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The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community.
The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance.
Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second.
This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.
The study of pre-modern (i.e. pre-sixteenth century) systems of enslavement and slave trading in sub-Saharan Africa have relied heavily on textual, especially Arabic, sources. By contrast, there have been few archaeological studies of these phenomena, although reference is often made to the Trans-Saharan and Red Sea/Indian Ocean slave trades in archaeological studies of early state formation and globalisation on the continent. This chapter provides a brief review of some of the key written sources concerning the presence of slaves in different regions of sub-Saharan Africa between c. 500-1500 CE, and what these can tell us about prevailing systems of enslavement. This is followed by discussion of the limited number of archaeological studies of enslavement during this same period across the continent, their main findings and the key interpretative challenges faced when trying to detect the presence of slaves from material evidence alone. The chapter concludes with suggestions for the direction of future work, laying emphasis on the need for multi-sited projects that aim to reconstruct landscapes of enslavement and how slave-based economies were organised and functioned.
This study aimed to identify the types of foods that constitute a vegan diet and establish patterns within the diet. Dietary pattern analysis, a key instrument for exploring the correlation between health and disease, was used to identify patterns within the vegan diet.
A modified version of the EPIC-Norfolk FFQ was created and validated to include vegan foods and launched on social media.
UK participants, recruited online.
A convenience sample of 129 vegans voluntarily completed the FFQ. Collected data were converted to reflect weekly consumption to enable factor and cluster analyses.
Factor analysis identified four distinct dietary patterns including: (1) convenience (22 %); (2) health conscious (12 %); (3) unhealthy (9 %) and (4) traditional vegan (7 %). Whilst two healthy patterns were defined, the convenience pattern was the most identifiable pattern with a prominence of vegan convenience meals and snacks, vegan sweets and desserts, sauces, condiments and fats. Cluster analysis identified three clusters, cluster 1 ‘convenience’ (26·8 %), cluster 2 ‘traditional’ (22 %) and cluster 3 ‘health conscious’ (51·2 %). Clusters 1 and 2 consisted of an array of ultraprocessed vegan food items. Together, both clusters represent almost half of the participants and yielding similar results to the predominant dietary pattern, strengthens the factor analysis.
These novel results highlight the need for further dietary pattern studies with full nutrition and blood metabolite analysis in larger samples of vegans to enhance and ratify these results.
Research on the social dimensions of climate change is increasingly focused on people's experiences, values and relations to the environment as a means to understand how people interpret and adapt to changes. However, a particular challenge has been making seemingly temporally and geographically distant climate change more immediate and local so as to prompt behavioural change. Environmental humanists, anthropologists and historians have tried to address the challenge through analysis of the experiences, philosophies and memories of weather. Archaeology, commonly preoccupied by hard science approaches to climate change, has largely been absent from this conversation. Nevertheless, with its insights into material outcomes of human experiences and relations, it can become integral to the discussion of ‘weathering’ climate change and historicizing weather. Here, drawing on the subtleties of responses by Ilchamus communities in Kenya and using a mix of historical and archaeological sources, we highlight their experiences of weather since the end of the Little Ice Age and explore the potential of building archaeologies of weather.
The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.
The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned.
The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement.
Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
Background: A prolonged outbreak of carbapenemase-producing Serratia marcescens (CPSM) was identified in our quaternary healthcare center over a 2-year period from 2015 through 2017. A reservoir of IMP-4–producing S. marcescens in sink drains of clinical hand basins (CHB) was implicated in propagating transmission, supported by evidence from whole-genome sequencing (WGS). We assessed the impact of manual bioburden reduction intervention on further transmission of CPSM. Methods: Environmental sampling of frequently touched wet and dry areas around CPSM clinical cases was undertaken to identify potential reservoirs and transmission pathways. After identifying CHB as a source of CPSM, a widespread annual CHB cleaning intervention involving manual scrubbing of sink drains and the proximal pipes was implemented. Pre- and postintervention point prevalence surveys (PPS) of CHB drains performed to assess for CPSM colonization. Surveillance for subsequent transmission was conducted through weekly screening of patients and annual screening of CHB in transmission areas, and 6-monthly whole-hospital PPS of patients. All CPSM isolates were assessed by WGS. Results: In total, 6 patients were newly identified with CPSM from 2015 to 2017 (4.3 transmission events per 100,000 surveillance bed days [SBD]; 95% CI, 1.6–9.4). All clinical CPSM isolates were linked to CHB isolates by WGS. The CHB cleaning intervention resulted in a reduction in CHB colonization with CPSM in transmission areas from 72% colonization to 28% (ARR, 0.44; 95% CI, 0.25–0.63). A single further clinical case of CPSM linked to the CHB isolates was detected over 2 years of surveillance from 2017 to 2019 following the implementation of the annual CHB cleaning program (0.7 transmissions per 100,000 SBD; 95% CI, 0.0–3.9). No transmissions were linked to undertaking the cleaning intervention. Conclusions: A simple intervention targeted at reducing the biological burden of CPSM in CHB drains at regular intervals was effective in preventing transmission of carbapenemase-producing Enterobacterales from the hospital environment to patients over a prolonged period of intensive surveillance. These findings highlight the importance of detailed cleaning for controlling the spread of multidrug-resistant organisms from healthcare environments.
Shanidar Cave in Iraqi Kurdistan became an iconic Palaeolithic site following Ralph Solecki's mid twentieth-century discovery of Neanderthal remains. Solecki argued that some of these individuals had died in rockfalls and—controversially—that others were interred with formal burial rites, including one with flowers. Recent excavations have revealed the articulated upper body of an adult Neanderthal located close to the ‘flower burial’ location—the first articulated Neanderthal discovered in over 25 years. Stratigraphic evidence suggests that the individual was intentionally buried. This new find offers the rare opportunity to investigate Neanderthal mortuary practices utilising modern archaeological techniques.
To outline the pathways a cohort of first attendees to our headache clinics had taken over the years in search of explanations and treatment for their headaches. To establish a greater awareness of the shortcomings and failures in their medical journey in the hope that better headache management will emerge in primary care.
At first attendance in primary care most headache sufferers will not receive a firm diagnosis. Treatments provided are often ineffective and so many patients embark on a somewhat random self-made journey searching for a remedy. If they reach a Headache Clinic the most common diagnoses are ‘chronic migraine’ and ‘medication overuse headache’. They are either no better or worse than when their headaches first started despite their efforts.
We undertook a prospective questionnaire-based study of over 200 patients on first attendance at each of our headache clinics, three based in District General Hospitals and one in a tertiary referral centre. We documented the patients’ headache characteristics, the ‘burden’ of their headaches, functional handicap and the financial costs incurred seeking help before referral. We also documented what our patients understood about their headache disorder and the treatments previously tried.
Most patients had not been given a formal diagnosis in primary care and many remained unconvinced of the benign nature of their headache problem and wanted further investigations. A few had sought help from headache charities. Many had unrealistic attitudes to their problem and medication overuse was rife. A few patients had been offered triptans in primary care. Key deficiencies in the primary care management of these patients included failure to provide a formal headache diagnosis, inadequate understanding of the nature and mechanism of headaches and failure to follow a resilient management strategy. We provide a more effective management pathway in primary care.
Recent years have seen growth in the number of historical archaeology studies in Eastern Africa. Combining critical analysis of material remains alongside the available documentary and oral sources, these offer new insights into the precolonial and colonial pasts of the region. However, the field is less well established than in either West or Southern Africa and the full potential of the subdiscipline has yet to be realised. This contribution reviews the main analytical and theoretical trends, drawing on a selection of examples. Several other research themes that might warrant investigation are also identified, and the general lack of engagement with material culture and the archaeology of the last few hundred years on the part of historians, is lamented.
The oldest layers occur atop sterile red clay, and it appears that 'Ain Ghazal began as a small village about 2 ha in area. The end of the MPPNB in the southern Levant was a tumultuous one, and there were severe disturbances in the settlement pattern of the region. Wholesale abandonment of farming villages in Israel and the Jordan valley began around this time, and many of the dislocated populations sought refuge elsewhere, probably often in highland Jordan. If the plastering of skulls of some family members might have had some relationship with ancestral veneration in the MPPNB, it is highly likely that the stunning plaster statuary from 'Ain Ghazal is an extension of the ancestral cult that characterized the central Levant. In view of larger cultic buildings, people prefer to call the smaller apsidal and circular buildings shrines to indicate a lower rank in a hierarchy of ritual buildings.
The paper reports the preliminary results from the short season of fieldwork that the Cyrenaican Prehistory Project was able to undertake with a small Anglo-Libyan team in September 2013. The work concentrated on continuing the excavation of Trench M down the southern side of the Middle Trench and of Trench D on the southern side of the Deep Sounding below it, the eventual objective being to link these so as to provide a high quality dataset of sedimentary and cultural data from the top to the bottom of the Pleistocene occupation deposit (some 12 m). The ~1 m of sediments investigated in Trench M in the 2013 fieldwork includes carbonate crusts possibly formed in oscillating sub-humid to arid climatic pulses, perhaps likely during Marine Isotope Stage (MIS) 4, around 60,000–70,000 years ago. One of these crusts formed the base on which a hearth-like structure had been built. In Trench D evidence for human occupation appears to decline moving up the profile, coinciding with sedimentary evidence of more frequent disruptive climatic events possibly associated with latter stages of MIS 5.
Previous studies of past labor relations in different parts of Africa have relied almost entirely on documentary sources. While such records can provide valuable insights into the range of different labor categories that have existed and the relative proportions of the population involved, for much of the continent they are severely restricted in a temporal sense. Thus, for many areas suitable documentary materials covering the periods prior to 1850 are scarce; as is the case, for example, for much of East Africa. To extend scholarly understanding of the nature of labor relations prior to this date, alternative sources need to be utilized. This paper presents a brief overview of the potential scope for utilizing archaeological data, with specific reference to mainland Tanzania. The paper also highlights the many limitations of archaeological data and offers some thoughts on how these might be addressed from both a conceptual and methodological perspective. The paper concludes with an appeal for more studies oriented toward investigation of the archaeological remains of the last five hundred years and greater dialogue between the region’s historians and archaeologists.
Subcortical hyperintensities (SH) on neuroimaging are a prominent feature of vascular dementia (VaD) and SH severity correlates with cognitive impairment in this population. Previous studies demonstrated that SH burden accounts for a degree of the cognitive burden among VaD patients, although it remains unclear if individual factors such as cognitive reserve influence cognitive status in VaD. To address this issue, we examined 36 individuals diagnosed with probable VaD (age = 77.56; education = 12). All individuals underwent MMSE evaluations and MRI brain scans. We predicted that individuals with higher educational attainment would exhibit less cognitive difficulty despite similar levels of SH volume, compared to individuals with less educational attainment. A regression analysis revealed that greater SH volume was associated with lower scores on the MMSE. Additionally, education moderated the relationship between SH volume and MMSE score, demonstrating that individuals with higher education had higher scores on the MMSE despite similar degrees of SH burden. These results suggest that educational attainment buffers the deleterious effects of SH burden on cognitive status among VaD patients. (JINS, 2011, 17, 531–536)
Interventional cardiology for paediatric and congenital cardiac disease is a relatively young and rapidly evolving field. As the profession begins to establish multi-institutional databases, a universal system of nomenclature is necessary for the field of interventional cardiology for paediatric and congenital cardiac disease. The purpose of this paper is to present the results of the efforts of The International Society for Nomenclature of Paediatric and Congenital Heart Disease to establish a system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease, focusing both on procedural nomenclature and the nomenclature of complications associated with interventional cardiology. This system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease is a component of The International Paediatric and Congenital Cardiac Code. This manuscript is the second part of the two-part series. Part 1 covered the procedural nomenclature associated with interventional cardiology as treatment for paediatric and congenital cardiac disease. Part 2 will cover the nomenclature of complications associated with interventional cardiology as treatment for paediatric and congenital cardiac disease.
Interventional cardiology for paediatric and congenital cardiac disease is a relatively young and rapidly evolving field. As the profession begins to establish multi-institutional databases, a universal system of nomenclature is necessary for the field of interventional cardiology for paediatric and congenital cardiac disease. The purpose of this paper is to present the results of the efforts of The International Society for Nomenclature of Paediatric and Congenital Heart Disease to establish a system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease, focusing both on procedural nomenclature and on the nomenclature of complications associated with interventional cardiology. This system of nomenclature for cardiovascular catheterisation for congenital and paediatric cardiac disease is a component of The International Paediatric and Congenital Cardiac Code. This manuscript is the first part of a two-part series. Part 1 will cover the procedural nomenclature associated with interventional cardiology as treatment for paediatric and congenital cardiac disease. This procedural nomenclature of The International Paediatric and Congenital Cardiac Code will be used in the IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment) of the National Cardiovascular Data Registry® of The American College of Cardiology. Part 2 will cover the nomenclature of complications associated with interventional cardiology as treatment for paediatric and congenital cardiac disease.