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Clinical ethics consultants navigate dilemmas across patient care, public health, healthcare policy, and professional guidelines with issues spanning from the beginning to the end of life, complex discharges, employment of novel technologies, and visitation restrictions. The second edition relays the narratives of fraught, complex consultations through richly detailed cases exploring the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult scenarios. Describing the affective aspects of ethics consultations, authors highlight the lasting effects of these cases on their practices and reflect candidly on evolving professional practice as well as contemporary concerns and innovations, with attention to equity and inclusivity. Featuring many new chapters, cases are grouped together by theme to aid teaching, discussion and professional growth. For clinicians, bioethicists and ethics committee members with an interest in the choices made in real-life medical dilemmas as well as the emotional cost to those working to improve the situations.
Foods consumed at lower eating rates (ER) lead to reductions in energy intake. Previous research has shown that texture-based differences in eating rateER can reduce meal size. The effect size and consistency of these effects across a wide range of composite and complex meals differing considerably in texture and varying in meal occasion have not been reported. We determined how consistently texture-based differences in ER can influence food and energy intake across a wide variety of meals. In a crossover design, healthy participants consumed twelve breakfast and twelve lunch meals that differed in texture to produce a fast or slow ER. A breakfast group (n = 15) and lunch group (n = 15) completed twelve ad libitum meal sessions each (six ‘fast’ and six ‘slow’ meals), where intake was measured and behavioural video annotation was used to characterise eating behaviour. Liking did not differ significantly between fast and slow breakfasts (P = 0·44) or lunches (P = 0·76). The slow meals were consumed on average 39 % ± 9 % (breakfast) and 45 % ± 7 % (lunch) slower than the fast meals (both P < 0·001). Participants consumed on average 22 % ± 5 % less food (84 g) and 13 % ± 6 % less energy (71 kcal) from slow compared with fast meals (mean ± SE; P < 0·001). Consuming meals with a slower ER led to a reduction in food intake, where an average decrease of 20 % in ER produced an 11 % ± 1 % decrease in food intake (mean ± SE). These findings add to the growing body of evidence showing that ER can be manipulated using food texture and that this has aits consistent effect on food and energy intake across a wide variety of Hedonically equivalent meals.
The meaning of the verb ἀλληγορέω stands at the heart of the debate concerning Paul's hermeneutic in Galatians 4.21–31. If by using the term Paul means ‘I am interpreting these things allegorically’, then the question of Paul's interpretive procedure would be all but answered – he would likely be allegorising as the Greeks did before him and the early church fathers did after. However, if he does not mean this, then the question remains open. This article argues that the phrase ἅτινά ἐστιν ἀλληγορούμɛνα means ‘these things are symbolic’, which would indeed leave this question open. This rendering is best for two reasons: First, the majority of the uses of ἀλληγορέω available in the two hundred or so years surrounding the writing of Galatians mean ‘to speak symbolically’. Second, the contextual clues surrounding Paul's use of the term in Galatians itself, such as his call to hear the law in verse 21, strongly suggest such a reading. To prove this thesis, this article provides detailed exposition of the texts in which ἀλληγορέω occurred around the time Paul wrote Galatians before turning to Paul's own use of the term in Galatians 4.24.
We assessed the impact of metagenomic next-generation sequencing (mNGS) on patient care using previously established criteria. Among 37 patients receiving mNGS testing, 16% showed results that had a positive clinical impact. While mNGS results may offer valuable supplementary information, results should be interpreted within the broader clinical context and evaluation.
In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.
Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
The title above specifies the spatial as well as the temporal limitations of this essay, which examines evidence of shipwrecks in Scotland during the sixteenth century alone. During this period many ships sailing out of Scottish ports were wrecked in other countries, including Norway, and these disasters sometimes had repercussions at home. The concern here, however, is with the legal and (to a lesser extent) the economic consequences of the shipwrecks that often occurred on the coasts of Scotland. More precisely, the concern is with the rights and duties people were believed to have when they were involved in recovering the remains of ships – including their equipment and cargoes – after they were destroyed while navigating near Scotland. Two main types of evidence are considered, both of which must be handled cautiously. In the first place, access to the subject is eased by the existence of several treatises touching on the legal aspects of shipwreck, written by lawyers during the last quarter of the century. The caveat requiring to be attached to this material is that its writers tended to draw their information from other books, and may not have provided an accurate account of how wrecks were dealt with in practice. In the second place, records survive of litigation relating to the subject, sometimes in burgh courts sitting in coastal towns, sometimes in central courts sitting in Edinburgh. The caveat requiring to be attached to this material is that for much of the century the expectation was that litigation relating to navigation would be dealt with in specialised admiralty courts, from which scarcely any records have survived. Since the treatise writers usually wrote about the law applicable in the admiralty courts, they may be taken to compensate to some extent for the absence of these records, just as the availability of records from other courts may be taken to compensate to some extent for the theoretical tendencies of the treatise writers. If viewed from the different perspectives provided by these two bodies of material, the consequences of shipwrecks in Scotland during the sixteenth century may come into view fairly clearly, but it needs to be remembered that there is a significant gap in the evidence available.
The maintenance of head-only minimum stunning currents for sheep to ≥ 1.0 Amp as per current legislation was examined in two trials in a commercial abattoir. In the first trial, a Jetco MS100 stunner failed to maintain the current to > 1.0 Amp in 118 of the 228 sheep. In a second trial, a Jetco MS105 delivered sufficient current in all sheep (n = 275) to meet the legislative requirement, apart from a single animal. Recorded electrocardiograms showed a regular heartbeat, with no evidence of ventricular fibrillation, in all animals in both trials following stunning and neck-cut. Only one of the two stun units may therefore be considered to meet the statutory requirements but both may meet the requirements for halal slaughter where pre-stun is considered acceptable.
We describe the association between job roles and coronavirus disease 2019 (COVID-19) among healthcare personnel. A wide range of hazard ratios were observed across job roles. Medical assistants had higher hazard ratios than nurses, while attending physicians, food service workers, laboratory technicians, pharmacists, residents and fellows, and temporary workers had lower hazard ratios.
As the COVID-19 pandemic took hold in the USA in early 2020, it became clear that knowledge of the prevalence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among asymptomatic individuals could inform public health policy decisions and provide insight into the impact of the infection on vulnerable populations. Two Clinical and Translational Science Award (CTSA) Hubs and the National Institutes of Health (NIH) set forth to conduct a national seroprevalence survey to assess the infection’s rate of spread. This partnership was able to quickly design and launch the project by leveraging established research capacities, prior experiences in large-scale, multisite studies and a highly skilled workforce of CTSA hubs and unique experimental capabilities at the NIH to conduct a diverse prospective, longitudinal observational cohort of 11,382 participants who provided biospecimens and participant-reported health and behavior data. The study was completed in 16 months and benefitted from transdisciplinary teamwork, information technology innovations, multimodal communication strategies, and scientific partnership for rigor in design and analytic methods. The lessons learned by the rapid implementation and dissemination of this national study is valuable in guiding future multisite projects as well as preparation for other public health emergencies and pandemics.
Serious illness conversations (SICs) can improve the experience and well-being of patients with advanced cancer. A structured Serious Illness Conversation Guide (SICG) has been shown to improve oncology patient outcomes but was developed and tested in a predominantly White population. To help address disparities in advanced cancer care, we aimed to assess the acceptability of the SICG among African Americans with advanced cancer and their clinicians.
Methods
A two-phase study conducted in Charleston, SC, included focus groups to gather perspectives on the SICG in Black Americans and a single-arm pilot study of a revised SICG with surveys and qualitative exit interviews to evaluate patient and clinician perspectives. We used descriptive analysis of survey results and thematic analysis of qualitative data.
Results
Community-based and patient focus group participants (N = 20) reported that a simulated conversation using an adapted SICG built connection, promoted control, and fostered consideration of religious faith and family. Black patients with advanced cancer (N = 23) reported that SICG-guided conversations were acceptable, helpful, and promoted conversations with loved ones. Oncologists found conversations feasible to implement and skill-building, and also identified opportunities for training and implementation that could support meeting the needs of their patients with low health literacy. An adapted SICG includes language to assess the strength and affirm the clinician–patient relationship.
Significance of results
An adapted structured communication tool to facilitate SIC, the SICG, appears acceptable to Black Americans with advanced cancer and seems feasible for use by oncology clinicians working with this population. Further testing in other marginalized populations may address disparities in advanced cancer care.
We describe COVID-19 cases among nonphysician healthcare personnel (HCP) by work location. The proportion of HCP with coronavirus disease 2019 (COVID-19) was highest in the emergency department and lowest among those working remotely. COVID-19 and non–COVID-19 units had similar proportions of HCP with COVID-19 (13%). Cases decreased across all work locations following COVID-19 vaccination.
Sleep is essential for our overall health and wellbeing. Unfortunately, stroke often induces insomnia, which has been shown to impede rehabilitation and recovery of function. Cognitive behavioral therapy for insomnia (CBT-I) is the treatment of choice for insomnia in the general population and is efficacious both when delivered face-to-face or online. The primary aim of this study was to evaluate efficacy of blended CBT-I (eCBT-I) in five poststroke participants with insomnia according to DSM-5 criteria.
Methods:
A randomized multiple baseline design was used to evaluate improvements in total sleep time, sleep onset latency, sleep efficiency, nocturnal awakenings and sleep quality. The intervention included six weeks of eCBT-I combined with two face-to-face sessions.
Results:
All participants completed the intervention. One participant stopped using the diary, while the other four completed it fully. All five sleep diary measures improved, significantly so for nocturnal awakenings. Moreover, after completion of the treatment, four out of five participants no longer fulfilled DSM-5 criteria for insomnia disorder
Conclusions:
This is the first study to show that blended CBT-I is potentially effective in participants with post-stroke insomnia. The findings justify extension to a randomized controlled trial.
The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
We analyzed blood-culture practices to characterize the utilization of the Infectious Diseases Society of America (IDSA) recommendations related to catheter-related bloodstream infection (CRBSI) blood cultures. Most patients with a central line had only peripheral blood cultures. Increasing the utilization of CRBSI guidelines may improve clinical care, but may also affect other quality metrics.