Search

In 2018, an NHS Trust (UK) implemented an innovative Nursing System Framework (NSF). The NSF formalized a two‐year strategy, which provided teams with clear aims and measurable objectives to deliver care. Failures of coordination of nursing services are well‐recognized threats to the quality, safety and sustainability of care provision. Aim: To evaluate the efficacy of introducing a NSF in an NHS Trust, using nursing sensitive indicators and pre‐selected mortality, data outcome measures. Design: A before and after implementation, observational study. Methods: 105,437 admissions were extracted at an admission record level. Data was extracted from 1st September 2018 through to the 31st August 2019. Results: Using SQUIRE guidelines to report the study, insufficient evidence was found to reject a null hypothesis with a chi‐squared test of association between in‐hospital death and the NSF intervention period, with a p‐value of.091. However, trends were seen in the data, which suggested a positive association. Conclusion: The NSF is a complex intervention, which provides direction for improvements but requires further research to understand the benefits for nurses, Midwives, Health Visitors and patients. [ABSTRACT FROM AUTHOR]

Background: There are limited randomized controlled trials with long-term outcomes comparing autologous chondrocyte implantation (ACI) versus alternative forms of surgical cartilage management within the knee. Purpose: To determine at 5 years after surgery whether ACI was superior to alternative forms of cartilage management in patients after a failed previous treatment for chondral or osteochondral defects in the knee. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In total, 390 participants were randomly assigned to receive either ACI or alternative management. Patients aged 18 to 55 years with one or two symptomatic cartilage defects who had failed 1 previous therapeutic surgical procedure in excess of 6 months prior were included. Dual primary outcome measures were used: (1) patient-completed Lysholm knee score and (2) time from surgery to cessation of treatment benefit. Secondary outcome measures included International Knee Documentation Committee and Cincinnati Knee Rating System scores, as well as number of serious adverse events. Analysis was performed on an intention-to-treat basis. Results: Lysholm scores were improved by 1 year in both groups (15.4 points [95% CI, 11.9 to 18.8] and 15.2 points [95% CI, 11.6 to 18.9]) for ACI and alternative, with this improvement sustained over the duration of the trial. However, no evidence of a difference was found between the groups at 5 years (2.9 points; 95% CI, −1.8 to 7.5; P =.46). Approximately half of the participants (55%; 95% CI, 47% to 64% with ACI) were still experiencing benefit at 5 years, with time to cessation of treatment benefit similar in both groups (hazard ratio, 0.97; 95% CI, 0.72 to 1.32; P >.99). There was a differential effect on Lysholm scores in patients without previous marrow stimulation compared with those with marrow stimulation (P =.03; 6.4 points in favor of ACI; 95% CI, −0.4 to 13.1). More participants experienced a serious adverse event with ACI (P =.02). Conclusion: Over 5 years, there was no evidence of a difference in Lysholm scores between ACI and alternative management in patients who had previously failed treatment. Previous marrow stimulation had a detrimental effect on the outcome of ACI. Registration: International Standard Randomised Controlled Trial Number: 48911177 [ABSTRACT FROM AUTHOR]

Accessible Summary: What is already known about this topic?: Individuals with severe mental illness (SMI) have elevated risks for physical health problems and low screening rates.No previous studies have compared the physical health promotion needs of people with SMI using the same screening tool across different international settings. What this paper adds to existing knowledge?: It appears feasible to use the HIP to profile and compare physical health‐related risks in people with SMI across different international settings.The HIP tool identified significant differences in areas of risk across the four countries. What are the implications for practice?: The HIP could be used to identify unique clusters of health promotion needs in different countries.Use of HIP health checks may support implementation of individualized interventions. Introduction: To date, no studies have contrasted physical health profiles of people with severe mental illness (SMI) in different countries. Aim: To evaluate feasibility of using the Health Improvement Profile (HIP) to compare and contrast physical health and health behaviours of people with SMI from four countries. Method: An observational feasibility study using secondary analysis of pooled health state and lifestyle data. Physical health checks using modified versions of HIP were administered in four countries. Results: Findings suggest feasibility of HIP screening to profile and compare physical health and health behaviours of people with SMI across international settings. High overall numbers of risk items (red flags) were identified in all but the Thailand sample. Despite some commonalities, there were important differences in health profiles across countries. Discussion: This is the first study to demonstrate feasibility of the HIP to compare health risks in individuals with SMI across countries. Future multi‐national HIP studies should recruit a fully powered stratified random sample of people with SMI that is representative of each setting. Implications for practice: It appears feasible to utilize the HIP to identify specific areas of health risk in different countries, which may help to better focus nursing interventions and use of resources. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has presented both challenges and opportunities for those working in health and social care in the United Kingdom (UK). With much focus on secondary and acute care at this time, there has been less communication and understanding about the impact on primary care. This discussion paper is based on the experience of one of the authors working as a general practitioner/family doctor during the pandemic and rapid changes are described during this time (April 2020). Two important themes emerged from this experience focusing on the importance of supporting one another and new roles and ways of working. It can be argued that the challenges presented by COVID-19 have expedited positive and potentially sustainable change in UK primary care that has been needed for some time. The authors discuss the implications for future working and make a series of recommendations for primary care relating to the importance of supporting the workforce, remote consultations and communication, regular team meetings, and development of integrated care. It is suggested that many of the challenges highlighted can be addressed by placing a greater emphasis on the use of interprofessional education (IPE) to underpin and support effective collaborative working. [ABSTRACT FROM AUTHOR]

Crisis resolution teams (CRTs) provide treatment at home to people experiencing mental health crises, as an alternative to hospital admission. Previous UK research, based on self‐report surveys, suggests that a loosely specified model has resulted in wide variations in CRTs' service delivery, organization and outcomes. A fidelity scale (developed through evidence review and stakeholder consensus) provided a means of objectively measuring adherence to a model of good practice for CRTs, via one‐day fidelity reviews of UK crisis teams. Reviews included interviews with service users, carers, staff and managers, and examination of data, policies, protocols and anonymized case notes. Of the 75 teams reviewed, 49 (65%) were assessed as being moderate fidelity and the rest as low fidelity, with no team achieving high fidelity. The median score was 122 (range: 73–151; inter‐quartile range: 111–132). Teams achieved higher scores on items about structure and organization, for example ease of referral, medication and safety systems, but scored poorly on items about the content of care and interventions. Despite a national mandate to implement the CRT model, there are wide variations in implementation in the UK and no teams in our sample achieved overall high fidelity. This suggests that a mandatory national policy is not in itself sufficient to achieve good quality implementation of a service model. The CRT Fidelity Scale provides a feasible and acceptable means to objectively assess model fidelity in CRTs. There is a need for development and testing of interventions to enhance model fidelity and facilitate improvements to these services. [ABSTRACT FROM AUTHOR]

The aim of the present qualitative, systematic review was to identify and summarize qualitative research that focussed on mental health nurse prescribing, synthesize findings, and outline key themes discerned. In November 2016, a systematic search was conducted for primary studies of the electronic databases PubMed, Excerpta Medica, (Embase), Cumulative Index to Nursing and Allied Health Literature, Scopus, and PsycINFO. Of the 101 papers identified through the search strategy, 12 qualitative studies met the review inclusion criteria. These studies included perspectives from nurses, doctors, and patients/clients regarding their attitudes about, and experiences of, nurse prescribing. Three themes emerged from the review: (i) patient-centred care; (ii) professional role; and (iii) professional support. Nurse prescribers embrace a patient-centred approach, providing timely and effective medication management. Adequate education and continuing professional development inclusive of clinical supervision enable competency development in nurse prescribing, supportive professional relationships, and patient safety. Further research is necessary to establish safety and demonstrate enhanced clinical outcomes from mental health nurse prescribing. [ABSTRACT FROM AUTHOR]

This article presents the outcomes of two workshops which explored historical and recent issues on patient safety that directly relate to leaders in the interprofessional field. The article considers the impact of flattened team-based structures where collaborative working constantly considers safe patient-centred high-quality care. These issues are mainly rooted in changes within a UK context, but the historical case studies present situations which could enlighten and enliven discussions of patient safety in an international context. The article was sparked by discussion of recurrent themes in healthcare that have undermined the abilities of medical practitioners to adequately manage hazard in clinical care settings throughout modern history. Examining the issues that confront healthcare practitioners and care workers in their dealings with patients and clients, such as the aged or the severely disabled, can reveal commonalities across global healthcare settings, in the past and present, that provide a useful tool in facilitating the goals of interprofessional education (IPE). The potential of IPE has links to both how professionals respond together to care situations and involve the general public in shared health understandings. The outcomes focus on how to ensure ministrations where optimal team-based collaborative care is recognised and constantly sought. We conclude that IPE has much to offer in this arena and more evidence of impact here is well worth pursuing. [ABSTRACT FROM PUBLISHER]

The authors summarize some sections of the interprofessional education (IPE) guidelines issued by the British Centre for the Advancement of Interprofessional Education. They discuss the implementation of interprofessional learning, adapting teaching and learning methods, and involving service users and their carers.

Crop research sectors in many countries are facing reduced public support with public breeding programs being gradually replaced by private ones. This paper explores the UK experience with the privatization of wheat breeding that began in 1987. The analysis presented in this paper is based on interviews with sixteen experts currently involved in wheat research breeding in the UK. Taking a snapshot of UK wheat research today, it would be easy to conclude that the UK sector made a smooth transition from public to private breeding. However, this is not the case. The UK faced many challenges in establishing an integrated wheat innovation system and has only recently developed policies and funding processes that have enabled upstream public scientists to work with private wheat breeding industry. As policy makers around the world contemplate the privatization of crop breeding, important lessons can be drawn from the UK crop research funding model. [ABSTRACT FROM PUBLISHER]

Controlling the positive symptoms in schizophrenia is difficult but current drugs are reasonably effective. Negative symptoms pose much more of a challenge. In this Expert Panel Discussion, chaired by Progress publisher Tim Dean, the participants consider issues and solutions around the management of negative symptoms in schizophrenia, as well as developments for the future. [ABSTRACT FROM AUTHOR]

Aim. To investigate primary care practitioner's attitudes to depression after myocardial infarction. Background. Depression after myocardial infarction affects almost half of all patients and has a considerable negative effect on recovery. Despite the increased prevalence of depression in this population, it is often not recognised or treated. Design. Survey. Method. A total of 813 (106 general practitioners and 707 nurses) practitioners responded. Our questionnaire developed for this project by the authors in collaboration with a group of ten cardiovascular nurse specialists contained 27 items that were summated into five subscales. Results. Primary care practitioners underestimated the prevalence of depression in the post-myocardial infarction population. General acknowledgement of the negative impact that depression can have was reported by the majority of participants. Diagnosing depression was perceived as complex by both groups but significantly more so by nurses. General practitioners were significantly more positive about their understanding of the signs and symptoms of depression and in using depression-screening tools. We observed that training seems to have a significant effect on reported practice. Practitioners who reported that they had recent training in the management of depression were significantly more accurate in their estimate of how common depression was in this population. Conclusion. Depression may be underdiagnosed in this population because primary care practitioners, especially nurses, are not aware of how common the disorder is and lack competence in diagnosis. There is merit in developing and testing a brief training intervention to ensure competence in depression screening and treatment in post-myocardial infarction patients. Relevance to clinical practice. Diagnosing depression in post-myocardial infarction patients is perceived by nurses as complex but training in the management of depression is seen as helping practice. [ABSTRACT FROM AUTHOR]

Objective To generate evidence on the longer term cost effectiveness of disease modifying treatments in patients with relapsing-remitting multiple sclerosis. Design Prospective cohort study with historical comparator. Setting Specialist multiple sclerosis clinics in 70 centres in the United Kingdom. Participants Patients with relapsing-remitting multiple sclerosis who started treatment from May 2002 to April 2005 under the UK risk sharing scheme. Interventions Treatment with interferon beta or glatiramer acetate in accordance with guidelines of the UK Association of British Neurologists. Main outcome measures Observed utility weighted progression in disability at two years' follow-up assessed on the expanded disability status scale (EDSS) compared with that expected by applying the progression rates in a comparator dataset, modified for patients receiving treatment by multiplying by the hazard ratio derived separately for each disease modifying treatment from the randomised trials. Results In the primary per protocol analysis, progression in disability was worse than that predicted and worse than that in the untreated comparator dataset ("deviation score" of 113%; excess in mean disability status scale 0.28). In sensitivity analyses, however, the deviation score varied from -72% (using raw baseline disability status scale scores, rather than applying a "no improvement" algorithm) to 156% (imputing missing data for year two from progression rates for year one). Conclusions It is too early to reach any conclusion about the cost effectiveness of disease modifying treatments from this first interim analysis. Important methodological issues, including the need for additional comparator datasets, the potential bias from missing data, and the impact of the "no improvement" rule, will need to be addressed and long term follow-up of all patients is essential to secure meaningful results. Future analyses of the cohort are likely to be more informative, not least because they will be less sensitive to short term fluctuations in disability. [ABSTRACT FROM AUTHOR]

Presents letters to the editor on topics in medicine. View that medical journals should select drug advertisements more carefully; Opinion that medical charities and patient groups should declare any special interests; Observation that this journal may have hyped the CURE study; Correction of a damaging impression by the British Thoracic Society; A shared scheme for assessing drugs for multiple sclerosis; Physicians and managers at the National Health Service; Discrimination in the discretionary points award scheme; Observation that walk-in medical centers are often the first line of contact for rape victims; Guidance of the General Medical Council on withholding life-prolonging treatment; Difficulty in balancing bioethics.

A strategy to revitalize coastal shipping within Great Britain is investigated. An examination of the regulatory environment shows government, at both the EU and British levels, aware of the environmental benefits of coastal shipping compared to road freight transport, if only mildly supportive in tangible terms. The geography of Great Britain and the modern preference for just-in-time deliveries have severely restricted the ability of coastal shipping to compete effectively with road freight transport. The primary objective of the paper is to investigate whether coastal shipping could be integrated into a multimodal door-to-door supply chain, where it is currently hampered by high costs of transhipment, slow transport speeds, and the incongruity of load sizes between land and sea modes. Integration requires the co-operation of all organizations within the multi-modal supply chain. However, coastal shipping companies have been known to be individualistic and mistrusting of alliances. Therefore, a Delphi study is undertaken to investigate the standpoint of leading managers in such companies towards multimodal integration. The results of the Delphi study indicate that managers are in favour of multimodal developments, in particular cooperation between coastal shipping and road haulage. However, there was agreement that the business is highly competitive, and this may prevent the forms of collaboration required for multimodal systems. The secretive nature of the coastal shipping sector could impede joint marketing to promote a mode of transport that is often 'invisible' to shippers. There was little consensus on the relationship that should exist between coastal shipping and ports, a topic worthy of further investigation. [ABSTRACT FROM AUTHOR]

Background: The physical management of violence in psychiatric in-patient settings is of great concern and interest. However, there are no guidelines concerning training providers, course content, or course length, and little is known about injuries to staff during training. Aim: To investigate training in physical restraint in Psychiatric Intensive Care Units (PICUs) and Regional Secure Units (RSUs) in England and Wales, with a view to comparing course content and length, and injuries in training across the training providers cited by respondents. Method: Questionnaires were completed by randomly selected PICU and RSU nursing staff on 63 participating wards (of a total of 112 such wards in England and Wales). Results: 338 nurses (47% response rate) replied. Training in a wide variety of techniques was reported, although in practice a core curriculum can be identified. Few respondents were able to state which provider conducted their initial training. The reported length of initial training courses and required frequency of refresher training was variable, and refresher training had not always been conducted within the previous year. Less frequently used techniques were reported as taught to a large number of respondents that were infrequently used in practice. Some key aspects of patient safety (e.g. positional asphyxia) were reported as not covered by some respondents. Nearly a third of respondents reported being hurt in training, although injuries requiring medical treatment were rare. Discussion: It appears that in practice a core curriculum is taught despite a lack of course standardisation. When these core elements are taught, training is also more likely to include theoretical aspects of the prevention and management of violence, as well as safety and ethical aspects. Reported confidence in the respondents' ability to use in practice the techniques that they have been taught was found to be related to whether they had been trained in the core curriculum and not to duration of training. Conclusion: Further research needs to be conducted on a wider range of adult inpatient nursing staff, preferably of a prospective nature, before a sufficient evidence base will be available to guide purchasers and upon which national guidance and standards can be based. [ABSTRACT FROM AUTHOR]

Examines the relation between mortality and the smoking habits of women doctors in Great Britain. Effects of cigarette smoking; Female death rates caused by smoking habits; Features of the smoking habits of men and women.

Assesses the risk of death associated to consumption of alcohol in Great Britain. Examination of British male doctors; Relation between all cause of mortality and the average amount of alcohol; Conclusion that consumption of alcohol reduces the risk of ischemic heart disease. INSET: Public health implications.

Examines the number of mortality associated to smoking in Great Britain. Assessment of British male doctors; Association of respiratory diseases to smoking; Conclusion on the hazards of long term use of tobacco. INSET: Clinical implications.

359 eligible children with acute myeloid leukaemia (AML) entered the MRC AML 10 trial between May 1988 and March 1995. Patients received four courses of intensive induction and consolidation chemotherapy, with or without subsequent autologous (A-BMT) or allogeneic (allo-BMT) bone marrow transplant. There were randomized comparisons of thioguanine versus etoposide in induction and of A-BMT versus not. Allo-BMT was recommended for patients with a HLA-matched sibling and was evaluated by donor versus no donor comparison. The complete remission rate was 92%. In first remission there were 20 deaths during consolidation chemotherapy and 11 after BMT (8/61 allo-BMTs, 1/60 A-BMTs and 2/4 matched unrelated donor transplants). The relapse rate was low, decreasing from 26% in the first year to 2% in the fourth. Long-term outcome was excellent with survival at 7 years from entry of 56% and event-free survival of 48%. There were no significant differences between thioguanine and etoposide, whereas both A-BMT and allo-BMT reduced relapse risk but did not produce a significant survival benefit. It appears that over half the children entered into AML 10 are cured, a result which compares favourably with other reported series. We conclude that four courses of intensive chemotherapy are an effective approach to the treatment of paediatric AML, which avoids the acute toxicity and long-term side-effects of BMT and also avoids the need for prolonged maintenance therapy or cranial irradiation. [ABSTRACT FROM AUTHOR]

Presents several letters related to medicine in Great Britain. Management of parental leaves among medical personnel; Complications of artificial ultraviolet radiation exposures; Examination of skin reactions on diphosphonate drugs.

Abstract: Clinical guidelines aim to assist health workers and service users in making effective decisions about the care and treatment of specific clinical conditions. Guidelines should be based on the best available evidence and are a way of bridging the gap between academic research and everyday practice. Despite evidence that their implementation can have a positive impact on the process of clinical decision making there has been much debate about the quality of clinical guidelines. In England and Wales it is NICE that has led the development of national guidelines, the first of which were the schizophrenia guidelines published in 2002. Guideline development follows a rigorous, inclusive and consultative process. The guideline addresses the major treatments and services for people with schizophrenia and is evidence based; each recommendation is graded based on the quality of supporting evidence. Implementation of the schizophrenia guidelines represents a major opportunity for clinicians and local health communities [Copyright &y& Elsevier]

Objective: To determine the current use of and the indications for laparoscopic uterine nerve ablation (LUNA) in the UK, and to establish practitioners' views regarding the desirability of a controlled clinical trial to assess the efficacy of LUNA. Setting: Gynaecologists associated with the British Society of Gynecological Endoscopy. Design A self-administered structured questionnaire was posted to 457 UK gynaecologists. Their surgical practice and willingness to participate in a randomized trial were surveyed. The postal questionnaire was returned by 249 (55% response rate). Results: The survey indicated that 113 (45%) of the responders performed LUNA. Of these, 86 (76%) carried out LUNA for chronic pelvic pain, 72 (64%) for endometriosis, and 16 (14%) for dyspaurenia/dysmenorrhoea. Diathermy was used as the surgical tool by 66 (59%) gynaecologists and laser was used by 57 (51%). Of the 113 currently using LUNA, 91 (81%) were willing to enter patients into a proposed clinical trial of LUNA. Conclusion: Current clinical practice regarding LUNA for pelvic pain is hung in equipoise. This means that the technique has been introduced without reliable evidence of efficacy but opinion regarding its use is not yet solidified. Hence, a rigorous randomized trial of LUNA's efficacy is urgently needed and is practicable. [ABSTRACT FROM AUTHOR]

The author discusses the efforts of Great Britain-based Centre for the Advancement of Interprofessional Education for improving interprofessional education (IPE) and shortcomings in patient care and safety in Great Britain. Topics include organizing presentations at universities to raise awareness of IPE among students; promoting publications that offer information regarding IPE; and participating in conferences and workshops related to IPE organized across the globe.

Focuses on the issue concerning the prescriptive authority for mental health nurses dealing with acute extrapyramidal symptoms in Great Britain. Advantage of the prescriptive authority to both nurses and patients; Impact of nurse prescribing on clinical outcomes; Efforts to establish guidelines for prescribing practices.

Artificial intelligence (AI) can predict the presence of molecular alterations directly from routine histopathology slides. However, training robust AI systems requires large datasets for which data collection faces practical, ethical and legal obstacles. These obstacles could be overcome with swarm learning (SL), in which partners jointly train AI models while avoiding data transfer and monopolistic data governance. Here, we demonstrate the successful use of SL in large, multicentric datasets of gigapixel histopathology images from over 5,000 patients. We show that AI models trained using SL can predict BRAF mutational status and microsatellite instability directly from hematoxylin and eosin (H&E)-stained pathology slides of colorectal cancer. We trained AI models on three patient cohorts from Northern Ireland, Germany and the United States, and validated the prediction performance in two independent datasets from the United Kingdom. Our data show that SL-trained AI models outperform most locally trained models, and perform on par with models that are trained on the merged datasets. In addition, we show that SL-based AI models are data efficient. In the future, SL can be used to train distributed AI models for any histopathology image analysis task, eliminating the need for data transfer., (© 2022. The Author(s).)

Background: The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis ® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported., Objectives: To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas., Design: A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial., Setting: Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland., Participants: Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin., Interventions: Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]., Main Outcome Measures: The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness., Results: Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000., Limitations: Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up., Conclusions: The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS., Future Work: Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment., Trial Registration: Current Controlled Trials ISRCTN78352529., 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. 23, No. 21. See the NIHR Journals Library website for further project information., Competing Interests: David G Jayne was a member of the Health Technology Assessment (HTA) Surgery Themed Call Board from 2012 to 2013 and a member of the Efficacy and Mechanism Evaluation Strategy Group from 2015 to 2018. John Scholefield was a member of the HTA Surgery Themed Call Board from 2012 to 2013. Claire T Hulme was a member of the HTA Commissioning Board from 2012 to 2017.

Background: Very late (aged ≥60 years) onset schizophrenia-like psychosis occurs frequently but no placebo-controlled, randomised trials have assessed the efficacy and risks of antipsychotic treatment. We investigated whether low-dose amisulpride (100 mg daily) is superior to placebo in reducing psychosis symptoms over 12 weeks and whether any benefit is maintained by continuing treatment after 12 weeks., Methods: The ATLAS double-blind controlled trial enrolled participants from 25 old age psychiatry services in the UK. Eligible participants (ie, those with a diagnosis of very late-onset schizophrenia-like psychosis and a Brief Psychiatric Rating Scale [BPRS] score of ≥30, without cognitive impairment) were randomly assigned (1:1:1) to one of three groups in a two-stage trial: amisulpride in stage 1 and 2 (group A), amisulpride then placebo (group B), or placebo then amisulpride (group C). Treatment (100 mg oral amisulpride daily vs placebo) was given for 12 weeks in stage 1 and, initially, 24 weeks then reduced to 12 weeks in stage 2. Participants, investigators, and outcome assessors were masked to treatment allocation. Primary outcomes were psychosis symptoms assessed by the BPRS at 4, 12, and 24, or 36 weeks, and trial treatment discontinuation for non-efficacy. The primary, secondary, and safety endpoints were all analysed in participants given at least one dose of study treatment in modified intention-to-treat analyses. This study is registered with EudraCT, number 2010-022184-35, and ISRCTN, number ISRCTN45593573., Findings: Between Sept 27, 2012, and June 28, 2016, we recruited 101 participants. 92 (91%) of 101 participants took trial medication, of whom 59 (64%) completed stage 1 and 34 (58%) of these 59 participants completed stage 2 treatment. Despite suboptimal compliance, improvements in BPRS scores at 12 weeks were 7·7 points (95% CI 3·8-11·5, p=0·0002) greater with amisulpride (mean 11·9 points [SE 1·3]) than with placebo (4·2 points [1·0]). In stage 2, BPRS scores improved by a mean of 1·1 points (1·6) from 12 weeks to the final assessment in those who continued amisulpride but deteriorated by 5·2 points (2·0) in those who switched from amisulpride to placebo (difference 6·3 points [95% CI 0·9-11·7], p=0·024). Fewer participants who were allocated amisulpride than placebo stopped treatment because of non-efficacy in stage 1 (p=0·010) and stage 2 (p=0·031). Serious adverse events were reported more frequently in the amisulpride group than in the placebo group in stage 1 (p=0·057) and stage 2 (p=0·19). The most common serious adverse events were infection (five patients in the amisulpride group, three in the placebo group) and extrapyramidal side-effects (three patients in the amisulpride group, none in the placebo group). Five patients died during the study, one from a gastric ulcer bleed before treatment started (group B), two while taking stage 2 treatment (one in group A and one in group C), and two who stopped trial treatment in stage 1 and died many weeks later (one in group B and one in group C). No deaths were related to treatment., Interpretation: Low-dose amisulpride is effective and well tolerated as a treatment for very late-onset schizophrenia-like psychosis, with benefits maintained by prolonging treatment., Funding: UK National Institute for Health Research., (Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)