In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 (...) and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results. (shrink)

This article is concerned with exploring the idea of places as providing persons with nourishment. This version of person–place relations is displayed in a paper by McHugh and, in provocative fashion, in Michel Serres’s analysis of the human condition as a parasitic one. Unlike McHugh, Serres combines his analysis of parasites with a concern that principled actors may be insufficiently attached to places. His views are revealed in his interpretations of works by Molière and Plato. By reinterpreting these works, I (...) try to suggest that Serres’s well-founded scepticism as to the level of commitment of principled actors to the places that, as he rightly points out, are nourishing them, may not apply to the sub-set of principled actors who deserve to be called particular. (shrink)

The question of the moral significance of Scripture is in reality a question about what kind of community the church must be to make the narratives of Scripture central for its life.

Aquesta publicació recull els textos de les ponències de "L'encontre Fora d'equi libri", organitzat pel Departament de Cultura i Mitjans de Comunicació els dies 5, 6 i 7 de setembre de 2008, que planteja el paper de la inestabilitat i la tra nsformació en el món contemporani. Les causes, els mecanismes i les conseqüèncie s d'estar fora d'equilibri apareixen de forma diversa en els més diversos àmbits de les ciències, les humanitats i la creació en general. L'encontre s'organitzàe n tres (...) sessions: "homo ecologicus", que reflexiona sobre el fer de manera respec tuosa amb l'ambient; "viure el canvi", que reflexiona sobre la necessitat d'adap tació a un món canviant, i "artistes al laboratori", que reflexiona sobre les co ndicions favorables al procés de creació. (shrink)

This book is a volume in the Penn Press Anniversary Collection. To mark its 125th anniversary in 2015, the University of Pennsylvania Press rereleased more than 1,100 titles from Penn Press's distinguished backlist from 1899-1999 that had fallen out of print. Spanning an entire century, the Anniversary Collection offers peer-reviewed scholarship in a wide range of subject areas.

Remembering Fermi MORREL H. COHEN Department of Physics and Astronomy, Rutgers University Frelinghuysen Road. Piscataway, NJ 08854-8019 USA and Department ...

Too many patients are injured in the course of care. Clinicians may mistakenly cause new harm to a patient or fail to take established steps to improve the presenting condition. Medical institutions within which they work may lack mechanisms to reduce errors or prevent them from harming patients. Many, perhaps even most, injuries are preventable, probably numbering in the hundreds of thousands a year for hospital care alone. Long ignored by medical practitioners and health-care payers and little appreciated by the (...) public, the problem of medical injury is finally receiving high-level policy attention. Much credit goes to the Institute of Medicine for its landmark report of November 1999, which marshaled the evidence about medical injuries and highlighted new approaches to systematic improvement of safety within systems of care. (shrink)

Too many patients are injured in the course of care. Clinicians may mistakenly cause new harm to a patient or fail to take established steps to improve the presenting condition. Medical institutions within which they work may lack mechanisms to reduce errors or prevent them from harming patients. Many, perhaps even most, injuries are preventable, probably numbering in the hundreds of thousands a year for hospital care alone. Long ignored by medical practitioners and health-care payers and little appreciated by the (...) public, the problem of medical injury is finally receiving high-level policy attention. Much credit goes to the Institute of Medicine for its landmark report of November 1999, which marshaled the evidence about medical injuries and highlighted new approaches to systematic improvement of safety within systems of care. (shrink)

Complex systems can be characterized by classes of equivalency of their elements defined according to system specific rules. We propose a generalized preferential attachment model to describe the class size distribution. The model postulates preferential growth of the existing classes and the steady influx of new classes. According to the model, the distribution changes from a pure exponential form for zero influx of new classes to a power law with an exponential cut-off form when the influx of new classes is (...) substantial. Predictions of the model are tested through the analysis of a unique industrial database, which covers both elementary units (products) and classes (markets, firms) in a given industry (pharmaceuticals), covering the entire size distribution. The model's predictions are in good agreement with the data. The paper sheds light on the emergence of the exponent tau approximately 2 observed as a universal feature of many biological, social and economic problems. (shrink)

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The (...) authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they would (...) enrol the patient in a trial and how sure they were of this decision. Demographic characteristics of the investigators were also collected. OUTCOME MEASURES: The difference in enrolment decisions between subjective and objective criteria, and the difference in the certainty associated with these decisions. RESULTS: Of 365 questionnaires sent out, 224 usable ones were returned. Compared with the objective criteria, the subjective criteria were associated with more variable enrolment decisions (p = 0.07 for the "eligible" scenario and p = 0.0001 for the "ineligible" and "uncertain" scenarios), and investigators were less sure about the decisions they made (p = 0.0001 for all scenarios). Demographic characteristics of the investigators failed to explain the observed differences. CONCLUSIONS: Subjective eligibility criteria may interfere with the conduct and interpretation of RCTs and, therefore, their use ought to be justified explicitly in the study protocol. RCT designers, funding agencies and research ethics boards have an important role in reviewing eligibility criteria for their necessity. (shrink)