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Clinical research professionals (CRPs) are essential members of research teams serving in multiple job roles. However, recent turnover rates have reached crisis proportions, negatively impacting clinical trial metrics. Gaining an understanding of job satisfaction factors among CRPs working at academic medical centers (AMCs) can provide insights into retention efforts.
Materials/Methods:
A survey instrument was developed to measure key factors related to CRP job satisfaction and retention. The survey included 47 rating items in addition to demographic questions. An open-text question solicited respondents to provide their top three factors for job satisfaction. The survey was distributed through listservs of three large AMCs. Here, we present a factor analysis of the instrument and quantitative and qualitative results of the subsequent survey.
Results:
A total of 484 CRPs responded to the survey. A principal components analysis with Varimax rotation was performed on the 47 rating items. The analysis resulted in seven key factors and the survey instrument was reduced to 25 rating items. Self-efficacy and pride in work were top ranked in the quantitative results; work complexity and stress and salary and benefits were top ranked in the qualitative findings. Opportunities for education and professional development were also themes in the qualitative data.
Discussion:
This study addresses the need for a tool to measure job satisfaction of CRPs. This tool may be useful for additional validation studies and research to measure the effectiveness of improvement initiatives to address CRP job satisfaction and retention.
The extent to which the oro-faecal route contributes to the transmission of SARS-CoV-2 is not established.
We systematically reviewed the evidence on the presence of infectious SARS-CoV-2 in faeces and other gastrointestinal sources by examining studies that used viral culture to investigate the presence of replication-competent virus in these samples. We conducted searches in the WHO COVID-19 Database, LitCovid, medRxiv, and Google Scholar for SARS-CoV-2 using keywords and associated synonyms, with a search date up to 28 November 2023.
We included 13 studies involving 229 COVID-19 subjects – providing 308 faecal or rectal swab SARS-CoV2 reverse transcription-polymerase chain reaction (RT-PCR)-positive samples tested with viral culture. The methods used for viral culture across the studies were heterogeneous. Three studies (two cohorts and one case series) reported observing replication-competent SARS-CoV-2 confirmed by quantitative RT-PCR (qPCR) and whole-genome sequencing, and qPCR including appropriate cycle threshold changes. Overall, six (1.9%) of 308 faecal samples subjected to cell culture showed replication-competent virus. One study found replication-competent samples from one immunocompromised patient. No studies were identified demonstrating direct evidence of oro-faecal transmission to humans.
Our review found a relatively low frequency of replication-competent SARS-CoV-2 in faecal and other gastrointestinal sources. Although it is biologically plausible, more research is needed using standardized cell culture methods, control groups, adequate follow-up, and robust epidemiologic methods, including whether secondary infections occurred, to determine the role of the oro-faecal route in the transmission of SARS-CoV-2.
The role of mental health review tribunals is to oversee that standards of care and treatment are maintained for involuntary patients and for those on community treatment orders. This article considers some ways in which the basic principles of psychotherapy can be applied by tribunal members to offer patients a sense of hope, encouragement and optimism and reduce the emotional challenge of the tribunal review.
The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT’s are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment.
An alternative surgical approach for hypoplastic left heart syndrome is the Hybrid pathway, which delays the risk of acute kidney injury outside of the newborn period. We sought to determine the incidence, and associated morbidity, of acute kidney injury after the comprehensive stage 2 and the cumulative incidence after the first two operations in the Hybrid pathway.
Design:
A single centre, retrospective study was conducted of hypoplastic left heart patients completing the second-stage palliation in the Hybrid pathway from 2009 to 2018. Acute kidney injury was defined utilising Kidney Diseases Improving Global Outcomes criteria. Perioperative and post-operative characteristics were analysed.
Results:
Sixty-one patients were included in the study cohort. The incidence of acute kidney injury was 63.9%, with 36.1% developing severe injury. Cumulatively after the Hybrid Stage 1 and comprehensive stage 2 procedures, 69% developed acute kidney injury with 36% developing severe injury. The presence of post-operative acute kidney injury was not associated with an increase in 30-day mortality (acute kidney injury 7.7% versus none 9.1%; p = > 0.9). There was a significantly longer median duration of intubation among those with acute kidney injury (acute kidney injury 32 (8, 155) hours vs. no injury 9 (0, 94) hours; p = 0.018).
Conclusions:
Acute kidney injury after the comprehensive stage two procedure is common and accounts for most of the kidney injury in the first two operations of the Hybrid pathway. No difference in mortality was detected between those with acute kidney injury and those without, although there may be an increase in morbidity.
Background: The disease caused by SARS-CoV-2, COVID-19, has caused a pandemic leading to strained healthcare systems worldwide and an unprecedented public health crisis. Lower respiratory tract infections (LRTIs) and hypoxia caused by COVID-19 has led to an increase in hospitalizations. We sought to define the impact of COVID-19 on antimicrobial use and antimicrobial resistance (AMR) in an urban safety-net community hospital. Methods: Retrospective review of antimicrobial use and AMR in a 151-bed urban community hospital. Antimicrobial use was calculated in days of therapy per 1,000 patient days (DOT/1,000 PD) for ceftriaxone, piperacillin-tazobactam and meropenem during 2019 and 2020. Ceftriaxone, piperacillin-tazobactam and meropenem were reviewed for calendar year 2019 and 2020. AMR was assessed by comparing the carbapenem resistant Enterobacteriaceae (CRE) infection incidence rate per 1,000 patient days between 2019 and 2020. Results: The average quarterly DOT/1,000 PD increased from 359.5 in 2019 to 394.25 in 2020, with the highest increase in the second and fourth quarters of 2020, which temporarily correspond to the first and second waves of COVID-19. Ceftriaxone and meropenem use increased during the first and second waves of COVID-19. Piperacillin-tazobactam use increased during the first wave and declined thereafter (Figure 1). Rates of CRE increased from a quarterly average of 0.57 to 0.68 (Figure 2). Conclusions: Antimicrobial pressure increased during the first and second waves of COVID-19. Ceftriaxone was the most commonly used antimicrobial, reflecting internal guidelines and ASP interventions. CRE rates increased during COVID-19. This finding may be due to an overall increase in antimicrobial pressure in the community and in critically ill patients. Antibiotics are a precious resource, and antimicrobial stewardship remains important during the COVID-19 pandemic. Appropriate use of antimicrobials is critical to preventing AMR.
Background: The disease caused by SARS-CoV-2, COVID-19, has caused a pandemic leading to strained healthcare systems worldwide and an unprecedented public health crisis. The hallmark of severe COVID-19 is lower respiratory tract infection (LRTI) and hypoxia requiring hospitalization. A paucity of data on bacterial coinfection and a lack of therapeutic options for COVID-19 during the first surge of cases has increased pressure on antimicrobial use and has challenged antimicrobial stewardship programs (ASPs). We implemented a multimodal approach to antimicrobial stewardship in an urban safety-net community hospital targeting selection and duration of therapy. Methods: Retrospective review of cases during the first wave of COVID-19 in a 151-bed urban safety-net community hospital from March to June 2020. EMR order sets (Figure 1) and prospective audit and feedback by ASPs targeting empiric antimicrobial selection and duration were implemented as part of the COVID-19 response. Hospitalized patients with COVID-19 were reviewed retrospectively. Demographic information was collected. Data on antimicrobial use were tabulated, including selection and duration of antimicrobials (Figure 1). Results: In total, 302 patients were reviewed, of whom 221 (73%) received empiric antimicrobials. The most commonly used antimicrobials were ceftriaxone and azithromycin (Figure 2). Days of therapy per 1,000 patient days (DOT/1,000 PD) for ceftriaxone increased from 71 in the quarter prior to 113 during the study period. Average duration of therapy was 6 days. In the ICU, average duration was 8 days compared to 5 days in non-ICU settings. Average durations of parenteral therapy were 5.54 days in the ICU and 3.36 days in non-ICU settings. Procalcitonin was obtained in 37 cases (17%) and ranged from 0.09 to 12.57 ng/mL, with an average of 1.21 ng/mL. No cases had documented bacterial coinfection (Figure 1). Conclusions: Antimicrobials were commonly prescribed during the first wave of COVID-19 in a safety-net community hospital. Procalcitonin did not guide therapy nor did lack of documented coinfection change physician behavior. With limited resources, ASP successfully guided clinicians toward IDSA guideline recommendations for selection and duration, as evidenced by antimicrobial use. During this unprecedented surge of LRTIs, a multimodal approach to antimicrobial stewardship was used and guided toward early transition to oral agents and shorter durations.
Warfare on the periphery of Europe and across cultural boundaries is a particular focus of this volume. One article, on Castilian seapower, treats the melding of northern and southern naval traditions; another clarifies the military roles of the Ayyubid and Mamluk miners and stoneworkers in siege warfare; a third emphasizes cultural considerations in an Icelandic conflict; a fourth looks at how an Iberian prelate navigated the line between ecclesiastical and military responsibilities; and a fifth analyzes the different roles of early gunpowder weapons in Europe and China, linking technological history with the significance of human geography. Further contributions also consider technology, two dealing with fifteenth-century English artillery and the third with prefabricated mechanical artillery during the Crusades. Another theme of the volume is source criticism, with re-examinations of the sources for Owain Glyndwr's (possible) victory at Hyddgen in 1401, a (possible) Danish attack on England in 1128, and the role of non-milites in Salian warfare. Contributors: Nicolas Agrait, Tonio Andrade, David Bachrach, Oren Falk, Devin Fields, Michael S. Fulton, Thomas K. Heeboll-Holm, Rabei G. Khamisy, Michael Livingstone, Dan Spencer, L.J. Andrew Villalon
Acute kidney injury leads to worse outcomes following paediatric cardiac surgery. There is a lack of literature focusing on acute kidney injury after the Hybrid stage 1 palliation for single ventricle physiology. Patients undergoing the Hybrid Stage 1, as a primary option, may have a lower incidence of kidney injury than previously reported. When present, kidney injury may increase the risk of post-operative morbidity and mortality.
Methods:
A retrospective, single centre review was conducted in patients with hypoplastic left heart syndrome who underwent Hybrid Stage 1 from 2008 to 2018. Acute kidney injury was defined as a dichotomous yes (meeting any injury criteria) or no (no injury) utilising two different criteria utilised in paediatrics. The impact of kidney injury on perioperative characteristics and 30-day mortality was analysed.
Results:
The incidence of acute kidney injury is 13.4–20.7%, with a severe injury rate of 2.4%. Patients without a prenatal diagnosis of hypoplastic left heart syndrome have a higher incidence of kidney injury than those prenatally diagnosed, (40% versus 14.5%, p = 0.024). Patients with acute kidney injury have a significantly higher incidence of 30-day mortality, 27.3%, compared to without, 5.6% (p = 0.047).
Discussion:
The incidence of severe acute kidney injury after the Hybrid Stage 1 palliation is low. A prenatal diagnosis may be associated with a lower incidence of kidney injury following the Hybrid Stage 1. Though uncommon, severe acute kidney injury following Hybrid Stage 1 may be associated with higher 30-day mortality.
John Spencer (1630–1693) was an antiquarian at Cambridge and conceived of this book as a challenge to the prevailing belief in place since antiquity that prodigies—monstrous births human and animal—were signs from God. Instead, he argued that they were simply natural phenomena resulting from errors in the processes of conception and gestation. While this might seem like a radical break from tradition, Spencer's motives were quite orthodox: he was attempting to stop ordinary people from making their own interpretations of monstrous phenomena, which he argued were either in no way signs of God's will or, if they were, that they could only be interpreted by the Church. Signs should not be read, according to Spencer, as indications that the Church or Crown should be challenged. His explicitly stated goal, therefore, was to preserve “the quiet and tranquillity of the State” by explaining away a remarkable and diverse array of monsters through a process in which he attempts to “indict them at the bar of Reason.” It is unsurprising, then, that unlike the authors of broadsheets and other widely disseminated, inexpensive monster accounts, Spencer's hefty and costly volume, laiden with quotations in Greek and Latin, was aimed at the wealthy, learned establishment, which had no interest in seeing their own power and authority diminished by those who would read monsters as signs encouraging popular revolt and revolution. Spencer was a Protestant and held to a common belief that miracles had ceased to occur centuries before his own era.
Reading Questions
What sorts of explanations does Spencer offer for prodigies? What do his judgments imply about those who are interested in monsters and other strange phenomena?
Editorial Notes
Few changes to Spencer's text have been made; most spelling has been silently modernized, though Spencer's seventeenth-century style of capitalization and italicization has been maintained. The text reproduced here is from the 1665 second edition.
Further Reading
Burns, William E. An Age of Wonders: Prodigies, Politics, and Providence in England, 1657–1727. Manchester: Manchester University Press, 2002.
We numerically model the dynamics of the Enceladus plume ice grains and define our nominal plume model as having a particle size distribution n(R) ~ R−q with q = 4 and a total particulate mass rate of 16 kg s−1. This mass rate is based on average plume brightness observed by Cassini across a range of orbital positions. The model predicts sample volumes of ~1600 µg for a 1 m2 collector on a spacecraft making flybys at 20–60 km altitudes above the Enceladus surface. We develop two scenarios to predict the concentration of amino acids in the plume based on these assumed sample volumes. We specifically consider Glycine, Serine, α-Alanine, α-Aminoisobutyric acid and Isovaline. The first ‘abiotic’ model assumes that Enceladus has the composition of a comet and finds abundances between 2 × 10−6 to 0.003 µg for dissolved free amino acids and 2 × 10−5 to 0.3 µg for particulate amino acids. The second ‘biotic’ model assumes that the water of Enceladus's ocean has the same amino acid composition as the deep ocean water on Earth. We compute the expected captured mass of amino acids such as Glycine, Serine, and α-Alanine in the ‘biotic’ model to be between 1 × 10−5 to 2 × 10−5 µg for dissolved free amino acids and dissolved combined amino acids and about 0.0002 µg for particulate amino acids. Both models consider enhancements due to bubble bursting. Expected captured mass of amino acids is calculated for a 1 m2 collector on a spacecraft making flybys with a closest approach of 20 km during mean plume activity for the given nominal particle size distribution.
A controversy at the 2016 IUCN World Conservation Congress on the topic of closing domestic ivory markets (the 007, or so-called James Bond, motion) has given rise to a debate on IUCN's value proposition. A cross-section of authors who are engaged in IUCN but not employed by the organization, and with diverse perspectives and opinions, here argue for the importance of safeguarding and strengthening the unique technical and convening roles of IUCN, providing examples of what has and has not worked. Recommendations for protecting and enhancing IUCN's contribution to global conservation debates and policy formulation are given.
This chapter examines the efforts in Europe and and the UK to deal with the problem of people-trafficking. As readers will see, it is in five Sections. The first sets the scene by explaining what ‘people-trafficking’ is, and outlining the history of international attempts to repress it and to relieve its human consequences. The second describes the recent legislative attempts to deal with it in Europe, and in particular, the EU Framework Decision of 2002. The third examines the UK legislation enacted with the aim—not entirely accurate, as we shall see—of implementing it. The fourth looks at the way the UK legislation is working. And the final section concludes with two general reflections. It is based on a study carried out in 2007 for ECLAN, the European Criminal Law Academic Network. Any reader who reaches the end with a thirst for further knowledge will find further refreshment in the book that resulted from the ECLAN study, which was published earlier this year.
In broad terms, there are two approaches to returning suspects and convicted persons to the other countries where they are wanted, and would prefer for obvious reasons not to go.
One is what is called in the common law world ‘the backing of warrants’. Here, the authorities of the jurisdiction where the person is wanted issue their normal warrant of arrest, which is sent directly to the authorities of the jurisdiction where he is, who endorse it if it appears to be in order, and give it to their policemen to execute it as if it were their own. The suspect is then ‘lifted’, and handed over to the authorities of the country where he is wanted with the minimum of fuss—the unspoken premise being that the authorities of the requesting jurisdiction normally act lawfully and reasonably, and their arrest warrants can be taken at face value and acted upon unless a strong reason to the contrary can be given.
When a criminal case with trans-border ramifications is to be prosecuted within a given state, the following three problems typically arise:
— bringing the defendant, currently abroad, to that state, to enable the case against him to be tried;
— obtaining relevant evidence from other jurisdictions;
— persuading the courts of the state where the defendant is to be tried that they can use it.
The first of these problems is in principle the most important. Unless a legal system is prepared (as some were in the past) to try defendants in absentia and then punish them in effigy, the defendant’s physical presence within the jurisdiction of the court is usually required in order to bring the mechanism of the criminal law to bear upon him.
In 1997 the idea of a European Public Prosecutor was floated in the Corpus Juris Project as one of a series of measures designed to ensure that fraud on the Community budget would be detected and punished. This chapter describes how in the UK the proposal was misrepresented by the eurosceptic press, and how Parliament reacted to the distorted version by changing the law to render any future participation by the UK in a project to create a European Public Prosecutor practically impossible.
This collaborative work provides a detailed snapshot of child oral health in Australia. In doing so, it describes the levels of dental caries and its components, dental fluorosis and other oral health conditions and how they vary by social characteristics. It also describes protective factors such as toothbrushing, the use of fluoridated toothpastes and making dental visits.
The WAIS (West Antarctic Ice Sheet) Divide deep ice core was recently completed to a total depth of 3405 m, ending 50 m above the bed. Investigation of the visual stratigraphy and grain characteristics indicates that the ice column at the drilling location is undisturbed by any large-scale overturning or discontinuity. The climate record developed from this core is therefore likely to be continuous and robust. Measured grain-growth rates, recrystallization characteristics, and grain-size response at climate transitions fit within current understanding. Significant impurity control on grain size is indicated from correlation analysis between impurity loading and grain size. Bubble-number densities and bubble sizes and shapes are presented through the full extent of the bubbly ice. Where bubble elongation is observed, the direction of elongation is preferentially parallel to the trace of the basal (0001) plane. Preferred crystallographic orientation of grains is present in the shallowest samples measured, and increases with depth, progressing to a vertical-girdle pattern that tightens to a vertical single-maximum fabric. This single-maximum fabric switches into multiple maxima as the grain size increases rapidly in the deepest, warmest ice. A strong dependence of the fabric on the impurity-mediated grain size is apparent in the deepest samples.