System failures and learning from the case of Dr Manjula Arora: 21st century regulation needs to be compassionate, caring and supportive.

The recent judgement and suspension of Dr Manjula Arora has caused huge apprehension within the medical community and raised debate about whether the fitness to practise process is fit for purpose. This editorial focuses on the need for 21st century regulation to be proportionate, fair, supportive and compassionate.

PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation: a collaboratiVE study (PERCEIVE)-protocol for the PERCEIVE qualitative study.

INTRODUCTION: Deciding whether to proceed with a major lower limb amputation is life-changing and complex, and it is crucial that the right decision is made at the right time. However, medical specialists are known to poorly predict risk when assessing patients for major surgery, and there is little guidance and research regarding decisions about amputation. The process of shared decision-making between doctors and patients during surgical consultations is also little understood. Therefore, the aim of this study is to analyse in depth the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation. METHODS AND ANALYSIS: Consultations between patients and surgeons at which major lower limb amputation is discussed will be audio-recorded for 10-15 patients. Semi-structured follow-up interviews with patients (and relatives/carers) will then be conducted at two time points: as soon as possible/appropriate after a decision has been reached regarding surgery, and approximately 6 months later. Semi-structured interviews will also be conducted with 10-15 healthcare professionals working in the UK National Health Service (NHS) involved in amputation decision-making. This will include surgeons, anaesthetists and specialist physiotherapists at 2-4 NHS Health Boards/Trusts in Wales and England. Discourse analysis will be used to analyse the recorded consultations; interviews will be analysed thematically. Finally, workshops will be held with patients and healthcare professionals to help synthesise and interpret findings. ETHICS AND DISSEMINATION: The study has been approved by Wales REC 7 (20/WA/0351). Study findings will be published in international peer-reviewed journal(s) and presented at national and international scientific meetings. Findings will also be disseminated to a wide NHS and lay audience via presentations at meetings and written summaries for key stakeholder groups.

The PERCEIVE quantitative study: PrEdiction of Risk and Communication of outcome following major lower-limb amputation: protocol for a collaboratiVE study.

BACKGROUND: Accurate prediction of outcomes following surgery with high morbidity and mortality rates is essential for informed shared decision-making between patients and clinicians. It is unknown how accurately healthcare professionals predict outcomes following major lower-limb amputation (MLLA). Several MLLA outcome-prediction tools have been developed. These could be valuable in clinical practice, but most require validation in independent cohorts before routine clinical use can be recommended. The primary aim of this study is to evaluate the accuracy of healthcare professionals' predictions of outcomes in adult patients undergoing MLLA for complications of chronic limb-threatening ischaemia (CLTI) or diabetes. Secondary aims include the validation of existing outcome-prediction tools. METHOD: This study is an international, multicentre prospective observational study including adult patients undergoing a primary MLLA for CLTI or diabetes. Healthcare professionals' accuracy in predicting outcomes at 30-days (death, morbidity and MLLA revision) and 1-year (death, MLLA revision and ambulation) will be evaluated. Sixteen existing outcome-prediction tools specific to MLLA will be examined for validity. Data collection began on 1 October 2020; the end of follow-up will be 1 May 2022. The C-statistic, Hosmer-Lemeshow test, reclassification tables and Brier score will be used to evaluate the predictive performance of healthcare professionals and prediction tools, respectively. STUDY REGISTRATION AND DISSEMINATION: This study will be registered locally at each centre in accordance with local policies before commencing data collection, overseen by local clinician leads. Results will be disseminated to all centres, and any subsequent presentation(s) and/or publication(s) will follow a collaborative co-authorship model.

Vitamin D deficiency is endemic in neurosurgical patients and is associated with a longer length of inpatient stay.

INTRODUCTION: Vitamin D deficiency is common in spinal surgery and critical care. Hypovitaminosis D may impact on outcomes in cranial neurosurgical care and play roles in underlying disease processes. METHODS: A prospective observational cohort study was performed. All emergency cranial neurosurgical ward admissions from 1st January to 10th May 2017 were screened for inclusion (n = 406). Patients already receiving vitamin D supplementation, spinal patients and elective admissions were excluded. Admission vitamin D levels were checked for all remaining patients (n = 95). Patients with vitamin D <30 nmol/L were defined as "deficient" and those 30-50 nmol/L as "inadequate." All patients with levels <50 nmol/L were replaced, as per local guidelines. Descriptive analyses of the cohorts were undertaken, with multivariate regression used to assess the effect of vitamin D on length of stay, inpatient morbidity and mortality. RESULTS: The median age of participants was 61 years (n = 95; 57% male, 43% female). The median vitamin D level was 23 nmol/L (deficient). 84% (n = 80) of patients had low vitamin D levels, with 61% (n = 58) classed as deficient (<30 nmol/L). Vitamin D deficiency rates were similar in those aged below 65 years (86%; n = 38/44) and those above 65 years (82%; n = 42/51). Deficient vitamin D level was associated with longer hospital stay (P = .03), and this relationship persisted after adjusting for potential confounders such as age, sex and preadmission Charlson co-morbidity index. No statistically significant association was seen with vitamin D status and inpatient morbidity or mortality. CONCLUSIONS: Vitamin D deficiency is common in cranial neurosurgical patients, even in predefined low-risk groups (age <65). Lower vitamin D level was associated with longer length of stay. This study supports the need for: (a) further investigation into the roles of vitamin D in neurosurgical pathologies and management and (b) an appropriately powered, randomised investigation into the impact of vitamin D status upon neurosurgical diagnoses and complications.

Cerebral salt wasting following traumatic brain injury.

SUMMARY: Hyponatraemia is the most commonly encountered electrolyte disturbance in neurological high dependency and intensive care units. Cerebral salt wasting (CSW) is the most elusive and challenging of the causes of hyponatraemia, and it is vital to distinguish it from the more familiar syndrome of inappropriate antidiuretic hormone (SIADH). Managing CSW requires correction of the intravascular volume depletion and hyponatraemia, as well as mitigation of on-going substantial sodium losses. Herein we describe a challenging case of CSW requiring large doses of hypertonic saline and the subsequent substantial benefit with the addition of fludrocortisone. LEARNING POINTS: The diagnosis of CSW requires a high index of suspicion. Distinguishing it from SIADH is essential to enable prompt treatment in order to prevent severe hyponatraemia.The hallmarks of substantial CSW are hyponatraemia, reduced volume status and inappropriately high renal sodium loss.Substantial volumes of hypertonic saline may be required for a prolonged period of time to correct volume and sodium deficits.Fludrocortisone has a role in the management of CSW. It likely reduces the doses of hypertonic saline required and can maintain serum sodium levels of hypertonic saline.