A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier

Purpose: Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. Methods: This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18–46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4–12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. Results: No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device “easy” or “very easy” to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). Conclusion: Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy

EcoEvo-MAPS: An Ecology and Evolution Assessment for Introductory through Advanced Undergraduates

A new assessment tool, Ecology and Evolution–Measuring Achievement and Progression in Science or EcoEvo-MAPS, measures student thinking in ecology and evolution during an undergraduate course of study. EcoEvo-MAPS targets foundational concepts in ecology and evolution and uses a novel approach that asks students to evaluate a series of predictions, conclusions, or interpretations as likely or unlikely to be true given a specific scenario. We collected evidence of validity and reliability for EcoEvo-MAPS through an iterative process of faculty review, student interviews, and analyses of assessment data from more than 3000 students at 34 associate’s-, bachelor’s-, master’s-, and doctoral-granting institutions. The 63 likely/unlikely statements range in difficulty and target student understanding of key concepts aligned with the Vision and Change report. This assessment provides departments with a tool to measure student thinking at different time points in the curriculum and provides data that can be used to inform curricular and instructional modifications

Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation

Stakeholder engagement has become widely accepted as a necessary component of guideline development and implementation. While frameworks for developing guidelines express the need for those potentially affected by guideline recommendations to be involved in their development, there is a lack of consensus on how this should be done in practice. Further, there is a lack of guidance on how to equitably and meaningfully engage multiple stakeholders. We aim to develop guidance for the meaningful and equitable engagement of multiple stakeholders in guideline development and implementation. METHODS: This will be a multi-stage project. The first stage is to conduct a series of four systematic reviews. These will (1) describe existing guidance and methods for stakeholder engagement in guideline development and implementation, (2) characterize barriers and facilitators to stakeholder engagement in guideline development and implementation, (3) explore the impact of stakeholder engagement on guideline development and implementation, and (4) identify issues related to conflicts of interest when engaging multiple stakeholders in guideline development and implementation. DISCUSSION: We will collaborate with our multiple and diverse stakeholders to develop guidance for multi-stakeholder engagement in guideline development and implementation. We will use the results of the systematic reviews to develop a candidate list of draft guidance recommendations and will seek broad feedback on the draft guidance via an online survey of guideline developers and external stakeholders. An invited group of representatives from all stakeholder groups will discuss the results of the survey at a consensus meeting which will inform the development of the final guidance papers. Our overall goal is to improve the development of guidelines through meaningful and equitable multi-stakeholder engagement, and subsequently to improve health outcomes and reduce inequities in health

Phys-MAPS: a programmatic physiology assessment for introductory and advanced undergraduates

We describe the development of a new, freely available, online, programmatic-level assessment tool, Measuring Achievement and Progress in Science in Physiology, or Phys-MAPS ( http://cperl.lassp.cornell.edu/bio-maps ). Aligned with the conceptual frameworks of Core Principles of Physiology, and Vision and Change Core Concepts, Phys-MAPS can be used to evaluate student learning of core physiology concepts at multiple time points in an undergraduate physiology program, providing a valuable longitudinal tool to gain insight into student thinking and aid in the data-driven reform of physiology curricula. Phys-MAPS questions have a modified multiple true/false design and were developed using an iterative process, including student interviews and physiology expert review to verify scientific accuracy, appropriateness for physiology majors, and clarity. The final version of Phys-MAPS was tested with 2,600 students across 13 universities, has evidence of reliability, and has no significant statement biases. Over 90% of the physiology experts surveyed agreed that each Phys-MAPS statement was scientifically accurate and relevant to a physiology major. When testing each statement for bias, differential item functioning analysis demonstrated only a small effect size (&lt;0.008) of any tested demographic variable. Regarding student performance, Phys-MAPS can also distinguish between lower and upper division students, both across different institutions (average overall scores increase with each level of class standing; two-way ANOVA, P &lt; 0.001) and within each of three sample institutions (each ANOVA, P &le; 0.001). Furthermore, at the level of individual concepts, only evolution and homeostasis do not demonstrate the typical increase across class standing, suggesting these concepts likely present consistent conceptual challenges for physiology students.</p

Resources for Teaching and Assessing the Vision and Change Biology Core Concepts

The Vision and Change report called for the biology community to mobilize around teaching the core concepts of biology. This essay describes a collection of resources developed by several different groups that can be used to respond to the report’s call to transform undergraduate education at both the individual course and departmental levels. First, we present two frameworks that help articulate the Vision and Change core concepts, the BioCore Guide and the Conceptual Elements (CE) Framework, which can be used in mapping the core concepts onto existing curricula and designing new curricula that teach the biology core concepts. Second, we describe how the BioCore Guide and the CE Framework can be used alongside the Partnership for Undergraduate Life Sciences Education curricular rubric as a way for departments to self-assess their teaching of the core concepts. Finally, we highlight three sets of instruments that can be used to directly assess student learning of the core concepts: the Biology Card Sorting Task, the Biology Core Concept Instruments, and the Biology—Measuring Achievement and Progression in Science instruments. Approaches to using these resources independently and synergistically are discussed

GenBio-MAPS: A Programmatic Assessment to Measure Student Understanding of Vision and Change Core Concepts across General Biology Programs

The Vision and Change report provides a nationally agreed upon framework of core concepts that undergraduate biology students should master by graduation. While identifying these concepts was an important first step, departments also need ways to measure the extent to which students understand these concepts. Here, we present the General Biology-Measuring Achievement and Progression in Science (GenBio-MAPS) assessment as a tool to measure student understanding of the core concepts at key time points in a biology degree program. Data from more than 5000 students at 20 institutions reveal that this instrument distinguishes students at different stages of the curriculum, with an upward trend of increased performance at later time points. Despite this trend, we identify several concepts that advanced students find challenging. Linear mixed-effects models reveal that gender, race/ethnicity, English-language status, and first-generation status predict overall performance and that different institutions show distinct performance profiles across time points. GenBio-MAPS represents the first programmatic assessment for general biology programs that spans the breadth of biology and aligns with the Vision and Change core concepts. This instrument provides a needed tool to help departments monitor student learning and guide curricular transformation centered on the teaching of core concepts.</p

The consequences of sickness presenteeism on health and wellbeing over time: A systematic review

Rationale The association between sickness presenteeism, defined as going to work despite illness, and different health outcomes is increasingly being recognized as a significant and relevant area of research. However, the long term effects on future employee health are less well understood, and to date there has been no review of the empirical evidence. The aim of this systematic review was to present a summary of the sickness presenteeism evidence so far, in relation to health and wellbeing over time. Methods Eight databases were searched for longitudinal studies that investigated the consequences of workplace sickness presenteeism, had a baseline and at least one follow-up point, and included at least one specific measure of sickness presenteeism. Of the 453 papers identified, 12 studies met the eligibility criteria and were included in the review. Findings We adopted a thematic approach to the analysis because of the heterogeneous nature of the sickness presenteeism research. The majority of studies found that sickness presenteeism at baseline is a risk factor for future sickness absence and decreased self-rated health. However, our findings highlight that a consensus has not yet been reached in terms of physical and mental health. This is because the longitudinal studies included in this review adopt a wide variety of approaches including the definition of sickness presenteeism, recall periods, measures used and different statistical approaches which is problematic if this research area is to advance. Future research directions are discussed

Community engagement to enhance trust between Gypsy/Travellers, and maternity, early years’ and child dental health services: protocol for a multimethod exploratory study

Gypsy/Travellers have poor health and experience discrimination alongside structural and cultural barriers when accessing health services and consequently may mistrust those services. Our study aims to investigate which approaches to community engagement are most likely to be effective at enhancing trust between Gypsy/Travellers and mainstream health services. Methods This multi-method 30-month study, commenced in June 2015, and comprises four stages. 1. Three related reviews: a) systematic review of Gypsy/Travellers’ access to health services; b) systematic review of reviews of how trust has been conceptualised within healthcare; c) realist synthesis of community engagement approaches to enhance trust and increase Gypsy/Travellers’ participation in health services. The reviews will consider any economic literature; 2. Online consultation with health and social care practitioners, and civil society organisations on existing engagement activities, including perceptions of barriers and good practice; 3. Four in-depth case studies of different Gypsy/Traveller communities, focusing on maternity, early years and child dental health services. The case studies include the views of 32–48 mothers of pre-school children, 32–40 healthcare providers and 8–12 informants from third sector organisations. 4. Two stakeholder workshops exploring whether policy options are realistic, sustainable and replicable. Case study data will be analysed thematically informed by the evaluative framework derived from the realist synthesis in stage one. The main outputs will be: a) an evaluative framework of Gypsy/Travellers’ engagement with health services; b) recommendations for policy and practice; c) evidence on which to base future implementation strategies including estimation of costs. Discussion Our novel multi-method study seeks to provide recommendations for policy and practice that have potential to improve uptake and delivery of health services, and to reduce lifetime health inequalities for Gypsy/Travellers. The findings may have wider resonance for other marginalised populations. Strengths and limitations of the study are discussed

Human Natural Killer T Cells Are Heterogeneous in Their Capacity to Reprogram Their Effector Functions

BACKGROUND: Natural killer T (NKT) cells are a subset of T cells that help potentiate and regulate immune responses. Although human NKT cell subsets with distinct effector functions have been identified, it is unclear whether the effector functions of these subsets are imprinted during development or can be selectively reprogrammed in the periphery. RESULTS: We found that neonatal NKT cells are predominantly CD4+ and express higher levels of CCR7 and CD62L and lower levels of CD94 and CD161 than adult CD4+ or CD4− NKT cell subsets. Accordingly, neonatal NKT cells were more flexible than adult CD4+ NKT cells in their capacity to acquire Th1- or Th2-like functions upon either cytokine-mediated polarization or ectopic expression of the Th1 or Th2 transcription factors T-bet and GATA-3, respectively. Consistent with their more differentiated phenotype, CD4- NKT cells were predominantly resistant to functional reprogramming and displayed higher cytotoxic function. In contrast to conventional T cells, neither the expression of CXCR3 nor the cytotoxic capacity of neonatal NKT cells could be reprogrammed. CONCLUSIONS AND SIGNIFICANCE: Together, these results suggest that neonatal CD4+, adult CD4+, and adult CD4− NKT may represent unique states of maturation and that some functions of human NKT cells may be developmentally imprinted, while others are acquired similar to conventional T cell subsets during peripheral maturation and differentiation. Given the potent immuno-regulatory functions of NKT cells, these findings have important implications for the development of novel NKT cell-based therapeutics and vaccines