In evidence-based medicine, randomised trials are regarded as a gold standard in estimating relative treatment effects. Nevertheless, a potential gain in precision is forfeited by ignoring ...observational evidence. We describe a simple estimator that combines treatment estimates from randomised and observational data and investigate its properties by simulation. We show that a substantial gain in estimation accuracy, compared with the estimator based solely on the randomised trial, is possible when the observational evidence has low bias and standard error. In the contrasting scenario where the observational evidence is inaccurate, the estimator automatically discounts its contribution to the estimated treatment effect. Meta-analysis extensions, combining estimators from multiple observational studies and randomised trials, are also explored.
BACKGROUND
Information on actual sodium intake and its relationships with blood pressure (BP) and clinical events in South America is limited. The aim of this cohort study was to assess the ...relationship of sodium intake with BP, cardiovascular (CV) events, and mortality in South America.
METHODS
We studied 17,033 individuals, aged 35–70 years, from 4 South American countries (Argentina, Brazil, Chile, and Colombia). Measures of sodium excretion, estimated from morning fasting urine, were used as a surrogate for daily sodium intake. We measured BP and monitored the composite outcome of death and major CV events.
RESULTS
Overall mean sodium excretion was 4.70±1.43g/day. A positive, nonuniform association between sodium and BP was detected, with a significant steeper slope for the relationship at higher sodium excretion levels (P < 0.001 for interaction). With a median follow-up of 4.7 years, the primary composite outcome (all-cause death, myocardial infarction, stroke, or heart failure) occurred in 568 participants (3.4%). Compared with sodium excretion of 5–6g/day (reference group), participants who excreted >7g/day had increased risks of the primary outcome (odds ratio (OR) 1.73; 95% confidence interval (CI) 1.24 to 2.40; P < 0.001), as well as death from any cause (OR 1.87; 95% CI 1.23 to 2.83; P = 0.003) and major CV disease (OR 1.77; 95% CI 1.12 to 2.81; P = 0.014). Sodium excretion of <3g/day was associated with a statistically nonsignificant increased risk of the primary outcome (OR 1.20; 95% CI 0.86 to 1.65; P = 0.26) and death from any cause (OR 1.25; 95% CI 0.81 to 1.93; P = 0.29), and a significant increased risk of major CV disease (OR 1.50; 95% CI 1.01 to 2.24; P = 0.048), as compared to the reference group.
CONCLUSIONS
Our results support a positive, nonuniform association between estimated urinary sodium excretion and BP, and a possible J-shaped pattern of association between sodium excretion over the entire range and clinical outcomes.
Abstract Objective Individuals with rheumatoid arthritis (RA) are at increased risk for cardiovascular disease (CVD). Traditional prediction tools underestimate this risk. Vertebral fracture ...assessment (VFA)-detected aortic calcification enhances CVD risk stratification in the general population but its relationship in RA is unclear. We assessed the presence of abdominal aortic calcification (AAC) on VFA images, and its association with CVD in RA patients. Methods We determined the prevalence of cardiovascular events in a cohort of RA patients aged 40 years and older fulfilling the 1987 American College of Rheumatology classification criteria. Two blinded radiologists independently reviewed all VFA scans to determine the presence/severity of AAC using an established 24-point scale. Logistic regression analyses were performed to determine whether AAC could discriminate between RA patients with and without CVD, and to compare the ability of VFA-detected AAC to predict CVD to conventional CVD risk factors and the Framingham Risk Score. Results 603 subjects fulfilled study inclusion criteria. 230 (38%) subjects had 1 or more documented CVD event and 211 (35%) had AAC detected on VFA scans. Significantly more subjects with cardiovascular events had AAC on their VFA scans than controls (76% versus 10%; P < 0.05). VFA-detected AAC was a better predictor of CVD than traditional risk factors, and significantly out-performed the Framingham Risk Score for discriminating between the presence and absence of CVD (AUC 0.85 versus 0.58; P < 0.001). Conclusion There was a significant association between VFA-detected AAC and CVD in our study population. This finding may enhance cardiovascular disease risk prediction in RA patients.
Background and purpose
Heart failure is an independent risk factor for stroke. Anticoagulation is effective for prevention of cardio-embolic stroke secondary to atrial fibrillation or mechanical ...heart valves but is of uncertain benefit in heart failure patients. We performed this meta-analysis to obtain the best estimates of the efficacy and safety of warfarin as compared with antiplatelet therapy in patients with systolic heart failure who are in sinus rhythm.
Methods and results
A systematic search was performed using PubMed and Central Register of Controlled Trials databases for all randomized controlled trials, which compare warfarin with antiplatelet therapy given for at least one-month in heart failure patients with sinus rhythm and report at least one of the following outcomes: ischemic stroke, death, myocardial infarction, hospitalization due to worsening heart failure, intracranial hemorrhage, and major hemorrhage. Four randomized controlled trials involving adjusted-dose warfarin (4187 subjects) were included. When compared with antiplatelet therapy, warfarin reduced ischemic stroke by 0·74% per year (RR 0·49; 95% CI: 0·32–0·73: P = 0·0006; Number needed to treat = 135) but increased major hemorrhage by 0·99% per year (RR 2·15; 95% CI: 1·55–2·99: P < 0·00001; Number needed to harm = 101). Warfarin did not significantly affect the risk of death, myocardial infarction, hospitalization due to heart failure or intracranial hemorrhage as compared with antiplatelet therapy.
Conclusion
Warfarin as compared with antiplatelet therapy reduces risk of ischemic stroke, does not significantly affect death, myocardial infarction, hospitalization due to heart failure or intracranial hemorrhage and increases major hemorrhage in heart failure patients who are in sinus rhythm.
Abstract Aim Women with gestational diabetes mellitus (GDM) display adverse lifetime cardiometabolic health. We examined whether early metformin in GDM could impact cardiometabolic risk factors ...postpartum. Methods EMERGE, a double-blind, placebo-controlled trial, randomized pregnancies 1:1 to placebo or metformin at GDM diagnosis and followed participants from randomization until 12 ± 4 weeks postpartum. In total, 478 pregnancies were available for postpartum maternal assessment, 237 and 241 assigned to metformin and placebo respectively. Weight (kg), body mass index (BMI) (kg/m2), waist circumference (cm), and blood pressure (mmHg) were measured, infant feeding method documented, and blood specimens drawn for a 75-gram oral glucose tolerance test, fasting insulin, C-peptide, and lipid analysis. Results Despite similar weight and BMI at trial randomization, participants receiving metformin had significantly lower weight (79.5 ± 15.9 vs 82.6 ± 16.9 kg; P = .04) and BMI (29.3 5.6 vs 30.5 5.4; P = .018) at the postpartum visit. However, no difference in weight change from randomization to 12 weeks postpartum was observed between metformin and placebo groups. Overall, 29% (n = 139) of the cohort met criteria for prediabetes or diabetes, with no positive impact with metformin. There were also no differences in measurements of insulin resistance, blood pressure, or lipids between groups. Conclusion Early metformin use in GDM did not impact important cardiometabolic parameters in the early postpartum period despite significant benefits in weight gain and insulin use in pregnancy.
Statin treatment and variants in the gene encoding HMG-CoA reductase are associated with reductions in both the concentration of LDL cholesterol and the risk of coronary heart disease, but also with ...modest hyperglycaemia, increased bodyweight, and modestly increased risk of type 2 diabetes, which in no way offsets their substantial benefits. We sought to investigate the associations of LDL cholesterol-lowering PCSK9 variants with type 2 diabetes and related biomarkers to gauge the likely effects of PCSK9 inhibitors on diabetes risk.
In this mendelian randomisation study, we used data from cohort studies, randomised controlled trials, case control studies, and genetic consortia to estimate associations of PCSK9 genetic variants with LDL cholesterol, fasting blood glucose, HbA1c, fasting insulin, bodyweight, waist-to-hip ratio, BMI, and risk of type 2 diabetes, using a standardised analysis plan, meta-analyses, and weighted gene-centric scores.
Data were available for more than 550 000 individuals and 51 623 cases of type 2 diabetes. Combined analyses of four independent PCSK9 variants (rs11583680, rs11591147, rs2479409, and rs11206510) scaled to 1 mmol/L lower LDL cholesterol showed associations with increased fasting glucose (0·09 mmol/L, 95% CI 0·02 to 0·15), bodyweight (1·03 kg, 0·24 to 1·82), waist-to-hip ratio (0·006, 0·003 to 0·010), and an odds ratio for type diabetes of 1·29 (1·11 to 1·50). Based on the collected data, we did not identify associations with HbA1c (0·03%, −0·01 to 0·08), fasting insulin (0·00%, −0·06 to 0·07), and BMI (0·11 kg/m2, −0·09 to 0·30).
PCSK9 variants associated with lower LDL cholesterol were also associated with circulating higher fasting glucose concentration, bodyweight, and waist-to-hip ratio, and an increased risk of type 2 diabetes. In trials of PCSK9 inhibitor drugs, investigators should carefully assess these safety outcomes and quantify the risks and benefits of PCSK9 inhibitor treatment, as was previously done for statins.
British Heart Foundation, and University College London Hospitals NHS Foundation Trust (UCLH) National Institute for Health Research (NIHR) Biomedical Research Centre.
Abstract
Background
Patient involvement in healthcare is key to the provision of patient centred care. The national patient experience survey 2018 found that up to 40% of patients did not get ...adequate information about their condition after discharge.(1) As the planning phase in introducing a stroke information booklet, we sought to examine what patients, families and healthcare professionals feel are important components in such an information booklet.
Methods
We performed a cross sectional cohort study. A questionnaire was developed after a panel discussion among physicians, allied health professionals, and clinical nurse specialists about what would be important facets to include. Thirteen items were shortlisted and assessed using a Likert scale.
Results
There were 76 respondents to the questionnaire including nurses (17), allied health professionals (13), doctors (28), stroke patients (10) and relatives (8). Items viewed as most important to include were: an introduction to stroke, future stroke risk, and effects of stroke on daily life. Items viewed as least important to include were - an overview of medical treatments for stroke and information on equipment needs post stroke. A Mann Whitney U test found that patients/families rated information about future stroke risk as more important to include than healthcare professionals (p=0.021). Free text found that psychological effects of stroke, and sexual health post stroke were commonly suggested.
Conclusion
Patients/Families are keen to receive information regarding stroke, particularly about future risk of stroke. Empowering patients with information about stroke that is relevant to them and their care providers is a fundamental part of secondary stroke prevention. We also need to focus more on the psychological impact of stroke. Our booklet will incorporate information we have gathered in this study to make it a truly patient centred resource.
Prison Violence Kimmett Edgar, Ian O`Donnell And Carol Martin
11/2002
eBook
Prisons are dangerous places, and assaults, threats, theft and verbal abuse are pervasive - attributable both to the characteristics of the captive population and to an institutional sub culture ...which promotes violence as a means of resolving conflicts. Yet the crimes perpetrated by prisoners on other prisoners have attracted little interest, and criminological research has contributed little to an understanding of situations in which violence arises in penal institutions. This book seeks to remedy this, and to address and answer a number of key questions: how do features of the prison social setting shape conflicts?; what social norms guide the decision to use violence?; what are the personal and social consequences of spending months or years in places where distrust and anxiety are normal?; how do staff respond to the dangers that are part of daily life in many prisons?; is it possible to identify factors associated with risk and resilience?; and what methods of handling conflicts do prisoners use that could prevent violence? Prison Violence adopts a distinctive approach to answering these questions, and is based on extensive research, including interviews with both victims and perpetrators of prison violence; it pioneers a conflict-centred approach, seeking to understand the pathways into and out of situations where there is potential for violence, focusing on interpersonal and institutional dynamics rather than on individual psychological factors.
A gold dual‐microelectrode probe patterned on a silicon substrate for bio‐impedance measurement was fabricated, characterised and tested on different types of tissues. The aim of this study is to ...fabricate a device capable of using bioimpedance to discriminate different tissue types. This proof of concept of the device was characterised on meat and a gel/lard phantom which mimics fat and muscle. The initial results demonstrated that the gold dual‐microelectrode probe had excellent electrochemical recording potential. The bio‐impedance data derived was capable of differentiation between biological tissues. Bio‐impedance measurement may enhance cancer diagnostics by providing novel data in relation to cancer and surrounding healthy tissue. This manuscript describes the design, fabrication and validation of a gold dual‐microelectrode bioimpedance sensor with a potential future application in cancer diagnostics.
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