab., CA (United States)

    1993-08-01

    The purpose of this paper is to recommend regulatory guidance for reviewers examining real-time performance of computer-based safety systems used in nuclear power plants. Three areas of guidance are covered in this report. The first area covers how to determine if, when, and what prototypes should be required of developers to make a convincing demonstration that specific problems have been solved or that performance goals have been met. The second area has recommendations for timing analyses that will prove that the real-time system will meet its safety-imposed deadlines. The third area has description of means for assessing expected or actual real-time performance before, during, and after development is completed. To ensure that the delivered real-time software product meets performance goals, the paper recommends certain types of code-execution and communications scheduling. Technical background is provided in the appendix on methods of timing analysis, scheduling real-time computations, prototyping, real-time software development approaches, modeling and measurement, and real-time operating systems.

  2. Safety of Moxibustion: A Systematic Review of Case Reports

    Directory of Open Access Journals (Sweden)

    Ji Xu

    2014-01-01

    Full Text Available Moxibustion is a traditional medical treatment originating in China. It involves using the heat of burning moxa to stimulate acupoints. It is considered safe and effective and is widely used throughout the world. The increasing use of moxibustion has drawn attention to the procedure’s adverse events (AEs. This review covers a total of 64 cases of AEs associated with moxibustion in 24 articles, reported in six countries. Some evidence of the risks of moxibustion has been found in these cases. AEs include allergies, burns, infection, coughing, nausea, vomiting, fetal distress, premature birth, basal cell carcinoma (BCC, ectropion, hyperpigmentation, and even death. The position, duration, distance between moxa and skin, proficiency of the practitioners, conditions of the patients, presence of smoke, and even the environment of treatment can affect the safety of moxibustion. Improving practitioner skill and regulating operations may reduce the incidence of adverse reactions and improve the security of moxibustion.

  3. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1991-10-01

    The requirements for Westinghouse Hanford independent review of the Preliminary Safety Analysis Report (PSAR) are contained in Section 1.0, Subsection 4.3 of WCH-CM-4-46. Specifically, this manual requires the following: (1) Formal functional reviews of the HWVP PSAR by the future operating organization (HWVP Operations), and the independent review organizations (HWVP and Environmental Safety Assurance, Environmental Assurance, and Quality Assurance); and (2) Review and approval of the HWVP PSAR by the Tank Waste Disposal (TWD) Subcouncil of the Safety and Environmental Advisory Council (SEAC), which provides independent advice to the Westinghouse Hanford President and executives on matters of safety and environmental protection. 7 refs.

  4. Quality and safety in adult epilepsy monitoring units: A systematic review and meta-analysis.

    Science.gov (United States)

    Sauro, Khara M; Wiebe, Natalie; Macrodimitris, Sophie; Wiebe, Samuel; Lukmanji, Sara; Jetté, Nathalie

    2016-11-01

    The epilepsy monitoring unit (EMU) is a valuable resource for optimizing management of persons with epilepsy, but may place patients at risk for adverse events due to withdrawal of treatment and induction of symptoms. The purpose of this study was to synthesize data on the safety and quality of care in EMUs to inform the development of quality indicators for EMUs. A systematic review was conducted according to the Preferred Reporting and Items for Systematic Review and Meta-Analysis (PRISMA) statement. The search strategy, which included broad search terms and synonyms pertaining to the EMU, was run in six medical databases and included conference proceedings. Data abstracted included patient and EMU demographics and quality and safety variables. Study quality was evaluated using a modified 15-item Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. Descriptive statistics and meta-analyses were used to describe and synthesize the evidence. The search yielded 7,601 references, of which 604 were reviewed in full text. One-hundred thirty-five studies were included. The quality and safety data came from 181,823 patients and reported on 34 different quality and safety variables. Included studies commonly reported the number of patients (108 studies; median number patients, 171.5), age (49 studies; mean age 35.7 years old), and the reason for admission (34 studies). The most common quality and safety data reported were the utility of the EMU admission (38 studies). Thirty-three studies (24.4%) reported on adverse events, and yielded a pooled proportion of adverse events of 7% (95% confidence interval [CI] 5-9%). The mean quality score was 73.3% (standard deviation [SD] 17.2). This study demonstrates that there is a great deal of variation in the reporting of quality and safety measures and in the quality and safety in EMUs. Study quality also varied considerably from one study to the next. These findings highlight the need to develop

  5. Packaging review guide for reviewing safety analysis reports for packagings: Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Fisher, L.E.; Chou, C.K.; Lloyd, W.R.; Mount, M.E.; Nelson, T.A.; Schwartz, M.W.; Witte, M.C.

    1988-10-01

    The Department of Energy (DOE) has established procedures for obtaining certification of packagings used by DOE and its contractors for the transport of radioactive materials. The principal purpose of this document is to assure the quality and uniformity of PCS reviews and to present a well-defined base from which to evaluate proposed changes in the scope and requirements of reviews. The Packaging Review Guide (PRG) also sets forth solutions and approaches determined to be acceptable in the past in dealing with a specific safety issue or safety-related design area. These solutions and approaches are presented in this form so that reviewers can take consistent and well-understood positions as the same safety issues arise in future cases. An applicant submitting a SARP does not have to follow the solutions or approaches presented. It is also a purpose of the PRG to make information about DOE certification policy and procedures widely available to DOE field offices, DOE contractors, federal agencies, and interested members of the public. 77 refs., 16 figs., 15 tabs.

  6. GEOSAF Part II. Demonstration of the operational and long-term safety of geological disposal facilities for radioactive waste. IAEA international intercomparison and harmonization project

    Energy Technology Data Exchange (ETDEWEB)

    Kumano, Yumiko; Bruno, Gerard [International Atomic Energy Agency, Vienna (Austria). Vienna International Centre; Tichauer, Michael [IRSN, Institut de Radioprotection et de Surete Nucleaire, Fontenay-aux-Roses (France); Hedberg, Bengt [Swedish Radiation Safety Authority, Stockholm (Sweden)

    2015-07-01

    International intercomparison and harmonization projects are one of the mechanisms developed by the IAEA for examining the application and use of safety standards, with a view to ensuring their effectiveness and working towards harmonization of approaches to the safety of radioactive waste management. The IAEA has organized a number of international projects on the safety of radioactive waste management; in particular on the issues related to safety demonstration for radioactive waste management facilities. In 2008, GEOSAF, Demonstration of The Operational and Long-Term Safety of Geological Disposal Facilities for Radioactive Waste, project was initiated. This project was completed in 2011 by delivering a project report focusing on the safety case for geological disposal facilities, a concept that has gained in recent years considerable prominence in the waste management area and is addressed in several international safety standards. During the course of the project, it was recognized that little work was undertaken internationally to develop a common view on the safety approach related to the operational phase of a geological disposal although long-term safety of disposal facility has been discussed for several decades. Upon completion of the first part of the GEOSAF project, it was decided to commence a follow-up project aiming at harmonizing approaches on the safety of geological disposal facilities for radioactive waste through the development of an integrated safety case covering both operational and long-term safety. The new project was named as GEOSAF Part II, which was initiated in 2012 initially as 2-year project, involving regulators and operators. GEOSAF Part II provides a forum to exchange ideas and experience on the development and review of an integrated operational and post-closure safety case for geological disposal facilities. It also aims at providing a platform for knowledge transfer. The project is of particular interest to regulatory

  7. Current Sports: Medicine Issues. Annual Safety Education Review--1973.

    Science.gov (United States)

    Craig, Timothy T., Ed.

    This document is a collection of papers whose theme is sports safety. Section one, "Government Interest in Sports Safety," includes an article on Washington, D.C.'s focus on sports safety. Section two, "Medical Aspects of Safety in Sports," includes articles regarding the medical basis of restriction from athletics, orthopaedic restrictions, and…

  8. Safety of metamizole: a systematic review of the literature.

    Science.gov (United States)

    Andrade, S; Bartels, D B; Lange, R; Sandford, L; Gurwitz, J

    2016-10-01

    Metamizole was withdrawn from the market in the United States and several European countries following reports of fatal agranulocytosis among users, but is still available in many countries in Europe, South America and Asia. Over the past several decades, a number of epidemiologic studies have been conducted to quantify the risk of agranulocytosis and other adverse effects associated with metamizole and other non-narcotic analgesics. The objective of this study was to perform a systematic review of the safety of metamizole. Epidemiologic studies published between 1 January 1980 and 15 December 2014 were identified through systematic searches of PubMed and Google Scholar; the reference sections of selected articles were also reviewed to identify potentially relevant studies. Studies included in this review focused on the safety of metamizole, that is on outcomes such as haematologic abnormalities, gastrointestinal bleeding, anaphylaxis and hepatotoxicity. Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to prespecified criteria. A total of 22 articles met the criteria for evaluation. The majority of studies that evaluated agranulocytosis indicated an increased risk associated with metamizole, with relative risk (RR) estimates ranging from 1·5 (95% CI, 0·8-2·7) to 40·2 (95% CI, 14·7-113·3). Findings of three case-control studies do not suggest an association between metamizole and aplastic anaemia. Of the five case-control studies that evaluated the risk of upper gastrointestinal bleeding, four found a statistically significant increased risk associated with metamizole (RR estimates ranging from 1·4 to 2·7). There is insufficient evidence to determine whether metamizole increases the risk of other outcomes (e.g. hepatic effects, anaphylaxis, congenital anomalies). Few studies evaluated the effects of dose, route of administration or duration of therapy. Published studies reported differences in

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

    Science.gov (United States)

    Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

    2017-01-01

    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.

  10. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety......-analysis. METHODS: Randomized controlled trials comparing DES to each other or to BMS were searched through MEDLINE, EMBASE, and Cochrane databases and proceedings of international meetings. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted...

  11. Hypofractionated radiation therapy versus conventional radiation therapy in prostate cancer: A systematic review of its safety and efficacy.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Rodríguez-Melcón, J I; Angulo, J C; Luengo-Matos, S

    2015-01-01

    New therapeutic alternatives can improve the safety and efficacy of prostate cancer treatment. To assess whether hypofractionated radiation therapy results in better safety and efficacy in the treatment of prostate cancer. Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, ClinicalTrials and EuroScan, collecting indicators of safety and efficacy. We included 2 systematic reviews and a clinical trial. In terms of efficacy, there is considerable heterogeneity among the studies, and no conclusive results were found concerning the superiority of the hypofractionated option over the normal fractionated option. In terms of safety, there were no significant differences in the onset of acute genitourinary complications between the 2 treatments. However, one of the reviews found more acute gastrointestinal complications in patients treated with hypofractionated radiation therapy. There were no significant differences in long-term complications based on the type of radiation therapy used, although the studies did have limitations. To date, there are no conclusive results that show that hypofractionated radiation therapy is more effective or safer than normal fractionated radiation therapy in the treatment of localized prostate cancer. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Methotrexate in inflammatory bowel disease: a multicenter retrospective study focused on long-term efficacy and safety. The Madrid experience.

    Science.gov (United States)

    González-Lama, Yago; Taxonera, Carlos; López-Sanromán, Antonio; Pérez-Calle, José Lázaro; Bermejo, Fernando; Pajares, Ramón; McNicholl, Adrian G; Opio, Verónica; Mendoza, Juan Luis; López, Pilar; Algaba, Alicia; Estelles, Jesús; Barbero, Almudena; Mendoza, Jorge; Maté, José; Gisbert, Javier P

    2012-09-01

    Methotrexate is useful in inflammatory bowel disease (IBD), but its role is secondary because of its limited experience and a supposedly unfavorable safety profile. To describe the efficacy and safety of methotrexate in a long-term real clinical practice. Retrospectively reviewed records of IBD patients treated with methotrexate in eight hospitals of Madrid (Spain). A total of 77 patients were included (80% Crohn's disease); 94% received methotrexate because of steroid dependency. Overall, 82% of the patients initially responded (28% remission). Eighty-eight percent of the patients followed maintenance treatment for a mean of 17 (range: 1-108) months. Forty percent of the patients lost response at a mean of 57 weeks after starting methotrexate. No statistically significant differences were found in the response rates in terms of the disease type, route of administration, or the Montreal Classification category. The mean methotrexate cumulative dose was 1108 mg (range: 25-6480). The main adverse events included 10 cases of gastrointestinal symptoms, four of myelotoxicity, and 10 of abnormal liver function tests, and led to methotrexate withdrawal in four (5%) patients. Transient elastography, performed in 46 patients, detected six additional cases with significant fibrosis and normal liver function tests. Methotrexate is useful in inducing a response in IBD, although its efficacy decreases frequently through the follow-up. Although methotrexate seems safe in the long term, in addition to biochemical controls, a more accurate method to detect liver damage should be considered.

  13. A Review of Research on Procedures for Teaching Safety Skills to Persons with Developmental Disabilities

    Science.gov (United States)

    Dixon, Dennis R.; Bergstrom, Ryan; Smith, Marlena N.; Tarbox, Jonathan

    2010-01-01

    Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire. A number of studies…

  14. 78 FR 18965 - Submission for OMB Review; Comment Request: Safety Standard for Cigarette Lighters

    Science.gov (United States)

    2013-03-28

    ... COMMISSION Submission for OMB Review; Comment Request: Safety Standard for Cigarette Lighters AGENCY... a collection of information associated with the Commission's safety standard for cigarette lighters... the Safety Standard for Cigarette Lighters, 16 CFR part 1210. One comment was received in response to...

  15. Improving students' long-term knowledge retention through personalized review.

    Science.gov (United States)

    Lindsey, Robert V; Shroyer, Jeffery D; Pashler, Harold; Mozer, Michael C

    2014-03-01

    Human memory is imperfect; thus, periodic review is required for the long-term preservation of knowledge and skills. However, students at every educational level are challenged by an ever-growing amount of material to review and an ongoing imperative to master new material. We developed a method for efficient, systematic, personalized review that combines statistical techniques for inferring individual differences with a psychological theory of memory. The method was integrated into a semester-long middle-school foreign-language course via retrieval-practice software. Using a cumulative exam administered after the semester's end, we compared time-matched review strategies and found that personalized review yielded a 16.5% boost in course retention over current educational practice (massed study) and a 10.0% improvement over a one-size-fits-all strategy for spaced study.

  16. A review of the safety aspects of radio frequency ablation

    Directory of Open Access Journals (Sweden)

    Abhishek Bhaskaran

    2015-09-01

    Full Text Available In light of recent reports showing high incidence of silent cerebral infarcts and organized atrial arrhythmias following radiofrequency (RF atrial fibrillation (AF ablation, a review of its safety aspects is timely. Serious complications do occur during supraventricular tachycardia (SVT ablations and knowledge of their incidence is important when deciding whether to proceed with ablation. Evidence is emerging for the probable role of prophylactic ischemic scar ablation to prevent VT. This might increase the number of procedures performed. Here we look at the various complications of RF ablation and also the methods to minimize them. Electronic database was searched for relevant articles from 1990 to 2015. With better awareness and technological advancements in RF ablation the incidence of complications has improved considerably. In AF ablation it has decreased from 6% to less than 4% comprising of vascular complications, cardiac tamponade, stroke, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula (AEF and death. Safety of SVT ablation has also improved with less than 1% incidence of AV node injury in AVNRT ablation. In VT ablation the incidence of major complications was 5–11%, up to 3.4%, up to 1.8% and 4.1–8.8% in patients with structural heart disease, without structural heart disease, prophylactic ablations and epicardial ablations respectively. Vascular and pericardial complications dominated endocardial and epicardial VT ablations respectively. Up to 3% mortality and similar rates of tamponade were reported in endocardial VT ablation. Recent reports about the high incidence of asymptomatic cerebral embolism during AF ablation are concerning, warranting more research into its etiology and prevention.

  17. 76 FR 37375 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2011-06-27

    ... of Justice Programs Meeting of the Public Safety Officer Medal of Valor Review Board AGENCY: Office...: This is an announcement of a meeting via conference call of the Public Safety Officer Medal of Valor... Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C. 15202. Pursuant...

  18. Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

    Science.gov (United States)

    Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

    2009-01-01

    Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

  19. On-board safety monitoring systems for driving: review, knowledge gaps, and framework.

    Science.gov (United States)

    Horrey, William J; Lesch, Mary F; Dainoff, Marvin J; Robertson, Michelle M; Noy, Y Ian

    2012-02-01

    Fatal highway incidents remain the leading type of fatal work-related event, carrying tremendous personal, social, and economic costs. While employers with a fixed worksite can observe and interact directly with workers in an effort to promote safety and reduce risk, employers with workers who operate a motor vehicle as part of their job have fewer options. New technologies such as on-board safety monitoring systems offer the potential to further improve safety. These technologies allow vehicle owners to collect safety-specific information related to a driver's on-the-road behavior and performance. While many such devices are being developed and implemented in both commercial fleets and private vehicles, the scientific examination of these devices has lagged by comparison. In the current paper, we: (a) describe the general features and functionality of current generations of on-board monitoring devices and how they might impact various driver behaviors; (b) review the current state of scientific knowledge specific to on-board devices; (c) discuss knowledge gaps and potential areas for future research, borrowing from the related domain of computer-based electronic performance monitoring (EPM); and (d) propose a framework that can be used to explore some of the human-system interactions pertaining to monitoring systems. Motor vehicle crashes can carry tremendous costs for employers, in terms of injury, disability, and loss of potentially productive work years. New technologies can offer tremendous benefits in terms of promoting safer on-the-road behaviors. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

    Directory of Open Access Journals (Sweden)

    Moataz Alhaj

    2016-01-01

    Full Text Available Rift Valley Fever (RVF is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA, a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control.

  1. Safety in transportation: a review of the concept, its context, safety preservation and improvement effectiveness

    Directory of Open Access Journals (Sweden)

    Maciej SZCZUKOWSKI

    2017-06-01

    Full Text Available The article presents definitions of and approaches to the concept of safety in order to confirm the subjective character of its determination, description, and interpretation. By presenting examples of security statistics and safety-related behaviours, its ambiguity and complexity are revealed. The author draws attention to the media’s attitude towards safety-related incidents. With reference to contemporary scientific knowledge about the methods of improving safety in transportation organizations, the author also suggests that safety improvement initiatives should focus more strongly on facilitating closer cooperation between leaders, superiors and subordinates with different levels of experience.

  2. Review of health safety aspects of nanotechnologies in food production.

    Science.gov (United States)

    Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

    2009-02-01

    Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

  3. Factors influencing the microbial safety of fresh produce: a review.

    Science.gov (United States)

    Olaimat, Amin N; Holley, Richard A

    2012-10-01

    Increased consumption, larger scale production and more efficient distribution of fresh produce over the past two decades have contributed to an increase in the number of illness outbreaks caused by this commodity. Pathogen contamination of fresh produce may originate before or after harvest, but once contaminated produce is difficult to sanitize. The prospect that some pathogens invade the vascular system of plants and establish "sub-clinical" infection needs to be better understood to enable estimation of its influence upon risk of human illness. Conventional surface sanitation methods can reduce the microbial load, but cannot eliminate pathogens if present. Chlorine dioxide, electrolyzed water, UV light, cold atmospheric plasma, hydrogen peroxide, organic acids and acidified sodium chlorite show promise, but irradiation at 1 kGy in high oxygen atmospheres may prove to be the most effective means to assure elimination of both surface and internal contamination of produce by pathogens. Pathogens of greatest current concern are Salmonella (tomatoes, seed sprouts and spices) and Escherichia coli O157:H7 on leafy greens (spinach and lettuce). This review considers new information on illness outbreaks caused by produce, identifies factors which influence their frequency and size and examines intervention effectiveness. Research needed to increase our understanding of the factors influencing microbial safety of fresh produce is addressed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. The Safety of Ingested Caffeine: A Comprehensive Review

    Science.gov (United States)

    Temple, Jennifer L.; Bernard, Christophe; Lipshultz, Steven E.; Czachor, Jason D.; Westphal, Joslyn A.; Mestre, Miriam A.

    2017-01-01

    Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research. PMID:28603504

  5. The Safety of Ingested Caffeine: A Comprehensive Review.

    Science.gov (United States)

    Temple, Jennifer L; Bernard, Christophe; Lipshultz, Steven E; Czachor, Jason D; Westphal, Joslyn A; Mestre, Miriam A

    2017-01-01

    Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research.

  6. The Safety of Ingested Caffeine: A Comprehensive Review

    Directory of Open Access Journals (Sweden)

    Jennifer L. Temple

    2017-05-01

    Full Text Available Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood. Over the past decade, the introduction of new caffeine-containing food products, as well as changes in consumption patterns of the more traditional sources of caffeine, has increased scrutiny by health authorities and regulatory bodies about the overall consumption of caffeine and its potential cumulative effects on behavior and physiology. Of particular concern is the rate of caffeine intake among populations potentially vulnerable to the negative effects of caffeine consumption: pregnant and lactating women, children and adolescents, young adults, and people with underlying heart or other health conditions, such as mental illness. Here, we review the research into the safety and safe doses of ingested caffeine in healthy and in vulnerable populations. We report that, for healthy adults, caffeine consumption is relatively safe, but that for some vulnerable populations, caffeine consumption could be harmful, including impairments in cardiovascular function, sleep, and substance use. We also identified several gaps in the literature on which we based recommendations for the future of caffeine research.

  7. Review of SKB's Safety Assessment SR-Can: Contributions in Support of SKI's and SSI's Review by External Consultants

    Energy Technology Data Exchange (ETDEWEB)

    2008-03-15

    The Swedish Nuclear Fuel and Waste Management Co (SKB) plans to submit a license application for the construction of a repository for spent nuclear fuel in Sweden 2010. In support of this application SKB will present a safety report, SR-Site, on the repository's long-term safety and radiological consequences. As a preparation for SR-Site, SKB published the preliminary safety assessment SR-Can in November 2006. The purposes were to document a first evaluation of long-term safety for the two candidate sites at Forsmark and Laxemar and to provide feedback to SKB's future programme of work. An important objective of the authorities' review of SR-Can is to provide guidance to SKB on the complete safety reporting for the license application. The authorities have engaged external experts for independent modelling, analysis and review, with the aim to provide a range of expert opinions related to the sufficiency and appropriateness of various aspects of SR-Can. The conclusions and judgments in this report are those of the authors and may not necessarily coincide with those of SKI and SSI. The authorities own review will be published separately (SKI Report 2008:23, SSI Report 2008:04 E). This report compiles contributions from several specific research projects. The separate reviews cover topics regarding the engineered barrier system, the quality assurance, the climate evolution and its effects, and the ecosystems and environmental impacts. All contributions are in English apart from the review concerning ecosystems and environmental impacts, which is presented in Swedish

  8. Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review.

    Science.gov (United States)

    Bakker, Marina; Bunge, Eveline M; Marano, Cinzia; de Ridder, Marc; De Moerlooze, Laurence

    2016-07-01

    Hepatitis A and B are two of the most common vaccine-preventable diseases and vaccination for Hepatitis A virus (HAV) and hepatitis B virus (HBV) is recommended for those at risk of contracting HAV and/or HBV through their occupation, travel or lifestyle. To describe the vaccine efficacy, immunogenicity, effectiveness and safety of the combined vaccine against hepatitis A and hepatitis B. A systematic review of the literature published between 1990 and 2015. Anti-HAV seropositivity rates ranged from 96.2% to 100% and anti-HBs seroprotection rates from 82% to 100%. Antibodies persisted up to 15 years and geometric mean concentration (GMC) remained above the seropositivity cut-off value for both. Anti-HAV and anti-HBs immune responses were lower in less immunocompetent individuals one month after completion of the immunization schedule. The safety profiles of Twinrix(TM) and monovalent hepatitis A and B vaccines were similar. The vaccine offers satisfactory long-term immunogenicity rates, expected duration of protection and safety profile similar to the monovalent hepatitis A or B vaccines.

  9. Review of Policy Documents for Nuclear Safety and Regulation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Woong Sik; Choi, Kwang Sik; Choi, Young Sung; Kim, Hho Jung; Kim, Ho Ki [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

    2006-07-01

    The goal of regulation is to protect public health and safety as well as environment from radiological hazards that may occur as a result of the use of atomic energy. In September 1994, the Korean government issued the Nuclear Safety Policy Statement (NSPS) to establish policy goals of maintaining and achieving high-level of nuclear safety and also help the public understand the national policy and a strong will of the government toward nuclear safety. It declares the importance of establishing safety culture in nuclear community and also specifies five nuclear regulatory principles (Independence, Openness, Clarity, Efficiency and Reliability) and provides the eleven regulatory policy directions. In 2001, the Nuclear Safety Charter was declared to make the highest goal of safety in driving nuclear business clearer; to encourage atomic energy- related institutions and workers to keep in mind the mission and responsibility for assuring safety; to guarantee public confidence in related organizations. The Ministry of Science and Technology (MOST) also issues Yearly Regulatory Policy Directions at the beginning of every year. Recently, the third Atomic Energy Promotion Plan (2007-2011) has been established. It becomes necessary for the relevant organizations to prepare the detailed plans on such areas as nuclear development, safety management, regulation, etc. This paper introduces a multi-level structure of nuclear safety and regulation policy documents in Korea and presents some improvements necessary for better application of the policies.

  10. Measures of patient safety in developing and emerging countries: a review of the literature.

    Science.gov (United States)

    Carpenter, K B; Duevel, M A; Lee, P W; Wu, A W; Bates, D W; Runciman, W B; Baker, G R; Larizgoitia, I; Weeks, W B

    2010-02-01

    The World Alliance for Patient Safety was formed to accelerate worldwide research progress towards measurably improving patient safety. Although rates of adverse events have been studied in industrialised countries, little is known about the rates of adverse events in developing and emerging countries. To review the literature on patient safety issues in developing and emerging countries, to identify patient safety measures presently used in these countries and to propose a method of measurably improving patient safety measurement in these countries. Using the Medline database for 1998 to 2007, we identified and reviewed 23 English-language articles that examined patient safety measurement in developing and emerging countries. Results Our review included 12 studies that prospectively measured patient safety and 11 studies that retrospectively measured safety. Two studies used measures of structure and the remaining used process measures, outcome measures or both. Whereas a few studies used surveys or direct observation, most studies used chart audits to measure patient safety. Most studies addressed safety at a single facility. Investigation of patient safety in developing and emerging countries has been infrequent and limited in scope. Establishing fundamental safe patient practices, integrating those processes into routine health services delivery and developing patients' expectations that such processes be present are necessary prerequisites to measuring and monitoring progress towards safe patient care in emerging and developing countries.

  11. Safety impacts of bicycle infrastructure: A critical review.

    Science.gov (United States)

    DiGioia, Jonathan; Watkins, Kari Edison; Xu, Yanzhi; Rodgers, Michael; Guensler, Randall

    2017-06-01

    This paper takes a critical look at the present state of bicycle infrastructure treatment safety research, highlighting data needs. Safety literature relating to 22 bicycle treatments is examined, including findings, study methodologies, and data sources used in the studies. Some preliminary conclusions related to research efficacy are drawn from the available data and findings in the research. While the current body of bicycle safety literature points toward some defensible conclusions regarding the safety and effectiveness of certain bicycle treatments, such as bike lanes and removal of on-street parking, the vast majority treatments are still in need of rigorous research. Fundamental questions arise regarding appropriate exposure measures, crash measures, and crash data sources. This research will aid transportation departments with regard to decisions about bicycle infrastructure and guide future research efforts toward understanding safety impacts of bicycle infrastructure. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

  12. High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Rodríguez-Melcón, J I; Angulo, J C; Luengo-Matos, S

    2017-03-01

    High-dose rate brachytherapy (HDR-BT) is an increasingly popular treatment for patients with localised prostate cancer (PC). To assess the safety and efficacy of HDR-BT as monotherapy in PC. A systematic literature review was conducted through searches on MEDLINE (PubMed), Cochrane Library, CDR, ClinicalTrials and EuroScan. We assessed safety and efficacy indicators. We selected 2 reviews and 12 uncontrolled studies, included in these 2 reviews. In terms of efficacy, local control in 6 studies was 97-100%. The biochemical progression-free survival varied as follows: 85-100% for low risk and 79-92% for high risk. Survival free of metastases was >95% at 8 years, except in one study where the survival rate was 87% at 5 years. The overall survival was ≥95% in 8 studies. In terms of safety, most of the studies recorded acute and long-term genitourinary and gastrointestinal complications, especially grade ≥2. Only 3 studies found grade 4 complications. All studies, except for one without complications, observed genitourinary complications that were more frequent and severe than the gastrointestinal complications. Two studies assessed the quality of life and showed an initial reduction in various domains and subsequent partial or total recovery, except in the sexual domain. HDR-BT is effective as monotherapy, especially in cases of low to intermediate risk. There is insufficient information on high-risk patients. The short to medium-term toxicity was acceptable. Further research needs to be funded to provide more information on the long-term safety and efficacy of this treatment. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. Nuclear Safety: Technical progress review, January-March 1988

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1988-01-01

    This journal covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  14. Near-term electric-vehicle program. Phase II. Mid-term review summary report

    Energy Technology Data Exchange (ETDEWEB)

    1978-07-27

    The general objective of the Near-Term Electric Vehicle Program is to confirm that, in fact, the complete spectrum of requirements placed on the automobile (e.g., safety, producibility, utility, etc.) can still be satisfied if electric power train concepts are incorporated in lieu of contemporary power train concepts, and that the resultant set of vehicle characteristics are mutually compatible, technologically achievable, and economically achievable. The focus of the approach to meeting this general objective involves the design, development, and fabrication of complete electric vehicles incorporating, where necessary, extensive technological advancements. A mid-term summary is presented of Phase II which is a continuation of the preliminary design study conducted in Phase I of the program. Information is included on vehicle performance and performance simulation models; battery subsystems; control equipment; power systems; vehicle design and components for suspension, steering, and braking; scale model testing; structural analysis; and vehicle dynamics analysis. (LCL)

  15. Online review courses as preparation for first term remedial exams

    OpenAIRE

    Ricardo Domínguez-Reyes; Juan Meléndez; Aarón Hernández-Pérez

    2015-01-01

    At Universidad Carlos III de Madrid we have developed a review course (R-Course) with a SPOC structure intended for students who failed the first term regular exams. The purpose of the course is to help students prepare for the remedial exams at the same time they study the second term courses. The R-Course is implemented in an Open-EDX platform that holds digital documents, both theory and solved exercise videos, platform integrated exercises, and forums. The content of the course is divided...

  16. Efficacy and safety of pregabalin in generalised anxiety disorder: A critical review of the literature.

    Science.gov (United States)

    Baldwin, David S; den Boer, Johan A; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-10-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in GAD, including 11 randomised double-blind trials and two open-label studies. Pregabalin efficacy has been consistently demonstrated across the licensed dose range of 150-600 mg/day. Efficacy has been reported for pregabalin monotherapy in elderly patients with GAD, patients with severe anxiety, and for adjunctive therapy when added to a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in patients who have failed to respond to an initial course of antidepressant therapy. The two most common adverse events with pregabalin are somnolence and dizziness, both of which appear to be dose-related. Pregabalin appears to have a low potential for causing withdrawal symptoms when long-term therapy is discontinued; however, tapering over the course of at least one week is recommended. A review of available evidence indicates that pregabalin is a well-tolerated and consistently effective treatment for GAD, with a unique mechanism of action that makes it a useful addition to the therapeutic armamentarium. © The Author(s) 2015.

  17. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009.

    Science.gov (United States)

    2014-04-01

    In FY 2009, Federal and State enforcement personnel conducted more than 15,000 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR...

  18. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in FY 2008

    Science.gov (United States)

    2012-09-30

    In FY 2008, Federal and State enforcement personnel conducted 14,906 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR, carriers...

  19. Radioembolization for neuroendocrine liver metastases: safety, imaging, and long-term outcomes.

    Science.gov (United States)

    Memon, Khairuddin; Lewandowski, Robert J; Mulcahy, Mary F; Riaz, Ahsun; Ryu, Robert K; Sato, Kent T; Gupta, Ramona; Nikolaidis, Paul; Miller, Frank H; Yaghmai, Vahid; Gates, Vanessa L; Atassi, Bassel; Newman, Steven; Omary, Reed A; Benson, Al B; Salem, Riad

    2012-07-01

    To present long-term outcomes on the safety and efficacy of Yttrium-90 radioembolization in the treatment of unresectable hepatic neuroendocrine metastases refractory to standard-of-care therapy. This study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Forty patients with hepatic neuroendocrine metastases were treated with (90)Y radioembolization at a single center. Toxicity was assessed using National Cancer Institute Common Terminology Criteria v3.0. Response to therapy was assessed by World Health Organization (WHO) guidelines for size and European Association for the Study of the Liver disease (EASL) guidelines for necrosis. Time to response and overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed. The median dose was 113 Gy (29-299 Gy). Clinical toxicities included fatigue (63%), nausea/vomiting (40%), abdominal pain (18%), fever (8%), diarrhea and weight loss (5%); Grade 3 and 4 bilirubin toxicities were experienced by 2 patients and 1 patient, respectively. Different responses were noted by WHO (complete response, 1.2%; partial response, 62.7%) and EASL (complete response, 20.5%; partial response, 43.4%). Median time to response was 4 and 4.9 months by lesion and patient, respectively. The 1-, 2-, and 3-year overall survival rates were 72.5%, 62.5%, and 45%, respectively. Eastern Cooperative Oncology Group (ECOG) performance score 0 (p < 0.0001), tumor burden ≤25% (p = 0.0019), albumin ≥3.5 g/dL (p = 0.017), and bilirubin ≤1.2 mg/dL (p = 0.002) prognosticated survival on univariate analysis; only ECOG performance score 0 and bilirubin ≤1.2 mg/dL prognosticated better survival outcome on multivariate analysis (p = 0.0001 and p = 0.02). Yttrium-90 therapy for hepatic neuroendocrine metastases leads to satisfactory tumor response and patient survival with low toxicity, in line with published national guidelines

  20. Radioembolization for Neuroendocrine Liver Metastases: Safety, Imaging, and Long-Term Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Memon, Khairuddin; Lewandowski, Robert J. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Mulcahy, Mary F. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Riaz, Ahsun; Ryu, Robert K.; Sato, Kent T.; Gupta, Ramona; Nikolaidis, Paul; Miller, Frank H.; Yaghmai, Vahid; Gates, Vanessa L.; Atassi, Bassel [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Newman, Steven [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Omary, Reed A. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Benson, Al B. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Salem, Riad, E-mail: r-salem@northwestern.edu [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States)

    2012-07-01

    Purpose: To present long-term outcomes on the safety and efficacy of Yttrium-90 radioembolization in the treatment of unresectable hepatic neuroendocrine metastases refractory to standard-of-care therapy. Methods and Materials: This study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Forty patients with hepatic neuroendocrine metastases were treated with {sup 90}Y radioembolization at a single center. Toxicity was assessed using National Cancer Institute Common Terminology Criteria v3.0. Response to therapy was assessed by World Health Organization (WHO) guidelines for size and European Association for the Study of the Liver disease (EASL) guidelines for necrosis. Time to response and overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed. Results: The median dose was 113 Gy (29-299 Gy). Clinical toxicities included fatigue (63%), nausea/vomiting (40%), abdominal pain (18%), fever (8%), diarrhea and weight loss (5%); Grade 3 and 4 bilirubin toxicities were experienced by 2 patients and 1 patient, respectively. Different responses were noted by WHO (complete response, 1.2%; partial response, 62.7%) and EASL (complete response, 20.5%; partial response, 43.4%). Median time to response was 4 and 4.9 months by lesion and patient, respectively. The 1-, 2-, and 3-year overall survival rates were 72.5%, 62.5%, and 45%, respectively. Eastern Cooperative Oncology Group (ECOG) performance score 0 (p < 0.0001), tumor burden {<=}25% (p = 0.0019), albumin {>=}3.5 g/dL (p = 0.017), and bilirubin {<=}1.2 mg/dL (p = 0.002) prognosticated survival on univariate analysis; only ECOG performance score 0 and bilirubin {<=}1.2 mg/dL prognosticated better survival outcome on multivariate analysis (p = 0.0001 and p = 0.02). Conclusion: Yttrium-90 therapy for hepatic neuroendocrine metastases leads to satisfactory tumor response and patient survival

  1. Building safety and human behaviour in fire: A literature review

    NARCIS (Netherlands)

    Kobes, M.; Helsloot, I.; de Vries, B.; Post, J.

    2010-01-01

    The most crucial aspect of a building's safety in the face of fire is the possibility of safe escape. An important precondition is that its fire safety facilities enable independent and adequate fire response performances by the building's occupants. In practice, it appears that the measures

  2. Experiences from the LNPP-P and DSA review. Lessons learned from RBMK safety studies

    Energy Technology Data Exchange (ETDEWEB)

    Mankamo, T. [Avaplan Oy (Finland); Marttila, J.; Reponen, H. [Radiation and Nuclear Safety Authority, Helsinki (Finland)

    2000-09-01

    RBMK is the Russian acronym for 'Channelized Large Power Reactor'. The Soviet-designed RBMK plants deviate substantially from typical Western BWR or PWR plants. The safety of the RBMK plants has raised severe concerns since the major accident at Chernobyl Unit 4 in 1986. In addition, a fire destroyed the turbine hall of Chernobyl Unit 2 in 1991 resulting in a near-accident: the reactor cooling could only be maintained through improvised measures. Another well-known fire event is the control cable room fire at Ignalina Unit 2 in 1989, which led to a partial loss of the main control room functions. After the collapse of Soviet Union several multilateral safety programs were started to evaluate and improve the safety of the RBMK plants. A Probabilistic and Deterministic Safety Assessment (P and DSA) of the Leningrad Nuclear Power Plant (LNPP) Unit 2 was started in 1996. Phase 2 of the project was completed in January 1999. A Peer Review was performed by Russian and Western experts. This report describes the insights from the RBMK risk studies, especially from the LNPP P and DSA with emphasis on the deeper understanding of the risk-important design factors and identification of possible ways to increase safety. LNPP P and DSA has meant a significant progress in this respect. Despite of its certain limitations P and DSA Phase 2 could point out short-term measures, which substantially reduced the risk of identified weaknesses, mostly related to the reliability of the emergency feedwater function and its support systems. The findings of LNPP P and DSA and the review recommendations emphasise the extensions needed to the analysis scope. The spreading and other influences of fires and floods between connected spaces should be analysed because of incomplete separation and protection in these regards in the 16st generation RBMK plants. High priority should be given to the analysis of external hazards, which were found important at the Loviisa NPP on the Northern

  3. Neighborhood safety factors associated with older adults' health-related outcomes: A systematic literature review.

    Science.gov (United States)

    Won, Jaewoong; Lee, Chanam; Forjuoh, Samuel N; Ory, Marcia G

    2016-09-01

    Neighborhood safety is important for older adults' health and wellbeing, but there has not been a synthesis in the literature of what is currently known about this construct. This systematic literature review, following the PRISMA guidelines, focuses on identifying neighborhood safety factors associated with health-related outcomes and behaviors of older adults in the U.S. A search was conducted in 2014 via Academic Search Complete, CINAHL, Embase, MEDLINE, SportDis, and Transportation Databases. Based on our inclusion and exclusion criteria, we identified thirty-two articles for review. Sixteen studies examined health outcomes such as health status, mental health, physical function, morbidity/mortality, and obesity; the other sixteen studies focused on health behaviors, such as physical activity and walking. Four domains of neighborhood safety were identified: overall/general neighborhood safety; crime-related safety; traffic-related safety; and proxies for safety (e.g., vandalism, graffiti). Overall/general neighborhood safety appeared most relevant to mental health and physical function. Traffic-related safety was most pertinent to physical activity, while crime-related safety was more consistently associated with mental health and walking. While all safety variables were significantly associated with mental health, no significant associations were found for obesity. We also found that specific measures or constructs of safety were not applied consistently across the examined studies, making it difficult to compare the results. This review identified several important gaps in the existing studies dealing with neighborhood safety-health relationships among older adults. Further studies are needed that examine the different roles of multidimensional neighborhood safety in promoting the community health, not only in the U.S., but globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Online review courses as preparation for first term remedial exams

    Directory of Open Access Journals (Sweden)

    Ricardo Domínguez-Reyes

    2015-09-01

    Full Text Available At Universidad Carlos III de Madrid we have developed a review course (R-Course with a SPOC structure intended for students who failed the first term regular exams. The purpose of the course is to help students prepare for the remedial exams at the same time they study the second term courses. The R-Course is implemented in an Open-EDX platform that holds digital documents, both theory and solved exercise videos, platform integrated exercises, and forums. The content of the course is divided in videos of less than 10 minutes in length, allowing students to include the R-Course in any schedule and making it compatible with the second term courses. Interactive platform integrated exercises have been devised under different types of methodologies to increase the motivation of the students, and the platform forums give students and tutors a space to discuss and interact for a well-rounded academic experience.

  5. Development of the status of W and T for the realization of a long-term safety demonstration for the final repository using the examples VSG and Konrad. Report on the Working package 2. Review and development of safety-related assessments of disposal facilities of wastes with negligible heat generation; development and provision of the necessary set of tools using the example of the final repository Konrad; Entwicklung des Standes von W and T bei der Fuehrung eines Langzeitsicherheitsnachweises fuer Endlager an den Beispielen VSG und Konrad. Bericht zum Arbeitspaket 2. Untersuchung und Entwicklung von sicherheitstechnischen Bewertungen fuer Endlager fuer Abfaelle mit vernachlaessigbarer Waermeentwicklung und Bereitstellung des notwendigen Instrumentariums am Beispiel des Endlagers Konrad

    Energy Technology Data Exchange (ETDEWEB)

    Larue, Juergen; Fischer-Appelt, Klaus; Hartwig-Thurat, Eva

    2015-09-15

    In the research project on the ''Review and development of safety-related assessments of disposal facilities with negligible heat generation; development and provision of the necessary set of tools, using the example of the Konrad disposal facility'' (3612R03410), the state of the art in science and technology of the safety-related assessments and sets of tools for building a safety case was examined. The reports pertaining to the two work packages described the further development of the methodology for accident analyses (WP 1) and of building a safety case (WP 2); also, comparisons were drawn on a national and international scale with the methods applied in the licensing procedure of the Konrad disposal facility. A safety case as well as its underlying analyses and methods always has to be brought up to date with the development of the state of the art in science and technology. In Germany, two safety cases regarding the long-term safety of disposal facilities have been prepared. These are the licensing documentation for the Konrad disposal facility in the year 1990 and the research project regarding the preliminary safety case for the Gorleben site (Vorlaeufige Sicherheitsanalyse Gorleben - VSG) in the year 2013, both reflecting the state of development of building a safety case at the respective time. Comparing the two above-mentioned examples of safety cases and taking recent international recommendations and national regulations into account, this report on Work Package 2 presents the development of the international state of the art in science and technology. This has been done by summarising the essential differences and similarities of each element of the safety case for the Konrad disposal facility on the one hand and the VSG and the international status on the other hand.

  6. Patient safety culture in care homes for older people: a scoping review.

    Science.gov (United States)

    Gartshore, Emily; Waring, Justin; Timmons, Stephen

    2017-11-21

    In recent years, there has been an increasing focus on the role of safety culture in preventing incidents such as medication errors and falls. However, research and developments in safety culture has predominantly taken place in hospital settings, with relatively less attention given to establishing a safety culture in care homes. Despite safety culture being accepted as an important quality indicator across all health and social care settings, the understanding of culture within social care settings remains far less developed than within hospitals. It is therefore important that the existing evidence base is gathered and reviewed in order to understand safety culture in care homes. A scoping review was undertaken to describe the availability of evidence related to care homes' patient safety culture, what these studies focused on, and identify any knowledge gaps within the existing literature. Included papers were each reviewed by two authors for eligibility and to draw out information relevant to the scoping review. Twenty-four empirical papers and one literature review were included within the scoping review. The collective evidence demonstrated that safety culture research is largely based in the USA, within Nursing Homes rather than Residential Home settings. Moreover, the scoping review revealed that empirical evidence has predominantly used quantitative measures, and therefore the deeper levels of culture have not been captured in the evidence base. Safety culture in care homes is a topic that has not been extensively researched. The review highlights a number of key gaps in the evidence base, which future research into safety culture in care home should attempt to address.

  7. Patient safety culture in care homes for older people: a scoping review

    Directory of Open Access Journals (Sweden)

    Emily Gartshore

    2017-11-01

    Full Text Available Abstract Background In recent years, there has been an increasing focus on the role of safety culture in preventing incidents such as medication errors and falls. However, research and developments in safety culture has predominantly taken place in hospital settings, with relatively less attention given to establishing a safety culture in care homes. Despite safety culture being accepted as an important quality indicator across all health and social care settings, the understanding of culture within social care settings remains far less developed than within hospitals. It is therefore important that the existing evidence base is gathered and reviewed in order to understand safety culture in care homes. Methods A scoping review was undertaken to describe the availability of evidence related to care homes’ patient safety culture, what these studies focused on, and identify any knowledge gaps within the existing literature. Included papers were each reviewed by two authors for eligibility and to draw out information relevant to the scoping review. Results Twenty-four empirical papers and one literature review were included within the scoping review. The collective evidence demonstrated that safety culture research is largely based in the USA, within Nursing Homes rather than Residential Home settings. Moreover, the scoping review revealed that empirical evidence has predominantly used quantitative measures, and therefore the deeper levels of culture have not been captured in the evidence base. Conclusions Safety culture in care homes is a topic that has not been extensively researched. The review highlights a number of key gaps in the evidence base, which future research into safety culture in care home should attempt to address.

  8. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    Science.gov (United States)

    de Souza Nascimento, Simone; DeSantana, Josimari Melo; Ribeiro, Êurica Adélia Nogueira; da Silva, Daniel Lira; Araújo-Júnior, João Xavier; da Silva Almeida, Jackson Roberto Guedes; Bonjardim, Leonardo Rigoldi; de Souza Araújo, Adriano Antunes; Quintans-Júnior, Lucindo José

    2013-01-01

    To assess the effects of medicinal plants (MPs) or related natural products (RNPs) on fibromyalgia (FM) patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs) involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects. PMID:23861696

  9. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Simone de Souza Nascimento

    2013-01-01

    Full Text Available To assess the effects of medicinal plants (MPs or related natural products (RNPs on fibromyalgia (FM patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects.

  10. A review of the literature on preventive occupational health and safety activities in small enterprises

    DEFF Research Database (Denmark)

    Hasle, Peter; Limborg, Hans Jørgen

    2006-01-01

    that employees of small enterprises are subject to higher risks than the employees of larger ones, and that small enterprises have difficulties in controlling risk. The most effective preventive approaches seem to be simple and low cost solutions, disseminated through personal contact. It is important to develop......The scientific literature regarding preventive occupational health and safety activities in small enterprises has been reviewed in order to identify effective preventive approaches and to develop a future research strategy. During the last couple of years, there has been a significant increase...... in the number of studies of small enterprises, but the research community is scattered between many different disciplines and institutions. There is a lack of evaluation of intervention studies, both in terms of effect and practical applicability. However, there is sufficiently strong evidence to conclude...

  11. NASA Expendable Launch Vehicle (ELV) Payload Safety Review Process

    Science.gov (United States)

    Starbus, Calvert S.; Donovan, Shawn; Dook, Mike; Palo, Tom

    2007-01-01

    Issues addressed by this program: (1) Complicated roles and responsibilities associated with multi-partner projects (2) Working relationships and communications between all organizations involved in the payload safety process (3) Consistent interpretation and implementation of safety requirements from one project to the rest (4) Consistent implementation of the Tailoring Process (5) Clearly defined NASA decision-making-authority (6) Bring Agency-wide perspective to each ElV payload project. Current process requires a Payload Safety Working Group (PSWG) for eac payload with representatives from all involved organizations.

  12. Patient Safety Policy in Long-Term Care: A Research Protocol to Assess Executive WalkRounds to Improve Management of Early Warning Signs for Patient Safety.

    Science.gov (United States)

    van Dusseldorp, Loes; Hamers, Hub; van Achterberg, Theo; Schoonhoven, Lisette

    2014-07-15

    At many hospitals and long-term care organizations (such as nursing homes), executive board members have a responsibility to manage patient safety. Executive WalkRounds offer an opportunity for boards to build a trusting relationship with professionals and seem useful as a leadership tool to pick up on soft signals, which are indirect signals or early warnings that something is wrong. Because the majority of the research on WalkRounds has been performed in hospitals, it is unknown how board members of long-term care organizations develop their patient safety policy. Also, it is not clear if these board members use soft signals as a leadership tool and, if so, how this influences their patient safety policies. The objective of this study is to explore the added value and the feasibility of WalkRounds for patient safety management in long-term care. This study also aims to identify how executive board members of long-term care organizations manage patient safety and to describe the characteristics of boards. An explorative before-and-after study was conducted between April 2012 and February 2014 in 13 long-term care organizations in the Netherlands. After implementing the intervention in 6 organizations, data from 72 WalkRounds were gathered by observation and a reporting form. Before and after the intervention period, data collection included interviews, questionnaires, and studying reports of the executive boards. A mixed-method analysis is performed using descriptive statistics, t tests, and content analysis. Results are expected to be ready in mid 2014. It is a challenge to keep track of ongoing development and implementation of patient safety management tools in long-term care. By performing this study in cooperation with the participating long-term care organizations, insight into the potential added value and the feasibility of this method will increase.

  13. Shift and night work and long working hours--a systematic review of safety implications.

    Science.gov (United States)

    Wagstaff, Anthony Sverre; Sigstad Lie, Jenny-Anne

    2011-05-01

    In order to devise effective preventive strategies, it is important to study workplace stressors that might increase the risk of workplace accidents - both affecting workers themselves as well as causing harm to third-parties. The aim of this report is to provide a systematic, updated overview and scientific review of empirical research regarding accidents in relation to long work hours and shift work, primarily based on epidemiological studies. The search for articles was part of a large review study on the effects of work hours on various health outcomes, safety, and performance. The search strategy included 5 international scientific databases, and nearly 7000 articles were initially identified using our search string. Following the application of inclusion and exclusion criteria, 443 publications were found and evaluated using a pre-defined scoring system. Of these, 43 concerned safety and accidents but only 14 were considered to be of high quality (total score 2 or 3 on a scale from 0-3) and therefore used for this study. Both shift work and long working hours present a substantial and well-documented detrimental effect on safety - all the studies that are included in this review have one or more significant findings in this respect. The trends are quite coherent although the increases in accident rates are mostly from 50% to 100%. In epidemiological terms, this may be seen as rather small differences. The use of such data is therefore only of importance if the accident incidence is high or if accidents may have large effects. The findings are most relevant to safety-critical activities such as the transport and health sectors. Work periods >8 hours carry an increased risk of accidents that cumulates, so that the increased risk of accidents at around 12 hours is twice the risk at 8 hours. Shift work including nights carries a substantial increased risk of accidents, whereas "pure" night work may bring some protection against this effect due to

  14. International Expert Review of Sr-Can: Safety Assessment Methodology - External review contribution in support of SSI's and SKI's review of SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Sagar, Budhi (Center for Nuclear Waste Regulatory Analyses, Southwest Research Inst., San Antonio, TX (US)); Egan, Michael (Quintessa Limited, Henley-on-Thames (GB)); Roehlig, Klaus-Juergen (Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (DE)); Chapman, Neil (Independent Consultant (XX)); Wilmot, Roger (Galson Sciences Limited, Oakham (GB))

    2008-03-15

    In 2006, SKB published a safety assessment (SR-Can) as part of its work to support a licence application for the construction of a final repository for spent nuclear fuel. The purposes of the SR-Can project were stated in the main project report to be: 1. To make a first assessment of the safety of potential KBS-3 repositories at Forsmark and Laxemar to dispose of canisters as specified in the application for the encapsulation plant. 2. To provide feedback to design development, to SKB's research and development (R and D) programme, to further site investigations and to future safety assessments. 3. To foster a dialogue with the authorities that oversee SKB's activities, i.e. the Swedish Nuclear Power Inspectorate, SKI, and the Swedish Radiation Protection Authority, SSI, regarding interpretation of applicable regulations, as a preparation for the SR-Site project. To help inform their review of SKB's proposed approach to development of the longterm safety case, the authorities appointed three international expert review teams to carry out a review of SKB's SR-Can safety assessment report. Comments from one of these teams - the Safety Assessment Methodology (SAM) review team - are presented in this document. The SAM review team's scope of work included an examination of SKB's documentation of the assessment ('Long-term safety for KBS-3 Repositories at Forsmark and Laxemar - a first evaluation' and several supporting reports) and hearings with SKB staff and contractors, held in March 2007. As directed by SKI and SSI, the SAM review team focused on methodological aspects and sought to determine whether SKB's proposed safety assessment methodology is likely to be suitable for use in the future SR-Site and to assess its consistency with the Swedish regulatory framework. No specific evaluation of long-term safety or site acceptability was undertaken by any of the review teams. SKI and SSI's Terms of Reference for the SAM

  15. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

    Science.gov (United States)

    MacDonald, Elayne; Dadds, Mark R; Brennan, John L; Williams, Katrina; Levy, Florence; Cauchi, Avril J

    2011-09-01

    Human research investigating the impact of intranasal oxytocin on psychological processes has accelerated over the last two decades. No review of side effects, subjective reactions and safety is available. A systematic review of 38 randomised controlled trials conducted between 1990 and 2010 that investigated the central effects of intranasal oxytocin was undertaken. A systematic search for reports of adverse reactions involving intranasal oxytocin was also completed. Since 1990, research trials have reported on N=1529 (79% male) of which 8% were participants with developmental or mental health difficulties. Dosages ranged from 18 to 40 IU, mainly in single doses but ranged up to 182 administrations. Diverse methods have been used to screen and exclude participants, monitor side effects and subject reactions. Side effects are not different between oxytocin and placebo and participants are unable to accurately report on whether they have received oxytocin and placebo. Three case reports of adverse reactions due to misuse and longer-term use of intranasal oxytocin were reported. The evidence shows that intranasal oxytocin: (1) produces no detectable subjective changes in recipients, (2) produces no reliable side-effects, and (3) is not associated with adverse outcomes when delivered in doses of 18-40 IU for short term use in controlled research settings. Future research directions should include a focus on the dosage and duration of use, and application with younger age groups, vulnerable populations, and with females. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. A Literature Review of Pediatric Spinal Manipulation and Chiropractic Manipulative Therapy: Evaluation of Consistent Use of Safety Terminology.

    Science.gov (United States)

    Marchand, Aurélie M

    2015-01-01

    The purpose of this study was to perform a literature search to identify relevant studies on pediatric spinal manipulation and chiropractic manipulative therapy and to assess if safety terminology was consistent with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). A literature search was performed in PubMed using the following terms: spinal manipulation pediatric, chiropractic safety pediatric, and manual therapy safety pediatric. PubMed was searched from inception to April 2012 with no language limitations. The international standards included the terminology of the World Health Organization on side effects, adverse reactions, adverse events and the ICH guideline templates that were adapted for manual therapy for this study. Of the 9 relevant articles identified in this study, 3 reported methodology for classifying safety incidents, and all 9 used safety terminology (adverse effects or adverse events). However, terminology was not used consistently. Most of the articles identified in this literature review did not use terminology consistent with the standards established by the ICH when reporting on safety incidents following pediatric spinal manipulation or chiropractic manipulative therapy. More efforts should be taken to include consistent terminology for studies of spinal manipulation and chiropractic manipulative therapy for children. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  17. 14 CFR Appendix B of Part 415 - Safety Review Document Outline

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety Review Document Outline B Appendix B of Part 415 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION....3.4Trajectory and Debris Dispersion Data 4.3.5Flight Hazard Areas and Safety Clear Zones 4.3...

  18. Efficacy and safety of pregabalin in generalised anxiety disorder : A critical review of the literature

    NARCIS (Netherlands)

    Baldwin, David S.; den Boer, Johan A.; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-01-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in

  19. The Relationship Between Patient Safety Culture and Patient Outcomes: A Systematic Review.

    Science.gov (United States)

    DiCuccio, Margaret Hardt

    2015-09-01

    In the past 13 years since the Institute of Medicine report, To Err is Human, was published, considerable attention was placed on the relationship between patient safety culture and patient outcomes. Research to understand this relationship has been conducted; however, now, it is important to systematically review these studies to determine if there are tools, levels of measure and outcomes that have been shown to result in significant correlations. The purpose of this review is to evaluate the state of research connecting patient safety culture and patient outcomes to determine nurse-sensitive patient outcomes that have been significantly correlated to culture of safety and commonly used tools to measure culture of safety in the studies with significant correlations. Published English only research articles were considered for the review. Only studies that directly measured patient outcomes in relationship to patient safety culture in hospitals involving registered nurses as a participant were included. Evidence of relationships between patient safety culture and patient outcomes exist at the hospital and nursing unit level of analysis; however, the number of studies finding statistically significant correlations particularly using nurse-sensitive outcomes is limited. The findings from this review suggest that there are emerging trends indicating that the specific patient safety culture measurement tools, the level of analysis, and selection of outcome measures are important considerations in study design. More research is needed to determine interventions that improve patient safety culture and outcomes.

  20. A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates

    DEFF Research Database (Denmark)

    Munkholm-Larsen, Stine; Wan, Benjamin; Tian, David H

    2014-01-01

    BACKGROUND: MitraClip implantation has emerged as a viable option in high surgical risk patients with severe mitral regurgitation (MR). We performed the present systematic review to assess the safety and efficacy of the MitraClip system for high surgical risk candidates with severe organic and...... be implanted with reproducible safety and feasibility profile in this subgroup of patients. Further prospective trials with mid- to long-term follow-up are required....

  1. Safety concerns regarding binge drinking in pregnancy: a review.

    Science.gov (United States)

    Conover, Elizabeth Ann; Jones, Kenneth Lyons

    2012-08-01

    There is ongoing debate about the risks to the fetus associated with maternal binge drinking. This makes it difficult to counsel patients about the potential risks associated with their use of alcohol during pregnancy. This article reviews the literature on animal and human studies regarding binge drinking (four to five drinks at one time in humans, or the equivalent in laboratory animals). Animal studies provide evidence that high doses of alcohol over a short period of time can be more damaging than lower doses over a long period of time. Human data are more inconsistent, especially in terms of the association with malformations. Although neurobehavioral effects are the most commonly reported adverse outcome, some studies do not find such an association. Conclusions are confounded by the design of many studies, which fail to document pattern and total amount of alcohol consumption at one time. In addition, it has been suggested there is a bias against the null effect in publications. Although the evidence in humans is not conclusive, the incidence of binge exposures in pregnancy is high, and it appears prudent to counsel patients to avoid this exposure whenever possible. Women inadvertently exposed to a single binge episode of alcohol early in the first trimester before pregnancy recognition can be reassured that the risks for adverse effects in their baby are likely low if they are able to discontinue use for the duration of the pregnancy. Unfortunately, there may be some residual fetal risk. Copyright © 2012 Wiley Periodicals, Inc.

  2. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety

    NARCIS (Netherlands)

    Barends, Clemens R. M.; Absalom, Anthony; van Minnen, Baucke; Vissink, Arjan; Visser, Anita

    2017-01-01

    Objectives To systematically review the literature comparing the efficacy and safety of dexmedetomidine and midazolam when used for procedural sedation. Materials and Methods We searched MEDLINE, EMBASE and COCHRANE for clinical trials comparing dexmedetomidine and midazolam for procedural sedation

  3. Review of Studies on Pedestrian and Bicyclist Safety, 1991-2007

    Science.gov (United States)

    2012-06-01

    This report reviews the pedestrian and bicyclist safety research literature in print as of 2007. It summarizes and synthesizes the key studies, evaluates existing knowledge and identifies research gaps and provides recommendations for future directio...

  4. Deep geological repositories. Safe operation and long-term safety in the prism of reversibility

    Energy Technology Data Exchange (ETDEWEB)

    Espivent, Camille; Tichauer, Michael [IRSN, Fontenay-aux-Roses (France)

    2015-07-01

    A deep geological repository is the reference solution enshrined in the French law for the long-term management of high-level radioactive waste. The current project is led by Andra, the French radioactive waste management organization. As a technical support organization, IRSN's mission is, on the basis of the safety case produced by Andra, to assess the safety of such a facility at its various stages of development, that is to say the design, construction, operation and post-closure phases of the facility. Such a facility will have to meet specific requirements, within different time frames as stated above. One of the requirements is ''reversibility'': in fact, French law poses that the geological disposal will have to be ''reversible'' for a certain time, yet not fully defined. Reversibility is nevertheless believed encompassing both the decision making process related to the waste emplacement process during operational phase and the ability to retrieve waste, should such a decision be made. Thus, underground structures have to be designed and operated to allow both waste emplacement and removal. Moreover, future decision making about the disposal process will have to rely on a sound technical basis. This implies a data collection scheme and a monitoring program of the facility to check if the disposal process is bound by limits, controls and conditions compatible with (i) a safe operation of the facility and (ii) the state of the facility that the operator wants to achieve at the time of its closure, so that long-term safety is guaranteed. Therefore, technical criteria and key parameters have to be selected and monitored during construction and operation, that is to say for decades. Then, reversibility have to make room for corrective actions, including the retrieval of waste, if something goes wrong and especially if the facility is not seen as safe anymore, especially in the perspective of long-term safety. To

  5. Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease.

    Science.gov (United States)

    Faubion, William A; Dubinsky, Marla; Ruemmele, Frank M; Escher, Johanna; Rosh, Joel; Hyams, Jeffrey S; Eichner, Samantha; Li, Yao; Reilly, Nattanan; Thakkar, Roopal B; Robinson, Anne M; Lazar, Andreas

    2017-03-01

    IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.

  6. Draft safety review plan for accelerator production of tritium (APT) project

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    The purpose of this ``living`` Safety Review Plan (SRP) is to describe the products and processes that will be followed to conduct a systematic review of the Accelerator Production of Tritium (APT) Facility Preliminary Safety Analysis Report (PSAR), and subsequently to prepare a draft Safety Evaluation Report (SER) on the PSAR. This plan is prepared for and will be implemented by the APT Independent Safety Review Committee (ISRC) over the period July 1, 1997 through September 30, 1998, in accordance with provisions established in DOE-STD-1104-96. A core team of DOE, INEEL, and AMPARO Corporation engineers and scientists will prepare the initial draft SER with assistance from other ISRC team members on an as needed basis. Guidelines for preparing the draft SER are presented in Section 7 of this SRP. The PSAR reviews will focus exclusively on safety. The ever-present two-part question will be: Does the subject matter have safety significance? If so, does the APT structural, system, component, and/or process engineering design ensure an acceptable margin of safety? The APT mission, efficiency, and cost are not considerations of this plan. A more detailed discussion of the review philosophy is presented in Section 5 of this SRP.

  7. Deferasirox: appraisal of safety and efficacy in long-term therapy

    Directory of Open Access Journals (Sweden)

    Chaudhary P

    2013-08-01

    Full Text Available Preeti Chaudhary, Vinod PullarkatJane Ann Nohl Division of Hematology, University of Southern California Keck School of Medicine, Los Angeles, CA, USAAbstract: Deferasirox is a once-daily, oral iron chelator that is widely used in the management of patients with transfusional hemosiderosis. Several Phase II trials along with their respective extension studies as well as a Phase III trial have established the efficacy and safety of this novel agent in transfusion-dependent patients with β-thalassemia, sickle-cell disease and bone marrow-failure syndromes, including myelodysplastic syndrome and aplastic anemia. Data from various clinical trials show that a deferasirox dose of 20 mg/kg/day stabilizes serum ferritin levels and liver iron concentration, while a dose of 30–40 mg/kg/day reduces these parameters and achieves negative iron balance in red cell transfusion-dependent patients with iron overload. Across various pivotal clinical trials, deferasirox was well tolerated, with the most common adverse events being gastrointestinal disturbances, skin rash, nonprogressive increases in serum creatinine, and elevations in liver enzyme levels. Longer-term extension studies have also confirmed the efficacy and safety of deferasirox. However, it is essential that patients on deferasirox therapy are monitored regularly to ensure timely management for any adverse events that may occur with long-term therapy.Keywords: deferasirox, iron overload, thalassemia, sickle-cell disease, myelodysplastic syndrome

  8. Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

    Directory of Open Access Journals (Sweden)

    Iborra M

    2014-02-01

    Full Text Available Marisa Iborra,1 Diego Álvarez-Sotomayor,2 Pilar Nos1 1Gastroenterology Unit, Department of Digestive Disease, Centro de investigación biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD, La Fe University and Polytechnic Hospital, Valencia, Spain; 2Gastroenterology Unit, Department of Digestive Disease, La Fe University and Polytechnic Hospital, Valencia, Spain Abstract: Ulcerative colitis (UC is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon. Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide's usefulness in treating active mild to moderate ileocecal Crohn's disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide's efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide's long-term safety and efficacy in treating UC. Keywords: budesonide, ulcerative colitis, Crohn's disease, safety

  9. Long-term safety of human retinal progenitor cell transplantation in retinitis pigmentosa patients.

    Science.gov (United States)

    Liu, Yong; Chen, Shao Jun; Li, Shi Ying; Qu, Ling Hui; Meng, Xiao Hong; Wang, Yi; Xu, Hai Wei; Liang, Zhi Qing; Yin, Zheng Qin

    2017-09-29

    Retinitis pigmentosa is a common genetic disease that causes retinal degeneration and blindness for which there is currently no curable treatment available. Vision preservation was observed in retinitis pigmentosa animal models after retinal stem cell transplantation. However, long-term safety studies and visual assessment have not been thoroughly tested in retinitis pigmentosa patients. In our pre-clinical study, purified human fetal-derived retinal progenitor cells (RPCs) were transplanted into the diseased retina of Royal College of Surgeons (RCS) rats, a model of retinal degeneration. Based on these results, we conducted a phase I clinical trial to establish the safety and tolerability of transplantation of RPCs in eight patients with advanced retinitis pigmentosa. Patients were studied for 24 months. After RPC transplantation in RCS rats, we observed moderate recovery of vision and maintenance of the outer nuclear layer thickness. Most importantly, we did not find tumor formation or immune rejection. In the retinis pigmentosa patients given RPC injections, we also did not observe immunological rejection or tumorigenesis when immunosuppressive agents were not administered. We observed a significant improvement in visual acuity (P retinal sensitivity of pupillary responses in three of the eight patients between 2 and 6 months after the transplant, but this improvement did not appear by 12 months. Our study for the first time confirmed the long-term safety and feasibility of vision repair by stem cell therapy in patients blinded by retinitis pigmentosa. WHO Trial Registration, ChiCTR-TNRC-08000193 . Retrospectively registered on 5 December 2008.

  10. Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

    Directory of Open Access Journals (Sweden)

    Packer M

    2016-06-01

    Full Text Available Mark Packer Mark Packer MD Consulting, Inc., Boulder, CO, USA Abstract: The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL, and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.. Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594=1.33; P=0.18. The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks

  11. Efficacy and Safety of Aspiration Sclerotherapy of Simple Hepatic Cysts: A Systematic Review

    NARCIS (Netherlands)

    Wijnands, T.F.M.; Gortjes, A.P.; Gevers, T.J.G.; Jenniskens, S.F.M.; Schultze Kool, L.J.; Potthoff, A.; Ronot, M.; Drenth, J.P.H.

    2016-01-01

    OBJECTIVE: Aspiration sclerotherapy is a percutaneous procedure indicated for treatment of symptomatic simple hepatic cysts. The efficacy and safety of this procedure have been sources of debate and disagreement for years. The purpose of this study was to assess the long-term efficacy and safety of

  12. A systematic literature review of the effectiveness of occupational health and safety regulatory enforcement.

    Science.gov (United States)

    Tompa, Emile; Kalcevich, Christina; Foley, Michael; McLeod, Chris; Hogg-Johnson, Sheilah; Cullen, Kim; MacEachen, Ellen; Mahood, Quenby; Irvin, Emma

    2016-11-01

    We aimed to determine the strength of evidence on the effectiveness of legislative and regulatory policy levers in creating incentives for organizations to improve occupational health and safety processes and outcomes. A systematic review was undertaken to assess the strength of evidence on the effectiveness of specific policy levers using a "best-evidence" synthesis approach. A structured literature search identified 11,947 citations from 13 peer-reviewed literature databases. Forty-three studies were retained for synthesis. Strong evidence was identified for three out of nine clusters. There is strong evidence that several OHS policy levers are effective in terms of reducing injuries and/or increasing compliance with legislation. This study adds to the evidence on OHS regulatory effectiveness from an earlier review. In addition to new evidence supporting previous study findings, it included new categories of evidence-compliance as an outcome, nature of enforcement, awareness campaigns, and smoke-free workplace legislation. Am. J. Ind. Med. 59:919-933, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. The efficacy and safety of herbal medicines used in the treatment of hyperlipidemia; a systematic review.

    Science.gov (United States)

    Hasani-Ranjbar, Shirin; Nayebi, Neda; Moradi, Leila; Mehri, Avin; Larijani, Bagher; Abdollahi, Mohammad

    2010-01-01

    This review focuses on the efficacy and safety of effective herbal medicines in the management of hyperlipidemia in human. PubMed, Scopus, Google Scholar, Web of Science, and IranMedex databases were searched up to 11th May 2010. The search terms were "hyperlipidemia" and ("herbal medicine" or "medicine traditional", "extract plant") without narrowing or limiting search elements. All of the human studies on the effects of herbs with the key outcome of change in lipid profiles were included. Fifty three relevant clinical trials were reviewed for efficacy of plants. This study showed significant decrease in total cholesterol and LDL cholesterol after treatment with Daming capsule (DMC), chunghyul-dan, Glycyrrhiza glabra, garlic powder (Allicor), black tea, green tea, soy drink enriched with plant sterols, licorice, Satureja khuzestanica, Monascus purpureus Went rice, Fenugreek, Commiphora mukul (guggul), Achillea wilhelmsii C. Koch, Ningzhi capsule (NZC), cherry, compositie salviae dropping pill (CSDP), shanzha xiaozhi capsule, Ba-wei-wan (hachimijiogan), rhubarb stalk, Silybum marianum, Rheum Ribes and Jingmingdan granule (primrose oil). Conflicting data exist for red yeast rice, garlic and guggul. No significant adverse effect or mortality were observed except in studies with DMC, guggul, and Terminalia belerica, Terminalia chebula, Emblica officinalis, ginger, and garlic powder (Allium sativum). Amongst reviewed studies, 22 natural products were found effective in the treatment of hyperlipidemia that deserve further works to isolate and characterization of their constituents to reach novel therapeutic and more effective agents.

  14. A systematic review of the efficacy and safety of Rosa damascena Mill. with an overview on its phytopharmacological properties.

    Science.gov (United States)

    Nayebi, Neda; Khalili, Nahid; Kamalinejad, Mohammad; Emtiazy, Majid

    2017-10-01

    Rosa damascena Mill. is one of the most famous ornamental plants cultivated all over the world mostly for perfumery industries. Traditionally it has been used as an astringent, analgesic, cardiac and intestinal tonic.The paucity ofauthoritative monographs urged usto summarize its clinical effectiveness and safety with acomprehensive review of the literature. "PUBMED", "SCOPUS", "WEBOF SCIENCE" were searched up to April 30, 2017 with search terms:("Rosa damascena" OR "Damask Rose"). All human studies with any mono-preparation were included. In vitro and animal studies from "PUBMED"were also reviewed and outlined. Of "1000" identified publications, twelveeligibleclinical trials were retrieved. Antimicrobial, anti-inflammatory, antioxidant, anticancer, protective neuronal, cardiac, gastrointestinal and hepatic effectsin 30 in vitro and 21 animal studies were also shown. there are promising evidences for the effectiveness and safety of Rosa damascena Mill in pain relief, but confirmatory studies withstandardized products is suggested. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

    Science.gov (United States)

    Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

    The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

  16. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  17. Monitoring the Long-Term Effectiveness of Integrated Safety Management System (ISMS) Implementation Through Use of a Performance Dashboard Process

    Energy Technology Data Exchange (ETDEWEB)

    Michael D. Kinney and William D. Barrick

    2008-09-01

    This session will examine a method developed by Federal and Contractor personnel at the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) to examine long-term maintenance of DOE Integrated Safety Management System (ISMS) criteria, including safety culture attributes, as well as identification of process improvement opportunities. This process was initially developed in the summer of 2000 and has since been expanded to recognize the importance of safety culture attributes, and associated safety culture elements, as defined in DOE M 450.4-1, “Integrated Safety Management System Manual.” This process has proven to significantly enhance collective awareness of the importance of long-term ISMS implementation as well as support commitments by NNSA/NSO personnel to examine the continued effectiveness of ISMS processes.

  18. Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a protocol for a systematic review of reviews.

    Science.gov (United States)

    Ocloo, Josephine; Garfield, Sarah; Dawson, Shoba; Dean Franklin, Bryony

    2017-10-24

    The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse. This review will explore the literature on PPI across patient safety, healthcare and social care to identify theory, barriers and enablers that can be used to develop PPI in patient safety. Systematic searches of three electronic bibliographic databases will be conducted, using both MeSH and free-text terms to identify empirical literature published from database inception to May 2017. The screening process will involve input from at least two researchers and any disagreement will be resolved through discussion with a third reviewer. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Data extraction from included articles will be conducted by at least two researchers using a data extraction form. Extracted information will be analysed using a narrative review approach, which synthesises data using a descriptive method. No ethical approval is required for this review as no empirical data were collected. We believe that the findings and recommendations from this review will be particularly relevant for an audience of academics and policymakers. The findings will, therefore, be written up and disseminated in international peer-reviewed journals and academic conferences with a health focus. They will also be disseminated to leading health policy organisations in the NHS, such as NHS England and NHS Improvement and national policy bodies such as the Health Foundation. © Article author(s) (or their employer(s) unless otherwise

  19. Safety of Simultaneous Scalp or Intracranial EEG during MRI: A Review

    Directory of Open Access Journals (Sweden)

    Hassan B. Hawsawi

    2017-10-01

    Full Text Available Understanding the brain and its activity is one of the great challenges of modern science. Normal brain activity (cognitive processes, etc. has been extensively studied using electroencephalography (EEG since the 1930's, in the form of spontaneous fluctuations in rhythms, and patterns, and in a more experimentally-driven approach in the form of event-related potentials (ERPs allowing us to relate scalp voltage waveforms to brain states and behavior. The use of EEG recorded during functional magnetic resonance imaging (EEG-fMRI is a more recent development that has become an important tool in clinical neuroscience, for example for the study of epileptic activity. The purpose of this review is to explore the magnetic resonance imaging safety aspects specifically associated with the use of scalp EEG and other brain-implanted electrodes such as intracranial EEG electrodes when they are subjected to the MRI environment. We provide a theoretical overview of the mechanisms at play specifically associated with the presence of EEG equipment connected to the subject in the MR environment, and of the resulting health hazards. This is followed by a survey of the literature on the safety of scalp or invasive EEG-fMRI data acquisitions across field strengths, with emphasis on the practical implications for the safe application of the techniques; in particular, we attempt to summarize the findings in terms of acquisition protocols when possible.

  20. Safety Behaviors in Adults With Social Anxiety: Review and Future Directions.

    Science.gov (United States)

    Piccirillo, Marilyn L; Taylor Dryman, M; Heimberg, Richard G

    2016-09-01

    Safety behaviors are considered an important factor in the maintenance of social anxiety disorder (SAD). Safety behaviors are typically employed by socially anxious individuals to reduce anxiety in feared social situations. However, by preventing individuals with social anxiety from gathering evidence that would disconfirm their maladaptive beliefs about social situations, the use of safety behaviors ultimately maintains social anxiety over time. Twenty years ago, Wells and colleagues (1995) demonstrated that use of safety behaviors diminishes the efficacy of exposure treatment for SAD, suggesting that reduction in the use of safety behaviors during exposure can enhance treatment response. Research on safety behaviors has expanded considerably since Wells et al.'s seminal publication, and our understanding of the role safety behaviors may play in the maintenance of social anxiety has grown in breadth and depth. In this paper, we present a detailed review of the published research on safety behaviors relevant to social anxiety and social-anxiety-related processes. Finally, we evaluate the impact of safety behaviors on the outcome of treatment for SAD, and we look to the literature on safety behaviors in other anxiety disorders to inform our understanding of use of safety behaviors during exposure and to facilitate future research in SAD. Copyright © 2015. Published by Elsevier Ltd.

  1. Assessment of GE food safety using '-omics' techniques and long-term animal feeding studies.

    Science.gov (United States)

    Ricroch, Agnès E

    2013-05-25

    Despite the fact that a thorough, lengthy and costly evaluation of genetically engineered (GE) crop plants (including compositional analysis and toxicological tests) is imposed before marketing some European citizens remain sceptical of the safety of GE food and feed. In this context, are additional tests necessary? If so, what can we learn from them? To address these questions, we examined data from 60 recent high-throughput '-omics' comparisons between GE and non-GE crop lines and 17 recent long-term animal feeding studies (longer than the classical 90-day subchronic toxicological tests), as well as 16 multigenerational studies on animals. The '-omics' comparisons revealed that the genetic modification has less impact on plant gene expression and composition than that of conventional plant breeding. Moreover, environmental factors (such as field location, sampling time, or agricultural practices) have a greater impact than transgenesis. None of these '-omics' profiling studies has raised new safety concerns about GE varieties; neither did the long-term and multigenerational studies on animals. Therefore, there is no need to perform such long-term studies in a case-by-case approach, unless reasonable doubt still exists after conducting a 90-day feeding test. In addition, plant compositional analysis and '-omics' profiling do not indicate that toxicological tests should be mandatory. We discuss what complementary fundamental studies should be performed and how to choose the most efficient experimental design to assess risks associated with new GE traits. The possible need to update the current regulatory framework is discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. Long-term safety study of infliximab in moderate-to-severe chronic obstructive pulmonary disease.

    Science.gov (United States)

    Rennard, Stephen I; Flavin, Susan K; Agarwal, Prasheen K; Lo, Kim Hung; Barnathan, Elliot S

    2013-03-01

    There was an increased number of malignancies in infliximab-treated (5.7%) over placebo-treated (1.3%) patients in a 44-week, phase 2 clinical study of 234 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). To collect malignancy and mortality data from completed clinical studies of infliximab in COPD treatment. The multicenter, observational Remicade Safety Under Long-Term Study in COPD (RESULTS COPD) collected malignancy and mortality data every six months for five years from patients who received ≥1 study-agent dose in a phase 2 study. Co-primary endpoints were the number of patients with malignancy and the number of deaths. Secondary endpoints included the number of patients with a malignancy according to malignancy type. There was a gap period between the end of the phase 2 study and the initiation of RESULTS COPD, during which six malignancies and 14 deaths were reported spontaneously for the 107 (45.7%) of 234 patients with long-term safety information. Twenty-eight patients (overall 12.0%; placebo 10.4%, infliximab 12.7%) reported malignancies, including 12 patients during RESULTS COPD. Twenty-six patients (overall 11.1%; placebo 9.1%, infliximab 12.1%) died, including nine during RESULTS COPD. Lung cancer was the most common malignancy type (placebo n = 2; infliximab n = 10). The greater proportion of malignancies observed with infliximab versus placebo in a phase 2 study diminished over the long-term follow-up. Due to the observational nature, limited patient participation, potential reporting bias from the interim spontaneous reporting period, and unblinding of all patients, more definitive conclusions cannot be drawn. Copyright © 2012. Published by Elsevier Ltd.

  3. Defining and Measuring Safety Climate: A Review of the Construction Industry Literature.

    Science.gov (United States)

    Schwatka, Natalie V; Hecker, Steven; Goldenhar, Linda M

    2016-06-01

    Safety climate measurements can be used to proactively assess an organization's effectiveness in identifying and remediating work-related hazards, thereby reducing or preventing work-related ill health and injury. This review article focuses on construction-specific articles that developed and/or measured safety climate, assessed safety climate's relationship with other safety and health performance indicators, and/or used safety climate measures to evaluate interventions targeting one or more indicators of safety climate. Fifty-six articles met our inclusion criteria, 80% of which were published after 2008. Our findings demonstrate that researchers commonly defined safety climate as perception based, but the object of those perceptions varies widely. Within the wide range of indicators used to measure safety climate, safety policies, procedures, and practices were the most common, followed by general management commitment to safety. The most frequently used indicators should and do reflect that the prevention of work-related ill health and injury depends on both organizational and employee actions. Safety climate scores were commonly compared between groups (e.g. management and workers, different trades), and often correlated with subjective measures of safety behavior rather than measures of ill health or objective safety and health outcomes. Despite the observed limitations of current research, safety climate has been promised as a useful feature of research and practice activities to prevent work-related ill health and injury. Safety climate survey data can reveal gaps between management and employee perceptions, or between espoused and enacted policies, and trigger communication and action to narrow those gaps. The validation of safety climate with safety and health performance data offers the potential for using safety climate measures as a leading indicator of performance. We discuss these findings in relation to the related concept of safety culture and

  4. Source term derivation and radiological safety analysis for the TRICO II research reactor in Kinshasa

    Energy Technology Data Exchange (ETDEWEB)

    Muswema, J.L., E-mail: jeremie.muswem@unikin.ac.cd [Faculty of Science, University of Kinshasa, P.O. Box 190, KIN XI (Congo, The Democratic Republic of the); Ekoko, G.B. [Faculty of Science, University of Kinshasa, P.O. Box 190, KIN XI (Congo, The Democratic Republic of the); Lukanda, V.M. [Faculty of Science, University of Kinshasa, P.O. Box 190, KIN XI (Congo, The Democratic Republic of the); Democratic Republic of the Congo' s General Atomic Energy Commission, P.O. Box AE1 (Congo, The Democratic Republic of the); Lobo, J.K.-K. [Faculty of Science, University of Kinshasa, P.O. Box 190, KIN XI (Congo, The Democratic Republic of the); Darko, E.O. [Radiation Protection Institute, Ghana Atomic Energy Commission, P.O. Box LG 80, Legon, Accra (Ghana); Boafo, E.K. [University of Ontario Institute of Technology, 2000 Simcoe St. North, Oshawa, ONL1 H7K4 (Canada)

    2015-01-15

    Highlights: • Atmospheric dispersion modeling for two credible accidents of the TRIGA Mark II research reactor in Kinshasa (TRICO II) was performed. • Radiological safety analysis after the postulated initiating events (PIE) was also carried out. • The Karlsruhe KORIGEN and the HotSpot Health Physics codes were used to achieve the objectives of this study. • All the values of effective dose obtained following the accident scenarios were below the regulatory limits for reactor staff members and the public, respectively. - Abstract: The source term from the 1 MW TRIGA Mark II research reactor core of the Democratic Republic of the Congo was derived in this study. An atmospheric dispersion modeling followed by radiation dose calculation were performed based on two possible postulated accident scenarios. This derivation was made from an inventory of peak radioisotope activities released in the core by using the Karlsruhe version of isotope generation code KORIGEN. The atmospheric dispersion modeling was performed with HotSpot code, and its application yielded to radiation dose profile around the site using meteorological parameters specific to the area under study. The two accident scenarios were picked from possible accident analyses for TRIGA and TRIGA-fueled reactors, involving the case of destruction of the fuel element with highest activity release and a plane crash on the reactor building as the worst case scenario. Deterministic effects of these scenarios are used to update the Safety Analysis Report (SAR) of the reactor, and for its current version, these scenarios are not yet incorporated. Site-specific meteorological conditions were collected from two meteorological stations: one installed within the Atomic Energy Commission and another at the National Meteorological Agency (METTELSAT), which is not far from the site. Results show that in both accident scenarios, radiation doses remain within the limits, far below the recommended maximum effective

  5. Aviation and healthcare: a comparative review with implications for patient safety

    Science.gov (United States)

    Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

    2015-01-01

    Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

  6. Energy Storage System Safety: Plan Review and Inspection Checklist

    Energy Technology Data Exchange (ETDEWEB)

    Cole, Pam C (PNNL); Conover, David R (PNNL)

    2017-03-01

    Codes, standards, and regulations (CSR) governing the design, construction, installation, commissioning, and operation of the built environment are intended to protect the public health, safety, and welfare. While these documents change over time to address new technology and new safety challenges, there is generally some lag time between the introduction of a technology into the market and the time it is specifically covered in model codes and standards developed in the voluntary sector. After their development, there is also a timeframe of at least a year or two until the codes and standards are adopted. Until existing model codes and standards are updated or new ones are developed and then adopted, one seeking to deploy energy storage technologies or needing to verify the safety of an installation may be challenged in trying to apply currently implemented CSRs to an energy storage system (ESS). The Energy Storage System Guide for Compliance with Safety Codes and Standards1 (CG), developed in June 2016, is intended to help address the acceptability of the design and construction of stationary ESSs, their component parts, and the siting, installation, commissioning, operations, maintenance, and repair/renovation of ESS within the built environment.

  7. Gender issues in safety and health at work : a review

    NARCIS (Netherlands)

    Houtman, I.L.D.; Kauppinen, K.; Kumpulainen, R.; Goudswaard, A.

    2003-01-01

    This report explores the gender differences in occupational safety and health. There is strong segregation of women and men into different jobs and tasks at work. Both men and women face significant risks. In general, men suffer more accidents and injuries at work than women do, whereas women report

  8. Review of the World Bank Road Safety website.

    NARCIS (Netherlands)

    Maas, J.M.

    2006-01-01

    The Road Safety website of The World Bank needs to be redeveloped. The website should reflect the new developments in the work field and the IT policy of The World Bank and support its implementation. The report is meant as a brief business case, describing the target audience, purposes of the site,

  9. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    Background: The current rapid economic development has brought changes in workplaces in developing countries, including Ethiopia. The organization of occupational health and safety services is not yet resilient enough to handle the growing demands for workers' health in the context of industrialization. There is limited ...

  10. Safety of nanofood: A review | Ijabadeniyi | African Journal of ...

    African Journals Online (AJOL)

    Introduction of genetically modified (GM) foods generated a lot of controversy few years back, now it is the turn of nanofoods. There has been debate on the safety of foods that have been produced directly or indirectly with nanomaterials. Nanoparticles or nanotechnology procedures may be used to make food products, ...

  11. Efficacy and safety of mistletoe preparations (Viscum album) for patients with cancer diseases. A systematic review.

    Science.gov (United States)

    Melzer, Jörg; Iten, Felix; Hostanska, Katarina; Saller, Reinhard

    2009-08-01

    Mistletoe is often used as a complementary approach in oncology. Despite experimental anti-tumour effects and several reviews there remains controversy about its clinical role. Potentially relevant trials were identified to perform a systematic review (databases: e.g. EMBASE, MEDLINE; hand search: e.g. bibliographies; search terms: e.g. mistletoe). To be included, randomised or comparative clinical trials at least had to examine mistletoe preparations standardized according to manufacturing process and to describe interventions explicitly. Additionally, cohort studies were included for reasons of external validity. Results were summarised in tables. 18 clinical trials (>6,800 participants) were included. Their internal quality was mostly low. Due to heterogeneity between trials a meta-analysis was impossible. Regarding efficacy, findings were inconsistent regarding life expectancy, relation to tumour entity, dosing and treatment duration. Yet, studies indicate that quality of life (QoL) is improved. As these findings do not seem to be limited to one of the different parenteral mistletoe preparations reviewed the treatment may be summarised under the umbrella term 'mistletoe therapy'. Regarding safety, 1 serious adverse event (AE) related to mistletoe was described; non-serious AEs were local reactions at injection site. Allergic reactions were rare. Supportive 'mistletoe therapy' seems safe and beneficial for QoL in adult patients with solid tumours. But there is an urgent need to confirm its efficacy in patient-centred care in a complex oncological setting. This has to be evaluated systematically in prospective observational trials with validated, multidimensional patient-rated QoL questionnaires and comparisons of different preparations and dosages. Copyright 2009 S. Karger AG, Basel.

  12. Long-term safety in living kidney donors for paediatric transplantation. Single-centre prospective study.

    Science.gov (United States)

    Martin Benlloch, J; Román Ortiz, E; Mendizabal Oteiza, S

    There is enough evidence concerning the short-term safety of living donors after kidney transplantation. However, long-term complications continue to be studied, with a particular interest in young donors. Previous studies have been conducted in older donors for adult renal patients. We present a study of long-term complications in kidney donors for our paediatric population. We carried out a long-term donor study for the 54 living kidney-donor transplantations performed at our department from 1979 to June 2014. We monitored the glomerular filtration rate (GFR) on the basis of 24-hour urine creatinine clearance, 24-hour proteinuria and the development of arterial hypertension in the 48 donors who were followed up for more than one year. Only the 39 patients who were exclusively followed up by our department have been included in the results analysis. GFR through creatinine clearance was stable after an initial decrease. No proteinuria was observed in any of the cases. One patient developed chronic kidney disease (CKD), which resulted in a cumulative incidence of 2%. GFR below 60mL/min/1.73 m2 was not reported in any other patients. Arterial hypertension was diagnosed in 25% of donors, 90% of which were treated with antihypertensives. Risk of CKD and hypertension in living kidney donors for paediatric recipients, who are carefully monitored throughout their evolution, is similar to that of the general population. Therefore, this technique appears to be safe in both the short and long term. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study.

    Science.gov (United States)

    O'Connor, Paul; Goodman, Andrew; Kappos, Ludwig; Lublin, Fred; Polman, Chris; Rudick, Richard A; Hauswirth, Kathy; Cristiano, Lynda M; Forrestal, Fiona; Duda, Petra

    2014-07-01

    Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study. Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed. At data cutoff (February 9, 2012), natalizumab exposure was 3,460 patient-years; a median of 56 (range 1-70) infusions were received. Serious adverse events, including progressive multifocal leukoencephalopathy, were consistent with natalizumab's known profile. Upon natalizumab re-exposure, rates of anti-natalizumab antibodies and hypersensitivity reactions were 3% and 5% overall, and 40% and 24% among patients with 1 to 2 prior natalizumab doses. Patients originally randomized to placebo/another disease-modifying therapy vs natalizumab in previous studies had significantly higher EDSS scores at STRATA baseline; this difference persisted over 240 weeks. EDSS scores generally remained stable. Patients initially randomized to natalizumab had lower annualized relapse rates over 240 weeks. Serious adverse events were consistent with natalizumab's known safety profile; short exposure with a gap before redosing was associated with higher incidences of anti-natalizumab antibodies and hypersensitivity reactions. Stability of EDSS scores and consistently low relapse rates over 5 years of natalizumab treatment are consistent with its known efficacy profile. This study provides Class III evidence that in patients with relapsing-remitting multiple sclerosis, natalizumab stabilizes EDSS scores, decreases relapse rates, and is associated with an increased risk of progressive multifocal leukoencephalopathy. © 2014 American Academy of Neurology.

  14. Bronchial Thermoplasty – Long Term Safety and Effectiveness in Severe Persistent Asthma

    Science.gov (United States)

    Wechsler, Michael E.; Laviolette, Michel; Rubin, Adalberto S.; Fiterman, Jussara; Lapa e Silva, Jose R.; Shah, Pallav L.; Fiss, Elie; Olivenstein, Ronald; Thomson, Neil C.; Niven, Robert M.; Pavord, Ian D.; Simoff, Michael; Hales, Jeff B.; McEvoy, Charlene; Slebos, Dirk-Jan; Holmes, Mark; Phillips, Martin J.; Erzurum, Serpil C.; Hanania, Nicola A.; Sumino, Kaharu; Kraft, Monica; Cox, Gerard; Sterman, Daniel H.; Hogarth, Kyle; Kline, Joel N.; Mansur, Adel H.; Louie, Brian E.; Leeds, William M.; Barbers, Richard G.; Austin, John H.M.; Shargill, Narinder S.; Quiring, John; Armstrong, Brian; Castro, Mario

    2014-01-01

    Background Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective To assess effectiveness and safety of BT in asthma patients 5 years post therapy. Methods BT-treated subjects from the Asthma Intervention Research 2 (AIR2) Trial (ClinicalTrials.gov NCT01350414) were evaluated annually for 5 years to assess long-term safety of BT and durability of treatment effect. Outcomes assessed post-BT included severe exacerbations, adverse events, healthcare utilization, spirometry data, and high resolution computed tomography (HRCT) scans. Results 162/190 BT-treated subjects (85.3%) from the AIR2 Trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and Emergency Room visits, and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months prior to BT treatment (average 5 year reduction in proportions: 44% for exacerbations and 78% for ER visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in Years 2 through 5 as compared to the first year after BT. Pre-BD FEV1 values remained stable between years 1 and 5 after BT, despite a 17% reduction in average daily inhaled corticosteroid dose. HRCT scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. Conclusions These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ER visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking ICS (inhaled corticosteroids) and LABA (long-acting-β2-agonists). PMID:23998657

  15. Patient Safety Policy in Long-Term Care: A Research Protocol to Assess Executive WalkRounds to Improve Management of Early Warning Signs for Patient Safety

    NARCIS (Netherlands)

    Dusseldorp, L. van; Hamers, H.; Achterberg, T. van; Schoonhoven, L.

    2014-01-01

    BACKGROUND: At many hospitals and long-term care organizations (such as nursing homes), executive board members have a responsibility to manage patient safety. Executive WalkRounds offer an opportunity for boards to build a trusting relationship with professionals and seem useful as a leadership

  16. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Science.gov (United States)

    2011-09-22

    ... COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...-ISG-019 on ``Review of Evaluation to Address Gas Accumulation Issues in Safety Related Systems... is to clarify the NRC staff guidance to address issues of gas accumulation in safety related systems...

  17. Regional anesthesia for pediatric knee surgery: a review of the indications, procedures, outcomes, safety, and challenges

    Directory of Open Access Journals (Sweden)

    Muhly WT

    2015-11-01

    Full Text Available Wallis T Muhly, Harshad G Gurnaney, Arjunan GaneshDepartment of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Pennsylvania, PA, USAAbstract: The indications for surgery on the knee in children and adolescents share some similarity to adult practice in that there are an increasing number of sports-related injuries requiring surgical repair. In addition, there are some unique age-related conditions or congenital abnormalities that may present as indications for orthopedic intervention at the level of the knee. The efficacy and safety of peripheral nerve blocks (PNBs for postoperative analgesia following orthopedic surgery has been well established in adults. Recent studies have also demonstrated earlier functional recovery after surgery in patients who received PNBs. In children, PNB is gaining popularity, and increasing data are emerging to demonstrate the feasibility, efficacy, and safety in this population. In this paper, we will review some of the most common indications for surgery involving the knee in children and the anatomy of knee, associated dermatomal and osteotomal innervation, and the PNBs most commonly used to produce analgesia at the level of the knee. We will review the evidence in support of regional anesthesia in children in terms of both the quality conferred to the immediate postoperative care and the role of continuous PNBs in maintaining effective analgesia following discharge. Also we will discuss some of the subtle challenges in utilizing regional anesthesia in the pediatric patient including the use of general anesthesia when performing regional anesthesia and the issue of monitoring for compartment syndrome. Finally, we will offer some thoughts about areas of practice that are in need of further investigation.Keywords: pediatric surgery, regional anesthesia, analgesia, knee surgery

  18. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Kivelevitch D

    2014-04-01

    Full Text Available Dario Kivelevitch, Bobbak Mansouri, Alan Menter Department of Dermatology, Baylor University Medical Center, Dallas, TX, USA Abstract: Psoriasis is a chronic, immune-mediated inflammatory disease affecting both the skin and joints. Approximately 20% of patients suffer a moderate to severe form of skin disease and up to 30% have joint involvement. Standard therapies for psoriasis include topical medications, phototherapy, and both oral systemic and biological therapies whereas therapies for psoriatic arthritis include nonsteroidal anti-inflammatory drugs followed by disease modifying antirheumatic drugs and/or tumor necrosis factor (TNF-α inhibitors and interleukin-12/23p40 inhibitors. Treatment of both diseases is typically driven by disease severity. In the past decade, major advances in the understanding of the immunopathogenesis of psoriasis and psoriatic arthritis have led to the development of numerous biological therapies, which have revolutionized the treatment for moderate to severe plaque psoriasis and psoriatic arthritis. Anti-TNF-α agents are currently considered as first line biological therapies for the treatment of moderate to severe psoriasis and psoriatic arthritis. Currently approved anti-TNF-α agents include etanercept, adalimumab, and infliximab for psoriasis and psoriatic arthritis as well as golimumab and certolizumab for psoriatic arthritis. In this article, we aim to evaluate the long term safety and efficacy of etanercept in psoriasis and psoriatic arthritis. Keywords: psoriasis, psoriatic arthritis, etanercept, biological therapy, tumor necrosis factor, safety

  19. Long-term Safety of Pregnancy Following Breast Cancer According to Estrogen Receptor Status

    DEFF Research Database (Denmark)

    Lambertini, Matteo; Kroman, Niels; Ameye, Lieveke

    2018-01-01

    for guaranteed time bias. Survival estimates were calculated using the Kaplan-Meier analysis; groups were compared with the log-rank test. All reported P values were two-sided. At a median follow-up of 7.2 years after pregnancy, no difference in disease-free survival was observed between pregnant and nonpregnant......Safety of pregnancy in women with history of estrogen receptor (ER)-positive breast cancer remains controversial. In this multicenter case-control study, 333 patients with pregnancy after breast cancer were matched (1:3) to 874 nonpregnant patients of similar characteristics, adjusting......-negative patients in the pregnant cohort had better OS (HR = 0.57, 95% CI = 0.36 to 0.90, P = .01). Abortion, time to pregnancy, breastfeeding, and type of adjuvant therapy had no impact on patients' outcomes. This study provides reassuring evidence on the long-term safety of pregnancy in breast cancer survivors...

  20. Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants

    DEFF Research Database (Denmark)

    Hedén, Per; Bronz, Giorgio; Elberg, Jens Jørgen

    2009-01-01

    Style 410 shaped gel breast implant before examination. The secondary end points included lactation, reproductive and breast disease history before and after implantation, and quality-of-life measurements and complications after implantation. RESULTS: The implant rupture rate was 1.7% a median of 8......BACKGROUND: In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously published results across multiple European sites. METHODS: A total...... than the preimplantation rates. Breast implantation surgery was considered advantageous by 91% of the subjects, demonstrating high patient satisfaction. CONCLUSIONS: The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness....

  1. Improving the governance of patient safety in emergency care: a systematic review of interventions

    NARCIS (Netherlands)

    Hesselink, G.J.; Berben, S.A.; Beune, T.; Schoonhoven, L.

    2016-01-01

    OBJECTIVES: To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. DESIGN: A systematic review of the literature. METHODS: PubMed, EMBASE, Cumulative Index to Nursing and Allied Health

  2. Development of a draft of human factors safety review procedures for the Korean next generation reactor

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Moon, B. S.; Park, J. C.; Lee, Y. H.; Oh, I. S.; Lee, H. C. [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2000-02-01

    In this study, a draft of human factors engineering (HFE) safety review procedures (SRP) was developed for the safety review of KNGR based on HFE Safety and Regulatory Requirements and Guidelines (SRRG). This draft includes acceptance criteria, review procedure, and evaluation findings for the areas of review including HFE Program Management, Human Factors Analyses, Human Factors Design, and HFE Verification and Validation, based on Section 15.1 'Human Factors Engineering Design Process' and 15.2 'Control Room Human Factors Engineering' of KNGR Specific Safety Requirements and Chapter 15 'Human Factors Engineering' of KNGR Safety Regulatory Guides. For the effective review, human factors concerns or issues related to advanced HSI design that have been reported so far should be extensively examined. In this study, a total of 384 human factors issues related to the advanced HSI design were collected through our review of a total of 145 documents. A summary of each issue was described and the issues were identified by specific features of HSI design. These results were implemented into a database system. 8 refs., 2 figs. (Author)

  3. Long-term safety and efficacy of insulin degludec in the management of type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Thuillier P

    2015-10-01

    Full Text Available Philippe Thuillier,1 Zarrin Alavi,2 Véronique Kerlan1 1Department of Endocrinology, Diabetology and Metabolic Diseases, 2French Institute of Health and Medical Research CIC 1412, Medical University Hospital of Brest La Cavale Blanche, Brest, France Abstract: Insulin degludec (IDeg is a novel antiglycemic agent belonging to the therapeutic class of ultra-long duration basal insulin analogs. Its half-life and duration of action are 25 hours and 42 hours, respectively. This pharmacodynamic profile leads to a strict dosing schedule, ie, IDeg is injected at the same time each day to ensure optimal biological action and consistent glycemic control. According to the literature, IDeg provides glycemic control and nocturnal hypoglycemia reduction comparable with other long-acting analogs in type 2 diabetes mellitus. The risk of severe hypoglycemic episodes seems also to be reduced when using IDeg therapy; however, long-term follow-up is warranted for monitoring of possible but relatively infrequent adverse events. IDeg is also available in combination with aspart insulin and with liraglutide. The above preparations have been approved by the European Medicines Agency and other national health authorities. In 2012, the US Food and Drug Administration asked for a complementary study on IDeg-associated cardiovascular risk. Future prospective evaluation of large cohorts of patients with type 2 diabetes mellitus treated with IDeg, with long-term follow-up, can provide further relevant information on the safety of IDeg therapy. Keywords: degludec insulin, hypoglycemia, HbA1c, safety, type 2 diabetes mellitus, basal insulin analog

  4. Long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety?

    Directory of Open Access Journals (Sweden)

    Kissin I

    2013-07-01

    Full Text Available Igor Kissin Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Background: For the past 30 years, opioids have been used to treat chronic nonmalignant pain. This study tests the following hypotheses: (1 there is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective; and (2 the main problem associated with the safety of such treatment – assessment of the risk of addiction – has been neglected. Methods: Scientometric analysis of the articles representing clinical research in this area was performed to assess (1 the quality of presented evidence (type of study; and (2 the duration of the treatment phase. The sufficiency of representation of addiction was assessed by counting the number of articles that represent (1 editorials; (2 articles in the top specialty journals; and (3 articles with titles clearly indicating that the addiction-related safety is involved (topic-in-title articles. Results: Not a single randomized controlled trial with opioid treatment lasting >3 months was found. All studies with a duration of opioid treatment ≥6 months (n = 16 were conducted without a proper control group. Such studies cannot provide the consistent good-quality evidence necessary for a strong clinical recommendation. There were profound differences in the number of addiction articles related specifically to chronic nonmalignant pain patients and to opioid addiction in general. An inadequate number of chronic pain-related publications were observed with all three types of counted articles: editorials, articles in the top specialty journals, and topic-in-title articles. Conclusion: There is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective. The above identified signs indicating neglect of addiction associated with the

  5. Idaho National Laboratory Integrated Safety Management System 2010 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Thomas J. Haney

    2010-12-01

    Idaho National Laboratory completes an annual Integrated Safety Management System effectiveness review per 48 CFR 970.5223-1 “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assesses ISMS effectiveness, provides feedback to maintain system integrity, and helps identify target areas for focused improvements and assessments for the following year. Using one of the three Department of Energy (DOE) descriptors in DOE M 450.4-1 regarding the state of ISMS effectiveness during Fiscal Year (FY) 2010, the information presented in this review shows that INL achieved “Effective Performance.”

  6. A 100-Year Review: Microbiology and safety of milk handling.

    Science.gov (United States)

    Boor, Kathryn J; Wiedmann, Martin; Murphy, Sarah; Alcaine, Sam

    2017-12-01

    Microbes that may be present in milk can include pathogens, spoilage organisms, organisms that may be conditionally beneficial (e.g., lactic acid bacteria), and those that have not been linked to either beneficial or detrimental effects on product quality or human health. Although milk can contain a full range of organisms classified as microbes (i.e., bacteria, viruses, fungi, and protozoans), with few exceptions (e.g., phages that affect fermentations, fungal spoilage organisms, and, to a lesser extent, the protozoan pathogens Cryptosporidium and Giardia) dairy microbiology to date has focused predominantly on bacteria. Between 1917 and 2017, our understanding of the microbes present in milk and the tools available for studying those microbes have changed dramatically. Improved microbiological tools have enabled enhanced detection of known microbes in milk and dairy products and have facilitated better identification of pathogens and spoilage organisms that were not known or well recognized in the early 20th century. Starting before 1917, gradual introduction and refinement of pasteurization methods throughout the United States and many other parts of the world have improved the safety and quality of milk and dairy products. In parallel to pasteurization, others strategies for reducing microbial contamination throughout the dairy chain (e.g., improved dairy herd health, raw milk tests, clean-in-place technologies) also played an important role in improving microbial milk quality and safety. Despite tremendous advances in reducing microbial food safety hazards and spoilage issues, the dairy industry still faces important challenges, including but not limited to the need for improved science-based strategies for safety of raw milk cheeses, control of postprocessing contamination, and control of sporeforming pathogens and spoilage organisms. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  7. Efficacy and safety of blonanserin versus other antipsychotics: a review

    OpenAIRE

    Anant D. Patil

    2013-01-01

    Although many atypical antipsychotics are available, there is a need of an atypical antipsychotic effective in all symptom domains of schizophrenia and well tolerated especially for side effects like extrapyramidal side effects, weight gain and blood prolactin elevation. Blonanserin is an atypical antipsychotic which blocks dopamine D2 and serotonin 5HT2A receptors. Its efficacy and safety has been studied in patients with schizophrenia and delirium. Blonanserin is found to be effective and w...

  8. Second periodic safety review of Angra Nuclear Power Station, unit 1

    Energy Technology Data Exchange (ETDEWEB)

    Martins, Carlos F.O.; Crepaldi, Roberto; Freire, Enio M., E-mail: ottoncf@tecnatom.com.br, E-mail: emfreire46@gmail.com, E-mail: robcrepaldi@hotmail.com [Tecnatom do Brasil Engenharia e Servicos Ltda, Rio de Janeiro, RJ (Brazil); Campello, Sergio A., E-mail: sacampe@eletronuclear.gov.br [Eletrobras Termonuclear S.A. (ELETRONUCLEAR), Rio de Janeiro, RJ (Brazil)

    2015-07-01

    This paper describes the second Periodic Safety Review (PSR2-A1) of Angra Nuclear Power Station, Unit 1, prepared by Eletrobras Eletronuclear S.A. and Tecnatom do Brasil Engenharia e Servicos Ltda., during Jul.2013-Aug.2014, covering the period of 2004-2013. The site, in Angra dos Reis-RJ, Brazil, comprises: Unit 1, (640 MWe, Westinghouse PWR, operating), Unit 2 (1300 MWe, KWU/Areva, operating) and Unit 3 (1405 MWe, KWU/Areva, construction). The PSR2-A1 attends the Standards 1.26-Safety in Operation of Nuclear Power Plants, Brazilian Nuclear Regulatory Commission (CNEN), and IAEA.SSG.25-Periodic Safety Review of Nuclear Power Plants. Within 18 months after each 10 years operation, the operating organization shall perform a plant safety review, to investigate the evolution consequences of safety code and standards, regarding: Plant design; structure, systems and components behavior; equipment qualification; plant ageing management; deterministic and probabilistic safety analysis; risk analysis; safety performance; operating experience; organization and administration; procedures; human factors; emergency planning; radiation protection and environmental radiological impacts. The Review included 6 Areas and 14 Safety Parameters, covered by 33 Evaluations.After document evaluations and discussions with plant staff, it was generated one General and 33 Specific Guide Procedures, 33 Specific and one Final Report, including: Description, Strengths, Deficiencies, Areas for Improvement and Conclusions. An Action Plan was prepared by Electronuclear for the recommendations. It was concluded that the Unit was operated within safety standards and will attend its designed operational lifetime, including possible life extensions. The Final Report was submitted to CNEN, as one requisite for renewal of the Unit Permanent Operation License. (author)

  9. Systematic psychometric review of self-reported instruments to assess patient safety culture in primary care.

    Science.gov (United States)

    Desmedt, Melissa; Bergs, Jochen; Vertriest, Sonja; Vlayen, Annemie; Schrooten, Ward; Hellings, Johan; Vandijck, Dominique

    2017-09-27

    To give an overview of empirical studies using self-reported instruments to assess patient safety culture in primary care and to synthesize psychometric properties of these instruments. A key condition for improving patient safety is creating a supportive safety culture to identify weaknesses and to develop improvement strategies so recurrence of incidents can be minimized. However, most tools to measure and strengthen safety culture have been developed and tested in hospitals. Nevertheless, primary care is facing greater risks and a greater likelihood of causing unintentional harm to patients. A systematic literature review of research evidence and psychometric properties of self-reported instruments to assess patient safety culture in primary care. Three databases until November 2016. The review was carried out according to the protocol for systematic reviews of measurement properties recommended by the COSMIN panel and the PRISMA reporting guidelines. In total, 1.229 records were retrieved from multiple database searches (Medline = 865, Web of Science = 362 and Embase = 2). Resulting from an in-depth literature search, 14 published studies were identified, mostly originated from Western high-income countries. As these studies come with great diversity in tools used and outcomes reported, comparability of the results is compromised. Based on the psychometric review, the SCOPE-Primary Care survey was chosen as the most appropriate instrument to measure patient safety culture in primary care as the instrument had excellent internal consistency with Cronbach's alphas ranging from 0.70-0.90 and item factor loadings ranging from 0.40-0.96, indicating a good structural validity. The findings of the present review suggest that the SCOPE-Primary Care survey is the most appropriate tool to assess patient safety culture in primary care. Further psychometric techniques are now essential to ensure that the instrument provides meaningful information regarding safety

  10. Navigation in the electronic health record: A review of the safety and usability literature.

    Science.gov (United States)

    Roman, Lisette C; Ancker, Jessica S; Johnson, Stephen B; Senathirajah, Yalini

    2017-03-01

    Inefficient navigation in electronic health records has been shown to increase users' cognitive load, which may increase potential for errors, reduce efficiency, and increase fatigue. However, navigation has received insufficient recognition and attention in the electronic health record (EHR) literature as an independent construct and contributor to overall usability. Our aims in this literature review were to (1) assess the prevalence of navigation-related topics within the EHR usability and safety research literature, (2) categorize types of navigation actions within the EHR, (3) capture relationships between these navigation actions and usability principles, and (4) collect terms and concepts related to EHR navigation. Our goal was to improve access to navigation-related research in usability. We applied scoping literature review search methods with the assistance of a reference librarian to identify articles published since 1996 that reported evaluation of the usability or safety of an EHR user interface via user test, analytic methods, or inspection methods. The 4336 references collected from MEDLINE, EMBASE, Engineering Village, and expert referrals were de-duplicated and screened for relevance, and navigation-related concepts were abstracted from the 21 articles eligible for review using a standard abstraction form. Of the 21 eligible articles, 20 (95%) mentioned navigation in results and discussion of usability evaluations. Navigation between pages of the EHR was the more frequently documented type of navigation (86%) compared to navigation within a single page (14%). Navigation actions (e.g., scrolling through a medication list) were frequently linked to specific usability heuristic violations, among which flexibility and efficiency of use, recognition rather than recall, and error prevention were most common. Discussion of navigation was prevalent in results across all types of evaluation methods among the articles reviewed. Navigating between multiple

  11. Idaho National Laboratory Integrated Safety Management System FY 2012 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Farren Hunt

    2012-12-01

    Idaho National Laboratory (INL) performed an Annual Effectiveness Review of the Integrated Safety Management System (ISMS), per 48 Code of Federal Regulations (CFR) 970.5223 1, “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and identified target areas for focused improvements and assessments for fiscal year (FY) 2013. Results of the FY 2012 annual effectiveness review demonstrated that the INL’s ISMS program was significantly strengthened. Actions implemented by the INL demonstrate that the overall Integrated Safety Management System is sound and ensures safe and successful performance of work while protecting workers, the public, and environment. This report also provides several opportunities for improvement that will help further strengthen the ISM Program and the pursuit of safety excellence. Demonstrated leadership and commitment, continued surveillance, and dedicated resources have been instrumental in maturing a sound ISMS program. Based upon interviews with personnel, reviews of assurance activities, and analysis of ISMS process implementation, this effectiveness review concludes that ISM is institutionalized and is “Effective”.

  12. Strategies for improving patient safety culture in hospitals: a systematic review.

    Science.gov (United States)

    Morello, Renata Teresa; Lowthian, Judy A; Barker, Anna Lucia; McGinnes, Rosemary; Dunt, David; Brand, Caroline

    2013-01-01

    To determine the effectiveness of patient safety culture strategies to improve hospital patient safety climate. Electronic search of the Cochrane Library, OVID Medline, Embase, CINAHL, proQuest and psychinfo databases, with manual searches of quality and safety websites, bibliographies of included articles and key journals. English language studies published between January 1996 and April 2011 that measured the effectiveness of patient safety culture strategies using a quantitative measure of patient safety climate in a hospital setting. Studies included were randomised controlled trials (RCTs), non-RCTs, controlled before and after studies, interrupted time series and historically controlled studies. Data extraction and critical appraisal were conducted by two independent reviewers. Study design, intervention, level of application, setting, study participants, safety climate outcome measures and implementation lessons were extracted from each article. Over 2000 articles were screened, with 21 studies meeting the inclusion criteria, one cluster RCT, seven controlled before and after studies, and 13 historically controlled studies. There was marked methodological heterogeneity amongst studies. Impacts of 11 different strategies were reported. There was some evidence to support that leadership walk rounds (p=0.02) and multi-faceted unit-based programmes (p < 0.05) may have a positive impact on patient safety climate. Despite strong face validity for a variety of patient safety culture strategies, there is limited evidence to support definitive impacts on patient safety climate outcomes. Organisations are advised to consider robust evaluation designs when implementing these potentially resource intensive strategies.

  13. Patient-reported safety incidents in older patients with long-term conditions: a large cross-sectional study.

    Science.gov (United States)

    Panagioti, Maria; Blakeman, Thomas; Hann, Mark; Bower, Peter

    2017-05-30

    Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. © 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.

  14. Long-term safety and efficacy of lamotrigine (Lamictal) in paediatric patients with epilepsy.

    Science.gov (United States)

    Besag, F M; Dulac, O; Alving, J; Mullens, E L

    1997-02-01

    This study was initiated to evaluate the long-term safety, tolerability and effect on seizure control of lamotrigine (Lamictal) in paediatric patients with epilepsy. A total of 155 children (aged 2-19 years) with treatment-resistant epilepsy received add-on therapy or monotherapy lamotrigine for up to four years. Patients had already experienced benefit from lamotrigine treatment in an open one-year study before entering this open continuation study of up to three additional years of treatment. Overall, including both these studies, patients were treated with lamotrigine for 53-221 weeks, representing 417.9 patient-years of experience. The physician's global assessment of seizure control compared to the three-month period before lamotrigine treatment, indicated that seizure control was generally maintained during long-term lamotrigine treatment for up to four years. For 19 patients, the investigator recorded a subjective improvement in behaviour, alertness, seizure severity, quality of life and mobility with lamotrigine treatment, sometimes independent of seizure control. In total, 34 patients received lamotrigine monotherapy; 22 of these were maintained on lamotrigine monotherapy for at least one year. Lamotrigine was well tolerated. The majority of adverse experiences were classified by the physician as being mild in intensity and only six patients (4%) withdrew from the study due to adverse experiences.

  15. Rodent model for assessing the long term safety and performance of peripheral nerve recording electrodes

    Science.gov (United States)

    Vasudevan, Srikanth; Patel, Kunal; Welle, Cristin

    2017-02-01

    Objective. In the US alone, there are approximately 185 000 cases of limb amputation annually, which can reduce the quality of life for those individuals. Current prosthesis technology could be improved by access to signals from the nervous system for intuitive prosthesis control. After amputation, residual peripheral nerves continue to convey motor signals and electrical stimulation of these nerves can elicit sensory percepts. However, current technology for extracting information directly from peripheral nerves has limited chronic reliability, and novel approaches must be vetted to ensure safe long-term use. The present study aims to optimize methods to establish a test platform using rodent model to assess the long term safety and performance of electrode interfaces implanted in the peripheral nerves. Approach. Floating Microelectrode Arrays (FMA, Microprobes for Life Sciences) were implanted into the rodent sciatic nerve. Weekly in vivo recordings and impedance measurements were performed in animals to assess performance and physical integrity of electrodes. Motor (walking track analysis) and sensory (Von Frey) function tests were used to assess change in nerve function due to the implant. Following the terminal recording session, the nerve was explanted and the health of axons, myelin and surrounding tissues were assessed using immunohistochemistry (IHC). The explanted electrodes were visualized under high magnification using scanning electrode microscopy (SEM) to observe any physical damage. Main results. Recordings of axonal action potentials demonstrated notable session-to-session variability. Impedance of the electrodes increased upon implantation and displayed relative stability until electrode failure. Initial deficits in motor function recovered by 2 weeks, while sensory deficits persisted through 6 weeks of assessment. The primary cause of failure was identified as lead wire breakage in all of animals. IHC indicated myelinated and unmyelinated axons

  16. Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

    Science.gov (United States)

    Fu, Xiaping; Ying, Yibin

    2016-08-17

    In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

  17. A Review of Antiviral and Antifungal Use and Safety during Pregnancy.

    Science.gov (United States)

    Cottreau, Jessica M; Barr, Viktorija O

    2016-06-01

    Antiviral and antifungal use in pregnancy presents challenges because of the paucity of clinical and safety data for many agents in these classes. If untreated, viral and fungal infections can have deleterious effects on both maternal and fetal health. Understanding the use and risks of these medications in pregnancy is vital to provide appropriate care. This article reviews the current literature for the use of antiviral and antifungals, the pharmacokinetics of these agents, and their safety in pregnancy. © 2016 Pharmacotherapy Publications, Inc.

  18. Project JADE. Long-term function and safety. Comparison of repository systems

    Energy Technology Data Exchange (ETDEWEB)

    Birgersson, Lars; Pers, K.; Wiborgh, M. [Kemakta Konsult AB, Stockholm (Sweden)

    2001-12-01

    A comparison of the KBS-3 V(ertical deposition), KBS-3 H(orizontal deposition) and MLH repository systems with regard to the long-term repository performance and the radionuclide migration is presented in the report. Several differences between the repository systems have been identified. The differences are mainly related to the: distance between canister and backfilled tunnels, excavated rock volumes, deposition hole direction. The overall conclusion is that the differences are in general quite small with regard to the repository function and safety. None of the differences are of such importance for the long-term repository performance and radionuclide migration that they discriminate any of the repository systems. The differences between the two KBS-3 systems are small. Based on this study, there is no reason to change from the reference system KBS-3 V to KBS-3 H. MLH has the potential to be a very robust system, especially in a long-term perspective. However, the MLH system will require extensive research, development, and analysis before it will be as confident as the reference repository system, KBS-3 V. Although the MLH and KBS-3 H systems are in some ways favourable compared to the reference system KBS-3 V, the overall conclusion is that the KBS-3 V system is still a very attractive system. A major advantage with KBS-3 V is that it is by far the most investigated and developed system. The JADE-project was initiated in 1996, and the main part of the study was carried out during 1997 and 1998. The JADE study is consequently based on presumptions that were valid a few years ago. Some of these presumptions have been modified since then. The new presumptions are however not judged to change the overall conclusions.

  19. Review and Analysis of Development of "Safety by Design" Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Vance, Scott A.; Hockert, John

    2009-10-20

    This report, the deliverable for Task 4 of the NA-243 Safeguards by Design Work Plan for Fiscal Year 2009, develops the lessons to be learned for the institutionalization of Safeguards By Design (SBD) from the Department of Energy (DOE) experience developing and implementing DOE-STD-1189, Integration of Safety into the Design Process. This experience was selected for study because of the similarity of the challenges of integrating safety and safeguards into the design process. Development of DOE-STD-1189 began in January 2006 and the standard was issued for implementation in March 2008. The process was much more time consuming than originally anticipated and might not have come to fruition had senior DOE management been less committed to its success. Potentially valuable lessons can be learned from both the content and presentation of the integration approach in DOE-STD-1189 and from the DOE experience in developing and implementing DOE-STD-1189. These lessons are important because the instutionalization of SBD does not yet appear to have the level of senior management commitment afforded development and implementation of DOE-STD-1189.

  20. Review of the Safety and Efficacy of Moringa oleifera.

    Science.gov (United States)

    Stohs, Sidney J; Hartman, Michael J

    2015-06-01

    Moringa oleifera leaves, seeds, bark, roots, sap, and flowers are widely used in traditional medicine, and the leaves and immature seed pods are used as food products in human nutrition. Leaf extracts exhibit the greatest antioxidant activity, and various safety studies in animals involving aqueous leaf extracts indicate a high degree of safety. No adverse effects were reported in association with human studies. Five human studies using powdered whole leaf preparations of M. oleifera have been published, which have demonstrated anti-hyperglycemic (antidiabetic) and anti-dyslipidemic activities. These activities have been confirmed using extracts as well as leaf powders in animal studies. A rapidly growing number of published studies have shown that aqueous, hydroalcohol, or alcohol extracts of M. oleifera leaves possess a wide range of additional biological activities including antioxidant, tissue protective (liver, kidneys, heart, testes, and lungs), analgesic, antiulcer, antihypertensive, radioprotective, and immunomodulatory actions. A wide variety of polyphenols and phenolic acids as well as flavonoids, glucosinolates, and possibly alkaloids is believed to be responsible for the observed effects. Standardization of products is an issue. However, the results of published studies to date involving M. oleifera are very promising. Additional human studies using standardized extracts are highly desirable. © 2015 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

  1. Review of Safety and Efficacy of Sleep Medicines in Older Adults.

    Science.gov (United States)

    Schroeck, Jennifer L; Ford, James; Conway, Erin L; Kurtzhalts, Kari E; Gee, Megan E; Vollmer, Krista A; Mergenhagen, Kari A

    2016-11-01

    Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population. Search terms included medications approved by the US Food and Drug Administration for insomnia: benzodiazepines (triazolam, estazolam, temazepam, flurazepam, and quazepam), nonbenzodiazepine receptor agonists (non-BzRAs; zaleplon, zolpidem, and eszopiclone), suvorexant, ramelteon, doxepin and trazodone. Off-label drugs such as other antidepressants, antihistamines, antipsychotics, gabapentin, pramipexole, tiagabine, valerian, and melatonin were also included. Cognitive behavioral therapy and sleep hygiene are considered initial therapy for insomnia. Benzodiazepines are discouraged in the geriatric population, especially for long-term use. Although non-BzRAs have improved safety profiles compared with benzodiazepines, their side effects include dementia, serious injury, and fractures, which should limit their use. Ramelteon has a minimal adverse effect profile and is effective for sleep-onset latency and increased total sleep time, making it a valuable first-line option. Although the data on suvorexant are limited, this drug improves sleep maintenance and has mild adverse effects, including somnolence; residual daytime sedation has been reported, however. Sedating low-dose antidepressants should only be used for insomnia when the patient has comorbid depression. Antipsychotic agents, pramipexole, and tiagabine have all been used for insomnia, but none has been extensively studied in an older population, and all have considerable

  2. A systematic review of light-based home-use devices for hair removal and considerations on human safety

    DEFF Research Database (Denmark)

    Thaysen-Petersen, D; Bjerring, P; Dierickx, C

    2012-01-01

    , one CT, five UCTs) and limited evidence for laser devices (one diode laser, one UCT). Most studies evaluated short-term hair reduction up to 3 and 6 months following light exposure at different body sites. Hair reduction percentages ranged from 6% to 72% after repetitive treatments. The most......Background Hair removal with professional light-based devices is established as an effective, mainstream treatment. The field of optical home-based hair removal is evolving and movement from control by physicians into hands of consumers warrants understanding efficacy and human safety. Objectives...... To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. Methods A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled...

  3. Panel Resource Management (PRM) Implementation and Effects within Safety Review Panel Settings and Dynamics

    Science.gov (United States)

    Taylor, Robert W.; Nash, Sally K.

    2007-01-01

    While technical training and advanced degree's assure proficiency at specific tasks within engineering disciplines, they fail to address the potential for communication breakdown and decision making errors familiar to multicultural environments where language barriers, intimidating personalities and interdisciplinary misconceptions exist. In an effort to minimize these pitfalls to effective panel review, NASA's lead safety engineers to the ISS Safety Review Panel (SRP), and Payload Safety Review Panel (PSRP) initiated training with their engineers, in conjunction with the panel chairs, and began a Panel Resource Management (PRM) program. The intent of this program focuses on the ability to reduce the barriers inhibiting effective participation from all panel attendees by bolstering participants confidence levels through increased communication skills, situational awareness, debriefing, and a better technical understanding of requirements and systems.

  4. Does classroom-based Crew Resource Management training improve patient safety culture? A systematic review.

    Science.gov (United States)

    Verbeek-van Noord, Inge; de Bruijne, Martine C; Zwijnenberg, Nicolien C; Jansma, Elise P; van Dyck, Cathy; Wagner, Cordula

    2014-01-01

    To evaluate the evidence of the effectiveness of classroom-based Crew Resource Management training on safety culture by a systematic review of literature. Studies were identified in PubMed, Cochrane Library, PsycINFO, and Educational Resources Information Center up to 19 December 2012. The Methods Guide for Comparative Effectiveness Reviews was used to assess the risk of bias in the individual studies. In total, 22 manuscripts were included for review. Training settings, study designs, and evaluation methods varied widely. Most studies reporting only a selection of culture dimensions found mainly positive results, whereas studies reporting all safety culture dimensions of the particular survey found mixed results. On average, studies were at moderate risk of bias. Evidence of the effectiveness of Crew Resource Management training in health care on safety culture is scarce and the validity of most studies is limited. The results underline the necessity of more valid study designs, preferably using triangulation methods.

  5. Idaho National Laboratory Integrated Safety Management System 2011 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Farren Hunt

    2011-12-01

    Idaho National Laboratory (INL) performed an annual Integrated Safety Management System (ISMS) effectiveness review per 48 Code of Federal Regulations (CFR) 970.5223-1, 'Integration of Environment, Safety and Health into Work Planning and Execution.' The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and helped identify target areas for focused improvements and assessments for fiscal year (FY) 2012. The information presented in this review of FY 2011 shows that the INL has performed many corrective actions and improvement activities, which are starting to show some of the desired results. These corrective actions and improvement activities will continue to help change culture that will lead to better implementation of defined programs, resulting in moving the Laboratory's performance from the categorization of 'Needs Improvement' to the desired results of 'Effective Performance.'

  6. Long-Term Benefits of Prompts to Use Safety Belts among Drivers Exiting Senior Communities

    Science.gov (United States)

    Cox, Cory D.; Cox, Brian S.; Cox, Daniel J.

    2005-01-01

    Senior drivers are vulnerable to automobile crashes and subsequent injury and death. Safety belts reduce health risks associated with auto crashes. Therefore, it is important to encourage senior drivers to wear safety belts while driving. Using a repeated baseline design (AAB), we previously reported that motivating signs boosted safety belt usage…

  7. Occupational Health and Safety in Ethiopia: A review of Situational ...

    African Journals Online (AJOL)

    kim

    gaps that may require attention in areas of OSH services, training, research, exposure assessment, and capacity building. The review study was approved at. Department level through ... machine characterizes manufacturing undertakings. About 85% of the ...... clusters in 21 regions, 1990–2010: a systematic analysis for the ...

  8. Table Egg Production and Consumers Safety: A Review | Usman ...

    African Journals Online (AJOL)

    which may accumulate in the egg and cause public health hazards. Microbial contamination of eggs in the process of production, handling and marketing has also been of a major public health concern. This paper reviews some of the ways table eggs can get contaminated and become unsafe for human consumption, ...

  9. A Review of Digital Addiction: A Call for Safety Education

    Science.gov (United States)

    Rugai, Joseph; Hamiliton-Ekeke, Joy-Telu

    2016-01-01

    In reviewing digital addiction, this paper recognized that digital technology has been useful in various spheres of life and the reach is undeniable, with an "average" user spending long hours on their phone or online daily. These hours increase as new applications are released by various technological companies. The demands of modern…

  10. The effectiveness of road safety education : a literature review.

    NARCIS (Netherlands)

    Dragutinovic, N. & Twisk, D.A.M.

    2007-01-01

    This literature review of traffic education programmes addresses the current practice in evaluation research, the effectiveness of programmes and their constituting components and the differences and similarities with other fields of education. The study leads to a number of conclusions which can be

  11. Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

    2015-01-01

    Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity

  12. Acupuncture safety in patients receiving anticoagulants: a systematic review.

    Science.gov (United States)

    Mcculloch, Michael; Nachat, Arian; Schwartz, Jonathan; Casella-Gordon, Vicki; Cook, Joseph

    2015-01-01

    Theoretically, acupuncture in anticoagulated patients could increase bleeding risk. However, precise estimates of bleeding complication rates from acupuncture in anticoagulated patients have not been systematically examined. To critically evaluate evidence for safety of acupuncture in anticoagulated patients. We searched PubMed, EMBASE, the Physiotherapy Evidence Database, and Google Scholar. Of 39 potentially relevant citations, 11 met inclusion criteria: 2 randomized trials, 4 case series, and 5 case reports. Seven provided reporting quality sufficient to assess acupuncture safety in 384 anticoagulated patients (3974 treatments). Minor-moderate bleeding related to acupuncture in an anticoagulated patient occurred in one case: a large hip hematoma, managed with vitamin K reversal and warfarin discontinuation following reevaluation of its medical justification. Blood-spot bleeding, typical for any needling/injection and controlled with pressure/cotton, occurred in 51 (14.6%) of 350 treatments among a case series of 229 patients. Bleeding deemed unrelated to acupuncture during anticoagulation, and more likely resulting from inappropriately deep needling damaging tissue or from complex anticoagulation regimens, occurred in 5 patients. No bleeding was reported in 2 studies (74 anticoagulated patients): 1 case report and 1 randomized trial prospectively monitoring acupuncture-associated bleeding as an explicit end point. Altogether, 1 moderate bleeding event occurred in 3974 treatments (0.003%). Acupuncture appears to be safe in anticoagulated patients, assuming appropriate needling location and depth. The observed 0.003% complication rate is lower than the previously reported 12.3% following hip/knee replacement in a randomized trial of 27,360 anticoagulated patients, and 6% following acupuncture in a prospective study of 229,230 all-type patients. Prospective trials would help confirm our findings.

  13. Design Review Report for formal review of safety class features of exhauster system for rotary mode core sampling

    Energy Technology Data Exchange (ETDEWEB)

    JANICEK, G.P.

    2000-06-08

    Report documenting Formal Design Review conducted on portable exhausters used to support rotary mode core sampling of Hanford underground radioactive waste tanks with focus on Safety Class design features and control requirements for flammable gas environment operation and air discharge permitting compliance.

  14. Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

    Science.gov (United States)

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

  15. Review of Overall Safety Manual for space nuclear systems. An evaluation of a nuclear safety analysis methodology for plutonium-fueled space nuclear systems

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, J.; Inhaber, H.

    1984-02-01

    As part of its duties in connection with space missions involving nuclear power sources, the Office of Nuclear Safety (ONS) of the Office of Assistant Secretary for Environmental Protection, Safety, and Emergency Preparedness has been assigned the task of reviewing the Overall Safety Manual (OSM) (memo from B.J. Rock to J.R. Maher, December 1, 1982). The OSM, dated July 1981 and in four volumes, was prepared by NUS Corporation, Rockville, Maryland, for the US Department of Energy. The OSM provides many of the technical models and much of the data which are used by (1) space launch contractors in safety analysis reports and (2) the broader Interagency Nuclear Safety Review Panel (INSRP) safety evaluation reports. If fhs interaction between the OSM, contractors, and INSRP is to work effectively, the OSM must be accurate, comprehensive, understandable, and usable.

  16. Changes of the eye during long-term spaceflight. Review

    Directory of Open Access Journals (Sweden)

    I. A. Makarov

    2016-01-01

    Full Text Available The review includes the publications of the scientific literature on the eye change during long-term spaceflight. The any eye changes such as visual impairment, hyperopic shift in refraction, changes in the intraocular pressure, increased the intracranial pressure, globe flattening, choroidal folding, optic disc edema, and optic nerve kinking and other changes were reported. The main cause of eye disorders, in all probability, is the increase of the intracranial pressure during long-term spaceflight. The reasons of the increased intracranial pressure are a collection of various factors of adaptation mechanisms in the body to weightless conditions. The leading role in the development of intracranial hypertension takes a redistribution of the body fluids (blood and lymph in the direction of the head, but the opportunities and the effect of other factors are present. Also the displacement and increase of the internal organs volume of the chest can cause external compression of the jugular veins, increasing the pressure of the blood in them, and as the result to lead to the increase of the intracranial pressure. The role of trigger such mechanisms in the development of the intracranial hypertension in the microgravity environment as anatomical predisposition of the body, race, metabolic changes under the influence of high carbon dioxide content in the different compartments of the station, high sodium intake, the enzyme dysfunction, weight exercises of the astronauts was discussed. However, the pathogenic mechanisms is currently still under investigation. An important role in the study of the adaptation mechanisms is given to research not only before and after the flight, but also during the space flight. The accumulated knowledge and experience about the changes in organs and systems in the conditions of human adaptation to microgravity will help answer many questions related to the implementation of the long spaceflights.

  17. Realistic integration of sorption processes in transport codes for long-term safety assessments

    Energy Technology Data Exchange (ETDEWEB)

    Noseck, Ulrich; Fluegge, Judith; Britz, Susan; Schneider, Anke [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Brendler, Vinzenz; Stockmann, Madlen; Schikora, Johannes [Helmholtz-Zentrum Dresden-Rossendorf e.V., Dresden (Germany); Lampe, Michael [Frankfurt Univ. (Germany). Goethe Center for Scientific Computing

    2012-09-15

    One important aspect in long-term safety assessment is related to radionuclide transport in geologic formations. In order to assess its consequences over assessment periods of one million years numerical models describing flow and transport are applied. Sorption on mineral surfaces is the most relevant process retarding radionuclide transport. On the one hand an increased transport time might cause a decrease in radionuclide concentration by radioactive decay. On the other hand it might increase concentrations of dose-relevant daughter nuclides in decay chains. In order to treat the radionuclide sorption processes in natural systems close to reality the so-called smart K{sub d}-concept is implemented into the transport program r{sup 3}t, which is applied to large model areas and very long time scales in long-term safety assessment. In the first stage this approach is developed for a typical sedimentary system covering rock salt and clay formations in Northern Germany. The smart K{sub d}-values are based on mechanistic surface complexation models (SCM), varying in time and space and de-pending on the actual geochemical conditions, which might change in the future e. g. due to the impact of climate changes. The concept developed and introduced here is based on a feasible treatment of the most relevant geochemical parameters in the transport code as well as on a matrix of smart K{sub d}-values calculated in dependence on these parameters. The implementation of the concept comprises the selection of relevant elements and minerals to be considered, an experimental program to fill data gaps of the thermody-namic sorption database, an uncertainty and sensitivity analysis to identify the most important environmental parameters influencing sorption of long-term relevant radionu-clides, the creation of a matrix with K{sub d}-values dependent on the selected environmental parameters, and the development and realisation of the conceptual model for treatment of temporal and

  18. Drug safety surveillance in China and other countries: a review and comparison.

    Science.gov (United States)

    Du, Wenmin; Guo, Jeff J; Jing, Yonghua; Li, Xing; Kelton, Christina M L

    2008-03-01

    Drug safety and postmarketing surveillance have become important public health issues in China. This study reviews the relatively new drug safety surveillance system in China and compares it with the systems in the United States and Europe. An extensive literature review was conducted in the following four areas: 1) the organizational structure of the State Food and Drug Administration (SFDA) in China; 2) the development of an adverse drug reaction (ADR) monitoring system in China; 3) regulatory issues related to drug safety in China; and 4) similarities and differences between drug safety surveillance in China and surveillance in the United States and Europe. The SFDA oversees an extensive network of drug safety "watchdogs," including the China National Center for ADR Monitoring and 32 regional centers throughout China. China's system has faced a number of recent challenges. It has had to respond quickly to the withdrawal of various high-profile drugs like Vioxx (rofecoxib) and Baycol (cerivastatin) from other markets. Together with China's Ministry of Health, the SFDA has faced several unique drug safety events. Three of those events, involving the injectable form of the heartleaf houttuyinia herb (Yu Xing Cao), Armillarisni A injections, and clindamycin glucose infusions (Xinfu), are discussed. The rapid development of drug safety surveillance in China is manifested in extensive organizational structure, development of large databases, and laws and regulations supporting drug safety. The two major laws are the China Drug Administration Law issued in February 2001 and the Regulation for the Administration of ADR Reporting and Monitoring issued in March 2004. The study also discusses and compares recent developments in drug safety surveillance in the United States and the European Union. These developments will most likely have implications for the Chinese system in the near future. While postmarketing surveillance guidelines are not yet available in China, we

  19. Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M.; Plott, C.; Milanski, J.; Ronan, A.; Scheff, S.; Laux, L.; and Bzostek, J.

    2009-09-30

    The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance to support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.

  20. Long-term efficacy and safety of lamotrigine for all types of bipolar disorder.

    Science.gov (United States)

    Watanabe, Yoshinori; Hongo, Seiji

    2017-01-01

    We investigated whether the long-term efficacy and safety of lamotrigine (LTG) for bipolar disorder (BP) differs between disease types (BP-I, BP-II, or BP not otherwise specified [BP-NOS]), and the efficacy of the concomitant use of antidepressants (ADs). For >1 year, we observed 445 outpatients with BP (diagnosed by DSM-IV criteria) who initiated LTG treatment between July 1 and October 31, 2011, using the Himorogi Self-rating Depression (HSDS) and Anxiety Scales and the Clinical Global Impression-Improvement scale and also recorded adverse events. Treatment efficacy was observed at week 4, with the improved HSDS scores sustained until week 52 for all types of BP; 50% of the patients with any type of BP could be treated with LTG for 1 year, whereas ~40% could be treated for >1.5 years. However, 25% of the patients were withdrawn within the first 4 weeks. The overall incidence of adverse events was 22.9% (104/455): 34.1% (14/41) for BP-I, 22.7% (15/66) for BP-II, and 22.2% (75/338) for BP-NOS. The most common adverse event was skin rash: 22.0% for BP-I, 16.7% for BP-II, and 12.1% for BP-NOS. There was no control group. Data were collected retrospectively. With careful and adequate titration, long-term treatment with LTG is possible for any type of BP, with BP-NOS patients, the largest population in clinical practice, responding particularly well. Symptoms can improve with or without ADs. Large-scale prospective studies of the efficacy of ADs in bipolar treatment are warranted.

  1. Per-oral endoscopic myotomy (POEM): mid-term efficacy and safety.

    Science.gov (United States)

    Martinek, Jan; Svecova, Hana; Vackova, Zuzana; Dolezel, Radek; Ngo, Ondrej; Krajciova, Jana; Kieslichova, Eva; Janousek, Radim; Pazdro, Alexander; Harustiak, Tomas; Zdrhova, Lucie; Loudova, Pavla; Stirand, Petr; Spicak, Julius

    2017-08-10

    Per-oral endoscopic myotomy (POEM) is becoming a standard treatment for achalasia. Long-term efficacy and the rate of post-POEM reflux should be further investigated. The main aim of this study was to analyze safety and mid-term (12 and 24 months) clinical outcomes of POEM. Data on single tertiary center procedures were collected prospectively. The primary outcome was treatment success defined as an Eckardt score POEM; 133 patients were included into the analysis (22 patients will be analyzed separately as part of a multicenter randomized clinical trial). POEM was successfully completed in 132 (99.2%) patients, and the mean length of the procedure was 69.8 min (range 31-136). One patient underwent a drainage for pleural effusion; no other serious adverse events occurred. Treatment success at 3, 12, and 24 months was observed in 95.5% (CI 89.6-98.1), 93.4% (86.5-96.8), and 84.0% (71.4-91.4) of patients, respectively. A total of 11 patients (8.3%) reported initial treatment failure (n = 5) or later recurrence (n = 6). The majority of relapses occurred in patients with achalasia type I (16.7 vs. 1.1% achalasia type II vs. 0% achalasia type III; pPOEM reflux symptoms were present in 29.7% of patients. At 3 months, mild reflux esophagitis was diagnosed in 37.6% of patients, and pathological gastroesophageal reflux was detected in 41.5% of patients. A total of 37.8% of patients had been treated with a proton pump inhibitor. POEM resulted in greater than 90% treatment success at 12 months which tends to decrease to 84% after 2 years. More than one-third of the patients had mild reflux symptoms and/or mild esophagitis.

  2. Involving patients in patient safety programmes: A scoping review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care

    NARCIS (Netherlands)

    Trier, H.; Valderas, J.M.; Wensing, M.; Martin, H.M.; Egebart, J.

    2015-01-01

    BACKGROUND: Patient involvement has only recently received attention as a potentially useful approach to patient safety in primary care. OBJECTIVE: To summarize work conducted on a scoping review of interventions focussing on patient involvement for patient safety; to develop consensus-based

  3. Use and safety of azithromycin in neonates: a systematic review.

    Science.gov (United States)

    Smith, Coral; Egunsola, Oluwaseun; Choonara, Imti; Kotecha, Sailesh; Jacqz-Aigrain, Evelyne; Sammons, Helen

    2015-12-09

    To identify the use and adverse drug reactions associated with azithromycin in neonates. Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates. All studies involving neonates (azithromycin for which safety was evaluated. The primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome. A total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS). Azithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation. 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/

  4. Safety of Levetiracetam in Paediatrics: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Oluwaseun Egunsola

    Full Text Available To identify adverse events (AEs associated with Levetiracetam (LEV in children.Databases EMBASE (1974-February 2015 and Medline (1946-February 2015 were searched for articles in which paediatric patients (≤18 years received LEV treatment for epilepsy. All studies with reports on safety were included. Studies involving adults, mixed age population (i.e. children and adults in which the paediatric subpopulation was not sufficiently described, were excluded. A meta-analysis of the RCTs was carried out and association between the commonly reported AEs or treatment discontinuation and the type of regimen (polytherapy or monotherapy was determined using Chi2 analysis.Sixty seven articles involving 3,174 paediatric patients were identified. A total of 1,913 AEs were reported across studies. The most common AEs were behavioural problems and somnolence, which accounted for 10.9% and 8.4% of all AEs in prospective studies. 21 prospective studies involving 1120 children stated the number of children experiencing AEs. 47% of these children experienced AEs. Significantly more children experienced AEs with polytherapy (64% than monotherapy (22% (p<0.001. Levetiracetam was discontinued in 4.5% of all children on polytherapy and 0.9% on monotherapy (p<0.001, the majority were due to behavioural problems.Behavioural problems and somnolence were the most prevalent adverse events to LEV and the most common causes of treatment discontinuation. Children on polytherapy have a greater risk of adverse events than those receiving monotherapy.

  5. [Treatment for advanced Parkinson's disease with intestinal levodopa/carbidopa gel: review of efficacy and safety].

    Science.gov (United States)

    Timofeeva, A A

    2014-01-01

    Late stages of Parkinson's disease (PD) are characterized by the development of motor fluctuations and dyskinesia which inevitably emerge during the disease due to long-term use of levodopa and hinder treatment. The use of intestinal levodopa/carbidopa gel stabilizes the drug blood concentration and reduces the severity of motor parkinsonian symptoms. The literature of the last two decades on the efficacy and safety of intrarenal introduction of intestinal levodopa/carbidopa gel in PD patients is reviewed.A data analysis of intestinal levodopa/carbidopa gel revealed the efficacy of this method in the late stages of PD. The drug reduced motor symptoms, severity of motor fluctuations and dyskinesia and improved quality of life. Some studies demonstrated the decrease in PD stage, as evaluated by Hoehn and Yahr, during treatment with intestinal levodopa/carbidopa gel. The good tolerability profile allows for possibility of using this method for multiyear treatment. Side-effects were mostly related to drug delivery. All of them may be overcome in future in the process of technical improvement.

  6. Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease

    DEFF Research Database (Denmark)

    Chaparro, M; Verreth, A; Lobaton, T

    2018-01-01

    OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs ...

  7. Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children.

    NARCIS (Netherlands)

    Remitz, A.; Harper, J.; Rustin, M.; Goldschmidt, W.; Palatsi, R.; Valk, P.G.M. van der; Sharpe, G.; Smith, C.H.; Dobozy, A.; Turjanmaa, K.

    2007-01-01

    Tacrolimus ointment is a topical calcineurin inhibitor for the treatment of atopic dermatitis. The primary objective of this open-label study was to assess the long-term safety of tacrolimus ointment. The primary end-point was the incidence of adverse events. Secondary end-points included the Eczema

  8. Prospects for comparing European hospitals in terms of quality and safety : Lessons from a comparative study in five countries

    NARCIS (Netherlands)

    S. Burnett (Susan); A. Renz (Anna); S. Wiig (Siri); A. Fernandes (Alexandra); J.W.M. Weggelaar-Jansen (Anne Marie); J.E. Calltorp (Johan); J.E. Anderson (Janet); G. Robert (Glenn); C. Vincent (Charles); N.J. Fulop (Naomi)

    2013-01-01

    textabstractPurpose. Being able to compare hospitals in terms of quality and safety between countries is important for a number of reasons. For example, the 2011 European Union directive on patients’ rights to cross-border health care places a requirement on all member states to provide patients

  9. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.

    NARCIS (Netherlands)

    Leonardi, C.; Strober, B.; Gottlieb, A.B.; Elewski, B.E.; Ortonne, J.P.; Kerkhof, P.C.M. van de; Chiou, C.F.; Dunn, M.; Jahreis, A.

    2010-01-01

    BACKGROUND: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. OBJECTIVE: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe

  10. A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

    Science.gov (United States)

    Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

    2017-09-01

    This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

  11. Long-term efficacy and safety of lamotrigine for all types of bipolar disorder

    Directory of Open Access Journals (Sweden)

    Watanabe Y

    2017-03-01

    Full Text Available Yoshinori Watanabe,1,2 Seiji Hongo2 1Himorogi Psychiatric Institute, Tokyo, 2Nanko Clinic of Psychiatry, Shirakawa city, Fukushima, Japan Background: We investigated whether the long-term efficacy and safety of lamotrigine (LTG for bipolar disorder (BP differs between disease types (BP-I, BP-II, or BP not otherwise specified [BP-NOS], and the efficacy of the concomitant use of antidepressants (ADs.Methods: For >1 year, we observed 445 outpatients with BP (diagnosed by DSM-IV criteria who initiated LTG treatment between July 1 and October 31, 2011, using the Himorogi Self-rating Depression (HSDS and Anxiety Scales and the Clinical Global Impression-Improvement scale and also recorded adverse events.Results: Treatment efficacy was observed at week 4, with the improved HSDS scores sustained until week 52 for all types of BP; 50% of the patients with any type of BP could be treated with LTG for 1 year, whereas ~40% could be treated for >1.5 years. However, 25% of the patients were withdrawn within the first 4 weeks. The overall incidence of adverse events was 22.9% (104/455: 34.1% (14/41 for BP-I, 22.7% (15/66 for BP-II, and 22.2% (75/338 for BP-NOS. The most common adverse event was skin rash: 22.0% for BP-I, 16.7% for BP-II, and 12.1% for BP-NOS.Limitations: There was no control group. Data were collected retrospectively.Conclusion: With careful and adequate titration, long-term treatment with LTG is possible for any type of BP, with BP-NOS patients, the largest population in clinical practice, responding particularly well. Symptoms can improve with or without ADs. Large-scale prospective studies of the efficacy of ADs in bipolar treatment are warranted. Keywords: lamotrigine, bipolar disorder, long-term efficacy, antidepressant, skin rash, anxiety

  12. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia.

    Science.gov (United States)

    Hovingh, G Kees; Raal, Frederick J; Dent, Ricardo; Stefanutti, Claudia; Descamps, Olivier; Masana, Luis; Lira, Armando; Bridges, Ian; Coll, Blai; Sullivan, David

    Evolocumab, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9, is safe and effective when dosed biweekly (Q2W) or monthly (QM) in patients with heterozygous familial hypercholesterolemia (HeFH) as demonstrated in two 12-week trials: Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD; phase 2) and RUTHERFORD-2 (phase 3). The objective of the study was to evaluate long-term efficacy, safety, and tolerability of evolocumab during open-label extension trials. Patients completing parent trials were re-randomized 2:1 to evolocumab plus standard of care (SOC) or SOC alone for 52 weeks (Open-Label Study of Long-term Evaluation Against LDL-C [OSLER-1]) or 48 weeks (OSLER-2). Evolocumab dosing was 420 mg QM (OSLER-1) and 140 mg Q2W or 420 mg QM (OSLER-2). A pooled analysis of OSLER data was performed from this subset of HeFH patients. Four hundred forty HeFH patients from RUTHERFORD (n = 147) and RUTHERFORD-2 (n = 293) (mean [standard deviation] age 51 [12] years, 58% male, 90% White) were randomized to evolocumab plus SOC (n = 289) or SOC (n = 151). The 48-week period was completed by 425 patients (96.6%). Eight patients discontinued evolocumab plus SOC (2.8%) and 7 discontinued SOC (4.6%). Compared to parent study baseline, patients receiving evolocumab plus SOC experienced a mean 53.6% reduction in low-density lipoprotein cholesterol after 48 weeks. No patient experienced an adverse event leading to permanent evolocumab discontinuation during the 1-year SOC-controlled period. Serious adverse event rates were similar between groups (evolocumab plus SOC, 7.3%; SOC, 8.6%). Continued use of evolocumab added to SOC in patients with HeFH yields persistent and marked low-density lipoprotein cholesterol reductions during 48 weeks of follow-up. Long-term dosing of evolocumab with SOC was safe and well tolerated. Copyright © 2017 National Lipid Association. Published by

  13. Efficacy and safety of dronedarone: a review of randomized trials

    DEFF Research Database (Denmark)

    Christiansen, Christine Benn; Torp-Pedersen, Christian; Køber, Lars

    2010-01-01

    IMPORTANCE OF THE FIELD: Dronedarone is developed for treatment of atrial fibrillation (AF) or flutter (AFL). It is a noniodinized amiodarone analogue and believed to be without the adverse effects of amiodarone. However, long-term adverse effects are not yet well investigated. AREAS COVERED...... that amiodarone was superior to dronedarone to maintain sinus rhythm in patients with AF/AFL. TAKE HOME MESSAGE: Dronedarone is superior to placebo but less efficient than amiodarone in maintaining sinus rhythm in patients with a history of AF. In patients with AF and risk factors dronedarone reduces...

  14. 78 FR 40443 - Submission for OMB Review; Comment Request-Virginia Graeme Baker Pool and Spa Safety Act...

    Science.gov (United States)

    2013-07-05

    ... COMMISSION Submission for OMB Review; Comment Request--Virginia Graeme Baker Pool and Spa Safety Act... verify whether pools and spas are in compliance with the Virginia Graeme Baker Pool and Spa Safety Act... inspections per year under the Virginia Graeme Baker Pool and Spa Safety Act. Investigators typically...

  15. 77 FR 76005 - Submission for OMB Review; Comment Request-Safety Standard for Walk-Behind Power Lawn Mowers

    Science.gov (United States)

    2012-12-26

    ... COMMISSION Submission for OMB Review; Comment Request--Safety Standard for Walk-Behind Power Lawn Mowers... approval of a collection of information associated with the Commission's safety standard for walk- behind... required in the Safety Standard for Walk-Behind Power Lawn Mowers (16 CFR Part 1205). Three comments were...

  16. Contraceptive safety among women with cystic fibrosis: a systematic review.

    Science.gov (United States)

    Whiteman, Maura K; Oduyebo, Titilope; Zapata, Lauren B; Walker, Seth; Curtis, Kathryn M

    2016-12-01

    With dramatic improvements in life expectancy for cystic fibrosis (CF) patients, contraception for women with CF has become an important issue. There are theoretical concerns that hormonal contraceptive use among women with CF may impact disease severity or risk for other adverse health outcomes, including thrombosis and poor bone health, as well as concerns that malabsorption or altered drug metabolism might impact contraceptive effectiveness. To evaluate evidence on the safety and effectiveness of contraceptive methods among women with CF. We searched the PubMed database for all articles published from database inception through October 2015. We included studies that examined measures of disease severity, other health outcomes or indicators of contraceptive effectiveness among women with CF initiating or continuing a contraceptive method. Seven studies met our inclusion criteria. Three observational studies of fair to poor quality suggest that use of oral contraceptives (OCs) does not negatively impact CF disease severity, defined as changes in pulmonary function, number of exacerbations or need for intravenous antibiotics. Three small studies of poor quality reported on contraceptive failure among women with CF using combined hormonal contraceptives (combined OCs, patch or ring). One pregnancy was reported in a patch user out of 43 hormonal contraceptive users across all studies. One pharmacokinetic study reported that women with CF achieve steroid hormone plasma concentrations similar to healthy women after ingestion of combined OCs. Limited evidence suggests that hormonal contraceptive use does not negatively impact disease severity among women with CF and that hormonal contraceptive effectiveness is not impaired by CF. Studies were limited by small sample sizes and short duration of follow-up. No studies examined the effect of hormonal contraception on thrombosis or bone health among women with CF. Published by Elsevier Inc.

  17. Safety of bone marrow stem cell donation: a review.

    Science.gov (United States)

    Bosi, A; Bartolozzi, B

    2010-01-01

    Allogeneic hematopoietic stem cell transplantation (HSCT) represents the first choice of treatment or an important therapeutic option for several diseases, but it is still marked by morbidity and mortality. In contrast, the donation of hematopoietic stem cells (HSCs) is considered to be a safe procedure. The invaluable ethical source of donation and its central role in transplantation implies that the greatest attention be due to the donor and to the donation process through a serious monitoring protocol for donor safety. Both the Joint Accreditation Committee and the European Committee pay particular attention to the notification of adverse events and adverse reactions. Bone marrow donation is a well established procedure, that has now been performed for >30 years. Although it does not require drug administration, there is hospital admission for 1-3 days with 7-10 days off work. The main risk is related to the anesthesia. Pain in the aspiration area, together with astenia are considered to be the most frequent side effects, as shown by the USA National Marrow Donor Program experience in 1,193 donations. In the European Group for Blood and Marrow Transplantation analysis performed between 1993 and 2005 on 27,770 first HSCTs from bone marrow, only 1 fatal event (pulmonary embolism) and 12 serious adverse events were observed. The most frequent adverse events were cardiac. The incidence of adverse events was significantly lower (P donors, which confirms the necessity of accurate attention to donor selection and evaluation in bone marrow donation. Copyright 2010 Elsevier Inc. All rights reserved.

  18. [Long-term efficacy and safety of balloon kyphoplasty for treatment of osteoporotic vertebral fractures].

    Science.gov (United States)

    Bornemann, R; Deml, M; Wilhelm, K E; Jansen, T R; Wirtz, D C; Pflugmacher, R

    2012-09-01

    The aim of the evaluation of treatment protocols was an extension of the documentation regarding efficacy, duration of action and safety of balloon kyphoplasty. In addition, the data analysis should be used to clarify whether differences arise concerning the treatment success, depending on the number and/or position of the augmented vertebral bodies. The data of all patients who were admitted and operated on for vertebral body fractures between 2004 and 2009 were collected and evaluated for this study. The patients were examined pre-operatively and during the control visits clinically and radiologically. The intensity of pain was recorded on a visual analogue scale (VAS: 0-100 mm). To determine the functional limitations the Oswestry questionnaire was used. In addition, the middle and anterior heights of the vertebral body and the kyphosis angle were measured. To perform the balloon kyphoplasty the Kyphon® system was applied. The findings of all patients were documented in order to evaluate the efficacy and safety of balloon kyphoplasty for up to 3 years and to compare them with regard to the differences depending on the number and/or location of vertebral fractures (T = 1, T > 1, L = 1, L > 1, T + L). The overall evaluation of all patients (n = 464) in whom a balloon kyphoplasty was carried out showed an average improvement in VAS scores by 53 mm and the Oswestry scores by 47 percentage points. It was possible to demonstrate a significant improvement of the vertebral body height (mean 1.6 mm) and the kyphosis angle (1.3 degrees) in long-term controls up to 3 years. When comparing the findings in the groups that had been operated on a different number of vertebrae and/or at different positions in the spinal region (n = 466) it could be proven that the average decrease in pain intensity did not differ in all 5 groups (> 50 mm). Also for the Oswestry scores the reduction was almost comparable in all 5 groups. The radiological findings did not show striking

  19. Long-term Drug Treatment for Obesity: A Systematic and Clinical Review

    Science.gov (United States)

    Yanovski, Susan Z.; Yanovski, Jack A.

    2014-01-01

    Importance Thirty-six percent of US adults are obese and many cannot lose sufficient weight to improve health with lifestyle interventions alone. Objective Conduct a systematic review of medications currently approved in the US for obesity treatment in adults. We also discuss off-label use of medications studied for obesity and provide considerations for obesity medication use in clinical practice. Evidence Acquisition A PubMed search from inception through September, 2013 was performed to find meta-analyses, systematic reviews, and randomized, placebo-controlled trials for currently-approved obesity medications lasting ≥1y, that had a primary or secondary outcome of body weight, included ≥50 participants per group, reported ≥50% retention, and reported results on an intention-to-treat basis. Studies of medications approved for other purposes but tested for obesity treatment were also reviewed. Results Obesity medications approved for long-term use, when prescribed with lifestyle interventions, produce additional weight loss relative to placebo ranging from approximately 3% of initial weight for orlistat and lorcaserin to 9% for top-dose (15/92mg) phentermine/topiramate-ER at 1y. The proportion of patients achieving clinically-meaningful (≥5%) weight loss ranges from 37–47% for lorcaserin, 35–73% for orlistat, and 67–70% for top-dose phentermine/topiramate-ER. All three produce greater improvements in many cardiometabolic risk factors than placebo, but no obesity medication has been shown to reduce cardiovascular morbidity or mortality. Most prescriptions are for noradrenergic medications, despite their approval only for short-term use and limited data for their long-term safety and efficacy. Conclusions/Relevance Medications approved for long-term obesity treatment, when used as an adjunct to lifestyle intervention, lead to greater mean weight loss and an increased likelihood of achieving clinically-meaningful 1-year weight loss relative to placebo

  20. A comparative review of patient safety initiatives for national health information technology

    DEFF Research Database (Denmark)

    Magrabi, Farah; Aarts, Jos; Nøhr, Christian

    2013-01-01

    OBJECTIVE: To collect and critically review patient safety initiatives for health information technology (HIT). METHOD: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified...... were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security...... and privacy requirements may lead to safer systems. England appears to have the most comprehensive safety management programme for unregulated software, incorporating safety assurance at a local healthcare organisation level based on standards for risk management and user interface design, with national...

  1. The effect of neighborhood on crime and safety: a review of the evidence.

    Science.gov (United States)

    Brisson, Daniel; Roll, Susan

    2012-01-01

    There is a growing, multidisciplinary body of evidence on the effects that neighborhoods have on family outcomes. This evidence is important for social workers as we work with clients and communities from a person-in-environment perspective. In this article the authors present findings from a systematic, integrative review of neighborhood effects specifically for crime and safety. Thirty-seven research studies using random samples from urban, U.S. areas between 2002 and 2008 are reviewed. Findings suggest socio-demographic characteristics of neighborhoods and neighborhood processes are both predictive of crime and safety. Further, some neighborhood conditions may affect crime and safety in unexpected ways. Implications for social work practice, neighborhood interventions, and evidence-based practice are discussed.

  2. Teamwork, communication and safety climate: a systematic review of interventions to improve surgical culture.

    Science.gov (United States)

    Sacks, Greg D; Shannon, Evan M; Dawes, Aaron J; Rollo, Johnathon C; Nguyen, David K; Russell, Marcia M; Ko, Clifford Y; Maggard-Gibbons, Melinda A

    2015-07-01

    To define the target domains of culture-improvement interventions, to assess the impact of these interventions on surgical culture and to determine whether culture improvements lead to better patient outcomes and improved healthcare efficiency. Healthcare systems are investing considerable resources in improving workplace culture. It remains unclear whether these interventions, when aimed at surgical care, are successful and whether they are associated with changes in patient outcomes. PubMed, Cochrane, Web of Science and Scopus databases were searched from January 1980 to January 2015. We included studies on interventions that aimed to improve surgical culture, defined as the interpersonal, social and organisational factors that affect the healthcare environment and patient care. The quality of studies was assessed using an adapted tool to focus the review on higher-quality studies. Due to study heterogeneity, findings were narratively reviewed. The 47 studies meeting inclusion criteria (4 randomised trials and 10 moderate-quality observational studies) reported on interventions that targeted three domains of culture: teamwork (n=28), communication (n=26) and safety climate (n=19); several targeted more than one domain. All moderate-quality studies showed improvements in at least one of these domains. Two studies also demonstrated improvements in patient outcomes, such as reduced postoperative complications and even reduced postoperative mortality (absolute risk reduction 1.7%). Two studies reported improvements in healthcare efficiency, including fewer operating room delays. These findings were supported by similar results from low-quality studies. The literature provides promising evidence for various strategies to improve surgical culture, although these approaches differ in terms of the interventions employed as well as the techniques used to measure culture. Nevertheless, culture improvement appears to be associated with other positive effects, including

  3. Estradiol gel : review of the pharmacology, pharmacokinetics, efficacy, and safety in menopausal women

    NARCIS (Netherlands)

    Naunton, M.; Al Hadithy, A.F.Y.; Brouwers, J.R.B.J.; Archer, D.F.

    2006-01-01

    Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of a gel containing estradiol that is applied to the skin. Design: MEDLINE and EMBASE searches were conducted from 1966 to March 2005. Additional references were identified from bibliographies from selected studies in

  4. Efficacy and safety of medical cannabinoids in older subjects: A systematic review

    NARCIS (Netherlands)

    Elsen, G.A.H. van den; Ahmed, A.I.A.; Lammers, M.; Kramers, C.; Verkes, R.J.; Marck, M.A. van der; Olde Rikkert, M.G.M.

    2014-01-01

    This systematic review aims to integrate the evidence on indications, efficacy, safety and pharmacokinetics of medical cannabinoids in older subjects. The literature search was conducted using PubMed, EMBASE, CINAHL and Cochrane Library. We selected controlled trials including solely older subjects

  5. Efficacy and safety of uterine manipulators in laparoscopic surgery: a review

    NARCIS (Netherlands)

    Haak, L. van den; Alleblas, C.; Nieboer, T.E.; Rhemrev, J.P.; Jansen, F.W.

    2015-01-01

    PURPOSE: This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. METHODS: PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search

  6. Efficacy and safety of uterine manipulators in laparoscopic surgery : A review

    NARCIS (Netherlands)

    Van den Haak, L.; Alleblas, C.; Nieboer, T.E.; Rhemrev, J.P.; Jansen, F.W.

    2015-01-01

    Purpose This review aims to objectively assess the efficacy and safety of uterine manipulators as reported in scientific literature. Furthermore, it evaluates as to which manipulator best suits which surgical procedure. Methods PubMed, Embase, Web of Science, COCHRANE, CINAHL, Academic Search

  7. A Review and Comparative Analysis of Security Risks and Safety Measures of Mobile Health Apps

    National Research Council Canada - National Science Library

    Karen Scott; Deborah Richards; Rajindra Adhikari

    2015-01-01

    ...’ personal and health information. Based on a review of the literature, this paper identifies a set of risk and safety features for evaluating mHealth apps and uses those features to conduct a comparative analysis of the 20 most popular mHealth apps...

  8. Learning from aviation to improve safety in the operating room - a systematic literature review

    NARCIS (Netherlands)

    L.S.G.L. Wauben; J.F. Lange (Johan); R.H.M. Goossens (Richard)

    2012-01-01

    textabstractLessons learned from other high-risk industries could improve patient safety in the operating room (OR). This review describes similarities and differences between high-risk industries and describes current methods and solutions within a system approach to reduce errors in the OR. PubMed

  9. Safety of oscillating-rotating powered brushes compared to manual toothbrushes: a systematic review

    NARCIS (Netherlands)

    van der Weijden, F.A.; Campbell, S.L.; Dörfer, C.E.; Gonzalez-Cabezas, C.; Slot, D.E.

    2011-01-01

    Background: Oscillating-rotating power toothbrushes have been proven clinically efficacious. To our knowledge, a comprehensive review of all clinical and laboratory investigations solely comparing the safety of these toothbrushes to the standard of care (i.e., manual toothbrushes) has not been

  10. Systematic Review of Kinship Care Effects on Safety, Permanency, and Well-Being Outcomes

    Science.gov (United States)

    Winokur, Marc A.; Holtan, Amy; Batchelder, Keri E.

    2018-01-01

    Objective: Children in out-of-home placements typically display more educational, behavioral, and psychological problems than do their peers. This systematic review evaluated the effect of kinship care placement compared to foster care placement on the safety, permanency, and well-being of children removed from the home for maltreatment. Methods:…

  11. A review of case studies evaluating economic incentives to promote occupational safety and health

    NARCIS (Netherlands)

    Elsler, D.; Treutlein, D.; Rydlewska, I.; Frusteri, L.; Krüger, H.; Veerman, T.; Eeckelaert, L.; Roskams, N.; Broek, K. van den; Taylor, T.N.

    2010-01-01

    Objectives: In many European countries, external economic incentives are discussed as a policy instrument to promote occupational safety and health (OSH) in enterprises. This narrative case study review aims to support policy-makers in organizations providing such incentives by supplying information

  12. Speaking up for patient safety by hospital-based health care professionals: a literature review.

    NARCIS (Netherlands)

    Okuyama, A.; Wagner, C.; Bijnen, B.

    2014-01-01

    Background: Speaking up is important for patient safety, but often, health care professionals hesitate to voice concerns. Understanding the influencing factors can help to improve speaking-up behaviour and team communication. This review focused on health care professionals’ speaking-up behaviour

  13. Speaking up for patient safety by hospital-based health care professionals: a literature review

    NARCIS (Netherlands)

    Okuyama, A.; Wagner, C.; Bijnen, A.B.

    2014-01-01

    Background: Speaking up is important for patient safety, but often, health care professionals hesitate to voice concerns. Understanding the influencing factors can help to improve speaking-up behaviour and team communication. This review focused on health care professionals' speaking-up behaviour

  14. Use of mobile phones while driving : effects on road safety : a literature review.

    NARCIS (Netherlands)

    Dragutinovic, N. & Twisk, D.A.M.

    2006-01-01

    The use of mobile phones while driving has become a road safety concern and has been the focus of various behavioural studies. This literature review analyses studies published in the period 1999-2005, and include simulator studies, closed-track studies and studies on the real road. Although studies

  15. Renovated Korean nuclear safety and security system: A review and suggestions to successful settlement

    Energy Technology Data Exchange (ETDEWEB)

    Chung, W. S.; Yun, S. W.; Lee, D. S. [Korea Atomic Energy Research Inst., Dukjin-dong 150, Yusung-gu, Daejon, R.O., 305-353 (Korea, Republic of); Go, D. Y. [Kyung Hee Univ., Kyung Hee daero 26, Dongdaemoon-gu, Seoul, R.O., 130-701 (Korea, Republic of)

    2012-07-01

    Questions of whether past nuclear regulatory body of Korea is not a proper system to monitor and check the country's nuclear energy policy and utilization have been raised. Moreover, a feeling of insecurity regarding nuclear safety after the nuclear accident in Japan has spread across the public. This has stimulated a renovation of the nuclear safety regime in Korea. The Nuclear Safety and Security Commission (NSSC) was launched on October 26, 2011 as a regulatory body directly under the President in charge of strengthening independence and nuclear safety. This was a meaningful event as the NSSC it is a much more independent regulatory system for Korea. However, the NSSC itself does not guarantee an enhanced public acceptance of the nuclear policy and stable use nuclear energy. This study introduces the new NSSC system and its details in terms of organization structure, appropriateness of specialty, budget stability, and management system. (authors)

  16. Saccharin. Review of safety issues. Council on Scientific Affairs.

    Science.gov (United States)

    1985-11-08

    This report reviews the experimental and epidemiologic data related to the carcinogenicity of saccharin. The results of animal studies suggest a species and organ effect. In single-generation studies in rats, mice, hamsters, and monkeys, saccharin did not induce cancer in any organ. In two-generation studies involving rats, however, there was evidence that the incidence of bladder tumors was significantly greater in saccharin-treated males of the second generation than in controls; the development of bladder tumors in rats seems to be a species- and organ-specific phenomenon for which there is currently no explanation. In humans, available evidence indicates that the use of artificial sweeteners, including saccharin, is not associated with an increased risk of bladder cancer. Until there is firm evidence of its carcinogenicity in humans, saccharin should continue to be available as a food additive, and reports of adverse health effects associated with its use should be monitored.

  17. Status of patient safety culture in Arab countries: a systematic review.

    Science.gov (United States)

    Elmontsri, Mustafa; Almashrafi, Ahmed; Banarsee, Ricky; Majeed, Azeem

    2017-02-24

    To explore the status of patient safety culture in Arab countries based on the findings of the Hospital Survey on Patient Safety Culture (HSPSC). Systematic review. We performed electronic searches of the MEDLINE, EMBASE, CINAHL, ProQuest and PsychINFO, Google Scholar and PubMed databases, with manual searches of bibliographies of included articles and key journals. We included studies that were conducted in the Arab countries that were focused on patient safety culture. 2 reviewers independently verified that the studies met the inclusion criteria and critically assessed the quality of the studies. 18 studies met our inclusion criteria. The review identified that non-punitive response to error is seen as a serious issue which needs to be improved. Healthcare professionals in the Arab countries tend to think that a 'culture of blame' still exists that prevents them from reporting incidents. We found an overall similarity between the reported composite score for dimension of teamwork within units in all of the reviewed studies. Teamwork within units was found to be better than teamwork across hospital units. All of the reviewed studies reported that organisational learning and continuous improvement was satisfactory as the average score of this dimension for all studies was 73.2%. Moreover, the review found that communication openness seems to be a concerning issue for healthcare professionals in the Arab countries. There is a need to promote patient safety culture as a strategy for improving the patient safety in the Arab world. Improving patient safety culture should include all stakeholders, like policymakers, healthcare providers and those responsible for medical education. This review was limited only to English language publications. The varied settings in which the HSPSC was used may have influenced the areas of strengths and weaknesses as healthcare workers' perception of safety culture may differ. Published by the BMJ Publishing Group Limited. For

  18. Human safety review of "nano" titanium dioxide and zinc oxide.

    Science.gov (United States)

    Schilling, Karsten; Bradford, Bobbie; Castelli, Dominique; Dufour, Eric; Nash, J Frank; Pape, Wolfgang; Schulte, Stefan; Tooley, Ian; van den Bosch, Jeroen; Schellauf, Florian

    2010-04-01

    Based on the current weight of evidence of all available data, the risk for humans from the use of nano-structured titanium dioxide (TiO(2)) or zinc oxide (ZnO) currently used in cosmetic preparations or sunscreens is considered negligible. There is a large body of information that when viewed in its entirety is considered as sufficient to demonstrate that these nano-structured ultraviolet (UV) filters, irrespective of various treatments (coatings) or crystalline structure, can be regarded as safe for use at concentrations up to 25% in cosmetic products to protect the skin from harmful effects of solar UV radiation. "Nano" TiO(2) and ZnO formulated in topically applied sunscreen products exist as aggregates of primary particles ranging from 30-150 nm in size. These aggregates are bonded such that the force of sunscreen product application onto the skin would have no impact on their structure or result in the release of primary particles. Multiple studies have shown that under exaggerated test conditions neither nano-structured TiO(2) nor ZnO penetrates beyond the stratum corneum of skin. Further, the distribution and persistence of these nano-structured metal oxides is the same compared to larger pigment-grade (i.e., >100 nm) particles, demonstrating equivalence in the recognition and elimination of such material from the body. Finally, the in vitro genotoxic and photogenotoxic profiles of these nano-structured metal oxides are of no consequence to human health. Whereas the most logical, straightforward conclusion based on data from internationally-recognized guideline studies and current 20+ year history of human use is that nano-structured TiO(2) and ZnO are safe, there will continue to be questions as "nano" conjures images of technology gone awry. Despite this rather sober view, the public health benefits of sunscreens containing nano TiO(2) and/or ZnO outweigh human safety concerns for these UV filters.

  19. Lumbar epidural catheter placement in the presence of low back tattoos: a review of the safety concerns.

    Science.gov (United States)

    Welliver, Dawn; Welliver, Mark; Carroll, Tammy; James, Peggy

    2010-06-01

    Current fashion in body art includes low back tattoos of varying designs and colors, a trend that presents unique concerns for anesthesia providers. Does the placement of epidural catheters risk the introduction of tattoo pigment dyes into the epidural space through the process of coring? Are there specific risks associated with tattoo dyes and epidural needle placement? We performed a comprehensive review of the literature using multiple search databases with the intent to form guidelines for practice using a level of evidence taxonomy. The available evidence does not identify any specific risks associated with epidural catheter placement through low back tattoos, although tissue coring with tissue transport to deeper sites has been confirmed. Continued investigation is necessary before comprehensive practice guidelines regarding the practice of placing epidural needles and catheters through lumbar tattoos can be developed. We suggest avoidance of piercing tattoos when performing epidural punctures until there is sound evidence of short-term and long-term safety.

  20. A Systematic Review of the Safety and Effect of Neurofeedback on Fatigue and Cognition.

    Science.gov (United States)

    Luctkar-Flude, Marian; Groll, Dianne

    2015-07-01

    Many cancer survivors continue to experience ongoing symptoms, such as fatigue and cognitive impairment, which are poorly managed and have few effective, evidence-based treatment options. Neurofeedback is a noninvasive, drug-free form of brain training that may alleviate long-term symptoms reported by cancer patients. The purpose of this systematic review of the literature was to describe the effectiveness and safety of neurofeedback for managing fatigue and cognitive impairment. A systematic review of the literature was conducted using Joanna Briggs Institute (JBI) methodology. A comprehensive search of 5 databases was conducted: Medline, CINAHL, AMED, PsycInfo, and Embase. Randomized and nonrandomized controlled trials, controlled before and after studies, cohort, case control studies, and descriptive studies were included in this review. Twenty-seven relevant studies were included in the critical appraisals. The quality of most studies was poor to moderate based on the JBI critical appraisal checklists. Seventeen studies were deemed of sufficient quality to be included in the review: 10 experimental studies and 7 descriptive studies. Of these, only 2 were rated as high-quality studies and the remaining were rated as moderate quality. All 17 included studies reported positive results for at least one fatigue or cognitive outcome in a variety of populations, including 1 study with breast cancer survivors. Neurofeedback interventions were well tolerated with only 3 studies reporting any side effects. Despite issues with methodological quality, the overall positive findings and few reported side effects suggest neurofeedback could be helpful in alleviating fatigue and cognitive impairment. Currently, there is insufficient evidence that neurofeedback is an effective therapy for management of these symptoms in cancer survivors, however, these promising results support the need for further research with this patient population. More information about which

  1. Interventions to Improve Oral Chemotherapy Safety and Quality: A Systematic Review.

    Science.gov (United States)

    Zerillo, Jessica A; Goldenberg, Benjamin A; Kotecha, Ritesh R; Tewari, Alok K; Jacobson, Joseph O; Krzyzanowska, Monika K

    2017-06-01

    With the growing use of oral chemotherapy, there is an urgent need to develop safe and effective systems to administer and manage these agents. A comprehensive synthesis of literature on oral chemotherapy care delivery programs to which clinicians can look for best practices is lacking. To summarize the peer-reviewed and gray literature on interventions to improve oral chemotherapy care delivery toward describing best practices and identifying current gaps. Using search terms pertaining to the concepts of oral chemotherapy, cancer, and interventions and outcomes, we performed a systematic review of PubMed, EMBASE, and CINAHL from January 1995 to May 24, 2016, to identify oral chemotherapy intervention programs. We searched the gray literature from January 1995 through February 2016 and contacted gray literature authors for further information. Four physician abstractors reviewed the titles, abstracts, and articles. Quality of the articles was assessed using SQUIRE2 guidelines. Interventions were evaluated in the categories of prescribing, preparation/dispensing, education, administration, monitoring, and storage/disposal. The population of interest included all ages and was limited to traditional cytotoxic and targeted anticancer oral agents. From 7984 abstracts identified in the peer-reviewed literature search, 16 full-text articles met inclusion criteria representing 3612 patients. Interventions focused on prescribing (n = 1), preparation/dispensing (n = 2), education (n = 11), administration (n = 5), monitoring (n = 14), and storage/disposal (n = 1). In the 10 articles with adherence as the primary outcome, 4 evaluation methods were used. Most improvements were seen in toxic effects/safety compared with adherence. Of the 7 interventions with statistically significant improvement in the primary outcome, 3 nursing phone calls to contact patients within the first few days after treatment initiation, 2 of them with standardized toxic effects

  2. Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder.

    Science.gov (United States)

    Oviedo-Joekes, Eugenia; Brissette, Suzanne; MacDonald, Scott; Guh, Daphne; Marchand, Kirsten; Jutha, Salima; Harrison, Scott; Janmohamed, Amin; Zhang, Derek Z; Anis, Aslam H; Krausz, Michael; Marsh, David C; Schechter, Martin T

    2017-07-01

    To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance. This was a non-inferiority randomized double-blind controlled trial (Vancouver, Canada) testing hydromorphone (n=100) and diacetylmorphine (n=102) for the treatment of severe opioid use disorder. Medications were delivered under the supervision of trained Registered Nurses up to three times daily. AEs were described using MedDRA codes. Most common related AEs included immediate post-injection reaction or injection site pruritus reactions, somnolence and opioid overdoses. Adjusted analysis indicated that participants in the hydromorphone group were less likely to have any related AE or SAE compared to the diacetylmorphine group. Related somnolence and opioid overdose events were distributed throughout the six months treatment period. In the diacetylmorphine group, five of the eleven related SAE opioid overdoses (requiring naloxone) occurred in the first 30days since most recent treatment initiation. Analysis of somnolence and opioid overdose (AEs and SAEs) event rates by received dose suggested a non-linear relationship. However, in the diacetylmorphine group higher event rates per person days were recorded at lower doses. When injectable hydromorphone and diacetylmorphine are individually dosed and monitored, their opioid-related side effects, including potential fatal overdoses, are safely mitigated and treated by health care providers. In the midst of an opioid overdose epidemic, injectable options are timely to reach a very important minority of people who inject street opioids and are not attracted to other treatments. Copyright © 2017. Published by Elsevier B.V.

  3. Change in neighborhood traffic safety: does it matter in terms of physical activity?

    NARCIS (Netherlands)

    Jongeneel-Grimen, Birthe; Busschers, Wim; Droomers, Mariël; van Oers, Hans A. M.; Stronks, Karien; Kunst, Anton E.

    2013-01-01

    There is limited evidence on the causality of previously observed associations between neighborhood traffic safety and physical activity (PA). This study aims to contribute to this evidence by assessing the extent to which changes over time in neighborhood traffic safety were associated with PA.

  4. Change in neighborhood traffic safety : Does it matter in terms of physical activity?

    NARCIS (Netherlands)

    Jongeneel-Grimen, B.; Busschers, W.; van Oers, J.A.M.; Stronks, K.; Kunst, P.E.J.

    2013-01-01

    Background There is limited evidence on the causality of previously observed associations between neighborhood traffic safety and physical activity (PA). This study aims to contribute to this evidence by assessing the extent to which changes over time in neighborhood traffic safety were associated

  5. Improving the governance of patient safety in emergency care: a systematic review of interventions.

    Science.gov (United States)

    Hesselink, Gijs; Berben, Sivera; Beune, Thimpe; Schoonhoven, Lisette

    2016-01-29

    To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. A systematic review of the literature. PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures

  6. Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety

    Directory of Open Access Journals (Sweden)

    Davis Anne M

    2010-05-01

    Full Text Available Abstract Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein. Two hundred thirty-two (232 infants ≤ 14 days postnatal age were randomized and 220 (94.8% completed the study. Weight (g, head circumference (cm, and length (cm were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day from baseline to Week 16. Safety was assessed through monitoring of study events (SEs throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.

  7. Determinants of safety outcomes and performance: A systematic literature review of research in four high-risk industries.

    Science.gov (United States)

    Cornelissen, Pieter A; Van Hoof, Joris J; De Jong, Menno D T

    2017-09-01

    In spite of increasing governmental and organizational efforts, organizations still struggle to improve the safety of their employees as evidenced by the yearly 2.3 million work-related deaths worldwide. Occupational safety research is scattered and inaccessible, especially for practitioners. Through systematically reviewing the safety literature, this study aims to provide a comprehensive overview of behavioral and circumstantial factors that endanger or support employee safety. A broad search on occupational safety literature using four online bibliographical databases yielded 27.527 articles. Through a systematic reviewing process 176 online articles were identified that met the inclusion criteria (e.g., original peer-reviewed research; conducted in selected high-risk industries; published between 1980-2016). Variables and the nature of their interrelationships (i.e., positive, negative, or nonsignificant) were extracted, and then grouped and classified through a process of bottom-up coding. The results indicate that safety outcomes and performance prevail as dependent research areas, dependent on variables related to management & colleagues, work(place) characteristics & circumstances, employee demographics, climate & culture, and external factors. Consensus was found for five variables related to safety outcomes and seven variables related to performance, while there is debate about 31 other relationships. Last, 21 variables related to safety outcomes and performance appear understudied. The majority of safety research has focused on addressing negative safety outcomes and performance through variables related to others within the organization, the work(place) itself, employee demographics, and-to a lesser extent-climate & culture and external factors. This systematic literature review provides both scientists and safety practitioners an overview of the (under)studied behavioral and circumstantial factors related to occupational safety behavior. Scientists

  8. Change in neighborhood traffic safety: does it matter in terms of physical activity?

    Directory of Open Access Journals (Sweden)

    Birthe Jongeneel-Grimen

    Full Text Available BACKGROUND: There is limited evidence on the causality of previously observed associations between neighborhood traffic safety and physical activity (PA. This study aims to contribute to this evidence by assessing the extent to which changes over time in neighborhood traffic safety were associated with PA. METHODS: Data were accessed from the national survey Netherlands Housing Research for 2006 and 2009. The two samples of in total 57,092 Dutch residents aged 18-84 years lived in 320 neighbourhoods. Using multi-level hurdle models, the authors assessed whether the odds of being physically active and the mean hours of PA among active people (in 2009 were related to the levels of neighborhood traffic safety (in 2006 and changes in the levels of neighborhood traffic safety (between 2006 and 2009. Next, we examined if these associations varied according to gender, age, and employment status. RESULTS: Higher levels of neighborhood traffic safety were associated with higher odds of being active (OR 1.080 (1.025-1.139. An increase in levels of neighborhood traffic safety was associated with increased odds of being active (OR 1.060 (1.006-1.119. This association was stronger among women, people aged 35 to 59, and those who were gainfully employed. Neither levels of traffic safety nor changes in these levels were associated with the mean hours of PA among people who were physically active (OR 0.997 (0.975-1.020; OR 1.001 (0.978-1.025, respectively. CONCLUSION: Not only levels of neighborhood traffic safety, but also increases in neighborhood traffic safety were related to increased odds of being active. This relationship supports claims for a causal relationship between neighborhood traffic safety and PA.

  9. Change in neighborhood traffic safety: does it matter in terms of physical activity?

    Science.gov (United States)

    Jongeneel-Grimen, Birthe; Busschers, Wim; Droomers, Mariël; van Oers, Hans A M; Stronks, Karien; Kunst, Anton E

    2013-01-01

    There is limited evidence on the causality of previously observed associations between neighborhood traffic safety and physical activity (PA). This study aims to contribute to this evidence by assessing the extent to which changes over time in neighborhood traffic safety were associated with PA. Data were accessed from the national survey Netherlands Housing Research for 2006 and 2009. The two samples of in total 57,092 Dutch residents aged 18-84 years lived in 320 neighbourhoods. Using multi-level hurdle models, the authors assessed whether the odds of being physically active and the mean hours of PA among active people (in 2009) were related to the levels of neighborhood traffic safety (in 2006) and changes in the levels of neighborhood traffic safety (between 2006 and 2009). Next, we examined if these associations varied according to gender, age, and employment status. Higher levels of neighborhood traffic safety were associated with higher odds of being active (OR 1.080 (1.025-1.139)). An increase in levels of neighborhood traffic safety was associated with increased odds of being active (OR 1.060 (1.006-1.119)). This association was stronger among women, people aged 35 to 59, and those who were gainfully employed. Neither levels of traffic safety nor changes in these levels were associated with the mean hours of PA among people who were physically active (OR 0.997 (0.975-1.020); OR 1.001 (0.978-1.025), respectively). Not only levels of neighborhood traffic safety, but also increases in neighborhood traffic safety were related to increased odds of being active. This relationship supports claims for a causal relationship between neighborhood traffic safety and PA.

  10. Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review

    Science.gov (United States)

    Solmi, Marco; Murru, Andrea; Pacchiarotti, Isabella; Undurraga, Juan; Veronese, Nicola; Fornaro, Michele; Stubbs, Brendon; Monaco, Francesco; Vieta, Eduard; Seeman, Mary V; Correll, Christoph U; Carvalho, André F

    2017-01-01

    Since the discovery of chlorpromazine (CPZ) in 1952, first-generation antipsychotics (FGAs) have revolutionized psychiatric care in terms of facilitating discharge from hospital and enabling large numbers of patients with severe mental illness (SMI) to be treated in the community. Second-generation antipsychotics (SGAs) ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders (DSM) categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed

  11. Applying Risk Society Theory to findings of a scoping review on caregiver safety.

    Science.gov (United States)

    Macdonald, Marilyn; Lang, Ariella

    2014-03-01

    Chronic Illness represents a growing concern in the western world and individuals living with chronic illness are primarily managed at home by family caregivers. A scoping review of the home-care literature (2004-2009; updated with review articles from 2010 to January 2013) on the topic of the caregiver revealed that this group experiences the following safety-related concerns: caregivers are conscripted to the role, experience economic hardship, risk being abused as well as abusing, and may well become patients themselves. Methodology and methods used in the scoping review are presented as well as a brief overview of the findings. The concepts of risk and safety are defined. Risk Society Theory is introduced and used as a lens to view the findings, and to contribute to an understanding of the construction of risk in contemporary health-care. © 2013 John Wiley & Sons Ltd.

  12. Application of hyperspectral imaging in food safety inspection and control: a review.

    Science.gov (United States)

    Feng, Yao-Ze; Sun, Da-Wen

    2012-01-01

    Food safety is a great public concern, and outbreaks of food-borne illnesses can lead to disturbance to the society. Consequently, fast and nondestructive methods are required for sensing the safety situation of produce. As an emerging technology, hyperspectral imaging has been successfully employed in food safety inspection and control. After presenting the fundamentals of hyperspectral imaging, this paper provides a comprehensive review on its application in determination of physical, chemical, and biological contamination on food products. Additionally, other studies, including detecting meat and meat bone in feedstuffs as well as organic residue on food processing equipment, are also reported due to their close relationship with food safety control. With these applications, it can be demonstrated that miscellaneous hyperspectral imaging techniques including near-infrared hyperspectral imaging, fluorescence hyperspectral imaging, and Raman hyperspectral imaging or their combinations are powerful tools for food safety surveillance. Moreover, it is envisaged that hyperspectral imaging can be considered as an alternative technique for conventional methods in realizing inspection automation, leading to the elimination of the occurrence of food safety problems at the utmost.

  13. Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    O, J.M.; Higgins, J.; Stephen Fleger - NRC

    2011-09-19

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.

  14. Using Health Information Technology to Improve Safety in Neonatal Care: A Systematic Review of the Literature.

    Science.gov (United States)

    Melton, Kristin R; Ni, Yizhao; Tubbs-Cooley, Heather L; Walsh, Kathleen E

    2017-09-01

    Health information technology (HIT) interventions may improve neonatal patient safety but may also introduce new errors. The objective of this review was to evaluate the evidence for use of HIT interventions to improve safety in neonatal care. Evidence for improvement exists for interventions like computerized provider order entry in the neonatal population, but is lacking for several other interventions. Many unique applications of HIT are emerging as technology and use of the electronic health record expands. Future research should focus on the impact of these interventions in the neonatal population. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Measures of short-term memory: a historical review.

    Science.gov (United States)

    Richardson, John T E

    2007-07-01

    Following Ebbinghaus (1885/1964), a number of procedures have been devised to measure short-term memory using immediate serial recall: digit span, Knox's (1913) cube imitation test and Corsi's (1972) blocks task. Understanding the cognitive processes involved in these tasks was obstructed initially by the lack of a coherent concept of short-term memory and later by the mistaken assumption that short-term and long-term memory reflected distinct processes as well as different kinds of experimental task. Despite its apparent conceptual simplicity, a variety of cognitive mechanisms are responsible for short-term memory, and contemporary theories of working memory have helped to clarify these. Contrary to the earliest writings on the subject, measures of short-term memory do not provide a simple measure of mental capacity, but they do provide a way of understanding some of the key mechanisms underlying human cognition.

  16. The Role of Fear Appeals in Improving Driver Safety: A Review of the Effectiveness of Fear-Arousing (Threat) Appeals in Road Safety Advertising

    Science.gov (United States)

    Lewis, I.; Watson, B.; Tay, R.; White, K. M.

    2007-01-01

    This paper reviews theoretical and empirical evidence relating to the effectiveness of fear (threat) appeals in improving driver safety. The results of the review highlight the mixed and inconsistent findings that have been reported in the literature. While fear arousal appears important for attracting attention, its contribution to behaviour…

  17. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  18. SAFETY

    CERN Document Server

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  19. Modified cow-hitch suture fixation of transscleral sutured posterior chamber intraocular lenses: long-term safety and efficacy.

    Science.gov (United States)

    Chen, Simon X; Lee, Lawrence R; Sii, Freda; Rowley, Adrian

    2008-03-01

    To evaluate the long-term safety and efficacy of a new technique using a modified cow-hitch knot for transscleral suture fixation of posterior chamber intraocular lenses (PC IOLs). Public hospital in Brisbane, Australia. A retrospective chart review was conducted of consecutive patients who had transscleral sutured PC IOL implantation from March 2000 to June 2006 using the new technique, which was modified to eliminate free suture ends and minimize the risk for knot slippage. Data collected included demographic data, ocular history, preoperative and final best corrected visual acuities (BCVAs), preoperative and postoperative intraocular pressure (IOP), and postoperative complications. Eighty-two eyes of 79 patients (51 men, 28 women) with a mean age of 62.5 years+/-18.9 (SD) were included in the study. The mean follow-up was 22.9+/-21.2 months (range 5 to 76 months). The BCVA was 20/40 or better in 45 eyes (54.9%) and 20/200 or worse in 10 eyes (12.2%). The final BCVA was largely determined by the preoperative underlying ocular pathology. Postoperative complications included temporary increased IOP in 14 eyes (17.1%), escalated glaucoma in 7 eyes (8.5%), temporary hypotony in 7 eyes (8.5%), and retinal detachment, hyphema, and irregular astigmatism in 1 eye (1.2%) each. The PC IOLs remained well centered and without tilt in all eyes. The technique provided excellent PC IOL centration in the presence of no adequate capsule support. It was effective and safe for transscleral suturing of PC IOLs.

  20. Long-term efficacy and safety of botulinum toxin A injections to treat blepharospasm and hemifacial spasm.

    Science.gov (United States)

    Ababneh, Osama H; Cetinkaya, Altug; Kulwin, Dwight R

    2014-04-01

    To evaluate efficacy and safety of botulinum toxin A injections after more than 10 consecutive years of treatment for benign essential blepharospasm and hemifacial spasm. Retrospective chart review at university-affiliated hospital. Study consisted of 64 patients treated with botulinum toxin A injections between October 2005 and May 2006. Inclusion criteria included patients treated with at least one annual botulinum toxin-A injection for more than 10 consecutive years. Data collected included diagnoses and patient characteristics, injection dates, doses administered at each visit, response scores, duration of effect, and adverse events. Included changes in doses, response scores, duration of effects, and adverse events between the first and last botulinum toxin A injections. Thirty-two of 64 patients (mean age at first injection, 57.2 ± 12.4 years; 25 women) met the inclusion criteria. The mean duration of follow up was 14.1 ± 3.1 years (range 10-20 years; mean total visits 44.4 ± 19). A higher mean injection dose per visit was administered during the last year compared with the first year (26.8 ± 10.3 vs. 22.5 ± 7.5 units, respectively) (P = 0.003). The mean durations of effect during the first and last years were 12.4 ± 7.1 and 14.6 ± 7.0 weeks, respectively (P = 0.076). There were no significant differences between genders or between benign essential blepharospasm and hemifacial spasm subgroups. The most common adverse events were ptosis, lagophthalmos and dry eye. Botulinum toxin A is an effective, safe, long-term treatment for patients with benign essential blepharospasm and hemifacial spasm. Sustained treatment efficacy required higher doses; however, fewer adverse reactions developed. © 2013 Royal Australian and New Zealand College of Ophthalmologists.

  1. Work zone safety analysis and modeling: a state-of-the-art review.

    Science.gov (United States)

    Yang, Hong; Ozbay, Kaan; Ozturk, Ozgur; Xie, Kun

    2015-01-01

    Work zone safety is one of the top priorities for transportation agencies. In recent years, a considerable volume of research has sought to determine work zone crash characteristics and causal factors. Unlike other non-work zone-related safety studies (on both crash frequency and severity), there has not yet been a comprehensive review and assessment of methodological approaches for work zone safety. To address this deficit, this article aims to provide a comprehensive review of the existing extensive research efforts focused on work zone crash-related analysis and modeling, in the hopes of providing researchers and practitioners with a complete overview. Relevant literature published in the last 5 decades was retrieved from the National Work Zone Crash Information Clearinghouse and the Transport Research International Documentation database and other public digital libraries and search engines. Both peer-reviewed publications and research reports were obtained. Each study was carefully reviewed, and those that focused on either work zone crash data analysis or work zone safety modeling were identified. The most relevant studies are specifically examined and discussed in the article. The identified studies were carefully synthesized to understand the state of knowledge on work zone safety. Agreement and inconsistency regarding the characteristics of the work zone crashes discussed in the descriptive studies were summarized. Progress and issues about the current practices on work zone crash frequency and severity modeling are also explored and discussed. The challenges facing work zone safety research are then presented. The synthesis of the literature suggests that the presence of a work zone is likely to increase the crash rate. Crashes are not uniformly distributed within work zones and rear-end crashes are the most prevalent type of crashes in work zones. There was no across-the-board agreement among numerous papers reviewed on the relationship between work zone

  2. Anticonvulsant effectiveness and hemodynamic safety of midazolam in full-term infants treated with hypothermia

    NARCIS (Netherlands)

    Van Den Broek, Marcel P H; Van Straaten, Henrica L M; Huitema, Alwin D R; Egberts, Toine; Toet, Mona C.; De Vries, Linda S.; Rademaker, Karin; Groenendaal, Floris

    2015-01-01

    Background: Midazolam is used as an anticonvulsant in neonatology, including newborns with perinatal asphyxia treated with hypothermia. Hypothermia may affect the safety and effectiveness of midazolam in these patients. Objectives: The objective was to evaluate the anticonvulsant effectiveness and

  3. Anticonvulsant Effectiveness and Hemodynamic Safety of Midazolam in Full-Term Infants Treated with Hypothermia

    NARCIS (Netherlands)

    van den Broek, MPH; Van Straaten, Henrica L M; Huitema, Alwin D R; Egberts, Toine; Toet, MC; De Vries, Linda S.; Rademaker, Karin; Groenendaal, Floris

    2015-01-01

    Background: Midazolam is used as an anticonvulsant in neonatology, including newborns with perinatal asphyxia treated with hypothermia. Hypothermia may affect the safety and effectiveness of midazolam in these patients. Objectives: The objective was to evaluate the anticonvulsant effectiveness and

  4. Involving patients in patient safety programmes: A scoping review and consensus procedure by the LINNEAUS collaboration on patient safety in primary care.

    Science.gov (United States)

    Trier, Hans; Valderas, Jose M; Wensing, Michel; Martin, Helle Max; Egebart, Jonas

    2015-09-01

    Patient involvement has only recently received attention as a potentially useful approach to patient safety in primary care. To summarize work conducted on a scoping review of interventions focussing on patient involvement for patient safety; to develop consensus-based recommendations in this area. Scoping review of the literature 2006-2011 about methods and effects of involving patients in patient safety in primary care identified evidence for previous experiences of patient involvement in patient safety. This information was fed back to an expert panel for the development of recommendations for healthcare professionals and policy makers. The scoping review identified only weak evidence in support of the effectiveness of patient involvement. Identified barriers included a number of patient factors but also the healthcare workers' attitudes, abilities and lack of training. The expert panel recommended the integration of patient safety in the educational curricula for healthcare professionals, and expected a commitment from professionals to act as first movers by inviting and encouraging the patients to take an active role. The panel proposed a checklist to be used by primary care clinicians at the point of care for promoting patient involvement. There is only weak evidence on the effectiveness of patient involvement in patient safety. The recommendations of the panel can inform future policy and practice on patient involvement in safety in primary care.

  5. Safety of long-term video-electroencephalographic monitoring for evaluation of epilepsy.

    Science.gov (United States)

    Noe, Katherine H; Drazkowski, Joseph F

    2009-06-01

    To determine the rate of medical complications from long-term video-electroencephalographic (EEG) monitoring for epilepsy. We reviewed the medical records of 428 consecutive adult patients with epilepsy who were admitted for diagnostic scalp video-EEG monitoring at Mayo Clinic's site in Arizona from January 1, 2005, to December 31, 2006; 149 met inclusion criteria for the study. Seizure number and type as well as timing and presence of seizure-related adverse outcomes were noted. Of the 149 adult patients included in the study, seizure clusters occurred in 35 (23%); 752 seizures were recorded. The mean time to first seizure was 2 days, with a mean length of stay of 5 days. Among these patients, there was 1 episode of status epilepticus, 3 potentially serious electrocardiographic abnormalities, 2 cases of postictal psychosis, and 4 vertebral compression fractures during a generalized convulsion, representing 11% of patients with a recorded generalized tonic-clonic seizure. No deaths, transfers to the intensive care unit, falls, dental injuries, or pulmonary complications were recorded. An adverse event requiring intervention or interfering with normal activity occurred in 21% of these patients. Length of stay was not affected by occurrence of adverse events. Prolonged video-EEG monitoring is an acceptably safe procedure. Adverse events occur but need not result in substantial morbidity or increase length of hospitalization. Appropriate precautions must be in place to prevent falls and promptly detect and treat seizure clusters, status epilepticus, serious electrocardiographic abnormalities, psychosis, and fractures.

  6. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

    Energy Technology Data Exchange (ETDEWEB)

    Chopra, Omesh K. [Argonne National Lab., IL (United States). Environmental Science Division; Diercks, Dwight R. [Argonne National Lab., IL (United States). Nuclear Engineering Division; Ma, David Chia-Chiun [Argonne National Lab., IL (United States). Environmental Science Division; Garud, Yogendra S. [Argonne National Lab., IL (United States). Environmental Science Division

    2013-12-17

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In the U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978

  7. Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

    Directory of Open Access Journals (Sweden)

    Marta Sacchetti

    2015-01-01

    Full Text Available Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP, a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

  8. Safety profiles of Tripterygium wilfordii Hook F: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Chi Zhang

    2016-11-01

    Full Text Available Objective: Tripterygium wilfordii Hook F (TwHF is a widely used and effective treatment for inflammatory diseases. There have been concerns about its toxicity but no adequate synthesis of the evidence for adverse events (AEs. We aimed to undertake a clinically informative, systematic safety profile of TwHF.Methods: We undertook a systematic review and meta-analysis of experimental studies and observational studies. We searched electronic databases and conference abstracts. Safety outcomes were rates of common AEs. Results: We screened 4,137 abstracts for eligibility and included 594 studies in the analysis. The overall incidence of AEs was 26.7% (95% CI 24.8%, 28.8% in 23,256 TwHF users. The estimates did vary markedly when stratified by specific study types. The incidence of gastrointestinal symptoms, adverse reproductive outcomes, adverse skin reactions, hematologic events and cardiovascular events were 13.3% (95%CI 11.9%, 14.9%, 11.7% (95% CI 10.3%, 13.3%, 7.8% (95%CI 6.3%-9.5%, 6.5% (95%CI 5.7%-7.4% and 4.9% (95%CI 1.6%, 14.3%, respectively. The prevalence of irregular menstruation (IM was increased in patients taking TwHF compared with those given control (odds ratio [OR] 4.65, 95% CI 3.08 to 7.03. TwHF use has lower risk of weight gain (OR 0.12 [95%CI 0.04 to 0.39] and hair loss (OR 0.37 [95% CI 0.18 to 0.78]. Furthermore, long-term aspirin use (> 6 months has a higher AEs incidence (31.0% [95% CI 24.5%-38.5%].Conclusion: Our findings suggest that more than one in four patients who were taking TwHF had experienced AEs. A clear need exists for improved understanding of contributing risk factors, as well as of prevention and management strategies to improve patients' tolerance for TwHF.

  9. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data.

    Science.gov (United States)

    Strober, Bruce; Leonardi, Craig; Papp, Kim A; Mrowietz, Ulrich; Ohtsuki, Mamitaro; Bissonnette, Robert; Ferris, Laura K; Paul, Carle; Lebwohl, Mark; Braun, Daniel K; Mallbris, Lotus; Wilhelm, Stefan; Xu, Wen; Ljungberg, Anders; Acharya, Nayan; Reich, Kristian

    2017-03-01

    Safety of biologics is important when treating patients with psoriasis. We sought to determine the safety of ixekizumab in psoriasis. Integrated safety data are presented from a 12-week induction period, a 12- to 60-week maintenance period, and from all ixekizumab-treated patients from 7 clinical trials. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported. Overall, 4209 patients received ixekizumab (total exposure: 6480 patient-years). During the induction period, the IRs of patients experiencing 1 or more treatment-emergent adverse event (AE) were 251 and 236 among ixekizumab- and etanercept-treated patients, respectively, and for serious AEs was 8.3 in both groups. During maintenance, for ixekizumab, the IRs of treatment-emergent AEs and serious AEs were 100.4 and 7.8, respectively. Among all ixekizumab-treated patients from 7 trials, the IR of Candida infections was 2.5. The IRs of treatment-emergent AEs of special interest (including serious infections, malignancies, major adverse cardiovascular events) were comparable for ixekizumab and etanercept during the induction period. Additional long-term data are required. Ixekizumab had an acceptable safety profile with no unexpected safety findings during ixekizumab maintenance in psoriasis. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  10. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...... of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... of these changes in risk factors on accident occurrence cannot be predicted. On the whole, the research that has been reported so far regarding road safety effects of porous asphalt is inconclusive. The studies are not of high quality and the findings are inconsistent....

  11. A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

    Science.gov (United States)

    Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

    2017-03-01

    Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

  12. Knowledge, attitudes and practices of food handlers in food safety: An integrative review.

    Science.gov (United States)

    Zanin, Laís Mariano; da Cunha, Diogo Thimoteo; de Rosso, Veridiana Vera; Capriles, Vanessa Dias; Stedefeldt, Elke

    2017-10-01

    This study presents an overview of the relationship between knowledge, attitudes and practices (KAP) of food handlers with training in food safety, in addition to proposing reflections on the training of food handlers, considering its responsibility for food safety and health of consumers. The review was based on the integrative method. The descriptors used were: (food handler), (knowledge, attitudes and practice) and (training). Six databases were searched, 253 articles were consulted and 36 original articles were included. Fifty per cent of the articles pointed that there was no proper translation of knowledge into attitudes/practices or attitudes into practices after training. Knowledge, attitudes and practices of food handlers are important for identifying how efficient training in food safety is allowing prioritize actions in planning training. The evaluation of KAP is the first step to understand the food handler's point of view. After this evaluation other diagnostic strategies become necessary to enhance this understanding. Copyright © 2017. Published by Elsevier Ltd.

  13. Long-term Safety of Testosterone and Growth Hormone Supplementation: A Retrospective Study of Metabolic, Cardiovascular, and Oncologic Outcomes

    OpenAIRE

    Ginzburg, Enrique; Klimas, Nancy; Parvus, Chad; Life, Jeff; Willix, Robert; Barber, Michale J.; Lin, Alvin; Comite, Florence

    2010-01-01

    Background Clinical research into the effects of hormonal supplementation has tended to focus on beneficial changes in anthropometric measures. There are fewer data on long-term safety with extended hormonal supplementation. Methods As part of a retrospective database survey, clinical outcomes were tabulated among patients who received at least 1 year of testosterone and/or growth hormone (GH) supplementation. In patients who were treated for at least 2 years, changes in markers of glucose an...

  14. Safety of licensed vaccines in HIV-infected persons: a systematic review protocol.

    Science.gov (United States)

    Kagina, Benjamin M; Wiysonge, Charles S; Lesosky, Maia; Madhi, Shabir A; Hussey, Gregory D

    2014-09-11

    Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be feasible among HIV-infected persons

  15. Cannabis for therapeutic purposes and public health and safety: a systematic and critical review.

    Science.gov (United States)

    Sznitman, Sharon R; Zolotov, Yuval

    2015-01-01

    The use of Cannabis for Therapeutic Purposes (CTP) has recently become legal in many places. These policy and legal modifications may be related to changes in cannabis perceptions, availability and use and in the way cannabis is grown and sold. This may in turn have effects on public health and safety. To better understand the potential effects of CTP legalization on public health and safety, the current paper synthesizes and critically discusses the relevant literature. Twenty-eight studies were identified by a comprehensive search strategy, and their characteristics and main findings were systematically reviewed according to the following content themes: CTP and illegal cannabis use; CTP and other public health issues; CTP, crime and neighbourhood disadvantage. The research field is currently limited by a lack of theoretical and methodological rigorous studies. The review shows that the most prevalent theme of investigation so far has been the relation between CTP and illegal cannabis use. In addition, the literature review shows that there is an absence of evidence to support many common concerns related to detrimental public health and safety effects of CTP legalization. Although lack of evidence provides some reassurance that CTP legalization may not have posed a substantial threat to public health and safety, this conclusion needs to be examined in light of the limitations of studies conducted so far. Furthermore, as CTP policy continues to evolve, including incorporation of greater commercialization, it is possible that the full effects of CTP legalization have yet to take place. Ensuring study quality will allow future research to better investigate the complex role that CTP plays in relation to society at large, and public health and safety in particular. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

    Science.gov (United States)

    Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

    2012-01-01

    Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

  17. Enhancing Patient Safety Event Reporting. A Systematic Review of System Design Features.

    Science.gov (United States)

    Gong, Yang; Kang, Hong; Wu, Xinshuo; Hua, Lei

    2017-08-30

    Electronic patient safety event reporting (e-reporting) is an effective mechanism to learn from errors and enhance patient safety. Unfortunately, the value of e-reporting system (a software or web server based platform) in patient safety research is greatly overshadowed by low quality reporting. This paper aims at revealing the current status of system features, detecting potential gaps in system design, and accordingly proposing suggestions for future design and implementation of the system. Three literature databases were searched for publications that contain informative descriptions of e-reporting systems. In addition, both online publicly accessible reporting forms and systems were investigated. 48 systems were identified and reviewed. 11 system design features and their frequencies of occurrence (Top 5: widgets (41), anonymity or confidentiality (29), hierarchy (20), validator (17), review notification (15)) were identified and summarized into a system hierarchical model. The model indicated the current e-reporting systems are at an immature stage in their development, and discussed their future development direction toward efficient and effective systems to improve patient safety.

  18. The efficacy and safety of feverfew (Tanacetum parthenium L.): an update of a systematic review.

    Science.gov (United States)

    Ernst, E; Pittler, M H

    2000-12-01

    Feverfew (Tanacetum parthenium L.) is a popular herbal remedy often advocated for the prevention of migraine. The aims of this systematic review are to update the evidence from rigorous clinical trials for or against the efficacy of feverfew for migraine prevention and to provide a safety profile of this herbal remedy. Literature searches were performed using the following databases: Medline, Embase, Biosis, CISCOM and the Cochrane Library (all from their inception to December 1999). Only randomized, placebo-controlled, double-blind trials of feverfew mono-preparations for the prevention of migraine in human subjects were included. All articles were read by two independent reviewers. Data were extracted in a pre-defined, standardized fashion. The methodological quality of the trials was evaluated by the Jadad score. For the assessment of safety issues, major reference texts were also consulted. Six trials met the inclusion/exclusion criteria. The majority favour feverfew over placebo. Yet important caveats exist. The data also suggest that feverfew is associated with only mild and transient adverse effects and few other safety concerns. Feverfew is likely to be effective in the prevention of migraine. There are no major safety problems.

  19. Out-of-Hospital Pediatric Patient Safety Events: Results of the CSI Chart Review.

    Science.gov (United States)

    Meckler, Garth; Hansen, Matthew; Lambert, William; O'Brien, Kerth; Dickinson, Caitlin; Dickinson, Kathryn; Van Otterloo, Joshua; Guise, Jeanne-Marie

    2017-10-12

    Studies of adult hospital patients have identified medical errors as a significant cause of morbidity and mortality. Little is known about the frequency and nature of pediatric patient safety events in the out-of-hospital setting. We sought to quantify pediatric patient safety events in EMS and identify patient, call, and care characteristics associated with potentially severe events. As part of the Children's Safety Initiative -EMS, expert panels independently reviewed charts of pediatric critical ambulance transports in a metropolitan area over a three-year period. Regression models were used to identify factors associated with increased risk of potentially severe safety events. Patient safety events were categorized as: Unintended injury; Near miss; Suboptimal action; Error; or Management complication ("UNSEMs") and their severity and potential preventability were assessed. Overall, 265 of 378 (70.1%) unique charts contained at least one UNSEM, including 146 (32.8%) errors and 199 (44.7%) suboptimal actions. Sixty-one UNSEMs were categorized as potentially severe (23.3% of UNSEMs) and nearly half (45.3%) were rated entirely preventable. Two factors were associated with heightened risk for a severe UNSEM: (1) age 29 days to 11 months (OR 3.3, 95% CI 1.25-8.68); (2) cases requiring resuscitation (OR 3.1, 95% CI 1.16-8.28). Severe UNSEMs were disproportionately higher among cardiopulmonary arrests (8.5% of cases, 34.4% of severe UNSEMs). During high-risk out-of-hospital care of pediatric patients, safety events are common, potentially severe, and largely preventable. Infants and those requiring resuscitation are important areas of focus to reduce out-of-hospital pediatric patient safety events.

  20. A Review of Safety and Design Requirements of the Artificial Pancreas.

    Science.gov (United States)

    Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

    2016-11-01

    As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

  1. Climate considerations in long-term safety assessments for nuclear waste repositories.

    Science.gov (United States)

    Näslund, Jens-Ove; Brandefelt, Jenny; Liljedahl, Lillemor Claesson

    2013-05-01

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  2. Peer tutoring to prevent firearm play acquisition, generalization, and long-term maintenance of safety skills.

    Science.gov (United States)

    Jostad, Candice M; Miltenberger, Raymond G; Kelso, Pamela; Knudson, Peter

    2008-01-01

    Hundreds of accidental injuries and deaths to children occur annually in the United States as a result of firearm play. Behavioral skills training (BST) and in situ training have been found to be effective in teaching children the skills to use if they find a firearm, but training requires substantial time and effort. The current study examined the use of peers as tutors as a potential way to decrease the time and resources needed to teach these safety skills to youngsters. Peer trainers conducted BST and in situ training with other children. Children taught by the peer trainers acquired the safety skills and demonstrated them in naturalistic situations in which the skills were needed. Furthermore, all of the peer trainers acquired and maintained the skills. These results support the use of peer tutoring for teaching safety skills to other children.

  3. Peer Tutoring to Prevent Firearm Play: Acquisition, Generalization, and Long-term Maintenance of Safety Skills

    Science.gov (United States)

    Jostad, Candice M; Miltenberger, Raymond G; Kelso, Pamela; Knudson, Peter

    2008-01-01

    Hundreds of accidental injuries and deaths to children occur annually in the United States as a result of firearm play. Behavioral skills training (BST) and in situ training have been found to be effective in teaching children the skills to use if they find a firearm, but training requires substantial time and effort. The current study examined the use of peers as tutors as a potential way to decrease the time and resources needed to teach these safety skills to youngsters. Peer trainers conducted BST and in situ training with other children. Children taught by the peer trainers acquired the safety skills and demonstrated them in naturalistic situations in which the skills were needed. Furthermore, all of the peer trainers acquired and maintained the skills. These results support the use of peer tutoring for teaching safety skills to other children. PMID:18468285

  4. Climate Considerations in Long-Term Safety Assessments for Nuclear Waste Repositories

    Energy Technology Data Exchange (ETDEWEB)

    Naeslund, Jens-Ove; Brandefelt, Jenny; Claesson Liljedahl, Lillemor [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)], E-mail: jens-ove.naslund@skb.se

    2013-05-15

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  5. A clinical and safety review of paracetamol and ibuprofen in children.

    Science.gov (United States)

    Kanabar, Dipak J

    2017-02-01

    The antipyretic analgesics, paracetamol, and non-steroidal anti-inflammatory agents NSAIDs are one of the most widely used classes of medications in children. The aim of this review is to determine if there are any clinically relevant differences in safety between ibuprofen and paracetamol that may recommend one agent over the other in the management of fever and discomfort in children older than 3 months of age.

  6. Impact of safety-related regulatory action on clinical practice: a systematic review.

    Science.gov (United States)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Vries, Jonie T N; van der Elst, Menno E; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M

    2012-05-01

    After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or 'Dear Doctor' letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the

  7. Review and assessments of potential environmental, health and safety impacts of MHD technology. Final draft

    Energy Technology Data Exchange (ETDEWEB)

    1978-01-01

    The purpose of this document is to develop an environmental, health and safety (EH and S) assessment and begin a site - specific assessment of these and socio - economic impacts for the magnetohydrodynamics program of the United States Department of Energy. This assessment includes detailed scientific and technical information on the specific EH and S issues mentioned in the MHD Environmental Development Plan. A review of current literature on impact-related subjects is also included. This document addresses the coal-fired, open-cycle MHD technology and reviews and assesses potential EH and S impacts resulting from operation of commercially-installed technology.

  8. Idaho National Laboratory Integrated Safety Management System FY 2013 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, Farren [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2013-12-01

    Idaho National Laboratory (INL) performed an Annual Effectiveness Review of the Integrated Safety Management System (ISMS), per 48 Code of Federal Regulations (CFR) 970.5223 1, “Integration of Environment, Safety and Health into Work Planning and Execution.” The annual review assessed Integrated Safety Management (ISM) effectiveness, provided feedback to maintain system integrity, and identified target areas for focused improvements and assessments for Fiscal Year (FY) 2014. Results of the FY 2013 annual effectiveness review demonstrate that the INL’s ISMS program is “Effective” and continually improving and shows signs of being significantly strengthened. Although there have been unacceptable serious events in the past, there has also been significant attention, dedication, and resources focused on improvement, lessons learned and future prevention. BEA’s strategy of focusing on these improvements includes extensive action and improvement plans that include PLN 4030, “INL Sustained Operational Improvement Plan, PLN 4058, “MFC Strategic Excellence Plan,” PLN 4141, “ATR Sustained Excellence Plan,” and PLN 4145, “Radiological Control Road to Excellence,” and the development of LWP 20000, “Conduct of Research.” As a result of these action plans, coupled with other assurance activities and metrics, significant improvement in operational performance, organizational competence, management oversight and a reduction in the number of operational events is being realized. In short, the realization of the fifth core function of ISMS (feedback and continuous improvement) and the associated benefits are apparent.

  9. The safety of low melting point bismuth/lead alloys: a review.

    Science.gov (United States)

    Glasgow, G P

    1991-03-01

    Low melting temperature bismuth alloys that contain about 20% to 25% lead and 10% cadmium are widely used in radiotherapy to construct shielding blocks. Since 1980, five papers have addressed questions concerning potential metal toxicity, safe shop practices, measurement of airborne vapors and metal particulates, and the results of biological testing of personnel fabricating secondary field shaping blocks. In February, 1990, the Occupational Safety and Health Administration (OSHA), proposed new occupational air concentration safety standards for cadmium and cadmium compounds. This review presents the potential toxicity of the components metals in low melting temperature bismuth lead alloys, reviews the proposed OSHA air concentrations standards, and describes proper practices of shop safety required to minimize the hazards of these metals and other potentially hazardous materials used in the block fabrication process. The review reveals that if proper practices are followed, fabrication of those blocks, including those containing cadmium, should not produce a shop environment that would produce metal toxicity in employees, and radiotherapy mold room personnel are unlikely to generate air concentrations of cadmium that exceed new proposed standards.

  10. Perspectives on the Termination of Debt Review in Terms of Section ...

    African Journals Online (AJOL)

    However, a debt review in terms of section 86 does not end or lapse automatically if a specific event fails to occur or upon the expiry of a specific time period. Before a credit provider can enforce a credit agreement that is the subject of a pending debt review, the debt review must be terminated in accordance with section ...

  11. Idaho National Laboratory Integrated Safety Management System FY 2016 Effectiveness Review and Declaration Report

    Energy Technology Data Exchange (ETDEWEB)

    Hunt, Farren J. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-12-01

    Idaho National Laboratory’s (INL’s) Integrated Safety Management System (ISMS) effectiveness review of fiscal year (FY) 2016 shows that INL has integrated management programs and safety elements throughout the oversight and operational activities performed at INL. The significant maturity of Contractor Assurance System (CAS) processes, as demonstrated across INL’s management systems and periodic reporting through the Management Review Meeting process, over the past two years has provided INL with current real-time understanding and knowledge pertaining to the health of the institution. INL’s sustained excellence of the Integrated Safety and effective implementation of the Worker Safety and Health Program is also evidenced by other external validations and key indicators. In particular, external validations include VPP, ISO 14001, DOELAP accreditation, and key Laboratory level indicators such as ORPS (number, event frequency and severity); injury/illness indicators such as Days Away, Restricted and Transfer (DART) case rate, back & shoulder metric and open reporting indicators, demonstrate a continuous positive trend and therefore improved operational performance over the last few years. These indicators are also reflective of the Laboratory’s overall organizational and safety culture improvement. Notably, there has also been a step change in ESH&Q Leadership actions that have been recognized both locally and complex-wide. Notwithstanding, Laboratory management continues to monitor and take action on lower level negative trends in numerous areas including: Conduct of Operations, Work Control, Work Site Analysis, Risk Assessment, LO/TO, Fire Protection, and Life Safety Systems, to mention a few. While the number of severe injury cases has decreased, as evidenced by the reduction in the DART case rate, the two hand injuries and the fire truck/ambulance accident were of particular concern. Aggressive actions continue in order to understand the causes and

  12. Efficacy and Safety of Bromocriptine-QR in Type 2 Diabetes: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Liang, W; Gao, L; Li, N; Wang, B; Wang, L; Wang, Y; Yang, H; You, L; Hou, J; Chen, S; Zhu, H; Jiang, Y; Pan, H

    2015-10-01

    Bromocriptine-QR (quick release) is a novel treatment for type 2 diabetes. The objective of this study is to assess the efficacy and safety of bromocriptine-QR in adults with type 2 diabetes mellitus based on randomized controlled trials published in peer-reviewed journals or as abstracts. We performed a comprehensive literature search of MEDLINE, Pubmed, Web of Science, EMBASE, and the Cochrane Library up to May 2015. Randomized controlled trials of bromocriptine-QR therapy in type 2 diabetes mellitus were eligible. Two reviewers independently assessed the eligibility of trials based on predefined inclusion criteria. Information was collected concerning basic study data, patient characteristics, efficacy and safety outcomes, and methodological quality. Bromocriptine-QR add-on therapy lowered hemoglobin A1c compared with placebo (weighted mean difference, - 6.52 mmol/mol; 95% CI, - 8.07 to - 4.97 mmol/mol). Bromocriptine-QR exhibited an increase in achieving an HbA1c level ≤ 53 mmol/mol (≤ 7.0%) (32.0 vs. 9.5%; odds ratio, 4.57; 95% CI, 2.42-8.62). Fasting plasma glucose was reduced with bromocriptine-QR compared with placebo (weighted mean difference,-1.04 mmol/l; 95% CI,-1.49 to-0.59 mmol/l). Moreover, bromocriptine-QR had neutral effects on postprandial glycemia, Body Mass Index (BMI), and lipid profile. Bromocriptine-QR had more gastrointestinal side effects of nausea and vomiting. Bromocriptine-QR had no increased risk of hypoglycemia, hypotension, or cardiovascular effects. Bromocriptine-QR therapy offers an alternative option to currently available antidiabetic agents for type 2 diabetes mellitus adults. Neither hypoglycemia nor other metabolic changes occur with this drug. More data for long-term efficacy and safety are needed for further observation. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Safety of oral use of nimesulide in children: systematic review of randomized controlled trials.

    Science.gov (United States)

    Gupta, Piyush; Sachdev, H P S

    2003-06-01

    Nimesulide has been widely used to treat fever in children. Due to reports of adverse drug reactions, discontinuation or modification of its use has been suggested. To evaluate the safety of oral use of nimesulide in children. Systematic review of published randomized controlled trials. Electronic searches of databases (PubMed, Cochrane, Toxnet) for relevant trials upto January 2003 using specified key words. The studies were also identified by searching the references of available meta-analyses and review articles, and bibliography of pertinent references. Randomized controlled trials in children (less than or equal to 18 years of age) comparing the use of oral nimesulide with placebo or other antipyretic, anti-inflammatory or analgesic agents. The primary outcome variable included the commonly encountered adverse effects of nimesulide therapy, i.e., hypothermia, abdominal symptoms, gastrointestinal bleeding, and elevated liver enzymes. One of the authors developed a questionnaire and independently extracted data on methods, type of participants, interventions and outcomes. The meta-analysis was conducted using pooled relative risk with 95% confidence intervals, with random effects model assumption. We identified 16 trials that fulfilled the inclusion criteria. These included 1254 subjects, with mean age between 22 -140 months. Nimesulide was primarily used for its antipyretic (10 trials) or anti-inflammatory and analgesic activity (4 trials). One study each evaluated the symptomatic improvement in ARI and bronchial asthma. The control group included administration of placebo (3 studies), paracetamol (9 studies), and ketoprofen, naproxen, mefanemic acid and aspirin in one study each. The pooled effect sizes of various adverse events as compared between nimesulide and different control groups were: hypothermia (RR: 1.055; 95% CI: 0.184 - 6.047; P = 0.952), abdominal symptoms (RR: 0.464; 95% CI: 0.264 - 0.816; P = 0.008), gastrointestinal bleeding (RR: 0.914; 95% CI

  14. Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang (and others)

    2006-01-15

    This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area.

  15. Bronchial thermoplasty : Long-term safety and effectiveness in patients with severe persistent asthma

    NARCIS (Netherlands)

    Wechsler, Michael E.; Laviolette, Michel; Rubin, Adalberto S.; Fiterman, Jussara; Silva, Jose R. Lapa e; Shah, Pallav L.; Fiss, Elie; Olivenstein, Ronald; Thomson, Neil C.; Niven, Robert M.; Pavord, Ian D.; Simoff, Michael; Hales, Jeff B.; McEvoy, Charlene; Slebos, Dirk-Jan; Holmes, Mark; Phillips, Martin J.; Erzurum, Serpil C.; Hanania, Nicola A.; Sumino, Kaharu; Kraft, Monica; Cox, Gerard; Sterman, Daniel H.; Hogarth, Kyle; Kline, Joel N.; Mansur, Adel H.; Louie, Brian E.; Leeds, William M.; Barbers, Richard G.; Austin, John H. M.; Shargill, Narinder S.; Quiring, John; Armstrong, Brian; Castro, Mario

    2013-01-01

    Background: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. Methods: BT-treated subjects from the

  16. A Systematic Method for Search Term Selection in Systematic Reviews

    Science.gov (United States)

    Thompson, Jenna; Davis, Jacqueline; Mazerolle, Lorraine

    2014-01-01

    The wide variety of readily available electronic media grants anyone the freedom to retrieve published references from almost any area of research around the world. Despite this privilege, keeping up with primary research evidence is almost impossible because of the increase in professional publishing across disciplines. Systematic reviews are a…

  17. Vortioxetine : a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder.

    Science.gov (United States)

    Al-Sukhni, Mayce; Maruschak, Nadia A; McIntyre, Roger S

    2015-08-01

    Vortioxetine is a pharmacodynamically novel antidepressant that exerts effects on various neurotransmitters including serotonin, noradrenaline, dopamine, glutamate, histamine and acetylcholine. Its efficacy in the symptomatic management of major depressive disorder (MDD) has been established in several short- and long-term trials. Vortioxetine has also demonstrated independent pro-cognitive effects in adults with MDD. This report provides a concise review of the pharmacology, efficacy and safety of vortioxetine as they pertain to cognition. The significant impact of cognitive dysfunction in MDD has achieved increased consideration among researchers over the past decade. Vortioxetine is the first antidepressant agent to demonstrate meaningful clinical efficacy in the improvement of cognition in adults with MDD, independent of improvement in affective symptomatology. These results provide the impetus for further study into the potential pro-cognitive effects of vortioxetine in other conditions wherein cognitive dysfunction is prominent.

  18. Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.

    Science.gov (United States)

    Eichenfield, Lawrence F; Call, Robert S; Forsha, Douglass W; Fowler, Joseph; Hebert, Adelaide A; Spellman, Mary; Stein Gold, Linda F; Van Syoc, Merrie; Zane, Lee T; Tschen, Eduardo

    2017-10-01

    Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease. To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302). Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed. During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs. Long-term efficacy was not analyzed. Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  19. Consumer food handling in the home: a review of food safety studies.

    Science.gov (United States)

    Redmond, Elizabeth C; Griffith, Christopher J

    2003-01-01

    Epidemiological data from Europe, North America, Australia, and New Zealand indicate that a substantial proportion of foodborne disease is attributable to improper food preparation practices in consumers' homes. International concern about consumer food safety has prompted considerable research to evaluate domestic food-handling practices. The majority of consumer food safety studies in the last decade have been conducted in the United Kingdom and Northern Ireland (48%) and in the United States (42%). Surveys (questionnaires and interviews), the most frequent means of data collection, were used in 75% of the reviewed studies. Focus groups and observational studies have also been used. One consumer food safety study examined the relationship between pathogenic microbial contamination from raw chicken and observed food-handling behaviors, and the results of this study indicated extensive Campylobacter cross-contamination during food preparation sessions. Limited information about consumers' attitudes and intentions with regard to safe food-handling behaviors has been obtained, although a substantial amount of information about consumer knowledge and self-reported practices is available. Observation studies suggest that substantial numbers of consumers frequently implement unsafe food-handling practices. Knowledge, attitudes, intentions, and self-reported practices did not correspond to observed behaviors, suggesting that observational studies provide a more realistic indication of the food hygiene actions actually used in domestic food preparation. An improvement in consumer food-handling behavior is likely to reduce the risk and incidence of foodborne disease. The need for the development and implementation of food safety education strategies to improve specific food safety behaviors is reviewed in this paper.

  20. Exposure measurement in bicycle safety analysis: A review of the literature.

    Science.gov (United States)

    Vanparijs, Jef; Int Panis, Luc; Meeusen, Romain; de Geus, Bas

    2015-11-01

    Cycling, as an active mode of transportation, has well-established health benefits. However, the safety of cyclists in traffic remains a major concern. In-depth studies of potential risk factors and safety outcomes are needed to ensure the most appropriate actions are taken to improve safety. However, the lack of reliable exposure data hinders meaningful analysis and interpretation. In this paper, we review the bicycle safety literature reporting different methods for measuring cycling exposure and discuss their findings. A literature search identified studies on bicycle safety that included a description of how cycling exposure was measured, and what exposure units were used (e.g. distance, time, trips). Results were analyzed based on whether retrospective or prospective measurement of exposure was used, and whether safety outcomes controlled for exposure. We analyzed 20 papers. Retrospective studies were dominated by major bicycle accidents, whereas the prospective studies included minor and major bicycle accidents. Retrospective studies indicated higher incidence rates (IR) of accidents for men compared to women, and an increased risk of injury for cyclists aged 50 years or older. There was a lack of data for cyclists younger than 18 years. The risk of cycling accidents increased when riding in the dark. Wearing visible clothing or a helmet, or having more cycling experience did not reduce the risk of being involved in an accident. Better cyclist-driver awareness and more interaction between car driver and cyclists, and well maintained bicycle-specific infrastructure should improve bicycle safety. The need to include exposure in bicycle safety research is increasingly recognized, but good exposure data are often lacking, which makes results hard to interpret and compare. Studies including exposure often use a retrospective research design, without including data on minor bicycle accidents, making it difficult to compare safety levels between age categories or

  1. Efficacy and safety of fumaric acid esters in the long-term treatment of psoriasis--a retrospective study (FUTURE).

    Science.gov (United States)

    Reich, Kristian; Thaci, Diamant; Mrowietz, Ulrich; Kamps, Anja; Neureither, Marcus; Luger, Thomas

    2009-07-01

    This study collected data on the safety and efficacy of fumaric acid esters (FAE; Fumaderm) in the long-term treatment of psoriasis. Patients were included at 163 dermatological centers if they either had been treated continuously with FAE for at least 24 months, or for 36 months with interruptions of no longer than 6 months. Data were reported from baseline, after 3, 6, 12, 24, and 36 or more months of therapy. Safety parameters were monitored and the severity of skin symptoms was assessed by "Physician's Global Assessment" (PGA) and "Psoriasis Area and Severity Index" (PASI). 984 patients were included with a mean duration of 44 months of continuous treatment. The percentage of patients documented as markedly improved or clear was 67 % after six months, 78 % after 24 months, and 82 % after 36 months of therapy. Improvement was similar in patients with moderate and severe disease. Changes of laboratory parameters were usually insignificant and did not require a modification of FAE treatment in more than 90 % of the cases. In the long-term treatment of patients with moderate and severe psoriasis FAE show a good and sustained clinical efficacy combined with a favorable safety profile.

  2. A systematic review of light-based home-use devices for hair removal and considerations on human safety.

    Science.gov (United States)

    Thaysen-Petersen, D; Bjerring, P; Dierickx, C; Nash, J F; Town, G; Haedersdal, M

    2012-05-01

    Hair removal with professional light-based devices is established as an effective, mainstream treatment. The field of optical home-based hair removal is evolving and movement from control by physicians into hands of consumers warrants understanding efficacy and human safety. To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled, uncontrolled or randomized and with a sample size of at least 10 individuals. We identified a total of seven studies: one controlled (CT) and six uncontrolled trials (UCTs). No randomized controlled trials (RCT) were recognized. The best evidence was found for IPL (intense pulsed light) (three devices, one CT, five UCTs) and limited evidence for laser devices (one diode laser, one UCT). Most studies evaluated short-term hair reduction up to 3 and 6 months following light exposure at different body sites. Hair reduction percentages ranged from 6% to 72% after repetitive treatments. The most frequently reported side-effect was erythema, but oedema, blistering, crusting and pigment changes were also reported. Theoretical concerns about ocular damage and paradoxical hair growth have not been reported in any of the studies reviewed. Available evidence from prospective, uncontrolled clinical trials indicates short-term hair removal efficacy of currently available home-use light-based hair removal devices. Additional controlled trials will be helpful to substantiate the efficacy and to better predict the incidence of adverse events associated with optical home-use hair removal. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  3. The Impact of System Factors on Quality and Safety in Arterial Surgery: A Systematic Review.

    Science.gov (United States)

    Lear, R; Godfrey, A D; Riga, C; Norton, C; Vincent, C; Bicknell, C D

    2017-07-01

    A systems approach to patient safety proposes that a wide range of factors contribute to surgical outcome, yet the impact of team, work environment, and organisational factors, is not fully understood in arterial surgery. The aim of this systematic review is to summarize and discuss what is already known about the impact of system factors on quality and safety in arterial surgery. A systematic review of original research papers in English using MEDLINE, Embase, PsycINFO, and Cochrane databases, was performed according to PRISMA guidelines. Independent reviewers selected papers according to strict inclusion and exclusion criteria, and using predefined data fields, extracted relevant data on team, work environment, and organisational factors, and measures of quality and/or safety, in arterial procedures. Twelve papers met the selection criteria. Study endpoints were not consistent between papers, and most failed to report their clinical significance. A variety of tools were used to measure team skills in five papers; only one paper measured the relationship between team factors and patient outcomes. Two papers reported that equipment failures were common and had a significant impact on operating room efficiency. The influence of hospital characteristics on failure-to-rescue rates was tested in one large study, although their conclusions were limited to the American Medicare population. Five papers implemented changes in the patient pathway, but most studies failed to account for potential confounding variables. A small number of heterogenous studies have evaluated the relationship between system factors and quality or safety in arterial surgery. There is some evidence of an association between system factors and patient outcomes, but there is more work to be done to fully understand this relationship. Future research would benefit from consistency in definitions, the use of validated assessment tools, measurement of clinically relevant endpoints, and adherence to

  4. In Vivo Transplantation of Enteric Neural Crest Cells into Mouse Gut; Engraftment, Functional Integration and Long-Term Safety.

    Directory of Open Access Journals (Sweden)

    Julie E Cooper

    Full Text Available Enteric neuropathies are severe gastrointestinal disorders with unsatisfactory outcomes. We aimed to investigate the potential of enteric neural stem cell therapy approaches for such disorders by transplanting mouse enteric neural crest cells (ENCCs into ganglionic and aganglionic mouse gut in vivo and analysing functional integration and long-term safety.Neurospheres generated from yellow fluorescent protein (YFP expressing ENCCs selected from postnatal Wnt1-cre;R26R-YFP/YFP murine gut were transplanted into ganglionic hindgut of wild-type littermates or aganglionic hindgut of Ednrbtm1Ywa mice (lacking functional endothelin receptor type-B. Intestines were then assessed for ENCC integration and differentiation using immunohistochemistry, cell function using calcium imaging, and long-term safety using PCR to detect off-target YFP expression.YFP+ ENCCs engrafted, proliferated and differentiated into enteric neurons and glia within recipient ganglionic gut. Transplanted cells and their projections spread along the endogenous myenteric plexus to form branching networks. Electrical point stimulation of endogenous nerve fibres resulted in calcium transients (F/F0 = 1.16 ± 0.01;43 cells, n = 6 in YFP+ transplanted ENCCs (abolished with TTX. Long-term follow-up (24 months showed transplanted ENCCs did not give rise to tumours or spread to other organs (PCR negative in extraintestinal sites. In aganglionic gut ENCCs similarly spread and differentiated to form neuronal and glial networks with projections closely associated with endogenous neural networks of the transition zone.Transplanted ENCCs successfully engrafted into recipient ganglionic and aganglionic gut showing appropriate spread, localisation and, importantly, functional integration without any long-term safety issues. This study provides key support for the development and use of enteric neural stem cell therapies.

  5. Long Term Resource Monitoring Program Water Quality Component Review

    Science.gov (United States)

    2006-06-01

    Water Adequacy and Suitability of the Water Quality Laboratory. The panel also agreed that Quality Procedures Manual the potential for obtaining formal ... formally recognize the high level of work being performed 5 in LTRMP water quality and increase the national from the LTRMP field stations. However...transmission as the primary method for obtaining findings to external peer review is the final steptranmision s te prmar metod or otaiing in quality

  6. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

  7. Long-term safety for KBS-3 repositories at Forsmark and Laxemar - a first evaluation. Main Report of the SR-Can project

    Energy Technology Data Exchange (ETDEWEB)

    Hedin, Allan (ed.)

    2006-10-15

    . The risk limit corresponds to an effective dose limit of about 1.4x10{sup -5} Sv/yr. This, in turn, corresponds to around one percent of the effective dose due to natural background radiation in Sweden. The time frame for the assessment is one million years after repository closure, in accordance with regulatory requirements. The above risk limit is applicable as a quantitative regulatory limit during approximately the first one hundred thousand years, and thereafter as a basis for discussing the protective capability of the repository, according to SSI. Following the introductory Chapter 1, this report outlines the methodology for the SR-Can assessment in Chapter 2, and presents in Chapter 3 the handling of features, events and processes, FEPs, of importance for long-term safety. Chapters 4, and 6 present the initial state of the system for both of the sites, and the plans and methods for handling external influences and internal processes, respectively. Safety functions and safety function indicators are discussed in Chapter 7. The collection of input data for the assessment is described in Chapter 8. The Material presented in the first eight chapters is utilised in the analysis of the reference evolution in Chapter 9, focussing on isolation, and Chapter 10, addressing radionuclide transport and dose assessments. Scenarios for the further evaluation of safety are selected in Chapter 11 and the selected scenarios are analysed in Chapter 12. Finally, conclusions and feedback are provided in Chapter 13. References are provided in Chapter 14. Appendix A is an account of how applicable regulations are addressed in the assessment. Miscellaneous calculation models are presented in Appendix B and Material relating to reviews of previous assessments in Appendix C. A glossary of abbreviations and specialised terms used in SR-Can is found in Appendix D.

  8. Discrepancy Between Identification of Early-Term Elective Deliveries by Manual Chart Review and Data Vendor.

    Science.gov (United States)

    Yamasato, Kelly; Tsai, Pai-Jong Stacy; Bartholomew, Marguerite; Durbin, Marsha; Kimata, Chieko; Kaneshiro, Bliss

    2016-12-01

    Elective delivery from 37 to 39 weeks gestation (early-term deliveries) is a Joint Commission National Quality Measure, and hospitals report on early-term elective delivery rates through Outcome Research Yields Excellence (ORYX) vendors. The objective of this study was to compare early-term elective deliveries, identified through ORYX vendors with those identified through manual chart review, the traditional method of medical record review. We reviewed early-term labor inductions and cesarean deliveries at a single hospital from June 1, 2010 to May 31, 2012. Rates of early-term elective deliveries identified by the data vendor were compared to physician chart review. Overall, the rate of elective deliveries by ORYX was 3% compared to 2% by physician chart review (RR 1.51 [95% CI 1.12-2.03], P chart review, vendors classified significantly more inductions and cesareans as elective (P chart review, including 69.0% of cesareans and 36.1% of inductions. Findings from this study suggest substantial discrepancy between identification of early-term elective deliveries by data vendors and physician chart review, and indicate that vendor-derived data may overestimate the number of electively delivered patients.

  9. Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia
.

    Science.gov (United States)

    Ross, Mikel; Fischer-Cartlidge, Erica

    2017-04-01

    More than 75% of patients with cancer cite alopecia as the most feared side effect of treatment, with as many as 10% considering treatment refusal. Despite wide acceptance in other countries, scalp cooling to reduce chemotherapy-induced alopecia (CIA) has been uncommon in the United States because of longstanding concerns of scalp metastases and a lack of reliable efficacy data. 
. This article reviews 40 years of efficacy, safety, and tolerability literature on scalp cooling to prevent CIA. 
. A systematic review was performed in PubMed and CINAHL®. Forty articles were reviewed, with 12 articles demonstrating high levels of evidence and meeting inclusion criteria. Comparative trials, systematic reviews, and one large single-arm trial were included. 
. Scalp cooling efficacy is dependent on many factors but demonstrates better hair preservation than no cooling. No increase in scalp metastases or statistically significant difference in overall survival was seen in retrospective safety data when cooling was used. Few patients discontinue cooling early because of adverse experiences.

  10. Critical review of the current literature on the safety of sucralose.

    Science.gov (United States)

    Magnuson, Bernadene A; Roberts, Ashley; Nestmann, Earle R

    2017-08-01

    Sucralose is a non-caloric high intensity sweetener that is approved globally for use in foods and beverages. This review provides an updated summary of the literature addressing the safety of use of sucralose. Studies reviewed include chemical characterization and stability, toxicokinetics in animals and humans, assessment of genotoxicity, and animal and human feeding studies. Endpoints evaluated include effects on growth, development, reproduction, neurotoxicity, immunotoxicity, carcinogenicity and overall health status. Human clinical studies investigated potential effects of repeated consumption in individuals with diabetes. Recent studies on the safety of sucralose focused on carcinogenic potential and the effect of sucralose on the gut microflora are reviewed. Following the discovery of sweet taste receptors in the gut and studies investigating the activation of these receptors by sucralose lead to numerous human clinical studies assessing the effect of sucralose on overall glycemic control. Estimated daily intakes of sucralose in different population subgroups, including recent studies on children with special dietary needs, consistently find that the intakes of sucralose in all members of the population remain well below the acceptable daily intake. Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Supreme Court Term Review: Cell Phones, Protests, and Prayer

    Science.gov (United States)

    Cohen, Mark

    2014-01-01

    If there is one thing that teenagers like to talk about when it comes to the law, it's who does and does not have the right to search their "stuff." And in the world of "stuff," there is nothing more important to average American teenagers than their cell phones. So when, in the waning days of its 2013-2014 term, the U.S.…

  12. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients.

    Science.gov (United States)

    Son, Seung Yeon; Jang, Hye Ryoun; Lee, Jung Eun; Yoo, Heejin; Kim, Kyunga; Park, Jae Berm; Kim, Sung Joo; Oh, Ha Young; Huh, Wooseong

    2017-01-01

    This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR]tacrolimus as a first-line immunosuppressive drug. Producers of generics should support further study of their products after approval to assure physicians of their efficacy and safety.

  13. FOOD QUALITY AND SAFETY ASSURANCE IN TERMS OF LOSS AND WASTE LIMITATION

    Directory of Open Access Journals (Sweden)

    Maria Śmiechowska

    2016-06-01

    Full Text Available One of the greatest challenges of 21st century is satisfying the food needs of the fast growing population of the world. Food must fulfill quality and safety standards.  The access to safe and appropriate food is not the same everywhere.  Food excess and, in consequence, food waste is present in many regions of the world. This study is meant to explain the causes of food waste on the basis of the author’s own research and study results of other scientists. The lack of authenticity and falsification belong to the new factors endangering food safety and food waste related thereto. This analysis proves that the authenticity of food improves its safety through the implementation of quality management systems, the appropriate system of food labelling and food identification by means of applicable law regulations, supervision and control systems. Main aim of this study is to address why, even though there are so many quality standards and systems, a significant problem with food loss and waste constantly occurs. Waste-causing factors have been determined on the example of bread and the handling of unconsumed bread has been attempted in this study. Waste limiting actions are necessary as food production is significantly overburdening the natural environment and generating increasing amount of waste, hazardous to the clean air. 

  14. The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

    National Research Council Canada - National Science Library

    Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

    2015-01-01

    .... A systematic review. Embase, Ovid Medline and PsycINFO databases. Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014...

  15. Electronic Nicotine Delivery Systems (“E-Cigarettes”): Review of Safety and Smoking Cessation Efficacy

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2015-01-01

    Background and Objectives Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems (“e-cigarettes”) are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. Data Sources The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. Review Methods We conducted a structured search of the current literature up to and including November 2013. Results E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking is suggestive, but ultimately inconclusive. Conclusions Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. Implications for Practice In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients, and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. PMID:24898072

  16. Safety of contraceptive use among women with peripartum cardiomyopathy: a systematic review.

    Science.gov (United States)

    Tepper, Naomi K; Paulen, Melissa E; Marchbanks, Polly A; Curtis, Kathryn M

    2010-07-01

    Women with peripartum cardiomyopathy (PPCM) have significant health risks during subsequent pregnancies and therefore have a critical need for safe and effective contraception. This systematic review examines evidence regarding the safety of contraceptive use among women with PPCM. We searched the PubMed database for all primary research articles published through February 2009 that addressed the safety of any contraceptive method among women with PPCM or other cardiomyopathy of any type. Of 110 articles that addressed contraceptive safety among women with cardiac disease, three met our inclusion criteria. In these three studies, which included a total of five women with cardiomyopathy, though not specifically PPCM, cases of hypertension, transient ischemic attack (TIA), thromboembolism or heart failure were found among women with cardiac disease who used hormonal methods of contraception including combined oral contraceptives, progestin-only pills and depot medroxyprogesterone acetate. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used intrauterine devices (IUDs). We found no data concerning the safety of contraceptive use among women with PPCM, though we did find limited evidence of hypertension, TIA, thromboembolism and heart failure among women with cardiac disease who used hormonal methods of contraception. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used IUDs. Published by Elsevier Inc.

  17. The U.S. commercial air tour industry: a review of aviation safety concerns.

    Science.gov (United States)

    Ballard, Sarah-Blythe

    2014-02-01

    The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

  18. A Review of Numerical Simulation and Analytical Modeling for Medical Devices Safety in MRI.

    Science.gov (United States)

    Kabil, J; Belguerras, L; Trattnig, S; Pasquier, C; Felblinger, J; Missoffe, A

    2016-11-10

    To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges.

  19. Efficacy and safety results of long-term growth hormone treatment of idiopathic short stature.

    Science.gov (United States)

    Kemp, Stephen F; Kuntze, Joyce; Attie, Kenneth M; Maneatis, Thomas; Butler, S; Frane, James; Lippe, Barbara

    2005-09-01

    Small clinical trials of GH treatment of idiopathic short stature (ISS) show variable efficacy. The study was an analysis of a large GH registry for efficacy and safety of GH treatment of ISS. There was also a comparison with a specific clinical trial. Up to 7 yr of GH treatment of ISS was evaluated for efficacy and safety in the National Cooperative Growth Study (NCGS). The NCGS study was conducted at Genentech, Inc. and included 47,226 patients. The ISS group included maximum stimulated GH 10 ng/ml or more and/or a report of ISS by investigator (n = 8018; all included for safety). Cohort 1 (n = 2520) was similar to the clinical trial, cohort 2 (n = 283) included subjects younger than 5 yr of age, and cohort 3 (n = 940) was pubertal at GH start. GH, approximately 0.30 mg/kg.wk, was given. These included growth velocities and height sd (HtSDS). Mean first-year growth velocities in cohorts 1, 2, and 3 increased 4.6, 3.9, and 4.4 cm/yr over pretreatment, respectively. Measures included: baseline mean HtSDS, -2.9, -3.2, and -2.8; mean HtSDS at 1 yr, -2.4, -2.3, and -2.3, respectively. Mean HtSDS after 7 yr in cohorts 1 (n = 303) and 2 (n = 85) and 5 yr in cohort 3 (n = 58) were: -1.2, -1.0, and -1.5, respectively. Cohort 3 shorter treatment time was due to advanced baseline age (mean 13.8 yr) and puberty. Mean HtSDS gain in cohort 1 was comparable with the clinical trial. No new safety signals specific to the NCGS ISS population were observed. ISS patients in the GH registry demonstrate a significant increase in HtSDS with the safety profile similar to GH-deficient patients. RESULTS were similar to the clinical trial.

  20. Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management.

    Science.gov (United States)

    Walsh, Kevin M; Machado, Andre G; Krishnaney, Ajit A

    2015-08-01

    There is currently no consensus on appropriate perioperative management of patients with spinal cord stimulator implants. Magnetic resonance imaging (MRI) is considered safe under strict labeling conditions. Electrocautery is generally not recommended in these patients but sometimes used despite known risks. The aim was to discuss the perioperative evaluation and management of patients with spinal cord stimulator implants. A literature review, summary of device labeling, and editorial were performed, regarding the safety of spinal cord stimulator devices in the perioperative setting. A literature review was performed, and the labeling of each Food and Drug Administration (FDA)-approved spinal cord stimulation system was reviewed. The literature review was performed using PubMed and the FDA website (www.fda.gov). Magnetic resonance imaging safety recommendations vary between the models. Certain systems allow for MRI of the brain to be performed, and only one system allows for MRI of the body to be performed, both under strict labeling conditions. Before an MRI is performed, it is imperative to ascertain that the system is intact, without any lead breaks or low impedances, as these can result in heating of the spinal cord stimulation (SCS) and injury to the patient. Monopolar electrocautery is generally not recommended for patients with SCS; however, in some circumstances, it is used when deemed required by the surgeon. When cautery is necessary, bipolar electrocautery is recommended. Modern electrocautery units are to be used with caution as there remains a risk of thermal injury to the tissue in contact with the SCS. As with MRI, electrocautery usage in patients with SCS systems with suspected breaks or abnormal impedances is unsafe and may cause injury to the patient. Spinal cord stimulation is increasingly used in patients with pain of spinal origin, particularly to manage postlaminectomy syndrome. Knowledge of the safety concerns of SCS and appropriate

  1. [Cannabinoids in palliative care: Systematic review and meta-analysis of efficacy, tolerability and safety].

    Science.gov (United States)

    Mücke, M; Carter, C; Cuhls, H; Prüß, M; Radbruch, L; Häuser, W

    2016-02-01

    Cannabinoids have multiple medical indications in palliative care, such as relief of pain or nausea or increase of appetite and weight stabilisation. The value of cannabinoids for these indications is not resolved sufficiently for palliative patients. A systematic review with meta-analysis of the efficacy, tolerability and safety on the basis of randomised controlled studies (RCT) or randomised open label or crossover studies has not yet been conducted. An extensive search for RCTs, randomised open label or crossover studies dealing with the underlying question was performed in the databases of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PubMed, Scopus and Clinicaltrials.gov up to April 2015. Studies with a duration of ≥ 2 weeks and ≥ 10 participants per treatment group were included into analysis. Using a random effects model, pooled estimates of event rates for categorical data and standardized mean differences (SMD) for continuous variables and risk differences (RD) for dichotomous variables were calculated. Out of initially 108 studies 9, with a total of 1561 participants suffering from advanced or end stage diseases, were included. The median study duration of the cancer research was 8 weeks (16 days-11 weeks), of the HIV research 6 weeks (3-12 weeks) and of the study concentrating on Alzheimer's 2 × 6 weeks. The outcome results for cannabis/cannabinoids vs. placebo in patients with cancer were not significant for the 30 % decrease in pain (RD: 0.07; 95 % confidence interval (CI): - 0.01 to 0.16; p = 0.07), caloric intake (SMD: 0.2; 95 % CI: - 0.66 to 1.06; p = 0.65) or sleep problems (SMD: - 0.09; 95 % CI: - 0.62 to 0.43; p = 0.72). In the treatment of HIV cannabinoids were superior to placebo for the outcome of weight change (SMD: 0.57; 95 % CI: 0.22-0.92; p = 0.001). Change in appetite was significant for the treatment of HIV (SMD: 0.57; 95 % CI: 0.11-1.03; p = 0.02), but

  2. Spent Fuel Dissolution and Source Term Modelling in Safety Assessment. Report from a Workshop. Synthesis and extended abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-05-15

    This report describes a workshop that was organised by the Swedish Nuclear Power Inspectorate (SKI) for assessment of the handling of near-field radionuclide retention processes by the Swedish Nuclear Fuel and Waste Management Company (SKB). The general objective with this type of meeting is to improve the knowledge and awareness of recent developments and to provide preliminary review comments. A number of SKB reports provided the general background for the workshop discussions. One report addresses the release of radionuclides from spent fuel, another the concentration limits related to radionuclide solubility and a third buffer radionuclide sorption and migration parameters. These reports comprise a basis for the handling of the spent fuel, solubility and sorption processes in new complete safety assessment SR-Can. The discussion and analysis of these background reports at the workshop therefore provide an essential element of preparation for the planned review of SR-Can. The review comments provided in this report are nonetheless of a preliminary character since the SR-Can report was not available at the time of the workshop and details about the incorporation of various potential safety features into the entirety of safety assessment were not known. The present report sets out the detailed objectives and format of the workshop in Section 2. Section 3 provides a high-level overview of processes that need to be taken into account. In Section 4, there is a brief discussion about the chemical and physical environment near the engineered barriers. Section 5 gives a more detailed description of spent fuel processes that affect the radionuclide releases. In Section 6, the key issues for radionuclide chemistry and the estimation of concentration limits for various radionuclides are discussed. Section 7 discusses radionuclide sorption and migration in the buffer and Section 8 presents overall conclusions from the workshop.

  3. Safety, efficacy and reliability of 180-W GreenLight laser technology for prostate vaporization: review of the literature.

    Science.gov (United States)

    Castellan, Pietro; Castellucci, Roberto; Schips, Luigi; Cindolo, Luca

    2015-05-01

    The aim of this study is to investigate the efficacy and safety of 180-W XPS GreenLight laser technology for photoselective prostate vaporization. A systematic search of the electronic databases was performed. Inclusion criteria were: full-text peer-reviewed journal article, with original data analysis that evaluates the feasibility and the outcome only of 180-W XPS GL laser system. Data at baseline and during follow-up have been taken into account. Intra-operative and postoperative (functional results and complications) data were collected and analyzed. We found 165 articles in our research, among which only nine articles were selected (total 991 patients). A certain grade of variability is present in all the studies in terms of scientific design, sample size and methods of reporting functional results and complications. Nevertheless, a homogenous benefit for patients in terms of symptom score improvement, post-void residual volume reduction and urinary max flow rate improvement was shown. According to Clavien-Dindo classification, 292 (83.7%) adverse events were recorded ≤ grade 2. Adverse events ≥ grade 3 were 57 (16.3%), among which bleeding, urinary retention and residual obstructive tissue represented the wide majority. No mortality was reported. Male sexual function was poorly investigated. The 180-W XPS GL laser technique is feasible and safe, with a remarkable clinical benefit. Long-term evidence on outcomes and complications are suitable even in the sphere of male sexuality.

  4. Development of safety analysis technology for LMR; development of safety analysis technology for LMR/ development of radioactive source terms in liquid metal reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kamg, Chang Sun; Song, Jae Hyuk; Cho, Young Ho; Go, Hyun Seok; Lee, Young Wook; Jang, Mee [Seoul National Univ., Seoul (Korea)

    2002-05-01

    PRISM source term is reviewed that had much influence on development of KALIMER. A series of experiments and simulations made in many countries are studied and source terms for liquid metal reactors except for PRISM are also reviewed. Thus, KALIMER HCDA source term is determined reasonably and conservatively. Sodium pool fire and sodium spray fire are selected as HCDA scenarios for performance analysis for KALIMER containment dome. Performance analysis for KALIMER containment dome was carried out using CONTAIN-LMR code. Comparing code calculation results with containment design parameters, we determined whether KALIMER containment dome would fail or not. The major parameters are peak pressure and peak temperature. Then, using CONTAIN-LMR code and MACCS code, radiation dose at site boundary was calculated. By comparing code calculation results with PAG guideline and 10 CFR limit, radiological consequences for HCDA was evaluated. The performance analysis showed that KALIMER containment could maintain its integrity and achieve its purpose to mitigate accident consequences and prevent release of radioactive materials in case of HCDA. Sodium pool fire caused higher radiation doses than sodium spray fire. But, dose values evaluated for HCDA were much lower than dose limit values for both sodium pool fire and sodium spray fire. 23 refs., 55 figs., 21 tabs. (Author)

  5. Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience.

    Science.gov (United States)

    Martino, M; Console, G; Dattola, A; Callea, I; Messina, G; Moscato, T; Massara, E; Irrera, G; Fedele, R; Gervasi, A; Bresolin, G; Iacopino, P

    2009-08-01

    Healthy donors (HDs) who were mobilized using lenograstim (LENO) and who were undergoing peripheral haematopoietic progenitor cell collection with apheresis (HPC-A) were enrolled in a surveillance protocol. In all, 184 HDs have been assessed with a median follow-up of 62 months (range 2-155). HDs received LENO at a median dose of 10 microg/kg (range 5-15). Bone pain was reported as the most frequent short-term adverse event (71.2%). Other commonly observed short-term symptoms included fatigue (19.0%), fever (5.4%), headache (27.7%), nausea (12.0%) and insomnia (22.3%). Spleen size increased in 4.3% of the donors. No vascular disorders or cardiac disease occurred. Long-term follow-up included monitoring of adverse events, neoplastic disease or other pathologies. Transit ischaemic attack occurred in one donor (39 months post-donation). One autoimmune event was reported at 28 months post-recombinant human granulocyte (rhG)-CSF (ankylosing spondylitis); one donor with a history of chronic obstructive pulmonary disease developed secondary polyglobulia (50 months post-rhG-CSF). One donor was diagnosed with lung cancer at 19 months post-donation. No haematological disease was observed. In conclusion, the short-term safety appears to be verified, whereas, although the study identified no increased risks of malignancy among HDs who received rhG-CSF, long-term safety requires more complete data sets, especially a longer follow-up and a larger number of HDs.

  6. Overstretched and unreciprocated commitment: reviewing research on the occupational health and safety effects of downsizing and job insecurity.

    Science.gov (United States)

    Quinlan, Michael; Bohle, Philip

    2009-01-01

    Over the past two decades, a leading business practice has been often-repeated rounds of downsizing and restructuring (also referred to as reorganization, re-engineering, and a host of other euphemistic terms) by large private and public sector employers. Frequently associated with other practices such as outsourcing, privatization, and the increased use of temporary workers, downsizing/restructuring has increased the level of job insecurity among workers as well as leading to changes in work processes (including work intensification and multi-tasking) and management behavior. How has downsizing/restructuring and increased job insecurity affected the occupational health, safety, and well-being of workers, and what measures have employers, unions, and governments taken to address any adverse effects? The authors reviewed international studies of the occupational health and safety (OHS) effects of downsizing/restructuring and increased job insecurity undertaken over the past 20 years. After imposing quality filters, they obtained 86 studies. Analysis revealed that 73 (85%) of the studies found poorer OHS outcomes (using a range of measures). Studies were examined to see whether they provided clues as to the reasons for negative outcomes.

  7. Efficacy and Safety of Oral or Nasal Fentanyl for Treatment of Breakthrough Pain in Cancer Patients: A Systematic Review.

    Science.gov (United States)

    Rogríguez, Dulce; Urrutia, Gerard; Escobar, Yolanda; Moya, Jordi; Murillo, Maite

    2015-09-01

    Formulations of fentanyl that use buccal, sublingual, or nasal transmucosal routes of administration have been developed for the treatment of BTP in opioid-tolerant patients with cancer. The purposes of this analysis were to identify and review published data describing the efficacy and safety of different oral or nasal transmucosal fentanyl formulations for treatment of cancer-related BTP, based on a critical analysis of scientific literature. Oral transmucosal or intranasal fentanyl is an effective treatment for management of BTP episodes due to a potent analgesic effect, rapid onset of action, and sustained effect. Furthermore, it is a reasonably safe treatment, causing generally mild adverse events not leading to treatment discontinuation. Nevertheless, further progress in standardizing methodology, definitions, and criteria used both in research and in clinical practice is needed in order to generate quality information allowing a better understanding of the comparable efficacy of available formulations of fentanyl. A more rigorous assessment of long-term safety is also needed to establish a balance between benefits and risks of the available options.

  8. Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review.

    Science.gov (United States)

    Pierce, Catherine A; Voss, Bryan

    2010-03-01

    To evaluate the analgesic and antipyretic efficacy and safety of ibuprofen compared to acetaminophen in children and adults. Literature searches were performed using PubMed/MEDLINE (through August 2009) and EMBASE (through January 2008) and were restricted to the English language. In PubMed/MEDLINE, search terms used were ibuprofen, acetaminophen, paracetamol, clinical trials, and randomized controlled trials. EMBASE search terms included ibuprofen and acetaminophen, restricted to human and clinical trials. All English-language articles identified from the data sources were reviewed. Multiple review articles were studied for any pertinent references and this yielded additional articles. Only articles that directly compared ibuprofen and acetaminophen were eligible for this review. Eighty-five studies that directly compared ibuprofen to acetaminophen were identified; 54 contained analgesic efficacy data, 35 contained antipyretic/temperature reduction data, and 66 contained safety data (some articles contained more than 1 type of data). Qualitative review of the literature revealed that, for the most part, ibuprofen was more efficacious than acetaminophen for the treatment of pain and fever in both pediatric and adult populations, and that these 2 drugs were equally safe. Meta-analyses on the subset of randomized clinical trial articles that reported sufficient quantitative information to calculate either an odds ratio (adverse event [AE]) or standardized mean difference (pain and fever) confirmed the qualitative results for adult (standardized mean difference [SMD] 0.69; 95% CI 0.57 to 0.81) and pediatric (SMD 0.28; 95% CI 0.10 to 0.46) pain at 2 hours postdose and pediatric fever (SMD 0.26; 95% CI 0.10 to 0.41) at 4 hours postdose. Conclusions regarding adult fever/temperature reduction could not be made due to a lack of evaluable data. The combined odds ratio for the proportion of adult subjects experiencing at least 1 AE slightly favored ibuprofen; however, the

  9. Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Kaiser, Christoph; Galatius, Søren; Jeger, Raban

    2015-01-01

    BACKGROUND: Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should......-DES. CONCLUSIONS: In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. CLINICAL TRIAL...

  10. How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review

    Science.gov (United States)

    Stavropoulou, Charitini; Doherty, Carole; Tosey, Paul

    2015-01-01

    Context Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however, little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. Methods Our systematic literature review identified 2 groups of studies: (1) those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. Findings In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures, and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. Conclusions The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and led by clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs. PMID:26626987

  11. Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review.

    Science.gov (United States)

    Ahmed, Mansoor; Hwang, Jung Hye; Choi, Soojeung; Han, Dongwoon

    2017-11-14

    High prevalence of herbal medicines used in pregnancy and the lack of information on their safety is a public concern. Despite this, no significant research has been done regarding potential adverse effects of using herbal medicines during pregnancy, especially among developing Asian countries. Cross-sectional studies were searched up to year 2016 on PubMed/Medline and EMBASE, the data were extracted and quality of studies was assessed using the quality appraisal tool. The findings are reported in accordance to the PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Classification on safety of identified herbal medicines was done based on current scientific literature. This study included eight cross-sectional studies (2729 participants) from seven different Asian countries, of which 1283 (47.01%) women used one or more herbal medicines during pregnancy. Peppermint (22.8%), aniseed (14.7%), olibanum (12.9%), flixweed seed (12.2%) and ginger (11.5%) were the most frequently used herbal medicines. Out of the 33 identified herbal medicines, 13 were classified as safe to use, five as use with caution, eight were potentially harmful to use in pregnancy and information on seven herbal medicines was not available in the current literature. Several herbal medicines identified in this review were classified to be potentially harmful or the information regarding safety in pregnancy was missing. It is recommended that contraindicated herbal medicines should be avoided and other herbals should be taken under supervision of a qualified health care practitioner. The classification regarding safety of herbal medicines in pregnancy can be utilized to create awareness on prevention of adverse effects.

  12. Safety of vaccines used for routine immunization of U.S. children: a systematic review.

    Science.gov (United States)

    Maglione, Margaret A; Das, Lopamudra; Raaen, Laura; Smith, Alexandria; Chari, Ramya; Newberry, Sydne; Shanman, Roberta; Perry, Tanja; Goetz, Matthew Bidwell; Gidengil, Courtney

    2014-08-01

    Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Copyright © 2014 by the American Academy of Pediatrics.

  13. Systematic review of the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion for the treatment of refractory chronic cluster headache.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Pinel-González, A; Oreja-Guevara, C; Luengo-Matos, S

    2018-01-12

    This study aimed to assess the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion (SPG) in the treatment of refractory chronic cluster headache. Various medical databases were used to perform a systematic review of the scientific literature. The search for articles continued until 31 October 2016, and included clinical trials, systematic reviews and/or meta-analyses, health technology assessment reports, and clinical practice guidelines that included measurements of efficiency/effectiveness or adverse effects associated with the treatment. The review excluded cohort studies, case-control studies, case series, literature reviews, letters to the editor, opinion pieces, editorials, and studies that had been duplicated or outdated by later publications from the same institution. Regarding effectiveness, we found that SPG stimulation had positive results for pain relief, attack frequency, medication use, and patients' quality of life. In the results regarding safety, we found a significant number of adverse events in the first 30 days following the intervention. Removal of the device was necessary in some patients. Little follow-up data, and no long-term data, is available. These results are promising, despite the limited evidence available. We consider it essential for research to continue into the safety and efficacy of SPG stimulation for patients with refractory chronic cluster headache. In cases where this intervention may be indicated, treatment should be closely monitored. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

    Science.gov (United States)

    Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

    2017-08-01

    Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Ankylosing spondylitis and comorbidity: safety of long-term use of nimesulide

    Directory of Open Access Journals (Sweden)

    R. M. Balabanova

    2017-01-01

    Full Text Available Ankylosing spondylitis (AS is a socially significant rheumatic disease that generally starts in young adults and, if untreated, often leads to temporary incapacitation, and by 40 years, and to disability. Despite the relatively young age of patients, the course of AS is accompanied by a number of comorbidities that most commonly include hypertension, dyslipidemia, and involvement of the gastrointestinal tract and kidney. The main group of drugs recommended for the treatment of the disease is nonsteroidal anti-inflammatory drugs (NSAIDs that, when used long, exert analgesic, anti-inflammatory, and even disease-modifying effects on the one hand and can cause adverse reactions on the other. When choosing NSAIDs, one should consider not only the activity of the pathological process, but also the presence of comorbidities in the patient. The paper gives data on the efficacy and safety of nimesulide in AS. The drug has proven its efficacy and safety in various rheumatic diseases over nearly a quarter century of its use in Russia. 

  16. Routine maintenance: safety term based work selection; Selecao de trabalho baseado no prazo seguro

    Energy Technology Data Exchange (ETDEWEB)

    Camargo, Albair de; Filho, Antnio S.; Brendler, Fabiano E.; Adamatti, Gilberto A.; Naruto, Itiro; Araujo, Luiz C.F.; Puerari, Roberto [PETROBRAS, Rio de Janeiro, RJ (Brazil)

    2004-07-01

    This work has objective to present the experience of improvement of routine maintenance system in some refineries of the PETROBRAS system, with the purpose to increase the efficiency in the Industrial Maintenance Management (cost), Utilization and HSE (Health, Safety and Environment), key of success of a petroleum company. The new system is based on the implantation of the culture of work selection in the safe period, through elaboration of new maintenance procedure, with emphasis in decisions shared between Operation and Maintenance Team, resulting in reduction of emergencies, making possible contract of services of maintenance for packages and improved allocation of resources. This work treat about improvement of the system in use, in view of that it has already taken in consideration the consequence of fail in the maintenance with participation of the operators. Besides of these challenge, this modification was made without causing riots in the process of implantation of SAP. As main result, financial profits had got better of resources with increase of safety, considering that they are analyzed in a way it that systematized potential risks. (author)

  17. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Xie Cheng-long

    2013-01-01

    Full Text Available Abstract Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well

  18. The safety of candidate vaginal microbicides since nonoxynol-9: a systematic review of published studies.

    Science.gov (United States)

    Poynten, I Mary; Millwood, Iona Y; Falster, Michael O; Law, Matthew G; Andresen, David N; Van Damme, Lut; Kaldor, John M

    2009-06-19

    To gain a greater understanding of published safety data for candidate vaginal microbicides. A systematic review of human safety trials of candidate vaginal microbicides - agents designed to protect women against HIV and other sexually transmitted infections. Trials were published in peer-reviewed journals, and publication cut-off was August week 4, 2008. Trials of nonoxynol-9 were excluded, as were trials without a control group, trials that enrolled only male participants or reported on the investigation of a product for the treatment of a genital infection. Twenty-one trials of 11 products, involving 1465 women, satisfied review criteria. Most trials reported on genital epithelial findings and urogenital symptoms and a number reported a range of other local and systemic toxicity endpoints. Trials were generally of short duration (2 weeks or less) with small sample sizes. There were few findings of significant difference between women in active and control arms. Among the products assessed in more than one study, there were significantly more genital findings with intact epithelium in recipients of PRO2000 [relative risk (RR) 1.68, 95% confidence interval (CI) 1.08-2.60] and a lower incidence of bacterial vaginosis in dextrin sulphate recipients (RR 0.61, 95% CI 0.42-0.88). CIs were generally very wide, and most studies were unable to exclude differences of a substantial magnitude between treated and control women. Larger and longer safety studies are necessary to detect clinically important toxicities, including those that indicate a potential increase in HIV risk, and provide assurance that agents are ready for large-scale effectiveness trials.

  19. [Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy].

    Science.gov (United States)

    Krupitsky, E M; Nunes, E V; Ling, W; Gastfriend, D R; Memisoglu, A; Blokhina, E A; Silverman, B L

    2014-01-01

    To evaluate efficacy and safety of injectable extended-release naltrexone (XR-NTX, Vivitrol), an opioid receptor antagonist, in the treatment of opioid dependence, we carried out a 1-year open-label extension study. The study followed the initial 6-month randomized, double-blind, PBO-controlled investigation of XR-NTX, used in dose 380 mg, as a treatment for opioid dependence. The study was conducted at 13 clinical sites in Russia. The main measurements were monthly urine samples (efficacy) and adverse events (safety). The open-label extension included 114 patients (67 continued on XR-NTX and 47 switched from placebo). Overall, 62.3% (95% CI: 52.7%, 71.2%) of patients completed the extension. Urine testing revealed that 50.9% (41.5%, 60.4%) were abstinent from opioids at all assessments during the 1-year open-label phase. Adverse events were reported by 21.1% of patients. Elevations in liver function tests occurred in 16.7% of patients. No severe adverse events were reported. The data obtained demonstrate the long-term safety and efficacy of XR-NTX in opioid dependent patients.

  20. Critical review of the reactor-safety study radiological health effects model. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, D.W.; Evans, J.S.; Jacob, N.; Kase, K.R.; Maletskos, C.J.; Robertson, J.B.; Smith, D.G.

    1983-03-01

    This review of the radiological health effects models originally presented in the Reactor Safety Study (RSS) and currently used by the US Nuclear Regulatory Commission (NRC) was undertaken to assist the NRC in determining whether or not to revise the models and to aid in the revision, if undertaken. The models as presented in the RSS and as implemented in the CRAC (Calculations of Reactor Accident Consequences) Code are described and critiqued. The major elements analyzed are those concerning dosimetry, early effects, and late effects. The published comments on the models are summarized, as are the important findings since the publication of the RSS.

  1. Long-term safety and efficacy of Omnitrope?, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study

    OpenAIRE

    Iughetti, Lorenzo; Tornese, Gianluca; Street, Maria Elisabeth; Napoli, Flavia; Giavoli, Claudia; Antoniazzi, Franco; Stagi, Stefano; Luongo, Caterina; Azzolini, Sara; Ragusa, Letizia; Bona, Gianni; Zecchino, Clara; Aversa, Tommaso; Persani, Luca; Guazzarotti, Laura

    2016-01-01

    Background PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope?, a somatropin biosimilar to Genotropin?, in children with growth disturbances. The primary endpoint of PATRO Children is long-term safety and the secondary endpoint is effectiveness, which is assessed by analysing auxological data such as height (HSDS) and height velocity (HVSDS) standard ...

  2. Evolution of International Space Station Program Safety Review Processes and Tools

    Science.gov (United States)

    Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.

    2013-01-01

    The International Space Station Program at NASA is constantly seeking to improve the processes and systems that support safe space operations. To that end, the ISS Program decided to upgrade their Safety and Hazard data systems with 3 goals: make safety and hazard data more accessible; better support the interconnection of different types of safety data; and increase the efficiency (and compliance) of safety-related processes. These goals are accomplished by moving data into a web-based structured data system that includes strong process support and supports integration with other information systems. Along with the data systems, ISS is evolving its submission requirements and safety process requirements to support the improved model. In contrast to existing operations (where paper processes and electronic file repositories are used for safety data management) the web-based solution provides the program with dramatically faster access to records, the ability to search for and reference specific data within records, reduced workload for hazard updates and approval, and process support including digital signatures and controlled record workflow. In addition, integration with other key data systems provides assistance with assessments of flight readiness, more efficient review and approval of operational controls and better tracking of international safety certifications. This approach will also provide new opportunities to streamline the sharing of data with ISS international partners while maintaining compliance with applicable laws and respecting restrictions on proprietary data. One goal of this paper is to outline the approach taken by the ISS Progrm to determine requirements for the new system and to devise a practical and efficient implementation strategy. From conception through implementation, ISS and NASA partners utilized a user-centered software development approach focused on user research and iterative design methods. The user-centered approach used on

  3. The Cochrane Library and safety of systemic corticosteroids for acute respiratory conditions in children: an overview of reviews.

    Science.gov (United States)

    Fernandes, Ricardo M; Oleszczuk, Marta; Woods, Charles R; Rowe, Brian H; Cates, Christopher J; Hartling, Lisa

    2014-09-01

    Acute respiratory conditions are a leading cause of childhood morbidity and mortality. Corticosteroids are effective and established treatments in some acute respiratory infections (e.g. croup) and asthma exacerbations; however, their role is controversial in other conditions owing to inconsistent effectiveness or safety concerns (e.g. bronchiolitis, acute wheeze). To examine clinically relevant short-term safety outcomes related to acute single or recurrent systemic short-term (corticosteroid use based on systematic reviews of acute respiratory conditions. We searched the Cochrane Database of Systematic Reviews in February 2013 for systematic reviews comparing systemic corticosteroids with placebo for children (aged 0-18 years) with acute asthma, preschool wheezing, bronchiolitis, croup, pharyngitis/tonsillitis or pneumonia. We selected the following outcomes a priori: gastrointestinal (GI) bleeding and abdominal pain; behavioural effects (tremor or hyperactivity, jitteriness, irritability or emotional distress); hypertension; serious adverse events, including death, length of stay in hospital; and relapse leading to hospitalization. One reviewer extracted data and another reviewer independently verified data. Results were combined using Peto odds ratios and risk differences (RD) for dichotomous outcomes and mean differences for continuous outcomes. Seven reviews containing 44 relevant randomized controlled trials were included. Three reviews were on asthma and one each on bronchiolitis, croup, wheeze and pharyngitis/tonsillitis. Six trials (2114 patients) assessed GI bleeding and/or abdominal pain and showed no significant differences between corticosteroids and placebo (1.5% vs. 1.8%, respectively). Various behavioural effects and hypertension/blood pressure were measured in four trials each (838 and 1617 patients, respectively), with no significant differences reported. None of the trials reported deaths in any of the treatment groups. Based on 17 trials (2056

  4. Long-term efficacy and safety of carotid artery stenting versus endarterectomy: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Yang; Yang, Jing-Jing; Zhu, Su-Hui; Xu, Biao; Wang, Lian

    2017-01-01

    Many recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included. Eight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses. Carotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made.

  5. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis.

    Science.gov (United States)

    Nasrallah, Henry A; Earley, Willie; Cutler, Andrew J; Wang, Yao; Lu, Kaifeng; Laszlovszky, István; Németh, György; Durgam, Suresh

    2017-08-24

    Schizophrenia is a chronic and debilitating neuropsychiatric disorder that often requires long-term pharmacotherapy to manage symptoms and prevent relapse. Cariprazine is a potent dopamine D3 and D2 receptor partial agonist that is FDA-approved in the US for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults; the recommended dose range is 1.5-6 mg/d. To further characterize the long-term safety of cariprazine, data from two 48-week open-label, flexible-dose extension studies were pooled for post hoc analyses. Outcomes were evaluated in the pooled safety population (patients who received ≥1 dose of cariprazine during an open-label extension period); findings were summarized using descriptive statistics for the overall cariprazine group and in modal daily dose groups (1.5-3, 4.5-6, and 9 mg/d). Of the 679 patients in the overall cariprazine safety population, 40.1% completed the study. The only adverse events (AEs) leading to discontinuation of ≥2% of patients in any dose group were akathisia, worsening of schizophrenia, and psychotic disorder. Treatment-emergent AEs (TEAEs) of akathisia, insomnia, weight increased, and headache were reported in ≥10% of the overall population. Mean prolactin levels decreased in all dose groups (overall, -15.4 ng/mL). Clinically insignificant changes in aminotransferase levels and alkaline phosphatase were observed; no dose-response relationship was observed across groups. Mean total (-5.3 mg/dL), low-density lipoprotein (-3.5 mg/dL), and high-density lipoprotein (-0.8 mg/dL) cholesterol levels decreased; no dose-response relationship was observed for metabolic parameters. Mean change in body weight was 1.58 kg; body weight increase and decrease ≥7% occurred in 27% and 11% of patients, respectively. Mean changes in cardiovascular parameters, including blood pressure and pulse, were generally not considered clinically significant. EPS-related TEAEs that occurred in

  6. Prospects for comparing European hospitals in terms of quality and safety: lessons from a comparative study in five countries

    Science.gov (United States)

    Burnett, Susan; Renz, Anna; Wiig, Siri; Fernandes, Alexandra; Weggelaar, Anne Marie; Calltorp, Johan; Anderson, Janet E.; Robert, Glenn; Vincent, Charles; Fulop, Naomi

    2013-01-01

    Purpose Being able to compare hospitals in terms of quality and safety between countries is important for a number of reasons. For example, the 2011 European Union directive on patients' rights to cross-border health care places a requirement on all member states to provide patients with comparable information on health-care quality, so that they can make an informed choice. Here, we report on the feasibility of using common process and outcome indicators to compare hospitals for quality and safety in five countries (England, Portugal, The Netherlands, Sweden and Norway). Main Challenges Identified The cross-country comparison identified the following seven challenges with respect to comparing the quality of hospitals across Europe: different indicators are collected in each country; different definitions of the same indicators are used; different mandatory versus voluntary data collection requirements are in place; different types of organizations oversee data collection; different levels of aggregation of data exist (country, region and hospital); different levels of public access to data exist; and finally, hospital accreditation and licensing systems differ in each country. Conclusion Our findings indicate that if patients and policymakers are to compare the quality and safety of hospitals across Europe, then further work is urgently needed to agree the way forward. Until then, patients will not be able to make informed choices about where they receive their health care in different countries, and some governments will remain in the dark about the quality and safety of care available to their citizens as compared to that available in neighbouring countries. PMID:23292003

  7. Efficacy and safety of acupuncture in children: an overview of systematic reviews.

    Science.gov (United States)

    Yang, Chunsong; Hao, Zilong; Zhang, Ling-Li; Guo, Qin

    2015-08-01

    In recent years, acupuncture has increasingly being integrated into pediatric health care. It was used on ~150,000 children (0.2%). We aim to update the evidence for the efficacy and safety of acupuncture for children and evaluate the methodological qualities of these studies to improve future research in this area. We included 24 systematic reviews, comprising 142 randomized controlled trials (RCTs) with 12,787 participants. Only 25% (6/24) reviews were considered to be high quality (10.00 ± 0.63). High-quality systematic reviews and Cochrane systematic reviews tend to yield neutral or negative results (P = 0.052, 0.009 respectively). The efficacy of acupuncture for five diseases (Cerebral Palsy (CP), nocturnal enuresis, tic disorders, amblyopia, and pain reduction) is promising. It was unclear for hypoxic ischemic encephalopathy, attention deficit hyperactivity disorder, mumps, autism spectrum disorder (ASD), asthma, nausea/vomiting, and myopia. Acupuncture is not effective for epilepsy. Only six reviews reported adverse events (AEs) and no fatal side effects were reported. The efficacy of acupuncture for some diseases is promising and there have been no fatal side effects reported. Further high-quality studies are justified, with five diseases in particular as research priorities.

  8. The Impact of Short-Term Professional Development on Participant Outcomes: A Review of the Literature

    Science.gov (United States)

    Lauer, Patricia A.; Christopher, Debra E.; Firpo-Triplett, Regina; Buchting, Francisco

    2014-01-01

    A narrative literature review was conducted to identify the design features of effective short-term face-to-face professional development (PD) events. The 23 reviewed studies described PD with durations of 30 hours or less and involved participants in education or human service-related professions. Design features associated with positive impacts…

  9. Sigmoid volvulus: Long-term clinical outcome and review of the ...

    African Journals Online (AJOL)

    Sigmoid volvulus: Long-term clinical outcome and review of the literature. ... Patients undergoing primary resection and anastomosis (PRA) or Hartmann's procedure (HP) for sigmoid volvulus between September 1992 and August 2000 were reviewed. Eligible patients who had had the initial procedure at least 5 years ...

  10. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

    Science.gov (United States)

    Senabre-Gallego, José Miguel; Santos-Ramírez, Carlos; Santos-Soler, Gregorio; Salas-Heredia, Esteban; Sánchez-Barrioluengo, Mabel; Barber, Xavier; Rosas, José

    2013-01-01

    To date, anti-tumor necrosis factor alfa (anti-TNF-α) therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, hematologic disorders like aplastic anemia and pancytopenia, vasculitis, immunogenicity, and exacerbation or induction of psoriasis are class effects of all the anti-TNF drugs, and have been seen in patients with ankylosing spondylitis. However, etanercept is less likely to induce reactivation of tuberculosis than the other anti-TNF drugs and it has been suggested that etanercept might be less immunogenic, especially in ankylosing spondylitis. Acute uveitis, Crohn’s disease, and sarcoidosis are other adverse events that have been rarely associated with etanercept

  11. Safety and long-term outcomes of endoscopic papillary balloon dilation in children with bile duct stones.

    Science.gov (United States)

    Osanai, Manabu; Maguchi, Hiroyuki; Takahashi, Kuniyuki; Katanuma, Akio; Yane, Kei; Kaneko, Maki; Hashigo, Syunpei; Katoh, Shin; Harada, Ryo; Katoh, Ryusuke; Tanno, Satoshi

    2011-03-01

    Although experience with diagnostic and therapeutic ERCP in children is growing, little is known about the safety and technical outcomes of endoscopic papillary balloon dilation (EPBD) in pediatric patients with bile duct stones (BDSs). To assess the safety and long-term outcomes of EPBD in pediatric patients with BDSs. Case study. Tertiary referral center. This study involved 5 children who had BDSs combined with gallstones who underwent EPBD. Successful EPBD, successful stone removal, procedure-related complications, and long-term outcomes. ERCP was successful in all cases, with cannulation and subsequent EPBD. Stone removal was performed in 1 session in all patients. No EPBD-related complications were observed in any patient. After EPBD, 1 patient subsequently underwent laparoscopic cholecystectomy for gallstones. The remaining 4 were followed without surgery. In 2 patients, gallstones were spontaneously passed from the bile duct into the duodenum. During the follow-up period, over a mean of 7.1 years (range 3.7-9.3 years), no recurrence of BDSs was observed in any patient. Small number of patients. Although BDSs are rare in pediatric patients, EPBD may be a safe and effective technique for the management of such stones in some children. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  12. An inventory of European data sources for the long-term safety evaluation of methylphenidate

    NARCIS (Netherlands)

    Murray, M.L.; Insuk, S.; Banaschewski, T.; Neubert, A.C.; McCarthy, S.; Buitelaar, J.K.; Coghill, D.; Dittmann, R.W.; Konrad, K.; Panei, P.; Rosenthal, E.; Sonuga-Barke, E.J.; Wong, I.C.

    2013-01-01

    To compile an inventory of European healthcare databases with potential to study long-term effects of methylphenidate (MPH) in patients with attention deficit hyperactivity disorder (ADHD). Potential databases were identified through expert opinion, the website of the European Network of Centres for

  13. Workplace Violence and Safety Issues in Long-Term Medical Care Facilities: Nurses' Perspectives

    Directory of Open Access Journals (Sweden)

    Bankole K. Fasanya

    2016-06-01

    Conclusion: WPV is an epidemic problem that affects all health-care professionals. The findings of this study could help long-term medical care facilities' management identify the areas to focus on mitigating, controlling, and/or eliminating incidents of WPV.

  14. Learning from Aviation to Improve Safety in the Operating Room - a Systematic Literature Review

    Directory of Open Access Journals (Sweden)

    Linda S. G. L. Wauben

    2012-01-01

    Full Text Available Lessons learned from other high-risk industries could improve patient safety in the operating room (OR. This review describes similarities and differences between high-risk industries and describes current methods and solutions within a system approach to reduce errors in the OR. PubMed and Scopus databases were systematically searched for relevant articles written in the English language published between 2000 and 2011. In total, 25 articles were included, all within the medical domain focusing on the comparison between surgery and aviation. In order to improve safety in the OR, multiple interventions have to be implemented. Additionally, the healthcare organization has to become a ‘learning organization’ and the OR team has to become a team with shared responsibilities and flat hierarchies. Interpersonal and technical skills can be trained by means of simulation and can be supported by implementing team briefings, debriefings and cross-checks. However, further development and research is needed to prove if these solutions are useful, practical, and actually increase safety.

  15. QMRA and water safety management: review of application in drinking water systems.

    Science.gov (United States)

    Petterson, S R; Ashbolt, N J

    2016-08-01

    Quantitative microbial risk assessment (QMRA), the assessment of microbial risks when model inputs and estimated health impacts are explicitly quantified, is a valuable tool to support water safety plans (WSP). In this paper, research studies undertaken on the application of QMRA in drinking water systems were reviewed, highlighting their relevance for WSP. The important elements for practical implementation include: the data requirements to achieve sufficient certainty to support decision-making; level of expertise necessary to undertake the required analysis; and the accessibility of tools to support wider implementation, hence these aspects were the focus of the review. Recommendations to support the continued and growing application of QMRA to support risk management in the water sector are provided.

  16. Occupational safety and health management in the construction industry: a review.

    Science.gov (United States)

    Jaafar, Mohd Hafiidz; Arifin, Kadir; Aiyub, Kadaruddin; Razman, Muhammad Rizal; Ishak, Muhammad Izzuddin Syakir; Samsurijan, Mohamad Shaharudin

    2017-09-11

    The construction industry plays a significant role in contributing to the economy and development globally. During the process of construction, various hazards coupled with the unique nature of the industry contribute to high fatality rates. This review refers to previous published studies and related Malaysian legislation documents. Four main elements consisting of human, worksite, management and external elements which cause occupational accidents and illnesses were identified. External and management elements are the underlying causes contributing to occupational safety and health (OSH), while human and worksite elements are more apparent causes of occupational accidents and illnesses. An effective OSH management approach is required to contain all hazards at construction sites. An approach to OSH management constructed by elements of policy, process, personnel and incentive developed in previous work is explored. Changes to the sub-elements according to previous studies and the related Malaysian legislation are also covered in this review.

  17. Safety culture in long-term care: a cross-sectional analysis of the Safety Attitudes Questionnaire in nursing and residential homes in the Netherlands

    NARCIS (Netherlands)

    Dr. C.M. Dekker-van Doorn; J.D.H. van Wijngaarden; M. Buljac-Samardzic

    2015-01-01

    The first objective was to investigate if the Safety Attitudes Questionnaire (SAQ) is appropriate to measure the safety attitude of caregivers in nursing and residential homes, and second, to compare safety attitude of these caregivers with available data of caregivers in other settings (ie,

  18. Safety of Animal Fats for Biodiesel Production: A Critical Review of Literature

    Energy Technology Data Exchange (ETDEWEB)

    Greene, A.; Dawson, P.; Nixon, D.; Atkins, J.; Pearl, G. [Clemson University, SC (United States)

    2007-05-15

    An in-depth review of available literature was conducted on the safety of using animal fats for biodiesel. The review indicated little or no known risk to human and animal health and to the environment relative to inherent microbial, organic or inorganic agents in animal fats destined for biodiesel production. Animal by-products are generated from the inedible tissues derived from meat, poultry and fish production. This material is thermally processed by the rendering industry to generate a number of industrial materials including use of the fat portion to produce biodiesel. As the biodiesel industry continues to develop, questions have emerged about the safety of animal versus vegetable fats for biodiesel production and utilization. The following report is the result of a detailed literature search into the potential microbial, organic, and inorganic contaminants that may be present in animal fats and the potential for human or environmental safety issues associated with each. The potential safety risks associated with prions are discussed in a separate report, 'Biodiesel from Specified Risk Material Tallow: An Appraisal of TSE Risks and their Reduction'. In certain instances, very little was reported about the potential contaminating moiety and its fate in biodiesel production and usage. Establishing an absolute zero risk assessment is impossible on any fat utilized for biodiesel production. Among the potential microbial contaminants, bacteria, viruses, fungi, yeast, parasites, and microbial toxins were considered. In each instance, the nature of the production process and usage of biodiesel via combustion reduce the possibility that microbial contaminants would be a cause for concern to humans, animals, or the environment. Potential organic moieties contaminating the fat should meet a similar fate. Current evidence suggests that metals and metalloids within animal fats will not cause significant safety issues in the production and use of rendered fat

  19. Review of Occupational Health and Safety Organization in Expanding Economies: The Case of Southern Africa.

    Science.gov (United States)

    Moyo, Dingani; Zungu, Muzimkhulu; Kgalamono, Spoponki; Mwila, Chimba D

    2015-01-01

    Globally, access to occupational health and safety (OHS) by workers has remained at very low levels. The organization and implementation of OHS in South Africa, Zimbabwe, Zambia, and Botswana has remained at suboptimal levels. Inadequacy of human resource capital, training, and education in the field of OHS has had a major negative impact on the improvement of worker access to such services in expanding economies. South Africa, Zimbabwe, Zambia, and Botswana have expanding economies with active mining and agricultural activities that pose health and safety risks to the working population. A literature review and country systems inquiry on the organization of OHS services in the 4 countries was carried out. Because of the infancy and underdevelopment of OHS in southern Africa, literature on the status of this topic is limited. In the 4 countries under review, OHS services are a function shared either wholly or partially by 3 ministries, namely Health, Labor, and Mining. Other ministries, such as Environment and Agriculture, carry small fragments of OHS function. The 4 countries are at different stages of OHS legislative frameworks that guide the practice of health and safety in the workplace. Inadequacies in human resource capital and expertise in occupational health and safety are noted major constraints in the implementation and compliance to health and safety initiatives in the work place. South Africa has a more mature system than Zimbabwe, Zambia, and Botswana. Lack of specialized training in occupational health services, such as occupational medicine specialization for physicians, has been a major drawback in Zimbabwe, Zambia, and Botswana. The full adoption and success of OHS systems in Southern Africa remains constrained. Training and education in OHS, especially in occupational medicine, will enhance the development and maturation of occupational health in southern Africa. Capacitating primary health services with basic occupational health knowledge would

  20. Evaluation of safety of excessive intake and efficacy of long-term intake of beverages containing apple polyphenols.

    Science.gov (United States)

    Akazome, Yoko; Kametani, Norihiro; Kanda, Tomomasa; Shimasaki, Hiroyuki; Kobayashi, Shuhei

    2010-01-01

    In the present study, a randomized, double-blind, placebo-controlled study was performed to evaluate the safety of an excessive intake and the efficacy of a long-term intake of polyphenols derived from apples for moderately underweight to moderately obese subjects (long-term intake: 94 subjects; excessive intake: 30 subjects). For each trial, the subjects were divided into the following two groups: a group that drank beverages with apple polyphenols (600 mg) (hereinafter referred to as the apple group) and a group that drank beverages without apple polyphenols (hereinafter referred to as the placebo group). For the long-term intake trial, the subjects were given a regular amount of the beverage (340 g) each day for 12 weeks. For the excessive intake trial, the subjects were given three times the regular amount of the beverage each day for 4 weeks. It is noteworthy that the visceral fat area (VFA) of subjects in the apple group for the long-term intake trial had decreased significantly by the 8- and 12-week marks (week 8: p apple group compared to those in the placebo group was significantly lower by the 8- and 12-week marks (p apple group that started with a high VFA (VFA > or = 100 cm(2)) had decreased significantly by the 8- and 12-week marks compared to the baseline (week 8: p apple group that started with a normal VFA (VFA apple polyphenols.

  1. Long-term risks of kidney living donation: review and position paper by the ERA-EDTA DESCARTES working group.

    Science.gov (United States)

    Maggiore, Umberto; Budde, Klemens; Heemann, Uwe; Hilbrands, Luuk; Oberbauer, Rainer; Oniscu, Gabriel C; Pascual, Julio; Schwartz Sorensen, Soren; Viklicky, Ondrej; Abramowicz, Daniel

    2017-02-01

    Two recent matched cohort studies from the USA and Norway published in 2014 have raised some concerns related to the long-term safety of kidney living donation. Further studies on the long-term risks of living donation have since been published. In this position paper, Developing Education Science and Care for Renal Transplantation in European States (DESCARTES) board members critically review the literature in an effort to summarize the current knowledge concerning long-term risks of kidney living donation to help physicians for decision-making purposes and for providing information to the prospective live donors. Long-term risk of end-stage renal disease (ESRD) can be partially foreseen by trying to identify donors at risk of developing ‘de novo’ kidney diseases during life post-donation and by predicting lifetime ESRD risk. However, lifetime risk may be difficult to assess in young donors, especially in those having first-degree relatives with ESRD. The study from Norway also found an increased risk of death after living donor nephrectomy, which became visible only after >15 years of post-donation follow-up. However, these findings are likely to be largely the result of an overestimation due to the confounding effect related to a family history of renal disease. DESCARTES board members emphasize the importance of optimal risk–benefit assessment and proper information to the prospective donor, which should also include recommendations on health-promoting behaviour post-donation.

  2. Safety relevant aspects of the long-term intermediate storage of spent fuel elements and vitrified high-level radioactive wastes; Sicherheitstechnische Aspekte der langfristigen Zwischenlagerung von bestrahlten Brennelementen und verglastem HAW

    Energy Technology Data Exchange (ETDEWEB)

    Ellinger, A.; Geupel, S.; Gewehr, K.; Gmal, B.; Hannstein, V.; Hummelsheim, K.; Kilger, R.; Wagner, M. [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Schmidt, G.; Spieth-Achtnich, A. [Oeko-Institut e.V. - Institut fuer angewandte Oekolgie (Germany)

    2010-04-15

    The currently in Germany pursued concept for management of spent fuel from nuclear power plants provides intermediate dry cask storage at the NPP sites until direct disposal in a deep geologic repository. In addition the earlier commissioned centralized dry storage facilities are being used for storage of high level radioactive waste returned from foreign reprocessing of German spent fuel performed so far. The dry interim storage facilities are licensed for 40 years of operation time. According to the German regulations a full scope periodic safety review is not required so far, neither practical experience on dry storage for this period of time is available. With regard to this background the report at hand is dealing with long term effects, which may affect safety of the interim storage during the 40 years period or beyond if appropriate, and with the question, whether additional analyses or monitoring measures may be required. Therefore relevant publications have been evaluated, calculations have been performed as well as a systematic screening with regard to loads and possible ageing effects has been applied to structures and components important for safety of the storage, in order to identify relevant long term effects, which may not have been considered sufficiently so far and to provide proposals for an improved ageing management. The report firstly provides an overview on the current state of technology describing shortly the national and international practice and experience. In the following chapters safety aspects of interim storage with regard to time dependent effects and variations are being analyzed and discussed. Among this not only technical aspects like the long term behavior of fuel elements, canisters and storage systems are addressed, but also operational long term aspects regarding personnel planning, know how conservation, documentation and quality management are taken into account. A separate chapter is dedicated to developing and describing

  3. Trauma case review: A quality and safety feature of the Victorian State Trauma System.

    Science.gov (United States)

    Pinto, Carolyn; Cameron, Peter A; Gabbe, Belinda; McLellan, Susan; Walker, Tony

    2017-11-07

    The aim of the present study was to describe the trauma case review process and its role in a regionalised trauma system. Victoria has a population of 5.9 million people, accounting for 26% of Australia's population. Victoria has been serviced by an inclusive, organised trauma system since 2000 comprising 138 health services with trauma designations and three major trauma services. Pre- and interhospital guidelines prescribe the timely transport of patients to the appropriate level of trauma service. A review of the role and contribution of 10 years of operation of the trauma case review group (CRG) was undertaken to describe the aims, processes and governance surrounding the implementation of an individual case review for specified major trauma patients. Specified patients were those identified by the Victorian State Trauma Registry as being managed outside of established Victorian State Trauma System prehospital and interhospital guidelines. A state-wide trauma case review process was implemented across the trauma system using data-informed detection flags and screening criteria. Using data from the Victorian State Trauma Registry, detection flags were correlated with patients at risk of a poorer outcome, thereby ensuring that all patients managed outside of the requirements of established trauma triage and transfer guidelines were subject to review. The CRG provides an individual review process as a technique for assessing and monitoring major trauma patient care and compliance with trauma system triage and transfer guidelines. The process has been effective as a quality and safety strategy by improving clinician knowledge of major trauma triage and transfer guidelines and facilitating improved compliance, particularly with interhospital transfers. Strong compliance has been achieved from health services with the requirement to internally review and respond to CRG concerns regarding 'high-risk' trauma cases. Anecdotal feedback from health services regarding

  4. A review on leadership of head nurses and patient safety and quality of care.

    Science.gov (United States)

    Verschueren, Marc; Kips, Johan; Euwema, Martin

    2013-01-01

    The purpose of the study was to explore in literature what different leadership styles and behaviors of head nurses have a positive influence on the outcomes of patient safety or quality of care. We reviewed the literature from January 2000 until September 2011. We searched Pubmed, Embase, Cinahl, Psychlit, and Econlit. We found 10 studies addressing the relationship between head nurse leadership and safety and quality. A wide array of styles and practices were associated with different patient outcomes. Transformational leadership was the most used concept in the studies. A trend can be observed over these studies suggesting that a trustful relationship between the head nurse and subordinates is an important driving force for the achievement of positive patient outcomes. Furthermore, the effects of these trustful relationships seem to be amplified by supporting mechanisms, often objective conditions like clinical pathways and, especially, staffing level. This study offers an up-to-date review of the limited number of studies on the relationship between nurse leadership and patient outcomes. Although mostly transformational leadership was found to be responsible for positive associations with outcomes, also contingent reward had positive influence on outcomes. We formulated some comments on the predominance of the transformational leadership concept and suggested the application of complexity theory and political leadership for the current context of care. We formulated some implications for practice and further research, mainly the need for more systematic empirical and cross cultural studies and the urgent need for the development of a validated set of nurse-sensitive patient outcome indicators.

  5. Fructus Ligustri Lucidi in Osteoporosis: A Review of its Pharmacology, Phytochemistry, Pharmacokinetics and Safety.

    Science.gov (United States)

    Chen, Beibei; Wang, Lili; Li, Lin; Zhu, Ruyuan; Liu, Haixia; Liu, Chenyue; Ma, Rufeng; Jia, Qiangqiang; Zhao, Dandan; Niu, Jianzhao; Fu, Min; Gao, Sihua; Zhang, Dongwei

    2017-09-05

    Background : Fructus Ligustri Lucidi (FLL) has now attracted increasing attention as an alternative medicine in the prevention and treatment of osteoporosis. This study aimed to provide a general review of traditional interpretation of the actions of FLL in osteoporosis, main phytochemical constituents, pharmacokinetics, pharmacology in bone improving effect, and safety. Materials and Methods : Several databases, including PubMed, China National Knowledge Infrastructure, National Science and Technology Library, China Science and Technology Journal Database, and Web of Science were consulted to locate publications pertaining to FLL. The initial inquiry was conducted for the presence of the following keywords combinations in the abstracts: Fructus Ligustri Lucidi , osteoporosis, phytochemistry, pharmacokinetics, pharmacology, osteoblasts, osteoclasts, salidroside. About 150 research papers and reviews were consulted. Results : FLL is assumed to exhibit anti-osteoporotic effects by improving liver and kidney deficiencies and reducing lower back soreness in Traditional Chinese Medicine (TCM). The data from animal and cell experiments demonstrate that FLL is able to improve bone metabolism and bone quality in ovariectomized, growing, aged and diabetic rats through the regulation of PTH/FGF-23/1,25-(OH)₂D₃/CaSR, Nox4/ROS/NF-κB, and OPG/RANKL/cathepsin K signaling pathways. More than 100 individual compounds have been isolated from this plant. Oleanolic acid, ursolic acid, salidroside, and nuzhenide have been reported to exhibit the anti-osteoporosis effect. The pharmacokinetics data reveals that salidroside is one of the active constituents, and that tyrosol is hard to detect under physiological conditions. Acute and subacute toxicity studies show that FLL is well tolerated and presents no safety concerns. Conclusions : FLL provides a new option for the prevention and treatment of osteoporosis, which attracts rising interests in identifying potential anti

  6. THE INTERRELATION BETWEEN THE ADEQUACY OF AVIATION TERMS TRANSLATION AND SAFETY OF FLIGHTS

    Directory of Open Access Journals (Sweden)

    R.A. Gilchenko

    2005-02-01

    Full Text Available  The article considers the common aspects of aerospace terminology of Ukrainian language creation. Its author determines main ways of term-formation, ways of aerospace terminology enrichment as well as some objective difficulties of the corresponding terminological system in Ukraine. The article enlightens the issue of bilinguism of Ukrainian society, and the main requirements to be met in order to decrease the language problems related accidents rate. The author gives a recommendation for development of clear and monosemantic Ukrainian aviation terminology, its standards and English-Ukrainian dictionaries.

  7. Long-term efficacy, safety and durability of Juvéderm® XC

    Science.gov (United States)

    Ballin, Annelyse C; Cazzaniga, Alex; Brandt, Fredric S

    2013-01-01

    Over the last decade, there has been increasing interest in minimally invasive cosmetic treatments, especially for facial rejuvenation. Next to botulinum toxin injection, the injection of soft tissue fillers is the second most frequent minimally invasive procedure performed in the USA. Hyaluronic acid (HA) is the most commonly used dermal filler. One of patients’ main concerns about filler injections pertains to pain and discomfort. Topical anesthetics, nerve blocks, and/or the incorporation of lidocaine to the filler have been applied in order to reduce distress and pain. Despite nerve blocks being an effective form of anesthesia, they may distort the area to be treated, as well as lengthen and complicate the procedure. Studies have shown that the incorporation of lidocaine to HA fillers significantly reduces pain and discomfort. Yet, one of the dilemmas about the addition of lidocaine solution to HA fillers is the possible alteration of the physical characteristics of the product by negatively impacting the efficacy and/or duration of the filler. The concern is that the addition of lidocaine could dilute the product, creating less correction per mL, changing the product’s viscosity and consequently the “lifting” ability. Also, this dilution could reduce the product’s duration. There may be a difference between a physician adding an aqueous solution into a lidocaine-free version of HA and the pre-incorporated lidocaine version of HA. An aqueous solution might dilute the product, while the pre-incorporated powder lidocaine appears to avoid this problem. Juvéderm® XC is manufactured with powder lidocaine 0.3%; it is associated with significantly less injection pain than Juvéderm® and other lidocaine-free versions of HA. Studies have shown that lidocaine enhances treatment comfort and optimizes the injection experience while maintaining a similar safety and effectiveness profile. Regarding the longevity, further study is necessary to determine if there

  8. Long-term treatment with bisphosphonates and their safety in postmenopausal osteoporosis

    Directory of Open Access Journals (Sweden)

    Michael Pazianas

    2010-07-01

    epidemiologic studies or prospective RCTs.Keywords: bisphosphonates, osteoporosis, safety

  9. Safety and feasibility of long-term intravenous sodium nitrite infusion in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Ryszard M Pluta

    Full Text Available BACKGROUND: Infusion of sodium nitrite could provide sustained therapeutic concentrations of nitric oxide (NO for the treatment of a variety of vascular disorders. The study was developed to determine the safety and feasibility of prolonged sodium nitrite infusion. METHODOLOGY: Healthy volunteers, aged 21 to 60 years old, were candidates for the study performed at the National Institutes of Health (NIH; protocol 05-N-0075 between July 2007 and August 2008. All subjects provided written consent to participate. Twelve subjects (5 males, 7 females; mean age, 38.8±9.2 years (range, 21-56 years were intravenously infused with increasing doses of sodium nitrite for 48 hours (starting dose at 4.2 µg/kg/hr; maximal dose of 533.8 µg/kg/hr. Clinical, physiologic and laboratory data before, during and after infusion were analyzed. FINDINGS: The maximal tolerated dose for intravenous infusion of sodium nitrite was 267 µg/kg/hr. Dose limiting toxicity occurred at 446 µg/kg/hr. Toxicity included a transient asymptomatic decrease of mean arterial blood pressure (more than 15 mmHg and/or an asymptomatic increase of methemoglobin level above 5%. Nitrite, nitrate, S-nitrosothiols concentrations in plasma and whole blood increased in all subjects and returned to preinfusion baseline values within 12 hours after cessation of the infusion. The mean half-life of nitrite estimated at maximal tolerated dose was 45.3 minutes for plasma and 51.4 minutes for whole blood. CONCLUSION: Sodium nitrite can be safely infused intravenously at defined concentrations for prolonged intervals. These results should be valuable for developing studies to investigate new NO treatment paradigms for a variety of clinical disorders, including cerebral vasospasm after subarachnoid hemorrhage, and ischemia of the heart, liver, kidney and brain, as well as organ transplants, blood-brain barrier modulation and pulmonary hypertension. CLINICAL TRIAL REGISTRATION INFORMATION: http

  10. Effect of inhaled corticosteroid particle size on asthma efficacy and safety outcomes: a systematic literature review and meta-analysis.

    Science.gov (United States)

    El Baou, Céline; Di Santostefano, Rachael L; Alfonso-Cristancho, Rafael; Suarez, Elizabeth A; Stempel, David; Everard, Mark L; Barnes, Neil

    2017-02-07

    Inhaled corticosteroids (ICS) are the primary treatment for persistent asthma. Currently available ICS have differing particle size due to both formulation and propellant, and it has been postulated that this may impact patient outcomes. This structured literature review and meta-analysis compared the effect of small and standard particle size ICS on lung function, symptoms, rescue use (when available) and safety in patients with asthma as assessed in head-to-head randomized controlled trials (RCTs). A systematic literature search of MEDLINE was performed to identify RCTs (1998-2014) evaluating standard size (fluticasone propionate-containing medications) versus small particle size ICS medication in adults and children with asthma. Efficacy outcomes included forced expiratory volume in 1 s (FEV 1 ), morning peak expiratory flow (PEF), symptom scores, % predicted forced expiratory flow between 25 and 75% of forced vital capacity (FEF 25-75% ) , and rescue medication use. Safety outcomes were also evaluated when available. Twenty-three independent trials that met the eligibility criteria were identified. Benefit-risk plots did not demonstrate any clinically meaningful differences across the five efficacy endpoints considered and no appreciable differences were noted for most safety endpoints. Meta-analysis results, using a random-effects model, demonstrated no significant difference between standard and small size particle ICS medications in terms of effects on mean change from baseline FEV 1 (L) (-0.011, 95% confidence interval [CI]: -0.037, 0.014 [N = 3524]), morning PEF (L/min) (medium/low doses: -3.874, 95% CI: -10.915, 3.166 [N = 1911]; high/high-medium doses: 5.551, 95% CI: -1.948, 13.049 [N = 749]) and FEF 25-75% predicted (-2.418, 95% CI: -6.400; 1.564 [N = 115]). Based on the available literature, no clinically significant differences in efficacy or safety were observed comparing small and standard particle size ICS medications for the

  11. Long-term efficacy and safety of transanal irrigation in multiple sclerosis.

    Science.gov (United States)

    Passananti, V; Wilton, A; Preziosi, G; Storrie, J B; Emmanuel, A

    2016-09-01

    Multiple sclerosis (MS) is the commonest disabling neurological disease in young adults. A majority of patients experience bowel dysfunction, reporting a wide spectrum of bowel symptoms that significantly negatively impact social activities and emotional state. Transanal irrigation (TAI) is a method of managing such bowel symptoms. We aimed to investigate long-term efficacy of TAI, to measure health status-related quality of life and identify factors predictive of TAI outcome. Forty-nine consecutive MS patients (37 female; mean age 51, range 26-80) were studied. We investigated predominant symptoms, reason for beginning TAI and medical comorbidity. All patients underwent anorectal physiology testing. They completed Neurogenic Bowel Dysfunction and EQ-5D questionnaires at baseline and annual follow-up. Mean follow-up was 40 months, at which there was 55% rate of continuation of TAI. Severe bowel dysfunction was present in 47% at baseline, falling to 18%. The EQ-5D scores at latest follow-up were not statistically significant, but 42% had improved visual analog scores. The only predictive factor for successful therapy was impaired anal electrosensitivity (p = 0.008). Long-term continuation of TAI, with improved bowel symptomatology, is seen in the majority of patients. The EQ-5D is insufficiently sensitive to show change in MS patients that using TAI. © 2016 John Wiley & Sons Ltd.

  12. Patient Safety and Quality Improvement in Otolaryngology Education: A Systematic Review.

    Science.gov (United States)

    Gettelfinger, John D; Paulk, P Barrett; Schmalbach, Cecelia E

    2017-06-01

    Objective The breadth and depth of patient safety/quality improvement (PS/QI) research dedicated to otolaryngology-head and neck surgery (OHNS) education remains unknown. This systematic review aims to define this scope and to identify knowledge gaps as well as potential areas of future study to improved PS/QI education and training in OHNS. Data Sources A computerized Ovid/Medline database search was conducted (January 1, 1965, to May 15, 2015). Similar computerized searches were conducted using Cochrane Database, PubMed, and Google Scholar. Review Methods The study protocol was developed a priori using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles were classified by year, subspecialty, Institute of Medicine (IOM) Crossing the Chasm categories, and World Health Organization (WHO) subclass. Results Computerized searches yielded 8743 eligible articles, 267 (3.4%) of which met otolaryngology PS/QI inclusion criteria; 51 (19%) were dedicated to resident/fellow education and training. Simulation studies (39%) and performance/competency evaluation (23.5%) were the most common focus. Most projects involved general otolaryngology (47%), rhinology (18%), and otology (16%). Classification by the IOM included effective care (45%), safety/effective care (41%), and effective and efficient care (7.8%). Most research fell into the WHO category of "identifying solutions" (61%). Conclusion Nineteen percent of OHNS PS/QI articles are dedicated to education, the majority of which are simulation and focus on effective care. Knowledges gaps for future research include facial plastics PS/QI and the WHO category of "studies translating evidence into safer care."

  13. A review of case studies evaluating economic incentives to promote occupational safety and health.

    Science.gov (United States)

    Elsler, Dietmar; Treutlein, Daniela; Rydlewska, Iza; Frusteri, Liliana; Krüger, Henning; Veerman, Theo; Eeckelaert, Lieven; Roskams, Nele; Van Den Broek, Karla; Taylor, Terry N

    2010-06-01

    In many European countries, external economic incentives are discussed as a policy instrument to promote occupational safety and health (OSH) in enterprises. This narrative case study review aims to support policy-makers in organizations providing such incentives by supplying information about different incentive schemes and their main characteristics such as effectiveness, efficiency, and feasibility. The focal point and topic centre network of the European Agency for Safety and Health at Work were used to collect case studies about incentive schemes aimed at supporting the prevention of occupational accidents and diseases in enterprises. Such incentives are rarely described in the scientific literature. To be considered for this review, studies had to focus on external financial benefits that could be provided as part of an insurance-related incentive or a governmental subsidy scheme. In total, 14 cases were included in the review: 6 insurance premium- and 8 subsidy-based schemes. Of these, 13 contained an evaluation of the incentive scheme, of which 7 use quantitative criteria. Three cases provided sufficient data to conduct a cost-benefit analysis. Most qualitative evaluations related to the successful management of the program and the effectiveness of the promoted measures in the workplace. Regarding the latter, quantitative criteria covered accident rates, sick leave, and general improvement in working conditions. The cost-benefit analyses all resulted in a positive payout ratio, ranging from 1.01-4.81 euros return for every 1 euro invested. Generally, we found economic incentive schemes to be feasible and reasonably effective. However, analysis regarding the efficiency of such schemes is scarce and our evaluation of the cost-benefit analysis had to rely on few cases that, nevertheless, delivered positive results for large samples. Besides this finding, our study also revealed deficits in the quality of evaluations. In order to enable policy-makers to make

  14. Report on inspection of concerns regarding the Martin Marietta Corporate Review of health and safety at Martin Marietta Energy Systems

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-18

    An Office of Inspector General Hotline allegation was received from an anonymous complainant regarding a July 1994 Martin Marietta Corporation Team`s health and safety review at three Department of Energy sites managed and operated by the then Martin Marietta Energy Systems. Inc. (Energy Systems), at Oak Ridge, Tennessee. We determined that the President of Energy Systems had requested a Corporate review at the three sites because of his concerns about safety incidents and accidents during the late Spring and early Summer of 1994. The Corporate Team`s charter was to determine if root causes existed for these safety incidents and accidents and to produce recommendations for the reduction or prevention of future safety incidents or accidents.

  15. Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy.

    Science.gov (United States)

    Skjæret, Nina; Nawaz, Ather; Morat, Tobias; Schoene, Daniel; Helbostad, Jorunn Lægdheim; Vereijken, Beatrix

    2016-01-01

    There has been a rapid increase in research on the use of virtual reality (VR) and gaming technology as a complementary tool in exercise and rehabilitation in the elderly population. Although a few recent studies have evaluated their efficacy, there is currently no in-depth description and discussion of different game technologies, physical functions targeted, and safety issues related to older adults playing exergames. This integrative review provides an overview of the technologies and games used, progression, safety measurements and associated adverse events, adherence to exergaming, outcome measures used, and their effect on physical function. We undertook systematic searches of SCOPUS and PubMed databases. Key search terms included "game", "exercise", and "aged", and were adapted to each database. To be included, studies had to involve older adults aged 65 years or above, have a pre-post training or intervention design, include ICT-implemented games with weight-bearing exercises, and have outcome measures that included physical activity variables and/or clinical tests of physical function. Sixty studies fulfilled the inclusion criteria. The studies had a broad range of aims and intervention designs and mostly focused on community-dwelling healthy older adults. The majority of the studies used commercially available gaming technologies that targeted a number of different physical functions. Most studies reported that they had used some form of safety measure during intervention. None of the studies reported serious adverse events. However, only 21 studies (35%) reported on whether adverse events occurred. Twenty-four studies reported on adherence, but only seven studies (12%) compared adherence to exergaming with other forms of exercise. Clinical measures of balance were the most frequently used outcome measures. PEDro scores indicated that most studies had several methodological problems, with only 4 studies fulfilling 6 or more criteria out of 10. Several

  16. Emergency preparedness source term development for the Office of Nuclear Material Safety and Safeguards-Licensed Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Sutter, S.L.; Mishima, J.; Ballinger, M.Y.; Lindsey, C.G.

    1984-08-01

    In order to establish requirements for emergency preparedness plans at facilities licensed by the Office of Nuclear Materials Safety and Safeguards, the Nuclear Regulatory Commission (NRC) needs to develop source terms (the amount of material made airborne) in accidents. These source terms are used to estimate the potential public doses from the events, which, in turn, will be used to judge whether emergency preparedness plans are needed for a particular type of facility. Pacific Northwest Laboratory is providing the NRC with source terms by developing several accident scenarios for eleven types of fuel cycle and by-product operations. Several scenarios are developed for each operation, leading to the identification of the maximum release considered for emergency preparedness planning (MREPP) scenario. The MREPP scenarios postulated were of three types: fire, tornado, and criticality. Fire was significant at oxide fuel fabrication, UF/sub 6/ production, radiopharmaceutical manufacturing, radiopharmacy, sealed source manufacturing, waste warehousing, and university research and development facilities. Tornadoes were MREPP events for uranium mills and plutonium contaminated facilities, and criticalities were significant at nonoxide fuel fabrication and nuclear research and development facilities. Techniques for adjusting the MREPP release to different facilities are also described.

  17. Research on the maximum utilization of PSR (Periodic Safety Review) results

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Tae Myung; Lee, Jae Kyung; Ahn, Jin Chul; Kim, G. U.; Ryu, Y. S.; Lee, G. B.; Park, D. H. [Chungju Univ., Cheongju (Korea, Republic of)

    2002-03-15

    This is the final report of 'research on the maximum utilization of PSR results' focused on linkage strategy of PSR with continued operation over design life of operating NPP. Study was mace mainly on the analysis of current status of continued operation over plant design life in foreign countries, analysis of domestic PSR implementation status and establishment of basic strategy for linking PSR with continued operation. The results of the study performed so far can be summarized as below, the recent worldwide trend of promoting efficiency of NPP operation is focused on life extension of the plants rather than building of new. Considering the fact that some developed countries have already implemented the plant life extension and not a few countries at least have invested a good amount of fund for R and D of plant life management, we can not disregard the owner's request for review of life extension application without any reasonable description. As a result of investigation and analysis for the current status of continued operation over plant design life in foreign countries, it is concluded that most countries tend to link PSR with continued operation over plant design life and the extended operation has already been implemented in some developed countries. From the point, it turned out to be more desirable to couple those two systems for continued operation over plant design life of Korean NPP. A less than 7 years left until the end of design life for the oldest NPP Kori unit 1, it is strongly recommended to establish institutional frame including a legal basis and regulatory guidelines for continued operation over plant design life before long. For the prioritization methods of corrective actions in consideration of safety significance of shortcomings picked up from PSR, some related systems are reviewed including IAEA guidelines, PSR implementation experience of UK and US prioritization system for GSI (Generic Safety Issue). Basic principles are

  18. Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

    Energy Technology Data Exchange (ETDEWEB)

    Cottrell, W.B.; Klein, A.

    1977-02-23

    This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

  19. Index to Nuclear Safety: a technical progress review by chrology, permuted title, and author, Volume 11(1) through Volume 20(6)

    Energy Technology Data Exchange (ETDEWEB)

    Cottrell, W B; Passiakos, M

    1980-06-01

    This index to Nuclear Safety, a bimonthly technical progress review, covers articles published in Nuclear Safety, Volume II, No. 1 (January-February 1970), through Volume 20, No. 6 (November-December 1979). It is divided into three sections: a chronological list of articles (including abstracts) followed by a permuted-title (KWIC) index and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center (NSIC), covers all safety aspects of nuclear power reactors and associated facilities. Over 600 technical articles published in Nuclear Safety in the last ten years are listed in this index.

  20. Long-term efficacy, safety and durability of Juvéderm® XC

    Directory of Open Access Journals (Sweden)

    Ballin AC

    2013-08-01

    maintaining a similar safety and effectiveness profile. Regarding the longevity, further study is necessary to determine if there is any difference in durability.Keywords: dermal filler, hyaluronic acid, Juvéderm XC, lidocaine, Juvéderm, dermatologic procedures

  1. Mathematical models as tools for probing long-term safety of CO2 storage

    Energy Technology Data Exchange (ETDEWEB)

    Pruess, Karsten; Birkholzer, Jens; Zhou, Quanlin

    2009-02-01

    Subsurface reservoirs being considered for storing CO{sub 2} include saline aquifers, oil and gas reservoirs, and unmineable coal seams (Baines and Worden, 2004; IPCC, 2005). By far the greatest storage capacity is in saline aquifers (Dooley et al., 2004), and our discussion will focus primarily on CO{sub 2} storage in saline formations. Most issues for safety and security of CO{sub 2} storage arise from the fact that, at typical temperature and pressure conditions encountered in terrestrial crust, CO{sub 2} is less dense than aqueous fluids. Accordingly, CO{sub 2} will experience an upward buoyancy force in most subsurface environments, and will tend to migrate upwards whenever (sub-)vertical permeable pathways are available, such as fracture zones, faults, or improperly abandoned wells (Bachu, 2008; Pruess, 2008a, b; Tsang et al., 2008). CO{sub 2} injection will increase fluid pressures in the target formation, thereby altering effective stress distributions, and potentially triggering movement along fractures and faults that could increase their permeability and reduce the effectiveness of a caprock in containing CO{sub 2} (Rutqvist et al., 2008; Chiaramonte et al., 2008). Induced seismicity as a consequence of fluid injection is also a concern (Healy et al., 1968; Raleigh et al., 1976; Majer et al., 2007). Dissolution of CO{sub 2} in the aqueous phase generates carbonic acid, which may induce chemical corrosion (dissolution) of minerals with associated increase in formation porosity and permeability, and may also mediate sequestration of CO{sub 2} as solid carbonate (Gaus et al., 2008). Chemical dissolution of caprock minerals could promote leakage of CO{sub 2} from a storage reservoir (Gherardi et al., 2007). Chemical dissolution and geomechanical effects could reinforce one another in compromising CO{sub 2} containment. Additional issues arise from the potential of CO{sub 2} to mobilize hazardous chemical species (Kharaka et al., 2006), and from migration of

  2. Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review

    OpenAIRE

    Araújo, Jimmy de Oliveira; Motta, Rogério Heládio Lopes; Bergamaschi, Cristiane de Cássia; Guimarães, Caio Chaves; Ramacciato, Juliana Cama; de Andrade, Natalia Karol; Fiqueiró, Mabel Fernandes; Lopes, Luciane Cruz

    2018-01-01

    Introduction The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures. Method/d...

  3. Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review

    Directory of Open Access Journals (Sweden)

    Thangavel Mahalingam Vijayakumar, M.Pharm, PhD

    2017-01-01

    Implications: From this updated review, it was found that metformin was the most widely used component of FDCs with other OHAs. Studies on the safety and efficacy of newly approved OHAs such as sodium glucose cotransporter inhibitors were limited. An increasing number of randomized trials on the safety and efficacy of newly emerging FDCs suggests that they would be better treatment options for T2DM patients.

  4. Long-term Safety of Testosterone and Growth Hormone Supplementation: A Retrospective Study of Metabolic, Cardiovascular, and Oncologic Outcomes.

    Science.gov (United States)

    Ginzburg, Enrique; Klimas, Nancy; Parvus, Chad; Life, Jeff; Willix, Robert; Barber, Michale J; Lin, Alvin; Comite, Florence

    2010-08-18

    Clinical research into the effects of hormonal supplementation has tended to focus on beneficial changes in anthropometric measures. There are fewer data on long-term safety with extended hormonal supplementation. As part of a retrospective database survey, clinical outcomes were tabulated among patients who received at least 1 year of testosterone and/or growth hormone (GH) supplementation. In patients who were treated for at least 2 years, changes in markers of glucose and lipid metabolism were analyzed with and without concomitant use of oral hypoglycemics and statins. In 263 patients (mean age 56) treated for at least 2 years, the only statistically significant effect on markers of glucose metabolism was an increase in glycated hemoglobin (still within normal limits) in patients receiving GH alone or in combination with testosterone but without oral hypoglycemics; with or without hypoglycemics, insulin levels showed no significant change. The only significant effects on markers of lipid metabolism were decreases in total cholesterol and low-density lipoprotein (LDL) in patients receiving combined testosterone and GH without statins. Decreases in LDL were significant in both the statin and non-statin groups; decreases in triglycerides were significant only in the statin group. In 531 patients treated for at least 1 year (mean age 54), the overall incidence of adverse clinical outcomes (prostate disease, diabetes, cardiovascular disease, cancer) was 1.3%. In this retrospective survey, extended testosterone and/or GH supplementation did not adversely affect metabolic markers or clinical outcomes. Safety; Testosterone; Growth hormone; Supplementation.

  5. Systematic review: the effects of long-term proton pump inhibitor use on serum gastrin levels and gastric histology.

    Science.gov (United States)

    Lundell, L; Vieth, M; Gibson, F; Nagy, P; Kahrilas, P J

    2015-09-01

    Proton pump inhibitors (PPIs) have a well-established safety profile. However, concerns have been raised about a potential relationship between PPI-induced hypergastrinaemia and the development of enterochromaffin-like (ECL) cell hyperplasia, neuroendocrine tumours and gastric cancer during long-term therapy. To review the effects of long-term PPI use on serum gastrin levels and gastric histopathology. A systematic literature search was conducted in PubMed on 21 April 2015 to identify studies reporting the effects of long-term (defined as >3 years) PPI use on gastrin levels and gastric histopathology. A total of 16 studies (1920 patients) met the inclusion criteria. During long-term PPI therapy, mean gastrin levels rose to one to three times the upper limit of the normal range (~100 pg/mL), and an increased prevalence of ECL cell hyperplasia was observed (+7.8-52.0%). Helicobacter pylori-positive patients had a significantly increased risk of developing ECL linear/micronodular hyperplasia compared with H. pylori-negative patients [OR: 2.45 (95% CI: 1.47-4.10), P = 0.0006]; however, no evidence of neoplastic changes was found. The risk of corpus atrophy was markedly higher in H. pylori-positive patients than in H. pylori-negative patients [OR: 11.45 (95% CI: 6.25-20.99), P < 0.00001]. Not a single case of gastric adenocarcinoma was found. Long-term PPI therapy induced moderate hypergastrinaemia in most patients and an increased prevalence of ECL cell hyperplasia. H. pylori-positive patients receiving long-term PPI therapy were exposed to a higher risk of corpus atrophy than H. pylori-negative patients. No neuroendocrine tumours or gastric cancers were found. © 2015 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  6. Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer

    DEFF Research Database (Denmark)

    Tombal, Bertrand; Borre, Michael; Rathenborg, Per

    2015-01-01

    patients with metastases at baseline, 13 (50%) had a complete and four (15.4%) had a partial response as best overall tumor response up to 97 wk on treatment. There was overall maintenance of total-body bone mineral density (BMD) and moderate changes in lean and fat body mass at 49 and 97 wk. The most......BACKGROUND: Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer (HNPC) showed a high response rate...... for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability. OBJECTIVE: To determine the long-term efficacy and safety of enzalutamide monotherapy at 1 and 2 yr. DESIGN, SETTING, AND PARTICIPANTS: Open-label, single...

  7. Execution and evaluation of safety reviews in Schleswig-Holstein; Durchfuehrung und Bewertung von Sicherheitsueberpruefungen in Schleswig-Holstein

    Energy Technology Data Exchange (ETDEWEB)

    Glaser, H.; Scharlaug, F.H. [Ministerium fuer Soziales, Gesundheit, Familie, Jugend und Senioren des Landes Schleswig-Holstein, Kiel (Germany). Abt. VIII 6 - Reaktorsicherheit und Strahlenschutz

    2008-05-15

    The obligations contained in the operating permits of the Brokdorf (KBR) and Kruemmel (KKK) nuclear power stations, and Sec.19a of the Atomic Energy Act as amended on April 22, 2002, require safety reviews of the complete plants of KBR, KKK, and KKB Brunsbuettel to be conducted in time before a period of ten years has elapsed. The respective state of the art, operating experience, and advanced development of safety technology must be taken into account in this effort. Experience in conducting safety reviews has been available in Schleswig-Holstein since early 1989. In the interest of uniform evaluation of the safety reviews of the KRB, KKK, and KKB plants, the competent technical unit of the Schleswig-Holstein supervisory and licensing authority elaborated the main criteria for the scope of the analysis, the representation and evaluation of results in the light of the 'Guideline of Probabilistic Safety Analyses' adopted by the Safety Analyses of Nuclear Power Plants Working Party, and compiled it in an internal evaluation guideline. This serves to conduct a regular, transparent procedure limited in time and based on uniform, clear evaluation criteria. For level 1 and 2 PSA, for instance, the objective defined states that the core damage frequency must be on the order of 1E-05/a or lower, and the frequency of large early releases must be one order of magnitude (1E-06/a) less probable. The MSGF, with the assistance of expert consultants, seeks to perform the safety review and its final evaluation within two years after filing. If required, appropriate improvements must be proposed on the basis of this evaluation. In demonstrating that the goals of protection were complied with, the findings of the evaluation of plant operation as well as of deterministic and probabilistic analyses must be taken into account. The findings resulting from the review will be summarized by the MSGF in a report open to the public. (orig.)

  8. Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

    Directory of Open Access Journals (Sweden)

    Matricciani Lisa

    2011-12-01

    Full Text Available Abstract Background Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. Methods The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science was undertaken (6/1/11. The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. Results The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. Conclusions This review indicates that there is good evidence (Level II to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of

  9. GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS

    Directory of Open Access Journals (Sweden)

    R. V. Denisova

    2012-01-01

    Full Text Available The article represents the results of efficacy and safety evaluation of the human monoclonal antibodies — golimumab, according to the data of international multicenter randomized double-blind placebo-controlled trials, including patients with active stage of rheumatoid arthritis. It was shown, that golimumab was reliably more effective than placebo both when administered hypodermic and intravenous. The safety profile of golimumab is comparable to that of the other tumor necrosis factor alpha blockers. The review also contains information on the 3d phase of golimumab efficacy and safety research in patients with juvenile idiopathic arthritis.

  10. A detailed review of hip reduction maneuvers: a focus on physician safety and introduction of the Waddell technique

    Directory of Open Access Journals (Sweden)

    Bradford S. Waddell

    2016-03-01

    Full Text Available Dislocation of the hip is a well-described event that occurs in conjunction with highenergy trauma or postoperatively after total hip arthroplasty. Bigelow first described closed treatment of a dislocated hip in 1870, and in the last decade many reduction techniques have been proposed. In this article, we review all described techniques for the reduction of hip dislocation while focusing on physician safety. Furthermore, we introduce a modified technique for the reduction of posterior hip dislocation that allows the physician to adhere to the back safety principles set for by the Occupational Safety and Health Administration.

  11. Safety review and stress test of the uranium enrichment facility Gronau; Compact. Sicherheitsueberpruefung und Stresstest der Urananreicherungsanlage Gronau

    Energy Technology Data Exchange (ETDEWEB)

    Kleiboemer, Burkhard [URENCO Deutschland GmbH, Gronau (Germany). Ueberwachung

    2013-07-01

    As a consequence of the earthquake and tsunami in Japan in 2011 and the subsequent catastrophic destruction of the nuclear power plant in Fukushima URENCO has agreed to perform the safety check of the uranium enrichment facility Gronau (UAG) two years earlier than planned. The review was started in May 2011. The contribution deals with the requirements for the safety analysis and the questionnaire for the stress test, the methodology for realization of the safety check and the results of the investigations performed by URENCO and experts of ESK.

  12. Long-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study.

    Science.gov (United States)

    O'Connor, Paul; Comi, Giancarlo; Freedman, Mark S; Miller, Aaron E; Kappos, Ludwig; Bouchard, Jean-Pierre; Lebrun-Frenay, Christine; Mares, Jan; Benamor, Myriam; Thangavelu, Karthinathan; Liang, Jinjun; Truffinet, Philippe; Lawson, Victoria J; Wolinsky, Jerry S

    2016-03-08

    To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg. By June 2013, median (maximum) teriflunomide exposure exceeded 190 (325) weeks per patient; 468 patients (63%) remained on treatment. Teriflunomide was well-tolerated with continued exposure. The most common adverse events (AEs) matched those in the core study. In extension year 1, first AEs of transient liver enzyme increases or reversible hair thinning were generally attributable to patients switching from placebo to teriflunomide. Approximately 11% of patients discontinued treatment owing to AEs. Twenty percent of patients experienced serious AEs. There were 3 deaths unrelated to teriflunomide. Soon after the extension started, annualized relapse rates and gadolinium-enhancing T1 lesion counts fell in patients switching from placebo to teriflunomide, remaining low thereafter. Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48). In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years. Disease activity decreased in patients switching from placebo and remained low in patients continuing on teriflunomide. This study provides Class III evidence that long-term treatment with teriflunomide is well-tolerated and efficacy of teriflunomide is maintained long-term. © 2016 American Academy of Neurology.

  13. Methodological aspects in the assessment of safety culture in the hospital setting: a review of the literature.

    Science.gov (United States)

    Pumar-Méndez, María J; Attree, Moira; Wakefield, Ann

    2014-02-01

    A thematic literature review was undertaken to identify methodological aspects in the assessment of safety culture and critically examine how these have been addressed in hospital-based studies of safety culture, for the period 1999-2012. The literature search included an electronic database search (BNI, CINAHL, EMBASE, MEDLINE and PsycINFO), access to websites of organizations dedicated to the enhancement of patient safety, and a manual search of reference lists of the papers included. The analysis of the 43 records included in the review revealed that discussion regarding the measurement of safety culture in the hospital setting revolves around three methodological areas, namely: research approaches; survey tools for data collection; and levels of data aggregation. To advance these discussions, robust research is needed to clarify what dimensions belong to the core of safety culture and what the main sources of safety culture variability are. Studies using a mixed methods approach to assess safety culture would be useful, since they permit the in-depth research necessary to depict the multiple components of this construct. © 2014.

  14. Reviewing the Evidence Base for the Children and Young People Safety Thermometer (CYPST: A Mixed Studies Review

    Directory of Open Access Journals (Sweden)

    Lydia Aston

    2016-01-01

    Full Text Available The objective was to identify evidence to support use of specific harms for the development of a children and young people’s safety thermometer (CYPST. We searched PubMed, Web of Knowledge, and Cochrane Library post-1999 for studies in pediatric settings about pain, skin integrity, extravasation injury, and use of pediatric early warning scores (PEWS. Following screening, nine relevant articles were included. Convergent synthesis methods were used drawing on thematic analysis to combine findings from studies using a range of methods (qualitative, quantitative, and mixed methods. A review of PEWS was identified so other studies on this issue were excluded. No relevant studies about extravasation injury were identified. The synthesized results therefore focused on pain and skin integrity. Measurement and perception of pain were complex and not always carried out according to best practice. Skin abrasions were common and mostly associated with device related injuries. The findings demonstrate a need for further work on perceptions of pain and effective communication of concerns about pain between parents and nursing staff. Strategies for reducing device-related injuries warrant further research focusing on prevention. Together with the review of PEWS, these synthesized findings support the inclusion of pain, skin integrity, and PEWS in the CYPST.

  15. Efficacy and safety of nimodipine in treatment of vascular dementia: a systematic review

    Directory of Open Access Journals (Sweden)

    Tao CHEN

    2015-07-01

    Full Text Available Objective To systematically evaluate the clinical efficacy and safety of nimodipine in treating vascular dementia (VaD.  Methods Taking "nimodipine AND vascular dementia" as search terms, retrieve in databases such as PubMed, Cochrane Library, EMBASE/SCOPUS, Science Citation Index (SCI, China National Knowledge Infrastructure (CNKI, VIP and Wanfang Data (January 1995-March 2015. Annual searching was applied to retrieve partial periodical literatures and unpublished studies. Google Scholar was used for randomized controlled trials (RCTs about nimodipine in treating VaD. Jadad scale was used to evaluate the quality of literature, and Meta-analyses were performed by using RevMan 5.3 software.  Results Eleven literatures met inclusion criteria, including 10 clinical studies (1333 patients. All 10 studies were RCTs, including 4 nimodipine vs placebo, 5 nimodipine vs donepezil and one nimodipne vs hydergine, but only 2 described randomization methods. The results of Meta-analysis showed: nimodipine had better Mini-Mental State Examination (MMSE score than before treatment and placebo group (3 studies, MD = 0.270, 95%CI: 0.070—0.460, P = 0.007; one study of blank control, MD = 2.950, 95% CI: 1.670—4.200, P = 0.000. Patients treated with nimodipne had no significantly improved Activities of Daily Living (ADL score than placebo group [one study of ADL, MD = 5.800, 95%CI: 2.480—9.120, P = 0.000; one study of ADL Index, MD = -0.040, 95%CI: -0.110—0.030, P = 0.230; one study of instrumental ADL (IADL, MD = -0.080, 95%CI: -0.110—0.000, P = 0.060]. Both nimodipine and donepezil can improve MMSE and ADL scores, but the efficacy of nimodipine was not superior to donepezil [4 studies of MMSE (12-week observation, MD = -4.400, 95% CI: -4.870— -3.920, P = 0.000; one study of MMSE (24-week observation, MD = -8.800, 95% CI: -8.970— -7.430, P = 0.000; 2 studies of ADL, MD = 1.800, 95% CI: 1.360—2.230, P = 0.000]. Compared with hydergine

  16. The Clinical Efficacy and Safety of Tulsi in Humans: A Systematic Review of the Literature

    Directory of Open Access Journals (Sweden)

    Negar Jamshidi

    2017-01-01

    Full Text Available Tulsi, also known as holy basil, is indigenous to the Indian continent and highly revered for its medicinal uses within the Ayurvedic and Siddha medical systems. Many in vitro, animal and human studies attest to tulsi having multiple therapeutic actions including adaptogenic, antimicrobial, anti-inflammatory, cardioprotective, and immunomodulatory effects, yet to date there are no systematic reviews of human research on tulsi’s clinical efficacy and safety. We conducted a comprehensive literature review of human studies that reported on a clinical outcome after ingestion of tulsi. We searched for studies published in books, theses, conference proceedings, and electronic databases including Cochrane Library, Google Scholar, Embase, Medline, PubMed, Science Direct, and Indian Medical databases. A total of 24 studies were identified that reported therapeutic effects on metabolic disorders, cardiovascular disease, immunity, and neurocognition. All studies reported favourable clinical outcomes with no studies reporting any significant adverse events. The reviewed studies reinforce traditional uses and suggest tulsi is an effective treatment for lifestyle-related chronic diseases including diabetes, metabolic syndrome, and psychological stress. Further studies are required to explore mechanisms of action, clarify the dosage and dose form, and determine the populations most likely to benefit from tulsi’s therapeutic effects.

  17. Evaluation of the antipsychotic medication review process at four long-term facilities in Alberta

    Directory of Open Access Journals (Sweden)

    Birney A

    2016-10-01

    Full Text Available Arden Birney,1 Paola Charland,1 Mollie Cole,2 Mubashir Aslam Arain1 1Workforce Research & Evaluation, 2Seniors Health Strategic Clinical Network, Alberta Health Services, Calgary, AB, Canada Purpose: The goal of this evaluation was to understand how four long-term care (LTC ­facilities in Alberta have implemented medication reviews for the Appropriate Use of Antipsychotics (AUA initiative. We aimed to determine how interprofessional (IP collaboration was incorporated in the antipsychotic medication reviews and how the reviews had been sustained.Methods: Four LTC facilities in Alberta participated in this evaluation. We conducted semistructured interviews with 18 facility staff and observed one antipsychotic medication review at each facility. We analyzed data according to the following key components that we identified as relevant to the antipsychotic medication reviews: the structure of the reviews, IP interactions between the staff members, and strategies for sustaining the reviews.Results: The duration of antipsychotic medication reviews ranged from 1 to 1.5 hours. The number of professions in attendance ranged from 3 to 9; a pharmacist led the review at two sites, while a registered nurse led the review at one site and a nurse practitioner at the remaining site. The number of residents discussed during the review ranged from 6 to 20. The process at some facilities was highly IP, demonstrating each of the six IP competencies. Other facilities conducted the review in a less IP manner due to challenges of physician involvement and staff workload, particularly of health care aides. Facilities that had a nurse practitioner on site were more efficient with the process of implementing recommendations resulting from the medication reviews.Conclusion: The LTC facilities were successful in implementing the medication review process and the process seemed to be sustainable. A few challenges were observed in the implementation process at two facilities

  18. Duodopa® treatment for advanced Parkinson's disease: a review of efficacy and safety.

    Science.gov (United States)

    Nyholm, Dag

    2012-09-01

    Enterally administered levodopa/carbidopa gel (Duodopa®) is used for the treatment of advanced Parkinson's disease (PD) in patients with motor fluctuations and dyskinesias. This review summarizes the current efficacy and safety data on this drug. Clinically important differences (CID) have been used to assess whether statistical improvements in symptoms translate into meaningful improvements for the patients. A PubMed search in February 2012 found 23 papers with efficacy data and 33 with safety data. Of 11 studies reporting Unified Parkinson's Disease Rating Scale (UPDRS) III scores, 10 found improvements that met the CID of 10.8 points. Of 7 studies reporting UPDRS IV scores, 5 found improvements meeting the CID of 2.3 points. Quality of life (QoL) was assessed in 6 studies using the 8- or 39-question version of the Parkinson's disease Questionnaire, and all reported improvements meeting the CID (10 points). Due to the nature of the data, it is not possible to give exact numbers for the frequency of adverse events. However, the findings seem to be in line with a previous report stating the majority of adverse events were related to the infusion system or surgical procedure rather than the drug. In conclusion, the large majority of studies have reported that Duodopa® is clinically effective in relieving the symptoms of advanced PD and improving QoL in comparison with conventional therapy. High-quality randomized trials with larger patient numbers will yield greater insights into the efficacy and safety of this treatment. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Safety, tolerability, and risks associated with first- and second-generation antipsychotics: a state-of-the-art clinical review

    Directory of Open Access Journals (Sweden)

    Solmi M

    2017-06-01

    -generation antipsychotics (SGAs ushered in a progressive shift from the paternalistic management of SMI symptoms to a patient-centered approach, which emphasized targets important to patients – psychosocial functioning, quality of life, and recovery. These drugs are no longer limited to specific Diagnostic and Statistical Manual of Mental Disorders (DSM categories. Evidence indicates that SGAs show an improved safety and tolerability profile compared with FGAs. The incidence of treatment-emergent extrapyramidal side effects is lower, and there is less impairment of cognitive function and treatment-related negative symptoms. However, treatment with SGAs has been associated with a wide range of untoward effects, among which treatment-emergent weight gain and metabolic abnormalities are of notable concern. The present clinical review aims to summarize the safety and tolerability profile of selected FGAs and SGAs and to link treatment-related adverse effects to the pharmacodynamic profile of each drug. Evidence, predominantly derived from systematic reviews, meta-analyses, and clinical trials of the drugs amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, sertindole, ziprasidone, CPZ, haloperidol, loxapine, and perphenazine, is summarized. In addition, the safety and tolerability profiles of antipsychotics are discussed in the context of the “behavioral toxicity” conceptual framework, which considers the longitudinal course and the clinical and therapeutic consequences of treatment-emergent side effects. In SMI, SGAs with safer metabolic profiles should ideally be prescribed first. However, alongside with safety, efficacy should also be considered on a patient-tailored basis. Keywords: antipsychotics, side effects, tolerability, safety, psychosis, psychiatry

  20. Development of nuclear fuel cycle technologies - bases of long-term provision of fuel and environmental safety of nuclear power

    Energy Technology Data Exchange (ETDEWEB)

    Solonin, M.I.; Polyakov, A.S.; Zakharkin, B.S.; Smelov, V.S.; Nenarokomov, E.A.; Mukhin, I.V. [SSC, RF, A.A. Bochvar ALL-Russia Research Institute of Inorganic Materials, Moscow (Russian Federation)

    2000-07-01

    To-day nuclear power is one of the options, however, to-morrow it may become the main source of the energy, thus, providing for the stable economic development for the long time to come. The availability of the large-scale nuclear power in the foreseeable future is governed by not only the safe operation of nuclear power plants (NPP) but also by the environmentally safe management of spent nuclear fuel, radioactive waste conditioning and long-term storage. More emphasis is to be placed to the closing of the fuel cycle in view of substantial quantities of spent nuclear fuel arisings. The once-through fuel cycle that is cost effective at the moment cannot be considered to be environmentally safe even for the middle term since the substantial build-up of spent nuclear fuel containing thousands of tons Pu will require the resolution of the safe management problem in the nearest future and is absolutely unjustified in terms of moral ethics as a transfer of the responsibility to future generations. The minimization of radioactive waste arisings and its radioactivity is only feasible with the closed fuel cycle put into practice and some actinides and long-lived fission radionuclides burnt out. The key issues in providing the environmentally safe fuel cycle are efficient processes of producing fuel for NPP, radionuclide after-burning included, a long-term spent nuclear fuel storage and reprocessing as well as radioactive waste management. The paper deals with the problems inherent in producing fuel for NPP with a view for the closed fuel cycle. Also discussed are options of the fuel cycle, its effectiveness and environmental safety with improvements in technologies of spent nuclear fuel reprocessing and long-lived radionuclide partitioning. (authors)

  1. Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes

    Directory of Open Access Journals (Sweden)

    Ahmadi H

    2014-07-01

    Full Text Available Hamed Ahmadi, Siamak Daneshmand Institute of Urology, University of Southern California, Los Angeles, CA, USA Abstract: Androgen deprivation therapy (ADT constitutes the first-line treatment for patients with locally advanced tumors, recurrent or metastatic disease. Given its widespread use, clinicians should be familiar with common side effects of this treatment. This review focuses on common side effects of ADT and available treatment options to control the side effects. Also, it briefly compares continuous ADT with other therapeutic approaches for androgen deprivation in prostate cancer patients. Similar to hormonal medications, newer non-hormonal therapeutic options including gabapentin and acupuncture have at best moderate effect in controlling hot flashes in patients on ADT. Supervised and/or home exercise programs significantly improve ADT-related fatigue, metabolic/cardiovascular side effects, and cognitive dysfunction. Denosumab, a human monoclonal antibody against RANK-L, is more effective than bisphosphonates in preventing skeletal-related events in patients with metastatic or castrate-resistant prostate cancer and unlike bisphosphonates, it can also reduce the risk of vertebral fractures in men receiving ADT for non-metastatic prostate cancer. Toremifene, a selective estrogen receptor inhibitor, has dual beneficial effects on ADT-related osteoporosis and metabolic dysfunction. Metformin coupled with lifestyle modification is also a well-tolerated treatment for metabolic changes during ADT. While producing similar oncological outcomes, intermittent ADT is associated with higher quality of life in patients under ADT by improving bone health, less metabolic and hematologic complications, and fewer hot flashes and sexual dysfunction events. Keywords: prostate cancer, androgen deprivation therapy, adverse effects, therapy

  2. Is a community still a community? Reviewing definitions of key terms in community ecology.

    Science.gov (United States)

    Stroud, James T; Bush, Michael R; Ladd, Mark C; Nowicki, Robert J; Shantz, Andrew A; Sweatman, Jennifer

    2015-11-01

    Community ecology is an inherently complicated field, confounded by the conflicting use of fundamental terms. Nearly two decades ago, Fauth et al. (1996) demonstrated that imprecise language led to the virtual synonymy of important terms and so attempted to clearly define four keywords in community ecology; "community," "assemblage," "guild," and "ensemble". We revisit Fauth et al.'s conclusion and discuss how the use of these terms has changed over time since their review. An updated analysis of term definition from a selection of popular ecological textbooks suggests that definitions have drifted away from those encountered pre-1996, and slightly disagreed with results from a survey of 100 ecology professionals (comprising of academic professors, nonacademic PhDs, graduate and undergraduate biology students). Results suggest that confusion about these terms is still widespread in ecology. We conclude with clear suggestions for definitions of each term to be adopted hereafter to provide greater cohesion among research groups.

  3. Mapping patient safety: a large-scale literature review using bibliometric visualisation techniques.

    Science.gov (United States)

    Rodrigues, S P; van Eck, N J; Waltman, L; Jansen, F W

    2014-03-13

    The amount of scientific literature available is often overwhelming, making it difficult for researchers to have a good overview of the literature and to see relations between different developments. Visualisation techniques based on bibliometric data are helpful in obtaining an overview of the literature on complex research topics, and have been applied here to the topic of patient safety (PS). On the basis of title words and citation relations, publications in the period 2000-2010 related to PS were identified in the Scopus bibliographic database. A visualisation of the most frequently cited PS publications was produced based on direct and indirect citation relations between publications. Terms were extracted from titles and abstracts of the publications, and a visualisation of the most important terms was created. The main PS-related topics studied in the literature were identified using a technique for clustering publications and terms. A total of 8480 publications were identified, of which the 1462 most frequently cited ones were included in the visualisation. The publications were clustered into 19 clusters, which were grouped into three categories: (1) magnitude of PS problems (42% of all included publications); (2) PS risk factors (31%) and (3) implementation of solutions (19%). In the visualisation of PS-related terms, five clusters were identified: (1) medication; (2) measuring harm; (3) PS culture; (4) physician; (5) training, education and communication. Both analysis at publication and term level indicate an increasing focus on risk factors. A bibliometric visualisation approach makes it possible to analyse large amounts of literature. This approach is very useful for improving one's understanding of a complex research topic such as PS and for suggesting new research directions or alternative research priorities. For PS research, the approach suggests that more research on implementing PS improvement initiatives might be needed.

  4. Long-term safety and efficacy of fractionated stereotactic body radiation therapy for spinal metastases

    Energy Technology Data Exchange (ETDEWEB)

    Mantel, Frederick; Glatz, Stefan; Toussaint, Andre; Flentje, Michael; Guckenberger, Matthias [University Hospital Wuerzburg, Department of Radiation Oncology, Wuerzburg (Germany)

    2014-12-15

    Patients with long life expectancy despite metastatic status might benefit from long-term local control of spinal metastases. Dose-intensified radiotherapy (RT) is believed to control tumor growth better and thus offers longer pain relief. This single-institution study reports on fractionated stereotactic body radiation therapy (SBRT) for spinal metastases in patients with good life expectancy based on performance status, extent of metastases, histology, and time to metastasis. Between 2004 and 2010, 36 treatment sites in 32 patients (median age 55 years; male 61 %; median Karnofsky performance score 85) were treated with fractionated SBRT. The median treatment dose was 60 Gy (range, 48.5-65 Gy) given in a median of 20 fractions (range, 17-33); the median maximum dose to the planning risk volume for the spinal cord (PRV-SC) was 46.6 Gy. All patients suffering from pain prior to RT reported pain relief after treatment; after a median follow-up of 20.3 months, 61 % of treatment sites were pain-free, another 25 % associated with mild pain. In 86 % of treatments, patients were free from neurological symptoms at the time of the last clinical follow-up. Acute grade 1 toxicities (CTCAE 3.0) were observed in 11 patients. Myelopathy did not occur in any patient. Radiologically controlled freedom from local progression was 92 and 84 % after 12 and 24 months, respectively. Median overall survival (OS) was 19.6 months. Patient selection resulted in long OS despite metastatic disease, and dose-intensified fractionated SBRT for spinal metastases was safe and achieved long-term local tumor control and palliation of pain. (orig.) [German] Patienten mit guter Lebenserwartung trotz metastasierter Erkrankung koennten von einer lang andauernden lokalen Kontrolle von Wirbelsaeulenmetastasen profitieren. Eine dosisintensivierte Radiotherapie (RT) kann vermutlich eine bessere Tumorkontrolle und daher eine laengere Schmerzpalliation erreichen. Ausgewertet wurden die monozentrischen

  5. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Zhiqiang Wang

    2017-06-01

    Full Text Available Cortex Moutan (CM, a well-known traditional Chinese medicine, is commonly used for treating various diseases in China and other eastern Asian countries. Recorded in Pharmacopeias of several countries, CM is now drawing increasing attention and under extensive studies in various fields. Phytochemical studies indicate that CM contains many valuable secondary metabolites, such as monoterpene glycosides and phenols. Ample evidence from pharmacological researches suggest that CM has a wide spectrum of activities, such as anti-inflammatory, anti-oxidant, anti-tumor, anti-diabetic, cardiovascular protective, neuroprotective, hepatoprotective effects. Moreover, various analytical methods were established for the quality evaluation and safety control of CM. This review synopsizes updated information concerning the origins, phytochemistry, pharmacology, analytical method and safety of CM, aiming to provide favorable references for modern CM research and application. In conclusion, continuing pharmacological investigations concerning CM should be conducted to unravel its pharmacological mechanisms. Further researches are necessary to obtain comprehensive and applicable analytical approach for quality evaluation and establish harmonized criteria of CM.

  6. A Review and Comparative Analysis of Security Risks and Safety Measures of Mobile Health Apps

    Directory of Open Access Journals (Sweden)

    Karen Scott

    2015-11-01

    Full Text Available In line with a patient-centred model of healthcare, Mobile Health applications (mhealth apps provide convenient and equitable access to health and well-being resources and programs that can enable consumers to monitor their health related problems, understand specific medical conditions and attain personal fitness goals. This increase in access and control comes with an increase in risk and responsibility to identify and manage the associated risks, such as the privacy and security of consumers’ personal and health information. Based on a review of the literature, this paper identifies a set of risk and safety features for evaluating mHealth apps and uses those features to conduct a comparative analysis of the 20 most popular mHealth apps. The comparative analysis reveals that current mHealth apps do pose a risk to consumers. To address the safety and privacy concerns, recommendations to consumers and app developers are offered together with consideration of mHealth app future trends.

  7. Applications of hyperspectral imaging in chicken meat safety and quality detection and evaluation: a review.

    Science.gov (United States)

    Xiong, Zhenjie; Xie, Anguo; Sun, Da-Wen; Zeng, Xin-An; Liu, Dan

    2015-01-01

    Currently, the issue of food safety and quality is a great public concern. In order to satisfy the demands of consumers and obtain superior food qualities, non-destructive and fast methods are required for quality evaluation. As one of these methods, hyperspectral imaging (HSI) technique has emerged as a smart and promising analytical tool for quality evaluation purposes and has attracted much interest in non-destructive analysis of different food products. With the main advantage of combining both spectroscopy technique and imaging technique, HSI technique shows a convinced attitude to detect and evaluate chicken meat quality objectively. Moreover, developing a quality evaluation system based on HSI technology would bring economic benefits to the chicken meat industry. Therefore, in recent years, many studies have been conducted on using HSI technology for the safety and quality detection and evaluation of chicken meat. The aim of this review is thus to give a detailed overview about HSI and focus on the recently developed methods exerted in HSI technology developed for microbiological spoilage detection and quality classification of chicken meat. Moreover, the usefulness of HSI technique for detecting fecal contamination and bone fragments of chicken carcasses are presented. Finally, some viewpoints on its future research and applicability in the modern poultry industry are proposed.

  8. Safety of oral midazolam sedation use in paediatric dentistry: a review.

    Science.gov (United States)

    Papineni, Arathi; Lourenço-Matharu, Liege; Ashley, Paul F

    2014-01-01

    Little information is available as to the safety of midazolam when used as an oral sedative. To evaluate the side effects and other adverse outcomes following use of oral midazolam for behaviour management in paediatric dentistry. A review of published literature relating to the safety and side effects of oral midazolam for use in paediatric dental procedures was conducted. Both randomised controlled trials and non-randomised studies were assessed. Reported side effects were recorded and classified as either significant or minor. The percentage prevalence of significant or minor side effects per episode of treatment was calculated. Sixteen papers of randomised controlled trials met the inclusion criteria. None of the side effects recorded were considered as significant. Minor side effects were reported (n = 68, 14%), with nausea and vomiting being the most frequently recorded (n = 30, 6%). Eleven papers of non-randomised studies were included. No significant side effects were recorded. Minor side effects were recorded (n = 157, 8%), with paradoxical reaction being the most common at 3.8%. Significant side effects associated with oral midazolam usage for behaviour management in children and adolescents requiring dental treatment appear to be rare. Minor side effects are more common but determining precise figures is complicated by poor reporting. © 2012 John Wiley & Sons Ltd, BSPD and IAPD.

  9. Cleaning and asthma: A systematic review and approach for effective safety assessment.

    Science.gov (United States)

    Vincent, Melissa J; Parker, Ann; Maier, Andrew

    2017-11-01

    Research indicates a correlative relationship between asthma and use of consumer cleaning products. We conduct a systematic review of epidemiological literature on persons who use or are exposed to cleaning products, both in occupational and domestic settings, and risk of asthma or asthma-like symptoms to improve understanding of the causal relationship between exposure and asthma. A scoring method for assessing study reliability is presented. Although research indicates an association between asthma and the use of cleaning products, no study robustly investigates exposure to cleaning products or ingredients along with asthma risk. This limits determination of causal relationships between asthma and specific products or ingredients in chemical safety assessment. These limitations, and a lack of robust animal models for toxicological assessment of asthma, create the need for a weight-of-evidence (WoE) approach to examine an ingredient or product's asthmatic potential. This proposed WoE method organizes diverse lines of data (i.e., asthma, sensitization, and irritation information) through a systematic, hierarchical framework that provides qualitatively categorized conclusions using hazard bands to predict a specific product or ingredient's potential for asthma induction. This work provides a method for prioritizing chemicals as a first step for quantitative and scenario-specific safety assessments based on their potential for inducing asthmatic effects. Acetic acid is used as a case study to test this framework. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Shelf life and safety concerns of bakery products--a review.

    Science.gov (United States)

    Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

    2004-01-01

    Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

  11. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew): A Systematic Review.

    Science.gov (United States)

    Wang, Zhiqiang; He, Chunnian; Peng, Yong; Chen, Feihu; Xiao, Peigen

    2017-06-07

    Cortex Moutan (CM), a well-known traditional Chinese medicine, is commonly used for treating various diseases in China and other eastern Asian countries. Recorded in Pharmacopeias of several countries, CM is now drawing increasing attention and under extensive studies in various fields. Phytochemical studies indicate that CM contains many valuable secondary metabolites, such as monoterpene glycosides and phenols. Ample evidence from pharmacological researches suggest that CM has a wide spectrum of activities, such as anti-inflammatory, anti-oxidant, anti-tumor, anti-diabetic, cardiovascular protective, neuroprotective, hepatoprotective effects. Moreover, various analytical methods were established for the quality evaluation and safety control of CM. This review synopsizes updated information concerning the origins, phytochemistry, pharmacology, analytical method and safety of CM, aiming to provide favorable references for modern CM research and application. In conclusion, continuing pharmacological investigations concerning CM should be conducted to unravel its pharmacological mechanisms. Further researches are necessary to obtain comprehensive and applicable analytical approach for quality evaluation and establish harmonized criteria of CM.

  12. Micro-Encapsulated Phase Change Materials: A Review of Encapsulation, Safety and Thermal Characteristics

    Directory of Open Access Journals (Sweden)

    Ahmed Hassan

    2016-10-01

    Full Text Available Phase change materials (PCMs have been identified as potential candidates for building energy optimization by increasing the thermal mass of buildings. The increased thermal mass results in a drop in the cooling/heating loads, thus decreasing the energy demand in buildings. However, direct incorporation of PCMs into building elements undermines their structural performance, thereby posing a challenge for building integrity. In order to retain/improve building structural performance, as well as improving energy performance, micro-encapsulated PCMs are integrated into building materials. The integration of microencapsulation PCMs into building materials solves the PCM leakage problem and assures a good bond with building materials to achieve better structural performance. The aim of this article is to identify the optimum micro-encapsulation methods and materials for improving the energy, structural and safety performance of buildings. The article reviews the characteristics of micro-encapsulated PCMs relevant to building integration, focusing on safety rating, structural implications, and energy performance. The article uncovers the optimum combinations of the shell (encapsulant and core (PCM materials along with encapsulation methods by evaluating their merits and demerits.

  13. [Efficacy, tolerability and safety of cannabinoids for chronic neuropathic pain: A systematic review of randomized controlled studies].

    Science.gov (United States)

    Petzke, F; Enax-Krumova, E K; Häuser, W

    2016-02-01

    Recently published systematic reviews came to different conclusions with respect to the efficacy, tolerability and safety of cannabinoids for treatment of chronic neuropathic pain. A systematic search of the literature was carried out in MEDLINE, the Cochrane central register of controlled trials (CENTRAL) and clinicaltrials.gov up until November 2015. We included double-blind randomized placebo-controlled studies (RCT) of at least 2 weeks duration and with at least 9 patients per treatment arm comparing medicinal cannabis, plant-based or synthetic cannabinoids with placebo or any other active drug treatment in patients with chronic neuropathic pain. Clinical endpoints of the analyses were efficacy (more than 30 % or 50 % reduction of pain, average pain intensity, global improvement and health-related quality of life), tolerability (drop-out rate due to side effects, central nervous system and psychiatric side effects) and safety (severe side effects). Using a random effects model absolute risk differences (RD) were calculated for categorical data and standardized mean differences (SMD) for continuous variables. The methodological quality of RCTs was rated by the Cochrane risk of bias tool. We included 15 RCTs with 1619 participants. Study duration ranged between 2 and 15 weeks. Of the studies 10 used a plant-derived oromucosal spray with tetrahydrocannabinol/cannabidiol, 3 studies used a synthetic cannabinoid (2  with nabilone and 1  with dronabinol) and 2 studies used medicinal cannabis. The 13 studies with parallel or cross-over design yielded the following results with 95 % confidence intervals (CI): cannabinoids were superior to placebo in the reduction of mean pain intensity with SMD - 0.10 (95 % CI - 0.20- - 0.00, p = 0.05, 13 studies with 1565 participants), in the frequency of at least a 30 % reduction in pain with an RD of 0.10 [95 % CI 0.03-0.16, p = 0.004, 9 studies with 1346 participants, number needed to treat for

  14. Safety concerns associated with the use of serotonin reuptake inhibitors and other serotonergic/noradrenergic antidepressants during pregnancy: a review.

    Science.gov (United States)

    Tuccori, Marco; Testi, Arianna; Antonioli, Luca; Fornai, Matteo; Montagnani, Sabrina; Ghisu, Narcisa; Colucci, Rocchina; Corona, Tiberio; Blandizzi, Corrado; Del Tacca, Mario

    2009-06-01

    There is ongoing debate about the safety of selective serotonin reuptake inhibitors (SSRIs) and other serotonergic/noradrenergic antidepressants when used during pregnancy. This article reviews the available literature on the main safety concerns associated with the use of SSRIs and other serotonergic/noradrenergic antidepressants (serotonin-norepinephrine reuptake inhibitors, norepinephrine reuptake inhibitors, noradrenergic and specific serotonergic antidepressants) during pregnancy. English-language reports of analytical and descriptive studies, including case reports, case series, and meta-analyses, were identified through searches of MEDLINE, EMBASE, and PsycINFO (1966-April 2009). The search terms were fluoxetine, paroxetine, sertraline, Citalopram, escitalopram, fluvoxamine, venlafaxine, mirtazapine, reboxetine, duloxetine, SSRI, SNRI, NaSSA, and NRI in association with depression, pregnancy, prenatal exposure, miscarriage, spontaneous abortion, malformation, in utero exposure, and neonatal complications. Paroxetine has been associated with significant risks of major malformation, particularly cardiac defects, when used during pregnancy. Significant associations between maternal exposure to SSRIs and both persistent pulmonary hypertension of the newborn and a self-limiting neonatal behavioral syndrome have been reported in a number of recent original studies and meta-analyses. Some studies have suggested a relationship between the use of SSRIs or other serotonergic/noradrenergic antidepressants and the occurrence of miscarriage, although these studies had methodologic limitations that affected the strength of the data. Evidence for a possible association between in ute