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.

Enseignement prégradué de la médecine ambulatoire a la PMU: quelques repères [Pregraduate training in ambulatory care: a Swiss perspective].

The current lack of general practitioners in Switzerland is the result of health care policy which aimed in the past years to reduce the number of medical students and physicians in private practice. Furthermore, during the past decades, the Swiss Medical Schools emphasized on the transmission of medical care by specialists and neglected primary care medicine. The Faculty of medicine at the University of Lausanne recently decided to renew the curriculum. The Department of ambulatory care and community medicine (Policlinique Médicale Universitaire) of Lausanne is committed to the elaboration of this move. The biomedical model, essential to the acquisition of clinical competence, is still taught to the students. Nevertheless, from the beginning to the end of the curriculum, an emphasis is now put on the clinical skills and the clinical reasoning.

Producció de biopolímers amb cultius bacterians mixtes. Comparació de tres reactors discontinus seqüencials (SBR) amb diferents condicions operacionals

La producció de biopolímers (polihidroxialcanoats (PHA) i substàncies polimèriques extracel·lulars (EPS)) a nivell industrial, resulta una nova àrea d’investigació que recull diverses disciplines, entre elles les Ciències Ambientals. Aquest projecte final de carrera amb el títol: “Producció de biopolímers amb cultius bacterians mixtes”, s’ha desenvolupat sota la supervisió de la directora de projecte Dra. María Eugenia Suárez Ojeda del Departament d’Enginyeria Química de la Universitat Autònoma de Barcelona (UAB) i s’ha dut a terme per l’estudiant Jordi Pérez i Forner de la Llicenciatura de Ciències Ambientals, Facultat de Ciències de la UAB, en el Departament d’Enginyeria Química de la mateixa universitat. L’objectiu d’aquest projecte ha estat produir biopolímers simultàniament amb l’eliminació de fòsfor i matèria orgànica en aigües residuals per obtenir un residu final amb un alt valor afegit. Aquests biopolímers reuneixen les característiques necessàries per a poder competir amb els plàstics convencionals i així, reduir l’elevat consum del petroli i la generació de residus no biodegradables. En aquest projecte s’ha dut a terme la posta en marxa d’un reactor discontinu seqüencial (SBR) per a l’acumulació de biopolímers amb cultius bacterians mixtes. Diferents investigadors han estudiat que aquests tipus de cultius bacterians arriben a nivells de fins el 53-97% [Pijuan et al., 2009] de contingut de biopolímers a la biomassa, sometent als microorganismes a diferents situacions d’estrés ja sigui per dèficit de nutrients o per variacions en les fases de feast-famine (festí-fam). Durant el projecte, s’ha realitzat el monitoratge del reactor alimentat amb una aigua sintètica, elaborada en el laboratori, amb les característiques d’un aigua residual provinent de la industria làctica. S’ha sotmès als microorganismes a diferents condicions operacionals, una d’elles amb limitació de fòsfor com a nutrient i una tercera condició amb una variació a les fases feast-famine. D’altra banda, com a segon objectiu, s’ha analitzat el contingut de biopolímers a la biomassa de dos SBRs més, del grup de recerca Bio-GLS del Departament d’Enginyeria Química de la UAB, alimentats amb diferents fonts de carboni, glicerol i àcids grassos de cadena llarga (AGCLL), per observar les influències que té el tipus de substrat en l’acumulació de biopolímers. Els resultats obtinguts en la primera part d’aquest projecte han estat similars als resultats d’altres investigadors [Pijuan et al., 2009; Guerrero et al., 2012]. S’ha determinat que sotmetre als microorganismes a situacions d’estrés té un efecte directe pel que fa a l’acumulació de biopolímers. També s’ha observat com al mateix temps que acumulaven aquests compostos, els microorganismes desenvolupaven la seva tasca de depurar l’aigua residual, obtenint al final del cicle una aigua amb un baix contingut en matèria orgànica i altres contaminants com amoni i fòsfor, en aquest cas. En la segona part del projecte, s’ha observat com el tipus de substrat té un efecte directe pel que fa a l’acumulació de biopolímers i també a l’activitat metabòlica dels microorganismes. Per tant, s’ha conclòs que la producció de biopolímers mitjançant la depuració d’aigües residuals es una via d’investigació molt prometedora pel que fa als resultats obtinguts. Alhora que es tracta un residu, s’obté una producte residual amb un alt valor afegit que pot ser utilitzat per la producció de bioplàstics 100% biodegradables.

Survey of Biobanks at a Swiss University Hospital

Human biobanks are a valuable source of biospecimens and personal data to be used for research. Little is known of how many biobanks exist at a given Swiss University Hospital. The purpose of this survey conducted at the CHUV hospital ( >40'000 patients hospitalized per year) and the faculty of biology and medicine (FBM) at the University in Lausanne, Switzerland was a) to provide an overview of the number of biobanks, b) to assess their purpose and size, c) to determine the kinds of biospecimens collected and d) to analyse the extent to which the biobanks follow the Swiss Academy of Medical Sciences (SAMS) guidelines on biobanks

08018-010 Walnut Creek Final Report

In 2004 Walnut Creek was placed on the 303d list of impaired water bodies for lack of aquatic life with biological causes. Sediment from farmland as well as the stream banks was listed as the most likely stressor. In response to this listing a preliminary watershed assessment was completed by the six counties which have land in the Walnut Creek watershed. Walnut Creek flows through portions of Shelby, Pottawattamie, Montgomery, Mills, Page, and Fremont Counties before reaching its confluence with the West Nishnabotna River. The preliminary study assessed resource concerns and evaluated anticipated landowner participation levels for the six Huc 12 sub-watersheds which divide the Walnut Creek basin. These preliminary assessments revealed a priority sub-watershed which lies between US Hwy 6 and Hwy 34. A development grant was then funded by the Division of Soil Conservation to conduct a detailed assessment of this area. The detailed assessment involved an assessment of the uplands as well as the stream itself. A better understanding of the resource concerns was gained through the assessment, allowing for a comprehensive watershed plan to be developed. A variety of best management practices will be necessary for our project to be a success, many of which will be funded by other sources besides the WIRB. This grant is the first request for funding submitted by the East Pottawattamie and Montgomery SWCDs’. This grant will serve as the first critical step in building what is destined to be a true watershed success story.

Safety & You, September 2011

Iowa State University Police Department annually prepares and distributes “Safety & You” to all students, faculty, staff, as well as potential students and employees. Campus crime, arrest and referral statistics include those reported to the ISU Police, designated campus officials (including, but not limited to, Department of Residence, Dean of Students Office, athletic coaches, and advisors to student organizations), Ames Police and the Story County Sheriff’s Office. The ISU Counseling and Thielen Student Health Centers are exempted by patient confidentiality laws from disclosing reported information. Iowa State University does not have a voluntary confidential procedure for reporting crimes to law enforcement

Safety & You, September 2012

Iowa State University Police Department annually prepares and distributes “Safety & You” to all students, faculty, staff, as well as potential students and employees. Campus crime, arrest and referral statistics include those reported to the ISU Police, designated campus officials (including, but not limited to, Department of Residence, Dean of Students Office, athletic coaches, and advisors to student organizations), Ames Police and the Story County Sheriff’s Office. The ISU Counseling and Thielen Student Health Centers are exempted by patient confidentiality laws from disclosing reported information. Iowa State University does not have a voluntary confidential procedure for reporting crimes to law enforcement

Safety & You, September 2013

Iowa State University Police Department annually prepares and distributes “Safety & You” to all students, faculty, staff, as well as potential students and employees. Campus crime, arrest and referral statistics include those reported to the ISU Police, designated campus officials (including, but not limited to, Department of Residence, Dean of Students Office, athletic coaches, and advisors to student organizations), Ames Police and the Story County Sheriff’s Office. The ISU Counseling and Thielen Student Health Centers are exempted by patient confidentiality laws from disclosing reported information. Iowa State University does not have a voluntary confidential procedure for reporting crimes to law enforcement

Safety & You, September 2014

Iowa State University Police Department annually prepares and distributes “Safety & You” to all students, faculty, staff, as well as potential students and employees. Campus crime, arrest and referral statistics include those reported to the ISU Police, designated campus officials (including, but not limited to, Department of Residence, Dean of Students Office, athletic coaches, and advisors to student organizations), Ames Police and the Story County Sheriff’s Office. The ISU Counseling and Thielen Student Health Centers are exempted by patient confidentiality laws from disclosing reported information. Iowa State University does not have a voluntary confidential procedure for reporting crimes to law enforcement

The burnout syndrome and associated personality disturbances. The study in three graduate programs in Dentistry at the University of Barcelona

Objective: Determine the presence of"burnout" syndrome and characteristic personality patterns in the students and faculty of three graduate programs in Dentistry at the University of Barcelona: Department of Oral Surgery and Implantology, Department of Orthodontics and Department of Integrated Dentistry. Materials and Methods: The study was carried out in 78 dentists. The level of"burnout" was evaluated using the Maslach Burnout Inventory, socio-demographic variables and, finally, the personality test. Results: Oral surgeons constituted the group of highlevel"burnout". The profile of an individual with a propensity to"burn out" is a single man, with a median age of 27, that is in the first years of the graduate program and that combines studies with 30 hours of clinical practice and/or other work (p<0,05). Narcissistic and borderline are the types of personality most frequently found in the individuals that present"burnout" syndrome (p<0,05). Conclusions: In general, no high levels of"burnout" were registered in the studied population, only 2-3%, if applying strict definition of"burnout", and 10% if these criteria were amplified. We believe it is necessary to identify the individuals with a tendency towards"burnout", in order to establish preventive measures and avoid future negative behaviour at work as well as at the personal level.

Aortic remodelling in Fabry disease

Aims To evaluate thoracic aortic dilation in patients with Fabry disease (FD). Methods and results A cohort of 106 patients with FD (52 males; 54 females) from three European centres were studied. The diameter of the thoracic aorta was assessed at three levels (sinus of Valsalva, ascending aorta, and descending aorta) using echocardiograms and cardiovascular magnetic resonance imaging. Aortic dilation at the sinus of Valsalva was found in 32.7% of males and 5.6% of females; aneurysms were present in 9.6% of males and 1.9% of females. No aortic dilation was observed in the descending aorta. There was no correlation between aortic diameter at the sinus of Valsalva and cardiovascular risk factors. Conclusion Fabry disease should be considered as a cardiovascular disease that affects the heart and arterial vasculature, including the thoracic aorta. Thus, patients with FD should be closely monitored for the presence, and possible progression and complications of aortic dilation. Clinical Trial Registration: Protocol 101/01. Ethics committee, Faculty of Medicine, Lausanne.

Issue review : fiscal year 2011 general fund budget projection.

This issue review provides an overall summary of Iowa's general fund budget. This issue review provides projections for the 2010 fiscal year and fiscal year 2011 budgets based on the October 7, 2009 revenue estimating conference's (REC) revenue estimate. The projection also includes the impact of the Governor's 10 percent across-the-board reduction to fiscal year 2010 general fund appropriations, and the Legislative Services Agency's most recent estimates of built-in and anticipated expenditures for fiscal year 2011.

The estimation of PMP and PMF on alpine basins in Switzerland

This paper presents a very fine grid hydrological model based on the spatiotemporal repartition of precipitation and on the topography. The goal is to estimate the flood on a catchment area, using a Probable Maximum Precipitation (PMP) leading to a Probable Maximum Flood (PMF). The spatiotemporal distribution of the precipitation was realized using six clouds modeled by the advection-diffusion equation. The equation shows the movement of the clouds over the terrain and also gives the evolution of the rain intensity in time. This hydrological modeling is followed by a hydraulic modeling of the surface and subterranean flows, done considering the factors that contribute to the hydrological cycle, such as the infiltration, the exfiltration and the snowmelt. This model was applied to several Swiss basins using measured rain, with results showing a good correlation between the simulated and observed flows. This good correlation proves that the model is valid and gives us the confidence that the results can be extrapolated to phenomena of extreme rainfall of PMP type. In this article we present some results obtained using a PMP rainfall and the developed model.

Frontshear and backshear instabilities of the mean longshore current

An analytical model based on Bowen and Holman [1989] is used to prove the existence of instabilities due to the presence of a second extremum of the background vorticity at the front side of the longshore current. The growth rate of the so-called frontshear waves depends primarily upon the frontshear but also upon the backshear and the maximum and the width of the current. Depending on the values of these parameters, either the frontshear or the backshear instabilities may dominate. Both types of waves have a cross-shore extension of the order of the width of the current, but the frontshear modes are localized closer to the coast than are the backshear modes. Moreover, under certain conditions both unstable waves have similar growth rates with close wave numbers and angular frequencies, leading to the possibility of having modulated shear waves in the alongshore direction. Numerical analysis performed on realistic current profiles confirm the behavior anticipated by the analytical model. The theory has been applied to a current profile fitted to data measured during the 1980 Nearshore Sediment Transport Studies experiment at Leadbetter Beach that has an extremum of background vorticity at the front side of the current. In this case and in agreement with field observations, the model predicts instability, whereas the theory based only on backshear instability fai led to do so.