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Background: As part of a UK programme of work focusing on older people with intellectual disabilities, the circumstance of those who reside in generic services for older people were investigated. Materials and methods: Questionnaires were sent to 2570 residential and nursing homes in 53 local authorities across the UK. Results: Five hundred and thirty returned questionnaires identified 215 people with intellectual disabilities currently living in 150 homes. They were significantly younger than the other residents, and were placed in these homes more often because of organizational change or the ageing/death of a family carer, rather than any changes in their own needs. Several potential indicators of a low quality of life were identified, including limited opportunities to get out, to access day services, to have contact with family or friends and to receive input from professionals outside the home. Conclusions: Attention needs to be given both to people with intellectual disabilities already residing in older people's services and to the prevention of further inappropriate placements.

As part of a UK programme of work focusing on older people with intellectual disabilities, the circumstance of those who reside in generic services for older people were investigated. Questionnaires were sent to 2570 residential and nursing homes in 53 local authorities across the UK. Five hundred and thirty returned questionnaires identified 215 people with intellectual disabilities currently living in 150 homes. They were significantly younger than the other residents, and were placed in these homes more often because of organizational change or the ageing/death of a family carer, rather than any changes in their own needs. Several potential indicators of a low quality of life were identified, including limited opportunities to get out, to access day services, to have contact with family or friends and to receive input from professionals outside the home. Attention needs to be given both to people with intellectual disabilities already residing in older people's services and to the prevention of further inappropriate placements. [ABSTRACT FROM AUTHOR]

This study surveyed the availability and current practice of renal replacement therapy on adult general intensive care units in the United Kingdom. Questionnaires were returned from 236 units (89%). Renal replacement therapy was provided by 212 (90%) of responding units, treating 9442 patients per year. Renal physicians were involved in the initiation and prescription of treatment in 22 (11%) units. Ninety-one units (43%) had no step down facility on-site for those patients still requiring renal replacement therapy but no longer requiring intensive care. Continuous techniques are used by the majority of units, most commonly, continuous veno-venous haemofiltration, with an ultrafiltration rate of 2000 ml.h−1. Fifty-eight units (28%) use haemofiltration as adjuvant treatment in septic shock. The provision and practice of renal replacement therapy is now an integral part of intensive care medicine in the United Kingdom. [ABSTRACT FROM AUTHOR]

A postal questionnaire survey was employed in regional secure and psychiatric intensive care units in England and Wales, in respect of mental health nurses' training in the use of physical restraint. The nurses' views were sought relating to their last experience of implementing the procedure. Whilst most nurses (n = 259, 96.3%) reported positive outcomes in so far that the incident was brought under control, the views of the aftereffects of the procedure were of concern and ambivalence. The literature suggests that service users did not necessarily hold the same positive views. A range of alternatives, which were consistent with the literature, was made by staff to improve intervention in the management of violence. Negative aspects relating to the use of physical restraint were also highlighted. They included procedural, injury, clinical and management issues. Some respondents also expressed concerns about the negative attitudes of their colleagues. The findings of this aspect of the survey highlights that the therapeutic value of physical restraint can only be achieved with appropriate monitoring and with emphasis on psychological intervention in the prevention and management of violence. [ABSTRACT FROM AUTHOR]

AIM OF THE STUDY: The aim of the study was to examine the content of Trust policies concerning the prevention and management of violence in acute in-patient settings in order to establish their usefulness as guidance for staff in this difficult, complex, and controversial aspect of inpatient psychiatric care. BACKGROUND: Violence is a commonly encountered problem in inpatient psychiatric settings. There are legal requirements for workplaces in general and mental health care facilities in particular to develop safe systems of work based upon the findings of assessments of this risk. Policies have a key role to play in making explicit the responsibilities of both employer and employees, and specifying standards of acceptable practice. DESIGN: A cross-sectional survey methodology was used, which entailed examination of the content of management of violence policies that had been forwarded to the authors from 40 Trusts providing acute inpatient psychiatric care throughout England, Scotland, Wales, and Northern Ireland. FINDINGS: Policies were found to vary widely in their content, and serious shortcomings were noted in the extent to which policies included information regarding their status and review, advice on the prevention of violence, the management of violent incidents, and postincident action. CONCLUSIONS: Further research is needed to tease out the extent to policies which are lacking in content, reflect shortcomings in the organizational approach to the prevention and management of violence by Trusts, and the extent to which such shortcomings result in harm being suffered by staff and/or patients. An alternative format for the presentation of management of violence policies is discussed, and items that should be included in inpatient units' management of violence policies are suggested. [ABSTRACT FROM AUTHOR]

Background: Two recently developed measures intended for clinical use are HoNOS (Health of the Nation Outcome Scales), measuring social functioning, and CANSAS (Camberwell Assessment of Need Short Appraisal Schedule), for measuring need.Aims: We investigated the association between CANSAS and HoNOS.Results: For some domains there were substantial associations, with high HoNOS rating correlated with CANSAS rating of the presence of a need. For other areas the agreement was less than might be expected. Seven factors were identified within the 22 CANSAS domains, and the presence of needs in the Drug/alcohol and Activities of daily living factors was associated with high scores in the related HoNOS domains.Conclusions: CANSAS and HoNOS assessments differ. HoNOS can track changes in social functioning over time, but may be less useful for treatment planning, and should not be used to infer the level of morbidity in a case-load. CANSAS indicates when treatment should be commenced or continued. It can also be used as a case-load measure, but may be insufficiently sensitive to be used as an outcome measure at the individual level. [ABSTRACT FROM AUTHOR]

The article focuses on a study that aims to establish a practice with regard to the investigation of respiratory failure affecting the use of non-invasive positive pressure ventilation (NIPPV) across Great Britain and Australasian (ANZ) paediatric cystic fibrosis (CF) centres. It notes that 21 closed and open-ended questions were sent to CF consultants and physiologists. Findings confirmed 19 reported NIPPV failures in children due to claustrophobia, poor adherence and discomfort.

To date, little research has focused directly on health-related support in school for children with a chronic illness or physical disability, yet these children are known to be at increased risk for psychosocial and academic problems. In addition, few studies have sought the views of pupils directly: those which have report a wide range of problems with school life. The increasing numbers of children surviving and managing their health conditions, together with UK policy for inclusive education, means that a growing proportion of pupils in mainstream schools require understanding of their special health needs and may need service support from education and health professionals. This paper presents findings from semistructured interviews with 33 mainstream secondary school pupils with a variety of illnesses and disabilities on the impact of their health condition on school life. Results show that young people valued school and were actively managing the effects of their condition, but needed support from others. Informal support was most frequently cited, including parents — particularly mothers — teachers and close friends. The main difficulties were implications of school absence, exclusion from school life, teachers’ reactions to the illness or disability, and peer relationships. The discussion focuses on ways in which health professionals can play a part in supporting pupils both directly and indirectly, through helping others in school understand the condition and its impact on school life. [ABSTRACT FROM AUTHOR]

Pharmacogenetic testing in the United Kingdom's National Health Service (NHS) has historically been reactive in nature, undertaken in the context of single gene-drug relationships in specialist settings. Using a discrete choice experiment we aimed to identify healthcare professional preferences for development of a pharmacogenetic testing service in primary care in the NHS. Respondents, representing two professions groups (general practitioners or pharmacists), completed one of two survey versions, asking them to select their preferred pharmacogenetic testing service in the context of a presentation of low mood or joint pain. Responses from 235 individuals were included. All respondents preferred pharmacogenetic testing over no testing, though preference heterogeneity was identified. Both professional groups, but especially GPs, were highly sensitive to service design, with uptake varying depending on the service offered. This study demonstrates uptake of a pharmacogenetic testing service is impacted by service design and highlights key areas which should be prioritised within future initiatives., (© 2024. The Author(s).)

Aims: Genetic testing can be used to improve the safety and effectiveness of commonly prescribed medicines-a concept known as pharmacogenetics. This study aimed to quantify members of the UK public's preferences for a pharmacogenetic service to be delivered in primary care in the National Health Service., Methods: Members of the UK population were surveyed via an online panel company. Respondents completed 1 of 2 survey versions, asking respondents to select their preferred pharmacogenetic testing service in the context of a presentation of low mood or pain. A conditional logit model was estimated, before the best functional form for the dataset was identified. Preference heterogeneity was identified via latent class analysis. Coefficients from the final selected models were used to estimate uptake in the context of different hypothetical pharmacogenetic services., Results: Responses from 1993 individuals were included in the analysis. There were no differences observed in preference between the 2 clinical scenarios. Conditional logit analysis, using maximum likelihood estimation, indicated that respondents preferred to have noninvasive tests and wanted their data to be shared between different healthcare organizations to guide future prescribing. There was a preference for regional over national data sharing initiatives, and respondents preferred to have access to their data. Predicted uptake varied considerably, ranging from 51% to >99%, depending on design of the service., Conclusion: This study identifies public preferences for a pharmacogenetic testing service and demonstrates how predicted uptake can be impacted by relatively minor adaptations. This highlights areas for prioritization during development of future pharmacogenetic services., (© 2024 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

Background: Insect bite inflammation may mimic cellulitis and promote unnecessary antibiotic usage, contributing to antimicrobial resistance in primary care. We wondered how general practice clinicians assess and manage insect bites, diagnose cellulitis, and prescribe antibiotics., Method: This is a Quality Improvement study in which 10 general practices in England and Wales investigated patients attending for the first time with insect bites between April and September 2021 to their practices. Mode of consultation, presentation, management plan, and reattendance or referral were noted. Total practice flucloxacillin prescribing was compared to that for insect bites., Results: A combined list size of 161,346 yielded 355 insect bite consultations. Nearly two-thirds were female, ages 3-89 years old, with July as the peak month and a mean weekly incidence of 8 per 100,000. GPs still undertook most consultations; most were phone consultations, with photo support for over half. Over 40% presented between days 1 and 3 and common symptoms were redness, itchness, pain, and heat. Vital sign recording was not common, and only 22% of patients were already taking an antihistamine despite 45% complaining of itch. Antibiotics were prescribed to nearly three-quarters of the patients, mainly orally and mostly as flucloxacillin. Reattendance occurred for 12% and referral to hospital for 2%. Flucloxacillin for insect bites contributed a mean of 5.1% of total practice flucloxacillin prescriptions, with a peak of 10.7% in July., Conclusions: Antibiotics are likely to be overused in our insect bite practice and patients could make more use of antihistamines for itch before consulting., (© The Author(s) 2023. Published by Oxford University Press.)

The prevalence of chronic, non-communicable diseases has risen sharply in recent decades, especially in industrialized countries. While several studies implicate the microbiome in this trend, few have examined the evolutionary history of industrialized microbiomes. Here we sampled 235 ancient dental calculus samples from individuals living in Great Britain (∼2200 BCE to 1853 CE), including 127 well-contextualized London adults. We reconstructed their microbial history spanning the transition to industrialization. After controlling for oral geography and technical biases, we identified multiple oral microbial communities that coexisted in Britain for millennia, including a community associated with Methanobrevibacter, an anaerobic Archaea not commonly prevalent in the oral microbiome of modern industrialized societies. Calculus analysis suggests that oral hygiene contributed to oral microbiome composition, while microbial functions reflected past differences in diet, specifically in dairy and carbohydrate consumption. In London samples, Methanobrevibacter-associated microbial communities are linked with skeletal markers of systemic diseases (for example, periostitis and joint pathologies), and their disappearance is consistent with temporal shifts, including the arrival of the Second Plague Pandemic. This suggests pre-industrialized microbiomes were more diverse than previously recognized, enhancing our understanding of chronic, non-communicable disease origins in industrialized populations., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)

Objectives: To compare the real-world effectiveness of newer disease-modifying therapies (DMTs) vs injectables in children with relapsing-remitting multiple sclerosis (RRMS)., Methods: In this retrospective, multicenter study, from the UK Childhood Inflammatory Demyelination Network, we identified children with RRMS receiving DMTs from January 2012 to December 2018. Clinical and paraclinical data were retrieved from the medical records. Annualized relapse rates (ARRs) before and on treatment, time to relapse, time to new MRI lesions, and change in Expanded Disability Status Scale (EDSS) score were calculated., Results: Of 103 children treated with DMTs, followed up for 3.8 years, relapses on treatment were recorded in 53/89 (59.5%) on injectables vs 8/54 (15%) on newer DMTs. The ARR was reduced from 1.9 to 1.1 on injectables ( p < 0.001) vs 1.6 to 0.3 on newer DMTs ( p = 0.002). New MRI lesions occurred in 77/89 (86.5%) of patients on injectables vs 26/54 (47%) on newer DMTs ( p = 0.0001). Children on newer DMTs showed longer time to relapse, time to switch treatment, and time to new radiologic activity than patients on injectables (log-rank p < 0.01). After adjustment for potential confounders, multivariable analysis showed that injectables were associated with 12-fold increased risk of clinical relapse (adjusted hazard ratio [HR] = 12.12, 95% CI = 1.64-89.87, p = 0.015) and a 2-fold increased risk of new radiologic activity (adjusted HR = 2.78, 95% CI = 1.08-7.13, p = 0.034) compared with newer DMTs. At 2 years from treatment initiation, 38/103 (37%) patients had MRI activity in the absence of clinical relapses. The EDSS score did not change during the follow-up, and only 2 patients had cognitive impairment., Conclusion: Newer DMTs were associated with a lower risk of clinical and radiologic relapses in patients compared with injectables. Our study adds weight to the argument for an imminent shift in practice toward the use of newer, more efficacious DMTs in the first instance., Classification of Evidence: This study provides Class IV evidence that newer DMTs (oral or infusions) are superior to injectables (interferon beta/glatiramer acetate) in reducing both clinical relapses and radiologic activity in children with RRMS., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.)

Introduction: Thy3a (AUS/FLUS) is an indeterminate and heterogeneous category in thyroid cytology. Thy3a reporting rates vary widely, with many laboratories documenting overuse. Subclassification of Thy3a helps with risk stratification. We aimed to investigate whether subclassification can also help address Thy3a overuse. We compare the UK reporting system with other terminologies., Methods: An audit of thyroid fine needle aspirations (FNAs) reported at our institution between 2012 and 2017 was performed. Thy3a FNAs followed by histology were reviewed and subcategorised into four subgroups: Scanty Atypia (SA), Scanty Microfollicular (SMF), Favour Benign (FB) and Thyroiditis versus Neoplasm (TVN). Review and subclassification were blinded to histology outcomes. FNAs were correlated with histology and statistical analysis was performed., Results: Our Thy3a rate was high (24% of all thyroid FNAs). For 336 Thy3a FNAs with histology, the malignancy rates of the four subgroups were: SA 68%, SMF 20%, FB 4%, TVN 31%. There were significant associations between subgroup and malignancy risk, and between subgroup and tumour risk. On histology, SA had more malignancies than expected and FB had fewer. SA and SMF had more tumours than expected and FB had fewer. SMF and Thy3f FNAs were similar in terms of tumour and malignancy outcomes., Conclusions: Subclassification of Thy3a FNAs into these four subgroups is recommended. This can improve risk stratification and help address overuse of Thy3a. We propose that some FB and SMF cases could be safely diverted to Thy2 and Thy3f respectively. We compare various reporting terminologies and question how indeterminate FNAs should be classified., (© 2020 John Wiley & Sons Ltd.)

Background: Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries., Objectives: To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial., Design: We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods., Setting: Home-based care without 24/7 paid care provision, in three UK sites., Participants: Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency., Intervention: Intervention-group carers received training by local nurses using a manualised training package., Main Outcome Measures: Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures., Results: In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n  = 10; usual care, n  = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care., Conclusion: The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial., Trial Registration: Current Controlled Trials ISRCTN11211024., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 25. See the NIHR Journals Library website for further project information., Competing Interests: Anthony Byrne reports grants from Marie Curie (London, UK), Health and Care Research Wales, the End of Life Board for Wales and the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme outside the submitted work; he is also a member of the End of Life Board for Wales, which is responsible to the Welsh Government for developing and implementing strategy for end-of-life care in Wales. Bee Wee reports that she is National Clinical Director for End of Life Care, Chairperson of the National Institute for Health and Care Excellence Quality Standards Advisory Committee and has a NIHR-funded grant outside the submitted work. She has also received royalties for a book published by Oxford University Press (Oxford, UK). Dyfrig Hughes reports that he was a member of the HTA Programme Pharmaceuticals Panel (2008–12) and member of the HTA Programme Clinical Evaluation and Trials Board (2010–16). Marlise Poolman was a member of the HTA Prioritisation Committee: Integrated Community Health and Social Care (A) from 2013 to 2019. Zoe Hoare reports that she is an associate member of NIHR Health Services and Delivery Research board. Clare Wilkinson reports that she was chairperson of the HTA Commissioning Panel – Primary Care, Community, Preventive Interventions (2013–18) and a member of the HTA Rapid and Add-0n Trials Board (2012–13).

This paper examines the role of affective landscapes in the formation of attendees' experiences at a re-provisioned, integrated sexual and reproductive healthcare facility. The 'One-Stop Shop' (OSS) is an example of the organisational shift towards integrated services occurring across the UK, bringing together in one clinic the historically discreet services of genitourinary medicine, HIV medicine and Family Planning. An ethnographically-informed study of new spaces of care and changed organisation, this paper focuses on the experiences of 29 attendees as they made their way along the clinic's care pathways. Drawing on concepts of affect and atmosphere to augment the analytic lens of 'therapeutic landscapes', this paper demonstrates how various spaces of the clinic influenced attendees' experiences. A cramped, featureless 'holding pen', the foyer served to exacerbate pre-existing anxieties while creating new fears. The main waiting room, an organisational sorting space, both soothed and aggravated attendees' concerns. Serving as an architectural feature to connect the old Victorian hospital with the new clinical extension, the atrium was experienced as a space to breathe, with an affective atmosphere that challenged the assumed unpleasantness of sexual health clinics. This paper demonstrates how affective landscapes of the clinic shape attendee experiences in a novel setting., (© 2019 Foundation for the Sociology of Health & Illness.)

Objective: To investigate the outcomes of biennial guaiac faecal occult blood test (gFOBT) screening after once-only flexible sigmoidoscopy (FS) screening., Methods: Between 1994 and 1999, as part of the UK FS Screening Trial (UKFSST), adults aged 55-64 were randomly allocated to an intervention group (offered FS screening) or a control group (not contacted). From 2006, a subset of UKFSST participants (20,895/44,041 intervention group; 41,497/87,149 control group) were invited to biennial gFOBT screening by the English Bowel Cancer Screening Programme. We analysed gFOBT uptake, test positivity, yield of colorectal cancer (CRC), and positive predictive value (PPV) for CRC, advanced adenomas (AAs), and advanced colorectal neoplasia (ACN: AA/CRC)., Results: Uptake of gFOBT at first invitation was 1.9% lower (65.7% vs. 67.6%, p < 0.01) among intervention versus control group participants. Positivity was 0.4% lower (2.0% vs. 2.4%, p < 0.01) and CRC yield was 0.08% lower (0.19% vs. 0.27%, p = 0.14). PPVs were also lower in the intervention versus control group, at 10.3% vs. 12.3% ( p = 0.44) for CRC, 22.7% vs. 31.4% ( p < 0.01) for AA, and 33.0% vs. 43.7% ( p < 0.01) for ACN. Among those who refused FS ( n = 5532), gFOBT uptake at first invitation was 47.7%, CRC yield was 0.25%, and PPV for ACN was 46.2%. Among FS attenders ( n = 15,363), uptake was 72.2%, CRC yield was 0.18%, and PPV for ACN was 27.9%., Conclusions: Uptake, positivity and PPV of gFOBT screening were reduced following prior offer of FS screening. However, a quarter of FS screened participants receiving a diagnostic examination after positive gFOBT were diagnosed with ACN.

Changes in the nature and structure of healthcare pathways have implications for healthcare professionals' jurisdictional boundaries. The introduction of treatment focused BRCA1 and 2 genetic testing (TFGT) for newly diagnosed patients with breast cancer offers a contemporary example of pathway change brought about by technological advancements in gene testing and clinical evidence, and reflects the cultural shift towards genomics. Forming part of an ethnographically informed study of patient and practitioner experiences of TFGT at a UK teaching hospital, this paper focuses on the impact of a proposal to pilot a mainstreamed TFGT pathway on healthcare professionals' negotiations of professional jurisdiction. Based upon semi-structured interviews (n = 19) with breast surgeons, medical oncologists and members of the genetics team, alongside observations of breast multidisciplinary team meetings, during the time leading up to the implementation of the pilot, we describe how clinicians responded to the anticipated changes associated with mainstreaming. Interviews suggest that mainstreaming the breast cancer pathway, and the associated jurisdictional reconfigurations, had advocates as well as detractors. Medical oncologists championed the plans, viewing this adaptation in care provision and their professional role as a logical next step. Breast surgeons, however, regarded mainstreaming as an unfeasible expansion of their workload and questioned the relevance of TFGT to their clinical practice. The genetics team, who introduced the pilot, appeared cautiously optimistic about the potential changes. Drawing on sociological understandings of the negotiation of professional jurisdictions our work contributes a timely, micro-level examination of the responses among clinicians as they worked to renegotiate professional boundaries in response to the innovative application of treatment-focused BRCA testing in cancer care - a local and dynamic process which we refer to as an 'oncogenetic taskscape in the making'., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK., Methods: This paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life and wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval., Discussion: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37)., Trial Registration: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

Background: Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness., Objective: To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible., Design: Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation., Setting: UK NHS burns services. Interviews and the pilot trial were run in seven burns services., Participants: Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial., Interventions: The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises., Main Outcome Measures: Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery., Results: NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6-18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed., Limitations: The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study., Conclusions: A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required., Future Work: We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this., Trial Registration: Current Controlled Trials ISRCTN34483199., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 36. See the NIHR Journals Library website for further project information., Competing Interests: Laura Jones reports personal fees from Quit51 Bionical outside the submitted work. Jonathan Mathers reports personal fees from Health Education England outside the submitted work. Melanie Calvert reports personal fees from Astellas Pharma Inc. and Ferring Pharmaceuticals outside the submitted work. Jonathan Deeks was a member of the National Institute for Health Research (NIHR) Health Technology Assessment Commissioning Board and the NIHR Efficient Study Designs Board.

Background: Cannabidiol (CBD) exhibits anti-inflammatory properties that could improve disease activity in inflammatory bowel disease. This proof-of-concept study assessed efficacy, safety and tolerability of CBD-rich botanical extract in ulcerative colitis (UC) patients., Methods: Patients aged 18 years or older, with left-sided or extensive UC, Mayo scores of 4-10 (endoscopy scores ≥1), and on stable 5-aminosalicylic acid dosing, were randomized to 10-weeks' CBD-rich botanical extract or placebo capsules. The primary endpoint was the percentage of patients in remission after treatment. Statistical testing was 2-sided, using a 10% significance level., Results: Patients were less tolerant of CBD-rich botanical extract compared with placebo, taking on average one-third fewer capsules, and having more compliance-related protocol deviations (principally insufficient exposure), prompting identification of a per protocol (PP) analysis set. The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). However, PP analysis of total and partial Mayo scores favoured CBD-rich botanical extract (P = 0.068 and P = 0.038, respectively). Additionally, PP analyses of the more subjective physician's global assessment of illness severity, subject global impression of change, and patient-reported quality-of-life outcomes were improved for patients taking CBD-rich botanical extract (P = 0.069, P = 0.003, and P = 0.065, respectively). Adverse events (AEs) were predominantly mild/moderate with many in the CBD-rich botanical extract group potentially attributable to the ∆9-tetrahydrocannabinol content. A greater proportion of gastrointestinal-related AEs, indicative of UC worsening, was seen on placebo., Conclusion: Although the primary endpoint was not reached, several signals suggest CBD-rich botanical extract may be beneficial for symptomatic treatment of UC.

Objective: Trials in critical care have previously used unvalidated systems to classify cause of death. We aimed to provide initial validation of a method to classify cause of death in intensive care unit patients., Design, Setting and Participants: One hundred case scenarios of patients who died in an ICU were presented online to raters, who were asked to select a proximate and an underlying cause of death for each, using the ICU Deaths Classification and Reason (ICU-DECLARE) system. We evaluated two methods of categorising proximate cause of death (designated Lists A and B) and one method of categorising underlying cause of death. Raters were ICU specialists and research coordinators from Australia, New Zealand and the United Kingdom., Main Outcome Measures: Inter-rater reliability, as measured by the Fleiss multirater kappa, and the median proportion of raters choosing the most likely diagnosis (defined as the most popular classification choice in each case)., Results: Across all raters and cases, for proximate cause of death List A, kappa was 0.54 (95% CI, 0.49-0.60), and for proximate cause of death List B, kappa was 0.58 (95% CI, 0.53-0.63). For the underlying cause of death, kappa was 0.48 (95% CI, 0.44-0.53). The median proportion of raters choosing the most likely diagnosis for proximate cause of death, List A, was 77.5% (interquartile range [IQR], 60.0%-93.8%), and the median proportion choosing the most likely diagnosis for proximate cause of death, List B, was 82.5% (IQR, 60.0%-92.5%). The median proportion choosing the most likely diagnosis for underlying cause was 65.0% (IQR, 50.0%-81.3%). Kappa and median agreement were similar between countries. ICU specialists showed higher kappa and median agreement than research coordinators., Conclusions: The ICU-DECLARE system allowed ICU doctors to classify the proximate cause of death of patients who died in the ICU with substantial reliability.

Background: The NSF for Renal Services stresses the importance of collaboration between renal services and critical care networks in managing patients with acute renal failure in the most clinically appropriate setting. Anecdotal evidence in our region suggested that some patients were remaining on critical care inappropriately because of a lack of capacity for step-down care in local renal units., Aim: To determine the number of extra days patients spend on critical care receiving single-organ renal support before transfer to a renal unit., Design: Prospective, multi-centre, service evaluation., Methods: Prospective data were collected over a one-year period by either daily telephone calls or bedside review. Follow-up data were retrieved from electronic and patient records., Results: Five hundred and forty-two patients received renal replacement therapy (RRT) in critical care. With 68 (12.5%) patients already receiving RRT for end-stage renal failure, this gave an incidence of new RRT on critical care of 234 per million population per year. The median duration of RRT on critical care was 4 days (range 1-30). One hundred and twenty-seven patients (23%) were discharged from critical care still requiring RRT. A period of single-organ renal support (median 2 days, range 1-8) was provided to 74 of these patients (58%) using 113 critical care bed days., Discussion: Over half of patients receiving RRT on discharge from critical care in our network received a short period of single-organ renal support before step-down. This may represent either delayed discharge from critical care or a potential opportunity for care in an alternative high-dependency facility.

Background: Continuity of care is a central objective of community psychiatric services, but there is no consensus about its measurement., Aims: We developed measures of continuity of care suitable for routine use, and measured continuity and individual patient outcome over a period in which community services were developing., Method: One hundred patients with severe mental illness receiving continuing care from two sectorised services were sampled and interviewed. Data were collected concerning their care over 20 months prior to interview. After 20 months prospective follow-up, they were re-interviewed. Continuity was defined as: perceived accessibility of services and knowledge about them, the number of keyworkers in a defined period of time, and the proportion of time out of contact with services., Results: Continuity of care improved significantly on all measures over the period of the study. Individual patient outcome also improved, but in multiple regression models including clinical and demographic variables, measures of continuity were not significant predictors of outcome. Continuity was similar for white and non-white patients., Conclusion: Simple measures of continuity are useful in evaluating changes in the process of care, but they are not straightforwardly related to individual outcome.

We describe two British families with similar, dominantly-inherited, temperature-related variants of hereditary stomatocytosis, consistent with the original description of 'cryohydrocytosis'. The cells show a 5-6-fold increase in passive permeability at 37 degrees C with abnormal intracellular Na and K levels at 15-20 and 60-65 mmol/(l cells) respectively. Marked temperature effects were evident: lysis of red cells on storage in the cold was blatant and when whole heparinized blood was stored at room temperature, K accumulated in the plasma, producing 'pseudohyperkalaemia'. Studies of the temperature dependence of passive permeability showed that the minimum in the passive permeability, which is seen in normal cells at 8-10 degrees C, was shifted up to 23 degrees C in these abnormal cells, such that the permeability at 0 degrees C exceeded that at 37 degrees C. The abnormal temperature dependence in these genetically abnormal red cells strongly resembles that seen in normal cells when suspended in media in which either Na or Cl has been replaced by an organic cation or anion: it could be said these cells had a genetic mutation that somehow rendered the cell resistant to the stabilizing action of NaCl at low temperatures.

This two-part series on the making of dentures in the National Health Service includes useful practical advice for the general practitioner. Part 1 discussed complete denture, whilst part 2 covers partial dentures.