Body weight as an indicator of fat-free mass in active elderly women

Objective: Fat-free mass (FFM) reduction and the tendency for a reduction in surrounding fatty issue and increase in the middle are a natural consequence of growing old and should be studied in order to gain a better understanding of the aging process. This study set out to find the FFM differences between active elderly women in two age groups (60-69 and 70-80 years) and to determine which of the anthropometric measurements, body weight (BW), abdominal circumference (AC), or body mass index (BMI) are the best predictors of FFM variation within the group. Methods: Eighty-one (n = 81) active elderly women of the Third Age willingly signed up to participate in the research during the activities at the University of the Third Age (UTA) in Brazil. The research was approved by the Research Ethics Committee of the Faculty of Medical Sciences of the State University of Campinas (UNICAMP). Body weight (BW), height (H) and the BMI were measured according to the international standards. The AC was measured in centimetres at the H of the navel and body composition was ascertained using bioimpedance analysis. The SAS program was used to perform the statistical analysis of independent samples and parametric data. Results: The results showed FFM values with significant differences between the two groups, with the lowest values occurring among the women who were over 70 years of age. In the analysis, the Pearson`s Correlation Coefficient for each measured independent variable was ascertained, with the BW measurement showing the highest ratio (0.900). Conclusions: The BW measurement was regarded as reliable, low-cost and easy to use for monitoring FFM in elderly women who engage in physical activities. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

Reliability assessment of Cobb angle measurements using manual and digital methods

BACKGROUND CONTEXT: The vertebral spine angle in the frontal plane is an important parameter in the assessment of scoliosis and may be obtained from panoramic X-ray images. Technological advances have allowed for an increased use of digital X-ray images in clinical practice. PURPOSE: In this context, the objective of this study is to assess the reliability of computer-assisted Cobb angle measurements taken from digital X-ray images. STUDY DESIGN/SETTING: Clinical investigation quantifying scoliotic deformity with Cobb method to evaluate the intra- and interobserver variability using manual and digital techniques. PATIENT SAMPLE: Forty-nine patients diagnosed with idiopathic scoliosis were chosen based on convenience, without predilection for gender, age, type, location, or magnitude of the curvature. OUTCOME MEASURES: Images were examined to evaluate Cobb angle variability, end plate selection, as well as intra- and interobserver errors. METHODS: Specific software was developed to digitally reproduce the Cobb method and calculate semiautomatically the degree of scoliotic deformity. During the study, three observers estimated the Cobb angle using both the digital and the traditional manual methods. RESULTS: The results showed that Cobb angle measurements may be reproduced in the computer as reliably as with the traditional manual method, in similar conditions to those found in clinical practice. CONCLUSIONS: The computer-assisted method (digital method) is clinically advantageous and appropriate to assess the scoliotic curvature in the frontal plane using Cobb method. (C) 2010 Elsevier Inc. All rights reserved.

Validity and reliability of a computer method to estimate vertebral axial rotation from digital radiographs

Axial vertebral rotation, an important parameter in the assessment of scoliosis may be identified on X-ray images. In line with the advances in the field of digital radiography, hospitals have been increasingly using this technique. The objective of the present study was to evaluate the reliability of computer-processed rotation measurements obtained from digital radiographs. A software program was therefore developed, which is able to digitally reproduce the methods of Perdriolle and Raimondi and to calculate semi-automatically the rotation degree of vertebra on digital radiographs. Three independent observers estimated vertebral rotation employing both the digital and the traditional manual methods. Compared to the traditional method, the digital assessment showed a 43% smaller error and a stronger correlation. In conclusion, the digital method seems to be reliable and enhance the accuracy and precision of vertebral rotation measurements.

Publicació científica : política sobre l'accés obert

El següent informe revela la necessitat d'establir una política europea sobre la publicació d'accés obert. Per començar, es fan unes recomanacions sobre el paper que hauria de jugar la Comissió com a entitat finançadora, política i de suport d'aquest tipus de publicació. Aquesta política europea, un cop establerta, s'hauria de desplegar per fases, donada la seva complexitat, i es proposa començar per la recerca feta en el marc del programa FP7 i de la recerca finançada amb fons públics. Es defineixen els conceptes clau relacionats amb la publicació d'Accés Obert i després s'analitzen les polítiques sobre l'accés obert. Finalment, s'analitza també l'estat de la qüestió de l'accés obert dins la comunitat investigadora i s'apunten unes directrius que hauria de seguir la política europea.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications

OBJECTIVE: To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. DESIGN: Cohort of protocols of randomised controlled trial and subsequent full journal publications. SETTING: Six research ethics committees in Switzerland, Germany, and Canada. DATA SOURCES: 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. RESULTS: Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. CONCLUSIONS: Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials.

'Hearts and bones': the ups and downs of 'plasticity' in stem cell biology.

More than a decade ago, 'plasticity' suddenly became a 'fashionable' topic with overemphasized implications for regenerative medicine. The concept of 'plasticity' is supported by old transplantation work, at least for embryonic cells, and metaplasia is a classic example of plasticity observed in patients. Nevertheless, the publication of a series of papers showing rare conversion of a given cell type into another unrelated cell raised the possibility of using any unaffected tissue to create at will new cells to replace a different failing tissue or organ. This resulted in disingenuous interpretations and a reason not to fund anymore research on embryonic stem cells (ESc). Moreover, many papers on plasticity were difficult to reproduce and thus questioned; raising issues about plasticity as a technical artefact or a consequence of rare spontaneous cells fusion. More recently, reprogramming adult differentiated cells to a pluripotent state (iPS) became possible, and later, one type of differentiated cell could be directly reprogrammed into another (e.g. fibroblasts into neurons) without reverting to pluripotency. Although the latter results from different and more robust experimental protocols, these phenomena also exemplify 'plasticity'. In this review, we want to place 'plasticity' in a historical perspective still taking into account ethical and political implications.

Prevalence, characteristics, and publication of discontinued randomized trials.

IMPORTANCE: The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear. OBJECTIVES: To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication. DESIGN AND SETTING: Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013. MAIN OUTCOMES AND MEASURES: Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys. RESULTS: After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P < .001) and a larger planned sample size in increments of 100 (-0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P < .001). CONCLUSIONS AND RELEVANCE: In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials.

La quête du consentement éclairé en médecine comme construction sociale [The application of informed consent in medicine as social construction].

The aim of this article is to propose an anthropological point of view about informed consent in medicine. This quest for legitimacy should be read as a relational and social construction. In the heart of clinical complexity we find on one side various techniques employed by the medical community to validate research and to obtain the consent of patients. On the other side patients offer plural and subjective answers due to the doctor patient hierarchical and long relationship. Between constraints and freedoms, informed consent brings to light social relation.

Accidental intoxication of the infant-juvenile population in households: profiles of emergency care

OBJECTIVE Analyzing profiles of intoxication and accidental poisoning of infant-juvenile population (0-24 years) in the household, treated at a reference facility for Emergency and Primary Care, during the year 2013. METHOD A descriptive, cross-sectional study. Data were analyzed using Epi-Info, by way of simple and bivariate analyzes. The project was approved by the Research Ethics Committee (protocol 405.578). RESULTS There were 45 intoxications, with a prevalence of males (60.0%), aged 1-4 years (71.1%). Among children under one, there was a higher frequency of pesticide poisoning (66.6%), between the ages of 1-4 by cleaning products (34.4%), and between 5-9 years of age by pharmacological substances (66.6%). The primary assistance was provided only at health institutions, with hospital admissions in 24.4% of the cases. CONCLUSION The importance of prevention through legislation is evident, in order to ensure greater safety in packaging of various products, and community awareness to eliminate risks in the household environment.

Informed consent: Biobank donors should have a say.

Comment on: Saha K, Hurlbut JB. Research ethics: treat donors as partners in biobank research. Nature. 2011;478(7369):312-3. doi: 10.1038/478312a. PMID: 22012372.

Ice-Retardant Pavement, HR-290, 1991

During 1986, the City of Des Moines placed an experimental asphaltic concrete overlay containing an ice-retardant additive (Verglimit) on Euclid Avenue (U.S. Highway 6). Verglimit is a chemical multi-component deicer which is added to the surface course of an asphalt overlay. The additive was uniformly distributed through the mix at the asphalt plant, which allows exposure of the particles as the finished surface wears under traffic. During a snowfall, the exposed particles attract and absorb moisture creating a deicing solution which dampens the pavement. The Verglimit additive used on this project cost $1,180 per metric ton. The Verglimit was added at a rate of 6.3% by weight, which was 126 pounds per ton, or $66.38 per ton of hot mix asphalt. The purchase of Verglimit additive was funded by the Iowa Department of Transportation through a research project recommended by the Highway Research Advisory Board. The pavement surface experienced severe wetting due to the additive's affinity for water immediately after the project was completed and during periods of high humidity. This wetting created slippery conditions both on the project itself and where vehicles tracked the additive. The only way to remove the slipperiness was by flushing the street with water. The ice-retardant overlay appears to perform as expected in reducing the adherence of ice and snow, especially at temperatures just below freezing. It performs better in light snowfalls than in heavy ones. The ice retardant overlay is effective in eliminating thin coatings of ice due to freezing drizzle or widespread frost. The accident data showed a reduction in the number of snow and ice related accidents but due to the low number of this type of accident the results are inconclusive.

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.

Plan Reading Course, HR-324

This booklet is part of the Bridge Plan Reading Course developed by the Department of Civil and Construction Engineering of Iowa State University under contract with the Highway Research Advisory Board, Project HR-324. It is intended to be an instructional tool for Iowa DOT and county and municipal employees within the state of Iowa. The questions in this booklet are designed to test your knowledge of the material in the Bridge Plan Reading Course. You are free to use both the plans and the text material to assist you in answering these questions. There is a separate ANSWER BOOKLET which contains the answers to these questions. Consult that booklet to make sure you have answered these questions correctly. If you miss the answer to a question, go back and review the text material and the plans to make sure you understand the correct answer.

Planning and reporting of quality-of-life outcomes in cancer trials.

BACKGROUND: Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. DESIGN: Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. RESULTS: Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. CONCLUSIONS: About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers.

Multimorbidity in primary care : protocol of a national cross-sectional study in Switzerland.

INTRODUCTION: With the ageing of the population and the general improvement of care, an increasing number of people are living with multiple chronic health conditions or 'multimorbidity'. Multimorbidity often implies multiple medical treatments. As a consequence, the risk of adverse events and the time spent by patients for their treatments increase exponentially. In many cases, treatment guidelines traditionally defined for single conditions are not easily applicable. Primary care for individuals with multimorbidity requires complex patient-centred care and good communication between the patient and the general practitioner (GP). This often includes prioritising among the different chronic conditions. METHODS AND ANALYSIS: The main objectives of this study are to describe the burden related to multimorbidity (disease-related burden and burden of treatment) in primary care and to identify the factors influencing it. Other objectives include evaluating patients' perception of treatment burden and quality of life, assessing factors influencing that perception, and investigating prioritisation in the management of multimorbidity from the perspectives of GPs and patients. For this cross-sectional study, patient enrolment will take place in GP's private practices across Switzerland. A convenient sample of 100 GPs will participate; overall, 1000 patients with at least three chronic health conditions will be enrolled. Data will be collected as paper-based questionnaires for GPs and delayed telephone interview questionnaires for patients. GPs will provide demographic and practice-related data. In addition, each GP will complete a paper-based questionnaire for each patient that they enrol. Each patient will complete a telephone interview questionnaire. ETHICS AND DISSEMINATION: This study has been approved by the research ethics committee of Canton Vaud, Switzerland (Protocol 315/14). The results of the study will be reported in international peer-reviewed journals.