The Readability of Information and Consent Forms in Clinical Research in France

BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use

Decisions at the end of life: have we come of age?

Decision making is a complex process and it is particularly challenging to make decisions with, or for, patients who are near the end of their life. Some of those challenges will not be resolved - due to our human inability to foresee the future precisely and the human proclivity to change stated preferences when faced with reality. Other challenges of the decision-making process are manageable. This commentary offers a set of approaches which may lead to progress in this field

Domestic burglary drop and the security hypothesis

This study examines the role of household security devices in producing the domestic burglary falls in England and Wales. It extends the study of the security hypothesis as an explanation for the 'crime drop'. Crime Survey for England and Wales data are analysed from 1992 to 2011/12 via a series of data signatures indicating the nature of, and change in, the relationship between security devices and burglary. The causal role of improved security is strongly indicated by a set of interlocking data signatures: rapid increases in the prevalence of security, particularly in the availability of combinations of the most effective devices (door and window locks plus security lighting); a steep decline in the pro-portion of households without security accompanied by disproportionate rises in their burglary risk; and the decline being solely in forced rather than unforced entries to households. The study concludes that there is strong evidence that security caused the decline in burglary in England and Wales in the 1990s. Testing the security hypothesis across a wider range of crime types, countries and forms of security than examined to date, is required both to understand the crime drop and to derive lessons for future crime prevention practice and policy

Patterns of Ancestry, Signatures of Natural Selection, and Genetic Association with Stature in Western African Pygmies

African Pygmy groups show a distinctive pattern of phenotypic variation, including short stature, which is thought to reflect past adaptation to a tropical environment. Here, we analyze Illumina 1M SNP array data in three Western Pygmy populations from Cameroon and three neighboring Bantu-speaking agricultural populations with whom they have admixed. We infer genome-wide ancestry, scan for signals of positive selection, and perform targeted genetic association with measured height variation. We identify multiple regions throughout the genome that may have played a role in adaptive evolution, many of which contain loci with roles in growth hormone, insulin, and insulin-like growth factor signaling pathways, as well as immunity and neuroendocrine signaling involved in reproduction and metabolism. The most striking results are found on chromosome 3, which harbors a cluster of selection and association signals between approximately 45 and 60 Mb. This region also includes the positional candidate genes DOCK3, which is known to be associated with height variation in Europeans, and CISH, a negative regulator of cytokine signaling known to inhibit growth hormone-stimulated STAT5 signaling. Finally, pathway analysis for genes near the strongest signals of association with height indicates enrichment for loci involved in insulin and insulin-like growth factor signaling

Integrin αvβ5 is a primary receptor for adenovirus in CAR-negative cells

<p>Abstract</p> <p>Background</p> <p>Viruses bind to specific cellular receptors in order to infect their hosts. The specific receptors a virus uses are important factors in determining host range, cellular tropism, and pathogenesis. For adenovirus, the existing model of entry requires two receptor interactions. First, the viral fiber protein binds Coxsackie and Adenovirus Receptor (CAR), its primary cellular receptor, which docks the virus to the cell surface. Next, viral penton base engages cellular integrins, coreceptors thought to be required exclusively for internalization and not contributing to binding. However, a number of studies reporting data which conflicts with this simple model have been published. These observations have led us to question the proposed two-step model for adenovirus infection.</p> <p>Results</p> <p>In this study we report that cells which express little to no CAR can be efficiently transduced by adenovirus. Using competition experiments between whole virus and soluble viral fiber protein or integrin blocking peptides, we show virus binding is not dependent on fiber binding to cells but rather on penton base binding cellular integrins. Further, we find that binding to low CAR expressing cells is inhibited specifically by a blocking antibody to integrin αvβ5, demonstrating that in these cells integrin αvβ5 and not CAR is required for adenovirus attachment. The binding mediated by integrin αvβ5 is extremely high affinity, in the picomolar range.</p> <p>Conclusions</p> <p>Our data further challenges the model of adenovirus infection in which binding to primary receptor CAR is required in order for subsequent interactions between adenovirus and integrins to initiate viral entry. In low CAR cells, binding occurs through integrin αvβ5, a receptor previously thought to be used exclusively in internalization. We show for the first time that integrin αvβ5 can be used as an alternate binding receptor.</p

Implementation Science and Nutrition: From Research to Practice

Implementation science (IS) is a young field that seeks to minimize the gap between what we know and what we practice, otherwise known as the "know-do gap." Recently, IS has focused on research that expedites the dissemination of evidence-based knowledge, accelerates the translation of interventions to improve knowledge gaps, shrinks healthcare disparities, enhances care of complex medical conditions, and narrows variation in clinical practice and policy. This article seeks to review theoretical frameworks of IS and demonstrate how IS can be utilized to improve nutrition care. Specific examples in this article include implementation of initiatives to improve documentation of malnutrition, increase provision of oral nutrition supplements, increase use of Enhanced Recovery After Surgery protocols, and increase energy and protein delivery. Clinical nutrition is a growing field with more and more research findings pointing to new therapies. In implementing these new therapies, practitioners should recognize the complex system present in healthcare and lean on IS findings to speed implementation and more rapidly improve clinical outcomes