Clinical Decision Science suggests different research questions need to be asked related to informed consent

The author examines the literature relating to informed consent for early cardiac catheterization to treat Non-ST-segment elevation acute coronary syndrome, and considers whether Clinical Decision Science might provide new directions for applying the clinical research literature

Teaching percutaneous renal biopsy using unfixed human cadavers

Background: Percutaneous renal biopsy (PRB) is an important diagnostic procedure. Despite advances in its safety profile there remains a small but significant risk of bleeding complications. Traditionally, operators train to perform PRB through tutor instruction and directly supervised PRB attempts on real patients. We describe an approach to teaching operators to perform PRB using cadaveric simulation. Methods: We devised a full day course hosted in the Clinical Anatomy Skills Centre, with places for nine candidates. Course faculty consisted of two Consultant Nephrologists, two Nephrology trainees experienced in PRB, and one Radiologist. Classroom instruction included discussion of PRB indications, risk minimisation, and management of complications. Two faculty members acted as models for the demonstration of kidney localisation using real-time ultrasound scanning. PRB was demonstrated using a cadaveric model, and candidates then practised PRB using each cadaver model. Results: Written candidate feedback was universally positive. Faculty considered the cadaveric model a realistic representation of live patients, while the use of multiple cadavers introduced anatomical variation. Conclusions: Our model facilitates safe simulation of a high risk procedure. This might reduce serious harm associated with PRB and improve patient safety, benefiting trainee operators and patients alike

The Incredible Shrinking Victory: Eli Lilly v. Canada, Success, Judicial Reversal, and Continuing Threats from Pharmaceutical ISDS

This Article examines the Eli Lilly v. Canada arbitration award and its potential impact on intellectual property-based investor-state dispute settlements affecting pharmaceuticals. It begins by providing contextual background on ISDS and the underlying Eli Lilly patent invalidations. It then critiques the award and discusses the dangers of its overly cautious grounds of decision and its explicit validation of IP-based ISDS. The Article further illustrates these dangers through a discussion of the stunning judicial reversal of the promise/utility doctrine by the Canadian Supreme Court, the withdrawal of a compulsory licensing proposal in Colombia, and the deregistration of a competing generic Hepatitis C medicine in Ukraine. Ultimately, it recommends that ISDS provisions be removed or rewritten to prevent the possibility of bringing IP-related claims

ptype: probabilistic type inference

Type inference refers to the task of inferring the data type of a given column of data. Current approaches often fail when data contains missing data and anomalies, which are found commonly in real-world data sets. In this paper, we propose ptype, a probabilistic robust type inference method that allows us to detect such entries, and infer data types. We further show that the proposed method outperforms the existing methods

Scottish Food Practices: Household food practices and the use of dietary information

© 2020 The Author(s). This an open access work distributed under the terms of the Creative Commons Attribution Licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.This report presents findings from The Scottish Food Practices study, designed to investigate what and how households across Scotland use dietary information (if at all) when cooking/eating at home, shopping for food and eating outside the home.The study aims to inform the work of Food Standards Scotland (FSS) as they develop new dietary guidance that is accessible and suitable for different population groups in Scotland. The study explores the extent to which dietary information was available, and how it was perceived and taken into account by households when cooking, eating and purchasing food, both in and outside of the home.The study adopted an in-depth qualitative approach with ten households, including those on low incomes, families with younger and older children, single-person households and older adults. Participants were recruited via networks of third sector and food advocacy organisations, as well as via NHS and FSS contacts. Fieldwork with participating households took place between January and March 2020; it ended earlier than planned, due to the social distancing restrictions put in place to control the COVID-19 outbreak.The research design comprised of three visits with each household.1. A semi-structured interview was carried out with the key participant (and other household members if they wished), followed by a photographic ‘kitchen tour’. Participants were asked about their typical patterns of cooking/eating at home, food shopping, and eating outside the home, with particular reference to dietary information.2. A video-recorded food shopping trip was conducted with the household member who was primarily responsible for food shopping in each household.3. An observation took place with one or more household members when ‘eating out of home’.Across households, participants reported having a good general understanding of dietary information. Nonetheless, this knowledge seemed to be inconsistently or rarely applied by households when purchasing food, or when eating in and out of the home. This was a consequence of participants’ apparent misunderstanding of some of the information available to them, contradictions in guidance as perceived by participants, and participants’ reliance on knowledge gained through their own lives or experiences (experiential knowledge). Price was the key deciding factor informing participants’ food purchasing decisions, except in cases where health conditions and/or special dietary requirements made it essential to pay closer attention to dietary information on food packaging.The research provides some pointers for FSS regarding the development of dietary guidance in terms of clarity of information required by consumers. This relates to addressing the interpretation of traffic light labelling and the incorporation of guidance into a healthy diet for those living with/shopping for specific health conditions, allergies, intolerances or preferences. Using price and ‘value for money’ could be a way to leverage healthier food choices in Scotland. Experiential, ‘common sense’ knowledge is important to households therefore an understanding and awareness of this, including among health care professionals, is important when considering the acceptability and efficacy of dietary guidance or information. COVID-19 has impacted on many aspects of food and eating for people in Scotland, perhaps especially so for those whose income, health or vulnerability has been affected in some way. Finding ways to support households to manage their physical and mental health and dietary preferences/needs, despite these ongoing challenges, therefore continues to be important.Final Published versio

Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis

Objective To assess whether lithium has a specific preventive effect for suicide and self harm in people with unipolar and bipolar mood disorders. Design Systematic review and meta-analysis. Data sources Medline, Embase, CINAHL, PsycINFO, CENTRAL, web based clinical trial registries, major textbooks, authors of important papers and other experts in the discipline, and websites of pharmaceutical companies that manufacture lithium or the comparator drugs (up to January 2013). Inclusion criteria Randomised controlled trials comparing lithium with placebo or active drugs in long term treatment for mood disorders. Review methods Two reviewers assessed studies for inclusion and risk of bias and extracted data. The main outcomes were the number of people who completed suicide, engaged in deliberate self harm, and died from any cause. Results 48 randomised controlled trials (6674 participants, 15 comparisons) were included. Lithium was more effective than placebo in reducing the number of suicides (odds ratio 0.13, 95% confidence interval 0.03 to 0.66) and deaths from any cause (0.38, 0.15 to 0.95). No clear benefits were observed for lithium compared with placebo in preventing deliberate self harm (0.60, 0.27 to 1.32). In unipolar depression, lithium was associated with a reduced risk of suicide (0.36, 0.13 to 0.98) and also the number of total deaths (0.13, 0.02 to 0.76) compared with placebo. When lithium was compared with each active individual treatment a statistically significant difference was found only with carbamazepine for deliberate self harm. Lithium tended to be generally better than the other active comparators, with small statistical variation between the results. Conclusions Lithium is an effective treatment for reducing the risk of suicide in people with mood disorders. Lithium may exert its antisuicidal effects by reducing relapse of mood disorder, but additional mechanisms should also be considered because there is some evidence that lithium decreases aggression and possibly impulsivity, which might be another mechanism mediating the antisuicidal effect

Bistability in a simple fluid network due to viscosity contrast

We study the existence of multiple equilibrium states in a simple fluid network using Newtonian fluids and laminar flow. We demonstrate theoretically the presence of hysteresis and bistability, and we confirm these predictions in an experiment using two miscible fluids of different viscosity--sucrose solution and water. Possible applications include bloodflow, microfluidics, and other network flows governed by similar principles

Risk factors of ischemic stroke and subsequent outcome in hemodialysis patients

Background and purpose: End stage renal disease (ESRD) requiring hemodialysis (HD) carries up to a 10-fold greater risk of stroke than normal renal function. Knowledge concerning risk factors and management strategies derived from the general population may not be applicable to those with ESRD. We studied a large ESRD population to identify risk factors and outcomes for stroke. Methods: All adult patients receiving HD for ESRD from 01/01/2007 to 31/12/2012 were extracted from the electronic patient record. Variables associated with stroke were identified by survival analysis; demographic, clinical, imaging and dialysis related variables were assessed and case-fatality determined. Follow-up was until 31/12/2013. Results: 1382 patients were identified (mean age 60.5 years, 58.5% male). The prevalence of AF was 21.2% and 59.4% were incident HD patients. 160 (11.6%) experienced a stroke during 3471 patient-years of follow-up (95% ischemic). Stroke incidence was 41.5/1000 patient-years in prevalent and 50.1/1000 patient-years in incident HD patients. Factors associated with stroke on regression analysis were prior stroke, diabetes and age at starting renal replacement therapy. AF was not significantly associated with stroke and warfarin did not affect stroke risk in warfarin treated patients. Fatality was 18.8% at 7, 26.9% at 28 and 56.3% 365 days after stroke.<p></p> Conclusions: Incidence of stroke is high in patients with ESRD on HD with high case-fatality. Incident HD patients had the highest stroke incidence. Many, but not all, important risk factors commonly associated with stroke in the general population were not associated with stroke in patients receiving HD

Prevalence and incidence of clinical outcomes in patients presenting to secondary mental health care with mood instability and sleep disturbance

Background. Mood instability and sleep disturbance are common symptoms in people with mental illness. Both features are clinically important and associated with poorer illness trajectories. We compared clinical outcomes in people presenting to secondary mental health care with mood instability and/or sleep disturbance with outcomes in people without either mood instability or sleep disturbance. / Methods. Data were from electronic health records of 31,391 patients ages 16–65 years presenting to secondary mental health services between 2008 and 2016. Mood instability and sleep disturbance were identified using natural language processing. Prevalence of mood instability and sleep disturbance were estimated at baseline. Incidence rate ratios were estimates for clinical outcomes including psychiatric diagnoses, prescribed medication, and hospitalization within 2-years of presentation in persons with mood instability and/or sleep disturbance compared to individuals without either symptom. / Results. Mood instability was present in 9.58%, and sleep disturbance in 26.26% of patients within 1-month of presenting to secondary mental health services. Compared with individuals without either symptom, those with mood instability and sleep disturbance showed significantly increased incidence of prescription of any psychotropic medication (incidence rate ratios [IRR] = 7.04, 95% confidence intervals [CI] 6.53–7.59), and hospitalization (IRR = 5.32, 95% CI 5.32, 4.67–6.07) within 2-years of presentation. Incidence rates of most clinical outcomes were considerably increased among persons with both mood instability and sleep disturbance, relative to persons with only one symptom. / Conclusions. Mood instability and sleep disturbance are present in a wide range of mental disorders, beyond those in which they are conventionally considered to be symptoms. They are associated with poor outcomes, particularly when they occur together. The poor prognosis associated with mood instability and sleep disorder may be, in part, because they are often treated as secondary symptoms. Mood instability and sleep disturbance need better recognition as clinical targets for treatment in their own right