A new threshold for kidney asymmetry improves association with abnormal renal-aortic ratio for diagnosis of renal artery stenosis.

BACKGROUND: Renal artery stenosis (RAS) reflects more widespread atherosclerosis deposition and is associated with high morbidity and mortality. According to the guidelines, a discrepancy in the size of the kidneys of over 15 mm found in an ultrasound should initiate the RAS diagnostic algorithm. This study aims to find the optimal threshold for renal asymmetry that better reflects the frequency of a significantly abnormal renal-aortic ratio (RAR), justifying further RAS diagnostic workup, than the currently used cut-off of 15 mm difference in renal diameters. METHODS: The analysis included 1175 patients (mean age: 52 years, IQR: 38-66, men/women: 597/578) who underwent Doppler ultrasonography screening of renal arteries with recorded kidney size and RAR calculation. Ultrasound features of RAS were defined as a RAR greater than 3.5 or signs of renal artery occlusion. Receiver operating characteristic (ROC) curves were created and analyzed for absolute differences in kidney size and abnormal RAR. We calculated the area under the curve (AUC) and optimal cut-off values for sensitivity and specificity analysis. RESULTS: The final analysis included 169 patients with a significant difference in renal dimension. RAS features were met in 61 patients. According to ROC curve analysis, the optimal index of renal asymmetry was 12 mm. The sensitivity and specificity for this method were 82.0% and 83.3%, respectively, and AUC was 86.3%. CONCLUSION: Changing the definition of a significant difference in kidney size from 15 mm to 12 mm increases sensitivity and specificity for abnormal RAR and this finding may accelerate the diagnosis of RAS.

Cardiac Morphology, Function, and Hemodynamics in Patients With Morbid Obesity and Nonalcoholic Steatohepatitis.

Background The patients with nonalcoholic fatty liver disease demonstrate an increased cardiovascular risk. The adverse influence of liver abnormalities on cardiac function are among many postulated mechanisms behind this association. The aim of the study was to evaluate cardiac morphology and function in patients with morbid obesity referred for bariatric surgery with liver biopsy. Methods and Results We evaluated with echocardiography 171 consecutive patients without known cardiac disease (median age 42 [interquartile range, 37-48] years, median body mass index 43.7 [interquartile range, 41.0-47.5], 67% female patients. Based on the liver biopsy results, there were 44 patients with nonalcoholic steatohepatitis (NASH), 69 patients with isolated steatosis, and 58 patients without steatosis. Patients with NASH demonstrated signs of left ventricular concentric remodeling and hyperdynamic circulation, including indexed left ventricular end-diastolic diameter [cm/m2]: NASH 1.87 [0.22]; isolated steatosis 2.03 [0.33]; without steatosis 2.01 [0.19], P=0.001; relative wall thickness: NASH 0.49±0.05, isolated steatosis 0.47±0.06, without steatosis 0.46±0.06, P=0.011; cardiac index [L/m2]: NASH 3.05±0.54, isolated steatosis 2.80±0.44, without steatosis 2.79±0.50, P=0.013. After adjustment for sex, age, blood pressure, and heart rate, most of the measures of the left ventricular systolic and diastolic function, left atrial size, right ventricular function, and right ventricular size did not differ between groups. Conclusions In a group of patients with extreme obesity, NASH was associated with left ventricular concentric remodeling and hyperdynamic circulation. Increased cardiac output in NASH may represent an additional risk factor for incident cardiovascular events in this population.

Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them.

Using the best quality of clinical research evidence is essential for choosing the right treatment for patients. How to identify the best research evidence is, however, difficult. In this narrative review we summarise these threats and describe how to minimise them. Pertinent literature was considered through literature searches combined with personal files. Treatments should generally not be chosen based only on evidence from observational studies or single randomised clinical trials. Systematic reviews with meta-analysis of all identifiable randomised clinical trials with Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment represent the highest level of evidence. Even though systematic reviews are trust worthier than other types of evidence, all levels of the evidence hierarchy are under threats from systematic errors (bias); design errors (abuse of surrogate outcomes, composite outcomes, etc.); and random errors (play of chance). Clinical research infrastructures may help in providing larger and better conducted trials. Trial Sequential Analysis may help in deciding when there is sufficient evidence in meta-analyses. If threats to the validity of clinical research are carefully considered and minimised, research results will be more valid and this will benefit patients and heath care systems.

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

BACKGROUND: The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. METHODS: Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. RESULTS: 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. CONCLUSIONS: There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.