Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Contains fulltext : 110505.pdf (publisher's version ) (Open Access)BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813

Rye kernel breakfast increases satiety in the afternoon - an effect of food structure

<p>Abstract</p> <p>Background</p> <p>The structure of whole grain cereals is maintained to varying degrees during processing and preparation of foods. Food structure can influence metabolism, including perceived hunger and satiety. A diet that enhances satiety per calorie may help to prevent excessive calorie intake. The objective of this work was to compare subjective appetite ratings after consumption of intact and milled rye kernels.</p> <p>Methods</p> <p>Two studies were performed using a randomized, cross-over design. Ratings for appetite (hunger, satiety and desire to eat) were registered during an 8-h period after consumption of whole and milled rye kernels prepared as breads (study 1, n = 24) and porridges (study 2, n = 20). Sifted wheat bread was used as reference in both study parts and the products were eaten in iso-caloric portions with standardized additional breakfast foods. Breads and porridges were analyzed to determine whether structure (whole vs. milled kernels) effected dietary fibre content and composition after preparation of the products. Statistical evaluation of the appetite ratings after intake of the different breakfasts was done by paired t-tests for morning and afternoon ratings separately, with subjects as random effect and type of breakfast and time points as fixed effects.</p> <p>Results</p> <p>All rye breakfasts resulted in higher satiety ratings in the morning and afternoon compared with the iso-caloric reference breakfast with sifted wheat bread. Rye bread with milled or whole kernels affected appetite equally, so no effect of structure was observed. In contrast, after consumption of the rye kernel breakfast, satiety was increased and hunger suppressed in the afternoon compared with the milled rye kernel porridge breakfast. This effect could be related to structural differences alone, because the products were equal in nutritional content including dietary fibre content and composition.</p> <p>Conclusions</p> <p>The study demonstrates that small changes in diet composition such as cereal grain structure have the potential to effect feelings of hunger and satiety.</p> <p>Trial registration</p> <p>This trial was registered at clinicaltrials.gov as <a href="http://www.clinicaltrials.gov/ct2/show/NCT01042418">NCT01042418</a>.</p

An exploratory study of Muslim adolescents' views on sexuality: Implications for sex education and prevention

<p>Abstract</p> <p>Background</p> <p>This paper describes the results of an exploratory qualitative study on Muslim adolescents' views on sexuality in the Netherlands.</p> <p>Methods</p> <p>Data were gathered from an Internet forum on which 44 Muslim and 33 non-Muslim adolescents discussed sexuality as it relates to Islam. These discussions were subsequently analyzed for content using Nvivo 2.0.</p> <p>Results</p> <p>Our analysis revealed several issues that are relevant for the design of future sex education programs targeting Muslim youth. Apart from some expected outcomes regarding, for example, taboos on sexuality, sex outside marriage, abortion, homosexuality and conservative gender roles, our analyses showed that in cases of disputes 1) discussions were polarized, 2) opponents used the same Qur'anic passages to support their views, and 3) the authority of an Imam was questioned when his interpretation of Qur'anic passages was not in line with the views of participants.</p> <p>Conclusions</p> <p>Our findings show that current approaches to sex education among Muslim youth are likely to be unsuccessful given the rigidity of sexual norms in Muslim society. In addition, we also identified new barriers to sex education among Muslim youth (e.g. lack of respect for an Imam who opposes a youth's views on sexuality).</p

Mapping Migratory Bird Prevalence Using Remote Sensing Data Fusion

This is the publisher’s final pdf. The published article is copyrighted by the Public Library of Science and can be found at: http://www.plosone.org/home.action.Background: Improved maps of species distributions are important for effective management of wildlife under increasing anthropogenic pressures. Recent advances in lidar and radar remote sensing have shown considerable potential for mapping forest structure and habitat characteristics across landscapes. However, their relative efficacies and integrated use in habitat mapping remain largely unexplored. We evaluated the use of lidar, radar and multispectral remote sensing data in predicting multi-year bird detections or prevalence for 8 migratory songbird species in the unfragmented temperate deciduous forests of New Hampshire, USA. \ud \ud Methodology and Principal Findings: A set of 104 predictor variables describing vegetation vertical structure and variability from lidar, phenology from multispectral data and backscatter properties from radar data were derived. We tested the accuracies of these variables in predicting prevalence using Random Forests regression models. All data sets showed more than 30% predictive power with radar models having the lowest and multi-sensor synergy ("fusion") models having highest accuracies. Fusion explained between 54% and 75% variance in prevalence for all the birds considered. Stem density from discrete return lidar and phenology from multispectral data were among the best predictors. Further analysis revealed different relationships between the remote sensing metrics and bird prevalence. Spatial maps of prevalence were consistent with known habitat preferences for the bird species. \ud \ud Conclusion and Significance: Our results highlight the potential of integrating multiple remote sensing data sets using machine-learning methods to improve habitat mapping. Multi-dimensional habitat structure maps such as those generated from this study can significantly advance forest management and ecological research by facilitating fine-scale studies at both stand and landscape level

Resolution of inflammation: a new therapeutic frontier

Dysregulated inflammation is a central pathological process in diverse disease states. Traditionally, therapeutic approaches have sought to modulate the pro- or anti-inflammatory limbs of inflammation, with mixed success. However, insight into the pathways by which inflammation is resolved has highlighted novel opportunities to pharmacologically manipulate these processes — a strategy that might represent a complementary (and perhaps even superior) therapeutic approach. This Review discusses the state of the art in the biology of resolution of inflammation, highlighting the opportunities and challenges for translational research in this field

A communal catalogue reveals Earth's multiscale microbial diversity

Our growing awareness of the microbial world's importance and diversity contrasts starkly with our limited understanding of its fundamental structure. Despite recent advances in DNA sequencing, a lack of standardized protocols and common analytical frameworks impedes comparisons among studies, hindering the development of global inferences about microbial life on Earth. Here we present a meta-analysis of microbial community samples collected by hundreds of researchers for the Earth Microbiome Project. Coordinated protocols and new analytical methods, particularly the use of exact sequences instead of clustered operational taxonomic units, enable bacterial and archaeal ribosomal RNA gene sequences to be followed across multiple studies and allow us to explore patterns of diversity at an unprecedented scale. The result is both a reference database giving global context to DNA sequence data and a framework for incorporating data from future studies, fostering increasingly complete characterization of Earth's microbial diversity.Peer reviewe

A communal catalogue reveals Earth’s multiscale microbial diversity

Our growing awareness of the microbial world’s importance and diversity contrasts starkly with our limited understanding of its fundamental structure. Despite recent advances in DNA sequencing, a lack of standardized protocols and common analytical frameworks impedes comparisons among studies, hindering the development of global inferences about microbial life on Earth. Here we present a meta-analysis of microbial community samples collected by hundreds of researchers for the Earth Microbiome Project. Coordinated protocols and new analytical methods, particularly the use of exact sequences instead of clustered operational taxonomic units, enable bacterial and archaeal ribosomal RNA gene sequences to be followed across multiple studies and allow us to explore patterns of diversity at an unprecedented scale. The result is both a reference database giving global context to DNA sequence data and a framework for incorporating data from future studies, fostering increasingly complete characterization of Earth’s microbial diversity