Multi-site Field Study Research Articles

Field Study and Correlative Studies of Factor IX Variant FIX-R338L in Participants Treated with Fidanacogene Elaparvovec.

Fidanacogene elaparvovec, an adeno-associated virus-based gene therapy vector expressing the high-activity factor IX (FIX) variant FIX-R338L, is in development for hemophilia B. One-stage clotting (OS) assays and chromogenic substrate (CS) assays are commonly used to measure FIX-R338L variant activity. Data from ongoing trials suggest FIX activity varies between different OS and CS assays. To better understand FIX-R338L activity in clinical samples, an international multisite field study was conducted across a central laboratory and 18 local laboratories, using standard protocols, reagents, and instrumentation, with individual participant samples from a phase 1/2a study of fidanacogene elaparvovec. Unlike the wild-type FIX control, FIX-R338L activity was higher with the OS silica-based assay versus OS ellagic acid-based and CS assays. Variation in FIX activity was greater at the lowest activity levels. Activated FIX (FIXa) in plasma could result in higher OS assay activity or increased thrombin generation, which could overestimate FIX activity. However, FIXa was not detected in the participant samples, indicating that it was not contributing to the OS assay differences. Since individuals on gene therapy may receive exogenous replacement FIX products, replacement products were spiked into patient plasma samples to target a therapeutic concentration. Exogenous FIX was additive to endogenous FIX-R338L, with no interference from FIX-R338L. These results demonstrate FIX-R338L activity can be measured with OS and CS assays in clinical laboratories and provide insight into assay variability when measuring FIX with endogenously produced FIX-R338L. The findings may help establish best practices for measuring FIX-R338L activity (Clinicaltrials.gov identifier: NCT02484092).

Neoliberally framed suffering in professionals and patients in palliative care settings – ’telling cases’ from an ethnographic multi-sited field study in Denmark

ABSTRACT In western countries, palliative care is a part of the formal healthcare system, ruled by neoliberal, organisational ideas. This Danish study illuminates how nurses and patients with non-western immigrant backgrounds (inter)act in relation to encounters in palliative care settings. Two ‘telling’ cases were selected, based on interviews and participating observations from a multi-sited ethnographic field study in Denmark. The results showed different care consequences of the structural framework, referring to, for example, political healthcare logics, strategies, and priorities, and illuminated how neoliberally organised healthcare systems inflicted suffering on patients and frustration amongst professionals. It did not seem that the immigrant background per se induced the challenges. The understandings of care and treatment conflicted as nurses often represented a medical, neoliberal logic of disease, treatment, and care, and patients often represented a non-medical logic of disease, formed by their lives. When palliative care took place in a general setting, (inter)actions were also influenced by a curative agenda of treatment and care. The study added to the evidence of the power of neo-liberal rationality across different forms of care and populations, regardless of ethnicity or location of that care.

The sense of a patient: An ethnographic multi-site field study exploring the influence of manikins on nursing students' learning

The purpose of this ethnographic study was to gain insight into the influence of full-body human-like manikins on nursing students’ learning. The research question that guided the study was: How do the presence and use of human-like manikins influence nursing students’ learning? Data were collected during 15 educational sessions, using different manikins for various activities. Applying cultural-historical activity theory, this study explored the use of manikins as a mediated activity.The study's main result was the interplay of five categories. In the first category, manikin as an object, manikins were used to teach and learn technical skills. In the second category, manikin as a subject, manikins were used to teach and learn to perform those skills with care. The third category, the interplay, illustrates how these two approaches were present in all sessions. Category four, the individual learning space, provided students with a feeling of working with a patient. Category five, the collective learning space, awarded collaborative and reflexive learning opportunities.We concluded from this study that manikins may introduce students to the balance between the technical and interpersonal aspects of nursing practice. Being aware of how manikins influence learning, educators can make more targeted use of manikins and support lower-grade nursing students in their learning process and professional development.

Effectiveness of a mindfulness- and skill-based health-promoting leadership intervention on supervisor and employee levels: A quasi-experimental multisite field study.

Acknowledging increasing demands for workforce health, new theoretical concepts of health-oriented leadership (HoL) have been introduced, emphasizing the supervisor's direct and explicit engagement in workplace health by focusing on their self- and staff-care. However, empirical evidence of the effectiveness of HoL interventions for supervisors and their staff is still scarce. We developed a mindfulness- and skill-based HoL intervention and investigated its effectiveness in a quasi-experimental multisite field study including supervisor and employee ratings from 12 German companies. A total of n = 117 supervisors and their employees (n = 744) completed assessments on mental distress and perceived HoL before and after the intervention as well as during the 3-month follow-up period. The intervention group was compared to a passive control cohort based on propensity score matching. Hierarchical linear models showed that the supervisors who had participated in the HoL intervention experienced a significantly larger decrease in mental distress and an increase in health-oriented self-care as well as staff-care than did their matched controls (g = 0.18-0.59). These results were confirmed by intent-to-treat analyses. The effect on supervisors' mental distress was mediated by an increase of their health-oriented self-care and moderated by the frequency of their mindfulness practice. No significant effects appeared between groups regarding outcomes at the employee level. Overall, these findings indicate how HoL can be effectively trained to increase supervisors' self- and staff-care and reduce their mental distress. Future research should explore additional moderator variables, linkages to established work stress models, and improvements of these interventions to increase their effectiveness for employees. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

In Their Best Interests

The international circulation of children requires a multiplicity of interventions. Adoptive flows must respect the ethical standards defined by the Hague Convention (1993) and be realized in the context of a drastic contraction of the migration of children for adoptive purposes. For a dozen years, the French government has been following a partially contradictory double imperative: the moral respect of universal principles enacted by international treaties, and the political maintenance of France among the adoptive “great nations” that are able to favor its nationals. Based on a multi-site field study, this contribution aims to shed light on the architecture, discourse, and actions of these “adoptive public agents.” Drawing on interviews and observations conducted in France and abroad, this article describes how bureaucrats act in practice to create French adoptive families, at the blurred and troubled intersection between the promotion of universal children’s rights and the favoring of French national interests.

“Being Chinese Means Becoming Cheap Labour”: Education, National Belonging and Social Positionality among Youth in Contemporary China

AbstractSince the 1990s, the Chinese party-state has attempted to teach its youth how to think and speak about the nation through a “patriotic education” campaign waged in schools, the media and on public sites. The reception of these messages by youth of different social backgrounds remains a disputed issue, however. Drawing on a multi-sited field study conducted among rural and urban Han Chinese youth attending different types of schools, this article explores the effects of the patriotic education campaign on youth conceptions of the nation by examining the rhetoric high-school students employ when asked to reflect upon their nation. The study reveals that a majority of youth statements conform to the language and contents of the patriotic education campaign; however, there are significant differences in the discursive stances of urban youth and rural youth and of those attending academic and non-academic, vocational schools. These findings call into question the party-state's current vision of China as a “unified” national collectivity. They highlight the existence of variances in the sense of collective belonging and national identity of Chinese youth, while underscoring the importance of social positioning and perceived life chances in producing these variances.

Oral bait preferences for rabies vaccination in free-ranging black-backed jackal (Canis mesomelas) and non-target species in a multi-site field study in a peri-urban protected area in South Africa

Black-backed jackals (Canis mesomelas) are small meso-predators that occur in the wild and around cities and towns in southern Africa and have been associated with the spread of rabies in South Africa. Oral bait rabies vaccine has been used in Europe and the USA for the control of rabies in reservoir species. The effectiveness of an oral vaccination strategy depends not only on the efficacy of the vaccine but on the uptake of the bait in the target species. This study evaluated factors associated with the uptake of oral bait by free ranging jackal and other wildlife species in a multi-site field study in Gauteng Province, South Africa. Three different baits were offered: commercial fishmeal polymer, pieces of red meat and chicken heads. Bait uptake was observed using camera traps and patterns of uptake assessed by multiple correspondence analysis and Cox proportional hazards models. In general, all the baits were well accepted with an uptake of 91%. Median consumption time of bait for jackal was 18 h (IQR: 8−21 hours; range 7−66 hours) and for all other species it was 21 h (IQR: 4–44, range 1–283). In species other than jackals there was a faster uptake in the winter months when less food was available, and the vegetation was sparse, whereas jackal showed no seasonal preference. Jackal consumed 20% of baits placed and took all three bait types but showed a clear preference for chicken heads if available (Hazard ratio (HR) = 3.41; 95%CI: 1.16–9.99; p = 0.025). Species other than carnivores preferred fishmeal polymer or red meat. Jackals showed no preference for time of day whereas herbivores and other species clearly preferred day; other carnivores preferred either day or night but not both, depending upon species. This study showed that chicken heads may be the preferred bait type for oral vaccination of black-backed jackal in this area, and that consideration should be given to placing bait during summer and at dusk, in order to minimize uptake by non-target species.

Effects and potential of water-saving irrigation for rice production in China

Water-saving irrigation (WSI) is a promising management practice for sustainable rice production. Shallow-wet irrigation (SWI), controlled irrigation (CI), intermittent irrigation (II), and rain-gathering irrigation (RGI) are four common WSI regimes used in China. Their water saving, pollutant reducing, and yield increasing effects were analysed based on literature survey from multi-site field studies across China. An index system considering the applicability and effect of different WSI regimes was developed to identify their potential distributions across China. The potential overall effect of WSI practices at the country level was then estimated. Results showed that CI had the highest average water saving rate (WSR) of 35.12% and the highest average pollutant reducing rate (PRR) of 54.97%, followed by RGI, SWI, and II; while CI had the lowest average yield increasing rate (YIR) (0.79%), followed by II (5.40%), SWI (8.12%), and RGI (11.80%). Overall, the larger the WSR, the larger higher PRR; but the yield increasing effect will be diminished when the WSR is increased to a certain extent due to the resulting rice water stress. About 94.19% of the total paddy area in China are suitable for WSI practices and the unsuitable ones are mainly due to soil structure deterioration and low soil fertility. SWI is the most applicable WSI regime, suitable for 90.03% of paddy fields, followed by CI and II (23.33%), and RGI (4.16%). By full implementation of appropriate WSI regimes at the country level, the total WSR, PRR, and YIR are likely to reach 22.06–26.41%, 32.11–39.11%, and 5.39–6.87%, respectively. The application of WSI practices in China has noticeable potential to alleviate water shortage and non-point source pollution while ensuring high yield.

Introducing a Fragmentation Perspective on Coordination in Crisis Management

Coordination theories are characterized primarily by a focus on integration, in which coordination is aimed at achieving a coherent and unified set of actions. However, in the extreme settings in which fast-response organizations operate, achieving integration is often challenging. In this study we employ a fragmentation perspective to show that dealing with ambiguity and discontinuity is not only inevitable for these organizations, it is a key characteristic of coordinating. We undertook an inductive, qualitative field study on how officers in command from the fire department, medical services, and police coordinate during emergency response operations. Our data are based on a four-year multi-site field study of 40 emergency management exercises in the Netherlands, combined with 56 retrospective interviews. Our inductive analysis of this data shows that officers use three coordination practices to deal with ambiguity and discontinuity: working around procedures, delegating tasks, and demarcating expertise. We theorize our findings by showing how these practices lead to conditions in which fragmentation can become an effective method of coordination. In doing so, we provide a more complete understanding of the process of coordinating in fast-response settings that will benefit both crisis management practice and organizational theory.

Do the hospital rooms make a difference for patients’ stress? A multilevel analysis of the role of perceived control, positive distraction, and social support

The physical environment of healthcare settings can contribute to preventing or reducing patients' stress. Using Ulrich's theory of supportive design (1991), this study tested whether this relationship occurs because the physical environment promotes perceptions of control, positive distractions, and social support. The research disentangles the contribution of the objective qualities of physical environment to stress, over and above patients' perceptions about the environment. In a multi-site field study (five hospital units from two countries), 57 hospital rooms were assessed in terms of the number of favorable design features, and 187 patients responded to a questionnaire after surgery. Multilevel regression analysis showed that the greater the number of favorable design features, the less the patients' stress, that positive perceptions about the room qualities in terms of how much social support and distraction they provide explain this effect, and that the relative importance of these dimensions may differ between cultures.

Who gets involved with what? A discourse analysis of gender and caregiving in everyday family life with depression

The recent process of deinstitutionalization of the psychiatric treatment system, in both Denmark and other European countries, has relied heavily on the involvement in treatment and recovery of cohabitant relatives of diagnosed people. However, political objectives regarding depression and involvement rely on a limited body of knowledge about people’s ways of managing illness-related problems in everyday life. Drawing on a discursive notion of gender laid out by Raewyn Connell, the aim of the article is to elucidate how the involvement of relatives is guided by an extra- individual rationale about gender and caregiving, and how this gendered discourse might frame different challenges and burdens, depending on the gender of the diagnosed person and the cohabitant relative. Drawn from a larger, multisited field study on involvement processes in Danish psychiatry, the article is based on field notes and 21 interviews with seven heterosexual couples. The analysis shows that gender works as a decisive premise for the division of caregiving labour among the couples, and clarifies how the couples’ gendered institution is disrupted after the onset of depression. The article argues that gender-blind involvement strategies could produce divergent treatment outcomes and varying social effects in relation to couples’ everyday family lives.

Who and What Does Involvement Involve? A Multi-Sited Field Study of Involvement of Relatives in Danish Psychiatry

This article gives an account of aspects of a multi-sited field study of involvement of relatives in Danish psychiatry. By following metaphors of involvement across three sites of the psychiatric system—a family site, a clinical site and a policy site—the first author (J.O.) investigated how, and on what grounds, involvement of relatives is perceived in Danish psychiatry. Paradoxically, the current understanding of involvement of relatives fails to take into consideration the perspectives of the relatives per se and families that were being studied. By analyzing involvement from a discourse theoretical perspective laid out by Ernesto Laclau and Chantal Mouffe, the aim of this study is to show how the dominant discourse about involvement at the political and clinical sites is constituted by understandings of mentally ill individuals and by political objectives of involvement. The analysis elucidates how a psycho-ideological discourse positions the mentally ill person as weak, incapable, and ineffective. By contrast, the supporting relative is positioned as a strong, capable, and effective co-therapist. Furthermore, the analysis considers how this dominant discourse of involvement is constituted by a broader discourse of neoliberalism and market orientation, which justifies involvement as a subtle institutionalization of social control. The article highlights that the role of the relative as a co-therapist may be contested by the families’ discourse, which emphasizes issues concerning the responsibility toward the mental health of the ill individual as well as toward the psychological milieu of the family.

A multi-site clinical field study to evaluate the effectiveness of manual cleaning for flexible gastrointestinal endoscopes

An ATP bioluminesce assay (ATP Water Test), measuring organic bioburden including microbes, was used to monitor the cleanliness of flexible GI endoscopes after the manual cleaning step of the decontamination and disinfection process, in seven US hospitals.

The Politics of Mental Illness and Involvement—<i>A Discourse Analysis of Danish Anti-Stigma and Social Inclusion Campaigns</i>

The present study is a part of a broader multisited field study on involvement of relatives in Danish psychiatry. The article aims to elucidate which political classifications of normality and mental illness that are displayed in two health political campaigns regarding anti-stigmatization and social inclusion and how such classifications co-constitute the subjectivity of individuals suffering from mental illness and their relatives. Drawing on a discourse theoretical perspective laid out by political theorists Laclau and Mouffe, we analyze how the campaigns bring into effect a weak and ineffective subject of deviance and how it is constituted by a subject of normality characterized by opposing traits. The article takes up the discussion of how the campaigns’ articulations of the subjects of normality and deviance are imbedded in a hegemonic discourse of neoliberalism and individualism that asserts involvement as an expanded division of responsibility for the identification, classification and regulation of mentally ill subjects between public and private spheres of the Danish welfare state.

Food-branding places – A sensory perspective

This article takes as its starting point the observation that food, meals and gastronomy are frequently used in the branding of places. The knowledge of how and why this takes place is, however, rather limited, and the aim of this article is thus to identify and describe the role of food, meals and gastronomy in the direct and indirect branding of places. The article contains three main sections, where the first is a clarification of key concepts and the methodology applied. The second part is an account of the ways in which food is used in branding places, based on the observations we have made as part of a multisite field study of large metropolitan cities. The third part of the article is a tentative and illustrated conceptual framework, based on the assumption that places can be seen as sensescapes. Food, meals and gastronomy contribute to the spatial configuration (sensory topography), time-space flow (orchestration) and iconography (sensory mapping) of these place-sensescapes. The conclusion of the article is that the character of a place does not only affect the experience of food and gastronomy in that place, but also that food and gastronomy is – directly and indirectly – affecting the character of the place and its brand-image.

Model-Based Tolerance Intervals Derived from Cumulative Historical Composition Data: Application for Substantial Equivalence Assessment of a Genetically Modified Crop

Compositional analysis is a requisite component of the substantial equivalence framework utilized to assess genetically modified (GM) crop safety. Statistical differences in composition data between GM and non-GM crops require a context in which to determine biological relevance. This context is provided by surveying the natural variation of key nutrient and antinutrient levels within the crop population with a history of safe use. Data accumulated from various genotypes with a history of safe use cultivated in relevant commercial crop-growing environments over multiple seasons are discussed as the appropriate data representative of this natural variation. A model-based parametric tolerance interval approach, which accounts for the correlated and unbalanced data structure of cumulative historical data collected from multisite field studies conducted over multiple seasons, is presented. This paper promotes the application of this tolerance interval approach to generate reference ranges for evaluation of the biological relevance of statistical differences identified during substantial equivalence assessment of a GM crop.

The Maple Spring as the Background for the Flourishing of the Fifth Estate in Québec

The political disengagement of the Millennials has long been a subject of scholarly debate. Using ethnographic research methods, our lab conducted a multi-sited field study to investigate the digital practices of some of the community networks that have emerged or consolidated since the Maple Spring. Our field findings suggest that the Millennial student protesters – alongside citizens from all generations who have lent them their support – have actively engaged in their own forms of political participation and by doing so, have helped to firmly entrench the Fifth Estate in Québec society. In particular, we have found that these grassroots networks might have expanded Québec’s alternative press by using interactive technologies to self-publish, self-represent and self-document issues that are of great concern to them and have typically not been topics up for debate on the public agenda. Our analysis brings to the fore the fraught relationship between the Fifth Estate and the four traditional democratic institutions.

The relationship between N isotopic fractionation within soybean and N2 fixation during soybean development

The contribution of N(2) fixation to overall soybean N uptake has most commonly been quantified by N isotope-based methods, which rely on isotopic differences in plant N between legumes and non-fixing reference plants. The choice of non-fixing reference plants is critical for the accuracy of isotope-based methods, and mismatched reference plants remain a potential source of error. Accurate estimates of soybean N(2) fixation also require information on N isotopic fractionation within soybean. On the basis of a previous observation of a close correlation between an expression of N fractionation within soybean and the proportion of plant N derived from atmosphere (%Ndfa) determined by (15) N natural abundance, this field study aimed at assessing the relationship between various expressions describing intraplant (15) N or N partitioning and %Ndfa during soybean development. Starting from a late vegetative stage until beginning senescence, the N content and N isotopic composition of shoots, roots and nodules of nodulated and non-nodulated soybeans was determined at eight different developmental stages. Regression analysis showed that %Ndfa most closely correlated with the difference in the N isotopic composition of shoot N minus that of root including nodule N, and that this relationship was similar to that obtained in a previous multi-site field study. We therefore consider this expression to hold promise as a means of quantifying %Ndfa independent of a reference plant, which would avoid some of the external sources of error introduced by the use of reference plants in determining %Ndfa.

Political performance, boundary spaces, and active spectatorship: Media production at the 2012 Democratic National Convention

We present the results of a 5-day, observation and interview-based, multi-sited field study of the 2012 Democratic National Convention. We combine literatures on journalistic and political fields with scholarship on performance theory to provide a framework for understanding conventions as contemporary media events. Through analysis of field notes, photographic documentation, and interview data, we detail the layered production of performance in the journalistic and political fields, revealing how performances were directed both internally and across fields for strategic advantage, as well as for co-present spectators and the public at-large. We argue that conventions provide ‘boundary spaces’ where actors from different fields gather and perform distinct democratic roles, as well as mediated, integrative spaces for the polity. Media events provide occasions for networked practices of ‘active spectatorship’ that offer citizens a means of control over the publicity of elites.

A grey-based DEMATEL model for evaluating business process management critical success factors

Although business process management (BPM) is an important organizational practice for improving operational competitiveness of organizations, research has shown that as many as 60–80% of BPM initiatives are unsuccessful. This study provides a methodology to evaluate BPM implementation critical success factors (CSFs) that can aid project managers make proper BPM investment strategies. Through a review of the literature, eight CSFs for the successful implementation of BPM are identified. To help advance research on the implementation of BPM, this paper uses multi-site field study data with a novel grey-based DEMATEL (the decision making trial and evaluation laboratory) approach to visualize the structure of complicated causal relationships between these CSFs and obtain the influence level of these factors. The field study data uses three Chinese manufacturers as the setting. The four most important factors found in the field study, from amongst the identified CSFs, include Strategic alignment, Top management support, Project management and a Collaborative environment. We also found a number of direct and indirect relationships amongst the CSF factors. Insights into the application of the technique and results from both a research and managerial perspective are presented. Aggregate analysis for the methodology and future research directions are also introduced in the final section.