Enhancing involvement of people with multiple sclerosis in clinical trial design.

BACKGROUND: Although often overlooked, patient and public involvement (PPI) is vital when considering the design and delivery of complex and adaptive clinical trial designs for chronic health conditions such as multiple sclerosis (MS). METHODS: We conducted a rapid review to assess current status of PPI in the design and conduct of clinical trials in MS over the last 5 years. We provide a case study describing PPI in the development of a platform clinical trial in progressive MS. RESULTS: We identified only eight unique clinical trials that described PPI as part of articles or protocols; nearly, all were linked with funders who encourage or mandate PPI in health research. The OCTOPUS trial was co-designed with people affected by MS. They were central to every aspect from forming part of a governance group shaping the direction and strategy, to the working groups for treatment selection, trial design and delivery. They led the PPI strategy which enabled a more accessible, acceptable and inclusive design. CONCLUSION: Active, meaningful PPI in clinical trial design increases the quality and relevance of studies and the likelihood of impact for the patient community. We offer recommendations for enhancing PPI in future MS clinical trials.

The Cold Futures of Mouse Genetics: Modes of Strain Cryopreservation Since the 1970s.

Cryopreservation, or the freezing of embryos or sperm, has become a routine part of many research projects involving laboratory mice. In this article, we combine historical and sociological methods to produce a cryopolitical analysis of this less explored aspect of animal research. We provide a longitudinal account of mouse embryo and semen storage and uses in the UK and show that cryopreservation enabled researchers to overcome particular challenges-fears of strain loss, societal disapproval, and genetic drift-in ways which enabled the continued existence of strains and contributed to the scaling up of mouse research since World War II. We use the theoretical lens of cryopolitics to explore three different, yet overlapping, cryopolitical strategies that we identify. All share the ability to ensure the continued maintenance of genetically defined strains without the need for continually breeding colonies of mice. We argue that, in contrast to more common imaginaries of species conservation, the cryopolitical rationale can best be understood as purposefully not letting the strain die without requiring animals to live. The ability to freeze mice, then, had the potential to unsettle who the objects of care are in mouse research, from individual animals to the concept of the strain itself.

Laboratory animal strain mobilities: handling with care for animal sentience and biosecurity.

The global distribution of laboratory mouse strains is valued for ensuring the continuity, validity and accessibility of model organisms. Mouse strains are therefore assumed mobile and able to travel. We draw on the concept of 'animal mobilities' (Hodgetts and Lorimer 2019) to explain how attending to laboratory mice as living animal, commodity and scientific tool is shaping how they are transported through contemporary scientific infrastructures and communities. Our paper is framed around exploring how animal strains travel, rather than animals, as we show that it is only through understanding strain mobility that we can explain how and why live animal movement can be replaced by germinal products. The research is based on qualitative fieldwork in 2018 and 2019 that included 2 weeks ethnography and interviews with key informants involved in the movement of laboratory animals. The empirical analysis discusses practices that relate to managing biosecurity and animal welfare concerns when moving laboratory animal strains. In closing we reflect more broadly on the contemporary 'ethico-onto-epistemological' (Barad, 2014) entanglement that shapes who or what travels to support laboratory science data-making practices, and the intensity of care 'tinkering' practices (Mol and Law 2010) that facilitate the movement. We explain how a laboratory animal strain exceeds its value solely as a mobile and thus exchangeable commodity, illustrated in how values that relate to animal sentience and infection-risk supports its material transformation. Consequently, it is becoming increasingly common for non-sentient germinal products - embryos and gametes - to replace live sentient animals when being moved.

Animal research nexus: a new approach to the connections between science, health and animal welfare.

Animals used in biological research and testing have become integrated into the trajectories of modern biomedicine, generating increased expectations for and connections between human and animal health. Animal research also remains controversial and its acceptability is contingent on a complex network of relations and assurances across science and society, which are both formally constituted through law and informal or assumed. In this paper, we propose these entanglements can be studied through an approach that understands animal research as a nexus spanning the domains of science, health and animal welfare. We introduce this argument through, first, outlining some key challenges in UK debates around animal research, and second, reviewing the way nexus concepts have been used to connect issues in environmental research. Third, we explore how existing social sciences and humanities scholarship on animal research tends to focus on different aspects of the connections between scientific research, human health and animal welfare, which we suggest can be combined in a nexus approach. In the fourth section, we introduce our collaborative research on the animal research nexus, indicating how this approach can be used to study the history, governance and changing sensibilities around UK laboratory animal research. We suggest the attention to complex connections in nexus approaches can be enriched through conversations with the social sciences and medical humanities in ways that deepen appreciation of the importance of path-dependency and contingency, inclusion and exclusion in governance and the affective dimension to research. In conclusion, we reflect on the value of nexus thinking for developing research that is interdisciplinary, interactive and reflexive in understanding how accounts of the histories and current relations of animal research have significant implications for how scientific practices, policy debates and broad social contracts around animal research are being remade today.

The social aspects of genome editing: publics as stakeholders, populations and participants in animal research.

The application of genome editing to animal research connects to a wide variety of policy concerns and public conversations. We suggest focusing narrowly on public opinion of genome editing is to overlook the range of positions from which people are brought into relationships with animal research through these technologies. In this paper, we explore three key roles that publics are playing in the development of genome editing techniques applied to animals in biomedical research. First, publics are positioned by surveys and focus groups as stakeholders with opinions that matter to the development of research technologies. Learning lessons from controversies over genetically modified food in Europe, these methods are used to identify problems in science-society relations that need to be managed. Second, people are recruited into research projects through participating in biobanks and providing data, where their contributions are encouraged by appeals to the public good and maintained by public confidence. Thirdly, patients are increasingly taking positions within research governance, as lay reviewers on funding panels, where their expertise helps align research priorities and practices with public expectations of research. These plural publics do not easily aggregate into a simple or singular public opinion on genome editing. We conclude by suggesting more attention is needed to the multiple roles that different publics expect - and are expected - to play in the future development of genomic technologies.

Seed Banking as Cryopower: A Cryopolitical Account of the Work of the International Board of Plant Genetic Resources, 1973-1984.

The implications of freezing seeds to conserve genes statically and for the long term are complex and deserve further reflection to appreciate seed banking as an attempt to detach seeds from their life cycle. Here, I use a cryopolitical framework to explore this in the context of the activities of the International Board of Plant Genetic Resources (IBPGR) between 1973 and 1984. I suggest that the emergence of seed banks is a shift toward a cryopower mode of governance, where technoscientific intervention in the biology of seeds was presented as a means to manage the survival of seeds. The project of ex situ conservation is a socio-technical effort by international institutions such as IBPGR and a variety of institutions with seed repositories. In creating a coldscape, they sought to make genetic resources into frozen seeds that were stable and mobile, not only across space but, importantly, over time. Consequently, our interpretations of seed banks as sites of geopolitical significance in the controversies over access to seeds can be complemented by considering their biopolitical importance as interventions that extend the power of IBPGR and other institutions toward plant life, and the future.

Saving the gene pool for the future: Seed banks as archives.

Ensuring the salvage of future sources is a challenge for plant geneticists and breeders, as well as historians and archivists. Here, this suggestion is illustrated with an account of the emergence, in the mid-20th century, of seed banks. These repositories are intended to enable the conservation of the world's crop genetic diversity against the 'genetic erosion' of crops, an unintended consequence of the global uptake of new high-yielding Green Revolution agricultural varieties. Plant breeders and scientists advocated a strategy of freezing and long-term storage of seed which enabled the salvage of genetic diversity for future users without requiring the continual cultivation of old varieties: seed banking could preserve valuable genetic material and enable agricultural modernisation to proceed. This account of crop genetic conservation therefore shows how breeders and geneticists sought to create their own seed archives from whence the evolutionary history of crops could be made accessible in ways that are useful for the future. This analysis suggests that conservation practices are informed by ideas about the future use of material, indicating that there is value in exploring concurrently the archival and historiographical issues relating to the biomolecular big biosciences.

Processo de transição para uma posição de liderança: um estudo com mulheres / Transitioning process to an organizational leardership position: a study with women

Parecem ser vários os desafios, emoções e constrangimentos com os quais as mulheres se deparam para alcançarem posições de liderança nas organizações. Nesse seguimento, este estudo tem como objetivos descrever o processo de transição de mulheres para uma posição de liderança em contexto organizacional e as representações de jovens mulheres sobre o mesmo. De forma a concretizar os objetivos definidos foram realizados dois estudos. O estudo 1 recorreu a entrevistas semiestruturadas a mulheres que viveram recentemente o processo de transição. No estudo 2 aplicou-se um questionário com perguntas abertas a 30 jovens mulheres universitárias. Os dados foram sujeitos a análise de conteúdo categorial. Os resultados permitiram identificar três fases no processo de transição para uma posição de liderança - Aprendizagem, Autonomização e Consolidação. Permitiu ainda identificar que ao longo do processo de transição as mulheres experienciam dificuldades a nível do assumir as novas funções, obter reconhecimento do papel de líder e mudanças nas relações. As representações das jovens mulheres vão ao encontro das vivências das mulheres, revelando-se conscientes do papel dos estereótipos de gênero na liderança feminina.

Women face challenges and constraints in reaching leadership positions in organizations. This research aims to describe the process of transition of women to a leadership position in an organizational context and the representations of young women regarding that process. In order to achieve this, two studies were conducted. Study 1 used semi-structured interviews with women who recently experienced the transition process. In study 2, a questionnaire with open questions was applied to 30 young university women. Data were subjected to categorical content analysis. The results allowed us to identify three phases in the process of transition to a leadership position - Learning, Empowerment and Consolidation. It was also identified that throughout the transition process women experience difficulties assuming the new role, gaining recognition of the leading role and changes in relationships. Representations of young women meet these women's experiences and we see they are aware of the role of gender stereotypes in female leadership.

Avaliação de adultos com dificuldades de leitura / Evaluation of adults with reading difficulties

Considerando a necessidade de instrumentos para a avaliação de adultos com dificuldades de leitura, o objetivo do presente estudo é comparar o desempenho de indivíduos com e sem queixas de dificuldades de leitura, por meio de instrumentos que avaliam as habilidades fonológicas, de leitura e de escrita. Por esta análise, verificar quais destes instrumentos se mostraram mais sensíveis na comparação entre o grupo com e sem dificuldade de leitura. Participaram da pesquisa 10 indivíduos sem dificuldades de leitura e 20 indivíduos com dificuldades, com idades entre 17 e 48 anos. Foram avaliadas as habilidades de leitura, de escrita e as habilidades fonológicas. Os resultados mostraram desempenhos significativamente piores pelo grupo com dificuldades na nomeação automatizada rápida de objetos e letras, memória de trabalho, consciência fonológica, ortografia, velocidade de leitura e compreensão no teste cloze. Assim como visto na literatura, os testes que melhor diferenciam indivíduos com e sem dificuldades de leitura são os que avaliam as habilidades de leitura, de escrita, consciência fonológica, nomeação automatizada rápida e memória de trabalho.

Considering the necessity of instruments to evaluate adults with reading difficulties, the aim of this paper is to compare the performance of individuals with and without reading disabilities complaints, by instruments that evaluate the phonological, reading and writing skills. Through this analysis, the objective is to verify which of these instruments were more sensitive in the comparison between the group with and without reading difficulties. The participants were 10 individuals without reading prejudices and 20 individuals with reading prejudices, aged between 17 and 48 years. Reading, writing and phonological skills were evaluated. The results showed significantly worse performance by the group with difficulties in rapid automatized naming on objects and letters, working memory, phonological awareness, orthography, reading speed and comprehension on cloze procedure. As seen in the literature, tests that differentiate individuals with and without reading difficulties are tests to measure reading skills, writing, phonological awareness, rapid automatized naming and working memory.