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In a cohort of inpatients with hematologic malignancy and positive enzyme immunoassay (EIA) or polymerase chain reaction (PCR) Clostridium difficile tests, we found that clinical characteristics and outcomes were similar between these groups. The method of testing is unlikely to predict infection in this population, and PCR-positive results should be treated with concern.
The genetic and environmental contributions of negative valence systems (NVS) to internalizing pathways study (also referred to as the Adolescent and Young Adult Twin Study) was designed to examine varying constructs of the NVS as they relate to the development of internalizing disorders from a genetically informed perspective. The goal of this study was to evaluate genetic and environmental contributions to potential psychiatric endophenotypes that contribute to internalizing psychopathology by studying adolescent and young adult twins longitudinally over a 2-year period. This report details the sample characteristics, study design, and methodology of this study. The first wave of data collection (i.e., time 1) is complete; the 2-year follow-up (i.e., time 2) is currently underway. A total of 430 twin pairs (N = 860 individual twins; 166 monozygotic pairs; 57.2% female) and 422 parents or legal guardians participated at time 1. Twin participants completed self-report surveys and participated in experimental paradigms to assess processes within the NVS. Additionally, parents completed surveys to report on themselves and their twin children. Findings from this study will help clarify the genetic and environmental influences of the NVS and their association with internalizing risk. The goal of this line of research is to develop methods for early internalizing disorder risk detection.
The final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.
Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.
The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.
Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
OBJECTIVES/SPECIFIC AIMS: Develop a plain language informed consent template that met IRB and regulatory requirements. Evaluate the effectiveness of the template at improving the readability of informed consents. Field test the informed consent with low health literacy. METHODS/STUDY POPULATION: We conducted a retrospective analysis of over 200 UAMS IRB approved, investigator initiated informed consents from 2013 to 2015 to determine the readability before intervention. The mean grade level readabilities were derived from the results of 3 readability formulas (Flesch-Kincaid, SMOG, and Fry) using open-source readability tools. A plain language informed consent template that meets IRB and regulatory requirements was developed, adhering to health literacy best practices for written communication. The template was made available to investigators as an optional resource, and IRB committees were trained on use of the template. In addition, a focus group will be conducted to qualitatively assess understandability of the template with study participants identified as having inadequate health literacy. Data analysis will include readability assessment of IRB approved informed consents post intervention with and without use of the plain language template, as well as qualitative feedback from focus group participants. RESULTS/ANTICIPATED RESULTS: The retrospective analysis revealed a mean readability of 10th grade for IRB approved informed consents from 2013 to 2015 (n=217). The readability of the developed plain language template was 5th grade. Preliminary post-intervention results show adoption of the template by investigators (n=16) resulted in informed consents with a mean readability of 7th grade (range 6–9th grade), compared to a mean of 10th grade (range 7–11th grade) for the comparator (“no adoption” group, n=24). Data collection will continue through May 2017. The focus group is forthcoming and results will be included in the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Low health literacy is common in individuals with healthcare disparities and can limit their participation in clinical research. Few studies have examined interventions to address this barrier to research. Preliminary results of this study support the utilization of a plain language informed consent template in investigator-initiated research. Moreover, this study demonstrates the importance of stakeholder engagement among CTSA leadership, health literacy experts, the institutional review board, investigators, and research subjects in the development and testing of this intervention to make informed consents “understandable to the subject” while containing all required elements.
A core challenge of a multidisciplinary and multi-organizational translational research enterprise such as a Clinical and Translational Research Award (CTSA) is coordinating and integrating the work of individuals, workgroups, and organizations accustomed to working independently and autonomously. Tufts Clinical and Translational Science Institute (CTSI) undertook and studied a multifacted intervention to address this challenge and to create a culture of systems thinking, process awareness, responsive to others' needs, and shared decision-making.
The intervention, based on relational coordination, included 1) relational interventions, in three staff retreats and a diagnostic survey to provide feedback on the current quality of relational coordination, and 2) structural interventions, in the launching of five new cross-functional teams with regular meeting structures.
A mixed-methods evaluation yielded quantitative data via two types of team surveys and qualitative data via interviews and meeting observations.
The findings suggest that interventions to improve relational coordination are feasible for CTSAs, including good fidelity to the model and staff/physician engagement. Survey and interview data suggest model improvements in coordination and alignment. Further research about their optimal design is warranted.
Background: Multiple sclerosis (MS) is a lifelong neurological disorder requiring care in a variety of settings. The purpose of this study is to describe preferences of general practitioners (GPs) with regards to providing care for MS patients.Methods: A stratified sample of 900 GPs in the province of Quebec were sent a questionnaire, with 266 returning completed questionnaires. Respondents were surveyed about their preferences using four clinical scenarios describing hypothetical patients experiencing different stages of MS. Respondents were asked whether they would continue managing the patient themselves, formally refer the patient to a specialist, or seek specialist advice.Results: In two scenarios representing stable courses, 40.9% and 61.6% of GPs, respectively, intended to manage the patient themselves. GPs who reported having experience with MS patients were more likely to report an intention to continue management. In one scenario, GPs operating in rural areas were less likely to consider management than those in the Montreal metropolitan area (odds ratio=0.422, 95% confidence interval 0.20-0.90). Conclusions: For MS patients with a stable disease course, an important proportion of GPs appear to be willing to manage long-term care for MS patients.
The aim of this study was to explore the factors affecting role development in practice nursing in the United Kingdom.
General practice is currently central to National Health Service reform, producing favourable conditions for the practice nurse role to be further strengthened and developed. However, the literature has continued to describe evidence that practice nurses are a disempowered, isolated group with many constraints reducing their ability to respond to opportunities to develop their role. The rationale for conducting the study was therefore to provide a greater understanding about the constraining factors and their influence on practice nurses wishing to develop their role.
The method used to conduct the research followed a case approach, as the subject being investigated was complex with multiple inter-related factors and the approach was exploratory. The cases comprised six UK general practices and the participants within each case were a practice nurse, a GP and a practice manager.
A combination of factors was found to contribute to the way the practice nurse role evolves. These are education, practice culture, practice nurse personal characteristics and empowerment. Empowerment holds the key to maximising the conditions favourable to practice nurse role evolution. This is not, however, a ‘single’ factor; it represents the combined synergistic effects of practice culture and practice nurse personal characteristics on creating an empowering environment. The inter-relationship between these was captured in a framework and given the title ‘empowering employment principles’.
The ‘empowering employment principles’ illustrate the features most conducive to role evolution, thus providing a tool for practice nurses and their employers to enhance opportunities for nurses to develop their role.
By 18 months children demonstrate a range of social–cognitive skills that can be considered important precursors to more advanced forms of social understanding such as theory of mind. Although individual differences in social cognition have been linked to neurocognitive maturation, sociocultural models of development suggest that environmental influences operate in the development of children's social–cognitive outcomes. In the current study of 501 children and their mothers, we tested and found support for a model in which distal environmental risk, assessed when children were newborns, was indirectly associated with children's social–cognitive competency at 18 months through mothers' responsivity at 18 months. Part of this effect also operated through children's concomitant language skills, suggesting both a language-mediated and a language-independent mechanism of social–cognitive development. These findings are discussed with respect to the Vygotskian themes of internalization and semiotic mediation.
Health care professionals (HCPs) caring for people with primary malignant glioma (PMG) and their carers see many of the profound challenges facing this group, yet their perspectives are not documented. This study aimed to understand and document the unique perspective of HCPs in relation to the supportive and palliative care needs of patients with PMG and their carers, with a view to developing a model of care.
Qualitative study involving semi-structured focus groups and interviews with 35 medical, nursing and allied health staff actively engaged in providing care for this patient group. Purposive and theoretical sampling from two major metropolitan hospitals and one community palliative care service in Australia was utilised to seek perspectives from a variety of disciplines and health care settings. Thematic analysis was conducted by three independent researchers, using a constant comparative method influenced by grounded theory.
Key themes relating to the needs of people with PMG which were apparent from the HCPs included: The difference in the illness course of glioma compared to other cancers; Limitations of current medical care; Challenges in balancing hope with reality of the illness; and Recommendations to improve care, including recognising the role of family and moving from a model where services are offered in response to demonstrated needs.
Significance of the results:
Current models of care based upon the classic cancer trajectory are unresponsive to the needs of people with PMG. Care may be enhanced by moving towards a proactive approach, extending the goals of care beyond medical needs and broadening the focus of care to include family needs.
Hunger continues to be one of humanity's greatest challenges despite the existence of a more-than-adequate global food supply equal to 2,800 kilocalories for every person every day. In measuring progress, policy-makers and concerned citizens across the globe rely on information supplied by the Food and Agriculture Organization (FAO), an agency of the United Nations. In 2010 the FAO reported that in the wake of the 2007–2008 food-price spikes and global economic crisis, the number of people experiencing hunger worldwide since 2005–2007 had increased by 150 million, rising above 1 billion in 2009. However, in its State of Food Insecurity in the World 2012 (SOFI 12) the FAO presented new estimates, having revamped its methods and reinterpreted its hunger data back to 1990. The revised numbers for the period 1990–1992 to 2010–2012 reverse the trend to a steadily falling one. Based on the FAO's new calculations, extreme undernourishment peaked in 1990 at a record-breaking one billion, followed by a significant decline through 2006, when progress stalled but did not reverse (see chart below).
A need exists to prolong the release of rapidly metabolized peptides of a low molecular weight, while delivering this peptide without environmental interference. Previous studies have used bovine serum albumin (BSA) as a model peptide to study release characteristics from alginate microcapsules. BSA is 66 kDa in size, while the peptide of interest here, connexin-43 carboxyl-terminus mimetic peptide (αCT1), is only 3.4 kDa. Such a change in size results in a much different set of release parameters. Our overall goal is a sustained release over a 24+ h period. Prolonged application of the peptide to a wound site to investigate therapeutic effects is ideal. As a result, a diffusion method using alginate microcapsules, along with the addition of poly-l-lysine and poly-l-ornithine, has been explored. We first aimed to establish and characterize our parameters through a set of parametric tests. Variations in polymer coating, change in pH, and changes in loading ratio have previously been shown to effect release using model compounds. Here we test specific changes in these parameters to show effects on the release of αCT1. Additionally, the microcapsules were attached to several biomaterials and surgical implants by ultraviolet cross-linking to study the effectiveness of attachment and delivery. Analysis and measurements using phase contrast microscopy, scanning electron microscopy, and atomic force microscopy were used to characterize changes in microcapsule morphology.
Mandatory reporting of healthcare-associated infections is common, but underreporting by hospitals limits meaningful interpretation.
To validate mandatory intensive care unit (ICU) central line–associated bloodstream infection (CLABSI) reporting by Oregon hospitals.
Blinded comparison of ICU CLABSI determination by hospitals and health department–based external reviewers with group adjudication.
Forty-four Oregon hospitals required by state law to report ICU CLABSIs.
Seventy-six patients with ICU CLABSIs and a systematic sample of 741 other patients with ICU-related bacteremia episodes.
External reviewers examined medical records and determined CLABSI status. All cases with CLABSI determinations discordant from hospital reporting were adjudicated through formal discussion with hospital staff, a process novel to validation of CLABSI reporting.
Hospital representatives and external reviewers agreed on CLABSI status in 782 (96%) of 817 bacteremia episodes (k = 0.77 [95% confidence interval (CI), 0.70-0.84]). Among the 27 episodes identified as CLABSIs by external reviewers but not reported by hospitals, the final status was CLABSI in 16 (59%). The measured sensitivities of hospital ICU CLABSI reporting were 72% (95% CI, 62%-81%) with adjudicated CLABSI determination as the reference standard and 60% (95% CI, 51%-69%) with external review alone as the reference standard (P = .07). Validation increased the statewide ICU CLABSI rate from 1.21 (95% CI, 0.95-1.51) to 1.54 (95% CI, 1.25-1.88) CLABSIs/1,000 central line–days; ICU CLABSI rates increased by more than 1.00 CLABSI/1,000 central line–days in 6 (14%) hospitals.
Validating hospital CLABSI reporting improves accuracy of hospital-based CLABSI surveillance. Discussing discordant findings improves the quality of validation.
Physical activity is influenced by genetic factors whose expression may change with age. We employed an extension to the classical twin model that allows a modifier variable, age, to interact with the effects of the latent genetic and environmental factors. The model was applied to self-reported data from twins aged 19 to 50 from seven countries that collaborated in the GenomEUtwin project: Australia, Denmark, Finland, Norway, Netherlands, Sweden and United Kingdom. Results confirmed the importance of genetic influences on physical activity in all countries and showed an age-related decrease in heritability for 4 countries. In the other three countries age did not interact with heritability but those samples were smaller or had a more restricted age range. Effects of shared environment were absent, except in older Swedish participants. The study confirms the importance of taking age effects into account when exploring the genetic and environmental contribution to physical activity. It also suggests that the power of genome-wide association studies to identify the genetic variants contributing to physical activity may be larger in young adult cohorts.