Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos

BackgroundPlacebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.Methods and FindingsWe conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.ConclusionsPILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials

Leaving College: Why Students Withdrew from a University

The purpose of this study was to determine the reasons why students withdrew during a semester from a mid-sized, comprehensive university located in the Midwest. Six hundred forty-five students were asked to complete the ACT Withdrawing/Non-returning Student Survey during the 1992-93 academic year and summer semester. Three hundred sixty-five completed surveys were returned for a 57% response rate. Respondents indicated many different reasons for leaving which varied by year in school and whether or not the respondent was a graduate or undergraduate student. There was no typical withdrawing student and there were many reasons students withdrew over which the university has little or no control. The report concludes with a discussion of Vincent Tinto\u27s (1993) ideas concerning institutional departure. The retention and persistence of students in higher education has been the focus of serious intellectual inquiry for many years. Various concepts of institutional departure, persistence and models for programmatic interventions to reduce departure have been developed. (For example, see Pascarella & Terenzini, 1991; Stage & Rushin, 1993; Steele, Kennedy, & Gordon, 1993; Tinto, 1993; Wolfe, 1993.) The purpose of this study was to focus on one aspect of student attrition, and. to investigate the reasons and general trends as . to why students withdrew during a semester from a midsized comprehensive university located in the Midwest. This information could then be used to guide institutional action

On evaluating parallel computer systems

A workshop was held in an attempt to program real problems on the MIT Static Data Flow Machine. Most of the architecture of the machine was specified but some parts were incomplete. The main purpose for the workshop was to explore principles for the evaluation of computer systems employing new architectures. Principles explored were: (1) evaluation must be an integral, ongoing part of a project to develop a computer of radically new architecture; (2) the evaluation should seek to measure the usability of the system as well as its performance; (3) users from the application domains must be an integral part of the evaluation process; and (4) evaluation results should be fed back into the design process. It is concluded that the general organizational principles are achievable in practice from this workshop

Optometry\u27s role in the county health department

This paper\u27 focuses on the overall structure and function of the county health department. The county or local health departrnent is part of a much larger public health system consisting of state, national, and international agencies. Public health has progressed from a crisis management type of organization to a virtually all-encompassing system designed to meet the health care needs of the population as a whole. Vision care is becoming an increasingly vital component of the public health system, and as such, the organizational structure of most health departments must be examined and changed in order to meet the vision care needs of the population. This paper examines the Multnomah County Health Department\u27s vision care program and makes recornmendations for its continued successful operation

Gross Domestic Product (GDP) and productivity of schizophrenia trials: an ecological study

The 5000 randomised controlled trials (RCTs) in the Cochrane Schizophrenia Group's database affords an opportunity to research for variables related to the differences between nations of their output of schizophrenia trials. Ecological study – investigating the relationship between four economic/demographic variables and number of schizophrenia RCTs per country. The variable with closest correlation was used to predict the expected number of studies. GDP closely correlated with schizophrenia trial output, with 76% of the total variation about the Y explained by the regression line (r = 0.87, 95% CI 0.79 to 0.92, r2 = 0.76). Many countries have a strong tradition of schizophrenia trials, exceeding their predicted output. All nations with no identified trial output had GDPs that predicted zero trial activity. Several nations with relatively small GDPs are, nevertheless, highly productive of trials. Some wealthy countries seem either not to have produced the expected number of randomised trials or not to have disseminated them to the English-speaking world. This hypothesis-generating study could not investigate causal relationships, but suggests, that for those seeking all relevant studies, expending effort searching the scientific literature of Germany, Italy, France, Brazil and Japan may be a good investment

Viscosity and the Soft Ridge at RHIC

Correlation studies exhibit a ridge-like feature in rapidity and azimuthal angle, with and without a jet trigger. We ask whether the feature in untriggered correlations can be a consequence of transverse flow and viscous diffusion.Comment: Proc. Quark Matter 2008, Jaipur, Indi

First Science Results From SOFIA/FORCAST: Super-Resolution Imaging of the S140 Cluster at 37\micron

We present 37\micron\ imaging of the S140 complex of infrared sources centered on IRS1 made with the FORCAST camera on SOFIA. These observations are the longest wavelength imaging to resolve clearly the three main sources seen at shorter wavelengths, IRS 1, 2 and 3, and are nearly at the diffraction limit of the 2.5-m telescope. We also obtained a small number of images at 11 and 31\micron\ that are useful for flux measurement. Our images cover the area of several strong sub-mm sources seen in the area -- SMM 1, 2, and 3 -- that are not coincident with any mid-infrared sources and are not visible in our longer wavelength imaging either. Our new observations confirm previous estimates of the relative dust optical depth and source luminosity for the components in this likely cluster of early B stars. We also investigate the use of super-resolution to go beyond the basic diffraction limit in imaging on SOFIA and find that the van Cittert algorithm, together with the "multi-resolution" technique, provides excellent results

Ariel - Volume 9 Number 5

Executive Editor Seth B. Paul Associate Editor Warren J. Ventriglia Business Manager Fredric Jay Matlin University News John Patrick Welch World News George Robert Coar Editorials Editor Steve Levine Features Mark Rubin Brad Feldstein Sports Editor Eli Saleeby Photo Editor Ken Buckwalter Circulation Victor Onufreiczuk Lee Wugofski Graphics and Art Steve Hulkower Commons Editor Brenda Peterso

Use of Erythropoietin in Cancer Patients: Assessment of Oncologists’ Practice Patterns in the United States and Other Countries

PURPOSE: To assess physician use of erythropoietin in cancer patients before publication of the American Society of Clinical Oncology/American Society of Hematology guidelines. METHODS: Questionnaires about erythropoietin use in practice and 12 hypothetical clinical scenarios involving patients with cancer were mailed to 2000 oncologists/hematologists in the United States and 19 other countries. Response rates were 30% in the United States and 25% internationally. Data on erythropoietin use for ovarian cancer were obtained from one clinical trial. Multivariate regression models assessed predictors of erythropoietin prescription. RESULTS: Most physicians selected a hemoglobin level ≤10 g/dL as an upper threshold for erythropoietin use (36% to 51% of U.S. physicians and 21% to 32% of foreign physicians). Frequent erythropoietin use (defined as use in at least 10% of cancer patients) was higher in the United States than elsewhere (adjusted odds ratio [OR]=5.8; 95% confidence interval [CI]: 2.5 to 13.4). Among U.S. physicians, those who said they used erythropoietin frequently were more likely to be in fee-for-service than managed care settings (OR=2.2; 95% CI: 1.3 to 3.7). Those who reported never using erythropoietin practiced in countries that had lower annual per capita health care expenditures, lower proportions of privately funded health care, and a national health service (P \u3c0.05 for all comparisons). Of 235 ovarian cancer patients who received topotecan, 38% (45/118) of U.S. patients and 2% (2/117) of European patients who developed grade 1 anemia (hemoglobin level between 10 and 12 g/dL) were treated with erythropoietin (P\u3c0.01). CONCLUSION: Financial considerations and a hemoglobin level \u3c10 g/dL appear to influence erythropoietin use in the United States, whereas financial considerations alone determine erythropoietin use abroad