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In medical negligence litigation, the standard for breach of duty is measured against the Bolam test which reflects accepted practice. Despite protracted debate and common law development, the Bolam standard remains the touchstone for litigation in this area. Clinical guidelines (CGs) are statements based upon best available medical evidence and are designed to facilitate clinical decision-making to optimise outcomes thereby reflecting expected practice. Nevertheless, there is little research that considers how CGs engage in litigation and their influence on judicial reasoning. Given the increasing pressures on the NHS amid rising costs of litigation, these are important issues. This study provides an original contribution to the literature on CGs in determining breach of duty in law. Using a mixed methods' approach, data from multiple sources have been gathered and analysed to assess the use of CGs by lawyers and the courts thereby adding to the discourse on the judicial shift away from deference to Bolam. It concludes by offering a conceptual basis for the use of CGs within a framework for reasonableness and promotes their principled use while avoiding constraints on expert testimony, experience, and exercise of clinical discretion. This study has relevance for academics, legal and medical practitioners, and policy makers. [ABSTRACT FROM AUTHOR]

Purpose: To gain a better understanding of eye care professionals' (ECPs) perceptions regarding the benefits of silicone hydrogel (SiH) daily disposable contact lenses (DDCL), particularly with respect to health, comfort and patient satisfaction.Methods: A survey was conducted with 300 ECPs in the United States, United Kingdom and Japan during November 2017. The survey comprised 34 statements relating to SiH DDCLs, to which the ECPs provided their level of agreement using a 6 point Likert scale. A minimum of 70% agreement was set to define majority agreement. Categories of statements included Health, Comfort, Patient Experience, and Standard of Care.Results: ECPs rated the highest levels of agreement to perceptions within the Patient Experiences and Health categories. The six statements receiving the highest ratings were "Silicone hydrogel 1 day lenses satisfy today's patients' demanding lifestyles" (93% agreement); "Silicone hydrogel 1 day lenses are the best choice to safeguard my patients' eye health related to contact lens wear" (92%); "Silicone hydrogel 1 day lenses provide the best benefits to my patients" (92%); "Silicone hydrogel 1 day lenses provide better long term eye health for my patients than hydrogel 1 day lenses" (91%); "Silicone hydrogel is the healthiest lens material for my daily disposable patients" (90%); and "Silicone hydrogel 1 day lenses provide a better wearing experience for my patients than hydrogel 1 day lenses" (90%).Conclusion: ECPs perceive that SiH DDCLs offer long-term eye health
and comfort for the patient and although the ECPs surveyed would not necessarily prescribe SiH DDCLs to all their patients, they would prescribe them to most of their patients. The results support the premise that while ECPs consider SiH 1 day contact lenses as the current "standard of care"; the principal barrier continues to be the perceived higher cost of these lenses. [ABSTRACT FROM AUTHOR]

Background: The concept "standard of care" (SOC) is invoked in legal cases, as well as evidence-based, and professional/ethical discussions in medicine and surgery. Methods: We reviewed key legal cases and relevant evidence-based medical articles, and then explored the implications for professional societies seeking to set guidelines for their members testifying as expert witnesses. Results: First, the legal concept of SOC plays a role in malpractice cases in assessing whether a physician's behavior was "within the SOC." The concept of SOC has evolved from a "standard of a responsible body of medical opinion" (Bolam case), which implicitly did not allow for multiple SOC, to a more evidence-based approach. Second, according to the evidence-based medical literature, there is more than one SOC in medicine and surgery, including neurosurgery. Third, professional, medical, and surgical societies have evoked the concept of SOC to set ethical guidelines for how their members should behave when testifying as expert witnesses. Specifically, the literature argues societies should avoid abusing singular, self-serving definitions of the SOC to sanction members, typically plaintiff's experts, who offer alternative SOC in depositions or in court. Conclusions: Recent legal decisions suggest that testimony should be based upon scientific evidence. The scientific evidence indicates that there is often more than one SOC. Thus, any subspecialty society, including the American Association of Neurological Surgeons, that ignores evidence-based medicine and the existence of multiple SOC, risks the appearance of fostering self-interest at the expense of patient care. [ABSTRACT FROM AUTHOR]

Aim: Due to extensive treatment switching in the MAVORIC trial, lack of UK regulatory licence for the comparator, overall survival (OS) with mogamulizumab was compared with patients with previously treated advanced mycosis fungoides/Sézary syndrome (MF/SS) in real-world setting. Design, setting & participants: Data were from the Hospital Episode Statistics database (all patients in NHS secondary care system in 2009-2019). Patients were selected according to trial inclusion criteria, then trial and HES samples were matched on selected variables with significant imbalance. Outcomes: The analysis indicated significant improvement in OS for mogamulizumab treatment compared with UK clinical practice (hazard ratio: 0.36, 95% CI: 0.24, 0.53). Conclusion: Results suggest an OS advantage for patients with advanced MF/SS treated with mogamulizumab in MAVORIC trial compared with UK clinical practice.

Acute stroke care has undergone momentous changes in recent years with the introduction of intravenous thrombolysis, mechanical thrombectomy and integrated stroke services. While these are welcome developments, they also carry unique medico-legal challenges. In 2015, a patient from Greater Manchester was awarded over £1 million in compensation after ambulance paramedics failed to admit her to a specialist unit. This paper explores the medico-legal implications of this first but over looked thrombolysis-related claim in the United Kingdom. It is submitted that the highly time-dependent and multidisciplinary nature of acute stroke care may expose a host of healthcare personnel, both medical and non-medical, to risks of legal pursuit for failing to provide appropriate care, and that available scientific evidence will likely support such claims. The situation calls for an urgent and concerted effort at implementing improvement measures at national levels. A reminder of the legal consequences of substandard acute stroke care is timely and necessary. [ABSTRACT FROM AUTHOR]

The cost of negligence claims in the NHS continues to rise, with NHS England alone paying out some £1.75 billion in compensation last year (NHS Resolution, 2018). Negligence law concerns liability for careless acts or omissions that harm another in breach of a duty of care (Sidaway v Bethlem Royal Hospital [1985]). To minimise the risk of liability it is essential that district nurses are aware of the circumstances that give rise to a duty of care and the standard expected of them in discharging their duty. [ABSTRACT FROM AUTHOR]

The article examines the nature of the duty of board directors to act in good faith in Great Britain.

Background: Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma., Methods: This international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m 2 by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40-50 mg/m 2 by body surface area once every 4 weeks; intravenous topotecan 4 mg/m 2 by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, and is active but not recruiting., Findings: Between Feb 27, 2014, and April 10, 2018, 260 patients were enrolled and randomly assigned to the trametinib group (n=130) or the standard-of-care group (n=130). At the primary analysis, there were 217 progression-free survival events (101 [78%] in the trametinib group and 116 [89%] in the standard-of-care group). Median progression-free survival in the trametinib group was 13·0 months (95% CI 9·9-15·0) compared with 7·2 months (5·6-9·9) in the standard-of-care group (hazard ratio 0·48 [95% CI 0·36-0·64]; p<0·0001). The most frequent grade 3 or 4 adverse events in the trametinib group were skin rash (17 [13%] of 128), anaemia (16 [13%]), hypertension (15 [12%]), diarrhoea (13 [10%]), nausea (12 [9%]), and fatigue (ten [8%]). The most frequent grade 3 or 4 adverse events in the standard-of-care group were abdominal pain (22 [17%]), nausea (14 [11%]), anaemia (12 [10%]), and vomiting (ten [8%]). There were no treatment-related deaths., Interpretation: Trametinib represents a new standard-of-care option for patients with recurrent low-grade serous carcinoma., Funding: NRG Oncology, Cancer Research UK, Target Ovarian Cancer, and Novartis., Competing Interests: Declaration of interests DMG reports payments made to his institution from the National Cancer Institute (NRG Oncology), Novartis, and the GOG Foundation for this study; royalties or licenses from Elsevier and UpToDate outside the submitted work; consulting fees from Genentech outside the submitted work; personal fees for service as a member of the Committee of the National Cancer Institute outside the submitted work; and stock or stock options from Johnson & Johnson, Bristol Myers Squibb, and Biogen outside the submitted work. AM reports service as a masked study statistician for VBL Therapeutics; provision of statistical institutional support for Advaxis; service as a data safety monitoring board reporting statistician for Regeneron; and service on a study steering committee for Genentech and AstraZeneca, all outside the submitted work. RLC reports consulting fees from AstraZeneca, Merck–GlaxoSmithKline, and Clovis; grants from Genmab, Genentech–Roche, Janssen, Agenus, Regeneron, and OncoQuest; payments or honoraria for lectures, presentations, speaker's bureaus, manuscript writing, or educational events from AstraZeneca, Merck–GlaxoSmithKline, and Clovis; and service on a data safety monitoring board or an advisory board for Janssen, VBL Therapeutics, and AstraZeneca, all outside the submitted work. KNM reports service on advisory boards for Alkemeres, AstraZeneca, Aravive, Blueprint Medicines, Eisai, Elevar, GlaxoSmithKline–Tesaro, Genentech–Roche, Hengrui, Immunogen, IMab, Merck, Mereo, Mersana, Myriad, OncXerna, Onconova, Novartis, Sorrento, Tarveda, and VBL Therapeutics, all outside the submitted work; grant funding from PTC Therapeutics, Lilly, Merck, and Genentech–Roche outside the submitted work; funding paid to her institution from Cyteir, Immunocore, Bolt Bio, Amgen, Artios, GlaxoSmithKline–Tesaro, Mereo, Regeneron, Aravive, Verastem, and AstraZeneca, for all of which she also serves as a local principal investigator; serving as national principal investigator for the IMaGYN050 trial of ovarian cancer (Genentech–Roche), the MIRASOL trial of ovarian cancer (Immunogen), the Relevare study of ovarian cancer (OncXerna), the FIRST study of ovarian cancer (GlaxoSmithKline–Tesaro), and the ETCTN 10422 study of ovarian cancer (National Cancer Institute); being the associate director for GOG Partners, on the GOG Foundation board of directors, and the NRG Oncology chair of the ovarian cancer committee; and receiving speaking reimbursement from PER, Research to Practice, Medscape, Great Debates and Updates, and Gyn Mal, all of which are outside the scope of this work but were active during the conduct of this study. SB reports grants paid to their institution from AstraZeneca, Tesaro, and GlaxoSmithKline; personal fees for participation in advisory boards from Amgen, AstraZeneca, Genmab, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Merck Serono, Mersana, Oncxerna, Seagen, Shattuck Lab, and Epsilogen; and personal fees for lectures from Amgen, AstraZeneca, Clovis, GlaxoSmithKline, Immunogen, Merck Sharp & Dohme, Mersana, Pfizer, Roche, and Takeda, all outside the submitted work. AAS reports a National Cancer Trial Network grant; grants paid to her institution from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Clovis, Eisai, Immutep, Merck, OncoQuest, PharmaMar, Genentech–Roche, Seagen, Tesaro–GlaxoSmithKline, and VBL Therapeutics; consulting fees from Aravive, AstraZeneca, Clovis, Cordgenics, Eisai, Merck, Mersana, Myriad, Oncoquest, Genentech–Roche, and Tesaro–GlaxoSmithKline; presentations for educational events on cervical cancer sponsored by Research to Practice; service on advisory boards (uncompensated) for AbbVie and Regeneron; service on clinical trial steering committees (all uncompensated) for the AtTEnd trial (Hoffman-LaRoche), the Oval Trial (VBL Therapeutics), and the FLORA-5 trial (Oncoquest); and service on the GOG Foundation Board of Directors, the Society of Gynecologic Oncology Board of Directors, and the American Association of Obstetricians and Gynecologists Foundation Board of Trustees, all outside the submitted work. DMO reports National Cancer Institute support for this clinical trial; research funding paid to their institution from AstraZeneca, Tesaro–GlaxoSmithKline, Immunogen, Janssen–Johnson & Johnson, AbbVie Regeneron, Amgen, Novocure, Genentech–Roche, VentiRx Array Biopharma EMD Serono, Ergomed, Ajinomoto, Ludwig Cancer Research Stemcentrx, Cerulean Pharma, the GOG Foundation, the National Cancer Institute, Bristol Myers Squibb, C Serono, TRACON Pharmaceuticals, Yale University, New Mexico Cancer Care Alliance, inVentiv Health Clinical, Iovance Biotherapeutics, PRA Intl, Eisai, Agenus, Merck, GenMab, SeaGen, Mersana, and Clovis; personal fees for consulting or advisory board membership, or both, from AstraZeneca, Tesaro–GlaxoSmithKline, Immunogen, Ambry, Janssen–Johnson & Johnson, BBI, Agenus, AbbVie, Regeneron, Amgen, Novocure, Genentech–Roche, GOG Foundation, Iovance Biotherapeutics, Myriad Genetics, Eisai, Agenus, Tarveda, Merck, SeaGen, Novartis, Mersana, Clovis, Rubius, and Elevar, all outside the submitted work. OD reports grants or contracts from AstraZeneca, Clovis, Genentech, AbbVie, IMV, Millenium, and Pharmamar; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Tesaro–GlaxoSmithKline and AstraZeneca; payment for expert testimony in one legal case unrelated to the current study; and participation on a data safety monitoring board or advisory board for Merck, Clovis, PACT, and Genentech, all outside the submitted work. SG reports financial support paid to her institution for the present study from the National Clinical Trials Network; grants or contracts from AstraZeneca, AbbVie, Pfizer, Rigel, Iovance, Tesaro, Genentech–Roche, PharmaMar, and GlaxoSmithKline; patents licensed to Sermonix (US patent numbers 10,905,659 and 10,258,604); participation on a data safety monitoring board or advisory board for Sermonix, Elevar Therapeutics, and GlaxoSmithKline; and service as an NRG Oncology phase 1 subcommittee co-chair, all outside the submitted work. BS reports personal fees for service on advisory boards for Abbvie, AstraZeneca, Bostongene, Clovis, Eisai, Genentech, GlaxoSmithKline, Jazz Pharmaceticals, Lilly, Merck, Myriad, Novartis, Nuvation, Onconova, and Seagen; and consulting for the GOG Foundation, all outside the submitted work. AE reports grants or contracts from UKRI for a post-doctoral fellowship outside the submitted work. CG reports grants from GlaxoSmithKline and Novartis for this study (trametinib, the test drug, was sold by GlaxoSmithKline to Novartis during the course of the study). WEB, JP, KCa, WR, DM, KCo, HG, PH, JF, MC, RLH, CSH, HQH, and LW declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objectives: DRAKO (NCT02850263) is a 24-month, prospective, non-interventional, multi-centre cohort study which enroled patients diagnosed with centre-involving diabetic macular oedema (DMO). The study aims to evaluate standard of care with intravitreal aflibercept (IVT-AFL) treatment in the UK. This analysis describes the anti-vascular endothelial growth factor (anti-VEGF) treatment-naive patient cohort after 12-month follow-up., Methods: Study eyes were treated with IVT-AFL as per local standard of care. The mean change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline at 12 months were measured and stratified by baseline factors. The number of injections and safety data were also evaluated., Results: A total of 507 patients were enroled from 35 centres. Mean (SD) baseline BCVA was 71.4 (12.0) letters and CST was 448.7 (88.7) µm, with 63.1% of patients presenting with baseline BCVA ≥ 70 letters (mean 78.1). Mean (SD) change in BCVA of 2.5 (12.2) letters and CST of -119.1 (116.4) µm was observed at month 12. A 7.3 letter gain was observed in patients with baseline BCVA < 70 letters. Mean number (SD) of injections in year one was 6.4 (2.1). No significant adverse events were recorded., Conclusion: Year one results indicated that IVT-AFL was an effective treatment for DMO in standard of care UK clinical practice, maintaining or improving visual acuity in treatment-naive patients with good baseline visual acuity, despite some patients being undertreated versus the summary of product characteristics. These results also demonstrated the clinical importance and meaningful impact of diabetic retinopathy screening in the UK., (© 2021. The Author(s).)

Background: Predict Prostate is a freely available online personalised risk communication tool for men with nonmetastatic prostate cancer. Its accuracy has been assessed in multiple validation studies, but its clinical impact among patients has not hitherto been assessed., Objective: To assess the impact of the tool on patient decision-making and disease perception., Design, Setting, and Participants: A multicentre randomised controlled trial was performed across eight UK centres among newly diagnosed men considering either active surveillance or radical treatment. A total of 145 patients were included between 2018 and 2020, with median age 67 yr (interquartile range [IQR] 61-72) and prostate-specific antigen 6.8 ng/ml (IQR 5.1-8.8)., Intervention: Participants were randomised to either standard of care (SOC) information or SOC and a structured presentation of the Predict Prostate tool., Outcome Measurements and Statistical Analysis: Validated questionnaires were completed by assessing the impact of the tool on decisional conflict, uncertainty, anxiety, and perception of survival., Results and Limitations: Mean Decisional Conflict Scale scores were 26% lower in the Predict Prostate group (mean = 16.1) than in the SOC group (mean = 21.7; p = 0.027). Scores on the "support", "uncertainty", and "value clarity" subscales all favoured Predict Prostate (all p < 0.05). There was no significant difference in anxiety scores or final treatment selection between the two groups. Patient perception of 15-yr prostate cancer-specific mortality (PCSM) and overall survival benefit from radical treatment were considerably lower and more accurate among men in the Predict Prostate group (p < 0.001). In total, 57% of men reported that the Predict Prostate estimates for PCSM were lower than expected, and 36% reported being less likely to select radical treatment. Over 90% of patients in the intervention group found it useful and 94% would recommend it to others., Conclusions: Predict Prostate reduces decisional conflict and uncertainty, and shifts patient perception around prognosis to be more realistic. This randomised trial demonstrates that Predict Prostate can directly inform the complex decision-making process in prostate cancer and is felt to be useful by patients. Future larger trials are warranted to test its impact upon final treatment decisions., Patient Summary: In this national study, we assessed the impact of an individualised risk communication tool, called Predict Prostate, on patient decision-making after a diagnosis of localised prostate cancer. Men were randomly assigned to two groups, which received either standard counselling and information, or this in addition to a structured presentation of the Predict Prostate tool. Men who saw the tool were less conflicted and uncertain in their decision-making, and recommended the tool highly. Those who saw the tool had more realistic perception about their long-term survival and the potential impact of treatment upon this., Take Home Message: The use of an individualised risk communication tool, such as Predict Prostate, reduces patient decisional conflict and uncertainty when deciding about treatment for nonmetastatic prostate cancer. The tool leads to more realistic perceptions about survival outcomes and prognosis., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

In Brady v Southend University Hospital NHS Trust, the High Court was asked to consider the applicability of Bolam and Bolitho principles in a so-called 'pure diagnosis' claim. The claimant suffered from the long-term effects of an undiagnosed bacterial infection after presenting at the defendant hospital with acute appendicitis. It was argued by claimant's counsel that where the primary allegation of fault concerns diagnosis, no issues of acceptable practice arise and therefore Bolam and Bolitho do not apply. Rejecting this, the High Court confirmed the applicability of Bolam and Bolitho and found that the defendant hospital had not been negligent. Initially, this result may signal a continued deference towards those in the medical profession, however, it is suggested that an alternative reading evidences a case which lays the groundwork for reconsidering the doctor-patient relationship in the context of treatment and diagnosis actions., (© The Author(s) 2021. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

The coronavirus disease 2019 (COVID-19) pandemic has significantly affected people at the end of life who are being cared for in community settings, as well as their families and the nurses who provide care. This article explores the challenges generated by the COVID-19 pandemic in relation to community end of life care in the UK and reflects on the psychological and emotional consequences for nurses, patients and families. It also discusses some of the fundamental aspects of end of life care in the community and explores how nursing interventions can be adapted to ensure that high standards of care are maintained. The pandemic may provide opportunities for transforming community end of life care and there is a need for further research into how health and social care services have adapted, which would inform future care planning and service provision., Competing Interests: None declared, (© 2021 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.)

The UK has the highest incidence of mesothelioma in the world, but services vary across the country partly due to uneven geographical distribution of cases. The Mesothelioma UK-funded national organisational audit has highlighted challenges in accessing diagnostic procedures such as thoracoscopy, as well as identifying examples of best practice, including access to clinical trials and specialist therapeutic procedures. To ensure equitable and optimal patient care, cancer alliances should have established referral pathways to specialist multidisciplinary team (MDT) services for discussion of all mesothelioma patients.

Fertility societies worldwide responded to the COVID-19 pandemic by recommending that fertility clinics close, or sharply reduce, the clinical operation, leading to a shift in the management of IVF laboratories in three phases: shutdown preparation; maintenance during shutdown; and restart. Each of these phases carries distinct risks that need identification and mitigation, forcing laboratory managers to rethink and adapt their procedures in response to the pandemic. The sudden and unprecedented nature of the pandemic forced laboratory managers from around the world to base decisions on opinion and experience when evidence-based response options were unavailable. These perspectives on pandemic response were presented during a virtual international symposium on COVID-19, held on 3 April 2020, and organized by the London Laboratory Managers' Group. Laboratory managers from seven different countries at different stages of the pandemic (China, Italy, Spain, France, UK, Brazil and Australia) presented their personal experiences to a select audience of experienced laboratory managers from 19 different countries. The intention of this paper is to collect the learnings and considerations from this group of laboratory managers who collaborated to share personal experiences to contribute to the debate surrounding what constitutes good IVF laboratory practice in extraordinary circumstances, such as the COVID-19 pandemic., (Copyright © 2020 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Background: Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care., Methods: In this open-label, randomised controlled trial, adults (aged 16-55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659., Findings: Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0-3]) than in the 113 with available data who received standard care (4 days [IQR 0-8]; p<0·0001; median difference 2 days [95% CI 1-3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging., Interpretation: Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention., Funding: UK National Institute for Health Research., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Managing elderly, frail patients with orthopaedic injuries, remains a challenge. Their poor bone stock and associated comorbidities makes this special cohort of patients unique in terms of their needs and the risk of developing complications. Published on line in 2019 (www.boa.ac.uk/uploads/assets/04b3091a-5398-4a3c-a01396c8194bfe16/the%20care%20of%20the%20older%20or%20frail%20orthopaedic%20trauma%20patient.pdf) the British Orthopaedic Association's Standards for Trauma focusing on the care of the older or frail patient with orthopaedic injuries, provides a contemporary guide for the holistic management of the spectrum of injury and pre-existing needs of this population., (Copyright © 2020 William Eardley. Published by Elsevier Ltd.. All rights reserved.)

Staphylococcus aureus bacteraemia (SAB) continues to affect ∼25,000 patients in the UK per year with a high crude mortality of 30% at 90 days. Prompt source control improves outcomes in sepsis and SAB and is included in sepsis guidelines. A recent clinical trial of adjunctive antibiotic treatment in SAB found that the majority of recurrences of SAB were associated with a failure of source management. In this condition, the ability to control the source of infection may be limited by the ability to detect a focus of infection. Echocardiogram is now a routinely used tool to detect such unknown foci in the form of unexpected infectious vegetations. We review the literature to explore the utility of advanced imaging techniques, such as [18F]fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) and magnetic resonance imaging (including whole-body MRI), to detect foci which may otherwise be missed. As unknown foci are associated with increased mortality, we propose that increasing the detection of foci could enable improved source control and result in improved outcomes in SAB., (Copyright © 2020. Published by Elsevier Ltd.)

Objective: To determine the cost-effectiveness/utility of a superabsorbent wound dressing (Zetuvit Plus Silicone) versus the current standard of care (SoC) dressings, from the NHS perspective in England, in patients with moderate-to-high exudating leg ulcers., Method: A model-based economic evaluation was conducted to analyse the cost-effectiveness/utility of a new intervention. We used a microsimulation state-transition model with a time horizon of six months and a cycle length of one week. The model uses a combination of incidence base and risk prediction approach to inform transition probabilities. All clinical efficiency, health-related quality of life (HRQoL), cost and resource use inputs were informed by conducting a systematic review of UK specific literature., Results: Treatment with the superabsorbent dressing leads to a total expected cost per patient for a six month period of £2887, associated with 15.933 expected quality adjusted life weeks and 10.9% healing rate. When treated with SoC, the total expected cost per patient for a six month period is £3109, 15.852 expected quality adjusted life weeks and 8% healing rate. Therefore, the superabsorbent dressing leads to an increase in quality-adjusted life weeks, an increase in healing rate by 2.9% and a cost-saving of £222 per single average patient over six months. Results of several scenario analyses, one-way deterministic sensitivity analysis, and probabilistic sensitivity analysis confirmed the robustness of base-case results. The probabilistic analysis confirmed that, in any combination of variable values, the superabsorbent dressing leads to cost saving results., Conclusion: According to the model prediction, the superabsorbent dressing leads to an increase in health benefits and a decrease in associated costs of treatment.

It is an established principle that nurses owe their patients a duty of care, which incorporates a legal, an ethical and a professional duty. However, they must also meet the standard of care deemed necessary to maintain safe and effective delivery of care to patients. Defining what is meant by the standard of care is complex, and meeting it can be challenging in an increasingly pressurised healthcare environment. This article describes the standard of care required using previous legal cases. It also explores some of the challenges involved in defining the standard of care in a rapidly changing healthcare environment., Competing Interests: None, (© 2020 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.)

Background: The Cystic Fibrosis Trust recently published a standards of care document which stated that patients should be given a physical activity (PA) programme based on their motivations, fitness, and willingness to be active. However, there remains much debate regarding the roles and responsibilities for PA promotion, as well as "optimal" recommendations and advice. This study aimed to qualitatively explore cystic fibrosis (CF) multidisciplinary teams (MDTs) advice, recommendations and practices relating to PA promotion for adolescents with CF., Method: Semi-structured interviews were conducted with fifteen members of CF MDTs (11 physiotherapists, two dieticians and two paediatricians). Thematic analysis was used to analyse the data., Results: Major themes identified were: (1) structure of MDTs, (2) recommendations relating to intensities, durations and types of PA, and (3) use of exercise testing. Participants reported variation between MDTs in terms of who is responsible for promoting and supporting PA, the nature of advice given to patients, and the use of exercise testing. Participants consistently lacked confidence in their own or others' knowledge to provide standardised recommendations to patients and highlighted that PA promotion and support was often overlooked during busy periods., Conclusions: Despite its importance, PA support and promotion is not always prioritised. MDTs lack confidence in their ability to promote PA. Standardised advice and training relating to optimal intensities, durations and types of PA would provide a baseline from which to individualise advice to each patient and could increase confidence in PA promotion among MDTs., (Copyright © 2019 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.)

Background: The De-ESCALaTE HPV trial confirmed the dominance of cisplatin over cetuximab for tumour control in patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC). Here, we present the analysis of health-related quality of life (HRQoL), resource use, and health care costs in the trial, as well as complete 2-year survival and recurrence., Materials and Methods: Resource use and HRQoL data were collected at intervals from the baseline to 24 months post treatment (PT). Health care costs were estimated using UK-based unit costs. Missing data were imputed. Differences in mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs) were compared using the Wilcoxon signed-rank test and linear regression, respectively. Mean resource usage and costs were compared through two-sample t-tests., Results: 334 patients were randomised to cisplatin (n = 166) or cetuximab (n = 168). Two-year overall survival (97·5% vs 90·0%, HR: 3.268 [95% CI 1·451 to 7·359], p = 0·0251) and recurrence rates (6·4% vs 16·0%, HR: 2·67 [1·38 to 5·15]; p = 0·0024) favoured cisplatin. No significant differences in EQ-5D-5L utility scores were detected at any time point. At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin (95% CI: 0·186 to 0·029, p = 0·007) driven by the mortality difference. Health care costs were similar across all categories except the procurement cost and delivery of the systemic agent, with cetuximab significantly more expensive than cisplatin (£7779 [P < 0.001]). Consequently, total costs at 24 months PT averaged £13517 (SE: £345) per patient for cisplatin and £21064 (SE: £400) for cetuximab (mean difference £7547 [95% CI: £6512 to £8582])., Conclusions: Cisplatin chemoradiotherapy provided more QALYs and was less costly than cetuximab bioradiotherapy, remaining standard of care for nonsurgical treatment of HPV-positive OPSCC., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background The 100,000 Genomes Project aims to improve cancer care for NHS patients in the UK through personalised medicine. Our target is to return WGS results to clinicians in a clinically meaningful timescale to facilitate diagnosis and treatment choices for patients, and in parallel to provide a research platform of genomic data linked to longitudinal clinical data. Methods We present here an overview of clinical utility for reported outcomes. To date, bioinformatics reports for WGS, with links to potentially relevant therapies and UK clinical trials, have been produced for more than 14,000 cancer patients in the UK Currently our bioinformatics analysis of WGS includes clinical interpretation of somatic small variants, somatic structural and copy number variants (SV/CNV), germline pertinent findings, mutational burden and signatures. To iteratively develop a high-quality bioinformatics pipeline and to monitor clinical utility of returned results, we are collecting feedback via the 100,000 Genomes Project Interpretation Portal from NHS Molecular Tumour Boards. These data suggest that WGS has the potential to affect patient management. Future applications will include the utilisation of pan-genomic markers to better stratify patients within the context of a clinical study. Results WGS has the ability to replace multiple standard of care tests as it has the potential to detect all types of variants (SV/CNV/SNV/indels) as well as emerging pan-genome biomarkers in a single test. In this study we use samples submitted as part of the 100,000 Genomes Project to investigate the feasibility of WGS as an alternative to conventional testing. Overall comparison of WGS with the results of NGS panels (96 patients, 156 clinically-relevant SNVs), high-depth exome sequencing (10 patients, 3150 SNVs, 140 indels), cytogenetic FISH tests (70 patients, 259 SVs, 100 CNVs), immunohistochemistry tests for Mismatch Repair Deficiency (265 patients) and HER2 status (154 patients) demonstrated Positive Percentage Agreement > 90% and False Positive Rate < 5%. Conclusions Further work is required to validate fully all aspects of the WGS analysis pipeline but these results indicate that WGS can reliably detect clinically relevant biomarkers in the genomes of cancer patients. Legal entity responsible for the study Genomics England. Funding Genomics England. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

Background A rheumatology service evaluation was carried out in 2016 whereby we sought to understand whether children and young people (CYP) are receiving appropriate pain relief post-administration of steroid intra-articular injections (IAI's) and whether extended time waiting for IAI's increases CYP experience of pain. The British Society for Rheumatology BSPAR section Standard of Care for children and young people with JIA recommends 4 weeks or less waiting time for steroid IAI under general anaesthetic (GA) and 10 days or less for steroid IAI under entonox. Methods Data collection was obtained by patient questionnaire over a 4-month period. Parents/carers and CYP were asked to complete a questionnaire pre-steroid IAI (by a member of staff on the day of the IAI) and the same questionnaire post-steroid IAI (by telephone by the author within 2 weeks of the date of the IAI). Twenty parents/carers or CYP completed the questionnaires. Sixteen of the CYP were female and 4 were male. Median age was 3 years. Eighty percent had a diagnosis of oligoarticular juvenile idiopathic arthritis (JIA). Seventy-five percent had IAI's under GA and 25% with Entonox. Fifty-four percent had knee(s) injected and 23.5% had ankle(s) injected. Results Sixty percent of CYP waited for 4 weeks or less for steroid IAI under GA. Twenty percent of CYP waited for less than 10 days for steroid IAI under entonox. The range of pain scores for CYP pre IAI was 0-10 and the median was 5. Post IAI the range of pain scores was 0-8 and the median was 3. A positive correlation was found between those waiting longer for IAI's and higher pain scores. P17 Table 1: CYP experience of pain   Pre IAI  Post IAI  Pain in joints injected or due to be injected  95%  55%  CYP taking pain medication  85%  55%  Type of pain medication:      Diclofenac  10%  10%  Ibuprofen  25%  10%  Naproxen  5%  5%  Naproxen & codeine  5%  0%  Naproxen & oramorph  0%  5%  Paracetamol  10%  10%  Paracetamol & ibuprofen  30%  15%  None  15%  40%  Refusing  0%  5%  General activity affected  90%  60%  Pain medication required  80%  50%  Pain medication effective  80% (100% of CYP requiring medication)  50% (100% of CYP requiring medication)    Pre IAI  Post IAI  Pain in joints injected or due to be injected  95%  55%  CYP taking pain medication  85%  55%  Type of pain medication:      Diclofenac  10%  10%  Ibuprofen  25%  10%  Naproxen  5%  5%  Naproxen & codeine  5%  0%  Naproxen & oramorph  0%  5%  Paracetamol  10%  10%  Paracetamol & ibuprofen  30%  15%  None  15%  40%  Refusing  0%  5%  General activity affected  90%  60%  Pain medication required  80%  50%  Pain medication effective  80% (100% of CYP requiring medication)  50% (100% of CYP requiring medication)  P17 Table 1: CYP experience of pain   Pre IAI  Post IAI  Pain in joints injected or due to be injected  95%  55%  CYP taking pain medication  85%  55%  Type of pain medication:      Diclofenac  10%  10%  Ibuprofen  25%  10%  Naproxen  5%  5%  Naproxen & codeine  5%  0%  Naproxen & oramorph  0%  5%  Paracetamol  10%  10%  Paracetamol & ibuprofen  30%  15%  None  15%  40%  Refusing  0%  5%  General activity affected  90%  60%  Pain medication required  80%  50%  Pain medication effective  80% (100% of CYP requiring medication)  50% (100% of CYP requiring medication)    Pre IAI  Post IAI  Pain in joints injected or due to be injected  95%  55%  CYP taking pain medication  85%  55%  Type of pain medication:      Diclofenac  10%  10%  Ibuprofen  25%  10%  Naproxen  5%  5%  Naproxen & codeine  5%  0%  Naproxen & oramorph  0%  5%  Paracetamol  10%  10%  Paracetamol & ibuprofen  30%  15%  None  15%  40%  Refusing  0%  5%  General activity affected  90%  60%  Pain medication required  80%  50%  Pain medication effective  80% (100% of CYP requiring medication)  50% (100% of CYP requiring medication)  Conclusion In our small cohort, fifty percent of CYP required no pain medication post-IAI, and fifty percent of CYP who did require pain medication post-IAI perceived the pain medication they were receiving was adequate (Table 1). A positive correlation was found between CYP waiting longer for IAI's and CYP experiencing higher pain scores therefore, accepting our modest sample size, this service evaluation supports ensuring timely access to IAI and the avoidance of longer waiting times. Conflicts of Interest The authors declare no conflicts of interest. [ABSTRACT FROM AUTHOR]

In Darnley v Croydon Health Services NHS Trust [2018] UKSC 50, the Supreme Court held that a hospital receptionist's misleading statement about A&E waiting times constituted a breach of duty and that the claimant's decision, based on this misinformation, to leave the hospital did not break the chain of causation when he was left paralysed as a result of a head injury. In this commentary, I argue that while the Supreme Court's treatment of duty of care and breach is, for the most part, a model of doctrinal clarity, its treatment of the causation issue is problematic as it elides the test of whether there has been a break in the chain of causation with that for remoteness. I then comment on the Supreme Court's construction of the patient in medical negligence cases., (© The Author(s) 2018. Published by Oxford University Press; All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Introduction: Cauda equina syndrome (CES) is a potentially devastating condition caused by compression of the cauda equina nerve roots. This can result in bowel, bladder and sexual dysfunction plus lower limb weakness, numbness and pain. CES occurs infrequently, but has serious potential morbidity and medicolegal consequences. This study aims to identify and describe the presentation and management of patients with CES in the UK., Methods and Analysis: Understanding Cauda Equina Syndrome (UCES) is a prospective and collaborative multicentre cohort study of adult patients with confirmed CES managed at specialist spinal centres in the UK. Participants will be identified using neurosurgical and orthopaedic trainee networks to screen referrals to spinal centres. Details of presentation, investigations, management and service usage will be recorded. Both patient-reported and clinician-reported outcome measures will be assessed for 1 year after surgery. This will establish the incidence of CES, current investigation and management practices, and adherence to national standards of care. Outcomes will be stratified by clinical presentation and patient management. Accurate and up to date information about the presentation, management and outcome of patients with CES will inform standards of service design and delivery for this important but infrequent condition., Ethics and Dissemination: UCES received a favourable ethical opinion from the South East Scotland Research Ethics Committee 02 (Reference: 18/SS/0047; IRAS ID: 233515). All spinal centres managing patients with CES in the UK will be encouraged to participate in UCES. Study results will be published in medical journals and shared with local participating sites., Trial Registration Number: ISRCTN16828522; Pre-results., Competing Interests: Competing interests: JW reports grants from the Wellcome Trust during this study. IH reports grants from the Association of British Neurologists/Patrick Berthoud Charitable Trust during this study. AABJ, SP, NS, MP, HR, AKD, PS, NE, PFXS and the BNTRC have nothing to disclose., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Background: Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources., Objective: To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting., Design, Setting, and Participants: We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy., Intervention: SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75mg/m 2 ) was administered alongside SOC for six three-weekly cycles., Outcome Measurements and Statistical Analysis: The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs)., Results and Limitations: The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled., Conclusions: Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available., Patient Summary: Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body., (Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Adjuvant therapies can prevent/delay bone metastasis development in breast cancer. We investigated whether serum bone turnover markers in early disease have clinical utility in identifying patients with a high risk of developing bone metastasis., Methods: Markers of bone formation (N-terminal propeptide of type-1 collagen [P1NP]) and bone resorption (C-telopeptide of type-1 collagen [CTX], pyridinoline cross-linked carboxy-terminal telopeptide of type-1 collagen [1-CTP]) were measured in baseline (pretreatment blood samples from 872 patients from a large randomized trial of adjuvant zoledronic acid (AZURE-ISRCTN79831382) in early breast cancer. Cox proportional hazards regression and cumulative incidence functions (adjusted for factors having a statistically significant effect on outcome) were used to investigate prognostic and predictive associations between recurrence events, bone marker levels, and clinical variables. All statistical tests were two-sided., Results: When considered as continuous variables (log transformed), P1NP, CTX, and 1-CTP were each prognostic for future bone recurrence at any time (P = .006, P = .009, P = .008, respectively). Harrell's c-indices were a P1NP of 0.57 (95% confidence interval [CI] = 0.51 to 0.63), CTX of 0.57 (95% CI = 0.51 to 0.62), and 1-CTP of 0.57 (95% CI = 0.52 to 0.63). In categorical analyses based on the normal range, high baseline P1NP (>70 ng/mL) and CTX (>0.299 ng/mL), but not 1-CTP (>4.2 ng/mL), were also prognostic for future bone recurrence (P = .03, P = .03, P = .10, respectively). None of the markers were prognostic for overall distant recurrence; that is, they were bone metastasis specific, and none of the markers were predictive of treatment benefit from zoledronic acid., Conclusions: Serum P1NP, CTX, and 1-CTP are clinically useful, easily measured markers that show good prognostic ability (though low-to-moderate discrimination) for bone-specific recurrence and are worthy of further study.

Emeritus Professor Alan Glasper, from the University of Southampton, discusses a recently published report from a consortium of health agencies led by the Royal College of Paediatrics and Child Health.

On Tuesday 22 November, the House of Lords (London, UK) held a short debate 'Improving the standard of wound care in the NHS.' It consisted of nine questions from the floor and a response from Lord O'Shaughnessy, The Parliamentary Under-Secretary of State for Health (Conservative). Here, Paul Browning, (Doctoral Research Student, University of Worcester, employed by 3M UK plc) summarises the key points from the evening and explains why it is so important we keep wound care on the Government's agenda.

Introduction: Hip fractures are a significant cause of morbidity and mortality to the increasing elderly population. The Scottish Hip Fracture Audit started in 1993 with national audits from 2002. It was a national prospective audit reporting on clinical standards in hip fracture care and produced an annual report. Due to national funding changes the continual audit was discontinued in 2008. In 2013, the MSK Audit Group published a "snapshot" into a 4 month period of hip fracture care in Scotland. Our purpose was to identify whether there had been an initial improvement in hip fracture care and whether this improvement was sustained with the discontinuation of the annual audit., Methods: The reported outcomes from the annual Scottish Hip Fracture Audit from 2003 to 2008 were compared to the latest MSK Hip Fracture Audit published in 2013. Some data is available from the 2014 MSK Hip Fracture Audit and this was also used for comparison purposes. Local audit co-ordinators at each participating site collected a data-set for all patients admitted with a hip fracture. The case mix variables and management variables were compared for the reported years., Results: The continual audit demonstrated an improvement in the percentage of patients discharged from accident and emergency in 4h (80.5% 2003 vs. 96% 2008) which was not maintained 5 years later. An improvement in the percentage of patients having surgery within 48 h of admission (89.9-98.4%) was also not maintained after 5 years (91.8%). 30 day mortality improved with continual audit, a trend which continued in 2013. The re-introduction of continuous audit in 2014 demonstrated an improvement in accident and emergency waiting times and time to theatre., Discussion: The Scottish Hip Fracture Audit demonstrated improved standards of care until it was discontinued in 2008. The improvement was not sustained throughout all variables with the 2013 audit. With the re-introduction of regular audit, standards once again improved. We would recommend a more regular audit in an effort to not only improve standards of care for patients with a hip fracture but to maintain them., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

This article provides a summary of the main outcome measures currently available and in use within modern cleft care. The fact that there are such a diverse range, including surgical, orthodontic, dental, speech and patient satisfaction measures, is a reflection of the complex, multidisciplinary and longitudinal nature of the care provided. The use of such measures of outcome is essential in the auditing and drive for continued improvements in the standards of care for patients affected with cleft lip and palate., (© 2014 British Orthodontic Society.)

Improved diagnosis of coeliac disease has increased incidence and therefore burden on the health care system. There are no quality outcome measures (QOM) in use nationally to assess hospital management of this condition. This study applied QOM devised by the East of England paediatric gastroenterology network to 99 patients reviewed at two tertiary hospitals in the Network, to assess the quality of care provided by nurse led and doctor led care models. The average performance across all QOM was 96.2% at Addenbrooke's Hospital (AH), and 98.7% at Norfolk and Norwich Hospital (NNUH), whilst 95% (n = 18) of QOM were met. Patient satisfaction was high at both sites (uptake of questionnaire 53 of 99 patients in the study). The study showed a comparably high level of care delivered by both a nurse and doctor led service. Our quality assessment tools could be applied in the future by other centres to measure standards of care.