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Background: Patient and public involvement (PPI) is a critical priority in research, policy, academia and advocacy organizations. PPI in dementia research is gaining momentum. However, these efforts are missing in international projects aimed at those living with advanced dementia in long‐term care (LTC) homes. Additional complexities can arise in enacting PPI within the context of integration of a palliative approach to care and experiences around end‐of‐life in (EOL) dementia. The mySupport study involved implementing the Family Carer Decision Support (FCDS) intervention for care partners of those living with advanced dementia in LTC in six countries. Research Design and Objective: An interpretive description study was conducted to explore the perspectives of international researchers from six countries on engaging people with lived experiences of dementia and EOL care in research processes. The findings from this study informed the development of a PPI strategy and a subsequent toolkit for the FCDS intervention. Findings: Thirty‐eight interviews were completed with project researchers: 12 from the United Kingdom, 8 from Canada, 7 from Ireland, 4 each from Italy and The Netherlands and 3 from the Czech Republic. Four broad themes describe international researchers' perspectives on advancing methods of engagement for people with lived experiences of dementia and EOL in international PPI activities: (1) Groundwork to engage in research; (2) planning for research activities is key; (3) focus on meaningful engagement and (4) having foresight for practical issues shaping PPI. Discussion and Implications: International projects that involve PPI can present many sources of challenges. The findings in this study highlight important considerations for foundational work for incorporating PPI in international projects. Learning from world leaders and those with lived experiences in various regions can be insightful and help share tools and resources. Patient or Public Contribution: PPI was envisioned as a critical part of conducting the mySupport study. The findings from this study informed the development of a PPI strategy and an international Strategic Guiding Council that included family carers of those living with advanced dementia in LTC homes in six countries. This manuscript focused on the perspectives of researchers on their engagement with people with lived experiences of dementia and EOL. The perspectives of persons with lived experiences on engaging in the mySupport research study will be reported in a forthcoming manuscript. [ABSTRACT FROM AUTHOR]

Background: PROs are valuable tools in clinical care to capture patients' perspectives of their health, symptoms and quality of life. However the COVID-19 pandemic has had profound impacts on all aspects of life, in particular healthcare and research. This study explores the views of UK and Irish health professionals, third sector and pharmaceutical industry representatives and academic researchers on the impact of COVID-19 on PRO collection, use and development in clinical practice. Methods: A volunteer sample took part in a 10 question cross sectional qualitative survey, on the impact of COVID-19, administered online via Qualtrics. Demographic data was descriptively analysed, and the qualitative free text response data was subject to thematic analysis and summarised within the Strengths, Weaknesses, Opportunities and Threats (SWOT) framework. Results: Forty nine participants took part located in a range of UK settings and professions. Participants highlighted staff strengths during the pandemic including colleagues' flexibility and ability to work collaboratively and the adoption of novel communication tools. Weaknesses were a lack of staff capacity to continue or start PRO projects and insufficient digital infrastructure to continue studies online. Opportunities included the added interest in PROs as useful outcomes, the value of electronic PROs for staff and patients particularly in relation to integration into systems and the electronic patient records. However, these opportunities came with an understanding that digital exclusion may be an issue for patient groups. Threats identified included that the majority of PRO research was stopped or delayed and funding streams were cut. Conclusions: Although most PRO research was on hold during the pandemic, the consensus from participants was that PROs as meaningful outcomes were valued more than ever. From the opportunities afforded by the pandemic the development of electronic PROs and their integration into electronic patient record systems and clinical practice could be a lasting legacy from the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Currently in the UK and Ireland, after a hip fracture most patients do not receive bone protection medication to reduce the risk of refracture. Yet randomised controlled trial data specifically examining patients with hip fracture have shown that intravenous zoledronate reduces refracture risk by a third. Despite this evidence, use of intravenous zoledronate is highly variable following a hip fracture; many hospitals are providing this treatment, whilst most are currently not. A range of clinical uncertainties, doubts over the evidence base and practical concerns are cited as reasons. This paper discusses these concerns and provides guidance from expert consensus, aiming to assist orthogeriatricians, pharmacists and health services managers establish local protocols to deliver this highly clinically and cost-effective treatment to patients before they leave hospital, in order to reduce costly re-fractures in this frail population. [ABSTRACT FROM AUTHOR]

Background A major shift in treatment of appendicitis occurred early in the SARS-CoV-2 pandemic with non-operative management used commonly outside research protocols and in units with limited previous experience. This study aims to compare real-world outcomes of surgery versus non-operative management of uncomplicated appendicitis in children with 1-year follow-up. Method A prospective multicentre observational study of children treated for uncomplicated appendicitis at 74 hospitals in the UK and Ireland from 1 April to 31 July 2020 was performed. Propensity-score matched analysis was conducted using age, sex, C-reactive protein at diagnosis and duration of symptoms as covariates. Primary outcomes were success of non-operative management defined as achieving 1-year follow-up without undergoing appendicectomy due to recurrent appendicitis or ongoing symptoms, and occurrence of any predefined complication (intra-abdominal collection, wound infection, bowel obstruction or reintervention). Results Of 1464 children with presumed uncomplicated appendicitis, 1027 (70.2 per cent) underwent surgery and 437 (29.9 per cent) underwent non-operative management. Ninety-four children (21.5 per cent) treated by initial non-operative management required appendicectomy during the index hospital admission while recurrent appendicitis after discharge occurred in 25 (10.4 per cent) children within 1 year. The overall success rate of non-operative management at 1 year was 63.1 per cent (95 per cent c.i. 58.0 to 68.3 per cent). For propensity-score matched analyses, 688 children undergoing surgery and 307 undergoing non-operative management were included. Any predefined complication occurred in 50 (7.3 per cent) children undergoing surgery and in four (1.3 per cent) children undergoing non-operative management (OR 5.9 (95 per cent c.i. 2.1 to 16.6)) in the propensity-score matched cohort. There was no mortality or stoma formation. Conclusion Non-operative management is a safe and valid alternative to appendicectomy in children with uncomplicated appendicitis. [ABSTRACT FROM AUTHOR]

Background the mySupport advance care planning intervention was originally developed and evaluated in Northern Ireland (UK). Family caregivers of nursing home residents with dementia received an educational booklet and a family care conference with a trained facilitator to discuss their relative's future care. Objectives to investigate whether upscaling the intervention adapted to local context and complemented by a question prompt list impacts family caregivers' uncertainty in decision-making and their satisfaction with care across six countries. Second, to investigate whether mySupport affects residents' hospitalisations and documented advance decisions. Design a pretest–posttest design. Setting in Canada, the Czech Republic, Ireland, Italy, the Netherlands and the UK, two nursing homes participated. Participants in total, 88 family caregivers completed baseline, intervention and follow-up assessments. Methods family caregivers' scores on the Decisional Conflict Scale and Family Perceptions of Care Scale before and after the intervention were compared with linear mixed models. The number of documented advance decisions and residents' hospitalisations was obtained via chart review or reported by nursing home staff and compared between baseline and follow-up with McNemar tests. Results family caregivers reported less decision-making uncertainty (−9.6, 95% confidence interval: −13.3, −6.0, P  < 0.001) and more positive perceptions of care (+11.4, 95% confidence interval: 7.8, 15.0; P  < 0.001) after the intervention. The number of advance decisions to refuse treatment was significantly higher after the intervention (21 vs 16); the number of other advance decisions or hospitalisations was unchanged. Conclusions the mySupport intervention may be impactful in countries beyond the original setting. [ABSTRACT FROM AUTHOR]

Objective: Despite progress in endonasal skull-base neurosurgery, cerebrospinal fluid (CSF) rhinorrhoea remains common and significant. The CRANIAL study sought to determine 1) the scope of skull-base repair methods used, and 2) corresponding rates of postoperative CSF rhinorrhoea in the endonasal transsphenoidal approach (TSA) and the expanded endonasal approach (EEA) for skull-base tumors. Methods: A prospective observational cohort study of 30 centres performing endonasal skull-base neurosurgery in the UK and Ireland (representing 91% of adult units). Patients were identified for 6 months and followed up for 6 months. Data collection and analysis was guided by our published protocol and pilot studies. Descriptive statistics, univariate and multivariable logistic regression models were used for analysis. Results: A total of 866 patients were included - 726 TSA (84%) and 140 EEA (16%). There was significant heterogeneity in repair protocols across centres. In TSA cases, nasal packing (519/726, 72%), tissue glues (474/726, 65%) and hemostatic agents (439/726, 61%) were the most common skull base repair techniques. Comparatively, pedicled flaps (90/140, 64%), CSF diversion (38/140, 27%), buttresses (17/140, 12%) and gasket sealing (11/140, 9%) were more commonly used in EEA cases. CSF rhinorrhoea (biochemically confirmed or requiring re-operation) occurred in 3.9% of TSA (28/726) and 7.1% of EEA (10/140) cases. A significant number of patients with CSF rhinorrhoea (15/38, 39%) occurred when no intraoperative CSF leak was reported. On multivariate analysis, there may be marginal benefits with using tissue glues in TSA (OR: 0.2, CI: 0.1-0.7, p<0.01), but no other technique reached significance. There was evidence that certain characteristics make CSF rhinorrhoea more likely - such as previous endonasal surgery and the presence of intraoperative CSF leak. Conclusions: There is a wide range of skull base repair techniques used across centres. Overall, CSF rhinorrhoea rates across the UK and Ireland are lower than generally reported in the literature. A large proportion of postoperative leaks occurred in the context of occult intraoperative CSF leaks, and decisions for universal sellar repairs should consider the risks and cost-effectiveness of repair strategies. Future work could include longer-term, higher-volume studies, such as a registry; and high-quality interventional studies. [ABSTRACT FROM AUTHOR]

Background: Family carers of people with profound and multiple intellectual disabilities (PMID) experienced a reduction in healthcare services due to the COVID-19 pandemic. Many subsequently turned to Non-Governmental Organisations who worked to support families. However, little research has sought to capture the experiences of family carers or identify effective interventions which might support them. To address these concerns we explored the views of Non-Governmental sector workers across the UK and Ireland who supported families people with PMID during the COVID-19 pandemic. We also sought to explore their views on the characteristics of online support programmes for family carers. Methods: This study employed a qualitative design using focus groups with participants (n = 24) from five Non-Governmental Organisations across the UK and Ireland. A focus group guide included questions on challenges, supports, coping and resources which helped during lockdown restrictions. Focus groups were held online, were audio recorded and transcribed verbatim. The resulting transcripts were pseudonymised and subjected to thematic analysis. Findings: Four themes were identified (i) 'mental and emotional health', (ii) 'they who shout the loudest' (fighting for services), (iii) 'lack of trust in statutory services' and (iv) 'creating an online support programme'. Mental and emotional health emerged as the most prominent theme and included three subthemes named as 'isolation', 'fear of COVID-19' and 'the exhaustion of caring'. Conclusions: The COVID-19 pandemic has increased the vulnerability of family carers who were already experiencing difficulties in accessing services and supports for their families. While Non-Governmental Organisations have been a crucial lifeline there is urgent need to design services, including online support programmes, in partnership with family carers which adequately address their needs. [ABSTRACT FROM AUTHOR]

Background: Family carers of people with profound and multiple intellectual disabilities (PMID) experienced a reduction in healthcare services due to the COVID-19 pandemic. Many subsequently turned to Non-Governmental Organisations who worked to support families. However, little research has sought to capture the experiences of family carers or identify effective interventions which might support them. To address these concerns we explored the views of Non-Governmental sector workers across the UK and Ireland who supported families people with PMID during the COVID-19 pandemic. We also sought to explore their views on the characteristics of online support programmes for family carers.  METHODS: This study employed a qualitative design using focus groups with participants (n = 24) from five Non-Governmental Organisations across the UK and Ireland. A focus group guide included questions on challenges, supports, coping and resources which helped during lockdown restrictions. Focus groups were held online, were audio recorded and transcribed verbatim. The resulting transcripts were pseudonymised and subjected to thematic analysis.Findings: Four themes were identified (i) 'mental and emotional health', (ii) 'they who shout the loudest' (fighting for services), (iii) 'lack of trust in statutory services' and (iv) 'creating an online support programme'. Mental and emotional health emerged as the most prominent theme and included three subthemes named as 'isolation', 'fear of COVID-19' and 'the exhaustion of caring'.Conclusions: The COVID-19 pandemic has increased the vulnerability of family carers who were already experiencing difficulties in accessing services and supports for their families. While Non-Governmental Organisations have been a crucial lifeline there is urgent need to design services, including online support programmes, in partnership with family carers which adequately address their needs. [ABSTRACT FROM AUTHOR]

Introduction: Social support is described by patients and other stakeholders to be a valuable component of palliative day care. Less is known about the range of hospice services that have been used in practice that facilitate social support. An online survey aimed to gain an overview of all hospice day services that facilitated social support for adults outside of their own homes. Methods: An online survey was distributed via email to people involved in managing hospice day services. Questions were asked on hospice characteristics, including staff and volunteer roles. Respondents were asked to identify services they felt offered social support to patients. Data collection took place between August 2017 and May 2018. Results: Responses were received from 103 hospices in the UK and ROI (response rate 49.5%). Results provide an overview of hospice day and outpatient services that offer social support to patients. These are: multi-component interventions, activity groups, formal support groups, befriending, and informal social activities. Multi-component interventions, such as palliative day care, were the most commonly reported. Their stated aims tend to focus on clinical aspects, but many survey respondents considered these multicomponent interventions to be the 'most social' service at their hospice. The survey also identified a huge variety of activity groups, as well as formal therapeutic support groups. Informal 'social-only' activities were present, but less common. Over a third of all the services were described as 'drop in'. Most responding hospices did not routinely use patient reported outcome measures in their 'most social' services. Conclusions: The survey documents hospice activity in facilitating social support to be diverse and evolving. At the time of data collection, many hospices offered multiple different services by which a patient might obtain social support outside of their own home and in the presence of other patients. [ABSTRACT FROM AUTHOR]

This manuscript presents a demonstration study of Quiet Time (QT), a classroom-based Transcendental Meditation intervention. The aim of the study is to assess the feasibility of implementing and evaluating QT in two pilot settings in the United Kingdom and Ireland. This study contributes to the field by targeting middle childhood, testing efficiency in two settings operating under different educational systems, and including a large array of measures. First, teacher and pupil engagement with QT was assessed. Second, the feasibility of using a quasi-experimental design and a wide range of instruments to measure changes in pupil outcomes before and after the intervention was assessed. This allows us to obtain information about which instruments might be feasible to administer and most sensitive to change. The first setting included 89 students from a primary school in the United Kingdom: those in sixth grade received the QT intervention, while those in fifth grade practiced meditation using the Headspace application. The second setting included 100 fifth- and sixth-grade students from two schools in Ireland: one received the QT intervention, the other served as a control. Recruitment and retention rates were high in both settings, and the intervention was feasible and accepted by students, parents and teachers. Implementation fidelity was lower in the United Kingdom setting where delivery started later in the school year and the practice was affected by preparation for the Standard Assessment Tests. These results show that QT may be feasibly delivered in school settings, and suggest the use of a compact battery of tests to measure impact. We find suggestive evidence that the intervention affected executive function as children who practiced QT showed improved working memory in both settings. In the Irish setting, pupils in the QT group had improved ability to control responses. These results have implications for future studies by a) demonstrating that implementation fidelity is highly context dependent and b) providing suggestive evidence of the malleability of children's skills in middle childhood. The results of this demonstration study will be used to inform a larger RCT of the QT intervention. [ABSTRACT FROM AUTHOR]

Background: Mindfulness can potentially positively impact well-being and resilience in undergraduate nursing students. The psychological well-being of such students undertaking clinical training is paramount to ensure optimal learning, and to equip them with skills to manage their wellbeing in future clinical practice. The aim of our study was to explore the views of undergraduate nursing students in relation to understanding and engaging with mindfulness, and how mindfulness could best be delivered within their university programme. Methods: An online survey was administered via a cloud-based student response system to a convenience sample of first year undergraduate nursing students completing a Bachelor of Science (BSc) Honours (Hons) degree in nursing at a University in the United Kingdom. Data were analysed using descriptive statistics and thematic analysis. Results: The survey achieved a response rate of 78% (n = 208). Seventy-nine percent of participants had heard of mindfulness and were interested in taking part in a mindfulness programme. Respondents reported that the ideal delivery of the programme would consist of weekly 45-min, in person group sessions, over a 6-week period. Respondents also indicated that a mobile application could potentially facilitate participation in the programme. Thematic analysis of open-ended comments, and free text, within the survey indicated 4 overarching themes: 1) Perceptions of what mindfulness is; 2) Previous mindfulness practice experiences; 3) Impact of mindfulness in nursing; 4) The need for a future well-being initiative for undergraduate nursing students. Conclusions: Undergraduate nursing students perceived that a mindfulness programme has the potential to enhance well-being and future clinical practice. This student cohort are familiar with mindfulness and want more integrated within their undergraduate curriculum. Further research is required to examine the effectiveness of a tailored mindfulness intervention for this population that incorporates the use of both face-to-face and mobile delivery. [ABSTRACT FROM AUTHOR]

Background: To have population-level impact, physical activity (PA) interventions must be effectively implemented and sustained under real-world conditions. Adequate Fundamental Movement Skills (FMS) is integral to children being able to actively participate in play, games, and sports. Yet, few FMS interventions have been implemented at scale, nor sustained in routine practice, and thus it is important to understand the influences on sustained implementation. The study's aim was to use Collective Intelligence (CI)—an applied systems science approach—with stakeholder groups to understand barriers to the implementation of FMS interventions, interdependencies between these barriers, and options to overcome the system of barriers identified. Methods: Three CI sessions were conducted with three separate groups of experienced FMS intervention researchers/practitioners (N = 22) in the United Kingdom and Ireland. Participants generated and ranked barriers they perceive most critical in implementing FMS interventions. Each group developed a structural model describing how highly ranked barriers are interrelated in a system. Participants then conducted action mapping to solve the problem based on the logical relations between barriers reflected in the model. Results: The top ranked barriers (of 76) are those related to policy, physical education curriculum, and stakeholders' knowledge and appreciation. As reflected in the structural model, these barriers have influences over stakeholders' efficacy in delivering and evaluating interventions. According to this logical structure, 38 solutions were created as a roadmap to inform policy, practice, and research. Collectively, solutions suggest that efforts in implementation and sustainability need to be coordinated (i.e., building interrelationship with multiple stakeholders), and a policy or local infrastructure that supports these efforts is needed. Conclusions: The current study is the first to describe the complexity of barriers to implementing and sustaining FMS interventions and provide a roadmap of actions that help navigate through the complexity. By directing attention to the ecological context of FMS intervention research and participation, the study provides researchers, policy makers, and practitioners with a framework of critical components and players that need to be considered when designing and operationalising future projects in more systemic and relational terms. [ABSTRACT FROM AUTHOR]

Background: The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant's autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.Methods: Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.Results: Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.Conclusions: Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.Trial Registration: Not applicable. [ABSTRACT FROM AUTHOR]

Background: The Great Recession, starting in 2008, was characterized by an overall reduction in living standards. This pushed several governments across Europe to restrict expenditures, also in the area of healthcare. These austerity measures are known to have affected access to healthcare, probably unevenly among social groups. This study examines the unequal effects of retrenchment in healthcare expenditures on access to medical care for different income groups across European countries. Method: Using data of two waves (2008 and 2014) of the European Union Statistics of Income and Living Conditions survey (EU-SILC), a difference-in-differences (DD) approach was used to analyse the overall change in unmet medical needs over time within and between countries. By adding another interaction, the differences in the effects between income quintiles (difference-in-difference-in-differences: DDD) were estimated. To do so, comparisons between two pairs of a treatment and a control case were made: Iceland versus Sweden, and Ireland versus the United Kingdom. These comparisons are made between countries with recessions equal in magnitude, but with different levels of healthcare cuts. This strategy allows isolating the effect of cuts, net of the severity of the recession. Results: The DD-estimates show a higher increase of unmet medical needs during the Great Recession in the treatment cases (Iceland vs. Sweden: + 3.24 pp.; Ireland vs. the United Kingdom: + 1.15 pp). The DDD-estimates show different results over the two models. In Iceland, the lowest income groups had a higher increase in unmet medical needs. This was not the case in Ireland, where middle-class groups saw their access to healthcare deteriorate more. Conclusion: Restrictions on health expenditures during the Great Recession caused an increase in self-reported unmet medical needs. The burden of these effects is not equally distributed; in some cases, the lower-income groups suffer most. The case of Ireland, nevertheless, shows that certain policy measures may relatively spare lower-income groups while affecting middle-class income groups more. These results bring in evidence that policies can reduce and even overshoot the general effect of income inequalities on access to healthcare. [ABSTRACT FROM AUTHOR]

Surgical training in the UK and Ireland has faced challenges following the implementation of the European Working Time Directive and postgraduate training reform. The health services are undergoing a digital transformation; digital technology is remodelling the delivery of surgical care and surgical training. This review aims to critically evaluate key issues in laparoscopic general surgical training and the digital technology such as virtual and augmented reality, telementoring and automated workflow analysis and surgical skills assessment. We include pre-clinical, proof of concept research and commercial systems that are being developed to provide solutions. Digital surgical technology is evolving through interdisciplinary collaboration to provide widespread access to high-quality laparoscopic general surgery training and assessment. In the future this could lead to integrated, context-aware systems that support surgical teams in providing safer surgical care. [ABSTRACT FROM AUTHOR]

Background In recent years an increasing number of patients with cerebral metastasis (CM) have been referred to the neuro-oncology multidisciplinary team (NMDT). Our aim was to obtain a national picture of CM referrals to assess referral volume and quality and factors affecting NMDT decision making. Methods A prospective multicenter cohort study including all adult patients referred to NMDT with 1 or more CM was conducted. Data were collected in neurosurgical units from November 2017 to February 2018. Demographics, primary disease, KPS, imaging, and treatment recommendation were entered into an online database. Results A total of 1048 patients were analyzed from 24 neurosurgical units. Median age was 65 years (range, 21-93 years) with a median number of 3 referrals (range, 1-17 referrals) per NMDT. The most common primary malignancies were lung (36.5%, n = 383), breast (18.4%, n = 193), and melanoma (12.0%, n = 126). A total of 51.6% (n = 541) of the referrals were for a solitary metastasis and resulted in specialist intervention being offered in 67.5% (n = 365) of cases. A total of 38.2% (n = 186) of patients being referred with multiple CMs were offered specialist treatment. NMDT decision making was associated with number of CMs, age, KPS, primary disease status, and extent of extracranial disease (univariate logistic regression, P <.001) as well as sentinel location and tumor histology (P <.05). A delay in reaching an NMDT decision was identified in 18.6% (n = 195) of cases. Conclusions This study demonstrates a changing landscape of metastasis management in the United Kingdom and Ireland, including a trend away from adjuvant whole-brain radiotherapy and specialist intervention being offered to a significant proportion of patients with multiple CMs. Poor quality or incomplete referrals cause delay in NMDT decision making. [ABSTRACT FROM AUTHOR]

Objective: Biochemical assessment is recommended for patients prior to initiating and following a ketogenic diet (KD). There is no published literature regarding current practice in the UK and Ireland. We aimed to explore practice in comparison with international guidelines, determine approximate costs of biochemical testing in KD patients across the UK and Ireland, and promote greater consistency in KD services nationally. Methods: A survey was designed to determine the biochemical tests requested for patients at baseline, 3, 6, 12, 18, and 24 months + on KD. The survey was circulated to 39 centers across the UK and Ireland. Results: Sixteen centers completed the survey. Full blood count, electrolytes, calcium, liver function tests (LFTs), lipid profile, and vitamin D were requested at all centers at baseline, in keeping with international guidelines. Bicarbonate, total protein, and urinalysis were less consistently requested. Magnesium and zinc were requested by all centers, despite not being specifically recommended for pre‐diet evaluation in guidelines. Urea and electrolyte profiles and some LFTs were consistently requested at follow‐up, in accordance with guidelines. Other LFTs and renal tests, full blood count, lipid profile, acylcarnitine profile, selenium, vitamin D, and urinalysis were less consistently requested at follow‐up. The mean costs of the lowest and highest number of tests requested at baseline in our participating centers were £167.54 and £501.93; the mean costs of the lowest and highest number of tests requested at 3‐month follow‐up were £19.17 and £450.06. Significance: Biochemical monitoring of KD patients varies widely across the UK and Ireland and does not fully correspond to international best practice guidelines. With an ongoing drive for cost‐effectiveness within health care, further work is needed to streamline practice while ensuring patient safety. [ABSTRACT FROM AUTHOR]

The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions. [ABSTRACT FROM AUTHOR]