Learning from failure--rationale and design for a study about discontinuation of randomized trials (DISCO study)

Background Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements.

Effects Of Perceived Financial Accessibility Of Colleges And Universities On Studentsâ¿ Assesment Of Institutional Desirability

This study focused on the effects of socioeconomic exclusivity indicators on college students¿ attitudes toward a hypothetical private liberal arts university. Students enrolled in two undergraduate courses in Education at an elite private liberal arts university in the northeast were randomly presented with one of three versions of an admissions brochure describing a fictitious university. The three versions of the brochure varied in their portrayals of the institution¿s financial exclusivity, ranging from high exclusivity to low exclusivity. Each student was asked to review the brochure and respond to a questionnaire, containing items pertaining to the overall desirability of the institution, as well as its student culture, academic program, campus traditions, and alumni network. Based on Thorstein Veblen¿s theory of the leisure class and Pierre Bourdieu¿s theory of social reproduction, it was hypothesized that students would judge the institution most favorably in all areas under the high exclusivity condition and least favorably under the low exclusivity condition. It was further hypothesized that differences in students¿ ratings of institutional desirability would be mediated by their own financial aid statuses. Results of a two-way multivariate analysis of variance (MANOVA) revealed significant (p < .05) interactive effects of institutional exclusivity and student aid status on the perceived desirability of the academic program and campus traditions of the institution. While recipients of need-based financial aid tended to rate more socioeconomically exclusive institutions more favorably on these two variables, those who were not receiving need-based financial aid tended to rate such institutions less favorably. Implications of the findings for student affairs practice are discussed and recommendations for further research are presented.

The Lily and the Lotus: Notes on Translation

This critical/creative project considers Stéphane Mallarmé’s critical poems in his 1897 Divagations as an invitation to explore the notion of criticism and the relationship between the conceptual and the nonconceptual aspects of writing and thinking. Informed by Emmanuel Levinas’s ethics of the face, Walter Benjamin’s essay “The Task of theTranslator” and the myth of Orpheus, I consider ways to approach that which may not be said or thought by following Mallarmé’s method of combining poetry and criticism to create a wandering, unclassifiable text where we may imagine the nonconceptual as a remoteness, as the presence of an absence.

The Ideology, Politics and Autonomous Art of Richard Weiner: (An Event in Discourse)"

The first aim of the project was to compile documentation on the life and work of Richard Weiner, a Czech journalist, writer and poet who spent the best part of his life as Paris correspondent for Lidove noviny. Langerova looked at the contexts and the growing independence of certain parts of his work, the distribution of thematic compositional elements into different parts of discourse and their position in the autonomous space of a work of art. Looking at the features of minority literature and the contemporary contexts of Weiner's life and work Langerova focuses on the situation of the Jewish community (Wiener came from an assimilated Jewish family). For this minorities, the function of language as a medium of communication which is able to create an autonomous world became increasingly important. Literature, which is based on this function of language, is a political matter par excellence before it begins forming as an autonomous, independent and divergent place. This means that everything private and intimate is closely connected to political and social responsibility, while supposedly objective genres contain subjective features. Another important characteristic is "nomadism", which asks the question of "Where do I belong". This was very important in Czechoslovakia after World War I , as in the issue of Zionism. Although Weiner rejected Zionism, he asks this question in his writing and it is reflected at a symbolic level in his work, which shows a fundamental thematic and compositional plan of a journey, cross-roads and wandering. These theses were reflected in Weiner's life, which was a series of continuous transfers and unplanned moves, often when he thought he had found his place. As well as tracing the course of his life, and his relations with and views of other writers, Langerova looks at his writings in various areas. Her major focus is the divergence of trivial and great events into different types of discourse in Richard Weiner's work, their transfer (small into great, trivial into mythical) and their historical context.

A Comparative Study on Higher Education Acts in Bulgaria, Hungary, Poland, Romania and Russia

The original aim of this project was to describe and analyse the higher education acts in force in five Central and Eastern European countries at present, trying to understand the dependence of higher education on the historical traditions, national peculiarities and all-European tendencies. The description and comparison of the main aspects of higher education was supplemented by a study of the possibilities of transferring experience in the field between the five countries and possible solutions to implementing foreign structural and functional models. Questions covered included the role of the state in the management of higher education, the structures of the higher education systems and the organisation of institutions, academic autonomy and the classifications of academic teaching staff, the main trends in the recent development of research, academic degrees, the accreditation of higher education institutions, and the financing of higher education. Popov found that it was almost impossible to understand the dependence of higher education on historical traditions and national peculiarities purely through a study of the relevant legislation. Education traditions in these countries have twice been broken, once with the start of communism (1917 in Russia and 1944-45 in Bulgaria, Hungary, Poland and Romania) and for a second time at the beginning of the 1990s. The most recent higher education acts in all five countries studied have abandoned many of their historical and national traditions, following instead all-European trends as determined by Western Europe, and the project included a study of the dependence on these trends. There were also difficulties in comparing some aspects of higher education as it depended on how far a given aspect has different or common features in the different countries and to what extent the application is comparable. While many possible areas for transferring experience between the five countries were identified, Popov concentrated on those where he felt that there was a real practical possibility of application in view of national academic differences. He concluded by defining some of the challenges facing each country in the field of higher education and by making some predictions as to the developments in the different countries.

When left becomes right and vice versa: mirrored vision after cerebral hypoxia

The combination of acquired mirror writing and reading is an extremely rare neurological disorder. It is encountered when brain damaged patients prefer horizontally mirrored over normal script in writing and reading. Previous theories have related this pathology to a disinhibition of mirrored engrams in the non-dominant hemisphere, possibly accompanied by a reversal of the preferred scanning direction. Here, we report the experimental investigation of PR, a patient who developed pronounced mirror writing and reading following septic shock that caused hypoxic brain damage. A series of five oculomotor experiments revealed that the patient's preferred scanning direction was indeed reversed. However, PR showed striking scanpath abnormalities and mirror reversals that cannot be explained by previous theories. Considered together with mirror phenomena she displayed in neuropsychological tasks and everyday activities, our findings suggest a horizontal reversal of visual information on a perceptual level. In addition, a systematic manipulation of visual variables within two further experiments had dramatic effects on her mirror phenomena. When confronted with moving, flickering or briefly presented stimuli, PR showed hardly any left-right reversals. Not only do these findings underline the perceptual nature of her disorder, but also allow interpretation of the pathology in terms of a dissociation between visual subsystems. We speculate that early visual cortices are crucially involved in this dissociation. More generally, her mirrored vision may represent an extreme clinical manifestation of the relative instability of the horizontal axis in spatial vision.

Diagnosis and treatment of peripartum bleeding

Severe peripartum hemorrhage (PPH) contributes to maternal morbidity and mortality and is one of the most frequent emergencies in obstetrics, occurring at a prevalence of 0.5-5.0%. Detection of antepartum risk factors is essential in order to implement preventive measures. Proper training of obstetric staff and publication of recommendations and guidelines can effectively reduce the frequency of PPH and its resulting morbidity and mortality. Therefore, an interdisciplinary expert committee was formed, with members from Germany, Austria, and Switzerland, to summarize recent scientific findings. An up-to-date presentation of the importance of embolization and of the diagnosis of coagulopathy in PPH is provided. Furthermore, the committee recommends changes in the management of PPH including new surgical options and the off-label use of recombinant factor VIIa.

Add a Dash of Rhetoric, a Pinch of Technical Communication, a Handful of Pedagogy, and Mix Well: Cookbooks and Recipes as Instructional Texts, and What Domestic Texts from 1870 to 1935 Can Teach Us About Technical Communication

Through the use of rhetoric centered on authority and risk avoidance, scientific method has co-opted knowledge, especially women's everyday and experiential knowledge in the domestic sphere. This, in turn, has produced a profound affect on technical communication in the present day. I am drawing on rhetorical theory to study cookbooks and recipes for their contributions to changes in instructional texts. Using the rhetorical lenses of metis (cunning intelligence), kairos (timing and fitness) and mneme (memory), I examine the way in which recipes and cookbooks are constructed, used and perceived. This helps me uncover lost voices in history, the voices of women who used recipes, produced cookbooks and changed the way instructions read. Beginning with the earliest cookbooks and recipes, but focusing on the pivotal temporal interval of 1870-1935, I investigate the writing and rhetorical forces shaping instruction sets and domestic discourse. By the time of scientific cooking and domestic science, everyday and experiential knowledge were being excluded to make room for scientific method and the industrial values of the public sphere. In this study, I also assess how the public sphere, via Cooperative Extension Services and other government agencies, impacted the domestic sphere, further devaluing everyday knowledge in favor of the public scientific model. I will show how the changes in the production of food, cookbooks and recipes were related to changes in technical communication. These changes had wide rippling effects on the field of technical communication. By returning to some of the tenets and traditions of everyday and experiential knowledge, technical communication scholars, practitioners and instructors today can find new ways to encounter technical communication, specifically regarding the creation of instructional texts. Bringing cookbooks, recipes and everyday knowledge into the classroom and the field engenders a new realm of epistemological possibilities.

Teaching Information Literacy to Undergraduate Students: Reflecting on the Past, Present and Future of Library Instruction

The need to teach information literacy skills to undergraduate students is often framed as a 21st century concern, but debate over the value and practice of teaching this set of skills can be found as far back as the early 1900’s. This article reviews the history of information literacy instruction in academic libraries from its origins to the present, examines the current state of information literacy instruction in academic libraries, and explores possible future directions that this instruction may take. Looking to the past, present and future shows that while library instruction has evolved, many central concerns remain unanswered.

Resisting Postmodernity: Swedish social policy in the 1990s

The purpose of this paper is to introduce ideas that have emerged during the course of writing a book on Swedish welfare in the 1990s. The book is the result of many years of writing about two subjects: Swedish drug policy and the Swedish welfare state. The one very specialised, the other, more general. I first became interested in Swedish drug policy on a research visit to Örebro Län in 1986. A social worker showed me a copy of the county's drug policy programme and explained the significance of the 'restrictive line'. I have spent the years since that visit, trying to understand and explain the Swedish goal of a drug-free society (Gould 1988, 1994, 1996b). I only began to write about the welfare state in Sweden in the early 1990s, just as things were beginning to go wrong for the economy (Gould 1993a, 1993b, 1996a, 1999). For the last few years I have intended to write a book on the events covered by the period 1991-1998 - the years of a Bourgeois and a Social Democratic Government -which would bring the two halves of my work together. Material for this study has been accumulated over many years. A number of research visits have been made; large numbers of academics, politicians, civil servants, journalists, unemployed people, social workers and their clients have been interviewed; and extensive use has been made of academic, administrative and public libraries. Since September 1991 I have systematically collected articles from Dagens Nyheter about social services, social insurance, health care, employment, social issues and problems, the economy and politics. The journal Riksdag och Departement (Parliament and Ministry), which summarises a wide range of public documents, has been invaluable. Friends and informal contacts have also given me insights into the Swedish way of life. The new book is based upon all of these experiences. This paper will begin with a brief account of major global social and economic changes that have occurred in the last twenty years. This is intended to provide a background to the more recent changes that have occurred in Swedish society in the last decade. It will be suggested that the changes in Sweden, particularly in the field of welfare, have been less severe than elsewhere and that this is due to political, institutional and cultural resistance. The paper will conclude by arguing that Sweden, as an exemplar of an Apollonian modern society, has had much to fear from the Dionysian characteristics of postmodernity.

Skehill, Caroline: History of the Present of Child Protection and Welfare Social Work in Ireland

This unique book has at least three significant strengths. First, it offers an interesting angle on Irish social history and how social work and child protection and welfare services have been developed from the 1860s to the 1990s. Secondly, the author uses the 'history of the present' method of Michel Foucault in a promising manner, incorporating his concepts of archaeology, genealogy and discourse. Most of all she has succeeded in further developing Michel Foucault's concepts and strategies of writing. Although this is a national history, she has made a remarkable contribution to social work research. Her conceptual and methodological innovations are undoubtedly fully applicable to other social and societal contexts. This book is recommendable to those who want to implement genealogical analysis in their own research. Thirdly, her skill in writing and the way she renders the difficult language and concepts of Michel Foucault accessible means that here is a book that can also be read with ease by those whose mother tongue is not English. From the viewpoint of women and women's research the focus in this book is minor but if you are interested in social work history and genealogical analysis, this is a book you have to read!

Social inequality and smoking in young Swiss men: intergenerational transmission of cultural capital and health orientation

OBJECTIVES Smoking is related to income and education and contributes to social inequality in morbidity and mortality. Socialisation theories focus on one's family of origin as regards acquisition of norms, attitudes and behaviours. Aim of this study is to assess associations of daily smoking with health orientation and academic track in young Swiss men. Further, to assess associations of health orientation and academic track with family healthy lifestyle, parents' cultural capital, and parents' economic capital. METHODS Cross-sectional data were collected during recruitment for compulsory military service in Switzerland during 2010 and 2011. A structural equation model was fitted to a sample of 18- to 25-year-old Swiss men (N = 10,546). RESULTS Smoking in young adults was negatively associated with academic track and health orientation. Smoking was negatively associated with parents' cultural capital through academic track. Smoking was negatively associated with health orientation which in turn was positively associated with a healthy lifestyle in the family of origin. CONCLUSIONS Results suggest two different mechanisms of intergenerational transmissions: first, the family transmission path of health-related dispositions, and secondly, the structural transmission path of educational inequality.

In vivo bisphenol-a release from dental pit and fissure sealants: a systematic review

OBJECTIVE To search the literature and assess the short- and long-term release of bisphenol-A (BPA) in human tissues after treatment with dental sealants. DATA Two review authors performed data extraction independently and in duplicate using data collection forms. Disagreements were resolved by discussion with an arbiter. SOURCES Electronic database searches of published and unpublished literature were performed. The following electronic databases with no language and publication date restrictions were searched: MEDLINE (via Ovid and Pubmed), EMBASE (via ovid), Cochrane Trials Register and CENTRAL. The reference lists of all eligible studies were hand-searched. STUDY SELECTION In the absence of RCTs, six interventional and two observational studies, examining in vivo BPA release in human salivary, blood and urinary samples, were included. Due to the heterogeneity in methodology and reporting, the main synthesis of the results was qualitative. The quantitative synthesis based on the weighted Z-test could only include two studies. BPA levels identified in saliva ranged from traces below the method's detection limit to 30 μg/ml. In urine, BPA quantities spanned from 0.17 mg/g to 45.4 mg/g. BPA was not traced in any blood sample at any point of time in the relevant studies. The quantitative analysis showed evidence of BPA release one hour after sealant placement compared to the amount traced before restoration (Stouffer's z trend: <0.001). CONCLUSIONS The available evidence on this topic derived from studies that represent a moderate level of evidence. Nevertheless, the available evidence supports that BPA is released in saliva after sealant placement. CLINICAL SIGNIFICANCE From the qualititative and quantitative synthesis of studies, it is reasonable to conclude that BPA is released after placement of some dental pit and fissure sealants in the oral cavity. The biggest quantities are detected in saliva immediately after or one hour after their placement.

Bisphenol-A and residual monomer leaching from orthodontic adhesive resins and polycarbonate brackets: a systematic review

INTRODUCTION The objective of this systematic review was to assess the short- and long-term release of components of orthodontic adhesives and polycarbonate brackets in the oral environment. METHODS Electronic database searches of published and unpublished literature were performed. The following electronic databases with no language and publication date restrictions were searched: MEDLINE (via Ovid and PubMed), EMBASE (via Ovid), Cochrane Oral Health Group's Trials Register, and CENTRAL. Unpublished literature was searched on ClinicalTrials.gov, the National Research Register, and Pro-Quest Dissertation Abstracts and Thesis database. The reference lists of all eligible studies were checked for additional studies. Two review authors performed data extraction independently and in duplicate using data collection forms. Disagreements were resolved by discussion or the involvement of an arbiter. RESULTS No randomized controlled trial was identified. In the absence of randomized controlled trials, observational studies were included. Eleven studies met the inclusion criteria. All were observational studies conducted in vivo or in vitro. The bisphenol-A release from orthodontic bonding resins was found to be between 0.85 and 20.88 ng per milliliter in vivo, and from traces to 65.67 ppm in vitro. Polycarbonate brackets released amounts of 22.24 μg per gram in ethanol solution and 697 μg per gram after 40 months in water. Bis-GMA and TEGDMA leaching in vitro reached levels of 64 and 174 mg per 10 μL, respectively. Because of the heterogeneity in methodologies and reporting, only qualitative synthesis was performed. CONCLUSIONS The available evidence on this topic derived from observational in-vivo and in-vitro studies that represent a moderate level of evidence. The variety of setups and the different units allied to the diversity of reporting among studies did not allow calculation of pooled estimates.