Integrating Process with Outcome Data in a Randomized Controlled Trial of Sex Education

Integration of process with outcome evaluations has been recommended as a way of addressing some of the criticisms of Randomized Controlled Trials (RCTs) for evaluating social interventions. This is the second of two articles (the first was published in issue 10(4) of this journal) discussing the design, implementation and analysis of a process evaluation as an integral part of the RIPPLE (Randomized Intervention of Pupil Peer-Led sex Education) Study. The methods for integrating process and outcome data are outlined and findings are presented to illustrate how integration of process and outcome data enabled exploration of: 1) variation between schools in the extent and quality of the intervention implemented, and any impact of this on outcomes; 2) the processes by which the intervention might affect outcomes; and 3) the extent to which different subgroups of students or schools may have responded differently to the intervention. The article concludes with a discussion of the methodological issues arising from this attempt at integrating process and outcome evaluations within the design of an RCT

A robust clustering algorithm for identifying problematic samples in genome-wide association studies

Summary: High-throughput genotyping arrays provide an efficient way to survey single nucleotide polymorphisms (SNPs) across the genome in large numbers of individuals. Downstream analysis of the data, for example in genome-wide association studies (GWAS), often involves statistical models of genotype frequencies across individuals. The complexities of the sample collection process and the potential for errors in the experimental assay can lead to biases and artefacts in an individual's inferred genotypes. Rather than attempting to model these complications, it has become a standard practice to remove individuals whose genome-wide data differ from the sample at large. Here we describe a simple, but robust, statistical algorithm to identify samples with atypical summaries of genome-wide variation. Its use as a semi-automated quality control tool is demonstrated using several summary statistics, selected to identify different potential problems, and it is applied to two different genotyping platforms and sample collections

Development of Geriatric Competencies for Emergency Medicine Residents Using an Expert Consensus Process

The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes.The objective was to develop a consensus document, “Geriatric Competencies for Emergency Medicine Residents,” by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training.This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project.In Phase I, participants ( n =  363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel ( n =  24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions.The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population.ACADEMIC EMERGENCY MEDICINE 2010; 17:316–324 © 2010 by the Society for Academic Emergency MedicinePeer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/79220/1/j.1553-2712.2010.00684.x.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/79220/2/ACEM_684_sm_DataSupplementS1.pd

Psychiatric Treatment Team: A Structured Approach

Psychiatric treatment team meetings are a required element of care on inpatient behavioral health units; however, they can be a disorganized waste of time and energy that creates frustration among team members. The purpose of this project was to improve the quality of the current psychiatric treatment team process on a 51-bed inpatient behavioral health unit by replacing it with one that is evidence-based, and patient centered. The main objective was to improve team member satisfaction by making it more efficient and effective for all involved. The intervention involved implementation of role-based templates and initiation of strong meeting facilitation. Pre- and post- intervention surveys were conducted among a sample of treatment team members who had experienced both old and new formats to determine team member satisfaction, perception of meeting efficiency, and helpfulness to patients. Additionally, observations were conducted to count delays and reports were analyzed to determine effects on patient length of stay and recidivism. There were statistically significant improvements in team member satisfaction and perceptions of efficiency. While there were also improvements in perceptions of helpfulness to patients, length of stay, and recidivism, they did not prove to be statistically significant. Treatment team members are more satisfied when meetings are efficient. Leadership involvement and meeting facilitation are important to ensure meeting efficiency. Patients may benefit when their care team is engaged in treatment planning. Using this evidence-based treatment team meeting format provided a method to improve the overall meeting experience while minimizing waste

The Changing Nature of NGO Activity in a Globalising World:

Summary As a result of the ruling neo?liberal paradigm and increasing economic, social and political globalisation, the nature of the relationship between transnational corporations (TNCs) and non?governmental organisations (NGOs) has been transformed significantly. TNCs are increasingly perceived as more powerful than governments. In response, NGOs identify TNCs as prime targets to affect change and have diversified their responses and strategies accordingly New alliances have been forged and new types of integrated NGOs have been created. In addition, NGOs have sought direct engagement with corporations through strategies of engagement and confrontation. With this three?tier response (alliance?building, integration and engagement), NGOs have driven the corporate responsibility agenda, which, while part of a longer history, is a particular response of both NGOs and TNCs initiated by the value?changes brought about by globalisation

SARS-CoV-2 detection by a clinical diagnostic RT-LAMP assay [version 1; peer review: 1 approved with reservations]

The ongoing pandemic of SARS-CoV-2 calls for rapid and cost-effective methods to accurately identify infected individuals. The vast majority of patient samples is assessed for viral RNA presence by RT-qPCR. Our biomedical research institute, in collaboration between partner hospitals and an accredited clinical diagnostic laboratory, established a diagnostic testing pipeline that has reported on more than 252,000 RT-qPCR results since its commencement at the beginning of April 2020. However, due to ongoing demand and competition for critical resources, alternative testing strategies were sought. In this work, we present a clinically-validated procedure for high-throughput SARSCoV-2 detection by RT-LAMP in 25 minutes that is robust, reliable, repeatable, sensitive, specific, and inexpensive

Common polygenic variation in coeliac disease and confirmation of ZNF335 and NIFA as disease susceptibility loci

Coeliac disease (CD) is a chronic immune-mediated disease triggered by the ingestion of gluten. It has an estimated prevalence of approximately 1% in European populations. Specific HLA-DQA1 and HLA-DQB1 alleles are established coeliac susceptibility genes and are required for the presentation of gliadin to the immune system resulting in damage to the intestinal mucosa. In the largest association analysis of CD to date, 39 non-HLA risk loci were identified, 13 of which were new, in a sample of 12 014 individuals with CD and 12 228 controls using the Immunochip genotyping platform. Including the HLA, this brings the total number of known CD loci to 40. We have replicated this study in an independent Irish CD case–control population of 425 CD and 453 controls using the Immunochip platform. Using a binomial sign test, we show that the direction of the effects of previously described risk alleles were highly correlated with those reported in the Irish population, (P=2.2 × 10−16). Using the Polygene Risk Score (PRS) approach, we estimated that up to 35% of the genetic variance could be explained by loci present on the Immunochip (P=9 × 10−75). When this is limited to non-HLA loci, we explain a maximum of 4.5% of the genetic variance (P=3.6 × 10−18). Finally, we performed a meta-analysis of our data with the previous reports, identifying two further loci harbouring the ZNF335 and NIFA genes which now exceed genome-wide significance, taking the total number of CD susceptibility loci to 42

An inherited duplication at the gene p21 protein-activated Kinase 7 (PAK7) is a risk factor for psychosis

FUNDING Funding for this study was provided by the Wellcome Trust Case Control Consortium 2 project (085475/B/08/Z and 085475/Z/08/Z), the Wellcome Trust (072894/Z/03/Z, 090532/Z/09/Z and 075491/Z/04/B), NIMH grants (MH 41953 and MH083094) and Science Foundation Ireland (08/IN.1/B1916). We acknowledge use of the Trinity Biobank sample from the Irish Blood Transfusion Service; the Trinity Centre for High Performance Computing; British 1958 Birth Cohort DNA collection funded by the Medical Research Council (G0000934) and the Wellcome Trust (068545/Z/02) and of the UK National Blood Service controls funded by the Wellcome Trust. Chris Spencer is supported by a Wellcome Trust Career Development Fellowship (097364/Z/11/Z). Funding to pay the Open Access publication charges for this article was provided by the Wellcome Trust. ACKNOWLEDGEMENTS The authors sincerely thank all patients who contributed to this study and all staff who facilitated their involvement. We thank W. Bodmer and B. Winney for use of the People of the British Isles DNA collection, which was funded by the Wellcome Trust. We thank Akira Sawa and Koko Ishzuki for advice on the PAK7–DISC1 interaction experiment and Jan Korbel for discussions on mechanism of structural variation.Peer reviewedPublisher PD