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.

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.

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.

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.

Background. Excessive worry is required by DSM-IV, but not ICD-10, for a diagnosis of generalized anxiety disorder (GAD). No large-scale epidemiological study has ever examined the implications of this requirement for estimates of prevalence, severity, or correlates of GAD.

Method. Data were analyzed from the US National Comorbidity Survey Replication, a nationally representative, face-to-face survey of adults in the USA household population that was fielded in 2001–2003. DSM-IV GAD was assessed with Version 3.0 of the WHO Composite International Diagnostic Interview. Non-excessive worriers meeting all other DSM-IV criteria for GAD were compared with respondents who met full GAD criteria as well as with other survey respondents to consider the implications of removing the excessiveness requirement.

Results. The estimated lifetime prevalence of GAD increases by ~40% when the excessiveness requirement is removed. Excessive GAD begins earlier in life, has a more chronic course, and is associated with greater symptom severity and psychiatric co-morbidity than non-excessive GAD. However, non-excessive cases nonetheless evidence substantial persistence and impairment of GAD, high rates of treatment-seeking, and significantly elevated co-morbidity compared with respondents without GAD. Non-excessive cases also have sociodemographic characteristics and familial aggregation of GAD comparable to excessive cases.

Conclusions. Individuals who meet all criteria for GAD other than excessiveness have a somewhat milder presentation than those with excessive worry, yet resemble excessive worriers in a number of important ways. These findings challenge the validity of the excessiveness requirement and highlight the need for further research into the optimal definition of GAD.

Background. The proposed revisions of the ICD and DSM diagnostic systems have led to increased interest in evaluation of diagnostic criteria. This report focuses on the DSM-IV requirement that episodes of generalized anxiety disorder (GAD) must persist for at least 6 months. Community epidemiological data are used to study the implications of changing this requirement in the range 1–12 months for estimates of prevalence, onset, course, impairment, co-morbidity, associations with parental GAD, and sociodemographic correlates.

Method. Data come from the US National Comorbidity Survey Replication (NCS-R), a US household survey carried out during 2001–2003. Version 3.0 of the WHO Composite International Diagnostic Interview (WMH-CIDI) was used to assess DSM-IV anxiety disorders, mood disorders, substance disorders, and impulse-control disorders.

Results. Lifetime, 12-month, and 30-day prevalence estimates of DSM-IV GAD changed from 6·1%, 2·9%, and 1·8% to 4·2–12·7%, 2·2–5·5%, and 1·6–2·6% when the duration requirement was changed from 6 months to 1–12 months. Cases with episodes of 1–5 months did not differ greatly from those with episodes of [ges ]6 months in onset, persistence, impairment, co-morbidity, parental GAD, or sociodemographic correlates.

Conclusions. A large number of people suffer from a GAD-like syndrome with episodes of <6 months duration. Little basis for excluding these people from a diagnosis is found in the associations examined here.

Researchers at the Pacific Northwest National Laboratory (PNNL) investigated the effects of gadolinium oxide concentration on the air oxidization of gadolinium oxide-doped uranium dioxide using thermogravimetry and differential scanning calorimetry to determine if such doping could improve uraniumdioxide's stability as a nuclear fuel during potential accident scenarios in a nuclear reactor or during long-term disposal. We undertook this study to determine whether the resistance of the uranium dioxide to oxidation to the orthorhombic U3O8 with its attendant crystal expansion could be prevented by addition of gadolinium oxide. Our studies found that gadolinium has little effect on the thermal initiation of the first step of the reported two-step air oxidation of UO2; however, increasing gadolinium oxide content does stabilize the initial tetragonal or cubic product allowing significant oxidation before the second expansive step to U3O8 begins.

Gallium–indium–oxide films (GaxIn2⊟xO3), where x = 0.0–1.1, were grown by low-pressure metalorganic chemical vapor deposition using the volatile metalorganic precursors In(dpm)3 and Ga(dpm)3 (dpm = 2,2,6,6-tetramethyl-3,5-heptanedionato). The films were smooth (root mean square roughness = 50–65 Å) with a homogeneously Ga-substituted, cubic In2O3 microstructure, randomly oriented on quartz or heteroepitaxial on (100) yttria-stabilized zirconia single-crystal substrates. The highest conductivity of the as-grown films was found at x = 0.12, with σ = 700 S/cm [n-type; carrier density = 8.1 × 1019 cm⊟3; mobility = 55.2 cm2/(V s); dσ/dT<0]. The optical transmission window of such films is considerably broader than that of Sn-doped In2O3, and the absolute transparency rival or exceeds that of the most transparent conductive oxides known. Reductive annealing, carried out at 400–425 C° in a flowing gas mixture of H2 (4%) and N2, resulted in increased conductivity (σ 1400 S/cm; n-type), carrier density (1.4 × 1020 cm⊟3), and mobility as high as 64.6 cm2/(V s), with little loss in optical transparency. No significant difference in carrier mobility or conductivity is observed between randomly oriented and heteroepitaxial films, arguing in combination with other data that carrier scattering effects at high-angle grain/domain boundaries play a minor role in the conductivity mechanism.