Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents

Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range.

Doing Focus Groups and Interviews with Recent Migrants to Northern Ireland: A Dynamic Interplay of Ethics, Language and Access

This case describes a qualitative social science research project that was conducted in 2009 and that examined the experiences of recent migrants to Northern Ireland. While background to the research and key findings are presented, the topic forms a backdrop to the case. The following aspects of the study are presented: the theoretical context; formulating the research question, design and methodology; key methodological issues; data collection and analysis; project dissemination; and research funding and reporting. The case pays particular attention to the needs and impact of different groups including the researcher, the funding body, the researcher’s employer and the researched. The significance of access, language and ethics to this study are examined. Finally, the way in which the research unfolded in an often-unpredictable way throughout the implementation process is highlighted in the narrative.

RAS testing of colorectal carcinoma—a guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Group

Analysis of colorectal carcinoma (CRC) tissue for KRAS codon 12 or 13 mutations to guide use of anti-epidermal growth factor receptor (EGFR) therapy is now considered mandatory in the UK. The scope of this practice has been recently extended because of data indicating that NRAS mutations and additional KRAS mutations also predict for poor response to anti-EGFR therapy. The following document provides guidance on RAS (i.e., KRAS and NRAS) testing of CRC tissue in the setting of personalised medicine within the UK and particularly within the NHS. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such RAS testing.

From the past to the Future: integrating archaeology and conflict resolution in Northern Ireland

Contested understandings about the past continue to reify the divided character of post-Troubles Northern Ireland. In particular, the unresolved legacies of the extension of English control over Ireland in the late sixteenth and early seventeenth centuries through warfare and plantation continue to structure daily lives in the province. Yet the archaeological record of this period complicates the accepted dichotomous narratives through highlighting complexity. These nuances, however, have been lost in recent decades as an overly simplistic model of colonizer versus colonized has emerged as the dominant political paradigm. The management and presentation of sites associated with the process of plantation can arguably create the space necessary to bridge the divide, and to challenge accepted understandings. Cross-community engagement in the process of archaeological discovery and interpretation on plantation-period sites in Northern Ireland highlights the critical role archaeology can play in peace and reconciliation in post-conflict societies.

How individual participant data meta-analyses have influenced trial design, conduct, and analysis

OBJECTIVES: To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.

STUDY DESIGN AND SETTING: Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses.

RESULTS: We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials.

CONCLUSIONS: IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.

Physical rehabilitation interventions for adult intensive care patients across the continuum of recovery (i.e. within the intensive care unit (ICU) and following ICU and hospital discharge): an overview of systematic reviews

Background
Patients admitted to the intensive care unit with critical illness often experience significant physical impairments, which typically persist for many years following resolution of the original illness. Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit, following discharge to the ward and beyond hospital discharge. Multiple systematic reviews have been published appraising the expanding evidence investigating these physical rehabilitation interventions, although there appears to be variability in review methodology and quality. We aim to conduct an overview of existing systematic reviews of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery.

Methods/design
This protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will search the Cochrane Systematic Review Database, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials, MEDLINE, Excerpta Medica Database and Cumulative Index to Nursing and Allied Health Literature databases. We will include systematic reviews of randomised controlled trials of adult patients, admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery. Data extraction will include systematic review aims and rationale, study types, populations, interventions, comparators, outcomes and quality appraisal method. Primary outcomes of interest will focus on findings reflecting recovery of physical function. Quality of reporting and methodological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Reviews tool.

Discussion
We anticipate the findings from this novel overview of systematic reviews will contribute to the synthesis and interpretation of existing evidence regarding physical rehabilitation interventions and physical recovery in post-critical illness patients across the continuum of recovery.

Methodologic rigor of clinical trials on surgical management of eyes with coexisting cataract and glaucoma.

OBJECTIVE:

To assess the methodologic quality of published studies of the surgical management of coexisting cataract and glaucoma.

DESIGN:

Literature review and analysis.

METHOD:

We performed a systematic search of the literature to identify all English language articles pertaining to the surgical management of coexisting cataract and glaucoma in adults. Quality assessment was performed on all randomized controlled trials, nonrandomized controlled trials, and cohort studies. Overall quality scores and scores for individual methodologic domains were based on the evaluations of two experienced investigators who independently reviewed articles using an objective quality assessment form.

MAIN OUTCOME MEASURES:

Quality in each of five domains (representativeness, bias and confounding, intervention description, outcomes and follow-up, and statistical quality and interpretation) measured as the percentage of methodologic criteria met by each study.

RESULTS:

Thirty-six randomized controlled trials and 45 other studies were evaluated. The mean quality score for the randomized, controlled clinical trials was 63% (range, 11%-88%), and for the other studies the score was 45% (range, 3%-83%). The mean domain scores were 65% for description of therapy (range, 0%-100%), 62% for statistical analysis (range, 0%-100%), 58% for representativeness (range, 0%-94%), 49% for outcomes assessment (range, 0%-83%), and 30% for bias and confounding (range, 0%-83%). Twenty-five of the studies (31%) received a score of 0% in the bias and confounding domain for not randomizing patients, not masking the observers to treatment group, and not having equivalent groups at baseline.

CONCLUSIONS:

Greater methodologic rigor and more detailed reporting of study results, particularly in the area of bias and confounding, could improve the quality of published clinical studies assessing the surgical management of coexisting cataract and glaucoma.

Intimate Ecologies: An exploration of the languages of contemporary exhibitions and making in museums and related cultural spaces in the UK

Intimate Ecologies considers the practice of exhibition-making over the past decade in formal museum and gallery spaces and its relationship to creating a concept of craft in contemporary Britain. Different forms of expression found in traditions of still life painting, film and moving image, poetic text and performance are examined to highlight the complex layers of language at play in exhibitions and within a concept of craft. The thesis presents arguments for understanding the value of embodied material knowledge to aesthetic experience in exhibitions, across a spectrum of human expression. These are supported by reference to exhibition case studies, critical and theoretical works from fields including social anthropology, architecture, art and design history and literary criticism and a range of individual, original works of art. Intimate Ecologies concludes that the museum exhibition, as a creative medium for understanding objects, becomes enriched by close study of material practice, and embodied knowledge that draws on a concept of craft. In turn a concept of craft is refreshed by the makers’ participation in shifting patterns of exhibition-making in cultural spaces that allow the layers of language embedded in complex objects to be experienced from different perspectives. Both art-making and the experience of objects are intimate, and infinitely varied: a vibrant ecology of exhibition-making gives space to this diversity.

An Analysis of Local Wind and Air Mass Directions and Their Impact on Cladosporium Distribution Using HYSPLIT and Circular Statistics

Ecological studies that examine species-environment relationships are often limited to several meteorological parameters, i.e. mean air temperature, relative humidity, precipitation, vapour pressure deficit and solar radiation. The impact of local wind, its speed and direction are less commonly investigated in aerobiological surveys mainly due to difficulties related to the employment of specific analytical tools and interpretation of their outputs. Identification of inoculum sources of economically important plant pathogens, as well as highly allergenic bioaerosols like Cladosporium species, has not been yet explored with remote sensing data and atmospheric models such as Hybrid Single Particle Lagrangian Integrated Trajectory (HYSPLIT). We, therefore, performed an analysis of 24 h intra-diurnal cycle of Cladosporium spp. spores from an urban site in connection with both the local wind direction and overall air mass direction computed by HYSPLIT. The observational method was a volumetric air sampler of the Hirst design with 1 h time resolution and corresponding optical detection of fungal spores with light microscopy. The atmospheric modelling was done using the on-line data set from GDAS with 1° resolution and circular statistical methods. Our results showed stronger, statistically significant correlation (p ≤ 0.05) between high Cladosporium spp. spore concentration and air mass direction compared to the local wind direction. This suggested that a large fraction of the investigated fungal spores had a regional origin and must be located more than a few kilometers away from the sampling point.

Still Playing Together(?): A Recall to Physical Education and Sport History Intersections.

As academic disciplines, Physical Education and Sport History share interests in performance, participation, physique and the politics of corporeal praxis. Engendering unity between the two disciplines, however, has not been without concern. Scholars working within (and across) both fields have highlighted how the potential for shared knowledge production and meaning making has been, to a degree, stymied by epistemological and methodological criticism and trepidation. Issues over contextualization, rigour, narrative schemas, conceptualizations of the body, and notions of agency and power still, in particular, constrain our current educational and historical readings and renderings of physical culture(s). Scholarly schisms and methodological differences can be overcome, however, and need not prohibit disciplinary collaborations that might better address prevailing ethical questions and affect political cause; vis-à-vis the body, the physical and sport. This brief piece is, consequently, recourse to the scholarly symbiosis between Physical Education and Sport History and echoes the encouragement of our earlier colleagues to play, inquire, create and produce together.

Invisible cities: the table of contents and the labyrinths of reality

In Invisible Cities (1972), Italo Calvino contrasts a rigid outline structure with a flexible textual content. The tension comprised by the numerical structure proposed in the table of contents stands out against the set of polissemic texts which make up the subject matter of the book. The opposition between form and content point to a fruitful dichotomy in the conception of the novel linked to the theories of the open and closed work. This essay will investigate the structural construction of Invisible Cities by looking at its table of contents, seeking to discuss some models of formalistic representation proposed by the criticism and the specific contribution they may, or may not, provide. The objective is to analyse the pertinence of such theories in the light of historical and cultural approaches. Aiming to uncover possible meanings which arise from the debate, this essay will question to what extent structural complexities can be considered literary if they are not ultimately related to the culture in which a text is found.

Some reflections on acquisition, processing and analysis of statistical data in forest soils

Beyond the classical statistical approaches (determination of basic statistics, regression analysis, ANOVA, etc.) a new set of applications of different statistical techniques has increasingly gained relevance in the analysis, processing and interpretation of data concerning the characteristics of forest soils. This is possible to be seen in some of the recent publications in the context of Multivariate Statistics. These new methods require additional care that is not always included or refered in some approaches. In the particular case of geostatistical data applications it is necessary, besides to geo-reference all the data acquisition, to collect the samples in regular grids and in sufficient quantity so that the variograms can reflect the spatial distribution of soil properties in a representative manner. In the case of the great majority of Multivariate Statistics techniques (Principal Component Analysis, Correspondence Analysis, Cluster Analysis, etc.) despite the fact they do not require in most cases the assumption of normal distribution, they however need a proper and rigorous strategy for its utilization. In this work, some reflections about these methodologies and, in particular, about the main constraints that often occur during the information collecting process and about the various linking possibilities of these different techniques will be presented. At the end, illustrations of some particular cases of the applications of these statistical methods will also be presented.

Ab initio modeling and molecular dynamics simulation of the alpha 1b-adrenergic receptor activation.

This work describes the ab initio procedure employed to build an activation model for the alpha 1b-adrenergic receptor (alpha 1b-AR). The first version of the model was progressively modified and complicated by means of a many-step iterative procedure characterized by the employment of experimental validations of the model in each upgrading step. A combined simulated (molecular dynamics) and experimental mutagenesis approach was used to determine the structural and dynamic features characterizing the inactive and active states of alpha 1b-AR. The latest version of the model has been successfully challenged with respect to its ability to interpret and predict the functional properties of a large number of mutants. The iterative approach employed to describe alpha 1b-AR activation in terms of molecular structure and dynamics allows further complications of the model to allow prediction and interpretation of an ever-increasing number of experimental data.