"Party Line" Information Use Studies and Implications for ATC Datalink Communications

NASA Technical Reports Server (NTRS)

Hansman, R. John; Pritchett, Amy; Midkiff, Alan

1995-01-01

The perceived importance and utilization of 'party line' information by air carrier flight crews was investigated through pilot surveys and a flight simulation study. The importance, availability, and accuracy of party line information elements were explored through surveys of pilots of several operational types. The survey identified numerous traffic and weather party line information elements which were considered important. These elements were scripted into a full-mission flight simulation which examined the utilization of party line information by studying subject responses to specific information element stimuli. The awareness of the different Party Line elements varied, and awareness was also affected by pilot workload. In addition, pilots were aware of some traffic information elements, but were reluctant to act on Party Line Information alone. Finally, the results of both the survey and the simulation indicated that the importance of party line information appeared to be greatest for operations near or on the airport. This indicates that caution should be exercised when implementing datalink communications in tower and close-in terminal control sectors.

Data-linked pilot reply time on controller workload and communication in a simulated terminal option

DOT National Transportation Integrated Search

2001-05-01

This report describes an analysis of air traffic control communication and workload in a simulated terminal radar approach : control environment. The objective of this study was to investigate how pilot-to-controller data-link acknowledgment time : m...

UAV Data-Links: Tasks, Types, Technologies and Examples

DTIC Science & Technology

2000-04-01

Services Mercedes - Benz *Clapra Mercedes - Benz Al cmercial *Leasing *rinancial R ail Systams aftrs Services *smar * lpmoser F reightliner commerciali...highlighting the basic variants of data-links Blohm, MTU and others to form Daimler- Benz and their general advantages and disadvantages a Aerospace (now...bandwidth devices for the consumer market . antenna characteristics Generally speaking, the data-rate of a digital-link signal processing. using BPSK

Design and evaluation of an advanced air-ground data-link system for air traffic control

NASA Technical Reports Server (NTRS)

Denbraven, Wim

1992-01-01

The design and evaluation of the ground-based portion of an air-ground data-link system for air traffic control (ATC) are described. The system was developed to support the 4D Aircraft/ATC Integration Study, a joint simulation experiment conducted at NASA's Ames and Langley Research Centers. The experiment focused on airborne and ground-based procedures for handling aircraft equipped with a 4D-Flight Management System (FMS) and the system requirements needed to ensure conflict-free traffic flow. The Center/TRACON Automation System (CTAS) at Ames was used for the ATC part of the experiment, and the 4D-FMS-equipped aircraft was simulated by the Transport Systems Research Vehicle (TSRV) simulator at Langley. The data-link system supported not only conventional ATC communications, but also the communications needed to accommodate the 4D-FMS capabilities of advanced aircraft. Of great significance was the synergism gained from integrating the data link with CTAS. Information transmitted via the data link was used to improve the monitoring and analysis capability of CTAS without increasing controller input workload. Conversely, CTAS was used to anticipate and create prototype messages, thus reducing the workload associated with the manual creation of data-link messages.

Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink.

PubMed

Vickers, Elizabeth R; McClure, David L; Naleway, Allison L; Jacobsen, Steven J; Klein, Nicola P; Glanz, Jason M; Weintraub, Eric S; Belongia, Edward A

2017-10-13

Influenza-like illness and inflammation are known risk factors for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). However, few studies have characterized the risk of VTE following influenza vaccination. We examined VTE risk after vaccination in adults 50years old and older within the Vaccine Safety Datalink (VSD). We used the self-controlled case series method to determine the risk of VTE among age-eligible adults who received influenza vaccine (with or without pandemic H1N1) and experienced a VTE during the months of September through December in 2007 through 2012. Presumptive VTE cases were identified among VSD participants using diagnostic codes, diagnostic tests, and oral anticoagulant prescription. Potential cases were validated by medical record review. The VTE incidence rate ratio was calculated among confirmed cases for the risk window 1 to 10days after vaccination relative to all other person-time from September through December. Of the 1,488 presumptive cases identified, 508 were reviewed, of which 492 (97%) were confirmed cases of VTE. The analysis included 396 incident, confirmed cases. Overall, there was no increased risk of VTE in the 1 to 10days after influenza vaccination (IRR=0.89, 95% CI 0.69-1.17) compared to the control period. Results were similar when all person-time was censored before vaccination. A post hoc analysis showed an increased risk among current tobacco smokers (IRR=2.57, 95% CI 1.06-6.23). No clustering of VTE was observed in the 1-42days after vaccination. Overall, there was no evidence that inactivated influenza vaccine was associated with VTE in adults ≥50years old. An increased risk was found among current smokers in a post hoc analysis. These findings are consistent with previous research and support the safety of annual vaccination in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

DATALINK: Records inventory data collection software. User`s guide

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

Cole, B.A.

1995-03-01

DATALINK was created to provide an easy to use data collection program for records management software products. It provides several useful tools for capturing and validating record index data in the field. It also allows users to easily create a comma delimited, ASCII text file for data export into most records management software products. It runs on virtually any computer us MS-DOS.

Situational Awareness Issues in the Implementation of Datalink: Shared Situational Awareness in the Joint Flight Deck-ATC Aviation System

NASA Technical Reports Server (NTRS)

Hansman, Robert John, Jr.

1999-01-01

MIT has investigated Situational Awareness issues relating to the implementation of Datalink in the Air Traffic Control environment for a number of years under this grant activity. This work has investigated: 1) The Effect of "Party Line" Information. 2) The Effect of Datalink-Enabled Automated Flight Management Systems (FMS) on Flight Crew Situational Awareness. 3) The Effect of Cockpit Display of Traffic Information (CDTI) on Situational Awareness During Close Parallel Approaches. 4) Analysis of Flight Path Management Functions in Current and Future ATM Environments. 5) Human Performance Models in Advanced ATC Automation: Flight Crew and Air Traffic Controllers. 6) CDTI of Datalink-Based Intent Information in Advanced ATC Environments. 7) Shared Situational Awareness between the Flight Deck and ATC in Datalink-Enabled Environments. 8) Analysis of Pilot and Controller Shared SA Requirements & Issues. 9) Development of Robust Scenario Generation and Distributed Simulation Techniques for Flight Deck ATC Simulation. 10) Methods of Testing Situation Awareness Using Testable Response Techniques. The work is detailed in specific technical reports that are listed in the following bibliography, and are attached as an appendix to the master final technical report.

Identification of Important "Party Line" Information Elements and the Implications for Situational Awareness in the Datalink Environment

NASA Technical Reports Server (NTRS)

Midkiff, Alan H.; Hansman, R. John, Jr.

1992-01-01

Air/ground digital datalink communications are an integral component of the FAA's Air Traffic Control (ATC) modernization strategy. With the introduction of datalink into the ATC system, there is concern over the potential loss of situational awareness by flight crews due to the reduction in the "party line" information available to the pilot. "Party line" information is gleaned by flight crews overhearing communications between ATC and other aircraft. In the datalink environment, party line information may not be available due to the use of discrete addressing. Information concerning the importance, availability, and accuracy of party line elements was explored through an opinion survey of active air carrier flight crews. The survey identified numerous important party line elements. These elements were scripted into a full-mission flight simulation. The flight simulation experiment examined the utilization of party line information by studying subject responses to the specific information elements. Some party line elements perceived as important were effectively utilized by flight crews in the simulated operational environment. However, other party line elements stimulated little or no increase in situational awareness. The ability to assimilate and use party line information appeared to be dependent on workload, time availability, and the tactical/strategic nature of the situations. In addition, the results of both the survey and the simulation indicated that the importance of party line information appeared to be greatest for operations near or on the airport. This indicates that caution must be exercised when implementing datalink communications in these high workload, tactical sectors. This document is based on the thesis of Alan H. Midkiff submitted in partial fulfillment of the degree of Master of Science in Aeronautics and Astronautics at the Massachusetts Institute of Technology.

Datalink in air traffic management: Human factors issues in communications.

PubMed

Stedmon, Alex W; Sharples, Sarah; Littlewood, Robert; Cox, Gemma; Patel, Harshada; Wilson, John R

2007-07-01

This paper examines issues underpinning the potential move in aviation away from real speech radiotelephony (R/T) communications towards datalink communications involving text and synthetic speech communications. Using a novel air traffic control (ATC) task, two experiments are reported. Experiment 1 compared the use of speech and text while Experiment 2 compared the use of real and synthetic speech communications. Results indicated that generally there were no significant differences between speech and text communications and that either type could be used without any main effects on performance. However, a number of specific differences were observed across the different phases of the scenarios indicating that workload levels may be more varied when speech communications are used. Experiment 2 illustrated that participants placed a greater level of trust in real speech than synthetic speech, and trusted true communications more than false communications (regardless of whether they were real or synthetic voices). The findings are considered in terms of datalink initiatives for future air traffic management, the importance placed on real speech R/T communications, and the need to develop more natural synthetic speech in this application area.

GOLD assessment of COPD severity in the Clinical Practice Research Datalink (CPRD).

PubMed

Rebordosa, Cristina; Plana, Estel; Aguado, Jaume; Thomas, Steven; García-Gil, Esther; Perez-Gutthann, Susana; Castellsague, Jordi

2018-05-08

To evaluate availability of spirometry and symptom data in the Clinical Practice Research Datalink (United Kingdom) to assess COPD severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016 definition and comparing it with an algorithm used in other studies. This was a descriptive, noninterventional, secondary database cohort study of patients with COPD aged 40 years or older, who initiated treatment with specific COPD medications. Patients were classified according to COPD severity (1) in GOLD 2016 "ABCD" categories based on symptoms (Medical Research Council dyspnea grade, COPD Assessment Test, breathlessness), percent predicted FEV1, and exacerbation history and (2) as mild, moderate, severe, or very severe based on treatment and exacerbation history. The study included 63 900 patients with COPD aged 40 years or older that were new users of 1 or more COPD medication of interest. Percent predicted FEV1 was available for 80.9% of patients; symptoms for 75.6% of patients. Classification into GOLD 2016 ABCD categories was possible for 75.6% of the patients. The GOLD 2016 ABCD definition classified more patients under the high-risk categories (22.1%, A; 18.8%, B; 21.3%, C; 37.9%, D) than did the adapted algorithm (7.9%, mild; 48.6%, moderate; 42.1%, severe; 1.4%, very severe). Using our adaptation of the GOLD 2016 COPD severity classification, the information in the Clinical Practice Research Datalink allowed us to ascertain COPD severity in approximately 75% of patients with COPD. Algorithms that include medication use tend to misclassify patients with the extreme COPD severity categories. Copyright © 2018 John Wiley & Sons, Ltd.

Internet over the VDL-2 Subnetwork: the VDL-2/IP Aviation Datalink System

NASA Technical Reports Server (NTRS)

Grappel, R. D.

2000-01-01

This report describes the design to operate the standard Internet communications protocols (IP) over the VHF aviation Data Link Mode 2 (VDL-2) subnetwork. The VDL-2/IP system specified in this report can operate transparently with the current aviation users of VDL-2 (Airline Communications and Reporting System, ACARS and Aeronautical Telecommunications Network, ATN) and proposed users (Flight Information Service via Broadcast, FIS-B). The VDL-2/IP system provides a straightforward mechanisms to utilize inexpensive, commercial off-the-shelf (COTS) communications packages developed for the Internet as part of the aviation datalink system.

Estimating the diagnostic accuracy of rheumatoid factor in UK primary care: a study using the Clinical Practice Research Datalink.

PubMed

Miller, Anne; Nightingale, Alison L; Sammon, Cormac J; Mahtani, Kamal R; Holt, Tim A; McHugh, Neil J; Luqmani, Raashid A

2015-10-01

To investigate the diagnostic accuracy of RF as a test for RA in primary care and its impact on referral times using the Clinical Practice Research Datalink. We identified all patients with a first RF test recorded in the Clinical Practice Research Datalink between 1 January 2000 and 31 December 2008 and those diagnosed with RA within 2 years of testing. We calculated likelihood ratios (LRs), sensitivity, specificity and predictive values of RF for a diagnosis of RA. We compared time to hospital referral in those testing positive and negative using Kaplan-Meier failure curves and log-rank tests. Of 62 436 first RF tests, 4679 (7.5%) were positive. There were 1753 incident cases of RA, of which 57.8% were seropositive. The positive LR for RF was 9.5 (95% CI 9.0, 10.0) and the negative LR was 0.5 (95% CI 0.4, 0.5). Sensitivity and specificity were 57.8% (95% CI 55.4%, 60.1%) and 93.9% (95% CI 93.7%, 94.1%) and the positive predictive value and negative predictive value were 21.4% (95% CI 20.3%, 22.6%) and 98.7% (95% CI 98.6%, 98.8%), respectively. Median time to first hospital contact after the first RF test in those with seropositive vs seronegative results was 54 days (95% CI 49, 58) vs 150 (95% CI 147, 152). Only 2.8% of patients undergoing RF testing were diagnosed with RA, suggesting that RF is used to screen patients with musculoskeletal symptoms rather than those with more specific features of RA. A positive RF test may be helpful in diagnosing RA in primary care but performs badly in excluding RA and may delay referral. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Data-Link and Surface Map Traffic Intent Displays for NextGen 4DT and Equivalent Visual Surface Operations

NASA Technical Reports Server (NTRS)

Shelton, Kevin J.; Prinzel, Lawrence J., III; Arthur, Jarvis J., III; Jones, Deise R.; Allamandola, Angela S.; Bailey, Randall E.

2009-01-01

By 2025, U.S. air traffic is predicted to increase 3-fold and may strain the current air traffic management system, which may not be able to accommodate this growth. In response to this challenge, a consortium of industry, academia and government agencies have proposed a revolutionary new concept for U.S. aviation operations, termed the Next Generation Air Transportation System or "NextGen". Many key capabilities are being identified to enable NextGen, including the concept of "net-centric" operations whereby each aircraft and air services provider shares information to allow real-time adaptability to ever-changing factors such as weather, traffic, flight trajectories, and security. Data-link is likely to be the primary source of communication in NextGen. Because NextGen represents a radically different approach to air traffic management and requires a dramatic shift in the tasks, roles, and responsibilities for the flight deck, there are numerous research issues and challenges that must be overcome to ensure a safe, sustainable air transportation system. Flight deck display and crew-vehicle interaction concepts are being developed that proactively investigate and overcome potential technology and safety barriers that might otherwise constrain the full realization of NextGen.

An algorithm to identify rheumatoid arthritis in primary care: a Clinical Practice Research Datalink study

PubMed Central

Muller, Sara; Hider, Samantha L; Raza, Karim; Stack, Rebecca J; Hayward, Richard A; Mallen, Christian D

2015-01-01

Objective Rheumatoid arthritis (RA) is a multisystem, inflammatory disorder associated with increased levels of morbidity and mortality. While much research into the condition is conducted in the secondary care setting, routinely collected primary care databases provide an important source of research data. This study aimed to update an algorithm to define RA that was previously developed and validated in the General Practice Research Database (GPRD). Methods The original algorithm consisted of two criteria. Individuals meeting at least one were considered to have RA. Criterion 1: ≥1 RA Read code and a disease modifying antirheumatic drug (DMARD) without an alternative indication. Criterion 2: ≥2 RA Read codes, with at least one ‘strong’ code and no alternative diagnoses. Lists of codes for consultations and prescriptions were obtained from the authors of the original algorithm where these were available, or compiled based on the original description and clinical knowledge. 4161 people with a first Read code for RA between 1 January 2010 and 31 December 2012 were selected from the Clinical Practice Research Datalink (CPRD, successor to the GPRD), and the criteria applied. Results Code lists were updated for the introduction of new Read codes and biological DMARDs. 3577/4161 (86%) of people met the updated algorithm for RA, compared to 61% in the original development study. 62.8% of people fulfilled both Criterion 1 and Criterion 2. Conclusions Those wishing to define RA in the CPRD, should consider using this updated algorithm, rather than a single RA code, if they wish to identify only those who are most likely to have RA. PMID:26700281

Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009–2011

PubMed Central

Greene, Sharon K.; Rett, Melisa D.; Vellozzi, Claudia; Li, Lingling; Kulldorff, Martin; Marcy, S. Michael; Daley, Matthew F.; Belongia, Edward A.; Baxter, Roger; Fireman, Bruce H.; Jackson, Michael L.; Omer, Saad B.; Nordin, James D.; Jin, Robert; Weintraub, Eric S.; Vijayadeva, Vinutha; Lee, Grace M.

2013-01-01

Background Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited. Methods We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009–10 MIV, 2010–11 trivalent inactivated influenza vaccine (TIV), and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls. Results Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009–10 MIV recipients and 2.80 million 2010–11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009–10 MIV/2010–11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI), 0.59–3.99; risk difference = 0.93 per million doses, 95% CI, −0.71–5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60–16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49–26.94. These findings were consistent in sensitivity analyses using alternative infection definitions

Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.

PubMed

Gee, Julianne; Naleway, Allison; Shui, Irene; Baggs, James; Yin, Ruihua; Li, Rong; Kulldorff, Martin; Lewis, Edwin; Fireman, Bruce; Daley, Matthew F; Klein, Nicola P; Weintraub, Eric S

2011-10-26

In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009. Sequential analyses were conducted weekly to detect associations between HPV4 exposure and pre-specified outcomes. The pre-specified outcomes identified by ICD-9 codes using computerized data at the participating MCOs included: Guillan-Barré Syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope, allergic reactions, and anaphylaxis. For rare outcomes, historical background rates were used as the comparison group. For more common outcomes, a concurrent unexposed comparison group was utilized. A standardized review of medical records was conducted for all cases of GBS, VTE, and anaphylaxis. A total of 600,558 HPV4 doses were administered during the study period. We found no statistically significant increased risk for the outcomes studied. However, a non-statistically significant relative risk (RR) for VTE ICD-9 codes following HPV4 vaccination of 1.98 was detected among females age 9-17 years. Medical record review of all 8 vaccinated potential VTE cases in this age group revealed that 5 met the standard case definition for VTE. All 5 confirmed cases had known risk factors for VTE (oral contraceptive use, coagulation disorders, smoking, obesity or prolonged hospitalization). In a study of over 600,000 HPV4 vaccine doses administered, no statistically significant increased risk for any of the pre-specified adverse events after vaccination was detected. Further study of a possible association with VTE following HPV4 vaccination is warranted. Published by Elsevier Ltd.

Prevalence, incidence, indication, and choice of antidepressants in patients with and without chronic kidney disease: a matched cohort study in UK Clinical Practice Research Datalink.

PubMed

Iwagami, Masao; Tomlinson, Laurie A; Mansfield, Kathryn E; McDonald, Helen I; Smeeth, Liam; Nitsch, Dorothea

2017-07-01

People with chronic kidney disease (CKD) have an increased prevalence of depression, anxiety, and neuropathic pain. We examined prevalence, incidence, indication for, and choice of antidepressants among patients with and without CKD. Using the UK Clinical Practice Research Datalink, we identified patients with CKD (two measurements of estimated glomerular filtration rate < 60 mL/min/1.73m 2 for ≥3 months) between April 2004 and March 2014. We compared those with CKD to a general population cohort without CKD (matched on age, sex, general practice, and calendar time [index date]). We identified any antidepressant prescribing in the six months prior to index date (prevalence), the first prescription after index date among non-prevalent users (incidence), and recorded diagnoses (indication). We compared antidepressant choice between patients with and without CKD among patients with a diagnosis of depression. There were 242 349 matched patients (median age 76 [interquartile range 70-82], male 39.3%) with and without CKD. Prevalence of antidepressant prescribing was 16.3 and 11.9%, and incidence was 57.2 and 42.4/1000 person-years, in patients with and without CKD, respectively. After adjusting for confounders, CKD remained associated with higher prevalence and incidence of antidepressant prescription. Regardless of CKD status, selective serotonin reuptake inhibitors were predominantly prescribed for depression or anxiety, while tricyclic antidepressants were prescribed for neuropathic pain or other reasons. Antidepressant choice was similar in depressed patients with and without CKD. The rate of antidepressant prescribing was nearly one and a half times higher among people with CKD than in the general population. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design.

PubMed

Xu, Stanley; Newcomer, Sophia; Nelson, Jennifer; Qian, Lei; McClure, David; Pan, Yi; Zeng, Chan; Glanz, Jason

2014-05-01

The Vaccine Safety Datalink project captures electronic health record data including vaccinations and medically attended adverse events on 8.8 million enrollees annually from participating managed care organizations in the United States. While the automated vaccination data are generally of high quality, a presumptive adverse event based on diagnosis codes in automated health care data may not be true (misclassification). Consequently, analyses using automated health care data can generate false positive results, where an association between the vaccine and outcome is incorrectly identified, as well as false negative findings, where a true association or signal is missed. We developed novel conditional Poisson regression models and fixed effects models that accommodate misclassification of adverse event outcome for self-controlled case series design. We conducted simulation studies to evaluate their performance in signal detection in vaccine safety hypotheses generating (screening) studies. We also reanalyzed four previously identified signals in a recent vaccine safety study using the newly proposed models. Our simulation studies demonstrated that (i) outcome misclassification resulted in both false positive and false negative signals in screening studies; (ii) the newly proposed models reduced both the rates of false positive and false negative signals. In reanalyses of four previously identified signals using the novel statistical models, the incidence rate ratio estimates and statistical significances were similar to those using conventional models and including only medical record review confirmed cases. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Construction of a multisite DataLink using electronic health records for the identification, surveillance, prevention, and management of diabetes mellitus: the SUPREME-DM project.

PubMed

Nichols, Gregory A; Desai, Jay; Elston Lafata, Jennifer; Lawrence, Jean M; O'Connor, Patrick J; Pathak, Ram D; Raebel, Marsha A; Reid, Robert J; Selby, Joseph V; Silverman, Barbara G; Steiner, John F; Stewart, W F; Vupputuri, Suma; Waitzfelder, Beth

2012-01-01

Electronic health record (EHR) data enhance opportunities for conducting surveillance of diabetes. The objective of this study was to identify the number of people with diabetes from a diabetes DataLink developed as part of the SUPREME-DM (SUrveillance, PREvention, and ManagEment of Diabetes Mellitus) project, a consortium of 11 integrated health systems that use comprehensive EHR data for research. We identified all members of 11 health care systems who had any enrollment from January 2005 through December 2009. For these members, we searched inpatient and outpatient diagnosis codes, laboratory test results, and pharmaceutical dispensings from January 2000 through December 2009 to create indicator variables that could potentially identify a person with diabetes. Using this information, we estimated the number of people with diabetes and among them, the number of incident cases, defined as indication of diabetes after at least 2 years of continuous health system enrollment. The 11 health systems contributed 15,765,529 unique members, of whom 1,085,947 (6.9%) met 1 or more study criteria for diabetes. The nonstandardized proportion meeting study criteria for diabetes ranged from 4.2% to 12.4% across sites. Most members with diabetes (88%) met multiple criteria. Of the members with diabetes, 428,349 (39.4%) were incident cases. The SUPREME-DM DataLink is a unique resource that provides an opportunity to conduct comparative effectiveness research, epidemiologic surveillance including longitudinal analyses, and population-based care management studies of people with diabetes. It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions.

Risk factors for Burkitt lymphoma: a nested case-control study in the UK Clinical Practice Research Datalink.

PubMed

Karimi, Parisa; Birmann, Brenda M; Anderson, Lesley A; McShane, Charlene M; Gadalla, Shahinaz M; Sampson, Joshua N; Mbulaiteye, Sam M

2018-04-20

Burkitt lymphoma (BL) occurs as three subtypes: endemic BL, immunosuppression-related BL and sporadic BL. Descriptive studies of BL age-specific incidence patterns have suggested multimodal peaks near 10, 40 and 70 years of age, but the risk factors for BL at different ages are unknown. We investigated risk factors for BL in the United Kingdom among 156 BL cases and 608 matched BL-free controls identified in the Clinical Practice Research Datalink (CPRD) between 1992 and 2016. Associations with pre-diagnostic body mass index, cigarette smoking, alcohol consumption, hepatitis, Epstein-Barr virus (EBV), human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS), malaria, allergic and autoimmune conditions, and prednisone use were evaluated. Overall, we identified inverse associations between smoking and BL risk, and positive associations between prior EBV infection, HIV/AIDS and prescription or use of prednisone with BL risk. In age-group stratified analyses, BL was associated with malaria exposure (vs. no exposure, odds ratio [OR] 8·00, 95% confidence interval [CI] 1·46-43·7) among those aged 20-59 years old and with hepatitis infection (vs. no infection, OR 3·41, 95% CI 1·01-11·5) among those aged 60+ years old. The effects of EBV, malaria, HIV/AIDS, prednisone and hepatitis on BL remained significant in mutually-adjusted age-group-specific analyses. No risk factors were associated with childhood BL. We report novel associations for BL in non-endemic settings. © 2018 John Wiley & Sons Ltd.

Flight Test Results of VDL-3, 1090ES, and UAT Datalinks for Weather Information Communication

NASA Technical Reports Server (NTRS)

Griner, James

2006-01-01

This presentation describes final test results for the Weather Information Communications (WINCOMM) program at the NASA Glenn Research Center on flight testing of the 1090 Extended Squitter (1090ES), VDL Mode 3, and Universal Access Transceiver (UAT) data links as a medium for weather data exchange. It presents an architectural description of the use of 1090ES to meet the program objectives of sending turbulence information, the use of VDL Mode 3 to send graphical weather images, and the use of UAT for transmitting weather sensor data. This presentation provides a high level definition of the changes made to both avionics and ground-based receivers as well as the ground infrastructure used to support flight testing and future implementation. Summary of results from flight tests of these datalinks will also be presented.

Which Patients with Giant Cell Arteritis Will Develop Cardiovascular or Cerebrovascular Disease? A Clinical Practice Research Datalink Study.

PubMed

Robson, Joanna C; Kiran, Amit; Maskell, Joe; Hutchings, Andrew; Arden, Nigel; Dasgupta, Bhaskar; Hamilton, William; Emin, Akan; Culliford, David; Luqmani, Raashid

2016-06-01

To evaluate the risk of cerebrovascular disease and cardiovascular disease (CVD) in patients with giant cell arteritis (GCA), and to identify predictors. The UK Clinical Practice Research Datalink 1991-2010 was used for a parallel cohort study of 5827 patients with GCA and 37,090 age-, sex-, and location-matched controls. A multivariable competing risk model (non-cerebrovascular/CV-related death as the competing risk) determined the relative risk [subhazard ratio (SHR)] between patients with GCA compared with background controls for cerebrovascular disease, CVD, or either. Each cohort (GCA and controls) was then analyzed individually using the same multivariable model, with age and sex now present, to identify predictors of CVD or cerebrovascular disease. Patients with GCA, compared with controls, had an increased risk SHR (95% CI) of cerebrovascular disease (1.45, 1.31-1.60), CVD (1.49, 1.37-1.62), or either (1.47, 1.37-1.57). In the GCA cohort, predictors of "cerebrovascular disease or CVD" included increasing age, > 80 years versus < 65 years (1.98, 1.62-2.42), male sex (1.20, 1.05-1.38), and socioeconomic status, most deprived quintile versus least deprived (1.34, 1.01-1.78). These predictors were also present within the non-GCA cohort. Patients with GCA are more likely to develop cerebrovascular disease or CVD than age-, sex-, and location-matched controls. In common with the non-GCA cohort, patients who are older, male, and from the most deprived compared with least deprived areas have a higher risk of cerebrovascular disease or CVD. Further work is needed to understand how this risk may be mediated by specific behavioral, social, and economic factors.

Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink

PubMed Central

Langham, Julia; Bhaskaran, Krishnan; Brauer, Ruth; Smeeth, Liam

2013-01-01

Objective To measure the association between orlistat and acute liver injury. Design Self controlled case series study. Setting Population based primary care setting, United Kingdom. Participants 94 695 patients receiving orlistat and registered in the UK Clinical Practice Research Datalink and linked with Hospital Episode Statistics data between 1999 and 2011. Main outcome measure Relative incidence of acute liver injury comparing periods when patients were receiving orlistat with periods of non-usage. Results Among 94 695 patients who received orlistat, 988 cases of acute liver injury were identified, with 335 confirmed as definite cases and 653 as probable cases. For all cases an increased incidence of liver injury was detected during the 90 day period before orlistat was first started, with an incidence rate ratio of 1.50 (95% confidence interval 1.10 to 2.06). The incidence remained raised during the first 30 days of treatment (2.21, 1.43 to 3.42), before returning to baseline levels with prolonged treatment. When the risk during the first 90 days of treatment was compared with the 90 days preceding first treatment, the incidence of liver injury was not increased (1.02, 0.67 to 1.56). An analysis restricted to definite cases showed no evidence of an increased risk of liver injury during treatment. Conclusion The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment. This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug. PMID:23585064

NASA Aviation Safety Program Weather Accident Prevention/weather Information Communications (WINCOMM)

NASA Technical Reports Server (NTRS)

Feinberg, Arthur; Tauss, James; Chomos, Gerald (Technical Monitor)

2002-01-01

Weather is a contributing factor in approximately 25-30 percent of general aviation accidents. The lack of timely, accurate and usable weather information to the general aviation pilot in the cockpit to enhance pilot situational awareness and improve pilot judgment remains a major impediment to improving aviation safety. NASA Glenn Research Center commissioned this 120 day weather datalink market survey to assess the technologies, infrastructure, products, and services of commercial avionics systems being marketed to the general aviation community to address these longstanding safety concerns. A market survey of companies providing or proposing to provide graphical weather information to the general aviation cockpit was conducted. Fifteen commercial companies were surveyed. These systems are characterized and evaluated in this report by availability, end-user pricing/cost, system constraints/limits and technical specifications. An analysis of market survey results and an evaluation of product offerings were made. In addition, recommendations to NASA for additional research and technology development investment have been made as a result of this survey to accelerate deployment of cockpit weather information systems for enhancing aviation safety.

Pattern of risks of rheumatoid arthritis among patients using statins: A cohort study with the clinical practice research datalink.

PubMed

de Jong, Hilda J I; Cohen Tervaert, Jan Willem; Lalmohamed, Arief; de Vries, Frank; Vandebriel, Rob J; van Loveren, Henk; Klungel, Olaf H; van Staa, Tjeerd P

2018-01-01

We examined the association between statin use and the risk of rheumatoid arthritis (RA), with special focus on describing the patterns of risks of RA during statin exposure in a large population-based cohort in the United Kingdom. In the Clinical Practice Research Datalink, patients aged ≥40 years with at least one prescription of statins (1995-2009) were selected, and matched by age (+/-5 years), sex, practice and date of first prescription of statins to non-users. The follow-up period of statin use was divided into periods of current, recent and past exposure, with patients moving between these three exposure categories over time. Time-dependent Cox models were used to derive hazard ratios (HRs) of RA, adjusted for disease history and previous drug use. The study population included 1,023,240 patients, of whom 511,620 were statin users. No associations were found between RA and current (HRadj,1.06;99%CI:0.88-1.27) or past statin users (HRadj,1.18;99%CI:0.88-1.57). However, in patients who currently used statins, hazard rates were increased shortly after the first prescription of statins and then gradually decreased to baseline level. The risk of developing RA was increased in recent statin users, as compared to non-users (HRadj,1.39;99%CI:1.01-1.90). The risk of RA is substantially increased in the first year after the start of statins and then diminishes to baseline level. These findings may suggest that statins might accelerate disease onset in patients susceptible to develop RA, but in other patients, statins are probably safe and well tolerated, even after prolonged use. Alternatively, we cannot rule out that confounding by cardiovascular risk factors and ascertainment bias may have influenced the findings.

Pattern of risks of rheumatoid arthritis among patients using statins: A cohort study with the clinical practice research datalink

PubMed Central

de Jong, Hilda J. I.; Cohen Tervaert, Jan Willem; Lalmohamed, Arief; de Vries, Frank; Vandebriel, Rob J.; van Loveren, Henk; van Staa, Tjeerd P.

2018-01-01

We examined the association between statin use and the risk of rheumatoid arthritis (RA), with special focus on describing the patterns of risks of RA during statin exposure in a large population-based cohort in the United Kingdom. In the Clinical Practice Research Datalink, patients aged ≥40 years with at least one prescription of statins (1995–2009) were selected, and matched by age (+/-5 years), sex, practice and date of first prescription of statins to non-users. The follow-up period of statin use was divided into periods of current, recent and past exposure, with patients moving between these three exposure categories over time. Time-dependent Cox models were used to derive hazard ratios (HRs) of RA, adjusted for disease history and previous drug use. The study population included 1,023,240 patients, of whom 511,620 were statin users. No associations were found between RA and current (HRadj,1.06;99%CI:0.88–1.27) or past statin users (HRadj,1.18;99%CI:0.88–1.57). However, in patients who currently used statins, hazard rates were increased shortly after the first prescription of statins and then gradually decreased to baseline level. The risk of developing RA was increased in recent statin users, as compared to non-users (HRadj,1.39;99%CI:1.01–1.90). The risk of RA is substantially increased in the first year after the start of statins and then diminishes to baseline level. These findings may suggest that statins might accelerate disease onset in patients susceptible to develop RA, but in other patients, statins are probably safe and well tolerated, even after prolonged use. Alternatively, we cannot rule out that confounding by cardiovascular risk factors and ascertainment bias may have influenced the findings. PMID:29474418

Safety of the yellow Fever vaccine: a retrospective study.

PubMed

Nordin, James D; Parker, Emily D; Vazquez-Benitez, Gabriela; Kharbanda, Elyse O; Naleway, Allison; Marcy, S Michael; Molitor, Beth; Kuckler, Leslie; Baggs, James

2013-01-01

Yellow fever (YF) vaccine is considered safe; however, severe illness and death following vaccination have been reported. Vaccine Safety Datalink (VSD) and US Department of Defense (DoD) data were used to identify adverse reactions following YF vaccination. Within the VSD, YF-vaccine-exposed subjects were compared to age-, site-, and gender-matched unexposed subjects. YF-vaccine-exposed DoD subjects were studied using a risk-interval design. For both cohorts, ICD-9 codes were analyzed for allergic and local reactions, mild systemic reactions, and possible visceral and neurologic adverse events (AEs). The VSD cohort received 47,159 doses from 1991 through 2006. The DoD cohort received 1.12 million doses from 1999 through 2007. Most subjects received other vaccines simultaneously. In the VSD cohort, rates of allergic, local, and mild systemic reactions were not statistically different between YF-vaccine-exposed and -unexposed subjects. In the DoD, there was an increased risk for outpatient allergic events in the period following vaccination with YF and other vaccines rate ratios [RR 3.85, 95% confidence interval (CI) 3.35-4.41] but with no increased risk for inpatient allergic reactions. In both cohorts, inpatient ICD-9 codes for visceral events were significantly less common following vaccination; inpatient codes for neurologic events were less common in the VSD YF-vaccine-exposed adult cohort, but did not differ between exposed and unexposed periods in the DoD. In the DoD, one fatal case of YF-vaccine-associated viscerotropic disease (YF-vaccine-AVD) was detected. The estimated death rate was 0.89 for 1,000,000 YF vaccine doses (95% CI 0.12-6.31/1,000,000 doses). No YF vaccine-associated deaths occurred in the VSD. In these closed cohorts we did not detect increased risk for visceral or neurologic events following YF vaccination. The death rate following YF vaccine was consistent with previous reports. These data support current recommendations for use of YF

Validation of suicide and self-harm records in the Clinical Practice Research Datalink

PubMed Central

Thomas, Kyla H; Davies, Neil; Metcalfe, Chris; Windmeijer, Frank; Martin, Richard M; Gunnell, David

2013-01-01

Aims The UK Clinical Practice Research Datalink (CPRD) is increasingly being used to investigate suicide-related adverse drug reactions. No studies have comprehensively validated the recording of suicide and nonfatal self-harm in the CPRD. We validated general practitioners' recording of these outcomes using linked Office for National Statistics (ONS) mortality and Hospital Episode Statistics (HES) admission data. Methods We identified cases of suicide and self-harm recorded using appropriate Read codes in the CPRD between 1998 and 2010 in patients aged ≥15 years. Suicides were defined as patients with Read codes for suicide recorded within 95 days of their death. International Classification of Diseases codes were used to identify suicides/hospital admissions for self-harm in the linked ONS and HES data sets. We compared CPRD-derived cases/incidence of suicide and self-harm with those identified from linked ONS mortality and HES data, national suicide incidence rates and published self-harm incidence data. Results Only 26.1% (n = 590) of the ‘true’ (ONS-confirmed) suicides were identified using Read codes. Furthermore, only 55.5% of Read code-identified suicides were confirmed as suicide by the ONS data. Of the HES-identified cases of self-harm, 68.4% were identified in the CPRD using Read codes. The CPRD self-harm rates based on Read codes had similar age and sex distributions to rates observed in self-harm hospital registers, although rates were underestimated in all age groups. Conclusions The CPRD recording of suicide using Read codes is unreliable, with significant inaccuracy (over- and under-reporting). Future CPRD suicide studies should use linked ONS mortality data. The under-reporting of self-harm appears to be less marked. PMID:23216533

Comparability of the age and sex distribution of the UK Clinical Practice Research Datalink and the total Dutch population.

PubMed

de Jong, Roy G P J; Gallagher, Arlene M; Herrett, Emily; Masclee, Ad A M; Janssen-Heijnen, Maryska L G; de Vries, Frank

2016-12-01

The UK Clinical Practice Research Datalink (CPRD) is increasingly being used by Dutch researchers in epidemiology and pharmacoepidemiology. It is however unclear if the UK CPRD is representative of the Dutch population and whether study results would apply to the Dutch population. Therefore, as first step, our objective was to compare the age and sex distribution of the CPRD with the total Dutch population. As a measure of representativeness, the age and sex distribution of the UK CPRD were visually and numerically compared with Dutch census data from the StatLine database of the Dutch National Bureau of Statistics in 2011. The age distribution of men and women in the CPRD population was comparable to the Dutch male and female population. Differences of more than 10% only occurred in older age categories (75+ in men and 80+ in women). Results from observational studies that have used CPRD data are applicable to the Dutch population, and a useful resource for decision making in the Netherlands. Nevertheless, differences in drug exposure likelihood between countries should be kept in mind, as these could still cause variations in the actual population studied, thereby decreasing its generalizability. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.

PubMed

Daley, Matthew F; Glanz, Jason M; Newcomer, Sophia R; Jackson, Michael L; Groom, Holly C; Lugg, Marlene M; McLean, Huong Q; Klein, Nicola P; Weintraub, Eric S; McNeil, Michael M

2017-04-04

To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias such studies. To assess risk of misclassification of vaccination status within the Vaccine Safety Datalink (VSD). A retrospective cohort study was conducted in three phases. In phase 1, electronic health record (EHR) data were used to identify patterns of under-vaccination during the first 24months of life potentially due to parental choice. In phase 2, a random sample of records of under-vaccinated children was manually reviewed. In phase 3, a separate sample of parents were surveyed to assess whether EHR data accurately reflected their child's vaccination status. Phases 1 and 2 were conducted at 6 VSD sites, phase 3 at 1 site. The study cohort included 361,901 children born 2004 through 2012. By 24months of age, 198,249 (54.8%) were fully vaccinated with no delays, 84,698 (23.4%) experienced delays but were fully vaccinated by 24months of age, 4865 (1.3%) received no vaccines, 3789 (1.0%) delayed starting vaccination until ≥4months of age, 4781 (1.3%) had consistent vaccine-limiting (≤2 vaccines per visit), and the remaining 65,519 (18.1%) were missing vaccine series or doses. When a diagnosis code for vaccine refusal was present in EHR data, encounter notes confirmed vaccine refusal as the reason for under-vaccination for nearly 100% of sampled records. Parent surveys confirmed these findings. Parents of under-vaccinated children were more likely to report visiting an alternative medical provider than parents of fully vaccinated children. Specific groups of children, under-vaccinated due to parental choice, can be identified with relatively low likelihood of misclassification of vaccination status using EHR-based vaccine data and diagnosis codes

Near real-time vaccine safety surveillance with partially accrued data.

PubMed

Greene, Sharon K; Kulldorff, Martin; Yin, Ruihua; Yih, W Katherine; Lieu, Tracy A; Weintraub, Eric S; Lee, Grace M

2011-06-01

The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered during a short period, such as influenza vaccines, timeliness can be improved by undertaking analyses while risk windows following vaccination are ongoing and by accommodating predictable and unpredictable data accrual delays. We describe practical solutions to these challenges, which were adopted by the VSD Project during pandemic and seasonal influenza vaccine safety surveillance in 2009/2010. Adjustments were made to two sequential analytic approaches. The Poisson-based approach compared the number of pre-defined adverse events observed following vaccination with the number expected using historical data. The expected number was adjusted for the proportion of the risk window elapsed and the proportion of inpatient data estimated to have accrued. The binomial-based approach used a self-controlled design, comparing the observed numbers of events in risk versus comparison windows. Events were included in analysis only if they occurred during a week that had already passed for both windows. Analyzing data before risk windows fully elapsed improved the timeliness of safety surveillance. Adjustments for data accrual lags were tailored to each data source and avoided biasing analyses away from detecting a potential safety problem, particularly early during surveillance. The timeliness of vaccine and drug safety surveillance can be improved by properly accounting for partially elapsed windows and data accrual delays. Copyright © 2011 John Wiley & Sons, Ltd.

Understanding flucloxacillin prescribing trends and treatment non-response in UK primary care: a Clinical Practice Research Datalink (CPRD) study

PubMed Central

Francis, Nick A.; Hood, Kerenza; Lyons, Ronan; Butler, Christopher C.

2016-01-01

Objectives The volume of prescribed antibiotics is associated with antimicrobial resistance and, unlike most other antibiotic classes, flucloxacillin prescribing has increased. We aimed to describe UK primary care flucloxacillin prescribing and factors associated with subsequent antibiotic prescribing as a proxy for non-response. Patients and methods Clinical Practice Research Datalink patients with acute prescriptions for oral flucloxacillin between January 2004 and December 2013, prescription details, associated Read codes and patient demographics were identified. Monthly prescribing rates were plotted and logistic regression identified factors associated with having a subsequent antibiotic prescription within 28 days. Results 3 031 179 acute prescriptions for 1 667 431 patients were included. Average monthly prescription rates increased from 4.74 prescriptions per 1000 patient-months in 2004 to 5.74 (increase of 21.1%) in 2013. The highest prescribing rates and the largest increases in rates were seen in older adults (70+ years), but the overall increase in prescribing was not accounted for by an ageing population. Prescribing 500 mg tablets/capsules rather than 250 mg became more common. Children were frequently prescribed low doses and small volumes (5 day course) and prescribing declined for children, including for impetigo. Only 4.2% of new prescriptions involved co-prescription of another antibiotic. Age (<5 and ≥60 years), diagnosis of ‘cellulitis or abscess’ or no associated code, and 500 mg dose were associated with a subsequent antibiotic prescription, which occurred after 17.6% of first prescriptions. Conclusions There is a need to understand better the reasons for increased prescribing of flucloxacillin in primary care, optimal dosing (and the need to co-prescribe other antibiotics) and the reasons why one in five patients are prescribed a further antibiotic within 4 weeks. PMID:27090629

Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine.

PubMed

Daley, Matthew F; Yih, W Katherine; Glanz, Jason M; Hambidge, Simon J; Narwaney, Komal J; Yin, Ruihua; Li, Lingling; Nelson, Jennifer C; Nordin, James D; Klein, Nicola P; Jacobsen, Steven J; Weintraub, Eric

2014-05-23

In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events. To assess the risk of serious adverse events following DTaP-IPV vaccination. The study was conducted from January 2009 through September 2012 in the Vaccine Safety Datalink (VSD) project. In the VSD, electronic vaccination and encounter data are updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barré syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis; and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the VSD population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis. During the study period, 201,116 children received DTaP-IPV vaccine. Ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically measles-mumps-rubella and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates. In this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barré syndrome. Copyright © 2014 Elsevier Ltd. All rights reserved.

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study.

PubMed

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998-2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis - using only patients with complete data - and longitudinal MI - adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). CC may substantially affect relative risk estimation in EMR-based drug

Validation of asthma recording in the Clinical Practice Research Datalink (CPRD)

PubMed Central

Morales, Daniel R; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J; Quint, Jennifer K

2017-01-01

Objectives The optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD). Methods 684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms. A questionnaire was sent to the GPs to confirm asthma status and provide additional information to support an asthma diagnosis. Two study physicians independently reviewed and adjudicated the questionnaires and additional information to form a gold standard for asthma diagnosis. The PPV was calculated for each algorithm. Results 684 questionnaires were sent, of which 494 (72%) were returned and 475 (69%) were complete and analysed. All five algorithms including a specific Read code indicating asthma or non-specific Read code accompanied by additional conditions performed well. The PPV for asthma diagnosis using only a specific asthma code was 86.4% (95% CI 77.4% to 95.4%). Extra information on asthma medication prescription (PPV 83.3%), evidence of reversibility testing (PPV 86.0%) or a combination of all three selection criteria (PPV 86.4%) did not result in a higher PPV. The algorithm using non-specific asthma codes, information on reversibility testing and respiratory medication use scored highest (PPV 90.7%, 95% CI (82.8% to 98.7%), but had a much lower identifiable population. Algorithms based on asthma symptom codes had low PPVs (43.1% to 57.8%)%). Conclusions People with asthma can be accurately identified from UK primary care records using specific Read codes. The inclusion of spirometry or asthma medications in the algorithm did not clearly improve accuracy

Flu Vaccine and People with Egg Allergies

MedlinePlus

... 12 through 2014–15 reported maximum amounts of ≤1 µg/0.5 mL dose for flu shots and 0.24 µg/0.2 mL dose ... reactions, including anaphylaxis. In a Vaccine Safety Datalink study, there were ... other vaccines, (rate of 1.35 per one million doses). Most of these ...

Associations of NSAID and paracetamol use with risk of primary liver cancer in the Clinical Practice Research Datalink.

PubMed

Yang, Baiyu; Petrick, Jessica L; Chen, Jie; Hagberg, Katrina Wilcox; Sahasrabuddhe, Vikrant V; Graubard, Barry I; Jick, Susan; McGlynn, Katherine A

2016-08-01

Liver cancer incidence has been rising rapidly in Western countries. Nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol are widely-used analgesics that may modulate the risk of liver cancer, but population-based evidence is limited. We conducted a case-control study (1195 primary liver cancer cases and 4640 matched controls) within the United Kingdom's Clinical Practice Research Datalink to examine the association between the use of prescription NSAIDs and paracetamol and development of liver cancer. Multivariable-adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were estimated using conditional logistic regression. Overall, ever-use of NSAIDs was not associated with risk of liver cancer (aOR=1.05, 95% CI=0.88-1.24), regardless of recency and intensity of use. Use of paracetamol was associated with a slightly increased risk of liver cancer (aOR=1.18, 95% CI=1.00-1.39), particularly among individuals with body mass index<25kg/m(2) (aOR=1.56, 95% CI=1.17-2.09). Our results suggest that NSAID use was not associated with liver cancer risk in this population. Ever-use of paracetamol may be associated with slightly higher liver cancer risk, but results should be interpreted cautiously due to methodological limitations. Given that paracetamol is a widely-used analgesic, further examination of its relationship with liver cancer is warranted. Published by Elsevier Ltd.

Health care resource use by patients before and after a diagnosis of chronic fatigue syndrome (CFS/ME): a clinical practice research datalink study.

PubMed

Collin, Simon M; Bakken, Inger J; Nazareth, Irwin; Crawley, Esther; White, Peter D

2017-05-05

Our aim was to investigate patterns of health care resource use by patients before and after a diagnosis of CFS/ME, as recorded by Clinical Practice Research Datalink (CPRD) GP practices in the UK. We used a case-control study design in which patients who had a first recorded diagnosis of CFS/ME during the period 01/01/2001 to 31/12/2013 were matched 1:1 with controls by age, sex, and GP practice. We compared rates of GP consultations, diagnostic tests, prescriptions, referrals, and symptoms between the two groups from 15 years (in adults) or 10 years (in children) before diagnosis to 10 years after diagnosis. Data were available for 6710 adult and 916 child (age <18 years) matched case-control pairs. Rates of GP consultations, diagnostic tests, prescriptions, referrals, and symptoms spiked dramatically in the year when a CFS/ME diagnosis was recorded. GP consultation rates were 50% higher in adult cases compared to controls 11-15 years before diagnosis (rate ratio (RR) 1.49 (95% CI 1.46, 1.52)) and 56% higher 6-10 years after diagnosis (RR 1.56 (1.54, 1.57)). In children, consultation rates in cases were 45% higher 6-10 years before diagnosis (RR 1.45 (1.40, 1.51)) and 62% higher 6-10 years after diagnosis (RR 1.62 (1.54, 1.70)). For adults and children, rates of tests, prescriptions, referrals, and symptoms were higher in cases compared to controls for up to 10 years before and after diagnosis. Adults and children with CFS/ME have greater health care needs than the rest of the population for at least ten years before their diagnosis, and these higher levels of health care resource use continue for at least ten years after diagnosis.

Evaluating efficiency and statistical power of self-controlled case series and self-controlled risk interval designs in vaccine safety.

PubMed

Li, Rongxia; Stewart, Brock; Weintraub, Eric

2016-01-01

The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. In this study, we derived the asymptotic relative efficiency (ARE) between these two methods to quantify this loss in power in the SCRI design. The equation is formulated as [Formula: see text] (a: control window-length ratio between SCRI and SCCS designs; b: ratio of risk window length and control window length in the SCCS design; and [Formula: see text]: relative risk of exposed window to control window). According to this equation, the relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk [Formula: see text]. We provide an example utilizing data from the Vaccine Safety Datalink (VSD) to study the potential elevated risk of febrile seizure following seasonal influenza vaccine in the 2010-2011 season.

Cancer recording in patients with and without type 2 diabetes in the Clinical Practice Research Datalink primary care data and linked hospital admission data: a cohort study.

PubMed

Williams, Rachael; van Staa, Tjeerd-Pieter; Gallagher, Arlene M; Hammad, Tarek; Leufkens, Hubert G M; de Vries, Frank

2018-05-26

Conflicting results from studies using electronic health records to evaluate the associations between type 2 diabetes and cancer fuel concerns regarding potential biases. This study aimed to describe completeness of cancer recording in UK primary care data linked to hospital admissions records. Patients aged 40+ years with insulin or oral antidiabetic prescriptions in Clinical Practice Research Datalink (CPRD) primary care without type 1 diabetes were matched by age, sex and general practitioner practice to non-diabetics. Those eligible for linkage to Hospital Episode Statistics Admitted Patient Care (HES APC), and with follow-up during April 1997-December 2006 were included. Cancer recording and date of first record of cancer were compared. Characteristics of patients with cancer most likely to have the diagnosis recorded only in a single data source were assessed. Relative rates of cancer estimated from the two datasets were compared. 53 585 patients with type 2 diabetes matched to 47 435 patients without diabetes were included. Of all cancers (excluding non-melanoma skin cancer) recorded in CPRD, 83% were recorded in HES APC. 94% of cases in HES APC were recorded in CPRD. Concordance was lower when restricted to same-site cancer records, and was negatively associated with increasing age. Relative rates for cancer were similar in both datasets. Good concordance in cancer recording was found between CPRD and HES APC among type 2 diabetics and matched controls. Linked data may reduce misclassification and increase case ascertainment when analysis focuses on site-specific cancers. © 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.

Convection Weather Detection by General Aviation Pilots with Convectional and Data-Linked Graphical Weather Information Sources

NASA Technical Reports Server (NTRS)

Chamberlain, James P.; Latorella, Kara A.

2001-01-01

This study compares how well general aviation (GA) pilots detect convective weather in flight with different weather information sources. A flight test was conducted in which GA pilot test subjects were given different in-flight weather information cues and flown toward convective weather of moderate or greater intensity. The test subjects were not actually flying the aircraft, but were given pilot tasks representative of the workload and position awareness requirements of the en route portion of a cross country GA flight. On each flight, one test subject received weather cues typical of a flight in visual meteorological conditions (VMC), another received cues typical of flight in instrument meteorological conditions (IMC), and a third received cues typical of flight in IMC but augmented with a graphical weather information system (GWIS). The GWIS provided the subject with near real time data-linked weather products, including a weather radar mosaic superimposed on a moving map with a symbol depicting the aircraft's present position and direction of track. At several points during each flight, the test subjects completed short questionnaires which included items addressing their weather situation awareness and flight decisions. In particular, test subjects were asked to identify the location of the nearest convective cells. After the point of nearest approach to convective weather, the test subjects were asked to draw the location of convective weather on an aeronautical chart, along with the aircraft's present position. This paper reports preliminary results on how accurately test subjects provided with these different weather sources could identify the nearest cell of moderate or greater intensity along their route of flight. Additional flight tests are currently being conducted to complete the data set.

The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study

PubMed Central

Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

2018-01-01

Background Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. Aim To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). Methods New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998–2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis – using only patients with complete data – and longitudinal MI – adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Results Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). Conclusion CC may substantially

Trends in the incidence of chronic fatigue syndrome and fibromyalgia in the UK, 2001-2013: a Clinical Practice Research Datalink study.

PubMed

Collin, Simon M; Bakken, Inger J; Nazareth, Irwin; Crawley, Esther; White, Peter D

2017-06-01

Objective Trends in recorded diagnoses of chronic fatigue syndrome (CFS, also known as 'myalgic encephalomyelitis' (ME)) and fibromyalgia (FM) in the UK were last reported more than ten years ago, for the period 1990-2001. Our aim was to analyse trends in incident diagnoses of CFS/ME and FM for the period 2001-2013, and to investigate whether incidence might vary by index of multiple deprivation (IMD) score. Design Electronic health records cohort study. Setting NHS primary care practices in the UK. Participants Participants: Patients registered with general practices linked to the Clinical Practice Research Datalink (CPRD) primary care database from January 2001 to December 2013. Main outcome measure Incidence of CFS/ME, FM, post-viral fatigue syndrome (PVFS), and asthenia/debility. Results The overall annual incidence of recorded cases of CFS/ME was 14.8 (95% CI 14.5, 15.1) per 100,000 people. Overall annual incidence per 100,000 people for FM was 33.3 (32.8-33.8), for PVFS 12.2 (11.9, 12.5), and for asthenia/debility 7.0 (6.8, 7.2). Annual incidence rates for CFS/ME diagnoses decreased from 17.5 (16.1, 18.9) in 2001 to 12.6 (11.5, 13.8) in 2013 (annual percent change -2.8% (-3.6%, -2.0%)). Annual incidence rates for FM diagnoses decreased from 32.3 (30.4, 34.3) to 27.1 (25.5, 28.6) in 2007, then increased to 38.2 (36.3, 40.1) per 100,000 people in 2013. Overall annual incidence of recorded fatigue symptoms was 2246 (2242, 2250) per 100,000 people. Compared with the least deprived IMD quintile, incidence of CFS/ME in the most deprived quintile was 39% lower (incidence rate ratio (IRR) 0.61 (0.50, 0.75)), whereas rates of FM were 40% higher (IRR 1.40 (0.95, 2.06)). Conclusion These analyses suggest a gradual decline in recorded diagnoses of CFS/ME since 2001, and an increase in diagnoses of fibromyalgia, with opposing socioeconomic patterns of lower rates of CFS/ME diagnoses in the poorest areas compared with higher rates of FM diagnoses.

Lansoprazole use and tuberculosis incidence in the United Kingdom Clinical Practice Research Datalink: A population based cohort

PubMed Central

Yates, Tom A.; Tomlinson, Laurie A.; Bhaskaran, Krishnan; Langan, Sinead; Thomas, Sara; Smeeth, Liam

2017-01-01

Background Recent in vitro and animal studies have found the proton pump inhibitor (PPI) lansoprazole to be highly active against Mycobacterium tuberculosis. Omeprazole and pantoprazole have no activity. There is no evidence that, in clinical practice, lansoprazole can treat or prevent incident tuberculosis (TB) disease. Methods and findings We studied a cohort of new users of lansoprazole, omeprazole, or pantoprazole from the United Kingdom Clinical Practice Research Datalink to determine whether lansoprazole users have a lower incidence of TB disease than omeprazole or pantoprazole users. Negative control outcomes of myocardial infarction (MI) and herpes zoster were also studied. Multivariable Cox proportional hazards regression was used to adjust for potential confounding by a wide range of factors. We identified 527,364 lansoprazole initiators and 923,500 omeprazole or pantoprazole initiators. Lansoprazole users had a lower rate of TB disease (n = 86; 10.0 cases per 100,000 person years; 95% confidence interval 8.1–12.4) than omeprazole or pantoprazole users (n = 193; 15.3 cases per 100,000 person years; 95% confidence interval 13.3–17.7), with an adjusted hazard ratio (HR) of 0.68 (0.52–0.89). No association was found with MI (adjusted HR 1.04; 95% confidence interval 1.00–1.08) or herpes zoster (adjusted HR 1.03; 95% confidence interval 1.00–1.06). Limitations of this study are that we could not determine whether TB disease was due to reactivation of latent infection or a result of recent transmission, nor could we determine whether lansoprazole would have a beneficial effect if given to people presenting with TB disease. Conclusions In this study, use of the commonly prescribed and cheaply available PPI lansoprazole was associated with reduced incidence of TB disease. Given the serious problem of drug resistance and the adverse side effect profiles of many TB drugs, further investigation of lansoprazole as a potential antituberculosis agent is

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.

Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis and Influenza Vaccinations in Pregnancy.

PubMed

Sukumaran, Lakshmi; McCarthy, Natalie L; Kharbanda, Elyse O; Weintraub, Eric S; Vazquez-Benitez, Gabriela; McNeil, Michael M; Li, Rongxia; Klein, Nicola P; Hambidge, Simon J; Naleway, Allison L; Lugg, Marlene M; Jackson, Michael L; King, Jennifer P; DeStefano, Frank; Omer, Saad B; Orenstein, Walter A

2015-11-01

To evaluate the safety of coadministering tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines during pregnancy by comparing adverse events after concomitant and sequential vaccination. We conducted a retrospective cohort study of pregnant women aged 14-49 years in the Vaccine Safety Datalink from January 1, 2007, to November 15, 2013. We compared medically attended acute events (fever, any acute reaction) and adverse birth outcomes (preterm delivery, low birth weight, small for gestational age) in women receiving concomitant Tdap and influenza vaccination and women receiving sequential vaccination. Among 36,844 pregnancies in which Tdap and influenza vaccines were administered, the vaccines were administered concomitantly in 8,464 (23%) pregnancies and sequentially in 28,380 (77%) pregnancies. Acute adverse events after vaccination were rare. We found no statistically significant increased risk of fever or any medically attended acute adverse event in pregnant women vaccinated concomitantly compared with sequentially. When analyzing women at 20 weeks of gestation or greater during periods of influenza vaccine administration, there were no differences in preterm delivery, low-birth-weight, or small-for-gestational-age neonates between women vaccinated concomitantly compared with sequentially in pregnancy. Concomitant administration of Tdap and influenza vaccines during pregnancy was not associated with a higher risk of medically attended adverse acute outcomes or birth outcomes compared with sequential vaccination. II.

The management of acne vulgaris in primary care: a cohort study of consulting and prescribing patterns using the Clinical Practice Research Datalink.

PubMed

Francis, N A; Entwistle, K; Santer, M; Layton, A M; Eady, E A; Butler, C C

2017-01-01

Effective management of acne vulgaris in primary care involves support (usually provided over a number of consultations) and prescription of effective treatments. However, consulting and prescribing patterns for acne in primary care are not well described. To describe the rate of primary-care consultations and follow-up consultations; prescribing patterns, including overall use of acne-related medications (ARMs); and initial and follow-up prescription for acne vulgaris in the U.K. U.K. primary-care acne consultations and prescriptions for ARMs were identified in the Clinical Practice Research Datalink. Annual consultation rates (between 2004 and 2013) by age and sex, new consultations and consultations in the subsequent year were calculated, along with prescribing trends - during a new consultation and over the subsequent 90 days and year - using the number of registered patients as the denominator. Two-thirds (66·1%) of patients who had a new acne consultation had no further acne consultations in the subsequent year. Overall 26·7%, 24·9%, and 23·6% and 2·8% of patients were prescribed no ARM, an oral antibiotic, a topical antibiotic or an oral plus topical antibiotic, respectively, during a new acne consultation. In total 60·1% and 38·6% of patients prescribed an ARM received no further ARM prescriptions in the following 90 days and 1 year, respectively, despite most prescriptions being for 2 months or less. Prescribing rates for lymecycline and topical combined clindamycin and benzoyl peroxide increased substantially between 2004 and 2013. There were no important changes in consultation rates between 2004 and 2013. These data suggest that patients with acne are receiving a suboptimal initial choice of ARMs, longitudinal care and prescribing. © 2016 British Association of Dermatologists.

Can commonly prescribed drugs be repurposed for the prevention or treatment of Alzheimer's and other neurodegenerative diseases? Protocol for an observational cohort study in the UK Clinical Practice Research Datalink

PubMed Central

Davies, Neil M; Jones, Tim; Kehoe, Patrick G; Martin, Richard M

2016-01-01

Introduction Current treatments for Alzheimer's and other neurodegenerative diseases have only limited effectiveness meaning that there is an urgent need for new medications that could influence disease incidence and progression. We will investigate the potential of a selection of commonly prescribed drugs, as a more efficient and cost-effective method of identifying new drugs for the prevention or treatment of Alzheimer's disease, non-Alzheimer's disease dementias, Parkinson's disease and amyotrophic lateral sclerosis. Our research will focus on drugs used for the treatment of hypertension, hypercholesterolaemia and type 2 diabetes, all of which have previously been identified as potentially cerebroprotective and have variable levels of preclinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. Methods and analysis We will conduct a hypothesis testing observational cohort study using data from the Clinical Practice Research Datalink (CPRD). Our analysis will consider four statistical methods, which have different approaches for modelling confounding. These are multivariable adjusted Cox regression; propensity matched regression; instrumental variable analysis and marginal structural models. We will also use an intention-to-treat analysis, whereby we will define all exposures based on the first prescription observed in the database so that the target parameter is comparable to that estimated by a randomised controlled trial. Ethics and dissemination This protocol has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will publish the results of the study as open-access peer-reviewed publications and disseminate findings through national and international conferences as are appropriate. PMID:27965247

AN overview of the FLYSAFE datalink solution for the exchange of weather information: supporting aircrew decision making processes.

NASA Astrophysics Data System (ADS)

Mirza, A.; Drouin, A.

2009-09-01

FLYSAFE is an Integrated Project of the 6th framework of the European Commission with the aim to improve flight safety through the development of an avionics solution the Next Generation Integrated Surveillance System (NGISS), which is supported by a ground based network of Weather Information Management Systems (WIMS) and access points in the form of the Ground Weather Processor (GWP). The NGISS provides information to the flight crew on the three major external hazards for aviation: weather, air traffic and terrain. The NGISS has the capability of displaying data about all three hazards on a single display screen, facilitating rapid appreciation of the situation by the flight crew. Weather Information Management Systems (WIMS) were developed to provide the NGISS and the flight crew with weather related information on in-flight icing, thunderstorms and clear-air turbulence. These products are generated on the ground from observations and model forecasts. WIMS will supply relevant information on three different scales: global, regional and local (over airport Terminal Manoeuvring Area). The Ground Weather Processor is a client-server architecture that utilises open source components, which include a geospatial database and web feature services. The GWP stores Weather Objects generated by the WIMS. An aviation user can retrieve on-demand all Weather Objects that intersect the volume of space that is of interest to them. The Weather Objects are fused with in-situ observation data and can be used by the flight management system to propose a route to avoid the hazard. In addition they can be used to display the current hazardous weather to the Flight Crew thereby raising their awareness. Within the FLYSAFE program, around 120 hours of flight trials were performed during February 2008 and August 2008. Two aircraft were involved each with separate objectives: - to assess FLYSAFE's innovative solutions for the data-link, on-board data-fusion and data-display and data

Live attenuated influenza vaccine use and safety in children and adults with asthma.

PubMed

Duffy, Jonathan; Lewis, Melissa; Harrington, Theresa; Baxter, Roger; Belongia, Edward A; Jackson, Lisa A; Jacobsen, Steven J; Lee, Grace M; Naleway, Allison L; Nordin, James; Daley, Matthew F

2017-04-01

Live attenuated influenza vaccine (LAIV) might increase the risk of wheezing in persons with asthma or children younger than 5 years with a history of recurrent wheezing. To describe the use and assess the safety of LAIV in persons with asthma in the Vaccine Safety Datalink population. We identified persons with asthma using diagnosis codes and medication records in 7 health care organizations over 3 influenza seasons (2008-2009 through 2010-2011) and determined their influenza vaccination rates. Using the self-controlled risk interval method, we calculated the incidence rate ratio of medically attended respiratory events in the 14 days after LAIV compared with 29 to 42 days after vaccination in persons 2 through 49 years old. In our population of 6.3 million, asthma prevalence was 5.9%. Of persons with asthma, approximately 50% received any influenza vaccine but less than 1% received LAIV. The safety study included 12,354 LAIV doses (75% in children; 93% in those with intermittent or mild persistent asthma). The incidence rate ratio for inpatient and emergency department visits for lower respiratory events (including asthma exacerbation and wheezing) was 0.98 (95% confidence interval 0.63-1.51) and the incidence rate ratio for upper respiratory events was 0.94 (95% confidence interval 0.48-1.86). The risk of lower respiratory events was similar for intermittent and mild persistent asthma, across age groups, and for seasonal trivalent LAIV and 2009 H1N1 pandemic monovalent LAIV. LAIV use in asthma was mostly in persons with intermittent or mild persistent asthma. LAIV was not associated with an increased risk of medically attended respiratory adverse events. Published by Elsevier Inc.

Representativeness and optimal use of body mass index (BMI) in the UK Clinical Practice Research Datalink (CPRD)

PubMed Central

Bhaskaran, Krishnan; Forbes, Harriet J; Douglas, Ian; Leon, David A; Smeeth, Liam

2013-01-01

Objectives To assess the completeness and representativeness of body mass index (BMI) data in the Clinical Practice Research Datalink (CPRD), and determine an optimal strategy for their use. Design Descriptive study. Setting Electronic healthcare records from primary care. Participants A million patient random sample from the UK CPRD primary care database, aged ≥16 years. Primary and secondary outcome measures BMI completeness in CPRD was evaluated by age, sex and calendar period. CPRD-based summary BMI statistics for each calendar year (2003–2010) were age-standardised and sex-standardised and compared with equivalent statistics from the Health Survey for England (HSE). Results BMI completeness increased over calendar time from 37% in 1990–1994 to 77% in 2005–2011, was higher among females and increased with age. When BMI at specific time points was assigned based on the most recent record, calendar–year-specific mean BMI statistics underestimated equivalent HSE statistics by 0.75–1.1 kg/m2. Restriction to those with a recent (≤3 years) BMI resulted in mean BMI estimates closer to HSE (≤0.28 kg/m2 underestimation), but excluded up to 47% of patients. An alternative strategy of imputing up-to-date BMI based on modelled changes in BMI over time since the last available record also led to mean BMI estimates that were close to HSE (≤0.37 kg/m2 underestimation). Conclusions Completeness of BMI in CPRD increased over time and varied by age and sex. At a given point in time, a large proportion of the most recent BMIs are unlikely to reflect current BMI; consequent BMI misclassification might be reduced by employing model-based imputation of current BMI. PMID:24038008

Evaluating the validity of clinical codes to identify cataract and glaucoma in the UK Clinical Practice Research Datalink.

PubMed

Kang, Elizabeth M; Pinheiro, Simone P; Hammad, Tarek A; Abou-Ali, Adel

2015-01-01

The aim of this study is to determine (i) the positive predictive value (PPV) of an algorithm using clinical codes to identify incident glaucoma and cataract events in the Clinical Practice Research Datalink (CPRD) and (ii) the ability to capture the correct timing of these clinical events. A total of 21,339 and 5349 potential cataract and glaucoma cases, respectively, were identified in CPRD between 1 January 1990 and 31 December 2010. Questionnaires were sent to the general practitioners (GP) of 1169 (5.5%) cataract and 1163 (21.7%) glaucoma cases for validation. GPs were asked to verify the diagnosis and the timing of the diagnosis and to provide other supporting information. A total of 986 (84.3%) valid cataract questionnaires and 863 (74.2%) glaucoma questionnaires were completed. 92.1% and 92.4% of these used information beyond EMR to verify the diagnosis. Cataract and glaucoma diagnoses were confirmed in the large majority of the cases. The PPV (95% CI) of the cataract and glaucoma Read code algorithm were 92.0% (90.3-93.7%) and 84.1% (81.7-86.6%), respectively. However, timing of diagnosis was incorrect for a substantial proportion of the cases (20.3% and 32.8% of the cataract and glaucoma cases, respectively) among whom 30.4% and 49.2% had discrepancies in diagnosis timing greater than 1 year. High PPV suggests that the algorithms based on the clinical Read codes are sufficient to identify the cataract and glaucoma cases in CPRD. However, these codes alone may not be able to accurately identify the timing of the diagnosis of these eye disorders. Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

Validation of chronic obstructive pulmonary disease recording in the Clinical Practice Research Datalink (CPRD-GOLD)

PubMed Central

Quint, Jennifer K; Müllerova, Hana; DiSantostefano, Rachael L; Forbes, Harriet; Eaton, Susan; Hurst, John R; Davis, Kourtney; Smeeth, Liam

2014-01-01

Objectives The optimal method of identifying people with chronic obstructive pulmonary disease (COPD) from electronic primary care records is not known. We assessed the accuracy of different approaches using the Clinical Practice Research Datalink, a UK electronic health record database. Setting 951 participants registered with a CPRD practice in the UK between 1 January 2004 and 31 December 2012. Individuals were selected for ≥1 of 8 algorithms to identify people with COPD. General practitioners were sent a brief questionnaire and additional evidence to support a COPD diagnosis was requested. All information received was reviewed independently by two respiratory physicians whose opinion was taken as the gold standard. Primary outcome measure The primary measure of accuracy was the positive predictive value (PPV), the proportion of people identified by each algorithm for whom COPD was confirmed. Results 951 questionnaires were sent and 738 (78%) returned. After quality control, 696 (73.2%) patients were included in the final analysis. All four algorithms including a specific COPD diagnostic code performed well. Using a diagnostic code alone, the PPV was 86.5% (77.5–92.3%) while requiring a diagnosis plus spirometry plus specific medication; the PPV was slightly higher at 89.4% (80.7–94.5%) but reduced case numbers by 10%. Algorithms without specific diagnostic codes had low PPVs (range 12.2–44.4%). Conclusions Patients with COPD can be accurately identified from UK primary care records using specific diagnostic codes. Requiring spirometry or COPD medications only marginally improved accuracy. The high accuracy applies since the introduction of an incentivised disease register for COPD as part of Quality and Outcomes Framework in 2004. PMID:25056980

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.

The impact of persistence with bisphosphonates on health resource utilization and fracture risk in the UK: a study of patient records from the UK Clinical Practice Research Datalink.

PubMed

Ferguson, Samara; Feudjo Tepie, Maurille; Taylor, Andrew; Roddam, Andrew; Critchlow, Cathy; Iqbal, Mazhar; Spangler, Leslie; Bayly, Jonathan

2016-02-01

Clinical trial data suggest that patients who have received bisphosphonates continue to benefit from them after discontinuation. However, data from real-world clinical practice are inconclusive. We assessed the impact of persistence and discontinuation on health resource utilization (HRU) and fracture rate in women who were prescribed oral bisphosphonates. The study used data from the UK Clinical Practice Research Datalink. Women aged 50 years or older with a first prescription of oral bisphosphonate therapy between January 2000 and December 2007 were included. Multivariate modelling compared rate ratios for fracture and HRU between patients who had discontinued medication (shorter persistence group) and patients who took their medication for longer (longer persistence group). The interactions of elapsed time (measured as 6-month intervals) with HRU and with fracture rate for all patients within paired groups were also assessed. Overall, 36 320 patients were included. Pairwise comparisons showed that HRU and fracture rates were lower in longer persistence groups than in shorter persistence groups. Analysis by 6-month interval showed that, across all patients in persistence group pairs, HRU significantly increased for each additional 6 months elapsed; trends towards increased risk of fracture were also seen. In contrast to results from clinical trials, in this patient population the protective effect of oral bisphosphonates after discontinuation was not sufficient to reduce HRU and fracture rates to the levels that would be seen if patients had continued on therapy. Reducing the rate of treatment discontinuation may decrease the burden that osteoporosis places on both patients and health care systems. © 2015 AMGEN Inc. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Can commonly prescribed drugs be repurposed for the prevention or treatment of Alzheimer's and other neurodegenerative diseases? Protocol for an observational cohort study in the UK Clinical Practice Research Datalink.

PubMed

Walker, Venexia M; Davies, Neil M; Jones, Tim; Kehoe, Patrick G; Martin, Richard M

2016-12-13

Current treatments for Alzheimer's and other neurodegenerative diseases have only limited effectiveness meaning that there is an urgent need for new medications that could influence disease incidence and progression. We will investigate the potential of a selection of commonly prescribed drugs, as a more efficient and cost-effective method of identifying new drugs for the prevention or treatment of Alzheimer's disease, non-Alzheimer's disease dementias, Parkinson's disease and amyotrophic lateral sclerosis. Our research will focus on drugs used for the treatment of hypertension, hypercholesterolaemia and type 2 diabetes, all of which have previously been identified as potentially cerebroprotective and have variable levels of preclinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. We will conduct a hypothesis testing observational cohort study using data from the Clinical Practice Research Datalink (CPRD). Our analysis will consider four statistical methods, which have different approaches for modelling confounding. These are multivariable adjusted Cox regression; propensity matched regression; instrumental variable analysis and marginal structural models. We will also use an intention-to-treat analysis, whereby we will define all exposures based on the first prescription observed in the database so that the target parameter is comparable to that estimated by a randomised controlled trial. This protocol has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will publish the results of the study as open-access peer-reviewed publications and disseminate findings through national and international conferences as are appropriate. 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/.

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…

Weather Information Communications (WINCOMM) Overview and Status

NASA Technical Reports Server (NTRS)

Martzaklis, K.

2003-01-01

The second annual project review of Weather Information Communications (WINCOMM) is presented. The topics of discussion include: 1) In-Flight Weather Information; 2) System Elements; 3) Technology Investment Areas; 4) NAS Information Exchange; 5) FIS Datalink Architecture Analyses; 6) Hybrid FIS Datalink Architecture; 7) FIS Datalink Architecture Analyses; 8) Air Transport: Ground and Satellite-based Datalinks; 9) General Aviation: Ground and Satellite-based Datalinks; 10) Low Altitude AutoMET Reporting; 11) AutoMET: Airborne-based Datalinks; 12) Network Protocols Development; and 13) FAA/NASA Collaboration. A summary of WINCOMM is also included. This paper is in viewgraph form.

Trivalent inactivated influenza vaccine is not associated with sickle cell crises in children.

PubMed

Hambidge, Simon J; Ross, Colleen; Glanz, Jason; McClure, David; Daley, Matthew F; Xu, Stan; Shoup, Jo Ann; Narwaney, Komal; Baggs, James; Weintraub, Eric

2012-01-01

Children with sickle cell disease are considered at high risk for complications from influenza infection and are recommended to receive annual influenza vaccination. However, data on the safety of influenza vaccination in children with sickle cell anemia are sparse. Using a retrospective cohort of children aged 6 months to 17 years in 8 managed care organizations that comprise the Vaccine Safety Datalink and who had a diagnosis of sickle cell anemia from 1999 to 2006, we conducted matched case-control and self-controlled case series studies to examine the association of trivalent inactivated influenza vaccination with hospitalization for sickle cell crisis in the 2 weeks after vaccination. From an original pool of 1085 pediatric subjects with a diagnosis of sickle cell anemia, we identified 179 children with at least 1 sickle cell crisis during any influenza season (October 1-March 31). In the matched case-control study (matching on age category, gender, Vaccine Safety Datalink site, and season), the odds ratio of hospitalization for a crisis in vaccinated compared with unvaccinated children was not significant: 1.3 (95% confidence interval 0.8-2.2). In the self-controlled case series study of hospitalized cases, the incident rate ratio for hospitalization with sickle cell crisis in the 2 weeks after trivalent inactivated influenza vaccination was also not significant: 1.2 (95% confidence interval 0.75-1.95). This large cohort study did not find an association of influenza vaccination and hospitalization for sickle cell crises in children with sickle cell anemia.

An error-resistant linguistic protocol for air traffic control

NASA Technical Reports Server (NTRS)

Cushing, Steven

1989-01-01

The research results described here are intended to enhance the effectiveness of the DATALINK interface that is scheduled by the Federal Aviation Administration (FAA) to be deployed during the 1990's to improve the safety of various aspects of aviation. While voice has a natural appeal as the preferred means of communication both among humans themselves and between humans and machines as the form of communication that people find most convenient, the complexity and flexibility of natural language are problematic, because of the confusions and misunderstandings that can arise as a result of ambiguity, unclear reference, intonation peculiarities, implicit inference, and presupposition. The DATALINK interface will avoid many of these problems by replacing voice with vision and speech with written instructions. This report describes results achieved to date on an on-going research effort to refine the protocol of the DATALINK system so as to avoid many of the linguistic problems that still remain in the visual mode. In particular, a working prototype DATALINK simulator system has been developed consisting of an unambiguous, context-free grammar and parser, based on the current air-traffic-control language and incorporated into a visual display involving simulated touch-screen buttons and three levels of menu screens. The system is written in the C programming language and runs on the Macintosh II computer. After reviewing work already done on the project, new tasks for further development are described.

Use of demographic and pharmacy data to identify patients included within both the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN).

PubMed

Carbonari, Dena M; Saine, M Elle; Newcomb, Craig W; Blak, Betina; Roy, Jason A; Haynes, Kevin; Wood, Jennifer; Gallagher, Arlene M; Bhullar, Harshvinder; Cardillo, Serena; Hennessy, Sean; Strom, Brian L; Lo Re, Vincent

2015-09-01

Pharmacoepidemiology researchers often utilize data from two UK electronic medical record databases, the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN), and may choose to combine the two in an effort to increase sample size. To minimize duplication of data, previous studies examined the practice-level overlap between these databases. However, the proportion of overlapping patients remains unknown. We developed a method using demographic and pharmacy variables to identify patients included in both CPRD and THIN, and applied this method to measure the proportion of overlapping patients who initiated the oral anti-diabetic drug saxagliptin. We conducted a cross-sectional study among patients initiating saxagliptin in CPRD and THIN between October 2009 and September 2012. Within both databases, we identified patients: (i) ≥18 years, (ii) newly prescribed saxagliptin, and (iii) with ≥180 days enrollment prior to saxagliptin initiation. Demographic data (birth year, sex, patient registration date, family number, and marital status) and prescriptions (including dates) for the first two oral anti-diabetic drugs prescribed within the study period were used to identify matching patients. Among 4202 CPRD and 3641 THIN patients initiating saxagliptin, 2574 overlapping patients (61% of CPRD saxagliptin initiators; 71% of THIN saxagliptin initiators) were identified. Among these patients, 2474 patients (96%) perfectly matched on all demographic and prescription data. Within each database, over 60% of patients initiating saxagliptin were included within both CPRD and THIN. Combined demographic and prescription data can be used to identify patients included in both CPRD and THIN. Copyright © 2015 John Wiley & Sons, Ltd.

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.

Ischaemic cardiac events and use of strontium ranelate in postmenopausal osteoporosis: a nested case-control study in the CPRD.

PubMed

Cooper, C; Fox, K M; Borer, J S

2014-02-01

We explored the cardiac safety of the osteoporosis treatment strontium ranelate in the UK Clinical Practice Research Datalink. While known cardiovascular risk factors like obesity and smoking were associated with increased cardiac risk, use of strontium ranelate was not associated with any increase in myocardial infarction or cardiovascular death. It has been suggested that strontium ranelate may increase risk for cardiac events in postmenopausal osteoporosis. We set out to explore the cardiac safety of strontium ranelate in the Clinical Practice Research Datalink (CPRD) and linked datasets. We performed a nested case-control study. Primary outcomes were first definite myocardial infarction, hospitalisation with myocardial infarction, and cardiovascular death. Cases and matched controls were nested in a cohort of women treated for osteoporosis. The association with exposure to strontium ranelate was analysed by multivariate conditional logistic regression. Of the 112,445 women with treated postmenopausal osteoporosis, 6,487 received strontium ranelate. Annual incidence rates for first definite myocardial infarction (1,352 cases), myocardial infarction with hospitalisation (1,465 cases), and cardiovascular death (3,619 cases) were 3.24, 6.13, and 14.66 per 1,000 patient-years, respectively. Obesity, smoking, and cardiovascular treatments were associated with significant increases in risk for cardiac events. Current or past use of strontium ranelate was not associated with increased risk for first definite myocardial infarction (odds ratio [OR] 1.05, 95 % confidence interval [CI] 0.68-1.61 and OR 1.12, 95 % CI 0.79-1.58, respectively), hospitalisation with myocardial infarction (OR 0.84, 95 % CI 0.54-1.30 and OR 1.17, 95 % CI 0.83-1.66), or cardiovascular death (OR 0.96, 95 % CI 0.76-1.21 and OR 1.16, 95 % CI 0.94-1.43) versus patients who had never used strontium ranelate. Analysis in the CPRD did not find evidence for a higher risk for cardiac events associated

Interval between onset of psoriasis and psoriatic arthritis comparing the UK Clinical Practice Research Datalink with a hospital-based cohort.

PubMed

Tillett, William; Charlton, Rachel; Nightingale, Alison; Snowball, Julia; Green, Amelia; Smith, Catherine; Shaddick, Gavin; McHugh, Neil

2017-12-01

To describe the time interval between the onset of psoriasis and PsA in the UK primary care setting and compare with a large, well-classified secondary care cohort. Patients with PsA and/or psoriasis were identified in the UK Clinical Practice Research Datalink (CPRD). The secondary care cohort comprised patients from the Bath PsA longitudinal observational cohort study. For incident PsA patients in the CPRD who also had a record of psoriasis, the time interval between PsA diagnosis and first psoriasis record was calculated. Comparisons were made with the time interval between diagnoses in the Bath cohort. There were 5272 eligible PsA patients in the CPRD and 815 in the Bath cohort. In both cohorts, the majority of patients (82.3 and 61.3%, respectively) had psoriasis before their PsA diagnosis or within the same calendar year (10.5 and 23.8%), with only a minority receiving their PsA diagnosis first (7.1 and 14.8%). Excluding those who presented with arthritis before psoriasis, the median time between diagnoses was 8 years [interquartile range (IQR) 2-15] in the CPRD and 7 years (IQR 0-20) in the Bath cohort. In the CPRD, 60.1 and 75.1% received their PsA diagnosis within 10 and 15 years of their psoriasis diagnosis, respectively; this was comparable with 57.2 and 67.7% in the Bath cohort. A similar distribution for the time interval between psoriasis and arthritis was observed in the CPRD and secondary care cohort. These data can inform screening strategies and support the validity of data from each cohort. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Understanding the health economic burden of patients with tuberous sclerosis complex (TSC) with epilepsy: a retrospective cohort study in the UK Clinical Practice Research Datalink (CPRD).

PubMed

Shepherd, Charles; Koepp, Matthias; Myland, Melissa; Patel, Keyur; Miglio, Cristiana; Siva, Vathani; Gray, Elizabeth; Neary, Maureen

2017-10-05

Epilepsy is highly prevalent in tuberous sclerosis complex (TSC), a multi-system genetic disorder. The clinical and economic burden of this condition is expected to be substantial due to treatment challenges, debilitating co-morbidities and the relationship between TSC-related manifestations. This study estimated healthcare resource utilisation (HCRU) and costs for patients with TSC with epilepsy (TSC+E) in the UK. Patients with TSC+E in the Clinical Practice Research Datalink (CPRD) linked to Hospital Episodes Statistics were identified from April 1997 to March 2012. Clinical data were extracted over the entire history, and costs were reported over the most recent 3-year period. HCRU was compared with a matched Comparator cohort, and the key cost drivers were identified by regression modelling. In total, 209 patients with TSC+E were identified, of which 40% recorded ≥2 other primary organ system manifestations and 42% had learning disability. Treatment with ≥2 concomitant antiepileptic drugs (AEDs) was prevalent (60%), potentially suggesting refractory epilepsy. Notwithstanding, many patients with TSC+E (12%) had no record of AED use in their entire history, which may indicate undertreatment for these patients.Brain surgery was recorded in 12% of patients. Routine electroencephalography and MRI were infrequently performed (30% of patients), yet general practitioner visits, hospitalisations and outpatient visits were more frequent in patients with TSC+E than the Comparator. This translated to threefold higher clinical costs (£14 335 vs £4448), which significantly increased with each additional primary manifestation (p<0.0001). Patients with TSC+E have increased HCRU compared with the general CPRD population, likely related to manifestations in several organ systems, substantial cognitive impairment and severe epilepsy, which is challenging to treat and may be intractable. Disease surveillance and testing appears to be inadequate with few treatments

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.

Vaccine adverse events in a safety net healthcare system and a managed care organization.

PubMed

Narwaney, Komal J; Breslin, Kristin; Ross, Colleen A; Shoup, Jo Ann; Wain, Kris F; Weintraub, Eric S; McNeil, Michael M; Hambidge, Simon J

2017-03-01

The Institute of Medicine, in a 2013 report, recommended that the Vaccine Safety Datalink (VSD) expand collaborations to include more diversity in the study population. Kaiser Permanente Colorado (KPCO), an established VSD site, partnered with Denver Health (DH), an integrated safety net healthcare system, to demonstrate the feasibility of integrating DH data within the VSD. Prior to incorporating the data, we examined the identification of specific vaccine associated adverse events (VAEs) in these two distinct healthcare systems. We conducted retrospective cohort analyses within KPCO and DH to compare select VAEs between the two populations. We examined the following associations between January 1, 2004 and December 31, 2013: Measles, Mumps, and Rubella (MMR) vaccine and febrile seizures in children 2years and younger, intussusception after rotavirus vaccine in infants 4-34weeks, syncope after adolescent vaccines (Tetanus, Diphtheria, acellular Pertussis; Meningococcal and Human Papillomavirus) in adolescents 13-17years and medically attended local reactions after pneumococcal polysaccharide (PPSV23) vaccine in adults 65years and older. Both sites used similar data procurement methods and chart review processes. For seizures after MMR vaccine (KPCO - 3.15vs. DH - 2.97/10,000 doses) and syncope after all adolescent vaccines (KPCO - 3.0vs. DH - 2.37/10,000 doses), the chart confirmed rates were comparable at the two sites. However, for medically attended local reactions after PPSV23, there were differences in chart confirmed rates between the sites (KPCO - 31.65vs. DH - 14.90/10,000 doses). For intussusception after rotavirus vaccine, the number of cases was too low to make a valid comparison (KPCO - 0vs. DH - 0.13/10,000 doses). We demonstrated that data on important targeted VAEs can be captured at DH and rates appear similar to those at KPCO. Work is ongoing on the optimal approach to assimilate DH data as a potential safety net healthcare system in the VSD

Diagnosis and treatment of chlamydia and gonorrhoea in general practice in England 2000-2011: a population-based study using data from the UK Clinical Practice Research Datalink.

PubMed

Wetten, Sally; Mohammed, Hamish; Yung, Mandy; Mercer, Catherine H; Cassell, Jackie A; Hughes, Gwenda

2015-04-22

To determine the relative contribution of general practices (GPs) to the diagnosis of chlamydia and gonorrhoea in England and whether treatment complied with national guidelines. Analysis of longitudinal electronic health records in the Clinical Practice Research Datalink (CPRD) and national sexually transmitted infection (STI) surveillance databases, England, 2000-2011. GPs, and community and specialist STI services. Patients diagnosed with chlamydia (n=1,386,169) and gonorrhoea (n=232,720) at CPRD GPs, and community and specialist STI Services from 2000-2011. Numbers and rates of chlamydia and gonorrhoea diagnoses; percentages of patients diagnosed by GPs relative to other services; percentage of GP patients treated and antimicrobials used; percentage of GP patients referred. The diagnosis rate (95% CI) per 100,000 population of chlamydia in GP increased from 22.8 (22.4-23.2) in 2000 to 29.3 (28.8-29.7) in 2011 (p<0.001), while the proportion treated increased from 59.5% to 78.4% (p=0.001). Over 90% were prescribed a recommended antimicrobial. Over the same period, the diagnosis rate (95% CI) per 100,000 population of gonorrhoea in GP ranged between 3.2 (3-3.3) and 2.4 (2.2-2.5; p=0.607), and the proportion treated ranged between 32.7% and 53.6% (p=0.262). Despite being discontinued as a recommended therapy for gonorrhoea in 2005, ciprofloxacin accounted for 42% of prescriptions in 2007 and 20% in 2011. Over the study period, GPs diagnosed between 9% and 16% of chlamydia cases and between 6% and 9% of gonorrhoea cases in England. GP makes an important contribution to the diagnosis and treatment of bacterial STIs in England. While most patients diagnosed with chlamydia were managed appropriately, many of those treated for gonorrhoea received antimicrobials no longer recommended for use. Given the global threat of antimicrobial resistance, GPs should remain abreast of national treatment guidelines and alert to treatment failure in their patients. Published by the

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...

Does Angiotensin-Converting Enzyme Inhibitor and β-Blocker Use Reduce the Risk of Primary Liver Cancer? A Case-Control Study Using the U.K. Clinical Practice Research Datalink.

PubMed

Hagberg, Katrina Wilcox; Sahasrabuddhe, Vikrant V; McGlynn, Katherine A; Jick, Susan S

2016-02-01

It has been suggested that use of the antihypertensive drugs angiotensin-converting enzyme (ACE) inhibitors and β-blockers may decrease the risk of primary liver cancer; thus, the objective of this study was to evaluate whether use of ACE inhibitors and/or β-blockers is associated with a lower risk of liver cancer. Nested case-control study. United Kingdom Clinical Practice Research Datalink. We identified 490 cases with hypertension and a first-time (incident) diagnosis of primary liver cancer between 1988 and 2011. To account for an induction period, the index date was defined as the date of the first recorded liver cancer diagnosis minus 1 year. Controls were selected from patients with hypertension in the CPRD during the study period with a recorded diagnosis of hypertension who had no diagnosis of liver cancer and were free of any other cancer (except nonmelanoma skin cancer) before the index date; they were matched up to a 4:1 ratio to cases based on index date (same index date as that of their matched case), age (same year of birth), sex, general practice, and number of years of recorded history in the CPRD before the index date (1909 controls). Both cases and controls were required to have at least 2 years of recorded activity in the database before the index date. Exposure was defined as receipt of two or more prescriptions for ACE inhibitors and/or β-blockers before the index date; the reference group was nonuse (0-1 prescription) of ACE or β-blocker prescriptions before the index date. We also examined the effect of duration of use and, separately, the effect of individual drugs within each medication class on risk of liver cancer, and conducted analyses restricted to patients without liver disease or diabetes mellitus. Conditional logistic regression analysis was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). No association was found between use of ACE inhibitors and/or β-blockers and the risk of liver cancer compared

Support of Helicopter 'Free Flight' Operations in the 1996 Olympics

NASA Technical Reports Server (NTRS)

Branstetter, James R.; Cooper, Eric G.

1996-01-01

The microcosm of activity surrounding the 1996 Olympic Games provided researchers an opportunity for demonstrating state-of-the art technology in the first large-scale deployment of a prototype digital communication/navigation/surveillance system in a confined environment. At the same time it provided an ideal opportunity for transportation officials to showcase the merits of an integrated transportation system in meeting the operational needs to transport time sensitive goods and provide public safety services under real-world conditions. Five aeronautical CNS functions using a digital datalink system were chosen for operational flight testing onboard 91 aircraft, most of them helicopters, participating in the Atlanta Short-Haul Transportation System. These included: GPS-based Automatic Dependent Surveillance, Cockpit Display of Traffic Information, Controller-Pilot Communications, Graphical Weather Information (uplink), and Automated Electronic Pilot Reporting (downlink). Atlanta provided the first opportunity to demonstrate, in an actual operating environment, key datalink functions which would enhance flight safety and situational awareness for the pilot and supplement conventional air traffic control. The knowledge gained from such a large-scale deployment will help system designers in development of a national infrastructure where aircraft would have the ability to navigate autonomously.

Supplementing electronic health records through sample collection and patient diaries: A study set within a primary care research database.

PubMed

Joseph, Rebecca M; Soames, Jamie; Wright, Mark; Sultana, Kirin; van Staa, Tjeerd P; Dixon, William G

2018-02-01

To describe a novel observational study that supplemented primary care electronic health record (EHR) data with sample collection and patient diaries. The study was set in primary care in England. A list of 3974 potentially eligible patients was compiled using data from the Clinical Practice Research Datalink. Interested general practices opted into the study then confirmed patient suitability and sent out postal invitations. Participants completed a drug-use diary and provided saliva samples to the research team to combine with EHR data. Of 252 practices contacted to participate, 66 (26%) mailed invitations to patients. Of the 3974 potentially eligible patients, 859 (22%) were at participating practices, and 526 (13%) were sent invitations. Of those invited, 117 (22%) consented to participate of whom 86 (74%) completed the study. We have confirmed the feasibility of supplementing EHR with data collected directly from patients. Although the present study successfully collected essential data from patients, it also underlined the requirement for improved engagement with both patients and general practitioners to support similar studies. © 2017 The Authors. Pharmacoepidemiology & Drug Safety published by John Wiley & Sons Ltd.

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

Diagnosis and treatment of chlamydia and gonorrhoea in general practice in England 2000–2011: a population-based study using data from the UK Clinical Practice Research Datalink

PubMed Central

Wetten, Sally; Mohammed, Hamish; Yung, Mandy; Mercer, Catherine H; Cassell, Jackie A; Hughes, Gwenda

2015-01-01

Objectives To determine the relative contribution of general practices (GPs) to the diagnosis of chlamydia and gonorrhoea in England and whether treatment complied with national guidelines. Design Analysis of longitudinal electronic health records in the Clinical Practice Research Datalink (CPRD) and national sexually transmitted infection (STI) surveillance databases, England, 2000–2011. Setting GPs, and community and specialist STI services. Participants Patients diagnosed with chlamydia (n=1 386 169) and gonorrhoea (n=232 720) at CPRD GPs, and community and specialist STI Services from 2000–2011. Main outcome measures Numbers and rates of chlamydia and gonorrhoea diagnoses; percentages of patients diagnosed by GPs relative to other services; percentage of GP patients treated and antimicrobials used; percentage of GP patients referred. Results The diagnosis rate (95% CI) per 100 000 population of chlamydia in GP increased from 22.8 (22.4–23.2) in 2000 to 29.3 (28.8–29.7) in 2011 (p<0.001), while the proportion treated increased from 59.5% to 78.4% (p=0.001). Over 90% were prescribed a recommended antimicrobial. Over the same period, the diagnosis rate (95% CI) per 100 000 population of gonorrhoea in GP ranged between 3.2 (3–3.3) and 2.4 (2.2–2.5; p=0.607), and the proportion treated ranged between 32.7% and 53.6% (p=0.262). Despite being discontinued as a recommended therapy for gonorrhoea in 2005, ciprofloxacin accounted for 42% of prescriptions in 2007 and 20% in 2011. Over the study period, GPs diagnosed between 9% and 16% of chlamydia cases and between 6% and 9% of gonorrhoea cases in England. Conclusions GP makes an important contribution to the diagnosis and treatment of bacterial STIs in England. While most patients diagnosed with chlamydia were managed appropriately, many of those treated for gonorrhoea received antimicrobials no longer recommended for use. Given the global threat of antimicrobial resistance, GPs should remain

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...

Proceedings of the Fifth Integrated Communications, Navigation, and Surveillance (ICNS) Conference and Workshop

NASA Technical Reports Server (NTRS)

Fujikawa, Gene (Compiler)

2005-01-01

Contents includes papers on the following: JPDO: Inter-Agency Cooperation for the Next Generation ATS; R&T Programs; Integrated CNS Systems and Architectures; Datalink Communication Systems; Navigation, System Demonstrations and Operations; Safety and Security Initiatives Impacting CNS; Global Communications Initiatives; Airborne Internet; Avionics for System-Level Enhancements; SWIM (System Wide Information Management); Weather Products and Data Dissemination Technologies; Airsapce Communication Networks; Surveillance Systems; Workshop Breakouts Sessions and ; ICNS Conference Information.

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.

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…

The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES)

PubMed Central

Samnaliev, Mihail; Kuo, Tzu-Chun; Ni Choitir, Caitriona; Tierney, Travis S; Cumming, David; Manca, Andrea; Taylor, Rod S; Eldabe, Sam

2017-01-01

Objective To characterise incidence and healthcare costs associated with persistent postoperative pain (PPP) following lumbar surgery. Design Retrospective, population-based cohort study. Setting Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases. Participants Population-based cohort of 10 216 adults who underwent lumbar surgery in England from 1997/1998 through 2011/2012 and had at least 1 year of presurgery data and 2 years of postoperative follow-up data in the linked CPRD–HES. Primary and secondary outcomes measures Incidence and total healthcare costs over 2, 5 and 10 years attributable to persistent PPP following initial lumbar surgery. Results The rate of individuals undergoing lumbar surgery in the CPRD–HES linked data doubled over the 15-year study period, fiscal years 1997/1998 to 2011/2012, from 2.5 to 4.9 per 10 000 adults. Over the most recent 5-year period (2007/2008 to 2011/2012), on average 20.8% (95% CI 19.7% to 21.9%) of lumbar surgery patients met criteria for PPP. Rates of healthcare usage were significantly higher for patients with PPP across all types of care. Over 2 years following initial spine surgery, the mean cost difference between patients with and without PPP was £5383 (95% CI £4872 to £5916). Over 5 and 10 years following initial spine surgery, the mean cost difference between patients with and without PPP increased to £10 195 (95% CI £8726 to £11 669) and £14 318 (95% CI £8386 to £19 771), respectively. Extrapolated to the UK population, we estimate that nearly 5000 adults experience PPP after spine surgery annually, with each new cohort costing the UK National Health Service in excess of £70 million over the first 10 years alone. Conclusions Persistent pain affects more than one-in-five lumbar surgery patients and accounts for substantial long-term healthcare costs. There is a need for formal, evidence-based guidelines for a coherent, coordinated management

The incidence and healthcare costs of persistent postoperative pain following lumbar spine surgery in the UK: a cohort study using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES).

PubMed

Weir, Sharada; Samnaliev, Mihail; Kuo, Tzu-Chun; Ni Choitir, Caitriona; Tierney, Travis S; Cumming, David; Bruce, Julie; Manca, Andrea; Taylor, Rod S; Eldabe, Sam

2017-09-11

To characterise incidence and healthcare costs associated with persistent postoperative pain (PPP) following lumbar surgery. Retrospective, population-based cohort study. Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases. Population-based cohort of 10 216 adults who underwent lumbar surgery in England from 1997/1998 through 2011/2012 and had at least 1 year of presurgery data and 2 years of postoperative follow-up data in the linked CPRD-HES. Incidence and total healthcare costs over 2, 5 and 10 years attributable to persistent PPP following initial lumbar surgery. The rate of individuals undergoing lumbar surgery in the CPRD-HES linked data doubled over the 15-year study period, fiscal years 1997/1998 to 2011/2012, from 2.5 to 4.9 per 10 000 adults. Over the most recent 5-year period (2007/2008 to 2011/2012), on average 20.8% (95% CI 19.7% to 21.9%) of lumbar surgery patients met criteria for PPP. Rates of healthcare usage were significantly higher for patients with PPP across all types of care. Over 2 years following initial spine surgery, the mean cost difference between patients with and without PPP was £5383 (95% CI £4872 to £5916). Over 5 and 10 years following initial spine surgery, the mean cost difference between patients with and without PPP increased to £10 195 (95% CI £8726 to £11 669) and £14 318 (95% CI £8386 to £19 771), respectively. Extrapolated to the UK population, we estimate that nearly 5000 adults experience PPP after spine surgery annually, with each new cohort costing the UK National Health Service in excess of £70 million over the first 10 years alone. Persistent pain affects more than one-in-five lumbar surgery patients and accounts for substantial long-term healthcare costs. There is a need for formal, evidence-based guidelines for a coherent, coordinated management strategy for patients with continuing pain after lumbar surgery. © Article author(s) (or their employer

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...

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

Modelling Conditions and Health Care Processes in Electronic Health Records: An Application to Severe Mental Illness with the Clinical Practice Research Datalink.

PubMed

Olier, Ivan; Springate, David A; Ashcroft, Darren M; Doran, Tim; Reeves, David; Planner, Claire; Reilly, Siobhan; Kontopantelis, Evangelos

2016-01-01

The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists.

Modelling Conditions and Health Care Processes in Electronic Health Records: An Application to Severe Mental Illness with the Clinical Practice Research Datalink

PubMed Central

Olier, Ivan; Springate, David A.; Ashcroft, Darren M.; Doran, Tim; Reeves, David; Planner, Claire; Reilly, Siobhan; Kontopantelis, Evangelos

2016-01-01

Background The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. Methods We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. Results We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. Conclusion We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists. PMID:26918439

Cockpit display of hazardous wind shear information

NASA Technical Reports Server (NTRS)

Wanke, Craig; Hansman, R. John, Jr.

1990-01-01

Information on cockpit display of wind shear information is given in viewgraph form. Based on the current status of windshear sensors and candidate data dissemination systems, the near-term capabilities for windshear avoidance will most likely include: (1) Ground-based detection: TDWR (Terminal Doppler Weather Radar), LLWAS (Low-Level Windshear Alert System), Automated PIREPS; (2) Ground-Air datalinks: Air traffic control voice channels, Mode-S digital datalink, ACARS alphanumeric datalink. The possible datapaths for integration of these systems are illustrated in a diagram. In the future, airborne windshear detection systems such as lidars, passive IR detectors, or airborne Doppler radars may also become available. Possible future datalinks include satellite downlink and specialized en route weather channels.

Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

PubMed

Bergman, Lina M; Pettersson, Monica E; Chaboyer, Wendy P; Carlström, Eric D; Ringdal, Mona L

2017-10-01

To identify, classify, and describe safety hazards during the process of intrahospital transport of critically ill patients. A prospective observational study. Data from participant observations of the intrahospital transport process were collected over a period of 3 months. The study was undertaken at two ICUs in one university hospital. Critically ill patients transported within the hospital by critical care nurses, unlicensed nurses, and physicians. None. Content analysis was performed using deductive and inductive approaches. We detected a total of 365 safety hazards (median, 7; interquartile range, 4-10) during 51 intrahospital transports of critically ill patients, 80% of whom were mechanically ventilated. The majority of detected safety hazards were assessed as increasing the risk of harm, compromising patient safety (n = 204). Using the System Engineering Initiative for Patient Safety, we identified safety hazards related to the work system, as follows: team (n = 61), tasks (n = 83), tools and technologies (n = 124), environment (n = 48), and organization (n = 49). Inductive analysis provided an in-depth description of those safety hazards, contributing factors, and process-related outcomes. Findings suggest that intrahospital transport is a hazardous process for critically ill patients. We have identified several factors that may contribute to transport-related adverse events, which will provide the opportunity for the redesign of systems to enhance patient safety.

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.

77 FR 4048 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

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

76 FR 52330 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

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

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... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or..., Number 177, Pages 56235-56236. Contact Person for More Information: Price Connor, Ph.D., NIOSH Health...

77 FR 51810 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

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2012-08-27

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

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).

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.

77 FR 27776 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

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

76 FR 18220 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

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

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.

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...

Technological advances for studying human behavior

NASA Technical Reports Server (NTRS)

Roske-Hofstrand, Renate J.

1990-01-01

Technological advances for studying human behavior are noted in viewgraph form. It is asserted that performance-aiding systems are proliferating without a fundamental understanding of how they would interact with the humans who must control them. Two views of automation research, the hardware view and the human-centered view, are listed. Other viewgraphs give information on vital elements for human-centered research, a continuum of the research process, available technologies, new technologies for persistent problems, a sample research infrastructure, the need for metrics, and examples of data-link technology.

Aerospace Communications Security Technologies Demonstrated

NASA Technical Reports Server (NTRS)

Griner, James H.; Martzaklis, Konstantinos S.

2003-01-01

In light of the events of September 11, 2001, NASA senior management requested an investigation of technologies and concepts to enhance aviation security. The investigation was to focus on near-term technologies that could be demonstrated within 90 days and implemented in less than 2 years. In response to this request, an internal NASA Glenn Research Center Communications, Navigation, and Surveillance Aviation Security Tiger Team was assembled. The 2-year plan developed by the team included an investigation of multiple aviation security concepts, multiple aircraft platforms, and extensively leveraged datalink communications technologies. It incorporated industry partners from NASA's Graphical Weather-in-the-Cockpit research, which is within NASA's Aviation Safety Program. Two concepts from the plan were selected for demonstration: remote "black box," and cockpit/cabin surveillance. The remote "black box" concept involves real-time downlinking of aircraft parameters for remote monitoring and archiving of aircraft data, which would assure access to the data following the loss or inaccessibility of an aircraft. The cockpit/cabin surveillance concept involves remote audio and/or visual surveillance of cockpit and cabin activity, which would allow immediate response to any security breach and would serve as a possible deterrent to such breaches. The datalink selected for the demonstrations was VDL Mode 2 (VHF digital link), the first digital datalink for air-ground communications designed for aircraft use. VDL Mode 2 is beginning to be implemented through the deployment of ground stations and aircraft avionics installations, with the goal of being operational in 2 years. The first demonstration was performed December 3, 2001, onboard the LearJet 25 at Glenn. NASA worked with Honeywell, Inc., for the broadcast VDL Mode 2 datalink capability and with actual Boeing 757 aircraft data. This demonstration used a cockpitmounted camera for video surveillance and a coupling to

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 Alerts: An Observational Study in Portugal.

PubMed

Soares, Sara; Roque, Fátima; Teixeira Rodrigues, António; Figueiras, Adolfo; Herdeiro, Maria Teresa

2015-09-01

The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

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

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.

Evaluation of methods to estimate missing days' supply within pharmacy data of the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN).

PubMed

Lum, Kirsten J; Newcomb, Craig W; Roy, Jason A; Carbonari, Dena M; Saine, M Elle; Cardillo, Serena; Bhullar, Harshvinder; Gallagher, Arlene M; Lo Re, Vincent

2017-01-01

The extent to which days' supply data are missing in pharmacoepidemiologic databases and effective methods for estimation is unknown. We determined the percentage of missing days' supply on prescription and patient levels for oral anti-diabetic drugs (OADs) and evaluated three methods for estimating days' supply within the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN). We estimated the percentage of OAD prescriptions and patients with missing days' supply in each database from 2009 to 2013. Within a random sample of prescriptions with known days' supply, we measured the accuracy of three methods to estimate missing days' supply by imputing the following: (1) 28 days' supply, (2) mode number of tablets/day by drug strength and number of tablets/prescription, and (3) number of tablets/day via a machine learning algorithm. We determined incidence rates (IRs) of acute myocardial infarction (AMI) using each method to evaluate the impact on ascertainment of exposure time and outcomes. Days' supply was missing for 24 % of OAD prescriptions in CPRD and 33 % in THIN (affecting 48 and 57 % of patients, respectively). Methods 2 and 3 were very accurate in estimating days' supply for OADs prescribed at a consistent number of tablets/day. Method 3 was more accurate for OADs prescribed at varying number of tablets/day. IRs of AMI were similar across methods for most OADs. Missing days' supply is a substantial problem in both databases. Method 2 is easy and very accurate for most OADs and results in IRs comparable to those from method 3.

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.

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…

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.

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 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

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

ITS data management system : year one activities

DOT National Transportation Integrated Search

1997-08-01

This report documents research conducted in the development of an ITS data management system, hereafter referred to as ITS DataLink. The objective of the ITS DataLink system is to retain, manage, share, and analyze ITS data for a variety of tra...

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…

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 :...

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.

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.

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.

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.

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

Pre-Departure Clearance (PDC): An Analysis of Aviation Safety Reporting System Reports Concerning PDC Related Errors

NASA Technical Reports Server (NTRS)

Montalyo, Michael L.; Lebacqz, J. Victor (Technical Monitor)

1994-01-01

Airlines operating in the United States are required to operate under instrument flight rules (EFR). Typically, a clearance is issued via voice transmission from clearance delivery at the departing airport. In 1990, the Federal Aviation Administration (FAA) began deployment of the Pre-Departure Clearance (PDC) system at 30 U.S. airports. The PDC system utilizes aeronautical datalink and Aircraft Communication and Reporting System (ACARS) to transmit departure clearances directly to the pilot. An objective of the PDC system is to provide an immediate reduction in voice congestion over the clearance delivery frequency. Participating airports report that this objective has been met. However, preliminary analysis of 42 Aviation Safety Reporting System (ASRS) reports has revealed problems in PDC procedures and formatting which have caused errors in the proper execution of the clearance. It must be acknowledged that this technology, along with other advancements on the flightdeck, is adding more responsibility to the crew and increasing the opportunity for error. The present study uses these findings as a basis for further coding and analysis of an additional 82 reports obtained from an ASRS database search. These reports indicate that clearances are often amended or exceptions are added in order to accommodate local ATC facilities. However, the onboard ACARS is limited in its ability to emphasize or highlight these changes which has resulted in altitude and heading deviations along with increases in ATC workload. Furthermore, few participating airports require any type of PDC receipt confirmation. In fact, 35% of all ASRS reports dealing with PDC's include failure to acquire the PDC at all. Consequently, this study examines pilots' suggestions contained in ASRS reports in order to develop recommendations to airlines and ATC facilities to help reduce the amount of incidents that occur.

Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study.

PubMed

Donegan, Katherine; Owen, Rebecca; Bird, Helena; Burch, Brian; Smith, Alex; Tregunno, Phil

2018-05-03

Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform. Safety signals raised at the UK Medicines and Healthcare products Regulatory Agency (MHRA) between July 2014 and June 2015 were individually reviewed by a multi-disciplinary team. They assessed the feasibility of identifying the exposure and event of interest using primary care data from the Clinical Practice Research Datalink (CPRD) within the Commonwealth Vigilance Workbench (CVW) Longitudinal Module platform, which was designed to facilitate routine descriptive analysis of signals using EHR. Three signals, where exposure and event could be well identified, were retrospectively analysed using the platform. Of 69 unique new signals, 20 were for drugs prescribed predominately in secondary care or available without prescription, which would not be identified in primary care. A further 17 were brand, formulation, or dose-specific issues, were related to mortality, were relevant only to a subgroup of patients, or were drug interactions, and hence could not be reviewed using the platform given its limitations. Analyses of exposure and incidence of the adverse event could be produced using CPRD within the CMV Longitudinal Module for 32 (46%) signals. The case studies demonstrated that the data provided supporting evidence for confirming initial assessment of the signal and deciding upon the need for further action. CPRD can routinely provide useful early insights into clinical context when assessing a large proportion of safety

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).

Weather Information System

NASA Technical Reports Server (NTRS)

1995-01-01

WxLink is an aviation weather system based on advanced airborne sensors, precise positioning available from the satellite-based Global Positioning System, cockpit graphics and a low-cost datalink. It is a two-way system that uplinks weather information to the aircraft and downlinks automatic pilot reports of weather conditions aloft. Manufactured by ARNAV Systems, Inc., the original technology came from Langley Research Center's cockpit weather information system, CWIN (Cockpit Weather INformation). The system creates radar maps of storms, lightning and reports of surface observations, offering improved safety, better weather monitoring and substantial fuel savings.

Trajectory Specification for Automation of Terminal Air Traffic Control

NASA Technical Reports Server (NTRS)

Paielli, Russell A.

2016-01-01

"Trajectory specification" is the explicit bounding and control of aircraft tra- jectories such that the position at each point in time is constrained to a precisely defined volume of space. The bounding space is defined by cross-track, along-track, and vertical tolerances relative to a reference trajectory that specifies position as a function of time. The tolerances are dynamic and will be based on the aircraft nav- igation capabilities and the current traffic situation. A standard language will be developed to represent these specifications and to communicate them by datalink. Assuming conformance, trajectory specification can guarantee safe separation for an arbitrary period of time even in the event of an air traffic control (ATC) sys- tem or datalink failure, hence it can help to achieve the high level of safety and reliability needed for ATC automation. As a more proactive form of ATC, it can also maximize airspace capacity and reduce the reliance on tactical backup systems during normal operation. It applies to both enroute airspace and the terminal area around airports, but this paper focuses on arrival spacing in the terminal area and presents ATC algorithms and software for achieving a specified delay of runway arrival time.

Trajectory Specification for Terminal Air Traffic: Pairwise Conflict Detection and Resolution

NASA Technical Reports Server (NTRS)

Paielli, Russ; Erzberger, Heinz

2017-01-01

Trajectory specification is the explicit bounding and control of aircraft trajectories such that the position at each point in time is constrained to a precisely defined volume of space. The bounding space is defined by cross-track, along-track, and vertical tolerances relative to a reference trajectory that specifies position as a function of time. The tolerances are dynamic and will be based on the aircraft navigation capabilities and the current traffic situation. A standard language will be developed to represent these specifications and to communicate them by datalink. Assuming conformance, trajectory specification can guarantee safe separation for an arbitrary period of time even in the event of an air traffic control (ATC) system or datalink failure, hence it can help to achieve the high level of safety and reliability needed for ATC automation. As a more proactive form of ATC, it can also maximize airspace capacity and reduce the reliance on tactical backup systems during normal operation. It applies to both enroute airspace and the terminal area around airports, but this paper focuses on the terminal area and presents algorithms and software for spacing arrivals and deconflicting both arrivals and departures.

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...

The Effects of Safety Discrimination Training and Frequent Safety Observations on Safety-Related Behavior

ERIC Educational Resources Information Center

Taylor, Matthew A.; Alvero, Alicia M.

2012-01-01

The intent of the present study was to assess the effects of discrimination training only and in combination with frequent safety observations on five participants' safety-related behavior in a simulated office setting. The study used a multiple-baseline design across safety-related behaviors. Across all participants and behavior, safety improved…

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

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)

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…

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.

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.

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

[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.

Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes.

PubMed

Lo Re, Vincent; Carbonari, Dena M; Saine, M Elle; Newcomb, Craig W; Roy, Jason A; Liu, Qing; Wu, Qufei; Cardillo, Serena; Haynes, Kevin; Kimmel, Stephen E; Reese, Peter P; Margolis, David J; Apter, Andrea J; Reddy, K Rajender; Hennessy, Sean; Bhullar, Harshvinder; Gallagher, Arlene M; Esposito, Daina B; Strom, Brian L

2017-01-01

To evaluate the risk of serious adverse events among patients with type 2 diabetes mellitus initiating saxagliptin compared with oral antidiabetic drugs (OADs) in classes other than dipeptidyl peptidase-4 (DPP-4) inhibitors. Cohort studies using 2009-2014 data from two UK medical record data sources (Clinical Practice Research Datalink, The Health Improvement Network) and two USA claims-based data sources (HealthCore Integrated Research Database, Medicare). All eligible adult patients newly prescribed saxagliptin (n=110 740) and random samples of up to 10 matched initiators of non-DPP-4 inhibitor OADs within each data source were selected (n=913 384). Outcomes were hospitalized major adverse cardiovascular events (MACE), acute kidney injury (AKI), acute liver failure (ALF), infections, and severe hypersensitivity events, evaluated using diagnostic coding algorithms and medical records. Cox regression was used to determine HRs with 95% CIs for each outcome. Meta-analyses across data sources were performed for each outcome as feasible. There were no increased incidence rates or risk of MACE, AKI, ALF, infection, or severe hypersensitivity reactions among saxagliptin initiators compared with other OAD initiators within any data source. Meta-analyses demonstrated a reduced risk of hospitalization/death from MACE (HR 0.91, 95% CI 0.85 to 0.97) and no increased risk of hospitalization for infection (HR 0.97, 95% CI 0.93 to 1.02) or AKI (HR 0.99, 95% CI 0.88 to 1.11) associated with saxagliptin initiation. ALF and hypersensitivity events were too rare to permit meta-analysis. Saxagliptin initiation was not associated with increased risk of MACE, infection, AKI, ALF, or severe hypersensitivity reactions in clinical practice settings. NCT01086280, NCT01086293, NCT01086319, NCT01086306, and NCT01377935; Results.

Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes

PubMed Central

Carbonari, Dena M; Saine, M Elle; Newcomb, Craig W; Roy, Jason A; Liu, Qing; Wu, Qufei; Cardillo, Serena; Haynes, Kevin; Kimmel, Stephen E; Reese, Peter P; Margolis, David J; Apter, Andrea J; Reddy, K Rajender; Hennessy, Sean; Bhullar, Harshvinder; Gallagher, Arlene M; Esposito, Daina B; Strom, Brian L

2017-01-01

Objective To evaluate the risk of serious adverse events among patients with type 2 diabetes mellitus initiating saxagliptin compared with oral antidiabetic drugs (OADs) in classes other than dipeptidyl peptidase-4 (DPP-4) inhibitors. Research design and methods Cohort studies using 2009–2014 data from two UK medical record data sources (Clinical Practice Research Datalink, The Health Improvement Network) and two USA claims-based data sources (HealthCore Integrated Research Database, Medicare). All eligible adult patients newly prescribed saxagliptin (n=110 740) and random samples of up to 10 matched initiators of non-DPP-4 inhibitor OADs within each data source were selected (n=913 384). Outcomes were hospitalized major adverse cardiovascular events (MACE), acute kidney injury (AKI), acute liver failure (ALF), infections, and severe hypersensitivity events, evaluated using diagnostic coding algorithms and medical records. Cox regression was used to determine HRs with 95% CIs for each outcome. Meta-analyses across data sources were performed for each outcome as feasible. Results There were no increased incidence rates or risk of MACE, AKI, ALF, infection, or severe hypersensitivity reactions among saxagliptin initiators compared with other OAD initiators within any data source. Meta-analyses demonstrated a reduced risk of hospitalization/death from MACE (HR 0.91, 95% CI 0.85 to 0.97) and no increased risk of hospitalization for infection (HR 0.97, 95% CI 0.93 to 1.02) or AKI (HR 0.99, 95% CI 0.88 to 1.11) associated with saxagliptin initiation. ALF and hypersensitivity events were too rare to permit meta-analysis. Conclusions Saxagliptin initiation was not associated with increased risk of MACE, infection, AKI, ALF, or severe hypersensitivity reactions in clinical practice settings. Trial registration number NCT01086280, NCT01086293, NCT01086319, NCT01086306, and NCT01377935; Results. PMID:28878934

Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies

PubMed Central

Vazquez-Benitez, Gabriela; Kharbanda, Elyse O.; Naleway, Allison L.; Lipkind, Heather; Sukumaran, Lakshmi; McCarthy, Natalie L.; Omer, Saad B.; Qian, Lei; Xu, Stanley; Jackson, Michael L.; Vijayadev, Vinutha; Klein, Nicola P.; Nordin, James D.

2016-01-01

Vaccines are increasingly targeted toward women of reproductive age, and vaccines to prevent influenza and pertussis are recommended during pregnancy. Prelicensure clinical trials typically have not included pregnant women, and when they are included, trials cannot detect rare events. Thus, postmarketing vaccine safety assessments are necessary. However, analysis of observational data requires detailed assessment of potential biases. Using data from 8 Vaccine Safety Datalink sites in the United States, we analyzed the association of monovalent H1N1 influenza vaccine (MIV) during pregnancy with preterm birth (<37 weeks) and small-for-gestational-age birth (birth weight < 10th percentile). The cohort included 46,549 pregnancies during 2009–2010 (40% of participants received the MIV). We found potential biases in the vaccine–birth outcome association that might occur due to variable access to vaccines, the time-dependent nature of exposure to vaccination within pregnancy (immortal time bias), and confounding from baseline differences between vaccinated and unvaccinated women. We found a strong protective effect of vaccination on preterm birth (relative risk = 0.79, 95% confidence interval: 0.74, 0.85) when we ignored potential biases and no effect when accounted for them (relative risk = 0.91; 95% confidence interval: 0.83, 1.0). In contrast, we found no important biases in the association of MIV with small-for-gestational-age birth. Investigators conducting studies to evaluate birth outcomes after maternal vaccination should use statistical approaches to minimize potential biases. PMID:27449414

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)

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.

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.

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.

Flightdeck and air traffic control collaboration evaluation (FACE): evaluating aviation communication in the laboratory and field.

PubMed

Sharples, Sarah; Stedmon, Alex; Cox, Gemma; Nicholls, Alistair; Shuttleworth, Tracey; Wilson, John

2007-07-01

The challenge to anticipate the human factors impact of introducing new technologies into a safety critical environment can be addressed in a number of ways. This paper presents a research programme that utilised both laboratory- and field-based assessments to examine the way in which datalink and freeflight may affect the communication and collaboration between pilots, air traffic controllers, and other actors and artefacts in the flightdeck-air traffic control (ATC) joint cognitive system. An overview of the results from these studies is presented, and guidance is provided as to the likely situations in which this new technology is most likely to be successfully applied. In addition, the methodological approach of combining results from field and laboratory data is discussed.

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.

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.

Assessing the healthcare resource use associated with inappropriate prescribing of inhaled corticosteroids for people with chronic obstructive pulmonary disease (COPD) in GOLD groups A or B: an observational study using the Clinical Practice Research Datalink (CPRD).

PubMed

Chalmers, James D; Poole, Chris; Webster, Samantha; Tebboth, Abigail; Dickinson, Scott; Gayle, Alicia

2018-04-11

Recent recommendations from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) position inhaled corticosteroids (ICS) for use in chronic obstructive pulmonary disease (COPD) patients experiencing exacerbations (≥ 2 or ≥ 1 requiring hospitalisation); i.e. GOLD groups C and D. However, it is known that ICS is frequently prescribed for patients with less severe COPD. Potential drivers of inappropriate ICS use may be historical clinical guidance or a belief among physicians that intervening early with ICS would improve outcomes and reduce resource use. The objective of this study was to compare healthcare resource use in the UK for COPD patients in GOLD groups A and B (0 or 1 exacerbation not resulting in hospitalisation) who have either been prescribed an ICS-containing regimen or a non-ICS-containing regimen. Linked data from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) database were used. For the study period (1 July 2005 to 30 June 2015) a total 4009 patients met the inclusion criteria; 1745 receiving ICS-containing therapy and 2264 receiving non-ICS therapy. Treatment groups were propensity score-matched to account for potential confounders in the decision to prescribe ICS, leaving 1739 patients in both treatment arms. Resource use was assessed in terms of frequency of healthcare practitioner (HCP) interactions and rescue therapy prescribing. Treatment acquisition costs were not assessed. Results showed no benefit associated with the addition of ICS, with numerically higher all-cause HCP interactions (72,802 versus 69,136; adjusted relative rate: 1.07 [p = 0.061]) and rescue therapy prescriptions (24,063 versus 21,163; adjusted relative rate: 1.05 [p = 0.212]) for the ICS-containing group compared to the non-ICS group. Rate ratios favoured the non-ICS group for eight of nine outcomes assessed. Outcomes were similar for subgroup analyses surrounding potential influential parameters, including

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.

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.

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...

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.

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

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...

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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 ...

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.

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.

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.

Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

PubMed

Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

2017-06-01

The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

PubMed

Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

2015-12-01

Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher

Patient safety priorities in mental healthcare in Switzerland: a modified Delphi study

PubMed Central

Mascherek, Anna C

2016-01-01

Objective Identifying patient safety priorities in mental healthcare is an emerging issue. A variety of aspects of patient safety in medical care apply for patient safety in mental care as well. However, specific aspects may be different as a consequence of special characteristics of patients, setting and treatment. The aim of the present study was to combine knowledge from the field and research and bundle existing initiatives and projects to define patient safety priorities in mental healthcare in Switzerland. The present study draws on national expert panels, namely, round-table discussion and modified Delphi consensus method. Design As preparation for the modified Delphi questionnaire, two round-table discussions and one semistructured questionnaire were conducted. Preparative work was conducted between May 2015 and October 2015. The modified Delphi was conducted to gauge experts' opinion on priorities in patient safety in mental healthcare in Switzerland. In two independent rating rounds, experts made private ratings. The modified Delphi was conducted in winter 2015. Results Nine topics were defined along the treatment pathway: diagnostic errors, non-drug treatment errors, medication errors, errors related to coercive measures, errors related to aggression management against self and others, errors in treatment of suicidal patients, communication errors, errors at interfaces of care and structural errors. Conclusions Patient safety is considered as an important topic of quality in mental healthcare among experts, but it has been seriously neglected up until now. Activities in research and in practice are needed. Structural errors and diagnostics were given highest priority. From the topics identified, some are overlapping with important aspects of patient safety in medical care; however, some core aspects are unique. PMID:27496233

To what extent can theory account for the findings of road safety evaluation studies?

PubMed

Elvik, Rune

2004-09-01

This paper proposes a conceptual framework that can be used to assess to what extent the findings of road safety evaluation research make sense from a theoretical point of view. The effects of road safety measures are modelled as passing through two causal chains. One of these, termed the engineering effect, refers to the intended effects of a road safety measure on a set of risk factors related to accident occurrence or injury severity. The engineering effect of road safety measures is modelled in terms of nine basic risk factors, one or more of which any road safety measure needs to influence in order to have the intended effect on accidents or injuries. The other causal chain producing the effects of road safety measures is termed the behavioural effect, and refers to road user behavioural adaptations to road safety measures. The behavioural effect is related to the engineering effect, in the sense that certain properties of the engineering effect of a road safety measure influence the likelihood that behavioural adaptation will occur. The behavioural effect of a road safety measure is modelled in terms of six factors that influence the likelihood that behavioural adaptation will occur. The nine basic risk factors representing the engineering effect of a road safety measure, and the six factors influencing the likelihood of behavioural adaptation can be used as checklists in assessing whether or not the findings of road safety evaluation studies make sense from a theoretical point of view. At the current state of knowledge, a more stringent evaluation of the extent to which theory can explain the findings of road safety evaluation studies is, in most cases, not possible. Copyright 2003 Elsevier Ltd.

Federal and tribal lands road safety audits : case studies

DOT National Transportation Integrated Search

2009-12-01

A road safety audit (RSA) is a formal safety performance examination by an independent, multidisciplinary team. RSAs are an effective tool for proactively improving the safety performance of a road project during the planning and design stages, and f...

Safety belt usage attitude study

DOT National Transportation Integrated Search

1979-02-01

Despite increasing evidence that occupant restraint laws are effective in getting people to wear safety belts and an extremely cost-effective measure for reducing highway deaths and injuries, strong opposition at the state-level has prevented passage...

Food safety issues in China: a case study of the dairy sector.

PubMed

Dong, Xiaoxia; Li, Zhemin

2016-01-15

Over the past 10 years, food safety incidents have occurred frequently in China. Food safety issues in the dairy sector have increasingly gained the attention of the Chinese government and the public. The objective of this research is to explore consumption changes of dairy products of different income groups after these dairy safety incidents. The research indicates that consumers' response to dairy safety risk is very intense. Dairy consumption has experienced a declining trend in recent years, and the impact of dairy safety incidents has lasted for at least 5 years. Until 2012, dairy consumption had not yet fully recovered from this influence. Using the random effects model, this study examined the relationship between food safety incident and consumption. Overall, the results show that consumers in the low-income group are more sensitive to safety risk than those in the high-income group. It can be seen from this paper that the decrease of urban residents' dairy consumption was mainly driven by changes in fresh milk consumption, while the decline of milk powder consumption, which was affected by the melamine incident, was relatively moderate, and milk powder consumption for the high-income group even increased. © 2015 Society of Chemical Industry.

Promoting a Culture of Safety as a Patient Safety Strategy

PubMed Central

Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

2015-01-01

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

Study on occupational safety and health strategy for Taiwan.

PubMed

Chuang, Kuen-Yuan; Su, Teh-Sheng; Kuo, Chao-Yin; Lin, Chien-Liang; Lin, Han-Yu; Yu, Yi-Chun

2009-12-01

The aim of this study was to establish a set of occupational safety and health (OSH) issues and development policies suitable for adoption in Taiwan. A survey was conducted on a sample of 102 experts and 235 industrial work safety personnel in Taiwan for statistical analysis of the general consensus, with the results showing such consensus in 104 individual policy indicators. Our results reveal that the most appropriate targets were considered to be annual 10% reductions in the 'occupational accident disability rate', 'occupational accident injury rate' and 'occupational diseases before 2010'. Responding to the specific question of the appropriate method of achieving a reduction in the number of accidents in Taiwan, the primary consideration for 13.4% of the experts and 10.6% of the industry personnel was 'promoting OSH awareness and enhancing the overall safety culture'. As regards the current OSH policy focus, 11.2% of the experts considered 'improving OSH legislation, standards and systems' to be the most important, whilst 8.9% of the industry personnel felt that 'recognizing work stress, overwork and emerging OSH issues' were the most important.

Application of patient safety indicators internationally: a pilot study among seven countries.

PubMed

Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

2009-08-01

To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

The interplay between teamwork, clinicians' emotional exhaustion, and clinician-rated patient safety: a longitudinal study.

PubMed

Welp, Annalena; Meier, Laurenz L; Manser, Tanja

2016-04-19

Effectively managing patient safety and clinicians' emotional exhaustion are important goals of healthcare organizations. Previous cross-sectional studies showed that teamwork is associated with both. However, causal relationships between all three constructs have not yet been investigated. Moreover, the role of different dimensions of teamwork in relation to emotional exhaustion and patient safety is unclear. The current study focused on the long-term development of teamwork, emotional exhaustion, and patient safety in interprofessional intensive care teams by exploring causal relationships between these constructs. A secondary objective was to disentangle the effects of interpersonal and cognitive-behavioral teamwork. We employed a longitudinal study design. Participants were 2100 nurses and physicians working in 55 intensive care units. They answered an online questionnaire on interpersonal and cognitive-behavioral aspects of teamwork, emotional exhaustion, and patient safety at three time points with a 3-month lag. Data were analyzed with cross-lagged structural equation modeling. We controlled for professional role. Analyses showed that emotional exhaustion had a lagged effect on interpersonal teamwork. Furthermore, interpersonal and cognitive-behavioral teamwork mutually influenced each other. Finally, cognitive-behavioral teamwork predicted clinician-rated patient safety. The current study shows that the interrelations between teamwork, clinician burnout, and clinician-rated patient safety unfold over time. Interpersonal and cognitive-behavioral teamwork play specific roles in a process leading from clinician emotional exhaustion to decreased clinician-rated patient safety. Emotionally exhausted clinicians are less able to engage in positive interpersonal teamwork, which might set in motion a vicious cycle: negative interpersonal team interactions negatively affect cognitive-behavioral teamwork and vice versa. Ultimately, ineffective cognitive

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and

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).

The association between EMS workplace safety culture and safety outcomes.

PubMed

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

Indicators of Faculty and Staff Perceptions of Campus Safety: A Case Study

ERIC Educational Resources Information Center

Woolfolk, Willie A.

2013-01-01

The study addressed the problem of a critical increase in campus crime between 1999 and 2009, a period during which overall crime in the United States declined. Further the research explored the perceptions of campus safety among faculty and staff at an institution where campus safety initiatives are nationally ranked as exemplary and incidents of…

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

PubMed

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Development of a large truck safety data needs study plan. Vol. 1, Summary

DOT National Transportation Integrated Search

1986-02-01

This report discusses the results of a study to determine the data needs necessary to address truck safety issues and to develop a data collection and analysis plan. Priority truck safety issues that are amenable to truck accident data analyses were ...

Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

PubMed Central

Nabili, Marjan; Geist, Craig; Zderic, Vesna

2015-01-01

Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm2, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm2 (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety of this

Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

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

Nabili, Marjan, E-mail: mnabili@gwmail.gwu.edu; Geist, Craig, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu; Zderic, Vesna, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu

Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications ofmore » different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine

Consideration of future safety consequences: a new predictor of employee safety.

PubMed

Probst, Tahira M; Graso, Maja; Estrada, Armando X; Greer, Sarah

2013-06-01

Compliance with safety behaviors is often associated with longer term benefits, but may require some short-term sacrifices. This study examines the extent to which consideration of future safety consequences (CFSC) predicts employee safety outcomes. Two field studies were conducted to evaluate the reliability and validity of the newly developed Consideration of Future Safety Consequences (CFSC) scale. Surveys containing the CFSC scale and other measures of safety attitudes, behaviors, and outcomes were administered during working hours to a sample of 128 pulp and paper mill employees; after revising the CFSC scale based on these initial results, follow-up survey data were collected in a second sample of 212 copper miners. In Study I, CFSC was predictive of employee safety knowledge and motivation, compliance, safety citizenship behaviors, accident reporting attitudes and behaviors, and workplace injuries - even after accounting for conscientiousness and demographic variables. Moreover, the effects of CFSC on the variables generally appear to be direct, as opposed to mediated by safety knowledge or motivation. These findings were largely replicated in Study II. CFSC appears to be an important personality construct that may predict those individuals who are more likely to comply with safety rules and have more positive safety outcomes. Future research should examine the longitudinal stability of CFSC to determine the extent to which this construct is a stable trait, rather than a safety attitude amenable to change over time or following an intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

Statewide traffic safety study phase I : review of current traffic safety research, practice, analytical procedures and databases.

DOT National Transportation Integrated Search

2005-05-01

This report synthesized the research findings of Phase I of the Statewide Traffic Safety Study of Louisiana, sponsored by the Louisiana Department of Transportation and Development. The objective of Phase I was to provide a comprehensive review of th...

77 FR 19414 - Pipeline Safety: Public Comment on Leak and Valve Studies Mandated by the Pipeline Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID... Safety, Regulatory Certainty, and Job Creation Act of 2011 AGENCY: Pipeline and Hazardous Materials... Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) is providing an important...

Patient safety priorities in mental healthcare in Switzerland: a modified Delphi study.

PubMed

Mascherek, Anna C; Schwappach, David L B

2016-08-05

Identifying patient safety priorities in mental healthcare is an emerging issue. A variety of aspects of patient safety in medical care apply for patient safety in mental care as well. However, specific aspects may be different as a consequence of special characteristics of patients, setting and treatment. The aim of the present study was to combine knowledge from the field and research and bundle existing initiatives and projects to define patient safety priorities in mental healthcare in Switzerland. The present study draws on national expert panels, namely, round-table discussion and modified Delphi consensus method. As preparation for the modified Delphi questionnaire, two round-table discussions and one semistructured questionnaire were conducted. Preparative work was conducted between May 2015 and October 2015. The modified Delphi was conducted to gauge experts' opinion on priorities in patient safety in mental healthcare in Switzerland. In two independent rating rounds, experts made private ratings. The modified Delphi was conducted in winter 2015. Nine topics were defined along the treatment pathway: diagnostic errors, non-drug treatment errors, medication errors, errors related to coercive measures, errors related to aggression management against self and others, errors in treatment of suicidal patients, communication errors, errors at interfaces of care and structural errors. Patient safety is considered as an important topic of quality in mental healthcare among experts, but it has been seriously neglected up until now. Activities in research and in practice are needed. Structural errors and diagnostics were given highest priority. From the topics identified, some are overlapping with important aspects of patient safety in medical care; however, some core aspects are unique. 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/

Total Diet Studies as a Tool for Ensuring Food Safety

PubMed Central

Lee, Joon-Goo; Kim, Sheen-Hee; Kim, Hae-Jung

2015-01-01

With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety. PMID:26483881

Identifying research priorities for patient safety in mental health: an international expert Delphi study.

PubMed

Dewa, Lindsay H; Murray, Kevin; Thibaut, Bethan; Ramtale, Sonny Christian; Adam, Sheila; Darzi, Ara; Archer, Stephanie

2018-03-03

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. 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. Academic and service user experts from the USA, UK, Switzerland, Netherlands, Ireland, Denmark, Finland, Germany, Sweden, Australia, New Zealand and Singapore were included. Agreement in research priorities on a five-point scale. 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. 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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All

Putting the ‘patient’ in patient safety: a qualitative study of consumer experiences

PubMed Central

Rathert, Cheryl; Brandt, Julie; Williams, Eric S.

2011-01-01

Abstract Background  Although patient safety has been studied extensively, little research has directly examined patient and family (consumer) perceptions. Evidence suggests that clinicians define safety differently from consumers, e.g. clinicians focus more on outcomes, whereas consumers may focus more on processes. Consumer perceptions of patient safety are important for several reasons. First, health‐care policy leaders have been encouraging patients and families to take a proactive role in ensuring patient safety; therefore, an understanding of how patients define safety is needed. Second, consumer perceptions of safety could influence outcomes such as trust and satisfaction or compliance with treatment protocols. Finally, consumer perspectives could be an additional lens for viewing complex systems and processes for quality improvement efforts. Objectives  To qualitatively explore acute care consumer perceptions of patient safety. Design and methods  Thirty‐nine individuals with a recent overnight hospital visit participated in one of four group interviews. Analysis followed an interpretive analytical approach. Results  Three basic themes were identified: Communication, staffing issues and medication administration. Consumers associated care process problems, such as delays or lack of information, with safety rather than as service quality problems. Participants agreed that patients need family caregivers as advocates. Conclusions  Consumers seem acutely aware of care processes they believe pose risks to safety. Perceptual measures of patient safety and quality may help to identify areas where there are higher risks of preventable adverse events. PMID:21624026

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

The association between EMS workplace safety culture and safety outcomes

PubMed Central

Weaver, Matthew D.; Wang, Henry E.; Fairbanks, Rollin J.; Patterson, Daniel

2012-01-01

Objective Prior studies have highlighted wide variation in EMS workplace safety culture across agencies. We sought to determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. Methods We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, perceptions of working conditions, stress recognition, and job satisfaction. A panel of medical directors, paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Results Sixteen percent of all respondents reported experiencing an injury in the past 3 months, four of every 10 respondents reported an error or adverse event (AE), and 90% reported safety-compromising behaviors. Respondents reporting injury scored lower on 5 of the 6 domains of safety culture. Respondents reporting an error or AE scored lower for 4 of the 6 domains, while respondents reporting safety-compromising behavior had lower safety culture scores for 5 of 6 domains. Conclusions Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes. PMID:21950463

Safety leadership: extending workplace safety climate best practices across health care workforces.

PubMed

McCaughey, Deirdre; Halbesleben, Jonathon R B; Savage, Grant T; Simons, Tony; McGhan, Gwen E

2013-01-01

Hospitals within the United States consistently have injury rates that are over twice the national employee injury rate. Hospital safety studies typically investigate care providers rather than support service employees. Compounding the lack of evidence for this understudied population is the scant evidence that is available to examine the relationship of support service employees'perceptions of safety and work-related injuries. To examine this phenomenon, the purpose of this study was to investigate support service employees' perceptions of safety leadership and social support as well as the relationship of safety perception to levels of reported injuries. A nonexperimental survey was conducted with the data collected from hospital support service employees (n = 1,272) and examined. (1) relationships between safety leadership (supervisor and organization) and individual and unit safety perceptions; (2) the moderating effect of social support (supervisor and coworker) on individual and unit safety perceptions; and (3) the relationship of safety perception to reported injury rates. The survey items in this study were based on the items from the AHRQ Patient Safety Culture Survey and the U.S. National Health Care Surveys. Safety leadership (supervisor and organization) was found to be positively related to individual safety perceptions and unit safety grade as was supervisor and coworker support. Coworker support was found to positively moderate the following relationships: supervisor safety leadership and safety perceptions, supervisor safety leadership and unit safety grade, and senior management safety leadership and safety perceptions. Positive employee safety perceptions were found to have a significant relationship with lower reported injury rates. These findings suggest that safety leadership from supervisors and senior management as well as coworker support has positive implications for support service employees' perceptions of safety, which, in turn, are

A cross-cultural study of organizational factors on safety: Japanese vs. Taiwanese oil refinery plants.

PubMed

Hsu, Shang Hwa; Lee, Chun-Chia; Wu, Muh-Cherng; Takano, Kenichi

2008-01-01

This study attempts to identify idiosyncrasies of organizational factors on safety and their influence mechanisms in Taiwan and Japan. Data were collected from employees of Taiwanese and Japanese oil refinery plants. Results show that organizational factors on safety differ in the two countries. Organizational characteristics in Taiwanese plants are highlighted as: higher level of management commitment to safety, harmonious interpersonal relationship, more emphasis on safety activities, higher devotion to supervision, and higher safety self-efficacy, as well as high quality of safety performance. Organizational characteristics in Japanese plants are highlighted as: higher level of employee empowerment and attitude towards continuous improvement, more emphasis on systematic safety management approach, efficient reporting system and teamwork, and high quality of safety performance. The casual relationships between organizational factors and workers' safety performance were investigated using structural equation modeling (SEM). Results indicate that the influence mechanisms of organizational factors in Taiwan and Japan are different. These findings provide insights into areas of safety improvement in emerging countries and developed countries respectively.

Relating voltage and thermal safety in Li-ion battery cathodes: a high-throughput computational study.

PubMed

Jain, Anubhav; Hautier, Geoffroy; Ong, Shyue Ping; Dacek, Stephen; Ceder, Gerbrand

2015-02-28

High voltage and high thermal safety are desirable characteristics of cathode materials, but difficult to achieve simultaneously. This work uses high-throughput density functional theory computations to evaluate the link between voltage and safety (as estimated by thermodynamic O2 release temperatures) for over 1400 cathode materials. Our study indicates that a strong inverse relationship exists between voltage and safety: just over half the variance in O2 release temperature can be explained by voltage alone. We examine the effect of polyanion group, redox couple, and ratio of oxygen to counter-cation on both voltage and safety. As expected, our data demonstrates that polyanion groups improve safety when comparing compounds with similar voltages. However, a counterintuitive result of our study is that polyanion groups produce either no benefit or reduce safety when comparing compounds with the same redox couple. Using our data set, we tabulate voltages and oxidation potentials for over 105 combinations of redox couple/anion, which can be used towards the design and rationalization of new cathode materials. Overall, only a few compounds in our study, representing limited redox couple/polyanion combinations, exhibit both high voltage and high safety. We discuss these compounds in more detail as well as the opportunities for designing safe, high-voltage cathodes.

Aviation Communications Emulation Testbed

NASA Technical Reports Server (NTRS)

Sheehe, Charles; Mulkerin, Tom

2004-01-01

Aviation related applications that rely upon datalink for information exchange are increasingly being developed and deployed. The increase in the quantity of applications and associated data communications will expose problems and issues to resolve. NASA Glenn Research Center has prepared to study the communications issues that will arise as datalink applications are employed within the National Airspace System (NAS) by developing a aviation communications emulation testbed. The Testbed is evolving and currently provides the hardware and software needed to study the communications impact of Air Traffic Control (ATC) and surveillance applications in a densely populated environment. The communications load associated with up to 160 aircraft transmitting and receiving ATC and surveillance data can be generated in real time in a sequence similar to what would occur in the NAS.

Safety climate and mindful safety practices in the oil and gas industry.

PubMed

Dahl, Øyvind; Kongsvik, Trond

2018-02-01

The existence of a positive association between safety climate and the safety behavior of sharp-end workers in high-risk organizations is supported by a considerable body of research. Previous research has primarily analyzed two components of safety behavior, namely safety compliance and safety participation. The present study extends previous research by looking into the relationship between safety climate and another component of safety behavior, namely mindful safety practices. Mindful safety practices are defined as the ability to be aware of critical factors in the environment and to act appropriately when dangers arise. Regression analysis was used to examine whether mindful safety practices are, like compliance and participation, promoted by a positive safety climate, in a questionnaire-based study of 5712 sharp-end workers in the oil and gas industry. The analysis revealed that a positive safety climate promotes mindful safety practices. The regression model accounted for roughly 31% of the variance in mindful safety practices. The most important safety climate factor was safety leadership. The findings clearly demonstrate that mindful safety practices are highly context-dependent, hence, manageable and susceptible to change. In order to improve safety climate in a direction which is favorable for mindful safety practices, the results demonstrate that it is important to give the fundamental features of safety climate high priority and in particular that of safety leadership. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

The Estimation of Gestational Age at Birth in Database Studies.

PubMed

Eberg, Maria; Platt, Robert W; Filion, Kristian B

2017-11-01

Studies on the safety of prenatal medication use require valid estimation of the pregnancy duration. However, gestational age is often incompletely recorded in administrative and clinical databases. Our objective was to compare different approaches to estimating the pregnancy duration. Using data from the Clinical Practice Research Datalink and Hospital Episode Statistics, we examined the following four approaches to estimating missing gestational age: (1) generalized estimating equations for longitudinal data; (2) multiple imputation; (3) estimation based on fetal birth weight and sex; and (4) conventional approaches that assigned a fixed value (39 weeks for all or 39 weeks for full term and 35 weeks for preterm). The gestational age recorded in Hospital Episode Statistics was considered the gold standard. We conducted a simulation study comparing the described approaches in terms of estimated bias and mean square error. A total of 25,929 infants from 22,774 mothers were included in our "gold standard" cohort. The smallest average absolute bias was observed for the generalized estimating equation that included birth weight, while the largest absolute bias occurred when assigning 39-week gestation to all those with missing values. The smallest mean square errors were detected with generalized estimating equations while multiple imputation had the highest mean square errors. The use of generalized estimating equations resulted in the most accurate estimation of missing gestational age when birth weight information was available. In the absence of birth weight, assignment of fixed gestational age based on term/preterm status may be the optimal approach.

Patient safety and patient assessment in pre-hospital care: a study protocol.

PubMed

Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

2016-02-12

Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

Transformational and passive leadership as cross-level moderators of the relationships between safety knowledge, safety motivation, and safety participation.

PubMed

Jiang, Lixin; Probst, Tahira M

2016-06-01

While safety knowledge and safety motivation are well-established predictors of safety participation, less is known about the impact of leadership styles on these relationships. The purpose of the current study was to examine whether the positive relationships between safety knowledge and motivation and safety participation are contingent on transformational and passive forms of safety leadership. Using multilevel modeling with a sample of 171 employees nested in 40 workgroups, we found that transformational safety leadership strengthened the safety knowledge-participation relationship, whereas passive leadership weakened the safety motivation-participation relationship. Under low transformational leadership, safety motivation was not related to safety participation; under high passive leadership, safety knowledge was not related to safety participation. These results are discussed in light of organizational efforts to increase safety-related citizenship behaviors. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Analysis of reportable events in Kansas City air route traffic control center

DOT National Transportation Integrated Search

2017-02-10

The implementation of ControllerPilot Datalink Communications (CPDLC) in domestic en route airspace will change the controllers and pilots : tasks, which will, in turn change the types of observed errors. This study characterizes the current...

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.

Short communication: Labeling Listeria with anaerobic fluorescent protein for food safety studies.

PubMed

Landete, José M; Peirotén, Ángela; Medina, Margarita; Arqués, Juan L

2017-01-01

Many food safety-related studies require the tracking of inoculated food-borne pathogens to monitor their fate in food complex environments. In the current study, we demonstrate the potential of plasmids containing the fluorescence protein gene evoglow-Pp1 (Evocatal, Dusseldorf, Germany) as a real-time reporter system for Listeria strains. This anaerobic fluorescent protein provides an easily detectable phenotype of microorganisms for food safety studies. This work is the first to report a reliable method to identify fluorescently labeled Listeria strains in food ecosystems. Copyright © 2017 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Safety Hazards in Child Care Settings. CPSC Staff Study.

ERIC Educational Resources Information Center

Consumer Product Safety Commission, Washington, DC.

Each year, thousands of children in child care settings are injured seriously enough to need emergency medical treatment. This national study identified potential safety hazards in 220 licensed child care settings in October and November 1998. Eight product areas were examined: cribs, soft bedding, playground surfacing, playground surface…

Disentangling the roles of safety climate and safety culture: Multi-level effects on the relationship between supervisor enforcement and safety compliance.

PubMed

Petitta, Laura; Probst, Tahira M; Barbaranelli, Claudio; Ghezzi, Valerio

2017-02-01

Despite increasing attention to contextual effects on the relationship between supervisor enforcement and employee safety compliance, no study has yet explored the conjoint influence exerted simultaneously by organizational safety climate and safety culture. The present study seeks to address this literature shortcoming. We first begin by briefly discussing the theoretical distinctions between safety climate and culture and the rationale for examining these together. Next, using survey data collected from 1342 employees in 32 Italian organizations, we found that employee-level supervisor enforcement, organizational-level safety climate, and autocratic, bureaucratic, and technocratic safety culture dimensions all predicted individual-level safety compliance behaviors. However, the cross-level moderating effect of safety climate was bounded by certain safety culture dimensions, such that safety climate moderated the supervisor enforcement-compliance relationship only under the clan-patronage culture dimension. Additionally, the autocratic and bureaucratic culture dimensions attenuated the relationship between supervisor enforcement and compliance. Finally, when testing the effects of technocratic safety culture and cooperative safety culture, neither safety culture nor climate moderated the relationship between supervisor enforcement and safety compliance. The results suggest a complex relationship between organizational safety culture and safety climate, indicating that organizations with particular safety cultures may be more likely to develop more (or less) positive safety climates. Moreover, employee safety compliance is a function of supervisor safety leadership, as well as the safety climate and safety culture dimensions prevalent within the organization. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

DOT National Transportation Integrated Search

2012-06-01

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

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

PubMed Central

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

2017-01-01

Background Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. Methods The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Results Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). Conclusions We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. PMID:28559454

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

PubMed Central

Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

2011-01-01

Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland-A cross-sectional survey study.

PubMed

Mascherek, Anna C; Schwappach, David L B

2017-01-01

Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of "climate strength" has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely.

Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland—A cross-sectional survey study

PubMed Central

Mascherek, Anna C.

2017-01-01

Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of “climate strength” has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely. PMID:28753633

Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

PubMed

Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

2016-02-01

This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. © 2015 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for SHIL.

Integrated Safety Risk Reduction Approach to Enhancing Human-Rated Spaceflight Safety

NASA Astrophysics Data System (ADS)

Mikula, J. F. Kip

2005-12-01

This paper explores and defines the current accepted concept and philosophy of safety improvement based on a Reliability enhancement (called here Reliability Enhancement Based Safety Theory [REBST]). In this theory a Reliability calculation is used as a measure of the safety achieved on the program. This calculation may be based on a math model or a Fault Tree Analysis (FTA) of the system, or on an Event Tree Analysis (ETA) of the system's operational mission sequence. In each case, the numbers used in this calculation are hardware failure rates gleaned from past similar programs. As part of this paper, a fictional but representative case study is provided that helps to illustrate the problems and inaccuracies of this approach to safety determination. Then a safety determination and enhancement approach based on hazard, worst case analysis, and safety risk determination (called here Worst Case Based Safety Theory [WCBST]) is included. This approach is defined and detailed using the same example case study as shown in the REBST case study. In the end it is concluded that an approach combining the two theories works best to reduce Safety Risk.

Monitoring road safety development at regional level: A case study in the ASEAN region.

PubMed

Chen, Faan; Wang, Jianjun; Wu, Jiaorong; Chen, Xiaohong; Zegras, P Christopher

2017-09-01

Persistent monitoring of progress, evaluating the results of interventions and recalibrating to achieve continuous improvement over time is widely recognized as being crucial towards the successful development of road safety. In the ASEAN (Association of Southeast Asian Nations) region there is a lack of well-resourced teams that contain multidisciplinary safety professionals, and specialists in individual countries, who are able to carry out this work effectively. In this context, not only must the monitoring framework be effective, it must also be easy to use and adapt. This paper provides a case study that can be easily reproduced; based on an updated and refined Road Safety Development Index (RSDI), by means of the RSR (Rank-sum ratio)-based model, for monitoring/reporting road safety development at regional level. The case study was focused on the road safety achievements in eleven Southeast Asian countries; identifying the areas of poor performance, potential problems and delays. These countries are finally grouped into several classes based on an overview of their progress and achievements regarding to road safety. The results allow the policymakers to better understand their own road safety progress toward their desired impact; more importantly, these results enable necessary interventions to be made in a quick and timely manner. Keeping action plans on schedule if things are not progressing as desired. This would avoid 'reinventing the wheel' and trial and error approaches to road safety, making the implementation of action plans more effective. Copyright © 2017 Elsevier Ltd. All rights reserved.

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%.

Cumulative and episodic vaccine aluminum exposure in a population-based cohort of young children.

PubMed

Glanz, Jason M; Newcomer, Sophia R; Daley, Matthew F; McClure, David L; Baxter, Roger P; Jackson, Michael L; Naleway, Allison L; Lugg, Marlene M; DeStefano, Frank

2015-11-27

In addition to antigens, vaccines contain small amounts of preservatives, adjuvants, and residual substances from the manufacturing process. Some parents have concerns about the safety of these ingredients, yet no large epidemiological studies have specifically examined associations between health outcomes and vaccine ingredients, other than thimerosal. This study examined the extent to which the Vaccine Safety Datalink (VSD) could be used to study vaccine ingredient safety in children. Children born 2004-2011 were identified in VSD data. Using immunization records, two cohorts were identified: children who were up-to-date and children who were undervaccinated before age 2 years. A database was also created linking vaccine type and manufacturer with ingredient amounts documented in vaccine package inserts. Thirty-four ingredients in two or more infant vaccines were identified. However, only amounts (in mg) for aluminum were consistently documented and commonly contained in infant vaccines. Analyses compared vaccine aluminum exposure across cohorts and determined the statistical power for studying associations between aluminum exposure and hypothetical vaccine adverse events. Among 408,608 children, mean cumulative vaccine aluminum exposure increased from 1.11 to 4.00 mg between ages 92-730 days. Up-to-date children were exposed to 11-26% more aluminum from vaccines than undervaccinated children. Power analyses demonstrated that safety studies of aluminum could detect relative risks ranging from 1.1 to 5.8 for a range of adverse event incidence. The safety of vaccine aluminum exposure can be feasibly studied in the VSD. However, possible biological mechanisms and confounding variables would need to be considered before conducting any studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Study on safety level of RC beam bridges under earthquake

NASA Astrophysics Data System (ADS)

Zhao, Jun; Lin, Junqi; Liu, Jinlong; Li, Jia

2017-08-01

This study considers uncertainties in material strengths and the modeling which have important effects on structural resistance force based on reliability theory. After analyzing the destruction mechanism of a RC bridge, structural functions and the reliability were given, then the safety level of the piers of a reinforced concrete continuous girder bridge with stochastic structural parameters against earthquake was analyzed. Using response surface method to calculate the failure probabilities of bridge piers under high-level earthquake, their seismic reliability for different damage states within the design reference period were calculated applying two-stage design, which describes seismic safety level of the built bridges to some extent.

Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies.

PubMed

Coloma, Preciosa M; Becker, Benedikt; Sturkenboom, Miriam C J M; van Mulligen, Erik M; Kors, Jan A

2015-10-01

There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following associations as case studies: (1) rosiglitazone and cardiovascular events (i.e. stroke and myocardial infarction); and (2) human papilloma virus (HPV) vaccine and infertility. We collected publicly accessible, English-language posts on Facebook, Google+, and Twitter until September 2014. Data were queried for co-occurrence of keywords related to the drug/vaccine and event of interest within a post. Messages were analysed with respect to geographical distribution, context, linking to other web content, and author's assertion regarding the supposed association. A total of 2537 posts related to rosiglitazone/cardiovascular events and 2236 posts related to HPV vaccine/infertility were retrieved, with the majority of posts representing data from Twitter (98 and 85%, respectively) and originating from users in the US. Approximately 21% of rosiglitazone-related posts and 84% of HPV vaccine-related posts referenced other web pages, mostly news items, law firms' websites, or blogs. Assertion analysis predominantly showed affirmation of the association of rosiglitazone/cardiovascular events (72%; n = 1821) and of HPV vaccine/infertility (79%; n = 1758). Only ten posts described personal accounts of rosiglitazone/cardiovascular adverse event experiences, and nine posts described HPV vaccine problems related to infertility. Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise

SHPPS 2006: School Health Policies and Programs Study--Food Safety

ERIC Educational Resources Information Center

Centers for Disease Control and Prevention, 2007

2007-01-01

The School Health Policies and Programs Study (SHPPS) is a national survey periodically conducted to assess school health policies and programs at the state, district, school, and classroom levels. This brief reports study results in the area of food safety, covering the following topics: (1) Health Education; (2) Health Services; and (3)…

Crashworthiness of Small Poststandard School Buses: Safety Study.

ERIC Educational Resources Information Center

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

In 1977, a series of Federal Motor Vehicle Safety Standards (FMVSS) for school buses became effective, mandating different performance standards for school buses compared to other buses. Because data on the crash performance of school buses built to these standards were lacking, the National Transportation Safety Board conducted a series of…

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

PubMed

Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

2008-12-01

We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

2006-01-01

The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

PubMed

Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

2015-01-01

The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research.

Strengthening leadership as a catalyst for enhanced patient safety culture: a repeated cross-sectional experimental study.

PubMed

Kristensen, Solvejg; Christensen, Karl Bang; Jaquet, Annette; Møller Beck, Carsten; Sabroe, Svend; Bartels, Paul; Mainz, Jan

2016-05-13

Current literature emphasises that clinical leaders are in a position to enable a culture of safety, and that the safety culture is a performance mediator with the potential to influence patient outcomes. This paper aims to investigate staff's perceptions of patient safety culture in a Danish psychiatric department before and after a leadership intervention. A repeated cross-sectional experimental study by design was applied. In 2 surveys, healthcare staff were asked about their perceptions of the patient safety culture using the 7 patient safety culture dimensions in the Safety Attitudes Questionnaire. To broaden knowledge and strengthen leadership skills, a multicomponent programme consisting of academic input, exercises, reflections and discussions, networking, and action learning was implemented among the clinical area level leaders. In total, 358 and 325 staff members participated before and after the intervention, respectively. 19 of the staff members were clinical area level leaders. In both surveys, the response rate was >75%. The proportion of frontline staff with positive attitudes improved by ≥5% for 5 of the 7 patient safety culture dimensions over time. 6 patient safety culture dimensions became more positive (increase in mean) (p<0.05). Frontline staff became more positive on all dimensions except stress recognition (p<0.05). For the leaders, the opposite was the case (p<0.05). Staff leaving the department after the first measurement had rated job satisfaction lower than the staff staying on (p<0.05). The improvements documented in the patient safety culture are remarkable, and imply that strengthening the leadership can act as a significant catalyst for patient safety culture improvement. Further studies using a longitudinal study design are recommended to investigate the mechanism behind leadership's influence on patient safety culture, sustainability of improvements over time, and the association of change in the patient safety culture measures

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.

An exploratory study of parents' use and knowledge of car safety seats in Beijing, China.

PubMed

Purc-Stephenson, Rebecca J; Ren, Jianhua; Snowdon, Anne W

2010-12-01

As the number of vehicles in China rapidly increases and there is no child safety seat law, the issue of road safety for children is a growing concern. The purpose of this study was to examine parents' use and knowledge of car safety seats in Beijing, China. Using a convenience sample of 843 parents, survey results showed that only 64.8% of parents used a safety restraint for their children; the remaining 35.2% of children, of which most were toddlers or school-aged children, travelled unrestrained in vehicles. Among parents who used a safety restraint, only 24.2% were using it correctly based on the child's age (for infants), weight and height. Common reasons for not using a safety seat included difficulty finding safety seats (56.6%), cost (26.1%), and a preference to hold the child (18.1%). Moreover, a large proportion of parents prematurely transitioned their child from a safety seat to seat belt. The results highlight the need to develop injury prevention interventions that communicate the benefits and encourage the use of child safety restraints in China.

Assessing patient safety culture in Tunisian operating rooms: A multicenter study.

PubMed

Mallouli, Manel; Tlili, Mohamed Ayoub; Aouicha, Wiem; Ben Rejeb, Mohamed; Zedini, Chekib; Salwa, Amrani; Mtiraoui, Ali; Ben Dhiab, Mohamed; Ajmi, Thouraya

2017-04-01

To assess the patient safety culture (PSC) in operating rooms (ORs) and to determine influencing factors. A cross-sectional descriptive multicenter study which was conducted over a period of 7 months (October 2014-April 2015) using the French validated version of the Hospital Survey On Patient Safety Culture questionnaire. Of the note, 15 ORs of public and private healthcare institutions. In total, there were 368 participants including surgeons, anesthesiologists, surgical and anesthesia technicians, nurses and caregivers, divided into 316 professionals exercising in public sector and 52 working in private one. A self-administrated questionnaire investigating 10 dimensions of PSC (including 45 items), two items examining the staff perception of patient safety quality and reporting events, and five items regarding demographic characteristics of respondents. The participation rate in the study was 70.8%. All 10 dimensions were to be improved. The overall perception of patient safety had a score of 34.9%. The dimension that had the lowest score (20.5%) was the non-punitive response to error, and the one that had the highest score (41.67%) was teamwork in the ORs. Three dimensions were developed in private sector, and none in public hospitals. This study showed that the level of the PSC needs to be improved not only in public hospitals but also in private ones. The obtained results highlight the importance of implementing quality management systems and developing PSC. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

A hybrid simulation approach for integrating safety behavior into construction planning: An earthmoving case study.

PubMed

Goh, Yang Miang; Askar Ali, Mohamed Jawad

2016-08-01

One of the key challenges in improving construction safety and health is the management of safety behavior. From a system point of view, workers work unsafely due to system level issues such as poor safety culture, excessive production pressure, inadequate allocation of resources and time and lack of training. These systemic issues should be eradicated or minimized during planning. However, there is a lack of detailed planning tools to help managers assess the impact of their upstream decisions on worker safety behavior. Even though simulation had been used in construction planning, the review conducted in this study showed that construction safety management research had not been exploiting the potential of simulation techniques. Thus, a hybrid simulation framework is proposed to facilitate integration of safety management considerations into construction activity simulation. The hybrid framework consists of discrete event simulation (DES) as the core, but heterogeneous, interactive and intelligent (able to make decisions) agents replace traditional entities and resources. In addition, some of the cognitive processes and physiological aspects of agents are captured using system dynamics (SD) approach. The combination of DES, agent-based simulation (ABS) and SD allows a more "natural" representation of the complex dynamics in construction activities. The proposed hybrid framework was demonstrated using a hypothetical case study. In addition, due to the lack of application of factorial experiment approach in safety management simulation, the case study demonstrated sensitivity analysis and factorial experiment to guide future research. Copyright © 2015 Elsevier Ltd. All rights reserved.

The influence of environmental conditions on safety management in hospitals: a qualitative study.

PubMed

Alingh, Carien W; van Wijngaarden, Jeroen D H; Huijsman, Robbert; Paauwe, Jaap

2018-05-02

Hospitals are confronted with increasing safety demands from a diverse set of stakeholders, including governmental organisations, professional associations, health insurance companies, patient associations and the media. However, little is known about the effects of these institutional and competitive pressures on hospital safety management. Previous research has shown that organisations generally shape their safety management approach along the lines of control- or commitment-based management. Using a heuristic framework, based on the contextually-based human resource theory, we analysed how environmental pressures affect the safety management approach used by hospitals. A qualitative study was conducted into hospital care in the Netherlands. Five hospitals were selected for participation, based on organisational characteristics as well as variation in their reputation for patient safety. We interviewed hospital managers and staff with a central role in safety management. A total of 43 semi-structured interviews were conducted with 48 respondents. The heuristic framework was used as an initial model for analysing the data, though new codes emerged from the data as well. In order to ensure safe care delivery, institutional and competitive stakeholders often impose detailed safety requirements, strong forces for compliance and growing demands for accountability. As a consequence, hospitals experience a decrease in the room to manoeuvre. Hence, organisations increasingly choose a control-based management approach to make sure that safety demands are met. In contrast, in case of more abstract safety demands and an organisational culture which favours patient safety, hospitals generally experience more leeway. This often results in a stronger focus on commitment-based management. Institutional and competitive conditions as well as strategic choices that hospitals make have resulted in various combinations of control- and commitment-based safety management. A balanced

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.

The influence of situation awareness training on nurses' confidence about patient safety skills: A prospective cohort study.

PubMed

Stomski, Norman; Gluyas, Heather; Andrus, Prue; Williams, Anne; Hopkins, Martin; Walters, Jennifer; Sandy, Martinique; Morrison, Paul

2018-04-01

Several studies report that patient safety skills, especially non-technical skills, receive scant attention in nursing curricula. Hence, there is a compelling reason to incorporate material that enhances non-technical skills, such as situation awareness, in nursing curricula in order to assist in the reduction of healthcare related adverse events. The objectives of this study were to: 1) understand final year nursing students' confidence in their patient safety skills; and 2) examine the impact of situation awareness training on final year nursing students' confidence in their patient safety skills. Participants were enrolled from a convenience sample comprising final year nursing students at a Western Australia university. Self-reported confidence in patient safety skills was assessed with the Health Professional in Patient Safety Survey before and after the delivery of a situation awareness educational intervention. Pre/post educational intervention differences were examined by repeated measures ANOVA. No significant differences in confidence about patient safety skills were identified within settings (class/clinical). However, confidence in patient safety skills significantly decreased between settings i.e. nursing students lost confidence after clinical placements. The educational intervention delivered in this study did not seem to improve confidence in patient safety skills, but substantial ceiling effects may have confounded the identification of such improvement. Further studies are required to establish whether the findings of this study can be generalised to other university nursing cohorts. Copyright © 2018 Elsevier Ltd. All rights reserved.

Commuter Train Passenger Safety Model Using Positive Behavior Approach: The Case Study in Suburban Area

NASA Astrophysics Data System (ADS)

Suryanto, D. A.; Adisasmita, S. A.; Hamid, S.; Hustim, M.

2018-04-01

Currently, Train passanger safety measures are more predominantly measurable using negative dimensions in user mode behavior, such as accident rate, accident intensity and accident impact. This condition suggests that safety improvements aim only to reduce accidents. Therefore, this study aims to measure the safety level of light train transit modes (KRL) through the dimensions of traveling safety on commuters based on positive safety indicators with severel condition departure times and returns for work purposes and long trip rates above KRL. The primary survey were used in data collection methods. Structural Equation Modeling (SEM) were used in data analysis. The results show that there are different models of the safety level of departure and return journey. The highest difference is in the security dimension which is the internal variable of KRL users.

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.

System Safety in Early Manned Space Program: A Case Study of NASA and Project Mercury

NASA Technical Reports Server (NTRS)

Hansen, Frederick D.; Pitts, Donald

2005-01-01

This case study provides a review of National Aeronautics and Space Administration s (NASA's) involvement in system safety during research and evolution from air breathing to exo-atmospheric capable flight systems culminating in the successful Project Mercury. Although NASA has been philosophically committed to the principals of system safety, this case study points out that budget and manpower constraints-as well as a variety of internal and external pressures can jeopardize even a well-designed system safety program. This study begins with a review of the evolution and early years of NASA's rise as a project lead agency and ends with the lessons learned from Project Mercury.

In-situation safety behaviors among patients with panic disorder: descriptive and correlational study.

PubMed

Funayama, Tadashi; Furukawa, Toshi A; Nakano, Yumi; Noda, Yumiko; Ogawa, Sei; Watanabe, Norio; Chen, Junwen; Noguchi, Yuka

2013-07-01

In-situation safety behaviors play an important role in the maintenance of anxiety because they prevent patients from experiencing unambiguous disconfirmation of their unrealistic beliefs about feared catastrophes. Strategies for identifying particular safety behaviors, however, have not been sufficiently investigated. The aims of the present study were to (i) develop a comprehensive list of safety behaviors seen in panic disorder and to examine their frequency; and (ii) correlate the safety behaviors with panic attack symptoms, agoraphobic situations and treatment response. The subjects consisted of 46 consecutive patients who participated in group cognitive behavioral treatment (CBT) for panic disorder. All the patients completed a Safety Behavior List that was developed based on experiences with panic disorder patients. Carrying medications, distracting attention, carrying a plastic bottle, and drinking water were reported by more than half of the patients. The strongest correlations between panic symptoms and safety behaviors were found between symptoms of derealization and listening to music with headphones, paresthesia and pushing a cart while shopping, and nausea and squatting down. The strongest association between agoraphobic situations and safety behaviors was found between the fear of taking a bus or a train alone and moving around. Staying still predicted response to the CBT program, while concentrating on something predicted lack of response. An approximate guideline has been developed for identifying safety behaviors among patients with panic disorder and should help clinicians use CBT more effectively for these patients. © 2013 The Authors. Psychiatry and Clinical Neurosciences © 2013 Japanese Society of Psychiatry and Neurology.

Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

PubMed

Jones, Sarahjane

2016-10-01

The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

Safety and security in acute admission psychiatric wards in Ireland and London: a comparative study.

PubMed

Cowman, Seamus; Bowers, Len

2009-05-01

The comparative element of this study is to describe safety and security measures in psychiatric acute admission wards in the Republic of Ireland and London; to describe differences and similarities in terms of safety and security patterns in the Republic of Ireland and London; and to make recommendations on safety and security to mental health services management and psychiatric nurses. Violence is a serious problem in psychiatric services and staff experience significant psychological reactions to being assaulted. Health and Safety Authorities in the UK and Ireland have expressed concern about violence and assault in healthcare, however, there remains a lack of clarity on matters of procedure and policy pertaining to safety and security in psychiatric hospitals. A descriptive survey research design was employed. Questionnaires were circulated to all acute wards in London and in Ireland and the resulting data compared. A total of 124 psychiatric wards from London and 43 wards from Ireland were included in this study and response rates of 70% (London) and 86% (Ireland) were obtained. Differences and similarities in safety and security practices were identified between London and Ireland, with Irish wards having generally higher and more intensive levels of security. There is a lack of coherent policy and procedure in safety and security measures across psychiatric acute admission wards in the Republic of Ireland and London. Given the trends in European Union (EU) regulation, there is a strong argument for the publication of acceptable minimum guidelines for safety and security in mental health services across the EU. There must be a concerted effort to ensure that all policy and procedure in safety and security is founded on evidence and best practice. Mental health managers must establish a review of work safety and security procedures and practices. Risk assessment and environmental audits of all mental health clinical environments should be mandatory.

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

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

PubMed

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

2014-01-01

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

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

PubMed Central

Sinaci, A. Anil; Laleci Erturkmen, Gokce B.; Gonul, Suat; Yuksel, Mustafa; Invernizzi, Paolo; Thakrar, Bharat; Pacaci, Anil; Cinar, H. Alper; Cicekli, Nihan Kesim

2015-01-01

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases. PMID:26543873

Measuring patient safety culture in maternal and child health institutions in China: a qualitative study.

PubMed

Wang, Yuanyuan; Liu, Weiwei; Shi, Huifeng; Liu, Chaojie; Wang, Yan

2017-07-12

Patient safety culture (PSC) plays a critical role in ensuring safe and quality care. Extensive PSC studies have been undertaken in hospitals. However, little is known about PSC in maternal and child health (MCH) institutions in China, which provide both population-based preventive services as well as individual care for patients. This study aimed to develop a theoretical framework for conceptualising PSC in MCH institutions in China. The study was undertaken in six MCH institutions (three in Hebei and three in Beijing). Participants (n=118) were recruited through stratified purposive sampling: 20 managers/administrators, 59 care providers and 39 patients. In-depth interviews were conducted with the participants. The interview data were coded using both inductive (based on the existing PSC theory developed by the Agency for Healthcare Research and Quality) and deductive (open coding arising from data) approaches. A PSC framework was formulated through axial coding that connected initial codes and selective coding that extracted a small number of themes. The interviewees considered patient safety in relation to six aspects: safety and security in public spaces, safety of medical services, privacy and information security, financial security, psychological safety and gap in services. A 12-dimensional PSC framework was developed, containing 69 items. While the existing PSC theory was confirmed by this study, some new themes emerged from the data. Patients expressed particular concerns about psychological safety and financial security. Defensive medical practices emerged as a PSC dimension that is associated with not only medical safety but also financial security and psychological safety. Patient engagement was also valued by the interviewees, especially the patients, as part of PSC. Although there are some common features in PSC across different healthcare delivery systems, PSC can also be context specific. In MCH settings in China, the meaning of 'patient safety

Combustion Safety Simplified Test Protocol Field Study

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

Brand, L; Cautley, D.; Bohac, D.

2015-11-05

"9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies onmore » combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.« less

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

PubMed

Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

2017-03-01

The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. �

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers

PubMed Central

Lyu, Sainan; Chan, Albert P. C.; Wong, Francis K. W.

2018-01-01

In many countries, it is common practice to attract and employ ethnic minority (EM) or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East. PMID:29522503

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers.

PubMed

Lyu, Sainan; Hon, Carol K H; Chan, Albert P C; Wong, Francis K W; Javed, Arshad Ali

2018-03-09

In many countries, it is common practice to attract and employ ethnic minority (EM) or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

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

Identifying positive deviants in healthcare quality and safety: a mixed methods study.

PubMed

O'Hara, Jane K; Grasic, Katja; Gutacker, Nils; Street, Andrew; Foy, Robbie; Thompson, Carl; Wright, John; Lawton, Rebecca

2018-01-01

Objective Solutions to quality and safety problems exist within healthcare organisations, but to maximise the learning from these positive deviants, we first need to identify them. This study explores using routinely collected, publicly available data in England to identify positively deviant services in one region of the country. Design A mixed methods study undertaken July 2014 to February 2015, employing expert discussion, consensus and statistical modelling to identify indicators of quality and safety, establish a set of criteria to inform decisions about which indicators were robust and useful measures, and whether these could be used to identify positive deviants. Setting Yorkshire and Humber, England. Participants None - analysis based on routinely collected, administrative English hospital data. Main outcome measures We identified 49 indicators of quality and safety from acute care settings across eight data sources. Twenty-six indicators did not allow comparison of quality at the sub-hospital level. Of the 23 remaining indicators, 12 met all criteria and were possible candidates for identifying positive deviants. Results Four indicators (readmission and patient reported outcomes for hip and knee surgery) offered indicators of the same service. These were selected by an expert group as the basis for statistical modelling, which supported identification of one service in Yorkshire and Humber showing a 50% positive deviation from the national average. Conclusion Relatively few indicators of quality and safety relate to a service level, making meaningful comparisons and local improvement based on the measures difficult. It was possible, however, to identify a set of indicators that provided robust measurement of the quality and safety of services providing hip and knee surgery.

Aviation safety data accessibility study index: a report on the issues related to public interest in aviation safety data

DOT National Transportation Integrated Search

1997-01-20

This paper reviews aviation safety data and measurement issues relevant to the determination of the best means of providing safety information to the public while ensuring the integrity of the aviation safety system. In addition , the paper examines ...

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

Training General Aviation Pilots for Convective Weather Situations.

PubMed

Blickensderfer, Elizabeth L; Lanicci, John M; Vincent, Michael J; Thomas, Robert L; Smith, MaryJo; Cruit, Jessica K

2015-10-01

Over the past 10-15 yr, considerable research has occurred for the development, testing, and fielding of real-time Datalink weather products for general aviation (GA) pilots to use before and during flight. As is the case with the implementation of most new technologies, work is needed to ensure that the users (in this case, the pilots) understand both the capabilities and limitations of the new technologies as well as how to use the new systems to improve their task performance. The purpose of this study was to replicate and extend a previous study on training pilots how and when to use these new weather technologies. This field study used a quasi-experimental design (pre- vs. post-test with a control group). There were 91 GA pilots from the Midwest, Northeastern, and Southeastern United States who participated in a 2-h short course or a control activity. The lecture-based short course covered radar basics, Next Generation Weather Radar (NEXRAD), NEXRAD specifics/limitations, thunderstorm basics, radar products, and decision making. The pilots who participated in the course earned higher knowledge test scores, improved at applying the concepts in paper-based flight scenarios, had higher self-efficacy in post-training assessments as compared to pre-training assessments, and also performed better than did control subjects on post-test knowledge and skills assessments. GA pilots lack knowledge about real-time Datalink weather technology. This study indicates that a relatively short training program was effective for fostering Datalink weather-related knowledge and skills in GA pilots.

Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

PubMed Central

Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

2016-01-01

Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors

Prescription safety eyewear: impact studies of lens and frame failure.

PubMed

Vinger, P F; Woods, T A

2000-02-01

To determine if a plano lens could be the test lens for all prescription (Rx) lenses and to investigate why Rx lenses pop out of safety eyewear. Plano and Rx polycarbonate lenses (n = 641) with varying thickness and edge geometry, mounted on steel lens holders, and Rx safety eyewear (n = 128) placed on headforms were impacted with test objects of varying diameter and hardness. Impacts were studied with 500 to 2,000 frames-per-second motion analysis. Plano lenses were at least, or more, prone to failure (dislodgment, perforation, shatter, or crack) than -3.00 or +3.00 lenses of the same minimum thickness. More than 40% of safety frames with removable lenses broke or had lenses pop out when impacted with energies expected in industry and sports. Plano lenses can be used as the test lenses for all Rx lenses made of the same material with the same minimal thickness. The ANSI Z87.1-1989 industrial standard for Rx eyewear is inadequate for sports or other activities with high-impact potential. The best lens-retention system has, as a component, a frame with a bevel perpendicular to a frontal impact force.

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

. Coaching construction site foremen to include safety in their daily verbal exchanges with workers has a significantly positive and lasting effect on the level of safety, which is a proximal estimate for work-related accidents. It is recommended that future studies include coaching and feedback at all organizational levels and for all involved parties in the construction process. Building client regulations could assign the task of coaching to the client appointed safety coordinators or a manager/supervisor, and studies should measure longitudinal effects of coaching by following foremen and their work gangs from site to site. Copyright © 2010 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study.

PubMed

de Vries, Sieta T; van der Sar, Maartje J M; Coleman, Anna Marie; Escudero, Yvette; Rodríguez Pascual, Alfonso; Maciá Martínez, Miguel-Ángel; Cupelli, Amelia; Baldelli, Ilaria; Šipić, Ivana; Andrić, Adriana; Michan, Line; Denig, Petra; Mol, Peter G M

2018-07-01

National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ 2  test per country and post hoc Pearson χ 2  tests in the case of statistically significant differences. Of the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs' awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91

Changes in patient safety culture after restructuring of intensive care units: Two cross-sectional studies.

PubMed

Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

2016-02-01

Compare changes in registered nurses' perception of the patient safety culture in restructured and not restructured intensive care units during a four-year period. Two cross-sectional surveys were performed, in 2008/2009 (time 1) and 2012/2013 (time 2). During a period of 0-3 years after time 1, three of six hospitals merged their general and medical intensive care units (restructured). The other hospitals maintained their structure of the intensive care units (not restructured). Intensive care units in hospitals at one Norwegian hospital trust. The safety culture was measured with Hospital Survey on Patient Safety Culture. At times 1 and 2, 217/302 (72%) and 145/289 (50%) registered nurses participated. Restructuring was negatively associated with change in the safety culture, in particular, the dimensions of the safety culture within the unit level. The dimensions most vulnerable for restructuring were manager expectations and actions promoting safety, teamwork within hospital units and staffing. In this study, the restructuring of intensive care units was associated with a negative impact on the safety culture. When restructuring, the management should be particularly aware of changes in the safety culture dimensions manager expectations and actions promoting safety, teamwork within hospital units and staffing. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Lessons Learned from JTA Tester Safety Studies

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

R. L. Bierbaum

2001-05-01

EP401575, Issue C, calls out a requirement to perform safety studies for testers that are used to accept Joint Test Assembly (JTA) product at Pantex (Reference 1). The underlying motivation is to ensure that personnel hazards due to inadvertent initiation of electro-explosive devices (EEDs) during JTA testing are understood and minimized. Studies have been performed on the B61-7/11 JTA, B61-3/4/10 JTA, B83 JTA, and W76 Type 2F testers at Pantex (References 2-5). Each of these studies includes an examination of the relevant Pantex tester as well as the instrumentation and War Reserve (WR) hardware. In performing these analyses, several themesmore » have emerged that could be useful for the Phase 6.3 design efforts for the weapons, the associated instrumentation, and the JTA testers. This report summarizes the lessons learned from these studies. Note that in some cases, the recommendations provided below to enhance safety during JTA testing operations (e.g., adding isolation resistors in the monitoring lines) may result in a reliability degradation or other surety impact. Thus it is important to consider these lessons learned in the context of the overall design and to make tradeoffs in light of the integrated surety objectives. The lessons learned are listed in five different categories, summarized as: (1) Instrumentation considerations; (2) WR design considerations; (3) Tester considerations; (4) Administrative procedures during JTA assembly; and (5) Administrative procedures prior to and during JTA testing. The first three focus on minimizing the probability of inadvertent application of power to EED initiation lines due to component, connector, and assembly failures. The last two describe procedural steps that can be taken at Pantex to either minimize the risk (e.g., by ensuring that tester power supplies cannot supply excessive power to the unit under test) or to mitigate the consequences of unexpected EED initiation (e.g., by instructing test operators to

Patient safety culture in Norwegian primary care: a study in out-of-hours casualty clinics and GP practices.

PubMed

Bondevik, Gunnar Tschudi; Hofoss, Dag; Hansen, Elisabeth Holm; Deilkås, Ellen Catharina Tveter

2014-09-01

This study aimed to investigate patient safety attitudes amongst health care providers in Norwegian primary care by using the Safety Attitudes Questionnaire, in both out-of-hours (OOH) casualty clinics and GP practices. The questionnaire identifies five major patient safety factors: Teamwork climate, Safety climate, Job satisfaction, Perceptions of management, and Working conditions. Cross-sectional study. Statistical analysis included multiple linear regression and independent samples t-tests. Seven OOH casualty clinics and 17 GP practices in Norway. In October and November 2012, 510 primary health care providers working in OOH casualty clinics and GP practices (316 doctors and 194 nurses) were invited to participate anonymously. To study whether patterns in patient safety attitudes were related to professional background, gender, age, and clinical setting. The overall response rate was 52%; 72% of the nurses and 39% of the doctors answered the questionnaire. In the OOH clinics, nurses scored significantly higher than doctors on Safety climate and Job satisfaction. Older health care providers scored significantly higher than younger on Safety climate and Working conditions. In GP practices, male health professionals scored significantly higher than female on Teamwork climate, Safety climate, Perceptions of management and Working conditions. Health care providers in GP practices had significant higher mean scores on the factors Safety climate and Working conditions, compared with those working in the OOH clinics. Our study showed that nurses scored higher than doctors, older health professionals scored higher than younger, male GPs scored higher than female GPs, and health professionals in GP practices scored higher than those in OOH clinics - on several patient safety factors.

Safety self-efficacy and safety performance: potential antecedents and the moderation effect of standardization.

PubMed

Katz-Navon, Tal; Naveh, Eitan; Stern, Zvi

2007-01-01

The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy antecedents: enactive mastery experiences; managers as safety role models; verbal persuasion; and safety priority, that relate to the perceived level of standardization and safety self-efficacy. Confirmatory factor analysis was used to assess the scale's construct validity. Regression models were used to test hypotheses regarding the antecedents and influence of safety self-efficacy. Results indicate that: managers as safety role models; distributing safety information; and priority given to safety, contributed to safety self-efficacy. Additionally, standardization moderated the effects of safety self-efficacy and patient safety such that safety self-efficacy was positively associated with patient safety when standardization was low rather than high. Hospital managers should be aware of individual motivations as safety self-efficacy when evaluating the potential influence of standardization on patient safety. Theoretically, the study introduces a new safety self-efficacy concept, and captures its antecedents and influence on safety performance. Also, the study suggests safety self-efficacy as a boundary condition for the influence of standardization on safety performance. Implementing standardization in healthcare is problematic because not all processes can be standardized. In this case, self-efficacy plays an important role in securing patient safety. Hence, safety self-efficacy may serve as a "substitute-for-standardization," by promoting staff behaviors that affect patient safety.

An exploratory study of the relationship between socioeconomic status and motor vehicle safety features.

PubMed

Girasek, Deborah C; Taylor, Brett

2010-04-01

The purpose of this study was to assess the association between motor vehicle owners' socioeconomic status (SES) and the safety of their motor vehicles. Truncated vehicle identification numbers (VINs) were obtained from the Maryland Motor Vehicle Administration office. ZIP code-level income and educational data were assigned to each VIN. Software was used to identify safety-related vehicle characteristics including crash test rating, availability of electronic stability control and side impact air bags, age, and weight. Correlations and analyses of variance were performed to assess whether a ZIP code's median household income and educational level were associated with its proportion of registered vehicles with safety features. For 13 of the 16 correlations performed, SES was significantly associated with the availability of vehicle safety features in a direction that favored upper-income individuals. Vehicle weight was not associated with income or education. When ZIP codes were divided into median household income quintiles, their mean proportions of safety features also differed significantly, in the same direction, for availability of electronic stability control, side impact air bags, vehicle age, and crash test ratings. Safer motor vehicles appear to be distributed along socioeconomic lines, with lower income groups experiencing more risk. This previously unidentified mechanism of disparity merits further study and the attention of policy makers.

Safety Education and Science.

ERIC Educational Resources Information Center

Ralph, Richard

1980-01-01

Safety education in the science classroom is discussed, including the beginning of safe management, attitudes toward safety education, laboratory assistants, chemical and health regulation, safety aids, and a case study of a high school science laboratory. Suggestions for safety codes for science teachers, student behavior, and laboratory…

75 FR 56549 - National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section (SOHSS...-1403. Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate... pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH...

Safety Study of Double-Decker Motorcoaches with Rear Luggage Compartment : Technology Brief

DOT National Transportation Integrated Search

2017-12-01

The study was conducted through a combination of analyses and tests with a double-decker motorcoach. State transportation safety and law enforcement officials were consulted, and the study plan was revised according to their comments. An exemplar mot...

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-09-01

There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care.

A longitudinal study of an intervention to improve road safety climate: climate as an organizational boundary spanner.

PubMed

Naveh, Eitan; Katz-Navon, Tal

2015-01-01

This study presents and tests an intervention to enhance organizational climate and expands existing conceptualization of organizational climate to include its influence on employee behaviors outside the organization's physical boundaries. In addition, by integrating the literatures of climate and work-family interface, the study explored climate spillover and crossover from work to the home domain. Focusing on an applied practical problem within organizations, we investigated the example of road safety climate and employees' and their families' driving, using a longitudinal study design of road safety intervention versus control groups. Results demonstrated that the intervention increased road safety climate and decreased the number of traffic violation tickets and that road safety climate mediated the relationship between the intervention and the number of traffic violation tickets. Road safety climate spilled over to the family domain but did not cross over to influence family members' driving. (c) 2015 APA, all rights reserved.

Effects of organizational safety on employees' proactivity safety behaviors and occupational health and safety management systems in Chinese high-risk small-scale enterprises.

PubMed

Mei, Qiang; Wang, Qiwei; Liu, Suxia; Zhou, Qiaomei; Zhang, Jingjing

2018-06-07

Based on the characteristics of small-scale enterprises, the improvement of occupational health and safety management systems (OHS MS) needs an effective intervention. This study proposed a structural equation model and examined the relationships of perceived organization support for safety (POSS), person-organization safety fit (POSF) and proactivity safety behaviors with safety management, safety procedures and safety hazards identification. Data were collected from 503 employees of 105 Chinese high-risk small-scale enterprises over 6 months. The results showed that both POSS and POSF were positively related to improvement in safety management, safety procedures and safety hazards identification through proactivity safety behaviors. Our findings provide a new perspective on organizational safety for improving OHS MS for small-scale enterprises and extend the application of proactivity safety behaviors.

Understanding the relationship between safety investment and safety performance of construction projects through agent-based modeling.

PubMed

Lu, Miaojia; Cheung, Clara Man; Li, Heng; Hsu, Shu-Chien

2016-09-01

The construction industry in Hong Kong increased its safety investment by 300% in the past two decades; however, its accident rate has plateaued to around 50% for one decade. Against this backdrop, researchers have found inconclusive results on the causal relationship between safety investment and safety performance. Using agent-based modeling, this study takes an unconventional bottom-up approach to study safety performance on a construction site as an outcome of a complex system defined by interactions among a worksite, individual construction workers, and different safety investments. Instead of focusing on finding the absolute relationship between safety investment and safety performance, this study contributes to providing a practical framework to investigate how different safety investments interacting with different parameters such as human and environmental factors could affect safety performance. As a result, we could identify cost-effective safety investments under different construction scenarios for delivering optimal safety performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Safety Program that Integrated Behavior-Based Safety and Traditional Safety Methods and Its Effects on Injury Rates of Manufacturing Workers

ERIC Educational Resources Information Center

Hermann, Jaime A.; Ibarra, Guillermo V.; Hopkins, B. L.

2010-01-01

The present research examines the effects of a complex safety program that combined Behavior-Based Safety (BBS) and traditional safety methods. The study was conducted in an automobile parts plant in Mexico. Two sister plants served as comparison. Some of the components of the safety programs addressed behaviors of managers and included methods…

Exploring relationships between hospital patient safety culture and Consumer Reports safety scores.

PubMed

Smith, Scott Alan; Yount, Naomi; Sorra, Joann

2017-02-16

A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p < 0.05). For 10 of the 12 Hospital SOPS composites, higher patient safety culture scores were associated with higher CR patient experience scores on communication about medications and discharge. This study found a relationship between hospital staff perceptions of patient safety culture and the Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer

Strategies to reduce safety violations for working from heights in construction companies: study protocol for a randomized controlled trial.

PubMed

van der Molen, Henk F; Frings-Dresen, Monique H W

2014-05-31

Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries. However, according to the labor inspectorate, more than 80% of Dutch construction sites violate safety regulations for working from heights. To increase compliance with safety regulations, employers and workers have to select, implement and monitor safety measures. To facilitate this behavioral change, stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques. For this study, two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate. These strategies consist of 1) face-to-face contacts with safety consultants and 2) direct mail with access to internet facilities. The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights, the process and the cost measures. This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy (N = 9), a direct mailing strategy (N = 9) and a control condition of no guidance (N = 9) on safety violations to record by labor inspectors after three months. A process evaluation for both strategies will be performed to determine program implementation (reach, dose delivered and dose received), satisfaction, knowledge and perceived safety behavior. A cost analysis will be performed to establish the financial costs for both strategies. The present study is in accordance with the CONSORT statement. This study increases insight into performing practice-based randomized controlled trials. The outcome will help to evaluate the effect of two guidance strategies on safety violations. If these strategies are effective, implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with

The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

PubMed

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Serious adverse events in randomized psychosocial treatment studies: Safety or Arbitrary Edicts?

PubMed Central

Petry, Nancy M.; Roll, John M.; Rounsaville, Bruce J.; Ball, Samuel A.; Stitzer, Maxine; Peirce, Jessica M.; Blaine, Jack; Kirby, Kimberly C.; McCarty, Dennis; Carroll, Kathleen M.

2009-01-01

Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance abusing participants (N=1,687) were randomized to standard care or standard care plus either contingency management or motivational enhancement. Twelve percent of participants experienced one or more SAEs during the 27,198 person-weeks of follow-up. Of the 260 SAEs recorded, none were judged by the Data Safety Monitoring Board to be study related, and there were no significant differences between experimental and control conditions in SAE incidence rates. These data underscore the need to reconsider the rationale behind, and appropriate methods for, monitoring safety during psychosocial therapy trials. PMID:19045975

Improving safety in high-speed work zones : a Super 70 study.

DOT National Transportation Integrated Search

2011-01-01

Super 70 was an urban reconstruction project (March-November 2007) along I-70 in the central part of Indianapolis. INDOT : applied in that project several innovative and traditional solutions. This study investigates the safety effect of the solution...

Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

PubMed

Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

2016-01-01

Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

National Chemistry Teacher Safety Survey

NASA Astrophysics Data System (ADS)

Plohocki, Barbra A.

This study evaluated the status of secondary school instructional chemistry laboratory safety using a survey instrument which focused on Teacher background Information, Laboratory Safety Equipment, Facility Safety, General Safety, and a Safety Content Knowledge Survey. A fifty question survey instrument based on recent research and questions developed by the researcher was mailed to 500 secondary school chemistry teachers who participated in the 1993 one-week Woodrow Wilson National Fellowship Foundation Chemistry Institute conducted at Princeton University, New Jersey. The data received from 303 respondents was analyzed by t tests and Analysis of Variance (ANOVA). The level of significance for the study was set at ~\\ <.05. There was no significant mean difference in test performance on the Safety Content Knowledge Survey and secondary school chemistry teachers who have had undergraduate and/or graduate safety training and those who have not had undergraduate and/or graduate safety training. Secondary school chemistry teachers who attended school district sponsored safety inservices did not score higher on the Safety Content Knowledge Survey than teachers who did not attend school district sponsored safety inservice sessions. The type of school district (urban, suburban, or rural) had no significant correlation to the type of laboratory safety equipment found in the instructional chemistry laboratory. The certification area (chemistry or other type of certificate which may or may not include chemistry) of the secondary school teacher had no significant correlation to the type of laboratory equipment found in the instructional chemistry laboratory. Overall, this study indicated a majority of secondary school chemistry teachers were interested in attending safety workshops applicable to chemistry safety. Throughout this research project, many teachers indicated they were not adequately instructed on the collegiate level in science safety and had to rely on common

Space station crew safety alternatives study, volume 1

NASA Technical Reports Server (NTRS)

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

1985-01-01

The first 15 years of accumulated space station concepts for initial operational capability (IOC) during the early 1990's were 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.

The Impact of Transformational Leadership on Safety Climate and Individual Safety Behavior on Construction Sites.

PubMed

Shen, Yuzhong; Ju, Chuanjing; Koh, Tas Yong; Rowlinson, Steve; Bridge, Adrian J

2017-01-05

Unsafe acts contribute dominantly to construction accidents, and increasing safety behavior is essential to reduce accidents. Previous research conceptualized safety behavior as an interaction between proximal individual differences (safety knowledge and safety motivation) and distal contextual factors (leadership and safety climate). However, relatively little empirical research has examined this conceptualization in the construction sector. Given the cultural background of the sample, this study makes a slight modification to the conceptualization and views transformational leadership as an antecedent of safety climate. Accordingly, this study establishes a multiple mediator model showing the mechanisms through which transformational leadership translates into safety behavior. The multiple mediator model is estimated by the structural equation modeling (SEM) technique, using individual questionnaire responses from a random sample of construction personnel based in Hong Kong. As hypothesized, transformational leadership has a significant impact on safety climate which is mediated by safety-specific leader-member exchange (LMX), and safety climate in turn impacts safety behavior through safety knowledge. The results suggest that future safety climate interventions should be more effective if supervisors exhibit transformational leadership, encourage construction personnel to voice safety concerns without fear of retaliation, and repeatedly remind them about safety on the job.

The Impact of Transformational Leadership on Safety Climate and Individual Safety Behavior on Construction Sites

PubMed Central

Shen, Yuzhong; Ju, Chuanjing; Koh, Tas Yong; Rowlinson, Steve; Bridge, Adrian J.

2017-01-01

Unsafe acts contribute dominantly to construction accidents, and increasing safety behavior is essential to reduce accidents. Previous research conceptualized safety behavior as an interaction between proximal individual differences (safety knowledge and safety motivation) and distal contextual factors (leadership and safety climate). However, relatively little empirical research has examined this conceptualization in the construction sector. Given the cultural background of the sample, this study makes a slight modification to the conceptualization and views transformational leadership as an antecedent of safety climate. Accordingly, this study establishes a multiple mediator model showing the mechanisms through which transformational leadership translates into safety behavior. The multiple mediator model is estimated by the structural equation modeling (SEM) technique, using individual questionnaire responses from a random sample of construction personnel based in Hong Kong. As hypothesized, transformational leadership has a significant impact on safety climate which is mediated by safety-specific leader–member exchange (LMX), and safety climate in turn impacts safety behavior through safety knowledge. The results suggest that future safety climate interventions should be more effective if supervisors exhibit transformational leadership, encourage construction personnel to voice safety concerns without fear of retaliation, and repeatedly remind them about safety on the job. PMID:28067775

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

Improving operating room safety

PubMed Central

2009-01-01

Despite the introduction of the Universal Protocol, patient safety in surgery remains a daily challenge in the operating room. This present study describes one community health system's efforts to improve operating room safety through human factors training and ultimately the development of a surgical checklist. Using a combination of formal training, local studies documenting operating room safety issues and peer to peer mentoring we were able to substantially change the culture of our operating room. Our efforts have prepared us for successfully implementing a standardized checklist to improve operating room safety throughout our entire system. Based on these findings we recommend a multimodal approach to improving operating room safety. PMID:19930577

Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

NASA Technical Reports Server (NTRS)

1972-01-01

Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

NASA Technical Reports Server (NTRS)

Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

2010-01-01

We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-01-01

ABSTRACT Background: There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. Objective: To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Methods: Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. Results: The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Conclusion: Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care. PMID:26339832

Talonavicular joint arthroscopic portals: A cadaveric study of feasibility and safety.

PubMed

Xavier, Gabriel; Oliva, Xavier Martin; Rotinen, Mauri; Monzo, Mariano

2016-09-01

The objectives of the study were to evaluate the safety of hypothetical arthroscopic portals from talonavicular joint and to evaluate their reproducibility and enforceability. 19 cadaveric feet were marked and four arthroscopic portals were made (medial, dorsomedial, dorsolateral and lateral). The specimens were dissected in layers and the distances between neurovascular structures and the trocars were measured. Medial and dorsomedial portals were in average 8.3 and 8.7, respectively, to the saphenous vein and nerve. Dorsolateral portal was in average 8.1mm to the deep peroneal nerve and dorsalis pedis artery, and 9.1mm to the medial dorsal cutaneous branch of the superficial peroneal nerve. Lateral portal was in average 12.3mm to the intermediate dorsal cutaneous branch of the superficial peroneal nerve. Tested portals shown to have a good safety margin for the foot neurovascular deep dorsal structures and an acceptable safety margin for the superficial neurovascular structures. Copyright © 2015 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

A medication safety model: a case study in Thai hospital.

PubMed

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-06-12

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital.

Annual Targets, UAVs and Range Operations Symposium and Exhibition (49th) Held in Fort Walton Beach, Florida on October 25-27, 2011

DTIC Science & Technology

2011-10-27

COMP Mountain Home COMP Shaw COMP Barksdale COMP Hill COMP Homestead ARB COMP Savannah CRTC COMP Gulfport CRTC COMP Alpena CRTC COMP Montana...Spangdahlem AB Aviano AB Kadena AB Programmed: 165 Baseline Pods purchase in FY12 (del FY13) Alpena CRTC Holloman AFB Eielson AFB Planned: 368...ARQ-52(V)2 ARQ-52B(V)2 ARDS (HDIS) ASQ- T35A P4NS (NACTS-RSI) KITS (Kadena) ASQ-T34 ASQ-T46 AKITS ( Alpena ) Israel No Datalink No Datalink P4R1 ASQ

Language barriers and patient safety risks in hospital care. A mixed methods study.

PubMed

van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula

2016-02-01

A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a

Safety of oral alpha-lipoic acid treatment in pregnant women: a retrospective observational study.

PubMed

Parente, E; Colannino, G; Picconi, O; Monastra, G

2017-09-01

Alpha-lipoic acid is a natural molecule, which directly or by means of its reduced form, dihydrolipoic acid, exerts antioxidant, anti-inflammatory and immunomodulatory activities, very helpful also in preventing miscarriage and preterm delivery. Used as dietary supplement alpha-lipoic acid was demonstrated to be safe for living organisms even when administered at high doses. However, no study was made so far to verify the safety of its continuous administration on a substantial number of pregnant women. The present investigation was performed to answer this issue. An observational retrospective study was carried out analyzing 610 expectant mothers. They had been treated daily by oral route with 600 mg alpha-lipoic acid, for at least 7 weeks during gestation. The primary outcome was to verify alpha-lipoic acid safety in the mother and infant. Maternal safety was assessed by monitoring for adverse reactions, physical and clinical examination, including a morbidity assessment. Laboratory and clinical examinations were performed monthly. Neonatal safety was assessed by the evaluation of birth weight, gestational age, Apgar scores, neonatal death with the related cause of death. Data collected from the Birth Registry of Campania Region were used as control. This study provided a very clear and reassuring picture about the safety of alpha-lipoic acid oral treatment during pregnancy. No adverse effect was noticed in mothers or newborns. The two sets of monitored data, from treated and controls, were completely superimposable or, in some cases, better in alpha-lipoic acid group. Our results open a reassuring scenario regarding the administration of alpha-lipoic acid during pregnancy.

[The role of safety climate and the relationship with job satisfaction: an exploratory study across three different occupational contexts.

PubMed

Emanuel, Federica; Colombo, Lara; Cortese, Claudio G; Ghislieri, Chiara

2017-12-01

This study examined the role of the "safety climate", or the organization's attention to health and safety of workers, and of job demand and resources in relation with job satisfaction. Wellbeing at work is a topic of growing interest, in line with the legislation and the programs on health and safety of workers and management and the evaluation of psychosocial risks. Several studies show that organizational actions concerning health and safety can be an indicator of the attention to employees' wellbeing, even if studies about the relationship between safety climate and some psychosocial outcomes are scant. The study analysed the relationship between job demand, job resources, safety climate and job satisfaction in three different occupational contexts (public authority, N = 224; social care organization, N = 115; pharmaceutical company, N = 127); workers were divided into groups based on the risk level appeared in the objective assessment of work-related stress, in order to identify differences. The self-report questionnaire gathered information about: job satisfaction, work efforts, supervisors' support, colleagues support, safety climate (α between .72 and .93). Data analysis provided: Cronbach α, analysis of variance, correlations, stepwise multiple regressions. The results showed that job satisfaction (R2 between .23 and .88) had a negative relationship with efforts and a positive relationship with job resources and safety climate. It emerges the importance of safety climate: to support and promote wellbeing at work, organizations could endorse training and information programs on health and safety for all workers and management, not only for professional groups with high-risk level. Future studies could explore the relation between safety climate and other outcomes, such as emotional exhaustion or objective indicators of organizational health (e.g. absenteeism, accidents, etc.). Copyright© by Aracne Editrice, Roma, Italy.

The effect of nurses' empowerment perceptions on job safety behaviours: a research study in Turkey.

PubMed

Yıldız, Ahmet; Kaya, Sıdıka; Teleş, Mesut; Korku, Cahit

2018-05-03

This study aimed to investigate the effect of nurses' empowerment perceptions on job safety behaviours. A survey of 377 nurses working in five hospitals in Turkey was conducted using the conditions of work effectiveness questionnaire, psychological empowerment instrument, universal precautions compliance scale and occupational health and safety obligations compliance scale. Relations between variables were tested using Pearson's correlation and path analysis. There was a moderate and statistically significant relationship between psychological and structural empowerment and complying with universal safety measures and meeting occupational health and safety obligations. Also, an increase of 1 unit on the level of psychological empowerment was found to correspond to an increase of 0.37 units on the level of universal precautions compliance and to an increase of 0.46 units on the level of occupational health and safety obligations compliance. As such, an increase of 1 unit in structural empowerment corresponds to an increase of 0.53 units on the level of universal precautions compliance and to an increase of 0.36 units (total effect) on the level of occupational health and safety obligations compliance. The findings reveal that empowerment is a valuable tool for nurses' positive job safety behaviours.

Rationales for home safety promotion in the Iranian primary healthcare system: results from a pilot study.

PubMed

Mohammadi, R; Ekman, R; Svanström, L; Gooya, M M

2006-01-01

To analyse the prerequisites for a nationwide primary healthcare (PHC) home safety promotion programme in Iran. Injury is a major public health problem throughout the world, currently accounting for one-seventh of all premature deaths and disabilities. Within 20 years, it is estimated that the proportion will increase to one-fifth. The present healthcare system in Iran was started in 1979, with a major focus on easy access to services and prevention. The system is based on the 'health house', which is run by community health workers. A survey shows that 36% of injuries occur in the home environment. A pilot phase of the Home Safety Promotion Programme was initiated in 1994, and included safety checking at home for fences, kitchens, drugs and poisons, heaters, electricity, and stairs and ladders. The pilot study covered 478,551 households out of the 12 million (approximately) in Iran. Sixty-nine supervisors were involved individually, assembled into eight focus groups. Household safety increased by 10-20% over the 4 years of the study. The frequency of home visits changed from annual to seasonal, since all participants agreed that there were seasonal differences in safety problems. The supervisors showed a high level of knowledge of injury as a public health problem, and also positive attitudes towards doing something about safety on the basis of a PHC scheme. The role of a surveillance system was highlighted, and it was suggested that such a system should be added to the programme. Based on our preliminary findings, there were reasons to obtain a policy decision concerning a national programme for safety promotion before extending the pilot scheme to the whole country. A national safety programme was decided upon following completion of the pilot study. It includes a home-related-injury surveillance system that is mandatory in rural areas and voluntary in some cities.

Correlation between safety climate and contractor safety assessment programs in construction.

PubMed

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

Patient safety culture in China: a case study in an outpatient setting in Beijing

PubMed Central

Liu, Chaojie; Liu, Weiwei; Wang, Yuanyuan; Zhang, Zhihong; Wang, Peng

2014-01-01

Objectives To investigate the patient safety culture in an outpatient setting in Beijing and explore the meaning and implications of the safety culture from the perspective of health workers and patients. Methods A mixed methods approach involving a questionnaire survey and in-depth interviews was adopted. Among the 410 invited staff members, 318 completed the Hospital Survey of Patient Safety Culture (HSOPC). Patient safety culture was described using 12 subscale scores. Inter-subscale correlation analysis, ANOVA and stepwise multivariate regression analyses were performed to identify the determinants of the patient safety culture scores. Interviewees included 22 patients selected through opportunity sampling and 27 staff members selected through purposive sampling. The interview data were analysed thematically. Results The survey respondents perceived high levels of unsafe care but had personally reported few events. Lack of ‘communication openness’ was identified as a major safety culture problem, and a perception of ‘penalty’ was the greatest barrier to the encouragement of error reporting. Cohesive ‘teamwork within units’, while found to be an area of strength, conversely served as a protective and defensive mechanism for medical practice. Low levels of trust between providers and consumers and lack of management support constituted an obstacle to building a positive patient safety culture. Conclusions This study in China demonstrates that a punitive approach to error is still widespread despite increasing awareness of unsafe care, and managers have been slow in acknowledging the importance of building a positive patient safety culture. Strong ‘teamwork within units’, a common area of strength, could fuel the concealment of errors. PMID:24351971

Staying silent about safety issues: Conceptualizing and measuring safety silence motives.

PubMed

Manapragada, Archana; Bruk-Lee, Valentina

2016-06-01

Communication between employees and supervisors about safety-related issues is an important component of a safe workplace. When supervisors receive information from employees about safety issues, they may gain otherwise-missed opportunities to correct these issues and/or prevent negative safety outcomes. A series of three studies were conducted to identify various safety silence motives, which describe the reasons that employees do not speak up to supervisors about safety-related issues witnessed in the workplace, and to develop a tool to assess these motives. Results suggest that employees stay silent about safety issues based on perceptions of altering relationships with others (relationship-based), perceptions of the organizational climate (climate-based), the assessment of the safety issue (issue-based), or characteristics of the job (job-based). We developed a 17-item measure to assess these four motives, and initial evidence was found for the construct and incremental validity of the safety silence motives measure in a sample of nurses. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and... vaccine annually) and an explanation of how the proposed study will either help support product approval...

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.

Multimedia for occupational safety and health training: a pilot study examining a multimedia learning theory.

PubMed

Wallen, Erik S; Mulloy, Karen B

2006-10-01

Occupational diseases are a significant problem affecting public health. Safety training is an important method of preventing occupational illness. Training is increasingly being delivered by computer although theories of learning from computer-based multimedia have been tested almost entirely on college students. This study was designed to determine whether these theories might also be applied to safety training applications for working adults. Participants viewed either computer-based multimedia respirator use training with concurrent narration, narration prior to the animation, or unrelated safety training. Participants then took a five-item transfer test which measured their ability to use their knowledge in new and creative ways. Participants who viewed the computer-based multimedia trainings both did significantly better than the control group on the transfer test. The results of this pilot study suggest that design guidelines developed for younger learners may be effective for training workers in occupational safety and health although more investigation is needed.

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

PubMed

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

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.

A Validation Study of the Revised Personal Safety Decision Scale

ERIC Educational Resources Information Center

Kim, HaeJung; Hopkins, Karen M.

2017-01-01

Objective: The purpose of this study is to examine the reliability and validity of an 11-item Personal Safety Decision Scale (PSDS) in a sample of child welfare workers. Methods: Data were derived from a larger cross-sectional online survey to a random stratified sample of 477 public child welfare workers in a mid-Atlantic State. An exploratory…

Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

PubMed

Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

2012-03-01

The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation. Copyright © 2011 Elsevier Ltd. All rights reserved.

Hospital safety climate surveys: measurement issues.

PubMed

Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

2010-12-01

Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration.

PubMed

Taylor, Jennifer A; Gerwin, Daniel; Morlock, Laura; Miller, Marlene R

2011-12-01

To evaluate the need for triangulating case-finding tools in patient safety surveillance. This study applied four case-finding tools to error-associated patient safety events to identify and characterise the spectrum of events captured by these tools, using puncture or laceration as an example for in-depth analysis. Retrospective hospital discharge data were collected for calendar year 2005 (n=48,418) from a large, urban medical centre in the USA. The study design was cross-sectional and used data linkage to identify the cases captured by each of four case-finding tools. Three case-finding tools (International Classification of Diseases external (E) and nature (N) of injury codes, Patient Safety Indicators (PSI)) were applied to the administrative discharge data to identify potential patient safety events. The fourth tool was Patient Safety Net, a web-based voluntary patient safety event reporting system. The degree of mutual exclusion among detection methods was substantial. For example, when linking puncture or laceration on unique identifiers, out of 447 potential events, 118 were identical between PSI and E-codes, 152 were identical between N-codes and E-codes and 188 were identical between PSI and N-codes. Only 100 events that were identified by PSI, E-codes and N-codes were identical. Triangulation of multiple tools through data linkage captures potential patient safety events most comprehensively. Existing detection tools target patient safety domains differently, and consequently capture different occurrences, necessitating the integration of data from a combination of tools to fully estimate the total burden.

Performance Evaluation and Analysis of Rural Drinking Water Safety Project——A Case Study in Jiangsu, China

NASA Astrophysics Data System (ADS)

Du, Xiaorong

2017-04-01

Water is the basic condition for human survival and development. As China is the most populous country, rural drinking water safety problems are most conspicuous. Therefore, the Chinese government keeps increasing investment and has built a large number of rural drinking water safety projects. Scientific evaluation of project performance is of great significance to promote the sustainable operation of the project and the sustainable development of rural economy. Previous studies mainly focus on the economic benefits of the project, while ignoring the fact that the rural drinking water safety project is quasi-public goods, which has economic, social and ecological benefits. This paper establishes a comprehensive evaluation model for rural drinking water safety performance, which adapts the rules of "5E" (economy, efficiency, effectiveness, equity and environment) as the value orientation, and selects a rural drinking water safety project as object in case study at K District, which is in the north of Jiangsu Province, China. The results shows: 1) the comprehensive performance of K project is in good condition; 2) The performance of every part shows that the scores of criteria "efficiency", "environment" and "effect" are higher than the mean performance, while the "economy" is slightly lower than the mean and the "equity" is the lowest. 3) The performance of indicator layer shows that: the planned completion rate of project, the reduction rate of project cost and the penetration rate of water-use population are significantly lower than other indicators. Based on the achievements of previous studies and the characteristics of rural drinking water safety project, this study integrates the evaluation dimensions of equity and environment, which can contribute to a more comprehensive and systematic assessment of project performance and provide empirical data for performance evaluation and management of rural drinking water safety project. Key Words: Rural drinking water

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.

Safety management by walking around (SMBWA): a safety intervention program based on both peer and manager participation.

PubMed

Luria, Gil; Morag, Ido

2012-03-01

"Management by walking around" (MBWA) is a practice that has aroused much interest in management science and practice. The purpose of this study is to demonstrate adaptation of this practice to safety management. We describe a three-year long case study that collected empirical data in which a modified MBWA was practiced in order to improve safety in a semiconductor fabrication facility. The main modification involved integrating an information system with the MBWA in order to create a practice that would generate safety leadership development and an organizational safety learning mechanism, while promoting employee safety participation. The results of the case study demonstrate that the SMBWA practice facilitated thousands of tours in which safety leadership behaviors were practiced by managers and by employees (employees performed five times as many tours as managers). The information system collected information about safety behaviors and safety conditions that could not otherwise be obtained. Thus, this study presents a new organizational safety practice SMBWA, and demonstrates the ways in which SMBWA may improve safety in organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Safety assessment in pediatric studies.

PubMed

Koren, Gideon; Elzagallaai, Abdelbasset; Etwel, Fatma

2011-01-01

It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.

Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

PubMed

Gyekye, Seth Ayim; Haybatollahi, Mohammad

2014-01-01

This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

Towards patient safety in anaesthesia.

PubMed

Cooper, J B

1994-07-01

The anaesthesia specialty has focused on the safety of the patient and examination of untoward outcomes. Serious injuries are now rare in medically advanced countries. Still, anaesthesia deaths and complications are important because the anaesthetic itself has no intended therapeutic effect. Safety is a never-ending battle that requires continued effort because many forces have the potential to diminish whatever progress is made. This paper describes the modern movement in anaesthesia patient safety--the reasons it started, the major foci and explanations for why anaesthesia seems now to be safer than at any time in history. The American legal system, critical incident studies, studies of malpractice claims and large-scale studies of anaesthesia outcomes played a role in increasing the awareness of the need to enhance anaesthesia safety. Many efforts are believed to have contributed to improvements in the safety of anaesthesia: improved training of anaesthesia clinicians, new pharmaceuticals, new technologies for monitoring (especially pulse oximetry and capnography), standards for monitoring and other aspects of anaesthesia care, safety enhancements in anaesthesia equipment and the implementation of quality assurance and risk management programmes. The creation of the Anesthesia Patient Safety Foundation in the United States and a similar organization in Australia have helped to bring about awareness of safety issues and to support study of patient safety. Ultimately, the motto of the Anesthesia Patient Safety Foundation should be the goal of all anaesthesia professionals: "That no patient shall be harmed by anaesthesia".

Safety Challenges and Improvement Strategies of Ethnic Minority Construction Workers: A Case Study in Hong Kong.

PubMed

Wu, Chunlin; Luo, Xiaowei; Wang, Tao; Wang, Yue; Sapkota, Bibek

2018-04-18

Due to cultural differences, ethnic minority construction workers are more difficult to manage and more vulnerable to accidents. This study aims to identify the major barriers faced by ethnic minority workers from their own perspectives and determine potential strategies to enhance safety climate of construction projects, thus ultimately improve their safety performance. A survey with modified Nordic safety climate questionnaire was conducted in a certain sub-contractor in Hong Kong. In-depth interviews, status quo description, major challenge investigation and safety knowledge tests were carried as well. The top three most important safety challenges identified are improper stereotypes from the whole industry, lack of opportunities for job assignment, and language barriers. To improve the safety performance, employers should allocate sufficient personal protective equipment and governments should organize unannounced site visits more frequently. Besides, the higher-level management should avoid giving contradictory instructions to foremen against to the standards of supervisors.

Real-time differential GPS/GLONASS trials in Europe using all-in-view 20-channel receivers

NASA Astrophysics Data System (ADS)

Capaccio, S.; Lowe, D.; Walsh, D. M. A.; Daly, P.

Following the initial development of 20-channel, all-in-view Global Navigation Satellite System (GNSS), GPS/GLONASS/Inmarsat-3, receivers at the Institute of Satellite Navigation (ISN), University of Leeds, a modification programme has been undertaken to allow real-time differential corrections to be sent from one 20-channel receiver to another identical receiver using a serial link between them. The differential correction software incorporates the RTCM SC-104 and RTCA DO-217 format developed specifically for GPS and adjusted by the ISN to allow simultaneous GLONASS operation.After successful laboratory testing, real-time differential GNSS tests were successfully completed in static mode between Aberdeen and Leeds via the SkyFix differential data-link, and in dynamic mode at DTEO Boscombe Down using a C-band data-link between the ground and a receiver on board the DRA BAC 1-11 aircraft. The aims of the tests were, (i) to demonstrate real-time differential GNSS position-fixing, (ii) to establish the accuracy improvements brought about, and (iii) to examine the effects of data-link latency and satellite PDOP on the solution accuracy.

Applying health education theory to patient safety programs: three case studies.

PubMed

Gilkey, Melissa B; Earp, Jo Anne L; French, Elizabeth A

2008-04-01

Program planning for patient safety is challenging because intervention-oriented surveillance data are not yet widely available to those working in this nascent field. Even so, health educators are uniquely positioned to contribute to patient safety intervention efforts because their theoretical training provides them with a guide for designing and implementing prevention programs. This article demonstrates the utility of applying health education concepts from three prominent patient safety campaigns, including the concepts of risk perception, community participation, and social marketing. The application of these theoretical concepts to patient safety programs suggests that health educators possess a knowledge base and skill set highly relevant to patient safety and that their perspective should be increasingly brought to bear on the design and evaluation of interventions that aim to protect patients from preventable medical error.

Pipeline Transportation Safety : Volume I, NTSB Reports, Studies, and Recommendations, 1970-1979

DOT National Transportation Integrated Search

1980-09-01

This document provides a compendium of all National Transportation Safety Board (NTSB) Pipeline Accident Reports (PAR) and Pipeline. Special Studies (PSS) published from 1970 through 1979. Abstracts, accident causes, and NTSB recommendations are incl...

Assumptions made when preparing drug exposure data for analysis have an impact on results: An unreported step in pharmacoepidemiology studies.

PubMed

Pye, Stephen R; Sheppard, Thérèse; Joseph, Rebecca M; Lunt, Mark; Girard, Nadyne; Haas, Jennifer S; Bates, David W; Buckeridge, David L; van Staa, Tjeerd P; Tamblyn, Robyn; Dixon, William G

2018-04-17

Real-world data for observational research commonly require formatting and cleaning prior to analysis. Data preparation steps are rarely reported adequately and are likely to vary between research groups. Variation in methodology could potentially affect study outcomes. This study aimed to develop a framework to define and document drug data preparation and to examine the impact of different assumptions on results. An algorithm for processing prescription data was developed and tested using data from the Clinical Practice Research Datalink (CPRD). The impact of varying assumptions was examined by estimating the association between 2 exemplar medications (oral hypoglycaemic drugs and glucocorticoids) and cardiovascular events after preparing multiple datasets derived from the same source prescription data. Each dataset was analysed using Cox proportional hazards modelling. The algorithm included 10 decision nodes and 54 possible unique assumptions. Over 11 000 possible pathways through the algorithm were identified. In both exemplar studies, similar hazard ratios and standard errors were found for the majority of pathways; however, certain assumptions had a greater influence on results. For example, in the hypoglycaemic analysis, choosing a different variable to define prescription end date altered the hazard ratios (95% confidence intervals) from 1.77 (1.56-2.00) to 2.83 (1.59-5.04). The framework offers a transparent and efficient way to perform and report drug data preparation steps. Assumptions made during data preparation can impact the results of analyses. Improving transparency regarding drug data preparation would increase the repeatability, reproducibility, and comparability of published results. © 2018 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

A study of leading indicators for occupational health and safety management systems in healthcare.

PubMed

Almost, Joan M; VanDenKerkhof, Elizabeth G; Strahlendorf, Peter; Caicco Tett, Louise; Noonan, Joanna; Hayes, Thomas; Van Hulle, Henrietta; Adam, Ryan; Holden, Jeremy; Kent-Hillis, Tracy; McDonald, Mike; Paré, Geneviève C; Lachhar, Karanjit; Silva E Silva, Vanessa

2018-04-23

In Ontario, Canada, approximately $2.5 billion is spent yearly on occupational injuries in the healthcare sector. The healthcare sector has been ranked second highest for lost-time injury rates among 16 Ontario sectors since 2009 with female healthcare workers ranked the highest among all occupations for lost-time claims. There is a great deal of focus in Ontario's occupational health and safety system on compliance and fines, however despite this increased focus, the injury statistics are not significantly improving. One of the keys to changing this trend is the development of a culture of healthy and safe workplaces including the effective utilization of leading indicators within Occupational Health and Safety Management Systems (OHSMSs). In contrast to lagging indicators, which focus on outcomes retrospectively, a leading indicator is associated with proactive activities and consists of selected OHSMSs program elements. Using leading indicators to measure health and safety has been common practice in high-risk industries; however, this shift has not occurred in healthcare. The aim of this project is to conduct a longitudinal study implementing six elements of the Ontario Safety Association for Community and Healthcare (OSACH) system identified as leading indicators and evaluating the effectiveness of this intervention on improving selected health and safety workplace indicators. A quasi-experimental longitudinal research design will be used within two Ontario acute care hospitals. The first phase of the study will focus on assessing current OHSMSs using the leading indicators, determining potential facilitators and barriers to changing current OHSMSs, and identifying the leading indicators that could be added or changed to the existing OHSMS in place. Phase I will conclude with the development of an intervention designed to support optimizing current OHSMSs in participating hospitals based on identified gaps. Phase II will pilot test and evaluate the tailored

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.

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.

PubMed

Chhatbar, Pratik Y; Chen, Rong; Deardorff, Rachael; Dellenbach, Blair; Kautz, Steven A; George, Mark S; Feng, Wuwei

A prior meta-analysis revealed that higher doses of transcranial direct current stimulation (tDCS) have a better post-stroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability of single session of up to 4 mA in stroke patients. We adapted a traditional 3 + 3 study design with a current escalation schedule of 1»2»2.5»3»3.5»4 mA for this tDCS safety study. We administered one 30-min session of bihemispheric montage tDCS and simultaneous customary occupational therapy to patients with first-ever ischemic stroke. We assessed safety with pre-defined stopping rules and investigated tolerability through a questionnaire. Additionally, we monitored body resistance and skin temperature in real-time at the electrode contact site. Eighteen patients completed the study. The current was escalated to 4 mA without meeting the pre-defined stopping rules or causing any major safety concern. 50% of patients experienced transient skin redness without injury. No rise in temperature (range 26°C-35 °C) was noted and skin barrier function remained intact (i.e. body resistance >1 kΩ). Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients. A phase II study to further test the safety and preliminary efficacy with multi-session tDCS at 4 mA (as compared with lower current and sham stimulation) is a logical next step. ClinicalTrials.gov Identifier: NCT02763826. Copyright © 2017 Elsevier Inc. 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.

Safety studies on vacuum insulated liquid helium cryostats

NASA Astrophysics Data System (ADS)

Weber, C.; Henriques, A.; Zoller, C.; Grohmann, S.

2017-12-01

The loss of insulating vacuum is often considered as a reasonable foreseeable accident for the dimensioning of cryogenic safety relief devices (SRD). The cryogenic safety test facility PICARD was designed at KIT to investigate such events. In the course of first experiments, discharge instabilities of the spring loaded safety relief valve (SRV) occurred, the so-called chattering and pumping effects. These instabilities reduce the relief flow capacity, which leads to impermissible over-pressures in the system. The analysis of the process dynamics showed first indications for a smaller heat flux than the commonly assumed 4W/cm2. This results in an oversized discharge area for the reduced relief flow rate, which corresponds to the lower heat flux. This paper presents further experimental investigations on the venting of the insulating vacuum with atmospheric air under variation of the set pressure (p set) of the SRV. Based on dynamic process analysis, the results are discussed with focus on effective heat fluxes and operating characteristics of the spring-loaded SRV.

A Medication Safety Model: A Case Study in Thai Hospital

PubMed Central

Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha

2013-01-01

Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110

Sample size for post-marketing safety studies based on historical controls.

PubMed

Wu, Yu-te; Makuch, Robert W

2010-08-01

As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

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.

Immortal time bias in observational studies of drug effects in pregnancy.

PubMed

Matok, Ilan; Azoulay, Laurent; Yin, Hui; Suissa, Samy

2014-09-01

The use of decongestants during the second or third trimesters of pregnancy has been associated with a decreased risk of preterm delivery in two observational studies. This effect may have been subject to immortal time bias, a bias arising from the improper classification of exposure during follow-up. We illustrate this bias by repeating the studies using a different data source. The United Kingdom Hospital Episodes Statistics and the Clinical Practice Research Datalink databases were linked to identify all live singleton pregnancies among women aged 15 to 45 years between 1997 and 2012. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals of preterm delivery (before 37 weeks of gestation) by considering the use of decongestants during the third trimester as a time-fixed (biased analysis which misclassifies unexposed person-time as exposed person-time) and time-varying exposure (unbiased analysis with proper classification of unexposed person-time). All models were adjusted for maternal age, smoking status, maternal diabetes, maternal hypertension, preeclampsia, and parity. Of the 195,582 singleton deliveries, 10,248 (5.2%) were born preterm. In the time-fixed analysis, the HR of preterm delivery for the use of decongestants was below the null and suggestive of a 46% decreased risk (adjusted HR = 0.54; 95% confidence interval, 0.24-1.20). In contrast, the HR was closer to null (adjusted HR = 0.93 95% confidence interval, 0.42-2.06) when the use of decongestants was treated as a time-varying variable. Studies of drug safety in pregnancy should use the appropriate statistical techniques to avoid immortal time bias, particularly when the exposure occurs at later stages of pregnancy. © 2014 Wiley Periodicals, Inc.

Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data.

PubMed

D'Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D'Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

2015-01-01

Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. The overall safety profile of glycopyrronium was similar to its comparators indicating no

The Perception, Level of Safety Satisfaction and Safety Feedback on Occupational Safety and Health Management among Hospital Staff Nurses in Sabah State Health Department.

PubMed

Cheah, Whye Lian; Giloi, Nelbon; Chang, Ching Thon; Lim, Jac Fang

2012-07-01

This study aimed to determine the perception and level of safety satisfaction of staff nurses with regards to Occupational Safety and Health (OSH) management practice in the Sabah Health Department, and to associate the OSH management dimensions, to Safety Satisfaction and Safety Feedback. A cross-sectional study using a validated self-administered questionnaire was conducted among randomly respondents. 135 nurses responded the survey. Mean (SD) score for each dimension ranged from 1.70 ± 0.68-4.04 ± 0.65, with Training and Competence dimension (mean [SD], 4.04 ± 0.65) had the highest while Safety Incidence was the least score (mean [SD], 1.70 ± 0.68). Both mean (SD) scores for Safety Satisfaction and Safety Feedback was high, 3.28 ± 0.51 and 3.57 ± 0.73, respectively. Pearson's correlation analysis indicated that all OSH dimensions had significant correlation with Safety Satisfaction and Safety Feedback (r coefficient ranged from 0.176-0.512) except for Safety Incidence. The overall perception of OSH management was rather low. Significant correlation between Safety Satisfaction and Safety Feedback and several dimensions, suggest that each organization to put in place the leaders who have appropriate leadership and supervisory skills and committed in providing staff training to improve staff's competency in OSH practice. In addition, clear goals, rules, and reporting system will help the organization to implement proper OSH management practice.

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.

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

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

PubMed

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

2016-01-01

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

Safety behavior: Job demands, job resources, and perceived management commitment to safety.

PubMed

Hansez, Isabelle; Chmiel, Nik

2010-07-01

The job demands-resources model posits that job demands and resources influence outcomes through job strain and work engagement processes. We test whether the model can be extended to effort-related "routine" safety violations and "situational" safety violations provoked by the organization. In addition we test more directly the involvement of job strain than previous studies which have used burnout measures. Structural equation modeling provided, for the first time, evidence of predicted relationships between job strain and "routine" violations and work engagement with "routine" and "situational" violations, thereby supporting the extension of the job demands-resources model to safety behaviors. In addition our results showed that a key safety-specific construct 'perceived management commitment to safety' added to the explanatory power of the job demands-resources model. A predicted path from job resources to perceived management commitment to safety was highly significant, supporting the view that job resources can influence safety behavior through both general motivational involvement in work (work engagement) and through safety-specific processes.

Understanding parental motivators and barriers to uptake of child poison safety strategies: a qualitative study.

PubMed

Gibbs, L; Waters, E; Sherrard, J; Ozanne-Smith, J; Robinson, J; Young, S; Hutchinson, A

2005-12-01

To develop an understanding of factors acting as barriers and motivators to parental uptake of child poison safety strategies. A qualitative study involving semistructured interviews and focus groups. A grounded theory approach was used for the collection and analysis of data. Sixty five parents of children under 5 years of age, some of whom had experienced an unintentional child poisoning incident. A range of knowledge based, environmental, and behavioral barriers to comprehensive parental uptake of poison safety practices were identified. As a result there tended to be only partial implementation of safety initiatives in the home. Selection of safety practices was often guided by the interests and behaviors of the child. This made the child vulnerable to changes in the home environment, inadequate supervision, and/or shifts in their own behavior and developmental ability. Personal or vicarious exposure of a parent to a child poisoning incident was a significant motivator for parental review of safety practices. Environmental measures targeting child resistant containers, warning labels, and lockable poisons cupboards will support parents' efforts to maintain poison safety. Additional education campaigns using stories of actual poisoning incidents may help to increase awareness of risk and encourage increased uptake.

Note on evaluating safety performance of road infrastructure to motivate safety competition.

PubMed

Han, Sangjin

2016-01-01

Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

Healthcare databases in Europe for studying medicine use and safety during pregnancy.

PubMed

Charlton, Rachel A; Neville, Amanda J; Jordan, Sue; Pierini, Anna; Damase-Michel, Christine; Klungsøyr, Kari; Andersen, Anne-Marie Nybo; Hansen, Anne Vinkel; Gini, Rosa; Bos, Jens H J; Puccini, Aurora; Hurault-Delarue, Caroline; Brooks, Caroline J; de Jong-van den Berg, Lolkje T W; de Vries, Corinne S

2014-06-01

The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

A Study on Urban Road Traffic Safety Based on Matter Element Analysis