Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

Fosfomycin versus meropenem in bacteraemic urinary tract infections caused by extended-spectrum β-lactamase-producing Escherichia coli (FOREST): study protocol for an investigator-driven randomised controlled trial.

INTRODUCTION Finding therapeutic alternatives to carbapenems in infections caused by extended-spectrum β-lactamase-producing Escherichia coli (ESBL-EC) is imperative. Although fosfomycin was discovered more than 40 years ago, it was not investigated in accordance with current standards and so is not used in clinical practice except in desperate situations. It is one of the so-called neglected antibiotics of high potential interest for the future. METHODS AND ANALYSIS The main objective of this project is to demonstrate the clinical non-inferiority of intravenous fosfomycin with regard to meropenem for treating bacteraemic urinary tract infections (UTI) caused by ESBL-EC. This is a 'real practice' multicentre, open-label, phase III randomised controlled trial, designed to compare the clinical and microbiological efficacy, and safety of intravenous fosfomycin (4 g/6 h) and meropenem (1 g/8 h) as targeted therapy for this infection; a change to oral therapy is permitted after 5 days in both arms, in accordance with predetermined options. The study design follows the latest recommendations for designing trials investigating new options for multidrug-resistant bacteria. Secondary objectives include the study of fosfomycin concentrations in plasma and the impact of both drugs on intestinal colonisation by multidrug-resistant Gram-negative bacilli. ETHICS AND DISSEMINATION Ethical approval was obtained from the Andalusian Coordinating Institutional Review Board (IRB) for Biomedical Research (Referral Ethics Committee), which obtained approval from the local ethics committees at all participating sites in Spain (22 sites). Data will be presented at international conferences and published in peer-reviewed journals. DISCUSSION This project is proposed as an initial step in the investigation of an orphan antimicrobial of low cost with high potential as a therapeutic alternative in common infections such as UTI in selected patients. These results may have a major impact on the use of antibiotics and the development of new projects with this drug, whether as monotherapy or combination therapy. TRIAL REGISTRATION NUMBER NCT02142751. EudraCT no: 2013-002922-21. Protocol V.1.1 dated 14 March 2014.

Iowa Public Library Statistics, 2004-2005

Public library statistics are taken from the annual survey. The statistics are used at the local, regional, state, and national levels to compare library performance, justify budget requests, track library data over time, assist in planning and evaluation, and provide valuable information for grants and other library programs. The annual survey collects current information from 543 public libraries about public service outlets, holdings, staffing, income, expenditures, circulation, services, and hours open. Furthermore, it helps provide a total picture of libraries on a state and nationwide basis. This report is authorized by law (Iowa Code 256.51 (H)). Each of the 50 states collects public library information according to guidelines established by the Federal State Cooperative System for public library data (FSCS). The information contained in the Iowa Public Library Statistics is based on definitions approved by FSCS. For additional information, contact Gerry Rowland, State Library, gerry.rowland@lib.state.ia.us; 1-800-248-4483.

Iowa Public Library Statistics, 2003-2004

Public library statistics are taken from the annual survey. The statistics are used at the local, regional, state, and national levels to compare library performance, justify budget requests, track library data over time, assist in planning and evaluation, and provide valuable information for grants and other library programs. The annual survey collects current information from 543 public libraries about public service outlets, holdings, staffing, income, expenditures, circulation, services, and hours open. Furthermore, it helps provide a total picture of libraries on a state and nationwide basis. This report is authorized by law (Iowa Code 256.51 (H)). Each of the 50 states collects public library information according to guidelines established by the Federal State Cooperative System for public library data (FSCS). The information contained in the Iowa Public Library Statistics is based on definitions approved by FSCS. For additional information, contact Gerry Rowland, State Library, gerry.rowland@lib.state.ia.us; 1-800-248-4483.

Addressing Practical Issues Related Tto Nursing Care For International Visitors To Hiroshima

When nine million foreigners visited Japan in 2013, the federal government set a goal to attract an additional two and a half million visitors including medical tourists by 2020. This research investigates the attitudes and concerns of Japanese nurses when they are in a situation dealing with foreign patients. The data were collected from March through September 2010, from 114 nurses at three hospitals, in close proximity to popular tourist destinations in Hiroshima. A questionnaire was developed for this research, named Mari Meter, which included a section to write answers to an open question for the nurses to express their opinions. These responses were examined statistically and by word analysis using Text Mining Studio. Japanese nurses expressed greatest concern about payment options, foreign language skills, and issues of informed consent, when dealing with foreigners. The results confirm that, in order to provide a high quality of patient care, extra preparation and a greater knowledge of international workers and visitors are required by nursing professionals in Japan.


TOPSpro Data Dictionary, July 1, 2005–June 30, 2006

The passage of the Workforce Investment Act (WIA) of 1998 [Public Law 105-220] by the 105th Congress has ushered in a new era of collaboration, coordination, cooperation and accountability. The overall goal of the Act is “to increase the employability, retention, and earnings of participants, and increase occupational skill attainment by participants, and, as a result improve the quality of the workforce, reduce welfare dependency, and enhance the productivity and competitiveness of the Nation.” The key principles inculcated in the Act are: • Streamlining services; • Empowering individuals; • Universal access; • Increased accountability; • New roles for local boards; • State and local flexibility; • Improved youth programs. The purpose of Title II, The Adult Education and Family Literacy Act (AEFLA), of the Workforce Investment Act of 1998 is to create a partnership among the federal government, states, and localities to provide, on a voluntary basis, adult education and literacy services in order to: • Assist adults become literate and obtain the knowledge and skills necessary for employment and self-sufficiency; • Assist adults who are parents obtain the educational skills necessary to become full partners in the educational development of their children; • Assist adults in the completion of a secondary school education. Adult education is an important part of the workforce investment system. Title II restructures and improves programs previously authorized by the Adult Education Act. AEFLA focuses on strengthening program quality by requiring States to give priority in awarding funds to local programs that are based on a solid foundation of research, address the diverse needs of adult learners, and utilize other effective practices and strategies. To promote continuous program involvement and to ensure optimal return on the Federal investment, AEFLA also establishes a State performance accountability system. Under this system, the Secretary and each State must reach agreement on annual levels of performance for a number of “core indicators” specified in the law: • Demonstrated improvements in literacy skill levels in reading, writing, and speaking the English language, numeracy, problem solving, English language acquisition, and other literacy skills. • Placement in, retention in, or completion of postsecondary education, training, unsubsidized employment or career advancement. • Receipt of a secondary school diploma or its recognized equivalent. Iowa’s community college based adult basic education program has implemented a series of proactive strategies in order to effectively and systematically meet the challenges posed by WIA. The Iowa TOPSpro Data Dictionary is a direct result of Iowa’s pro-active efforts in this educational arena.

Investigation of Luther City Council Violation of Open Meetings Law, 2006

Case File 0603454 The Ombudsman received a complaint on August 29, 2006 alleging violations of the Iowa Open Meetings Law by the Luther City Council (Council) in its meeting on August 2, 2006. Based upon my review of the complaint, I identified the following allegations for investigation: • The Council violated Iowa Code section 21.5 by failing to announce the reason session on the August 2, 2006 meeting agenda. • The Council violated Iowa Code section 21.5 by holding a closed session for an impermissible reason. • The Council violated Iowa Code section 21.5(2) by discussing unrelated issues in the closed session.

Status of Young Women in the Juvenile Justice System Preliminary Data, 2007

Young women involved in the juvenile justice system present with characteristics and experiences that differentiate them from their male counterparts. As such, the juvenile justice system in Iowa must consider these factors if it is to effectively and efficiently impact recidivism and rehabilitation.

Determinants of economic growth: Will data tell?

Many factors inhibiting and facilitating economic growth havebeen suggested. Can agnostics rely on international incomedata to tell them which matter? We find that agnostic priorslead to conclusions that are sensitive to differences acrossavailable income estimates. For example, the PWT 6.2 revisionof the 1960-96 income estimates in the PWT 6.1 leads tosubstantial changes regarding the role of government,international trade, demography, and geography. We concludethat margins of error in international income estimates appeartoo large for agnostic growth empirics.

2008 Iowa Real Property Appraisal Manual, May 2008

********NOTE: There are nine sections to this manual, all in separate files.************* **********NOTE: Large files may take longer to open******** The basis of real property assessment in Iowa is market value as defined in Iowa Code §441.21. Iowa Code §§ 421.17(17) and 441.21(h) provide that assessment jurisdictions follow the guidelines and rules in this manual to help achieve uniformity in assessments. Assessors are encouraged to use the International Association of Assessing Officers’ Standard on Mass Appraisal of Real Property in their mass appraisal practices. Estimating market value in mass appraisal involves accurately listing properties, developing a sales file that includes the primary influences on market value, and developing models for subsets of properties that share common market influences using recognized mass appraisal techniques. The assessment of an individual property should not be based solely on the sale price. The Uniform Standards of Professional Appraisal Practice (USPAP) standard 6 says “In developing a mass appraisal, an appraiser must be aware of, understand, and correctly employ those recognized methods and techniques necessary to produce and communicate credible mass appraisals.” Accurate listing of property is the basis of a good mass appraisal program. On-site inspection and listing of property is essential in developing a good data base for revaluation. A physical review, including an on-site verification of property characteristics, should be conducted at least every four to six years. Land values should be reviewed every two years. Factors influencing the market of each property type should be identified and collected so that these factors can be considered in the mass appraisal model. It is equally important to maintain the data once it is collected. Accessing local government permit systems should be a part of a good data maintenance program along with an inspection program. Current cadastral maps and geographical information systems (GIS) are tools that are integral in checking accuracy of listings and maintaining a comprehensive data base.

Higher Standards Lead to Better Results, Data Download, Iowa Department of Corrections, February 2010

Like many businesses and government agencies, the Iowa Department of Corrections has been measuring our results for some years now. Certain performance measures are collected and reported to the Governor as part of the Director’s Flexible Performance Agreement used to evaluate the DOC Director. Updates of these measures are forwarded to DOC staff on a quarterly basis. In addition, the Iowa Department of Management requires each state agency to report on certain performance measures as part of Iowa’s effort to ensure accountability in state government. These measures and their progress are posted to www.ResultsIowa.org

Accessing Legal Information in Catalonia. Open Acces to Legislation and Case Law

The article outlines free online legal resources to conduct research on Catalan and Spanish legislation and case-law. Most of these resources are primary sources made public by government bodies. The list shows how the Spanish and Catalan governments, in their attempt to promote equal access to legislation and case-law, cover the different jurisdictions. The text also mentions some resources to conduct historical legal research about legislation and case law, and some free legal private websites.

Iowa Department of Transportation Office of Research & Analytics Guidance on Data Management Plan (DMP) Requirements for Federally Funded Research Projects

The Iowa Department of Transportation Office of Research & Analytics has created this Guide to help researchers and contractors of the Iowa DOT attain compliance with Federal and Iowa DOT Public Access Policies for transportation-related research publications and datasets. This guide provides direction for filling out the data management plan template (also attached to this record) that will help satisfy Iowa DOT and U.S. DOT requirements.

Análisis discursivo de las actitudes lingüísticas de los escolares de origen inmigrante en Cataluña

La continua llegada de población inmigrante a los países de la Europa Occidental está produciendo transformaciones en estas sociedades. Evidentemente, la sociedad catalana no es ajena a estos cambios y, año tras año, ve incrementado el número de recién llegados/ as procedentes de orígenes geográficos, culturales y lingüísticos muy diversos. Estas personas, en ocasiones sin un conocimiento previo, se encuentran con las peculiaridades socioculturales y lingüísticas de la sociedad receptora. En el caso de Cataluña, nos interesa destacar la cuestión lingüística, a la cual se han dedicado muchos esfuerzos durante los últimos años en un intento de acercarse a una situación de normalidad en lo referente al conocimiento y uso de la lengua catalana. En el presente artículo se presentan los principales resultados de una investigación centrada en el análisis de los discursos sobre los que anclan las actitudes lingüísticas de los escolares de origen inmigrante en Cataluña. La técnica de investigación social utilizada ha sido la entrevista en profundidad semidirigida, realizando el análisis del contenido de las mismas a partir del «Análisis de contenido temático basado en categorías» (Bardin, 1986). Las conclusiones más relevantes indican que, por encima del Área de Origen o la Condición Lingüística Familiar, la principal variable que permite articular los discursos detectados es la que se puede denominar «Satisfacción y Percepción de Valoración e Integración Escolar y Social», de tal manera que los jóvenes de origen inmigrante que se sienten más valorados e integrados escolar y socialmente desarrollan mejores actitudes hacia la lengua catalana y castellana. Este hecho tiene claras repercusiones respecto las generalizaciones reduccionistas y estereotipadas que vinculan un área de origen con unas determinadas actitudes hacia las lenguas oficiales en Cataluña, así como de cara a la política lingüística y las ideologías lingüísticas de la sociedad en general.

Julkishallinnon sähköisten palveluiden arkkitehtuurit

Sähköinen asiointi on yleistynyt viime vuosien aikana nopeasti. Toimivia julkishallinnon sähköisiä palveluita kehitetään jatkuvasti yhä uusiin tarkoituksiin. Tällä hetkellä sähköisten palveluiden tarjontaa leimaa hajanaisuus. Jokainen palveluita tarjoava organisaatio kehittää palveluita itsenäisesti, omalla tavallaan. Palveluiden kehittäminen asiakaslähtöisesti edellyttää palvelukokonaisuuksien suunnittelua arkkitehtuuritasolla. Yksittäisten sovellusten kehittämisen lisäksi on huomioitava näiden sovellusten toimivuus yhteen, osana suurempaa kokonaisuutta. Palvelukeskeisessä arkkitehtuurisuunnittelussa lähtökohta on se, että jokainen yksittäinen sovellus on itsessään palvelu, joka tuottaa määritelmänsä mukaisen tulosteen sellaisessa muodossa, jota muut sovellukset kykenevät ymmärtämään. Työn tuloksena havaittiin, että vaikka sähköiselle hallinnolle on kehitetty useita viitearkkitehtuureja, on käytännön työ palveluiden integroimiseksi vielä kesken. Yksittäisten palveluiden liittäminen suuremmiksi kokonaisuuksiksi vaatii määrätietoista arkkitehtuurisuunnittelua sekä kansallista suunnittelun koordinointia. Tiedon jakaminen organisaatiorajojen yli muodostaa joukon kysymyksiä, joihin ei ole vielä vastausta. Tietosuojaa ja yksityisyyttä ei voida uhrata sähköistä hallintoa suunniteltaessa.