Safety of topical minoxidil solution: a one-year, prospective, observational study.

PubMed

Shapiro, Jerry

2003-01-01

Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study

PubMed Central

Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-01-01

Objective The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. Design A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. Setting 34 elderly medical wards within a northern region of England, UK. Participants Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Results Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. Conclusions This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however

Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI).

PubMed

Kuzman, Ilija; Bezlepko, Alexandr; Kondova Topuzovska, Irena; Rókusz, László; Iudina, Liudmyla; Marschall, Hans-Peter; Petri, Thomas

2014-06-30

Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n=1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n=2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from "moderate" or "severe" in 91.8% of patients at baseline to "no infection" or "mild" in 95.5% at last visit. In the safety population (n=2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. The efficacy and safety profiles of moxifloxacin at the recommended dose of 400 mg daily are characterized in this large observational study of

Comparison of food safety cognitions and self-reported food-handling behaviors with observed food safety behaviors of young adults.

PubMed

Abbot, J M; Byrd-Bredbenner, C; Schaffner, D; Bruhn, C M; Blalock, L

2009-04-01

Developing tailored and effective food safety education for young adults is critical given their future roles as caregivers likely to be preparing food for populations who may be at greater risk for foodborne disease (FBD). The objective of this study was to examine the relationship between food safety self-reported food-handling behaviors and cognitions of young adults to observed food-handling behaviors. Participants were 153 young adults (mean age 20.74+/-1.30 s.d.) attending a major American university. Each prepared a meal under observation in a controlled laboratory setting, permitted researchers to observe their home kitchen and completed an online survey assessing food safety knowledge, behavior and psychosocial measures. Descriptive statistics were generated for participants' self-reported food-handling behaviors, psychosocial characteristics, knowledge, food preparation observations and home kitchen observations. Determinants of compliance with safe food-handling procedures while preparing a meal and home food storage/rotation practices were identified using backward regression models. Participants engaged in less than half of the recommended safe food-handling practices evaluated and correctly answered only two-thirds of the food safety knowledge items. They reported positive food safety beliefs and high food safety self-efficacy. Self-reported compliance with cross-contamination prevention, disinfection procedures and knowledge of groups at greatest risk for FBD were the best measures for predicting compliance with established safe food-handling practices. Food safety education directed toward young adults should focus on increasing awareness of FBD and knowledge of proper cross-contamination prevention procedures to help promote better compliance with actual safe food handling.

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England.

PubMed

Osborne, Vicki; Davies, Miranda; Layton, Deborah; Shakir, Saad A W

2018-03-01

Deferasirox (EXJADE ® , Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated. The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2-17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine. These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.

Postauthorization safety study of Clottafact® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study.

PubMed

Négrier, C; Ducloy-Bouthors, A-S; Piriou, V; De Maistre, E; Stieltjes, N; Borel-Derlon, A; Colson, P; Picard, J; Lambert, T; Claeyssens, S; Boileau, S; Bertrand, A; André, M-H; Fourrier, F; Ozier, Y; Sié, P; Gruel, Y; Tellier, Z

2018-02-01

A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact ® in acquired fibrinogen deficiency in real-life medical practice in France. One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed. One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%). The Clottafact ® safety profile observed during the study matched the known profile of fibrinogen during use. © 2017 International Society of Blood Transfusion.

Identifying positively deviant elderly medical wards using routinely collected NHS Safety Thermometer data: an observational study.

PubMed

Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Pye, Victoria; Mohammed, Mohammed A; Lawton, Rebecca

2018-02-16

The positive deviance approach seeks to identify and learn from exceptional performers. Although a framework exists to apply positive deviance within healthcare organisations, there is limited guidance to support its implementation. The approach has also rarely explored exceptional performance on broad outcomes, been implemented at ward level, or applied within the UK. This study develops and critically appraises a pragmatic method for identifying positively deviant wards using a routinely collected, broad measure of patient safety. A two-phased observational study was conducted. During phase 1, cross-sectional and temporal analyses of Safety Thermometer data were conducted to identify a discrete group of positively deviant wards that consistently demonstrated exceptional levels of safety. A group of matched comparison wards with above average performances were also identified. During phase 2, multidisciplinary staff and patients on the positively deviant and comparison wards completed surveys to explore whether their perceptions of safety supported the identification of positively deviant wards. 34 elderly medical wards within a northern region of England, UK. Multidisciplinary staff (n=161) and patients (n=188) clustered within nine positively deviant and comparison wards. Phase 1: A combination of analyses identified five positively deviant wards that performed best in the region, outperformed their organisation and performed consistently well over 12 months. Five above average matched comparator wards were also identified. Phase 2: Staff and patient perceptions of safety generally supported the identification of positively deviant wards using Safety Thermometer data, although patient perceptions of safety were less concordant with the routinely collected data. This study tentatively supports a pragmatic method of using routinely collected data to identify positively deviant elderly medical wards; however, it also highlights the various challenges that are faced

The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

PubMed Central

Damas, Fátima; Páramo, Maria Dolores; Ruiz-Peña, Juan Luis; Navarro, Guillermo

2017-01-01

Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville’s’ (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (p<0.0001 all cases). However, patients previously treated with natalizumab kept a constant ARR. The ARR results and the consequent increase in the proportion of relapse-free patients were independent of the age at treatment initiation, number of prior treatments, gender and basal Gd+ lesions. Although fingolimod was effective regardless the basal EDSS score and ARR prior to fingolimod treatment, better outcomes were observed in patients with basal EDSS score <3 (0.2 vs. 0.4; p = 0.0244) and ARR ≥ 2 prior to fingolimod treatment (p = 0.0338). Only the basal EDSS score was association with ARR in the first 24 months of fingolimod treatment in the multivariante model (p = 0.0439). The cumulative probability of disability progression was 20% (month-24) in the total cohort, and was independent from prior treatment, age at treatment initiation, number of prior treatments

Direct observation of safety belt use in Michigan : Fall 1997

DOT National Transportation Integrated Search

1997-10-01

The present survey reports the results of a direct observation survey of safety belt use conducted in the fall of 1997. In this study, 10,307 occupants traveling in four vehicle types (oassenger cars, sport-utility vehicles, vans, and pickup trucks) ...

Direct observation of safety belt use in Michigan : Fall 2000

DOT National Transportation Integrated Search

2000-11-01

Reported here are the results of a direct observation survey of safety belt use conducted in the fall of 2000. In this study, 14,366 occupants traveling in four vehicle types (passenger cars, sport-utility vehicles, vans/minivans, and pickup trucks) ...

Direct observation of safety belt use in Michigan : Fall 1998

DOT National Transportation Integrated Search

1998-10-01

Reported here are the results of a direct observation survey of safety belt use conducted in the fall of 1998. In this study, 11,413 occupants traveling in four vehicle types (passenger cars, sport utility vehicles, vans/minvans, and pickup trucks) w...

Direct observation of safety belt use in Michigan : Fall 1999

DOT National Transportation Integrated Search

1999-01-01

Reported here are the results of a direct observation survey of safety belt use conducted in the fall of 1999. In this study, 9,414 occupants traveling in four vehicle types (passenger cars, sport-utility vehicles, vans/minivans, and pickup trucks) w...

Safety aspects of lipidapheresis using DALI and MONET - Multicenter observational study.

PubMed

Kozik-Jaromin, Justyna; Röseler, Eberhard; Heigl, Franz; Spitthöver, Ralf; Ringel, Jens; Schmitz, Gerd; Heinzler, Rainer; Abdul-Rahman, Nadim; Leistikow, Frank; Himmelsbach, Frido; Schettler, Volker; Uhlenbusch-Körwer, Ingrid; Ramlow, Wolfgang

2017-11-01

Lipidapheresis was introduced for intractable hyperlipidemia as a more selective therapy than plasma exchange aiming to enhance efficacy and limit side-effects. Although this therapy is regarded safe, multicenter data from routine application are limited. We investigated direct adsorption of lipoproteins (DALI) and lipofiltration (MONET) regarding the short and the long-term safety aspects. This multicenter observational study prospectively evaluated 2154 DALI and 1297 MONET sessions of 122 patients during a period of 2 years. Safety parameters included clinical side-effects (adverse device effects, ADEs), technical complications, blood pressure and pulse rate. Also routinely performed laboratory parameters were documented. Analysis of laboratory parameters was not corrected for blood dilution. Overall 0.4% DALI and 0.5% MONET treatments were affected by ADE. Technical complications occurred in 2.1% and in 0.8% DALI and MONET sessions, respectively. The most frequent ADE was hypotension, and the majority of technical problems were related to vascular access. Both types of treatments led to a drop of thrombocytes in the range of 7-8%. Hematocrit and erythrocytes decreased only during the DALI treatments by about 6%. Leucocytes decreased during the DALI therapy (∼15%), whereas they increased during the MONET application (∼11%). MONET treatment was associated with a higher reduction of proteins (fibrinogen: 58% vs. 23%, albumin: 12% vs. 7%, CRP: 33% vs. 19% for MONET and DALI, respectively). Apart from severe thrombocytopenia in two DALI patients, changes of other parameters were typically transient. Under routine use the frequency of side-effects was low. Still, monitoring of blood count and proteins in chronic apheresis patients is recommended. Copyright © 2017. Published by Elsevier B.V.

Distracted Biking: An Observational Study.

PubMed

Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J

2016-01-01

Commuting via bicycle is a very popular mode of transportation in the Northeastern United States. Boston, MA, has seen a rapid increase in bicycle ridership over the past decade, which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at 4 high traffic intersections in Boston during various peak commuting hours for 2 types of distractions: auditory (earbuds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%), 95% CI [29, 33%], were distracted. Of those observed, auditory distractions were the most common (N = 349; 17.7%), 95% CI [16, 19], p = .0003, followed by visual/tactile distractions (N = 266; 13.5%), 95% CI [12, 15]. The highest proportion (40.7%), 95% CI [35, 46], of distracted bicyclists was observed during the midday commute (between 13:30 and 15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost a third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured.

The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

PubMed

Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

2010-02-01

The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

Distracted Biking: An Observational Study

PubMed Central

Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J.

2016-01-01

Commuting via bicycle is a very popular mode of transportation in the Northeastern United States (US). Boston, MA has seen a rapid increase in bicycle ridership over the past decade which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at four high traffic intersections in Boston during various peak commuting hours for two types of distractions: auditory (ear buds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%, 95% CI: 29%-33%) were distracted. Of those observed, auditory distractions were the most common (N= 349 [17.7%, 95% CI: 16%-19%], p=0.0003) followed by visual/tactile distractions (N= 266 [13.5%, 95% CI: 12%-15%]). The highest proportion (40.7%, 95% CI: 35%-46%) of distracted bicyclists was observed during the midday commute (between 13:30-15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost one-third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured. PMID:26953533

Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study.

PubMed

Watanabe, Junichiro; Ito, Yoshinori; Ohsumi, Shozo; Mizutani, Mitsuhiro; Tashiro, Hideya; Sakurai, Kenichi; Takahashi, Masato; Saito, Tsuyoshi; Tsurutani, Junji; Mukai, Hirofumi; Yoshinami, Tetsuhiro; Takao, Shintaro; Yamamoto, Yasuhisa; Matsuoka, Toshiyuki; Iwase, Hirotaka; Iwata, Hiroji; Nakamura, Seigo; Saeki, Toshiaki

2017-12-01

Background This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible patients with inoperable or recurrent breast cancer receiving eribulin for the first time were centrally registered and observed for 1 year. Eribulin was administered intravenously (1.4 mg/m 2 ) on days 1 and 8 of every 3-week cycle. The primary endpoint was the frequency and intensity of adverse drug reactions (ADRs). Secondary endpoints included overall response rate (ORR) and time to treatment failure (TTF). Results Of 968 patients registered at 325 institutions, 951 and 671 were included in the safety and effectiveness analyses, respectively. In the safety population, ADRs were observed in 841 patients (88.4%). The most common (≥15% incidence) were neutropenia (66.6%), leukopenia (62.4%), lymphopenia (18.4%), and peripheral neuropathy (16.8%). The most common grade ≥ 3 ADRs (>5% incidence) were neutropenia (59.8%), leukopenia (50.5%), lymphopenia (16.1%), and febrile neutropenia (7.7%). In the effectiveness population, ORR was 16.5% (95% confidence interval: 13.7, 19.4). The median TTF was 127 days (95% confidence interval: 120, 134). Conclusions The safety and effectiveness profile of eribulin was consistent with prior studies. Eribulin had a favorable risk-benefit balance when used in real-world clinical settings.

Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

PubMed

Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

2017-11-01

Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

Stiripentol efficacy and safety in Dravet syndrome: a 12-year observational study.

PubMed

Myers, Kenneth A; Lightfoot, Paul; Patil, Shekhar G; Cross, J Helen; Scheffer, Ingrid E

2018-06-01

To assess long-term safety and efficacy of stiripentol as an antiepileptic medication for people with Dravet syndrome. A prospective, observational open-label study (2003-2015) of the efficacy and long-term safety of stiripentol in patients with Dravet syndrome and ongoing seizures. Frequency of generalized tonic-clonic seizures, focal seizures, status epilepticus, and adverse events were recorded. Forty-one patients started stiripentol, with median age at enrolment 5 years 7 months (range 11mo-22y) and median duration of treatment 37 months (range 2-141mo). Twenty out of 41 patients had greater than or equal to 50% long-term reduction in frequency of generalized tonic-clonic seizures. Frequency of focal seizures was decreased by greater than or equal to 50% in 11 out of 23 patients over the long-term. Frequency of status epilepticus was decreased by 50% or more in 11 out of 26 patients. The most common adverse events were anorexia, weight loss, sedation, and behavioural changes. One patient had worsening of absence and myoclonic seizures. Another developed recurrent pancreatitis on concurrent valproate. Stiripentol improves long-term seizure frequency in approximately 50% of patients with Dravet syndrome, when used as part of unrestricted polytherapy. Long-term use appears safe. In more than 40% of patients, episodes of status epilepticus markedly decrease after stiripentol initiation. What this paper adds Frequency of status epilepticus is reduced in 40% of patients with Dravet syndrome after stiripentol initiation. Stiripentol is effective for generalized tonic-clonic and focal seizures. Stiripentol can be safely used with a range of antiepileptic drugs. © 2018 Mac Keith Press.

Work stress and patient safety: observer-rated work stressors as predictors of characteristics of safety-related events reported by young nurses.

PubMed

Elfering, A; Semmer, N K; Grebner, S

This study investigates the link between workplace stress and the 'non-singularity' of patient safety-related incidents in the hospital setting. Over a period of 2 working weeks 23 young nurses from 19 hospitals in Switzerland documented 314 daily stressful events using a self-observation method (pocket diaries); 62 events were related to patient safety. Familiarity of safety-related events and probability of recurrence, as indicators of non-singularity, were the dependent variables in multilevel regression analyses. Predictor variables were both situational (self-reported situational control, safety compliance) and chronic variables (job stressors such as time pressure, or concentration demands and job control). Chronic work characteristics were rated by trained observers. The most frequent safety-related stressful events included incomplete or incorrect documentation (40.3%), medication errors (near misses 21%), delays in delivery of patient care (9.7%), and violent patients (9.7%). Familiarity of events and probability of recurrence were significantly predicted by chronic job stressors and low job control in multilevel regression analyses. Job stressors and low job control were shown to be risk factors for patient safety. The results suggest that job redesign to enhance job control and decrease job stressors may be an important intervention to increase patient safety.

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

PubMed

Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2018-03-12

We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

[Efficacy and safety of TS-1 monotherapy for advanced/metastatic breast cancer - an observational study by the Kumamoto Breast Cancer Cooperative Group(KBCCG)].

PubMed

Yamamoto, Yutaka; Nishimura, Reiki; Tanigawa, Tomio; Kawano, Ichiro; Hayashi, Kyoji; Kuramoto, Masafumi; Yamamoto-Ibusuki, Mutsuko; Iwase, Hirotaka

2014-10-01

TS-1, an oral fluoropyrimidine, is known to be effective for the treatment of various carcinomas including advanced/metastatic breast cancer.The Kumamoto Breast Cancer Cooperative Group(KBCCG)conducted an observational study, wherein, the efficacy and safety of TS-1 monotherapy was analyzed in 35 patients with recurrent or metastatic breast cancer.The median time to cancer progression was 3.7 months, overall response rate was 12%, and clinical benefit rate was 32%. Adverse events were observed in 27 patients(77%), and adverse events of Grade >3 were observed in 7 patients(20%). The rate of treatment-related Grade 3 and 4 adverse events increased, and was associated with poor levels of creatinine clearance(Ccr)ie <60mL/min.This study suggests that TS-1 monotherapy can potentially be used as a salvage treatment for advanced/metastatic breast cancer owing to its safety and efficacy.Measuring the level of Ccr before TS-1 therapy should be considered to avoid severe adverse events.

White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

PubMed

Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Omer, Saad B; Bednarczyk, Robert A; Shoup, Jo Ann; DeStefano, Frank; Daley, Matthew F

2016-02-15

While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule. Copyright © 2015 Elsevier Ltd. All rights

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Improving patient safety during insertion of peripheral venous catheters: an observational intervention study.

PubMed

Kampf, Günter; Reise, Gesche; James, Claudia; Gittelbauer, Kirsten; Gosch, Jutta; Alpers, Birgit

2013-01-01

Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps. The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention. In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps were done; p<0.001). The

Improving patient safety during insertion of peripheral venous catheters: an observational intervention study

PubMed Central

Kampf, Günter; Reise, Gesche; James, Claudia; Gittelbauer, Kirsten; Gosch, Jutta; Alpers, Birgit

2013-01-01

Background: Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps. Methods: The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention. Results: In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps

Using Total Lightning Observations to Enhance Lightning Safety

NASA Technical Reports Server (NTRS)

Stano, Geoffrey T.

2012-01-01

Lightning is often the underrated threat faced by the public when it comes to dangerous weather phenomena. Typically, larger scale events such as floods, hurricanes, and tornadoes receive the vast majority of attention by both the general population and the media. This comes from the fact that these phenomena are large, longer lasting, can impact a large swath of society at one time, and are dangerous events. The threat of lightning is far more isolated on a case by case basis, although millions of cloud-to-ground lightning strikes hit this United States each year. While attention is given to larger meteorological events, lightning is the second leading cause of weather related deaths in the United States. This information raises the question of what steps can be taken to improve lightning safety. Already, the meteorological community s understanding of lightning has increased over the last 20 years. Lightning safety is now better addressed with the National Weather Service s access to the National Lightning Detection Network data and enhanced wording in their severe weather warnings. Also, local groups and organizations are working to improve public awareness of lightning safety with easy phrases to remember, such as "When Thunder Roars, Go Indoors." The impacts can be seen in the greater array of contingency plans, from airports to sports stadiums, addressing the threat of lightning. Improvements can still be made and newer technologies may offer new tools as we look towards the future. One of these tools is a network of sensors called a lightning mapping array (LMA). Several of these networks exist across the United States. NASA s Short-term Prediction Research and Transition Center (SPoRT), part of the Marshall Spaceflight Center, has access to three of these networks from Huntsville, Alabama, the Kennedy Space Center, and Washington D.C. The SPoRT program s mission is to help transition unique products and observations into the operational forecast environment

Evaluation of safety effect of turbo-roundabout lane dividers using floating car data and video observation.

PubMed

Kieć, Mariusz; Ambros, Jiří; Bąk, Radosław; Gogolín, Ondřej

2018-06-01

Roundabouts are one of the safest types of intersections. However, the needs to meet the requirements of operation, capacity, traffic organization and surrounding development lead to a variety of design solutions. One of such alternatives are turbo-roundabouts, which simplify drivers' decision making, limit lane changing in the roundabout, and induce low driving speed thanks to raised lane dividers. However, in spite of their generally positive reception, the safety impact of turbo-roundabouts has not been sufficiently studied. Given the low number of existing turbo-roundabouts and the statistical rarity of accident occurrence, the prevalent previously conducted studies applied only simple before-after designs or relied on traffic conflicts in micro-simulations. Nevertheless, the presence of raised lane dividers is acknowledged as an important feature of well performing and safe turbo-roundabouts. Following the previous Polish studies, the primary objective of the present study was assessment of influence of presence of lane dividers on road safety and developing a reliable and valid surrogate safety measure based on field data, which will circumvent the limitations of accident data or micro-simulations. The secondary objective was using the developed surrogate safety measure to assess and compare the safety levels of Polish turbo-roundabout samples with and without raised lane dividers. The surrogate safety measure was based on speed and lane behaviour. Speed was obtained from video observations and floating car data, which enabled the construction of representative speed profiles. Lane behaviour data was gathered from video observations. The collection of the data allowed for a relative validation of the method by comparing the safety performance of turbo-roundabouts with and without raised lane dividers. In the end, the surrogate measure was applied for evaluation of safety levels and enhancement of the existing safety performance functions, which combine

Long-term safety and efficacy of deferasirox in young pediatric patients with transfusional hemosiderosis: Results from a 5-year observational study (ENTRUST).

PubMed

Vichinsky, Elliott; El-Beshlawy, Amal; Al Zoebie, Azzam; Kamdem, Annie; Koussa, Suzanne; Chotsampancharoen, Thirachit; Bruederle, Andreas; Gilotti, Geralyn; Han, Jackie; Elalfy, Mohsen

2017-09-01

Children with red blood cell disorders may receive regular transfusions from an early age and consequently accumulate iron. Adequate iron chelation therapy can prevent organ damage and delayed growth/development. Deferasirox is indicated for treatment of pediatric patients with chronic iron overload due to transfusional hemosiderosis; however, fewer than 10% of patients in the registration studies were aged 2 to less than 6 years. Deferasirox, a once-daily oral iron chelator, was evaluated in young pediatric patients with transfusional hemosiderosis during the observational 5-year ENTRUST study. Patients aged 2 to less than 6 years at enrollment received deferasirox according to local prescribing information, with the primary objective of evaluating safety, specifically renal and hepatic function. Serum ferritin was observed as a surrogate efficacy parameter. In total, 267 patients (mean age 3.2 years) predominantly with β-thalassemia (n = 176, 65.9%) were enrolled. Mean ± standard deviation deferasirox dose was 25.8 ± 6.5 mg/kg per day over a median of 59.9 months. A total of 145 patients (54.3%) completed 5 years' treatment. The proportion of patients with two or more consecutive postbaseline measurements (≥7 days apart) of serum creatinine higher than age-adjusted upper limit of normal (ULN) and alanine aminotransferase more than five times the ULN was 4.4% (95% confidence interval [CI]: 2.1-7.9) and 4.0% (95% CI: 1.8-7.4), respectively. Median serum ferritin decreased from 1,702 ng/ml at baseline to 1,127 ng/ml at 5 years. There were no new safety signals. Safety and efficacy of deferasirox in young pediatric patients in this long-term, observational study in everyday clinical practice were consistent with the known deferasirox profile. © 2017 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study

PubMed Central

Scavone, Cristina; Sportiello, Liberata; Sullo, Maria G.; Ferrajolo, Carmen; Ruggiero, Rosanna; Sessa, Maurizio; Berrino, Pasquale M.; di Mauro, Gabriella; Berrino, Liberato; Rossi, Francesco; Rafaniello, Concetta; Capuano, Annalisa; Valentini, G.

2017-01-01

Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline. Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred. Conclusions: The results of our study demonstrated that the majority of AEs were not serious and

Consumer food handling in the home: a review of food safety studies.

PubMed

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.

Safety and effectiveness of long-term growth hormone therapy in Japanese patients with adult growth hormone deficiency: a postmarketing, multicenter, observational study.

PubMed

Shimatsu, Akira; Ishii, Hitoshi; Nishinaga, Hiromi; Murai, Osamu; Chihara, Kazuo

2017-07-28

We aimed to evaluate the long-term safety and effectiveness of growth hormone (GH) therapy in Japanese patients with adult growth hormone deficiency (AGHD). In this observational, multicenter study, Norditropin ® (Novo Nordisk A/S, Bagsvaerd, Denmark) was administered as injections of 0.021 mg/kg/week as a starting dose divided into 6-7 doses/week. The dose was increased according to clinical response. Patients' data were obtained from medical records. Measurements (lipids, glucose metabolism, and body composition) taken at baseline; 3, 6, and 12 months; and yearly until the end of the study were collected. Adverse drug reactions (ADRs), serious ADRs, and serious adverse events (SAEs) were evaluated. Of 387 registered patients, 334 were eligible for safety. After GH treatment initiation, a marked decrease in total cholesterol was observed earlier in the child-onset group than in the adult-onset group. LDL-cholesterol also decreased, but no significant differences in changes in LDL-cholesterol between adult-onset and child-onset groups were found. A significant increase in HDL-cholesterol starting 1 year after GH treatment initiation was found in the adult-onset group. There was no effect of GH treatment on glucose metabolism. Because of the small number of dual-energy X-ray absorptiometry data, the overall assessment of changes of body composition was difficult. Fifty-six (16.8%), 12 (3.6%), and 35 (10.5%) patients experienced ADRs, serious ADRs, and SAEs, respectively. This study demonstrated a favorable long-term safety and effectiveness profile of GH therapy in AGHD patients in the real-life Japanese clinical practice setting.

An observational survey of safety belt and child safety seat use in Virginia : the 1988 update.

DOT National Transportation Integrated Search

1989-01-01

Observational surveys of safety belt use in Virginia have been conducted in two series. The first covered 1974 through 1977, and the second 1983 through 1988. This report is concerned only with the latter series and encompasses use rates that are the...

Safety of Intravenous Application of Mistletoe (Viscum album L.) Preparations in Oncology: An Observational Study

PubMed Central

Steele, Megan L.; Axtner, Jan; Happe, Antje; Kröz, Matthias; Matthes, Harald; Schad, Friedemann

2014-01-01

Background. Traditional mistletoe therapy in cancer patients involves subcutaneous applications of Viscum album L. preparations, with doses slowly increasing based on patient responses. Intravenous infusion of high doses may improve therapeutic outcomes and is becoming more common. Little is known about the safety of this “off-label” application of mistletoe. Methods. An observational study was performed within the Network Oncology. Treatment with intravenous mistletoe applications is described. The frequency of adverse drug reactions (ADRs) to intravenous mistletoe applications was calculated and compared to ADR data from a study on subcutaneous applications. Results. Of 475 cancer patients who received intravenous infusions of Helixor, Abnoba viscum, or Iscador mistletoe preparations, 22 patients (4.6%) reported 32 ADRs of mild (59.4%) or moderate severity (40.6%). No serious ADRs occurred. ADRs were more frequently reported to i.v. mistletoe administered alone (4.3%), versus prior to chemotherapy (1.6%). ADR frequency differed with respect to preparation type, with Iscador preparations showing a higher relative frequency, compared to Abnoba viscum and Helixor. Overall, patients were almost two times less likely to experience an ADR to intravenous compared to subcutaneous application of mistletoe. Conclusion. Intravenous mistletoe therapy was found to be safe and prospective studies for efficacy are recommended. PMID:24955100

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

PubMed

Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

2014-01-01

To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

Effectiveness and safety of fixed dose combination of acarbose/metformin in Indian Type 2 diabetes patients: Results from observational GLOBE Study

PubMed Central

Saboo, Banshi; Reddy, Gundam Chandrasekhara; Juneja, Subhashchander; Kedia, Ashok Kumar; Manjrekar, Pravin; Rathod, Rahul

2015-01-01

Primary objective - evaluate effectiveness and safety of acarbose/metformin fixed dose FDC on glycemic control in Indian T2DM patients in real life clinical setting. Secondary objective - evaluate safety and satisfaction of treatment. Materials and Methods: Open-label, prospective, multicentre, single-arm, non-interventional study. Patients included were aged ≥18 years with T2DM on Acarbose (25/50 mg) and Metformin (500 mg) FDC. Glycemic parameters were recorded during observation. Results: Total 9364 patients were enrolled in the study (mean age, 50.7 years and 60.1% were male). Mean (SD) FBG and PPG was significantly reduced by 42.4 (32.6) mg/dl (P < 0.0001) and 80.2 (49.7) mg/dl (P < 0.0001) respectively at the end of observation. Mean (SD) HbA1c reduced by -1.0% (0.8) to 7.3% (0.7) at the last follow-up visit (P <0.0001). Majority of patients (97.5%) and physicians (98.42%) were satisfied with acarbose/metformin FDC treatment. Also, significant reduction in body weight by -1.7 (2.2) kg was observed (P < 0.0001). Patients with known T2DM and newly diagnosed showed a similar glycemic control (P < 0.0001). Drug-related adverse events were reported by only 1.4% patients mostly gastrointestinal. Conclusions: Acarbose/metformin FDC was efficacious, safe well accepted in routine clinical practice. It was well-tolerated without significant risk of hypoglycemia and can be used in early T2DM management PMID:25593840

Home safety practices in an urban low-income population: level of agreement between parental self-report and observed behaviors.

PubMed

Lee, Lois K; Walia, Taranjeev; Forbes, Peter W; Osganian, Stavroula K; Samuels, Ronald; Cox, Joanne E; Mooney, David P

2012-12-01

Home-related injuries are overrepresented in children from low-income households. The objectives of this study were to determine frequencies of home safety behaviors and the level of agreement between parental self-report and observed safety practices in low-income homes. In a prospective, interventional home injury prevention study of 49 low-income families with children <5 years old, a trained home visitor administered baseline parental home safety behavior questionnaires and assessments. There was high agreement between caregiver self-report and home visitor observation for lack of cabinet latch (99%, 95% confidence interval [CI] = 88%-99%) and stair gate use (100%, 95% CI = 88-100%). There was lower agreement for the safe storage of cleaning supplies (62%, 95% CI = 46%-75%), sharps (74%, 95% CI = 59%-85%), and medicines/vitamins (83%, 95% CI = 69%-92%) because of the overreporting of safe practices. Self-reports of some home safety behaviors are relatively accurate, but certain practices may need to be verified by direct assessment.

Observational study of child restraining practice on Norwegian high-speed roads: restraint misuse poses a major threat to child passenger safety.

PubMed

Skjerven-Martinsen; Naess, P A; Hansen, T B; Staff, T; Stray-Pedersen, A

2013-10-01

Restraint misuse and other occupant safety errors are the major cause of fatal and, severe injuries among child passengers in motor vehicle collisions. The main objectives of the present, study were to provide estimates of restraining practice among children younger than 16 years, traveling on Norwegian high-speed roads, and to uncover the high-risk groups associated with, restraint misuse and other safety errors. A cross-sectional observational study was performed in conjunction with regular traffic, control posts on high-speed roads. The seating and restraining of child occupants younger than 16, years were observed, the interior environment of the vehicles was examined, and a structured, interview of the driver was conducted according to a specific protocol. In total, 1260 child occupants aged 0-15 years were included in the study. Misuse of restraints, was observed in 38% of cases, with this being severe or critical in 24%. The presence of restraint, misuse varied significantly with age (p<0.001), with the frequency being highest among child, occupants in the age group 4-7 years. The most common error in this group was improperly routed, seat belts. The highest frequency of severe and critical errors was observed among child occupants in, the age group 0-3 years. The most common errors were loose or improperly routed harness straps and, incorrect installations of the child restraint system. Moreover, 24% of the children were seated in, vehicles with heavy, unsecured objects in the passenger compartment and/or the trunk that were, likely to move into the compartment upon impact and cause injury. No totally unrestrained children, were observed. This study provides a detailed description of the characteristics of restraint misuse and, the occupant's exposure to unsecured objects. Future education and awareness campaigns should, focus on children aged <8 years. The main challenges are to ensure correct routing and tightness of, harness straps and seat belts

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

PubMed

Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

2018-01-01

The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

The effect of safety initiatives on safety performance: a longitudinal study.

PubMed

Hoonakker, Peter; Loushine, Todd; Carayon, Pascale; Kallman, James; Kapp, Andrew; Smith, Michael J

2005-07-01

Construction industry is one of the most dangerous industries, not only in the USA, but worldwide. In this longitudinal study we examined the effects of safety initiatives on the safety performance of construction companies. One of the measures commonly used in the USA to track a company's safety performance is the experience modification rate (EMR). The EMR is based on the company's safety records (injury claims) from the past three full years and is used to calculate the workers' compensation insurance premiums. In a longitudinal study, we studied the effects of safety efforts and initiatives on the EMR. The results show that safety initiatives and money spent on safety do improve safety performance, but only over time.

Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers.

PubMed

Park, Peter W; Casiano, Errol M; Escoto, Laarni; Claveria, Angelica M

2011-10-01

Varenicline, an α4β2 receptor nicotinic receptor partial agonist, is known to be an effective aid for smoking cessation. To date, few observational studies of varenicline have been conducted. This prospective, non-interventional, post-marketing surveillance study (NCT00794365) was designed to monitor the efficacy and safety of varenicline for 12 weeks in Filipino smokers who were motivated to quit. This study was conducted between July 2, 2008, and November 23, 2009, in 70 centers throughout the Philippines. Participants were adult smokers who were prescribed varenicline (0.5 mg orally once daily, days 1 to 3; 0.5 mg twice daily, days 4 to 7; 1 mg twice daily for the remainder of a 12-week treatment period) for the first time. Participants made five clinic visits (weeks 0, 1, 4, 8, and 12). Adverse events (AEs) were recorded at each clinic visit and up to 28 days after administration of the last study treatment. Seven-day point prevalence of smoking cessation was measured at weeks 4, 8, and 12. A total of 330 participants were enrolled into the study, of whom 251 (76.1%) completed the study. At the end of week 12, 57.6% (95% confidence interval, 52.0, 63.0) of participants had been abstinent for the previous 7 days. The most frequently reported AEs were headache (5.5%), dizziness (3.9%), and nausea (3.6%). Ten participants (3.0%) permanently discontinued varenicline treatment due to AEs, and 13 (3.9%) reduced their varenicline dose or discontinued treatment temporarily due to AEs. There were no reports of any serious AEs, deaths, suicidal ideation, or behavior. The results of this study in adult Filipino smokers prescribed varenicline for the first time during routine clinical practice demonstrate that varenicline was well tolerated and efficacious as an aid for smoking cessation.

Behavior-based safety on construction sites: a case study.

PubMed

Choudhry, Rafiq M

2014-09-01

This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

Civility norms, safety climate, and safety outcomes: a preliminary investigation.

PubMed

McGonagle, Alyssa K; Walsh, Benjamin M; Kath, Lisa M; Morrow, Stephanie L

2014-10-01

Working environments that are both civil and safe are good for business and employee well-being. Civility has been empirically linked to such important outcomes as organizational performance and individuals' positive work-related attitudes, yet research relating civility to safety is lacking. In this study, we link perceptions of civility norms to perceptions of safety climate and safety outcomes. Drawing on social exchange theory, we proposed and tested a model in 2 samples wherein civility norms indirectly relate to safety outcomes through associations with various safety climate facets. Our results supported direct relationships between civility and management safety climate and coworker safety climate. Additionally, indirect effects of civility norms on unsafe behaviors and injuries were observed. Indirect effects of civility norms on unsafe behaviors were observed through coworker safety climate and work-safety tension. Indirect effects of civility norms on injuries were observed through management safety climate and work-safety tension for full-time employees, although these effects did not hold for part-time employees. This study provides initial evidence that researchers and practitioners may want to look beyond safety climate to civility norms to more comprehensively understand the origins of unsafe behaviors and injuries and to develop appropriate preventive interventions. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

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

PubMed

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

2017-09-01

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

Safety of artemisinins in first trimester of prospectively followed pregnancies: an observational study.

PubMed

Moore, Kerryn A; Simpson, Julie A; Paw, Moo Kho; Pimanpanarak, MuPawJay; Wiladphaingern, Jacher; Rijken, Marcus J; Jittamala, Podjanee; White, Nicholas J; Fowkes, Freya J I; Nosten, François; McGready, Rose

2016-05-01

Artemisinins, the most effective antimalarials available, are not recommended for falciparum malaria during the first trimester of pregnancy because of safety concerns. Therefore, quinine is used despite its poor effectiveness. Assessing artemisinin safety requires weighing the risks of malaria and its treatment. We aimed to assess the effect of first-trimester malaria and artemisinin treatment on miscarriage and major congenital malformations. In this observational study, we assessed data from antenatal clinics on the Thai-Myanmar border between Jan 1, 1994, and Dec 31, 2013. We included women who presented to antenatal clinics during their first trimester with a viable fetus. Women were screened for malaria, and data on malaria, antimalarial treatment, and birth outcomes were collected. The relationship between artemisinin treatments (artesunate, dihydroartemisinin, or artemether) and miscarriage or malformation was assessed using Cox regression with left-truncation and time-varying exposures. Of 55 636 pregnancies registered between 1994 and 2013, 25 485 pregnancies were analysed for first-trimester malaria and miscarriage, in which 2558 (10%) had first-trimester malaria. The hazard of miscarriage increased 1·61-fold after an initial first-trimester falciparum episode (95% CI 1·32-1·97; p<0·0001), 3·24-fold following falciparum recurrence (2·24-4·68; p<0·0001), and 2·44-fold (1·01-5·88; p=0·0473) following recurrent symptomatic vivax malaria. No difference was noted in miscarriage in first-line falciparum treatments with artemisinin (n=183) versus quinine (n=842; HR 0·78 [95% CI 0·45-1·34]; p=0·3645) or in risk of major congenital malformations (two [2%] of 109 [95% CI 0·22-6·47] versus eight (1%) of 641 [0·54-2·44], respectively). First-trimester falciparum and vivax malaria both increase the risk of miscarriage. We noted no evidence of an increased risk of miscarriage or of major congenital malformations associated with first

Safety of artemisinins in first trimester of prospectively followed pregnancies: an observational study

PubMed Central

Moore, Kerryn A; Simpson, Julie A; Paw, Moo Kho; Pimanpanarak, MuPawJay; Wiladphaingern, Jacher; Rijken, Marcus J; Jittamala, Podjanee; White, Nicholas J; Fowkes, Freya J I; Nosten, François; McGready, Rose

2016-01-01

Summary Background Artemisinins, the most effective antimalarials available, are not recommended for falciparum malaria during the first trimester of pregnancy because of safety concerns. Therefore, quinine is used despite its poor effectiveness. Assessing artemisinin safety requires weighing the risks of malaria and its treatment. We aimed to assess the effect of first-trimester malaria and artemisinin treatment on miscarriage and major congenital malformations. Methods In this observational study, we assessed data from antenatal clinics on the Thai–Myanmar border between Jan 1, 1994, and Dec 31, 2013. We included women who presented to antenatal clinics during their first trimester with a viable fetus. Women were screened for malaria, and data on malaria, antimalarial treatment, and birth outcomes were collected. The relationship between artemisinin treatments (artesunate, dihydroartemisinin, or artemether) and miscarriage or malformation was assessed using Cox regression with left-truncation and time-varying exposures. Findings Of 55 636 pregnancies registered between 1994 and 2013, 25 485 pregnancies were analysed for first-trimester malaria and miscarriage, in which 2558 (10%) had first-trimester malaria. The hazard of miscarriage increased 1·61-fold after an initial first-trimester falciparum episode (95% CI 1·32–1·97; p<0·0001), 3·24-fold following falciparum recurrence (2·24–4·68; p<0·0001), and 2·44-fold (1·01–5·88; p=0·0473) following recurrent symptomatic vivax malaria. No difference was noted in miscarriage in first-line falciparum treatments with artemisinin (n=183) versus quinine (n=842; HR 0·78 [95% CI 0·45–1·34]; p=0·3645) or in risk of major congenital malformations (two [2%] of 109 [95% CI 0·22–6·47] versus eight (1%) of 641 [0·54–2·44], respectively). Interpretation First-trimester falciparum and vivax malaria both increase the risk of miscarriage. We noted no evidence of an increased risk of miscarriage or

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

PubMed

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

2017-08-01

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

Direct comparative effectiveness and safety between non-vitamin K antagonist oral anticoagulants for stroke prevention in nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies.

PubMed

Li, Guowei; Lip, Gregory Y H; Holbrook, Anne; Chang, Yaping; Larsen, Torben B; Sun, Xin; Tang, Jie; Mbuagbaw, Lawrence; Witt, Daniel M; Crowther, Mark; Thabane, Lehana; Levine, Mitchell A H

2018-06-08

The non-vitamin K antagonist oral anticoagulants (NOACs) have been increasingly prescribed in clinical practice for stroke prevention in patients with nonvalvular atrial fibrillation (AF). Direct comparisons between NOACs in trials are lacking, leaving an important clinical decision-making gap. We aimed to perform a systematic review and meta-analysis to summarize the evidence of observational studies for direct comparative effectiveness and safety amongst NOACs in patients with AF. Conference proceedings and electronic databases including MEDLINE, CINAHL, EMBASE and PUBMED were systematically searched. We included observational studies directly comparing individual NOACs in patients with nonvalvular AF who were aged ≥ 18 years for stroke prevention. Primary outcome included effectiveness outcome (stroke or systemic embolism) and safety outcome (major bleeding). Data were extracted in duplicated by two reviewers independently. A random-effects meta-analysis was conducted to synthesize the data from included observational studies. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to rate the overall quality of evidence for each outcome. Fifteen studies were included for qualitative synthesis, twelve studies for meta-analyses. It was found that rivaroxaban and dabigatran were similar with regard to risk of stroke or systemic embolism (Hazard ratio [HR] = 1.00, 95% CI 0.91-1.10; evidence quality: low), but rivaroxaban was associated with higher risk of major bleeding (HR = 1.39, 95% CI 1.28-1.50; evidence quality: moderate). Compared with apixaban, a significantly higher risk of major bleeding was observed with rivaroxaban (HR = 1.71, 95% CI 1.51-1.94; evidence quality: low). Apixaban was associated with lower risk of major bleeding, in comparison with dabigatran (HR = 0.80, 95% CI 0.68-0.95; evidence quality: low). No differences in risk of stroke or systemic embolism was observed between rivaroxaban versus

Improving safety culture through the health and safety organization: a case study.

PubMed

Nielsen, Kent J

2014-02-01

International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

Regional citrate anticoagulation in hemodialysis: an observational study of safety, efficacy, and effect on calcium balance during routine care.

PubMed

Singer, Richard F; Williams, Oliver; Mercado, Chari; Chen, Bonny; Talaulikar, Girish; Walters, Giles; Roberts, Darren M

2016-01-01

Regional citrate hemodialysis anticoagulation is used when heparin is contraindicated, but most protocols require large infusions of calcium and frequent intradialytic plasma ionized calcium measurements. The objective of this study was to determine the safety, efficacy, and effect on calcium balance of regional citrate anticoagulation using sparse plasma ionized calcium sampling. The design of this study was observational. The setting of this study was the hospital hemodialysis center. The subjects of this study were the hospital hemodialysis patients. Dialysate calcium concentration by atomic absorption spectroscopy and total dialysate weight were used as measurements. Regional citrate anticoagulation was introduced using zero calcium dialysate, pre-dialyzer citrate infusion, and post-dialyzer calcium infusion. Infusions were adjusted based on pre- and post-dialyzer calcium measurements obtained at least twice during a 4-h dialysis. The protocol was simplified after the first 357 sessions to dispense with post-dialyzer calcium measurements. Heparin-anticoagulated sessions were performed using acetate-acidified 1.25 mmol/L calcium or citrate-acidified 1.5 mmol/L calcium dialysate. Calcium balance assessment was by complete dialysate recovery. Safety and efficacy were assessed prospectively using a point-of-care database to record ionized calcium and clinical events. Groups were compared using t test, ANOVA, Wilcoxon rank sum, or Kruskal-Wallis as appropriate. Seventy-five patients received regional citrate-anticoagulated dialysis over 1051 dialysis sessions. Of these, 357 dialysis sessions were performed using the original citrate anticoagulation protocol and 694 using the simplified protocol. Dialysis was effective and safe. Only 3 dialyzers clotted; 1 patient suffered symptomatic hypercalcemia and none suffered symptomatic hypocalcemia. Calcium balance was assessed in 15 regional citrate-anticoagulated dialysis sessions and 30 heparin-anticoagulated sessions

[Roadside observation on the use of safety belt in Guangzhou and Nanning cites of China].

PubMed

Li, Li-ping; Stevenson, Mark; Ivers, Rebecca; Zhou, Ying

2006-08-01

To determine the rates of correct use of safety belt (CUSB) among drivers and front seat passengers in Guangzhou and Nanning through roadside observation and to provide scientific evidence for the development of intervention plan and to strengthen road safety law enforcement. Observational sites were randomly selected from three road types (Highway, Main Street and Subordinate Street). Targeted automobiles were observed at each site at four different times and uniformed checklists were used to record safety belt use during observations. Within each vehicle, belt use by drivers of different sex, road type, workday/weekend, day/night and seating position were calculated. Data was analyzed, using Chi-square tests to compare the statistic significance. (1)The rate of CUSB and non-use rate among drivers were higher in Nanning than in Guangzhou (P= 0.00) but the rate of incorrect use was on the contrarary. (2) The rate of CUSB by front seat passengers in Guangzhou was higher than that in Nanning (P = 0.04); as well as the rate of (P = 0.00) incorrect use while the non-use rate was on the contrarary. (3)In general, the rate of CUSB was higher on highways than on local streets (P = 0.00). (4) The CUSB rate of drivers and front seat passengers was higher at daytime than at night (P = 0.00), and the rate of incorrect use was higher at working days than weekends (P = 0.00). (5) The CUSB rate was higher for female drivers than for males in Guangzhou (P = 0.00), but there no statistical significance was found in Nanning (P = 0.21). Results suggested that intervention actions should be undertaken to raise the awareness of the importance of safety belt use. Effective public information and education programs, law enforcement and mandatory safety belt use, prioritizing programs on people neglegent to the importance are necessary to increase the safety belt use and to decrease the mortality and injuries caused by traffic accidents.

Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study

PubMed Central

Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

2017-01-01

Objective Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Design Observational studies nested in a cluster randomised controlled feasibility study. Setting 30 primary schools in a health and demographic surveillance system in rural western Kenya. Participants Menstruating primary schoolgirls aged 14–16 years participating in a menstrual feasibility study. Interventions Insertable menstrual cup, monthly sanitary pads or ‘usual practice’ (controls). Outcome measures Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Results Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureusprevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65 S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Conclusions Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. PMID:28473520

School Safety Study: Phase I.

ERIC Educational Resources Information Center

Arora, Alka

This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

Relative efficacy and safety of topical non-steroidal anti-inflammatory drugs for osteoarthritis: a systematic review and network meta-analysis of randomised controlled trials and observational studies

PubMed Central

Persson, Monica S M; Sarmanova, Aliya; Doherty, Michael; Xie, Dongxing; Wang, YiLun; Li, Xiaoxiao; Li, Jiatian; Long, Huizhong

2018-01-01

Objectives To compare the efficacy and safety of topical non-steroidal anti-inflammatory drugs (NSAIDs), including salicylate, for the treatment of osteoarthritis (OA). Methods PubMed, Embase, Cochrane Library and Web of Science were searched from 1966 to January 2017. Randomised controlled trials (RCTs) comparing topical NSAIDs with placebo or each other in patients with OA and observational studies comparing topical NSAIDs with no treatment or each other irrespective of disease were included. Two investigators identified studies and independently extracted data. Bayesian network and conventional meta-analyses were conducted. The primary outcomes were pain relief for RCTs and risk of adverse effects (AEs) for observational studies. Results 43 studies, comprising 36 RCTs (7 900 patients with OA) and seven observational studies (218 074 participants), were included. Overall, topical NSAIDs were superior to placebo for relieving pain (standardised mean difference (SMD)=−0.30, 95% CI −0.40 to –0.20) and improving function (SMD=−0.35, 95% CI −0.45 to –0.24) in OA. Of all topical NSAIDs, diclofenac patches were most effective for OA pain (SMD=−0.81, 95% CI −1.12 to –0.52) and piroxicam was most effective for functional improvement (SMD=−1.04, 95% CI −1.60 to –0.48) compared with placebo. Although salicylate gel was associated with higher withdrawal rates due to AEs, the remaining topical NSAIDs were not associated with any increased local or systemic AEs. Conclusions Topical NSAIDs were effective and safe for OA. Diclofenac patches may be the most effective topical NSAID for pain relief. No serious gastrointestinal and renal AEs were observed in trials or the general population. However, confirmation of the cardiovascular safety of topical NSAIDs still warrants further observational study. PMID:29436380

Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East.

PubMed

Achiron, Anat; Aref, Hany; Inshasi, Jihad; Harb, Mohamad; Alroughani, Raed; Bijarnia, Mahendra; Cooke, Kathryn; Yuksel, Ozgur

2017-08-07

Evidence on the use of fingolimod in real-world clinical practice and data on patient-reported health-related quality of life (HRQoL) in countries such as the Middle East are sparse. The Prospective Evaluation of Treatment with Fingolimod for Multiple Sclerosis (PERFORMS) study assessed HRQoL and effectiveness and safety of fingolimod in patients with relapsing-remitting multiples sclerosis (RRMS), primarily in Middle Eastern countries. This 12-month, observational, multicentre, prospective, real-world study was conducted in patients with RRMS who initiated fingolimod or another approved disease-modifying treatment (DMT) within 4 weeks before study entry. Patients were enrolled in a 2:1 ratio to obtain more data in fingolimod and parallel in other DMTs cohort by physicians during routine medical care. Key study outcomes included HRQoL assessed using MS International QoL (MusiQoL), MS relapses and disability. Safety was assessed throughout the study period. Due to the observational nature of the study, no neuroimaging assessments were mandated and central reading was not performed. Of 249 enrolled patients, 247 were included in the analysis (fingolimod cohort 172; other DMTs cohort 75). Overall, the mean age of patients was 36.5 years, 64.4% were women and ~90% were Caucasians. At baseline, mean MS duration since diagnosis was 7.2 years in the fingolimod and 4.8 years in the other DMTs cohorts. Overall, mean changes in MusiQoL index scores were -2.1 in the fingolimod cohort and -0.7 in the other DMTs cohort at Month 12, but improvement was not significant vs. baseline in both cohorts. Proportion of relapse-free patients increased significantly during the study vs. 0-12 months before the study in the fingolimod cohort (80.2% vs. 24.4%; p < 0.0001). Proportion of patients free from disability progression was 86.5% in the fingolimod cohort. The incidences of AEs were 59.9% and 50.6% in the fingolimod and other DMTs cohorts, respectively. First-dose monitoring of

Safety effects of low-cost engineering measures. An observational study in a Portuguese multilane road.

PubMed

Vieira Gomes, Sandra; Cardoso, João Lourenço

2012-09-01

Single carriageway multilane roads are not, in general, a very safe type of road, mainly because of the high number of seriously injured victims in head-on collisions, when compared with dual carriageway multilane roads, with a median barrier. In this paper the results of a study on the effect of the application of several low cost engineering measures, aimed at road infrastructure correction and road safety improvement on a multilane road (EN6), are presented. The study was developed by the National Laboratory of Civil Engineering (LNEC) for the Portuguese Road Administration and involved a comparison of selected aspects of motorized traffic behaviour (traffic volumes and speeds) measured in several sections of EN6, as well as monitoring of road safety developments in the same road. The applied low cost engineering measures allowed a reduction of 10% in the expected annual number of personal injury accidents and a 70% decrease in the expected annual number of head-on collisions; the expected annual frequency of accidents involving killed and seriously injured persons was reduced by 26%. Copyright © 2012 Elsevier Ltd. All rights reserved.

Long-term Safety and Efficacy of Low-dose Azathioprine and Allopurinol Cotherapy in Inflammatory Bowel Disease: A Large Observational Study.

PubMed

Pavlidis, Polychronis; Stamoulos, Panagiotis; Abdulrehman, Answar; Kerr, Patrick; Bull, Claire; Duley, John; Ansari, Azhar

2016-07-01

Low-dose azathioprine with allopurinol (LDAA) has been proposed as a potent therapy in inflammatory bowel disease (IBD) with the benefit of overcoming side effects regularly associated with thiopurine monotherapy and poor responses. Concerns regarding safety remain, while a layer of complexity has been added by the trend toward treatment directed by red cell thioguanine nucleotide (TGN) profiling. We report on the clinical efficacy and safety of LDAA use in IBD undirected by metabolite profiling. Observational study of clinical practice from a single IBD center. Patient outcomes were defined clinically based on established activity scores and corticosteroid withdrawal. Red cell TGN was monitored only for suspected nonadherence. Overall, 113/164 (69%) patients with Crohn's disease and 83/136 (61%) patients with ulcerative/unclassified colitis had a clinical response by the end of follow-up (median 19 months), while 85 (52%) patients with Crohn's disease and 74 (54%) patients with ulcerative/unclassified colitis were in clinical remission. Clinical response was seen in 45/57 (79%) patients with Crohn's disease and 34/53 (64%) patients with ulcerative/unclassified colitis who were thiopurine naive, had active IBD, and received LDAA as the first line immunomodulator, while in 35 (61%) and 28 (53%), respectively, remission was achieved. LDAA was stopped in 20/300 (7%) patients because of side effects, all of which resolved on drug cessation. This is the largest cohort supporting the favorable safety profile and high efficacy of LDAA in IBD. It presents 2 advances in therapy: prescribing LDAA for thiopurine-naive patients, and bypassing TGN monitoring in favor of clinical monitoring (blood counts, etc.), which will make it more accessible for clinics without access to TGN assays.

Safety and effectiveness of room temperature stable recombinant factor VIIa in patients with haemophilia A or B and inhibitors: Results of a multinational, prospective, observational study.

PubMed

Kavakli, K; Demartis, F; Karimi, M; Eshghi, P; Neme, D; Chambost, H; Sommer, L; Zak, M; Benson, G

2017-07-01

A room temperature stable formulation of recombinant activated factor VII (NovoSeven ® ), allowing convenient storage and therefore improved treatment access, has been developed. Bioequivalence to the previous NovoSeven ® was demonstrated in healthy humans, leading to European approval (2008). Although no confirmed cases of neutralising antibodies to rFVIIa in patients with haemophilia A or B have been observed with the original formulation, changes in formulation or storage condition may alter immunogenicity. SMART-7™ was designed to investigate the safety of NovoSeven ® in a real-world setting in patients with haemophilia A or B with inhibitors. Study medication was not provided by the sponsor, and treatment was at the discretion of the treating physician, in accordance with the local label. Patient baseline information was collected at enrolment. Information on safety, drug exposure and bleeding episodes was collected and FVII antibody screening was encouraged at baseline and performed at the investigator's discretion. Fifty-one patients were enrolled and 31 completed the study. Forty-one adverse events (AEs) were reported in 23 patients; 25 AEs in 14 patients were serious. No thromboembolic events were observed. Although four cases of reduced therapeutic response were reported, FVII antibody screening was negative. Forty-eight patients experienced 618 bleeding episodes and 93.4% of 609 evaluated bleeds were stopped by treatment. Of the 538 bleeding episodes treated with NovoSeven ® monotherapy, 94.2% stopped by end of treatment. Data collected during the SMART-7™ study revealed no treatment-related safety issues and no FVII-binding antibodies for patients treated with NovoSeven ® under real-world conditions. © 2017 John Wiley & Sons Ltd.

Examining the safety of menstrual cups among rural primary school girls in western Kenya: observational studies nested in a randomised controlled feasibility study.

PubMed

Juma, Jane; Nyothach, Elizabeth; Laserson, Kayla F; Oduor, Clifford; Arita, Lilian; Ouma, Caroline; Oruko, Kelvin; Omoto, Jackton; Mason, Linda; Alexander, Kelly T; Fields, Barry; Onyango, Clayton; Phillips-Howard, Penelope A

2017-05-04

Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. Observational studies nested in a cluster randomised controlled feasibility study. 30 primary schools in a health and demographic surveillance system in rural western Kenya. Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls). Staphylococcus aureus vaginal colonization, Escherichia coli growth on sampled used cups, toxic shock syndrome or other adverse health outcomes. Among 604 eligible girls tested, no adverse event or TSS was detected over a median 10.9 months follow-up. S. aureus prevalence was 10.8%, with no significant difference over intervention time or between groups. Of 65  S.aureus positives at first test, 49 girls were retested and 10 (20.4%) remained positive. Of these, two (20%) sample isolates tested positive for toxic shock syndrome toxin-1; both girls were provided pads and were clinically healthy. Seven per cent of cups required replacements for loss, damage, dropping in a latrine or a poor fit. Of 30 used cups processed for E. coli growth, 13 (37.1%, 95% CI 21.1% to 53.1%) had growth. E. coli growth was greatest in newer compared with established users (53%vs22.2%, p=0.12). Among this feasibility sample, no evidence emerged to indicate menstrual cups are hazardous or cause health harms among rural Kenyan schoolgirls, but large-scale trials and post-marketing surveillance should continue to evaluate cup safety. © 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.

Observational study comparing long-term safety and efficacy of Deferasirox with Desferrioxamine therapy in chelation-naïve children with transfusional iron overload.

PubMed

Aydinok, Yesim; Unal, Sule; Oymak, Yesim; Vergin, Canan; Türker, Zeynep D; Yildiz, Dilek; Yesilipek, Akif

2012-05-01

An observational study was conducted to explore postmarketing safety and efficacy of Deferasirox (DFX) in comparison with conventional Desferrioxamine (DFO) in chelation-naïve children with transfusional iron overload. Transfusion-dependent children (aged ≤ 5 yr) who had serum ferritin above 1000 μg/L and had been prescribed either first-line DFX or DFO for at least 12 months to maintain serum ferritin between 500 and 1000 μg/L were included. Initial DFX dose was 20 mg/kg/d for 7 d a week, and DFO dose was 25-35 mg/kg/d subcutaneously, given for 5 d a week. Dose adjustments were based on serum ferritin changes and safety markers. The primary efficacy endpoint was change in serum ferritin from baseline. The effect of transfusional iron loading rate (ILR) and different doses of chelators on serum ferritin was also assessed. A total of 111 patients were observed for a median of 2.29 yr on DFX (n = 71) and 2.75 yr on DFO (n = 40). Absolute change in serum ferritin from baseline to the last available observation was not significant with DFX (91 μg/L, P = 0.5) but significantly higher with DFO (385 μg/L, P < 0.005). ILR and DFX doses had a major impact on serum ferritin changes in DFX cohort. The height- and weight-standard deviation scores did not differ significantly in both cohorts during the study. Fluctuations in liver enzymes and non-progressive increase in serum creatinine were the most common adverse events (DFX; 9.8%, 18.0% and DFO; 5.0%, 7.5%, respectively). DFX is well tolerable and at least as effective as DFO to maintain safe serum ferritin levels and normal growth progression in chelation-naïve children. © 2012 John Wiley & Sons A/S.

Mixed methods study on the use of and attitudes towards safety checklists in interventional radiology.

PubMed

Munn, Zachary; Giles, Kristy; Aromataris, Edoardo; Deakin, Anita; Schultz, Timothy; Mandel, Catherine; Peters, Micah Dj; Maddern, Guy; Pearson, Alan; Runciman, William

2018-02-01

The use of safety checklists in interventional radiology is an intervention aimed at reducing mortality and morbidity. Currently there is little known about their practical use in Australian radiology departments. The primary aim of this mixed methods study was to evaluate how safety checklists (SC) are used and completed in radiology departments within Australian hospitals, and attitudes towards their use as described by Australian radiologists. A mixed methods approach employing both quantitative and qualitative techniques was used for this study. Direct observations of checklist use during radiological procedures were performed to determine compliance. Medical records were also audited to investigate whether there was any discrepancy between practice (actual care measured by direct observation) and documentation (documented care measured by an audit of records). A focus group with Australian radiologists was conducted to determine attitudes towards the use of checklists. Among the four participating radiology departments, overall observed mean completion of the components of the checklist was 38%. The checklist items most commonly observed to be addressed by the operating theatre staff as noted during observations were correct patient (80%) and procedure (60%). Findings from the direct observations conflicted with the medical record audit, where there was a higher percentage of completion (64% completion) in comparison to the 38% observed. The focus group participants spoke of barriers to the use of checklists, including the culture of radiology departments. This is the first study of safety checklist use in radiology within Australia. Overall completion was low across the sites included in this study. Compliance data collected from observations differed markedly from reported compliance in medical records. There remain significant barriers to the proper use of safety checklists in Australian radiology departments. © 2017 The Royal Australian and New Zealand

Bovine thrombin safety reporting: an example of study design and publication bias.

PubMed

Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

2010-01-01

Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

MAXimising Involvement in MUltiMorbidity (MAXIMUM) in primary care: protocol for an observation and interview study of patients, GPs and other care providers to identify ways of reducing patient safety failures

PubMed Central

Daker-White, Gavin; Hays, Rebecca; Esmail, Aneez; Minor, Brian; Barlow, Wendy; Brown, Benjamin; Blakeman, Thomas; Bower, Peter

2014-01-01

Introduction Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention. Methods and analysis We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors. Ethics and dissemination Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision

Stennis Space Center observes 2009 Safety and Health Day

NASA Technical Reports Server (NTRS)

2009-01-01

Sue Smith, a medical clinic employee at NASA's John C. Stennis Space Center, takes the temperature of colleague Karen Badon during 2009 Safety and Health Day activities Oct. 22. Safety Day activities included speakers, informational sessions and a number of displays on safety and health issues. Astronaut Dominic Gorie also visited the south Mississippi rocket engine testing facility during the day to address employees and present several Silver Snoopy awards for outstanding contributions to flight safety and mission success. The activities were part of an ongoing safety and health emphasis at Stennis.

Relative efficacy and safety of topical non-steroidal anti-inflammatory drugs for osteoarthritis: a systematic review and network meta-analysis of randomised controlled trials and observational studies.

PubMed

Zeng, Chao; Wei, Jie; Persson, Monica S M; Sarmanova, Aliya; Doherty, Michael; Xie, Dongxing; Wang, YiLun; Li, Xiaoxiao; Li, Jiatian; Long, Huizhong; Lei, Guanghua; Zhang, Weiya

2018-05-01

To compare the efficacy and safety of topical non-steroidal anti-inflammatory drugs (NSAIDs), including salicylate, for the treatment of osteoarthritis (OA). PubMed, Embase, Cochrane Library and Web of Science were searched from 1966 to January 2017. Randomised controlled trials (RCTs) comparing topical NSAIDs with placebo or each other in patients with OA and observational studies comparing topical NSAIDs with no treatment or each other irrespective of disease were included. Two investigators identified studies and independently extracted data. Bayesian network and conventional meta-analyses were conducted. The primary outcomes were pain relief for RCTs and risk of adverse effects (AEs) for observational studies. 43 studies, comprising 36 RCTs (7 900 patients with OA) and seven observational studies (218 074 participants), were included. Overall, topical NSAIDs were superior to placebo for relieving pain (standardised mean difference (SMD)=-0.30, 95% CI -0.40 to -0.20) and improving function (SMD=-0.35, 95% CI -0.45 to -0.24) in OA. Of all topical NSAIDs, diclofenac patches were most effective for OA pain (SMD=-0.81, 95% CI -1.12 to -0.52) and piroxicam was most effective for functional improvement (SMD=-1.04, 95% CI -1.60 to -0.48) compared with placebo. Although salicylate gel was associated with higher withdrawal rates due to AEs, the remaining topical NSAIDs were not associated with any increased local or systemic AEs. Topical NSAIDs were effective and safe for OA. Diclofenac patches may be the most effective topical NSAID for pain relief. No serious gastrointestinal and renal AEs were observed in trials or the general population. However, confirmation of the cardiovascular safety of topical NSAIDs still warrants further observational study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The role of electronic checklists - case study on MRI-safety.

PubMed

Landmark, Andreas; Selnes, May-Britt; Larsen, Elisabeth; Svensli, Astrid; Solum, Linda; Brattheim, Berit

2012-01-01

Checklists can be used to improve and standardize safety critical processes and their communication. The introduction of potentially harmful medical technology and equipment has created additional requirements for the safe delivery of health care. We have studied the implementation of an electronic checklist to ensure the safety of patients scheduled for Magnetic Resonance Imaging examinations. Through a combination of observations and semi-structured interviews we investigated how health care workers in a Norwegian University hospital dealt with variations in checklist compliance, missing and lack of information. The checklist provided different functionality for the different users, ranging from a memory/attention support to a standardized form of communication on safety matters. However, the rigidity afforded by the electronic implementation, showed some serious drawbacks over the prior, simpler, paper-based versions.

A work observation study of nuclear medicine technologists: interruptions, resilience and implications for patient safety

PubMed Central

Larcos, George; Prgomet, Mirela; Georgiou, Andrew; Westbrook, Johanna

2017-01-01

Background Errors by nuclear medicine technologists during the preparation of radiopharmaceuticals or at other times can cause patient harm and may reflect the impact of interruptions, busy work environments and deficient systems or processes. We aimed to: (a) characterise the rate and nature of interruptions technologists experience and (b) identify strategies that support safety. Methods We performed 100 hours of observation of 11 technologists at a major public hospital and measured the proportions of time spent in eight categories of work tasks, location of task, interruption rate and type and multitasking (tasks conducted in parallel). We catalogued specific safety-oriented strategies used by technologists. Results Technologists completed 5227 tasks and experienced 569 interruptions (mean, 4.5 times per hour; 95% CI 4.1 to 4.9). The highest interruption rate occurred when technologists were in transit between rooms (10.3 per hour (95% CI 8.3 to 12.5)). Interruptions during radiopharmaceutical preparation occurred a mean of 4.4 times per hour (95% CI 3.3 to 5.6). Most (n=426) tasks were interrupted once only and all tasks were resumed after interruption. Multitasking occurred 16.6% of the time. At least some interruptions were initiated by other technologists to convey important information and/or to render assistance. Technologists employed a variety of verbal and non-verbal strategies in all work areas (notably in the hot-lab) to minimise the impact of interruptions and optimise the safe conduct of procedures. Although most were due to individual choices, some strategies reflected overt or subliminal departmental policy. Conclusions Some interruptions appear beneficial. Technologists' self-initiated strategies to support safe work practices appear to be an important element in supporting a resilient work environment in nuclear medicine. PMID:27707869

Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study.

PubMed

Ali, Mohammad; Nelson, Allyson; Luquero, Francisco J; Azman, Andrew S; Debes, Amanda K; M'bang'ombe, Maurice Mwesawina; Seyama, Linly; Kachale, Evans; Zuze, Kingsley; Malichi, Desire; Zulu, Fatima; Msyamboza, Kelias Phiri; Kabuluzi, Storn; Sack, David A

2017-05-01

Pregnancy increases the risk of harmful effects from cholera for both mothers and their fetuses. A killed oral cholera vaccine, Shanchol (Shantha Biotechnics, Hydrabad, India), can protect against the disease for up to 5 years. However, cholera vaccination campaigns have often excluded pregnant women because of insufficient safety data for use during pregnancy. We did an observational cohort study to assess the safety of Shanchol during pregnancy. This observational cohort study was done in two adjacent districts (Nsanje and Chikwawa) in Malawi. Individuals older than 1 year in Nsanje were offered oral cholera vaccine during a mass vaccination campaign between March 30 and April 30, 2015, but no vaccines were administered in Chikwawa. We enrolled women who were exposed to oral cholera vaccine during pregnancy in Nsanje district, and women who were pregnant in Chikwawa district (and thus not exposed to oral cholera vaccine) during the same period. The primary endpoint of our analysis was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were neonatal deaths and malformations. We evaluated these endpoints using log-binomial regression, adjusting for the imbalanced baseline characteristics between the groups. This study is registered with ClinicalTrials.gov, number NCT02499172. We recruited 900 women exposed to oral cholera vaccine and 899 women not exposed to the vaccine between June 16 and Oct 10, 2015, and analysed 835 in each group. 361 women exposed to the vaccine and 327 not exposed to the vaccine were recruited after their pregnancies had ended. The incidence of pregnancy loss was 27·54 (95% CI 18·41-41·23) per 1000 pregnancies among those exposed to the vaccine and 21·56 (13·65-34·04) per 1000 among those not exposed. The adjusted relative risk for pregnancy loss among those exposed to oral cholera vaccine was 1·24 (95% CI 0·64-2·43; p=0·52) compared with those not exposed to the vaccine. The neonatal mortality rate

Applying ethnography to the study of context in healthcare quality and safety.

PubMed

Leslie, Myles; Paradis, Elise; Gropper, Michael A; Reeves, Scott; Kitto, Simon

2014-02-01

Translating and scaling healthcare quality improvement (QI) and patient safety interventions remains a significant challenge. Context has been identified as a major factor in this. QI and patient safety research have begun to focus on context, with ethnography seen as a promising methodology for understanding the professional, organisational and cultural aspects of context. While ethnography is used to investigate the context of a variety of QI and safety interventions, the challenges inherent in effectively importing a qualitative methodology and its social science practitioners into this work have been largely unexamined. We explain ethnography as a research practice grounded in theory and dependent on observations gathered and interpreted in particular ways. We then review the approach of health services literature to evaluating this sort of qualitative research. Although the study of context is an interest shared by both social scientists and healthcare QI and safety researchers, we identify three key points at which those 'exporting' ethnography as a methodology and those 'importing' it to deal with QI and safety challenges may diverge. We describe perspectival divergences on the methodology's mission, form and scale. At the level of mission we demonstrate how ethnography has been adapted to a 'describe and feed back' role in the service of QI. At the level of form, we show how the long-term embedded observation at the heart of ethnography can be adapted only so far to accommodate QI interests if both data quality and ethical standards are to be upheld. Finally, at the level of scale, we demonstrate one ethnographic study design that balances breadth of exposure with depth of experience in its observations and so generates a particular type of scalable findings. The effective export of ethnography into QI and safety research requires discussion and negotiation between social scientific and health services research perspectives, as well as creative approaches

The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

PubMed

Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

2015-12-01

School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools.

Railway safety climate: a study on organizational development.

PubMed

Cheng, Yung-Hsiang

2017-09-07

The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

Multivariate dynamic Tobit models with lagged observed dependent variables: An effectiveness analysis of highway safety laws.

PubMed

Dong, Chunjiao; Xie, Kun; Zeng, Jin; Li, Xia

2018-04-01

Highway safety laws aim to influence driver behaviors so as to reduce the frequency and severity of crashes, and their outcomes. For one specific highway safety law, it would have different effects on the crashes across severities. Understanding such effects can help policy makers upgrade current laws and hence improve traffic safety. To investigate the effects of highway safety laws on crashes across severities, multivariate models are needed to account for the interdependency issues in crash counts across severities. Based on the characteristics of the dependent variables, multivariate dynamic Tobit (MVDT) models are proposed to analyze crash counts that are aggregated at the state level. Lagged observed dependent variables are incorporated into the MVDT models to account for potential temporal correlation issues in crash data. The state highway safety law related factors are used as the explanatory variables and socio-demographic and traffic factors are used as the control variables. Three models, a MVDT model with lagged observed dependent variables, a MVDT model with unobserved random variables, and a multivariate static Tobit (MVST) model are developed and compared. The results show that among the investigated models, the MVDT models with lagged observed dependent variables have the best goodness-of-fit. The findings indicate that, compared to the MVST, the MVDT models have better explanatory power and prediction accuracy. The MVDT model with lagged observed variables can better handle the stochasticity and dependency in the temporal evolution of the crash counts and the estimated values from the model are closer to the observed values. The results show that more lives could be saved if law enforcement agencies can make a sustained effort to educate the public about the importance of motorcyclists wearing helmets. Motor vehicle crash-related deaths, injuries, and property damages could be reduced if states enact laws for stricter text messaging rules, higher

An observational study of defensible space in the neighbourhood park

NASA Astrophysics Data System (ADS)

Marzukhi, M. A.; Afiq, M. A.; Zaki, S. Ahmad; Ling, O. H. L.

2018-02-01

The planning of neighborhood park is important to provide space for interaction, leisure, and recreation among residents in any neighbourhood area. However, on an almost daily basis, newspapers report inappropriate incidents such as snatch theft, robbery and street attack that occurred in the neighborhood park. These cases reflect the significance of physical planning and design of neighborhood park that directly affect the safety and comfort of the users. Thus, this study attempts to engage with the defensible space concept in ensuring the security elements be applied in the planning of the recreational area. This study adopts a qualitative method form of research that is retrofitted to an observational study. The observational study is significant for revealing the condition of a neighbourhood park in the ‘real-world,’ in which direct observation is conducted on Taman Tasik Puchong Perdana. The observer focused on four elements or variables of defensible space concept including the provision of facilities in the neighborhood park, territoriality, surveillance, image and milieu. The findings revealed that the planning of Taman Tasik Puchong Perdana does not deliberate the defensible space elements, which may contribute to the crime activities in the park. In these circumstances, the planning of neighbourhood park needs to include proposals for the implementation of defensible space in response to the challenges underpinned by crime problems. Besides, the awareness among the residents needs to be emphasized with the support from local authorities and other organizations to manage and sustain the safety environment in the neighborhood park.

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

PubMed

Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2017-07-01

This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

Active-comparator design and new-user design in observational studies

PubMed Central

Yoshida, Kazuki; Solomon, Daniel H.; Kim, Seoyoung C.

2015-01-01

SUMMARY Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of rheumatoid arthritis treatments. However, unlike randomized controlled trials (RCTs), observational studies of drug effects face methodological challenges including confounding by indication. Two design principles - active comparator design and new user design can help mitigate such challenges in observational studies. To improve validity of study findings, observational studies should be designed in such a way that makes them more closely approximate RCTs. The active comparator design compares the drug of interest to another commonly used agent for the same indication, rather than a ‘non-user’ group. This principle helps select treatment groups similar in treatment indications (both measured and unmeasured characteristics). The new user design includes a cohort of patients from the time of treatment initiation, so that it can assess patients’ pretreatment characteristics and capture all events occurring anytime during follow-up. PMID:25800216

A work observation study of nuclear medicine technologists: interruptions, resilience and implications for patient safety.

PubMed

Larcos, George; Prgomet, Mirela; Georgiou, Andrew; Westbrook, Johanna

2017-06-01

Errors by nuclear medicine technologists during the preparation of radiopharmaceuticals or at other times can cause patient harm and may reflect the impact of interruptions, busy work environments and deficient systems or processes. We aimed to: (a) characterise the rate and nature of interruptions technologists experience and (b) identify strategies that support safety. We performed 100 hours of observation of 11 technologists at a major public hospital and measured the proportions of time spent in eight categories of work tasks, location of task, interruption rate and type and multitasking (tasks conducted in parallel). We catalogued specific safety-oriented strategies used by technologists. Technologists completed 5227 tasks and experienced 569 interruptions (mean, 4.5 times per hour; 95% CI 4.1 to 4.9). The highest interruption rate occurred when technologists were in transit between rooms (10.3 per hour (95% CI 8.3 to 12.5)). Interruptions during radiopharmaceutical preparation occurred a mean of 4.4 times per hour (95% CI 3.3 to 5.6). Most (n=426) tasks were interrupted once only and all tasks were resumed after interruption. Multitasking occurred 16.6% of the time. At least some interruptions were initiated by other technologists to convey important information and/or to render assistance. Technologists employed a variety of verbal and non-verbal strategies in all work areas (notably in the hot-lab) to minimise the impact of interruptions and optimise the safe conduct of procedures. Although most were due to individual choices, some strategies reflected overt or subliminal departmental policy. Some interruptions appear beneficial. Technologists' self-initiated strategies to support safe work practices appear to be an important element in supporting a resilient work environment in nuclear medicine. 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/.

A Semantic Transformation Methodology for the Secondary Use of Observational Healthcare Data in Postmarketing Safety Studies.

PubMed

Pacaci, Anil; Gonul, Suat; Sinaci, A Anil; Yuksel, Mustafa; Laleci Erturkmen, Gokce B

2018-01-01

Background: Utilization of the available observational healthcare datasets is key to complement and strengthen the postmarketing safety studies. Use of common data models (CDM) is the predominant approach in order to enable large scale systematic analyses on disparate data models and vocabularies. Current CDM transformation practices depend on proprietarily developed Extract-Transform-Load (ETL) procedures, which require knowledge both on the semantics and technical characteristics of the source datasets and target CDM. Purpose: In this study, our aim is to develop a modular but coordinated transformation approach in order to separate semantic and technical steps of transformation processes, which do not have a strict separation in traditional ETL approaches. Such an approach would discretize the operations to extract data from source electronic health record systems, alignment of the source, and target models on the semantic level and the operations to populate target common data repositories. Approach: In order to separate the activities that are required to transform heterogeneous data sources to a target CDM, we introduce a semantic transformation approach composed of three steps: (1) transformation of source datasets to Resource Description Framework (RDF) format, (2) application of semantic conversion rules to get the data as instances of ontological model of the target CDM, and (3) population of repositories, which comply with the specifications of the CDM, by processing the RDF instances from step 2. The proposed approach has been implemented on real healthcare settings where Observational Medical Outcomes Partnership (OMOP) CDM has been chosen as the common data model and a comprehensive comparative analysis between the native and transformed data has been conducted. Results: Health records of ~1 million patients have been successfully transformed to an OMOP CDM based database from the source database. Descriptive statistics obtained from the source and

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

An observational survey of safety belt and child safety seat use in Virginia : the 1989 update.

DOT National Transportation Integrated Search

1991-01-01

The report has been prepared in response to a request from the Transportation Safety Administration of the Department of Motor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virginia l...

Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

PubMed

Kvalheim, Sverre A; Dahl, Øyvind

2016-12-01

Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

77 FR 75633 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...) Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

Facility safety study

NASA Technical Reports Server (NTRS)

1979-01-01

The safety of NASA's in house microelectronics facility is addressed. Industrial health standards, facility emission control requirements, operation and safety checklists, and the disposal of epitaxial vent gas are considered.

A multinational, observational study to investigate the efficacy, safety and tolerability of acarbose as add-on or monotherapy in a range of patients: the Gluco VIP study.

PubMed

Zhang, Weiwei; Kim, Dongjun; Philip, Elizabeth; Miyan, Zahid; Barykina, Irina; Schmidt, Birgit; Stein, Herbert

2013-04-01

The burden of type 2 diabetes mellitus is growing rapidly, particularly in the Asia-Pacific region. The aim of this international, large-scale, observational study was to investigate the efficacy and tolerability of the antidiabetic agent acarbose as add-on or monotherapy in a range of patients with type 2 diabetes, including those with cardiovascular morbidities. The majority of practices were included from high-burden regions (predominantly those in the Asia-Pacific region). This was an observational study conducted in 15 countries/regions. Adults with pre-treated or untreated type 2 diabetes prescribed acarbose as add-on or monotherapy were eligible. Two-hour postprandial blood glucose (2-h PPG), glycosylated haemoglobin (HbA1c) and fasting blood glucose (FBG) were measured over a 3-month observation period. A total of 15,034 patients were valid for the efficacy analysis and 15,661 for the safety analysis (mean age was 57.6 years and 92.6 % of patients were Asian). Mean (SD) 2-h PPG decreased by -71.9 (62.3) mg/dL, to 170.2 (46.5) mg/dL at final visit (after 12.8 [4.1] weeks). Mean HbA1c decreased by -1.1 % (1.3) to 7.2 % (1.1) and mean FBG decreased by -33.0 (43.3) mg/dL to 124.8 (30.5) mg/dL. Acarbose was effective regardless of the presence of cardiovascular co-morbidities or diabetic complications. The efficacy of acarbose was rated 'very good' or 'good' in 85.5 % of patients, and tolerability as 'very good' or 'good' in 84.9 % of patients. Drug-related adverse events, mainly gastrointestinal, were reported in 490/15,661 patients (3.13 %). The results of this observational study support the notion that acarbose is effective, safe and well tolerated in a large cohort of Asian patients with type 2 diabetes.

Wisconsin large truck safety and enforcement study.

DOT National Transportation Integrated Search

2011-07-01

The Wisconsin Large Truck Safety and Enforcement Study (LTS&E) focused on a system-wide evaluation of large truck safety in the : state of Wisconsin. This study analyzes crash data related to large trucks that are close to the following criteria: gre...

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

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

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.

PubMed

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter; Sedrakyan, Art

2015-10-13

To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort. Population based cohort study. Outpatient interventional setting in New York State. Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. © Mao et al 2015.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

PubMed Central

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter

2015-01-01

Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures

Comparison of self-reported and observed prevalence of safety belt and helmet use in Florence.

PubMed

Lorini, C; Pieralli, F; Mersi, A; Cecconi, R; Garofalo, G; Santini, M G; Bonaccorsi, G

2014-01-01

Safety belt and helmet use was estimated from PASSI data and measured through Ulisse observations. Between 2008 and 2012 a total of 2,081 cars and motorcycle users were interviewed in the LHU of Florence and a total of 59,787 drivers (11,870 front passengers, 1,129 rear passengers and 16,816 motorcyclists) were observed. The comparison between self-reported and observed prevalences was performed by calculating the over-reporting factor (ORF), defined as the ratio of the self-reported to the observed prevalence of seat belt or helmet use. The time trend of the prevalence (both from self-reported and observed data) and of the ORF was assessed by using linear regression and Poisson's regression, respectively. The correlation between self-reported and observed prevalence is high, with a Pearson's correlation coefficient of 0.95 (p <0.05). Regarding front seat belt use rates, the difference between self-reported and observed data increases over time and the ORF range varies from 1.12 to 1.32. Rear seat belt data show a great variability, and the ORF varies from 0.67 to 1.37. In 2011 and 2012, the observed prevalence was higher than the self-reported one (ORF <1). Helmet use rates are very high, close to 100% with both methods; ORF has very small oscillations and ranges from 0.98 to 1, showing a good correlation between self-reported and observational data. There are no significant temporal variations both for the prevalences of use and for the ORF. The reasonable accuracy of self-reported data makes this method fit in the routinary assessment of safety belts and helmet usage, in order to limit the observations of the Ulisse system at predetermined time intervals. However, self-reported estimates need to be adjusted using an appropriate over-reporting factor.

A direct observation of the use of child safety seats in metropolitan areas of Virginia during summer 1993 : final report.

DOT National Transportation Integrated Search

1994-01-01

Observational surveys of child safety seat use were conducted at the request of the Transportation Safety Administration of the Department of Motor Vehicles. The present survey was conducted in the four areas of the state with the largest populations...

A post-marketing observational study to assess the safety of mibefradil in the community in England.

PubMed

Riley, J; Wilton, L V; Shakir, S A W

2002-06-01

To conduct a post-marketing observational cohort study to assess the safety of mibefradil in the community, using Prescription-Event Monitoring (PEM). Data were collected and analyzed on patients prescribed mibefradil by 1,996 General Practitioners (GPs) throughout England. Incidence densities were calculated for all reported events and selected events were followed-up by means of further questionnaires. The study was terminated early due to the voluntary withdrawal of mibefradil from the market because of potential drug interactions. A cohort of 3,085 patients was recruited, with a mean age of 64.5 years. The major indication for use was hypertension (55% of the cohort), the indication was not specified in 33% of patients. 80% of GPs expressing an opinion rated mibefradil as effective. The major reason for stopping was withdrawal from the market (2,342 patients). The commonest reported adverse events and reasons for stopping were malaise/lassitude, dizziness, edema and headache. Seven clinically serious reports of bradycardia/collapse were considered to be possible adverse drug reactions (ADRs) to mibefradil. All were in the elderly (> 65 years), 6 were considered to be a result of possible drug interactions. In total, 11 possible drug interactions occurred. Nine (8 reports of bradycardia and 1 of syncope) involved beta-blockers. Another, a report of collapse and severe bradycardia, occurred in a patient who had started a dihydropyridine calcium channel blocker within 24 hours of stopping mibefradil and the other was a report of palpitations and dyspnea in a patient on concomitant digoxin and sotalol. None of the 53 deaths occurring during the study was attributed to mibefradil. Mibefradil was only available on the UK market for 6 months before it was withdrawn from the market because of potential drug interactions. With respect to the reasons leading to its withdrawal, in this cohort of 3,085 patients, 11 possible drug interactions were detected (6 clinically

Observing the work of an urban safety-net psychiatric emergency room: managing the unmanageable

PubMed Central

Lincoln, Alisa K.; White, Andrew; Aldsworth, Casandra; Johnson, Peggy; Strunin, Lee

2010-01-01

Staff in the psychiatric emergency room (PER) have demanding jobs requiring a complex balance between the needs and safety of the individual and the community, systemic resources, and job responsibilities while providing timely, effective care. Little research exists concerning day-to-day work activities of PER staff, their interaction, and their perceptions of their work. This study explored the work of PER staff and the organisational context of the PER work setting. Observations of staff were conducted in the public spaces of a public urban PER using two observational techniques. The first was designed to measure the types of work activities staff engaged in and the time spent in these work activities (work task data). The second technique was the gathering of observational data by a peripheral-member-researcher (participant observation data). Analyses were conducted of both the work task and participant observation data. Results indicate that most PER staff time is spent in administrative and phone tasks, while less than a third is spent on direct clinical work. Four important issues for PER work were identified: a workload that is unmanageable, managing the unmanageable, bogus referrals and dumping and insurance problems. The PER remains the front-line of the medical and social service systems. Work done in these settings is of critical importance; however little attention is paid to the content and nature of the work. Our study demonstrates that staff of the PER face challenges on many levels as they struggle with the task of working with people presenting in psychiatric and social crisis. PMID:20149148

Efficacy and safety of long-term losartan therapy demonstrated by a prospective observational study in Japanese patients with hypertension: The Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH) study.

PubMed

Naritomi, Hiroaki; Fujita, Toshiro; Ito, Sadayoshi; Ogihara, Toshio; Shimada, Kazuyuki; Shimamoto, Kazuaki; Tanaka, Heizo; Yoshiike, Nobuo

2008-02-01

The Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH) study is a nationwide, prospective, multicentered, observational study that was designed to enroll 30,000 hypertensive Japanese patients from more than 3,000 private practitioners. It is the first large-scale observational study to assess the efficacy and safety of losartan, an angiotensin II receptor antagonist, in Japan. Patients were enrolled between June 2000 and May 2002, and followed up to June 2005. The data from 29,850 patients were used for the analysis of safety and efficacy. These patients were treated with losartan mostly at a daily dose of 25-50 mg. The mean follow-up period was 2.9 years. The patients were aged 62.4+/-12.1 years (mean+/-SD) and their mean systolic/diastolic blood pressure was 165.3+/-17.2/94.3+/-11.7 mmHg (mean+/-SD). Mean blood pressure in patients who were evaluated for efficacy decreased from 165.8/94.8 mmHg (n=26,512) at baseline to 145.5/84.4 mmHg after 3 months (n=21,269) and 138.6/80.0 mmHg after 36 months of treatment (n=13,879). Blood pressure was well controlled during the study period by losartan alone or losartan-based combination therapy. In nearly half of the patients, blood pressure was reduced to less than 140/90 mmHg during the study period. In addition to its antihypertensive effect, losartan reduced the uric acid level in patients whose baseline uric acid level was > or =7 mg/dL. Losartan also prevented acceleration of proteinuria. Adverse drug reactions occurred in 1,081 of the 29,850 patients. Long-term losartan therapy was effective and well tolerated in Japanese clinical practice.

Lessons learned from measuring safety culture: an Australian case study.

PubMed

Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

2010-10-01

adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture

Are health professionals' perceptions of patient safety related to figures on safety incidents?

PubMed

Martijn, Lucie; Harmsen, Mirjam; Gaal, Sander; Mettes, Dirk; van Dulmen, Simone; Wensing, Michel

2013-10-01

The study aims to explore whether health care professionals' perceptions of patient safety in their practice were associated with the number of patient safety incidents identified in patient records. Seventy primary care practices of general practice, general dental practice, midwifery practices and allied health care practices were used in the study. A retrospective audit of 50 patient records was performed to identify patient safety incidents in each of the practices and a survey among health professionals to identify their perceptions of patient safety. All health professions felt that 'communication breakdowns inside the practice' as well as 'communication breakdowns outside the practice' and 'reporting of patient safety concerns' were a threat to patient safety in their work setting. We found little association between the perceptions of health professionals and the number of safety incidents. The only item with a significant relation to a higher number of safety incidents referred to the perception of 'communication problems outside the practice' as a threat to patient safety. This study indicates that the assessment of professionals' perceptions may be complementary to observed safety incidents, but not linked to an objective measure of patient safety. © 2012 John Wiley & Sons Ltd.

Food safety behaviors observed in celebrity chefs across a variety of programs.

PubMed

Maughan, Curtis; Chambers, Edgar; Godwin, Sandria

2017-03-01

Consumers obtain information about foodborne illness prevention from many sources, including television media. The purpose of this study was to evaluate a variety of cooking shows with celebrity chefs to understand their modeling of food safety behaviors. Cooking shows (100 episodes) were watched from 24 celebrity chefs preparing meat dishes. A tabulation of food safety behaviors was made for each show using a checklist. Proper modeling of food safety behaviors was limited, with many incidences of errors. For example, although all chefs washed their hands at the beginning of cooking at least one dish, 88% did not wash (or were not shown washing) their hands after handling uncooked meat. This was compounded with many chefs who added food with their hands (79%) or ate while cooking (50%). Other poor behaviors included not using a thermometer (75%), using the same cutting board to prepare ready-to-eat items and uncooked meat (25%), and other hygiene issues such as touching hair (21%) or licking fingers (21%). This study suggests that there is a need for improvement in demonstrated and communicated food safety behaviors among professional chefs. It also suggests that public health professionals must work to mitigate the impact of poorly modeled behaviors. © The Author 2016. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy and safety of thrice weekly DOTS in tuberculosis patients with and without HIV co-infection: an observational study

PubMed Central

2013-01-01

Background Despite the latest World Health Organization guidelines advocating daily therapy in HIV-TB co-infected individuals, there are few recent studies comparing outcomes of thrice-weekly anti-tuberculosis treatment in HIV-positive and HIV-negative patients with TB. The present study sets out to compare TB treatment outcomes in these two groups in the Indian national programme, which currently involves thrice-weekly therapy for all, regardless of HIV status. Methods HIV-positive and HIV-negative were consecutively screened for enrolment into this prospective observational study, carried out at the All India Institute of Medical Sciences hospital, New Delhi, India, between 2006 and 2010. Patients were given short-course thrice-weekly rifampicin-based therapy, with all HIV-positive patients being started on highly active antiretroviral therapy at least 14 days after commencing TB treatment. Patients were regularly followed-up for 24 months after completion of treatment. Results 150 HIV-positive, 155 HIV-negative patients were enrolled consecutively for the study. Significantly higher treatment success (93.5% vs. 76.7% at end of treatment, p < 0.001) and lower mortality (2.8% vs. 21.6% on follow up, p < 0.001) were observed in HIV-negative patients. No significant difference was found in treatment failure (p = 0.16), sputum smear (p = 0.58) and culture conversion (p = 0.55), and non-serious adverse event incidence (p = 0.851) between the two groups. Low baseline CD4 cell count (<100 cells/ mm3) was the only predictor of mortality in HIV-TB patients (odds ratio 8 · 43, p = 0 · 013). Conclusions Thrice-weekly anti-tuberculosis therapy is more effective in HIV-negative than in HIV-positive patients. However, outcomes in this HIV co-infected cohort were found to be similar to those reported previously with daily therapy, with no safety concerns. This should prompt further study into whether intermittent or daily therapy should be

An observational analysis of surgical team compliance with perioperative safety practices after crew resource management training.

PubMed

France, Daniel J; Leming-Lee, Susie; Jackson, Tom; Feistritzer, Nancye R; Higgins, Michael S

2008-04-01

Acknowledging the need to improve team communication and coordination among health care providers, health care administrators and improvement officers have been quick to endorse and invest in aviation crew resource management (CRM). Despite the increased interest in CRM there exists limited data on the effectiveness of CRM to change team behavior and performance in clinical settings. Direct observational analyses were performed on 30 surgical teams (15 neurosurgery cases and 15 cardiac cases) to evaluate surgical team compliance with integrated safety and CRM practices after extensive CRM training. Observed surgical teams were compliant with only 60% of the CRM and perioperative safety practices emphasized in the training program. The results highlight many of the challenges the health care industry faces in its efforts to adapt CRM from aviation to medicine. Additional research is needed to develop and test new team training methods and performance feedback mechanisms for clinical teams.

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study.

PubMed

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC).The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan-Meier method.A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2-19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75-5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function.Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study

PubMed Central

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

Abstract This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC). The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan–Meier method. A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2–19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75–5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function. Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. PMID:29505026

78 FR 56235 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... delivery of occupational safety and health services, and the prevention of work-related injury and illness... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or... occupational safety and health, and allied areas. It is the intent of NIOSH to support broad-based research...

78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... improvements in the delivery of occupational safety and health services, and the prevention of work-related... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or... issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broad...

Preventive effects of car safety seat use on clinical outcomes in infants and young children with road traffic injuries: A 7-year observational study.

PubMed

Park, Gwan Jin; Ro, Young Sun; Shin, Sang Do; Song, Kyoung Jun; Hong, Ki Jeong; Jeong, Joo

2018-06-01

Road traffic injury (RTI) is one of the major mechanisms of injury leading to high disability and case-fatality in infants and children. Proper car safety seat use can reduce fatal outcomes in pediatric patients with RTI; however, the use rate is still low. This study aimed to measure the preventive effects of car safety seat use on clinical outcomes among infants and young children injured from RTI. A multicenter cross-sectional study was conducted using the Emergency Department-based Injury In-depth Surveillance (EDIIS) registry from 23 EDs between Jan 2010 and Dec 2016. All pediatric patients who were under 6 years of age and who sustained RTI in a vehicle with fewer than 10-seats were eligible. Primary and secondary endpoints were intracranial injury and mortality. We calculated the adjusted odds ratio (AOR) of the car safety seat for related outcomes adjusting for potential confounders. Among 5545 eligible patients, 1452 (26.2%) patients were in car safety seats at the time of the crash (12.5% in 2010 to 33.9% in 2016, p-for-trend <0.01), and 104 (1.9%) patients had intracranial injuries. The patients using car safety seats were less likely to have intracranial injuries compared with the patients not using car safety seats (0.8% vs. 2.2%, AOR: 0.31 (0.17-0.57)). However, there was no significant difference in mortality between the two groups (0.4% vs. 0.6%, AOR: 0.50 (0.20-1.25)). Use of the car safety seat has significant preventive effects on intracranial injury. Public health efforts to increase use of car safety seats for infants and young children are needed to reduce the burden of RTI. Copyright © 2018 Elsevier Ltd. All rights reserved.

Improving construction site safety through leader-based verbal safety communication.

PubMed

Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

2010-10-01

The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease

PubMed Central

Meeuwis, Kim; van Hees, Colette; van Dorst, Eleonora; Bulten, Johan; Bosse, Tjalling; IntHout, Joanna; Boll, Dorry; Slangen, Brigitte; van Seters, Manon; van Beurden, Marc; van Poelgeest, Mariëtte; de Hullu, Joanne

2017-01-01

Background Vulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical “cake icing” scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called “Paget cells” with abundant pale cytoplasm in the epithelium confirms the diagnosis. The origin of these Paget cells is still unclear. Treatment of choice is wide local excision with negative margins. Obtaining clear surgical margins is challenging and may lead to extensive and mutilating surgery. Even then, recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. A number of case reports, retrospective case series, and one observational study have shown promising results using the topical immune response modifier imiquimod. Objective This study aims to investigate the efficacy, safety, and immunological response in patients with noninvasive vulvar Paget disease using a standardized treatment schedule with 5% imiquimod cream. Methods Topical 5% imiquimod cream might be an effective and safe treatment alternative for vulvar Paget disease. The Paget Trial is a multicenter observational cohort study including eight tertiary referral hospitals in the Netherlands. It is ethically approved by the Medical-Ethical Committee of Arnhem-Nijmegen and registered in the Central Committee on Research Involving Human Subjects (CCMO) Register by as NL51648.091.14. Twenty patients with (recurrent) noninvasive vulvar Paget disease will be treated with topical 5% imiquimod cream three times a week for 16 weeks. The primary efficacy outcome is the reduction in lesion size at 12 weeks after end of treatment. Secondary outcomes are safety, immunological response, and

NASA Satellite Observations: A Unique Asset for the Study of the Environment and Implications for Public Health

NASA Technical Reports Server (NTRS)

Estes Sue M.

2010-01-01

This slide presentation highlights how satellite observation systems are assets for studying the environment in relation to public health. It includes information on current and future satellite observation systems, NASA's public health and safety research, surveillance projects, and NASA's public health partners.

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

PubMed

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.

Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study.

PubMed

Gilbert, Rachel E; Kozak, Melissa C; Dobish, Roxanne B; Bourrier, Venetia C; Koke, Paul M; Kukreti, Vishal; Logan, Heather A; Easty, Anthony C; Trbovich, Patricia L

2018-05-01

Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards. Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent. Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed. We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ryan, Patricia C., E-mail: ryanp@medimmune.com; Sleeman, Matthew A.; Rebelatto, Marlon

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

Public perception of drinking water safety in South Africa 2002-2009: a repeated cross-sectional study.

PubMed

Wright, Jim A; Yang, Hong; Rivett, Ulrike; Gundry, Stephen W

2012-07-27

In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. This repeated cross-sectional study draws on General Household Surveys from 2002-2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002-2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000-02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period.

An observational survey of safety belt and child safety seat use in Virginia : final report : the 1990 update.

DOT National Transportation Integrated Search

1992-01-01

This report was prepared in response to a request from the Transportation Safety Administration of the Virginia Department ofMotor Vehicles for data concerning the use of safety belts and child safety seats by the occupants of vehicles bearing Virgin...

Designing Effective Safety Signs, Based on a Study of Recall for Safety Signs.

ERIC Educational Resources Information Center

Berry, Dennis W.

Aside from direct supervision at a recreational facility, safety signs, if designed properly, are the most effective approach to facility safety. This study was conducted to investigate the effectiveness of various sign designs: (l) multiple concepts with text; (2) single concept with text; and (3) single concept with graphics. A discussion of…

Safety and immunogenicity of yellow fever 17D vaccine in adults receiving systemic corticosteroid therapy: an observational cohort study.

PubMed

Kernéis, Solen; Launay, Odile; Ancelle, Thierry; Iordache, Laura; Naneix-Laroche, Véronique; Méchaï, Frédéric; Fehr, Thierry; Leroy, Jean-Philippe; Issartel, Bertrand; Dunand, Jean; van der Vliet, Diane; Wyplosz, Benjamin; Consigny, Paul-Henri; Hanslik, Thomas

2013-09-01

To assess the safety and immunogenicity of live attenuated yellow fever (YF) 17D vaccine in adults receiving systemic corticosteroid therapy. All adult travelers on systemic corticosteroid therapy who had received the YF17D vaccine in 24 French vaccination centers were prospectively enrolled and matched with healthy controls (1:2) on age and history of YF17D immunization. Safety was assessed in a self-administered standardized questionnaire within 10 days after immunization. YF-specific neutralizing antibody titers were measured 6 months after vaccination in patients receiving corticosteroids. Between July 2008 and February 2011, 102 vaccine recipients completed the safety study (34 receiving corticosteroids and 68 controls). The median age was 54.9 years (interquartile range [IQR] 45.1-60.3 years) and 45 participants had a history of previous YF17D immunization. The median time receiving corticosteroid therapy was 10 months (IQR 1-67 months) and the prednisone or equivalent dosage was 7 mg/day (IQR 5-20). Main indications were autoimmune diseases (n = 14), rheumatoid arthritis (n = 9), and upper respiratory tract infections (n = 8). No serious adverse event was reported; however, patients receiving corticosteroids reported more frequent moderate/severe local reactions than controls (12% and 2%, respectively; relative risk 8.0, 95% confidence interval 1.4-45.9). All subjects receiving corticosteroids who were tested (n = 20) had neutralizing antibody titers >10 after vaccination. After YF17D immunization, moderate/severe local reactions may be more frequent in patients receiving systemic corticosteroid therapy. Immunogenicity seems satisfactory. Large-scale studies are needed to confirm these results. Copyright © 2013 by the American College of Rheumatology.

Safety sign designs for children by considering effect of the colors preferences: A case study

NASA Astrophysics Data System (ADS)

Iftadi, Irwan; Nugraha, Dian Cahya; Jauhari, Wakhid Ahmad

2018-02-01

Color has become a major consideration in ergonomics. Color conveys a message and it is an important element in safety signs. The importance of colors usage in safety sign designs makes the colors research into one of the things that must be done before designing them. So far, research in the related field only focused on the adult's perspective without involving children's perspective in designing the safety signs. This paper aims to find out how children's perception towards colors affects the safety sign designs. This study consist of eight sections which are literature study, direct observation, determining referents and other parameters, determining research respondents, making the booklet, assessing the colors preferences, determining the design's parameter value and creating the safety sign designs. Limitation of the research are the objects are the students with the age of 10 - 11 years old in Grade IV and then the research is conducted in the school day and hours that apply to the school. Chi square test and odds ratio are employed to assess the colors preferences. Twelve safety sign designs are proposed by considering the children's colors perception. The designs are grouped into three types of sign which are Mandatory Action Sign, Warning Sign and Prohibition Sign. Six colors are used to draw the safety signs i.e. red, orange, yellow, green, blue and black. On the basis of the study, it is concluded that the colors that often appears in safety signs is green with the percentage of 75% and that rarely appears is red with the percentage of 8.33%.

Relationship between preventable hospital deaths and other measures of safety: an exploratory study.

PubMed

Hogan, Helen; Healey, Frances; Neale, Graham; Thomson, Richard; Vincent, Charles; Black, Nick

2014-06-01

To explore associations between the proportion of hospital deaths that are preventable and other measures of safety. Retrospective case record review to provide estimates of preventable death proportions. Simple monotonic correlations using Spearman's rank correlation coefficient to establish the relationship with eight other measures of patient safety. Ten English acute hospital trusts. One thousand patients who died during 2009. The proportion of preventable deaths varied between hospitals (3-8%) but was not statistically significant (P = 0.94). Only one of the eight measures of safety (Methicillin-resistant Staphylococcus aureus bacteraemia rate) was clinically and statistically significantly associated with preventable death proportion (r = 0.73; P < 0.02). There were no significant associations with the other measures including hospital standardized mortality ratios (r = -0.01). There was a suggestion that preventable deaths may be more strongly associated with some other measures of outcome than with process or with structure measures. The exploratory nature of this study inevitably limited its power to provide definitive results. The observed relationships between safety measures suggest that a larger more powerful study is needed to establish the inter-relationship of different measures of safety (structure, process and outcome), in particular the widely used standardized mortality ratios. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Methods and processes of developing the strengthening the reporting of observational studies in epidemiology - veterinary (STROBE-Vet) statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

The reporting of observational studies in veterinary research presents many challenges that often are not adequately addressed in published reporting guidelines. To develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. A consensus meeting of experts was organized to develop an extension of the STROBE statement to address observational studies in veterinary medicine with respect to animal health, animal production, animal welfare, and food safety outcomes. Consensus meeting May 11-13, 2014 in Mississauga, Ontario, Canada. Seventeen experts from North America, Europe, and Australia attended the meeting. The experts were epidemiologists and biostatisticians, many of whom hold or have held editorial positions with relevant journals. Prior to the meeting, 19 experts completed a survey about whether they felt any of the 22 items of the STROBE statement should be modified and if items should be added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. At the meeting, the participants were provided with the survey responses and relevant literature concerning the reporting of veterinary observational studies. During the meeting, each STROBE item was discussed to determine whether or not re-wording was recommended, and whether additions were warranted. Anonymous voting was used to determine whether there was consensus for each item change or addition. The consensus was that six items needed no modifications or additions. Modifications or additions were made to the STROBE items numbered: 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14

Osteoporosis therapies: evidence from health-care databases and observational population studies.

PubMed

Silverman, Stuart L

2010-11-01

Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

A study of Michigan safety belt use prior to implementation of standard enforcement

DOT National Transportation Integrated Search

2000-02-01

Reported here are the results of a direct observation survey of safety belt use conducted in January 2000 to provide a baseline rate from which to measure safety belt use trends following the implementation of standard enforcement in Michigan. In thi...

A pre-clinical safety study of PEGylated recombinant human endostatin (M2ES) in Sprague Dawley rats.

PubMed

Geng, Xingchao; Guo, Lifang; Liu, Li; Wang, Chao; Peng, Qian; Qi, Weihong; Sun, Li; Liu, Xiaomeng; Miao, Yufa; Lin, Zhi; Fu, Yan; Luo, Yongzhang; Li, Bo

2018-06-01

PEGylated recombinant human endostatin (M 2 ES) exhibited prolonged serum half-life and enhanced antitumor activity when compared with endostatin. A pre-clinical study was performed to evaluate the safety of M 2 ES in rats. After intravenous (IV) infusions of M 2 ES at a dose level of 3, 15 and 75 mg/kg in Sprague Dawley (SD) rats, M 2 ES was well tolerated in animals, with no observable changes in clinical observation, body weight, food consumption, urine analysis, hematology and serum biochemical analysis. The increase of kidney weights, and slight to severe vacuolation and necrosis of proximal tubule epithelial cells in kidney were observed in 15 and 75 mg/kg M 2 ES groups, but this adverse-effect was reversible. In summary, the major toxicity target organ of M 2 ES might be kidney, and the no observed adverse effect level (NOAEL) of M 2 ES in rats was 3 mg/kg in this study. These pre-clinical safety data contribute to the initiation of the ongoing clinical study. Copyright © 2018. Published by Elsevier Inc.

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

40 CFR 720.90 - Data from health and safety studies.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Data from health and safety studies... Data from health and safety studies. (a) Information other than specific chemical identity. Except as... information included in a health and safety study, unless the information would disclose confidential business...

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective.

PubMed

Xu, Xiao Ping; Deng, Dong Ning; Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong's patient safety strategies in the context of Mainland China. A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff's patient safety culture mind-set, to realize a "bottom-up" approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety.

Safety Study--Crashworthiness of Large Poststandard Schoolbuses.

ERIC Educational Resources Information Center

National Transportation Safety Board (DOT), Washington, DC.

This study reports on the crash performance of large poststandard school buses (school buses manufactured after April 1, 1977, and weighing more than 10,000 pounds unloaded) in 43 accidents investigated by the National Transportation Safety Board. The report discusses the Safety Board's findings as to how well the standards are working to protect…

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

PubMed

Lydon, Sinéad; Cupples, Margaret E; Hart, Nigel; Murphy, Andrew W; Faherty, Aileen; O'Connor, Paul

2016-01-01

Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT. The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method. The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care

Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

PubMed

Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

2015-07-10

CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards

Post-marketing studies: the work of the Drug Safety Research Unit.

PubMed

Mackay, F J

1998-11-01

The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting.

PubMed

Kabanywanyi, Abdunoor M; Mulure, Nathan; Migoha, Christopher; Malila, Aggrey; Lengeler, Christian; Schlienger, Raymond; Genton, Blaise

2010-07-14

To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania. Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008). Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing

Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

PubMed Central

Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

2018-01-01

Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

Efficacy and safety of apatinib monotherapy in advanced bone and soft tissue sarcoma: An observational study.

PubMed

Zhu, Baorang; Li, Jing; Xie, Qiaosheng; Diao, Liyan; Gai, Lvhua; Yang, Wuwei

2018-03-04

Sarcomas are rare but malignant tumors with high risks of local recurrence and distant metastasis. Anti-angiogenic therapy is a potential strategy against un-controlled and not-organized tumor angiogenesis. We aimed to assess the safety and efficacy of apatinib, an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, in patients with advanced sarcoma. Thirty-one patients who received initial apatinib between September 2015 and August 2016 were retrospectively reviewed. Among them, 19 (61.3%) patients were heavily pretreated with two or more lines of cytotoxic chemotherapy. Apatinib was given at a start-dose of 425 mg qd. During therapy, 9 (29.0%) patients required dose interruption and 7 (22.6%) needed dose reduction, and the mean dosage of apatinib was 372.9 ± 68.4 mg/day. In the study cohort, one patient was treated as adjunctive therapy and 6 patients stopped treatment before radiographic response assessment. Thus, 24 patients were eligible for tumor response evaluation. The objective response rate was 33.3% and clinical benefit rate was as high as 75.0%. The progression free survival was 4.25 (95% confidence interval [CI], 2.22-5.11) months, whereas the overall survival was 9.43 (95% CI, 6.64-18.72) months. Compared with other histological subtypes, leiomyosarcoma did not show significant survival benefits. Most of the adverse events (AEs) were at grade 1 or 2. The main grade 3 AEs were hypertension (6.5%), hand foot skin reaction (6.5%), and diarrhea (3.2%). In conclusion, apatinib showed promising efficacy and acceptable safety profile in metastatic or recurrent sarcoma, giving rationale clinical evidence to conduct clinical trials.

The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease.

PubMed

van der Linden, Michelle; Meeuwis, Kim; van Hees, Colette; van Dorst, Eleonora; Bulten, Johan; Bosse, Tjalling; IntHout, Joanna; Boll, Dorry; Slangen, Brigitte; van Seters, Manon; van Beurden, Marc; van Poelgeest, Mariëtte; de Hullu, Joanne

2017-09-06

Vulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical "cake icing" scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called "Paget cells" with abundant pale cytoplasm in the epithelium confirms the diagnosis. The origin of these Paget cells is still unclear. Treatment of choice is wide local excision with negative margins. Obtaining clear surgical margins is challenging and may lead to extensive and mutilating surgery. Even then, recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. A number of case reports, retrospective case series, and one observational study have shown promising results using the topical immune response modifier imiquimod. This study aims to investigate the efficacy, safety, and immunological response in patients with noninvasive vulvar Paget disease using a standardized treatment schedule with 5% imiquimod cream. Topical 5% imiquimod cream might be an effective and safe treatment alternative for vulvar Paget disease. The Paget Trial is a multicenter observational cohort study including eight tertiary referral hospitals in the Netherlands. It is ethically approved by the Medical-Ethical Committee of Arnhem-Nijmegen and registered in the Central Committee on Research Involving Human Subjects (CCMO) Register by as NL51648.091.14. Twenty patients with (recurrent) noninvasive vulvar Paget disease will be treated with topical 5% imiquimod cream three times a week for 16 weeks. The primary efficacy outcome is the reduction in lesion size at 12 weeks after end of treatment. Secondary outcomes are safety, immunological response, and quality of life. Safety will be

Changes in safety climate and teamwork in the operating room after implementation of a revised WHO checklist: a prospective interventional study.

PubMed

Erestam, Sofia; Haglind, Eva; Bock, David; Andersson, Annette Erichsen; Angenete, Eva

2017-01-01

Inter-professional teamwork in the operating room is important for patient safety. The World Health Organization (WHO) checklist was introduced to improve intraoperative teamwork. The aim of this study was to evaluate the safety climate in a Swedish operating room setting before and after an intervention, using a revised version of the WHO checklist to improve teamwork. This study is a single center prospective interventional study. Participants were personnel working in operating room teams including surgeons, anesthesiologists, scrub nurses, nurse anaesthetists and nurse assistants. The study started with pre-interventional observations of the WHO checklist use followed by education on safety climate, the WHO checklist, and non-technical skills in the operating room. Thereafter a revised version of the WHO checklist was introduced. Post-interventional observations regarding the performance of the WHO checklist were carried out. The Safety Attitude Questionnaire was used to assess safety climate at baseline and post-intervention. At baseline we discovered a need for improved teamwork and communication. The participants considered teamwork to be important for patient safety, but had different perceptions of good teamwork between professions. The intervention, a revised version of the WHO checklist, did not affect teamwork climate. Adherence to the revision of the checklist was insufficient, dominated by a lack of structure. There was no significant change in teamwork climate by use of the revised WHO checklist, which may be due to insufficient implementation, as a lack of adherence to the WHO checklist was detected. We found deficiencies in teamwork and communication. Further studies exploring how to improve safety climate are needed. NCT02329691.

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

Determinants of Knowledge and Safety Practices of Occupational Hazards of Textile Dye Workers in Sokoto, Nigeria: A Descriptive Analytic Study.

PubMed

Okafoagu, Nneka Christina; Oche, Mansur; Awosan, Kehinde Joseph; Abdulmulmuni, Hashim Bala; Gana, Godwin Jiya; Ango, Jessica Timane; Raji, Ismail

2017-06-23

Textile dye workers are subject to occupational hazards on a daily basis due to exposure to precarious conditions in the workplace. This study aimed to assess the knowledge, attitude and safety practices and its determinants among textile dye workers in Sokoto metropolis, Nigeria. This is a descriptive cross-sectional study conducted among 200 textile dye workers and the respondents were selected by multi stage sampling technique. Data was collected using an interviewer administered questionnaire. Data was processed using SPSS IBM version 20 and analyzed using descriptive and inferential statistics. Majority of the respondents (74.0%) had good knowledge of workplace hazards; (81.0%) had positive attitude and only 20% observed all the safety practices. Formal education (P=0.047); working less than 5 days a week (P=0.001) and permanent employment (P=0.013) were found to be determinants of respondents' knowledge and attitude towards workplace hazards. Although the respondents had good knowledge and positive attitude, their lack of observance of safety practices brings to fore the need for direct safety instruction and training and retraining of textile dye workers on workplace hazards and safety practices.

The Role of Hospital Inpatients in Supporting Medication Safety: A Qualitative Study

PubMed Central

Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Dean Franklin, Bryony

2016-01-01

Background Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients’ involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. Methods We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses’ medication administration rounds, pharmacists’ ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Results Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Conclusion Patients appear to have more access to

The Role of Hospital Inpatients in Supporting Medication Safety: A Qualitative Study.

PubMed

Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Franklin, Bryony Dean

2016-01-01

Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients' involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses' medication administration rounds, pharmacists' ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Patients appear to have more access to paper-based records than electronic equivalents

Improving safety in small enterprises through an integrated safety management intervention.

PubMed

Kines, Pete; Andersen, Dorte; Andersen, Lars Peter; Nielsen, Kent; Pedersen, Louise

2013-02-01

This study tests the applicability of a participatory behavior-based injury prevention approach integrated with safety culture initiatives. Sixteen small metal industry enterprises (10-19 employees) are randomly assigned to receive the intervention or not. Safety coaching of owners/managers result in the identification of 48 safety tasks, 85% of which are solved at follow-up. Owner/manager led constructive dialogue meetings with workers result in the prioritization of 29 tasks, 79% of which are accomplished at follow-up. Intervention enterprises have significant increases on six of eight safety-perception-survey factors, while comparisons increase on only one factor. Both intervention and comparison enterprises demonstrate significant increases in their safety observation scores. Interview data validate and supplement these results, providing some evidence for behavior change and the initiation of safety culture change. Given that over 95% of enterprises in most countries have less than 20 employees, there is great potential for adapting this integrated approach to other industries. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

PubMed

Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z

2016-11-01

A new fibrinogen concentrate Clottafact ® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable. © 2016 International Society of Blood Transfusion.

Nanotechnology Safety Self-Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grogin, Phillip W.

2016-03-29

Nanoparticles are near-atomic scale structures between 1 and 100 nanometers (one billionth of a meter). Engineered nanoparticles are intentionally created and are used in research and development at Sandia National Laboratories (SNL) and Los Alamos National Laboratory (LANL). This course, Nanotechnology Safety Self-Study, presents an overview of the hazards, controls, and uncertainties associated with the use of unbound engineered nanoscale particles (UNP) in a laboratory environment.

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Public perception of drinking water safety in South Africa 2002–2009: a repeated cross-sectional study

PubMed Central

2012-01-01

Background In low and middle income countries, public perceptions of drinking water safety are relevant to promotion of household water treatment and to household choices over drinking water sources. However, most studies of this topic have been cross-sectional and not considered temporal variation in drinking water safety perceptions. The objective of this study is to explore trends in perceived drinking water safety in South Africa and its association with disease outbreaks, water supply and household characteristics. Methods This repeated cross-sectional study draws on General Household Surveys from 2002–2009, a series of annual nationally representative surveys of South African households, which include a question about perceived drinking water safety. Trends in responses to this question were examined from 2002–2009 in relation to reported cholera cases. The relationship between perceived drinking water safety and organoleptic qualities of drinking water, supply characteristics, and socio-economic and demographic household characteristics was explored in 2002 and 2008 using hierarchical stepwise logistic regression. Results The results suggest that perceived drinking water safety has remained relatively stable over time in South Africa, once the expansion of improved supplies is controlled for. A large cholera outbreak in 2000–02 had no apparent effect on public perception of drinking water safety in 2002. Perceived drinking water safety is primarily related to water taste, odour, and clarity rather than socio-economic or demographic characteristics. Conclusion This suggests that household perceptions of drinking water safety in South Africa follow similar patterns to those observed in studies in developed countries. The stability over time in public perception of drinking water safety is particularly surprising, given the large cholera outbreak that took place at the start of this period. PMID:22834485

Flammable Gas Safety Self-Study 52827

DOE Office of Scientific and Technical Information (OSTI.GOV)

Glass, George

2016-03-17

This course, Flammable Gas Safety Self-Study (COURSE 52827), presents an overview of the hazards and controls associated with commonly used, compressed flammable gases at Los Alamos National Laboratory (LANL).

Factors predicting change in hospital safety climate and capability in a multi-site patient safety collaborative: a longitudinal survey study.

PubMed

Benn, Jonathan; Burnett, Susan; Parand, Anam; Pinto, Anna; Vincent, Charles

2012-07-01

The study had two specific objectives: (1) To analyse change in a survey measure of organisational patient safety climate and capability (SCC) resulting from participation in the UK Safer Patients Initiative and (2) To investigate the role of a range of programme and contextual factors in predicting change in SCC scores. Single group longitudinal design with repeated measurement at 12-month follow-up. Multiple service areas within NHS hospital sites across England, Wales, Scotland and Northern Ireland. Stratified sample of 284 respondents representing programme teams at 19 hospital sites. A complex intervention comprising a multi-component quality improvement collaborative focused upon patient safety and designed to impact upon hospital leadership, communication, organisation and safety climate. A survey including a 31-item SCC scale was administered at two time-points. Modest but significant positive movement in SCC score was observed between the study time-points. Individual programme responsibility, availability of early adopters, multi-professional collaboration and extent of process measurement were significant predictors of change in SCC. Hospital type and size, along with a range of programme preconditions, were not found to be significant. A range of social, cultural and organisational factors may be sensitive to this type of intervention but the measurable effect is small. Supporting critical local programme implementation factors may be an effective strategy in achieving development in organisational patient SCC, regardless of contextual factors and organisational preconditions.

The effectiveness, safety, and economic evaluation of Korean medicine for unexplained infertile women: A multi-center, prospective, observational study protocol.

PubMed

Kim, Su-Hyun; Jo, Junyoung; Kim, Dong-Il

2017-12-01

Infertility is a condition in which a woman has not been pregnant despite having had normal intercourse for 1 year. The number of unexplained infertile females is increasing because of late marriage customs, as well as environmental and lifestyle habits. In Korea, infertile females have been treated with Korean medicine (KM). However, these effects have not been objectively confirmed through clinical trials. Therefore, this study was conducted to demonstrate the effectiveness of herbal medicine treatment in infertile patients and to demonstrate the economic feasibility through economical evaluation with assisted reproductive technology.This study is designed as a multicenter, single-arm clinical trial. All participants included will be from 3 Korean Medicine hospitals in Korea and will voluntarily sign an informed consent agreement. All recruited patients will conduct related surveys and tests, and be provided with treatment according to their menstrual cycle. Patients will take herbal medicines for 4 menstruation cycles and receive acupuncture and moxibustion treatment at 3 times (menstrual cycle day 3, 8, 14) during 4 menstruation cycles. They will also undergo an approximately 4 menstrual cycle treatment period, and 3 menstrual cycle observation period. If pregnant during the study, participants will take the herbal medicine for implantation for about 15 days. In this study, the primary outcome will be the clinical pregnancy rate, whereas the secondary outcome will include the implantation rate, ongoing pregnancy rate, and live birth rate.Ultimately, this study will provide clinical data regarding the effectiveness and safety of KM treatment for females with unexplained infertility and important evidence for establishing standard KM treatments for unexplained infertility. Moreover, we will identify the most cost-effective way to treat unexplained infertility. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002235. Date: February 21, 2017

Interprofessional communication supporting clinical handover in emergency departments: An observation study.

PubMed

Redley, Bernice; Botti, Mari; Wood, Beverley; Bucknall, Tracey

2017-08-01

Poor interprofessional communication poses a risk to patient safety at change-of-shift in emergency departments (EDs). The purpose of this study was to identify and describe patterns and processes of interprofessional communication impacting quality of ED change-of-shift handovers. Observation of 66 change-of-shift handovers at two acute hospital EDs in Victoria, Australia. Focus groups with 34 nurse participants complemented the observations. Qualitative data analysis involved content and thematic methods. Four structural components of ED handover processes emerged represented by (ABCD): (1) Antecedents; (2) Behaviours and interactions; (3) Content; and (4) Delegation of ongoing care. Infrequent and ad hoc interprofessional communication and discipline-specific handover content and processes emerged as specific risks to patient safety at change-of-shift handovers. Three themes related to risky and effective practices to support interprofessional communications across the four stages of ED handovers emerged: 1) standard processes and practices, 2) teamwork and interactions and 3) communication activities and practices. Unreliable interprofessional communication can impact the quality of change-of-shift handovers in EDs and poses risk to patient safety. Structured reflective analysis of existing practices can identify opportunities for standardisation, enhanced team practices and effective communication across four stages of the handover process to support clinicians to enhance local handover practices. Future research should test and refine models to support analysis of practice, and identify and test strategies to enhance ED interprofessional communication to support clinical handovers. Copyright © 2017 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

PubMed

Hasford, J; Lamprecht, T

1998-01-01

Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study

PubMed Central

Zahoor, Hafiz; Chan, Albert P. C.; Utama, Wahyudi P.; Gao, Ran; Zafar, Irfan

2017-01-01

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation, and negative impact on number of self-reported accidents/injuries. However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation, safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries. PMID:28350366

Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

PubMed

Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

2017-03-28

This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

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Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.

PubMed

Luna, Joaquin; Plata, Manuel; Gonzalez, Mauricio; Correa, Alfonso; Maldonado, Ivete; Nossa, Claudia; Radley, David; Vuocolo, Scott; Haupt, Richard M; Saah, Alfred

2013-01-01

Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women. Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up. There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported. Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women. Clinicaltrials.govNCT00090220.

Long-Term Follow-up Observation of the Safety, Immunogenicity, and Effectiveness of Gardasil™ in Adult Women

PubMed Central

Luna, Joaquin; Plata, Manuel; Gonzalez, Mauricio; Correa, Alfonso; Maldonado, Ivete; Nossa, Claudia; Radley, David; Vuocolo, Scott; Haupt, Richard M.; Saah, Alfred

2013-01-01

Background Previous analyses from a randomized trial in women aged 24–45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women. Methods Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up. Results There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported. Conclusions Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24–45 year-old women. Trial Registration Clinicaltrials.gov NCT00090220 PMID:24391768

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

PubMed

Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

2018-03-27

Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships

The Development and Deployment of a Maintenance Operations Safety Survey.

PubMed

Langer, Marie; Braithwaite, Graham R

2016-11-01

Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. © 2016, Human Factors and Ergonomics Society.

The Development and Deployment of a Maintenance Operations Safety Survey

PubMed Central

Langer, Marie; Braithwaite, Graham R.

2016-01-01

Objective: Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Background: Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. Method: In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. Results: In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. Conclusion: This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. Application: MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. PMID:27411354

Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

PubMed

Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

2013-12-01

This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them.

Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

PubMed Central

Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

2016-01-01

Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. Our objective was to develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. We conducted a consensus meeting with 17 experts in Mississauga, Canada. Experts completed a premeeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended, and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources and measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife.

A Multi-Perspective Study on Safety Performance at the Colorado DOT

DOT National Transportation Integrated Search

2018-01-01

This effort focuses on the safety culture within CDOT and the effectiveness of the CDOT safety programs on improving safety culture. The study used a survey approach based on interviews with senior safety officials to determine the scope of the surve...

Comparison of safety effect estimates obtained from empirical Bayes before-after study, propensity scores-potential outcomes framework, and regression model with cross-sectional data.

PubMed

Wood, Jonathan S; Donnell, Eric T; Porter, Richard J

2015-02-01

A variety of different study designs and analysis methods have been used to evaluate the performance of traffic safety countermeasures. The most common study designs and methods include observational before-after studies using the empirical Bayes method and cross-sectional studies using regression models. The propensity scores-potential outcomes framework has recently been proposed as an alternative traffic safety countermeasure evaluation method to address the challenges associated with selection biases that can be part of cross-sectional studies. Crash modification factors derived from the application of all three methods have not yet been compared. This paper compares the results of retrospective, observational evaluations of a traffic safety countermeasure using both before-after and cross-sectional study designs. The paper describes the strengths and limitations of each method, focusing primarily on how each addresses site selection bias, which is a common issue in observational safety studies. The Safety Edge paving technique, which seeks to mitigate crashes related to roadway departure events, is the countermeasure used in the present study to compare the alternative evaluation methods. The results indicated that all three methods yielded results that were consistent with each other and with previous research. The empirical Bayes results had the smallest standard errors. It is concluded that the propensity scores with potential outcomes framework is a viable alternative analysis method to the empirical Bayes before-after study. It should be considered whenever a before-after study is not possible or practical. Copyright © 2014 Elsevier Ltd. All rights reserved.

Observational safety study of specific outcomes after trivalent cell culture seasonal influenza vaccination (Optaflu® ) among adults in THIN database of electronic UK primary healthcare records.

PubMed

Hall, Gillian C; Davies, Paul T G; Karim, M Yousuf; Haag, Mendel D M; O'Leary, Caroline

2018-01-01

To investigate the safety of trivalent seasonal influenza vaccine (TIVc) (Optaflu ® ), the first cell culture seasonal trivalent influenza vaccine available in Europe. Codes and unstructured text in adult electronic healthcare records (The Health Improvement Network) were searched for a TIVc brand name or batch number and possible outcomes within a 3 month pre- to 6 month post-TIVc exposure study period (2012-2015). The outcomes were severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis (optic and brachial), vasculitis, inflammatory bowel disease, and thrombocytopenia. Risk periods were defined based on biologically plausible time frame postvaccination when an outcome caused by the vaccine might be expected to occur. Possible outcomes were adjudicated against outcome specific case definitions and a date of onset assigned by using electronic and other medical records. Observed (risk period) to expected (outside risk and preexposure periods) rate ratios, postexposure incidence, and plots of time from exposure to outcome were reported. Sixteen of 1011 events from 4578 exposures fulfilled a primary case definition and had a date of onset during the study period. Three were in observed time. The observed-to-expected rate ratios were (3.3, 95% CI 0.3, 31.7) for convulsions and (1.5, 95% CI 0.2, 14.9) for thrombocytopenia with 1 outcome each in observed time. There was 1 incident inflammatory bowel disease in observed, but none in expected, time. The small sample size restricts interpretation; however, no hypothesis of an increased risk of a study outcome was generated. Adjudication of events against case definitions to reduce misclassification of onset and outcomes allowed use of precise risk periods. KEY POINTS This observational study did not generate a hypothesis of an association between the first cell-culture seasonal influenza vaccination available in the European Union and any of the study

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Sociocultural contexts and worker safety and health: findings of a study with Chinese immigrant restaurant workers.

PubMed

Tsai, Jenny; Bruck, Annie

2009-02-01

More immigrants are seeking employment in restaurants. Drawing data from an ethnographic study, this article discusses what and how sociocultural contexts shape the safety and health of immigrant restaurant workers. Eighteen Chinese immigrants from China, Hong Kong, and Taiwan participated in the study. Data generation methods included a questionnaire, individual and focus group interviews, and participant observations. Ethnographic analysis revealed that immigration mechanisms, demands of English proficiency for employment, and existence of networks and ethnic communities shaped the participants' employment choices. Working hours and schedules, interpersonal relationships at work, job design and training, occupational safety and health training, and national events and economy further influenced the participants' occupational experiences and well-being. Issues were noted with job security, mental health, family relationships, and risks for occupational injuries and illnesses. Implications for occupational health nursing research and practice to reduce immigrant workers' vulnerability to poor safety and health outcomes conclude this article.

COLD-SAT feasibility study safety analysis

NASA Technical Reports Server (NTRS)

Mchenry, Steven T.; Yost, James M.

1991-01-01

The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.

PubMed

Pierot, Laurent; Costalat, Vincent; Moret, Jacques; Szikora, Istvan; Klisch, Joachim; Herbreteau, Denis; Holtmannspötter, Markus; Weber, Werner; Januel, Anne-Christine; Liebig, Thomas; Sychra, Vojtech; Strasilla, Christoph; Cognard, Christophe; Bonafé, Alain; Molyneux, Andrew; Byrne, James V; Spelle, Laurent

2016-05-01

OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

A cross-sectional study to identify organisational processes associated with nurse-reported quality and patient safety

PubMed Central

Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

2012-01-01

Objectives The purpose of this study was to identify organisational processes and structures that are associated with nurse-reported patient safety and quality of nursing. Design This is an observational cross-sectional study using survey methods. Setting Respondents from 31 Norwegian hospitals with more than 85 beds were included in the survey. Participants All registered nurses working in direct patient care in a position of 20% or more were invited to answer the survey. In this study, 3618 nurses from surgical and medical wards responded (response rate 58.9). Nurses' practice environment was defined as organisational processes and measured by the Nursing Work Index Revised and items from Hospital Survey on Patient Safety Culture. Outcome measures Nurses' assessments of patient safety, quality of nursing, confidence in how their patients manage after discharge and frequency of adverse events were used as outcome measures. Results Quality system, nurse–physician relation, patient safety management and staff adequacy were process measures associated with nurse-reported work-related and patient-related outcomes, but we found no associations with nurse participation, education and career and ward leadership. Most organisational structures were non-significant in the multilevel model except for nurses’ affiliations to medical department and hospital type. Conclusions Organisational structures may have minor impact on how nurses perceive work-related and patient-related outcomes, but the findings in this study indicate that there is a considerable potential to address organisational design in improvement of patient safety and quality of care. PMID:23263021

Social signals of safety and risk confer utility and have asymmetric effects on observers' choices.

PubMed

Chung, Dongil; Christopoulos, George I; King-Casas, Brooks; Ball, Sheryl B; Chiu, Pearl H

2015-06-01

Individuals' risk attitudes are known to guide choices about uncertain options. However, in the presence of others' decisions, these choices can be swayed and manifest as riskier or safer behavior than one would express alone. To test the mechanisms underlying effective social 'nudges' in human decision-making, we used functional neuroimaging and a task in which participants made choices about gambles alone and after observing others' selections. Against three alternative explanations, we found that observing others' choices of gambles increased the subjective value (utility) of those gambles for the observer. This 'other-conferred utility' was encoded in ventromedial prefrontal cortex, and these neural signals predicted conformity. We further identified a parametric interaction with individual risk preferences in anterior cingulate cortex and insula. These data provide a neuromechanistic account of how information from others is integrated with individual preferences that may explain preference-congruent susceptibility to social signals of safety and risk.

Study of a safety margin system for powered-lift STOL aircraft

NASA Technical Reports Server (NTRS)

Heffley, R. K.; Jewell, W. F.

1978-01-01

A study was conducted to explore the feasibility of a safety margin system for powered-lift aircraft which require a backside piloting technique. The objective of the safety margin system was to present multiple safety margin criteria as a single variable which could be tracked manually or automatically and which could be monitored for the purpose of deriving safety margin status. The study involved a pilot-in-the-loop analysis of several safety margin system concepts and a simulation experiment to evaluate those concepts which showed promise of providing a good solution. A system was ultimately configured which offered reasonable compromises in controllability, status information content, and the ability to regulate the safety margin at some expense of the allowable low speed flight path envelope.

Impact of health education intervention on food safety and hygiene of street vendors: A pilot study.

PubMed

Singh, Ansk Kumar; Dudeja, Puja; Kaushal, Nitin; Mukherji, Sandip

2016-07-01

Street foods are major source of food to millions of people. However, these are frequently associated with food-borne illnesses. It is imperative that street food vendors are educated to maintain hygiene and hence safety of food. With this background, a pilot study was undertaken to assess the impact of health education intervention on food safety and hygiene of street vendors. The aim of this study was to assess impact of health education intervention on food safety of street vendors. It was a before and after study conducted in twenty street vendors of an urban area. Tool based on Bureau of Indian Standards (BIS) 2012 was prepared with scoring system to rate hygiene and sanitation of street vendors (score 0-156). Health education was given to all and scores of these vendors on same tool were reassessed after four weeks. Mean age of the study subjects was 35 ± 13.2 years. Highest score attained in BIS tool for food safety was 104 out of 156 (66.6%). No vendor was found to have achieved excellent score. Reasons for poor score were poor condition of vending cart, location, lack personal hygiene and incorrect and unsafe food handling practices. After intervention, it was observed that there was no significant improvement in overall score of vendors. However, scores in domains of personal habits, hygiene and food handling practices improved significantly after intervention (p < 0.05). The street vendors do not meet required standards given by BIS for food safety. Health education alone can only partly improve food safety practices of street vendors.

An observational survey of child car safety practices in private pre-primary and primary schools in two local government areas of Lagos State, Nigeria.

PubMed

Olufunlayo, T F; Odeyemi, K A; Ogunnowo, B E; Onajole, A T; Oyediran, M A

2012-08-01

To describe child car safety practices among children aged 0-8 years. Eight schools from two local government areas (LGAs) were selected by simple random sampling. Passenger cars were observed for child seating position and restraint use at each selected school as children were being dropped off in the morning. Observed child restraint use was very low, as was the rate of appropriate restraint for age (10.8% and 4.2%, respectively, in Eti-Osa, and 7.0% and 1.8% in Ikeja). Child restraint use decreased with increasing age group from 25% in those below 1 year, to 12% in those aged 1-3 years, and 7.4% in those aged 4-8 years. A large proportion of restrained passengers were inappropriately restrained in a seatbelt alone. Front seating among observed child passengers was not as high as in studies from similar environments (9.4% and 17.5% in Eti-Osa and Ikeja, respectively). Factors associated with child restraint use were number of child passengers in car, and whether or not the driver wore a seatbelt. Seating position of the child was significantly associated with the relationship of the driver to the child, and driver's gender. The level of child restraint use observed in this study is unacceptably low. The relatively low prevalence of front seating while riding in cars should however be further reduced. The study recommends the enactment of specific country legislation on the use of child restraints, accompanied by multifaceted intervention programmes to improve the availability and use of child car safety seats and booster seats.

Consumer confidence in the safety of food and newspaper coverage of food safety issues: a longitudinal perspective.

PubMed

de Jonge, Janneke; Van Trijp, Hans; Renes, Reint Jan; Frewer, Lynn J

2010-01-01

This study develops a longitudinal perspective on consumer confidence in the safety of food to explore if, how, and why consumer confidence changes over time. In the first study, a theory-based monitoring instrument for consumer confidence in the safety of food was developed and validated. The monitoring instrument assesses consumer confidence together with its determinants. Model and measurement invariance were validated rigorously before developments in consumer confidence in the safety of food and its determinants were investigated over time. The results from the longitudinal analysis show that across four waves of annual data collection (2003-2006), the framework was stable and that the relative importance of the determinants of confidence was, generally, constant over time. Some changes were observed regarding the mean ratings on the latent constructs. The second study explored how newspaper coverage of food safety related issues affects consumer confidence in the safety of food through subjective consumer recall of food safety incidents. The results show that the newspaper coverage on food safety issues is positively associated with consumer recall of food safety incidents, both in terms of intensity and recency of media coverage.

Outcomes studies of the gastrointestinal safety of cyclooxygenase-2 inhibitors.

PubMed

Scheiman, James M

2002-01-01

Short-term endoscopic studies of the highly selective cyclooxygenase-2 (COX-2) inhibitors (coxibs) rofecoxib and celecoxib have shown that these agents are well tolerated and have efficacy equivalent to nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) with fewer adverse effects on the upper gastrointestinal (GI) tract. These studies are limited, however, as the detection of endoscopic lesions is not well correlated with symptomatic ulcers and ulcer complications. Outcomes studies of the GI safety are, therefore, essential to understanding how coxibs are likely to perform in a clinical practice setting. Four large outcomes studies (Vioxx Gastrointestinal Outcomes Research, VIGOR; Assessment of Difference Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness trial, ADVANTAGE; Celecoxib Long-term Arthritis Safety Study, CLASS; and the Successive Celecoxib Efficacy and Safety Studies, SUCCESS) examined the GI safety of rofecoxib and celecoxib in over 39,000 patients with osteoarthritis or rheumatoid arthritis. Results of these studies showed that patients taking a supratherapeutic dose of rofecoxib or celecoxib had significantly lower rates of GI-related adverse events than those taking a nonselective NSAID (naproxen, ibuprofen, or diclofenac). Reduced risk of upper GI events was seen in patients with multiple risk factors and in patients using low-dose aspirin and corticosteroids concomitantly with a coxib. Results of large outcomes studies provide support for the COX-2 hypothesis and demonstrate the long-term safety and tolerability of coxibs.

Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study.

PubMed

Rosati, Gerardo; Pinto, Carmine; Di Fabio, Francesca; Chiara, Silvana; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrara, Raimondo; Antonuzzo, Lorenzo; Adua, Daniela; Racca, Patrizia; Bilancia, Domenico; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

2018-05-01

The influence of age (<70 years and ≥70 years) was retrospectively studied on the quality of life (QoL), incidence of side effects (including skin reactions) and efficacy of chemotherapy plus cetuximab in patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC). 225 patients of the Observed study (PS 0-1) were retrieved based on age (< 70 and ≥70 years) and evaluated through EORTC QLQ-C30 and DLQI questionnaires. The two patient groups (141 < 70 and 84 ≥ 70 years, respectively) were balanced with no differences in any of the clinical and pathological characteristics considered. Both groups underwent similar type of first-line chemotherapy plus cetuximab, treatment duration and compliance. Cetuximab therapy caused similar incidence of side effects and impact on QoL in older and younger patients. No difference was observed in progression free survival (PFS) and in disease control rates between the two patient populations. Median overall survival (OS) was higher in patients <70 (27 months, 95% CI: 22.7-31.27) than in patients ≥70 (19 months, 95% CI: 14.65-23.35) (p = 0.002), which is likely due to higher proportions of metastatic resection (27.0% vs 8.3%; p = 0.001) and utilization of second-line therapy in younger group (58.9% vs 42.9%; p = 0.028). The current data suggest that fit older patients with mCRC can be safely treated with a cetuximab-based therapy, as QoL and safety profile do not seem to be affected by age. In addition, age did not impact the choice of chemotherapy to be associated to cetuximab and treatment compliance. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

The use, safety, and effectiveness of herpes zoster vaccination in individuals with inflammatory and autoimmune diseases: a longitudinal observational study

PubMed Central

2011-01-01

Introduction Zostavax, a live attenuated vaccine, has been approved in the United States for use in older individuals to reduce the risk and severity of herpes zoster (HZ), also known as shingles. The vaccine is contraindicated in individuals taking anti-tumor necrosis factor alpha (anti-TNF) therapies or other biologics commonly used to treat autoimmune diseases because of the safety concern that zoster vaccine may be associated with a short-term HZ risk. The objective of the study was to examine the use, safety (short-term HZ risk after vaccination), and effectiveness of zoster vaccine in individuals with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases. Methods We conducted a cohort study of patients aged 50 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases by using administrative claims data from a nationwide health plan from January 1, 2005, to August 31, 2009. We examined the extent to which zoster vaccine was used; assessed factors associated with vaccine use (Cox proportional hazards regression); and compared the incidence rates of herpes zoster (HZ) between vaccinated and unvaccinated patients. Results Among 44,115 patients with the autoimmune diseases, 551 (1.2%) received zoster vaccine, and 761 developed HZ. Zoster vaccine use increased continuously after approval in 2006. Younger and healthier patients, those who had an HZ infection within the past 6 months, and those who were not using anti-TNF therapies were more likely to receive the vaccine. Approximately 6% of vaccinated patients were using anti-TNF therapies at the time of vaccination. The incidence rates of HZ were similar in vaccinated and unvaccinated patients (standardized incidence ratio, 0.99; 95% confidence interval, 0.29 to 3.43). Conclusions Use of the zoster vaccine was uncommon among older patients with autoimmune diseases, including those

The use, safety, and effectiveness of herpes zoster vaccination in individuals with inflammatory and autoimmune diseases: a longitudinal observational study.

PubMed

Zhang, Jie; Delzell, Elizabeth; Xie, Fenglong; Baddley, John W; Spettell, Claire; McMahan, Raechele M; Fernandes, Joaquim; Chen, Lang; Winthrop, Kevin; Curtis, Jeffrey R

2011-01-01

Zostavax, a live attenuated vaccine, has been approved in the United States for use in older individuals to reduce the risk and severity of herpes zoster (HZ), also known as shingles. The vaccine is contraindicated in individuals taking anti-tumor necrosis factor alpha (anti-TNF) therapies or other biologics commonly used to treat autoimmune diseases because of the safety concern that zoster vaccine may be associated with a short-term HZ risk. The objective of the study was to examine the use, safety (short-term HZ risk after vaccination), and effectiveness of zoster vaccine in individuals with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases. We conducted a cohort study of patients aged 50 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and/or inflammatory bowel diseases by using administrative claims data from a nationwide health plan from January 1, 2005, to August 31, 2009. We examined the extent to which zoster vaccine was used; assessed factors associated with vaccine use (Cox proportional hazards regression); and compared the incidence rates of herpes zoster (HZ) between vaccinated and unvaccinated patients. Among 44,115 patients with the autoimmune diseases, 551 (1.2%) received zoster vaccine, and 761 developed HZ. Zoster vaccine use increased continuously after approval in 2006. Younger and healthier patients, those who had an HZ infection within the past 6 months, and those who were not using anti-TNF therapies were more likely to receive the vaccine. Approximately 6% of vaccinated patients were using anti-TNF therapies at the time of vaccination. The incidence rates of HZ were similar in vaccinated and unvaccinated patients (standardized incidence ratio, 0.99; 95% confidence interval, 0.29 to 3.43). Use of the zoster vaccine was uncommon among older patients with autoimmune diseases, including those not exposed to immunosuppressive

Driver characteristics associated with child safety seat usage in Malaysia: a cross-sectional study.

PubMed

Kulanthayan, S; Razak, Ahmad; Schenk, Ellen

2010-03-01

The rapidly motorizing environment in Malaysia has made child occupant safety a current public health concern. The usage of child safety seats (CSS) is a widely regarded intervention to enhance child occupant safety, yet no study has been conducted on CSS in Malaysia. This study aims to determine the CSS usage rates in Malaysia and to assess driver characteristics that are associated with CSS usage. Nine variables - urban versus rural study location, age, gender, marital status, educational status, monthly family income, number of children present in the vehicle, distance traveled to the study location, and attitude - were examined through a cross-sectional study of interviewing drivers of 230 vehicles transporting at least one child <10 years of age at the time of the study. The vehicles were also observed for whether or not there was a CSS present. The interviews were conducted at six sampling locations - three urban and three rural - in the state of Melaka. 27.4% of the drivers were found to be using at least one CSS at the time of the survey. Among the nine variables studied, three of the driver characteristics showed statistical significance (p<0.05) with CSS usage: age (p=0.047), educational status (p=0.009), and attitude (p=0.009). This study begins to create knowledge on child occupant safety in Malaysia. The results indicate that interventional efforts should focus on educational programs geared toward drivers that are less educated or extended family members who inconsistently transport young children. Furthermore, any educational efforts could be strongly enhanced by legislation mandating the use of CSS. Every effort should be made to thoroughly assess the effectiveness of any educational or legislative activities that are implemented. Copyright 2009 Elsevier Ltd. All rights reserved.

Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

PubMed

Evans, Ellen W; Redmond, Elizabeth C

2014-03-01

Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

A Study in Iowa. Teaching Food Safety in Secondary FCS Classes

ERIC Educational Resources Information Center

Ellis, Jason D.; Henroid, Daniel H., Jr.

2005-01-01

Food safety is a significant issue in the United States and yet minimal research has been done on the inclusion of food safety in secondary school curricula. This study examined the feasibility of including food safety in Iowa FCS middle and secondary classes. Teachers reported food safety was important; only a few believed students were…

Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study.

PubMed

Nolan, Terry; Chotpitayasunondh, Tawee; Capeding, Maria Rosario; Carson, Simon; Senders, Shelly David; Jaehnig, Peter; de Rooij, Richard; Chandra, Richa

2016-01-04

Cell culture-derived inactivated influenza vaccines (TIVc) are necessary for scale and predictability of production to meet global demand. This study compared the safety and tolerability of TIVc with an egg-derived trivalent influenza vaccine (TIVf) in 4-17 yearolds. A Phase 3 observer blind, multicenter study enrolled 2055 healthy participants randomized 2:1 to receive either TIVc or TIVf, respectively (1372 TIVc and 683 TIVf evaluable subjects). Participants received one dose each on Days 1 and 28 (4-8 year-olds not previously vaccinated [NPV]) or one dose on Day 1 (4-8 and 9-17 yearolds previously vaccinated [PV]). Solicited adverse events (AEs) occurring within 7 days after each vaccination were assessed; participants were followed up for 6 months after their last dose for safety. Most solicited and unsolicited AEs were mild to moderate with <1% in the severe category. No withdrawals due to AEs, deaths or vaccine-related SAEs were reported. TIVc and TIVf were similar in percentages of participants reporting solicited reactions in 4-8 years NPV group after the 1st dose: local reactions, TIVc: 48%, TIVf: 43%; systemic reactions, TIVc: 34%, TIVf: 32%; percentages were lower following the 2nd dose in TIVc; local reactions: TIVc: 40%; TIVf: 43%; systemic reactions: TIVc: 21%; TIVf: 22%. In 4-17 years PV group, solicited reactions were lower following TIVf, local reactions: TIVc: 53%; TIVf: 43%; systemic reactions: TIVc: 37%, TIVf: 30%. Injection-site pain was the most common solicited reaction, and was similar following TIVc and TIVf in 4-8 yearolds (TIVc: 56%; TIVf: 55%), and lower following TIVf in 9-17 years group (TIVc: 52%; TIVf: 42%). Reporting of unsolicited AEs was similar for TIVc and TIVf across the two age groups. TIVc was well tolerated and had a safety and reactogenicity profile similar to that of TIVf in healthy 4-17 yearolds (NCT01857206). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

PubMed

Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

Three-day treatment with imipenem for unexplained fever during prolonged neutropaenia in haematology patients receiving fluoroquinolone and fluconazole prophylaxis: a prospective observational safety study.

PubMed

Slobbe, Lennert; Waal, Loes van der; Jongman, Lydia R; Lugtenburg, Pieternella J; Rijnders, Bart J A

2009-11-01

Guidelines advocate >7d of broad-spectrum antibiotics for unexplained fever (UF) during neutropaenia. However, effective antimicrobial prophylaxis reduces the incidence of gram-negative infections, which may allow shorter treatment. This study evaluates the safety of discontinuing empirical broad-spectrum antibiotics if no microbial source is documented after an initial work-up of 72 h. Prospective observational study at a tertiary-care haematology-unit in patients suffering from haematologic malignancies and treatment-induced prolonged neutropaenia of 10d. Oral fluoroquinolone and fluconazole prophylaxis was given from day 1. Fever was empirically treated with imipenem which was discontinued after 72 h if, following a standardised protocol, no infectious aetiology was documented. Duration of fever, antimicrobial therapy and overall mortality were registered. One hundred and sixty six patients were evaluated during 276 neutropaenic episodes. One hundred and thirty six patients (82.5%) experienced 1 febrile episode. A total of 317 febrile episodes were observed, of which 177 (56%) were diagnosed as UF. In 135 febrile episodes (43%), a probable/definite infectious origin was documented. Mean duration of fever in neutropaenic periods with 1 febrile episode was 5d, and mean time of treatment with imipenem was 4.7d. In patients without documented infection, mean time of imipenem treatment was only 3.7d. Overall mortality 30 d after neutrophil recovery was 3.6% (6/166); no patient died from untreated bacterial infection. Discontinuation of broad-spectrum antibiotics during neutropaenia in haematology patients on fluoroquinolone and fluconazole prophylaxis is safe, provided that no infectious aetiology is established after 72 h.

The role of safety signals in fear extinction: An analogue study.

PubMed

Restrepo-Castro, Juan C; Castro-Camacho, Leonidas; Javier Labrador, Francisco

2017-12-01

Safety signals are conditioned inhibitory stimuli that indicate the absence of unconditioned stimuli. It is not clear whether the presence of safety signals is detrimental or beneficial in extinction-based interventions. The purpose of this study was to evaluate the effect of safety signals on autonomic and expectancy fear-related responses. Following the conditional discrimination paradigm (AX +, BX-), undergraduate students (N = 48) underwent an aversive conditioning procedure, while safety signals were experimentally created. Participants were randomly assigned to one of two conditions during extinction: presence or absence of safety signals. Significant reductions of fear-related responses were found in both groups. Expectancy measures showed that the presence of safety signals did not interfere with reduction of fear related responses at follow-up. The analogue nature of the study affects its ecological validity. There are some methodological issues. Safety signals did not interfere with extinction learning. Attention may be a mechanism associated with the maintenance of fear responses. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety and feasibility audit of a home-based drug-transitioning approach for patients with pulmonary arterial hypertension: an observational study.

PubMed

Dawson, A; Reddecliffe, S; Coghlan, C; Schreiber, B E; Coghlan, J G

2018-04-01

Newer endothelin receptor antagonists (ERAs) used to treat patients with pulmonary arterial hypertension (PAH) are associated with fewer drug-drug interactions than bosentan and require less monitoring. This, combined with a pharmacokinetic basis for improved efficacy, means there may be a clinical rationale for changing therapies. However, this can be challenging and few data on its safety in patients with PAH are available. At the Royal Free Hospital in London, UK, home-based medication transitioning has been standard practice since 2009 to avoid unnecessary hospital visits for patients, unless there is a clinical imperative. In this audit of standard practice we evaluated the consequences of adopting such a strategy when transitioning PAH patients between ERA therapies. Using a Clinical Nurse Specialist-led, home-based transitioning strategy, 92 patients with PAH were transitioned from bosentan to macitentan or ambrisentan. Observational data were analysed retrospectively. The majority of patients were female with PAH associated with connective tissue disease and their ERA was changed in the hope of improving efficacy. The process was well tolerated with no adverse events associated with the process. Seventeen patients died during the study (macitentan, n = 5; ambrisentan, n = 12). None of the deaths was considered related to ERA treatment. The majority of patients remained clinically stable, based on WHO functional class and exercise capacity. An established home-based transitioning strategy can be adopted safely for patients with PAH changing ERA therapies. Most patients remained stable and the therapy change was well tolerated.

A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

PubMed

Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

2018-01-01

Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

Studies on Labour Safety in Construction Sites

PubMed Central

Kanchana, S.; Sivaprakash, P.; Joseph, Sebastian

2015-01-01

Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

Studies on Labour Safety in Construction Sites.

PubMed

Kanchana, S; Sivaprakash, P; Joseph, Sebastian

2015-01-01

Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites.

Improving patient safety culture in general practice: an interview study

PubMed Central

Verbakel, Natasha J; de Bont, Antoinette A; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

2015-01-01

Background When improving patient safety a positive safety culture is key. As little is known about improving patient safety culture in primary care, this study examined whether administering a culture questionnaire with or without a complementary workshop could be used as an intervention for improving safety culture. Aim To gain insight into how two interventions affected patient safety culture in everyday practice. Design and setting After conducting a randomised control trial of two interventions, this was a qualitative study conducted in 30 general practices to aid interpretation of the previous quantitative findings. Method Interviews were conducted at practice locations (n = 27) with 24 GPs and 24 practice nurses. The theory of communities of practice — in particular, its concepts of a domain, a community, and a practice — was used to interpret the findings by examining which elements were or were not present in the participating practices. Results Communal awareness of the problem was only raised after getting together and discussing patient safety. The combination of a questionnaire and workshop enhanced the interaction of team members and nourished team feelings. This shared experience also helped them to understand and develop tools and language for daily practice. Conclusion In order for patient safety culture to improve, the safety culture questionnaire was more successful when accompanied by a practice workshop. Initial discussion and negotiation of shared goals during the workshop fuelled feelings of coherence and belonging to a community wishing to learn about enhancing patient safety. Team meetings and day-to-day interactions enhanced further liaison and sharing, making patient safety a common and conscious goal. PMID:26622035

Safety Relevant Observations on the ICE High Speed Train

DOT National Transportation Integrated Search

1991-07-01

The safety of high speed rail technology proposed for possible application in the United States is of concern to the Federal Railroad Administration. This report, one in a series of reports planned for high speed rail technologies presents an initial...

Mobilising a team for the WHO Surgical Safety Checklist: a qualitative video study.

PubMed

Korkiakangas, Terhi

2017-03-01

One challenge identified in the Surgical Safety Checklist literature is the inconsistent participation of operating teams in the safety checks. Less is known about how teams move from preparatory activities into a huddle, and how communication underpins this gathering. The objective of this study is to examine the ways of mobilising teams and the level of participation in the safety checks. Team participation in time-out and sign-out was examined from a video corpus of 20 elective surgical operations. Teams included surgeons, nurses and anaesthetists in a UK teaching hospital, scheduled to work in the operations observed. Qualitative video analysis of team participation was adapted from the study of social interaction. The key aspects of team mobilisation were the timing of the checklist, the distribution of personnel in the theatre and the instigation practices used. These were interlinked in bringing about the participation outcomes, the number of people huddling up for time-out and sign-out. Timing seemed appropriate when most personnel were present in the theatre suite; poor timing was marked by personnel dispersed through the theatre. Participation could be managed using the instigation practices, which included or excluded participation within teams. The factors hindering full-team participation at time-out and sign-out were the overlapping (eg, anaesthetic and nursing) responsibilities and the use of exclusive instigation practices. The implementation of the Surgical Safety Checklist represents a global concern in patient safety research. Yet how teams huddle for the checks has to be acknowledged as an issue in its own right. Appropriate mobilisation practices can help bringing fuller teams together, which has direct relevance to team training. 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/.

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

The reporting of observational studies in veterinary research presents many challenges that often are not adequately addressed in published reporting guidelines. A consensus meeting of experts was organized to develop an extension of the STROBE statement to address observational studies in veterinary medicine with respect to animal health, animal production, animal welfare and food safety outcomes. The consensus meeting was held 11-13 May 2014 in Mississauga, Ontario, Canada. Seventeen experts from North America, Europe and Australia attended the meeting. The experts were epidemiologists and biostatisticians, many of whom hold or have held editorial positions with relevant journals. Prior to the meeting, 19 experts completed a survey about whether they felt any of the 22 items of the STROBE statement should be modified and whether items should be added to address unique issues related to observational studies in animal species with health, production, welfare or food safety outcomes. At the meeting, the participants were provided with the survey responses and relevant literature concerning the reporting of veterinary observational studies. During the meeting, each STROBE item was discussed to determine whether or not re-wording was recommended, and whether additions were warranted. Anonymous voting was used to determine whether there was consensus for each item change or addition. The consensus was that six items needed no modifications or additions. Modifications or additions were made to the STROBE items numbered as follows: 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations) and 22 (funding). Published literature was not always available to support modification to, or inclusion of, an item. The methods and processes used in the

Exposure to fall hazards and safety climate in the aircraft maintenance industry.

PubMed

Neitzel, Richard L; Seixas, Noah S; Harris, Michael J; Camp, Janice

2008-01-01

Falls represent a significant occupational hazard, particularly in industries with dynamic work environments. This paper describes rates of noncompliance with fall hazard prevention requirements, perceived safety climate and worker knowledge and beliefs, and the association between fall exposure and safety climate measures in commercial aircraft maintenance activities. Walkthrough observations were conducted on aircraft mechanics at two participating facilities (Sites A and B) to ascertain the degree of noncompliance. Mechanics at each site completed questionnaires concerning fall hazard knowledge, personal safety beliefs, and safety climate. Questionnaire results were summarized into safety climate and belief scores by workgroup and site. Noncompliance rates observed during walkthroughs were compared to the climate-belief scores, and were expected to be inversely associated. Important differences were seen in fall safety performance between the sites. The study provided a characterization of aircraft maintenance fall hazards, and also demonstrated the effectiveness of an objective hazard assessment methodology. Noncompliance varied by height, equipment used, location of work on the aircraft, shift, and by safety system. Although the expected relationship between safety climate and noncompliance was seen for site-average climate scores, workgroups with higher safety climate scores had greater observed noncompliance within Site A. Overall, use of engineered safety systems had a significant impact on working safely, while safety beliefs and climate also contributed, though inconsistently. The results of this study indicate that safety systems are very important in reducing noncompliance with fall protection requirements in aircraft maintenance facilities. Site-level fall safety compliance was found to be related to safety climate, although an unexpected relationship between compliance and safety climate was seen at the workgroup level within site. Finally, observed

Safety of intravenous metoprolol use in unmonitored wards: a single-centre observational study.

PubMed

Kelly, D; Hawdon, G; Reeves, J; Morris, A; Cunningham, M; Barrett, J

2015-09-01

This study aims to examine and quantify the risks associated with the use of intravenous metoprolol on unmonitored wards. This study was a retrospective single-centre observational study from 1 January 2009 to 31 December 2013. The study hospital was a 415-bed, private hospital in Melbourne, Victoria. The study population was all patients who received intravenous metoprolol on an unmonitored ward. The primary outcome measure was the rate of serious adverse events (SAE), defined as a complication of intravenous metoprolol resulting in transfer to a critical-care environment, a medical emergency team call or death. Six hundred and nine patients received a total of 8260 doses of intravenous metoprolol. Seven cases were identified with a SAE deemed possibly related to beta-blocker use and there was one death. All SAE were hypotension, giving an overall rate of hypotension of 7/609 or 1.1% (95% confidence interval (CI), 0.5 to 2.4%) with a rate per dose delivered of 0.8/1000 doses (95% CI 0.3 to 1.7). The death occurred in a 94-year-old woman with abdominal sepsis. After case file review, consensus opinion deemed this to be unrelated to intravenous metoprolol. The use of intravenous metoprolol on unmonitored wards appears to be safe. The complication rate was low, suggesting that this may be a sensible approach to the management of in-hospital populations at risk of beta-blocker withdrawal. © 2015 Royal Australasian College of Physicians.

Professional environment and patient safety in emergency departments.

PubMed

Lambrou, Persefoni; Papastavrou, Evridiki; Merkouris, Anastasios; Middleton, Nicos

2015-04-01

The purpose of this study was to examine nurses' and physicians' perceptions of professional environment and its association with patient safety in public emergency departments in Cyprus. A total of 224 professionals (174 nurses and 50 physicians) participated (rr = 81%). Data were collected using the "Revised Professional Practice Environment" (RPPE) instrument and the Safety Climate Domain of the "Emergency Medical Services Safety Attitudes Questionnaire" (EMS-SAQ). The mean overall score of RPPE was 2.79 (SD = 0.30), among physicians 2.84 (SD = 0.25) and nurses 2.73 (SD = 0.33) (P-value = 0.07). Statistically significant differences were observed between the two study groups regarding "staff relationships", "motivation" and "cultural sensitivity" (P-values < 0.05). No significant differences were observed as regards EMS-SAQ (3.25 vs. 3.16 respectively; P-value = 0.28). All 8 components of the RPPE exhibited significant association with patient safety. Linear and stepwise regression analyses showed that "leadership" explains 28% of the variance of safety. This relationship suggests improvements in professional environment with the ultimate goal of improving patient safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

Observational Studies: Cohort and Case-Control Studies

PubMed Central

Song, Jae W.; Chung, Kevin C.

2010-01-01

Observational studies are an important category of study designs. To address some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. Instead, observational studies may be the next best method to address these types of questions. Well-designed observational studies have been shown to provide results similar to randomized controlled trials, challenging the belief that observational studies are second-rate. Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures. In this review article, we describe these study designs, methodological issues, and provide examples from the plastic surgery literature. PMID:20697313

Safety pharmacology investigations in toxicology studies: an industry survey.

PubMed

Authier, Simon; Vargas, Hugo M; Curtis, Michael J; Holbrook, Mark; Pugsley, Michael K

2013-01-01

The Safety Pharmacology (SP) Society (SPS) conducted an industry survey in 2012 in an attempt to define current industry practices as they relate to inclusion of safety pharmacology (SP) endpoints into Toxicology studies. A total of 361 participants from Asia (9.1%), Europe (19.4%) and North America (71.4%) responded to the survey. The preponderance of respondents were toxicologists (53.2%) followed by safety pharmacologists (27.2%) and scientists involved in the conduct of both disciplines (19.6%). Most participants (58.6%) were from pharmaceutical companies employing more than 500 employees. A majority (68.2%) reported having experience in designing, performing or interpreting the SP component of a study when performed as part of a toxicology study. Some participants (42.0%) had submitted data to a regulatory agency where ICHS7 studies were performed as part of a toxicology study rather than as a standalone study. When comparing species that were used in studies in which SP was added to toxicology studies, canines were the most frequently reported animals used for new chemical entities (NCE) whereas non-human (NH) primates were the most frequent for the assessment of biological agents. The most frequent primary motivator for adding ICHS7 SP endpoints to regulatory toxicology studies was to generate additional data to allow for determination of an integrated risk assessment thereby testing Confidence in Safety (CIS) to better manage and/or mitigate risk. The current ability to add safety pharmacology endpoints into regulatory toxicology studies was used to address a specific concern (by 42.1% of respondents) to allow management of risk more effectively (36.8%) or to generate data that contributes to cessation of the progression of a compound (21.1%). For an NCE, SP measurements in toxicology studies were conducted in addition to standalone SP studies (by 40.6% of respondents) or in addition/instead of standalone safety pharmacology studies (by 39.8% of respondents

A predictive index of biomarkers for ictogenesis from tier I safety pharmacology testing that may warrant tier II EEG studies.

PubMed

Gauvin, David V; Zimmermann, Zachary J; Yoder, Joshua; Harter, Marci; Holdsworth, David; Kilgus, Quinn; May, Jonelle; Dalton, Jill; Baird, Theodore J

2018-05-08

Three significant contributions to the field of safety pharmacology were recently published detailing the use of electroencephalography (EEG) by telemetry in a critical role in the successful evaluation of a compound during drug development (1] Authier, Delatte, Kallman, Stevens & Markgraf; JPTM 2016; 81:274-285; 2] Accardi, Pugsley, Forster, Troncy, Huang & Authier; JPTM; 81: 47-59; 3] Bassett, Troncy, Pouliot, Paquette, Ascaha, & Authier; JPTM 2016; 70: 230-240). These authors present a convincing case for monitoring neocortical biopotential waveforms (EEG, ECoG, etc) during preclinical toxicology studies as an opportunity for early identification of a central nervous system (CNS) risk during Investigational New Drug (IND) Enabling Studies. This review is about "ictogenesis" not "epileptogenesis". It is intended to characterize overt behavioral and physiological changes suggestive of drug-induced neurotoxicity/ictogenesis in experimental animals during Tier 1 safety pharmacology testing, prior to first dose administration in man. It is the presence of these predictive or comorbid biomarkers expressed during the requisite conduct of daily clinical or cage side observations, and in early ICH S7A Tier I CNS, pulmonary and cardiovascular safety study designs that should initiate an early conversation regarding Tier II inclusion of EEG monitoring. We conclude that there is no single definitive clinical marker for seizure liability but plasma exposures might add to set proper safety margins when clinical convulsions are observed. Even the observation of a study-related full tonic-clonic convulsion does not establish solid ground to require the financial and temporal investment of a full EEG study under the current regulatory standards. For purposes of this review, we have adopted the FDA term "sponsor" as it refers to any person who takes the responsibility for and initiates a nonclinical investigations of new molecular entities; FDA uses the term "sponsor" primarily

Patients' and families' perspectives of patient safety at the end of life: a video-reflexive ethnography study.

PubMed

Collier, Aileen; Sorensen, Ros; Iedema, Rick

2016-02-01

The aim of this study was to investigate patients' and families' perspectives of safety and quality in the setting of a life-limiting illness. Data reported here were generated from a qualitative study using video-reflexive ethnographic methodology. Data were collected over 18 months and generated through participant observation, shadowing of clinicians, field-interviews and semi-structured interviews with patients and families. The study was conducted at two hospital sites in Sydney, Australia and in patients' homes. Patients with an advanced life-limiting illness (n = 29) ranging in age between 27 and 89 years and family members (n = 5) participated in the study. Patient safety remains important to dying patients and families. For dying people, iatrogenic harm is not regarded as 'one off' incidents. Rather, harm is experienced as a result of an unfolding series of negative events. Critically, iatrogenic harm is emotional, social and spiritual and not solely technical-clinical misadventure and is inextricably linked with feeling unsafe. Thus, patient safety extends beyond narrowly defined technical-clinical parameters to include interpersonal safety. Current approaches to patient safety do not address fully the needs of dying patients and their families. Patients and their families regard poor communication with and by health professionals to be harmful in and of itself. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Canadian Consumer Food Safety Practices and Knowledge: Foodbook Study.

PubMed

Murray, Regan; Glass-Kaastra, Shiona; Gardhouse, Christine; Marshall, Barbara; Ciampa, Nadia; Franklin, Kristyn; Hurst, Matt; Thomas, M Kate; Nesbitt, Andrea

2017-10-01

Understanding consumers' food safety practices and knowledge supports food safety education for the prevention of foodborne illness. The objective of this study was to describe Canadian consumer food safety practices and knowledge. This study identifies demographic groups for targeted food safety education messaging and establishes a baseline measurement to assess the effectiveness of food safety interventions over time. Questions regarding consumer food safety practices and knowledge were included in a population-based telephone survey, Foodbook, conducted from November 2014 to March 2015. The results were analyzed nationally by age group and by gender. The results showed that approximately 90% of Canadians reported taking the recommended cleaning and separating precautions when handling raw meat to prevent foodborne illness. Only 29% of respondents reported using a food thermometer when cooking any meat, and even fewer (12%) reported using a food thermometer for small cuts of meat such as chicken pieces. The majority (>80%) of Canadians were aware of the foodborne illness risks related to chicken and hamburger, but fewer (<40%) were aware of the risks related to frozen chicken nuggets, alfalfa sprouts, soft unpasteurized cheese, and unpasteurized juices. Generally, men were less likely to follow cooking instructions on packaging and took fewer steps to prevent cross-contamination than women. The youngest (18 to 29 years) age group was less likely to take steps to avoid cross-contamination and was less aware of the risks associated with eating an undercooked hamburger. The oldest (60+ years) respondents were less likely to be aware of the risks associated with raw eggs, alfalfa sprouts, and unpasteurized juice than the middle (30 to 59 years) age group. As a priority, food safety education in Canada should focus on increasing people's awareness of high-risk foods, specifically foods for which the awareness of risk found in this study was low; targeting messaging

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. To develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. Consensus meeting of experts. Mississauga, Canada. Seventeen experts from North America, Europe, and Australia. Experts completed a pre-meeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

PubMed

Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

2012-05-01

To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non

Observational studies: a valuable source for data on the true value of RA therapies.

PubMed

van Vollenhoven, Ronald F; Severens, Johan L

2011-03-01

The validity of observational studies is sometimes questioned because of the limitations of non-randomly assigned controls, various biases such as channeling bias, confounding by indication, and other pitfalls. Yet, (post-marketing) observational data can provide important information regarding not only drug safety but also the effectiveness and appropriate use of agents in the real world, outside of clinical trials. Observational studies also provide data regarding the wider value of these agents in terms of, for example, reducing the need for surgical procedures, reducing absenteeism and increasing productivity. Importantly, data from some observational registry studies have subsequently been confirmed by clinical trials, supporting the overall validity of the registry-based approach. Observational studies also allow measures such as health assessment questionnaire scores, disease activity scores, and glucocorticoid use over time to be monitored for longer periods. Furthermore, observational data in real, less strictly selected patients without the constraints of formal study populations may produce findings not observed in clinical trials but that warrant further investigation in a controlled trial environment. For example, recent data from the Stockholm tumor necrosis factor follow-up registry in Sweden showed increases in the time people worked after initiation of biologics that, surprisingly, continued into the fourth and fifth years of treatment--a finding not observed with standardized outcomes. Observational studies are truly an underappreciated and valuable source of data on the real value of anti-rheumatic therapies, and these data are essential for making sound decisions regarding coverage and reimbursement.

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Comparison between self-reported and observed food handling behaviors among Latinas.

PubMed

Dharod, Jigna Morarji; Pérez-Escamilla, Rafael; Paciello, Stefania; Bermúdez-Millán, Angela; Venkitanarayanan, Kumar; Damio, Grace

2007-08-01

The study was conducted to compare and identify the magnitude of differences between self-reported and observed food safety behaviors among women preparing a chicken and salad dish at home. The observed food safety practices also were compared according to sociodemographic variables and prior food safety education. Sixty Puerto Rican women who were the main meal preparers for their households were recruited in Hartford, Conn. Three household visits were made to (i) deliver food ingredients to prepare the chicken and salad meal, (ii) conduct household observation, and (iii) conduct a self-reported survey. The difference between self-reported and observed behaviors varied across food handling and sanitation behaviors. There was a high level of inaccuracy for socially desirable behaviors such as hand washing; the vast majority of participants reported practicing these behaviors but they were not observed doing so. Cutting board washing also was considerably overreported, questioning the validity of these self-reported data for regression analyses. There was a significant association (P < 0.05) between proper thawing method and prior food safety education, use of cutting board and higher income, and washing tomatoes and having a positive attitude towards food safety. Results revealed that overreporting errors must be considered when analyzing and/or interpreting data derived from self-reported food safety consumer surveys and that food safety education and positive food safety attitudes are associated with recommended food safety behaviors.

An observational study: associations between nurse-reported hospital characteristics and estimated 30-day survival probabilities

PubMed Central

Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

2014-01-01

Background There is a growing body of evidence for associations between the work environment and patient outcomes. A good work environment may maximise healthcare workers’ efforts to avoid failures and to facilitate quality care that is focused on patient safety. Several studies use nurse-reported quality measures, but it is uncertain whether these outcomes are correlated with clinical outcomes. The aim of this study was to determine the correlations between hospital-aggregated, nurse-assessed quality and safety, and estimated probabilities for 30-day survival in and out of hospital. Methods In a multicentre study involving almost all Norwegian hospitals with more than 85 beds (sample size=30, information about nurses’ perceptions of organisational characteristics were collected. Subscales from this survey were used to describe properties of the organisations: quality system, patient safety management, nurse–physician relationship, staffing adequacy, quality of nursing and patient safety. The average scores for these organisational characteristics were aggregated to hospital level, and merged with estimated probabilities for 30-day survival in and out of hospital (survival probabilities) from a national database. In this observational, ecological study, the relationships between the organisational characteristics (independent variables) and clinical outcomes (survival probabilities) were examined. Results Survival probabilities were correlated with nurse-assessed quality of nursing. Furthermore, the subjective perception of staffing adequacy was correlated with overall survival. Conclusions This study showed that perceived staffing adequacy and nurses’ assessments of quality of nursing were correlated with survival probabilities. It is suggested that the way nurses characterise the microsystems they belong to, also reflects the general performance of hospitals. PMID:24728887

Study Abroad Programs: Making Safety a Priority

ERIC Educational Resources Information Center

Buddan, Michael Craig; Budden, Connie B.; Juban, Rusty; Baraya, Aristides

2014-01-01

Increasingly, students are participating in study abroad programs. Such programs provide participants a variety of learning experiences. Developing cross-cultural appreciation, communication skills, maturity and a less ethno-centric mindset are among the impacts study abroad programs offer. However, care must be taken to assure student safety and…

The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

PubMed

Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

2016-08-01

The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

Safety and effectiveness of a 12-week course of sofosbuvir and simeprevir ± ribavirin in HCV-infected patients with or without HIV infection: a multicentre observational study.

PubMed

Bruno, Giuseppe; Saracino, Annalisa; Fabrizio, Claudia; Scudeller, Luigia; Milano, Eugenio; Dell'Acqua, Raffaele; Ladisa, Nicoletta; Fasano, Massimo; Minniti, Salvatore; Buccoliero, Giovanni; Tartaglia, Alessandra; Giammario, Adele; Milella, Michele; Angarano, Gioacchino

2017-03-01

The combination of sofosbuvir and simeprevir ± ribavirin (SOF + SMV ± RBV) for hepatitis C virus (HCV) treatment has been associated with high rates of sustained virological response (SVR). Few data are available regarding this regimen in HIV/HCV co-infected patients. This study evaluated the effectiveness and safety of a 12-week course of SOF + SMV ± RBV in a cohort of HCV monoinfected and HIV/HCV co-infected individuals. HCV-infected patients, with or without HIV infection, receiving a 12-week course of SOF + SMV ± RBV in four Italian centres from February to October 2015, were included in this retrospective observational study. Clinical and biochemical data were retrieved for all patients. A total of 88 individuals were evaluated: 29 (33.0%) HIV/HCV co-infected and 59 (67.0%) monoinfected. Most patients were males with HCV genotype 1b (62.5%) and 1a (25%) infection. RBV was used in 41 HCV monoinfected and 6 HIV/HCV co-infected patients. Cirrhosis was found in 67 patients (76.1%). The most common adverse events (AEs) were rash and/or pruritus (23.9%), fatigue (13.6%) and anaemia (9.1%). Serious AEs occurred in three patients (3.4%). No treatment discontinuations were observed. RBV use was associated with multiple AEs (P = 0.02). An overall SVR12 of 93.2% was achieved; 96.6% in HCV monoinfected and 86.2% in HIV/HCV co-infected individuals, without significance both in univariate (P = 0.09) and multivariate analyses (P = 0.12). A baseline platelet count ≥90 000/mm 3 was associated with higher rates of SVR (P = 0.005). A 12-week course of SOF + SMV ± RBV was associated with good safety and high SVR12 rate both in HCV monoinfected and HIV-HCV co-infected individuals. Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

40 CFR 725.92 - Data from health and safety studies of microorganisms.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

40 CFR 725.92 - Data from health and safety studies of microorganisms.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

40 CFR 725.92 - Data from health and safety studies of microorganisms.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

40 CFR 725.92 - Data from health and safety studies of microorganisms.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

40 CFR 725.92 - Data from health and safety studies of microorganisms.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Data from health and safety studies of... Public Access to Information § 725.92 Data from health and safety studies of microorganisms. (a..., EPA will deny any claim of confidentiality with respect to information included in a health and safety...

A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

DOT National Transportation Integrated Search

2016-07-01

To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

PubMed

Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

2017-08-01

Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from

Space Station crew safety alternatives study. Volume 5: Space Station safety plan

NASA Technical Reports Server (NTRS)

Mead, G. H.; Peercy, R. L., Jr.; Raasch, R. F.

1985-01-01

The Space Station Safety Plan has been prepared as an adjunct to the subject contract final report, suggesting the tasks and implementation procedures to ensure that threats are addressed and resolution strategy options identified and incorporated into the space station program. The safety program's approach is to realize minimum risk exposure without levying undue design and operational constraints. Safety objectives and risk acceptances are discussed.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

PubMed

Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Technological aspects of hospital communication challenges: an observational study.

PubMed

Popovici, Ilinca; Morita, Plinio P; Doran, Diane; Lapinsky, Stephen; Morra, Dante; Shier, Ashleigh; Wu, Robert; Cafazzo, Joseph A

2015-06-01

To gain insights into how technological communication tools impact effective communication among clinicians, which is critical for patient safety. This multi-site observational study analyzes inter-clinician communication and interaction with information technology, with a focus on the critical process of patient transfer from the Emergency Department to General Internal Medicine. Mount Sinai Hospital, Sunnybrook Health Sciences Centre and Toronto General Hospital. At least five ED and general internal medicine nurses and physicians directly involved in patient transfers were observed on separate occasions at each institution. N/A. N/A. The study provides insight into clinician workflow, evaluates current hospital communication systems and identifies key issues affecting communication: interruptions, issues with numeric pagers, lack of integrated communication tools, lack of awareness of consultation status, inefficiencies related to the paper chart, unintuitive user interfaces, mixed use of electronic and paper systems and lack of up-to-date contact information. It also identifies design trade-offs to be negotiated: synchronous communication vs. reducing interruptions, notification of patient status vs. reducing interruptions and speed vs. quality of handovers. The issues listed should be considered in the design of new technology for hospital communications. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Alaska Humans Factors Safety Study: The Southern Coastal Area

NASA Technical Reports Server (NTRS)

Chappell, Sheryl L.; Reynard, William (Technical Monitor)

1995-01-01

At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASA-ASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the southern coastal areas, specifically: Anchorage, Dillingham, King Salmon, Kodiak, Cold Bay, Juneau, and Ketchikan. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

Pediatric Nurses' Perceptions of Medication Safety and Medication Error: A Mixed Methods Study.

PubMed

Alomari, Albara; Wilson, Val; Solman, Annette; Bajorek, Beata; Tinsley, Patricia

2018-06-01

This study aims to outline the current workplace culture of medication practice in a pediatric medical ward. The objective is to explore the perceptions of nurses in a pediatric clinical setting as to why medication administration errors occur. As nurses have a central role in the medication process, it is essential to explore nurses' perceptions of the factors influencing the medication process. Without this understanding, it is difficult to develop effective prevention strategies aimed at reducing medication administration errors. Previous studies were limited to exploring a single and specific aspect of medication safety. The methods used in these studies were limited to survey designs which may lead to incomplete or inadequate information being provided. This study is phase 1 on an action research project. Data collection included a direct observation of nurses during medication preparation and administration, audit based on the medication policy, and guidelines and focus groups with nursing staff. A thematic analysis was undertaken by each author independently to analyze the observation notes and focus group transcripts. Simple descriptive statistics were used to analyze the audit data. The study was conducted in a specialized pediatric medical ward. Four key themes were identified from the combined quantitative and qualitative data: (1) understanding medication errors, (2) the busy-ness of nurses, (3) the physical environment, and (4) compliance with medication policy and practice guidelines. Workload, frequent interruptions to process, poor physical environment design, lack of preparation space, and impractical medication policies are identified as barriers to safe medication practice. Overcoming these barriers requires organizations to review medication process policies and engage nurses more in medication safety research and in designing clinical guidelines for their own practice.

Are long physician working hours harmful to patient safety?

PubMed

Ehara, Akira

2008-04-01

Pediatricians of Japanese hospitals including not only residents but also attending physicians work long hours, and 8% work for >79 h per week. Most of them work consecutively for >or=32 h when they are on call. The aim of the present study was to evaluate the effect of long work hours on patient safety. The electronic databases MEDLINE and EMBASE to searched identify the English- and Japanese-language literature for studies on work hours, medical errors, patient safety, and malpractice for years 1966-2005. Studies that analyzed the relationship between physician work hours and outcomes directly related to patient safety were selected. Seven studies met the criteria. Four studies suggest that reduction of work hours has a favorable effect on patient safety indicators. In the other three studies no significant changes of the indicators were observed, but no report found that shorter work hours were harmful to patient safety. Decrease of physician work hours is not harmful but favorable to patient safety.

Outdoor play among children in relation to neighborhood characteristics: a cross-sectional neighborhood observation study.

PubMed

Aarts, Marie-Jeanne; de Vries, Sanne I; van Oers, Hans Am; Schuit, Albertine J

2012-08-17

Although environmental characteristics as perceived by parents are known to be related to children's outdoor play behavior, less is known about the relation between independently measured neighborhood characteristics and outdoor play among children. The purpose of this study was to identify quantitative as well as qualitative neighborhood characteristics related to outdoor play by means of neighborhood observations. Questionnaires including questions on outdoor play behavior of the child were distributed among 3,651 parents of primary school children (aged 4-12 years). Furthermore, neighborhood observations were conducted in 33 Dutch neighborhoods to map neighborhood characteristics such as buildings, formal outdoor play facilities, public space, street pattern, traffic safety, social neighborhood characteristics, and general impression. Data of the questionnaires and the neighborhood observations were coupled via postal code of the respondents. Multilevel GEE analyses were performed to quantify the correlation between outdoor play and independently measured neighborhood characteristics. Parental education was negatively associated with outdoor play among children. Neither the presence nor the overall quality of formal outdoor play facilities were (positively) related to outdoor play among children in this study. Rather, informal play areas such as the presence of sidewalks were related to children's outdoor play. Also, traffic safety was an important characteristic associated with outdoor play. This study showed that, apart from individual factors such as parental education level, certain modifiable characteristics in the neighborhood environment (as measured by neighborhood observations) were associated with outdoor play among boys and girls of different age groups in The Netherlands. Local policy makers from different sectors can use these research findings in creating more activity-friendly neighborhoods for children.

Outdoor play among children in relation to neighborhood characteristics: a cross-sectional neighborhood observation study

PubMed Central

2012-01-01

Background Although environmental characteristics as perceived by parents are known to be related to children’s outdoor play behavior, less is known about the relation between independently measured neighborhood characteristics and outdoor play among children. The purpose of this study was to identify quantitative as well as qualitative neighborhood characteristics related to outdoor play by means of neighborhood observations. Methods Questionnaires including questions on outdoor play behavior of the child were distributed among 3,651 parents of primary school children (aged 4–12 years). Furthermore, neighborhood observations were conducted in 33 Dutch neighborhoods to map neighborhood characteristics such as buildings, formal outdoor play facilities, public space, street pattern, traffic safety, social neighborhood characteristics, and general impression. Data of the questionnaires and the neighborhood observations were coupled via postal code of the respondents. Multilevel GEE analyses were performed to quantify the correlation between outdoor play and independently measured neighborhood characteristics. Results Parental education was negatively associated with outdoor play among children. Neither the presence nor the overall quality of formal outdoor play facilities were (positively) related to outdoor play among children in this study. Rather, informal play areas such as the presence of sidewalks were related to children’s outdoor play. Also, traffic safety was an important characteristic associated with outdoor play. Conclusions This study showed that, apart from individual factors such as parental education level, certain modifiable characteristics in the neighborhood environment (as measured by neighborhood observations) were associated with outdoor play among boys and girls of different age groups in The Netherlands. Local policy makers from different sectors can use these research findings in creating more activity-friendly neighborhoods for

Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study.

PubMed

Swinglehurst, Deborah; Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

2011-11-03

To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. Ethnographic case study. Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. Potential threats to patient safety and characteristics of good practice. Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as "exceptions" by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge. Clinicians were often unaware of this input and it did not feature in policy

Why is patient safety so hard? A selective review of ethnographic studies.

PubMed

Dixon-Woods, Mary

2010-01-01

Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

PubMed

Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

2011-10-26

although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the

Small town health care safety nets: report on a pilot study.

PubMed

Taylor, Pat; Blewett, Lynn; Brasure, Michelle; Call, Kathleen Thiede; Larson, Eric; Gale, John; Hagopian, Amy; Hart, L Gary; Hartley, David; House, Peter; James, Mary Katherine; Ricketts, Thomas

2003-01-01

Very little is known about the health care safety net in small towns, especially in towns where there is no publicly subsidized safety-net health care. This pilot study of the primary care safety net in 7 such communities was conducted to start building knowledge about the rural safety net. Interviews were conducted and secondary data collected to assess the community need for safety-net care, the health care safety-net role of public officials, and the availability of safety-net care at private primary care practices and its financial impact on these practices. An estimated 20% to 40% of the people in these communities were inadequately insured and needed access to affordable health care, and private primary care practices in most towns played an important role in making primary care available to them. Most of the physician practices were owned or subsidized by a hospital or regional network, though not explicitly to provide charity care. It is likely this ownership or support enabled the practices to sustain a higher level of charity care than would have been possible otherwise. In the majority of communities studied, the leading public officials played no role in ensuring access to safety-net care. State and national government policy makers should consider subsidy programs for private primary care practices that attempt to meet the needs of the inadequately insured in the many rural communities where no publicly subsidized primary safety-net care is available. Subsidies should be directed to physicians in primary care shortage areas who provide safety-net care; this will improve safety-net access and, at the same time, improve physician retention by bolstering physician incomes. Options include enhanced Medicare physician bonuses and grants or tax credits to support income-related sliding fee scales.

Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

PubMed Central

Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

2016-01-01

This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

Occupational safety of different industrial sectors in Khartoum State, Sudan. Part 1: Safety performance evaluation.

PubMed

Zaki, Gehan R; El-Marakby, Fadia A; H Deign El-Nor, Yasser; Nofal, Faten H; Zakaria, Adel M

2012-12-01

Safety performance evaluation enables decision makers improve safety acts. In Sudan, accident records, statistics, and safety performance were not evaluated before maintenance of accident records became mandatory in 2005. This study aimed at evaluating and comparing safety performance by accident records among different cities and industrial sectors in Khartoum state, Sudan, during the period from 2005 to 2007. This was a retrospective study, the sample in which represented all industrial enterprises in Khartoum state employing 50 workers or more. All industrial accident records of the Ministry of Manpower and Health and those of different enterprises during the period from 2005 to 2007 were reviewed. The safety performance indicators used within this study were the frequency-severity index (FSI) and fatal and disabling accident frequency rates (DAFR). In Khartoum city, the FSI [0.10 (0.17)] was lower than that in Bahari [0.11 (0.21)] and Omdurman [0.84 (0.34)]. It was the maximum in the chemical sector [0.33 (0.64)] and minimum in the metallurgic sector [0.09 (0.19)]. The highest DAFR was observed in Omdurman [5.6 (3.5)] and in the chemical sector [2.5 (4.0)]. The fatal accident frequency rate in the mechanical and electrical engineering industry was the highest [0.0 (0.69)]. Male workers who were older, divorced, and had lower levels of education had the lowest safety performance indicators. The safety performance of the industrial enterprises in Khartoum city was the best. The safety performance in the chemical sector was the worst with regard to FSI and DAFR. The age, sex, and educational level of injured workers greatly affect safety performance.

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

Safety climate in dialysis centers in Saudi Arabia: a multicenter study.

PubMed

Taher, Saadi; Hejaili, Fayez; Karkar, Ayman; Shaheen, Faissal; Barahmien, Majdah; Al Saran, Khalid; Jondeby, Mohamed; Suleiman, Mohamed; Al Sayyari, Abdulla Ahmed

2014-06-01

The aim of this study was to assess the safety climate as perceived by nurses and physicians in the dialysis units in Saudi Arabia. This is a cross-sectional survey-based multicenter study using the Safety Climate Scale, which assesses the perception by staff of the prevailing climate of safety. We used 17 items in this survey. These could be further divided into 3 summative categories: (a) handling of errors and safety concerns (9 items), (b) leadership emphasis of safety (7 items), and (c) overall safety recommendation (1 item). The survey uses 5 Likert scale options (1, disagree strongly; 2, disagree slightly; 3, neutral; 4, agree slightly; and 5, agree strongly). There were 509 respondents--a response rate of 76.6% and 53.3% among nurses and physicians, respectively. The internal consistency using Cronbach α was 0.899. The overall mean (SD) of satisfaction with safety climate was higher among the nurses than the physicians (4.13 [1.1] and 4.05 [1.7], respectively; P = 0.029). The overall agreement rate was 73.8%, with more nurses than physicians agreeing that safety climate prevails the dialysis center (75.4% versus 72.1%, respectively; P = 0.047).The respondents perceived a stronger commitment to safety from their clinical area leaders than from senior leaders in the organization (76.2% and 72.4%, respectively). In addition, the physicians gave lower scores to more questions than the nurses particularly in 3 areas, namely, "leadership is driving us to be a safety-centered institution" (71.5% versus 76.5%; P = 0.037), "I am encouraged by my colleagues to report any patient safety concerns I may have" (67.4% versus 84.7%; P = 0.03), and "I know proper channels to ask questions about safety" (69.6% versus 87.2%; P = 0.002).The scores by the physicians in all the 3 summative categories were again less than the scores by the nurses, but this did not reach a statistical significance. The nurses had higher perceptions of a prevailing safety climate than the

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

PubMed

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

2017-01-01

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

Driver hand-held mobile phone use and safety belt use.

PubMed

Eby, David W; Vivoda, Jonathon M

2003-11-01

The purposes of the study were to identify hand-held mobile phone use trends for Michigan and to compare safety belt use between users and nonusers. Mobile phone and safety belt use was investigated by a direct observation survey of drivers at intersections in Michigan. Data were weighted to calculate mobile phone use and safety belt use rates statewide. The study showed 2.7% of Michigan drivers were using a mobile phone at any given daylight time. Safety belt use of current mobile phone users was significantly lower than those not using mobile phones.

Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins.

PubMed

Atar, Dan; Ong, Seleen; Lansberg, Peter J

2015-01-01

It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). To examine the role that observational studies can play in complementing data from RCTs, we reviewed published studies for statins, a class of drugs that have been widely used to reduce the risk of cardiovascular (CV) events by lowering low-density lipoprotein cholesterol levels. RCTs have consistently demonstrated the benefits of statin treatment in terms of CV risk reduction and have demonstrated that more intensive statin therapy has incremental benefits over less intensive treatment. Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.

Efficacy and safety of dexmedetomidine infusion for patients undergoing awake craniotomy: An observational study.

PubMed

Mahajan, Charu; Rath, Girija Prasad; Singh, Gyaninder Pal; Mishra, Nitasha; Sokhal, Suman; Bithal, Parmod Kumar

2018-01-01

The goal of awake craniotomy is to maintain adequate sedation, analgesia, respiratory, and hemodynamic stability and also to provide a cooperative patient for neurologic testing. An observational study carried out to evaluate the efficacy of dexmedetomidine sedation for awake craniotomy. Adult patients with age >18 year who underwent awake craniotomy for intracranial tumor surgery were enrolled. Those who were uncooperative and had difficult airway were excluded from the study. In the operating room, the patients received a bolus dose of dexmedetomidine 1 μg/kg followed by an infusion of 0.2-0.7 μg/kg/h (bispectral index target 60-80). Once the patients were sedated, scalp block was given with bupivacaine 0.25%. The data on hemodynamics at various stages of the procedure, intraoperative complications, total amount of fentanyl used, intravenous fluids required, blood loss and transfusion, duration of surgery, Intensive Care Unit (ICU), and hospital stay were collected. The patients were assessed for Glasgow outcome scale (GOS) score and patient satisfaction score (PSS). A total of 27 patients underwent awake craniotomy during a period of 2 years. Most common intraoperative complication was seizures; observed in five patients (18.5%). None of these patients experienced any episode of desaturation. Two patients had tight brain for which propofol boluses were administered. The average fentanyl consumption was 161.5 ± 85.0 μg. The duration of surgery, ICU, and hospital stays were 231.5 ± 90.5 min, 14.5 ± 3.5 h, and 4.7 ± 1.5 days, respectively. The overall PSS was 8 and GOS was good in all the patients. The use of dexmedetomidine infusion with regional scalp block in patients undergoing awake craniotomy is safe and efficacious. The absence of major complications and higher PSS makes it close to an ideal agent for craniotomy in awake state.

Bus safety study : a report to Congress.

DOT National Transportation Integrated Search

2013-11-01

Section 20021(b) of the Moving Ahead for Progress for the 21st Century (MAP-21) legislation requires the Secretary of Transportation : to submit a report of the results of a Bus Safety Study to the Committee on Banking, Housing, and Urban Affai...

Subsonic Aircraft Safety Icing Study

NASA Technical Reports Server (NTRS)

Jones, Sharon Monica; Reveley, Mary S.; Evans, Joni K.; Barrientos, Francesca A.

2008-01-01

NASA's Integrated Resilient Aircraft Control (IRAC) Project is one of four projects within the agency s Aviation Safety Program (AvSafe) in the Aeronautics Research Mission Directorate (ARMD). The IRAC Project, which was redesigned in the first half of 2007, conducts research to advance the state of the art in aircraft control design tools and techniques. A "Key Decision Point" was established for fiscal year 2007 with the following expected outcomes: document the most currently available statistical/prognostic data associated with icing for subsonic transport, summarize reports by subject matter experts in icing research on current knowledge of icing effects on control parameters and establish future requirements for icing research for subsonic transports including the appropriate alignment. This study contains: (1) statistical analyses of accident and incident data conducted by NASA researchers for this "Key Decision Point", (2) an examination of icing in other recent statistically based studies, (3) a summary of aviation safety priority lists that have been developed by various subject-matter experts, including the significance of aircraft icing research in these lists and (4) suggested future requirements for NASA icing research. The review of several studies by subject-matter experts was summarized into four high-priority icing research areas. Based on the Integrated Resilient Aircraft Control (IRAC) Project goals and objectives, the IRAC project was encouraged to conduct work in all of the high-priority icing research areas that were identified, with the exception of the developing of methods to sense and document actual icing conditions.

Pilot Study: A Pediatric Pedestrian Safety Curriculum for Preschool Children.

PubMed

Bovis, Stephanie E; Harden, Taijha; Hotz, Gillian

2016-01-01

To evaluate and implement the WalkSafe Pre-Kindergarten Pedestrian Safety Curriculum. A quasi-experimental pretest-posttest design without a control group was used to measure children's pedestrian safety knowledge. Knowledge assessments consisting of multiple-choice and short-answer questions were administered pre- and post-curriculum implementation by classroom teachers. Knowledge assessments gauged prekindergarten students' knowledge of pedestrian safety activities prior to safety curriculum implementation and, again, after the students received the curriculum. A total of 605 children (aged 3- to 5-year) from 38 prekindergarten classrooms in 16 randomly selected elementary schools participated in the pedestrian safety education pilot program. Subjects were of multiethnic and diverse backgrounds from the Miami-Dade County Public School District. Of the 605 educated subjects, 454 children completed both pre- and posttests. A statistically significant difference was found between pretest knowledge (M = 5.49, SD = 1.54) and posttest knowledge (M = 6.64, SD = 1.35) assessment scores across all 454 subjects, t(452) = -16.22, p < .001, 95% CI [-1.29, -1.01]. Previous studies have shown that classroom-based training of children as young as 4 years old can yield significant improvements in traffic safety knowledge. The statistical findings of the WalkSafe Pre-Kindergarten Pedestrian Safety Curriculum revealed statistically significant improvements in pedestrian safety knowledge of these young children. Future research efforts will focus on longitudinal behavioral changes in these students and an increase in pedestrian safety behaviors (e.g., utilization of crosswalks or sidewalks).

Industrial Student Apprenticeship: Understanding Health and Safety

NASA Astrophysics Data System (ADS)

Simanjuntak, M. V.; Abdullah, A. G.; Puspita, R. H.; Mahdan, D.; Kamaludin, M.

2018-02-01

The level of accident in industry is very high caused by lack of knowledge and awareness of workers toward the health and safety. Health and Safety are efforts to create a comfortable and productive atmosphere to accomplish a purpose or goal as maximum risk in the workplace. Vocational Education students must conduct training on business and industry, prior to that they should have a clear understanding on occupational health and safety. The purpose of this research is to analyze the understanding, preparation, and implementation of work health and safety of the students. Method used is descriptive method and data are collected using instrument, observation and interview. The result of study is conclusion of understanding occupational health and safety of vocational education students.

75 FR 29754 - Claims of Confidentiality of Certain Chemical Identities Contained in Health and Safety Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... Certain Chemical Identities Contained in Health and Safety Studies and Data from Health and Safety Studies... identities in health and safety studies, and in data from health and safety studies, submitted under the.... Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from...

Impact of the World Health Organization's Surgical Safety Checklist on safety culture in the operating theatre: a controlled intervention study

PubMed Central

Haugen, A. S.; Søfteland, E.; Eide, G. E.; Sevdalis, N.; Vincent, C. A.; Nortvedt, M. W.; Harthug, S.

2013-01-01

Background Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization's Surgical Safety Checklist (SSC). We aimed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospective controlled intervention design at a single Norwegian university hospital. Methods We conducted a study with pre- and post-intervention surveys using the intervention and control groups. The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions. Safety culture was measured using the validated Norwegian version of the Hospital Survey on Patient Safety Culture. Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded. A mixed linear regression model was used to assess changes in safety culture. Results The response rate was 61% (349/575) at baseline and 51% (292/569) post-intervention. Checklist compliance ranged from 77% to 85%. We found significant positive changes in the checklist intervention group for the culture factors ‘frequency of events reported’ and ‘adequate staffing’ with regression coefficients at −0.25 [95% confidence interval (CI), −0.47 to −0.07] and 0.21 (95% CI, 0.07–0.35), respectively. Overall, the intervention group reported significantly more positive culture scores—including at baseline. Conclusions Implementation of the SSC had rather limited impact on the safety culture within this hospital. PMID:23404986

Radiological Safety Handbook.

ERIC Educational Resources Information Center

Army Ordnance Center and School, Aberdeen Proving Ground, MD.

Written to be used concurrently with the U.S. Army's Radiological Safety Course, this publication discusses the causes, sources, and detection of nuclear radiation. In addition, the transportation and disposal of radioactive materials are covered. The report also deals with the safety precautions to be observed when working with lasers, microwave…

Lung Function Measurements in Rodents in Safety Pharmacology Studies

PubMed Central

Hoymann, Heinz Gerd

2012-01-01

The ICH guideline S7A requires safety pharmacology tests including measurements of pulmonary function. In the first step – as part of the “core battery” – lung function tests in conscious animals are requested. If potential adverse effects raise concern for human safety, these should be explored in a second step as a “follow-up study”. For these two stages of safety pharmacology testing, both non-invasive and invasive techniques are needed which should be as precise and reliable as possible. A short overview of typical in vivo measurement techniques is given, their advantages and disadvantages are discussed and out of these the non-invasive head-out body plethysmography and the invasive but repeatable body plethysmography in orotracheally intubated rodents are presented in detail. For validation purposes the changes in the respective parameters such as tidal midexpiratory flow (EF50) or lung resistance have been recorded in the same animals in typical bronchoconstriction models and compared. In addition, the technique of head-out body plethysmography has been shown to be useful to measure lung function in juvenile rats starting from day two of age. This allows safety pharmacology testing and toxicological studies in juvenile animals as a model for the young developing organism as requested by the regulatory authorities (e.g., EMEA Guideline 1/2008). It is concluded that both invasive and non-invasive pulmonary function tests are capable of detecting effects and alterations on the respiratory system with different selectivity and area of operation. The use of both techniques in a large number of studies in mice and rats in the last years have demonstrated that they provide useful and reliable information on pulmonary mechanics in safety pharmacology and toxicology testing, in investigations of respiratory disorders, and in pharmacological efficacy studies. PMID:22973226

Tritium safety study using Caisson Assembly (CATS) at TPL/JAEA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hayashi, T.; Kobayashi, K.; Iwai, Y.

Tritium confinement is required as the most important safety Junction for a fusion reactor. In order to demonstrate the confinement performance experimentally, an unique equipment, called CATS: Caisson Assembly for Tritium Safety study, was installed in Tritium Process Laboratory of Japan Atomic Energy Agency and operated for about 10 years. Tritium confinement and migration data in CATS have been accumulated and dynamic simulation code was accumulated using these data. Contamination and decontamination behavior on various materials and new safety equipment functions have been investigated under collaborations with a lot of laboratories and universities. (authors)

Evidence for oral agmatine sulfate safety--a 95-day high dosage pilot study with rats.

PubMed

Gilad, Gad M; Gilad, Varda H

2013-12-01

Agmatine, decarboxylated arginine, exerts beneficial effects in various experimental disease models. Clinical trials indicate the safety and effectiveness of short-term (up to 21 days) high dose regimens of oral agmatine sulfate, but longer term studies are lacking. This pilot study undertook to assess the safety of a longer term high dosage oral agmatine sulfate in laboratory rats. Adult Wistar rats consumed 5.3 g/l agmatine sulfate in their drinking water for 95 days, a regimen estimated to result in a daily dosage of absorbed agmatine of about 100mg/kg. Animals' body weight, water consumption and blood pressure were periodically measured, and general cage behavior, fur appearance, urination and feces appearance monitored. These parameters were also determined at 20 days after treatment cessation (day 115). On days 95 and 115, animals were euthanized for gross necropsy assessment. Agmatine-treated rats showed slight, but significant reductions in body weight and blood pressure, and reduced water consumption during treatment, which recovered completely within 20 days after treatment cessation. Otherwise, no abnormal behaviors or organ pathologies were observed. These findings are first to suggest apparent safety of sub-chronic high dosage dietary agmatine sulfate in laboratory rats, thus lending further support to the therapeutic applications of agmatine. Copyright © 2013 Elsevier Ltd. All rights reserved.

Environmental and psychosocial factors affecting seat belt use among Turkish front-seat occupants in Ankara: two observation studies.

PubMed

Simşekoğlu, Ozlem; Lajunen, Timo

2008-01-01

Low seat belt use rate among car occupants is one of the main problems contributing to low driver and passenger safety in Turkey, where injury and fatality rates of car occupants are very high in traffic crashes. The present article consists of two observation studies, which were conducted in Ankara. The first study aimed at investigating environmental factors and occupant characteristics affecting seat belt use among front-seat occupants, and the objective of the second study was to investigate the relationship between driver and front-seat passenger seat belt use. In the first study, 4, 227 front-seat occupants (drivers or front seat passengers) were observed on four different road sides and, in the second study 1, 398 front seat occupants were observed in car parks of five different shopping centers in Ankara. In both observations, front-seat occupants' seat bet use (yes, no), sex (male, female), and age (< 30 years, 30-50 years, > 50 years) were recorded. The data were analyzed using chi-square statistics and binary logistic regression techniques. Results of the first study showed that seat belt use proportion among observed front seat occupants was very low (25%). Being female and traveling on intercity roads were two main factors positively related to use a seat belt among front-seat occupants. High correlations between seat belt use of the drivers and front-seat passengers were found in the second study. Overall, low seat belt use rate (25%) among the front-seat occupants should be increased urgently for an improved driver and passenger safety in Turkey. Seat belt campaigns especially tailored for male front-seat occupants and for the front-seat occupants traveling on city roads are needed to increase seat belt use rates among them. Also, both drivers and passengers may have an important role in enforcing seat belt use among themselves.

Age and Workers' Perceptions of Workplace Safety: A Comparative Study

ERIC Educational Resources Information Center

Gyekye, Seth Ayim; Salminen, Simo

2009-01-01

The study examined the relationship between age and I) safety perception; ii) job satisfaction; iii) compliance with safety management policies; and (iv) accident frequency. Participants were Ghanaian industrial workers (N = 320) categorized into 4 age groups: 19-29 years; 30-39 years; 40-50 years; and 51 years and above. Workplace safety…

Safety assessment of transgenic Bacillus thuringiensis with VIP insecticidal protein gene by feeding studies.

PubMed

Peng, Donghai; Chen, Shouwen; Ruan, Lifang; Li, Lin; Yu, Ziniu; Sun, Ming

2007-07-01

The aim of this study was to evaluate the toxicology safety of a genetically modified (GM) Bacillus thuringiensis with vegetative insecticidal protein (VIP) gene. Acute and subacute toxicity studies by using its powder preparation were conducted in Wistar rats. The result of the acute study showed the no-observable-adverse-effect level (NOAEL) of this GM B. thuringiensis powder preparation was greater than 5000 mg/kg body weight (BW). In the subacute study, the data analysis of body weight gain, food and water consumptions, clinical observations, haematology, serum biochemistry, organ weight ratios and histopathological findings did not show significant differences between control and treated groups. These results proved the NOAEL of this GM B. thuringiensis powder preparation in subacute test was greater than 5000 mg/kg BW. Since both the acute and subacute oral toxicity were not detected at the highest dose recommended by OECD guidelines, this GM B. thuringiensis could be generally regarded as safe for use in bio-pesticide industry.

Michigan safety belt use immediately following implementation of standard enforcement

DOT National Transportation Integrated Search

2000-05-01

Reported here are the results of a direct observation survey of safety belt use conducted in March 2000 to determine the effect the implementation of standard enforcement legislation has had on Michigan's safety belt use rate. In this study, 11,687 o...

Key aspects in managing safety when working with multiple contractors: A case study.

PubMed

Drupsteen, Linda; Rasmussen, Hanna B; Ustailieva, Erika; van Kampen, Jakko

2015-01-01

Working with multiple contractors in a shared workplace can introduce and increase safety risks due to complexity. The aim of this study was to explore how safety issues are recognized in a specific case and to identify whether clients and contractors perceive problems similarly. The safety issues are explored through a brief survey and a workshop in the maintenance department of a logistics company. The results indicate that culture and behavior are recognized differently by clients and by contractors. The contractors and client had different perceptions of involvement of contractors by the client. The contractors complained on lack of involvement, which was not fully recognized by the client. The case study used a practical approach to show differences in perception of safety within a project. The study illustrates the need for more applied studies and interventions on contractor safety.

Interpreting observational studies: why empirical calibration is needed to correct p-values

PubMed Central

Schuemie, Martijn J; Ryan, Patrick B; DuMouchel, William; Suchard, Marc A; Madigan, David

2014-01-01

Often the literature makes assertions of medical product effects on the basis of ‘ p < 0.05’. The underlying premise is that at this threshold, there is only a 5% probability that the observed effect would be seen by chance when in reality there is no effect. In observational studies, much more than in randomized trials, bias and confounding may undermine this premise. To test this premise, we selected three exemplar drug safety studies from literature, representing a case–control, a cohort, and a self-controlled case series design. We attempted to replicate these studies as best we could for the drugs studied in the original articles. Next, we applied the same three designs to sets of negative controls: drugs that are not believed to cause the outcome of interest. We observed how often p < 0.05 when the null hypothesis is true, and we fitted distributions to the effect estimates. Using these distributions, we compute calibrated p-values that reflect the probability of observing the effect estimate under the null hypothesis, taking both random and systematic error into account. An automated analysis of scientific literature was performed to evaluate the potential impact of such a calibration. Our experiment provides evidence that the majority of observational studies would declare statistical significance when no effect is present. Empirical calibration was found to reduce spurious results to the desired 5% level. Applying these adjustments to literature suggests that at least 54% of findings with p < 0.05 are not actually statistically significant and should be reevaluated. © 2013 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:23900808

Study on lockage safety of LNG-fueled ships based on FSA

PubMed Central

Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

2017-01-01

In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region. PMID:28437482

Study on lockage safety of LNG-fueled ships based on FSA.

PubMed

Lv, Pengfei; Zhuang, Yuan; Deng, Jian; Su, Wei

2017-01-01

In the present study, formal safety assessment (FSA) is introduced to investigate lockage safety of LNG-fueled ships. Risk sources during lockage of LNG-fueled ships in four typical scenarios, namely, navigation between two dams, lockage, anchorage, and fueling, are identified, and studied in combination with fundamental leakage probabilities of various components of LNG storage tanks, and simulation results of accident consequences. Some suggestions for lockage safety management of LNG-fueled ships are then proposed. The present research results have certain practical significance for promoting applications of LNG-fueled ships along Chuanjiang River and in Three Gorges Reservoir Region.

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

PubMed

Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

Pharmaceuticals Safety Practices-A Comparative Pilot Study

PubMed Central

Tawfik, Kamilia A.; Jabeen, Arshia

2013-01-01

Introduction The safety of medicine is essential for the safety of patients. Inappropriate drug storage, expiration dates, sharing prescription drugs, self medication habits and misuse of some drugs are contributing factors affecting medication safety. One or more of these factors may lead to serious health complications and even death. Objectives The purpose of this study was to highlight the common errors and pharmaceutical malpractices that people usually engage in on a daily basis and to correlate these to culture, gender and educational levels. This may spread awareness in an easy and understandable manner and provide certain guidelines to drug consumers ensuring that pharmaceutical preparations are used correctly and safely. Methods Two hundred questionnaires were randomly distributed in two countries; Saudi Arabia and India. The collected data were statistically analyzed. Outcomes and conclusion Results showed that alarming percentages of various participants were using pharmaceuticals inappropriately due to carelessness, unawareness or intentional mistakes. Therefore, active participation by health care professionals is essential for the prevention of drug misuse. Increasing population awareness about self medication, products expiration, pharmaceuticals labels and optimum storage conditions would minimize the adverse effects and may even be life saving. PMID:24533025

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

Safety leadership: application in construction site.

PubMed

Cooper, Dominic

2010-01-01

The extant safety literature suggests that managerial Safety Leadership is vital to the success and maintenance of a behavioral safety process. The current paper explores the role of Managerial Safety Leadership behaviors in the success of a behavioral safety intervention in the Middle-East with 47,000 workers from multiple nationalities employed by fourteen sub-contractors and one main contractor. A quasi-experimental repeating ABABAB, within groups design was used. Measurement focused on managerial Safety Leadership and employee safety behaviors as well as Corrective Actions. Data was collected over 104 weeks. During this time, results show safety behavior improved by 30 percentage points from an average of 65% during baseline to an average of 95%. The site achieved 121 million man-hours free of lost-time injuries on the longest run. Stepwise multiple regression analyses indicated 86% of the variation in employee safety behavior was associated with senior, middle and front-line manager's Safety Leadership behaviors and the Corrective Action Rate. Approximately 38% of the variation in the Total Recordable Incident Rate (TRIR) was associated with the Observation rate, Corrective Action Rate and Observers Records of managerial safety leaders (Visible Ongoing Support). The results strongly suggest manager's Safety Leadership influences the success of Behavioral Safety processes.

Primary and secondary patient data in contrast: the use of observational studies like RABBIT.

PubMed

Richter, Adrian; Meißner, Yvette; Strangfeld, Anja; Zink, Angela

2016-01-01

The study of secondary patient data, particularly represented by claims data, has increased in recent years. The strength of this approach involves easy access to data that have been generated for administrative purposes. By contrast, collection of primary data for research is time-consuming and may therefore appear outdated. Both administrative data and data collected prospectively in clinical care can address similar research questions concerning effectiveness and safety of treatments. Therefore, why should we invest the precious time of rheumatologists to generate primary patient data? This article will outline some features of primary patient data collection illustrated by the German biologics register RABBIT (Rheumatoid arthritis: observation of biologic therapy). RABBIT is a long-term observational cohort study that was initiated more than 15 years ago. We will discuss as quality indicators: (i) study design, (ii) type of documentation, standardisation of (iii) clinical and (iv) safety data, (v) monitoring of the longitudinal follow-up, (vi) losses to follow-up as well as (vii) the possibilities to link the data base. The impact of these features on interpretation and validity of results is illustrated using recent publications. We conclude that high quality and completeness of data prospectively-collected offers many advantages over large quantities of non-standardised data collected in an unsupervised manner. We expect the enthusiasm about the use of secondary patient data to decline with more awareness of their methodological limitations while studies with primary patient data like RABBIT will maintain and broaden their impact on daily clinical practice.

Using community-based participatory research to design and initiate a study on immigrant worker health and safety in San Francisco's Chinatown restaurants.

PubMed

Minkler, Meredith; Lee, Pam Tau; Tom, Alex; Chang, Charlotte; Morales, Alvaro; Liu, Shaw San; Salvatore, Alicia; Baker, Robin; Chen, Feiyi; Bhatia, Rajiv; Krause, Niklas

2010-04-01

Restaurant workers have among the highest rates of work-related illness and injury in the US, but little is known about the working conditions and occupational health status of Chinese immigrant restaurant workers. Community-based participatory research (CBPR) was employed to study restaurant working conditions and worker health in San Francisco's Chinatown. A community/academic/health department collaborative was formed and 23 restaurant workers trained on research techniques and worker health and safety. A worker survey instrument and a restaurant observational checklist were collaboratively developed. The checklist was piloted in 71 Chinatown restaurants, and the questionnaire administered to 433 restaurant workers. Restaurant workers, together with other partners, made substantial contributions to construction of the survey and checklist tools and improved their cultural appropriateness. The utility of the checklist tool for restaurant-level data collection was demonstrated. CBPR holds promise for both studying worker health and safety among immigrant Chinese restaurant workers and developing culturally appropriate research tools. A new observational checklist also has potential for restaurant-level data collection on worker health and safety conditions. (c) 2010 Wiley-Liss, Inc.

Food safety self-reported behaviors and cognitions of young adults: results of a national study.

PubMed

Byrd-Bredbenner, Carol; Maurer, Jaclyn; Wheatley, Virginia; Schaffner, Donald; Bruhn, Christine; Blalock, Lydia

2007-08-01

With limited opportunities to learn safe food handling via observation, many young adults lack the knowledge needed to keep them safe from foodborne disease. It is important to reach young adults with food safety education because of their current and future roles as caregivers. With a nationwide online survey, the demographic characteristics, self-reported food handling and consumption behaviors, food safety beliefs, locus of control, self-efficacy, stage of change, and knowledge of young adults with education beyond high school (n = 4,343) were assessed. Young adults (mean age, 19.92 +/- 1.67 SD) who participated were mainly female, white, never married, and freshmen or sophomores. Participants correctly answered 60% of the knowledge questions and were most knowledgeable about groups at greatest risk for foodborne disease and least knowledgeable about common food sources of foodborne disease pathogens. They reported less than optimal levels of safe food handling practices. Young adults generally had a limited intake of foods that increase the risk of foodborne disease, positive food safety beliefs, an internal food safety locus of control, and confidence in their ability to handle food safely, and they were contemplating an improvement in, or preparing to improve, their food handling practices. Females significantly outperformed males on nearly all study measures. Future food safety educational efforts should focus on increasing knowledge and propelling young adults into the action stage of safe food handling, especially males. Efforts to improve knowledge and, ultimately, food safety behaviors are essential to safeguard the health of these young adults and enable them to fulfill the role of protecting the health of their future families.

A literature review of safety culture.

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 endeavormore » 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

Food safety knowledge and hygiene practices among veterinary medicine students at Trakia University, Bulgaria.

PubMed

Stratev, Deyan; Odeyemi, Olumide A; Pavlov, Alexander; Kyuchukova, Ralica; Fatehi, Foad; Bamidele, Florence A

The results from the first survey on food safety knowledge, attitudes and hygiene practices (KAP) among veterinary medicine students in Bulgaria are reported in this study. It was designed and conducted from September to December 2015 using structured questionnaires on food safety knowledge, attitudes and practices. Data were collected from 100 undergraduate veterinary medicine students from the Trakia University, Bulgaria. It was observed that the age and the gender did not affect food safety knowledge, attitudes and practices. There was no significant difference (p>0.05) on food safety knowledge and practices among students based on the years of study. A high level of food safety knowledge was observed among the participants (85.06%), however, the practice of food safety was above average (65.28%) while attitude toward food safety was high (70%). Although there was a significant awareness of food safety knowledge among respondents, there is a need for improvement on food safety practices, interventions on food safety and foodborne diseases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Efficacy and safety of dexmedetomidine infusion for patients undergoing awake craniotomy: An observational study

PubMed Central

Mahajan, Charu; Rath, Girija Prasad; Singh, Gyaninder Pal; Mishra, Nitasha; Sokhal, Suman; Bithal, Parmod Kumar

2018-01-01

Background: The goal of awake craniotomy is to maintain adequate sedation, analgesia, respiratory, and hemodynamic stability and also to provide a cooperative patient for neurologic testing. An observational study carried out to evaluate the efficacy of dexmedetomidine sedation for awake craniotomy. Materials and Methods: Adult patients with age >18 year who underwent awake craniotomy for intracranial tumor surgery were enrolled. Those who were uncooperative and had difficult airway were excluded from the study. In the operating room, the patients received a bolus dose of dexmedetomidine 1 μg/kg followed by an infusion of 0.2–0.7 μg/kg/h (bispectral index target 60–80). Once the patients were sedated, scalp block was given with bupivacaine 0.25%. The data on hemodynamics at various stages of the procedure, intraoperative complications, total amount of fentanyl used, intravenous fluids required, blood loss and transfusion, duration of surgery, Intensive Care Unit (ICU), and hospital stay were collected. The patients were assessed for Glasgow outcome scale (GOS) score and patient satisfaction score (PSS). Results: A total of 27 patients underwent awake craniotomy during a period of 2 years. Most common intraoperative complication was seizures; observed in five patients (18.5%). None of these patients experienced any episode of desaturation. Two patients had tight brain for which propofol boluses were administered. The average fentanyl consumption was 161.5 ± 85.0 μg. The duration of surgery, ICU, and hospital stays were 231.5 ± 90.5 min, 14.5 ± 3.5 h, and 4.7 ± 1.5 days, respectively. The overall PSS was 8 and GOS was good in all the patients. Conclusion: The use of dexmedetomidine infusion with regional scalp block in patients undergoing awake craniotomy is safe and efficacious. The absence of major complications and higher PSS makes it close to an ideal agent for craniotomy in awake state. PMID:29628833

[Study of post marketing safety reevaluation of shenqi fuzheng injection].

PubMed

Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

2014-09-01

In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

Clinical studies of the effectiveness and safety of antivenoms.

PubMed

Williams, David J; Habib, Abdulrazaq G; Warrell, David A

2018-05-07

In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomized comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomized controlled trial data. Antivenoms in some poorly regulated markets may have high rates of potentially fatal adverse effects and their use must be balanced by demonstrable effectiveness. Even those manufactured to strict regulatory requirements may pose a rare risk of severe adverse reactions. Most antivenoms currently marketed around the world were registered without first being studied clinically. There is increasing pressure to subject antivenoms, even those that are long-established, to the same protocols of rigorous pre-clinical and clinical assessment that are standard regulatory requirements for other drugs. Conventional clinical testing progresses through Phases I, II, III to IV. Most authorities consider antivenoms too dangerous to be used in Phase I studies in healthy volunteers. An alternative method for preliminary estimation of safety, dose-finding and effectiveness, is proposed - the "3 + 3" dose escalation or de-escalation design, in volunteer patients, as used in oncology to test cytotoxic drugs. Antivenoms are so widely used and well trusted, that there are few ethical justifications for placebo controls. However, placebo might be ethically justified if there were no proven effective treatment and or if withholding or delaying treatment posed acceptably negligible risks to the participants. Antivenom trials are most urgently needed in low-to middle-income countries where there are many

Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study

PubMed Central

Greenhalgh, Trisha; Russell, Jill; Myall, Michelle

2011-01-01

Objective To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. Design Ethnographic case study. Setting Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. Participants 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. Main outcome measures Potential threats to patient safety and characteristics of good practice. Methods Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as “exceptions” by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge

Associations of Neighborhood Crime and Safety and With Changes in Body Mass Index and Waist Circumference: The Multi-Ethnic Study of Atherosclerosis.

PubMed

Powell-Wiley, Tiffany M; Moore, Kari; Allen, Norrina; Block, Richard; Evenson, Kelly R; Mujahid, Mahasin; Diez Roux, Ana V

2017-08-01

Using data from the Multi-Ethnic Study of Atherosclerosis (MESA), we evaluated associations of neighborhood crime and safety with changes in adiposity (body mass index (BMI) and waist circumference). MESA is a longitudinal study of cardiovascular disease among adults aged 45-84 years at baseline in 2000-2002, from 6 US sites, with follow-up for MESA participants until 2012. Data for this study were limited to Chicago, Illinois, participants in the MESA Neighborhood Ancillary Study, for whom police-recorded crime data were available, and who had complete baseline data (n = 673). We estimated associations of individual-level safety, aggregated neighborhood-level safety, and police-recorded crime with baseline levels and trajectories of BMI and waist circumference over time using linear mixed modeling with random effects. We also estimated how changes in these factors related to changes in BMI and waist circumference using econometric fixed-effects models. At baseline, greater individual-level safety was associated with more adiposity. Increasing individual- and neighborhood-level safety over time were associated with decreasing BMI over the 10-year period, with a more pronounced effect observed in women for individual-level safety and men for neighborhood-level safety. Police-recorded crime was not associated with adiposity. Neighborhood-level safety likely influences adiposity change and subsequent cardiovascular risk in multiethnic populations. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

The utility of observational studies in clinical decision making: lessons learned from statin trials.

PubMed

Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

2010-05-01

Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4,191 cases.

PubMed

Cho, H-J; Kim, Y J

2009-04-01

Citicoline is an essential precursor in the synthesis of phosphatidylcholine, a key cell membrane phospholipid, and is known to have neuroprotective effects in acute ischemic stroke. The aim of this study was to determine the efficacy and safety of oral citicoline in Korean patients with acute ischemic stroke. A drug surveillance study was carried out in 4,191 patients with a diagnosis of acute ischemic stroke. Oral citicoline (500-4000 mg/day) was administered within less than 24 h after acute ischemic stroke in 3,736 patients (early group) and later than 24 h after acute ischemic stroke in 455 patients (late group) for at least 6 weeks. For efficacy assessment, primary outcomes were patients' scores obtained with a short form of the National Institutes of Health Stroke Scale (s-NIHSS), a short form of the Barthel Index of activities of daily living (s-BI) and a modified Rankin Scale (mRS) at enrollment, after 6 weeks and at the end of therapy for those patients with extended treatment. All adverse reactions were monitored during the study period for safety assessment. All measured outcomes, including s-NIHSS, s-BI and mRS, were improved after 6 weeks of therapy (P < 0.05). Further improvement was observed in 125 patients who continued citicoline therapy for more than 12 weeks when compared with those who ended therapy at week 6. Improvements were more significant in the higher dose group (> or = 2000 mg/day) (P < 0.001). s-BI scores showed no differences between the early and late groups at the end of therapy. Citicoline safety was excellent; 37 side effects were observed in 31 patients (0.73%). The most frequent findings were nervous system-related symptoms (8 of 37, 21.62%), followed by gastrointestinal symptoms (5 of 37, 13.5%). Oral citicoline improved neurological, functional and global outcomes in patients with acute ischemic stroke without significant safety concerns. Copyright 2009 Prous Science, S.A.U. or its licensors. All rights reserved.

Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

PubMed

Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

2015-01-01

The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

Study Gives Good Odds on Nuclear Reactor Safety

ERIC Educational Resources Information Center

Russell, Cristine

1974-01-01

Summarized is data from a recent study on nuclear reactor safety completed by Norman C. Rasmussen and others. Non-nuclear events are about 10,000 times more likely to produce large accidents than nuclear plants. (RH)

Patient safety event reporting in critical care: a study of three intensive care units.

PubMed

Harris, Carolyn B; Krauss, Melissa J; Coopersmith, Craig M; Avidan, Michael; Nast, Patricia A; Kollef, Marin H; Dunagan, W Claiborne; Fraser, Victoria J

2007-04-01

To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Prospective, single-center, interventional study. A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Adult patients admitted to these three study ICUs. Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79-2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p < .001). This card-based reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These

Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study.

PubMed

Schaefer, Franz; Hoppe, Bernd; Jungraithmayr, Therese; Klaus, Günter; Pape, Lars; Farouk, Mourad; Addison, Janet; Manamley, Nick; Vondrak, Karel

2016-03-01

Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD). In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded. A total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion. No new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.

Space Station crew safety alternatives study. Volume 4: Appendices

NASA Technical Reports Server (NTRS)

Peercy, R. L., Jr.; Raasch, R. F.; Rockoff, L. A.

1985-01-01

The scope of this study considered the first 15 years of accumulated space station concepts for Initial Operational Capability (10C) during the early 1990's. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris.

Safe medication management in specialized home healthcare - an observational study.

PubMed

Lindblad, Marléne; Flink, Maria; Ekstedt, Mirjam

2017-08-24

Medication management is a complex, error-prone process. The aim of this study was to explore what constitutes the complexity of the medication management process (MMP) in specialized home healthcare and how healthcare professionals handle this complexity. The study is theoretically based in resilience engineering. Data were collected during the MMP at three specialized home healthcare units in Sweden using two strategies: observation of workplaces and shadowing RNs in everyday work, including interviews. Transcribed material was analysed using grounded theory. The MMP in home healthcare was dynamic and complex with unclear boundaries of responsibilities, inadequate information systems and fluctuating work conditions. Healthcare professionals adapted their everyday clinical work by sharing responsibility and simultaneously being authoritative and preserving patients' active participation, autonomy and integrity. To promote a safe MMP, healthcare professionals constantly re-prioritized goals, handled gaps in communication and information transmission at a distance by creating new bridging solutions. Trade-offs and workarounds were necessary elements, but also posed a threat to patient safety, as these interim solutions were not systematically evaluated or devised learning strategies. To manage a safe medication process in home healthcare, healthcare professionals need to adapt to fluctuating conditions and create bridging strategies through multiple parallel activities distributed over time, space and actors. The healthcare professionals' strategies could be integrated in continuous learning, while preserving boundaries of safety, instead of being more or less interim solutions. Patients' and family caregivers' as active partners in the MMP may be an underestimated resource for a resilient home healthcare.

A Study on Drug Safety Monitoring Program in India

PubMed Central

Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

2014-01-01

Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

A study on drug safety monitoring program in India.

PubMed

Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

2014-09-01

Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.

A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

PubMed

van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

2015-03-01

The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Middle School Students' Perceptions of Safety: A Mixed-Methods Study.

PubMed

Sweeney, Shannon M; Von Hagen, Leigh Ann

2015-10-01

Active travel to school has been on the decline, despite its beneficial influence on children's current and future well-being. Adults' safety perceptions have been shown to influence children's active travel. Children's perceptions, particularly of safety, may be an important link not only to their present health and travel behaviors, but also their future health and behaviors. This study examined middle school students' perceptions of the built environment and safety. Overall, 776 students from 3 schools in Hudson County, New Jersey participated in a visual survey and structured, interactive classroom discussions. Emergent themes from the discussions were tested using multivariate statistical models. Findings suggest that older students, boys, and students who self-identified as black, rated built environment scenes as safer. Students also perceived being near adults, traveling in a group, and using crosswalks as significantly safer and want additional recognition of these to further improve safety. Students perceived that being near a school, in daylight, and aesthetics as factors contributing to safety. Schools and municipalities may increase programs for students to travel in groups, prioritize maintenance in school zones, and increase the number of crossing guards, particularly outside the immediate school proximity to further improve safety. © 2015, American School Health Association.

Individual employee's perceptions of " Group-level Safety Climate" (supervisor referenced) versus " Organization-level Safety Climate" (top management referenced): Associations with safety outcomes for lone workers.

PubMed

Huang, Yueng-Hsiang; Lee, Jin; McFadden, Anna C; Rineer, Jennifer; Robertson, Michelle M

2017-01-01

Research has shown that safety climate is among the strongest predictors of safety behavior and safety outcomes in a variety of settings. Previous studies have established that safety climate is a multi-faceted construct referencing multiple levels of management within a company, most generally: the organization level (employee perceptions of top management's commitment to and prioritization of safety) and group level (employee perceptions of direct supervisor's commitment to and prioritization of safety). Yet, no research to date has examined the potential interaction between employees' organization-level safety climate (OSC) and group-level safety climate (GSC) perceptions. Furthermore, prior research has mainly focused on traditional work environments in which supervisors and workers interact in the same location throughout the day. Little research has been done to examine safety climate with regard to lone workers. The present study aims to address these gaps by examining the relationships between truck drivers' (as an example of lone workers) perceptions of OSC and GSC, both potential linear and non-linear relationships, and how these predict important safety outcomes. Participants were 8095 truck drivers from eight trucking companies in the United States with an average response rate of 44.8%. Results showed that employees' OSC and GSC perceptions are highly correlated (r= 0.78), but notable gaps between the two were observed for some truck drivers. Uniquely, both OSC and GSC scores were found to have curvilinear relationships with safe driving behavior, and both scores were equally predictive of safe driving behavior. Results also showed the two levels of climate significantly interacted with one another to predict safety behavior such that if either the OSC or GSC scores were low, the other's contribution to safety behavior became stronger. These findings suggest that OSC and GSC may function in a compensatory manner and promote safe driving behavior even

Statistical issues in the design, conduct and analysis of two large safety studies.

PubMed

Gaffney, Michael

2016-10-01

The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

Perceived Neighborhood Safety and Adolescent School Functioning

PubMed Central

Martin-Storey, Alexa; Crosnoe, Robert

2014-01-01

This study examined the association between adolescents’ perceptions of their neighborhoods’ safety and multiple elements of their functioning in school with data on 15 year olds from the NICHD Study of Early Child Care and Youth Development (n = 924). In general, perceived neighborhood safety was more strongly associated with aspects of schooling that were more psychosocial in nature (e.g., school attachment) than those that were more cognitive (e.g., test scores). Examination of neighborhood and family moderators of these associations revealed that perceived neighborhood safety was negatively associated with grades for youth from low-income families but was positively associated with school attachment for youth from such families when they lived in neighborhoods rated by observers as high in physical disorder. PMID:25045245

Study on attitudes of students of Islamic Azad University Tehran Medical Branch toward food safety, 2016

PubMed Central

Miri, Ali; Poursadeghiyan, Mohsen; Baneshi, Mohammad Mehdi; Biglari, Hamed; Yari, Ahmad Reza; Khammar, Alireza

2017-01-01

Background Given the importance of high-quality healthy food for humans, contamination control is the most important concern for healthy staff. Aim To determine the attitudes of students at Islamic Azad University (Tehran Medical Branch) toward food safety. Methods This cross-sectional and analytic-descriptive study was conducted on 326 students of Azad University of Medical Sciences in 2016. A self-made questionnaire consisting of 40 questions was used. The reliability of the questionnaire was confirmed using internal consistency method (Cronbach’s alpha coefficient of 0.80). After collecting data, we use descriptive statistical indexes (mean and standard deviation) among demographic variables and the level of knowledge to describe and analyze the data. The participants’ attitudes and operation are measured by Spearman tests, and the analytical results are given using SPSS version 20. Results According to the findings, 55.3, 30 and 14.7 percent of students had high, moderate and low attitude scores toward food safety, respectively. In addition, male and female students had equal attitudes toward food safety, and no significant relationship between sex and attitude was observed a significant difference (p>0.05), but between educational levels (p=0.008) and ages (p=0.001) of students significance was a positive correlation. Conclusions Due to the low attitudes score of about half of the students of Islamic Azad University Tehran Medical Branch toward food safety, it can be claimed, food safety training in this community is required. PMID:28713497

Study on attitudes of students of Islamic Azad University Tehran Medical Branch toward food safety, 2016.

PubMed

Miri, Ali; Poursadeghiyan, Mohsen; Baneshi, Mohammad Mehdi; Biglari, Hamed; Yari, Ahmad Reza; Khammar, Alireza

2017-05-01

Given the importance of high-quality healthy food for humans, contamination control is the most important concern for healthy staff. To determine the attitudes of students at Islamic Azad University (Tehran Medical Branch) toward food safety. This cross-sectional and analytic-descriptive study was conducted on 326 students of Azad University of Medical Sciences in 2016. A self-made questionnaire consisting of 40 questions was used. The reliability of the questionnaire was confirmed using internal consistency method (Cronbach's alpha coefficient of 0.80). After collecting data, we use descriptive statistical indexes (mean and standard deviation) among demographic variables and the level of knowledge to describe and analyze the data. The participants' attitudes and operation are measured by Spearman tests, and the analytical results are given using SPSS version 20. According to the findings, 55.3, 30 and 14.7 percent of students had high, moderate and low attitude scores toward food safety, respectively. In addition, male and female students had equal attitudes toward food safety, and no significant relationship between sex and attitude was observed a significant difference (p>0.05), but between educational levels (p=0.008) and ages (p=0.001) of students significance was a positive correlation. Due to the low attitudes score of about half of the students of Islamic Azad University Tehran Medical Branch toward food safety, it can be claimed, food safety training in this community is required.

Space station crew safety alternatives study. Volume 3: Safety impact of human factors

NASA Technical Reports Server (NTRS)

Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

1985-01-01

The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

Clinical Impact Research - how to choose experimental or observational intervention study?

PubMed

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

Pressure Safety: Advanced Self-Study 30120

DOE Office of Scientific and Technical Information (OSTI.GOV)

Glass, George

2016-02-29

Pressure Safety Advance Self-Study (Course 30120) consists of an introduction, five modules, and a quiz. To receive credit in UTrain for completing this course, you must score 80% or better on the 15-question quiz (check UTrain). Directions for initiating the quiz are appended to the end of this training manual. This course contains several links to LANL websites. UTrain might not support active links, so please copy links into the address line in your browser.

Travtek Evaluation Safety Study

DOT National Transportation Integrated Search

1996-02-01

One of the major evaluation goals of the TravTek operational test was to assess the safety impact of the TravTek system as implemented in Orlando, Florida during the 1 -year deployment phase. Also, the results of the TravTek operational test, with re...

Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

PubMed

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-06-01

To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: A real-life observational study.

PubMed

Zeng, Qing-Lei; Xu, Guang-Hua; Zhang, Ji-Yuan; Li, Wei; Zhang, Da-Wei; Li, Zhi-Qin; Liang, Hong-Xia; Li, Chun-Xia; Yu, Zu-Jiang

2017-06-01

Few patients from developing countries can afford brand name direct-acting antiviral agents for treating hepatitis C virus (HCV) infection, and controversy regarding the bioequivalence of generics exists. This study aimed to observe the safety and efficacy of 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin for Chinese genotype 1b HCV-infected patients. In this open-labelled observational study, 63 cirrhotic (group 1) and 65 non-cirrhotic (group 2) patients were administered generic ledipasvir-sofosbuvir plus 1000-1200mg of ribavirin daily for 12 and 8weeks, respectively; and 64 non-cirrhotic patients (group 3) received ledipasvir-sofosbuvir for 8weeks. The primary efficacy endpoint was undetectable HCV RNA at week 12 (SVR12) after cessation of therapy. Safety and pharmacokinetic data were collected. One hundred and eighty-seven patients completed treatment, and the latest undetectable HCV RNA was observed in three patients with cirrhosis at week 5 during treatment. Intention-to-treat analysis revealed 96.8% (61/63), 96.9% (63/65), and 96.9% (62/64) of SVR12 rates in groups 1, 2, and 3, respectively. One patient in group 3 relapsed at post-treatment week 4. The regimens were generally well-tolerated. The most common adverse events were fatigue (17.8%), diarrhea (10.9%), and headache (9.9%). Four patients discontinued therapy due to diarrhea and vomiting. One patient from group 2 discontinued treatment on day 29 because of drug-unaffordability; fortunately, she achieved SVR12. This study demonstrated that 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin are safe and effective for patients with genotype 1b HCV infection. The price of Harvoni® has led to restrictions and access limitations in many developing and even developed countries with limited healthcare budgets. Gilead approved generic ledipasvir-sofosbuvir costs far less than Harvoni® and presents a similar cure rate for patients with chronic hepatitis C

Feasibility of Forecasting Highway Safety in Support of Safety Incentive and Safety Target Programs.

DOT National Transportation Integrated Search

2007-11-01

Using the frequency of fatal crashes from the current observation period (e.g. month, year, etc.) as the : prediction of expected future performance does not account for changes in safety that result from : increases in exposure (population, addition...

Ventilatory function assessment in safety pharmacology: Optimization of rodent studies using normocapnic or hypercapnic conditions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Goineau, Sonia; Rompion, Sonia; Guillaume, Philippe

2010-09-15

Although the whole body plethysmography for unrestrained animals is the most widely used method to assess the respiratory risk of new drugs in safety pharmacology, non-appropriate experimental conditions may mask deleterious side effects of some substances. If stimulant or bronchodilatory effects can be easily evidenced in rodents under standard experimental conditions, i.e. normal air breathing and diurnal phase, drug-induced respiratory depression remains more difficult to detect. This study was aimed at comparing the responsiveness of Wistar rats, Duncan Hartley guinea-pigs or BALB/c mice to the respiratory properties of theophylline (50 or 100 mg/kg p.o.) or morphine (30 mg/kg i.p.) undermore » varying conditions (100% air versus 5% CO{sub 2}-enriched air, light versus dark day phase), in order to select the most appropriate experimental conditions to each species for safety airway investigations. Our results showed that under normocapnia the ventilatory depressant effects of morphine can be easily evidenced in mice, slightly observed in guinea-pigs and not detected in rats in any day phase. Slight hypercapnic conditions enhanced the responsiveness of rats to morphine but not that of guinea-pigs and importantly they did not blunt the airway responsiveness of rats to the stimulation and bronchodilation evoked by theophylline, the most widely used reference agent in safety pharmacology studies. In conclusion, hypercapnic conditions associated with the non-invasive whole body plethysmography should be considered for optimizing the assessment of both the ventilatory depressant potential of morphine-like substances or the respiratory stimulant effects of new drugs in the rat, the most extensively used species in rodent safety and toxicological investigations.« less

75 FR 42455 - Safety and Occupational Health Study Section: Notice of Charter Renewal

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

... Occupational Health Study Section: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Safety and Occupational Health Study Section... Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600...

Workflow interruptions and mental workload in hospital pediatricians: an observational study.

PubMed

Weigl, Matthias; Müller, Andreas; Angerer, Peter; Hoffmann, Florian

2014-09-24

Pediatricians' workload is increasingly thought to affect pediatricians' quality of work life and patient safety. Workflow interruptions are a frequent stressor in clinical work, impeding clinicians' attention and contributing to clinical malpractice. We aimed to investigate prospective associations of workflow interruptions with multiple dimensions of mental workload in pediatricians during clinical day shifts. In an Academic Children's Hospital a prospective study of 28 full shift observations was conducted among pediatricians providing ward coverage. The prevalence of workflow interruptions was based on expert observation using a validated observation instrument. Concurrently, Pediatricians' workload ratings were assessed with three workload dimensions of the well-validated NASA-Task Load Index: mental demands, effort, and frustration. Observed pediatricians were, on average, disrupted 4.7 times per hour. Most frequent were interruptions by colleagues (30.2%), nursing staff (29.7%), and by telephone/beeper calls (16.3%). Interruption measures were correlated with two workload outcomes of interest: frequent workflow interruptions were related to less cognitive demands, but frequent interruptions were associated with increased frustration. With regard to single sources, interruptions by colleagues showed the strongest associations to workload. The findings provide insights into specific pathways between different types of interruptions and pediatricians' mental workload. These findings suggest further research and yield a number of work and organization re-design suggestions for pediatric care.

A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

2013-08-30

In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd.

Health risk appraisal and safety belt use

DOT National Transportation Integrated Search

1987-05-01

The primary objective of this study was to determine the effectiveness of health risk appraisal (HRA) programs for increasing claimed and observed safety belt use. HRA programs were field tested with and without supplemental educational materials on ...

How Useful Are Home Safety Behaviours for Predicting Childhood Injury? A Cohort Study

ERIC Educational Resources Information Center

Kendrick, Denise; Watson, Michael; Mulvaney, Caroline; Burton, Paul

2005-01-01

Little work has examined the utility of home safety behaviours in predicting childhood injury. This study examines the relationship between safety behaviours and child injury using a cohort of 1717 families, with 2357 children aged 0-7 years. Safety behaviours, and sociodemographic and family characteristics were measured using a validated…

Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

PubMed Central

Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

2014-01-01

Background To elucidate the relationship between safety culture maturity and safety performance of a particular company. Methods To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. Results The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. Conclusion The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance. PMID:25180135

Trends in child passenger safety practices in Indiana from 2009 to 2015.

PubMed

O'Neil, Joseph; Bull, Marilyn J; Talty, Judith

2018-02-28

This study reviews trends in rear-facing direction, top tether use, booster seat use, and seating position for children 12 years or younger among motor vehicle passengers in Indiana. This is an observational, cross-sectional survey of drivers transporting children 15 years and younger collected at 25 convenience locations randomly selected in Indiana during summers of 2009-2015. Observations were conducted by certified child passenger safety technicians (CPST). As the driver completed a written survey collecting demographic data on the driver, the CPST recorded the child demographic data, vehicle seating location, the type of restraint, direction the car safety seat (CSS) was facing, and use of the CSS harness or safety belt as appropriate. Data were analyzed for infants and toddlers younger than 24 months, children in forward-facing CSS, booster seat use, and seating position for children 12 years or younger. During the study period, 4,876 drivers were queried, and 7,725 children 15 years and younger were observed in motor vehicles. Between 2009 and 2015, 1,115 infants and toddlers (age birth to 23 months) were observed in motor vehicles. For infants <1 year, rear-facing increased from 84% to 91%. During the study years the greatest increase in rear facing was for toddlers age 12-17 months (12-61%). Rear facing for those from 18-23 months did not significantly change. Of the 1,653 vehicles observed with a forward-facing car seat, using either the seat belt system or lower anchors, an average of 27% had the top tether attached. For installations of forward-facing seats using the lower anchor, 66% employed the top tether. Among children age 4-7 years observed booster seat use decreased from 72% to 65% during the observation period. Finally, for vehicle seating position, in our sample, more than 85% of children 12 years or younger were seated in a rear seat vehicle position. Unfortunately, 31% of 8- to 12-year-old children were observed in the front seat

A study for safety and health management problem of semiconductor industry in Taiwan.

PubMed

Chao, Chin-Jung; Wang, Hui-Ming; Feng, Wen-Yang; Tseng, Feng-Yi

2008-12-01

The main purpose of this study is to discuss and explore the safety and health management in semiconductor industry. The researcher practically investigates and interviews the input, process and output of the safety and health management of semiconductor industry by using the questionnaires and the interview method which is developed according to the framework of the OHSAS 18001. The result shows that there are six important factors for the safety and health management in Taiwan semiconductor industry. 1. The company should make employee clearly understand the safety and health laws and standards. 2. The company should make the safety and health management policy known to the public. 3. The company should put emphasis on the pursuance of the safety and health management laws. 4. The company should prevent the accidents. 5. The safety and health message should be communicated sufficiently. 6. The company should consider safety and health norm completely.

75 FR 5333 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... aggregate health burden associated with occupational injuries and illnesses, as well as to support more... health services, and the prevention of work-related injury and illness. It is anticipated that research... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...

76 FR 3908 - Safety and Occupational Health Study Section (SOHSS); National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... the aggregate health burden associated with occupational injuries and illnesses, as well as to support... and health services, and the prevention of work-related injury and illness. It is anticipated that... Occupational Health Study Section (SOHSS); National Institute for Occupational Safety and Health (NIOSH...

The implementation of nice guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England

PubMed Central

2013-01-01

Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. Methods A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. Results Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference −3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). Conclusions The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis. PMID:23734903

Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

PubMed

Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

2008-10-01

In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

Safety in home care: A research protocol for studying medication management

PubMed Central

2010-01-01

Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS), we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange throughout the study with the use

Fire safety: A case study of technology transfer

NASA Technical Reports Server (NTRS)

Heins, C. F.

1975-01-01

Two basic ways in which NASA-generated technology is being used by the fire safety community are described. First, improved products and systems that embody NASA technical advances are entering the marketplace. Second, NASA test data and technical information related to fire safety are being used by persons concerned with reducing the hazards of fire through improved design information and standards. The development of commercial fire safety products and systems typically requires adaptation and integration of aerospace technologies that may not have been originated for NASA fire safety applications.

Compliance and safety of a novel home exercise program for patients with high-grade brain tumors, a prospective observational study.

PubMed

Baima, Jennifer; Omer, Zehra B; Varlotto, John; Yunus, Shakeeb

2017-09-01

The purpose of this study is to evaluate compliance with and safety of a novel independent home exercise program for patients with high-grade brain tumors. We designed this program around the preferences and individual capabilities of this population as well as the potential barriers to exercise in cancer patients. Demographics were collected to better understand those that persisted with exercise. Subjects with high-grade brain tumor received one-time training that included watching an exercise video and live demonstration of resistance band exercises, a balance exercise, and recommendations for walking. Subjects were instructed to do the exercises every day for 1 month. Main outcome measures were percentage of subjects who exercised throughout the month, frequency of exercising, demographic factors, quality of life scores (assessed by FACT-BR), and self report of adverse events. Fourteen of the 15 (93%) subjects started the exercises during the course of the month. Nine of the fifteen (60%) continued the exercises throughout the month. Three additional subjects would have continued to exercise if formal or supervised rehabilitation had been offered. Among the subjects who continued the exercises regularly, higher frequency of exercising was significantly associated with living as married (p = 0.033), annual income >$50,000 (p = 0.047), scores of physical well-being (p = 0.047), and brain cancer specific well-being (p = 0.054) subscales. Among those who exercised frequently, there was also a trend towards increase in total FACT-BR scores (p = 0.059). The subjects who scored higher on the social well-being subscale of the FACT-BR at baseline self-reported a higher likelihood to continue the exercises after 1 month of participation in the study (p = 0.018). No adverse events were reported. Our small group of subjects with high-grade brain tumors demonstrated compliance with and safety of a novel independent strength and balance exercise program in the

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

PubMed

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

The relationship between patient safety climate and occupational safety climate in healthcare - A multi-level investigation.

PubMed

Pousette, Anders; Larsman, Pernilla; Eklöf, Mats; Törner, Marianne

2017-06-01

Patient safety climate/culture is attracting increasing research interest, but there is little research on its relation with organizational climates regarding other target domains. The aim of this study was to investigate the relationship between patient safety climate and occupational safety climate in healthcare. The climates were assessed using two questionnaires: Hospital Survey on Patient Safety Culture and Nordic Occupational Safety Climate Questionnaire. The final sample consisted of 1154 nurses, 886 assistant nurses, and 324 physicians, organized in 150 work units, within hospitals (117units), primary healthcare (5units) and elderly care (28units) in western Sweden, which represented 56% of the original sample contacted. Within each type of safety climate, two global dimensions were confirmed in a higher order factor analysis; one with an external focus relative the own unit, and one with an internal focus. Two methods were used to estimate the covariation between the global climate dimensions, in order to minimize the influence of bias from common method variance. First multilevel analysis was used for partitioning variances and covariances in a within unit part (individual level) and a between unit part (unit level). Second, a split sample technique was used to calculate unit level correlations based on aggregated observations from different respondents. Both methods showed associations similar in strength between the patient safety climate and the occupational safety climate domains. The results indicated that patient safety climate and occupational safety climate are strongly positively related at the unit level, and that the same organizational processes may be important for the development of both types of organizational climate. Safety improvement interventions should not be separated in different organizational processes, but be planned so that both patient safety and staff safety are considered concomitantly. Copyright © 2017 National Safety

Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register.

PubMed

Swaen, Gerard M H; Carmichael, Neil; Doe, John

2011-05-01

To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. The advantages of an OSR outweigh its disadvantages. The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value. Copyright © 2011 Elsevier Inc. All rights reserved.

Injection safety practices in a main referral hospital in Northeastern Nigeria.

PubMed

Gadzama, G B; Bawa, S B; Ajinoma, Z; Saidu, M M; Umar, A S

2014-01-01

No adherence of safe injection policies remains a major challenge, and, worldwide, annually, it leads to 21 million new hepatitis B cases and 260,000 HIV infection cases. This descriptive observational survey was conducted to determine the level of adherence to universal precaution for safe injection practices in the hospital. The study units were selected using a simple random sampling of injection services provider/phlebotomist in 27 units/wards of the hospital. The study instruments were observation checklist and interviewer administered questionnaires. EPI info (version 3.5.2) software was used for data entry and generation of descriptive statistics was done with units of analysis (units/wards) on injection safety practices of health workers, availability of logistics and supplies, and disposal methods. Only 33.3% of the units (95% CI, 16-54) had non-sharps infectious healthcare waste of any type inside containers specific for non-sharps infectious waste and 17 (77.3%) of the observed therapeutic injections were prepared on a clean, dedicated table or tray, where contamination of the equipment with blood, body fluids, or dirty swabs was unlikely. Absence of recapping of needles was observed in 11 (50.0%) units giving therapeutic injections. Only 7.4% of units surveyed had separate waste containers for infectious non-sharps. This study depicts poor knowledge and a practice of injection safety, inadequate injection safety supplies, and non-compliance to injection safety policy and guidelines.

Multi-sectoral action for child safety-a European study exploring implicated sectors.

PubMed

Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

2017-06-01

Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Professional conceptualisation and accomplishment of patient safety in mental healthcare: an ethnographic approach

PubMed Central

2011-01-01

Background This study seeks to broaden current understandings of what patient safety means in mental healthcare and how it is accomplished. We propose a qualitative observational study of how safety is produced or not produced in the complex context of everyday professional mental health practice. Such an approach intentionally contrasts with much patient safety research which assumes that safety is achieved and improved through top-down policy directives. We seek instead to understand and articulate the connections and dynamic interactions between people, materials, and organisational, legal, moral, professional and historical safety imperatives as they come together at particular times and places to perform safe or unsafe practice. As such we advocate an understanding of patient safety 'from the ground up'. Methods/Design The proposed project employs a six-phase data collection framework in two mental health settings: an inpatient unit and a community team. The first four phases comprise multiple modes of focussed, unobtrusive observation of professionals at work, to enable us to trace the conceptualisation and enactment of safety as revealed in dialogue and narrative, use of artefacts and space, bodily activity and patterns of movement, and in the accomplishment of specific work tasks. An interview phase and a social network analysis phase will subsequently be conducted to offer comparative perspectives on the observational data. This multi-modal and holistic approach to studying patient safety will complement existing research, which is dominated by instrumentalist approaches to discovering factors contributing to error, or developing interventions to prevent or manage adverse events. Discussion This ethnographic research framework, informed by the principles of practice theories and in particular actor-network ideas, provides a tool to aid the understanding of patient safety in mental healthcare. The approach is novel in that it seeks to articulate an 'anatomy

Predicting safety culture: the roles of employer, operations manager and safety professional.

PubMed

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China.

PubMed

Jia, P L; Zhang, L H; Zhang, M M; Zhang, L L; Zhang, C; Qin, S F; Li, X L; Liu, K X

2014-06-30

To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC. Cross-sectional study. Data were obtained from 20 hospital pharmacies in the southwest part of China. We performed χ(2) test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test-retest was performed to assess reproducibility of the items. A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions ('Teamwork', 'Staff Training and Skills' and 'Staffing, Work Pressure and Pace') was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (p<0.05). There was a statistical difference in the perception of patient safety culture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89). The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Building Alliances with (In)Voluntary Clients: A Study Focused on Therapists' Observable Behaviors.

PubMed

Sotero, Luciana; Cunha, Diana; da Silva, José Tomás; Escudero, Valentín; Relvas, Ana Paula

2017-12-01

This study aimed to compare therapists' observable behaviors to promote alliances with involuntary and voluntary clients during brief family therapy. The therapists' contributions to fostering alliances were rated in sessions 1 and 4 using videotapes of 29 families who were observed in brief therapy. Using the System for Observing Family Therapy Alliances, trained raters searched for specific therapist behaviors that contributed to or detracted from the four alliance dimensions: engagement in the therapeutic process, an emotional connection with the therapist, safety within the therapeutic system, and a shared sense of purpose within the family. The results showed that when working with involuntary clients, therapists presented more behaviors to foster the clients' engagement and to promote a shared sense of purpose within the family. However, in the fourth session, the therapists in both groups contributed to the alliance in similar ways. The results are discussed in terms of (a) the therapists' alliance-building behaviors, (b) the specificities of each client group, and (c) the implications for clinical practice, training, and research. © 2016 Family Process Institute.

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.

PubMed

Latkovskis, Gustavs; Saripo, Vita; Sokolova, Emma; Upite, Dana; Vanaga, Ilona; Kletnieks, Ugis; Erglis, Andrejs

2016-01-01

Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM. In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography. Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (P<0.001 and P=0.018, respectively). Muscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry. Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

The impact of health and safety committees. A study based on survey, interview, and Occupational Safety and Health Administration data.

PubMed

Boden, L I; Hall, J A; Levenstein, C; Punnett, L

1984-11-01

In a study conducted to determine if the existence of a joint labor-management health and safety committee (HSC) was correlated with either the number of Occupational Safety and Health Administration (OSHA) complaints or hazardousness, as measured by OSHA serious citations, virtually no effect could be detected in a sample of 127 Massachusetts manufacturing firms. At a sample of 13 firms, interviews of HSC members were conducted. Committee attributes and perceptions about committee effectiveness were compared with the number of OSHA complaints and serious citations. There were fewer complaints and fewer serious citations at firms with HSCs that were perceived as effective. Results of the study suggest that the objective attributes of the committee may be less important to its success than the commitment of management and labor to solving workplace safety problems.

Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

PubMed

Sinclair, Robert R; Martin, James E; Sears, Lindsay E

2010-09-01

Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

NASA Astrophysics Data System (ADS)

Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

2014-11-01

All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

Using naturalistic driving data to explore the association between traffic safety-related events and crash risk at driver level.

PubMed

Wu, Kun-Feng; Aguero-Valverde, Jonathan; Jovanis, Paul P

2014-11-01

There has been considerable research conducted over the last 40 years using traffic safety-related events to support road safety analyses. Dating back to traffic conflict studies from the 1960s these observational studies of driver behavior have been criticized due to: poor quality data; lack of available and useful exposure measures linked to the observations; the incomparability of self-reported safety-related events; and, the difficulty in assessing culpability for safety-related events. This study seeks to explore the relationships between driver characteristics and traffic safety-related events, and between traffic safety-related events and crash involvement while mitigating some of those limitations. The Virginia Tech Transportation Institute 100-Car Naturalistic Driving Study dataset, in which the participants' vehicles were instrumented with various cameras and sensors during the study period, was used for this study. The study data set includes 90 drivers observed for 12-13 months driving. This study focuses on single vehicle run-off-road safety-related events only, including 14 crashes and 182 safety-related events (30 near crashes, and 152 crash-relevant incidents). Among the findings are: (1) drivers under age 25 are significantly more likely to be involved in safety-related events and crashes; and (2) significantly positive correlations exist between crashes, near crashes, and crash-relevant incidents. Although there is still much to learn about the factors affecting the positive correlation between safety-related events and crashes, a Bayesian multivariate Poisson log-normal model is shown to be useful to quantify the associations between safety-related events and crash risk while controlling for driver characteristics. Copyright © 2014 Elsevier Ltd. All rights reserved.

Nurses' experiences and perspectives on medication safety practices: an explorative qualitative study.

PubMed

Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester

2014-04-01

To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.

Post-approval safety issues with innovative drugs: a European cohort study.

PubMed

Mol, Peter G M; Arnardottir, Arna H; Motola, Domenico; Vrijlandt, Patrick J; Duijnhoven, Ruben G; Haaijer-Ruskamp, Flora M; de Graeff, Pieter A; Denig, Petra; Straus, Sabine M J M

2013-11-01

At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval. We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation. A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation. In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having

Stories from the Sharp End: Case Studies in Safety Improvement

PubMed Central

McCarthy, Douglas; Blumenthal, David

2006-01-01

Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

Hospital safety climate and safety behavior: A social exchange perspective.

PubMed

Ancarani, Alessandro; Di Mauro, Carmela; Giammanco, Maria D

Safety climate is considered beneficial to the improvement of hospital safety outcomes. Nevertheless, the relations between two of its key constituents, namely those stemming from leader-subordinate relations and coworker support for safety, are still to be fully ascertained. This article uses the theoretical lens of Social Exchange Theory to study the joint impact of leader-member exchange in the safety sphere and coworker support for safety on safety-related behavior at the hospital ward level. Social exchange constructs are further related to the existence of a shame-/blame-free environment, seen as a potential antecedent of safety behavior. A cross-sectional study including 166 inpatients in hospital wards belonging to 10 public hospitals in Italy was undertaken to test the hypotheses developed. Hypothesized relations have been analyzed through a fully mediated multilevel structural equation model. This methodology allows studying behavior at the individual level, while keeping into account the heterogeneity among hospital specialties. Results suggest that the linkage between leader support for safety and individual safety behavior is mediated by coworker support on safety issues and by the creation of a shame-free environment. These findings call for the creation of a safety climate in which managerial efforts should be directed not only to the provision of new safety resources and the enforcement of safety rules but also to the encouragement of teamwork and freedom to report errors as ways to foster the capacity of the staff to communicate, share, and learn from each other.

Safety and efficacy of venom immunotherapy: a real life study.

PubMed

Kołaczek, Agnieszka; Skorupa, Dawid; Antczak-Marczak, Monika; Kuna, Piotr; Kupczyk, Maciej

2017-04-01

Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. To analyze the safety and efficacy of VIT in a real life setting. One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. Significantly more patients were allergic to wasp than bee venom (146 vs. 34, p < 0.0001). Early and late side effects were more common during the maintenance (48 patients, 26.7%) than during the induction of VIT (32 patients, 17.8%), were more frequent in patients allergic to bees, and were not associated with angiotensin convertase inhibitors (ACEi) or β-adrenergic antagonists use. Systemic reactions were observed in 4 individuals on wasp VIT (2.7%) and in 6 patients allergic to bees (17.65%). The VIT was efficacious as most patients reported no reactions (50%) or reported only mild local reactions (43.75%) to field stings. The decrease in sIgE at completion of VIT correlated with the dose of vaccine received ( r = 0.53, p = 0.004). Beekeeping (RR = 29.54, p < 0.0001) and female sex (RR = 1.27, p = 0.033) were associated with a higher risk of venom allergy. Venom immunotherapy is highly efficacious and safe as most of the adverse events during the induction and maintenance phase are mild and local. Side effects of VIT are more common in subjects on bee VIT. Beekeeping and female sex are associated with a higher risk of allergy to Hymenoptera venom.

Public acceptability of highway safety countermeasures. Volume 1, Background of study and methodology

DOT National Transportation Integrated Search

1981-06-01

This study provides information about public attitudes towards proposed highway safety countermeasures in three program areas: alcohol and drugs, unsafe driving behaviors, and pedestrian safety. This volume describes the three research methodologies ...

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

PubMed Central

Ayres, J G; Frost, C D; Holmes, W F; Williams, D R R; Ward, S M

1998-01-01

Objective To evaluate the safety of a non-chlorofluorocarbon metered dose salbutamol inhaler. Design This was a postmarketing surveillance study, conducted under formal guidelines for company sponsored safety assessment of marketed medicines (SAMM). A non-randomised, non-interventional, observational design compared patients prescribed metered doses of salbutamol delivered by inhalers using either hydrofluoroalkane or chlorofluorocarbon as the propellant. Follow up was three months. Setting 646 general practices throughout the United Kingdom. Subjects 6614 patients with obstructive airways disease (1667 patient years of exposure). Main outcome measures Proportions of patients who were: admitted to hospital for respiratory diseases, reported adverse side effects, or withdrew because of adverse affects. Results There were no significant differences between the hydrofluoroalkane (HFA 134a) and chlorofluorocarbon inhaler groups in relation to the proportions of patients admitted to hospital for respiratory diseases (odds ratio 0.75; 95% confidence interval 0.51 to 1.08) or the proportions who reported adverse events (1.01; 0.88 to 1.17). However, more patients using the hydrofluoroalkane inhaler than the chlorofluorocarbon inhaler withdrew because of adverse events (3.8% and 0.9% respectively). Conclusion The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies. Key messagesCredibility of postmarketing surveillance studies is expected to increase after the introduction of guidelines covering their conduct The study design successfully fulfilled the requirements of these guidelines in terms of the number, rate, and

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

Vital signs monitoring and nurse-patient interaction: A qualitative observational study of hospital practice.

PubMed

Cardona-Morrell, M; Prgomet, M; Lake, R; Nicholson, M; Harrison, R; Long, J; Westbrook, J; Braithwaite, J; Hillman, K

2016-04-01

High profile safety failures have demonstrated that recognising early warning signs of clinical and physiological deterioration can prevent or reduce harm resulting from serious adverse events. Early warning scoring systems are now routinely used in many places to detect and escalate deteriorating patients. Timely and accurate vital signs monitoring are critical for ensuring patient safety through providing data for early warning scoring systems, but little is known about current monitoring practices. To establish a profile of nurses' vital signs monitoring practices, related dialogue, and adherence to health service protocol in New South Wales, Australia. Direct observations of nurses' working practices were conducted in two wards. The observations focused on times of the day when vital signs were generally measured. Patient interactions were recorded if occurring any time during the observation periods. Participants (n=42) included nursing staff on one chronic disease medical and one acute surgical ward in a large urban teaching hospital in New South Wales. We observed 441 patient interactions. Measurement of vital signs occurred in 52% of interactions. The minimum five vital signs measures required by New South Wales Health policy were taken in only 6-21% of instances of vital signs monitoring. Vital signs were documented immediately on 93% of vitals-taking occasions and documented according to the policy in the patient's chart on 89% of these occasions. Nurse-patient interactions were initiated for the purpose of taking vital signs in 49% of interactions, with nurse-patient discourse observed during 88% of all interactions. Nurse-patient dialogue led to additional care being provided to patients in 12% of interactions. The selection of appropriate vital signs measured and responses to these appears to rely on nurses' clinical judgement or time availability rather than on policy-mandated frequency. The prevalence of incomplete sets of vital signs may limit

Identifying research priorities for patient safety in mental health: an international expert Delphi study

PubMed Central

Murray, Kevin; Thibaut, Bethan; Ramtale, Sonny Christian; Adam, Sheila; Darzi, Ara; Archer, Stephanie

2018-01-01

Objective Physical healthcare has dominated the patient safety field; research in mental healthcare is not as extensive but findings from physical healthcare cannot be applied to mental healthcare because it delivers specialised care that faces unique challenges. Therefore, a clearer focus and recognition of patient safety in mental health as a distinct research area is still needed. The study aim is to identify future research priorities in the field of patient safety in mental health. Design Semistructured interviews were conducted with the experts to ascertain their views on research priorities in patient safety in mental health. A three-round online Delphi study was used to ascertain consensus on 117 research priority statements. Setting and participants Academic and service user experts from the USA, UK, Switzerland, Netherlands, Ireland, Denmark, Finland, Germany, Sweden, Australia, New Zealand and Singapore were included. Main outcome measures Agreement in research priorities on a five-point scale. Results Seventy-nine statements achieved consensus (>70%). Three out of the top six research priorities were patient driven; experts agreed that understanding the patient perspective on safety planning, on self-harm and on medication was important. Conclusions This is the first international Delphi study to identify research priorities in safety in the mental field as determined by expert academic and service user perspectives. A reasonable consensus was obtained from international perspectives on future research priorities in patient safety in mental health; however, the patient perspective on their mental healthcare is a priority. The research agenda for patient safety in mental health identified here should be informed by patient safety science more broadly and used to further establish this area as a priority in its own right. The safety of mental health patients must have parity with that of physical health patients to achieve this. PMID:29502096

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

Clinical Impact Research – how to choose experimental or observational intervention study?

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

Protocol for a mixed-methods study on leader-based interventions in construction contractors' safety commitments.

PubMed

Pedersen, Betina Holbaek; Dyreborg, Johnny; Kines, Pete; Mikkelsen, Kim Lyngby; Hannerz, Harald; Andersen, Dorte Raaby; Spangenberg, Søren

2010-06-01

Owing to high injury rates, safety interventions are needed in the construction industry. Evidence-based interventions tailored to this industry are, however, scarce. Leader-based safety interventions have proven more effective than worker-based interventions in other industries. To test a leader-based safety intervention for construction sites. The intervention consists of encouraging safety coordinators to provide feedback on work safety to the client and line management. The intention is to increase communication and interactions regarding safety within the line management and between the client and the senior management. It is hypothesised that this, in turn, will lead to increased communication and interaction about safety between management and coworkers as well as an increased on-site safety level. A group-randomised double-blinded case study of six Danish construction sites (three intervention sites and three control sites). The recruitment of the construction sites is performed continuously from January 2010 to June 2010. The investigation of each site lasts 20 continuous weeks. Confirmatory statistical analysis is used to test if the safety level increased, and if the probability of safety communications between management and coworkers increases as a consequence of the intervention. The data collection will be blinded. Qualitative methods are used to evaluate if communication and interactions about safety at all managerial levels, including the client, increase. (1) The proportion of safety-related communications out of all studied communications between management and coworkers. (2) The safety level index of the construction sites.

Safety and efficacy of pirfenidone in severe Idiopathic Pulmonary Fibrosis: A real-world observational study.

PubMed

Tzouvelekis, Argyrios; Ntolios, Paschalis; Karampitsakos, Theodoros; Tzilas, Vasilios; Anevlavis, Stavros; Bouros, Evangelos; Steiropoulos, Paschalis; Koulouris, Nikolaos; Stratakos, Grigoris; Froudarakis, Marios; Bouros, Demosthenes

2017-10-01

Pirfenidone is a novel anti-fibrotic drug that has shown efficacy in five randomized multicenter clinical trials enrolling patients with Idiopathic Pulmonary Fibrosis of mild-to-moderate disease severity. Scarce data supports the use of pirfenidone in IPF patients with more advanced disease. To investigate the safety and efficacy profile of pirfenidone in IPF patients with severe lung function impairment. This was a retrospective study enrolling patients with advanced IPF (FVC%predicted < 50% and/or (DLco%predicted <35%) receiving pirfenidone for at least 6 months. Between September 2011 and March 2013, we identified 43 patients with severe IPF (baseline meanFVC%predicted±SD: 63.8 ± 20.3, meanDL CO %predicted: 27.3 ± 8.2), of mean age±SD: 66.3 + 9.7, 34 males (81%) that received pirfenidone (2.403 mg/daily) for one year. Pirfenidone treatment was associated with a trend towards decrease in functional decline compared to 6-months before treatment initiation but failed to show any benefit after one year of treatment (ΔFVC: -3.3 ± 4.6 vs 0.49 ± 11.4 and vs. -5.8 ± 11.8, p = 0.06 and p = 0.04, respectively and ΔDL CO : -13.3 ± 15.2 vs. -10.1 ± 16.6 and vs. 28.3 ± 19.2, p = 0.39 and p = 0.002, respectively). Gastrointestinal disorders (34.9%), fatigue (23.2%) and photosensitivity (18.6%) were the most common adverse events. Adverse events led to treatment discontinuation in 9 patients (20.9%) and dose reduction in 14 (32.5%). Pirfenidone appears to be safe when administered in patients with advanced IPF. Pirfenidone efficacy in IPF patients with severe lung function impairment may diminish after 6 months of treatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

Influence of visual clutter on the effect of navigated safety inspection: a case study on elevator installation.

PubMed

Liao, Pin-Chao; Sun, Xinlu; Liu, Mei; Shih, Yu-Nien

2018-01-11

Navigated safety inspection based on task-specific checklists can increase the hazard detection rate, theoretically with interference from scene complexity. Visual clutter, a proxy of scene complexity, can theoretically impair visual search performance, but its impact on the effect of safety inspection performance remains to be explored for the optimization of navigated inspection. This research aims to explore whether the relationship between working memory and hazard detection rate is moderated by visual clutter. Based on a perceptive model of hazard detection, we: (a) developed a mathematical influence model for construction hazard detection; (b) designed an experiment to observe the performance of hazard detection rate with adjusted working memory under different levels of visual clutter, while using an eye-tracking device to observe participants' visual search processes; (c) utilized logistic regression to analyze the developed model under various visual clutter. The effect of a strengthened working memory on the detection rate through increased search efficiency is more apparent in high visual clutter. This study confirms the role of visual clutter in construction-navigated inspections, thus serving as a foundation for the optimization of inspection planning.

Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.