Generic professional capabilities hub: developing leadership and management skills in trainees.

High quality leadership is key to delivering high standards of patient care. For many reasons, doctors in training are not currently well represented in leadership positions and struggle to access opportunities to develop these skills. As a key cohort within the medical workforce, using existing present opportunities within clinical training programmes would allow them to engage in leadership development and support them to lead on projects within their trusts and make sustainable changes within their own organisation.Within our anaesthetic department, we designed the Generic Professional Capabilities Hub (GPC hub)-a framework that aims to address some of the barriers to engagement in clinical leadership. Involvement in the GPC hub can be at three different levels, which allows for flexibility around other training needs. Currently, there are seven workstreams within the framework, with trainees being involved through symposia attendance, leading on projects linked to the hub or becoming a trainee workstream lead. We share our learning from setting up this framework, the benefits it brings to trainees and departments, initial evaluation results and our next steps which include regional roll out to four other anaesthetic departments.

Perspectives of agriculture, nutrition and health researchers regarding research governance in Malawi. Using a leadership, ethics, governance and systems framework.

BACKGROUND: Research ethics is intertwined with and depends on building robust and responsive research governance systems alongside researchers. Globally there has been substantial investment in agriculture, nutrition, and health (ANH) research motivated by the need to improve health outcomes, such as micronutrient deficiencies in Sub-Saharan Africa. Although there has been a notable focus on ethical issues inherent in ANH studies, there has been scanty research examining researchers' attitudes related to ANH research. This study was conducted to explore the perspectives of researchers who conducted an agronomic biofortification study in Malawi. METHODOLOGY: In-depth interviews were conducted with a purposive sample of ten ANH researchers. Interviews were conducted online via Zoom, audio-recorded, transcribed verbatim, and thematically analysed using the Leadership, Ethics, Governance and Systems Framework. RESULTS: Four core aspects emerged: Leadership: The relevance of building ethics leadership and ethical competence among researchers. ETHICS: There is a need to develop a framework that operationalises core ethical values that can guide the implementation of ANH research. Governance: Research guidelines were perceived to be too generic to guide ANH research. Systems: Researchers' recommended the establishment of a specialised ANH research ethics committee. CONCLUSIONS: The findings highlight the significance of building ethics leadership and supporting ethical competency amongst researchers. Researchers recommended the development of tailored approaches rather than utilising generic governance systems and frameworks that are drawn from medical research and thus not fit for purpose in this field. In Malawi, specialised ethics review committees are needed to guide ANH research.

Standard setting Very Short Answer Questions (VSAQs) relative to Single Best Answer Questions (SBAQs): does having access to the answers make a difference?

BACKGROUND: We investigated whether question format and access to the correct answers affect the pass mark set by standard-setters on written examinations. METHODS: Trained educators used the Angoff method to standard set two 50-item tests with identical vignettes, one in a single best answer question (SBAQ) format (with five answer options) and the other in a very short answer question (VSAQ) format (requiring free text responses). Half the participants had access to the correct answers and half did not. The data for each group were analysed to determine if the question format or having access to the answers affected the pass mark set. RESULTS: A lower pass mark was set for the VSAQ test than the SBAQ test by the standard setters who had access to the answers (median difference of 13.85 percentage points, Z = -2.82, p = 0.002). Comparable pass marks were set for the SBAQ test by standard setters with and without access to the correct answers (60.65% and 60.90% respectively). A lower pass mark was set for the VSAQ test when participants had access to the correct answers (difference in medians -13.75 percentage points, Z = 2.46, p = 0.014). CONCLUSIONS: When given access to the potential correct answers, standard setters appear to appreciate the increased difficulty of VSAQs compared to SBAQs.

Operationalising a real-time research ethics approach: supporting ethical mindfulness in agriculture-nutrition-health research in Malawi.

BACKGROUND: There have been notable investments in large multi-partner research programmes across the agriculture-nutrition-health (ANH) nexus. These studies often involve human participants and commonly require research ethics review. These ANH studies are complex and can raise ethical issues that need pre-field work, ethical oversight and also need an embedded process that can identify, characterise and manage ethical issues as the research work develops, as such more embedded and dynamic ethics processes are needed. This work builds on notions of 'ethics in practice' by developing an approach to facilitate ethical reflection within large research programmes. This study explores the application of a novel 'real-time research ethics approach' (RTREA) and how this can support ethical mindfulness. This involves embedding ethical analysis and decision-making within research implementation, with a continuous dialogue between participants and researchers. The aim is to improve ethical responsiveness and participant experience, which in turn may ethically support adherence and retention. In this case study, a bioethics team (BT) was embedded in a community-based randomised, controlled trial conducted in rural Malawi, titled the 'Addressing Hidden Hunger with Agronomy'. To identify ethical issues, the researchers conducted ten focus group discussions, fourteen in-depth interviews with key informants, two workshops, observed two sensitisation and three activity meetings conducted by the trial team, and analysed fifteen reports from pre-trial to trial implementation. RESULTS: The RTREA facilitated the identification of social and ethical concerns and made researchers aware of participants' 'lived research experience'. To address concerns and experiences, the BT worked with researchers to facilitate conversation spaces where social and ethical issues were discussed. Conversation spaces were designed to create partnerships and promote participatory methods to capture trial participants' (TPs) perspectives and experiences. CONCLUSIONS: The use of RTREA showed the value of real-time and continuous engagement between TPs and researchers. These real-time processes could be embedded to complement traditional ethical guidance and expert opinions. A deeper engagement appeared to support greater operationalising of principles of inclusion, empowerment, and participant autonomy and supported researchers 'ethical mindfulness' which in turn may support instrumental outcomes of high recruitment, retention, and adherence levels.

BLANKETS: a toasty tool to improve social history documentation for our older patients.

A thorough social history is an important component of all medical clerkings and is particularly crucial when admitting an older patient. Standards exist to guide the social history content but are rarely referenced in practice. This quality improvement project conceived and implemented the novel BLANKETS (Bladder and bowels, Legal arrangements, Activities of daily living, Neurology (cognition), Kit (dentures, hearing or visual aids), EtOH and smoking, Trips, walking aids and exercise tolerance, Setup at home) tool for social history documentation, derived from existing standards, at a specialist medical inpatient hospital setting. Over a 15-week period with two cycles of intervention involving 125 patients in total, there was good staff engagement and overall improvement in social history documentation with 194/403 (48.1%) vs 199/545 (36.5%) criteria met overall and on average 6.3/13 vs 4.7/13 criteria documented for each patient. The social history BLANKETS tool is a memorable acronym to prompt clerking doctors to take a thorough and focused social history which is intrinsic to determining appropriate rehabilitation goals for effective discharge planning and setting appropriate ceiling of care decisions.

Examining study participants' decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi.

BACKGROUND: The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants' motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi. METHODS: We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation. FINDINGS: The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role. CONCLUSION: These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants' concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants' needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups. TRIAL REGISTRATION: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451).

Preparing for a community-based agriculture-to-nutrition trial in rural Malawi: formative research to assess feasibility and inform design and implementation decisions.

BACKGROUND: This study reports findings from formative research conducted to assess the feasibility and inform the design and implementation of the Addressing Hidden Hunger with Agronomy (AHHA) trial. The AHHA trial was a randomised, controlled trial conducted in rural Malawi, in which participants were given maize flour biofortified with selenium or control flour not biofortified with selenium for a period of 10 weeks, after which blood samples were taken to measure selenium status. METHODS: Formative research was conducted in villages near to the AHHA trial study site 1 year before the planned intervention. A short questionnaire with adult women (n = 50), focus group discussions with male (n groups = 3) and female (n groups = 3) community members, and in-depth key informant interviews (n = 7) were conducted to understand community practices and perceptions. FINDINGS: Meals were typically cooked and eaten at home in this community, while participants reported that maize flour would be less readily sold than maize grain - important considerations for the design of the trial. Regarding intervention delivery, we identified potential concerns around effects on fertility, links between blood sampling and witchcraft, and the potential for social stigma if community members considered participants lazy for receiving free flour. Participants reported that involvement of the Malawi government partners including health extension workers would increase trust. INTERPRETATION: Following the formative research, the AHHA trial appeared feasible. However, community sensitisation would be essential to address potential fears and concerns; effective sensitisation would support recruitment and treatment adherence, and would protect the safety and wellbeing of participants and researchers. People in positions of authority and trust including village headmen, religious leaders, health and agriculture extension workers, and community care groups should be involved in community sensitisation.

Telling their own stories: Encouraging veterinary students to ethically reflect.

BACKGROUND: Veterinary practice raises complex and unique professional ethical dilemmas. There is increasing discussion of how best to deliver ethics education to veterinary students, so that they are fully prepared to address ethical conflicts in professional practice. This paper proposes the use of innovative methods to allow students to share and reflect on their own experiences of ethical dilemmas. METHODS: Two innovations are described. The first is formal and compulsory, and involves a small-group facilitated session for final year students, wholly designed around student dilemmas. The second is informal and voluntary, and constitutes a short-story writing competition. RESULTS: The methods described are conducive to student engagement in ethics and ethical reflection. CONCLUSION: Veterinary schools should consider adopting student-led techniques, deliberately designed to allow students to tell their own stories. Similar methods could also be adapted for use in clinical practice, thereby creating opportunities for professional dialogue on ethical dilemmas.

Exploring the feasibility of using very short answer questions (VSAQs) in team-based learning (TBL).

BACKGROUND: Team-based learning (TBL) currently relies on single best answer questions (SBAQs) to provide immediate feedback. Very short answer questions (VSAQs) are a reliable and discriminatory alternative that encourage learners to use more authentic clinical reasoning strategies compared to SBAQs. However, the challenge of marking VSAQs has limited their integration into TBL; we therefore explored the feasibility of VSAQs within a TBL session. METHODS: An online platform was developed to allow immediate marking of VSAQs during the TBL sessions. As part of the readiness assurance process, students completed VSAQs and SBAQs, which were marked in real time. RESULTS: Instructors were able to mark all VSAQs during the individual readiness assurance test (iRAT), which facilitated the provision of immediate feedback during the team readiness assurance test (tRAT). The mean time to mark five VSAQs was 422 seconds (SD 73 seconds). For VSAQs, the number of attempts to reach the correct answer ranged from 1 to 38, compared to 1 to 4 for SBAQs. In total, 71.6% of students agreed that using VSAQs in TBL helped to emphasise group discussions. DISCUSSION: The wide range of attempts at, and students' perspectives of VSAQs are suggestive of their positive impact on student discussion during TBL. We demonstrate how new technology allows VSAQs to be feasibly integrated into TBL with the potential to enrich group discussions.

Biofortified Maize Improves Selenium Status of Women and Children in a Rural Community in Malawi: Results of the Addressing Hidden Hunger With Agronomy Randomized Controlled Trial.

Background: Selenium deficiency is widespread in the Malawi population. The selenium concentration in maize, the staple food crop of Malawi, can be increased by applying selenium-enriched fertilizers. It is unknown whether this strategy, called agronomic biofortification, is effective at alleviating selenium deficiency. Objectives: The aim of the Addressing Hidden Hunger with Agronomy (AHHA) trial was to determine whether consumption of maize flour, agronomically-biofortified with selenium, affected the serum selenium concentrations of women, and children in a rural community setting. Design: An individually-randomized, double-blind placebo-controlled trial was conducted in rural Malawi. Participants were randomly allocated in a 1:1 ratio to receive either intervention maize flour biofortified with selenium through application of selenium fertilizer, or control maize flour not biofortified with selenium. Participant households received enough flour to meet the typical consumption of all household members (330 g capita -1 day-1) for a period of 8 weeks. Baseline and endline serum selenium concentration (the primary outcome) was measured by inductively coupled plasma mass spectrometry (ICP-MS). Results: One woman of reproductive age (WRA) and one school-aged child (SAC) from each of 180 households were recruited and households were randomized to each group. The baseline demographic and socioeconomic status of participants were well-balanced between arms. No serious adverse events were reported. In the intervention arm, mean (standard deviation) serum selenium concentration increased over the intervention period from 57.6 (17.0) µg L-1 (n = 88) to 107.9 (16.4) µg L-1 (n = 88) among WRA and from 46.4 (14.8) µg L-1 (n = 86) to 97.1 (16.0) µg L-1 (n = 88) among SAC. There was no evidence of change in serum selenium concentration in the control groups. Conclusion: Consumption of maize flour biofortified through application of selenium-enriched fertilizer increased selenium status in this community providing strong proof of principle that agronomic biofortification could be an effective approach to address selenium deficiency in Malawi and similar settings. Clinical Trial Registration: http://www.isrctn.com/ISRCTN85899451, identifier: ISRCTN85899451.

Animal Research beyond the Laboratory: Report from a Workshop on Places Other than Licensed Establishments (POLEs) in the UK.

Research involving animals that occurs outside the laboratory raises an array of unique challenges. With regard to UK legislation, however, it receives only limited attention in terms of official guidelines, support, and statistics, which are unsurprisingly orientated towards the laboratory environment in which the majority of animal research takes place. In September 2019, four social scientists from the Animal Research Nexus program gathered together a group of 13 experts to discuss nonlaboratory research under the Animals (Scientific Procedures) Act (A(SP)A) of 1986 (mirroring European Union (EU) Directive 2010/63/EU), which is the primary mechanism for regulating animal research in the UK. Such nonlaboratory research under the A(SP)A often occurs at Places Other than Licensed Establishments (POLEs). The primary objective of the workshop was to assemble a diverse group with experience across a variety of POLEs (e.g., wildlife field sites, farms, fisheries, veterinary clinics, zoos) to explore the practical, ethical, and regulatory challenges of conducting research at POLEs. While consensus was not sought, nor reached on every point of discussion, we collectively identified five key areas that we propose require further discussion and attention. These relate to: (1) support and training; (2) ethical review; (3) cultures of care, particularly in nonregulated research outside of the laboratory; (4) the setting of boundaries; and (5) statistics and transparency. The workshop generated robust discussion and thereby highlighted the value of focusing on the unique challenges posed by POLEs, and the need for further opportunities for exchanging experiences and sharing best practice relating to research projects outside of the laboratory in the UK and elsewhere.

Is it just about grazing? UK citizens have diverse preferences for how dairy cows should be managed.

Conflicting views between the dairy industry and the public about how dairy cows should be managed, together with an increase in the availability of alternatives to dairy foods, challenge future markets for milk producers. Members of the public value animal welfare as well as naturalness and grazing, but neither the relative importance of specific aspects of management nor the diversity of views underlying these preferences have been established. To better understand these issues, 2,054 UK citizens recruited through a research panel took part in an online survey. They were asked to rank 17 attributes relating to dairy cow management and milk production through the novel application of best-worst scaling, a discrete choice methodology that allows a trade-off between items. Hierarchical Bayesian analysis of the results revealed 3 attributes of equal top importance: (1) access to grazing, (2) cow health and welfare, and (3) cow comfort. Alongside this overarching ranking, underlying differences in preferences were identified in 6 approximately equally sized citizen groups within the sample, which were identified through latent class analysis. Each latent class expressed significantly different priorities from the other, and each had different indicative sociodemographic, attitudinal, experiential, and value-oriented characteristics, as established through a multinomial logistic model. If the diversity of preference between the citizen groups found in the sample is reflected within wider populations, there may be opportunities for the dairy industry to improve communication about positive practices, develop new dairy product markets, and consider changes to dairy farming systems to better meet different citizens' needs. Furthermore, the defining characteristics and priorities of each group raise the question of whether grazing in particular, but also other attributes presented within the study, is understood in different ways by different subgroups of citizens.

Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial.

BACKGROUND: Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi. METHODS: A double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20-45 years) and 180 school-age children (SAC) (5-10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (µg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry. DISCUSSION: Findings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals. TRIAL REGISTRATION: The Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).

Informed consent in veterinary medicine: Ethical implications for the profession and the animal 'patient'.

Informed consent processes are a vital component of both human and veterinary medicine. Current practice encourages veterinarians to learn from insights in the human medical field about how best to achieve valid consent. However, drawing on published literature in veterinary and medical ethics, this paper identifies considerable differences between the purposes of veterinary and human medical consent. Crucially, it is argued that the legal status of animal patients as 'property' has implications for the ethical role of veterinary informed consent and the protection of the animal 'patient'. It is suggested that veterinary informed consent should be viewed as an ethical pivot point where the multiple responsibilities of a veterinary professional converge. In practice, balancing these responsibilities creates considerable ethical challenges. As an example, the paper discusses the renewed call for UK veterinarians to make animal welfare their first priority; we predict that this imperative may increasingly cause veterinary informed consent to become an ethical pressure point due to tensions caused by the often conflicting interests of animals, owners and the veterinary profession. In conclusion, the paper argues that whilst gaining informed consent can often be presented as a robust ethical justification in human medicine, the same cannot be said in veterinary medicine. If the veterinary profession wish to prioritise animal welfare, there is an urgent need to re-evaluate the nature of authority gained through owner informed consent and to consider whether animal patients might need to be better protected outside the consent process in certain circumstances.