Analytical and Clinical Performance of the NeuMoDx™ Platform for Cytomegalovirus and Epstein-Barr Virus Viral Load Testing.

DNA assays for viral load (VL) monitoring are key tools in the management of immunocompromised patients with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection. In this study, the analytical and clinical performances of the NeuMoDx™ CMV and EBV Quant Assays were compared with artus CMV and EBV QS-RGQ Kits in a primary hospital testing laboratory. Patient plasma samples previously tested using artus kits were randomly selected for testing by NeuMoDx assays. The NeuMoDx CMV Quant Assay and artus CMV QS-RGQ Kit limits of detection (LoDs) are 20.0 IU/mL and 69.7 IU/mL, respectively; 33/75 (44.0%) samples had CMV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.9503; 20 samples (60.6%) had lower NeuMoDx CMV quantification values versus the artus kit. The LoD of the NeuMoDx EBV Quant Assay and artus EBV QS-RGQ Kit are 200 IU/mL and 22.29 IU/mL, respectively; 16/75 (21.3%) samples had EBV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.8990. EBV quantification values with the NeuMoDx assay were higher versus the artus kit in 15 samples (93.8%). In conclusion, NeuMoDx CMV and EBV Quant Assays are sensitive and accurate tools for CMV and EBV DNA VL quantification.

Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey.

BACKGROUND: The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective 'nocebo' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced. METHODS: We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics committee members, industry representatives, medico-legal experts, psychologists and trial managers. Each participant was asked to rate their degree of agreement or disagreement with each statement on a 9-point Likert scale. In the second round, participants were invited to reappraise their ratings after reviewing the results of the first round. Finally, two members from each stakeholder group participated in a meeting to confirm those statements for which there was agreement. RESULTS: Two hundred and fifty participants completed round 1, and 201 participants completed round 2. In round 1, consensus was reached for 16 statements. In round 2, consensus was reached for an additional three statements. The consensus meeting confirmed the survey results and consolidated the statements. This process resulted in seven principles: (1) all potential harms of a given intervention should be listed, (2) all potential harms should be separated into serious and less serious, (3) it must be made explicit that not all potential harms are known, (4) all potential benefits should be listed, (5) all potential benefits and harms need to be compared with what would happen if the participant did not take part in the trial, (6) suitable visual representations should be added where appropriate and (7) information regarding potential benefits and harms should not be presented apart by one or more pages. CONCLUSIONS: Our modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms.

The footprint of ship anchoring on the seafloor.

With the COVID-19 pandemic came what media has deemed the "port congestion pandemic". Intensified by the pandemic, the commonplace anchoring of high-tonnage ships causes a substantial geomorphologial footprint on the seabed outside marine ports globally, but isn't yet quantified. We present the first characterisation of the footprint and extent of anchoring in a low congestion port in New Zealand-Aotearoa, demonstrating that high-tonnage ship anchors excavate the seabed by up to 80 cm, with the impacts preserved for at least 4 years. The calcuated volume of sediment displaced by one high-tonnage ship (> 9000 Gross Tonnage) on anchor can reach 2800 m3. Scaled-up globally, this provides the first estimates of the footprint of anchoring to the coastal seabed, worldwide. Seafloor damage due to anchoring has far-reaching implications for already stressed marine ecosystems and carbon cycling. As seaborne trade is projected to quadruple by 2050, the poorly constrained impacts of anchoring must be considered to avoid irreversible damage to marine habitats.

A 10-Year Systematic Review of Photovoice Projects With Youth in the United States.

INTRODUCTION: Photovoice is a method used in community-based participatory research that places cameras in the hands of people and invites them to record their lives, engage in critical dialogue, and advocate for changes needed in their communities. This article presents a review of the literature from 2010 to 2019 on photovoice projects implemented with U.S. youth informed by an emancipatory research conceptual framework. METHOD: Information on 30 project elements was extracted from each of the 47 publications, representing 39 unique projects that met our inclusion criteria. Projects were also assessed for whether they met the goals of photovoice as originally conceptualized by Wang and Burris in 1997. RESULTS: Participants, policy makers, and community members were affected by photovoice projects. Outcomes ranged from researcher specific needs to community change and policy awareness and changes. Common outcomes included (1) gaining knowledge, (2) participant empowerment, (3) community change/action, (4) new partnerships, and (5) reaching policy makers. Of the 39 unique projects, 17 addressed all three photovoice goals, 12 addressed two, and 10 addressed only one. All the projects met the goal of enabling participants to record and reflect their community's strengths and concerns. Twenty-four were aligned with all three principles of emancipatory research. DISCUSSION: Photovoice is a valuable, flexible tool that can enable participants to play an active, guiding role in assessing the needs and assets of their community. Through critical reflection and dialogue, youth can become change agents in their communities. No single set of strategies will work best for every project.

Pro-judge study: Nurses' professional judgement in nurse staffing systems.

AIMS: Aim of this study is to better understand the role of nurses' professional judgment in nurse staffing systems. DESIGN: Qualitative comparative case study design of nurse staffing systems in England and Wales. METHODS: Data will be collected through a variety of sources: individual interviews, observations of relevant meetings and analysis of key documents. Ethical approval for the study was granted in August 2020 from The Healthcare Research Ethics Committee (SREC reference: REC741). Data generation will be informed by science and technology studies and practice theories. DISCUSSION: Ensuring adequate numbers of nurses are available to care for patients in response to shifting demand is an international policy priority. Emerging evidence on the use of formal workforce planning methodologies across the developed world highlights both the centrality of nurses' professional judgement in nurse staffing methodologies and the urgent need for theoretically informed research to better understand and conceptualise its contribution to decision-making. This study is designed to address this gap in understanding. It takes advantage of nurses' experiences of managing the service and staffing impacts of the Covid-19 pandemic and differences in strategic approaches to nurse staffing systems between England and Wales. IMPACT: The research will: make visible the knowledge and skills that underpin professional judgement in nurse staffing decisions and provide a conceptual language with which to articulate this; lay the foundations for evidence-based programmes of nurse education and continuing professional development; furnish the evidence to inform the development of nurse-led decision support tools to augment professional judgement; and generate wider insights into the effectiveness of nurse staffing systems in practice.

Community advisory boards: Experiences and common practices of clinical and translational science award programs.

Community advisory boards (CABs) are a valuable strategy for engaging and partnering with communities in research. Eighty-nine percent of Clinical and Translational Science Awardees (CTSA) responding to a 2011 survey reported having a CAB. CTSAs' experiences with CABs are valuable for informing future practice. This study was conducted to describe common CAB implementation practices among CTSAs; document perceived benefits, challenges, and contributions; and examine their progress toward desirable outcomes. A cross-CTSA collaborative team collected survey data from respondents representing academic and/or community members affiliated with CTSAs with CABs. Data representing 44 CTSAs with CABs were analyzed using descriptive statistics. A majority of respondents reported practices reflecting respect for CAB members' expertise and input such as compensation (75%), advisory purview beyond their CTSA's Community Engagement program (88%), and influence over CAB operations. Three-quarters provide members with orientation and training on roles and responsibilities and 89% reported evaluating their CAB. Almost all respondents indicated their CTSA incorporates the feedback of their CABs to some degree; over half do so a lot or completely. This study profiles practices that inform CTSAs implementing a CAB and provide an evaluative benchmark for those with existing CABs.

Worldwide measurements of bioturbation intensity, ventilation rate, and the mixing depth of marine sediments.

The activities of a diverse array of sediment-dwelling fauna are known to mediate carbon remineralisation, biogeochemical cycling and other important properties of marine ecosystems, but the contributions that different seabed communities make to the global inventory have not been established. Here we provide a comprehensive georeferenced database of measured values of bioturbation intensity (Db, n = 1281), burrow ventilation rate (q, n = 765, 47 species) and the mixing depth (L, n = 1780) of marine soft sediments compiled from the scientific literature (1864-2018). These data provide reference information that can be used to inform and parameterise global, habitat specific and/or species level biogeochemical models that will be of value within the fields of geochemistry, ecology, climate, and palaeobiology. We include metadata relating to the source, timing and location of each study, the methodology used, and environmental and experimental information. The dataset presents opportunity to interrogate current ecological theory, refine functional typologies, quantify uncertainty and/or test the relevance and robustness of models used to project ecosystem responses to change.

Newborn screening for haemophilia: The views of families and adults living with haemophilia in the UK.

INTRODUCTION: As genomic sequencing become more efficient and cost-effective, the number of conditions identified through newborn screening globally is set to dramatically increase. Haemophilia is a candidate condition; however, very little is known about the attitudes of the haemophilia community towards screening. AIM: This study aimed to outline the perspectives of adults with haemophilia and their families towards newborn screening. METHODS: A paper and online survey on screening were distributed to every family known to the Haemophilia Society UK. Data collection occurred between January and June 2018. In total, 327 participants completed the survey: 76% were a relative of a person with haemophilia and 24% had haemophilia themselves; 83% were living with haemophilia A and 17% with haemophilia B. RESULTS: The vast majority supported newborn screening (77%) and preferred it to other forms of screening (preconception or prenatal). Participants supported newborn screening primarily because they viewed it as a means to facilitate early support and treatment, facilitate informed decisions about future pregnancies and prevent the "diagnostic odyssey." The 23% who did not support the screen did not associate these particular benefits with newborn screening. CONCLUSION: Haemophilia emerged from this analysis as a condition that the vast majority of participants considered a "liveable" disability and one best suited to newborn screening programmes that could improve support to affected families rather than reduce the birth rate of affected children.

Preventing lives affected by hemophilia: A mixed methods study of the views of adults with hemophilia and their families toward genetic screening.

BACKGROUND: Genomic sequencing technologies have made the possibility of population screening for whole panels of genetic disorders more feasible than ever before. As one of the most common single gene disorders affecting the UK population, hemophilia is an attractive candidate to include on such screening panels. However, very little is known about views toward genetic screening amongst people with hemophilia or their family members, despite the potential for a wide range of impacts on them. METHODS: Twenty-two in-depth qualitative interviews were undertaken to explore the views of adults with hemophilia and their family members, recruited through the Haemophilia Society UK. These interviews were used to develop a survey, the Haemophilia Screening Survey (UK), which was distributed in paper and online format through the support group, receiving 327 returns between January and June 2018. RESULTS: Fifty-seven per cent of the sample supported preconception carrier screening of the population for hemophilia, and 59% supported prenatal carrier screening. Key reasons for support included a desire to reduce pregnancy terminations and increase awareness of hemophilia. Despite support for screening however, 90% of the sample disagreed with pregnancy terminations for hemophilia. CONCLUSIONS: Families and adults living with hemophilia are more supportive of screening for information and preparation purposes than to prevent boys with hemophilia from being born. A distinction was made between preventing the disease and preventing the lives of people with it, with support shown for the use of screening to achieve the former, but not at the expense of the latter.

"I didn't take it too seriously because I'd just never heard of it": Experiential knowledge and genetic screening for thalassaemia in the UK.

Members of the public face particular challenges when undergoing reproductive genetic screening. Lack of family history with genetic disease has been identified as a key barrier affecting screening uptake and responses to genetic risk. This study explores this obstacle using beta thalassaemia as a case study. Fifteen in-depth qualitative interviews were conducted exploring the reproductive views and decisions of people at risk of transmitting thalassaemia. Eleven participants had thalassaemia themselves and/or were members of an affected family. Four participants were identified as thalassaemia carriers through genetic screening programmes with no family history. Notable differences were observed between these two groups. For thalassaemic individuals and families, past experience clarified and facilitated their sense of reproductive responsibility, however carriers struggled to relate to, and incorporate the information into their lives. It was witnessing their child becoming symptomatic-rather than receiving a diagnosis or genetic risk information per se that had the most substantial influence on carriers' subsequent views and decisions. Educational resources used to support genetic screening programmes would benefit from an engagement with the experiential accounts of life with genetic disease in order to more effectively bridge the chasm in knowledge and understanding between affected families and the general public, towards whom expansive genetic screening is aimed.

Responsibility, identity, and genomic sequencing: A comparison of published recommendations and patient perspectives on accepting or declining incidental findings.

BACKGROUND: The use of genomic sequencing techniques is increasingly being incorporated into mainstream health care. However, there is a lack of agreement on how "incidental findings" (IFs) should be managed and a dearth of research on patient perspectives. METHODS: In-depth qualitative interviews were carried out with 31 patients undergoing genomic sequencing at a regional genetics service in England. Interviews explored decisions around IFs and were comparatively analyzed with published recommendations from the literature. RESULTS: Thirteen participants opted to receive all IFs from their sequence, 12 accepted some and rejected others, while six participants refused all IFs. The key areas from the literature, (a) genotype/phenotype correlation, (b) seriousness of the condition, and (c) implications for biological relatives, were all significant; however, patients drew on a broader range of social and cultural information to make their decisions. CONCLUSION: This study highlights the range of costs and benefits for patients of receiving IFs from a genomic sequence. While largely positive views toward the dissemination of genomic data were reported, ambivalence surrounding genetic responsibility and its associated behaviors (e.g., duty to inform relatives) was reported by both IF decliners and accepters, suggesting a need to further explore patient perspectives on this highly complex topic area.

How do genetically disabled adults view selective reproduction? Impairment, identity, and genetic screening.

BACKGROUND: Genomic medicine is rapidly evolving, particularly in the domain of reproduction. Population carrier screening for a range of disorders is becoming possible using whole genome/exome sequencing. However, very little is known about the views of genetically disabled adults toward selective reproduction. METHODS: Forty-three in-depth qualitative interviews were carried out with adults living with different types of genetic condition, recruited through support groups and clinics. Interviews covered participants' experiences of their condition and their views toward genetic intervention in reproduction. Thematic analysis of the data using NVivo 11 was undertaken, and participants were assigned categories as either supporting, not-supporting, or having ambivalent views toward selective reproduction. RESULTS: The majority of participants (65%) expressed either disapproval of, or held ambivalent views toward, selective reproduction. Key reasons for non-support included regarding genetic impairment as part of personal identity and the prioritization of social and environmental barrier removal. Key reasons for support of selective reproduction included negative and externalizing attitudes toward genetic impairment and a belief in the importance of informed reproductive decision-making. CONCLUSION: The degree to which participants identified with their impairment, more so than how they valued it, was significant in determining attitudes toward selective reproduction. Those who supported genetic screening viewed their impairment as separate to themselves, while participants who considered their impairment as integral to their identity were most likely to report ambivalent or negative attitudes. Policymakers and stakeholders considering the role of genetic carrier screening panels might usefully engage with adults affected by heritable disease as well as disability identity politics when considering the acceptability and social impact of genetic screening programs.

An Adaptable Pediatrics Faculty Mentoring Model.

An effective faculty mentoring program (FMP) is 1 approach that academic departments can use to promote professional fulfillment, faculty retention, and mitigate the risks of faculty burnout. Mentoring has both direct benefits for junior faculty mentees as they navigate the academic promotion process with their mentors, in addition to broader departmental and institutional benefits, with regard to recruitment, retention, and academic productivity. We describe a successful FMP model that has been adapted for use in 6 other pediatrics departments, summarizing the key personnel, mentoring process, and program evaluation methods. Important lessons learned and a generalizable mentoring "model" are provided. Program evaluation indicates a positive effect for the FMP on enhanced faculty self-efficacy, job satisfaction, and career development. The importance of communication, oversight, feedback, accountability, and valuing all faculty members is emphasized. Strategies to promote faculty engagement and the critical role of departmental leadership in prioritizing mentorship are discussed. The success of academic medical departments is inextricably linked to its commitment to the career development of individual faculty members at all levels and in all academic pathways. With our findings, we support the positive impact of a formal FMP in promoting enhanced self-efficacy and career satisfaction, which directly benefits the department and institution through enhanced productivity, retention, successful promotion, and overall professional fulfillment.

Cost-Effectiveness of Health Coaching: An Integrative Review.

PURPOSE/OBJECTIVES: The purpose of this review was to evaluate published literature to distinguish how health coaching influences the cost of chronic disease management in insured adults with chronic conditions. PRIMARY PRACTICE SETTING: An integrated literature review was conducted. MEDLINE, Business Source Complete, and OneSearch were searched for the years 2001-2016 utilizing the following key words: health coaching, health coaching AND insurance companies, health coaching AND cost, health coaching AND health insurance, and health coaching AND insurance cost. A total of 67 articles met inclusion criteria and were assessed for applicability. Of those, 27 articles were found to be relevant to the research question. The practice settings of these articles are mostly primary care and wellness programs. FINDINGS/CONCLUSIONS: Throughout the literature, health coaching has been found effective in chronic disease management such as hypertension, diabetes, and hyperlipidemia. Studies evaluating the cost-effectiveness of health coaching are limited. The current literature does not clearly demonstrate that health coaching lowers expenditures and patient copayments in the short term but projects future savings. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Health coaching has the potential to improve chronic disease management and lower health care expenditures. Further long-term research is needed to evaluate the cost-effectiveness of health coaching. It has been projected that the cost-effectiveness of health coaching will be long-term or over 12 months after initiating the health coaching program.

Important factors in predicting mortality outcome from stroke: findings from the Anglia Stroke Clinical Network Evaluation Study.

Background: Although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods: Data from a prospective multicentre study (2009­12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results: A total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11­28% (P < 0.0001) and in 1-year mortality of 8­12% (P < 0.001). Conclusions: There appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors.

Mediation of macronutrients and carbon by post-disturbance shelf sea sediment communities.

Benthic communities play a major role in organic matter remineralisation and the mediation of many aspects of shelf sea biogeochemistry. Few studies have considered how changes in community structure associated with different levels of physical disturbance affect sediment macronutrients and carbon following the cessation of disturbance. Here, we investigate how faunal activity (sediment particle reworking and bioirrigation) in communities that have survived contrasting levels of bottom fishing affect sediment organic carbon content and macronutrient concentrations ([NH4-N], [NO2-N], [NO3-N], [PO4-P], [SiO4-Si]). We find that organic carbon content and [NO3-N] decline in cohesive sediment communities that have experienced an increased frequency of fishing, whilst [NH4-N], [NO2-N], [PO4-P] and [SiO4-Si] are not affected. [NH4-N] increases in non-cohesive sediments that have experienced a higher frequency of fishing. Further analyses reveal that the way communities are restructured by physical disturbance differs between sediment type and with fishing frequency, but that changes in community structure do little to affect bioturbation and associated levels of organic carbon and nutrient concentrations. Our results suggest that in the presence of physical disturbance, irrespective of sediment type, the mediation of macronutrient and carbon cycling increasingly reflects the decoupling of organism-sediment relations. Indeed, it is the traits of the species that reside at the sediment-water interface, or that occupy deeper parts of the sediment profile, that are disproportionately expressed post-disturbance, that are most important for sustaining biogeochemical functioning.

Mediation of nitrogen by post-disturbance shelf communities experiencing organic matter enrichment.

Microbes and benthic macro-invertebrates interact in sediments to play a major role in the biogeochemical cycling of organic matter, but the extent to which their contributions are modified following natural and anthropogenic changes has received little attention. Here, we investigate how nitrogen transformations, ascertained from changes in archaeal and bacterial N-cycling microbes and water macronutrient concentrations ([NH4-N], [NO2-N], [NO3-N]), in sand and sandy mud sediments differ when macrofaunal communities that have previously experienced contrasting levels of chronic fishing disturbance are exposed to organic matter enrichment. We find that differences in macrofaunal community structure related to differences in fishing activity affect the capacity of the macrofauna to mediate microbial nitrogen cycling in sand, but not in sandy mud environments. Whilst we found no evidence for a change in ammonia oxidiser community structure, we did find an increase in archaeal and bacterial denitrifier (AnirKa, nirS) and anammox (hzo) transcripts in macrofaunal communities characterized by higher ratios of suspension to deposit feeders, and a lower density but higher biomass of sediment-reworking fauna. Our findings suggest that nitrogen transformation in shelf sandy sediments is dependent on the stimulation of specific nitrogen cycling pathways that are associated with differences in the composition and context-dependent expression of the functional traits that belong to the resident bioturbating macrofauna community.

Vulnerability of macronutrients to the concurrent effects of enhanced temperature and atmospheric pCO2 in representative shelf sea sediment habitats.

Fundamental changes in seawater carbonate chemistry and sea surface temperatures associated with the ocean uptake of anthropogenic CO2 are accelerating, but investigations of the susceptibility of biogeochemical processes to the simultaneous occurrence of multiple components of climate change are uncommon. Here, we quantify how concurrent changes in enhanced temperature and atmospheric pCO2, coupled with an associated shift in macrofaunal community structure and behavior (sediment particle reworking and bioirrigation), modify net carbon and nutrient concentrations (NH4-N, NOx-N, PO4-P) in representative shelf sea sediment habitats (mud, sandy-mud, muddy-sand and sand) of the Celtic Sea. We show that net concentrations of organic carbon, nitrogen and phosphate are, irrespective of sediment type, largely unaffected by a simultaneous increase in temperature and atmospheric pCO2. However, our analyses also reveal that a reduction in macrofaunal species richness and total abundance occurs under future environmental conditions, varies across a gradient of cohesive to non-cohesive sediments, and negatively moderates biogeochemical processes, in particular nitrification. Our findings indicate that future environmental conditions are unlikely to have strong direct effects on biogeochemical processes but, particularly in muddy sands, the abundance, activity, composition and functional role of invertebrate communities are likely to be altered in ways that will be sufficient to regulate the function of the microbial community and the availability of nutrients in shelf sea waters.

Education and training to enhance end-of-life care for nursing home staff: a systematic literature review.

BACKGROUND: The delivery of end-of-life care in nursing homes is challenging. This situation is of concern as 20% of the population die in this setting. Commonly reported reasons include limited access to medical care, inadequate clinical leadership and poor communication between nursing home and medical staff. Education for nursing home staff is suggested as the most important way of overcoming these obstacles. OBJECTIVES: To identify educational interventions to enhance end-of-life care for nursing home staff and to identify types of study designs and outcomes to indicate success and benchmark interventions against recent international guidelines for education for palliative and end-of-life care. DESIGN: Thirteen databases and reference lists of key journals were searched from the inception of each up to September 2014. Included studies were appraised for quality and data were synthesised thematically. RESULTS: Twenty-one studies were reviewed. Methodological quality was poor. Education was not of a standard that could be expected to alter clinical behaviour and was evaluated mainly from the perspectives of staff: self-reported increase in knowledge, skills and confidence delivering care rather than direct evidence of impact on clinical practice and patient outcomes. Follow-up was often short term, and despite sound economic arguments for delivering effective end-of-life care to reduce burden on the health service, no economic analyses were reported. CONCLUSIONS: There is a clear and urgent need to design educational interventions that have the potential to improve end-of-life care in nursing homes. Robust evaluation of these interventions should include impact on residents, families and staff and include economic analysis.