Sample records for safety information immune

  1. Factors influencing African-American mothers' concerns about immunization safety: a summary of focus group findings.

    PubMed Central

    Shui, Irene; Kennedy, Allison; Wooten, Karen; Schwartz, Benjamin; Gust, Deborah

    2005-01-01

    OBJECTIVE: To examine the vaccine safety concerns of African-American mothers who, despite concerns, have their children immunized. METHODS: Six focus groups of Atlanta-area African-American mothers who were very concerned about vaccine safety but whose children were fully vaccinated were conducted. RESULTS: Major factors influencing participants' concerns about immunizations included: lack of information and mistrust of the medical community and government. Factors that convinced parents to have their child immunized despite their concerns included social norms and/or laws supporting immunization and fear of the consequences of not immunizing. Suggestions given to reduce concerns included improving available information that addressed their concerns and provider-patient communication. CONCLUSIONS: Addressing mothers' concerns about immunization is important both from an ethical perspective, in assuring that they are fully informed of the risks and benefits of immunizations, as well as from a practical one, in reducing the possibility that they will decide not to immunize their child. Changes in the childhood immunization process should be made to reduce parental concern about vaccine safety. Some changes that may be considered include improved provider communication about immunizations and additional tailored information about the necessity and safety of vaccines. PMID:15926642

  2. Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.

    PubMed

    Baker, Meghan A; Nguyen, Michael; Cole, David V; Lee, Grace M; Lieu, Tracy A

    2013-12-30

    The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data. We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates. The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data. Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases. PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring. Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Immunization Information System and Informatics to Promote Immunizations: Perspective From Minnesota Immunization Information Connection.

    PubMed

    Muscoplat, Miriam Halstead; Rajamani, Sripriya

    2017-01-01

    The vision for management of immunization information is availability of real-time consolidated data and services for all ages, to clinical, public health, and other stakeholders. This is being executed through Immunization Information Systems (IISs), which are population-based and confidential computerized systems present in most US states and territories. Immunization Information Systems offer many functionalities, such as immunization assessment reports, client follow-up, reminder/recall feature, vaccine management tools, state-supplied vaccine ordering, comprehensive immunization history, clinical decision support/vaccine forecasting and recommendations, data processing, and data exchange. This perspective article will present various informatics tools in an IIS, in the context of the Minnesota Immunization Information Connection.

  4. Immunization safety in US print media, 1995-2005.

    PubMed

    Hussain, Hamidah; Omer, Saad B; Manganello, Jennifer A; Kromm, Elizabeth Edsall; Carter, Terrell C; Kan, Lilly; Stokley, Shannon; Halsey, Neal A; Salmon, Daniel A

    2011-05-01

    To identify and describe vaccine safety in US newspaper articles. Articles (1147) from 44 states and Washington, DC, between January 1, 1995, and July 15, 2005, were identified by using the search terms "immunize or vaccine" and "adverse events or safety or exemption or danger or risk or damage or injury or side effect" and were coded by using a standardized data-collection instrument. The mean number of vaccine-safety articles per state was 26. Six (not mutually exclusive) topics were identified: vaccine-safety concerns (46%); vaccine policy (44%); vaccines are safe (20%); immunizations are required (10%); immunizations are not required (8%); and state/school exemption (8%). Three spikes in the number of newspaper articles about vaccine-safety issues were observed: in 1999 regarding rotavirus vaccine and in 2002 and 2003 regarding smallpox vaccine. Excluding articles that referred to rotavirus and smallpox vaccines, 37% of the articles had a negative take-home message. Ongoing monitoring of news on vaccine safety may help the content and framing of vaccine-safety messages.

  5. The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.

    PubMed Central

    Chen, R. T.; DeStefano, F.; Davis, R. L.; Jackson, L. A.; Thompson, R. S.; Mullooly, J. P.; Black, S. B.; Shinefield, H. R.; Vadheim, C. M.; Ward, J. I.; Marcy, S. M.

    2000-01-01

    The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field. PMID:10743283

  6. The safety of maternal immunization

    PubMed Central

    Regan, Annette K.

    2016-01-01

    ABSTRACT Maternal vaccination offers the opportunity to protect pregnant women and their infants against potentially serious disease. As both pregnant women and their newborns are vulnerable to severe illness, the potential public health impact of mass maternal vaccination programs is remarkable. Several high-income countries recommend seasonal influenza and acellular pertussis vaccines, and many developing countries recommend immunization against tetanus during pregnancy. There is a significant amount of literature supporting the safety of vaccination during pregnancy. As other vaccines are newly introduced for pregnant women, routine systems for monitoring vaccine safety in pregnant women are needed. To facilitate meta-analyses and comparison across systems and studies, future research and surveillance initiatives should utilize the same criteria for defining adverse events following immunization among pregnant women. At least 2 areas require further exploration: 1) identification of pregnancy outcomes associated with concomitant and closely spaced vaccines; 2) evaluation of possible improvement in birth outcomes associated with maternal vaccination. Given the public health impact of maternal vaccination, the existing evidence supporting the safety of vaccination during pregnancy should be used to reassure pregnant women and their providers and improve vaccine uptake in pregnancy. PMID:27541370

  7. The National Immunization Information Hotline.

    PubMed

    Gust, D A; Gangarosa, P; Hibbs, B; Wilkins, C; Ford, K; Stuart, M; Brown-Bryant, R; Wallach, G; Chen, R T

    2004-01-01

    The National Immunization Information Hotline (NIIH) has been providing information regarding immunizations to the public and to health care professionals since March 1997. We describe the operations of the NIIH, its experience over the first two and a half years of operation and lessons learned for other immunization hotlines. From 1998-2000, the hotline answered 246,859 calls. Calls concerning immunization information requests totaled 175,367; data about the calls were collected from 35,102. Approximately a third of the 35,102 calls were from health care providers. Of the remaining calls from the public, the greatest number of calls concerned childhood immunizations. Immunization schedule queries from the public increased 323.0% from 1998 to 2000. While the major goal of the NIIH is to provide accurate and reliable information to the public and to health care providers, data from the hotline can be used to monitor changes over time in calls concerning inquiries about the immunization schedule in addition to other variables of interest.

  8. Progress in immunization information systems--United States, 2011.

    PubMed

    2013-01-25

    Immunization information systems (IIS) are confidential, computerized, population-based systems that collect and consolidate vaccination data from vaccination providers and provide important tools for designing and sustaining effective immunization strategies. A Healthy People 2020 objective (IID-18) is to increase to 95% the proportion of children aged <6 years whose immunization records are in fully operational, population-based IIS. The National Vaccine Advisory Committee (NVAC) has published goals for IIS, including required and optional core data elements for which IIS should collect information. Two of the required core data elements are vaccine manufacturer and vaccine lot number. To monitor progress toward achieving these and other program goals, CDC annually surveys 56 immunization program grantees using the IIS Annual Report (IISAR). Results from the 2011 IISAR (completed by 54 grantees) indicate that 84% (19.2 million) of U.S. children aged <6 years participated in IIS, as defined by having at least two recorded vaccinations, an increase from 82% (18.8 million) in 2010. Grantees reported that an average of 63% of vaccination records for these children contained data in the field for vaccine manufacturer and 60% contained data in the field for lot number. A new project under way to capture vaccine product information, expiration date, and lot number on two-dimensional (2D) barcodes on vaccine vials might increase completeness, accuracy, and availability of these data elements in patient medical records and IIS, which in turn might enhance vaccine safety and support vaccine inventory management.

  9. Historical aspects of immunization and vaccine safety communication.

    PubMed

    Helfert, Stephanie M

    2015-01-01

    It has been a long journey starting from the beginnings of variolation [3] leading up to the greatest success in the history of immunization: the eradication of smallpox [39]. Today, vaccines are an acknowledged important medical advance [40]. Nevertheless, immunization has been the subject of public controversy on several occasions [15, 24, 31]. This article shall provide a short overview of some aspects of the early stages of immunization in Western countries, including some examples of vaccine safety controversies in the past.

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

    PubMed

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

    2016-02-15

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

  11. Communicating vaccine safety in the context of immunization programs in low resource settings.

    PubMed

    Arwanire, Edison M; Mbabazi, William; Mugyenyi, Possy

    2015-01-01

    Vaccines are effective in preventing infectious diseases and their complications, hence reducing morbidity and infectious disease mortaity. Successful immunization programs, however, depend on high vaccine acceptance and coverage rates. In recent years there has been an increased level of public concern towards real or perceived adverse events associated with immunizations, leading to many people in high- as well as low-resource settings to refuse vaccines. Health care workers therefore must be able to provide parents and guardians of children with the most current and accurate information about the benefits and risks of vaccination. Communicating vaccine safety using appropriate channels plays a crucial role in maintaining public trust and confidence in vaccination programs. Several factors render this endeavor especially challenging in low-resource settings where literacy rates are low and access to information is often limited. Many languages are spoken in most countries in low-resource settings, making the provision of appropriate information difficult. Poor infrastructure often results in inadequate logistics. Recently, some concerned consumer groups have been able to propagate misinformation and rumors. To successfully communicate vaccine safety in a resource limited setting it is crucial to use a mix of communication channels that are both culturally acceptable and effective. Social mobilization through cultural, administrative and political leaders, the media or text messages (SMS) as well as the adoption of the Village Health Team (VHT) strategy whereby trained community members (Community Health Workers (CHWs)) are providing primary healthcare, can all be effective in increasing the demand for immunization.

  12. National Network for Immunization Information

    MedlinePlus

    NNii's mission is to provide the best possible science-based information to everyone who needs to know the facts about immunization. NNii believes that immunization is one of the most important ways to protect against serious infectious diseases. We ...

  13. Protective Immunity and Safety of a Genetically Modified Influenza Virus Vaccine

    PubMed Central

    Garcia, Cristiana Couto; Filho, Bruno Galvão; Gonçalves, Ana Paula de Faria; Lima, Braulio Henrique Freire; Lopes, Gabriel Augusto Oliveira; Rachid, Milene Alvarenga; Peixoto, Andiara Cristina Cardoso; de Oliveira, Danilo Bretas; Ataíde, Marco Antônio; Zirke, Carla Aparecida; Cotrim, Tatiane Marques; Costa, Érica Azevedo; Almeida, Gabriel Magno de Freitas; Russo, Remo Castro; Gazzinelli, Ricardo Tostes; Machado, Alexandre de Magalhães Vieira

    2014-01-01

    Recombinant influenza viruses are promising viral platforms to be used as antigen delivery vectors. To this aim, one of the most promising approaches consists of generating recombinant viruses harboring partially truncated neuraminidase (NA) segments. To date, all studies have pointed to safety and usefulness of this viral platform. However, some aspects of the inflammatory and immune responses triggered by those recombinant viruses and their safety to immunocompromised hosts remained to be elucidated. In the present study, we generated a recombinant influenza virus harboring a truncated NA segment (vNA-Δ) and evaluated the innate and inflammatory responses and the safety of this recombinant virus in wild type or knock-out (KO) mice with impaired innate (Myd88 -/-) or acquired (RAG -/-) immune responses. Infection using truncated neuraminidase influenza virus was harmless regarding lung and systemic inflammatory response in wild type mice and was highly attenuated in KO mice. We also demonstrated that vNA-Δ infection does not induce unbalanced cytokine production that strongly contributes to lung damage in infected mice. In addition, the recombinant influenza virus was able to trigger both local and systemic virus-specific humoral and CD8+ T cellular immune responses which protected immunized mice against the challenge with a lethal dose of homologous A/PR8/34 influenza virus. Taken together, our findings suggest and reinforce the safety of using NA deleted influenza viruses as antigen delivery vectors against human or veterinary pathogens. PMID:24927156

  14. [Evaluation of safety of haemophilus influenza type b(Hib) conjugate vaccine in postmarketing based on the immunization information management system].

    PubMed

    Wang, Zhiguo; Ma, Fubao; Zhang, Jinlin; Yu, Jing; Kang, Guodong; Gao, Jun

    2015-06-01

    To analyze the occurrence feature of adverse events following immunization (AEFI) of Hib conjugate vaccine (HibCV) and to evaluate the safety of HibCV in postmarketing. 2008-2013 HibCV AEFI data were collected through national AEFI information management system, which were downloaded in March 18, 2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of (χ² tests. A total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaccinees reported having adverse event, for a rate of 76.60/100 000 (95% CI: 74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000 (95% CI: 68.99/100 000-73.20/100 000) and 5.16/100 000 (95% CI: 4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever, swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000, 35.09/100 000, 12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination. The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001) (χ² = 74.92, P < 0.001). The incidence rate of common

  15. Safety of immunization injections in Africa: not simply a problem of logistics.

    PubMed Central

    Dicko, M.; Oni, A. Q.; Ganivet, S.; Kone, S.; Pierre, L.; Jacquet, B.

    2000-01-01

    In 1995, the WHO Regional Office for Africa launched a logistics project to address the four main areas of immunization logistics: the cold chain, transport, vaccine supply and quality, and the safety of injections in the countries of the region. The impact of this logistic approach on immunization injection safety was evaluated through surveys of injection procedures and an analysis of the injection materials (e.g. sterilizable or disposable syringes) chosen by the Expanded Programme on Immunization (EPI) and those actually seen to be used. Re-use of injection materials without sterilization, accidental needle-stick injuries among health care workers, and injection-related abscesses in patients were common in countries in the WHO African Region. Few health centres used time-steam saturation-temperature (TST) indicators to check the quality of sterilization and, in many centres, the injection equipment was boiled instead of being steam sterilized. Facilities for the proper disposal of used materials were rarely present. Although the official EPI choice was to use sterilizable equipment, use of a combination of sterilizable and disposable equipment was observed in the field. Unsafe injection practices in these countries were generally due to a failure to integrate nursing practices and public awareness with injection safety issues, and an absence of the influence of EPI managers on health care service delivery. Holistic rather than logistic approaches should be adopted to achieve safe injections in immunization, in the broader context of promoting safe vaccines and safety of all injections. PMID:10743280

  16. Surveillance of adverse effects following vaccination and safety of immunization programs.

    PubMed

    Waldman, Eliseu Alves; Luhm, Karin Regina; Monteiro, Sandra Aparecida Moreira Gomes; Freitas, Fabiana Ramos Martin de

    2011-02-01

    The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.

  17. Validation of the French national health insurance information system as a tool in vaccine safety assessment: application to febrile convulsions after pediatric measles/mumps/rubella immunization.

    PubMed

    Hanf, Matthieu; Quantin, Catherine; Farrington, Paddy; Benzenine, Eric; Hocine, N Mounia; Velten, Michel; Tubert-Bitter, Pascale; Escolano, Sylvie

    2013-12-02

    In the French national health insurance information system (SNIIR-AM), routine records of health claimed reimbursements are linked to hospital admissions for the whole French population. The main focus of this work is the usability of this system for vaccine safety assessment programme. Self-controlled case series analyses were performed using an exhaustive SNIIR-AM extraction of French children aged less than 3 years, to investigate the relationship between MMR immunization and children hospitalizations for febrile convulsions, a well-documented rare adverse event, over 2009-2010. The results suggest a significant increase of febrile convulsions during the 6-11 days period following any MMR immunization (IRR=1.49, 95% CI=1.22, 1.83; p=0.0001) and no increase 15-35 days post any MMR immunization (IRR=1.03, 95% CI=0.89, 1.18; p=0.72). These results are in accordance with other results obtained from large epidemiologic studies, which suggest the usability of the SNIIR-AM as a relevant database to study the occurrence of adverse events associated with immunization. For future use, results associated with risk of convulsion during the day of vaccination should nevertheless be considered with particular caution. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. State-Level Immunization Information Systems: Potential for Childhood Immunization Data Linkages.

    PubMed

    Fuller, Jill E; Walter, Emmanuel B; Dole, Nancy; O'Hara, Richard; Herring, Amy H; Durkin, Maureen S; Specker, Bonny; Wey, Betty

    2017-01-01

    Objectives Sources of immunization data include state registries or immunization information systems (IIS), medical records, and surveys. Little is known about the quality of these data sources or the feasibility of using IIS data for research. We assessed the feasibility of collecting immunization information for a national children's health study by accessing existing IIS data and comparing the completeness of these data against medical record abstractions (MRA) and parent report. Staff time needed to obtain IIS and MRA data was assessed. Methods We administered a questionnaire to state-level IIS representatives to ascertain availability and completeness of their data for research and gather information about data formats. We evaluated quality of data from IIS, medical records, and reports from parents of 119 National Children's Study participants at three locations. Results IIS data were comparable to MRA data and both were more complete than parental report. Agreement between IIS and MRA data was greater than between parental report and MRA, suggesting IIS and MRA are better sources than parental report. Obtaining IIS data took less staff time than chart review, making IIS data linkage for research a preferred choice. Conclusions IIS survey results indicate data can be obtained by researchers using data linkages. IIS are an accessible and feasible child immunization information source and these registries reduce reliance on parental report or medical record abstraction. Researchers seeking to link IIS data with large multi-site studies should consider acquiring IIS data, but may need strategies to overcome barriers to data completeness and linkage.

  19. Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment Network (CISA) 2004-2009

    PubMed Central

    Williams, S Elizabeth; Klein, Nicola P; Halsey, Neal; Dekker, Cornelia L; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Sparks, Robert C; Tokars, Jerome I; Pahud, Barbara A; Aukes, Laurie; Jakob, Kathleen; Coronel, Silvia; Choi, Howard; Slade, Barbara A; Edwards, Kathryn M

    2016-01-01

    Background In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. PMID:21801776

  20. Therapeutic Immunization In HIV Infected Ugandans Receiving Stable Antiretroviral Treatment: A Phase I Safety Study4

    PubMed Central

    Kityo, Cissy; Bousheri, Stephanie; Akao, Juliette; Ssali, Francis; Byaruhanga, Rose; Ssewanyana, Isaac; Muloma, Prossy; Myalo, Sula; Magala, Rose; Lu, Yichen; Mugyenyi, Peter; Cao, Huyen

    2011-01-01

    Therapeutic immunizations in HIV infection may boost immunity during antiretroviral treatment. We report on the first therapeutic vaccine trial in Uganda, Africa. This open label Phase I trial was designed to assess the safety, tolerability and immunogenicity of a therapeutic HIV-1 vaccine candidate. Thirty HIV positive volunteers receiving a stable regimen of antiretroviral therapy with CD4 counts > 400 were recruited for the safety evaluation of LFn-p24C, a detoxified anthrax-derived polypeptide fused to the subtype C HIV gag protein p24. The vaccine was well tolerated and HIV RNA levels remained undetectable following three immunizations. CD4 counts in vaccine recipients were significantly higher compared to the control individuals after 12 months. HIV-specific responses were associated with higher gain in CD4 counts following LFn-p24C immunizations. Volunteers were subsequently asked to undergo a 30-day period of observed treatment interruption. 8/24 (30%) individuals showed no evidence of viral rebound during treatment interruption. All demonstrated prompt suppression of viral load following resumption of ART. Our data demonstrates the safety of LFn-p24C and suggests that adjunct therapeutic immunization may benefit select individuals in further boosting an immune response. PMID:21211581

  1. Vaccine Safety Resources for Nurses

    PubMed Central

    Shimabukuro, Tom T.; Hibbs, Beth F.; Moro, Pedro L.; Broder, Karen R.; Vellozzi, Claudia

    2015-01-01

    Overview Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. PMID:26222474

  2. Parental vaccine concerns, information source, and choice of alternative immunization schedules.

    PubMed

    Wheeler, Marissa; Buttenheim, Alison M

    2013-08-01

    Alternative immunization schedules increase the time a child is unvaccinated and require greater resources from providers. Understanding what drives interest in alternative immunization schedules can potentially inform the design of effective, targeted messages that help to reduce time spent counseling and decrease requests for alternative immunization schedules. This study used the Theory of Planned Behavior to explore associations between sources of vaccine information, parental vaccine concerns, peer norms for vaccine behavior and intentions to follow an alternative immunization schedule. We performed logistic regression using medical record data from a private pediatric practice in a large northeastern city. Routine data were recorded in the EMR by the pediatrician during an initial vaccine counseling conversation with the parent(s). Parents who received vaccine information from doctors were less likely to have immunization concerns while parents who got vaccine information from friends and family or from books were more likely to report specific vaccine concerns. Our multivariate analysis shows that number of reported vaccine concerns and concerns about the utility or necessity of vaccines are strongly associated with alternative immunization intentions. We also find a direct relationship between sources of information about vaccines and alternative immunization intentions. Our results suggest that vaccine concerns and non-physician information sources play an important role in alternative immunization intentions while communication from physicians may play an important role in addressing vaccine concerns and promoting adherence to the ACIP immunization schedule.

  3. Parental hesitation in immunizing children in Utah.

    PubMed

    Luthy, Karlen E; Beckstrand, Renea L; Callister, Lynn Clark

    2010-01-01

    To determine why parents in a Utah community hesitated in immunizing their children. Cross-sectional descriptive study. Data were collected from a convenience sample of 86 parents of under-immunized children in the county health department and local pediatric and family practice offices. Participants were asked to complete an immunization hesitancy survey including questions regarding why parents hesitated to immunize their children, parental concerns regarding immunizations, and what advice they would give to a friend or family member who had concerns about childhood vaccines. Parents could also write in any other comment, concern, or suggestion they had regarding childhood immunizations. 2 major themes were identified: concerns regarding immunization safety and lack of perceived need. The most commonly reported concerns regarding immunization safety included autism, immune system overload, and other adverse reactions. Many parents did not recognize the need for childhood immunizations, especially multiple immunizations given simultaneously on a strict timeline. The manner in which immunization information is shared with hesitant parents can be particularly important. There is a need for health care providers to assess and increase parental knowledge regarding immunizations.

  4. Immunization information systems in Canada: Attributes, functionality, strengths and challenges. A Canadian Immunization Research Network study.

    PubMed

    Wilson, Sarah E; Quach, Susan; MacDonald, Shannon E; Naus, Monika; Deeks, Shelley L; Crowcroft, Natasha S; Mahmud, Salaheddin M; Tran, Dat; Kwong, Jeffrey C; Tu, Karen; Johnson, Caitlin; Desai, Shalini

    2017-03-01

    Canada does not have a national immunization registry. Diverse systems to record vaccine uptake exist, but these have not been systematically described. Our objective was to describe the immunization information systems (IISs) and non-IIS processes used to record childhood and adolescent vaccinations, and to outline the strengths and limitations of the systems and processes. We collected information from key informants regarding their provincial, territorial or federal organization's surveillance systems for assessing immunization coverage. Information collection consisted of a self-administered questionnaire and a follow-up interview. We evaluated systems against attributes derived from the literature using content analysis. Twenty-six individuals across 16 public health organizations participated over the period of April to August 2015. Twelve of Canada's 13 provinces and territories (P/Ts) and two organizations involved in health service delivery for on-reserve First Nations people participated. Across systems, there were differences in data collection processes, reporting capabilities and advanced functionality. Commonly cited challenges included timeliness and data completeness of records, particularly for physician-administered immunizations. Privacy considerations and the need for data standards were stated as challenges to the goal of information sharing across P/T systems. Many P/Ts have recently implemented new systems and, in some cases, legislation to improve timeliness and/or completeness. Considerable variability exists among IISs and non-IIS processes used to assess immunization coverage in Canada. Although some P/Ts have already pursued legislative or policy initiatives to address the completeness and timeliness of information, many additional opportunities exist in the information technology realm.

  5. 40 CFR 68.48 - Safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 16 2013-07-01 2013-07-01 false Safety information. 68.48 Section 68...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The owner or operator shall compile and maintain the following up-to-date safety information related to the...

  6. 49 CFR 385.19 - Safety fitness information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...

  7. 49 CFR 385.19 - Safety fitness information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...

  8. Flu Vaccine Safety Information

    MedlinePlus

    ... Types Seasonal Avian Swine Variant Pandemic Other Flu Vaccine Safety Information Questions & Answers Language: English (US) Español ... of flu vaccines monitored? Egg Allergy Are flu vaccines safe? Flu vaccines have good safety record. Hundreds ...

  9. Country Immunization Information System Assessments - Kenya, 2015 and Ghana, 2016.

    PubMed

    Scott, Colleen; Clarke, Kristie E N; Grevendonk, Jan; Dolan, Samantha B; Ahmed, Hussein Osman; Kamau, Peter; Ademba, Peter Aswani; Osadebe, Lynda; Bonsu, George; Opare, Joseph; Diamenu, Stanley; Amenuvegbe, Gregory; Quaye, Pamela; Osei-Sarpong, Fred; Abotsi, Francis; Ankrah, Joseph Dwomor; MacNeil, Adam

    2017-11-10

    The collection, analysis, and use of data to measure and improve immunization program performance are priorities for the World Health Organization (WHO), global partners, and national immunization programs (NIPs). High quality data are essential for evidence-based decision-making to support successful NIPs. Consistent recording and reporting practices, optimal access to and use of health information systems, and rigorous interpretation and use of data for decision-making are characteristics of high-quality immunization information systems. In 2015 and 2016, immunization information system assessments (IISAs) were conducted in Kenya and Ghana using a new WHO and CDC assessment methodology designed to identify root causes of immunization data quality problems and facilitate development of plans for improvement. Data quality challenges common to both countries included low confidence in facility-level target population data (Kenya = 50%, Ghana = 53%) and poor data concordance between child registers and facility tally sheets (Kenya = 0%, Ghana = 3%). In Kenya, systemic challenges included limited supportive supervision and lack of resources to access electronic reporting systems; in Ghana, challenges included a poorly defined subdistrict administrative level. Data quality improvement plans (DQIPs) based on assessment findings are being implemented in both countries. IISAs can help countries identify and address root causes of poor immunization data to provide a stronger evidence base for future investments in immunization programs.

  10. Evaluation of immunization data completeness within a large community health care system exchanging data with a state immunization information system.

    PubMed

    Hendrickson, Bryan K; Panchanathan, Sarada S; Petitti, Diana

    2015-01-01

    Information systems are used by most states to maintain registries of immunization data both for monitoring population-level adherence and for use in clinical practice and research. Direct data exchange between such systems and electronic health record systems presents an opportunity to improve the completeness and quality of information available. Our goals were to describe and compare the completeness of the Arizona State Immunization System, the electronic health record at a large community health provider in Arizona exchanging electronic data with the Arizona system, and personal immunization records in an effort to contribute to the discussion on the completeness of state-run immunization registries and data exchange with these registries. Immunization histories from these sources were collected and reviewed sequentially. Unique dates of vaccination administrations were counted for each patient and tagged on the basis of comparisons across sources. We quantified completeness by combining information from all 3 sources and comparing each source with the complete set. We determined that the state registry was 71.8% complete, the hospital electronic health record was 81.9% complete, and personal records were 87.8% complete. Of the 2017 unique vaccination administrations, 65% were present in all 3 sources, 24.6% in 2 of the 3 sources, and 10.4% in only 1 source. Only 11% of patients had records in complete agreement across the 3 sources. This study highlights issues related to data completeness, exchange, and reporting of immunization information to state registries and suggests that there is some degree of deficiency in completeness of immunization registries and other sources. This study indicates that there is a need to strengthen links between electronic data sources with immunization information and describes potential improvements in completeness that such efforts could provide, enabling providers to better rely on state immunization registries and to

  11. Safety Information, Transportation & Public Facilities, State of Alaska

    Science.gov Websites

    Department of Transportation & Public Facilities/ Safety Information Search DOT&PF State of Alaska DOT&PF> Safety Information DOT&PF Safety Information link to 511 511.alaska.gov - Traveler Information link to AHSO Alaska Highway Safety Office link to HSIP Highway Safety Improvement Program link to

  12. Direct and Electronic Health Record Access to the Clinical Decision Support for Immunizations in the Minnesota Immunization Information System.

    PubMed

    Rajamani, Sripriya; Bieringer, Aaron; Wallerius, Stephanie; Jensen, Daniel; Winden, Tamara; Muscoplat, Miriam Halstead

    2016-01-01

    Immunization information systems (IIS) are population-based and confidential computerized systems maintained by public health agencies containing individual data on immunizations from participating health care providers. IIS hold comprehensive vaccination histories given across providers and over time. An important aspect to IIS is the clinical decision support for immunizations (CDSi), consisting of vaccine forecasting algorithms to determine needed immunizations. The study objective was to analyze the CDSi presentation by IIS in Minnesota (Minnesota Immunization Information Connection [MIIC]) through direct access by IIS interface and by access through electronic health records (EHRs) to outline similarities and differences. The immunization data presented were similar across the three systems examined, but with varying ability to integrate data across MIIC and EHR, which impacts immunization data reconciliation. Study findings will lead to better understanding of immunization data display, clinical decision support, and user functionalities with the ultimate goal of promoting IIS CDSi to improve vaccination rates.

  13. Questions regarding the safety and duration of immunity following live yellow fever vaccination.

    PubMed

    Amanna, Ian J; Slifka, Mark K

    2016-12-01

    The World Health Organization (WHO) and other health agencies have concluded that yellow fever booster vaccination is unnecessary since a single dose of vaccine confers lifelong immunity. Areas covered: We reviewed the clinical studies cited by health authorities in their investigation of both the safety profile and duration of immunity for the YFV-17D vaccine and examined the position that booster vaccination is no longer needed. We found that antiviral immunity may be lost in 1-in-3 to 1-in-5 individuals within 5 to 10 years after a single vaccination and that children may be at greater risk for primary vaccine failure. The safety profile of YFV-17D was compared to other licensed vaccines including oral polio vaccine (OPV) and the rotavirus vaccine, RotaShield, which have subsequently been withdrawn from the US and world market, respectively. Expert commentary: Based on these results and recent epidemiological data on vaccine failures (particularly evident at >10 years after vaccination), we believe that current recommendations to no longer administer YFV-17D booster vaccination be carefully re-evaluated, and that further development of safer vaccine approaches should be considered.

  14. Questions regarding the safety and duration of immunity following live yellow fever vaccination

    PubMed Central

    Amanna, Ian J.; Slifka, Mark K.

    2016-01-01

    Introduction The World Health Organization (WHO) and other health agencies have concluded that yellow fever booster vaccination is unnecessary since a single dose of vaccine confers lifelong immunity. Areas Covered We reviewed the clinical studies cited by health authorities in their investigation of both the safety profile and duration of immunity for the YFV-17D vaccine and examined the position that booster vaccination is no longer needed. We found that antiviral immunity may be lost in 1-in-3 to 1-in-5 individuals within 5 to 10 years after a single vaccination and that children may be at greater risk for primary vaccine failure. The safety profile of YFV-17D was compared to other licensed vaccines including oral polio vaccine (OPV) and the rotavirus vaccine, RotaShield, which have subsequently been withdrawn from the US and world market, respectively. Expert Commentary Based on these results and recent epidemiological data on vaccine failures (particularly evident at >10 years after vaccination), we believe that current recommendations to no longer administer YFV-17D booster vaccination be carefully re-evaluated, and that further development of safer vaccine approaches should be considered. PMID:27267203

  15. Beyond empiricism: Informing vaccine development through innate immunity research

    PubMed Central

    Levitz, Stuart M.; Golenbock, Douglas T.

    2012-01-01

    Summary While a great public heath success, vaccines provide suboptimal protection in some patient populations and are not available to protect against many infectious diseases. Insights from innate immunity research have led to a better understanding of how existing vaccines work and informed vaccine development. New adjuvants and delivery systems are being designed based upon their capacity to stimulate innate immune sensors and target antigens to dendritic cells, the cells responsible for initiating adaptive immune responses. Incorporating these adjuvants and delivery systems in vaccines can beneficially alter the quantitative and qualitative nature of the adaptive immune response resulting in enhanced protection. PMID:22424235

  16. 49 CFR 385.19 - Safety fitness information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 5 2013-10-01 2013-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...

  17. 49 CFR 385.19 - Safety fitness information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 5 2012-10-01 2012-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...

  18. 49 CFR 385.19 - Safety fitness information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 5 2014-10-01 2014-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final ratings will be made available to other Federal and...

  19. Improving vaccine registries through mobile technologies: a vision for mobile enhanced Immunization information systems.

    PubMed

    Wilson, Kumanan; Atkinson, Katherine M; Deeks, Shelley L; Crowcroft, Natasha S

    2016-01-01

    Immunization registries or information systems are critical to improving the quality and evaluating the ongoing success of immunization programs. However, the completeness of these systems is challenged by a myriad of factors including the fragmentation of vaccine administration, increasing mobility of individuals, new vaccine development, use of multiple products, and increasingly frequent changes in recommendations. Mobile technologies could offer a solution, which mitigates some of these challenges. Engaging individuals to have more control of their own immunization information using their mobile devices could improve the timeliness and accuracy of data in central immunization information systems. Other opportunities presented by mobile technologies that could be exploited to improve immunization information systems include mobile reporting of adverse events following immunization, the capacity to scan 2D barcodes, and enabling bidirectional communication between individuals and public health officials. Challenges to utilizing mobile solutions include ensuring privacy of data, access, and equity concerns, obtaining consent and ensuring adoption of technology at sufficiently high rates. By empowering individuals with their own health information, mobile technologies can also serve as a mechanism to transfer immunization information as individuals cross local, regional, and national borders. Ultimately, mobile enhanced immunization information systems can help realize the goal of the individual, the healthcare provider, and public health officials always having access to the same immunization information. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Beyond empiricism: informing vaccine development through innate immunity research.

    PubMed

    Levitz, Stuart M; Golenbock, Douglas T

    2012-03-16

    Although a great public heath success, vaccines provide suboptimal protection in some patient populations and are not available to protect against many infectious diseases. Insights from innate immunity research have led to a better understanding of how existing vaccines work and have informed vaccine development. New adjuvants and delivery systems are being designed based upon their capacity to stimulate innate immune sensors and target antigens to dendritic cells, the cells responsible for initiating adaptive immune responses. Incorporating these adjuvants and delivery systems in vaccines can beneficially alter the quantitative and qualitative nature of the adaptive immune response, resulting in enhanced protection. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. Immunization Information Systems: A Decade of Progress in Law and Policy

    PubMed Central

    Martin, Daniel W.; Lowery, N. Elaine; Brand, Bill; Gold, Rebecca; Horlick, Gail

    2015-01-01

    This article reports on a study of laws, regulations, and policies governing Immunization Information Systems (IIS, also known as “immunization registries”) in states and selected urban areas of the United States. The study included a search of relevant statutes, administrative codes and published attorney general opinions/findings, an online questionnaire completed by immunization program managers and/or their staff, and follow-up telephone interviews. The legal/regulatory framework for IIS has changed considerably since 2000, largely in ways that improve IIS’ ability to perform their public health functions while continuing to maintain strict confidentiality and privacy controls. Nevertheless, the exchange of immunization data and other health information between care providers and public health and between entities in different jurisdictions remains difficult due in part to ongoing regulatory diversity. To continue to be leaders in health information exchange and facilitate immunization of children and adults, IIS will need to address the challenges presented by the interplay of federal and state legislation, regulations, and policies and continue to move toward standardized data collection and sharing necessary for interoperable systems. PMID:24402434

  2. Immunization information system progress--United States, 2004.

    PubMed

    2005-11-18

    One of the national health objectives for 2010 is to increase to at least 95% the proportion of children aged <6 years who participate in fully operational, population-based immunization registries (objective no. 14-26). Immunization registries are confidential, computerized information systems that collect and consolidate vaccination data from multiple health-care providers, generate reminder and recall notifications, and assess vaccination coverage within a defined geographic area. A registry with added capabilities, such as vaccine management, adverse event reporting, lifespan vaccination histories, and linkages with electronic data sources, is called an immunization information system (IIS). This report summarizes data from CDC's 2004 IIS Annual Report, a survey of 56 grantees in 50 states, five cities, and the District of Columbia (DC) that receive funding under section 317b of the Public Health Service Act. The findings indicate that approximately 48% of U.S. children aged <6 years participated in an IIS. Moreover, 76% of public vaccination provider sites and 39% of private vaccination provider sites submitted immunization data to an IIS during the last 6 months of 2004. Overcoming challenges and barriers to increasing the number of provider sites and the percentage of children aged <6 years participating in an IIS is critical to achieving the national health objective. CDC has developed a plan of action to address those challenges. Major components of the plan include, but are not limited to, a multiyear IIS business plan for each grantee and enhanced technical assistance to grantees with unresolved challenges.

  3. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  4. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  5. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  6. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  7. 40 CFR 170.135 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., pesticide safety information. (b) Pesticide safety poster. A safety poster must be displayed that conveys..., and telephone number of the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The agricultural employer shall inform workers promptly of any...

  8. A Service Oriented Architecture Approach to Achieve Interoperability between Immunization Information Systems in Iran.

    PubMed

    Hosseini, Masoud; Ahmadi, Maryam; Dixon, Brian E

    2014-01-01

    Clinical decision support (CDS) systems can support vaccine forecasting and immunization reminders; however, immunization decision-making requires data from fragmented, independent systems. Interoperability and accurate data exchange between immunization information systems (IIS) is an essential factor to utilize Immunization CDS systems. Service oriented architecture (SOA) and Health Level 7 (HL7) are dominant standards for web-based exchange of clinical information. We implemented a system based on SOA and HL7 v3 to support immunization CDS in Iran. We evaluated system performance by exchanging 1500 immunization records for roughly 400 infants between two IISs. System turnaround time is less than a minute for synchronous operation calls and the retrieved immunization history of infants were always identical in different systems. CDS generated reports were accordant to immunization guidelines and the calculations for next visit times were accurate. Interoperability is rare or nonexistent between IIS. Since inter-state data exchange is rare in United States, this approach could be a good prototype to achieve interoperability of immunization information.

  9. Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

    PubMed

    Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

    2013-04-18

    Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable

  10. Feasibilty of in utero DNA vaccination following naked gene transfer into pig fetal muscle: transgene expression, immunity and safety.

    PubMed

    Rinaldi, Monica; Signori, Emanuela; Rosati, Paolo; Cannelli, Giorgio; Parrella, Paola; Iannace, Enrico; Monego, Giovanni; Ciafrè, Silvia Anna; Farace, Maria Giulia; Iurescia, Sandra; Fioretti, Daniela; Rasi, Guido; Fazio, Vito Michele

    2006-05-22

    The high toll of death among first-week infants is due to infections occurring at the end of pregnancy, during birth or by breastfeeding. This problem significantly concerns industrialized countries also. To prevent the typical "first-week infections", a vaccine would be protective as early as at the birth. In utero DNA immunization has demonstrated the effectiveness in inducing specific immunity in newborns. We have already published results of a 2-year follow-up showing long-term safety, protective antibody titers at birth and long-term immune memory, following intramuscular in utero anti-HBV DNA immunization in 90-days pig fetuses. We have now analyzed further parameters of short-term safety. Two different reporter genes were injected in the thigh muscles of 90-days fetuses. At 8 days following DNA injection, we found high-level of transgenes expression in all injected fetuses. A step gradient of expression from the area of injection was observed with both reporter genes. CMV promoter/enhancer produced higher levels of expression compared to SV40 promoter/enhancer. Moreover, no evidence of local or systemic flogistic alterations or fetal malformations, mortality or haemorrhage following intramuscular injection were observed. A single anti-HBV s-antigen DNA immunization in 90-days fetuses supported protective antibody levels in all immunized newborns, lasting at least up to 4 months after birth. Our report further sustains safety and efficacy of intramuscular in utero naked gene transfer and immunization. This approach may support therapeutic or prophylactic procedure in many early life-threatening pathologic conditions.

  11. Dynamic node immunization for restraint of harmful information diffusion in social networks

    NASA Astrophysics Data System (ADS)

    Yang, Dingda; Liao, Xiangwen; Shen, Huawei; Cheng, Xueqi; Chen, Guolong

    2018-08-01

    To restrain the spread of harmful information is crucial for the healthy and sustainable development of social networks. We address the problem of restraining the spread of harmful information by immunizing nodes in the networks. Previous works have developed methods based on the network topology or studied how to immunize nodes in the presence of initial infected nodes. These static methods, in which nodes are immunized at once, may have poor performance in the certain situation due to the dynamics of diffusion. To tackle this problem, we introduce a new dynamic immunization problem of immunizing nodes during the process of the diffusion in this paper. We formulate the problem and propose a novel heuristic algorithm by dealing with two sub-problems: (1) how to select a node to achieve the best immunization effect at the present time? (2) whether the selected node should be immunized right now? Finally, we demonstrate the effectiveness of our algorithm through extensive experiments on various real datasets.

  12. Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

    PubMed

    MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

    2014-01-01

    Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

  13. Communicating immunization science: the genesis and evolution of the National Network for Immunization Information.

    PubMed

    Ledford, Christy J W; Willett, Kristen L; Kreps, Gary L

    2012-01-01

    For 10 years, the National Network for Immunization Information (NNii) has pursued its goal to "provide the public, health professionals, policy makers, and the media with up-to-date, scientifically valid information related to immunizations to help them understand the issues and to make informed decisions." This investigation provides a critical evaluation of the strategic communication planning and implementation of NNii from conception to present day. The study uses a case study methodology, developing a systematic analysis of organizational documents, the media environment, and in-depth interviews by applying Weick's model of organizing as an interpretive framework. Iterative data analysis included open coding, axial coding, and thematic saturation. Themes were compared with phases of strategic communication and present study propositions. Major themes identified included the organization's informative nature, funding credibility, nonbranding, reflective evaluation, collaborative partnerships, and media strategy. NNii meets the requirements of requisite variety, nonsummativity, and organizational flexibility proposed by Weick's model of organizing. However, a lack of systematic evaluation of organization goals prevents it from adapting communication tactics and strategies. In addition, the authors recommend that NNii, while maintaining its informative nature, adopt persuasive strategies to attract and retain the attention of its target audiences.

  14. A Service Oriented Architecture Approach to Achieve Interoperability between Immunization Information Systems in Iran

    PubMed Central

    Hosseini, Masoud; Ahmadi, Maryam; Dixon, Brian E.

    2014-01-01

    Clinical decision support (CDS) systems can support vaccine forecasting and immunization reminders; however, immunization decision-making requires data from fragmented, independent systems. Interoperability and accurate data exchange between immunization information systems (IIS) is an essential factor to utilize Immunization CDS systems. Service oriented architecture (SOA) and Health Level 7 (HL7) are dominant standards for web-based exchange of clinical information. We implemented a system based on SOA and HL7 v3 to support immunization CDS in Iran. We evaluated system performance by exchanging 1500 immunization records for roughly 400 infants between two IISs. System turnaround time is less than a minute for synchronous operation calls and the retrieved immunization history of infants were always identical in different systems. CDS generated reports were accordant to immunization guidelines and the calculations for next visit times were accurate. Interoperability is rare or nonexistent between IIS. Since inter-state data exchange is rare in United States, this approach could be a good prototype to achieve interoperability of immunization information. PMID:25954452

  15. Understanding and Managing Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

    PubMed Central

    Weinstein, Alyona; Gordon, Ruth-Ann; Kasler, Mary Kate; Burke, Matthew; Ranjan, Smita; Hodgetts, Jackie; Reed, Vanessa; Shames, Yelena; Prempeh-Keteku, Nana; Lingard, Karla

    2017-01-01

    The immune checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab represent a substantial improvement in treating advanced melanoma but are associated with adverse events (AEs) likely related to general immunologic enhancement. To ensure that patients receive optimal benefit from these agents, prompt assessment and treatment of AEs are essential. We review the efficacy and safety profiles of these immune checkpoint inhibitors and describe guidelines for managing immune-related AEs. We also present case studies describing the management of toxicities in patients receiving immune checkpoint inhibitor therapy. These cases illustrate the importance of collecting a detailed medical history when administering immunotherapy, as this information is necessary to establish baseline, inform monitoring, and determine the etiology of symptoms. Advanced practice nurses and physician assistants are uniquely positioned to educate patients on the early recognition of AEs and have an important role in establishing appropriate monitoring and open dialogue among services. PMID:29900017

  16. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  17. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  18. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  19. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  20. 40 CFR 170.235 - Posted pesticide safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... (b) Pesticide safety poster. A safety poster must be displayed that conveys, at a minimum, the... the nearest emergency medical care facility shall be on the safety poster or displayed close to the safety poster. (2) The handler employer shall inform handlers promptly of any change to the information...

  1. Postmarket Drug Safety Information for Patients and Providers

    MedlinePlus

    ... Information for Patients and Providers Postmarket Drug Safety Information for Patients and Providers Share Tweet Linkedin Pin ... communication to patients and healthcare providers. Latest Safety Information Index to Drug-Specific Information For patients, consumers, ...

  2. Safety Case Development as an Information Modelling Problem

    NASA Astrophysics Data System (ADS)

    Lewis, Robert

    This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

  3. Directory of aerospace safety specialized information sources

    NASA Technical Reports Server (NTRS)

    Fullerton, E. A.; Rubens, L. S.; Mandel, G.; Mckenna, P. J.

    1974-01-01

    Directory aids safety specialists in locating information sources and individual experts in engineering-related fields. Lists 170 organizations and approximately 300 individuals who can provide safety-related technical information in form of documentation, data, and consulting expertise. Information on hazard and failure cause identification, accident analysis, and materials characteristics are covered.

  4. 15 CFR 270.352 - Public safety information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence; Information Created Pursuant to an... Team, NIST, and any other investigation participant will not publicly release any information it...

  5. 15 CFR 270.352 - Public safety information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence; Information Created Pursuant to an... Team, NIST, and any other investigation participant will not publicly release any information it...

  6. 15 CFR 270.352 - Public safety information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence; Information Created Pursuant to an... Team, NIST, and any other investigation participant will not publicly release any information it...

  7. 15 CFR 270.352 - Public safety information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence; Information Created Pursuant to an... Team, NIST, and any other investigation participant will not publicly release any information it...

  8. Directory of aerospace safety specialized information sources

    NASA Technical Reports Server (NTRS)

    Fullerton, E. A.; Rubens, L. S.

    1973-01-01

    A directory is presented to make available to the aerospace safety community a handbook of organizations and experts in specific, well-defined areas of safety technology. It is designed for the safety specialist as an aid for locating both information sources and individual points of contact (experts) in engineering related fields. The file covers sources of data in aerospace design, tests, as well as information in hazard and failure cause identification, accident analysis, materials characteristics, and other related subject areas. These 171 organizations and their staff members, hopefully, should provide technical information in the form of documentation, data and consulting expertise. These will be sources that have assembled and collated their information, so that it will be useful in the solution of engineering problems. One of the goals of the project in the United States that have and are willing to share data of value to the aerospace safety community.

  9. 16 CFR 1025.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... provide other information and granting immunity. 1025.39 Section 1025.39 Commercial Practices CONSUMER... Process § 1025.39 Orders requiring witnesses to testify or provide other information and granting immunity... witness or deponent to testify or provide other information upon being granted immunity from prosecution...

  10. 16 CFR 1025.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... provide other information and granting immunity. 1025.39 Section 1025.39 Commercial Practices CONSUMER... Process § 1025.39 Orders requiring witnesses to testify or provide other information and granting immunity... witness or deponent to testify or provide other information upon being granted immunity from prosecution...

  11. 16 CFR 1025.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... provide other information and granting immunity. 1025.39 Section 1025.39 Commercial Practices CONSUMER... Process § 1025.39 Orders requiring witnesses to testify or provide other information and granting immunity... witness or deponent to testify or provide other information upon being granted immunity from prosecution...

  12. 16 CFR 1025.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... provide other information and granting immunity. 1025.39 Section 1025.39 Commercial Practices CONSUMER... Process § 1025.39 Orders requiring witnesses to testify or provide other information and granting immunity... witness or deponent to testify or provide other information upon being granted immunity from prosecution...

  13. 49 CFR 511.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... other information and granting immunity. 511.39 Section 511.39 Transportation Other Regulations Relating... testify or provide other information and granting immunity. (a) A party who desires the issuance of an order requiring a witness to testify or provide other information upon being granted immunity from...

  14. 12 CFR 1080.12 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... provide other information and granting immunity. 1080.12 Section 1080.12 Banks and Banking BUREAU OF... testify or provide other information and granting immunity. The Director has the nondelegable authority to... witness to testify or provide other information and granting immunity under 18 U.S.C. 6004. ...

  15. 49 CFR 511.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... other information and granting immunity. 511.39 Section 511.39 Transportation Other Regulations Relating... testify or provide other information and granting immunity. (a) A party who desires the issuance of an order requiring a witness to testify or provide other information upon being granted immunity from...

  16. 49 CFR 511.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... other information and granting immunity. 511.39 Section 511.39 Transportation Other Regulations Relating... testify or provide other information and granting immunity. (a) A party who desires the issuance of an order requiring a witness to testify or provide other information upon being granted immunity from...

  17. 49 CFR 511.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... other information and granting immunity. 511.39 Section 511.39 Transportation Other Regulations Relating... testify or provide other information and granting immunity. (a) A party who desires the issuance of an order requiring a witness to testify or provide other information upon being granted immunity from...

  18. 12 CFR 1080.12 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... provide other information and granting immunity. 1080.12 Section 1080.12 Banks and Banking BUREAU OF... testify or provide other information and granting immunity. The Director has the nondelegable authority to... witness to testify or provide other information and granting immunity under 18 U.S.C. 6004. ...

  19. 49 CFR 511.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... other information and granting immunity. 511.39 Section 511.39 Transportation Other Regulations Relating... testify or provide other information and granting immunity. (a) A party who desires the issuance of an order requiring a witness to testify or provide other information upon being granted immunity from...

  20. 12 CFR 1080.12 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... provide other information and granting immunity. 1080.12 Section 1080.12 Banks and Banking BUREAU OF... testify or provide other information and granting immunity. (a) The Assistant Director of the Division of... issuance of an order requiring a witness to testify or provide other information granting immunity under 18...

  1. Safety of vaccines used for routine immunization of U.S. children: a systematic review.

    PubMed

    Maglione, Margaret A; Das, Lopamudra; Raaen, Laura; Smith, Alexandria; Chari, Ramya; Newberry, Sydne; Shanman, Roberta; Perry, Tanja; Goetz, Matthew Bidwell; Gidengil, Courtney

    2014-08-01

    Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Copyright © 2014 by the American Academy of Pediatrics.

  2. The impact of health information technology on patient safety.

    PubMed

    Alotaibi, Yasser K; Federico, Frank

    2017-12-01

    Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety.  This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient's safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes.

  3. The impact of health information technology on patient safety

    PubMed Central

    Alotaibi, Yasser K.; Federico, Frank

    2017-01-01

    Since the original Institute of Medicine (IOM) report was published there has been an accelerated development and adoption of health information technology with varying degrees of evidence about the impact of health information technology on patient safety. This article is intended to review the current available scientific evidence on the impact of different health information technologies on improving patient safety outcomes. We conclude that health information technology improves patient’s safety by reducing medication errors, reducing adverse drug reactions, and improving compliance to practice guidelines. There should be no doubt that health information technology is an important tool for improving healthcare quality and safety. Healthcare organizations need to be selective in which technology to invest in, as literature shows that some technologies have limited evidence in improving patient safety outcomes. PMID:29209664

  4. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

    The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

  5. Alcohol/safety public information materials catalog. Number 5

    DOT National Transportation Integrated Search

    1981-06-01

    Author's abstract: The Alcohol/Safety Public Information Materials Catalog is designed for use by persons developing public information programs on alcohol and highway safety. It lists materials produced for campaigns along with journal articles and ...

  6. Patient safety goals for the proposed Federal Health Information Technology Safety Center.

    PubMed

    Sittig, Dean F; Classen, David C; Singh, Hardeep

    2015-03-01

    The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. 16 CFR 2.15 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... provide other information and granting immunity. 2.15 Section 2.15 Commercial Practices FEDERAL TRADE... and granting immunity. (a) The Bureau Director, Deputy Directors, and Assistant Directors in the... issuance of an order requiring a witness to testify or provide other information granting immunity under...

  8. 16 CFR 2.15 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... provide other information and granting immunity. 2.15 Section 2.15 Commercial Practices FEDERAL TRADE... and granting immunity. (a) The Bureau Director, Deputy Directors, and Assistant Directors in the... issuance of an order requiring a witness to testify or provide other information granting immunity under...

  9. 16 CFR 2.15 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... provide other information and granting immunity. 2.15 Section 2.15 Commercial Practices FEDERAL TRADE... and granting immunity. (a) The Bureau Director, Deputy Directors, and Assistant Directors in the... issuance of an order requiring a witness to testify or provide other information granting immunity under...

  10. 16 CFR 2.15 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... provide other information and granting immunity. 2.15 Section 2.15 Commercial Practices FEDERAL TRADE... and granting immunity. (a) The Bureau Director, Deputy Directors, and Assistant Directors in the... issuance of an order requiring a witness to testify or provide other information granting immunity under...

  11. Effectiveness and safety of traditional Chinese medicine in treating acquired immune deficiency syndrome: 2004-2014.

    PubMed

    Liu, Zhi-Bin; Yang, Ji-Ping; Xu, Li-Ran

    2015-12-23

    Substantial progress has been made in China in using traditional Chinese medicine (TCM) to treat acquired immune deficiency syndrome (AIDS). Our objective was to review the latest developments in TCM treatment of AIDS in China between 2004 and 2014. We reviewed the content of original articles investigating the efficacy and safety of TCM for treating AIDS published in Chinese and English language journals. Relevant references from 2004 to 2014 were found using PubMed and the China National Knowledge Infrastructure Database. We found that TCM has been widely used for treating AIDS and its complications in China. The number of TCM studies has increased, which indicates efficacy and safety. Measures of efficacy in the reviewed articles included the alleviation of human immunodeficiency virus (HIV)-related signs and symptoms, improvements in quality of life, improvements in long-term survival, counteraction of the adverse side effects of antiviral drugs, promotion of immune reconstitution, and improvement of laboratory results. In sum, the literature indicates that TCM is safe. TCM plays an important role in the treatment of AIDS. Some studies have attempted to measure the efficacy and safety of TCM for treating AIDS, but more evidence is needed. Therefore, more research on this topic is required in the future.

  12. 16 CFR 3.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... provide other information and granting immunity. 3.39 Section 3.39 Commercial Practices FEDERAL TRADE... granting immunity. (a) Where Commission complaint counsel desire the issuance of an order requiring a witness or deponent to testify or provide other information and granting immunity under 18 U.S.C. 6002...

  13. 16 CFR 3.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... provide other information and granting immunity. 3.39 Section 3.39 Commercial Practices FEDERAL TRADE... granting immunity. (a) Where Commission complaint counsel desire the issuance of an order requiring a witness or deponent to testify or provide other information and granting immunity under 18 U.S.C. 6002...

  14. 16 CFR 3.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... provide other information and granting immunity. 3.39 Section 3.39 Commercial Practices FEDERAL TRADE... granting immunity. (a) Where Commission complaint counsel desire the issuance of an order requiring a witness or deponent to testify or provide other information and granting immunity under 18 U.S.C. 6002...

  15. 16 CFR 3.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... provide other information and granting immunity. 3.39 Section 3.39 Commercial Practices FEDERAL TRADE... granting immunity. (a) Where Commission complaint counsel desire the issuance of an order requiring a witness or deponent to testify or provide other information and granting immunity under 18 U.S.C. 6002...

  16. 16 CFR 3.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... provide other information and granting immunity. 3.39 Section 3.39 Commercial Practices FEDERAL TRADE... granting immunity. (a) Where Commission complaint counsel desire the issuance of an order requiring a witness or deponent to testify or provide other information and granting immunity under 18 U.S.C. 6002...

  17. Innovative Strategies Designed to Improve Adult Pneumococcal Immunizations in Safety Net Patient-Centered Medical Homes.

    PubMed

    Park, Nina J; Sklaroff, Laura Myerchin; Gross-Schulman, Sandra; Hoang, Khathy; Tran, Helen; Campa, David; Scheib, Geoffrey; Guterman, Jeffrey J

    2016-08-01

    Streptococcus pneumoniae is a principal cause of serious illness, including bacteremia, meningitis, and pneumonia, worldwide. Pneumococcal immunization is proven to reduce morbidity and mortality in high-risk adult and elderly populations. Current pneumococcal vaccination practices are suboptimal in part because of recommendation complexity, the high cost of provider-driven immunization interventions, and outreach methods that are not patient-centric. These barriers are amplified within the safety net. This paper identifies efforts by the Los Angeles County Department of Health Services to increase pneumococcal immunization rates for adult indigent patient populations. A 4-part approach will be used to increase vaccination rates: (1) protocol driven care, (2) staff education, (3) electronic identification of eligible patients, and (4) automated patient outreach and scheduling. The proposed analytics plan and potential for scalability are described. (Population Health Management 2016;19:240-247).

  18. Transportation Safety Information Report : 1982 Annual Summary

    DOT National Transportation Integrated Search

    1983-01-01

    The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

  19. Transportation Safety Information Report : 1987 Annual Summary

    DOT National Transportation Integrated Search

    1988-01-01

    The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data for transportation fatalities, accidents, and injuries f...

  20. Transportation Safety Information Report : Second Quarter 1984

    DOT National Transportation Integrated Search

    1984-01-01

    The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

  1. Transportation Safety Information Report : Second Quarter 1985

    DOT National Transportation Integrated Search

    1985-10-01

    The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

  2. 75 FR 40863 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2010-0193] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice and request for comments. SUMMARY: In...

  3. 77 FR 74276 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0302] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice and request for comments. SUMMARY: In...

  4. 76 FR 50539 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2011-0136] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice and request for comments. SUMMARY: In...

  5. Information Scanning and Processing at the Nuclear Safety Information Center.

    ERIC Educational Resources Information Center

    Parks, Celia; Julian, Carol

    This report is a detailed manual of the information specialist's duties at the Nuclear Safety Information Center. Information specialists scan the literature for documents to be reviewed, procure the documents (books, journal articles, reports, etc.), keep the document location records, and return the documents to the plant library or other…

  6. Guide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety - executive summary.

    PubMed

    Heininger, U; Holm, K; Caplanusi, I; Bailey, S R

    2017-07-13

    In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines targeting diseases specifically endemic to many resource-limited countries (RLCs), e.g. malaria, dengue. The WG created a Guide to Active Vaccine Safety Surveillance (AVSS) to assist national regulatory authorities and national immunization program officers in RLCs in determining the best course of action with regards to non-routine pharmacovigilance activities, when confronted with a launch of a new vaccine or a vaccine that is new to their country. Here we summarize the results of the WG, further detailed in the Guide, which for the first time provides a structured approach to identifying and analyzing specific vaccines safety knowledge gaps, while considering all available sources of information, in order to determine whether AVSS is an appropriate solution. If AVSS is confirmed as being the appropriate tool, the Guide provides additional essential information on AVSS, a detailed overview of common types of AVSS and practical implementation considerations. It also provides a framework for a well-constructed and informative AVSS when needed, thus aiming to ensure the best possible safety of immunization in this new landscape. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. 78 FR 16764 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0302] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice and Request for Comments on a Previously...

  8. 75 FR 4610 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-28

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2009-0375] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous Materials Safety Administration. ACTION: Notice and request for comments. SUMMARY: On November 24, 2009, as...

  9. 77 FR 15453 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-15

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... information collection titled, ``Gas Pipeline Safety Program Certification and Hazardous Liquid Pipeline... collection request that PHMSA will be submitting to OMB for renewal titled, ``Gas Pipeline Safety Program...

  10. Could information about herd immunity help us achieve herd immunity? Evidence from a population representative survey experiment.

    PubMed

    Arnesen, Sveinung; Bærøe, Kristine; Cappelen, Cornelius; Carlsen, Benedicte

    2018-05-01

    Immunisation causes dramatic reductions in morbidity and mortality from infectious diseases; however, resistance to vaccination is nonetheless widespread. An understudied issue - explored here - is whether appeals to collective as opposed to individual benefits of vaccination encourage people to vaccinate. Knowledge of this is important not least with respect to the design of public health campaigns, which often lack information about the collective benefits of vaccination. Using a between-subjects experimental survey design, we test whether information about the effects of herd immunity influences people's decision to vaccinate. A representative sample of Norwegians was confronted with a hypothetical scenario in which a new and infectious disease is on its way to Norway. The sample was split in three - a control group and two treatment groups. The one treatment group was provided information about collective benefits of vaccination; the other was provided information about the individual benefits of vaccination. Both treatments positively affect people's decision to vaccinate; however, informing about the collective benefits has an even stronger effect than informing about the individual benefits. Our results suggest that people's decision about whether to vaccinate and thus contribute to herd immunity is influenced by concern for others. Thus, stressing the collective benefits of vaccination could increase the effectiveness of health campaigns.

  11. 16 CFR § 1025.39 - Orders requiring witnesses to testify or provide other information and granting immunity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... provide other information and granting immunity. § 1025.39 Section § 1025.39 Commercial Practices... immunity. (a) Applicability to Flammable Fabrics Act only. This section applies only to proceedings arising... witness or deponent to testify or provide other information upon being granted immunity from prosecution...

  12. Using information technology to improve adult immunization delivery in an integrated urban health system.

    PubMed

    Swenson, Carolyn J; Appel, Alicia; Sheehan, Moira; Hammer, Anne; Fenner, Zita; Phibbs, Stephanie; Harbrecht, Marjie; Main, Deborah S

    2012-01-01

    Adult immunizations prevent morbidity and mortality yet coverage remains suboptimal, in part due to missed opportunities. Clinical decision support systems (CDSSs) can improve immunization rates when integrated into routine work flow, implemented wherever care is delivered, and used by staff who can act on the recommendation. An adult immunization improvement project was undertaken in a large integrated, safety-net health care system. A CDSS was developed to query patient records and identify patients eligible for pneumococcal, influenza, or tetanus immunization and then generate a statement that recommends immunization or indicates a previous refusal. A new agency policy authorized medical assistants and nurses in clinics, and nurses in the hospital, to use the CDSS as a standing order. Immunization delivery work flow was standardized, and staff received feedback on immunization rates. The CDSS identified more patients than a typical paper standing order and can be easily modified to incorporate changes in vaccine indications. The intervention led to a 10% improvement in immunization rates in adults 65 years of age or older and in younger adults with diabetes or chronic obstructive pulmonary disease. Overall, the improvements were sustained beyond the project period. The CDSS was expanded to encompass additional vaccines. Interdepartmental collaboration was critical to identify needs, challenges, and solutions. Implementing the standing order policy in clinics and the hospital usually allowed immunizations to be taken out of the hands of clinicians. As an on-demand tool, CDSS must be used at each patient encounter to avoid missed opportunities. Staff retraining accompanied by ongoing assessment of immunization rates, work flow, and missed opportunities to immunize patients are critical to sustain and enhance improvements.

  13. Risk Informed Margins Management as part of Risk Informed Safety Margin Characterization

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

    Curtis Smith

    2014-06-01

    The ability to better characterize and quantify safety margin is important to improved decision making about Light Water Reactor (LWR) design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plantmore » safety and performance will become known. To support decision making related to economics, readability, and safety, the Risk Informed Safety Margin Characterization (RISMC) Pathway provides methods and tools that enable mitigation options known as risk informed margins management (RIMM) strategies.« less

  14. Information systems in food safety management.

    PubMed

    McMeekin, T A; Baranyi, J; Bowman, J; Dalgaard, P; Kirk, M; Ross, T; Schmid, S; Zwietering, M H

    2006-12-01

    Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in: Identifying pathogens in food at the genus or species level using applied systematics in automated ways. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as the genesis of an international web based searchable database (ComBase). Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting "pattern match" indicating problems that may arise from changes in product formulation or processing conditions. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices. In addition there are many other uses of information systems that benefit food safety more globally, including: Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents. Active surveillance networks allowing rapid dissemination

  15. Requirements Analysis for the Army Safety Management Information System (ASMIS)

    DTIC Science & Technology

    1989-03-01

    8217_>’ Telephone Number « .. PNL-6819 Limited Distribution Requirements Analysis for the Army Safety Management Information System (ASMIS) Final...PNL-6819 REQUIREMENTS ANALYSIS FOR THE ARMY SAFETY MANAGEMENT INFORMATION SYSTEM (ASMIS) FINAL REPORT J. S. Littlefield A. L. Corrigan March...accidents. This accident data is available under the Army Safety Management Information System (ASMIS) which is an umbrella for many databases

  16. Structure-informed insights for NLR functioning in plant immunity.

    PubMed

    Sukarta, Octavina C A; Slootweg, Erik J; Goverse, Aska

    2016-08-01

    To respond to foreign invaders, plants have evolved a cell autonomous multilayered immune system consisting of extra- and intracellular immune receptors. Nucleotide binding and oligomerization domain (NOD)-like receptors (NLRs) mediate recognition of pathogen effectors inside the cell and trigger a host specific defense response, often involving controlled cell death. NLRs consist of a central nucleotide-binding domain, which is flanked by an N-terminal CC or TIR domain and a C-terminal leucine-rich repeat domain (LRR). These multidomain proteins function as a molecular switch and their activity is tightly controlled by intra and inter-molecular interactions. In contrast to metazoan NLRs, the structural basis underlying NLR functioning as a pathogen sensor and activator of immune responses in plants is largely unknown. However, the first crystal structures of a number of plant NLR domains were recently obtained. In addition, biochemical and structure-informed analyses revealed novel insights in the cooperation between NLR domains and the formation of pre- and post activation complexes, including the coordinated activity of NLR pairs as pathogen sensor and executor of immune responses. Moreover, the discovery of novel integrated domains underscores the structural diversity of NLRs and provides alternative models for how these immune receptors function in plants. In this review, we will highlight these recent advances to provide novel insights in the structural, biochemical and molecular aspects involved in plant NLR functioning. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. The Effects of Safety Information on Aeronautical Decision Making

    NASA Technical Reports Server (NTRS)

    Lee, Jang R.; Fanjoy, Richard O.; Dillman, Brian G.

    2005-01-01

    The importance of aeronautical decision making (ADM) has been considered one of the most critical issues of flight education for future professional pilots. Researchers have suggested that a safety information system based on information from incidents and near misses is an important tool to improve the intelligence and readiness of pilots. This paper describes a study that examines the effect of safety information on aeronautical decision making for students in a collegiate flight program. Data was collected from study participants who were exposed to periodic information about local aircraft malfunctions. Participants were then evaluated using a flight simulator profile and a pen and pencil test of situational judgment. Findings suggest that regular access to the described safety information program significantly improves decision making of student pilots.

  18. Comics as a Medium for Providing Information on Adult Immunizations.

    PubMed

    Muzumdar, Jagannath M; Pantaleo, Nicholas L

    2017-10-01

    This study compared the following effects of two vaccine information flyers-one developed by the Centers for Disease Control and Prevention (CDC) versus one adapted from this information to a comic medium (comic)-on adults: (a) attitude toward the flyer; (b) perceived informativeness of the flyer; (c) intention to seek more information about adult immunizations after viewing the flyer; and (d) intention to get immunized after viewing the flyer. A between-group, randomized trial was used to randomly assign adults (age 18 years or older) at an ambulatory care center to review the CDC or comic flyer. Participants were asked to complete a survey to measure several outcome variables. Items were measured using a 7-point semantic differential scale. Independent-samples t-test was used for comparisons. A total of 265 surveys (CDC n = 132 vs comic n = 133) were analyzed. The comic flyer had a statistically significant effect on participants' attitudes and their perception of the flyer's informativeness compared to the CDC flyer. Flyer type did not have a statistically significant effect on intention-related variables. The study findings showed that the comic flyer was positively evaluated compared to the CDC flyer. These findings could provide a new direction for developing adult educational materials.

  19. Committee Opinion No. 661: Integrating Immunizations Into Practice.

    PubMed

    2016-04-01

    Immunization against vaccine-preventable diseases is an essential component of women's primary and preventive health care. Despite the importance of vaccination and clear guidance from public health agencies, rates of vaccination lag behind national goals. Obstetrician-gynecologists can play a major role in reducing morbidity and mortality from a range of vaccine-preventable diseases, including pertussis, influenza, human papillomavirus, and hepatitis. Given demonstrated vaccine efficacy and safety, and the large potential for prevention of many infectious diseases that affect adults, pregnant women, and newborns, obstetrician-gynecologists should include immunizations as an integral part of their practice. To do so, they must embrace their role as important sources of information and advice on immunization for adults, adolescents, and pregnant women, and advance their patients' well-being with continued efforts to augment immunization services in their offices. Increasing awareness combined with the many suggestions in this document will work to enhance immunization uptake.

  20. Resilient Practices in Maintaining Safety of Health Information Technologies

    PubMed Central

    Ash, Joan S.; Sittig, Dean F.; Singh, Hardeep

    2014-01-01

    Electronic health record systems (EHRs) can improve safety and reliability of health care, but they can also introduce new vulnerabilities by failing to accommodate changes within a dynamic EHR-enabled health care system. Continuous assessment and improvement is thus essential for achieving resilience in EHR-enabled health care systems. Given the rapid adoption of EHRs by many organizations that are still early in their experiences with EHR safety, it is important to understand practices for maintaining resilience used by organizations with a track record of success in EHR use. We conducted interviews about safety practices with 56 key informants (including information technology managers, chief medical information officers, physicians, and patient safety officers) at two large health care systems recognized as leaders in EHR use. We identified 156 references to resilience-related practices from 41 informants. Framework analysis generated five categories of resilient practices: (a) sensitivity to dynamics and interdependencies affecting risks, (b) basic monitoring and responding practices, (c) management of practices and resources for monitoring and responding, (d) sensitivity to risks beyond the horizon, and (e) reflecting on risks with the safety and quality control process itself. The categories reflect three functions that facilitate resilience: reflection, transcending boundaries, and involving sharp-end practitioners in safety management. PMID:25866492

  1. The CIS Database: Occupational Health and Safety Information Online.

    ERIC Educational Resources Information Center

    Siegel, Herbert; Scurr, Erica

    1985-01-01

    Describes document acquisition, selection, indexing, and abstracting and discusses online searching of the CIS database, an online system produced by the International Occupational Safety and Health Information Centre. This database comprehensively covers information in the field of occupational health and safety. Sample searches and search…

  2. Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

    PubMed

    Fox, Bethany

    2012-01-01

    While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

  3. 40 CFR 68.48 - Safety information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

  4. 40 CFR 68.48 - Safety information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

  5. 40 CFR 68.48 - Safety information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

  6. 40 CFR 68.48 - Safety information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 2 Prevention Program § 68.48 Safety information. (a) The... generally accepted good engineering practices. Compliance with Federal or state regulations that address...

  7. Organizing safety: conditions for successful information assurance programs.

    PubMed

    Collmann, Jeff; Coleman, Johnathan; Sostrom, Kristen; Wright, Willie

    2004-01-01

    Organizations must continuously seek safety. When considering computerized health information systems, "safety" includes protecting the integrity, confidentiality, and availability of information assets such as patient information, key components of the technical information system, and critical personnel. "High Reliability Theory" (HRT) argues that organizations with strong leadership support, continuous training, redundant safety mechanisms, and "cultures of high reliability" can deploy and safely manage complex, risky technologies such as nuclear weapons systems or computerized health information systems. In preparation for the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Office of the Assistant Secretary of Defense (Health Affairs), the Offices of the Surgeons General of the United States Army, Navy and Air Force, and the Telemedicine and Advanced Technology Research Center (TATRC), US Army Medical Research and Materiel Command sponsored organizational, doctrinal, and technical projects that individually and collectively promote conditions for a "culture of information assurance." These efforts include sponsoring the "P3 Working Group" (P3WG), an interdisciplinary, tri-service taskforce that reviewed all relevant Department of Defense (DoD), Miliary Health System (MHS), Army, Navy and Air Force policies for compliance with the HIPAA medical privacy and data security regulations; supporting development, training, and deployment of OCTAVE(sm), a self-directed information security risk assessment process; and sponsoring development of the Risk Information Management Resource (RIMR), a Web-enabled enterprise portal about health information assurance.

  8. The impact of access to immunization information on vaccine acceptance in three countries

    PubMed Central

    Handy, Lori K.; Maroudi, Stefania; Powell, Maura; Nfila, Bakanuki; Moser, Charlotte; Japa, Ingrid; Monyatsi, Ndibo; Tzortzi, Elena; Kouzeli, Ismini; Luberti, Anthony; Theodoridou, Maria; Offit, Paul; Steenhoff, Andrew; Shea, Judy A.; Feemster, Kristen A.

    2017-01-01

    Introduction Vaccine acceptance is a critical component of sustainable immunization programs, yet rates of vaccine hesitancy are rising. Increased access to misinformation through media and anti-vaccine advocacy is an important contributor to hesitancy in the United States and other high-income nations with robust immunization programs. Little is known about the content and effect of information sources on attitudes toward vaccination in settings with rapidly changing or unstable immunization programs. Objective The objective of this study was to explore knowledge and attitudes regarding vaccines and vaccine-preventable diseases among caregivers and immunization providers in Botswana, the Dominican Republic, and Greece and examine how access to information impacts reported vaccine acceptance. Methods We conducted 37 focus groups and 14 semi-structured interviews with 96 providers and 153 caregivers in Botswana, the Dominican Republic, and Greece. Focus groups were conducted in Setswana, English, Spanish, or Greek; digitally recorded; and transcribed. Transcripts were translated into English, coded in qualitative data analysis software (NVivo 10, QSR International, Melbourne, Australia), and analyzed for common themes. Results Dominant themes in all three countries included identification of health care providers or medical literature as the primary source of vaccine information, yet participants reported insufficient communication about vaccines was available. Comments about level of trust in the health care system and government contrasted between sites, with the highest level of trust reported in Botswana but lower levels of trust in Greece. Conclusions In Botswana, the Dominican Republic, and Greece, participants expressed reliance on health care providers for information and demonstrated a need for more communication about vaccines. Trust in the government and health care system influenced vaccine acceptance differently in each country, demonstrating the need

  9. 76 FR 70217 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Administration [Docket No. PHMSA... OMB approval of new Information Collection. AGENCY: Pipeline and Hazardous Materials Safety... Pipeline and Hazardous Materials Safety Administration (PHMSA) published a notice in the Federal Register...

  10. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ...The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is issuing a notice of proposed rulemaking that would establish a publicly available consumer product safety information database (``database''). Section 212 of the Consumer Product Safety Improvement Act of 2008 (``CPSIA'') amended the Consumer Product Safety Act (``CPSA'') to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The proposed rule would interpret various statutory requirements pertaining to the information to be included in the database and also would establish provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the database; and dealing with confidential and materially inaccurate information.

  11. 75 FR 53733 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2010-0246] Pipeline Safety: Information Collection Activities AGENCY: Pipeline and Hazardous... liquefied natural gas, hazardous liquid, and gas transmission pipeline systems operated by a company. The...

  12. [Progress of childhood immunization information management system in China in 2008].

    PubMed

    Cao, Ling-Sheng; Liu, Da-Wei; Guo, Biao

    2009-08-01

    To evaluate the coverage of childhood immunization information management system (CIIMS) in China (not include HongKong, Macao, and Taiwan) in 2008. Analyzing immunization cases and users' file record archives in CIIMS for china in 2008. These data indicated that 87.10% (27/31) of provinces and 30.36% (891/2935) of county level and 26.63% (11,512/43,231) of vaccination points of township level submitted immunization data to an CIIMS in 2008. The rate of implementation of the county > or = 90% are Fujian and Hubei. The rate of implementation of the township > or = 90% are Hubei, Fujian and Hebei. Coverage of eastern areas, middle areas and western areas were 28.91%, 43.20%, and 18.41% by county, 26.15%, 37.69%, and 16.44% by township respectively. The upload permissions against cases is in a total of 15,014 units, and the client software collect a total of 42,956,214 cases of immunization. 44.46% chinese children aged < 6 years old participated in an CIIMS in 2008. The vaccination point of township level submitted 8,793,334 cases to CIIMS, it accounted for 20.47% of client collection cases. To achieve the national CIIMS objectives for 2010, the extensive implementation must be promoted, the funding for system-building should be increased, an independent platform of CIIMS must be established, and admission of the issue of data exchange with the local information systems must be accelerated.

  13. Methods used for immunization coverage assessment in Canada, a Canadian Immunization Research Network (CIRN) study.

    PubMed

    Wilson, Sarah E; Quach, Susan; MacDonald, Shannon E; Naus, Monika; Deeks, Shelley L; Crowcroft, Natasha S; Mahmud, Salaheddin M; Tran, Dat; Kwong, Jeff; Tu, Karen; Gilbert, Nicolas L; Johnson, Caitlin; Desai, Shalini

    2017-08-03

    Accurate and complete immunization data are necessary to assess vaccine coverage, safety and effectiveness. Across Canada, different methods and data sources are used to assess vaccine coverage, but these have not been systematically described. Our primary objective was to examine and describe the methods used to determine immunization coverage in Canada. The secondary objective was to compare routine infant and childhood coverage estimates derived from the Canadian 2013 Childhood National Immunization Coverage Survey (cNICS) with estimates collected from provinces and territories (P/Ts). We collected information from key informants regarding their provincial, territorial or federal methods for assessing immunization coverage. We also collected P/T coverage estimates for select antigens and birth cohorts to determine absolute differences between these and estimates from cNICS. Twenty-six individuals across 16 public health organizations participated between April and August 2015. Coverage surveys are conducted regularly for toddlers in Quebec and in one health authority in British Columbia. Across P/Ts, different methodologies for measuring coverage are used (e.g., valid doses, grace periods). Most P/Ts, except Ontario, measure up-to-date (UTD) coverage and 4 P/Ts also assess on-time coverage. The degree of concordance between P/T and cNICS coverage estimates varied by jurisdiction, antigen and age group. In addition to differences in the data sources and processes used for coverage assessment, there are also differences between Canadian P/Ts in the methods used for calculating immunization coverage. Comparisons between P/T and cNICS estimates leave remaining questions about the proportion of children fully vaccinated in Canada.

  14. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    MedlinePlus

    ... Information and Adverse Event Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share ... use. [Posted 06/01/2018] More What's New FDA Approved Safety Information DailyMed (National Library of Medicine) ...

  15. [Evaluation of immunogenicity and safety of 2 immunizations with allantoic intranasal live influenza vaccine Ultragrivac].

    PubMed

    Shishkina, L N; Mazurkova, N A; Ternovoĭ, V A; Bulychev, L E; Tumanov, Iu V; Skarnovich, M O; Kabanov, A S; Ryndiuk, N N; Kuzubov, V I; Mironov, A N; Stavskiĭ, E A; Drozdov, I G

    2011-01-01

    Evaluate reactogenicity, safety and immunogenicity in phase 2 clinical trials of 2 immunization schedules with Ultragrivac--an allantoic intranasal life influenza vaccine based on A/17/ duck/Potsdam/86/92 [17/H5] reassortant strain. 4 groups of volunteers participated in the study: group 1--40 individuals were vaccinated twice with a 10 day interval; group 2--40 individuals were vaccinated twice with a 21 day interval; group 3 (control)--10 individuals received placebo twice with a 10 day interval; group 4 (control)--10 individuals received placebo twice with a 21 day interval. Local (secretory IgA), cellular and humoral immune response were evaluated. Humoral immunity was evaluated by the intensity of increase of geometric mean antibody titers against 2 influenza virus strains A/17/duck/Potsdam/86/92 [17/H5] and A/chicken/Suzdalka/Nov-1 1/2005 (H5N1), and by the level of significant (4 times or more) antibody seroconversions after the vaccination. After the use of Ultragrivac the level of secretory IgA in the nasal cavity of vaccinated volunteers in the groups with revaccination intervals of 10 and 21 days increased significantly. The second immunization with 10 or 21 day intervals significantly increased postvaccinal humoral immune response. Humoral immune response induction after 2 vaccinations with 10 day interval was no less effective than with 21 day interval. Ultragrivac allantoic intranasal live influenza vaccine is areactogenic, harmless for vaccinated individuals, safe for those around, and has immunogenic properties against not only homologous virus A(H5N2), but also against influenza strain A(H5N1).

  16. The Impact of Information Culture on Patient Safety Outcomes

    PubMed Central

    Mikkonen, Santtu; Saranto, Kaija; Bates, David W.

    2017-01-01

    Summary Background An organization’s information culture and information management practices create conditions for processing patient information in hospitals. Information management incidents are failures that could lead to adverse events for the patient if they are not detected. Objectives To test a theoretical model that links information culture in acute care hospitals to information management incidents and patient safety outcomes. Methods Reason’s model for the stages of development of organizational accidents was applied. Study data were collected from a cross-sectional survey of 909 RNs who work in medical or surgical units at 32 acute care hospitals in Finland. Structural equation modeling was used to assess how well the hypothesized model fit the study data. Results Fit indices indicated a good fit for the model. In total, 18 of the 32 paths tested were statistically significant. Documentation errors had the strongest total effect on patient safety outcomes. Organizational guidance positively affected information availability and utilization of electronic patient records, whereas the latter had the strongest total effect on the reduction of information delays. Conclusions Patient safety outcomes are associated with information management incidents and information culture. Further, the dimensions of the information culture create work conditions that generate errors in hospitals. PMID:28272647

  17. Determinants of immunization inequality among urban poor children: evidence from Nairobi's informal settlements.

    PubMed

    Egondi, Thaddaeus; Oyolola, Maharouf; Mutua, Martin Kavao; Elung'ata, Patricia

    2015-02-27

    Despite the relentless efforts to reduce infant and child mortality with the introduction of the National Expanded Programmes on Immunization (EPI) in 1974, major disparities still exist in immunizations coverage across different population sub-groups. In Kenya, for instance, while the proportion of fully immunized children increased from 57% in 2003 to 77% in 2008-9 at national level and 73% in Nairobi, only 58% of children living in informal settlement areas are fully immunized. The study aims to determine the degree and determinants of immunization inequality among the urban poor of Nairobi. We used data from the Nairobi Cross-Sectional Slum Survey of 2012 and the health outcome was full immunization status among children aged 12-23 months. The wealth index was used as a measure of social economic position for inequality analysis. The potential determinants considered included sex of the child and mother's education, their occupation, age at birth of the child, and marital status. The concentration index (CI) was used to quantify the degree of inequality and decomposition approach to assess determinants of inequality in immunization. The CI for not fully immunized was -0.08 indicating that immunization inequality is mainly concentrated among children from poor families. Decomposition of the results suggests that 78% of this inequality is largely explained by the mother's level of education. There exists immunization inequality among urban poor children in Nairobi and efforts to reduce this inequality should aim at targeting mothers with low level of education during immunization campaigns.

  18. Safety, tolerability and efficacy of intradermal rabies immunization with DebioJect™.

    PubMed

    Vescovo, Paul; Rettby, Nils; Ramaniraka, Nirinarilala; Liberman, Julie; Hart, Karen; Cachemaille, Astrid; Piveteau, Laurent-Dominique; Zanoni, Reto; Bart, Pierre-Alexandre; Pantaleo, Giuseppe

    2017-03-27

    In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ), standard intradermal with classical needle (IDS), also called Mantoux method, and intramuscular with classical needle (IM). "Vaccin rabique Pasteur®" and saline solution (NaCl 0.9%) were administered at D0, D7 and D28. Antigen doses for both intradermal routes were 1/5 of the dose for IM. Tolerability, safety and induced immunogenicity of IDJ were compared to IDS and IM routes. Pain was evaluated at needle insertion and at product injection for all vaccination visits. Solicited Adverse Event (SolAE) and local reactogenicity symptoms including pain, redness and pruritus were recorded daily following each vaccination visit. Adverse events (AE) were recorded over the whole duration of the study. Humoral immune response was measured by assessing the rabies virus neutralizing antibody (VNA) titers using Rapid Fluorescent Focus Inhibition Test (RFFIT). Results demonstrated that the DebioJect™ is a safe, reliable and efficient device. Significant decreases of pain at needle insertion and at vaccine injection were reported with IDJ compared to IDS and IM. All local reactogenicity symptoms (pain, redness and pruritus) after injection with either vaccine or saline solution, were similar for IDJ and IDS, except that IDJ injection induced more redness 30min after saline solution. No systemic SolAE was deemed related to DebioJect™ and classical needles. No AE was deemed related to DebioJect™. No Serious Adverse Event (SAE) was reported during the study. At the end of the study all participants were considered immunized against rabies and no significant difference in humoral response was observed between the 3 studied routes. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Pesticide Health and Safety Information

    Science.gov Websites

    español Pesticide Health and Safety Information Pesticides can be beneficial to society in many ways when pesticides are not used according to label directions, or when one is over-exposed to a pesticide . Examples of harm include: Mothballs may cause health problems when not used in air-tight containers as

  20. Safety Psychology Applicating on Coal Mine Safety Management Based on Information System

    NASA Astrophysics Data System (ADS)

    Hou, Baoyue; Chen, Fei

    In recent years, with the increase of intensity of coal mining, a great number of major accidents happen frequently, the reason mostly due to human factors, but human's unsafely behavior are affected by insecurity mental control. In order to reduce accidents, and to improve safety management, with the help of application security psychology, we analyse the cause of insecurity psychological factors from human perception, from personality development, from motivation incentive, from reward and punishment mechanism, and from security aspects of mental training , and put forward countermeasures to promote coal mine safety production,and to provide information for coal mining to improve the level of safety management.

  1. Methods used for immunization coverage assessment in Canada, a Canadian Immunization Research Network (CIRN) study

    PubMed Central

    Quach, Susan; MacDonald, Shannon E.; Naus, Monika; Deeks, Shelley L.; Crowcroft, Natasha S.; Mahmud, Salaheddin M.; Tran, Dat; Kwong, Jeff; Tu, Karen; Johnson, Caitlin; Desai, Shalini

    2017-01-01

    ABSTRACT Accurate and complete immunization data are necessary to assess vaccine coverage, safety and effectiveness. Across Canada, different methods and data sources are used to assess vaccine coverage, but these have not been systematically described. Our primary objective was to examine and describe the methods used to determine immunization coverage in Canada. The secondary objective was to compare routine infant and childhood coverage estimates derived from the Canadian 2013 Childhood National Immunization Coverage Survey (cNICS) with estimates collected from provinces and territories (P/Ts). We collected information from key informants regarding their provincial, territorial or federal methods for assessing immunization coverage. We also collected P/T coverage estimates for select antigens and birth cohorts to determine absolute differences between these and estimates from cNICS. Twenty-six individuals across 16 public health organizations participated between April and August 2015. Coverage surveys are conducted regularly for toddlers in Quebec and in one health authority in British Columbia. Across P/Ts, different methodologies for measuring coverage are used (e.g., valid doses, grace periods). Most P/Ts, except Ontario, measure up-to-date (UTD) coverage and 4 P/Ts also assess on-time coverage. The degree of concordance between P/T and cNICS coverage estimates varied by jurisdiction, antigen and age group. In addition to differences in the data sources and processes used for coverage assessment, there are also differences between Canadian P/Ts in the methods used for calculating immunization coverage. Comparisons between P/T and cNICS estimates leave remaining questions about the proportion of children fully vaccinated in Canada. PMID:28708945

  2. Preliminary Examination of Safety Issues on a University Campus: Personal Safety Practices, Beliefs & Attitudes of Female Faculty & Staff

    ERIC Educational Resources Information Center

    Fletcher, Paula C.; Bryden, Pamela J.

    2007-01-01

    University and college campuses are not immune to acts of violence. Unfortunately there is limited information regarding violence in the academic setting among women employees. As such, the purpose of this exploratory research was to examine issues that female faculty and staff members have about safety on and around campus, including concerns…

  3. Factors affecting access to information on routine immunization among mothers of under 5 children in Kaduna State Nigeria, 2015

    PubMed Central

    Taiwo, Lydia; Idris, Suleiman; Abubakar, Aisha; Nguku, Patrick; Nsubuga, Peter; Gidado, Saheed; Okeke, Lilian; Emiasegen, Samuel; Waziri, Endie

    2017-01-01

    Introduction Immunization is one of the most effective interventions to prevent disease and early child death. A substantial number of children worldwide do not complete immunization schedules because neither health services nor conventional communication mechanisms regularly reach their communities. Knowledge and perception of mothers/caregivers regarding VPDs influence demand and utilization of immunization services. We examined the associations between knowledge, perception and information on routine immunization received by mothers/caregivers in Kaduna State. Methods We enrolled 379 eligible caregivers in a community-based cross-sectional study. We sampled respondents using multistage sampling technique. We collected data on socio-demographic characteristics; knowledge and perception on routine immunization using semi-structured interviewer-administered questionnaire. We conducted bivariate analysis and logistic regression using Epi-InfoTM version 7 at 5% level of significance. Results Mean age of respondents was 28.6 years (standard deviation=±6.6 years), 34% completed secondary school, 65% were unemployed, 49% lived in rural settlements. Among respondents' children 53.3% were females and 62.8% fell within 2nd-5th birth order. Only 15.6% of these children were fully immunized. Seventy-five percent of respondent did not obtain information on routine immunization within 12 months prior to the study. About 64% had unsatisfactory knowledge while 55.4% exhibited poor perceptions regarding routine immunization. Commonest source of information was radio (61.61%). On logistic regression educated participants (Adjusted odds ratio (AOR)=1.9, 95% CI: 1.1-3.3), mothers' perception (AOR=2.6, 95% CI: 1.5-4.5) and monogamous family setting (AOR=2.4, 95% CI: 0.2-0.6) were likely to have obtained information on routine immunization. Conclusion There is low access to information, poor maternal knowledge on routine immunization with low vaccination coverage in this community

  4. Factors affecting access to information on routine immunization among mothers of under 5 children in Kaduna State Nigeria, 2015.

    PubMed

    Taiwo, Lydia; Idris, Suleiman; Abubakar, Aisha; Nguku, Patrick; Nsubuga, Peter; Gidado, Saheed; Okeke, Lilian; Emiasegen, Samuel; Waziri, Endie

    2017-01-01

    Immunization is one of the most effective interventions to prevent disease and early child death. A substantial number of children worldwide do not complete immunization schedules because neither health services nor conventional communication mechanisms regularly reach their communities. Knowledge and perception of mothers/caregivers regarding VPDs influence demand and utilization of immunization services. We examined the associations between knowledge, perception and information on routine immunization received by mothers/caregivers in Kaduna State. We enrolled 379 eligible caregivers in a community-based cross-sectional study. We sampled respondents using multistage sampling technique. We collected data on socio-demographic characteristics; knowledge and perception on routine immunization using semi-structured interviewer-administered questionnaire. We conducted bivariate analysis and logistic regression using Epi-InfoTM version 7 at 5% level of significance. Mean age of respondents was 28.6 years (standard deviation=±6.6 years), 34% completed secondary school, 65% were unemployed, 49% lived in rural settlements. Among respondents' children 53.3% were females and 62.8% fell within 2 nd -5 th birth order. Only 15.6% of these children were fully immunized. Seventy-five percent of respondent did not obtain information on routine immunization within 12 months prior to the study. About 64% had unsatisfactory knowledge while 55.4% exhibited poor perceptions regarding routine immunization. Commonest source of information was radio (61.61%). On logistic regression educated participants (Adjusted odds ratio (AOR)=1.9, 95% CI: 1.1-3.3), mothers' perception (AOR=2.6, 95% CI: 1.5-4.5) and monogamous family setting (AOR=2.4, 95% CI: 0.2-0.6) were likely to have obtained information on routine immunization. There is low access to information, poor maternal knowledge on routine immunization with low vaccination coverage in this community. Efforts should be made by the

  5. Mothers' knowledge and information needs relating to childhood immunizations.

    PubMed

    Baker, Lynda M; Wilson, Feleta L; Nordstrom, Cheryl K; Legwand, Carol

    2007-01-01

    The purpose of this pilot study was to determine mothers' literacy level and knowledge, information needs, and information-seeking behaviors related to the vaccine(s) their children were receiving. A convenience sample of 15 mothers with one child and 15 mothers with two or more children was recruited at a free, urban, walk-in immunization clinic in Detroit. Participants completed the REALM test and a demographic form. Structured interviews were conducted to assess a mother's knowledge, information needs, and information-seeking behavior relating to the vaccines. The average reading skills were at the 7th- to 8th-grade level. Only four mothers knew the name and purpose of the vaccine their child was receiving. Information needs of the 26 mothers who did not know the name or purpose of the vaccine were categorized as immediate or deferred according to Krikelas's model of information seeking. More mothers with one child had immediate information needs, while more mothers with two or more children had deferred information needs. Primary sources of vaccine information were physicians and nurses. More research needs to be done to determine which nursing interventions work best to satisfy a mother's information needs.

  6. Aviation Safety Reporting System: Process and Procedures

    NASA Technical Reports Server (NTRS)

    Connell, Linda J.

    1997-01-01

    The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

  7. [Topics from "Overseas Drug Safety Information" in the past five years].

    PubMed

    Amanuma, Kimiko

    2013-01-01

    The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

  8. Variability in Immunization Practices for Preterm Infants.

    PubMed

    Gopal, Srirupa Hari; Edwards, Kathryn M; Creech, Buddy; Weitkamp, Joern-Hendrik

    2018-06-08

     The Advisory Committee on Immunization Practices and the American Academy of Pediatrics (AAP) recommend the same immunization schedule for preterm and term infants. However, significant delays in vaccination of premature infants have been reported.  The objective of this study was to assess the variability of immunization practices in preterm infants.  We conducted an online survey of 2,443 neonatologists in the United States, who are members of the Section for Neonatal-Perinatal Medicine of the AAP. Questions were targeted at immunization practices in the neonatal intensive care unit (NICU).  Of the 420 responses (17%) received, 55% of providers administer the first vaccine at >2-month chronological age. Most providers (83%) surveyed reported delaying vaccines in the setting of clinical illness. Sixty percent reported increasing frequency of apnea-bradycardia events following immunization. More than half administer the initial vaccines over several days despite lack of supporting data. Reported considerations in delaying or spreading out 2-month vaccines were clinical instability, provider preference, lower gestational age, and lower birth weight.  This survey substantiates the variability of immunizations practices in the NICU and identifies reasons for this variability. Future studies should inform better practice guidance for immunization of preterm NICU patients based on vaccine safety and effectiveness. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  9. Towards an Inclusive Occupational Health and Safety For Informal Workers.

    PubMed

    Lund, Francie; Alfers, Laura; Santana, Vilma

    2016-08-01

    Large numbers of workers worldwide work informally. Yet the discipline and practice of occupational health and safety covers largely only formal workers, in formal work places. A comprehensive approach would have to take into account specific hazards faced by those in different occupations, working in "atypical" work places. Local authorities exert significant influence in the provision of infrastructure that impacts on health and safety, such as water and sanitation. Examples from Brazil and Ghana show that positive interventions are possible so long as informal workers are recognized as contributing to the economy. A more inclusive occupational health and safety is most likely to happen in contexts where informal workers have an organized voice and where there are responsive health and safety personnel who understand that the world of work has changed. Some policy interventions that impact on healthy and safe work will need to involve multiple stakeholders and institutions. © The Author(s) 2016.

  10. Immune response at birth, long-term immune memory and 2 years follow-up after in-utero anti-HBV DNA immunization.

    PubMed

    Fazio, V M; Ria, F; Franco, E; Rosati, P; Cannelli, G; Signori, E; Parrella, P; Zaratti, L; Iannace, E; Monego, G; Blogna, S; Fioretti, D; Iurescia, S; Filippetti, R; Rinaldi, M

    2004-03-01

    Infections occurring at the end of pregnancy, during birth or by breastfeeding are responsible for the high toll of death among first-week infants. In-utero DNA immunization has demonstrated the effectiveness in inducing specific immunity in newborns. A major contribution to infant immunization would be achieved if a vaccine proved able to be protective as early as at the birth, preventing the typical 'first-week infections'. To establish its potential for use in humans, in-utero DNA vaccination efficiency has to be evaluated for short- and long-term safety, protection at delivery, efficacy of boosts in adults and effective window/s for modulation of immune response during pregnancy, in an animal model suitable with human development. Here we show that a single intramuscular in-utero anti-HBV DNA immunization at two-thirds of pig gestation produces, at birth, antibody titers considered protective in humans. The boost of antibody titers in every animal following recall at 4 and 10 months demonstrates the establishment of immune memory. The safety of in-utero fetus manipulation is guaranteed by short-term (no fetus loss, lack of local alterations, at-term spontaneous delivery, breastfeeding) and long-term (2 years) monitoring. Treatment of fetuses closer to delivery results in immune ignorance without induction of tolerance. This result highlights the repercussion of selecting the appropriate time point when this approach is used to deliver therapeutic genes. All these findings illustrate the relevance of naked DNA-based vaccination technology in therapeutic efforts aimed to prevent the high toll of death among first-week infants.

  11. A safety and immunogenicity study of immunization with hVEGF26-104/RFASE in cynomolgus monkeys.

    PubMed

    Wentink, Madelon Q; Verheul, Henk M W; Griffioen, Arjan W; Schafer, Kenneth A; McPherson, Susan; Early, Richard J; van der Vliet, Hans J; de Gruijl, Tanja D

    2018-04-05

    Vascular endothelial growth factor (VEGF) is pivotal in tumor angiogenesis and therapies targeting the VEGF axis are widely used in the clinic for the treatment of cancer. We have developed a therapeutic vaccine targeting human (h)VEGF 165 . hVEGF 26-104 /RFASE is based on the truncated protein hVEGF 26-104 as antigen formulated in an oil-in-water emulsion containing the sulpholipopolysaccharide RFASE as adjuvant. Here we describe the toxicity and immunogenicity of this therapeutic vaccine in cynomolgus monkeys. In total 54 cynomolgus monkeys were used and divided in 7 groups. Groups 1-3 were control groups, either receiving PBS alone (group 1), RFASE alone (group 2) or hVEGF 26-104 alone (group 3). Animals allocated to groups 4-7 received hVEGF 26-104 together with RFASE, but with varying doses of the antigen or the adjuvant. All animals were immunized four times with 2-week intervals and safety and immunogenicity were monitored until 3 days after the final immunization. Immunization induced an RFASE adjuvant dependent acute phase response. High titers of antibodies against hVEGF 26-104 and cross-reactive with hVEGF 165 , were found in monkey sera, 28 days after primer immunization. These antibodies were able to inhibit the binding of the monoclonal antibody bevacizumab with hVEGF 165 in a competition ELISA. Moreover, the biological activity of hVEGF 165 could be inhibited by the addition of immunized monkey serum in a VEGF specific bioassay. Importantly, no adverse events commonly observed with VEGF neutralization were observed throughout the study. These data show that hVEGF 26-104 /RFASE can be safely administered in cynomolgus monkeys, induces the desired immune response and therefore support the clinical development of this vaccine. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Communication in crisis situations in the process of immunization.

    PubMed

    Ravlija, Jelena; Vasilj, Ivan

    2012-09-01

    Immunization is one of the most effective medical interventions in the prevention of the disease and represents the easiest and most cost-effective investment in health. The strategy of controlling contagious diseases that can be prevented through immunization has a long tradition in B&H. Mandatory immunizations are administered against ten diseases. Although the development of new technologies, the efforts of the pharmaceutical industry, the development of new vaccines provides better vaccines in terms of greater safety and effectiveness it should be pointed out that no vaccine is "absolutely effective and safe", and it will not achieve the immune response in 100% vaccinated, also there are possible side effects and unexpected reactions that could occur. Vaccination is often a media issue because previously unnoticed local, isolated events-side effects and complications of vaccination are now accompanied by media attention as there are now numerous and fast communication channels (internet, e-mail, TV1 etc.) and media evolved from being less "controlled" to more "commercial". Doubt in benefit of vaccination is growing even among health professionals who are expected to provide up-to-date, understandable information, and issue information about immunization benefits and potential risks. It is therefore important for health professionals to be well informed, to be a good source of authoritative, scientific and reasonable advice, and to speak openly about the benefits and risks of vaccination so that consumers fully understand both possible outcomes of vaccination. This takes communication skills, particularly in crisis situations connected with vaccination. Health professionals are thus faced with a changing attitude toward importance of immunization in the social climate where risk is less tolerated than ever before.

  13. Safety, humoral and cell-mediated immune responses to herpes zoster vaccine in subjects with diabetes mellitus.

    PubMed

    Hata, Atsuko; Inoue, Fukue; Yamasaki, Midori; Fujikawa, Jun; Kawasaki, Yukiko; Hamamoto, Yoshiyuki; Honjo, Sachiko; Moriishi, Eiko; Mori, Yasuko; Koshiyama, Hiroyuki

    2013-09-01

    To evaluate varicella zoster virus-specific cell-mediated immunity and humoral immunogenicity against the herpes zoster vaccine, which is licensed as the Live Varicella Vaccine (Oka Strain) in Japan, in elderly people with or without diabetes mellitus. A pilot study was conducted between May 2010 and November 2010 at Kitano Hospital, a general hospital in the city of Osaka in Japan. A varicella skin test, interferon-gamma enzyme-linked immunospot assay and immunoadherence hemagglutination tests were performed 0, 3, and 6 months after vaccination. Vaccine safety was also assessed using questionnaires for 42 days and development of zoster during the one-year observational period. We enrolled 10 healthy volunteers and 10 patients with diabetes mellitus aged 60-70 years. The live herpes zoster vaccine boosted virus-specific, cell-mediated and humoral immunity between elderly people, with or without diabetes. Moreover, no systemic adverse reaction was found. None of the study participants developed herpes zoster. The live herpes zoster vaccine was used safely. It effectively enhanced specific immunity to varicella zoster virus in older people with or without diabetes mellitus. Copyright © 2013 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

  14. Communicating Environment, Health, and Safety Information to Internal and External Audiences.

    ERIC Educational Resources Information Center

    Davis, Thomas S.

    1995-01-01

    Argues that today's corporation must keep informed a wide range of individuals who have a stake in environment, health, and safety issues. Describes four elements of an effective communications program for doing so: electronic media to communicate technical information, environmental and safety audits, public communications with company…

  15. Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants: A Randomized Clinical Trial

    PubMed Central

    Munoz, Flor M.; Bond, Nanette H.; Maccato, Maurizio; Pinell, Phillip; Hammill, Hunter A.; Swamy, Geeta K.; Walter, Emmanuel B.; Jackson, Lisa A.; Englund, Janet A.; Edwards, Morven S.; Healy, C. Mary; Petrie, Carey R.; Ferreira, Jennifer; Goll, Johannes B.; Baker, Carol J.

    2015-01-01

    Importance Maternal immunization with tetanus toxoid and reduced diphtheria toxoid acellular pertussis (Tdap) vaccine could prevent infant pertussis. The effect of vaccine-induced maternal antibodies on infant responses to diphtheria and tetanus toxoids acellular pertussis (DTaP) immunization is unknown. Objective To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to DTaP. Design, Setting and Participants Phase I, randomized, double-masked, placebo-controlled clinical trial conducted in private (Houston) and academic (Durham, Seattle) obstetric practices from 2008 to 2012. Forty eight healthy 18–45 year-old pregnant women received Tdap (n=33) or placebo (n=15) at 30–32 weeks’ gestation with cross-over Tdap immunization postpartum. Interventions Tdap vaccination at 30–32 weeks’ gestation or post-partum. Outcome Measures Primary: Maternal and infant adverse events, pertussis illness and infant growth and development (Bayley-III screening test) until 13 months of age. Secondary: Antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months postpartum, and in infants at birth, 2 months, and after the third (7 months) and fourth (13 months) doses of DTaP. Results All participants delivered healthy newborns. No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 78.8% (95% CI: 61.1%, 91.0%) and 80% (CI: 51.9%, 95.7%) pregnant and postpartum women, respectively. Injection site pain was the predominant symptom. Systemic symptoms were reported in 36.4% (CI: 20.4%, 54.9%) and 73.3% (CI: 44.9%, 92.2%) pregnant and postpartum women, respectively. Malaise and myalgia were most common. Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in

  16. Integrated care: an Information Model for Patient Safety and Vigilance Reporting Systems.

    PubMed

    Rodrigues, Jean-Marie; Schulz, Stefan; Souvignet, Julien

    2015-01-01

    Quality management information systems for safety as a whole or for specific vigilances share the same information types but are not interoperable. An international initiative tries to develop an integrated information model for patient safety and vigilance reporting to support a global approach of heath care quality.

  17. Directory of aerospace safety specialized information sources, volume 2

    NASA Technical Reports Server (NTRS)

    Rubinstein, R. I.; Pinto, J. J.; Meschkow, S. Z.

    1976-01-01

    A handbook of organizations and experts in specific and well-defined areas of safety technology is presented. It is designed for the safety specialist as an aid for locating both information sources and individual points of contact (experts) in engineering related fields. The file covers sources of data in aerospace design, tests, and operations, as well as information on hazard and failure cause identification, accident analysis, and materials characteristics. Other related areas include the handling and transportation of hazardous chemicals, radioactive isotopes, and liquified natural gases.

  18. 25 CFR 43.17 - Release of information for health or safety emergencies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Release of information for health or safety emergencies... MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.17 Release of information for health or safety emergencies. (a) Educational institutions may release information from student records to...

  19. Transactions of the Twenty-First Water Reactor Safety Information Meeting

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

    Monteleone, S.

    1993-10-01

    This report contains summaries of papers on reactor safety research to be presented at the 21st Water Reactor Safety Information Meeting at the Bethesda Marriott Hotel, Bethesda, Maryland, October 25--27, 1993. The summaries briefly describe the programs and results of nuclear safety research sponsored by the Office of Nuclear Regulatory Research, US NRC. Summaries of invited papers concerning nuclear safety issues from US government laboratories, the electric utilities, the Electric Power Research Institute (EPRI), the nuclear industry, and from foreign governments and industry are also included. The summaries have been compiled in one report to provide a basis for meaningfulmore » discussion and information exchange during the course of the meeting and are given in the order of their presentation in each session.« less

  20. 77 FR 69899 - Public Conference on Geographic Information Systems (GIS) in Transportation Safety

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... NATIONAL TRANSPORTATION SAFETY BOARD Public Conference on Geographic Information Systems (GIS) in... Geographic Information Systems (GIS) in transportation safety on December 4-5, 2012. GIS is a rapidly... visualization of data. The meeting will bring researchers and practitioners in transportation safety and GIS...

  1. Pre-flight safety briefings, mood and information retention.

    PubMed

    Tehrani, Morteza; Molesworth, Brett R C

    2015-11-01

    Mood is a moderating factor that is known to affect performance. For airlines, the delivery of the pre-flight safety briefing prior to a commercial flight is not only an opportunity to inform passengers about the safety features on-board the aircraft they are flying, but an opportunity to positively influence their mood, and hence performance in the unlikely event of an emergency. The present research examined whether indeed the pre-flight safety briefing could be used to positively impact passengers' mood. In addition, the present research examined whether the recall of key safety messages contained within the pre-flight safety briefing was influenced by the style of briefing. Eighty-two participants were recruited for the research and divided into three groups; each group exposed to a different pre-flight cabin safety briefing video (standard, humorous, movie theme). Mood was measured prior and post safety briefing. The results revealed that pre-flight safety briefing videos can be used to manipulate passengers' mood. Safety briefings that are humorous or use movie themes to model their briefing were found to positively affect mood. However, there was a trade-off between entertainment and education, the greater the entertainment value, the poorer the retention of key safety messages. The results of the research are discussed from both an applied and theoretical perspective. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.

  2. Safety, Protective Immunity, and DIVA Capability of a Rough Mutant Salmonella Pullorum Vaccine Candidate in Broilers.

    PubMed

    Guo, Rongxian; Jiao, Yang; Li, Zhuoyang; Zhu, Shanshan; Fei, Xiao; Geng, Shizhong; Pan, Zhiming; Chen, Xiang; Li, Qiuchun; Jiao, Xinan

    2017-01-01

    Salmonella enterica subsp. enterica serovar Gallinarum biovar Pullorum ( Salmonella Pullorum) is highly adapted to chickens causing an acute systemic disease that results in high mortality. Vaccination represents one approach for promoting animal health, food safety and reducing environmental persistence in Salmonella control. An important consideration is that Salmonella vaccination in poultry should not interfere with the salmonellosis monitoring program. This is the basis of the DIVA (Differentiation of Infected and Vaccinated Animals) program. In order to achieve this goal, waaL mutant was developed on a spiC mutant that was developed previously. The safety, efficacy, and DIVA features of this vaccine candidate ( Salmonella Pullorum Δ spiC Δ waaL ) were evaluated in broilers. Our results show that the truncated LPS in the vaccine strain has a differentiating use as both a bacteriological marker (rough phenotype) and also as a serological marker facilitating the differentiation between infected and vaccinated chickens. The rough mutant showed adequate safety being avirulent in the host chicks and showed increased sensitivity to environmental stresses. Single intramuscular immunization of day-old broiler chicks with the mutant confers ideal protection against lethal wild type challenge by significantly stimulating both humoral and cellular immune responses as well as reducing the colonization of the challenge strain. Significantly lower mean pathology scores were observed in the vaccination group compared to the control group. Additionally, the mutant strain generated cross-protection against challenge with the wild type Salmonella Gallinarum thereby improving survival and with the wild type Salmonella Enteritidis thereby reducing colonization. These results suggest that the double-mutant strain may be a safe, effective, and cross-protective vaccine against Salmonella infection in chicks while conforming to the requirements of the DIVA program.

  3. 25 CFR 43.17 - Release of information for health or safety emergencies.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... appropriate persons in an emergency if the information is necessary to protect the health or safety of a... 25 Indians 1 2013-04-01 2013-04-01 false Release of information for health or safety emergencies... MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.17 Release of information for health or...

  4. 25 CFR 43.17 - Release of information for health or safety emergencies.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... appropriate persons in an emergency if the information is necessary to protect the health or safety of a... 25 Indians 1 2012-04-01 2011-04-01 true Release of information for health or safety emergencies... MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.17 Release of information for health or...

  5. 25 CFR 43.17 - Release of information for health or safety emergencies.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... appropriate persons in an emergency if the information is necessary to protect the health or safety of a... 25 Indians 1 2011-04-01 2011-04-01 false Release of information for health or safety emergencies... MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.17 Release of information for health or...

  6. 25 CFR 43.17 - Release of information for health or safety emergencies.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... appropriate persons in an emergency if the information is necessary to protect the health or safety of a... 25 Indians 1 2014-04-01 2014-04-01 false Release of information for health or safety emergencies... MAINTENANCE AND CONTROL OF STUDENT RECORDS IN BUREAU SCHOOLS § 43.17 Release of information for health or...

  7. Strengthening immunization in a West African country: Mali.

    PubMed

    Milstien, J B; Tapia, M; Sow, S O; Keita, L; Kotloff, K

    2007-11-01

    OBJECTIVES AND CONTEXT: This paper describes the preliminary outcomes of a collaborative capacity-building initiative performed in Mali to strengthen the immunization program. We conducted baseline assessments, training and post-training assessments in four programmatic areas: vaccine management, immunization safety, surveillance, and vaccine coverage, using adapted World Health Organization (WHO) tools. Impact assessment was done by evaluation of trainee performance, programmatic impact and sustainability. Qualitative and quantitative improvement of trainee performance was seen after the training interventions: some knowledge improvement, greater compliance with vaccine management practices and improved vaccine coverage. Deficiencies in information transfer to the periphery were identified. The program involves shared responsibility for planning, implementation and financing with national stakeholders while emphasizing the training of leaders and managers to ensure sustainability. Although short-term gains were measured, our initial assessments indicate that sustained impact will require improvements in staffing, financing and guidelines to ensure delivery of information and skills to the periphery.

  8. The challenge of effectively communicating patient safety information.

    PubMed

    Hugman, Bruce; Edwards, I Ralph

    2006-07-01

    Rational use of drugs and patient safety are seriously compromised by a lack of good information, education and effective communication at all stages of drug development and use. From animal trials through to dispensing, there are misconceptions and opportunities for error which current methods of drug information communication do not adequately address: they do not provide those responsible for prescribing and dispensing drugs with the data and information they need to pass on complex and often changing messages to patients and the public. The incidence of adverse reactions due to the way drugs are used; the variable impact of regulatory guidelines and warnings on prescribing behaviour; drug scares and crises suggest a great gap between the ideals of the safe use of medicines and the reality in homes, clinics and hospitals around the world. To address these challenges, the authors review the several levels at which safety information is generated and communicated, and examine how, at each stage, the content and its significance, and the method of communication can be improved.

  9. Child Immunization: Prevention Is the Best Medicine. Nutrition, Health and Safety.

    ERIC Educational Resources Information Center

    Klein, Tanna

    1999-01-01

    Argues that immunizations are the most powerful and most effective way to prevent childhood infectious diseases. Presents immunization rates in Missouri and describes recent state legislation adding tetanus and pertussis to required immunizations for school attendance. Identifies factors contributing to Missouri's low preschool immunization level.…

  10. Vaccine Education During Pregnancy and Timeliness of Infant Immunization.

    PubMed

    Veerasingam, Priya; Grant, Cameron C; Chelimo, Carol; Philipson, Kathryn; Gilchrist, Catherine A; Berry, Sarah; Carr, Polly Atatoa; Camargo, Carlos A; Morton, Susan

    2017-09-01

    Pregnant women routinely receive information in support of or opposing infant immunization. We aimed to describe immunization information sources of future mothers' and determine if receiving immunization information is associated with infant immunization timeliness. We analyzed data from a child cohort born 2009-2010 in New Zealand. Pregnant women ( N = 6822) at a median gestation of 39 weeks described sources of information encouraging or discouraging infant immunization. Immunizations received by cohort infants were determined through linkage with the National Immunization Register ( n = 6682 of 6853 [98%]). Independent associations of immunization information received with immunization timeliness were described by using adjusted odds ratios (ORs) and 95% confidence intervals (CIs). Immunization information sources were described by 6182 of 6822 (91%) women. Of these, 2416 (39%) received information encouraging immunization, 846 (14%) received discouraging information, and 565 (9%) received both encouraging and discouraging information. Compared with infants of women who received no immunization information (71% immunized on-time), infants of women who received discouraging information only (57% immunized on time, OR = 0.49, 95% CI 0.38-0.64) or encouraging and discouraging information (61% immunized on time, OR = 0.51, 95% CI 0.42-0.63) were at decreased odds of receiving all immunizations on time. Receipt of encouraging information only was not associated with infant immunization timeliness (73% immunized on time, OR = 1.00, 95% CI 0.87-1.15). Receipt, during pregnancy, of information against immunization was associated with delayed infant immunization regardless of receipt of information supporting immunization. In contrast, receipt of encouraging information is not associated with infant immunization timeliness. Copyright © 2017 by the American Academy of Pediatrics.

  11. Effects of Health Level 7 Messaging on Data Quality in New York City's Immunization Information System, 2014.

    PubMed

    Metroka, Amy E; Papadouka, Vikki; Ternier, Alexandra; Zucker, Jane R

    2016-01-01

    We compared the quality of data reported to New York City's immunization information system, the Citywide Immunization Registry (CIR), through its real-time Health Level 7 (HL7) Web service from electronic health records (EHRs), with data submitted through other methods. We stratified immunizations administered and reported to the CIR in 2014 for patients aged 0-18 years by reporting method: (1) sending HL7 messages from EHRs through the Web service, (2) manual data entry, and (3) upload of a non-standard flat file from EHRs. We assessed completeness of reporting by measuring the percentage of immunizations reported with lot number, manufacturer, and Vaccines for Children (VFC) program eligibility. We assessed timeliness of reporting by determining the number of days from date of administration to date entered into the CIR. HL7 reporting accounted for the largest percentage (46.3%) of the 3.8 million immunizations reported in 2014. Of immunizations reported using HL7, 97.9% included the lot number and 92.6% included the manufacturer, compared with 50.4% and 48.0% for manual entry, and 65.9% and 48.8% for non-standard flat file, respectively. VFC eligibility was 96.9% complete when reported by manual data entry, 95.3% complete for HL7 reporting, and 87.2% complete for non-standard flat file reporting. Of the three reporting methods, HL7 was the most timely: 77.6% of immunizations were reported by HL7 in <1 day, compared with 53.6% of immunizations reported through manual data entry and 18.1% of immunizations reported through non-standard flat file. HL7 reporting from EHRs resulted in more complete and timely data in the CIR compared with other reporting methods. Providing resources to facilitate HL7 reporting from EHRs to immunization information systems to increase data quality should be a priority for public health.

  12. Plant Immunity Inducer Development and Application.

    PubMed

    Dewen, Qiu; Yijie, Dong; Yi, Zhang; Shupeng, Li; Fachao, Shi

    2017-05-01

    Plant immunity inducers represent a new and rapidly developing field in plant-protection research. In this paper, we discuss recent research on plant immunity inducers and their development and applications in China. Plant immunity inducers include plant immunity-inducing proteins, chitosan oligosaccharides, and microbial inducers. These compounds and microorganisms can trigger defense responses and confer disease resistance in plants. We also describe the mechanisms of plant immunity inducers and how they promote plant health. Furthermore, we summarize the current situation in plant immunity inducer development in China and the global marketplace. Finally, we also deeply analyze the development trends and application prospects of plant immunity inducers in environmental protection and food safety.

  13. Use of Immunization Information Systems in Primary Care.

    PubMed

    Kempe, Allison; Hurley, Laura P; Cardemil, Cristina V; Allison, Mandy A; Crane, Lori A; Brtnikova, Michaela; Beaty, Brenda L; Pabst, Laura J; Lindley, Megan C

    2017-02-01

    Immunization information systems (IISs) are highly effective for increasing vaccination rates but information about how primary care physicians use them is limited. Pediatricians, family physicians (FPs), and general internists (GIMs) were surveyed by e-mail and mail from January 2015 to April 2015 from all states with an existing IIS. Providers were recruited to be representative of national provider organization memberships. Multivariable log binomial regression examined factors associated with IIS use (October 2015-April 2016). Response rates among pediatricians, FPs, and GIMs, respectively, were 75% (325/435), 68% (310/459), and 63% (272/431). A proportion of pediatricians (5%), FPs (14%), and GIMs (48%) did not know there was a state/local IIS; 81%, 72%, and 27% reported using an IIS (p<0.0001). Among those who used IISs, 64% of pediatricians, 61% of FPs, and 22% of GIMs thought the IIS could tell them a patient's immunization needs; 22%, 29%, and 51% did not know. The most frequently reported major barriers to use included the IIS not updating the electronic medical record (29%, 28%, 35%) and lack of ability to submit data electronically (22%, 27%, 31%). Factors associated with lower IIS use included FP (adjusted risk ratio=0.85; 95% CI=0.75, 0.97) or GIM (adjusted risk ratio=0.33; 95% CI=0.25, 0.42) versus pediatric specialty and older versus younger provider age (adjusted risk ratio=0.96; 95 CI%=0.94, 0.98). There are substantial gaps in knowledge of IIS capabilities, especially among GIMs; barriers to interoperability between IISs and electronic medical records affect all specialties. Closing these gaps may increase use of proven IIS functions including decision support and reminder/recall. Copyright © 2016. Published by Elsevier Inc.

  14. Immunization Action Coalition

    MedlinePlus

    ... Email CDC: nipinfo@cdc.gov Contact: State Immunization Managers Email IAC: admin@immunize.org This page was ... STATE INFORMATION State Websites State Laws State Immunization Managers >> view all SUBSCRIBE SUPPORT IAC TECHNICALLY SPEAKING TRANSLATE ...

  15. Safety Management Information Statistics (SAMIS) - 1995 Annual Report

    DOT National Transportation Integrated Search

    1997-04-01

    The Safety Management Information Statistics 1995 Annual Report is a compilation and analysis of transit accident, casualty and crime statistics reported under the Federal Transit Administration's National Transit Database Reporting by transit system...

  16. Safety Management Information Statistics (SAMIS) - 1993 Annual Report

    DOT National Transportation Integrated Search

    1995-05-01

    The 1993 Safety Management Information Statistics (SAMIS) report, now in its fourth year of publication, is a compilation and analysis of transit accident and casualty statistics uniformly collected from approximately 400 transit agencies throughout ...

  17. Economics of immunization information systems in the United States: assessing costs and efficiency.

    PubMed

    Bartlett, Diana L; Molinari, Noelle-Angelique M; Ortega-Sanchez, Ismael R; Urquhart, Gary A

    2006-08-22

    One of the United States' national health objectives for 2010 is that 95% of children aged <6 years participate in fully operational population-based immunization information systems (IIS). Despite important progress, child participation in most IIS has increased slowly, in part due to limited economic knowledge about IIS operations. Should IIS need further improvement, characterizing costs and identifying factors that affect IIS efficiency become crucial. Data were collected from a national sampling frame of the 56 states/cities that received federal immunization grants under U.S. Public Health Service Act 317b and completed the federal 1999 Immunization Registry Annual Report. The sampling frame was stratified by IIS functional status, children's enrollment in the IIS, and whether the IIS had been developed as an independent system or was integrated into a larger system. These sites self-reported IIS developmental and operational program costs for calendar years 1998-2002 using a standardized data collection tool and underwent on-site interviews to verify reported data with information from the state/city financial management system and other financial records. A parametric cost-per-patient-record (CPR) model was estimated. The model assessed the impact of labor and non-labor resources used in development and operations tasks, as well as the impact of information technology, local providers' participation and compliance with federal IIS performance standards (e.g., ensuring the confidentiality and security of information, ensure timely vaccination data at the time of patient encounter, and produce official immunization records). Given the number of records minimizing CPR, the additional amount of resources needed to meet national health goals for the year 2010 was also calculated. Estimated CPR was as high as $10.30 and as low as $0.09 in operating IIS. About 20% of IIS had between 2.9 to 3.2 million records and showed CPR estimates of $0.09. Overall, CPR was

  18. Economics of immunization information systems in the United States: assessing costs and efficiency

    PubMed Central

    Bartlett, Diana L; Molinari, Noelle-Angelique M; Ortega-Sanchez, Ismael R; Urquhart, Gary A

    2006-01-01

    Background One of the United States' national health objectives for 2010 is that 95% of children aged <6 years participate in fully operational population-based immunization information systems (IIS). Despite important progress, child participation in most IIS has increased slowly, in part due to limited economic knowledge about IIS operations. Should IIS need further improvement, characterizing costs and identifying factors that affect IIS efficiency become crucial. Methods Data were collected from a national sampling frame of the 56 states/cities that received federal immunization grants under U.S. Public Health Service Act 317b and completed the federal 1999 Immunization Registry Annual Report. The sampling frame was stratified by IIS functional status, children's enrollment in the IIS, and whether the IIS had been developed as an independent system or was integrated into a larger system. These sites self-reported IIS developmental and operational program costs for calendar years 1998–2002 using a standardized data collection tool and underwent on-site interviews to verify reported data with information from the state/city financial management system and other financial records. A parametric cost-per-patient-record (CPR) model was estimated. The model assessed the impact of labor and non-labor resources used in development and operations tasks, as well as the impact of information technology, local providers' participation and compliance with federal IIS performance standards (e.g., ensuring the confidentiality and security of information, ensure timely vaccination data at the time of patient encounter, and produce official immunization records). Given the number of records minimizing CPR, the additional amount of resources needed to meet national health goals for the year 2010 was also calculated. Results Estimated CPR was as high as $10.30 and as low as $0.09 in operating IIS. About 20% of IIS had between 2.9 to 3.2 million records and showed CPR estimates

  19. Feedback from incident reporting: information and action to improve patient safety.

    PubMed

    Benn, J; Koutantji, M; Wallace, L; Spurgeon, P; Rejman, M; Healey, A; Vincent, C

    2009-02-01

    Effective feedback from incident reporting systems in healthcare is essential if organisations are to learn from failures in the delivery of care. Despite the wide-scale development and implementation of incident reporting in healthcare, studies in the UK suggest that information concerning system vulnerabilities could be better applied to improve operational safety within organisations. In this article, the findings and implications of research to identify forms of effective feedback from incident reporting are discussed, to promote best practices in this area. The research comprised a mixed methods review to investigate mechanisms of effective feedback for healthcare, drawing upon experience within established reporting programmes in high-risk industry and transport domains. Systematic searches of published literature were undertaken, and 23 case studies describing incident reporting programmes with feedback were identified for analysis from the international healthcare literature. Semistructured interviews were undertaken with 19 subject matter experts across a range of domains, including: civil aviation, maritime, energy, rail, offshore production and healthcare. In analysis, qualitative information from several sources was synthesised into practical requirements for developing effective feedback in healthcare. Both action and information feedback mechanisms were identified, serving safety awareness, improvement and motivational functions. The provision of actionable feedback that visibly improved systems was highlighted as important in promoting future reporting. Fifteen requirements for the design of effective feedback systems were identified, concerning: the role of leadership, the credibility and content of information, effective dissemination channels, the capacity for rapid action and the need for feedback at all levels of the organisation, among others. Above all, the safety-feedback cycle must be closed by ensuring that reporting, analysis and

  20. Mapping Sources of Food Safety Information for U.S. Consumers: Findings From a National Survey.

    PubMed

    Nan, Xiaoli; Verrill, Linda; Kim, Jarim

    2017-03-01

    This research examines the sources from which U.S. consumers obtain their food safety information. It seeks to determine differences in the types of information sources used by U.S. consumers of different sociodemographic background, as well as the relationships between the types of information sources used and food safety risk perceptions. Analyzing the 2010 Food Safety Survey (N = 4,568) conducted by the U.S. Food and Drug Administration, we found that age, gender, education, and race predicted the use of different sources for food safety information. Additionally, use of several information sources predicted perceived susceptibility to foodborne illnesses and severity of food contamination. Implications of the findings for food safety risk communication are discussed.

  1. 77 FR 28669 - Pipeline Safety: Information Collection Activities, Excess Flow Valve Census

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0086] Pipeline Safety: Information Collection Activities, Excess Flow Valve Census AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice and request for...

  2. Measuring and improving patient safety through health information technology: The Health IT Safety Framework

    PubMed Central

    Singh, Hardeep

    2016-01-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

  3. Quantifying Safety Margin Using the Risk-Informed Safety Margin Characterization (RISMC)

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

    Grabaskas, David; Bucknor, Matthew; Brunett, Acacia

    2015-04-26

    The Risk-Informed Safety Margin Characterization (RISMC), developed by Idaho National Laboratory as part of the Light-Water Reactor Sustainability Project, utilizes a probabilistic safety margin comparison between a load and capacity distribution, rather than a deterministic comparison between two values, as is usually done in best-estimate plus uncertainty analyses. The goal is to determine the failure probability, or in other words, the probability of the system load equaling or exceeding the system capacity. While this method has been used in pilot studies, there has been little work conducted investigating the statistical significance of the resulting failure probability. In particular, it ismore » difficult to determine how many simulations are necessary to properly characterize the failure probability. This work uses classical (frequentist) statistics and confidence intervals to examine the impact in statistical accuracy when the number of simulations is varied. Two methods are proposed to establish confidence intervals related to the failure probability established using a RISMC analysis. The confidence interval provides information about the statistical accuracy of the method utilized to explore the uncertainty space, and offers a quantitative method to gauge the increase in statistical accuracy due to performing additional simulations.« less

  4. Safety Management Information Statistics (SAMIS) - 1991 Annual Report

    DOT National Transportation Integrated Search

    1993-02-01

    The Safety Management Information Statistics 1991 Annual Report is a compilation and analysis of mass transit accident and casualty statistics reported by transit systems in the United States during 1991, under FTA's Section 15 reporting system.

  5. Safety Management Information Statistics (SAMIS) - 1994 Annual Report

    DOT National Transportation Integrated Search

    1996-07-01

    The Safety Management Information Statistics 1994 Annual Report is a compilation and analysis of mass transit accident and casualty statistics reported by transit systems in the United States during 1994, reported under the Federal Transit Administra...

  6. Immunization Coverage and Medicaid Managed Care in New Mexico: A Multimethod Assessment

    PubMed Central

    Schillaci, Michael A.; Waitzkin, Howard; Carson, E. Ann; López, Cynthia M.; Boehm, Deborah A.; López, Leslie A.; Mahoney, Sheila F.

    2004-01-01

    BACKGROUND We wanted to examine the association between Medicaid managed care (MMC) and changing immunization coverage in New Mexico, a predominantly rural, poor, and multiethnic state. METHODS As part of a multimethod assessment of MMC, we studied trends in quantitative data from the National Immunization Survey (NIS) using temporal plots, Fisher’s exact test, and the Cochran-Armitage trend test. To help explain changes in immunization rates in relation to MMC, we analyzed qualitative data gathered through ethnographic observations at safety net institutions: income support (welfare) offices, community health centers, hospital emergency departments, private physicians’ offices, mental health institutions, managed care organizations, and agencies of state government. RESULTS Immunization coverage decreased significantly after implementation of MMC, from 80% in 1996 to 73% in 2001 for the 4:3:1 vaccination series (Fisher’s exact test, P = .031). New Mexico dropped in rank among states from 30th for this vaccination series in 1996 to 50th in 2001. A significant decreasing trend (Cochran-Armitage P = .025) in coverage occurred between 1996 and 2001. Findings from the ethnographic study revealed conditions that might have contributed to decreased immunization coverage: (1) reduced funding for immunizations at public health clinics, and difficulties in gaining access to MMC providers; (2) informal referrals from managed care organizations and contracting physicians to community health centers and state-run public health clinics; and (3) increased workloads and delays at community health centers, linked partly to these informal referrals for immunizations. CONCLUSIONS Medicaid reform in New Mexico did not improve immunization coverage, which declined significantly to among the lowest in the nation. Reduced funding for public health clinics and informal referrals may have contributed to this decline. These observations show how unanticipated and adverse consequences

  7. 75 FR 36615 - Pipeline Safety: Information Collection Gas Distribution Annual Report Form

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 192 [Docket No. PHMSA-RSPA-2004-19854] Pipeline Safety: Information Collection Gas Distribution Annual Report Form AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Request...

  8. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

    PubMed

    Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

    2016-10-01

    The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

  9. Swimming Pool Safety

    MedlinePlus

    ... Spread the Word Shop AAP Find a Pediatrician Safety & Prevention Immunizations All Around At Home At Play ... Español Text Size Email Print Share Swimming Pool Safety Page Content ​What is the best way to ...

  10. Addressing immunization registry population inflation in adolescent immunization rates.

    PubMed

    Robison, Steve G

    2015-01-01

    While U.S. adolescent immunization rates are available annually at national and state levels, finding pockets of need may require county or sub-county information. Immunization information systems (IISs) are one tool for assessing local immunization rates. However, the presence of IIS records dating back to early childhood and challenges in capturing mobility out of IIS areas typically leads to denominator inflation. We examined the feasibility of weighting adolescent immunization records by length of time since last report to produce more accurate county adolescent counts and immunization rates. We compared weighted and unweighted adolescent denominators from the Oregon ALERT IIS, along with county-level Census Bureau estimates, with school enrollment counts from Oregon's annual review of seventh-grade school immunization compliance for public and private schools. Adolescent immunization rates calculated using weighted data, for the state as a whole, were also checked against comparable National Immunization Survey (NIS) rates. Weighting individual records by the length of time since last activity substantially improved the fit of IIS data to county populations for adolescents. A nonlinear logarithmic (ogive) weight produced the best fit to the school count data of all examined estimates. Overall, the ogive weighted results matched NIS adolescent rates for Oregon. The problem of mobility-inflated counts of teenagers can be addressed by weighting individual records based on time since last immunization. Well-populated IISs can rely on their own data to produce adolescent immunization rates and find pockets of need.

  11. Where Do Agricultural Producers Get Safety and Health Information?

    PubMed

    Chiu, Sophia; Cheyney, Marsha; Ramirez, Marizen; Gerr, Fred

    2015-01-01

    There is little empirical guidance regarding communication sources and channels used and trusted by agricultural producers. The goal of this study was to characterize frequency of use and levels of trust in agricultural safety and health information sources and channels accessed by agricultural producers. A sample of 195 agricultural producers was surveyed at county fairs in Iowa. Information was collected about the frequency of use and level of trust in 14 information sources and channels. Associations between age, gender, and education level and use and trust of each information source or channel were estimated using logistic regression. The sample consisted of 72% men with a mean age of 50.1 (SD = 15.6) years. Newspaper and magazine articles were the most commonly used agricultural safety and health information source or channel; 77% (n = 140) of respondents reporting using them at least monthly. Among those reporting monthly or more frequent use, 75% reported trusting mostly or completely, compared with 58% using and 49% trusting the Internet. High levels of use and trust of newspaper and magazine articles did not vary significantly by age, gender, or education level. Age in the highest tertile (57-83 years) was marginally associated with lower odds of using, as well as using and trusting, all the information sources and channels studied except for medical clinics (use only: odds ratio [OR], 3.51, 95% confidence interval [CI], 0.79-15.64; use and trust: OR, 5.90, 95% CI, 0.91-38.42). These findings suggest that traditional media may be more effective than digital media for delivering agricultural safety and health information to agricultural producers. Medical clinics may be an untapped venue for communicating with older agricultural producers.

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

    PubMed

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

    2013-09-01

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

  13. National Immunization Program: Computerized System as a tool for new challenges

    PubMed Central

    Sato, Ana Paula Sayuri

    2015-01-01

    The scope and coverage of the Brazilian Immunization Program can be compared with those in developed countries because it provides a large number of vaccines and has a considerable coverage. The increasing complexity of the program brings challenges regarding its development, high coverage levels, access equality, and safety. The Immunization Information System, with nominal data, is an innovative tool that can more accurately monitor these indicators and allows the evaluation of the impact of new vaccination strategies. The main difficulties for such a system are in its implementation process, training of professionals, mastering its use, its constant maintenance needs and ensuring the information contained remain confidential. Therefore, encouraging the development of this tool should be part of public health policies and should also be involved in the three spheres of government as well as the public and private vaccination services. PMID:26176746

  14. Progress in Childhood Vaccination Data in Immunization Information Systems - United States, 2013-2016.

    PubMed

    Murthy, Neil; Rodgers, Loren; Pabst, Laura; Fiebelkorn, Amy Parker; Ng, Terence

    2017-11-03

    In 2016, 55 jurisdictions in 49 states and six cities in the United States* used immunization information systems (IISs) to collect and manage immunization data and support vaccination providers and immunization programs. To monitor progress toward achieving IIS program goals, CDC surveys jurisdictions through an annual self-administered IIS Annual Report (IISAR). Data from the 2013-2016 IISARs were analyzed to assess progress made in four priority areas: 1) data completeness, 2) bidirectional exchange of data with electronic health record systems, 3) clinical decision support for immunizations, and 4) ability to generate childhood vaccination coverage estimates. IIS participation among children aged 4 months through 5 years increased from 90% in 2013 to 94% in 2016, and 33 jurisdictions reported ≥95% of children aged 4 months through 5 years participating in their IIS in 2016. Bidirectional messaging capacity in IISs increased from 25 jurisdictions in 2013 to 37 in 2016. In 2016, nearly all jurisdictions (52 of 55) could provide automated provider-level coverage reports, and 32 jurisdictions reported that their IISs could send vaccine forecasts to providers via Health Level 7 (HL7) messaging, up from 17 in 2013. Incremental progress was made in each area since 2013, but continued effort is needed to implement these critical functionalities among all IISs. Success in these priority areas, as defined by the IIS Functional Standards (1), bolsters clinicians' and public health practitioners' ability to attain high vaccination coverage in pediatric populations, and prepares IISs to develop more advanced functionalities to support state/local immunization services. Success in these priority areas also supports the achievement of federal immunization objectives, including the use of IISs as supplemental sampling frames for vaccination coverage surveys like the National Immunization Survey (NIS)-Child, reducing data collection costs, and supporting increased precision

  15. Effects of Health Level 7 Messaging on Data Quality in New York City's Immunization Information System, 2014

    PubMed Central

    Papadouka, Vikki; Ternier, Alexandra; Zucker, Jane R.

    2016-01-01

    Objective We compared the quality of data reported to New York City's immunization information system, the Citywide Immunization Registry (CIR), through its real-time Health Level 7 (HL7) Web service from electronic health records (EHRs), with data submitted through other methods. Methods We stratified immunizations administered and reported to the CIR in 2014 for patients aged 0–18 years by reporting method: (1) sending HL7 messages from EHRs through the Web service, (2) manual data entry, and (3) upload of a non-standard flat file from EHRs. We assessed completeness of reporting by measuring the percentage of immunizations reported with lot number, manufacturer, and Vaccines for Children (VFC) program eligibility. We assessed timeliness of reporting by determining the number of days from date of administration to date entered into the CIR. Results HL7 reporting accounted for the largest percentage (46.3%) of the 3.8 million immunizations reported in 2014. Of immunizations reported using HL7, 97.9% included the lot number and 92.6% included the manufacturer, compared with 50.4% and 48.0% for manual entry, and 65.9% and 48.8% for non-standard flat file, respectively. VFC eligibility was 96.9% complete when reported by manual data entry, 95.3% complete for HL7 reporting, and 87.2% complete for non-standard flat file reporting. Of the three reporting methods, HL7 was the most timely: 77.6% of immunizations were reported by HL7 in <1 day, compared with 53.6% of immunizations reported through manual data entry and 18.1% of immunizations reported through non-standard flat file. Conclusion HL7 reporting from EHRs resulted in more complete and timely data in the CIR compared with other reporting methods. Providing resources to facilitate HL7 reporting from EHRs to immunization information systems to increase data quality should be a priority for public health. PMID:27453603

  16. Support from Afar: Using Chemical Safety Information on the Internet.

    ERIC Educational Resources Information Center

    Stuart, Ralph

    One of the major challenges facing people committed to Teaching Safety in High Schools, Colleges, and Universities is keeping up with both the wide range of relevant technical information about potential hazards (ranging from fire protection to chemical hazards to biological issues) and the ever-changing world of safety regulations and standards.…

  17. 32 CFR 861.7 - Disclosure of voluntarily provided safety-related information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) Processing requests for disclosure of voluntarily provided safety-related information. Requests for public... will protect the information from public disclosure, and that it will not release such information...-related information. 861.7 Section 861.7 National Defense Department of Defense (Continued) DEPARTMENT OF...

  18. 32 CFR 861.7 - Disclosure of voluntarily provided safety-related information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) Processing requests for disclosure of voluntarily provided safety-related information. Requests for public... will protect the information from public disclosure, and that it will not release such information...-related information. 861.7 Section 861.7 National Defense Department of Defense (Continued) DEPARTMENT OF...

  19. 32 CFR 861.7 - Disclosure of voluntarily provided safety-related information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) Processing requests for disclosure of voluntarily provided safety-related information. Requests for public... will protect the information from public disclosure, and that it will not release such information...-related information. 861.7 Section 861.7 National Defense Department of Defense (Continued) DEPARTMENT OF...

  20. 32 CFR 861.7 - Disclosure of voluntarily provided safety-related information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) Processing requests for disclosure of voluntarily provided safety-related information. Requests for public... will protect the information from public disclosure, and that it will not release such information...-related information. 861.7 Section 861.7 National Defense Department of Defense (Continued) DEPARTMENT OF...

  1. 75 FR 27734 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... Glatz, Division of Policy and Planning, Office of Information Technology, Consumer Product Safety... appropriate, and other forms of information technology. Title: Safety Standard for Bicycle Helmets--16 CFR... and process for Commission acceptance of accreditation of third party conformity assessment bodies for...

  2. Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.

    PubMed

    Kesselheim, Aaron S; McGraw, Sarah A; Dejene, Sara Z; Rausch, Paula; Dal Pan, Gerald J; Lappin, Brian M; Zhou, Esther H; Avorn, Jerry; Campbell, Eric G

    2017-06-01

    The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations. We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone. We conducted interviews with 40 patients and ten physicians recruited from a combination of insurer claims databases and online sources. We evaluated (1) sources of drug safety information; (2) discussions between patients and physicians about the two medications; (3) their knowledge of the DSC; and (4) preferences for learning about future drug safety information. Interviews were transcribed and analyzed thematically. Patients cited their physicians, pharmacy inserts, and the Internet as sources of drug safety information. Physicians often referred to medical journals and online medical sources. Most patients reported being aware of information contained in the DSC summaries they were read. Almost all patients and physicians reported discussing side effects during patient-provider conversations, but almost no patients mentioned that physicians had communicated with them key messaging from the DSCs at issue: the risk of next-morning impairment with zolpidem and the lower recommended initial dose for women. Some risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients' decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner.

  3. Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

    PubMed

    Singh, Hardeep; Sittig, Dean F

    2016-04-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

  4. Firefighters as distributors of workplace safety and health information to small businesses

    PubMed Central

    Keller, Brenna M.; Cunningham, Thomas R.

    2016-01-01

    Background Small businesses bear a large burden of injury and death, and are difficult to reach with occupational safety and health (OSH) information. The National Institute for Occupational Safety and Health (NIOSH) developed a pilot study testing the feasibility of fire departments disseminating OSH information to small businesses during fire inspections. Methods Two sets of postcards were developed with unique, trackable URLs for the NIOSH Small Business Resource Guide. One set was distributed by firefighters, the other was mailed to small businesses. Participating inspectors were met with to discuss their experience. Results Neither distribution method resulted in a substantial number of site visits. Inspectors believed distributing postcards was an easy addition to their duties, and saw value in safety information. Conclusions There are barriers beyond awareness of availability that prevent small business owners from seeking OSH information. Research should focus on identifying barriers and developing better OSH information diffusion mechanisms. PMID:27594768

  5. 10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...

  6. 10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...

  7. 10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...

  8. 10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...

  9. Analyzing and strengthening the vaccine safety program in Manitoba.

    PubMed

    Montalban, J M; Ogbuneke, C; Hilderman, T

    2014-12-04

    The emergence of a novel influenza A virus in 2009 and the rapid introduction of new pandemic vaccines prompted an analysis of the current state of the adverse events following immunization (AEFI) surveillance response in several provinces. To highlight aspects of the situational analysis of the Manitoba Health, Healthy Living and Seniors (MHHLS's) AEFI surveillance system and to demonstrate how common business techniques could be usefully applied to a provincial vaccine safety monitoring program. Situational analysis of the AEFI surveillance system in Manitoba was developed through a strengths-weaknesses-opportunities-threats (SWOT) analysis and informed by the National Immunization Strategy vaccine safety priorities. Strategy formulation was developed by applying the threats-opportunities-weaknesses-strengths (TOWS) matrix. Thirteen strategies were formulated that use strengths to either take advantage of opportunities or avoid threats, that exploit opportunities to overcome weaknesses, or that rectify weaknesses to circumvent threats. These strategies entailed the development of various tools and resources, most of which are either actively underway or completed. The SWOT analysis and the TOWS matrix enabled MHHLS to enhance the capacity of its vaccine safety program.

  10. Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

    Curtis Smith; Diego Mandelli

    Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk-informed

  11. 75 FR 66384 - Notice of Proposed Information Collection for Public Comment; Exigent Health and Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... provides the property representative with a copy of the ``Notification of Exigent and Fire Safety Hazards... Information Collection for Public Comment; Exigent Health and Safety Deficiency Correction Certification... lists the following information: Title of Proposal: Exigent Health and Safety Deficiency Correction...

  12. A global survey of adverse event following immunization surveillance systems for pregnant women and their infants.

    PubMed

    Cassidy, Christine; MacDonald, Noni E; Steenbeek, Audrey; Ortiz, Justin R; Zuber, Patrick L F; Top, Karina A

    2016-08-02

    Strengthening antenatal care as a platform for maternal immunization is a priority of the World Health Organization (WHO). Systematic surveillance for adverse events following immunization (AEFI) in pregnancy is needed to identify vaccine safety events. We sought to identify active and passive AEFI surveillance systems for pregnant women and infants. Representatives from all National Pharmacovigilance Centers and a convenience sample of vaccine safety experts were invited to complete a 14-item online survey in English, French or Spanish. The survey captured maternal immunization policies, and active and passive AEFI surveillance systems for pregnant women and infants in respondents' countries. The analysis was descriptive. We received responses from 51/185 (28%) invited persons from 47/148 (32%) countries representing all WHO regions, and low, middle and high-income countries. Thirty countries had national immunization policies targeting pregnant women. Eleven countries had active surveillance systems to detect serious AEFI in pregnant women and/or their infants, including six low and middle-income countries (LMIC). Thirty-nine countries had passive surveillance systems, including 23 LMIC. These active and passive surveillance programs cover approximately 8% and 56% of the worldwide annual birth cohort, respectively. Data from one active and four passive systems have been published. We identified 50 active and passive AEFI surveillance systems for pregnant women and infants, but few have published their findings. AEFI surveillance appears to be feasible in low and high resource settings. Further expansion of AEFI surveillance for pregnant women and sharing of vaccine safety information will provide additional evidence in support of maternal immunization policies.

  13. Patterns of patient safety culture: a complexity and arts-informed project of knowledge translation.

    PubMed

    Mitchell, Gail J; Tregunno, Deborah; Gray, Julia; Ginsberg, Liane

    2011-01-01

    The purpose of this paper is to describe patterns of patient safety culture that emerged from an innovative collaboration among health services researchers and fine arts colleagues. The group engaged in an arts-informed knowledge translation project to produce a dramatic expression of patient safety culture research for inclusion in a symposium. Scholars have called for a deeper understanding of the complex interrelationships among structure, process and outcomes relating to patient safety. Four patterns of patient safety culture--blinding familiarity, unyielding determination, illusion of control and dismissive urgency--are described with respect to how they informed creation of an arts-informed project for knowledge translation.

  14. Health Information Technology in Healthcare Quality and Patient Safety: Literature Review.

    PubMed

    Feldman, Sue S; Buchalter, Scott; Hayes, Leslie W

    2018-06-04

    The area of healthcare quality and patient safety is starting to use health information technology to prevent reportable events, identify them before they become issues, and act on events that are thought to be unavoidable. As healthcare organizations begin to explore the use of health information technology in this realm, it is often unclear where fiscal and human efforts should be focused. The purpose of this study was to provide a foundation for understanding where to focus health information technology fiscal and human resources as well as expectations for the use of health information technology in healthcare quality and patient safety. A literature review was conducted to identify peer-reviewed publications reporting on the actual use of health information technology in healthcare quality and patient safety. Inductive thematic analysis with open coding was used to categorize a total of 41 studies. Three pre-set categories were used: prevention, identification, and action. Three additional categories were formed through coding: challenges, outcomes, and location. This study identifies five main categories across seven study settings. A majority of the studies used health IT for identification and prevention of healthcare quality and patient safety issues. In this realm, alerts, clinical decision support, and customized health IT solutions were most often implemented. Implementation, interface design, and culture were most often noted as challenges. This study provides valuable information as organizations determine where they stand to get the most "bang for their buck" relative to health IT for quality and patient safety. Knowing what implementations are being effectivity used by other organizations helps with fiscal and human resource planning as well as managing expectations relative to cost, scope, and outcomes. The findings from this scan of the literature suggest that having organizational champion leaders that can shepherd implementation, impact culture

  15. Handedness, immune disorders and information bias.

    PubMed

    Chavance, M; Dellatolas, G; Bousser, M G; Amor, B; Grardel, B; Kahan, A; Kahn, M F; Le Floch, J P; Tchobroutsky, G

    1990-01-01

    In order to investigate the relations between handedness and migraine or immune disorders, we performed a case control study comparing the handedness of patients suffering from systemic lupus erythematosus (SLE), type I diabetes, Graves' disease, or migraine to that of a random sample of controls from the general population. A handedness index was measured from a 10-item questionnaire. No significant difference was observed. But when the controls who denied having ever suffered from migraine or any allergic disease were set apart from those who gave at least one positive answer to the same questions, the former were found more right-handed, i.e. with a lower handedness index than the latter (P less than 0.05) and than the SLE patients (P less than 0.05). More generally, the mean observed handedness index of controls giving a positive answer to any question about their health was found repeatedly higher than that of controls giving a negative answer: this was observed for 27 of the 32 questions. These results are highly suggestive of an information bias, the subjects saying they use the right hand for each of the 10 activities considered in the questionnaire being more likely to deny having suffered from a given disease or used, more or less recently, some drug or medical service. Our conviction is that previous observations dealing with the same topic are also more easily explained by the presence of an information bias than by Geschwind's theory. The implications for the design of further epidemiologic studies are discussed.

  16. A Collection Scheme for Tracing Information of Pig Safety Production

    NASA Astrophysics Data System (ADS)

    Luo, Qingyao; Xiong, Benhai; Yang, Liang

    This study takes one main production pattern of smallhold pig farming in Tianjin as a study prototype, deeply analyzes characters of informations about tracing inputs including vaccines,feeds,veterinary drugs and supervision test in pig farming, proposesinputs metadata, criteria for integrating inputs event and interface norms for data transmision, developes and completes identification of 2D ear tags and traceability information collection system of pig safety production based on mobile PDA. The system has implemented functions including setting and invalidate of 2D ear tags, collection of tracing inputs and supervision in the mobile PDA and finally integration of tracing events (the epidemic event,feed event,drug event and supervision event) on the traceability data center (server). The PDA information collection system has been applied for demonstration in Tianjin, the collection is simple, convenient and feasible. It could meet with requirements of traceability information system of pig safety production

  17. Internet Exposure Associated With Canadian Parents' Perception of Risk on Childhood Immunization: Cross-Sectional Study.

    PubMed

    Tustin, Jordan Lee; Crowcroft, Natasha Sarah; Gesink, Dionne; Johnson, Ian; Keelan, Jennifer

    2018-01-19

    There is a large presence of provaccination and antivaccination content on the Internet. The Internet has been identified as an important source for parents to seek and share vaccine information. There are concerns that parental fears or hesitancy on childhood immunizations are increasing due to the popularity of social media and exposure to online antivaccination sentiment. No other studies have investigated the association between seeking vaccine information online and Canadian parents' perception of risk on childhood immunization. We aimed to investigate the potential association between seeking vaccine information on the Internet and Canadian parents' perception of risk on childhood immunization in order to quantify the perceived association and increase our understanding on the impact of the Internet to help guide public health interventions. We analyzed this association in two population samples: a self-selecting Web-based sample of Canadian parents recruited through Facebook (n=966) and a population-based sample of parents recruited by random digit dialing (RDD; n=951). The outcome was parental perception of vaccine safety on a seven-point ordinal scale from "not safe" to "extremely safe." An ordinal regression model was used to investigate if Internet information seeking on childhood vaccination predicted parental perception of vaccine safety. After adjusting for income level, Internet reliability, age of parent, and region, the odds of perceiving vaccines as less safe rather than more safe were 1.6 times higher (95% CI 1.3-2.1) for parents who used the Internet to search for vaccination information compared to parents who did not search the Internet in the Web-based sample, and 2.0 times higher (95% CI 1.6-2.5) in the population-based RDD sample. The results suggest the Internet is significantly associated with Canadian parents' negative perception of vaccine risk. Governmental and scientific sectors should consider the development and implementation of

  18. A single immunization with a recombinant canine adenovirus expressing the rabies virus G protein confers protective immunity against rabies in mice

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

    Li Jianwei; Faber, Milosz; Papaneri, Amy

    2006-12-20

    Rabies vaccines based on live attenuated rabies viruses or recombinant pox viruses expressing the rabies virus (RV) glycoprotein (G) hold the greatest promise of safety and efficacy, particularly for oral immunization of wildlife. However, while these vaccines induce protective immunity in foxes, they are less effective in other animals, and safety concerns have been raised for some of these vaccines. Because canine adenovirus 2 (CAV2) is licensed for use as a live vaccine for dogs and has an excellent efficacy and safety record, we used this virus as an expression vector for the RVG. The recombinant CAV2-RV G produces virusmore » titers similar to those produced by wild-type CAV2, indicating that the RVG gene does not affect virus replication. Comparison of RVG expressed by CAV2-RV G with that of vaccinia-RV G recombinant virus (V-RG) revealed similar amounts of RV G on the cell surface. A single intramuscular or intranasal immunization of mice with CAV2-RVG induced protective immunity in a dose-dependent manner, with no clinical signs or discomfort from the virus infection regardless of the route of administration or the amount of virus.« less

  19. Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

    PubMed

    Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

    2017-04-01

    This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

  20. Personal digital assistant-based drug information sources: potential to improve medication safety.

    PubMed

    Galt, Kimberly A; Rule, Ann M; Houghton, Bruce; Young, Daniel O; Remington, Gina

    2005-04-01

    This study compared the potential for personal digital assistant (PDA)-based drug information sources to minimize potential medication errors dependent on accurate and complete drug information at the point of care. A quality and safety framework for drug information resources was developed to evaluate 11 PDA-based drug information sources. Three drug information sources met the criteria of the framework: Eprocrates Rx Pro, Lexi-Drugs, and mobileMICROMEDEX. Medication error types related to drug information at the point of care were then determined. Forty-seven questions were developed to test the potential of the sources to prevent these error types. Pharmacists and physician experts from Creighton University created these questions based on the most common types of questions asked by primary care providers. Three physicians evaluated the drug information sources, rating the source for each question: 1=no information available, 2=some information available, or 3 = adequate amount of information available. The mean ratings for the drug information sources were: 2.0 (Eprocrates Rx Pro), 2.5 (Lexi-Drugs), and 2.03 (mobileMICROMEDEX). Lexi-Drugs was significantly better (mobileMICROMEDEX t test; P=0.05; Eprocrates Rx Pro t test; P=0.01). Lexi-Drugs was found to be the most specific and complete PDA resource available to optimize medication safety by reducing potential errors associated with drug information. No resource was sufficient to address the patient safety information needs for all cases.

  1. Evaluating Washington State's immunization information system as a research tool.

    PubMed

    Jackson, Michael L; Henrikson, Nora B; Grossman, David C

    2014-01-01

    Immunization information systems (IISs) are powerful public health tools for vaccination activities. To date, however, their use for public health research has been limited, in part as a result of insufficient understanding on accuracy and quality of IIS data. We evaluated the completeness and accuracy of Washington State IIS (WAIIS) data, with particular attention to data elements of research interest. We analyzed all WAIIS records on all children born between 2006 and 2010 with at least 1 vaccination recorded in WAIIS between 2006 and 2010. We assessed all variables for completeness and tested selected variables for internal validity. To assess external validity, we matched WAIIS data to records from Group Health, a large integrated health care organization in Washington State. On these children, we compared vaccination data in WAIIS with vaccination data from Group Health's immunization registry. The WAIIS data included 486,265 children and 8,670,234 unique vaccinations. Variables required by WAIIS (such as date of vaccination) were highly complete, but optional variables were often missing. For example, most records were missing data on route (80.7%) and anatomic site (81.7%) of vaccination. WAIIS data, when complete, were highly accurate relative to the Group Health immunization registry, with 96% to 99% agreement between fields such as vaccination code and anatomic site. Required data elements in WAIIS are highly complete and have both internal and external validity, suggesting that these variables are useful for research. Research requiring nonrequired variables should use additional validity checks before proceeding. Copyright © 2014 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  2. Food Safety and Nutrition Information for Kids and Teens

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Resources for You Consumers Kids & Teens ... More sharing options Linkedin Pin it Email Print Food Safety & Nutrition Information for Kids and Teens Fun & ...

  3. The system of technical diagnostics of the industrial safety information network

    NASA Astrophysics Data System (ADS)

    Repp, P. V.

    2017-01-01

    This research is devoted to problems of safety of the industrial information network. Basic sub-networks, ensuring reliable operation of the elements of the industrial Automatic Process Control System, were identified. The core tasks of technical diagnostics of industrial information safety were presented. The structure of the technical diagnostics system of the information safety was proposed. It includes two parts: a generator of cyber-attacks and the virtual model of the enterprise information network. The virtual model was obtained by scanning a real enterprise network. A new classification of cyber-attacks was proposed. This classification enables one to design an efficient generator of cyber-attacks sets for testing the virtual modes of the industrial information network. The numerical method of the Monte Carlo (with LPτ - sequences of Sobol), and Markov chain was considered as the design method for the cyber-attacks generation algorithm. The proposed system also includes a diagnostic analyzer, performing expert functions. As an integrative quantitative indicator of the network reliability the stability factor (Kstab) was selected. This factor is determined by the weight of sets of cyber-attacks, identifying the vulnerability of the network. The weight depends on the frequency and complexity of cyber-attacks, the degree of damage, complexity of remediation. The proposed Kstab is an effective integral quantitative measure of the information network reliability.

  4. 49 CFR 575.301 - Vehicle Labeling of Safety Rating Information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... this section is to aid potential purchasers in the selection of new passenger motor vehicles by providing them with safety rating information developed by NHTSA in its New Car Assessment Program (NCAP... placed on new automobiles with the manufacturer's suggested retail price and other consumer information...

  5. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors.

    PubMed

    Naing, Aung; Papadopoulos, Kyriakos P; Autio, Karen A; Ott, Patrick A; Patel, Manish R; Wong, Deborah J; Falchook, Gerald S; Pant, Shubham; Whiteside, Melinda; Rasco, Drew R; Mumm, John B; Chan, Ivan H; Bendell, Johanna C; Bauer, Todd M; Colen, Rivka R; Hong, David S; Van Vlasselaer, Peter; Tannir, Nizar M; Oft, Martin; Infante, Jeffrey R

    2016-10-10

    Purpose Interleukin-10 (IL-10) stimulates the expansion and cytotoxicity of tumor-infiltrating CD8+ T cells and inhibits inflammatory CD4+ T cells. Pegylation prolongs the serum concentration of IL-10 without changing the immunologic profile. This phase I study sought to determine the safety and antitumor activity of AM0010. Patients and Methods Patients with selected advanced solid tumors were treated with AM0010 in a dose-escalation study, which was followed by a renal cell cancer (RCC) dose-expansion cohort. AM0010 was self-administered subcutaneously at doses of 1 to 40 μg/kg once per day. Primary end points were safety and tolerability; clinical activity and immune activation were secondary end points. Results In the dose-escalation and -expansion cohorts, 33 and 18 patients, respectively, were treated with daily subcutaneous injection of AM0010. AM0010 was tolerated in a heavily pretreated patient population. Treatment-related adverse events (AEs) included anemia, fatigue, thrombocytopenia, fever, and injection site reactions. Grade 3 to 4 nonhematopoietic treatment-related AEs, including rash (n = 2) and transaminitis (n = 1), were observed in five of 33 patients. Grade 3 to 4 anemia or thrombocytopenia was observed in five patients. Most treatment-related AEs were transient or reversible. AM0010 led to systemic immune activation with elevated immune-stimulatory cytokines and reduced transforming growth factor beta in the serum. Partial responses were observed in one patient with uveal melanoma and four of 15 evaluable patients with RCC treated at 20 μg/kg (overall response rate, 27%). Prolonged stable disease of at least 4 months was observed in four patients, including one with colorectal cancer with disease stabilization for 20 months. Conclusion AM0010 has an acceptable toxicity profile with early evidence of antitumor activity, particularly in RCC. These data support the further evaluation of AM0010 both alone and in combination with other immune

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

    PubMed Central

    2016-01-01

    Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

  7. Information analysis of immune and endocrine organs. Morphological changes in the course of infection.

    PubMed

    Avtandilov, G G; Barsukov, V S

    1992-11-01

    Morphological and morphometric studies were conducted into lymphoid and endocrine organs of 259 human adults and infants with pyoinflammatory diseases (PID) and of 300 experimental mice. Informative and correlation analyses of the data thus recorded provided evidence to the effect that in the course of an infection process adaptation and compensation responses were characterized by intensified exchange of information within the immune-endocrine system (IES). Septic courses of PID were found to be accompanied by impairment of inter-organ correlations, increase in information entropy and progressive structural disorganization of the IES.

  8. Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

    DTIC Science & Technology

    2005-01-01

    have the potential to become solid tools for manufacturers, purchasers, and consumers to evaluate patient safety issues in various health related...323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical

  9. 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.

  10. Trade associations and labor organizations as intermediaries for disseminating workplace safety and health information.

    PubMed

    Okun, Andrea H; Watkins, Janice P; Schulte, Paul A

    2017-09-01

    There has not been a systematic study of the nature and extent to which business and professional trade associations and labor organizations obtain and communicate workplace safety and health information to their members. These organizations can serve as important intermediaries and play a central role in transferring this information to their members. A sample of 2294 business and professional trade associations and labor organizations in eight industrial sectors identified by the National Occupational Research Agenda was surveyed via telephone. A small percent of these organizations (40.9% of labor organizations, 15.6% of business associations, and 9.6% of professional associations) were shown to distribute workplace safety and health information to their members. Large differences were also observed between industrial sectors with construction having the highest total percent of organizations disseminating workplace safety and health information. There appears to be significant potential to utilize trade and labor organizations as intermediaries for transferring workplace safety and health information to their members. Government agencies have a unique opportunity to partner with these organizations and to utilize their existing communication channels to address high risk workplace safety and health concerns. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  11. Safety recommendation component of mobile information assistant of the tourist

    NASA Astrophysics Data System (ADS)

    Savchuk, Valeriya V.; Kunanec, Natalia E.; Pasichnyk, Volodymyr V.; Popiel, Piotr; Weryńska-Bieniasz, RóŻa; Kashaganova, Gulzhamal; Kalizhanova, Aliya

    2017-08-01

    The goal of article is to introduce and justify the need for the safety system components of Mobile Information of the tourist (MIAT). One of the objectives of the system is to determine the level of risk in a particular tourist destination on the basis of available information in the knowledge base.

  12. Neonatal Immunization: Rationale, Current State, and Future Prospects.

    PubMed

    Whittaker, Elizabeth; Goldblatt, David; McIntyre, Peter; Levy, Ofer

    2018-01-01

    Infections take their greatest toll in early life necessitating robust approaches to protect the very young. Here, we review the rationale, current state, and future research directions for one such approach: neonatal immunization. Challenges to neonatal immunization include natural concern about safety as well as a distinct neonatal immune system that is generally polarized against Th1 responses to many stimuli such that some vaccines that are effective in adults are not in newborns. Nevertheless, neonatal immunization could result in high-population penetration as birth is a reliable point of healthcare contact, and offers an opportunity for early protection of the young, including preterm newborns who are deficient in maternal antibodies. Despite distinct immunity and reduced responses to some vaccines, several vaccines have proven safe and effective at birth. While some vaccines such as polysaccharide vaccines have little effectiveness at birth, hepatitis B vaccine can prime at birth and requires multiple doses to achieve protection, whereas the live-attenuated Bacille Calmette-Guérin (BCG), may offer single shot protection, potentially in part via heterologous ("non-specific") beneficial effects. Additional vaccines have been studied at birth including those directed against pertussis, pneumococcus, Haemophilus influenza type B and rotavirus providing important lessons. Current areas of research in neonatal vaccinology include characterization of early life immune ontogeny, heterogeneity in and heterologous effects of BCG vaccine formulations, applying systems biology and systems serology, in vitro platforms that model age-specific human immunity and discovery and development of novel age-specific adjuvantation systems. These approaches may inform, de-risk, and accelerate development of novel vaccines for use in early life. Key stakeholders, including the general public, should be engaged in assessing the opportunities and challenges inherent to neonatal

  13. Neonatal Immunization: Rationale, Current State, and Future Prospects

    PubMed Central

    Whittaker, Elizabeth; Goldblatt, David; McIntyre, Peter; Levy, Ofer

    2018-01-01

    Infections take their greatest toll in early life necessitating robust approaches to protect the very young. Here, we review the rationale, current state, and future research directions for one such approach: neonatal immunization. Challenges to neonatal immunization include natural concern about safety as well as a distinct neonatal immune system that is generally polarized against Th1 responses to many stimuli such that some vaccines that are effective in adults are not in newborns. Nevertheless, neonatal immunization could result in high-population penetration as birth is a reliable point of healthcare contact, and offers an opportunity for early protection of the young, including preterm newborns who are deficient in maternal antibodies. Despite distinct immunity and reduced responses to some vaccines, several vaccines have proven safe and effective at birth. While some vaccines such as polysaccharide vaccines have little effectiveness at birth, hepatitis B vaccine can prime at birth and requires multiple doses to achieve protection, whereas the live-attenuated Bacille Calmette–Guérin (BCG), may offer single shot protection, potentially in part via heterologous (“non-specific”) beneficial effects. Additional vaccines have been studied at birth including those directed against pertussis, pneumococcus, Haemophilus influenza type B and rotavirus providing important lessons. Current areas of research in neonatal vaccinology include characterization of early life immune ontogeny, heterogeneity in and heterologous effects of BCG vaccine formulations, applying systems biology and systems serology, in vitro platforms that model age-specific human immunity and discovery and development of novel age-specific adjuvantation systems. These approaches may inform, de-risk, and accelerate development of novel vaccines for use in early life. Key stakeholders, including the general public, should be engaged in assessing the opportunities and challenges inherent to

  14. Safety and economic impact of Texas travel information centers.

    DOT National Transportation Integrated Search

    2014-12-01

    The overall goal of this research was to develop a methodology and gather sufficient data to quantify the : impact of Texas Travel Information Center staff and services on the safety of travelers on Texas roadways. : Researchers used data and analyti...

  15. Immunity's fourth dimension: approaching the circadian-immune connection.

    PubMed

    Arjona, Alvaro; Silver, Adam C; Walker, Wendy E; Fikrig, Erol

    2012-12-01

    The circadian system ensures the generation and maintenance of self-sustained ~24-h rhythms in physiology that are linked to internal and environmental changes. In mammals, daily variations in light intensity and other cues are integrated by a hypothalamic master clock that conveys circadian information to peripheral molecular clocks that orchestrate physiology. Multiple immune parameters also vary throughout the day and disruption of circadian homeostasis is associated with immune-related disease. Here, we discuss the molecular links between the circadian and immune systems and examine their outputs and disease implications. Understanding the mechanisms that underlie circadian-immune crosstalk may prove valuable for devising novel prophylactic and therapeutic interventions. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Does information about abortion safety affect Texas voters' opinions about restrictive laws? A randomized study.

    PubMed

    White, Kari; Grossman, Daniel; Stevenson, Amanda Jean; Hopkins, Kristine; Potter, Joseph E

    2017-12-01

    The objective was to assess whether information about abortion safety and awareness of abortion laws affect voters' opinions about medically unnecessary abortion regulations. Between May and June 2016, we randomized 1200 Texas voters to receive or not receive information describing the safety of office-based abortion care during an online survey about abortion laws using simple random assignment. We compared the association between receiving safety information and awareness of recent restrictions and beliefs that ambulatory surgical center (ASC) requirements for abortion facilities and hospital admitting privileges requirements for physicians would make abortion safer. We used Poisson regression, adjusting for political affiliation and views on abortion. Of 1200 surveyed participants, 1183 had complete data for analysis: 612 in the information group and 571 in the comparison group. Overall, 259 (46%) in the information group and 298 (56%) in the comparison group believed that the ASC requirement would improve abortion safety (p=.008); 230 (41%) in the information group and 285 (54%) in the comparison group believed that admitting privileges would make abortion safer (p<.001). After multivariable adjustment, the information group was less likely to report that the ASC [prevalence ratio (PR): 0.82; 95% confidence interval (CI): 0.72-0.94] and admitting privileges requirements (PR: 0.76; 95% CI: 0.65-0.88) would improve safety. Participants who identified as conservative Republicans were more likely to report that the ASC (82%) and admitting privileges requirements (83%) would make abortion safer if they had heard of the provisions than if they were unaware of them (ASC: 52%; admitting privileges: 47%; all p<.001). Informational statements reduced perceptions that restrictive laws make abortion safer. Voters' prior awareness of the requirements also was associated with their beliefs. Informational messages can shift scientifically unfounded views about abortion safety

  17. The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

    NASA Astrophysics Data System (ADS)

    Zhu, Wenmin; Jia, Yuanhua

    2018-01-01

    Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

  18. Analyzing and strengthening the vaccine safety program in Manitoba

    PubMed Central

    Montalban, JM; Ogbuneke, C; Hilderman, T

    2014-01-01

    Background: The emergence of a novel influenza A virus in 2009 and the rapid introduction of new pandemic vaccines prompted an analysis of the current state of the adverse events following immunization (AEFI) surveillance response in several provinces. Objectives To highlight aspects of the situational analysis of the Manitoba Health, Healthy Living and Seniors (MHHLS’s) AEFI surveillance system and to demonstrate how common business techniques could be usefully applied to a provincial vaccine safety monitoring program. Method Situational analysis of the AEFI surveillance system in Manitoba was developed through a strengths-weaknesses-opportunities-threats (SWOT) analysis and informed by the National Immunization Strategy vaccine safety priorities. Strategy formulation was developed by applying the threats-opportunities-weaknesses-strengths (TOWS) matrix. Results Thirteen strategies were formulated that use strengths to either take advantage of opportunities or avoid threats, that exploit opportunities to overcome weaknesses, or that rectify weaknesses to circumvent threats. These strategies entailed the development of various tools and resources, most of which are either actively underway or completed. Conclusion The SWOT analysis and the TOWS matrix enabled MHHLS to enhance the capacity of its vaccine safety program. PMID:29769910

  19. Differential misclassification between self-reported status and official HPV vaccination records in Japan: Implications for evaluating vaccine safety and effectiveness.

    PubMed

    Yamaguchi, Manako; Sekine, Masayuki; Kudo, Risa; Adachi, Sosuke; Ueda, Yutaka; Miyagi, Etsuko; Hara, Megumi; Hanley, Sharon J B; Enomoto, Takayuki

    2018-05-25

    Japan has no national vaccine registry and approximately 1700 municipalities manage the immunization records independently. In June 2013, proactive recommendations for the human papillomavirus (HPV) vaccine were suspended after unconfirmed reports of adverse events following immunization in the media, despite no vaccine safety signal having been raised. Furthermore, studies assessing HPV vaccine safety and effectiveness published post suspension are predominantly based on self-reported information. Our aim was to examine the accuracy of self-reported vaccination status compared with official municipal records. Participants were women aged 20-22 yrs, who were attending for cervical screening in Niigata city. Among the 1230 eligible registrants, vaccine uptake, defined as any dose, was 75.0% and 77.2% according to a self-reported questionnaire and municipal records, respectively. The accuracy rate of self-reported information was as follows: positive predictive value (PPV) was 87.7%; negative predictive value (NPV) was 54.5%; sensitivity was 85.2%; and specificity was 59.8%. The validity of self-reported information was only moderate (Kappa statistic = 0.44, 95% confidence interval 0.37-0.50). This combined with the low NPV may lead to reduced estimation of effectiveness and safety. A more reliable method, such as a national HPV vaccine registry, needs to be established for assessing HPV immunization status in Japan. Copyright © 2018. Published by Elsevier B.V.

  20. Pertussis Maternal Immunization: Narrowing the Knowledge Gaps on the Duration of Transferred Protective Immunity and on Vaccination Frequency

    PubMed Central

    Gaillard, María Emilia; Bottero, Daniela; Zurita, María Eugenia; Carriquiriborde, Francisco; Martin Aispuro, Pablo; Bartel, Erika; Sabater-Martínez, David; Bravo, María Sol; Castuma, Celina; Hozbor, Daniela Flavia

    2017-01-01

    Maternal safety through pertussis vaccination and subsequent maternal–fetal-antibody transfer are well documented, but information on infant protection from pertussis by such antibodies and by subsequent vaccinations is scarce. Since mice are used extensively for maternal-vaccination studies, we adopted that model to narrow those gaps in our understanding of maternal pertussis immunization. Accordingly, we vaccinated female mice with commercial acellular pertussis (aP) vaccine and measured offspring protection against Bordetella pertussis challenge and specific-antibody levels with or without revaccination. Maternal immunization protected the offspring against pertussis, with that immune protection transferred to the offspring lasting for several weeks, as evidenced by a reduction (4–5 logs, p < 0.001) in the colony-forming-units recovered from the lungs of 16-week-old offspring. Moreover, maternal-vaccination-acquired immunity from the first pregnancy still conferred protection to offspring up to the fourth pregnancy. Under the conditions of our experimental protocol, protection to offspring from the aP-induced immunity is transferred both transplacentally and through breastfeeding. Adoptive-transfer experiments demonstrated that transferred antibodies were more responsible for the protection detected in offspring than transferred whole spleen cells. In contrast to reported findings, the protection transferred was not lost after the vaccination of infant mice with the same or other vaccine preparations, and conversely, the immunity transferred from mothers did not interfere with the protection conferred by infant vaccination with the same or different vaccines. These results indicated that aP-vaccine immunization of pregnant female mice conferred protective immunity that is transferred both transplacentally and via offspring breastfeeding without compromising the protection boostered by subsequent infant vaccination. These results—though admittedly not

  1. Quality and Safety Implications of Emergency Department Information Systems

    PubMed Central

    Farley, Heather L.; Baumlin, Kevin M.; Hamedani, Azita G.; Cheung, Dickson S.; Edwards, Michael R.; Fuller, Drew C.; Genes, Nicholas; Griffey, Richard T.; Kelly, John J.; McClay, James C.; Nielson, Jeff; Phelan, Michael P.; Shapiro, Jason S.; Stone-Griffith, Suzanne; Pines, Jesse M.

    2013-01-01

    The Health Information Technology for Economic and Clinical Health Act of 2009 and the Centers for Medicare & Medicaid Services “meaningful use” incentive programs, in tandem with the boundless additional requirements for detailed reporting of quality metrics, have galvanized hospital efforts to implement hospital-based electronic health records. As such, emergency department information systems (EDISs) are an important and unique component of most hospitals’ electronic health records. System functionality varies greatly and affects physician decisionmaking, clinician workflow, communication, and, ultimately, the overall quality of care and patient safety. This article is a joint effort by members of the Quality Improvement and Patient Safety Section and the Informatics Section of the American College of Emergency Physicians. The aim of this effort is to examine the benefits and potential threats to quality and patient safety that could result from the choice of a particular EDIS, its implementation and optimization, and the hospital’s or physician group’s approach to continuous improvement of the EDIS. Specifically, we explored the following areas of potential EDIS safety concerns: communication failure, wrong order–wrong patient errors, poor data display, and alert fatigue. Case studies are presented that illustrate the potential harm that could befall patients from an inferior EDIS product or suboptimal execution of such a product in the clinical environment. The authors have developed 7 recommendations to improve patient safety with respect to the deployment of EDISs. These include ensuring that emergency providers actively participate in selection of the EDIS product, in the design of processes related to EDIS implementation and optimization, and in the monitoring of the system’s ongoing success or failure. Our recommendations apply to emergency departments using any type of EDIS: custom-developed systems, best-of-breed vendor systems, or

  2. 78 FR 34703 - Pipeline Safety: Information Collection Activities, Revision to Gas Distribution Annual Report

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0004] Pipeline Safety: Information Collection Activities, Revision to Gas Distribution Annual Report AGENCY: Pipeline and Hazardous Materials Safety Administration, DOT. ACTION: Notice and request...

  3. A qualitative exploration of the perceptions and information needs of public health inspectors responsible for food safety

    PubMed Central

    2010-01-01

    Background In Ontario, local public health inspectors play an important frontline role in protecting the public from foodborne illness. This study was an in-depth exploration of public health inspectors' perceptions of the key food safety issues in public health, and their opinions and needs with regards to food safety information resources. Methods Four focus group discussions were conducted with public health inspectors from the Central West region of Ontario, Canada during June and July, 2008. A questioning route was used to standardize qualitative data collection. Audio recordings of sessions were transcribed verbatim and data-driven content analysis was performed. Results A total of 23 public health inspectors participated in four focus group discussions. Five themes emerged as key food safety issues: time-temperature abuse, inadequate handwashing, cross-contamination, the lack of food safety knowledge by food handlers and food premise operators, and the lack of food safety information and knowledge about specialty foods (i.e., foods from different cultures). In general, participants reported confidence with their current knowledge of food safety issues and foodborne pathogens. Participants highlighted the need for a central source for food safety information, access to up-to-date food safety information, resources in different languages, and additional food safety information on specialty foods. Conclusions The information gathered from these focus groups can provide a basis for the development of resources that will meet the specific needs of public health inspectors involved in protecting and promoting food safety. PMID:20553592

  4. Hurricane Safety and Information - Central Pacific Hurricane Center -

    Science.gov Websites

    NOAA NWS United States Department of Commerce Central Pacific Hurricane Center National Oceanic and Distance Calculator Blank Tracking Maps ▾ Educational Resources Be Prepared! NWS Hurricane Prep Week Search For Go NWS All NOAA ▾ Hurricane Safety Hurricane Awareness Week Information from CPHC Red Cross

  5. 78 FR 2662 - Proposed Extension of Approval of Information Collection; Comment Request: Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... Information Collection; Comment Request: Safety Standard for Cigarette Lighters AGENCY: Consumer Product... disposable and novelty cigarette lighters. This collection of information consists of testing and recordkeeping requirements in certification regulations implementing the Safety Standard for Cigarette Lighters...

  6. Effectiveness and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients.

    PubMed

    Kawano, Yoshihiko; Suzuki, Michio; Kawada, Jun-ichi; Kimura, Hiroshi; Kamei, Hideya; Ohnishi, Yasuharu; Ono, Yasuyuki; Uchida, Hiroo; Ogura, Yasuhiro; Ito, Yoshinori

    2015-03-17

    Liver transplantation recipients are at high risk for severe complications due to infections because of being treated with immunosuppressive drugs that affect the immune system. Vaccination for liver transplantation candidates is generally recommended before surgery, but the opportunities for vaccination prior to transplantation in pediatric candidates are often limited by severe disease conditions. The participants in this study comprised 39 pediatric recipients of living donor liver transplantation performed between 2005 and 2013. Criteria for administering live-attenuated (measles, rubella, mumps, and varicella) and inactivated (hepatitis B, pertussis, and Japanese encephalitis) vaccines were as follows: (1) >1 year after transplantation; (2) no use of systemic steroids to treat acute rejection within the last 6 months; (3) serum trough concentration of tacrolimus <5 ng/mL; (4) no severe immunosuppression according to blood examinations; and (5) provision of written informed consent. Median age at transplantation was 17 months, and median period from transplantation to the beginning of immunization was 18 months. Seroprotection rates for measles, rubella, mumps, varicella, hepatitis B, pertussis, and Japanese encephalitis after post-transplant immunization were 44% (11/25), 70% (19/27), 48% (12/25), 32% (6/19), 83% (19/23), 87% (13/15), and 88% (7/8), respectively. Seroprotection rates for measles, rubella, mumps, and varicella after second vaccination for recipients with primary vaccine failure after first vaccination were 100% (8/8), 50% (1/2), 71% (5/7), and 50% (5/10), respectively. While four recipients contracted mumps and eight contracted varicella before immunization, one recipient developed varicella after immunization. No serious systemic adverse events were observed in vaccinated recipients. Seroprotection rates for measles, mumps, and varicella appeared low in children after the first post-transplantation vaccination. Immunizations with four live

  7. Smooth handling: the lack of safety-related consumer information in car advertisements.

    PubMed

    Wilson, Nick; Maher, Anthony; Thomson, George; Keall, Michael

    2007-10-01

    To examine the content and trends of safety-related consumer information in magazine vehicle advertisements, as a case study within the worldwide marketing of vehicles. Content analysis of popular current affairs magazines in New Zealand for the 5-year period 2001-2005 was undertaken (n = 514 advertisements), supplemented with vehicle data from official websites. Safety information in advertisements for light passenger vehicles was relatively uncommon with only 27% mentioning one or more of nine key safety features examined (average: 1.7 out of nine features in this 27%). Also included were potentially hazardous features of: speed imagery (in 29% of advertisements), power references (14%), and acceleration data (4%). The speed and power aspects became relatively more common over the 5-year period (p < 0.05 for trend). To enhance informed consumer choice and improve injury prevention, governments should consider regulating the content of vehicle advertisements and vehicle marketing - as already occurs with many other consumer products.

  8. Participatory approach to improving safety, health and working conditions in informal economy workplaces in Cambodia.

    PubMed

    Kawakami, Tsuyoshi; Tong, Leng; Kannitha, Yi; Sophorn, Tun

    2011-01-01

    The present study aimed to improve safety and health in informal economy workplaces such as home workplaces, small construction sites, and rural farms in Cambodia by using "participatory" approach. The government, workers' and employers' organizations and NGOs jointly assisted informal economy workers in improving safety and health by using participatory training methodologies. The steps taken were: (1) to collect existing good practices in safety and health in Cambodia; (2) to develop new participatory training programmes for home workers and small construction sites referring to ILO's WISE training programme, and (3) to train government officers, workers, employers and NGOs as safety and health trainers. The participatory training programmes developed consisted of action-checklists associated with illustrations, good example photo sheets, and texts explaining practical, low-cost improvement measures. The established safety and health trainers reached many informal economy workers through their human networks, and trained them by using the developed participatory training programmes. More than 3,000 informal economy workers were trained and they implemented improvements by using low-cost methods. Participatory training methodologies and active cooperation between the government, workers, employers and NGOs made it possible to provide practical training for those involved in the informal economy workplaces.

  9. 78 FR 65661 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey AGENCY... notice invites comments on a voluntary consumer survey entitled, ``Food Safety Survey.'' DATES: Submit... technology. Food Safety Survey--(OMB Control Number 0910-0345)--Reinstatement I. Background Under section 903...

  10. The immune complex CTA1-DD/IgG adjuvant specifically targets connective tissue mast cells through FcγRIIIA and augments anti-HPV immunity after nasal immunization.

    PubMed

    Fang, Y; Zhang, T; Lidell, L; Xu, X; Lycke, N; Xiang, Z

    2013-11-01

    We have previously reported that CTA1-DD/IgG immune complexes augment antibody responses in a mast cell-dependent manner following intranasal (IN) immunizations. However, from a safety perspective, mast cell activation could preclude clinical use. Therefore, we have extended these studies and demonstrate that CTA1-DD/IgG immune complexes administered IN did not trigger an anaphylactic reaction. Importantly, CTA1-DD/IgE immune complexes did not activate mast cells. Interestingly, only connective tissue, but not mucosal, mast cells could be activated by CTA1-DD/IgG immune complexes. This effect was mediated by FcγRIIIA, only expressed on connective tissue mast cells, and found in the nasal submucosa. FcγRIIIA-deficient mice had compromised responses to immunization adjuvanted by CTA1-DD/IgG. Proof-of-concept studies revealed that IN immunized mice with human papillomavirus (HPV) type 16 L1 virus-like particles (VLP) and CTA1-DD/IgG immune complexes demonstrated strong and sustained specific antibody titers in serum and vaginal secretions. From a mast cell perspective, CTA1-DD/IgG immune complexes appear to be safe and effective mucosal adjuvants.

  11. 77 FR 63800 - Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Safety Standard for Walk-Behind Power Lawn Mowers AGENCY: Consumer Product Safety.... Chapter 35), the Consumer Product Safety Commission (CPSC) requested comments on a proposed extension of...

  12. Improving postapproval drug safety surveillance: getting better information sooner.

    PubMed

    Hennessy, Sean; Strom, Brian L

    2015-01-01

    Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

  13. Information dissemination and use: critical components in occupational safety and health.

    PubMed

    Schulte, P A; Okun, A; Stephenson, C M; Colligan, M; Ahlers, H; Gjessing, C; Loos, G; Niemeier, R W; Sweeney, M H

    2003-11-01

    Information dissemination is a mandated, but understudied, requirement of occupational and environmental health laws and voluntary initiatives. Research is needed on the factors that enhance and limit the development, transfer, and use of occupational safety and health information (OSH). Contemporary changes in the workforce, workplaces, and the nature of work will require new emphasis on the dissemination of information to foster prevention. Legislative and regulatory requirements and voluntary initiatives for dissemination of OSH information were identified and assessed. Literature on information dissemination was reviewed to identify important issues and useful approaches. More than 20 sections of laws and regulations were identified that mandated dissemination of occupational and environmental safety and health information. A four-stage approach for tracking dissemination and considering the flow of information was delineated. Special areas of dissemination were identified: the information needs of the changing workforce, new and young workers; small businesses; and workers with difficulty in understanding or reading English. We offer a framework for dissemination of OSH information and underscore the need to focus on the extent to which decision-makers and others receive and use such information. More solid data are also needed on current investments in disseminating, diffusing and applying OSH information and on the utility of that information. Am. J. Ind. Med. 44:515-531, 2003. Published 2003 Wiley-Liss, Inc.

  14. Impact of pharmacists providing immunizations on adolescent influenza immunization.

    PubMed

    Robison, Steve G

    2016-01-01

    To determine if the Oregon law change in 2011 to allow pharmacists to immunize adolescents 11 to 17 years of age increased influenza immunizations or changed existing immunization venues. With the use of Oregon's ALERT Immunization Information System (IIS), 2 measures of impact were developed. First, the change in adolescent age 11-17 influenza immunizations before (2007-2010) and after (2011-2014) the pharmacy law change was evaluated against a reference cohort (aged 7-10) not affected by the law. Community pharmacies were also compared with other types of influenza immunization sites within one of the study influenza seasons (2013-2014). From 2007 to 2014, adolescent influenza immunizations at community pharmacies increased from 36 to 6372 per year. After the 2011 pharmacy law change, adolescents aged 11 to 17 were more likely to receive an influenza immunization compared with the reference population (odds ratio, 1.21; 95% CI, 1.19-1.22). Analysis of the 2013-2014 influenza season suggests that community pharmacies immunized a different population of adolescents than other providers. The 2011 change in Oregon law allowed pharmacists to increase the total of influenza immunizations given to adolescents. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  15. 78 FR 64538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... for OMB Review; Comment Request; Safety Standards for Underground Coal Mine Ventilation--Belt Entry... the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Safety Standards for Underground Coal Mine Ventilation--Belt Entry Used as an Intake Air Course to...

  16. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ...-0006; OMB Number 1014-0008] Information Collection Activities: Well Control and Production Safety... requirements in the regulations under Subpart O, ``Well Control and Production Safety Training.'' This notice... and Production Safety Training. OMB Control Number: 1014-0008. Abstract: The Outer Continental Shelf...

  17. An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams.

    PubMed

    Tscholl, David W; Weiss, Mona; Kolbe, Michaela; Staender, Sven; Seifert, Burkhardt; Landert, Daniel; Grande, Bastian; Spahn, Donat R; Noethiger, Christoph B

    2015-10-01

    An anesthesia preinduction checklist (APIC) to be performed before anesthesia induction was introduced and evaluated with respect to 5 team-level outcomes, each being a surrogate end point for patient safety: information exchange (the percentage of checklist items exchanged by a team, out of 12 total items); knowledge of critical information (the percentage of critical information items out of 5 total items such as allergies, reported as known by the members of a team); team members' perceptions of safety (the median scores given by the members of a team on a continuous rating scale); their perception of teamwork (the median scores given by the members of a team on a continuous rating scale); and clinical performance (the percentage of completed items out of 14 required tasks, e.g., suction device checked). A prospective interventional study comparing anesthesia teams using the APIC with a control group not using the APIC was performed using a multimethod design. Trained observers rated information exchange and clinical performance during on-site observations of anesthesia inductions. After the observations, each team member indicated the critical information items they knew and their perceptions of safety and teamwork. One hundred five teams using the APIC were compared with 100 teams not doing so. The medians of the team-level outcome scores in the APIC group versus the control group were as follows: information exchange: 100% vs 33% (P < 0.001), knowledge of critical information: 100% vs 90% (P < 0.001), perception of safety: 91% vs 84% (P < 0.001), perception of teamwork: 90% vs 86% (P = 0.028), and clinical performance: 93% vs 93% (P = 0.60). This study provides empirical evidence that the use of a preinduction checklist significantly improves information exchange, knowledge of critical information, and perception of safety in anesthesia teams-all parameters contributing to patient safety. There was a trend indicating improved perception of teamwork.

  18. Biomarkers of safety and immune protection for genetically modified live attenuated leishmania vaccines against visceral leishmaniasis - discovery and implications.

    PubMed

    Gannavaram, Sreenivas; Dey, Ranadhir; Avishek, Kumar; Selvapandiyan, Angamuthu; Salotra, Poonam; Nakhasi, Hira L

    2014-01-01

    Despite intense efforts there is no safe and efficacious vaccine against visceral leishmaniasis, which is fatal and endemic in many tropical countries. A major shortcoming in the vaccine development against blood-borne parasitic agents such as Leishmania is the inadequate predictive power of the early immune responses mounted in the host against the experimental vaccines. Often immune correlates derived from in-bred animal models do not yield immune markers of protection that can be readily extrapolated to humans. The limited efficacy of vaccines based on DNA, subunit, heat killed parasites has led to the realization that acquisition of durable immunity against the protozoan parasites requires a controlled infection with a live attenuated organism. Recent success of irradiated malaria parasites as a vaccine candidate further strengthens this approach to vaccination. We developed several gene deletion mutants in Leishmania donovani as potential live attenuated vaccines and reported extensively on the immunogenicity of LdCentrin1 deleted mutant in mice, hamsters, and dogs. Additional limited studies using genetically modified live attenuated Leishmania parasites as vaccine candidates have been reported. However, for the live attenuated parasite vaccines, the primary barrier against widespread use remains the absence of clear biomarkers associated with protection and safety. Recent studies in evaluation of vaccines, e.g., influenza and yellow fever vaccines, using systems biology tools demonstrated the power of such strategies in understanding the immunological mechanisms that underpin a protective phenotype. Applying similar tools in isolated human tissues such as PBMCs from healthy individuals infected with live attenuated parasites such as LdCen(-/-) in vitro followed by human microarray hybridization experiments will enable us to understand how early vaccine-induced gene expression profiles and the associated immune responses are coordinately regulated in normal

  19. Immune response to functionalized mesoporous silica nanoparticles for targeted drug delivery

    NASA Astrophysics Data System (ADS)

    Heidegger, Simon; Gößl, Dorothée; Schmidt, Alexandra; Niedermayer, Stefan; Argyo, Christian; Endres, Stefan; Bein, Thomas; Bourquin, Carole

    2015-12-01

    Multifunctional mesoporous silica nanoparticles (MSN) have attracted substantial attention with regard to their high potential for targeted drug delivery. For future clinical applications it is crucial to address safety concerns and understand the potential immunotoxicity of these nanoparticles. In this study, we assess the biocompatibility and functionality of multifunctional MSN in freshly isolated, primary murine immune cells. We show that the functionalized silica nanoparticles are rapidly and efficiently taken up into the endosomal compartment by specialized antigen-presenting cells such as dendritic cells. The silica nanoparticles showed a favorable toxicity profile and did not affect the viability of primary immune cells from the spleen in relevant concentrations. Cargo-free MSN induced only very low immune responses in primary cells as determined by surface expression of activation markers and release of pro-inflammatory cytokines such as Interleukin-6, -12 and -1β. In contrast, when surface-functionalized MSN with a pH-responsive polymer capping were loaded with an immune-activating drug, the synthetic Toll-like receptor 7 agonist R848, a strong immune response was provoked. We thus demonstrate that MSN represent an efficient drug delivery vehicle to primary immune cells that is both non-toxic and non-inflammagenic, which is a prerequisite for the use of these particles in biomedical applications.Multifunctional mesoporous silica nanoparticles (MSN) have attracted substantial attention with regard to their high potential for targeted drug delivery. For future clinical applications it is crucial to address safety concerns and understand the potential immunotoxicity of these nanoparticles. In this study, we assess the biocompatibility and functionality of multifunctional MSN in freshly isolated, primary murine immune cells. We show that the functionalized silica nanoparticles are rapidly and efficiently taken up into the endosomal compartment by specialized

  20. Childhood immunization: when physicians and parents disagree.

    PubMed

    Gilmour, Joan; Harrison, Christine; Asadi, Leyla; Cohen, Michael H; Vohra, Sunita

    2011-11-01

    Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

  1. T-cell receptor excision circle levels and safety of paediatric immunization: A population-based self-controlled case series analysis.

    PubMed

    Wilson, Kumanan; Duque, Daniel Rodriguez; Murphy, Malia Sq; Hawken, Steven; Pham-Huy, Anne; Kwong, Jeffrey; Deeks, Shelley L; Potter, Beth K; Crowcroft, Natasha S; Bulman, Dennis E; Chakraborty, Pranesh; Little, Julian

    2018-02-08

    T-cell receptor excision circle levels are a surrogate marker of T-cell production and immune system function. We sought to determine whether non-pathological levels of infant T-cell receptor excision circles were associated with adverse events following immunization. A self-controlled case series design was applied on a sample of 231,693 children who completed newborn screening for severe combined immunodeficiency in Ontario, Canada between August 2013 and December 2015. Exposures included routinely administered pediatric vaccines up to 15 months of age. Main outcomes were combined health services utilization for recognized adverse events following immunization. 1,406,981 vaccination events were included in the final dataset. 103,007 children received the Pneu-C-13 or Men-C-C vaccine and 97,998 received the MMR vaccine at 12 months of age. 67,725 children received the varicella immunization at 15 months. Our analysis identified no association between newborn T-cell receptor excision circle levels and subsequent health services utilization events following DTa-IPV-Hib, Pneu-C-13, and Men-C-C vaccinations at 2-month (RI 0.94[95%CI 0.87-1.02]), 4-month (RI 0.82[95%CI 0.75-0.9]), 6-month (RI 0.63[95%CI 0.57-0.7]) and 12-month (RI 0.49[95%CI 0.44-0.55]). We also found no trends in health services utilization following MMR (RI 1.43[95%1.34-1.52]) or varicella (RI 1.14[95%CI 1.05-1.23]) vaccination. Our findings provide further support for the safety of pediatric vaccinations.

  2. Prototype Input and Output Data Elements for the Occupational Health and Safety Information System

    NASA Technical Reports Server (NTRS)

    Whyte, A. A.

    1980-01-01

    The National Aeronautics and Space Administration plans to implement a NASA-wide computerized information system for occupational health and safety. The system is necessary to administer the occupational health and safety programs and to meet the legal and regulatory reporting, recordkeeping, and surveillance requirements. Some of the potential data elements that NASA will require as input and output for the new occupational health and safety information system are illustrated. The data elements are shown on sample forms that have been compiled from various sources, including NASA Centers and industry.

  3. 32 CFR 861.7 - Disclosure of voluntarily provided safety-related information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... THE AIR FORCE AIRCRAFT DEPARTMENT OF DEFENSE COMMERCIAL AIR TRANSPORTATION QUALITY AND SAFETY REVIEW...-related information voluntarily provided to DOD by an air carrier for the purposes of this Part if DOD determines that— (1) The disclosure of the information would, in the future, inhibit an air carrier from...

  4. Application of Bayesian informative priors to enhance the transferability of safety performance functions.

    PubMed

    Farid, Ahmed; Abdel-Aty, Mohamed; Lee, Jaeyoung; Eluru, Naveen

    2017-09-01

    Safety performance functions (SPFs) are essential tools for highway agencies to predict crashes, identify hotspots and assess safety countermeasures. In the Highway Safety Manual (HSM), a variety of SPFs are provided for different types of roadway facilities, crash types and severity levels. Agencies, lacking the necessary resources to develop own localized SPFs, may opt to apply the HSM's SPFs for their jurisdictions. Yet, municipalities that want to develop and maintain their regional SPFs might encounter the issue of the small sample bias. Bayesian inference is being conducted to address this issue by combining the current data with prior information to achieve reliable results. It follows that the essence of Bayesian statistics is the application of informative priors, obtained from other SPFs or experts' experiences. In this study, we investigate the applicability of informative priors for Bayesian negative binomial SPFs for rural divided multilane highway segments in Florida and California. An SPF with non-informative priors is developed for each state and its parameters' distributions are assigned to the other state's SPF as informative priors. The performances of SPFs are evaluated by applying each state's SPFs to the other state. The analysis is conducted for both total (KABCO) and severe (KAB) crashes. As per the results, applying one state's SPF with informative priors, which are the other state's SPF independent variable estimates, to the latter state's conditions yields better goodness of fit (GOF) values than applying the former state's SPF with non-informative priors to the conditions of the latter state. This is for both total and severe crash SPFs. Hence, for localities where it is not preferred to develop own localized SPFs and adopt SPFs from elsewhere to cut down on resources, application of informative priors is shown to facilitate the process. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

  5. State traffic safety information : current as of January 1, 1998

    DOT National Transportation Integrated Search

    1997-12-01

    The data and information contained in these fact sheets were obtained from the National Highway Traffic Safety Administration's (NHTSA) National Center for Statistics and Analysis (NRD-30), Plans and Policy (NPP 01), State and Community Services (NSC...

  6. Classification of antecedents towards safety use of health information technology: A systematic review.

    PubMed

    Salahuddin, Lizawati; Ismail, Zuraini

    2015-11-01

    This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future

  7. Modernizing Immunization Practice Through the Use of Cloud Based Platforms.

    PubMed

    Bell, Cameron; Atkinson, Katherine M; Wilson, Kumanan

    2017-04-01

    Collection of timely and accurate immunization information is essential for effective immunization programs. Current immunization information systems have important limitations that impact the ability to collect this data. Based on our experience releasing a national immunization app we describe a cloud-based platform that would allow individuals to store their records digitally and exchange these records with public health information systems thus improving the quality of immunization information held by individuals and public health officials.

  8. A noise-immune cryptographic information protection method for facsimile information transmission and the realization algorithms

    NASA Astrophysics Data System (ADS)

    Krasilenko, Vladimir G.; Bardachenko, Vitaliy F.; Nikolsky, Alexander I.; Lazarev, Alexander A.; Ogorodnik, Konstantin V.

    2006-04-01

    We analyse the existent methods of cryptographic defence for the facsimile information transfer, consider their shortcomings and prove the necessity of better information protection degree. The method of information protection that is based on presentation of input data as images is proposed. We offer a new noise-immune algorithm for realization of this method which consists in transformation of an input frame by pixels transposition according to an entered key. At decoding mode the reverse transformation of image with the use of the same key is used. Practical realization of the given method takes into account noise in the transmission channels and information distortions by scanners, faxes and others like that. We show that the given influences are reduced to the transformation of the input image coordinates. We show the algorithm in detail and consider its basic steps. We show the possibility of the offered method by the means of the developed software. The realized algorithm corrects curvature of frames: turn, scaling, fallout of pixels and others like that. At low noise level (loss of pixel information less than 10 percents) it is possible to encode, transfer and decode any types of images and texts with 12-size font character. The software filters for information restore and noise removing allow to transfer fax data with 30 percents pixels loss at 18-size font text. This percent of data loss can be considerably increased by the use of the software character recognition block that can be realized on fuzzy-neural algorithms. Examples of encoding and decryption of images and texts are shown.

  9. Making Patient Risk Visible: Implementation of a Nursing Document Information System to Improve Patient Safety.

    PubMed

    Wang, Panfeng; Zhang, Hongjun; Li, Baohua; Lin, Keke

    2016-01-01

    The aims of this study were to develop a nursing information system (NIS), enhance the visibility of patient risk, and identify challenges and facilitators to adoption of the NIS risk assessment system for nurse leaders. This article describes the function of a nursing risk assessment information system, and the results of a survey on the risk assessment system. The results suggested that quality of information processing in nursing significantly improved patient safety. Nurses surveyed demonstrated a high degree of satisfaction, with saving time and improving safety. The nursing document information system described was introduced to improve patient safety and decrease risk. The application of the system has greatly enhanced the efficiency of nursing work, and guides the nurses to make an accurate, comprehensive and objective assessment of patient information, contributing significantly to further improvement in care standards and care decisions.

  10. The Impact of Information Culture on Patient Safety Outcomes. Development of a Structural Equation Model.

    PubMed

    Jylhä, Virpi; Mikkonen, Santtu; Saranto, Kaija; Bates, David W

    2017-03-08

    An organization's information culture and information management practices create conditions for processing patient information in hospitals. Information management incidents are failures that could lead to adverse events for the patient if they are not detected. To test a theoretical model that links information culture in acute care hospitals to information management incidents and patient safety outcomes. Reason's model for the stages of development of organizational accidents was applied. Study data were collected from a cross-sectional survey of 909 RNs who work in medical or surgical units at 32 acute care hospitals in Finland. Structural equation modeling was used to assess how well the hypothesized model fit the study data. Fit indices indicated a good fit for the model. In total, 18 of the 32 paths tested were statistically significant. Documentation errors had the strongest total effect on patient safety outcomes. Organizational guidance positively affected information availability and utilization of electronic patient records, whereas the latter had the strongest total effect on the reduction of information delays. Patient safety outcomes are associated with information management incidents and information culture. Further, the dimensions of the information culture create work conditions that generate errors in hospitals.

  11. Enhancing vaccine safety capacity globally: a lifecycle perspective

    PubMed Central

    Chen, Robert T.; Shimabukuro, Tom T.; Martin, David B.; Zuber, Patrick L.F.; Weibel, Daniel M.; Sturkenboom, Miriam

    2015-01-01

    Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th Century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved in the future to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a “lifecycle” approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle- income countries. PMID:26433922

  12. Maternal Immune Activation Alters Nonspatial Information Processing in the Hippocampus of the Adult Offspring

    PubMed Central

    Ito, Hiroshi T.; Smith, Stephen E. P.; Hsiao, Elaine; Patterson, Paul H.

    2010-01-01

    The observation that maternal infection increases the risk for schizophrenia in the offspring suggests that the maternal immune system plays a key role in the etiology of schizophrenia. In a mouse model, maternal immune activation (MIA) by injection of poly(I:C) yields adult offspring that display abnormalities in a variety of behaviors relevant to schizophrenia. As abnormalities in the hippocampus are a consistent observation in schizophrenia patients, we examined synaptic properties in hippocampal slices prepared from the offspring of poly(I:C)- and saline-treated mothers. Compared to controls, CA1 pyramidal neurons from adult offspring of MIA mothers display reduced frequency and increased amplitude of miniature excitatory postsynaptic currents. In addition, the specific component of the temporoammonic pathway that mediates object-related information displays increased sensitivity to dopamine. To assess hippocampal network function in vivo, we used expression of the immediate early gene, c-Fos, as a surrogate measure of neuronal activity. Compared to controls, the offspring of poly(I:C)-treated mothers display a distinct c-Fos expression pattern in area CA1 following novel object, but not novel location, exposure. Thus, the offspring of MIA mothers may have an abnormality in modality-specific information processing. Indeed, the MIA offspring display enhanced discrimination in a novel object recognition, but not in an object location, task. Thus, analysis of object and spatial information processing at both synaptic and behavioral levels reveals a largely selective abnormality in object information processing in this mouse model. Our results suggest that altered processing of object-related information may be part of the pathogenesis of schizophrenia-like cognitive behaviors. PMID:20227486

  13. Maternal immune activation alters nonspatial information processing in the hippocampus of the adult offspring.

    PubMed

    Ito, Hiroshi T; Smith, Stephen E P; Hsiao, Elaine; Patterson, Paul H

    2010-08-01

    The observation that maternal infection increases the risk for schizophrenia in the offspring suggests that the maternal immune system plays a key role in the etiology of schizophrenia. In a mouse model, maternal immune activation (MIA) by injection of poly(I:C) yields adult offspring that display abnormalities in a variety of behaviors relevant to schizophrenia. As abnormalities in the hippocampus are a consistent observation in schizophrenia patients, we examined synaptic properties in hippocampal slices prepared from the offspring of poly(I:C)- and saline-treated mothers. Compared to controls, CA1 pyramidal neurons from adult offspring of MIA mothers display reduced frequency and increased amplitude of miniature excitatory postsynaptic currents. In addition, the specific component of the temporoammonic pathway that mediates object-related information displays increased sensitivity to dopamine. To assess hippocampal network function in vivo, we used expression of the immediate-early gene, c-Fos, as a surrogate measure of neuronal activity. Compared to controls, the offspring of poly(I:C)-treated mothers display a distinct c-Fos expression pattern in area CA1 following novel object, but not novel location, exposure. Thus, the offspring of MIA mothers may have an abnormality in modality-specific information processing. Indeed, the MIA offspring display enhanced discrimination in a novel object recognition, but not in an object location, task. Thus, analysis of object and spatial information processing at both synaptic and behavioral levels reveals a largely selective abnormality in object information processing in this mouse model. Our results suggest that altered processing of object-related information may be part of the pathogenesis of schizophrenia-like cognitive behaviors. Copyright 2010 Elsevier Inc. All rights reserved.

  14. 77 FR 63800 - Proposed Extension of Approval of Information Collection; Comment Request-Safety Standard for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Safety Standard for Automatic Residential Garage Door Operators AGENCY: Consumer Product... 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (CPSC) requested comments on a...

  15. Universal varicella vaccine immunization in Japan.

    PubMed

    Yoshikawa, Tetsushi; Kawamura, Yoshiki; Ohashi, Masahiro

    2016-04-07

    In 1974, Japanese scientists developed a live attenuated varicella vaccine based on the Oka strain. The efficacy of the vaccine for the prevention of varicella has been primarily demonstrated in studies conducted in the United States following the adoption of universal immunization using the Oka strain varicella vaccine in 1996. Although the vaccine was developed by Japanese scientists, until recently, the vaccine has been administered on a voluntary basis in Japan resulting in a vaccine coverage rate of approximately 40%. Therefore, Japan initiated universal immunization using the Oka strain varicella vaccine in November 2014. Given the transition from voluntary to universal immunization in Japan, it will also be important to monitor the epidemiology of varicella and herpes zoster. The efficacy and safety of co-administration of the varicella vaccine and measles, mumps, and rubella vaccine have been demonstrated in many countries; however, there was no data from Japan. In order to adopt the practice of universal immunization using the Oka strain varicella vaccine in Japan, data demonstrating the efficacy and safety of co-administration of varicella vaccine and measles and rubella (MR) vaccine were required. Additionally, we needed to elucidate the appropriate time interval between the first and second administrations of the vaccine. It is also important to differentiate between wild type and Oka vaccine type strains in herpes zoster patient with past history of varicella vaccine. Thus, there are many factors to consider regarding the adoption of universal immunization in Japan to control varicella zoster virus (VZV) infections. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Health information technology and hospital patient safety: a conceptual model to guide research.

    PubMed

    Paez, Kathryn; Roper, Rebecca A; Andrews, Roxanne M

    2013-09-01

    The literature indicates that health information technology (IT) use may lead to some gains in the quality and safety of care in some situations but provides little insight into this variability in the results that has been found. The inconsistent findings point to the need for a conceptual model that will guide research in sorting out the complex relationships between health IT and the quality and safety of care. A conceptual model was developed that describes how specific health IT functions could affect different types of inpatient safety errors and that include contextual factors that influence successful health IT implementation. The model was applied to a readily available patient safety measure and nationwide data (2009 AHA Annual Survey Information Technology Supplement and 2009 Healthcare Cost and Utilization Project State Inpatient Databases). The model was difficult to operationalize because (1) available health IT adoption data did not characterize health IT features and extent of usage, and (2) patient safety measures did not elucidate the process failures leading to safety-related outcomes. The sample patient safety measure--Postoperative Physiologic and Metabolic Derangement Rate--was not significantly related to self-reported health IT capabilities when adjusted for hospital structural characteristics. These findings illustrate the critical need for collecting data that are germane to health IT and the possible mechanisms by which health IT may affect inpatient safety. Well-defined and sufficiently granular measures of provider's correct use of health IT functions, the contextual factors surrounding health IT use, and patient safety errors leading to health care-associated conditions are needed to illuminate the impact of health IT on patient safety.

  17. Factors Associated With Provider Reporting of Child and Adolescent Vaccination History to Immunization Information Systems: Results From the National Immunization Survey, 2006-2012.

    PubMed

    Cardemil, Cristina V; Cullen, Karen A; Harris, LaTreace; Greby, Stacie M; Santibanez, Tammy A

    2016-01-01

    Use of Immunization information systems (IISs) by providers can improve vaccination rates by identifying missed opportunities. However, provider reporting of children's vaccination histories to IISs remains suboptimal. To assess factors associated with provider reporting to an IIS. Analysis of 2006-2012 National Immunization Survey (NIS) and NIS-Teen data. NIS and NIS-Teen are ongoing random-digit-dial telephone surveys of households with children and adolescents, respectively, followed by a mail survey to providers to obtain the patient's vaccination history. A total of 115 285 children aged 19 to 35 months and 83 612 adolescents aged 13 to 17 years and their immunization providers in the United States. The percentage of children and adolescents with 1 or more providers reporting to or obtaining vaccination information from their local IISs. Multivariable logistic regression was used to examine patient and provider factors associated with provider reporting to IISs and adjusted prevalence of children and adolescents with 1 or more providers reporting to IISs. In 2012, 79.4% of children and 77.4% of adolescents had 1 or more providers report any of their vaccination data to an IIS, and 41.9% of children and 51.5% of adolescents had providers who obtained any of their vaccination histories from an IIS. During 2006-2012, children and adolescents were more likely to have any of their vaccination data reported to an IIS if they received care from all public versus all private providers (children: 84.4% vs 69.6%, P < .0001; adolescents: 84.6% vs 66.4%, P < .0001), had 1 or more providers who ordered vaccines from a state or local health department (children: 76.7% vs 59.5%, P < .0001; adolescents: 77.0% vs 55.6%, P < .0001), or had 1 or more providers obtain vaccination information from the IIS (children: 86.1% vs 71.2%, P < .0001; adolescents: 83.7% vs 64.6%, P < .0001). Health department staff should target providers less likely to use IIS services, including private

  18. Biomarkers of Safety and Immune Protection for Genetically Modified Live Attenuated Leishmania Vaccines Against Visceral Leishmaniasis – Discovery and Implications

    PubMed Central

    Gannavaram, Sreenivas; Dey, Ranadhir; Avishek, Kumar; Selvapandiyan, Angamuthu; Salotra, Poonam; Nakhasi, Hira L.

    2014-01-01

    Despite intense efforts there is no safe and efficacious vaccine against visceral leishmaniasis, which is fatal and endemic in many tropical countries. A major shortcoming in the vaccine development against blood-borne parasitic agents such as Leishmania is the inadequate predictive power of the early immune responses mounted in the host against the experimental vaccines. Often immune correlates derived from in-bred animal models do not yield immune markers of protection that can be readily extrapolated to humans. The limited efficacy of vaccines based on DNA, subunit, heat killed parasites has led to the realization that acquisition of durable immunity against the protozoan parasites requires a controlled infection with a live attenuated organism. Recent success of irradiated malaria parasites as a vaccine candidate further strengthens this approach to vaccination. We developed several gene deletion mutants in Leishmania donovani as potential live attenuated vaccines and reported extensively on the immunogenicity of LdCentrin1 deleted mutant in mice, hamsters, and dogs. Additional limited studies using genetically modified live attenuated Leishmania parasites as vaccine candidates have been reported. However, for the live attenuated parasite vaccines, the primary barrier against widespread use remains the absence of clear biomarkers associated with protection and safety. Recent studies in evaluation of vaccines, e.g., influenza and yellow fever vaccines, using systems biology tools demonstrated the power of such strategies in understanding the immunological mechanisms that underpin a protective phenotype. Applying similar tools in isolated human tissues such as PBMCs from healthy individuals infected with live attenuated parasites such as LdCen−/− in vitro followed by human microarray hybridization experiments will enable us to understand how early vaccine-induced gene expression profiles and the associated immune responses are coordinately regulated in normal

  19. Efficacy and safety of rituximab for systemic lupus erythematosus-associated immune cytopenias: A multicenter retrospective cohort study of 71 adults.

    PubMed

    Serris, Alexandra; Amoura, Zahir; Canouï-Poitrine, Florence; Terrier, Benjamin; Hachulla, Eric; Costedoat-Chalumeau, Nathalie; Papo, Thomas; Lambotte, Olivier; Saadoun, David; Hié, Miguel; Blanche, Philippe; Lioger, Bertrand; Gottenberg, Jacques-Eric; Godeau, Bertrand; Michel, Marc

    2018-03-01

    The aim of the study was to assess the efficacy and safety of rituximab (RTX) for treating systemic lupus erythematosus (SLE)-associated immune cytopenias. This multicenter retrospective cohort study of adults from French referral centers and networks for adult immune cytopenias and SLE involved patients ≥18 years old with a definite diagnosis of SLE treated with RTX specifically for SLE-associated immune cytopenia from 2005 to 2015. Response assessment was based on standard definitions. In total, 71 patients, 61 women (85.9%), with median age 36 years [interquartile range 31-48], were included. The median duration of SLE at the time of the first RTX administration was 6.1 years [2.6-11.6] and the reason for using RTX was immune thrombocytopenia (ITP) for 44 patients (62.0%), autoimmune hemolytic anemia (AIHA) for 16 (22.5%), Evans syndrome for 10 (14.1%), and pure red cell aplasia for one patient. Before receiving RTX, patients had received a mean of 3.1 ± 1.3 treatments that included corticosteroids (100%), and hydroxychloroquine (88.5%). The overall initial response rate to RTX was 86% (91% with ITP, 87.5% with AIHA, and 60% with Evans syndrome), including 60.5% with complete response. Median follow-up after the first injection of RTX was 26.4 months [14.3-71.2]. Among 61 initial responders, relapse occurred in 24 (39.3%); for 18, RTX retreatment was successful in 16 (88.8%). Severe infections occurred after RTX in three patients, with no fatal outcome. No cases of RTX-induced neutropenia were observed. In conclusion, RTX seems effective and relatively safe for treating SLE-associated immune cytopenias. © 2017 Wiley Periodicals, Inc.

  20. 75 FR 30783 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2009-0064] Agency Information Collection... announcing an opportunity for public comment on the proposed collection of certain information by the agency... the Federal Register concerning each proposed collection of information, and to allow 60 days for...

  1. Database search for safety information on cosmetic ingredients.

    PubMed

    Pauwels, Marleen; Rogiers, Vera

    2007-12-01

    Ethical considerations with respect to experimental animal use and regulatory testing are worldwide under heavy discussion and are, in certain cases, taken up in legislative measures. The most explicit example is the European cosmetic legislation, establishing a testing ban on finished cosmetic products since 11 September 2004 and enforcing that the safety of a cosmetic product is assessed by taking into consideration "the general toxicological profile of the ingredients, their chemical structure and their level of exposure" (OJ L151, 32-37, 23 June 1993; OJ L066, 26-35, 11 March 2003). Therefore the availability of referenced and reliable information on cosmetic ingredients becomes a dire necessity. Given the high-speed progress of the World Wide Web services and the concurrent drastic increase in free access to information, identification of relevant data sources and evaluation of the scientific value and quality of the retrieved data, are crucial. Based upon own practical experience, a survey is put together of freely and commercially available data sources with their individual description, field of application, benefits and drawbacks. It should be mentioned that the search strategies described are equally useful as a starting point for any quest for safety data on chemicals or chemical-related substances in general.

  2. 41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

  3. 41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2014-01-01 2014-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

  4. 41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2013-07-01 2013-07-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

  5. 41 CFR 102-80.105 - What information must be included in an equivalent level of safety analysis?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... of Safety Analysis § 102-80.105 What information must be included in an equivalent level of safety... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false What information must be included in an equivalent level of safety analysis? 102-80.105 Section 102-80.105 Public Contracts and...

  6. The immune self: a selectionist theory of recognition, learning, and remembering within the immune system.

    PubMed

    Kradin, R L

    1995-01-01

    In this paper, I have briefly explored metaphors shared by the immune and nervous systems and shown that this exercise can lead to the elucidation of common principles of organization, as well as to predictions concerning how the immune system functions. Metaphor itself undoubtedly reflects the way in which we categorize and retrieve information 44], so it is not surprising that the deep processes of language tend to sample information from related data categories. Although the nervous and immune systems are obviously not the same and metaphors are indeed just that, my primary goal has been to suggest that by virtue of their having evolved in parallel over millions of years, the nervous and immune systems currently use the same archetypal principles and strategies to address related challenges in information processing and retrieval. Ultimately, nature is conservative. One need only look at a tree, a river, the airways, or the vascular bed in order to see how a fractal pattern of repetitive dichotomous branching has been used by each, in order to optimize the transport of fluids over large distances [45]. While each system has had to adopt different materials in order to solve the problem, the shape of their solutions is remarkably alike. In the immune and nervous systems, the elements used to produce optimal functional responses are also quite different, but again the solutions have been achieved by comparable strategies. I am certain that these two great systems of information processing, each responding with vastly different kinetics, will prove to be far more integrally interdependent than has been previously recognized. For example, should a swift response by the immune system be required in an overwhelming invasion by microbial pathogens, the immune system may be able to cooperate with the rapidly reacting nervous system to rid the host of the invaders. In this regard, we have shown that the beta-adrenergic hormone epinephrine rapidly increases the traffic of

  7. Biological safety concepts of genetically modified live bacterial vaccines.

    PubMed

    Frey, Joachim

    2007-07-26

    Live vaccines possess the advantage of having access to induce cell-mediated and antibody-mediated immunity; thus in certain cases they are able to prevent infection, and not only disease. Furthermore, live vaccines, particularly bacterial live vaccines, are relatively cheap to produce and easy to apply. Hence they are suitable to immunize large communities or herds. The induction of both cell-mediated immunity as well as antibody-mediated immunity, which is particularly beneficial in inducing mucosal immune responses, is obtained by the vaccine-strain's ability to colonize and multiply in the host without causing disease. For this reason, live vaccines require attenuation of virulence of the bacterium to which immunity must be induced. Traditionally attenuation was achieved simply by multiple passages of the microorganism on growth medium, in animals, eggs or cell cultures or by chemical or physical mutagenesis, which resulted in random mutations that lead to attenuation. In contrast, novel molecular methods enable the development of genetically modified organisms (GMOs) targeted to specific genes that are particularly suited to induce attenuation or to reduce undesirable effects in the tissue in which the vaccine strains can multiply and survive. Since live vaccine strains (attenuated by natural selection or genetic engineering) are potentially released into the environment by the vaccinees, safety issues concerning the medical as well as environmental aspects must be considered. These involve (i) changes in cell, tissue and host tropism, (ii) virulence of the carrier through the incorporation of foreign genes, (iii) reversion to virulence by acquisition of complementation genes, (iv) exchange of genetic information with other vaccine or wild-type strains of the carrier organism and (v) spread of undesired genes such as antibiotic resistance genes. Before live vaccines are applied, the safety issues must be thoroughly evaluated case-by-case. Safety assessment

  8. 77 FR 58616 - Pipeline Safety: Information Collection Activities, Revision to Gas Transmission and Gathering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2012-0024] Pipeline Safety: Information Collection Activities, Revision to Gas Transmission and Gathering Pipeline Systems Annual Report, Gas Transmission and Gathering Pipeline Systems Incident Report...

  9. Vaccine Safety Datalink

    Cancer.gov

    The Vaccine Safety Datalink is part of the National Immunization Program within the Centers for Disease Control and Prevention and was started in recognition of gaps in the scientific knowledge of rare vaccine side effects.

  10. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia.

    PubMed

    Robak, Tadeusz; Mainau, Claudia; Pyringer, Barbara; Chojnowski, Krzysztof; Warzocha, Krzysztof; Dmoszynska, Anna; Straub, Jan; Imbach, Paul

    2010-10-01

    Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam(®) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count ≤20×10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0·12 ml/kg/minute. Eighty per cent of patients attained the primary efficacy endpoint of clinical response (platelet count ≥50×10(9)/l within 6 days of dosing). The median time to response was 2 days and the median duration of response was 12 days; mean response duration was 24·1 days. octagam 10% was well tolerated and effective in this population representative of adult patients with ITP, even at the maximum infusion rate of 0·12 ml/kg/minute, without unexpected safety issues.

  11. Medication safety and knowledge-based functions: a stepwise approach against information overload.

    PubMed

    Patapovas, Andrius; Dormann, Harald; Sedlmayr, Brita; Kirchner, Melanie; Sonst, Anja; Müller, Fabian; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Vogler, Renate; Maas, Renke; Criegee-Rieck, Manfred; Prokosch, Hans-Ulrich; Bürkle, Thomas

    2013-09-01

    The aim was to improve medication safety in an emergency department (ED) by enhancing the integration and presentation of safety information for drug therapy. Based on an evaluation of safety of drug therapy issues in the ED and a review of computer-assisted intervention technologies we redesigned an electronic case sheet and implemented computer-assisted interventions into the routine work flow. We devised a four step system of alerts, and facilitated access to different levels of drug information. System use was analyzed over a period of 6 months. In addition, physicians answered a survey based on the technology acceptance model TAM2. The new application was implemented in an informal manner to avoid work flow disruption. Log files demonstrated that step I, 'valid indication' was utilized for 3% of the recorded drugs and step II 'tooltip for well-known drug risks' for 48% of the drugs. In the questionnaire, the computer-assisted interventions were rated better than previous paper based measures (checklists, posters) with regard to usefulness, support of work and information quality. A stepwise assisting intervention received positive user acceptance. Some intervention steps have been seldom used, others quite often. We think that we were able to avoid over-alerting and work flow intrusion in a critical ED environment. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

  12. Innovative Advances in Connectivity and Community Pharmacist Patient Care Services: Implications for Patient Safety.

    PubMed

    Bacci, Jennifer L; Berenbrok, Lucas A

    2018-06-07

    The scope of community pharmacy practice has expanded beyond the provision of drug product to include the provision of patient care services. Likewise, the community pharmacist's approach to patient safety must also expand beyond prevention of errors during medication dispensing to include optimization of medications and prevention of adverse events throughout the entire medication use process. Connectivity to patient data and other healthcare providers has been a longstanding challenge in community pharmacy with implications for the delivery and safety of patient care. Here, we describe three innovative advances in connectivity in community pharmacy practice that enhance patient safety in the provision of community pharmacist patient care services across the entire medication use process. Specifically, we discuss the growing use of immunization information systems, quality improvement platforms, and health information exchanges in community pharmacy practice and their implications for patient safety. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  13. [Global immunization policies and recommendations: objectives and process].

    PubMed

    Duclos, Philippe; Okwo-Bele, Jean-Marie

    2007-04-01

    The World Health Organization (WHO) has a dual mandate of providing global policies, standards and norms as well as support for member countries in applying such policies and standards to national programmes with the aim to improve health. The vaccine world is changing and with it the demands and expectations of the global and national policy makers, donors, and other interested parties. Changes pertain to : new vaccines and technologies developments, vaccine safety issues, regulation and approval of vaccines, and increased funding flowing through new financing mechanisms. This places a special responsibility on WHO to respond effectively. WHO has recently reviewed and optimized its policy making structure for vaccines and immunization and adjusted it to the new Global Immunization Vision and Strategy, which broadens the scope of immunization efforts to all age groups and vaccines with emphasis on integration of immunization delivery with other health interventions. This includes an extended consultation process to promptly generate evidence base recommendations, ensuring transparency of the decision making process and added communication efforts. This article presents the objectives and impact of the process set to develop global immunization policies, norms, standards and recommendations. The key advisory committees landscape contributing to this process is described. This includes the Strategic Advisory Group of Experts, the Global Advisory Committee on Vaccine Safety and the Expert Committee on Biological Standardization. The elaboration of WHO vaccine position papers is also described.

  14. Using Active Learning to Identify Health Information Technology Related Patient Safety Events.

    PubMed

    Fong, Allan; Howe, Jessica L; Adams, Katharine T; Ratwani, Raj M

    2017-01-18

    The widespread adoption of health information technology (HIT) has led to new patient safety hazards that are often difficult to identify. Patient safety event reports, which are self-reported descriptions of safety hazards, provide one view of potential HIT-related safety events. However, identifying HIT-related reports can be challenging as they are often categorized under other more predominate clinical categories. This challenge of identifying HIT-related reports is exacerbated by the increasing number and complexity of reports which pose challenges to human annotators that must manually review reports. In this paper, we apply active learning techniques to support classification of patient safety event reports as HIT-related. We evaluated different strategies and demonstrated a 30% increase in average precision of a confirmatory sampling strategy over a baseline no active learning approach after 10 learning iterations.

  15. Assessing barriers to immunization.

    PubMed

    Niederhauser, Victoria; Ferris, Catherine

    2016-05-03

    Parental barriers to childhood immunizations vary among countries, states and communities. There is a plethora of studies that exist to examine barriers to immunizations including many intervention studies designed to improve immunization rates in children. Often, intervention studies designed to minimize barriers and increase immunization uptake among children lack the inclusion of a standardized instrument to measure accurately parental barriers to childhood immunizations before and after interventions. The Searching for Hardships and Obstacles To Shots (SHOTS) survey is a standardized survey instrument to measure parental barriers to childhood immunizations. In several studies, the SHOTS survey has demonstrated consistent reliability and has been validated in diverse populations. The inclusion of the SHOTS survey instrument in studies to examine barriers to childhood immunization will provide researchers and clinicians with a better understanding of parents' individualized barriers to immunizations. Furthermore, use of the SHOTS survey instrument to collect information about parental barriers to immunizations can lead to targeted interventions to minimize these obstacles at the individual and community level and to help us to achieve our national, state and community childhood immunization goals.

  16. Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.

    PubMed

    Talwar, Sonia R; Randhawa, Amarita S; Dankiewicz, Erica H; Crudele, Nancy T; Haddox, J David

    2016-01-01

    Healthcare professionals and consumers refer to online drug-information compendia (eg, Epocrates and WebMD) to learn about prescription medications, including opioid analgesics. With the significant risks associated with opioids, including abuse, misuse, and addiction, any of which can result in life-threatening overdose, it is important for those seeking information from online compendia to have access to current, accurate, and complete drug information to help support clinical treatment decisions. Although compendia are informative, readily available, and user friendly, studies have shown that they may contain errors. To review and identify misinformation in drug summaries of online drug-information compendia for selected opioid analgesic products and submit content corrections to the respective editors. Between 2011 and 2013, drug summaries for Purdue's prescription opioid analgesic products from seven leading online drug-information compendia were systematically reviewed, and the requests for corrections were retrospectively categorized and classified. At least 2 months following requests, the same compendia were then reexamined to assess the degree of error resolution. A total of 859 errors were identified, with the greatest percentage in Safety and Patient Education categories. Across the seven compendia, the complete or partial resolution of errors was 34 percent; therefore, nearly two thirds of the identified errors remain. The results of this analysis, consistent with past studies, demonstrate that online drug-information compendia may contain inaccurate information. Healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.

  17. Influenza immunization during pregnancy: Benefits for mother and infant

    PubMed Central

    Sakala, Isaac G.; Honda-Okubo, Yoshikazu; Fung, Johnson; Petrovsky, Nikolai

    2016-01-01

    ABSTRACT The serious consequences of influenza infection during pregnancy have been recognized for almost a century. In this article, we reviewed the evidence on the immunogenicity, safety and impact of maternal influenza immunization for both mother and child. After vaccination, pregnant women have similar protective titers of anti-influenza antibodies as non-pregnant women, demonstrating that pregnancy does not alter the trivalent inactivated influenza vaccine immune response. Studies from the United States, Europe and resource-constrained regions demonstrate that maternal vaccination is associated with increased anti-influenza antibody concentrations and protection in the newborn child as well as the immunized mother. Given the acceptable safety profile of influenza vaccines and the World Health Organization's recommendation for its use in pregnant women, maternal vaccination with inactivated influenza vaccine is a cost-effective approach to decrease influenza disease in newborns. However, as seen for influenza immunization in the elderly, the protective efficacy of current inactivated vaccines in protection of newborns is 50% at best, indicating significant room for vaccine improvement, which could potentially be achieved by addition of a safe and effective adjuvant. Thus, global deployment of inactivated influenza immunization during pregnancy would have substantial and measurable health benefits for mothers and their newborns. PMID:27494630

  18. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

  19. A systematic evaluation of different methods for calculating adolescent vaccination levels using immunization information system data.

    PubMed

    Gowda, Charitha; Dong, Shiming; Potter, Rachel C; Dombkowski, Kevin J; Stokley, Shannon; Dempsey, Amanda F

    2013-01-01

    Immunization information systems (IISs) are valuable surveillance tools; however, population relocation may introduce bias when determining immunization coverage. We explored alternative methods for estimating the vaccine-eligible population when calculating adolescent immunization levels using a statewide IIS. We performed a retrospective analysis of the Michigan State Care Improvement Registry (MCIR) for all adolescents aged 11-18 years registered in the MCIR as of October 2010. We explored four methods for determining denominators: (1) including all adolescents with MCIR records, (2) excluding adolescents with out-of-state residence, (3) further excluding those without MCIR activity ≥ 10 years prior to the evaluation date, and (4) using a denominator based on U.S. Census data. We estimated state- and county-specific coverage levels for four adolescent vaccines. We found a 20% difference in estimated vaccination coverage between the most inclusive and restrictive denominator populations. Although there was some variability among the four methods in vaccination at the state level (2%-11%), greater variation occurred at the county level (up to 21%). This variation was substantial enough to potentially impact public health assessments of immunization programs. Generally, vaccines with higher coverage levels had greater absolute variation, as did counties with smaller populations. At the county level, using the four denominator calculation methods resulted in substantial differences in estimated adolescent immunization rates that were less apparent when aggregated at the state level. Further research is needed to ascertain the most appropriate method for estimating vaccine coverage levels using IIS data.

  20. Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years.

    PubMed

    Asturias, Edwin J; Wharton, Melinda; Pless, Robert; MacDonald, Noni E; Chen, Robert T; Andrews, Nicholas; Salisbury, David; Dodoo, Alexander N; Hartigan-Go, Kenneth; Zuber, Patrick L F

    2016-06-17

    In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Networking grassroots efforts to improve safety and health in informal economy workplaces in Asia.

    PubMed

    Kawakami, Tsuyoshi

    2006-01-01

    Many workers in Asia are in the informal economy. They often work in substandard conditions, exposed to hazards in the workplace. Learning from the recent successes of participatory training programmes to improve safety and health in Asia, the ILO has strengthened its partnership efforts with local people to improve safety and health of informal economy workplaces. The target groups were: (1) home workplaces in Cambodia and Thailand, (2) salt fields and fishing villages in Cambodia where many young workers are working, and (3) small construction sites in Cambodia, Laos, Mongolia, Thailand and Vietnam. The walk-through survey results showed that the workers and owners in the target informal economy workplaces had the strong will to improve safety and health at their own initiatives and needed practical support. In the participatory, action-oriented training workshops carried out, the participated workers and owners were able to identify their priority safety and health actions. Commonly identified were clear and safe transport ways, safer handling of hazardous substances, basic welfare needs such as drinking water and sanitary toilets, and work posture. The follow-up visits confirmed that many of the proposed actions were actually taken by using low-cost available materials. These positive changes were possible by applying the participatory training tools such as illustrated checklists and extensive use of photographs showing local good examples and placing emphasis on facilitator roles of trainers. In conclusion, the target informal economy workplaces in Asia made positive changes in safety and health through the participatory, action-oriented training focusing on local initiative and low-cost improvement measures. Local network support mechanisms to share lessons from good practices played essential roles in encouraging the voluntary implementation of practical improvement actions. It is important to increase our joint efforts to reach more informal economy

  2. The use of a computerized database to monitor vaccine safety in Viet Nam.

    PubMed Central

    Ali, Mohammad; Canh, Gia Do; Clemens, John D.; Park, Jin-Kyung; von Seidlein, Lorenz; Minh, Tan Truong; Thiem, Dinh Vu; Tho, Huu Le; Trach, Duc Dang

    2005-01-01

    Health information systems to monitor vaccine safety are used in industrialized countries to detect adverse medical events related to vaccinations or to prove the safety of vaccines. There are no such information systems in the developing world, but they are urgently needed. A large linked database for the monitoring of vaccine-related adverse events has been established in Khanh Hoa province, Viet Nam. Data collected during the first 2 years of surveillance, a period which included a mass measles vaccination campaign, were used to evaluate the system. For this purpose the discharge diagnoses of individuals admitted to polyclinics and hospitals were coded according to the International Classification of Diseases (ICD)-10 guidelines and linked in a dynamic population database with vaccination histories. A case-series analysis was applied to the cohort of children vaccinated during the mass measles vaccination campaign. The study recorded 107,022 immunizations in a catchment area with a population of 357,458 and confirmed vaccine coverage of 87% or higher for completed routine childhood vaccinations. The measles vaccination campaign immunized at least 86% of the targeted children aged 9 months to 10 years. No medical event was detected significantly more frequently during the 14 days after measles vaccination than before it. The experience in Viet Nam confirmed the safety of a measles vaccination campaign and shows that it is feasible to establish health information systems such as a large linked database which can provide reliable data in a developing country for a modest increase in use of resources. PMID:16193545

  3. Student pharmacists' perceptions of immunizations.

    PubMed

    Kubli, Kara; McBane, Sarah; Hirsch, Jan D; Lorentz, Sarah

    2017-05-01

    The primary aim of this study was to explore changes in knowledge level, perceived importance and apprehension of immunizations by first year pharmacy students pre- vs. post-immunization education and training. First year pharmacy students at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences (UC San Diego SSPPS) completed a pre- and post-immunization training course questionnaire. Knowledge base and perceived importance level of immunizations including hepatitis B, influenza, measles, mumps, rubella (MMR), varicella, tetanus, diphtheria, pertussis (Tdap), meningococcal and human papilloma virus (HPV) were assessed. In addition, apprehension of needle administration and fears regarding safety and efficacy were evaluated. Of 120 students, 85 (71%) completed pre- and post-course questionnaires for this study. Mean knowledge test scores increased from 56% pre-course to 83% post-course. Pre-course, 73% of participants considered immunizations as very important in preventing future disease outbreaks. Post-course, this percentage climbed to 94%. Prior to taking the course, 52% of students were apprehensive about administering injections; however, after completing the course this percentage declined to 33%. The majority of students who had been fearful prior to the course retained their fears of receiving needle injections. The proportion of students believing immunizations should be a personal choice, not mandatory, did not significantly change from pre-course (49%) to post-course (44%). The UC San Diego SSPPS immunization course increased student knowledge of immunization facts and the perceived importance of immunizations. However, a substantial portion of students retained apprehension about administering and receiving needle injections and the proportion believing immunizations should be a personal choice, almost half, did not change appreciably. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. 78 FR 50079 - Information Collection Activities: Safety and Environmental Management Systems (SEMS); Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... DEPARTMENT OF THE INTERIOR Bureau of Safety and Environmental Enforcement [Docket ID BSEE-2013-0005; OMB Control Number 1014-0017: 134E1700D2 EEEE500000 ET1SF0000.DAQ000] Information Collection Activities: Safety and Environmental Management Systems (SEMS); Proposed Collection; Comment Request Correction In notice document 2013-19416 appearing o...

  5. Novel vaccine development strategies for inducing mucosal immunity

    PubMed Central

    Fujkuyama, Yoshiko; Tokuhara, Daisuke; Kataoka, Kosuke; Gilbert, Rebekah S; McGhee, Jerry R; Yuki, Yoshikazu; Kiyono, Hiroshi; Fujihashi, Kohtaro

    2012-01-01

    To develop protective immune responses against mucosal pathogens, the delivery route and adjuvants for vaccination are important. The host, however, strives to maintain mucosal homeostasis by responding to mucosal antigens with tolerance, instead of immune activation. Thus, induction of mucosal immunity through vaccination is a rather difficult task, and potent mucosal adjuvants, vectors or other special delivery systems are often used, especially in the elderly. By taking advantage of the common mucosal immune system, the targeting of mucosal dendritic cells and microfold epithelial cells may facilitate the induction of effective mucosal immunity. Thus, novel routes of immunization and antigen delivery systems also show great potential for the development of effective and safe mucosal vaccines against various pathogens. The purpose of this review is to introduce several recent approaches to induce mucosal immunity to vaccines, with an emphasis on mucosal tissue targeting, new immunization routes and delivery systems. Defining the mechanisms of mucosal vaccines is as important as their efficacy and safety, and in this article, examples of recent approaches, which will likely accelerate progress in mucosal vaccine development, are discussed. PMID:22380827

  6. Why consumers behave as they do with respect to food safety and risk information.

    PubMed

    Verbeke, Wim; Frewer, Lynn J; Scholderer, Joachim; De Brabander, Hubert F

    2007-03-14

    In recent years, it seems that consumers are generally uncertain about the safety and quality of their food and their risk perception differs substantially from that of experts. Hormone and veterinary drug residues in meat persist to occupy a high position in European consumers' food concern rankings. The aim of this contribution is to provide a better understanding to food risk analysts of why consumers behave as they do with respect to food safety and risk information. This paper presents some cases of seemingly irrational and inconsistent consumer behaviour with respect to food safety and risk information and provides explanations for these behaviours based on the nature of the risk and individual psychological processes. Potential solutions for rebuilding consumer confidence in food safety and bridging between lay and expert opinions towards food risks are reviewed. These include traceability and labelling, segmented communication approaches and public involvement in risk management decision-making.

  7. 29 CFR 1960.12 - Dissemination of occupational safety and health program information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... establishment, and keep posted, a poster informing employees of the provisions of the Act, Executive Order 12196... furnish the core text of a poster to agencies. Each agency shall add the following items: (1) Details of...) Relevant information about any agency safety and health committees. Such posters and additions shall not be...

  8. 29 CFR 1960.12 - Dissemination of occupational safety and health program information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... establishment, and keep posted, a poster informing employees of the provisions of the Act, Executive Order 12196... furnish the core text of a poster to agencies. Each agency shall add the following items: (1) Details of...) Relevant information about any agency safety and health committees. Such posters and additions shall not be...

  9. 29 CFR 1960.12 - Dissemination of occupational safety and health program information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... establishment, and keep posted, a poster informing employees of the provisions of the Act, Executive Order 12196... furnish the core text of a poster to agencies. Each agency shall add the following items: (1) Details of...) Relevant information about any agency safety and health committees. Such posters and additions shall not be...

  10. 29 CFR 1960.12 - Dissemination of occupational safety and health program information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... establishment, and keep posted, a poster informing employees of the provisions of the Act, Executive Order 12196... furnish the core text of a poster to agencies. Each agency shall add the following items: (1) Details of...) Relevant information about any agency safety and health committees. Such posters and additions shall not be...

  11. 29 CFR 1960.12 - Dissemination of occupational safety and health program information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... establishment, and keep posted, a poster informing employees of the provisions of the Act, Executive Order 12196... furnish the core text of a poster to agencies. Each agency shall add the following items: (1) Details of...) Relevant information about any agency safety and health committees. Such posters and additions shall not be...

  12. 78 FR 10200 - Proposed Information Collection; Captive Wildlife Safety Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-LE-2013-N020; FF09L00200-FX-LE12200900000] Proposed Information Collection; Captive Wildlife Safety Act AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (U.S. Fish and Wildlife Service) will ask the...

  13. Guidelines for Reviewers and the Editor at the Nuclear Safety Information Center.

    ERIC Educational Resources Information Center

    Whetsel, H. B.

    The main purpose of this report is to help novice reviewers accelerate their apprenticeship at the Nuclear Safety Information Center, a computerized information service sponsored by the U.S. Atomic Energy Commission. Guidelines for reviewers are presented in Part 1; Part 2 contains guidelines for the novice editor. The goal of the reviewers and…

  14. 17 CFR 165.16 - No immunity.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false No immunity. 165.16 Section... § 165.16 No immunity. The Commodity Whistleblower Incentives and Protections provisions set forth in... information to the Commission with immunity from prosecution. The fact that an individual may become a...

  15. 17 CFR 165.16 - No immunity.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 17 Commodity and Securities Exchanges 1 2012-04-01 2012-04-01 false No immunity. 165.16 Section... § 165.16 No immunity. The Commodity Whistleblower Incentives and Protections provisions set forth in... information to the Commission with immunity from prosecution. The fact that an individual may become a...

  16. 17 CFR 165.16 - No immunity.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 2 2014-04-01 2014-04-01 false No immunity. 165.16 Section...) WHISTLEBLOWER RULES § 165.16 No immunity. The Commodity Whistleblower Incentives and Protections provisions set... provide information to the Commission with immunity from prosecution. The fact that an individual may...

  17. Local and systemic tumor immune dynamics

    NASA Astrophysics Data System (ADS)

    Enderling, Heiko

    Tumor-associated antigens, stress proteins, and danger-associated molecular patterns are endogenous immune adjuvants that can both initiate and continually stimulate an immune response against a tumor. In retaliation, tumors can hijack intrinsic immune regulatory programs that are intended to prevent autoimmune disease, thereby facilitating continued growth despite the activated antitumor immune response. In metastatic disease, this ongoing tumor-immune battle occurs at each site. Adding an additional layer of complexity, T cells activated at one tumor site can cycle through the blood circulation system and extravasate in a different anatomic location to surveil a distant metastasis. We propose a mathematical modeling framework that incorporates the trafficking of activated T cells between metastatic sites. We extend an ordinary differential equation model of tumor-immune system interactions to multiple metastatic sites. Immune cells are activated in response to tumor burden and tumor cell death, and are recruited from tumor sites elsewhere in the body. A model of T cell trafficking throughout the circulatory system can inform the tumor-immune interaction model about the systemic distribution and arrival of T cells at specific tumor sites. Model simulations suggest that metastases not only contribute to immune surveillance, but also that this contribution varies between metastatic sites. Such information may ultimately help harness the synergy of focal therapy with the immune system to control metastatic disease.

  18. A Systematic Evaluation of Different Methods for Calculating Adolescent Vaccination Levels Using Immunization Information System Data

    PubMed Central

    Gowda, Charitha; Dong, Shiming; Potter, Rachel C.; Dombkowski, Kevin J.; Stokley, Shannon

    2013-01-01

    Objective Immunization information systems (IISs) are valuable surveillance tools; however, population relocation may introduce bias when determining immunization coverage. We explored alternative methods for estimating the vaccine-eligible population when calculating adolescent immunization levels using a statewide IIS. Methods We performed a retrospective analysis of the Michigan State Care Improvement Registry (MCIR) for all adolescents aged 11–18 years registered in the MCIR as of October 2010. We explored four methods for determining denominators: (1) including all adolescents with MCIR records, (2) excluding adolescents with out-of-state residence, (3) further excluding those without MCIR activity ≥10 years prior to the evaluation date, and (4) using a denominator based on U.S. Census data. We estimated state- and county-specific coverage levels for four adolescent vaccines. Results We found a 20% difference in estimated vaccination coverage between the most inclusive and restrictive denominator populations. Although there was some variability among the four methods in vaccination at the state level (2%–11%), greater variation occurred at the county level (up to 21%). This variation was substantial enough to potentially impact public health assessments of immunization programs. Generally, vaccines with higher coverage levels had greater absolute variation, as did counties with smaller populations. Conclusion At the county level, using the four denominator calculation methods resulted in substantial differences in estimated adolescent immunization rates that were less apparent when aggregated at the state level. Further research is needed to ascertain the most appropriate method for estimating vaccine coverage levels using IIS data. PMID:24179260

  19. 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

  20. 76 FR 67201 - Information Collection Activities: Oil and Gas Production Safety Systems; Submitted for Office of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    .... BOEM-2011-0068; OMB Number 1014-0003] Information Collection Activities: Oil and Gas Production Safety... requirements in the regulations under Subpart H, ``Oil and Gas Production Safety Systems.'' This notice also... Gas Production Safety Systems. Abstract: The Outer Continental Shelf (OCS) Lands Act, as amended (43 U...

  1. The history of vaccines and immunization: familiar patterns, new challenges.

    PubMed

    Stern, Alexandra Minna; Markel, Howard

    2005-01-01

    Human beings have benefited from vaccines for more than two centuries. Yet the pathway to effective vaccines has been neither neat nor direct. This paper explores the history of vaccines and immunization, beginning with Edward Jenner's creation of the world's first vaccine for smallpox in the 1790s. We then demonstrate that many of the issues salient in Jenner's era-such as the need for secure funding mechanisms, streamlined manufacturing and safety concerns, and deep-seated public fears of inoculating agents-have frequently reappeared and have often dominated vaccine policies. We suggest that historical awareness can help inform viable long-term solutions to contemporary problems with vaccine research, production, and supply.

  2. Safety and efficacy of E coli enterotoxin adjuvant for urease-based rectal immunization against Helicobacter pylori.

    PubMed

    Sougioultzis, Stavros; Lee, Cynthia K; Alsahli, Mazen; Banerjee, Subhas; Cadoz, Michel; Schrader, Robert; Guy, Bruno; Bedford, Philip; Monath, Thomas P; Kelly, Ciaran P; Michetti, Pierre

    2002-12-13

    Low dose E. coli heat-labile enterotoxin (LT), delivered orally or enterically, has been used as an adjuvant for Helicobacter pylori (H. pylori) urease in healthy adults. In this study we aim to test the safety and adjuvant efficacy of LT delivered rectally together with recombinant H. pylori urease. Eighteen healthy adults without present or past H. pylori infection were enrolled in a double blind, randomized, ascending dose study to receive either urease (60 mg), or urease (60 mg) + LT (5 or 25 microg). The immunization preparation was administered per rectum on days 0, 14 and 28. Serum, stool and saliva anti-urease and anti-LT IgG and IgA antibodies (Abs) were measured and urease-specific and LT-specific antigen secreting cells (ASCs) were counted in peripheral blood at baseline and 7 (ASC counts) or 14 days (antibody levels) after each dosing. Peripheral blood lymphoproliferation assays were also performed at baseline and at the end of the study. Rectally delivered urease and LT were well tolerated. Among the 12 subjects assigned to urease+LT, 2 (16.7%) developed anti-urease IgG Abs, 1 (8.3%) developed anti-urease IgA Abs, and 3 (25%) showed urease-specific IgA(+) ASCs. Immune responses to LT were more vigorous, especially in subjects exposed to 5 microg LT. In the urease+ 5 microg LT group, anti-LT IgG and IgA Abs developed in 60 and 80% of the subjects, respectively, while LT-specific IgG(+) and IgA(+) ASCs were detected in all subjects. The magnitude of the anti-LT response was much higher than the response to urease. No IgA anti-urease or anti-LT Abs were detected in stool or saliva and lymphocyte proliferative responses to urease were unsatisfactory. In conclusion, rectal delivery of 5 microg LT is safe and induces vigorous systemic anti-LT immune responses. Further studies are needed to determine if LT can be an effective adjuvant for rectally delivered antigens.

  3. The Inside Information about Safety Surfacing.

    ERIC Educational Resources Information Center

    Thompson, Donna; Hudson, Susan

    2003-01-01

    Tested the impact attenuation characteristics of safety surfaces used in indoor child care play settings. Found that the most common surfaces used were indoor/outdoor carpet, various types of mats, and safety floor tiles. Nearly 60 percent of tested materials had a critical fall height of 1 foot or less. Concluded that carpet, safety tile, and…

  4. The administration of probiotics and synbiotics in immune compromised adults: is it safe?

    PubMed

    Van den Nieuwboer, M; Brummer, R J; Guarner, F; Morelli, L; Cabana, M; Claasen, E

    2015-03-01

    This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008-2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.

  5. The use of information technology to enhance patient safety and nursing efficiency.

    PubMed

    Lee, Tso-Ying; Sun, Gi-Tseng; Kou, Li-Tseng; Yeh, Mei-Ling

    2017-10-23

    Issues in patient safety and nursing efficiency have long been of concern. Advancing the role of nursing informatics is seen as the best way to address this. The aim of this study was to determine if the use, outcomes and satisfaction with a nursing information system (NIS) improved patient safety and the quality of nursing care in a hospital in Taiwan. This study adopts a quasi-experimental design. Nurses and patients were surveyed by questionnaire and data retrieval before and after the implementation of NIS in terms of blood drawing, nursing process, drug administration, bar code scanning, shift handover, and information and communication integration. Physiologic values were easier to read and interpret; it took less time to complete electronic records (3.7 vs. 9.1 min); the number of errors in drug administration was reduced (0.08% vs. 0.39%); bar codes reduced the number of errors in blood drawing (0 vs. 10) and transportation of specimens (0 vs. 0.42%); satisfaction with electronic shift handover increased significantly; there was a reduction in nursing turnover (14.9% vs. 16%); patient satisfaction increased significantly (3.46 vs. 3.34). Introduction of NIS improved patient safety and nursing efficiency and increased nurse and patient satisfaction. Medical organizations must continually improve the nursing information system if they are to provide patients with high quality service in a competitive environment.

  6. The electronic security partnership of safety/security and information systems departments.

    PubMed

    Yow, J Art

    2012-01-01

    The ever-changing world of security electronics is reviewed in this article. The author focuses on its usage in a hospital setting and the need for safety/security and information systems departments to work together to protect and get full value from IP systems.

  7. Identifying patterns of immune-related disease: use in disease prevention and management.

    PubMed

    Dietert, Rodney R; Zelikoff, Judith T

    2010-05-01

    Childhood susceptibility to diseases linked with immune dysfunction affects over a quarter of the pediatric population in some countries. While this alone is a significant health issue, the actual impact of immune-related diseases extends over a lifetime and involves additional secondary conditions. Some comorbidities are well known (e.g., allergic rhinitis and asthma). However, no systematic approach has been used to identify life-long patterns of immune-based disease where the primary condition arises in childhood. Such information is useful for both disease prevention and treatment approaches. Recent primary research papers as well as review articles were obtained from PubMed, Chem Abstracts, Biosis and from the personal files of the authors. Search words used were: the diseases and conditions shown Figs. 1 and 2 in conjunction with comorbid, comorbidities, pediatric, childhood, adult, immune, immune dysfunction, allergy, autoimmune, inflammatory, infectious, health risks, environment, risk factors. Childhood diseases such as asthma, type-1 diabetes, inflammatory bowel disease, respiratory infections /rhinitis, recurrent otitis media, pediatric celiac, juvenile arthritis and Kawasaki disease are examples of significant childhood health problems where immune dysfunction plays a significant role. Each of these pediatric diseases is associated with increased risk of several secondary conditions, many of which appear only later in life. To illustrate, four prototypes of immune-related disease patterns (i.e., allergy, autoimmunity, inflammation and infectious disease) are shown as tools for: 1) enhanced disease prevention; 2) improved management of immune-based pediatric diseases; and 3) better recognition of underlying pediatric immune dysfunction. Identification of immune-related disease patterns beginning in childhood provides the framework for examining the underlying immune dysfunctions that can contribute to additional diseases in later life. Many pediatric

  8. 14 CFR 193.5 - How may I submit safety or security information and have it protected from disclosure?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SUBMITTED INFORMATION § 193.5 How may I submit safety or security information and have it protected from... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false How may I submit safety or security information and have it protected from disclosure? 193.5 Section 193.5 Aeronautics and Space FEDERAL AVIATION...

  9. 14 CFR 193.5 - How may I submit safety or security information and have it protected from disclosure?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SUBMITTED INFORMATION § 193.5 How may I submit safety or security information and have it protected from... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false How may I submit safety or security information and have it protected from disclosure? 193.5 Section 193.5 Aeronautics and Space FEDERAL AVIATION...

  10. Patient and nurse safety: how information technology makes a difference.

    PubMed

    Simpson, Roy L

    2005-01-01

    The Institute of Medicine's landmark report asserted medical error is seldom the fault of individuals, but the result of faulty healthcare policy/procedure systems. Numerous studies have shown that information technology can shore up weak systems. For nursing, information technology plays a key role in protecting patients by eliminating nursing mistakes and protecting nurses by reducing their negative exposure. However, managing information technology is a function of managing the people who use it. This article examines critical issues that impact patient and nurse safety, both physical and professional. It discusses the importance of eliminating the culture of blame, the requirements of process change, how to implement technology in harmony with the organization and the significance of vision.

  11. Introducing auto-disable syringes to the national immunization programme in Madagascar.

    PubMed Central

    Drain, Paul K.; Ralaivao, Josoa S.; Rakotonandrasana, Alexander; Carnell, Mary A.

    2003-01-01

    OBJECTIVE: To evaluate the safety and coverage benefits of auto-disable (AD) syringes, weighed against the financial and logis- tical costs, and to create appropriate health policies in Madagascar. METHODS: Fifteen clinics in Madagascar, trained to use AD syringes, were randomized to implement an AD syringe only, mixed (AD syringes used only on non-routine immunization days), or sterilizable syringe only (control) programme. During a five-week period, data on administered vaccinations were collected, interviews were conducted, and observations were recorded. FINDINGS: The use of AD syringes improved coverage rates by significantly increasing the percentage of vaccines administered on non-routine immunization days (AD-only 4.3%, mixed 5.7%, control 1.1% (P<0.05)). AD-only clinics eliminated sterilization sessions for vaccinations, whereas mixed clinics reduced the number of sterilization sessions by 64%. AD syringes were five times more expensive than sterilizable syringes, which increased AD-only and mixed clinics' projected annual injection costs by 365% and 22%, respectively. However, introducing AD syringes for all vaccinations would only increase the national immunization budget by 2%. CONCLUSION: The use of AD syringes improved vaccination coverage rates by providing ready-to-use sterile syringes on non-routine immunization days and decreasing the number of sterilization sessions, thereby improving injection safety. The mixed programme was the most beneficial approach to phasing in AD syringes and diminishing logistical complications, and it had minimal costs. AD syringes, although more expensive, can feasibly be introduced into a developing country's immunization programme to improve vaccination safety and coverage. PMID:14576886

  12. Global Immunizations: Health Promotion and Disease Prevention Worldwide.

    PubMed

    Macintosh, Janelle L B; Eden, Lacey M; Luthy, Karlen E; Schouten, Aimee E

    Immunizations are one of the most important health interventions of the 20th century, yet people in many areas of the world do not receive adequate immunizations. Approximately 3 million people worldwide die every year from vaccine-preventable diseases; about half of these deaths are young children and infants. Global travel is more common; diseases that were once localized now can be found in communities around the world. Multiple barriers to immunizations have been identified. Healthcare access, cost, and perceptions of safety and trust in healthcare are factors that have depressed global immunization rates. Several global organizations have focused on addressing these barriers as part of their efforts to increase immunization rates. The Bill and Melinda Gates Foundation, The World Health Organization, and the United Nations Children's Emergency Fund each have a part of their organization that is concentrated on immunizations. Maternal child nurses worldwide can assist in increasing immunization rates. Nurses can participate in outreach programs to ease the burden of patients and families in accessing immunizations. Nurses can work with local and global organizations to make immunizations more affordable. Nurses can improve trust and knowledge about immunizations in their local communities. Nurses are a powerful influence in the struggle to increase immunization rates, which is a vital aspect of global health promotion and disease prevention.

  13. Quality of Chemical Safety Information in Printing Industry.

    PubMed

    Tsai, Chung-Jung; Mao, I-Fang; Ting, Jo-Yu; Young, Chi-Hsien; Lin, Jhih-Sian; Li, Wei-Lun

    2016-04-01

    Employees in printing industries can be exposed to multiple solvents in their work environment. The objectives of this study were to investigate the critical components of chemical solvents by analyzing the components of the solvents and collecting the Safety data sheets (SDSs), and to evaluate the hazard communication implementation status in printing industries. About 152 printing-related industries were recruited by area-stratified random sampling and included 23 plate-making, 102 printing and 27 printing-assistance companies in Taiwan. We analyzed company questionnaires (n = 152), SDSs (n = 180), and solvents (n = 20) collected from this sample of printing-related companies. Analytical results indicated that benzene and ethylbenzene, which were carcinogen and possibly carcinogen, were detectable in the cleaning solvents, and the detection rate were 54.5% (concentrations: <0.011-0.035 wt%) and 63.6% (concentrations: <0.011-6.22 wt%), respectively; however, neither compound was disclosed in the SDS for the solvents. Several other undisclosed components, including methanol, isopropanol and n-butanol, were also identified in the printing inks, fountain solutions and dilution solvents. We noted that, of the companies we surveyed, only 57.2% had a hazard communication program, 61.8% had SDSs on file and 59.9% provided employee safety and health training. We note that hazard communication programs were missing or ineffective in almost half of the 152 printing industries surveyed. Current safety information of solvents components in printing industries was inadequate, and many hazardous compounds were undisclosed in the SDSs of the solvents or the labels of the containers. The implementation of hazard communications in printing industries was still not enough for protecting the employees' safety and health. © The Author 2015. Published by Oxford University Press on behalf of the British Occupational Hygiene Society.

  14. Quality of Chemical Safety Information in Printing Industry

    PubMed Central

    Tsai, Chung-Jung; Mao, I-Fang; Ting, Jo-Yu; Young, Chi-Hsien; Lin, Jhih-Sian; Li, Wei-Lun

    2016-01-01

    Objectives: Employees in printing industries can be exposed to multiple solvents in their work environment. The objectives of this study were to investigate the critical components of chemical solvents by analyzing the components of the solvents and collecting the Safety data sheets (SDSs), and to evaluate the hazard communication implementation status in printing industries. Method: About 152 printing-related industries were recruited by area-stratified random sampling and included 23 plate-making, 102 printing and 27 printing-assistance companies in Taiwan. We analyzed company questionnaires (n = 152), SDSs (n = 180), and solvents (n = 20) collected from this sample of printing-related companies. Results: Analytical results indicated that benzene and ethylbenzene, which were carcinogen and possibly carcinogen, were detectable in the cleaning solvents, and the detection rate were 54.5% (concentrations: <0.011–0.035 wt%) and 63.6% (concentrations: <0.011–6.22 wt%), respectively; however, neither compound was disclosed in the SDS for the solvents. Several other undisclosed components, including methanol, isopropanol and n-butanol, were also identified in the printing inks, fountain solutions and dilution solvents. We noted that, of the companies we surveyed, only 57.2% had a hazard communication program, 61.8% had SDSs on file and 59.9% provided employee safety and health training. We note that hazard communication programs were missing or ineffective in almost half of the 152 printing industries surveyed. Conclusions: Current safety information of solvents components in printing industries was inadequate, and many hazardous compounds were undisclosed in the SDSs of the solvents or the labels of the containers. The implementation of hazard communications in printing industries was still not enough for protecting the employees’ safety and health. PMID:26568584

  15. Photodynamic immune modulation (PIM)

    NASA Astrophysics Data System (ADS)

    North, John R.; Hunt, David W. C.; Simkin, Guillermo O.; Ratkay, Leslie G.; Chan, Agnes H.; Lui, Harvey; Levy, Julia G.

    1999-09-01

    Photodynamic Therapy (PDT) is accepted for treatment of superficial and lumen-occluding tumors in regions accessible to activating light and is now known to be effective in closure of choroidal neovasculature in Age Related Macular Degeneration. PDT utilizes light absorbing drugs (photosensitizers) that generate the localized formation of reactive oxygen species after light exposure. In a number of systems, PDT has immunomodulatory effects; Photodynamic Immune Modulation (PIM). Using low- intensity photodynamic regimens applied over a large body surface area, progression of mouse autoimmune disease could be inhibited. Further, this treatment strongly inhibited the immunologically- medicated contact hypersensitivity response to topically applied chemical haptens. Immune modulation appears to result from selective targeting of activated T lymphocytes and reduction in immunostimulation by antigen presenting cells. Psoriasis, an immune-mediated skin condition, exhibits heightened epidermal cell proliferation, epidermal layer thickening and plaque formation at different body sites. In a recent clinical trial, approximately one-third of patients with psoriasis and arthritis symptoms (psoriatic arthritis) displayed a significant clinical improvement in several psoriasis-related parameters after four weekly whole-body PIM treatments with verteporfin. The safety profile was favorable. The capacity of PIM to influence other human immune disorders including rheumatoid arthritis is under extensive evaluation.

  16. 12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Standards for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

  17. 12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

  18. 12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

  19. Plain Talk about Childhood Immunizations.

    ERIC Educational Resources Information Center

    Alaska State Dept. of Health and Social Services, Juneau. Div. of Family and Youth Services.

    This booklet provides parents with information about immunizations and vaccine-preventable diseases, balances the benefits and risk of vaccination, and responds to inaccuracies or misinformation about immunizations and vaccine-preventable diseases. Section 1 presents a message to parents about vaccination. Section 2 offers facts about…

  20. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

    PubMed

    Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E

    2017-12-01

    This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Comparison of quality of internet pages on human papillomavirus immunization in Italian and in English.

    PubMed

    Tozzi, Alberto Eugenio; Buonuomo, Paola Sabrina; Ciofi degli Atti, Marta Luisa; Carloni, Emanuela; Meloni, Marco; Gamba, Fiorenza

    2010-01-01

    Information available on the Internet about immunizations may influence parents' perception about human papillomavirus (HPV) immunization and their attitude toward vaccinating their daughters. We hypothesized that the quality of information on HPV available on the Internet may vary with language and with the level of knowledge of parents. To this end we compared the quality of a sample of Web pages in Italian with a sample of Web pages in English. Five reviewers assessed the quality of Web pages retrieved with popular search engines using criteria adapted from the Good Information Practice Essential Criteria for Vaccine Safety Web Sites recommended by the World Health Organization. Quality of Web pages was assessed in the domains of accessibility, credibility, content, and design. Scores in these domains were compared through nonparametric statistical tests. We retrieved and reviewed 74 Web sites in Italian and 117 in English. Most retrieved Web pages (33.5%) were from private agencies. Median scores were higher in Web pages in English compared with those in Italian in the domain of accessibility (p < .01), credibility (p < .01), and content (p < .01). The highest credibility and content scores were those of Web pages from governmental agencies or universities. Accessibility scores were positively associated with content scores (p < .01) and with credibility scores (p < .01). A total of 16.2% of Web pages in Italian opposed HPV immunization compared with 6.0% of those in English (p < .05). Quality of information and number of Web pages opposing HPV immunization may vary with the Web site language. High-quality Web pages on HPV, especially from public health agencies and universities, should be easily accessible and retrievable with common Web search engines. Copyright 2010 Society for Adolescent Medicine. Published by Elsevier Inc. All rights reserved.

  2. 12 CFR 747.805 - Self-incrimination; immunity.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 7 2013-01-01 2013-01-01 false Self-incrimination; immunity. 747.805 Section... Applicable to Formal Investigative Proceedings § 747.805 Self-incrimination; immunity. (a) Self-incrimination...) Immunity. (1) No officer conducting any formal investigative proceeding (or any other informal...

  3. 12 CFR 747.805 - Self-incrimination; immunity.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 6 2011-01-01 2011-01-01 false Self-incrimination; immunity. 747.805 Section... Applicable to Formal Investigative Proceedings § 747.805 Self-incrimination; immunity. (a) Self-incrimination...) Immunity. (1) No officer conducting any formal investigative proceeding (or any other informal...

  4. 12 CFR 747.805 - Self-incrimination; immunity.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 7 2014-01-01 2014-01-01 false Self-incrimination; immunity. 747.805 Section... Applicable to Formal Investigative Proceedings § 747.805 Self-incrimination; immunity. (a) Self-incrimination...) Immunity. (1) No officer conducting any formal investigative proceeding (or any other informal...

  5. 12 CFR 747.805 - Self-incrimination; immunity.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 7 2012-01-01 2012-01-01 false Self-incrimination; immunity. 747.805 Section... Applicable to Formal Investigative Proceedings § 747.805 Self-incrimination; immunity. (a) Self-incrimination...) Immunity. (1) No officer conducting any formal investigative proceeding (or any other informal...

  6. 12 CFR 747.805 - Self-incrimination; immunity.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Self-incrimination; immunity. 747.805 Section... Applicable to Formal Investigative Proceedings § 747.805 Self-incrimination; immunity. (a) Self-incrimination...) Immunity. (1) No officer conducting any formal investigative proceeding (or any other informal...

  7. Knowledge management: Role of the the Radiation Safety Information Computational Center (RSICC)

    NASA Astrophysics Data System (ADS)

    Valentine, Timothy

    2017-09-01

    The Radiation Safety Information Computational Center (RSICC) at Oak Ridge National Laboratory (ORNL) is an information analysis center that collects, archives, evaluates, synthesizes and distributes information, data and codes that are used in various nuclear technology applications. RSICC retains more than 2,000 software packages that have been provided by code developers from various federal and international agencies. RSICC's customers (scientists, engineers, and students from around the world) obtain access to such computing codes (source and/or executable versions) and processed nuclear data files to promote on-going research, to ensure nuclear and radiological safety, and to advance nuclear technology. The role of such information analysis centers is critical for supporting and sustaining nuclear education and training programs both domestically and internationally, as the majority of RSICC's customers are students attending U.S. universities. Additionally, RSICC operates a secure CLOUD computing system to provide access to sensitive export-controlled modeling and simulation (M&S) tools that support both domestic and international activities. This presentation will provide a general review of RSICC's activities, services, and systems that support knowledge management and education and training in the nuclear field.

  8. An assessment of food safety information provision for UK chemotherapy patients to reduce the risk of foodborne infection.

    PubMed

    Evans, E W; Redmond, E C

    2017-12-01

    Given the increased risk of foodborne infection to cancer patients receiving chemotherapy treatment, and the risk of listeriosis reportedly five-times greater to this immunocompromised patient group, there is a need to ensure the implementation of domestic food safety practices among chemotherapy patients and their family caregivers. However, information regarding the adequacy of resources to inform and enable patients to implement domestic food safety practices to reduce the risk of foodborne infection is limited. Consequently, this study aimed to evaluate the provision of food safety information available to UK chemotherapy patients. In-depth semi-structured interviews and content analysis of online patient information resources. Interviews with patients and family caregivers (n = 15) were conducted to explore food-related experiences during chemotherapy treatment. Online food-related information resources for chemotherapy patients (n = 45) were obtained from 35 of 154 National Health Service chemotherapy providers in England, Scotland, and Wales, the Department of Health (DoH) and three of 184 identified UK cancer charities. Identified food-related information resources were reviewed using a content-analysis approach to assess the inclusion of food safety information for chemotherapy patients. In-depth interviews established that many patients indicated awareness of immunosuppression during treatment. Although patients reported practicing caution to reduce the risk of communicable diseases by avoiding crowded spaces/public transport, food safety was reported to be of minimal concern during treatment and the risk of foodborne infection was often underestimated. The review of online food-related patient information resources established that many resources failed to highlight the increased risk of foodborne infection and emphasize the importance of food safety for patients during chemotherapy treatment. Considerable information gaps exist, particularly in

  9. Insights from an international stakeholder consultation to identify informational needs related to seafood safety

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

    Tediosi, Alice, E-mail: alice.tediosi@aeiforia.eu; Fait, Gabriella; Jacobs, Silke

    Food safety assessment and communication have a strong importance in reducing human health risks related to food consumption. The research carried out within the ECsafeSEAFOOD project aims to assess seafood safety issues, mainly related to non-regulated priority environmental contaminants, and to evaluate their impact on public health. In order to make the research results accessible and exploitable, and to respond to actual stakeholders' demands, a consultation with international stakeholders was performed by means of a survey. The focus was on policy and decision makers, food producers and processors, and agencies (i.e. EU and National or Regional agencies related to Foodmore » Safety or Public Health) and consumer organisations. The survey considered questions related to: seafood safety assessment and mitigation strategies, availability of data, such as the level of information on different contaminants, and communication among different stakeholder groups. Furthermore, stakeholders were asked to give their opinion on how they believe consumers perceive risks associated with environmental contaminants. The survey was distributed to 531 key stakeholders and 91 responses were received from stakeholders from 30 EU and non-EU countries. The main results show that communication between different groups of stakeholders needs to be improved and that there is a deficit of information and data in the field of seafood safety. This pertains mainly to the transfer of contaminants between the environment and seafood, and to the diversity of environmental contaminants such as plastic additives, algal toxins and hormones. On-line tools were perceived to be the most useful communication channel. - Highlights: • We consulted stakeholders to identify their needs about seafood safety. • An on-line survey was prepared and sent to gather stakeholders' opinions. • Communication among stakeholders needs to be improved. • There is a deficit of information and data in the

  10. Survivorship Care Plan Information Needs: Perspectives of Safety-Net Breast Cancer Patients.

    PubMed

    Burke, Nancy J; Napoles, Tessa M; Banks, Priscilla J; Orenstein, Fern S; Luce, Judith A; Joseph, Galen

    2016-01-01

    Despite the Institute of Medicine's (IOM) 2005 recommendation, few care organizations have instituted standard survivorship care plans (SCPs). Low health literacy and low English proficiency are important factors to consider in SCP development. Our study aimed to identify information needs and survivorship care plan preferences of low literacy, multi-lingual patients to support the transition from oncology to primary care and ongoing learning in survivorship. We conducted focus groups in five languages with African American, Latina, Russian, Filipina, White, and Chinese medically underserved breast cancer patients. Topics explored included the transition to primary care, access to information, knowledge of treatment history, and perspectives on SCPs. Analysis of focus group data identified three themes: 1) the need for information and education on the transition between "active treatment" and "survivorship"; 2) information needed (and often not obtained) from providers; and 3) perspectives on SCP content and delivery. Our data point to the need to develop a process as well as written information for medically underserved breast cancer patients. An SCP document will not replace direct communication with providers about treatment, symptom management and transition, a communication that is missing in participating safety-net patients' experiences of cancer care. Women turned to peer support and community-based organizations in the absence of information from providers. "Clear and effective" communication of survivorship care for safety-net patients requires dedicated staff trained to address wide-ranging information needs and uncertainties.

  11. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP).

    PubMed

    2011-01-28

    This report is a revision of the General Recommendations on Immunization and updates the 2006 statement by the Advisory Committee on Immunization Practices (ACIP) (CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-15]). The report also includes revised content from previous ACIP recommendations on the following topics: adult vaccination (CDC. Update on adult immunization recommendations of the immunization practices Advisory Committee [ACIP]. MMWR 1991;40[No. RR-12]); the assessment and feedback strategy to increase vaccination rates (CDC. Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination rates-assessment and feedback of provider-based vaccination coverage information. MMWR 1996;45:219-20); linkage of vaccination services and those of the Supplemental Nutrition Program for Women, Infants, and Children (WIC program) (CDC. Recommendations of the Advisory Committee on Immunization Practices: programmatic strategies to increase vaccination coverage by age 2 years-linkage of vaccination and WIC services. MMWR 1996;45:217-8); adolescent immunization (CDC. Immunization of adolescents: recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR 1996;45[No. RR-13]); and combination vaccines (CDC. Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices [ACIP], the American Academy of Pediatrics [AAP], and the American Academy of Family Physicians [AAFP]. MMWR 1999;48[No. RR-5]). Notable revisions to the 2006 recommendations include 1) revisions to the tables of contraindications and precautions to vaccination, as well as a separate table of conditions that are commonly misperceived as contraindications and precautions; 2

  12. Safety assessment of adjuvanted vaccines: Methodological considerations

    PubMed Central

    Da Silva, Fernanda Tavares; Di Pasquale, Alberta; Yarzabal, Juan P; Garçon, Nathalie

    2015-01-01

    Adjuvants mainly interact with the innate immune response and are used to enhance the quantity and quality of the downstream adaptive immune response to vaccine antigens. Establishing the safety of a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in the laboratory, and that continues throughout the vaccine life-cycle. The strategy for the evaluation of safety pre-licensure is guided by the disease profile, vaccine indication, and target population, and it is also influenced by available regulatory guidelines. In order to allow meaningful interpretation of clinical data, clinical program methodology should be optimized and standardized, making best use of all available data sources. Post-licensure safety activities are directed by field experience accumulated pre- and post-licensure clinical trial data and spontaneous adverse event reports. Continued evolution of safety evaluation processes that keep pace with advances in vaccine technology and updated communication of the benefit-risk profile is necessary to maintain public confidence in vaccines. PMID:26029975

  13. AIDS: Acquired Immune Deficiency Syndrome, Information and Procedural Guidelines for Providing Services to Persons with AIDS/HTLV-III.

    ERIC Educational Resources Information Center

    Montana State Dept. of Health and Environmental Sciences, Helena.

    This manual presents information about the disease, Acquired Immune Deficiency Syndrome (AIDS), and guidelines for service delivery to Montana residents who have been diagnosed with AIDS or related disorders. The first section describes the disease's causes, symptoms, and transmission; risk factors; high-risk populations; prevention suggestions;…

  14. Development of a Culturally Informed Child Safety Curriculum for American Indian Families.

    PubMed

    Berns, Ryan M; Tomayko, Emily J; Cronin, Kate A; Prince, Ronald J; Parker, Tassy; Adams, Alexandra K

    2017-04-01

    American Indian (AI) children are disproportionately affected by unintentional injuries, with injury mortality rates approximately 2.3 times higher than the combined rates for all children in the United States. Although multiple risk factors are known to contribute to these increased rates, a comprehensive, culturally informed curriculum that emphasizes child safety is lacking for this population. In response to this need, academic and tribal researchers, tribal community members, tribal wellness staff, and national child safety experts collaborated to develop a novel child safety curriculum. This paper describes its development and community delivery. We developed the safety curriculum as part of a larger randomized controlled trial known as Healthy Children, Strong Families 2 (HCSF2), a family-based intervention targeting obesity prevention in early childhood (2-5 years). During the development of the HCSF2 intervention, participating tribal communities expressed concern about randomizing enrolled families to a control group who would not receive an intervention. To address this concern and the significant disparities in injuries and unintentional death rates among AI children, we added an active control group (Safety Journey) that would utilize our safety curriculum. Satisfaction surveys administered at the 12-month time point of the intervention indicate 94% of participants (N = 196) were either satisfied or very satisfied with the child safety curriculum. The majority of participants (69%) reported spending more than 15 min with the curriculum materials each month, and 83% thought the child safety newsletters were either helpful or very helpful in making changes to improve their family's safety. These findings indicate these child safety materials have been well received by HCSF2 participants. The use of community-engaged approaches to develop this curriculum represents a model that could be adapted for other at-risk populations and serves as an initial

  15. Small business owners' opinions about written health and safety information.

    PubMed

    Brosseau, Lisa M; Fredrickson, Ann L; Casey, Mary Anne

    2007-04-01

    Owners of small manufacturing businesses from twelve industrial sectors (n=40) participated in focus groups. They most frequently read trade and local business publications; few regularly read or receive health and safety materials. They select business-related materials that are specific to their business, give them new ideas, or have information that is easy to use. Insurance companies and business associations are the most frequently mentioned sources of health and safety information. The most important aspects of a prototype newsletter are sponsorship, color and graphics, length and relevance. Most are positive about a university logo, because it indicates a trusted source. The front page should have a table of contents with short descriptions of articles and catchy headlines. A newsletter should take no more than ten minutes to read. Owners did not like articles that were written in first person, used quotes, were too personal or gave no solutions. Owners think a newsletter will be successful if it is targeted to their industry, shows costs, includes case studies about local businesses, isn't too academic, focuses on a different topic with each issue, and gives readers an opportunity to provide feedback.

  16. 45 CFR 60.22 - Immunity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Immunity. 60.22 Section 60.22 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION NATIONAL PRACTITIONER DATA BANK Disclosure of Information by the National Practitioner Data Bank § 60.22 Immunity. Individuals, entities or their authorized...

  17. 45 CFR 60.22 - Immunity.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Immunity. 60.22 Section 60.22 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION NATIONAL PRACTITIONER DATA BANK Disclosure of Information by the National Practitioner Data Bank § 60.22 Immunity. Individuals, entities or their authorized...

  18. 45 CFR 61.16 - Immunity.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Immunity. 61.16 Section 61.16 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION HEALTHCARE INTEGRITY AND PROTECTION DATA BANK... Information by the Healthcare Integrity and Protection Data Bank § 61.16 Immunity. Individuals, entities or...

  19. 45 CFR 61.16 - Immunity.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Immunity. 61.16 Section 61.16 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION HEALTHCARE INTEGRITY AND PROTECTION DATA BANK... Information by the Healthcare Integrity and Protection Data Bank § 61.16 Immunity. Individuals, entities or...

  20. 45 CFR 61.16 - Immunity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Immunity. 61.16 Section 61.16 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION HEALTHCARE INTEGRITY AND PROTECTION DATA BANK... Information by the Healthcare Integrity and Protection Data Bank § 61.16 Immunity. Individuals, entities or...

  1. Assessment of source of information for polio supplementary immunization activities in 2014 and 2015, Somali, Ethiopia

    PubMed Central

    Bedada, Selamawit Yilma; Gallagher, Kathleen; Aregay, Aron Kassahun; Mohammed, Bashir; Maalin, Mohammed Adem; Hassen, Hassen Abdisemed; Ali, Yusuf Mohammed; Braka, Fiona; Kilebou, Pierre M’pele

    2017-01-01

    Introduction Communication is key for the successful implementation of polio vaccination campaigns. The purpose of this study is to review and analyse the sources of information utilized by caregivers during polio supplementary immunization activities (SIAs) in Somali, Ethiopia in 2014 and 2015. Methods Data on sources of information about the polio campaign were collected post campaign from caregivers by trained data collectors as part of house to house independent monitoring. The sources of information analysed in this paper include town criers (via megaphones), health workers, religious leaders, kebele leaders (Kebele is the lowest administrative structure in Ethiopia), radio, television, text message and others. The repetition of these sources of information was analysed across years and zones for trends. Polio vaccination campaign coverage was also reviewed by year and zones within the Somali region in parallel with the major sources of information used in the respective year and zones. 57,745 responses were used for this analysis but the responses were received from < or = 57,745 individuals since some of them may provide more than one response. Moreover, because sampling of households is conducted independently during each round of independent monitoring, the same household may have been included more than once in our analysis. The methodology used for independent monitoring does not allow for the calculation of response rates. Monitors go from house to house until information from 20 households is received. Results From the total 57,745 responses reviewed, over 37% of respondents reported that town criers were their source for information about the 2014 and 2015 polio SIAs. Zonal trends in using town criers as a major source of information in both study years remained consistent except in two zones. 87.5% of zones that reported at least 90% coverage during both study years had utilized town criers as a major source of information while the rest (12.5%) used

  2. Assessment of source of information for polio supplementary immunization activities in 2014 and 2015, Somali, Ethiopia.

    PubMed

    Bedada, Selamawit Yilma; Gallagher, Kathleen; Aregay, Aron Kassahun; Mohammed, Bashir; Maalin, Mohammed Adem; Hassen, Hassen Abdisemed; Ali, Yusuf Mohammed; Braka, Fiona; Kilebou, Pierre M'pele

    2017-01-01

    Communication is key for the successful implementation of polio vaccination campaigns. The purpose of this study is to review and analyse the sources of information utilized by caregivers during polio supplementary immunization activities (SIAs) in Somali, Ethiopia in 2014 and 2015. Data on sources of information about the polio campaign were collected post campaign from caregivers by trained data collectors as part of house to house independent monitoring. The sources of information analysed in this paper include town criers (via megaphones), health workers, religious leaders, kebele leaders (Kebele is the lowest administrative structure in Ethiopia), radio, television, text message and others. The repetition of these sources of information was analysed across years and zones for trends. Polio vaccination campaign coverage was also reviewed by year and zones within the Somali region in parallel with the major sources of information used in the respective year and zones. 57,745 responses were used for this analysis but the responses were received from < or = 57,745 individuals since some of them may provide more than one response. Moreover, because sampling of households is conducted independently during each round of independent monitoring, the same household may have been included more than once in our analysis. The methodology used for independent monitoring does not allow for the calculation of response rates. Monitors go from house to house until information from 20 households is received. From the total 57,745 responses reviewed, over 37% of respondents reported that town criers were their source for information about the 2014 and 2015 polio SIAs. Zonal trends in using town criers as a major source of information in both study years remained consistent except in two zones. 87.5% of zones that reported at least 90% coverage during both study years had utilized town criers as a major source of information while the rest (12.5%) used health workers. We found

  3. Investigating different approaches to develop informative priors in hierarchical Bayesian safety performance functions.

    PubMed

    Yu, Rongjie; Abdel-Aty, Mohamed

    2013-07-01

    The Bayesian inference method has been frequently adopted to develop safety performance functions. One advantage of the Bayesian inference is that prior information for the independent variables can be included in the inference procedures. However, there are few studies that discussed how to formulate informative priors for the independent variables and evaluated the effects of incorporating informative priors in developing safety performance functions. This paper addresses this deficiency by introducing four approaches of developing informative priors for the independent variables based on historical data and expert experience. Merits of these informative priors have been tested along with two types of Bayesian hierarchical models (Poisson-gamma and Poisson-lognormal models). Deviance information criterion (DIC), R-square values, and coefficients of variance for the estimations were utilized as evaluation measures to select the best model(s). Comparison across the models indicated that the Poisson-gamma model is superior with a better model fit and it is much more robust with the informative priors. Moreover, the two-stage Bayesian updating informative priors provided the best goodness-of-fit and coefficient estimation accuracies. Furthermore, informative priors for the inverse dispersion parameter have also been introduced and tested. Different types of informative priors' effects on the model estimations and goodness-of-fit have been compared and concluded. Finally, based on the results, recommendations for future research topics and study applications have been made. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. Trends in public information within the Fairfax Alcohol Safety Action Project, 1975.

    DOT National Transportation Integrated Search

    1976-01-01

    To assess current trends in the effectiveness of the public information and education countermeasure of the Fairfax Alcohol Safety Action Project, two pieces of survey type research are conducted on a periodic basis. The roadside survey has been cond...

  5. Nursing Information Systems Requirements: A Milestone for Patient Outcome and Patient Safety Improvement.

    PubMed

    Farzandipour, Mehrdad; Meidani, Zahra; Riazi, Hossein; Sadeqi Jabali, Monireh

    2016-12-01

    Considering the integral role of understanding users' requirements in information system success, this research aimed to determine functional requirements of nursing information systems through a national survey. Delphi technique method was applied to conduct this study through three phases: focus group method modified Delphi technique and classic Delphi technique. A cross-sectional study was conducted to evaluate the proposed requirements within 15 general hospitals in Iran. Forty-three of 76 approved requirements were clinical, and 33 were administrative ones. Nurses' mean agreements for clinical requirements were higher than those of administrative requirements; minimum and maximum means of clinical requirements were 3.3 and 3.88, respectively. Minimum and maximum means of administrative requirements were 3.1 and 3.47, respectively. Research findings indicated that those information system requirements that support nurses in doing tasks including direct care, medicine prescription, patient treatment management, and patient safety have been the target of special attention. As nurses' requirements deal directly with patient outcome and patient safety, nursing information systems requirements should not only address automation but also nurses' tasks and work processes based on work analysis.

  6. Kansas Department of Health and Environment - Immunization Program

    Science.gov Websites

    Immunize and Win a Prize Click on Immunize Win a Prize logo for more information Yellow Fever Click on the logo above for more information on Yellow Fever PERINATAL HEPATITIS B PREVENTION PROGRAM Click on logo

  7. 75 FR 80538 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ...The Department of Labor (DOL) hereby announces the submission of the Mine Safety and Health Administration (MSHA)sponsored information collection request (ICR) titled, ``Safety Defects; Examination, Correction, and Records,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

  8. Coast Guard : update on Marine Information for Safety and Law Enforcement System

    DOT National Transportation Integrated Search

    2001-10-01

    The Coast Guard is developing a web-based information system to replace an aging computer system that it uses to track safety and law-enforcement actions involving commercial and recreational vessels. In 1995 the Coast Guard awarded a contract to dev...

  9. Informing a pedestrian safety improvement program.

    DOT National Transportation Integrated Search

    2009-01-01

    Caltrans is scoping the development of a Pedestrian Safety Improvement Program (PSIP). In its mission, organization or implementation, such a program might be analogous to the agencys existing Highway Safety Improvement Program (HSIP). The HSIP (s...

  10. Incident reporting: Its role in aviation safety and the acquisition of human error data

    NASA Technical Reports Server (NTRS)

    Reynard, W. D.

    1983-01-01

    The rationale for aviation incident reporting systems is presented and contrasted to some of the shortcomings of accident investigation procedures. The history of the United State's Aviation Safety Reporting System (ASRS) is outlined and the program's character explained. The planning elements that resulted in the ASRS program's voluntary, confidential, and non-punitive design are discussed. Immunity, from enforcement action and misuse of the volunteered data, is explained and evaluated. Report generation techniques and the ASRS data analysis process are described; in addition, examples of the ASRS program's output and accomplishments are detailed. Finally, the value of incident reporting for the acquisition of safety information, particularly human error data, is explored.

  11. Immunogenicity and safety of two doses of catch-up immunization with Haemophilus influenzae type b conjugate vaccine in Indian children living with HIV.

    PubMed

    Arya, Bikas K; Bhattacharya, Sangeeta Das; Sutcliffe, Catherine G; Saha, Malay K; Bhattacharyya, Subhasish; Niyogi, Swapan Kumar; Moss, William J; Panda, Samiran; Das, Ranjan Saurav; Mallick, Mausom; Mandal, Sutapa

    2016-04-27

    Children living with HIV are at increased risk of disease from Haemophilus influenzae type b (Hib). Data are limited on the immunogenicity of a two-dose, catch-up schedule for Hib conjugate vaccine (HibCV) among HIV-infected children accessing antiretroviral therapy (ART) late. The objectives of the study were to: (1) evaluate baseline immunity to Hib and the immunogenicity and safety of two doses of HibCV among HIV-infected Indian children; and (2) document the threshold antibody level required to prevent Hib colonization among HIV-infected children following immunization. We conducted a prospective cohort study among HIV-infected children 2-15 years of age and HIV-uninfected children 2-5 years of age. HIV-infected children received two doses of HibCV and uninfected children received one. Serum anti-Hib PRP IgG antibodies were measured at baseline and two months after immunization in the HIV-infected children. Nasopharyngeal (NP) swabs were collected at baseline and follow-up. 125 HIV-infected and 44 uninfected children participated. 40% of HIV-infected children were receiving ART and 26% had a viral load >100,000 copies/mL. The geometric mean concentration of serum anti-Hib PRP antibody increased from 0.25 μg/mL at baseline to 2.65 μg/mL after two doses of HibCV, representing a 10.6-fold increase (p<0.0001). 76% percent of HIV-infected children mounted an immune response. Moderate or severe immune suppression, trimethoprim/sulfamethoxazole prophylaxis, and lower baseline antibody levels were associated with lower post-vaccine serum anti-Hib PRP IgG antibodies. A serum anti-Hib PRP IgG antibody level ≥ 3.3 μg/mL was protective against Hib NP colonization. There were no differences in adverse events between HIV-infected and uninfected children. Including a catch-up immunization schedule for older HIV infected children in countries introducing Hib vaccines is important. Older HIV-infected children with delayed access to ART and without suppressed viral loads

  12. Rural hospital information technology implementation for safety and quality improvement: lessons learned.

    PubMed

    Tietze, Mari F; Williams, Josie; Galimbertti, Marisa

    2009-01-01

    This grant involved a hospital collaborative for excellence using information technology over 3-year period. The project activities focused on the improvement of patient care safety and quality in Southern rural and small community hospitals through the use of technology and education. The technology component of the design involved the implementation of a Web-based business analytic tool that allows hospitals to view data, create reports, and analyze their safety and quality data. Through a preimplementation and postimplementation comparative design, the focus of the implementation team was twofold: to recruit participant hospitals and to implement the technology at each of the 66 hospital sites. Rural hospitals were defined as acute care hospitals located in a county with a population of less than 100 000 or a state-administered Critical Access Hospital, making the total study population target 188 hospitals. Lessons learned during the information technology implementation of these hospitals are reflective of the unique culture, financial characteristics, organizational structure, and technology architecture of rural hospitals. Specific steps such as recruitment, information technology assessment, conference calls for project planning, data file extraction and transfer, technology training, use of e-mail, use of telephones, personnel management, and engaging information technology vendors were found to vary greatly among hospitals.

  13. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2018.

    PubMed

    Kim, David K; Riley, Laura E; Hunter, Paul

    2018-02-09

    In October 2017, the Advisory Committee on Immunization Practices (ACIP) voted to approve the Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018. The 2018 adult immunization schedule summarizes ACIP recommendations in two figures and a table of contraindications and precautions for vaccines recommended for adults, and is intended is to assist health care providers in implementing the current ACIP recommendations for vaccinating adults. The schedule can be found at https://www.cdc.gov/vaccines/schedules.* The full ACIP recommendations for each vaccine are available at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. The 2018 adult immunization schedule has also been approved by the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), and the American College of Nurse-Midwives (http://www.midwife.org). The ACIP-recommended use of each vaccine is developed after an in-depth review of vaccine-related data, including data on disease epidemiology, vaccine efficacy and effectiveness, vaccine safety, feasibility of program implementation, and economic aspects of immunization policy (1).

  14. AIDS: Acquired Immune Deficiency Syndrome; Information and Procedural Guidelines for Providing Services to Persons with AIDS/HIV. Revised.

    ERIC Educational Resources Information Center

    Montana State Dept. of Health and Environmental Sciences, Helena. Health Education Bureau.

    This volume consists of updated information to be inserted into a Montana AIDS Project manual on providing services to persons with acquired immune deficiency syndrome/human immunodeficiency virus (AIDS/HIV), originally published in December 1985. The updates are mainly statistics and terminology, along with the addition of several new sections.…

  15. Nucleic Acid Immunity.

    PubMed

    Hartmann, G

    2017-01-01

    Organisms throughout biology need to maintain the integrity of their genome. From bacteria to vertebrates, life has established sophisticated mechanisms to detect and eliminate foreign genetic material or to restrict its function and replication. Tremendous progress has been made in the understanding of these mechanisms which keep foreign or unwanted nucleic acids from viruses or phages in check. Mechanisms reach from restriction-modification systems and CRISPR/Cas in bacteria and archaea to RNA interference and immune sensing of nucleic acids, altogether integral parts of a system which is now appreciated as nucleic acid immunity. With inherited receptors and acquired sequence information, nucleic acid immunity comprises innate and adaptive components. Effector functions include diverse nuclease systems, intrinsic activities to directly restrict the function of foreign nucleic acids (e.g., PKR, ADAR1, IFIT1), and extrinsic pathways to alert the immune system and to elicit cytotoxic immune responses. These effects act in concert to restrict viral replication and to eliminate virus-infected cells. The principles of nucleic acid immunity are highly relevant for human disease. Besides its essential contribution to antiviral defense and restriction of endogenous retroelements, dysregulation of nucleic acid immunity can also lead to erroneous detection and response to self nucleic acids then causing sterile inflammation and autoimmunity. Even mechanisms of nucleic acid immunity which are not established in vertebrates are relevant for human disease when they are present in pathogens such as bacteria, parasites, or helminths or in pathogen-transmitting organisms such as insects. This review aims to provide an overview of the diverse mechanisms of nucleic acid immunity which mostly have been looked at separately in the past and to integrate them under the framework nucleic acid immunity as a basic principle of life, the understanding of which has great potential to

  16. Immunization registries in the EMR Era

    PubMed Central

    Stevens, Lindsay A.; Palma, Jonathan P.; Pandher, Kiran K.; Longhurst, Christopher A.

    2013-01-01

    Background: The CDC established a national objective to create population-based tracking of immunizations through regional and statewide registries nearly 2 decades ago, and these registries have increased coverage rates and reduced duplicate immunizations. With increased adoption of commercial electronic medical records (EMR), some institutions have used unidirectional links to send immunization data to designated registries. However, access to these registries within a vendor EMR has not been previously reported. Purpose: To develop a visually integrated interface between an EMR and a statewide immunization registry at a previously non-reporting hospital, and to assess subsequent changes in provider use and satisfaction. Methods: A group of healthcare providers were surveyed before and after implementation of the new interface. The surveys addressed access of the California Immunization Registry (CAIR), and satisfaction with the availability of immunization information. Information Technology (IT) teams developed a “smart-link” within the electronic patient chart that provides a single-click interface for visual integration of data within the CAIR database. Results: Use of the tool has increased in the months since its initiation, and over 20,000 new immunizations have been exported successfully to CAIR since the hospital began sharing data with the registry. Survey data suggest that providers find this tool improves workflow and overall satisfaction with availability of immunization data. (p=0.009). Conclusions: Visual integration of external registries into a vendor EMR system is feasible and improves provider satisfaction and registry reporting. PMID:23923096

  17. A plant effector-triggered immunity signaling sector is inhibited by pattern-triggered immunity.

    PubMed

    Hatsugai, Noriyuki; Igarashi, Daisuke; Mase, Keisuke; Lu, You; Tsuda, Yayoi; Chakravarthy, Suma; Wei, Hai-Lei; Foley, Joseph W; Collmer, Alan; Glazebrook, Jane; Katagiri, Fumiaki

    2017-09-15

    Since signaling machineries for two modes of plant-induced immunity, pattern-triggered immunity (PTI) and effector-triggered immunity (ETI), extensively overlap, PTI and ETI signaling likely interact. In an Arabidopsis quadruple mutant, in which four major sectors of the signaling network, jasmonate, ethylene, PAD4, and salicylate, are disabled, the hypersensitive response (HR) typical of ETI is abolished when the Pseudomonas syringae effector AvrRpt2 is bacterially delivered but is intact when AvrRpt2 is directly expressed in planta These observations led us to discovery of a network-buffered signaling mechanism that mediates HR signaling and is strongly inhibited by PTI signaling. We named this mechanism the ETI-Mediating and PTI-Inhibited Sector (EMPIS). The signaling kinetics of EMPIS explain apparently different plant genetic requirements for ETI triggered by different effectors without postulating different signaling machineries. The properties of EMPIS suggest that information about efficacy of the early immune response is fed back to the immune signaling network, modulating its activity and limiting the fitness cost of unnecessary immune responses. © 2017 The Authors.

  18. A clinically parameterized mathematical model of Shigella immunity to inform vaccine design

    PubMed Central

    Wahid, Rezwanul; Toapanta, Franklin R.; Simon, Jakub K.; Sztein, Marcelo B.

    2018-01-01

    We refine and clinically parameterize a mathematical model of the humoral immune response against Shigella, a diarrheal bacteria that infects 80-165 million people and kills an estimated 600,000 people worldwide each year. Using Latin hypercube sampling and Monte Carlo simulations for parameter estimation, we fit our model to human immune data from two Shigella EcSf2a-2 vaccine trials and a rechallenge study in which antibody and B-cell responses against Shigella′s lipopolysaccharide (LPS) and O-membrane proteins (OMP) were recorded. The clinically grounded model is used to mathematically investigate which key immune mechanisms and bacterial targets confer immunity against Shigella and to predict which humoral immune components should be elicited to create a protective vaccine against Shigella. The model offers insight into why the EcSf2a-2 vaccine had low efficacy and demonstrates that at a group level a humoral immune response induced by EcSf2a-2 vaccine or wild-type challenge against Shigella′s LPS or OMP does not appear sufficient for protection. That is, the model predicts an uncontrolled infection of gut epithelial cells that is present across all best-fit model parameterizations when fit to EcSf2a-2 vaccine or wild-type challenge data. Using sensitivity analysis, we explore which model parameter values must be altered to prevent the destructive epithelial invasion by Shigella bacteria and identify four key parameter groups as potential vaccine targets or immune correlates: 1) the rate that Shigella migrates into the lamina propria or epithelium, 2) the rate that memory B cells (BM) differentiate into antibody-secreting cells (ASC), 3) the rate at which antibodies are produced by activated ASC, and 4) the Shigella-specific BM carrying capacity. This paper underscores the need for a multifaceted approach in ongoing efforts to design an effective Shigella vaccine. PMID:29304144

  19. A clinically parameterized mathematical model of Shigella immunity to inform vaccine design.

    PubMed

    Davis, Courtney L; Wahid, Rezwanul; Toapanta, Franklin R; Simon, Jakub K; Sztein, Marcelo B

    2018-01-01

    We refine and clinically parameterize a mathematical model of the humoral immune response against Shigella, a diarrheal bacteria that infects 80-165 million people and kills an estimated 600,000 people worldwide each year. Using Latin hypercube sampling and Monte Carlo simulations for parameter estimation, we fit our model to human immune data from two Shigella EcSf2a-2 vaccine trials and a rechallenge study in which antibody and B-cell responses against Shigella's lipopolysaccharide (LPS) and O-membrane proteins (OMP) were recorded. The clinically grounded model is used to mathematically investigate which key immune mechanisms and bacterial targets confer immunity against Shigella and to predict which humoral immune components should be elicited to create a protective vaccine against Shigella. The model offers insight into why the EcSf2a-2 vaccine had low efficacy and demonstrates that at a group level a humoral immune response induced by EcSf2a-2 vaccine or wild-type challenge against Shigella's LPS or OMP does not appear sufficient for protection. That is, the model predicts an uncontrolled infection of gut epithelial cells that is present across all best-fit model parameterizations when fit to EcSf2a-2 vaccine or wild-type challenge data. Using sensitivity analysis, we explore which model parameter values must be altered to prevent the destructive epithelial invasion by Shigella bacteria and identify four key parameter groups as potential vaccine targets or immune correlates: 1) the rate that Shigella migrates into the lamina propria or epithelium, 2) the rate that memory B cells (BM) differentiate into antibody-secreting cells (ASC), 3) the rate at which antibodies are produced by activated ASC, and 4) the Shigella-specific BM carrying capacity. This paper underscores the need for a multifaceted approach in ongoing efforts to design an effective Shigella vaccine.

  20. HIV-associated chronic immune activation

    PubMed Central

    Paiardini, Mirko; Müller-Trutwin, Michaela

    2013-01-01

    Summary Systemic chronic immune activation is considered today as the driving force of CD4+ T-cell depletion and acquired immunodeficiency syndrome (AIDS). A residual chronic immune activation persists even in HIV-infected patients in which viral replication is successfully inhibited by antiretroviral therapy, with the extent of this residual immune activation being associated with CD4+ T-cell loss. Unfortunately, the causal link between chronic immune activation and CD4+ T-cell loss has not been formally established. This article provides first a brief historical overview on how the perception of the causative role of immune activation has changed over the years and lists the different kinds of immune activation that have been observed to be characteristic for human immunodeficiency virus (HIV) infection. The mechanisms proposed to explain the chronic immune activation are multiple and are enumerated here, as well as the mechanisms proposed on how chronic immune activation could lead to AIDS. In addition, we summarize the lessons learned from natural hosts that know how to ‘show AIDS the door’, and discuss how these studies informed the design of novel immune modulatory interventions that are currently being tested. Finally, we review the current approaches aimed at targeting chronic immune activation and evoke future perspectives. PMID:23772616

  1. 77 FR 61513 - Information Disclosure Under Section 6(b) of the Consumer Product Safety Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1101 Information Disclosure Under Section 6(b) of the Consumer Product Safety Act CFR Correction 0 In Title 16 of the Code of Federal Regulations, Part 1000 to End, revised as of January 1, 2012, on page 147, in Sec. 1101.25 (a) and (b), the words ``5...

  2. Immunization delivery in British Columbia

    PubMed Central

    Omura, John; Buxton, Jane; Kaczorowski, Janusz; Catterson, Jason; Li, Jane; Derban, Andrea; Hasselback, Paul; Machin, Shelagh; Linekin, Michelle; Morgana, Tamsin; O’Briain, Barra; Scheifele, David; Dawar, Meena

    2014-01-01

    Abstract Objective To explore the experiences of family physicians and pediatricians delivering immunizations, including perceived barriers and supports. Design Qualitative study using focus groups. Setting Ten cities throughout British Columbia. Participants A total of 46 family physicians or general practitioners, 10 pediatricians, and 2 residents. Methods A semistructured dialogue guide was used by a trained facilitator to explore participants’ experiences and views related to immunization delivery in British Columbia. Verbatim transcriptions were independently coded by 2 researchers. Key themes were analyzed and identified in an iterative manner using interpretive description. Main findings Physicians highly valued vaccine delivery. Factors facilitating physician-delivered immunizations included strong beliefs in the value of vaccines and having adequate information. Identified barriers included the large time commitment and insufficient communication about program changes, new vaccines, and the adult immunization program in general. Some physicians reported good relationships with local public health, while others reported the opposite experience, and this varied by geographic location. Conclusion These findings suggest that physicians are supportive of delivering vaccines. However, there are opportunities to improve the sustainability of physician-delivered immunizations. While compensation schemes remain under the purview of the provincial governments, local public health authorities can address the information needs of physicians. PMID:24627403

  3. Ensuring Adequate Health and Safety Information for Decision Makers during Large-Scale Chemical Releases

    NASA Astrophysics Data System (ADS)

    Petropoulos, Z.; Clavin, C.; Zuckerman, B.

    2015-12-01

    The 2014 4-Methylcyclohexanemethanol (MCHM) spill in the Elk River of West Virginia highlighted existing gaps in emergency planning for, and response to, large-scale chemical releases in the United States. The Emergency Planning and Community Right-to-Know Act requires that facilities with hazardous substances provide Material Safety Data Sheets (MSDSs), which contain health and safety information on the hazardous substances. The MSDS produced by Eastman Chemical Company, the manufacturer of MCHM, listed "no data available" for various human toxicity subcategories, such as reproductive toxicity and carcinogenicity. As a result of incomplete toxicity data, the public and media received conflicting messages on the safety of the contaminated water from government officials, industry, and the public health community. Two days after the governor lifted the ban on water use, the health department partially retracted the ban by warning pregnant women to continue avoiding the contaminated water, which the Centers for Disease Control and Prevention deemed safe three weeks later. The response in West Virginia represents a failure in risk communication and calls to question if government officials have sufficient information to support evidence-based decisions during future incidents. Research capabilities, like the National Science Foundation RAPID funding, can provide a solution to some of the data gaps, such as information on environmental fate in the case of the MCHM spill. In order to inform policy discussions on this issue, a methodology for assessing the outcomes of RAPID and similar National Institutes of Health grants in the context of emergency response is employed to examine the efficacy of research-based capabilities in enhancing public health decision making capacity. The results of this assessment highlight potential roles rapid scientific research can fill in ensuring adequate health and safety data is readily available for decision makers during large

  4. 78 countries: immunization financing in developing and transitional countries.

    PubMed

    Deroeck, D; Levin, A

    1999-01-01

    The Special Initiative on Immunization Financing is a project that reviews available information on immunization costs and financing in developing countries in order to inform planned field-based activities to increase sustainability of immunization programs. While routine immunization costs just pennies a dose, newer vaccines such as hepatitis B vaccine cost much more; the full cost of making them routine are not yet known. However, a growing number of governments are paying for these vaccines. Three-quarters of the countries responding to the survey have immunization and vaccination programs in their national budgets. Moreover, international organizations have set up fund and procurement mechanisms to aid countries purchase low-cost, high-quality vaccines.

  5. Extracting Information from Narratives: An Application to Aviation Safety Reports

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

    Posse, Christian; Matzke, Brett D.; Anderson, Catherine M.

    2005-05-12

    Aviation safety reports are the best available source of information about why a flight incident happened. However, stream of consciousness permeates the narratives making difficult the automation of the information extraction task. We propose an approach and infrastructure based on a common pattern specification language to capture relevant information via normalized template expression matching in context. Template expression matching handles variants of multi-word expressions. Normalization improves the likelihood of correct hits by standardizing and cleaning the vocabulary used in narratives. Checking for the presence of negative modifiers in the proximity of a potential hit reduces the chance of false hits.more » We present the above approach in the context of a specific application, which is the extraction of human performance factors from NASA ASRS reports. While knowledge infusion from experts plays a critical role during the learning phase, early results show that in a production mode, the automated process provides information that is consistent with analyses by human subjects.« less

  6. Dengue vaccine safety signal: Immune enhancement, waning immunity, or chance occurrence?

    PubMed

    Gessner, Bradford D; Halsey, Neal

    2017-06-14

    A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2-5years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs. control children age 2-5years at the end of year 5 and lower for vaccinated vs. control children among older age groups; (d) the protective effect of vaccine against hospitalization decreased from years 1-2 to years 3-5 of follow-up for all age groups and regions. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  7. Perceptions of childhood immunization in a minority community: qualitative study.

    PubMed

    Henderson, Lesley; Millett, Christopher; Thorogood, Nicki

    2008-05-01

    To assess reasons for low uptake of immunization amongst orthodox Jewish families. Qualitative interviews with 25 orthodox Jewish mothers and 10 local health care workers. The orthodox Jewish community in North East London. Identification of views on immunization in the orthodox Jewish community. In a community assumed to be relatively insulated from direct media influence, word of mouth is nevertheless a potent source of rumours about vaccination dangers. The origins of these may lie in media scares that contribute to anxieties about MMR. At the same time, close community cohesion leads to a sense of relative safety in relation to tuberculosis, with consequent low rates of BCG uptake. Thus low uptake of different immunizations arises from enhanced feelings of both safety and danger. Low uptake was not found to be due to the practical difficulties associated with large families, or to perceived insensitive cultural practices of health care providers. The views and practices of members of this community are not homogeneous and may change over time. It is important that assumptions concerning the role of religious beliefs do not act as an obstacle for providing clear messages concerning immunization, and community norms may be challenged by explicitly using its social networks to communicate more positive messages about immunization. The study provides a useful example of how social networks may reinforce or challenge misinformation about health and risk and the complex nature of decision making about children's health.

  8. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies.

    PubMed

    Garcia-Sicilia, José; Arístegui, Javier; Omeñaca, Félix; Carmona, Alfonso; Tejedor, Juan C; Merino, José M; García-Corbeira, Pilar; Walravens, Karl; Bambure, Vinod; Moris, Philippe; Caplanusi, Adrian; Gillard, Paul; Dieussaert, Ilse

    2015-01-01

    In children, 2 AS03-adjuvanted A(H1N1)pdm09 vaccine doses given 21 days apart were previously shown to induce a high humoral immune response and to have an acceptable safety profile up to 42 days following the first vaccination. Here, we analyzed the persistence data from 2 open-label studies, which assessed the safety, and humoral and cell-mediated immune responses induced by 2 doses of this vaccine. The first study was a phase II, randomized trial conducted in 104 children aged 6-35 months vaccinated with the A(H1N1)pdm09 vaccine containing 1.9 µg haemagglutinin antigen (HA) and AS03B (5.93 mg tocopherol) and the second study, a phase III, non-randomized trial conducted in 210 children and adolescents aged 3-17 years vaccinated with the A(H1N1)pdm09 vaccine containing 3.75 µg HA and AS03A (11.86 mg tocopherol). Approximately one year after the first dose, all children with available data were seropositive for haemagglutinin inhibition and neutralising antibody titres, but a decline in geometric mean antibody titres was noted. The vaccine induced a cell-mediated immune response in terms of antigen-specific CD4(+) T-cells, which persisted up to one year post-vaccination. The vaccine did not raise any safety concern, though these trials were not designed to detect rare events. In conclusion, 2 doses of the AS03-adjuvanted A(H1N1)pdm09 vaccine at 2 different dosages had a clinically acceptable safety profile, and induced high and persistent humoral and cell-mediated immune responses in children aged 6-35 months and 3-17 years. These studies have been registered at www.clinicaltrials.gov NCT00971321 and NCT00964158.

  9. Immune challenges and visual signalling in tree frogs

    NASA Astrophysics Data System (ADS)

    Desprat, Julia L.; Lengagne, Thierry; Mondy, Nathalie

    2017-04-01

    In animals, mate-choice is often based on sexual signals that carry information and help the receiver make the best choice to improve the receiver's fitness. Orange visual sexual signals have been hypothesised to carry immune information because they are often due to carotenoid pigments which are also involved in immunity response. Although many studies have focused on the direct relationships between coloration and immunocompetence, few studies have simultaneously studied immunocompetent response and coloration variation after an immune challenge. We tested this hypothesis on starved and ad libitum-fed males of the European tree frog Hyla arborea. Our results show that male coloration is not a reliable indicator of its immune response capacity in this species. However, after an immune challenge induced by a PHA ( Phaseolus vulgaris phytohaemagglutinin) injection, starved males presented a significant coloration loss and this alteration was related to the immune response intensity. Taken together, these results suggest that the brighter (lighter) coloration may be used as a cue by female to exclude males with a recent immune challenge, due to diseases or parasites for example.

  10. Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

    PubMed

    Haslberger, Alexander G

    2006-05-03

    Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

  11. Data Analysis Approaches for the Risk-Informed Safety Margins Characterization Toolkit

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

    Mandelli, Diego; Alfonsi, Andrea; Maljovec, Daniel P.

    2016-09-01

    In the past decades, several numerical simulation codes have been employed to simulate accident dynamics (e.g., RELAP5-3D, RELAP-7, MELCOR, MAAP). In order to evaluate the impact of uncertainties into accident dynamics, several stochastic methodologies have been coupled with these codes. These stochastic methods range from classical Monte-Carlo and Latin Hypercube sampling to stochastic polynomial methods. Similar approaches have been introduced into the risk and safety community where stochastic methods (such as RAVEN, ADAPT, MCDET, ADS) have been coupled with safety analysis codes in order to evaluate the safety impact of timing and sequencing of events. These approaches are usually calledmore » Dynamic PRA or simulation-based PRA methods. These uncertainties and safety methods usually generate a large number of simulation runs (database storage may be on the order of gigabytes or higher). The scope of this paper is to present a broad overview of methods and algorithms that can be used to analyze and extract information from large data sets containing time dependent data. In this context, “extracting information” means constructing input-output correlations, finding commonalities, and identifying outliers. Some of the algorithms presented here have been developed or are under development within the RAVEN statistical framework.« less

  12. Safety of antimicrobial treatment during pregnancy: a current review of resistance, immunomodulation and teratogenicity.

    PubMed

    Lamont, Harriet F; Blogg, Henrietta J; Lamont, Ronald F

    2014-12-01

    The extent of antibiotic use in pregnancy remains unknown but may occur in > 40% of pregnant women for various indications, at different gestational ages from different sources. Antibiotic resistance, alterations to the neonatal immune system causing allergy, asthma and atopic disease in later life and teratogenicity. Although teratogenesis is not a major concern, it is important, and ignorance and complacency cast a long shadow. Robust evidence exists to guide clinicians in their choice of a safe agent with respect to teratogenicity. Antibiotic resistance is a major safety concern, and together with decreased research and development of new antibiotic agents, it has required legal initiatives to encourage Big Pharma to search for safe alternatives. New information from culture-independent, molecular-based techniques has resulted in a greater understanding of the adverse effects of antepartum/intrapartum antibiotics on the maternal vaginal microbiome and the neonatal gut microbiome. As this might adversely affect the development of the immature immune system and lead to asthma, allergy and atopic disease in later life, new research merits support in scrutinizing the safety of antibiotic use in pregnancy.

  13. Coverage and determinants of childhood immunization in Nigeria: A systematic review and meta-analysis.

    PubMed

    Adeloye, Davies; Jacobs, Wura; Amuta, Ann O; Ogundipe, Oluwatomisin; Mosaku, Oluwaseun; Gadanya, Muktar A; Oni, Gbolahan

    2017-05-19

    The proportion of fully immunized children in Nigeria is reportedly low. There are concerns over national immunization data quality, with this possibly limiting country-wide response. We reviewed publicly available evidence on routine immunization across Nigeria to estimate national and zonal coverage of childhood immunization and associated determinants. A systematic search of Medline, EMBASE, Global Health and African Journals Online (AJOL) was conducted. We included population-based studies on childhood immunization in Nigeria. A random effects meta-analysis was conducted on extracted crude rates to arrive at national and zonal pooled estimates for the country. Our search returned 646 hits. 21 studies covering 25 sites and 26,960 children were selected. The estimated proportion of fully immunized children in Nigeria was 34.4% (95% confidence interval [CI]: 27.0-41.9), with South-south zone having the highest at 51.5% (95% CI: 20.5-82.6), and North-west the lowest at 9.5% (95% CI: 4.6-14.4). Mother's social engagements (OR=4.0, 95% CI: 1.9-8.1) and vaccines unavailability (OR=3.9, 95% CI: 1.2-12.3) were mostly reported for low coverage. Other leading determinants were vaccine safety concerns (OR=3.0, 95% CI: 0.9-9.4), mother's low education (OR=2.5, 95% CI: 1.8-3.6) and poor information (OR=2.0, 95% CI: 0.8-4.7). Our study suggests a low coverage of childhood immunization in Nigeria. Due to the paucity of data in the Northern states, we are still uncertain of the quality of evidence presented. It is hoped that this study will prompt the needed research, public health and policy changes toward increased evenly-spread coverage of childhood immunization in the country. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Efficacy and Safety of Vaccination in Pediatric Patients with Systemic Inflammatory Rheumatic Diseases: a systematic review of the literature.

    PubMed

    Sousa, Sandra; Duarte, Ana Catarina; Cordeiro, Inês; Ferreira, Joana; Gonçalves, Maria João; Meirinhos, Tiago; Rocha, Teresa Martins; Romão, Vasco C; Santos, Maria José

    2017-01-01

    tolerated and effective in stable SIRD patients, yet antibody titers are frequently lower than in healthy controls. There is some evidence that biological therapy could hamper the immune response. Data on safety of live attenuated vaccines is limited. Although the available literature covers most vaccines included in the national immunization plan, there is a need for more information regarding new vaccines and new anti-rheumatic therapies.

  15. Development of a check sheet for collecting information necessary for occupational safety and health activities and building relevant systems in overseas business places.

    PubMed

    Kajiki, Shigeyuki; Kobayashi, Yuichi; Uehara, Masamichi; Nakanishi, Shigemoto; Mori, Koji

    2016-06-07

    This study aimed to develop an information gathering check sheet to efficiently collect information necessary for Japanese companies to build global occupational safety and health management systems in overseas business places. The study group consisted of 2 researchers with occupational physician careers in a foreign-affiliated company in Japan and 3 supervising occupational physicians who were engaged in occupational safety and health activities in overseas business places. After investigating information and sources of information necessary for implementing occupational safety and health activities and building relevant systems, we conducted information acquisition using an information gathering check sheet in the field, by visiting 10 regions in 5 countries (first phase). The accuracy of the information acquired and the appropriateness of the information sources were then verified in study group meetings to improve the information gathering check sheet. Next, the improved information gathering check sheet was used in another setting (3 regions in 1 country) to confirm its efficacy (second phase), and the information gathering check sheet was thereby completed. The information gathering check sheet was composed of 9 major items (basic information on the local business place, safety and health overview, safety and health systems, safety and health staff, planning/implementation/evaluation/improvement, safety and health activities, laws and administrative organs, local medical care systems and public health, and medical support for resident personnel) and 61 medium items. We relied on the following eight information sources: the internet, company (local business place and head office in Japan), embassy/consulate, ISO certification body, university or other educational institutions, and medical institutions (aimed at Japanese people or at local workers). Through multiple study group meetings and a two-phased field survey (13 regions in 6 countries), an information

  16. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study.

    PubMed

    McDermott, David F; Sosman, Jeffrey A; Sznol, Mario; Massard, Christophe; Gordon, Michael S; Hamid, Omid; Powderly, John D; Infante, Jeffrey R; Fassò, Marcella; Wang, Yan V; Zou, Wei; Hegde, Priti S; Fine, Gregg D; Powles, Thomas

    2016-03-10

    The objective was to determine the safety and clinical activity of atezolizumab (MPDL3280A), a humanized programmed death-ligand 1 (PD-L1) antibody, in renal cell carcinoma (RCC). Exploratory biomarkers were analyzed and associated with outcomes. Seventy patients with metastatic RCC, including clear cell (ccRCC; n = 63) and non-clear cell (ncc; n = 7) histologies, received atezolizumab intravenously every 3 weeks. PD-L1 expression was scored at four diagnostic levels (0/1/2/3) that were based on PD-L1 staining on tumor cells and tumor-infiltrating immune cells (IC) with the SP142 assay. Primary end points were safety and toxicity; secondary end points assessed clinical activity per Response Evaluation Criteria in Solid Tumors version 1.1 and immune-related response criteria. Plasma and tissue were analyzed for potential biomarkers of atezolizumab response. Grade 3 treatment-related and immune-mediated adverse events occurred in 17% and 4% of patients, respectively, and there were no grade 4 or 5 events. Sixty-three patients with ccRCC were evaluable for overall survival (median, 28.9 months; 95% CI, 20.0 months to not reached) and progression-free survival (median, 5.6 months; 95% CI, 3.9 to 8.2 months), and 62 patients were evaluable for objective response rate (ORR; 15%; 95% CI, 7% to 26%). ORR was evaluated on the basis of PD-L1 IC expression (IC1/2/3: n = 33; 18%; 95% CI, 7% to 35%; and IC0: n = 22; 9%; 95% CI, 1% to 29%). The ORR for patients with Fuhrman grade 4 and/or sarcomatoid histology was 22% (n = 18; 95% CI, 6% to 48%). Decreases in circulating plasma markers and acute-phase proteins and an increased baseline effector T-cell-to-regulatory T-cell gene expression ratio correlated with response to atezolizumab. Atezolizumab demonstrated a manageable safety profile and promising antitumor activity in patients with metastatic RCC. Correlative studies identified potential predictive and pharmacodynamic biomarkers. These results have guided ongoing studies

  17. [Dermatologic toxicities of immune checkpoint inhibitors].

    PubMed

    Sibaud, V; Boulinguez, S; Pagès, C; Riffaud, L; Lamant, L; Chira, C; Boyrie, S; Vigarios, E; Tournier, E; Meyer, N

    2018-05-01

    The development of immune checkpoint inhibitors (monoclonal antibodies targeting PD-1/PD-L1 or CTLA-4) represents a significant advance in the treatment of multiple cancers. Given their particular mechanism of action, which involves triggering CD4+/CD8+ T-cell activation and proliferation, they are associated with a specific safety profile. Their adverse events are primarily immune-related, and can affect practically all organs. In this context, dermatological toxicity is the most common, though it mostly remains mild to moderate and does not require discontinuation of treatment. More than a third of patients are faced with cutaneous adverse events, usually in the form of a maculopapular rash, pruritus or vitiligo (only in patients treated for melanoma). Much more specific dermatologic disorders, however, may occur such as lichenoid reactions, induced psoriasis, sarcoidosis, auto-immune diseases (bullous pemphigoid, dermatomyositis, alopecia areata), acne-like rash, xerostomia, etc. Rigorous dermatological evaluation is thus mandatory in the case of atypical, persistent/recurrent or severe lesions. In this article, we review the incidence and spectrum of dermatologic adverse events reported with immune checkpoint inhibitors. Finally, a management algorithm is proposed. Copyright © 2018. Published by Elsevier Masson SAS.

  18. Measuring the immune system: a comprehensive approach for the analysis of immune functions in humans.

    PubMed

    Claus, Maren; Dychus, Nicole; Ebel, Melanie; Damaschke, Jürgen; Maydych, Viktoriya; Wolf, Oliver T; Kleinsorge, Thomas; Watzl, Carsten

    2016-10-01

    The immune system is essential to provide protection from infections and cancer. Disturbances in immune function can therefore directly affect the health of the affected individual. Many extrinsic and intrinsic factors such as exposure to chemicals, stress, nutrition and age have been reported to influence the immune system. These influences can affect various components of the immune system, and we are just beginning to understand the causalities of these changes. To investigate such disturbances, it is therefore essential to analyze the different components of the immune system in a comprehensive fashion. Here, we demonstrate such an approach which provides information about total number of leukocytes, detailed quantitative and qualitative changes in the composition of lymphocyte subsets, cytokine levels in serum and functional properties of T cells, NK cells and monocytes. Using samples from a cohort of 24 healthy volunteers, we demonstrate the feasibility of our approach to detect changes in immune functions.

  19. Accuracy of a state immunization registry in the pediatric emergency department.

    PubMed

    Stecher, Dawn S; Adelman, Raymond; Brinkman, Traci; Bulloch, Blake

    2008-02-01

    The purpose of this study was to ascertain whether either parental recall or a state immunization registry was as accurate as the medical record in determining immunization status in the emergency department (ED). A convenience sample of children younger than 5 years who presented to the ED between July 2004 and May 2005 were enrolled prospectively. After obtaining informed consent, parents were asked about their child's immunization status. All children then had their immunization data accessed in the Arizona State Immunization Information System. The information obtained from the state registry, as well as the information from the parental interview, was then compared with the information on the medical record obtained from the primary care physician (PCP). Data were analyzed using simple descriptive statistics. A total of 332 children were enrolled in the study. A total of 302 (91%) children enrolled were found in the state database, and 222 (74%) of these had a medical record available for comparison. The database agreed with the PCP record in 130 (59%) cases; parental report agreed with the PCP record in 149 (62%) cases. Although most children can be found in the state immunization registry, it seems to be similar in accuracy to parental recall of immunization status when each is compared with the medical record. This may have been due to either underreporting of immunizations from the community or a delay in updating the state database. At this time, neither parental recall nor the database would accurately determine a child's immunization status during an ED visit.

  20. Male pregnancy and biparental immune priming.

    PubMed

    Roth, Olivia; Klein, Verena; Beemelmanns, Anne; Scharsack, Jörn P; Reusch, Thorsten B H

    2012-12-01

    In vertebrates, maternal transfer of immunity via the eggs or placenta provides offspring with crucial information on prevailing pathogens and parasites. Males contribute little to such transgenerational immune priming, either because they do not share the environment and parasite pressure of the offspring or because sperm are too small for transfer of immunity. In the teleost group of Syngnathids (pipefish, seahorses, and sea dragons), males brood female eggs in a placenta-like structure. Such sex-role-reversed species provide a unique opportunity to test for adaptive plasticity in immune transfer. Here, males and females should both influence offspring immunity. We experimentally tested paternal effects on offspring immunity by examining immune cell proliferation and immune gene expression. Maternal and paternal bacterial exposure induced offspring immune defense 5 weeks after hatching, and this effect persisted in 4-month-old offspring. For several offspring immune traits, double parental exposure (maternal and paternal) enhanced the response, whereas for another group of immune traits, the transgenerational induction already took place if only one parent was exposed. Our study shows that sex role reversal in connection with male pregnancy opens the door for biparental influences on offspring immunity and may represent an additional advantage for the evolution of male pregnancy.

  1. Immune-directed therapy for type 1 diabetes at the clinical level: the Immune Tolerance Network (ITN) experience.

    PubMed

    Ehlers, Mario R; Nepom, Gerald T

    2012-01-01

    Reestablishing immune tolerance in type 1 diabetes (T1D), a chronic autoimmune disease, is a major goal. The Immune Tolerance Network (ITN) has initiated eight clinical trials of immunomodulatory therapies in recent-onset T1D over the past decade. Results have been mixed in terms of clinical efficacy, but the studies have provided valuable mechanistic insight that are enhancing our understanding of the disease and guiding the design of future trials. Trials of non-Fc-binding anti-CD3 mAbs have revealed that modulation of this target leads to partial responses, and ITN's AbATE trial led to identification of a robust responder group that could be distinguished from non-responders by baseline metabolic and immunologic features. A pilot study of the combination of IL-2 and rapamycin gave the first demonstration that frequency and function of regulatory T cells (Tregs) can be enhanced in T1D subjects, although the therapy triggered the activation of effectors with transient β-cell dysfunction. Similarly, therapy with anti-thymocyte globulin led to substantial lymphocyte depletion, but also to the activation of the acute-phase response with no clinical benefit during preliminary analyses. These and other results provide mechanistic tools that can be used as biomarkers for safety and efficacy in future trials. Furthermore, our results, together with those of other organizations, notably TrialNet, delineate the roles of the major components of the immune response in T1D. This information is setting the stage for future combination therapy trials. The development of disease-relevant biomarkers will also enable the implementation of innovative trial designs, notably adaptive trials, which will increase efficiencies in terms of study duration and sample size, and which will expedite the conduct of trials in which there are uncertainties about dose response and effect size.

  2. Nurses' perspectives on the intersection of safety and informed decision making in maternity care.

    PubMed

    Jacobson, Carrie H; Zlatnik, Marya G; Kennedy, Holly Powell; Lyndon, Audrey

    2013-01-01

    To explore maternity nurses' perceptions of women's informed decision making during labor and birth to better understand how interdisciplinary communication challenges might affect patient safety. Constructivist grounded theory. Four hospitals in the western United States. Forty-six (46) nurses and physicians practicing in maternity units. Data collection strategies included individual interviews and participant observation. Data were analyzed using the constant comparative method, dimensional analysis, and situational analysis (Charmaz, 2006; Clarke, 2005; Schatzman, 1991). The nurses' central action of holding off harm encompassed three communication strategies: persuading agreement, managing information, and coaching of mothers and physicians. These strategies were executed in a complex, hierarchical context characterized by varied practice patterns and relationships. Nurses' priorities and patient safety goals were sometimes misaligned with those of physicians, resulting in potentially unsafe communication. The communication strategies nurses employed resulted in intended and unintended consequences with safety implications for mothers and providers and had the potential to trap women in the middle of interprofessional conflicts and differences of opinion. © 2013 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

  3. Immune memory in invertebrates.

    PubMed

    Milutinović, Barbara; Kurtz, Joachim

    2016-08-01

    Evidence for innate immune memory (or 'priming') in invertebrates has been accumulating over the last years. We here provide an in-depth review of the current state of evidence for immune memory in invertebrates, and in particular take a phylogenetic viewpoint. Invertebrates are a very heterogeneous group of animals and accordingly, evidence for the phenomenon of immune memory as well as the hypothesized molecular underpinnings differ largely for the diverse invertebrate taxa. The majority of research currently focuses on Arthropods, while evidence from many other groups of invertebrates is fragmentary or even lacking. We here concentrate on immune memory that is induced by pathogenic challenges, but also extent our view to a non-pathogenic context, i.e. allograft rejection, which can also show forms of memory and can inform us about general principles of specific self-nonself recognition. We discuss definitions of immune memory and a number of relevant aspects such as the type of antigens used, the route of exposure, and the kinetics of reactions following priming. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. The Immunogenicity and Immune Tolerance of Pluripotent Stem Cell Derivatives

    PubMed Central

    Liu, Xin; Li, Wenjuan; Fu, Xuemei; Xu, Yang

    2017-01-01

    Human embryonic stem cells (hESCs) can undergo unlimited self-renewal and differentiate into all cell types in human body, and therefore hold great potential for cell therapy of currently incurable diseases including neural degenerative diseases, heart failure, and macular degeneration. This potential is further underscored by the promising safety and efficacy data from the ongoing clinical trials of hESC-based therapy of macular degeneration. However, one main challenge for the clinical application of hESC-based therapy is the allogeneic immune rejection of hESC-derived cells by the recipient. The breakthrough of the technology to generate autologous-induced pluripotent stem cells (iPSCs) by nuclear reprogramming of patient’s somatic cells raised the possibility that autologous iPSC-derived cells can be transplanted into the patients without the concern of immune rejection. However, accumulating data indicate that certain iPSC-derived cells can be immunogenic. In addition, the genomic instability associated with iPSCs raises additional safety concern to use iPSC-derived cells in human cell therapy. In this review, we will discuss the mechanism underlying the immunogenicity of the pluripotent stem cells and recent progress in developing immune tolerance strategies of human pluripotent stem cell (hPSC)-derived allografts. The successful development of safe and effective immune tolerance strategy will greatly facilitate the clinical development of hPSC-based cell therapy. PMID:28626459

  5. The effects of compliance cost and specific consequence information on the use of safety equipment.

    PubMed

    Hathaway, J A; Dingus, T A

    1992-12-01

    The effects of compliance cost and warning content on the use of protective eyewear by racquetball players were evaluated. Four-hundred-twenty subjects were observed for use of eye protection in a field setting. Results indicate that proximal placement of eyewear and the inclusion of specific consequence warning information increased safety equipment use. Implications of this research for augmenting warning effectiveness and safety are discussed.

  6. Insights from an international stakeholder consultation to identify informational needs related to seafood safety.

    PubMed

    Tediosi, Alice; Fait, Gabriella; Jacobs, Silke; Verbeke, Wim; Álvarez-Muñoz, Diana; Diogene, Jorge; Reuver, Marieke; Marques, António; Capri, Ettore

    2015-11-01

    Food safety assessment and communication have a strong importance in reducing human health risks related to food consumption. The research carried out within the ECsafeSEAFOOD project aims to assess seafood safety issues, mainly related to non-regulated priority environmental contaminants, and to evaluate their impact on public health. In order to make the research results accessible and exploitable, and to respond to actual stakeholders' demands, a consultation with international stakeholders was performed by means of a survey. The focus was on policy and decision makers, food producers and processors, and agencies (i.e. EU and National or Regional agencies related to Food Safety or Public Health) and consumer organisations. The survey considered questions related to: seafood safety assessment and mitigation strategies, availability of data, such as the level of information on different contaminants, and communication among different stakeholder groups. Furthermore, stakeholders were asked to give their opinion on how they believe consumers perceive risks associated with environmental contaminants. The survey was distributed to 531 key stakeholders and 91 responses were received from stakeholders from 30 EU and non-EU countries. The main results show that communication between different groups of stakeholders needs to be improved and that there is a deficit of information and data in the field of seafood safety. This pertains mainly to the transfer of contaminants between the environment and seafood, and to the diversity of environmental contaminants such as plastic additives, algal toxins and hormones. On-line tools were perceived to be the most useful communication channel. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. 75 FR 35286 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... instructional literature requirements in the Safety Standard for Infant walkers. DATES: Submit written or... for marking and instructional literature. We estimate the burden of this collection of information as... literature that are disclosure requirements, thus falling within the definition of ``collections of...

  8. Support for immunization registries among parents of vaccinated and unvaccinated school-aged children: a case control study.

    PubMed

    Linkins, Robert W; Salmon, Daniel A; Omer, Saad B; Pan, William Ky; Stokley, Shannon; Halsey, Neal A

    2006-09-22

    Immunizations have reduced childhood vaccine preventable disease incidence by 98-100%. Continued vaccine preventable disease control depends on high immunization coverage. Immunization registries help ensure high coverage by recording childhood immunizations administered, generating reminders when immunizations are due, calculating immunization coverage and identifying pockets needing immunization services, and improving vaccine safety by reducing over-immunization and providing data for post-licensure vaccine safety studies. Despite substantial resources directed towards registry development in the U.S., only 48% of children were enrolled in a registry in 2004. Parental attitudes likely impact child participation. Consequently, the purpose of this study was to assess the attitudes of parents of vaccinated and unvaccinated school-aged children regarding: support for immunization registries; laws authorizing registries and mandating provider reporting; opt-in versus opt-out registry participation; and financial worth and responsibility of registry development and implementation. A case control study of parents of 815 children exempt from school vaccination requirements and 1630 fully vaccinated children was conducted. Children were recruited from 112 elementary schools in Colorado, Massachusetts, Missouri, and Washington. Surveys administered to the parents, asked about views on registries and perceived utility and safety of vaccines. Parental views were summarized and logistic regression models compared differences between parents of exempt and vaccinated children. Surveys were completed by 56.1% of respondents. Fewer than 10% of parents were aware of immunization registries in their communities. Among parents aware of registries, exempt children were more likely to be enrolled (65.0%) than vaccinated children (26.5%) (p value = 0.01). A substantial proportion of parents of exempt children support immunization registries, particularly if registries offer choice for

  9. Support for immunization registries among parents of vaccinated and unvaccinated school-aged children: a case control study

    PubMed Central

    Linkins, Robert W; Salmon, Daniel A; Omer, Saad B; Pan, William KY; Stokley, Shannon; Halsey, Neal A

    2006-01-01

    Background Immunizations have reduced childhood vaccine preventable disease incidence by 98–100%. Continued vaccine preventable disease control depends on high immunization coverage. Immunization registries help ensure high coverage by recording childhood immunizations administered, generating reminders when immunizations are due, calculating immunization coverage and identifying pockets needing immunization services, and improving vaccine safety by reducing over-immunization and providing data for post-licensure vaccine safety studies. Despite substantial resources directed towards registry development in the U.S., only 48% of children were enrolled in a registry in 2004. Parental attitudes likely impact child participation. Consequently, the purpose of this study was to assess the attitudes of parents of vaccinated and unvaccinated school-aged children regarding: support for immunization registries; laws authorizing registries and mandating provider reporting; opt-in versus opt-out registry participation; and financial worth and responsibility of registry development and implementation. Methods A case control study of parents of 815 children exempt from school vaccination requirements and 1630 fully vaccinated children was conducted. Children were recruited from 112 elementary schools in Colorado, Massachusetts, Missouri, and Washington. Surveys administered to the parents, asked about views on registries and perceived utility and safety of vaccines. Parental views were summarized and logistic regression models compared differences between parents of exempt and vaccinated children. Results Surveys were completed by 56.1% of respondents. Fewer than 10% of parents were aware of immunization registries in their communities. Among parents aware of registries, exempt children were more likely to be enrolled (65.0%) than vaccinated children (26.5%) (p value = 0.01). A substantial proportion of parents of exempt children support immunization registries, particularly

  10. Successful introduction of an underutilized elderly pneumococcal vaccine in a national immunization program by integrating the pre-existing public health infrastructure.

    PubMed

    Yang, Tae Un; Kim, Eunsung; Park, Young-Joon; Kim, Dongwook; Kwon, Yoon Hyung; Shin, Jae Kyong; Park, Ok

    2016-03-18

    Although pneumococcal vaccines had been recommended for the elderly population in South Korea for a considerable period of time, the coverage has been well below the optimal level. To increase the vaccination rate with integrating the pre-existing public health infrastructure and governmental funding, the Korean government introduced an elderly pneumococcal vaccination into the national immunization program with a 23-valent pneumococcal polysaccharide vaccine in May 2013. The aim of this study was to assess the performance of the program in increasing the vaccine coverage rate and maintaining stable vaccine supply and safe vaccination during the 20 months of the program. We qualitatively and quantitatively analyzed the process of introducing and the outcomes of the program in terms of the systematic organization, efficiency, and stability at the national level. A staggered introduction during the first year utilizing the public sector, with a target coverage of 60%, was implemented based on the public demand for an elderly pneumococcal vaccination, vaccine supply capacity, vaccine delivery capacity, safety, and sustainability. During the 20-month program period, the pneumococcal vaccine coverage rate among the population aged ≥65 years increased from 5.0% to 57.3% without a noticeable vaccine shortage or safety issues. A web-based integrated immunization information system, which includes the immunization registry, vaccine supply chain management, and surveillance of adverse events following immunization, reduced programmatic errors and harmonized the overall performance of the program. Introduction of an elderly pneumococcal vaccination in the national immunization program based on strong government commitment, meticulous preparation, financial support, and the pre-existing public health infrastructure resulted in an efficient, stable, and sustainable increase in vaccination coverage. Copyright © 2016. Published by Elsevier Ltd.

  11. Latino immigrant day laborer perceptions of occupational safety and health information preferences.

    PubMed

    Díaz Fuentes, Claudia M; Martinez Pantoja, Leonardo; Tarver, Meshawn; Geschwind, Sandy A; Lara, Marielena

    2016-06-01

    We address immigrant day laborers' experiences with occupational safety in the construction industry in New Orleans, and opinions about content and method of communication for educational interventions to reduce occupational risks. In 2011, we conducted seven focus groups with 48 Spanish-speaking day laborers (8 women, 40 men, 35 years on average). Focus group results are based on thematic analysis. Most employers did not provide safety equipment, threatened to dismiss workers who asked for it, and did not provide health insurance. Attitudes toward accepting unsafe work conditions varied. Women faced lower pay and hiring difficulties than men. Day laborers preferred audio format over written, and content about consequences from and equipment for different jobs/exposures. Day laborers have common occupational experiences, but differences existed by gender, literacy and sense of control over safety. Day laborer information preferences and use of media needs further studying. Am. J. Ind. Med. 59:476-485, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  12. Immune checkpoint inhibitors for metastatic bladder cancer.

    PubMed

    Massari, Francesco; Di Nunno, Vincenzo; Cubelli, Marta; Santoni, Matteo; Fiorentino, Michelangelo; Montironi, Rodolfo; Cheng, Liang; Lopez-Beltran, Anto; Battelli, Nicola; Ardizzoni, Andrea

    2018-03-01

    Chemotherapy has represented the standard therapy for unresectable or metastatic urothelial carcinoma for more than 20 years. The growing knowledge of the interaction between tumour and immune system has led to the advent of new classes of drugs, the immune-checkpoints inhibitors, which are intended to change the current scenario. To date, immunotherapy is able to improve the overall responses and survival. Moreover, thanks to its safety profile immune-checkpoint inhibitors could be proposed also to patients unfit for standard chemotherapy. No doubts that these agents have started a revolution expected for years, but despite this encouraging results it appears clear that not all subjects respond to these agents and requiring the development of reliable predictive response factors able to isolate patients who can more benefit from these treatments as well as new strategies aimed to improve immunotherapy clinical outcome. In this review we describe the active or ongoing clinical trials involving Programmed Death Ligand 1 (PD-L1), Programmed Death receptor 1 (PD-1) and Cytotoxic-T Lymphocyte Antigen 4 (CTLA 4) inhibitors in urothelial carcinoma focusing our attention on the developing new immune-agents and combination strategies with immune-checkpoint inhibitors. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. An immunologically relevant rodent model demonstrates safety of therapy using a tumour-specific IgE.

    PubMed

    Josephs, Debra H; Nakamura, Mano; Bax, Heather J; Dodev, Tihomir S; Muirhead, Gareth; Saul, Louise; Karagiannis, Panagiotis; Ilieva, Kristina M; Crescioli, Silvia; Gazinska, Patrycja; Woodman, Natalie; Lomardelli, Cristina; Kareemaghay, Sedigeh; Selkirk, Christopher; Lentfer, Heike; Barton, Claire; Canevari, Silvana; Figini, Mariangela; Downes, Noel; Dombrowicz, David; Corrigan, Christopher J; Nestle, Frank O; Jones, Paul S; Gould, Hannah J; Blower, Philip J; Tsoka, Sophia; Spicer, James F; Karagiannis, Sophia N

    2018-04-13

    Designing biologically informative models for assessing the safety of novel agents, especially for cancer immunotherapy, carries substantial challenges. The choice of an in vivo system for studies on IgE antibodies represents a major impediment to their clinical translation, especially with respect to class-specific immunological functions and safety. Fcε receptor expression and structure are different in humans and mice, so that the murine system is not informative when studying human IgE biology. By contrast, FcεRI expression and cellular distribution in rats mirrors that of humans. We are developing MOv18 IgE, a human chimeric antibody recognizing the tumour-associated antigen folate receptor alpha. We created an immunologically congruent surrogate rat model likely to recapitulate human IgE-FcεR interactions, and engineered a surrogate rat IgE equivalent to MOv18. Employing this model, we examined in vivo safety and efficacy of anti-tumour IgE antibodies. In immunocompetent rats, rodent IgE restricted growth of syngeneic tumours in the absence of clinical, histopathological or metabolic signs associated with obvious toxicity. No physiological or immunological evidence of a 'cytokine-storm' or allergic response was seen, even at 50 mg/kg weekly doses. IgE treatment was associated with elevated serum concentrations of TNFα, a mediator previously linked with IgE-mediated anti-tumour and anti-parasitic functions, alongside evidence of substantially elevated tumoural immune cell infiltration and immunological pathway activation in tumour-bearing lungs. Our findings indicate safety of MOv18 IgE, in conjunction with efficacy and immune activation, supporting the translation of this therapeutic approach to the clinical arena. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  14. Tolerability and safety of the intravenous immunoglobulin octagam® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials.

    PubMed

    Wietek, Stefan; Svorc, Daniel; Debes, Anette; Svae, Tor-Einar

    2018-05-01

    To provide detailed data on the tolerability and safety of octagam ® 10%, a ready-to-use intravenous immunoglobulin, in a subgroup of patients with immune thrombocytopenia (ITP) involved in an integrated analysis of post-authorisation safety surveillance (PASS) studies. A subgroup analysis was conducted using data collected from two non-interventional studies that included patients with ITP treated with octagam ® 10%. Patients were observed and monitored for possible adverse drug reactions (ADRs) during or after administration of octagam ® 10%, with a particular focus on thromboembolic events (TEEs). ADRs were analysed at the case and event level. In this analysis of 112 patients receiving octagam ® 10% (mean dose 0.4 g/kg/infusion), there were five cases with at least one adverse drug reaction (ADR) associated with 626 infusions of octagam ® 10% (case incidence of 0.8% per infusion). ADRs were of mild or moderate severity. There were a total of 10 events, most commonly back pain (n = 3) and headache (n = 2). Nausea, dizziness and a sensation of heaviness were also reported. The remaining two events involved drug exposure during pregnancy. There were no TEEs or other serious ADRs. In this subgroup analysis of patients who received octagam ® 10% (manufactured using an amended process) in two PASS studies, the overall ADR rate was low, with ADRs occurring in only 0.8% of all infusions. No TEEs or other serious ADRs were reported. Routine clinical use of octagam ® 10% was safe and well tolerated, with no unexpected safety issues, in patients with ITP. The two studies from which data were taken are registered with the International Standard Randomised Controlled Trial Number Registry, numbers ISRCTN58800347 and ISRCTN02245668.

  15. Attitudes towards HPV immunization of Italian mothers of adolescent girls and potential role of health professionals in the immunization program.

    PubMed

    Tozzi, Alberto E; Ravà, Lucilla; Stat, D; Pandolfi, Elisabetta; Marino, Maria G; Ugazio, Alberto G

    2009-04-28

    We assessed the knowledge of Italian mothers of adolescent girls about HPV and HPV vaccination, their willingness to immunize their daughters, and their perception of the role of different medical specialists in the HPV immunization strategy by a telephone interview. Fifty-four percent of the 807 interviewed mothers reported to have ever heard about HPV, and 84% of them were willing to immunize their daughters. Pediatricians most frequently provided information on HPV vaccine (31%), and were perceived as the preferred immunization providers (77%). Acceptance of HPV immunization was high and was not associated with knowledge of HPV.

  16. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older--United States, 2016.

    PubMed

    Kim, David K; Bridges, Carolyn B; Harriman, Kathleen H

    2016-02-05

    In October 2015, the Advisory Committee on Immunization Practices (ACIP)* approved the Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2016. This schedule provides a summary of ACIP recommendations for the use of vaccines routinely recommended for adults aged 19 years or older in two figures, footnotes for each vaccine, and a table that describes primary contraindications and precautions for commonly used vaccines for adults. Although the figures in the adult immunization schedule illustrate recommended vaccinations that begin at age 19 years, the footnotes contain information on vaccines that are recommended for adults that may begin at age younger than age 19 years. The footnotes also contain vaccine dosing, intervals between doses, and other important information and should be read with the figures.

  17. 78 FR 46588 - Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Vaccine Safety Monitoring and Post-Marketing Surveillance 4. Building Global Immunization Research and... activities not represented in the report where HHS efforts can offer a comparative advantage or where HHS... global immunization efforts and the role of HHS in enhancing those efforts. Examples of potential...

  18. The development and application of electronic information system for safety administration of newborns in the rooming-in care.

    PubMed

    Wang, Fang; Dong, Jian-Cheng; Chen, Jian-Rong; Wu, Hui-Qun; Liu, Man-Hua; Xue, Li-Ly; Zhu, Xiang-Hua; Wang, Jian

    2015-01-01

    To independently research and develop an electronic information system for safety administration of newborns in the rooming-in care, and to investigate the effects of its clinical application. By VS 2010 SQL SERVER 2005 database and adopting Microsoft visual programming tool, an interactive mobile information system was established, with integrating data, information and knowledge with using information structures, information processes and information technology. From July 2011 to July 2012, totally 210 newborns from the rooming-in care of the Obstetrics Department of the Second Affiliated Hospital of Nantong University were chosen and randomly divided into two groups: the information system monitoring group (110 cases) and the regular monitoring group (100 cases). Incidence of abnormal events and degree of satisfaction were recorded and calculated. ① The wireless electronic information system has four main functions including risk scaling display, identity recognition display, nursing round notes board and health education board; ② statistically significant differences were found between the two groups both on the active or passive discovery rate of abnormal events occurred in the newborns (P<0.05) and the satisfaction degree of the mothers and their families (P<0.05); ③ the system was sensitive and reliable, and the wireless transmission of information was correct and safety. The system is with high practicability in the clinic and can ensure the safety for the newborns with improved satisfactions.

  19. To give or not to give: Approaches to early childhood immunization delivery in Oregon rural primary care practices.

    PubMed

    Fagnan, Lyle J; Shipman, Scott A; Gaudino, James A; Mahler, Jo; Sussman, Andrew L; Holub, Jennifer

    2011-01-01

    Little is known about rural clinicians' perspectives regarding early childhood immunization delivery, their adherence to recommended best immunization practices, or the specific barriers they confront. To examine immunization practices, beliefs, and barriers among rural primary care clinicians for children in Oregon and compare those who deliver all recommended immunizations in their practices with those who do not. A mailed questionnaire was sent to all physicians, nurse practitioners, and physician assistants practicing primary care in rural communities throughout Oregon. While 39% of rural clinicians reported delivering all childhood immunizations in their clinic, 43% of clinicians reported that they refer patients elsewhere for some vaccinations, and 18% provided no immunizations in the clinic whatsoever. Leading reasons for referral include inadequate reimbursement, parental request, and storage and stocking difficulties. Nearly a third of respondents reported that they had some level of concern about the safety of immunizations, and 14% reported that concerns about safety were a specific reason for referring. Clinicians who delivered only some of the recommended immunizations were less likely than nonreferring clinicians to have adopted evidence-based best immunization practices. This study of rural clinicians in Oregon demonstrates the prevalence of barriers to primary care based immunization delivery in rural regions. While some barriers may be difficult to overcome, others may be amenable to educational outreach and support. Thus, efforts to improve population immunization rates should focus on promoting immunization "best practices" and enhancing the capacity of practices to provide immunizations and ensuring that any alternative means of delivering immunizations are effective. © 2011 National Rural Health Association.

  20. To Give or Not to Give: Approaches to Early Childhood Immunization Delivery in Oregon Rural Primary Care Practices

    PubMed Central

    Fagnan, Lyle J.

    2010-01-01

    Context Little is known about rural clinicians’ perspectives regarding early childhood immunization delivery, their adherence to recommended best immunization practices, or the specific barriers they confront. Purpose To examine immunization practices, beliefs, and barriers among rural primary care clinicians for children in Oregon and compare those who deliver all recommended immunizations in their practices with those who do not. Methods A mailed questionnaire sent to all physicians, nurse practitioners, and physician assistants practicing primary care in rural communities throughout Oregon. Findings While 39% of rural clinicians reported delivering all childhood immunizations in their clinic, 43% of clinicians reported that they refer patients elsewhere for some vaccinations and 18% provided no immunizations in the clinic whatsoever. Leading reasons for referral include inadequate reimbursement, parental request, and storage and stocking difficulties. Nearly a third of respondents reported that they had some level of concern about the safety of immunizations, and 14% reported that concerns about safety were a specific reason for referring. Clinicians who delivered only some of the recommended immunizations were less likely than non-referring clinicians to have adopted evidence-based best immunization practices. Conclusions This study of rural clinicians in Oregon demonstrates the prevalence of barriers to primary-care-based immunization delivery in rural regions. While some barriers may be difficult to overcome, others may be amenable to educational outreach and support. Thus, efforts to improve population immunization rates should focus on promoting immunization “best practices” and enhancing the capacity of practices to provide immunizations and assuring that any alternative means of delivering immunizations are effective. PMID:21967382

  1. Leader humility and team creativity: The role of team information sharing, psychological safety, and power distance.

    PubMed

    Hu, Jia; Erdogan, Berrin; Jiang, Kaifeng; Bauer, Talya N; Liu, Songbo

    2018-03-01

    In this study, we identify leader humility, characterized by being open to admitting one's limitations, shortcomings, and mistakes, and showing appreciation and giving credit to followers, as a critical leader characteristic relevant for team creativity. Integrating the literatures on creativity and leadership, we explore the relationship between leader humility and team creativity, treating team psychological safety and team information sharing as mediators. Further, we hypothesize and examine team power distance as a moderator of the relationship. We tested our hypotheses using data gathered from 72 work teams and 354 individual members from 11 information and technology firms in China using a multiple-source, time-lagged research design. We found that the positive relationship between leader humility and team information sharing was significant and positive only within teams with a low power distance value. In addition, leader humility was negatively related to team psychological safety in teams with a high power distance value, whereas the relationship was positive yet nonsignificant in teams with low power distance. Furthermore, team information sharing and psychological safety were both significantly related to team creativity. We discuss theoretical and practical implications for leadership and work teams. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  2. How Past Loss of Control Accidents May Inform Safety Cases for Advanced Control Systems on Commercial Aircraft

    NASA Technical Reports Server (NTRS)

    Holloway, C. M.; Johnson, C. W.

    2008-01-01

    This paper describes five loss of control accidents involving commercial aircraft, and derives from those accidents three principles to consider when developing a potential safety case for an advanced flight control system for commercial aircraft. One, among the foundational evidence needed to support a safety case is the availability to the control system of accurate and timely information about the status and health of relevant systems and components. Two, an essential argument to be sustained in the safety case is that pilots are provided with adequate information about the control system to enable them to understand the capabilities that it provides. Three, another essential argument is that the advanced control system will not perform less safely than a good pilot.

  3. Too much information? A document analysis of sport safety resources from key organisations

    PubMed Central

    Finch, Caroline F

    2016-01-01

    Objectives The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Design Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. Setting This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. Participants The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. Results The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. Conclusions People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based

  4. The immune system as a biomonitor: explorations in innate and adaptive immunity

    PubMed Central

    Thomas, Niclas; Heather, James; Pollara, Gabriel; Simpson, Nandi; Matjeka, Theres; Shawe-Taylor, John; Noursadeghi, Mahdad; Chain, Benjamin

    2013-01-01

    The human immune system has a highly complex, multi-layered structure which has evolved to detect and respond to changes in the internal microenvironment of the body. Recognition occurs at the molecular or submolecular scale, via classical reversible receptor–ligand interactions, and can lead to a response with great sensitivity and speed. Remarkably, recognition is coupled to memory, such that responses are modulated by events which occurred years or even decades before. Although the immune system in general responds differently and more vigorously to stimuli entering the body from the outside (e.g. infections), this is an emergent property of the system: many of the recognition molecules themselves have no inherent bias towards external stimuli (non-self) but also bind targets found within the body (self). It is quite clear that the immune response registers pathophysiological changes in general. Cancer, wounding and chronic tissue injury are some obvious examples. Against this background, the immune system ‘state’ tracks the internal processes of the body, and is likely to encode information regarding both current and past disease processes. Moreover, the distributed nature of most immune responses (e.g. typically involving lymphoid tissue, non-lymphoid tissue, bone marrow, blood, extracellular interstitial spaces, etc.) means that many of the changes associated with immune responses are manifested systemically, and specifically can be detected in blood. This provides a very convenient route to sampling immune cells. We consider two different and complementary ways of querying the human immune ‘state’ using high-dimensional genomic screening methodologies, and discuss the potentials of these approaches and some of the technological and computational challenges to be overcome. PMID:24427535

  5. Is there still an immunity gap in high-level national immunization coverage, Iran?

    PubMed

    Zahraei, Seyed Mohsen; Eshrati, Babak; Gouya, Mohammad Mehdi; Mohammadbeigi, Abolfazl; Kamran, Aziz

    2014-10-01

    As there is a significant number of Iranian immigrant and illegal refugees living in marginal areas of large cities that might induce immunization gap in these areas.  The aim of this study was to provide reliable information on vaccination status of these people. A cross sectional study was conducted on children 24-47 month old who lived in the suburb areas of five large cities of Iran in 2013. Proportional cluster sampling method was used in each city and standard questionnaire of the World Health Organization applied for the purpose of data collection. The survey counts immunizations based on immunization card plus the history of vaccination according to the mother's memory. All gathered data were analyzed using SPSS software (version 16). Overall, 4502 children (49.2% female) aged 24-47 month participated in this survey among which 88.1% were Iranian and 11.9% were Afghan or other nationalities. Totally, 4479 (99.4%, CI 95%: 99.2%-99.6%) of the children had a vaccination card while 828 (18.5%, CI 95%; 15.8%-21.1%) could not present it to the interviewers. 96.8% of children were fully immunized, 3.2% were partially immunized and 0.1% were not immunized. There was no significant difference in terms of vaccine coverage among males and females. The prevalence of partially immunization in non-Iranian children was six fold of Iranian children (11.9% vs. 2%). Immunization program is implemented appropriately with high coverage rates in suburb areas of the country. However, there is still an immunity gap in non-Iranian immigrants, which should be a health system considered as a high-risk group by the health system.

  6. 75 FR 43995 - Advisory Committee on Immunization Practices (ACIP)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-27

    ...: The conference call will originate at the National Center for Immunization and Respiratory Diseases in.... CONTACT PERSON FOR MORE INFORMATION: Leola Mitchell, National Center for Immunization and Respiratory...

  7. Safety and efficacy of Crotalidae Polyvalent Immune Fab in pediatric crotaline envenomations.

    PubMed

    Pizon, Anthony F; Riley, Bradley D; LoVecchio, Frank; Gill, Ruqayya

    2007-04-01

    Since it was approved by the Food and Drug Administration in October 2000, Crotalidae Polyvalent Immune Fab (CroFab) has largely replaced previously used crotaline antivenom. CroFab is more specifically tailored for crotalids of North America and is less allergenic than whole immunoglobulin antivenoms. However, premarketing and postmarketing studies have excluded children. To describe the safety and efficacy of CroFab in pediatric crotaline envenomations. Using admission and billing records, the authors identified all children 13 years of age and younger treated with CroFab at a pediatric hospital between October 2000 and September 2005. Charts were reviewed by two trained, blinded extractors. Data regarding age, signs of envenomation, laboratory values, total antivenom vials used, total vials used to gain control, transfused blood products, signs of acute allergy to antivenom, and any surgical procedures were abstracted. Data were analyzed using descriptive statistics. Twenty-four patients were identified, and their mean age was 7.3 (range, 1.9-13) years. At presentation, all had swelling, 14 (58%) had a prothrombin time >13 seconds, two (8.3%) had a fibrinogen level <150 mg/dL, and three (12.5%) had platelet counts <150,000/mL. The mean number of total antivenom vials used was 12.3 (range, 4-24). Five patients had resolution of swelling, but platelet counts continued to fall despite antivenom treatment. No patient required blood products, debridement of skin, or fasciotomy. There was only one (4.2%) possible acute allergy to CroFab, and there were no deaths. In this pediatric series, CroFab appears safe and effective, despite occasional resistant thrombocytopenia.

  8. Immunization Against Infectious Disease

    ERIC Educational Resources Information Center

    Mortimer, Edward A., Jr.

    1978-01-01

    The success of present and future immunization programs is endangered by public and physician complacency and by complex legal and ethical problems related to informed consent and responsibility for rare, vaccine-related injury. (BB)

  9. Immunization of pregnant women: Future of early infant protection

    PubMed Central

    Faucette, Azure N; Pawlitz, Michael D; Pei, Bo; Yao, Fayi; Chen, Kang

    2015-01-01

    Children in early infancy do not mount effective antibody responses to many vaccines against commons infectious pathogens, which results in a window of increased susceptibility or severity infections. In addition, vaccine-preventable infections are among the leading causes of morbidity in pregnant women. Immunization during pregnancy can generate maternal immune protection as well as elicit the production and transfer of antibodies cross the placenta and via breastfeeding to provide early infant protection. Several successful vaccines are now recommended to all pregnant women worldwide. However, significant gaps exist in our understanding of the efficacy and safety of other vaccines and in women with conditions associated with increased susceptible to high-risk pregnancies. Public acceptance of maternal immunization remained to be improved. Broader success of maternal immunization will rely on the integration of advances in basic science in vaccine design and evaluation and carefully planned clinical trials that are inclusive to pregnant women. PMID:26366844

  10. Immune modulation of i.v. immunoglobulin in women with reproductive failure.

    PubMed

    Han, Ae R; Lee, Sung K

    2018-04-01

    The mechanism of maternal immune tolerance of the semi-allogenic fetus has been explored extensively. The immune reaction to defend from invasion by pathogenic microorganisms should be maintained during pregnancy. An imbalance between the immune tolerance to the fetus and immune activation to the pathogenic organisms is associated with poor pregnancy outcomes. This emphasizes that the immune mechanism of successful reproduction is not just immune suppression, but adequate immune modulation. In this review, the action of i.v. immunoglobulin G (IVIg) on the immune system and its efficacy in reproductive failure (RF) was summarized. Also suggested is the indication of IVIg therapy for women with RF. Based on the mechanism of the immune regulation of IVIg and following confirmation of the immune modulation effects of it in various aberrant immune parameters in patients with RF, it is obvious that IVIg is effective in recurrent pregnancy losses and repeated implantation failures with immunologic disturbances. The authors recommend IVIg therapy in patients with RF with aberrant cellular immunologic parameters, including a high natural killer cell proportion and its cytotoxicity or elevated T helper 1 to T helper 2 ratio, based on each clinic's cut-off values. Further clinical studies about the safety of IVIg in the fetus and its efficacy in other immunologic abnormalities of RF are needed.

  11. Immune Repertoire after Immunization As Seen by Next-Generation Sequencing and Proteomics

    PubMed Central

    VanDuijn, Martijn M.; Dekker, Lennard J.; van IJcken, Wilfred F. J.; Sillevis Smitt, Peter A. E.; Luider, Theo M.

    2017-01-01

    The immune system produces a diverse repertoire of immunoglobulins in response to foreign antigens. During B-cell development, VDJ recombination and somatic mutations generate diversity, whereas selection processes remove it. Using both proteomic and NGS approaches, we characterized the immune repertoires in groups of rats after immunization with purified antigens. Proteomics and NGS data on the repertoire are in qualitative agreement, but did show quantitative differences that may relate to differences between the biological niches that were sampled for these approaches. Both methods contributed complementary information in the characterization of the immune repertoire. It was found that the immune repertoires resulting from each antigen had many similarities that allowed samples to cluster together, and that mutated immunoglobulin peptides were shared among animals with a response to the same antigen significantly more than for different antigens. However, the number of shared sequences decreased in a log-linear fashion relative to the number of animals that share them, which may affect future applications. A phylogenetic analysis on the NGS reads showed that reads from different individuals immunized with the same antigen populated distinct branches of the phylogram, an indication that the repertoire had converged. Also, similar mutation patterns were found in branches of the phylogenetic tree that were associated with antigen-specific immunoglobulins through proteomics data. Thus, data from different analysis methods and different experimental platforms show that the immunoglobulin repertoires of immunized animals have overlapping and converging features. With additional research, this may enable interesting applications in biotechnology and clinical diagnostics. PMID:29085363

  12. Waste isolation safety assessment program. Task 4. Third contractor information meeting

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

    Not Available

    1980-06-01

    The Contractor Information Meeting (October 14 to 17, 1979) was part of the FY-1979 effort of Task 4 of the Waste Isolation Safety Assessment Program (WISAP): Sorption/Desorption Analysis. The objectives of this task are to: evaluate sorption/desorption measurement methods and develop a standardized measurement procedure; produce a generic data bank of nuclide-geologic interactions using a wide variety of geologic media and groundwaters; perform statistical analysis and synthesis of these data; perform validation studies to compare short-term laboratory studies to long-term in situ behavior; develop a fundamental understanding of sorption/desorption processes; produce x-ray and gamma-emitting isotopes suitable for the study ofmore » actinides at tracer concentrations; disseminate resulting information to the international technical community; and provide input data support for repository safety assessment. Conference participants included those subcontracted to WISAP Task 4, representatives and independent subcontractors to the Office of Nuclear Waste Isolation, representatives from other waste disposal programs, and experts in the area of waste/geologic media interaction. Since the meeting, WISAP has been divided into two programs: Assessment of Effectiveness of Geologic Isolation Systems (AEGIS) (modeling efforts) and Waste/Rock Interactions Technology (WRIT) (experimental work). The WRIT program encompasses the work conducted under Task 4. This report contains the information presented at the Task 4, Third Contractor Information Meeting. Technical Reports from the subcontractors, as well as Pacific Northwest Laboratory (PNL), are provided along with transcripts of the question-and-answer sessions. The agenda and abstracts of the presentations are also included. Appendix A is a list of the participants. Appendix B gives an overview of the WRIT program and details the WRIT work breakdown structure for 1980.« less

  13. Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

    PubMed Central

    Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

    2006-01-01

    For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

  14. Improving Immunization Coverage in a Rural School District in Pierce County, Washington

    ERIC Educational Resources Information Center

    Peterson, Robin M.; Cook, Carolyn; Yerxa, Mary E.; Marshall, James H.; Pulos, Elizabeth; Rollosson, Matthew P.

    2012-01-01

    Washington State has some of the highest percentages of school immunization exemptions in the country. We compared school immunization records in a rural school district in Pierce County, Washington, to immunization records in the state immunization information system (IIS) and parent-held records. Correcting school immunization records resulted…

  15. The Concordance of Parent and Child Immunization.

    PubMed

    Robison, Steve G; Osborn, Andrew W

    2017-05-01

    A substantial body of work has related survey-based parental vaccine hesitancy to noncompliant childhood immunization. However little attention has been paid to the connection between parents' own immunization behavior and the immunizations their children receive. Using the Oregon ALERT Immunization Information System, we identified adult caregiver-child pairs for children between 9 months and 17 years of age. The likelihood of adult-child concordance of influenza immunization per influenza season from 2010-2011 through 2014-2015 was assessed. The utility of adult immunization as a predictor was also assessed for other, noninfluenza recommended immunizations for children and adolescents. A total of 450 687 matched adult caregiver-child pairs were included in the study. The children of immunizing adults were 2.77 times more likely to also be immunized for seasonal influenza across all seasons (95% confidence interval, 2.74-2.79), with similar results applying within each season. Adult immunization status was also significantly associated with the likelihood of children and adolescents getting other noninfluenza immunizations, such as the human papillomavirus vaccine (HPV). When adults improved their own behavior from nonimmunizing to immunizing across influenza seasons, their children if not immunized in the previous season were 5.44 times (95% confidence interval, 5.35-5.53) more likely to become immunized for influenza. Children's likelihood of following immunization recommendations is associated with the immunization behavior of their parents. Encouraging parental immunization is a potential tool for increasing children's immunization rates. Copyright © 2017 by the American Academy of Pediatrics.

  16. An evolutionary perspective on the systems of adaptive immunity.

    PubMed

    Müller, Viktor; de Boer, Rob J; Bonhoeffer, Sebastian; Szathmáry, Eörs

    2018-02-01

    We propose an evolutionary perspective to classify and characterize the diverse systems of adaptive immunity that have been discovered across all major domains of life. We put forward a new function-based classification according to the way information is acquired by the immune systems: Darwinian immunity (currently known from, but not necessarily limited to, vertebrates) relies on the Darwinian process of clonal selection to 'learn' by cumulative trial-and-error feedback; Lamarckian immunity uses templated targeting (guided adaptation) to internalize heritable information on potential threats; finally, shotgun immunity operates through somatic mechanisms of variable targeting without feedback. We argue that the origin of Darwinian (but not Lamarckian or shotgun) immunity represents a radical innovation in the evolution of individuality and complexity, and propose to add it to the list of major evolutionary transitions. While transitions to higher-level units entail the suppression of selection at lower levels, Darwinian immunity re-opens cell-level selection within the multicellular organism, under the control of mechanisms that direct, rather than suppress, cell-level evolution for the benefit of the individual. From a conceptual point of view, the origin of Darwinian immunity can be regarded as the most radical transition in the history of life, in which evolution by natural selection has literally re-invented itself. Furthermore, the combination of clonal selection and somatic receptor diversity enabled a transition from limited to practically unlimited capacity to store information about the antigenic environment. The origin of Darwinian immunity therefore comprises both a transition in individuality and the emergence of a new information system - the two hallmarks of major evolutionary transitions. Finally, we present an evolutionary scenario for the origin of Darwinian immunity in vertebrates. We propose a revival of the concept of the 'Big Bang' of

  17. Analysis of Drug Development Paradigms for Immune Checkpoint Inhibitors.

    PubMed

    Jardim, Denis L; de Melo Gagliato, Débora; Giles, Francis J; Kurzrock, Razelle

    2018-04-15

    Immune checkpoint inhibitors have unique toxicities and response kinetics compared with cytotoxic and gene-targeted anticancer agents. We investigated the impact of innovative/accelerated immunotherapy drug development/approval models on the accuracy of safety and efficacy assessments by searching the FDA website. Initial phase I trials for each agent were reviewed and safety and efficacy data compared with that found in later trials leading to regulatory approvals of the same agents. As of June 2017, the FDA approved six checkpoint inhibitors for a variety of cancer types. All checkpoint inhibitors received a priority review status and access to at least two additional FDA special access programs, more often breakthrough therapy designation and accelerated approval. Median clinical development time (investigational new drug application to approval) was 60.77 months [avelumab had the shortest timeline (52.33 months)]. Response rates during early phase I trials (median = 16%) are higher than for phase I trials of other agents (with the exception of gene-targeted agents tested with a biomarker). Doses approved were usually not identical to doses recommended on phase I trials. Approximately 50% of types of immune-related and 43% of types of clinically relevant toxicities from later trials were identified in early-phase trials. Even so, treatment-related mortality remains exceedingly low in later studies (0.33% of patients). In conclusion, efficacy and safety of immune checkpoint inhibitors appear to be reasonably predicted from the dose-finding portion of phase I trials, indicating that the fast-track development of these agents is safe and justified. Clin Cancer Res; 24(8); 1785-94. ©2017 AACR . ©2017 American Association for Cancer Research.

  18. Internet Access and Online Cancer Information Seeking Among Latino Immigrants From Safety Net Clinics

    PubMed Central

    SELSKY, CLAIRE; LUTA, GEORGE; NOONE, ANNE-MICHELLE; HUERTA, ELMER E.; MANDELBLATT, JEANNE S.

    2013-01-01

    Internet use is widespread, but little is known about Internet use for cancer information among Latinos, especially those who rely on safety net clinics. The authors investigated access to and intended use of the Internet for cancer information among low income, immigrant Latinos predominately from Central and South America. A cross-sectional study of 1,273 Latinos 21 years and older attending safety net clinics or health fairs was conducted from June 2007 to November 2008. The authors used logistic regression models to evaluate associations of age, acculturation, psychosocial factors and other covariates with Internet access and intended use of the Internet for cancer information among those with access. Of the sample, 44% reported Internet access. Higher information self-efficacy and greater trust in the Internet were independently associated with Internet access (p= .05 and p < .001, respectively). Among those with access, 53.8% reported they intended to seek cancer help online if they needed information. Those with younger age and higher acculturation, education and self-efficacy had higher odds of intended Internet use for cancer information, considering covariates. In addition, those with high (vs. low) perceived risk of cancer (OR = 1.76; 95% CI [1.14, 2.73]; p = .01) and higher levels of trust in online health information (OR = 1.47 per one-point increase; 95% [CI 1.19, 1.82]; p = .0004) were more likely to intend to seek cancer information online. These findings that Internet access is fairly high in the immigrant Latino population and that the Internet is a trusted source of cancer information suggest that the Internet may be a channel for cancer control interventions. PMID:23066874

  19. Bivalve immunity and response to infections: Are we looking at the right place?

    PubMed

    Allam, Bassem; Pales Espinosa, Emmanuelle

    2016-06-01

    Significant progress has been made in the understanding of cellular and molecular mediators of immunity in invertebrates in general and bivalve mollusks in particular. Despite this information, there is a lack of understanding of factors affecting animal resistance and specific responses to infections. This in part results from limited consideration of the spatial (and to some extent temporal) heterogeneity of immune responses and very limited information on host-pathogen (and microbes in general) interactions at initial encounter/colonization sites. Of great concern is the fact that most studies on molluscan immunity focus on the circulating hemocytes and the humoral defense factors in the plasma while most relevant host-microbe interactions occur at mucosal interfaces. This paper summarizes information available on the contrasting value of information available on focal and systemic immune responses in infected bivalves, and highlights the role of mucosal immune factors in host-pathogen interactions. Available information underlines the diversity of immune effectors at molluscan mucosal interfaces and highlights the tailored immune response to pathogen stimuli. This context raises fascinating basic research questions around host-microbe crosstalk and feedback controls of these interactions and may lead to novel disease mitigation strategies and improve the assessment of resistant crops or the screening of probiotic candidates. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. RhIG for the treatment of immune thrombocytopenia: consensus and controversy

    PubMed Central

    Despotovic, Jenny M.; Lambert, Michele P.; Herman, Jay H.; Gernsheimer, Terry B.; McCrae, Keith R.; Tarantino, Michael D.; Bussel, James B.

    2012-01-01

    Anti-D immune globulin (RhIG) is a front-line option in North America for the treatment of immune thrombocytopenia (ITP) in children and adults. Recently, addition of a Food and Drug Administration-mandated black box warning highlighted the risks of intravascular hemolysis, renal failure, and disseminated intravascular coagulation after anti-D infusion, prompting concern within the medical community regarding its use. A working group convened in response to this warning to prepare a consensus document regarding the safety of RhIG because there has been no increased incidence of adverse events since the initial discovery of these reactions many years ago. The efficacy of anti-D is well documented and only briefly reviewed. The estimated incidence and proposed mechanisms for the rare, major treatment-related complications are discussed, and signal detection data associated with heightened risk of acute hemolytic reactions are presented. The importance of considering host factors, given the rarity of severe reactions, is emphasized. Safety profiles of parallel treatment options are reviewed. The working group consensus is that RhIG has comparable safety and efficacy to other front-line agents for the treatment of children and adults with ITP. Safety may be further improved by careful patient selection. PMID:21981825

  1. Safety and immunogenicity of heterologous prime-boost immunization with viral-vectored malaria vaccines adjuvanted with Matrix-M™.

    PubMed

    Venkatraman, Navin; Anagnostou, Nicholas; Bliss, Carly; Bowyer, Georgina; Wright, Danny; Lövgren-Bengtsson, Karin; Roberts, Rachel; Poulton, Ian; Lawrie, Alison; Ewer, Katie; V S Hill, Adrian

    2017-10-27

    The use of viral vectors in heterologous prime-boost regimens to induce potent T cell responses in addition to humoral immunity is a promising vaccination strategy in the fight against malaria. We conducted an open-label, first-in-human, controlled Phase I study evaluating the safety and immunogenicity of Matrix-M adjuvanted vaccination with a chimpanzee adenovirus serotype 63 (ChAd63) prime followed by a modified vaccinia Ankara (MVA) boost eight weeks later, both encoding the malaria ME-TRAP antigenic sequence (a multiple epitope string fused to thrombospondin-related adhesion protein). Twenty-two healthy adults were vaccinated intramuscularly with either ChAd63-MVA ME-TRAP alone (n=6) or adjuvanted with 25μg (n=8) or 50μg (n=8) Matrix-M. Vaccinations appeared to be safe and generally well tolerated, with the majority of local and systemic adverse events being mild in nature. The addition of Matrix-M to the vaccine did not increase local reactogenicity; however, systemic adverse events were reported more frequently by volunteers who received adjuvanted vaccine in comparison to the control group. T cell ELISpot responses peaked at 7-days post boost vaccination with MVA ME-TRAP in all three groups. TRAP-specific IgG responses were highest at 28-days post boost with MVA ME-TRAP in all three groups. There were no differences in cellular and humoral immunogenicity at any of the time points between the control group and the adjuvanted groups. We demonstrate that Matrix-M can be safely used in combination with ChAd63-MVA ME-TRAP heterologous prime-boost immunization without any reduction in cellular or humoral immunogenicity. Clinical Trials Registration NCT01669512. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Dynamic of Immune Response induced in Hepatitis B Surface Antigen-transgenic Mice Immunized with a Novel Therapeutic Formulation

    PubMed Central

    Almeida, Freya M Freyre; Blanco, Aracelys; Trujillo, Heidy; Hernández, Dunia; García, Daymir; Alba, José S; Abad, Matilde López; Merino, Nelson; Lobaina, Yadira

    2016-01-01

    ABSTRACT The development of therapeutic vaccines against chronic hepatitis B requires the capacity of the formulation to subvert a tolerated immune response as well as the evaluation of histopathological damage resulting from the treatment. In the present study, the dynamicity of induced immune response to hepatitis B surface antigen (HBsAg) was evaluated in transgenic mice that constitutively express the HBsAg gene (HBsAg-tg mice). After immunization with a vaccine candidate containing both surface (HBsAg) and core (HBcAg) antigens of hepatitis B virus (HBV), the effect of vaccination on clearance of circulating HBsAg and the potential histological alterations were examined. Transgenic (tg) and non-transgenic (Ntg) mice were immunized by intranasal (IN) and subcutaneous (SC) routes simultaneously. A control group received phosphate-buffered saline (PBS) by IN route and aluminum by SC route. Positive responses, at both humoral and cellular levels, were obtained after five immunizations in HBsAg-tg mice. Such responses were delayed and of lower intensity in tg mice, compared to vaccinated Ntg mice. Serum IgG response was characterized by a similar IgG subclass pattern. Even when HBsAg-specific CD8+ T cell responses were clearly detectable by gamma-interferon ELISPOT assay, histopathological alterations were not detected in any organ, including the liver and kidneys. Our study demonstrated, that it is possible to subvert the immune tolerance against HBsAg in tg mice, opening a window for new studies to optimize the schedule, dose, and formulation to improve the immune response to the therapeutic vaccine candidate. These results can be considered a safety proof to support clinical developments for the formulation under study. How to cite this article Freyre FM, Blanco A, Trujillo H, Hernández D, García D, Alba JS, Lopez M, Merino N, Lobaina Y, Aguilar JC. Dynamic of Immune Response induced in Hepatitis B Surface Antigen-transgenic Mice Immunized with a Novel

  3. Immune tolerance: a synopsis of the international experience.

    PubMed

    Di Michele, D M

    1998-07-01

    Because of the increased morbidity and cost of care associated with inhibitor development, immune tolerance therapy (ITT) is of crucial value in the care of haemophilia. The 24-year experience with this modality, primarily in the treatment of factor VIII inhibitors, has included the use of both high and low doses of clotting factor, with and without immune modulation. Overall success rates for ITT in haemophilia A have been similar (63-83%), while median time to IT has been variable (1.2-24 months). The role of type and purity of clotting factor used remains unclear. Three immune tolerance registries have suggested the potential importance of treatment parameters such as pre-induction inhibitor titer and daily factor dose in the prediction of successful outcome. Ultimately, prospective randomized studies of ITT are required to definitively compare therapeutic regimens with respect to efficacy, safety, and cost effectiveness.

  4. Polio Endgame, Information Gaps Related to Vaccines and Immunity.

    PubMed

    Ahmad, Mohammad; Bahl, Sunil; Kunwar, Abhishek

    2016-08-07

    Evidence generated through research studies has guided programmatic actions and fine-tuned strategies for the Global Polio Eradication Initiative (GPEI). However, many gaps still persist in the understanding of a risk-free implementation of the polio endgame. Immediate concerns relate to the introduction of inactivated polio vaccine (IPV) and switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) in routine immunization schedule. A comprehensive understanding of mucosal immunity in populations and best response options against circulating vaccine derived poliovirus (cVDPV) outbreaks in post tOPV-bOPV switch is essential to mitigate the risks of wild and vaccine-derived poliovirus importations and emergence of cVDPVs in polio-free countries. A clearer picture is also needed on few operational issues, interference between polio vaccines and other EPI vaccines and products related to polio endgame. It is also extremely important to develop mechanisms to identify and manage long-term poliovirus excretors who may pose a risk of reintroduction into the population after global eradication of poliovirus.

  5. Self-adjuvanted mRNA vaccines induce local innate immune responses that lead to a potent and boostable adaptive immunity.

    PubMed

    Kowalczyk, Aleksandra; Doener, Fatma; Zanzinger, Kai; Noth, Janine; Baumhof, Patrick; Fotin-Mleczek, Mariola; Heidenreich, Regina

    2016-07-19

    mRNA represents a new platform for the development of therapeutic and prophylactic vaccines with high flexibility with respect to production and application. We have previously shown that our two component self-adjuvanted mRNA-based vaccines (termed RNActive® vaccines) induce balanced immune responses comprising both humoral and cellular effector as well as memory responses. Here, we evaluated the early events upon intradermal application to gain more detailed insights into the underlying mode of action of our mRNA-based vaccine. We showed that the vaccine is taken up in the skin by both non-leukocytic and leukocytic cells, the latter being mostly represented by antigen presenting cells (APCs). mRNA was then transported to the draining lymph nodes (dLNs) by migratory dendritic cells. Moreover, the encoded protein was expressed and efficiently presented by APCs within the dLNs as shown by T cell proliferation and immune cell activation, followed by the induction of the adaptive immunity. Importantly, the immunostimulation was limited to the injection site and lymphoid organs as no proinflammatory cytokines were detected in the sera of the immunized mice indicating a favorable safety profile of the mRNA-based vaccines. Notably, a substantial boostability of the immune responses was observed, indicating that mRNA can be used effectively in repetitive immunization schedules. The evaluation of the immunostimulation following prime and boost vaccination revealed no signs of exhaustion as demonstrated by comparable levels of cytokine production at the injection site and immune cell activation within dLNs. In summary, our data provide mechanistic insight into the mode of action and a rational for the use of mRNA-based vaccines as a promising immunization platform. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. El Camino Hospital: using health information technology to promote patient safety.

    PubMed

    Bukunt, Susan; Hunter, Christine; Perkins, Sharon; Russell, Diana; Domanico, Lee

    2005-10-01

    El Camino Hospital is a leader in the use of health information technology to promote patient safety, including bar coding, computerized order entry, electronic medical records, and wireless communications. Each year, El Camino Hospital's board of directors sets performance expectations for the chief executive officer, which are tied to achievement of local, regional, and national safety and quality standards, including the six Institute of Medicine quality dimensions. He then determines a set of explicit quality goals and measurable actions, which serve as guidelines for the overall hospital. The goals and progress reports are widely shared with employees, medical staff, patients and families, and the public. For safety, for example, the medication error reduction team tracks and reviews medication error rates. The hospital has virtually eliminated transcription errors through its 100% use of computerized physician order entry. Clinical pathways and standard order sets have reduced practice variation, providing a safer environment. Many projects focused on timeliness, such as emergency department wait time, lab turnaround time, and pneumonia time to initial antibiotic. Results have been mixed, with projects most successful when a link was established with patient outcomes, such as in reducing time to percutaneous transluminal coronary angioplasty for patients with acute myocardial infarction.

  7. Attitudes of Swiss Health Care Providers Toward Childhood Immunizations.

    PubMed

    Schuler, Marianne; Schaedelin, Sabine; Aebi, Christoph; Berger, Christoph; Crisinel, Pierre-Alex; Diana, Alessandro; Niederer-Loher, Anita; Siegrist, Claire-Anne; Vaudaux, Bernard; Heininger, Ulrich

    2017-06-01

    INFOVAC is a network providing information about immunization issues to health professionals. The aim of this study was to assess the attitude of INFOVAC subscribers toward the current Swiss immunization schedule, potential modifications, and current and hypothetical immunization practices regarding their own children. In March 2015, a Web-based survey was sent to 4260 physicians and pharmacists subscribed to INFOVAC. Participation was anonymous and voluntary. The following information was obtained: (1) current immunization status of own children; (2) which immunizations would currently be accepted for a hypothetical own child and (3) attitudes toward potential modifications of the Swiss immunization schedule. Descriptive methods and multivariate models to correct for covariables were used for data analysis. Nine hundred and fifty-five valid questionnaires were received: 886/3704 (23.9%) from physicians and 69/556 (12.4%) from pharmacists. Current (>95%) and hypothetical (>99%) immunization rates were high for diphtheria, tetanus, pertussis, poliomyelitis and measles-mumps-rubella. Most pediatricians (61%) would support more vaccines for their children than currently recommended by the Swiss immunization advisory committee, whereas about 50% of other physicians and pharmacists would decline at least one of the recommended immunizations, most frequently varicella, pneumococcal or meningococcal C conjugate vaccines. Strong general support was expressed for the expansion of human papillomavirus immunization to males, acceleration of the measles-mumps-rubella schedule and a 2 + 1 instead of 3 + 1 diphtheria-tetanus-pertussis, acellular-inactivated poliomyelitis vaccine (DTPa-IPV)/Haemophilus influenzae type b ± hepatitis B virus (HBV) schedule. Survey participants generally demonstrated a positive attitude toward immunization, with pediatricians being the most progressive subgroup with the largest percentage of participants (63.1%) neither declining nor postponing any

  8. Tornadoes: Nature's Most Violent Storms. A Preparedness Guide Including Safety Information for Schools.

    ERIC Educational Resources Information Center

    American National Red Cross, Washington, DC.

    This preparedness guide explains and describes tornadoes, and includes safety information for schools. A tornado is defined as a violently rotating column of air extending from a thunderstorm to the ground. The guide explains the cause of tornadoes, provides diagrams of how they form, describes variations of tornadoes, and classifies tornadoes by…

  9. Spaceflight and immune responses of Rhesus monkeys

    NASA Technical Reports Server (NTRS)

    Sonnenfeld, Gerald

    1994-01-01

    Evidence from both human and rodent studies indicates that alterations in immunological parameters occur after space flight. The objective of this project is to determine the effects of space flight on immune responses of Rhesus monkeys. The expected significance of the work is a determination of the range of immunological functions of the Rhesus monkey, a primate similar in many ways to man, affected by space flight. Changes in immune responses that could yield alterations in resistance to infection may be determined as well as the duration of alterations in immune responses. Additional information on the nature of cellular interactions for the generation of immune responses may also be obtained.

  10. Too much information? A document analysis of sport safety resources from key organisations.

    PubMed

    Bekker, Sheree; Finch, Caroline F

    2016-05-06

    The field of sport injury prevention has seen a marked increase in published research in recent years, with concomitant proliferation of lay sport safety resources, such as policies, fact sheets and posters. The aim of this study was to catalogue and categorise the number, type and topic focus of sport safety resources from a representative set of key organisations. Cataloguing and qualitative document analysis of resources available from the websites of six stakeholder organisations in Australia. This study was part of a larger investigation, the National Guidance for Australian Football Partnerships and Safety (NoGAPS) project. The NoGAPS study provided the context for a purposive sampling of six organisations involved in the promotion of safety in Australian football. These partners are recognised as being highly representative of organisations at national and state level that reflect similarly in their goals around sport safety promotion in Australia. The catalogue comprised 284 resources. More of the practical and less prescriptive types of resources, such as fact sheets, than formal policies were found. Resources for the prevention of physical injuries were the predominant sport safety issue addressed, with risk management, environmental issues and social behaviours comprising other categories. Duplication of resources for specific safety issues, within and across organisations, was found. People working within sport settings have access to a proliferation of resources, which creates a potential rivalry for sourcing of injury prevention information. Important issues that are likely to influence the uptake of safety advice by the general sporting public include the sheer number of resources available, and the overlap and duplication of resources addressing the same issues. The existence of a large number of resources from reputable organisations does not mean that they are necessarily evidence based, fully up to date or even effective in supporting sport

  11. Innate control of adaptive immunity: Beyond the three-signal paradigm

    PubMed Central

    Jain, Aakanksha; Pasare, Chandrashekhar

    2017-01-01

    Activation of cells in the adaptive immune system is a highly orchestrated process dictated by multiples cues from the innate immune system. Although the fundamental principles of innate control of adaptive immunity are well established, it is not fully understood how innate cells integrate qualitative pathogenic information in order to generate tailored protective adaptive immune responses. In this review, we discuss complexities involved in the innate control of adaptive immunity that extend beyond T cell receptor engagement, co-stimulation and priming cytokine production but are critical for generation of protective T cell immunity. PMID:28483987

  12. A bibliometric analysis of childhood immunization research productivity in Africa since the onset of the Expanded Program on Immunization in 1974

    PubMed Central

    2013-01-01

    Background The implementation of strategic immunization plans whose development is informed by available locally-relevant research evidence should improve immunization coverage and prevent disease, disability and death in Africa. In general, health research helps to answer questions, generate the evidence required to guide policy and identify new tools. However, factors that influence the publication of immunization research in Africa are not known. We, therefore, undertook this study to fill this research gap by providing insights into factors associated with childhood immunization research productivity on the continent. We postulated that research productivity influences immunization coverage. Methods We conducted a bibliometric analysis of childhood immunization research output from Africa, using research articles indexed in PubMed as a surrogate for total research productivity. We used zero-truncated negative binomial regression models to explore the factors associated with research productivity. Results We identified 1,641 articles on childhood immunization indexed in PubMed between 1974 and 2010 with authors from Africa, which represent only 8.9% of the global output. Five countries (South Africa, Nigeria, The Gambia, Egypt and Kenya) contributed 48% of the articles. After controlling for population and gross domestic product, The Gambia, Guinea-Bissau and Sao Tome and Principe were the most productive countries. In univariable analyses, the country's gross domestic product, total health expenditure, private health expenditure, and research and development expenditure had a significant positive association with increased research productivity. Immunization coverage, adult literacy rate, human development index and physician density had no significant association. In the multivarable model, only private health expenditure maintained significant statistical association with the number of immunization articles. Conclusions Immunization research productivity in

  13. Bronson Methodist Hospital: journey to excellence in quality and safety.

    PubMed

    Knapp, Cheryl

    2006-10-01

    Bronson Healthcare Group, a 343-bed not-for-profit health care system serving all of southwest Michigan and northern Indiana, has as its flagship Bronson Methodist Hospital, the recipient of the 2005 Malcolm Baldrige National Quality Award. The Baldrige criteria were used to formalize Bronson's approach to performance excellence. The strategic plan is condensed and communicated via a "Plan for Excellence" focused on three strategies: clinical excellence, customer and service excellence, and corporate effectiveness. Initiatives include clinical scene investigation (a system for reporting and investigating sentinel and atypical events), a strategy for educating staff in the Situation-Background-Assessment-Recommendations (SBAR) communication technique, and mandatory influenza immunization for health care staff (safety), patient health literacy needs and a health information center (patient centeredness); methods to reduce bloodstream and ventilator-acquired pneumonia infections (effectiveness); a physician portal for access to forms, test results, and patient information (efficiency); restaurant-style pagers for patients and families while waiting (timeliness); and community outreach (equity). Bronson's journey to excellence continues with more accountability for hand-off communication and teamwork, enhancing a non-punitive environment for patient safety reporting, and further incorporating patient and family involvement.

  14. Implementation of pertussis immunization in health-care personnel.

    PubMed

    Walther, Kathi; Burckhardt, Marie-Anne; Erb, Thomas; Heininger, Ulrich

    2015-04-21

    Infection with Bordetella pertussis is most severe in young infants who frequently acquire it from adults. Pertussis immunization in adults 25-29 years of age and all adults in close contact with infants <6 months was introduced in Switzerland in 2012. We immediately implemented this new recommendation in our hospital with a vaccination campaign. Between April 2012 and March 2013 we provided information about the campaign to our staff through several channels and offered appointments for counseling and immunization. After checking indications and contraindications of responding health-care personnel (HCP), informed consent for tetanus-diphtheria-acellular pertussis component (Tdap) immunization was obtained. Specific adverse events (AE) were self-assessed by standardized diaries for 7 days. Statistical analyses were performed using a t-test and Mann-Whitney U-tests SPSS (V21). Of 852 HCP eligible for pertussis immunization, 427 (51%) responded. Of these, 72 (17%) had already received Tdap <10 years ago, 304 (71%) received Tdap now, 38 (9%) were scheduled for vaccination and 12 (3%) declined. Diaries were returned by 272 (89%) of 304 vaccinees; 56 HCP reported ≥1 local AE, most frequently local swelling (8%), redness (2%), redness and swelling (7%), and fever (5=2%); no serious AE occurred. Comprehensive efforts were needed to achieve pertussis immunization coverage of ≥49% among all HCP in our institution. Good tolerability of the vaccine and continuous and individual information to HCP about the rationale and benefits of pertussis immunization contributed to this partial success, but increased efforts are needed to mobilize non-responding HCP. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study

    PubMed Central

    Medagama, Arjuna Bandara; Widanapahirana, Heshan; Prasanga, Tharindu

    2015-01-01

    Aims: There is an increase of over-the-counter (OTC) herbal products for use in diabetes mellitus. The aim of this study is to evaluate the safety information provided with OTC herbal remedies intended for diabetic patients in Sri Lanka and to assess the completeness of the information provided. Methods: Inclusion criteria consisted of OTC herbal remedies meant for use in diabetes. They were bought from local Sri Lankan supermarkets and non-ayurvedic pharmacies and product information regarding the risk of hypoglycemia, precautions for use, adverse events, dose, and interactions were assessed using a scoring system. The accuracy of the information was then compared against published data. Results: 11 products fulfilled the inclusion criteria. Five products contained a single constituent and five contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycemia. 9 out of 11 products (81.8%) carried ≤3 items of the five essential factual information we expected. Hypoglycemic coma, gastrointestinal symptoms, hepatotoxicity, carcinogenesis, and interactions causing elevated drug levels of Carbamazepine were some of the safety information that was missing. Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority. PMID:26649230

  16. Immunity: plants as effective mediators.

    PubMed

    Sultan, M Tauseef; Butt, Masood Sadiq; Qayyum, Mir M Nasir; Suleria, Hafiz Ansar Rasul

    2014-01-01

    In the domain of nutrition, exploring the diet-health linkages is major area of research. The outcomes of such interventions led to widespread acceptance of functional and nutraceutical foods; however, augmenting immunity is a major concern of dietary regimens. Indeed, the immune system is incredible arrangement of specific organs and cells that enabled humans to carry out defense against undesired responses. Its proper functionality is essential to maintain the body homeostasis. Array of plants and their components hold immunomodulating properties. Their possible inclusion in diets could explore new therapeutic avenues to enhanced immunity against diseases. The review intended to highlight the importance of garlic (Allium sativum), green tea (Camellia sinensis), ginger (Zingiber officinale), purple coneflower (Echinacea), black cumin (Nigella sativa), licorice (Glycyrrhiza glabra), Astragalus and St. John's wort (Hypericum perforatum) as natural immune boosters. These plants are bestowed with functional ingredients that may provide protection against various menaces. Modes of their actions include boosting and functioning of immune system, activation and suppression of immune specialized cells, interfering in several pathways that eventually led to improvement in immune responses and defense system. In addition, some of these plants carry free radical scavenging and anti-inflammatory activities that are helpful against cancer insurgence. Nevertheless, interaction between drugs and herbs/botanicals should be well investigated before recommended for their safe use, and such information must be disseminated to the allied stakeholders.

  17. Titanium dioxide nanoparticles stimulate sea urchin immune cell phagocytic activity involving TLR/p38 MAPK-mediated signalling pathway

    PubMed Central

    Pinsino, Annalisa; Russo, Roberta; Bonaventura, Rosa; Brunelli, Andrea; Marcomini, Antonio; Matranga, Valeria

    2015-01-01

    Titanium dioxide nanoparticles (TiO2NPs) are one of the most widespread-engineered particles in use for drug delivery, cosmetics, and electronics. However, TiO2NP safety is still an open issue, even for ethical reasons. In this work, we investigated the sea urchin Paracentrotus lividus immune cell model as a proxy to humans, to elucidate a potential pathway that can be involved in the persistent TiO2NP-immune cell interaction in vivo. Morphology, phagocytic ability, changes in activation/inactivation of a few mitogen-activated protein kinases (p38 MAPK, ERK), variations of other key proteins triggering immune response (Toll-like receptor 4-like, Heat shock protein 70, Interleukin-6) and modifications in the expression of related immune response genes were investigated. Our findings indicate that TiO2NPs influence the signal transduction downstream targets of p38 MAPK without eliciting an inflammatory response or other harmful effects on biological functions. We strongly recommend sea urchin immune cells as a new powerful model for nano-safety/nano-toxicity investigations without the ethical normative issue. PMID:26412401

  18. Effects of Food Additives on Immune Cells As Contributors to Body Weight Gain and Immune-Mediated Metabolic Dysregulation.

    PubMed

    Paula Neto, Heitor A; Ausina, Priscila; Gomez, Lilian S; Leandro, João G B; Zancan, Patricia; Sola-Penna, Mauro

    2017-01-01

    Food additives are compounds used in order to improve food palatability, texture, and shelf life. Despite a significant effort to assure safety of use, toxicological analysis of these substances, generally, rely on their direct toxicity to target organs (liver and kidney) or their genotoxic effects. Much less attention is paid to the effects of these compounds on cells of the immune system. This is of relevance given that metabolic dysregulation and obesity have a strong immune-mediated component. Obese individuals present a state of chronic low-grade inflammation that contributes to the establishment of insulin resistance and other metabolic abnormalities known as the metabolic syndrome. Obesity and metabolic syndrome are currently recognized as worldwide epidemics that pose a profound socioeconomic impact and represent a concern to public health. Cells of the immune system contribute to both the maintenance of "lean homeostasis" and the metabolic dysregulation observed in obese individuals. Although much attention has been drawn in the past decades to obesity and metabolic syndrome as a result of ingesting highly processed food containing large amounts of fat and simple sugars, mounting evidence suggest that food additives may also be important contributors to metabolic derangement. Herein, we review pieces of evidence from the literature showing that food additives have relevant effects on cells of the immune system that could contribute to immune-mediated metabolic dysregulation. Considering their potential to predispose individuals to develop obesity and metabolic syndrome, their use should be taken with caution or maybe revisited.

  19. Virtual Safety Training.

    ERIC Educational Resources Information Center

    Fuller, Scott; Davis, Jason

    2003-01-01

    The Multimedia Tool Box Talk is a web-based quick reference safety guide and training tool for construction personnel. An intended outcome of this effort was to provide an efficient and effective way to locate and interpret crucial safety information while at the job site. The tool includes information from the Occupational Safety and Health…

  20. 75 FR 64348 - BOEMRE Information Collection Activity: 1010-0182, Increased Safety Measures for Energy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-19

    ... No. BOEM-2010-0052] BOEMRE Information Collection Activity: 1010-0182, Increased Safety Measures for... the likelihood of blowouts, loss of well control, fires, spillages, physical obstruction to other... subsequent oil spill in the Gulf of Mexico. These events highlight the importance of ensuring safe operations...

  1. The immune response against Candida spp. and Sporothrix schenckii.

    PubMed

    Martínez-Álvarez, José A; Pérez-García, Luis A; Flores-Carreón, Arturo; Mora-Montes, Héctor M

    2014-01-01

    Candida albicans is the main causative agent of systemic candidiasis, a condition with high mortality rates. The study of the interaction between C. albicans and immune system components has been thoroughly studied and nowadays there is a model for the anti-C. albicans immune response; however, little is known about the sensing of other pathogenic species of the Candida genus. Sporothrix schenckii is the causative agent of sporotrichosis, a subcutaneous mycosis, and thus far there is limited information about its interaction with the immune system. In this paper, we review the most recent information about the immune sensing of species from genus Candida and S. schenckii. Thoroughly searches in scientific journal databases were performed, looking for papers addressing either Candida- or Sporothrix-immune system interactions. There is a significant advance in the knowledge of non-C. albicans species of Candida and Sporothrix immune sensing; however, there are still relevant points to address, such as the specific contribution of pathogen-associated molecular patterns (PAMPs) for sensing by different immune cells and the immune receptors involved in such interactions. This manuscript is part of the series of works presented at the "V International Workshop: Molecular genetic approaches to the study of human pathogenic fungi" (Oaxaca, Mexico, 2012). Copyright © 2013 Revista Iberoamericana de Micología. Published by Elsevier Espana. All rights reserved.

  2. Public service communications satellite. [health, education, safety and information transfer applications

    NASA Technical Reports Server (NTRS)

    Wolff, E. A.

    1978-01-01

    Health, education, public safety, and information transfer applications of public service communications satellites are discussed with particular attention to the use of communications satellites to improve rural health delivery. Health-care communications requirements are summarized. The communications system concept involves small inexpensive stationary, portable, and moving ground terminals which will provide communications between any two points in the U.S. with both fixed and moving terminals on a continuous 24-hour basis. User requirements, wavebands, and privacy techniques are surveyed.

  3. 34 CFR 99.36 - What conditions apply to disclosure of information in health and safety emergencies?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... student, in connection with an emergency if knowledge of the information is necessary to protect the... is necessary to protect the health or safety of the student or other individuals. If, based on the... 34 Education 1 2011-07-01 2011-07-01 false What conditions apply to disclosure of information in...

  4. 34 CFR 99.36 - What conditions apply to disclosure of information in health and safety emergencies?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... student, in connection with an emergency if knowledge of the information is necessary to protect the... is necessary to protect the health or safety of the student or other individuals. If, based on the... 34 Education 1 2013-07-01 2013-07-01 false What conditions apply to disclosure of information in...

  5. Health and Safety in Day Care.

    ERIC Educational Resources Information Center

    Sells, Clifford J.; Paeth, Susan

    1987-01-01

    Basic health and day care policies and procedures should be implemented and closely monitored with the help of a health consultant, particularly in terms of respiratory tract, enteric, skin, invasive bacterial, and multiple system infections; Acquired Immune Deficiency Syndrome; vaccine preventable diseases; and general safety procedures.…

  6. Immune response

    MedlinePlus

    Innate immunity; Humoral immunity; Cellular immunity; Immunity; Inflammatory response; Acquired (adaptive) immunity ... normal and usually does not react against them. INNATE IMMUNITY Innate, or nonspecific, immunity is the defense ...

  7. Evaluating Childhood Vaccination Coverage of NIP Vaccines: Coverage Survey versus Zhejiang Provincial Immunization Information System

    PubMed Central

    Hu, Yu; Chen, Yaping

    2017-01-01

    Vaccination coverage in Zhejiang province, east China, is evaluated through repeated coverage surveys. The Zhejiang provincial immunization information system (ZJIIS) was established in 2004 with links to all immunization clinics. ZJIIS has become an alternative to quickly assess the vaccination coverage. To assess the current completeness and accuracy on the vaccination coverage derived from ZJIIS, we compared the estimates from ZJIIS with the estimates from the most recent provincial coverage survey in 2014, which combined interview data with verified data from ZJIIS. Of the enrolled 2772 children in the 2014 provincial survey, the proportions of children with vaccination cards and registered in ZJIIS were 94.0% and 87.4%, respectively. Coverage estimates from ZJIIS were systematically higher than the corresponding estimates obtained through the survey, with a mean difference of 4.5%. Of the vaccination doses registered in ZJIIS, 16.7% differed from the date recorded in the corresponding vaccination cards. Under-registration in ZJIIS significantly influenced the coverage estimates derived from ZJIIS. Therefore, periodic coverage surveys currently provide more complete and reliable results than the estimates based on ZJIIS alone. However, further improvement of completeness and accuracy of ZJIIS will likely allow more reliable and timely estimates in future. PMID:28696387

  8. Evaluating Childhood Vaccination Coverage of NIP Vaccines: Coverage Survey versus Zhejiang Provincial Immunization Information System.

    PubMed

    Hu, Yu; Chen, Yaping

    2017-07-11

    Vaccination coverage in Zhejiang province, east China, is evaluated through repeated coverage surveys. The Zhejiang provincial immunization information system (ZJIIS) was established in 2004 with links to all immunization clinics. ZJIIS has become an alternative to quickly assess the vaccination coverage. To assess the current completeness and accuracy on the vaccination coverage derived from ZJIIS, we compared the estimates from ZJIIS with the estimates from the most recent provincial coverage survey in 2014, which combined interview data with verified data from ZJIIS. Of the enrolled 2772 children in the 2014 provincial survey, the proportions of children with vaccination cards and registered in ZJIIS were 94.0% and 87.4%, respectively. Coverage estimates from ZJIIS were systematically higher than the corresponding estimates obtained through the survey, with a mean difference of 4.5%. Of the vaccination doses registered in ZJIIS, 16.7% differed from the date recorded in the corresponding vaccination cards. Under-registration in ZJIIS significantly influenced the coverage estimates derived from ZJIIS. Therefore, periodic coverage surveys currently provide more complete and reliable results than the estimates based on ZJIIS alone. However, further improvement of completeness and accuracy of ZJIIS will likely allow more reliable and timely estimates in future.

  9. Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

    PubMed

    Pathirana, Jayani; Muñoz, Flor M; Abbing-Karahagopian, Victoria; Bhat, Niranjan; Harris, Tara; Kapoor, Ambujam; Keene, Daniel L; Mangili, Alexandra; Padula, Michael A; Pande, Stephen L; Pool, Vitali; Pourmalek, Farshad; Varricchio, Frederick; Kochhar, Sonali; Cutland, Clare L

    2016-12-01

    More than 40% of all deaths in children under 5 years of age occur during the neonatal period: the first month of life. Immunization of pregnant women has proven beneficial to both mother and infant by decreasing morbidity and mortality. With an increasing number of immunization trials being conducted in pregnant women, as well as roll-out of recommended vaccines to pregnant women, there is a need to clarify details of a neonatal death. This manuscript defines levels of certainty of a neonatal death, related to the viability of the neonate, who confirmed the death, and the timing of the death during the neonatal period and in relation to immunization of the mother. Copyright © 2016. Published by Elsevier Ltd.

  10. ImmuneDB: a system for the analysis and exploration of high-throughput adaptive immune receptor sequencing data.

    PubMed

    Rosenfeld, Aaron M; Meng, Wenzhao; Luning Prak, Eline T; Hershberg, Uri

    2017-01-15

    As high-throughput sequencing of B cells becomes more common, the need for tools to analyze the large quantity of data also increases. This article introduces ImmuneDB, a system for analyzing vast amounts of heavy chain variable region sequences and exploring the resulting data. It can take as input raw FASTA/FASTQ data, identify genes, determine clones, construct lineages, as well as provide information such as selection pressure and mutation analysis. It uses an industry leading database, MySQL, to provide fast analysis and avoid the complexities of using error prone flat-files. ImmuneDB is freely available at http://immunedb.comA demo of the ImmuneDB web interface is available at: http://immunedb.com/demo CONTACT: Uh25@drexel.eduSupplementary information: Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  11. Perceptions of Psychological and Physical Safety Environments of Information Technology Employees: A Phenomenological Study

    ERIC Educational Resources Information Center

    Payne, Sheila C.

    2012-01-01

    A qualitative phenomenological study was conducted to gain a deeper understanding of psychological and safety environments of an oil and gas multinational enterprise. Twenty information technology professionals were interviewed to explore their feelings, perceptions, beliefs, and values of the phenomenon. The interviews elicited data about facets…

  12. Apps for immunization: Leveraging mobile devices to place the individual at the center of care.

    PubMed

    Wilson, Kumanan; Atkinson, Katherine M; Westeinde, Jacqueline

    2015-01-01

    Mobile technology and applications (apps) have disrupted several industries including healthcare. The advantage of apps, being personally focused and permitting bidirectional communication, make them well suited to address many immunization challenges. As of April 25, 2015 searching the Android app store with the words 'immunize app' and 'immunization app' in Canada yielded 225 apps. On the Apple App Store a similar search produced 98 results. These include apps that provide immunization related information, permit vaccine tracking both for individuals and for animals, assist with the creation of customized schedules and identification of vaccine clinics and serve as sources of education. The diverse functionality of mobile apps creates the potential for transformation of immunization practice both at a personal level and a system level. For individuals, mobile apps offer the opportunity for better record keeping, assistance with the logistics of vaccination, and novel ways of communicating with and receiving information from public health officials. For the system, mobile apps offer the potential to improve the quality of information residing in immunization information systems and program evaluation, facilitate harmonization of immunization information between individuals, health care providers and public health as well as reduce vaccine hesitancy. As mobile technology continues to rapidly evolve there will emerge new ways in which apps can enhance immunization practice.

  13. A modified live canine parvovirus vaccine. II. Immune response.

    PubMed

    Carmichael, L E; Joubert, J C; Pollock, R V

    1983-01-01

    The safety and efficacy of an attenuated canine parvovirus (A-CPV) vaccine was evaluated in both experimental and in field dogs. After parenteral vaccination, seronegative dogs developed hemagglutination-inhibition (HI) antibody titers as early as postvaccination (PV) day 2. Maximal titers occurred within 1 week. Immunity was associated with the persistence of HI antibody titers (titers greater than 80) that endured at least 2 years. Immune dogs challenged with virulent CPV did not shed virus in their feces. The A-CPV vaccine did not cause illness alone or in combination with living canine distemper (CD) and canine adenovirus type-2 (CAV-2) vaccines, nor did it interfere with the immune response to the other viruses. A high rate (greater than 98%) of immunity was engendered in seronegative pups. In contrast, maternal antibody interfered with the active immune response to the A-CPV. More than 95% of the dogs with HI titers less than 10 responded to the vaccine, but only 50% responded when titers were approximately 20. No animal with a titer greater than 80 at the time of vaccination became actively immunized. Susceptibility to virulent CPV during that period when maternal antibody no longer protects against infection, but still prevents active immunization, is the principal cause of vaccinal failure in breeding kennels where CPV is present. Reduction, but not complete elimination, of CPV disease in large breeding kennels occurred within 1-2 months of instituting an A-CPV vaccination program.

  14. Colonic Immune Stimulation by Targeted Oral Vaccine

    PubMed Central

    Kathania, Mahesh; Zadeh, Mojgan; Lightfoot, Yaíma L.; Roman, Robert M.; Sahay, Bikash; Abbott, Jeffrey R.; Mohamadzadeh, Mansour

    2013-01-01

    Background Currently, sufficient data exist to support the use of lactobacilli as candidates for the development of new oral targeted vaccines. To this end, we have previously shown that Lactobacillus gasseri expressing the protective antigen (PA) component of anthrax toxin genetically fused to a dendritic cell (DC)-binding peptide (DCpep) induced efficacious humoral and T cell-mediated immune responses against Bacillus anthracis Sterne challenge. Methodology/Principal Finding In the present study, we investigated the effects of a dose dependent treatment of mice with L. gasseri expressing the PA-DCpep fusion protein on intestinal and systemic immune responses and confirmed its safety. Treatment of mice with different doses of L. gasseri expressing PA-DCpep stimulated colonic immune responses, resulting in the activation of innate immune cells, including dendritic cells, which induced robust Th1, Th17, CD4+Foxp3+ and CD8+Foxp3+ T cell immune responses. Notably, high doses of L. gasseri expressing PA-DCpep (1012 CFU) were not toxic to the mice. Treatment of mice with L. gasseri expressing PA-DCpep triggered phenotypic maturation and the release of proinflammatory cytokines by dendritic cells and macrophages. Moreover, treatment of mice with L. gasseri expressing PA-DCpep enhanced antibody immune responses, including IgA, IgG1, IgG2b, IgG2c and IgG3. L. gasseri expressing PA-DCpep also increased the gene expression of numerous pattern recognition receptors, including Toll-like receptors, C-type lectin receptors and NOD-like receptors. Conclusion/Significance These findings suggest that L. gasseri expressing PA-DCpep has substantial immunopotentiating properties, as it can induce humoral and T cell-mediated immune responses upon oral administration and may be used as a safe oral vaccine against anthrax challenge. PMID:23383086

  15. Testicular defense systems: immune privilege and innate immunity

    PubMed Central

    Zhao, Shutao; Zhu, Weiwei; Xue, Shepu; Han, Daishu

    2014-01-01

    The mammalian testis possesses a special immunological environment because of its properties of remarkable immune privilege and effective local innate immunity. Testicular immune privilege protects immunogenic germ cells from systemic immune attack, and local innate immunity is important in preventing testicular microbial infections. The breakdown of local testicular immune homeostasis may lead to orchitis, an etiological factor of male infertility. The mechanisms underlying testicular immune privilege have been investigated for a long time. Increasing evidence shows that both a local immunosuppressive milieu and systemic immune tolerance are involved in maintaining testicular immune privilege status. The mechanisms underlying testicular innate immunity are emerging based on the investigation of the pattern recognition receptor-mediated innate immune response in testicular cells. This review summarizes our current understanding of testicular defense mechanisms and identifies topics that merit further investigation. PMID:24954222

  16. Evaluation of Baby Advocate, a childhood immunization reminder system.

    PubMed

    Ludwig-Beymer, P; Hefferan, C

    2001-10-01

    Childhood immunizations, based on CDC recommendations, are recognized as a cost effective and health promoting practice. However, ensuring full immunization requires a long-term commitment on the part of parents and providers. This article describes a program at Advocate Health care to increase the percentage of children fully immunized at two years to 90%. Termed Baby Advocate, the program uses a mailed reminder system that includes vaccine and growth and development information along with gifts and incentives. Volume, satisfaction and immunization status data are presented.

  17. Lasting monitoring of immune state in patients with coronary atherosclerosis

    NASA Astrophysics Data System (ADS)

    Malinova, Lidia I.; Denisova, Tatyana P.; Tuchin, Valery V.

    2007-02-01

    Immune state monitoring is an expensive, invasive and sometimes difficult necessity in patients with different disorders. Immune reaction dynamics study in patients with coronary atherosclerosis provides one of the leading components to complication development, clinical course prognosis and treatment and rehabilitation tactics. We've chosen intravenous glucose injection as metabolic irritant in the following four groups of patients: men with proved coronary atherosclerosis (CA), non insulin dependent diabetes mellitus (NIDDM), men hereditary burden by CA and NIDDM and practically healthy persons with longlivers in generation. Immune state parameters such as quantity of leukocytes and lymphocytes, circulating immune complexes levels, serum immunoglobulin levels, HLA antigen markers were studied at 0, 30 and 60 minutes during glucose loading. To obtain continues time function of studied parameters received data were approximated by polynomials of high degree with after going first derivatives. Time functions analyze elucidate principally different dynamics studied parameters in all chosen groups of patients, which couldn't be obtained from discontinuous data compare. Leukocyte and lymphocyte levels dynamics correlated HLA antigen markers in all studied groups. Analytical estimation of immune state in patients with coronary atherosclerosis shows the functional "margin of safety" of immune system state under glucose disturbance. Proposed method of analytical estimation also can be used in immune system monitoring in other groups of patients.

  18. 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.

  19. Evaluation of the immune status against measles, mumps, and rubella in adult allogeneic hematopoietic stem cell transplantation recipients.

    PubMed

    Kawamura, Koji; Yamazaki, Rie; Akahoshi, Yu; Nakano, Hirofumi; Ugai, Tomotaka; Wada, Hidenori; Yamasaki, Ryoko; Ishihara, Yuko; Sakamoto, Kana; Ashizawa, Masahiro; Sato, Miki; Terasako-Saito, Kiriko; Kimura, Shun-ichi; Kikuchi, Misato; Nakasone, Hideki; Kanda, Junya; Kako, Shinichi; Tanihara, Aki; Nishida, Junji; Kanda, Yoshinobu

    2015-03-01

    Previous studies have shown that most patients lose immunity to measles, mumps, and rubella (MMR) during long-term follow-up after allogeneic hematopoietic stem cell transplantation (HSCT), and immunizations against them have been investigated. However, these previous studies mainly targeted pediatric patients and information in adult patients is still insufficient. We evaluated the immunity to MMR in 45 adult allogeneic HSCT patients. None of these patients received vaccination after HSCT. The seropositive rates at six years after allogeneic HSCT were estimated to be less than 44% for measles, less than 10% for mumps, and less than 36% for rubella. Thirteen of the 16 female patients who were 16-39 years old were negative or equivocal for rubella. Patients who developed grade II-IV acute graft-versus-host disease tended to become seronegative for measles and rubella at two years after HSCT, although the difference was not statistically significant. This study showed that most adult patients lost immunity to MMR after allogeneic HSCT. Although we did not evaluate the safety and efficacy of vaccination in this study, most HSCT guidelines recommend vaccination for HSCT recipients without active chronic graft-versus-host disease or ongoing immunosuppressive therapy at 24 months after HSCT. Immunization against rubella is especially important for female patients of reproductive age. Further studies will be necessary to evaluate the effect of vaccination on the antibody response in adult allogeneic HSCT recipients.

  20. Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

    PubMed

    Kochhar, Sonali; Bonhoeffer, Jan; Jones, Christine E; Muñoz, Flor M; Honrado, Angel; Bauwens, Jorgen; Sobanjo-Ter Meulen, Ajoke; Hirschfeld, Steven

    2017-12-04

    Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally. Copyright © 2017. Published by Elsevier Ltd.

  1. The role of immune system exhaustion on cancer cell escape and anti-tumor immune induction after irradiation.

    PubMed

    Mendes, Fernando; Domingues, Cátia; Rodrigues-Santos, Paulo; Abrantes, Ana Margarida; Gonçalves, Ana Cristina; Estrela, Jéssica; Encarnação, João; Pires, Ana Salomé; Laranjo, Mafalda; Alves, Vera; Teixo, Ricardo; Sarmento, Ana Bela; Botelho, Maria Filomena; Rosa, Manuel Santos

    2016-04-01

    Immune surveillance seems to represent an effective tumor suppressor mechanism. However, some cancer cells survive and become variants, being poorly immunogenic and able to enter a steady-state phase. These cells become functionally dormant or remain hidden clinically throughout. Neoplastic cells seem to be able to instruct immune cells to undergo changes promoting malignancy. Radiotherapy may act as a trigger of the immune response. After radiotherapy a sequence of reactions occurs, starting in the damage of oncogenic cells by multiple mechanisms, leading to the immune system positive feedback against the tumor. The link between radiotherapy and the immune system is evident. T cells, macrophages, Natural Killer cells and other immune cells seem to have a key role in controlling the tumor. T cells may be dysfunctional and remain in a state of T cell exhaustion, nonetheless, they often retain a high potential for successful defense against cancer, being able to be mobilized to become highly functional. The lack of clinical trials on a large scale makes data a little robust, in spite of promising information, there are still many variables in the studies relating to radiation and immune system. The clarification of the mechanisms underlying immune response to radiation exposure may contribute to treatment improvement, gain of life quality and span of patients. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Immunization against Genital Herpes with a Vaccine Virus That has Defects in Productive and Latent Infection

    NASA Astrophysics Data System (ADS)

    da Costa, Xavier J.; Jones, Cheryl A.; Knipe, David M.

    1999-06-01

    An effective vaccine for genital herpes has been difficult to achieve because of the limited efficacy of subunit vaccines and the safety concerns about live viruses. As an alternative approach, mutant herpes simplex virus strains that are replication-defective can induce protective immunity. To increase the level of safety and to prove that replication was not needed for immunization, we constructed a mutant herpes simplex virus 2 strain containing two deletion mutations, each of which eliminated viral replication. The double-mutant virus induces protective immunity that can reduce acute viral shedding and latent infection in a mouse genital model, but importantly, the double-mutant virus shows a phenotypic defect in latent infection. This herpes vaccine strain, which is immunogenic but has defects in both productive and latent infection, provides a paradigm for the design of vaccines and vaccine vectors for other sexually transmitted diseases, such as AIDS.

  3. Changes in the immune system during and after spaceflight

    NASA Technical Reports Server (NTRS)

    Taylor, G. R.; Konstantinova, I.; Sonnenfeld, G.; Jennings, R.

    1997-01-01

    The results of immunological analyses before, during and after spaceflight, have established the fact that spaceflight can result in a blunting of the immune mechanisms of human crew members and animal test species. There is some evidence that the immune function changes in short-term flights resemble those occurring after acute stress, while the changes during long-term flights resemble those caused by chronic stress. In addition, this blunting of the immune function occurs concomitant with a relative increase in potentially infectious microorganisms in the space cabin environment. This combination of events results in an increased probability of inflight infectious events. The realization of this probability has been shown to be partially negated by the judicious use of a preflight health stabilization program and other operational countermeasures. The continuation of these countermeasures, as well as microbial and immunological monitoring, are recommended for continued spaceflight safety.

  4. A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients.

    PubMed

    Davis, Gary L; Nelson, David R; Terrault, Norah; Pruett, Timothy L; Schiano, Thomas D; Fletcher, Courtney V; Sapan, Christine V; Riser, Laura N; Li, Yufeng; Whitley, Richard J; Gnann, John W

    2005-08-01

    Chronic hepatitis C is the most common indication for liver transplantation, but viral recurrence is universal and progressive graft injury occurs in most recipients. Our aim was to assess the safety, pharmacokinetics (PK), and antiviral effects of high doses of a human hepatitis C antibody enriched immune globulin product (HCIG) in patients undergoing liver transplantation for chronic hepatitis C. This was a multicenter, randomized, open-label, controlled trial conducted at 4 transplant centers in the United States. A total of 18 patients with chronic hepatitis C, who underwent liver transplantation, were randomized to receive low-dose HCIG (75 mg/kg) or high-dose HCIG (200 mg/kg), or no treatment. A total of 17 infusions of HCIG were administered in each treated patient over 14 weeks using a time-dependent dosing strategy based on the PK of anti-hepatitis B immune globulin in liver transplant recipients. Hepatitis C virus levels, liver enzymes, and liver biopsies were obtained serially throughout the study period. PK profiles of HCV antibodies were determined on days 4, 10, and 98. HCIG infusions were safe and tolerated. The infusion rate could not be maximized because of symptoms for 18% to 30% of the doses. The half-life of HCIG was extremely short immediately after transplantation but was gradually prolonged. In the high-dose group, serum alanine aminotransferase (ALT) levels normalized in most subjects and no patient developed hepatic fibrosis. However, serum HCV RNA levels were not suppressed at either dose. In conclusion, HCIG, an anti-HCV enriched immune globulin product, appears to be safe in patients with chronic hepatitis C undergoing liver transplantation. Further studies are required to determine whether the drug has beneficial effects in this group of patients.

  5. Observations Illustrating the Use of Health Informatics to Link Public Health Immunization Registries and Pharmacies to Increase Adult Immunization Rates and Improve Population Health Outcomes.

    PubMed

    Popovich, Michael; Altstadter, Brandy; Popovich, Lara Hargraves

    2016-01-01

    The Health Information Technology for Economic and Clinical Health (HITECH) Act encourages health information exchange between clinical care and public health through Meaningful Use measures. Meaningful Use specifically identifies objectives to support a number of public health programs including immunizations, cancer registries, syndromic surveillance, and disease case reports. The objective is to improve public and population health. Stage 2 of Meaningful Use focused on compliance to sending of information to public health. The next phase focuses on bi-directional information exchange to support immunization intelligence and to empower providers, pharmacists, and the consumer. The HITECH Act Stage 2 initiative provided incentive and motivation for healthcare providers to encourage their Electronic Medical Record (EMR) vendors to implement data exchanges with public health, with the expected result being timely awareness of health risks. The empowerment nugget in the HITECH Act is not in the compliance reporting to public health. The nugget is the ability for a provider to receive relevant information on the patient or consumer currently in front of them or to those they will connect to through their outreach efforts. The ability for public health to retain current immunization records of individuals from a variety of providers supports their program goals to increase immunization rates and mitigate the risk of vaccine-preventable disease (VPD). The ability for providers to receive at the point of service more complete immunization histories integrated with decision support enhances their delivery of care, thereby reducing the risk of VPD to their patients. Indirectly payers benefit through healthcare cost savings and when the focus is expanded from a health model to a business model, there are significant return on investment (ROI) opportunities that exponentially increase the value of a bi-directional immunization data exchange. This paper will provide

  6. Safety Study: Intraventricular Injection of a Modified Oncolytic Measles Virus into Measles-Immune, hCD46-Transgenic, IFNαRko Mice.

    PubMed

    Lal, Sangeet; Peng, Kah-Whye; Steele, Michael B; Jenks, Nathan; Ma, Hong; Kohanbash, Gary; Phillips, Joanna J; Raffel, Corey

    2016-12-01

    The modified Edmonston vaccine strain of measles virus (MV) has shown potent oncolytic efficacy against various tumor types and is being investigated in clinical trials. Our laboratory showed that MV effectively kills medulloblastoma tumor cells in both localized disease and when tumor cells are disseminated through cerebrospinal fluid (CSF). Although the safety of repeated intracerebral injection of modified MV in rhesus macaques has been established, the safety of administering MV into CSF has not been adequately investigated. In this study, we assessed the safety of MV-NIS (MV modified to express the human sodium iodide symporter protein) injected into the CSF of measles-immunized and measles virus-susceptible transgenic (CD46, IFNαRko) mice. Treated animals were administered a single intraventricular injection of 1 × 10 5 or 1 × 10 6 TCID 50 (50% tissue culture infective dose) of MV-NIS. Detailed clinical observation was performed over a 90-day period. Clinically, we did not observe any measles-related toxic effects or behavioral abnormality in animals of any treated cohort. The complete blood count and blood chemistry analysis results were found to be within normal range for all the cohorts. Histologic examination of brains and spinal cords revealed inflammatory changes, mostly related to the needle track; these resolved by day 21 postinjection. To assess viral biodistribution, quantitative RT-PCR to detect the measles virus N-protein was performed on blood and brain samples. Viral RNA was not detectable in the blood as soon as 2 days after injection, and virus cleared from the brain by 45 days postadministration in all treatment cohorts. In conclusion, our data suggest that a single injection of modified MV into the CSF is safe and can be used in future therapeutic applications.

  7. Improving Hospital Quality and Patient Safety an Examination of Organizational Culture and Information Systems

    ERIC Educational Resources Information Center

    Gardner, John Wallace

    2012-01-01

    This dissertation examines the effects of safety culture, including operational climate and practices, as well as the adoption and use of information systems for delivering high quality healthcare and improved patient experience. Chapter 2 studies the influence of both general and outcome-specific hospital climate and quality practices on process…

  8. 77 FR 22602 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-16

    ... Safety Training, Submitted for Office of Management and Budget (OMB) Review; Comment Request ACTION: 60... comments on a collection of information that we will submit to the Office of Management and Budget (OMB... the leasing provisions of the Act related to mineral resources on the OCS. Such rules and regulations...

  9. Effects of Food Additives on Immune Cells As Contributors to Body Weight Gain and Immune-Mediated Metabolic Dysregulation

    PubMed Central

    Paula Neto, Heitor A.; Ausina, Priscila; Gomez, Lilian S.; Leandro, João G. B.; Zancan, Patricia; Sola-Penna, Mauro

    2017-01-01

    Food additives are compounds used in order to improve food palatability, texture, and shelf life. Despite a significant effort to assure safety of use, toxicological analysis of these substances, generally, rely on their direct toxicity to target organs (liver and kidney) or their genotoxic effects. Much less attention is paid to the effects of these compounds on cells of the immune system. This is of relevance given that metabolic dysregulation and obesity have a strong immune-mediated component. Obese individuals present a state of chronic low-grade inflammation that contributes to the establishment of insulin resistance and other metabolic abnormalities known as the metabolic syndrome. Obesity and metabolic syndrome are currently recognized as worldwide epidemics that pose a profound socioeconomic impact and represent a concern to public health. Cells of the immune system contribute to both the maintenance of “lean homeostasis” and the metabolic dysregulation observed in obese individuals. Although much attention has been drawn in the past decades to obesity and metabolic syndrome as a result of ingesting highly processed food containing large amounts of fat and simple sugars, mounting evidence suggest that food additives may also be important contributors to metabolic derangement. Herein, we review pieces of evidence from the literature showing that food additives have relevant effects on cells of the immune system that could contribute to immune-mediated metabolic dysregulation. Considering their potential to predispose individuals to develop obesity and metabolic syndrome, their use should be taken with caution or maybe revisited. PMID:29163542

  10. Apps for immunization: Leveraging mobile devices to place the individual at the center of care

    PubMed Central

    Wilson, Kumanan; Atkinson, Katherine M; Westeinde, Jacqueline

    2015-01-01

    Mobile technology and applications (apps) have disrupted several industries including healthcare. The advantage of apps, being personally focused and permitting bidirectional communication, make them well suited to address many immunization challenges. As of April 25, 2015 searching the Android app store with the words ‘immunize app’ and ‘immunization app’ in Canada yielded 225 apps. On the Apple App Store a similar search produced 98 results. These include apps that provide immunization related information, permit vaccine tracking both for individuals and for animals, assist with the creation of customized schedules and identification of vaccine clinics and serve as sources of education. The diverse functionality of mobile apps creates the potential for transformation of immunization practice both at a personal level and a system level. For individuals, mobile apps offer the opportunity for better record keeping, assistance with the logistics of vaccination, and novel ways of communicating with and receiving information from public health officials. For the system, mobile apps offer the potential to improve the quality of information residing in immunization information systems and program evaluation, facilitate harmonization of immunization information between individuals, health care providers and public health as well as reduce vaccine hesitancy. As mobile technology continues to rapidly evolve there will emerge new ways in which apps can enhance immunization practice. PMID:26110351

  11. Level of concern and sources of information of a group of Brisbane hostelers for personal safety and terrorism when traveling abroad.

    PubMed

    Leggat, Peter A; Mills, Deborah; Speare, Richard

    2007-01-01

    Little is known about the level of concern and sources of information of hostelers concerning personal safety and terrorism. This study was designed to investigate these in the Australian context. In 2006, self-administered questionnaires were distributed to hostelers attending a travelers' information evening in Brisbane. Forty questionnaires (60.8%) were returned. Over two thirds of attendees were women (71.4%). About two thirds of the hostelers attending the travelers' information evening reported being aged 29 years or younger (64.2%). Anticipated main destinations were Europe (68.3%), Asia (14.3%), and North America (11.9%). Nearly two thirds (63.4%) intended to travel in more than 8 weeks time or were not sure. Of those departing within 8 weeks, only 40% had sought travel health advice from their general practitioner and/or travel clinic. Nonmedical sources of information on travel health included travel books and guides (40.5%), Internet (35.7%), and travel agents (19.0%). On a five-point rating scale (1 being not concerned to 5 being extremely concerned), median ratings of hostelers' concern for personal safety (4.0) was significantly higher than for terrorism (2.5), with the range being 1 to 5 in each case (p < 0.001). Nearly three quarters (73.8%) of hostelers would seek personal safety advice from multiple sources, and sources of information included the Internet (69.0%, 29), travel books and guides (59.5%), physicians (57.1%), and travel agents (45.2%). Only three (7.1%) nominated the physician as their only source of personal safety advice. Hostelers attending a travelers' information night in Australia expressed more concern for their personal safety when traveling than for terrorism. Since this group of travelers uses multiple sources of information with the Internet most commonly used, Web sites that provide accurate and relevant information in an acceptable format could play an important role in supporting this group. It is important that policies

  12. Electronic immunization data collection systems: application of an evaluation framework.

    PubMed

    Heidebrecht, Christine L; Kwong, Jeffrey C; Finkelstein, Michael; Quan, Sherman D; Pereira, Jennifer A; Quach, Susan; Deeks, Shelley L

    2014-01-14

    Evaluating the features and performance of health information systems can serve to strengthen the systems themselves as well as to guide other organizations in the process of designing and implementing surveillance tools. We adapted an evaluation framework in order to assess electronic immunization data collection systems, and applied it in two Ontario public health units. The Centers for Disease Control and Prevention's Guidelines for Evaluating Public Health Surveillance Systems are broad in nature and serve as an organizational tool to guide the development of comprehensive evaluation materials. Based on these Guidelines, and informed by other evaluation resources and input from stakeholders in the public health community, we applied an evaluation framework to two examples of immunization data collection and examined several system attributes: simplicity, flexibility, data quality, timeliness, and acceptability. Data collection approaches included key informant interviews, logic and completeness assessments, client surveys, and on-site observations. Both evaluated systems allow high-quality immunization data to be collected, analyzed, and applied in a rapid fashion. However, neither system is currently able to link to other providers' immunization data or provincial data sources, limiting the comprehensiveness of coverage assessments. We recommended that both organizations explore possibilities for external data linkage and collaborate with other jurisdictions to promote a provincial immunization repository or data sharing platform. Electronic systems such as the ones described in this paper allow immunization data to be collected, analyzed, and applied in a rapid fashion, and represent the infostructure required to establish a population-based immunization registry, critical for comprehensively assessing vaccine coverage.

  13. The sequence of disease-modifying therapies in relapsing multiple sclerosis: safety and immunologic considerations.

    PubMed

    Pardo, Gabriel; Jones, David E

    2017-12-01

    The treatment landscape for relapsing forms of multiple sclerosis (RMS) has expanded considerably over the last 10 years with the approval of multiple new disease-modifying therapies (DMTs), and others in late-stage clinical development. All DMTs for RMS are believed to reduce central nervous system immune-mediated inflammatory processes, which translate into demonstrable improvement in clinical and radiologic outcomes. However, some DMTs are associated with long-lasting effects on the immune system and/or serious adverse events, both of which may complicate the use of subsequent therapies. When customizing a treatment program, a benefit-risk assessment must consider multiple factors, including the efficacy of the DMT to reduce disease activity, the short- and long-term safety and immunologic profiles of each DMT, the criteria used to define switching treatment, and the risk tolerance of each patient. A comprehensive benefit-risk assessment can only be achieved by evaluating the immunologic, safety, and efficacy data for DMTs in the controlled clinical trial environment and the postmarketing clinical practice setting. This review is intended to help neurologists make informed decisions when treating RMS by summarizing the known data for each DMT and raising awareness of the multiple considerations involved in treating people with RMS throughout the entire course of their disease.

  14. 75 FR 13807 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... of Transportation, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue, SE...: Updates to Pipeline and Liquefied Natural Gas Reporting Requirements (One Rule). The Notice of Proposed...

  15. 76 FR 45904 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... at U.S. Department of Transportation, Pipeline and Hazardous Materials Safety Administration, 1200...: On Occasion. Title: Record Keeping for Natural Gas Pipeline Operators. OMB Control Number: 2137-0049...

  16. From ontology selection and semantic web to an integrated information system for food-borne diseases and food safety.

    PubMed

    Yan, Xianghe; Peng, Yun; Meng, Jianghong; Ruzante, Juliana; Fratamico, Pina M; Huang, Lihan; Juneja, Vijay; Needleman, David S

    2011-01-01

    Several factors have hindered effective use of information and resources related to food safety due to inconsistency among semantically heterogeneous data resources, lack of knowledge on profiling of food-borne pathogens, and knowledge gaps among research communities, government risk assessors/managers, and end-users of the information. This paper discusses technical aspects in the establishment of a comprehensive food safety information system consisting of the following steps: (a) computational collection and compiling publicly available information, including published pathogen genomic, proteomic, and metabolomic data; (b) development of ontology libraries on food-borne pathogens and design automatic algorithms with formal inference and fuzzy and probabilistic reasoning to address the consistency and accuracy of distributed information resources (e.g., PulseNet, FoodNet, OutbreakNet, PubMed, NCBI, EMBL, and other online genetic databases and information); (c) integration of collected pathogen profiling data, Foodrisk.org ( http://www.foodrisk.org ), PMP, Combase, and other relevant information into a user-friendly, searchable, "homogeneous" information system available to scientists in academia, the food industry, and government agencies; and (d) development of a computational model in semantic web for greater adaptability and robustness.

  17. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  18. [Survey on computerized immunization registries in Italy].

    PubMed

    Alfonsi, V; D'Ancona, F; Ciofi degli Atti, M L

    2008-01-01

    Computerized immunization registries are essential for conducting and monitoring vaccination programs. In fact, they enable to improve vaccine offering to target population, generating needed-immunization lists and assessing levels of vaccination coverage. In 2007, a national survey on immunization registries was conducted in Italy. In February 2007, all the 21 Regional Health Authorities (RHAs) completed and returned an ad hoc questionnaire. In June 2007, RHAs were further contacted by telephone in order to verify and update the information provided in questionnaires. In 9 Italian Regions (42.8%), vaccination registries are computerized in all Local Health Units (LHUs). In five of these Regions, all LHUs use the same software, while in the remaining four Regions, different softwares are in use. In six additional Regions (28.6%), only some LHUs use computerized immunization registries (range 61.5%-95%). In the remaining 6 Regions (28.6%), which are all in Southern Italy, there are no computerised immunization registries at all. In total, computerised immunization registries cover 126/180 Italian LHUs (70%); in 76/126 (60%) of these LUHs, immunization registries are linked with population registries. This survey shows the need to improve the implementation of computerised immunization registries in Italy, especially in Southern Regions.

  19. 75 FR 73160 - Pipeline Safety: Information Collection Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No...-Related Conditions on Gas, Hazardous Liquid, and Carbon Dioxide Pipelines and Liquefied Natural Gas... Pipelines and Liquefied Natural Gas Facilities.'' The Pipeline Safety Laws (49 U.S.C. 60132) require each...

  20. High dose Intravenous Anti-D Immune Globulin is More Effective and Safe in Indian Paediatric Patients of Immune Thrombocytopenic Purpura

    PubMed Central

    Jena, Rabindra Kumar; Swain, Kali Prasanna

    2016-01-01

    Introduction Immune Thrombocytopenia (ITP) is characterised by an autoimmune antibody-mediated destruction of platelets and impaired platelet production. Few controlled trials exist to guide management of patients with ITP in Indian scenario for which patients require an individualized approach. Anti-D (Rho (D) immune globulin) at a higher dose can prove to be a cost effective and safe alternative for Indian patients with ITP. Aim To compare the safety and efficacy of higher dose (75μg/kg) intravenous Anti-D immune globulin against the standard dose of 50μg/kg for the management of ITP in Indian patients. Materials and Methods One hundred and sixty four children with newly diagnosed ITP between 4-14 years were randomly selected for inclusion and were treated with 50μg/kg (standard dose) or 75μg /kg (higher dose) of Anti-D to compare the efficacy and safety of higher dose intravenous anti-D immune globulin. Efficacy of Anti-D was measured in terms of rate of response and median time to response for increase in platelet counts. Any adverse event was noted. A decrease in haemoglobin concentration suggested accompanying haemolysis. Results Seventy one out of 84 patients treated with Anti-D at 75μg/kg produced complete response (85%) with median time of response being 2.5 days. On the contrary, 45 patients (70%) patients treated with 50μg/kg had complete response. However, there was no significant increase in haemolysis with higher dose. A significant correlation was found between dose and peak increase in platelet count measured at 7th day following administration. However, there was no relationship between the decrease in haemoglobin and the dose given, or between the increase in platelet count and fall in haemoglobin. Conclusion A 75μg/kg dose of Anti-D is more effective with acceptable side effect in comparison to 50μg dose for treatment of newly diagnosed Indian patients of ITP. PMID:28208873

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