CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

International standards for programmes of training in intensive care medicine in Europe.

PURPOSE To develop internationally harmonised standards for programmes of training in intensive care medicine (ICM). METHODS Standards were developed by using consensus techniques. A nine-member nominal group of European intensive care experts developed a preliminary set of standards. These were revised and refined through a modified Delphi process involving 28 European national coordinators representing national training organisations using a combination of moderated discussion meetings, email, and a Web-based tool for determining the level of agreement with each proposed standard, and whether the standard could be achieved in the respondent's country. RESULTS The nominal group developed an initial set of 52 possible standards which underwent four iterations to achieve maximal consensus. All national coordinators approved a final set of 29 standards in four domains: training centres, training programmes, selection of trainees, and trainers' profiles. Only three standards were considered immediately achievable by all countries, demonstrating a willingness to aspire to quality rather than merely setting a minimum level. Nine proposed standards which did not achieve full consensus were identified as potential candidates for future review. CONCLUSIONS This preliminary set of clearly defined and agreed standards provides a transparent framework for assuring the quality of training programmes, and a foundation for international harmonisation and quality improvement of training in ICM.

Reporting quality of randomised controlled trials published in prosthodontic and implantology journals

The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making.

The influence of ideological interest groups on congressional financial support of international family planning

The World Health Organization estimates there are about 585,000 maternal deaths each year, with 98% of the maternal deaths in developing countries. Access to family planning methods is one method to decrease maternal mortality and morbidity. ^ The U.S. was the leader in providing financial and technical assistance to developing countries to enable women to have this access. The election of Ronald Regan changed the course of U.S. support; abortion became a central factor in the political decision-making with regards to the financial support of international family planning. ^ One factor that may sway policy-makers' decisions is the influence of ideological interest groups, Political Action Committees funding of candidates in relation to votes on bills that impacted on financial support of international family planning and the amount spent by these groups on lobbyist was reviewed. Pro-choice funding of candidates was greater for the four of the fives votes supporting family planning. Pro-Choice lobbyist spending was $185,000 vs. $8,184,000 spent by Pro-Life ideological groups. ^

Aeronautical Metadata Profile based on Geographic International Standards

The aeronautical information plays an essential rolein air safety, chief objective of the aeronautical industry. Community policies and projects are being currently developed for the adequate management of a single European air space. To make this possible, an appropriate information management and a set of tools that allow sharing and exchanging this information, ensuring its interoperability and integrity, are necessary. This paper presents the development and implementation of a metadata profile for description of the aeronautical information based on international regulations and recommendations applied within the geographic scope. The elements taken into account for its development are described, as well as the implementation process and the results obtained.

Modelo de gestión de costes medioambientales para el sector petroquímico venezolano

El crecimiento económico ha producido mejoras en el nivel de vida de la población que muchas veces tienen efectos medioambientales negativos en el largo plazo. Ante esta problemática, surge la necesidad a nivel empresarial de enmarcarse en un modelo de desarrollo sostenible que combine los objetivos de crecimiento económico con los de protección medioambiental. Esta situación puede representar altos costes para las empresas del sector petroquímico venezolano, debido al elevado riesgo de sus operaciones y al conjunto de regulaciones legales vigentes en materia medioambiental. Por lo tanto, el objetivo de la presente investigación ha sido proponer un modelo para la gestión de costes medioambientales de dicho sector fundamentado en la ecoeficiencia. Se planteó una investigación proyectiva, desde un enfoque holístico. Se utilizó un diseño de investigación univariable, transeccional contemporáneo, de fuente mixta. Univariable, porque se enfoca en la gestión de costes medioambientales como único evento a modificar. Transeccional contemporáneo, porque el evento se estudia en la actualidad y la medición de los datos se realiza en un solo momento. De fuente mixta, porque se combinó un diseño documental con un diseño de campo. Se utilizó un diseño documental para el análisis comparativo de las normativas de registro y control de costes medioambientales propuestas por organismos internacionales, mediante la aplicación de una matriz de análisis de categorías emergentes. Para el diagnóstico de la gestión de costes medioambientales en el sector petroquímico venezolano, se utilizó un diseño de campo en las empresas del sector que operan en la región zuliana. Para ello se aplicó un cuestionario con 100 ítems en escala Likert y 6 preguntas de opción múltiple. Dicho cuestionario fue validado mediante la revisión de expertos y se determinó su confiablidad a través del coeficiente alfa de Cronbach. Los resultados muestran que los principales asuntos tratados por las normativas analizadas pueden agruparse en seis temas: alcance de la contabilidad de gestión medioambiental, clasificación, tratamiento contable, asignación, informes de costes medioambientales e indicadores de gestión. Se evidenció que las guías de aplicación de la contabilidad de gestión medioambiental abordan todos los temas identificados pero no hay uniformidad en los criterios asumidos. Por el contrario, las normativas en el ámbito de la contabilidad financiera consideran principalmente los aspectos relacionados con el tratamiento contable de los costes medioambientales y su inclusión en los estados financieros. En cuanto a la gestión de costes medioambientales que realizan las empresas del sector petroquímico venezolano, se evidenció su limitación por la escasa consideración de criterios de ecoeficiencia y la poca aplicación de herramientas de contabilidad de gestión, que dificultan la determinación y el control de costes medioambientales. Tomando como base los resultados obtenidos, se diseñó el modelo de Gestión de Costes Medioambientales Ecoeficiente (GCME). Dicho modelo plantea como deben incorporarse los criterios de ecoeficiencia y las herramientas de contabilidad de gestión medioambiental para la planificación, coordinación y control en la gestión de costes medioambientales. Se plantea que estas etapas deben desarrollarse permanentemente para asegurar la mejora continua del proceso y su adaptación a los cambios tecnológicos y a las regulaciones legales. Se hace énfasis en las directrices que deben seguir las empresas del sector petroquímico venezolano para la aplicación del modelo GCME. Sin embargo, por su generalidad y adaptación a las Normas Internacionales de Contabilidad vigentes en Venezuela, dicho modelo es aplicable a diversos sectores industriales que requieran mejorar su desempeño económico-medioambiental. ABSTRACT Economic growth has led to improvements in the standard of living of the population that often have negative environmental effects over the long term. Faced with this problem, at the enterprise-level, the need to be framed in a sustainable development model that combines the goals of economic growth with environmental protection arises. This situation may represent high costs for the Venezuelan petrochemical companies due to the high risk of their operations and to all the applicable legal regulations on environmental matters. Therefore, this research aims to propose a model for the environmental costs management of these companies based on eco-efficiency. A projective research was performed from a holistic approach. An univariate, contemporary cross-sectional and mixed source research design was used. It is univariate, because it focuses on environmental costs management as the single event to change. It is contemporary cross-sectional, because the event is currently studied and the data measurement is performed in a single moment. It relies on mixed source, because it combines a documentary design with a field design. A documentary design was used for the comparative analysis of the standards of registration and control of environmental costs proposed by international organizations, by applying an analysis matrix of emerging categories. For the diagnosis of the environmental costs management in the Venezuelan petrochemical industry, a field design was applied in the companies that operate in the Zulia region. A questionnaire with 100 items on a Likert scale and 6 multiple-choice questions was used. The questionnaire was validated by peer review and internal consistency reliability was determined using Cronbach's alpha coefficient. The results show that the main issues addressed in the analyzed regulations can be grouped into six themes: scope of environmental management accounting, classification, accounting, allocation, reporting of environmental costs and performance indicators. It was evident that implementation guides of environmental management accounting address all issues identified but there is no uniformity in the assumed criteria. Meanwhile, regulations in the financial accounting field mainly consider aspects related to the accounting treatment of environmental costs and their inclusion in the financial statements. Regarding the environmental costs management performed by Venezuelan petrochemical companies, its limitations were made evident by the low status of eco-efficiency criteria and insufficient application of management accounting tools, which hinder the identification and control of environmental costs. Based on the results, the model of eco-efficient environmental costs management (EECM) was designed. This model indicates how eco-efficiency criteria and tools of environmental management accounting for planning, coordination and control in the environmental costs management should be incorporated. It argues that these stages must be continually developed to ensure a continuous process improvement and its adaptation to technological and legal regulatory changes. The guidelines which the Venezuelan petrochemical companies should follow for the EECM model application have been emphasized. However, due to its generality and adaptation to the International Accounting Standards enforced in Venezuela, this model is applicable to various industries that require an improvement of their economic and environmental performance.

Gender-sensitive reporting in medical research

Sex and gender differences influence the health and wellbeing of men and women. Although studies have drawn attention to observed differences between women and men across diseases, remarkably little research has been pursued to systematically investigate these underlying sex differences. Women continue to be underrepresented in clinical trials, and even in studies in which both men and women participate, systematic analysis of data to identify potential sex-based differences is lacking. Standards for reporting of clinical trials have been established to ensure provision of complete, transparent and critical information. An important step in addressing the gender imbalance would be inclusion of a gender perspective in the next Consolidated Standards of Reporting Trials (CONSORT) guideline revision. Uniform Requirements for Manuscripts Submitted to Biomedical Journals, as a set of well-recognized and widely used guidelines for authors and biomedical journals, should similarly emphasize the ethical obligation of authors to present data analyzed by gender as a matter of routine. Journal editors are also promoters of ethical research and adequate standards of reporting, and requirements for inclusion of gender analyses should be integrated into editorial policies as a matter of urgency.

The International Banking Facility Deposit Insurance Act : hearing before the Subcommittee on Financial Institutions Supervision, Regulation, and Insurance of the Committee on Banking, Finance, and Urban Affairs, House of Representatives, Ninety-seventh Congress, first session, on H.R. 4879 ... November 4, 1981.

Item 1013-A, 1013-B (microfiche)