Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.

BACKGROUND: The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24-48 h of their test result. METHODS: A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24-48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. RESULTS: Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. CONCLUSIONS: This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. TRIAL REGISTRATION: PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22 . 26/03/2020 ISRCTN registry: ISRCTN86534580 . 20/03/2020 REC number: 20/SC/058 IRAS number: 281958

Employability as sustainable balance of stakeholder expectations - towards a model for the health professions

The conceptual complexity of employability remains a barrier for its integration into discipline-based curricula. In the health professions, a particular challenge lies in integrating employability with the dominant paradigms of competency and professionalism. In this study, we explore these contextual challenges, and present the rationale and conceptual basis for a potential re-framing of employability within the context of this discipline group. We propose a novel definition and a conceptual model of employability better aligned to the needs of health professions. While employability has proven difficult to define broadly, it is framed around the expectations of both the employer and employee, thus may be viewed as a mutual transaction of expectations, which is most sustainable when all are optimally satisfied. Given that most work contexts involve multiple stakeholders, employability is defined here from an individual’s perspective as their capacity to sustainably satisfy the optimal balance of all stakeholder demands and expectations in a work context, including their own. We draw upon a scan of the literature and evidence from one health profession, veterinary science (including re-analysis of comments from a stakeholder survey), to inform a conceptual model of employability for these contexts. We propose employability is only partly comprised of skills and knowledge (human capital), and more of psychological capital spanning approaches to work, approaches to self, and approaches to others. The expectations underpinning employability are partly oriented to the work itself, and partly to the human interactions supporting it; partly to efficacy and partly to sustainability. These principles establish a matrix of five domains: effective practice, productive relationships, professional commitment, and psychological resources, plus a central element of reflective identity representing the fundamental growth process of self-awareness and identity formation. By this conception, employability is complementary to, but readily integrated with, outcomes frameworks such as competency and professionalism

Challenging identity: development of a measure of veterinary career motivations

BackgroundWhile little is known about the motivations underpinning veterinary work, previous literature has suggested that the main influences on veterinary career choice are early/formative exposure to animals or veterinary role models. The aim of this study was to develop and provisionally validate a veterinary career motivations questionnaire to assess the strength of various types of career motivations in graduating and experienced veterinarians.MethodsA cross-sectional sample of experienced veterinarians (n=305) and a smaller cohort of newly graduated veterinarians (n=53) were surveyed online using a long-form questionnaire. Exploratory factor analysis (EFA) was used to iteratively derive a final, short-form questionnaire for survey of a second cross-sectional sample of experienced veterinarians (n=751).ResultsEFA derived a final questionnaire with 22 items loading onto six factors (social purpose, animal orientation, vocational identity, challenge and learning, career affordances, and people orientation). While motivations based on animal orientation were predictably strong, those based on vocational identity were not universal and were weaker in younger and graduate veterinarians; both of these motivations were rated lower by male veterinarians. Motivations based on challenge and learning emerged as some of the strongest, most universal and most influential; people orientation and social purpose were also important, particularly for older veterinarians.ConclusionThe major motivations for pursuing a veterinary career may best be represented as an intrinsic passion for animal care and for learning through solving varied challenges. These motivations are largely intrinsically oriented and autonomously regulated, thus likely to be supportive of work satisfaction and wellbeing

Employability as a guiding outcome in veterinary education: Findings of the VetSet2Go Project

This paper presents a mini-review of employability as a guiding outcome in veterinary education—its conceptualisation, utility, core elements and dimensions, and pedagogical approaches—through a summary of the findings of a major international project with the same aims (the VetSet2Go project). Guided by a conception of the successful veterinary professional as one capable of navigating and sustainably balancing the (sometimes competing) needs and expectations of multiple stakeholders, the project integrated multiple sources of evidence to derive an employability framework representing the dimensions and capabilities most important to veterinary professional success. This framework provides a useful complement to those based in narrower views of competency and professionalism. One notable difference is its added emphasis on broad success outcomes of satisfaction and sustainability as well as task-oriented efficacy, thus inserting “the self” as a major stakeholder and bringing attention to resilience and sustainable well-being. The framework contains 18 key capabilities consistently identified as important to employability in the veterinary context, aligned to five broad, overlapping domains: veterinary capabilities (task-oriented work performance), effective relationships (approaches to others), professional commitment (approaches to work and the broader professional “mission”), psychological resources (approaches to self), plus a central process of reflective self-awareness and identity formation. A summary of evidence supporting these is presented, as well as recommendations for situating, developing, and accessing these as learning outcomes within veterinary curricula. Though developed within the specific context of veterinarian transition-to-practise, this framework would be readily adaptable to other professions, particularly in other health disciplines

Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments

Background The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24–48 h of their test result. Methods A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24–48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. Results Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. Conclusions This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. Trial registration PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22. 26/03/2020 ISRCTN registry: ISRCTN86534580. 20/03/2020 REC number: 20/SC/058 IRAS number: 28195

Dioxin- and POP-contaminated sites—contemporary and future relevance and challenges

Background, aim and scope Once they have been generated, polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans (PCDFs) and other persistent organic pollutants (POPs) can persist in soils and sediments and in waste repositories for periods extending from decades to centuries. In 1994, the US EPA concluded that contaminated sites and other reservoirs are likely to become the major source of contemporary pollution problems with these substances. With this in mind, this article is the first in a new series in ESPR under the title ‘Case Studies on Dioxin and POP Contaminated Sites—Contemporary and Future Relevance and Challenges’, which will address this important issue. The series will document various experiences from sites contaminated with PCDD/F and other POPs. This article provides an overview of the content of the articles comprising the series. In addition, it provides a review of the subject in its own right and identifies the key issues arising from dioxin/POP-contaminated sites. Additionally, it highlights the important conclusions that can be drawn from these examples. The key aim of this article and of the series as a whole is to provide a comprehensive overview of the types of PCDD/F contaminated sites that exist as a result of historical activities. It details the various processes whereby these sites became contaminated and attempts to evaluate their contemporary relevance as sources of PCDD/Fs and other POPs. It also details the various strategies used to assess these historical legacies of contamination and the concepts developed, or which are under development, to effect their remediation. Main features Special sessions on ‘Contaminated sites—Cases, remediation, risk and policy’ were held at the DIOXIN conferences in 2006 and 2007, and this theme will be continued at DIOXIN 2008 to be held in Birmingham. Selected cases from the approximately 70 contributions made to these sessions, together with some additional invited case studies are outlined together with the key issues they raise. By evaluating these cases and adding details of experiences published in the current literature, an overview will be given of the different features and challenges of dioxin and POP-contaminated sites. Results This article provides a systematic categorisation of types of PCDD/F and POP-contaminated sites. These are categorised according to the chemical or manufacturing process, which generated the PCDD/Fs or POPs and also includes the use and disposal aspects of the product life cycle in question. The highest historical PCDD/F and dioxin-like polychlorinated biphenyl (PCB) contamination burdens have arisen as a result of the production of chlorine and of chlorinated organic chemicals. In particular, the production of chlorinated pesticides, PCBs and the related contaminated waste streams are identified being responsible for historical releases of toxic equivalents (TEQs) at a scale of many tonnes. Along with such releases, major PCDD/F contaminated sites have been created through the application or improper disposal of contaminated pesticides, PCBs and other organochlorine chemicals, as well through the recycling of wastes and their attempted destruction. In some extreme examples, PCDD/F contaminated sites have also resulted from thermal processes such as waste incinerators, secondary metal industries or from the recycling or deposition of specific waste (e.g. electronic waste or car shredder wastes), which often contain chlorinated or brominated organic chemicals. The examples of PCDD/F and dioxin-like PCB contamination of fish in European rivers or the impact of contaminated sites upon fishing grounds and upon other food resources demonstrate the relevance of these historical problems to current and future human generations. Many of the recent food contamination problems that have emerged in Europe and elsewhere demonstrate how PCDD/F and dioxin like PCBs from historical sources can directly contaminate human and animal feedstuffs and indeed highlight their considerable contemporary relevance in this respect. Accordingly, some key experiences and lessons learnt regarding the production, use, disposal and remediation of POPs from the contaminated sites are summarised. Discussion An important criterion for evaluating the significance and risks of PCDD/Fs and other POPs at contaminated sites is their present or future potential for mobility. This, in turn, determines to a large degree their propensity for off-site transport and environmental accessibility. The detailed evaluation of contaminated site cases reveals different site-specific factors, which influence the varied pathways through which poor water-soluble POPs can be mobilised. Co-contaminants with greater water solubility are also typically present at such sites. Hence, pumping of groundwater (pump and treat) is often required in addition to attempting to physically secure a site. At an increasing number of contaminated sites, securing measures are failing after relatively short time spans compared to the time horizon, which applies to persistent organic pollutant contamination. Due to the immense costs and challenges associated with remediation of contaminated sites ‘monitored natural attenuation’ is increasingly gaining purchase as a conceptual remediation approach. However, these concepts may well prove limited in their practical application to contaminated sites containing persistent organic pollutants and other key pollutants like heavy metals. Conclusions It is inevitable, therefore, that dioxin/POP-contaminated sites will remain of contemporary and future relevance. They will continue to represent an environmental issue for future generations to address. The securing and/or remediation of dioxin/POP-contaminated sites is very costly, generally in the order of tens or hundreds of millions of dollars. Secured landfills and secured production sites need to be considered as constructions not made for ‘eternity’ but built for a finite time scale. Accordingly, they will need to be controlled, supervised and potentially repaired/renewed. Furthermore, the leachates and groundwater impacted by these sites will require ongoing monitoring and potential further remediation. These activities result in high maintenance costs, which are accrued for decades or centuries and should, therefore, be compared to the fully sustainable option of complete remediation. The contaminated site case studies highlight that, while extensive policies and established funds for remediation exist in most of the industrialised western countries, even these relatively well-regulated and wealthy countries face significant challenges in the implementation of a remediation strategy. This highlights the fact that ultimately only the prevention of contaminated sites represents a sustainable solution for the future and that the Polluter Pays Principle needs to be applied in a comprehensive way to current problems and those which may emerge in the future. Recommendations and perspectives With the continuing shift of industrial activities in developing and transition economies, which often have poor regulation (and weak self-regulation of industries), additional global challenges regarding POPs and other contaminated sites may be expected. In this respect, a comprehensive application of the “polluter pays principle” in these countries will also be a key to facilitate the clean-up of contaminated areas and the prevention of future contaminated sites. The threats and challenges of contaminated sites and the high costs of securing/remediating the problems highlight the need for a comprehensive approach based upon integrated pollution prevention and control. If applied to all polluting (and potentially polluting) industrial sectors around the globe, such an approach will prove to be both the cheapest and most sustainable way to underpin the development of industries in developing and transition economie