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Clinical trials are a fundamental tool in evaluating the safety and efficacy of new drugs, medical devices, and health system interventions. Clinical trial visits generally involve eligibility assessment, enrollment, intervention administration, data collection, and follow-up, with many of these steps performed during face-to-face visits between participants and the investigative team. Social distancing, which emerged as one of the mainstay strategies for reducing the spread of SARS-CoV-2, has presented a challenge to the traditional model of clinical trial conduct, causing many research teams to halt all in-person contacts except for life-saving research. Nonetheless, clinical research has continued during the pandemic because study teams adapted quickly, turning to virtual visits and other similar methods to complete critical research activities. The purpose of this special communication is to document this rapid transition to virtual methodologies at Clinical and Translational Science Awards hubs and highlight important considerations for future development. Looking beyond the pandemic, we envision that a hybrid approach, which implements remote activities when feasible but also maintains in-person activities as necessary, will be adopted more widely for clinical trials. There will always be a need for in-person aspects of clinical research, but future study designs will need to incorporate remote capabilities.
Mastitis, inflammation of the bovine mammary gland, is generally caused by intramammary infection with bacteria, and antimicrobials have long been a corner stone of mastitis control. As societal concern about antimicrobial use in animal agriculture grows, there is pressure to reduce antimicrobial use in dairy farming. Point-of-care tests for on-farm use are increasingly available as tools to support this. In this Research Reflection, we consider available culture-dependent and culture-independent tests in the context of ASSURED criteria for low-resource settings, including convenience criteria, scientific criteria and societal criteria that can be used to evaluate test performance. As tests become more sophisticated and sensitive, we may be generating more data than we need. Special attention is given to the relationship between test outcomes and treatment decisions, including issues of diagnostic refinement, antimicrobial susceptibility testing, and detection of viable organisms. In addition, we explore the role of technology, big data and people in improved performance and uptake of point-of-care tests, recognising that societal barriers may limit uptake of available or future tests. Finally, we propose that the 3Rs of reduction, refinement and replacement, which have been used in an animal welfare context for many years, could be applied to antimicrobial use for mastitis control on dairy farms.
In many advanced democracies, mainstream political parties have been disrupted either by the rise of new (populist) parties or by hostile takeovers. In this article we argue that immigration attitudes have had a powerful impact on the strategic environment of political parties and leaders. We show, based on evidence from a comparative study conducted by YouGov in spring of 2015, that immigration attitudes had, by that time, driven a wedge between mainstream parties – those that regularly play a role in government – and their partisans. This ‘immigration gap’ opened up enormous space for new political movements to form, either inside existing parties or outside. Furthermore, we show that the representation gap on immigration issues is a relevant predictor of vote choice, so that parties are particularly likely to lose votes when they are more distant from their supporters on immigration.
To describe infant feeding practices and predictors of exclusive breast-feeding among women attending a local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) programme.
Cross-sectional survey. Outcomes included reported infant feeding practices at 3 and 6 months, timing and reasons for introduction of formula. Descriptive statistics, χ2 tests and logistic regression were used describe the sample and explore relationships between variables.
Loudoun County, VA, USA.
A sample of 190 predominantly Hispanic women attending local WIC clinics.
Overall, 84 % of women reported ever breast-feeding and 61 % of infants received formula in the first few days of life. Mothers who reported on infant feeding practices were less likely to exclusively breast-feed (34 v. 45 %) and more likely to provide mixed feeding (50 v. 20 %) at 3 months compared with 6 months, respectively. Significant (P<0·05) predictors of exclusive breast-feeding at 3 months included setting an exclusive breast-feeding goal and completing some high school (compared with completing high school or more). Only education remained a significant predictor of exclusive breast-feeding at 6 months.
A high proportion of women reported giving formula in the first few days of life and many changed from mixed to exclusive breast-feeding or formula by 6 months, suggesting possibly modifiable factors. Further investigation can help drive direct service- as well as policy and systems-based interventions to improve exclusive breast-feeding.
Both qualitative and quantitative research routinely fall short, producing misleading causal inferences. Because these weaknesses are in part different, we are convinced that multimethod strategies are productive. Each approach can provide additional leverage that helps address shortcomings of the other. This position is quite distinct from that of Beck, who believes that the two types of analysis cannot be adjoined. We review examples of adjoining that Beck dismisses, based on what we see as his outdated view of qualitative methods. By contrast, we show that these examples demonstrate how qualitative and quantitative analysis can work together.
Objectives: The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of Kazakhstan
Methods: Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project.
Results: Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work.
Conclusions: The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.
In President Obama's words, the Democratic Party experienced a “shellacking” in the 2010 elections. In particular, the net loss of 63 House seats was the biggest midterm loss suffered by a party since 1938—the largest in the lifetimes of approximately 93% of the American population.
Scholars have hypothesized that policy choices by national, state, and local governments often have implications for “location choices” made by residents (e.g., tax policies affect where firms set up business, welfare benefits influence where the poor live, government restaurant smoking restrictions influence where people eat). We develop a spatially explicit strategic theory of policy diffusion driven by intergovernmental competition over residents’ location choices. The theory assumes that governments’ decisions constitute a strategic game in which governments are influenced by their neighbors. We suggest a variety of policy contexts in which the theory is applicable. For one such context—the adoption of lotteries by American states—we use the theory to generate several hypotheses and then test them using event history analysis. The results provide substantial support for the theory and indicate that states compete for lottery business in a much more sophisticated fashion than has been previously recognized.
Since the 1990s, scholarly accounts of globalization and its consequences have become prevalent throughout the social sciences (see Brady et al. 2007 for a review). While some view globalization as a centuries-long process of world system integration (Sklair 2002), others focus on recent changes in the last several decades. Although conceptualizations of globalization vary widely, they share a common insight that many phenomena previously centered in the local, sub-national, or national levels are increasingly interconnected on a global scale. Globalization implies increasing interpenetration and interdependency among societies, cultures, and peoples of the world often accompanied with a concern that the autonomy and sovereignty of the local setting is being diminished.
The changes created by globalization resemble the transformations discussed by those who advance social structures of accumulation (SSA) theory. Various scholars in this tradition place primary emphasis on the emergence of finance capital, neoliberalism, or other manifestations of globalization as the primary face of the new SSA. While having made numerous advances in SSA theory (Kotz, McDonough, and Reich 1994), we contend that SSA scholarship has strayed from Gordon, Edwards, and Reich's ([GER] 1982) central premise that the transformation of the labor process is a defining feature of each SSA (Wallace and Brady 2001). With the aim of restoring the centrality of the labor process, we extend the SSA approach in three ways.
In this article, we report results from a new study that surveyed a large, national sample of American adults about their willingness to pay for health reform. As in previous work, we find that self-identified Republicans, older Americans, and high-income Americans are less supportive of reform. However, these basic findings mask three important features of public opinion. First, income has a substantial effect on support for reform, even holding political affiliation constant. Indeed, income is the most important determinant of support for reform. Second, the negative effects of income on support for reform begin early in the income distribution, at annual family income levels of $25,000 to $50,000. Third, although older Americans have a less favorable view of reform than the young, much of their opposition is due to dislike of large policy changes than to reform per se.
Exposure therapy is a widely used and well-evidenced treatment for a variety of avoidance behaviours. This paper offers a modest proposal for an improvement in how it is carried out (‘dynamic hierarchies’). The theoretical and practical context is set out, including some thoughts on the role of appraisals and cognitive dissonance, and some advantages of the method are suggested.
Low temperature hydrothermal methods allow for growth of nanowires on novel substrates. We examine the impact of variations in chemical concentration, time, temperature, and seed layer on nanowire (NW) growth and crystallite formation. The majority of growth (NWs and crystallites) was found to occur within the first two hours. Lower Zn(NO3)2 concentrations produced a reduction in the undesired large crystallites, whereas hexamethylene tetramine (HMT) concentration did not largely impact crystallite density or nanowire morphology. Growth temperature appeared to impact NW diameter variation. Nanowires grow only on the ZnO seed layer and crystallites seem to attach preferentially to the bare Kevlar surface.
Cooper and Brady argue that the homogeneity of legislative parties' electoral constituencies varies over time. The more homogeneous the electoral constituency of a party, the more cohesive the legislative party. A cohesive legislative party, in turn, concentrates power in the hands of central leaders and relies more on leaders to direct policymaking. The less homogeneous the electoral constituency and the less cohesive the legislative party, the more power will be dispersed and the more leadership will be oriented toward bargaining and maintaining good relations within the party.
Leadership is an aspect of social life that has been extensively studied in a variety of institutional or organizational settings. Yet, it remains a topic in which our intellectual grasp falls far short of our pragmatic sense of the impacts leaders have on organizational operations and performance.
This is as true, if not more true, of Congress than of other organizations. Here, too, analysts are perplexed by the difficulties of conceptualizing key variables, treating highly transient and idiosyncratic personal factors, and identifying relationships amidst a maze of interactive effects. Moreover, the task is rendered even more complex by the highly politicized character of the Congress as compared with most of the organizational contexts in which leadership has been studied.
This is not to say that knowledge and understanding of congressional leadership have remained static. Nonetheless, our grip on the topic is as yet not firm; we continue to lack a developed sense of what we should be looking at and how to proceed.
Brady and Theriault argue that there are things legislators do that bring public disapproval upon their institution. Legislators devise procedures to avoid accountability, engage in hyperbolic rhetoric, and blame their own institution. Moreover, extremists in Congress get disproportionate media coverage so that the public sees more conflict and partisanship than actually exists.
That Americans disapprove of Congress is generally as well accepted as any stylized fact in American politics. From 1974 (when Gallup first asked a congressional approval question) through 1997, congressional approval hovered around 30 percent. The average for 54 Gallup polls taken over the 23 years was 31 percent. At no point did a majority of Americans approve of the way Congress did its job – approval climaxed in 1974 at 48 percent amid the Watergate proceedings. Such bleak numbers led Glenn Parker to conclude, “Congress, like Prometheus, is inevitably doomed to suffer indignities.” Sometimes, however, stylized facts turn out to be fiction. In 1998, Congress enjoyed widespread popular support, reaching a high of 63 percent in late September. Notwithstanding Congress' current popularity, the causes and consequences of the American public's disapproval of Congress have been studied in classrooms.
The myriad opinions and explanations of low congressional approval can generally be broken down into two schools of thought. The first argues that the American public's disapproval of Congress is based on policy or conditions. Low congressional approval is an artifact of either a recessing economy or policies inconsistent with the public's preferences.
To determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) colonization among older residents of care homes in Leeds, United Kingdom, and to identify resident and care home risk factors for carriage.
We conducted a cross-sectional prevalence survey of 715 residents from 39 care homes. All participants were tested for nasal colonization with S. aureus, including MRSA. A short questionnaire was completed about each participant and each care home. A multivariable model was used to determine which risk factors were independently associated with MRSA colonization.
Care homes for older residents in Leeds, United Kingdom.
All residents in participating homes who were able to give informed consent.
A total of 159 of 715 residents tested positive for MRSA, for a prevalence of 22% (95% confidence interval, 18%—27%) The resultant multivariate model showed that residence in a home with a low ratio of nurses to beds, residence in a care home in a deprived area, male sex, presence of an invasive device, and a hospitalization duration of more than 10 days during the previous 2 years were independently associated with MRSA colonization.
This study found a large reservoir of MRSA within the care home population. Control strategies need to be coordinated between care homes and hospitals. Increasing the ratio of nurses to beds, reducing the duration of hospitalization, and improving the management of invasive devices could help reduce the prevalence of MRSA colonization. Further research is required to ascertain the potential health benefits of reducing the rate of MRSA colonization among care home residents.
Although a rich body of research has explored the sources of party polarization in the US House of Representatives, it has focused primarily on the House since the late 1970s. Drawing on a dataset of historical election outcomes, legislative voting and survey data, this article takes an alternative approach that examines both the US Senate and the House in their broader historical contexts. It is argued that the unusually bipartisan era of the 1950s created a set of circumstances that enabled congressional parties to remain relatively unpolarized throughout the 1960s and early 1970s. Although the national parties became more ideologically distinct in the mid-1960s, congressional parties lagged behind. As a result, a group of moderate legislators emerged who were cross-pressured between their national parties and their constituencies. Only when natural patterns of electoral loss and retirement replaced these legislators did congressional party polarization re-emerge.
The discussion of qualitative and quantitative research methods in political science has followed a “long arc of development,” according to Andrew Bennett (this symposium). He sees our book Rethinking Social Inquiry: Diverse Tools, Standards (RSI) as a “key turning point” in this development and as contributing to a more pluralistic vision of methodology. We would certainly be gratified if we have indeed made this contribution. Yet this is an ongoing discussion, and this symposium points to fruitful directions this discussion can take.