Search

Objective: To determine the level of agreement of disease flare severity (distinguishing severe, moderate, and mild flare and persistent disease activity) in a large paper-patient exercise involving 988 individual cases of systemic lupus erythematosus.Methods: A total of 988 individual lupus case histories were assessed by 3 individual physicians. Complete agreement about the degree of flare (or persistent disease activity) was obtained in 451 cases (46%), and these provided the reference standard for the second part of the study. This component used 3 flare activity instruments (the British Isles Lupus Assessment Group [BILAG] 2004, Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] flare index [SFI] and the revised SELENA flare index [rSFI]). The 451 patient case histories were distributed to 18 pairs of physicians, carefully randomized in a manner designed to ensure a fair case mix and equal distribution of flare according to severity.Results: The 3-physician assessment of flare matched the level of flare using the 3 indices, with 67% for BILAG 2004, 72% for SFI, and 70% for rSFI. The corresponding weighted kappa coefficients for each instrument were 0.82, 0.59, and 0.74, respectively. We undertook a detailed analysis of the discrepant cases and several factors emerged, including a tendency to score moderate flares as severe and persistent activity as flare, especially when the SFI and rSFI instruments were used. Overscoring was also driven by scoring treatment change as flare, even if there were no new or worsening clinical features.Conclusion: Given the complexity of assessing lupus flare, we were encouraged by the overall results reported. However, the problem of capturing lupus flare accurately is not completely solved. [ABSTRACT FROM AUTHOR]

Objectives: A new patient-reported outcome (PRO) instrument to measure fatigue symptoms and impacts in relapsing multiple sclerosis (RMS) was developed in a qualitative stage, followed by psychometric validation and migration from paper to an electronic format.Methods: Adult patients with relapsing-remitting multiple sclerosis (RRMS) were interviewed to elicit fatigue-related symptoms and impacts. A draft questionnaire was debriefed in cognitive interviews with further RRMS patients, and revised. Content confirmation interviews were conducted with patients with progressive-relapsing multiple sclerosis (PRMS) and relapsing secondary-progressive multiple sclerosis (RSPMS). Psychometric analyses used data from adult patients with different RMS subtypes and matched non-RMS controls in a multicenter, observational study. After item reduction, the final instrument was migrated to a smartphone (eDiary) and usability was confirmed in interviews with additional adult RMS patients.Results: The qualitative stage included 37 RRMS, 5 PRMS, and 5 RSPMS patients. Saturation of concepts was reached during concept elicitation. Cognitive interviews confirmed that participants understood the instructions, items, and response options of the instrument-named FSIQ-RMS-as intended. Psychometric validation included 164 RMS and 74 control patients. Internal consistency and test-retest reliability were demonstrated. The symptoms domain discriminated along the RMS symptom-severity continuum and between patients and controls. Patients were able to attribute fatigue-related symptoms to RMS. Usability and conceptual equivalence of the eDiary were confirmed (n = 10 participants).Conclusions: With 7 symptom items and 13 impact items (in 3 impacts subdomains: physical, cognitive and emotional, and coping) after item reduction, the FSIQ-RMS is a comprehensive, valid, and reliable measure of fatigue-related symptoms and impacts in RMS patients. [ABSTRACT FROM AUTHOR]

Aim: To assess the reliability and predictive validity of the developmental and socio-emotional scales of the Standardized Infant NeuroDevelopmental Assessment (SINDA).Method: To assess reliability, two sets of three assessors forming eight assessor-pairs independently rated the developmental and socio-emotional scales of 60 infants. To evaluate predictive validity, 223 infants (gestational age 30wks [range 23-41wks]; 117 males, 106 females) attending a non-academic outpatient clinic were assessed by different assessors with SINDA's neurological, developmental, and socio-emotional scales. Atypical neurodevelopmental outcome at a corrected age of 24 months or older implied a Bayley Mental or Psychomotor Developmental Index score of less than 70 or neurological disorder (including cerebral palsy). Behavioural and emotional disorders were classified according to the International Classification of Diseases, 10th Revision. Predictive values were calculated from SINDA (2-12mo corrected age, median 7mo) and typical versus atypical outcome, and for intellectual disability only (Mental Developmental Index <70).Results: Assessors highly agreed on the developmental and socio-emotional assessments (developmental scores: Spearman's rank correlation coefficient ρ=0.972; single socio-emotional behaviour items: Cohen's κ=0.783-0.896). At 24 months or older, 65 children had atypical outcome. Atypical neurological scores predicted atypical outcome (sensitivity 83%, specificity 96%); atypical developmental scores predicted intellectual disability (sensitivity 77%, specificity 92%). Atypical emotionality and atypical self-regulation were associated with behavioural and emotional disorders.Interpretation: SINDA's three scales are reliable, and have a satisfactory predictive validity for atypical developmental outcome at 24 months or older in a non-academic outpatient setting. SINDA's developmental scale has promising predictive validity for intellectual disability. SINDA's socio-emotional scale is a tool for caregiver counselling.What This Paper Adds: Standardized Infant NeuroDevelopmental Assessment (SINDA)'s developmental and socio-emotional scales have excellent interrater reliability. Replication of the satisfactory validity of SINDA's neurological scale for atypical outcome. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: This paper explores the importance of electronic medical records (EMR) for predicting 30-day all-cause non-elective readmission risk of patients and presents a comparison of prediction performance of commonly used methods.Methods: The data are extracted from eight Advocate Health Care hospitals. Index admissions are excluded from the cohort if they are observation, inpatient admissions for psychiatry, skilled nursing, hospice, rehabilitation, maternal and newborn visits, or if the patient expires during the index admission. Data are randomly and repeatedly divided into fitting and validating sets for cross validations. Approaches including LACE, STEPWISE logistic, LASSO logistic, and AdaBoost, are compared with sample sizes varying from 2,500 to 80,000.Results: Our results confirm that LACE has moderate discrimination power with the area under receiver operating characteristic curve (AUC) around 0.65-0.66, which can be improved to 0.73-0.74 when additional variables from EMR are considered. These variables include Inpatient in the last six months, Number of emergency room visits or inpatients in the last year, Braden score, Polypharmacy, Employment status, Discharge disposition, Albumin level, and medical condition variables such as Leukemia, Malignancy, Renal failure with hemodialysis, History of alcohol substance abuse, Dementia and Trauma. When sample size is small (≤5000), LASSO is the best; when sample size is large (≥20,000), the predictive performance is similar. The STEPWISE method has a slightly lower AUC (0.734) comparing to LASSO (0.737) and AdaBoost (0.737). More than one half of the selected predictors can be false positives when using a single method and a single division of fitting/validating data.Conclusions: True predictors can be identified by repeatedly dividing data into fitting/validating subsets and referring the final model based on summarizing results. LASSO is a better alternative to the STEPWISE logistic regression, especially when sample size is not large. The evidence for adequate sample size can be explored by fitting models on gradually reduced samples. Our model comparison strategy is not only good for 30-day all-cause non-elective readmission risk predictions, but also applicable to other types of predictive models in clinical studies. [ABSTRACT FROM AUTHOR]

The brain connections in the different regions demonstrate the characteristics of brain activities. In addition, in various conditions and with neuropsychological disorders, the brain has special patterns in different regions. This paper presents a model to show and compare the connection patterns in different brain regions of children with autism (53 boys and 36 girls) and control children (61 boys and 33 girls). The model is designed by cellular neural networks and it uses the proper features of electroencephalography. The results show that there are significant differences and abnormalities in the left hemisphere, (p < 0.05) at the electrodes AF3, F3, P7, T7, and O1 in the children with autism compared with the control group. Also, the evaluation of the obtained connections values between brain regions demonstrated that there are more abnormalities in the connectivity of frontal and parietal lobes and the relations of the neighboring regions in children with autism. It is observed that the proposed model is able to distinguish the autistic children from the control subjects with an accuracy rate of 95.1% based on the obtained values of CNN using the SVM method. [ABSTRACT FROM AUTHOR]

Diagnostic information regarding the health status of the corneal endothelium may be obtained by analyzing the size and the shape of the endothelial cells in specular microscopy images. Prior to the analysis, the endothelial cells need to be extracted from the image. Up to today, this has been performed manually or semi-automatically. Several approaches to automatic segmentation of endothelial cells exist; however, none of them is perfect. Therefore this paper proposes to perform cell segmentation using a U-Net-based convolutional neural network. Particularly, the network is trained to discriminate pixels located at the borders between cells. The edge probability map outputted by the network is next binarized and skeletonized in order to obtain one-pixel wide edges. The proposed solution was tested on a dataset consisting of 30 corneal endothelial images presenting cells of different sizes, achieving an AUROC level of 0.92. The resulting DICE is on average equal to 0.86, which is a good result, regarding the thickness of the compared edges. The corresponding mean absolute percentage error of cell number is at the level of 4.5% which confirms the high accuracy of the proposed approach. The resulting cell edges are well aligned to the ground truths and require a limited number of manual corrections. This also results in accurate values of the cell morphometric parameters. The corresponding errors range from 5.2% for endothelial cell density, through 6.2% for cell hexagonality to 11.93% for the coefficient of variation of the cell size. [ABSTRACT FROM AUTHOR]

Lung sounds convey relevant information related to pulmonary disorders, and to evaluate patients with pulmonary conditions, the physician or the doctor uses the traditional auscultation technique. However, this technique suffers from limitations. For example, if the physician is not well trained, this may lead to a wrong diagnosis. Moreover, lung sounds are non-stationary, complicating the tasks of analysis, recognition, and distinction. This is why developing automatic recognition systems can help to deal with these limitations. In this paper, we compare three machine learning approaches for lung sounds classification. The first two approaches are based on the extraction of a set of handcrafted features trained by three different classifiers (support vector machines, k-nearest neighbor, and Gaussian mixture models) while the third approach is based on the design of convolutional neural networks (CNN). In the first approach, we extracted the 12 MFCC coefficients from the audio files then calculated six MFCCs statistics. We also experimented normalization using zero mean and unity variance to enhance accuracy. In the second approach, the local binary pattern (LBP) features are extracted from the visual representation of the audio files (spectrograms). The features are normalized using whitening. The dataset used in this work consists of seven classes (normal, coarse crackle, fine crackle, monophonic wheeze, polyphonic wheeze, squawk, and stridor). We have also experimentally tested dataset augmentation techniques on the spectrograms to enhance the ultimate accuracy of the CNN. The results show that CNN outperformed the handcrafted feature based classifiers. [ABSTRACT FROM AUTHOR]

Objective: This paper aims at developing an automated gastroscopic video summarization algorithm to assist clinicians to more effectively go through the abnormal contents of the video.Methods and Materials: To select the most representative frames from the original video sequence, we formulate the problem of gastroscopic video summarization as a dictionary selection issue. Different from the traditional dictionary selection methods, which take into account only the number and reconstruction ability of selected key frames, our model introduces the similar-inhibition constraint to reinforce the diversity of selected key frames. We calculate the attention cost by merging both gaze and content change into a prior cue to help select the frames with more high-level semantic information. Moreover, we adopt an image quality evaluation process to eliminate the interference of the poor quality images and a segmentation process to reduce the computational complexity.Results: For experiments, we build a new gastroscopic video dataset captured from 30 volunteers with more than 400k images and compare our method with the state-of-the-arts using the content consistency, index consistency and content-index consistency with the ground truth. Compared with all competitors, our method obtains the best results in 23 of 30 videos evaluated based on content consistency, 24 of 30 videos evaluated based on index consistency and all videos evaluated based on content-index consistency.Conclusions: For gastroscopic video summarization, we propose an automated annotation method via similar-inhibition dictionary selection. Our model can achieve better performance compared with other state-of-the-art models and supplies more suitable key frames for diagnosis. The developed algorithm can be automatically adapted to various real applications, such as the training of young clinicians, computer-aided diagnosis or medical report generation. [ABSTRACT FROM AUTHOR]

Objective: A model that can predict reliably the risk of pre-eclampsia (PE)-related pregnancy complications does not exist. The aim of this study was to develop and validate internally a clinical prediction model to predict the risk of a composite outcome of PE-related maternal and fetal complications within 7, 14 and 30 days of testing in women with suspected or confirmed PE.Methods: The data for this study were derived from a prospective, multicenter, observational cohort study on women with a singleton pregnancy and suspected or confirmed PE at 20 to < 37 weeks' gestation. For the development of the prediction model, the possible contribution of clinical and standard laboratory variables, as well as the biomarkers soluble fms-like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF) and their ratio, in the prediction of a composite outcome of PE-related complications, consisting of maternal and fetal adverse events within 7, 14 and 30 days, was explored using multivariable competing-risks regression analysis. The discriminative ability of the model was assessed using the concordance (c-) statistic. A bootstrap validation procedure with 500 replications was used to correct the estimate of the prediction model performance for optimism and to compute a shrinkage factor for the regression coefficients to correct for overfitting.Results: Among 384 women with suspected or confirmed PE, 96 (25%) had an adverse PE-related outcome at any time after hospital admission. Important predictors of adverse PE-related outcome included sFlt-1/PlGF ratio, gestational age at the time of biomarker measurement and protein-to-creatinine ratio as continuous variables. The c-statistics (corrected for optimism) for developing a PE-related complication within 7, 14 and 30 days were 0.89, 0.88 and 0.87, respectively. There was limited overfitting, as indicated by a shrinkage factor of 0.91.Conclusions: We propose a simple clinical prediction model with good discriminative performance to predict PE-related complications. Determination of its usefulness in clinical practice awaits further investigation and external validation. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Background: Early recurrences of atrial arrhythmias (ERAA) after atrial fibrillation (AF) catheter ablation do not predict procedural failure. A well-demarcated homogeneous lesion delivered by cryoballoon is less arrhythmogenic, and the recommended three-months blanking period may not refer to cryoballoon ablation (CBA).Objective: We aimed to evaluate the predictive role of ERAA after second-generation CBA using an implantable loop recorder.Methods: This prospective observational study enrolled 100 patients (58 males, median age 58) with paroxysmal/persistent AF undergoing pulmonary vein (PV) CBA using second-generation cryoballoon with simultaneous ECG loop recorder implantation. The duration of follow-up was 12 months, with scheduled visits at 3, 6 and 12 months.Results: 99 patients from 100 completed the 12-month follow-up period. ERAA occurred in 31.3 % of patients. 83.9 % of patients with ERAA also developed late recurrences. The 12-month freedom from AF in patients with ERAA was significantly lower than in those without ERAA (p < 0.0001). Non-paroxysmal AF and longer arrhythmia history were associated with increased risk of both early (HR 3.27; 95 % CI 1.32-8.08; p = 0.010 and HR 1.0147; 95 % CI 1.008-1.086; p = 0.015, respectively) and late recurrences (HR 3.89; 95 % CI 1.67-9.04; p = 0.002 and HR 1.0142; 95 % CI 1.007-1.078; p = 0.019, respectively) of AF. ERAA were another predictor for procedural failure (HR 15.2; 95 % CI (6.42-35.99; p = 0.019).Conclusions: ERAA occurred in the third of the patients after PV second-generation CBA and are strongly associated with procedural failure. Longer duration of AF history and persistent AF are independent predictors of AF's early and late recurrence. [ABSTRACT FROM AUTHOR]

Background: Noninvasive myocardial imaging modalities, such as cardiac magnetic resonance (CMR), single photon emission computed tomography (SPECT), and Positron emission tomography (PET), are well-established and extensively used to detect cardiac amyloid (CA). The purpose of this study is to directly compare CMR, SPECT, and PET scans in the diagnosis of CA, and to provide evidence for further scientific research and clinical decision-making.Methods: PubMed, Embase, and Cochrane Library were searched. Studies used CMR, SPECT and/or PET for the diagnosis of CA were included. Pooled sensitivity, specificity, positive and negative likelihood ratio (LR), diagnostic odds ratio (DOR), their respective 95% confidence intervals (CIs) and the area under the summary receiver operating characteristic (SROC) curve (AUC) were calculated. Quality assessment of included studies was conducted.Results: A total of 31 articles were identified for inclusion in this meta-analysis. The pooled sensitivities of CMR, SPECT and PET were 0.84, 0.98 and 0.78, respectively. Their respective overall specificities were 0.87, 0.92 and 0.95. Subgroup analysis demonstrated that 99mTc-HMDP manifested the highest sensitivity (0.99). 99mTc-PYP had the highest specificity (0.95). The AUC values of 99mTc-DPD, 99mTc-PYP, 99mTc-HMDP were 0.89, 0.99, and 0.99, respectively. PET scan with 11C-PIB demonstrated a pooled sensitivity of 0.91 and specificity of 0.97 with an AUC value of 0.98.Conclusion: Our meta-analysis reveals that SEPCT scans present better diagnostic performance for the identification of CA as compared with other two modalities. [ABSTRACT FROM AUTHOR]

Background: Among people living with HIV (PLHIV), more flexible and sensitive tuberculosis (TB) screening tools capable of detecting both symptomatic and subclinical active TB are needed to (1) reduce morbidity and mortality from undiagnosed TB; (2) facilitate scale-up of tuberculosis preventive therapy (TPT) while reducing inappropriate prescription of TPT to PLHIV with subclinical active TB; and (3) allow for differentiated HIV-TB care.Methods and Findings: We used Botswana XPRES trial data for adult HIV clinic enrollees collected during 2012 to 2015 to develop a parsimonious multivariable prognostic model for active prevalent TB using both logistic regression and random forest machine learning approaches. A clinical score was derived by rescaling final model coefficients. The clinical score was developed using southern Botswana XPRES data and its accuracy validated internally, using northern Botswana data, and externally using 3 diverse cohorts of antiretroviral therapy (ART)-naive and ART-experienced PLHIV enrolled in XPHACTOR, TB Fast Track (TBFT), and Gugulethu studies from South Africa (SA). Predictive accuracy of the clinical score was compared with the World Health Organization (WHO) 4-symptom TB screen. Among 5,418 XPRES enrollees, 2,771 were included in the derivation dataset; 67% were female, median age was 34 years, median CD4 was 240 cells/μL, 189 (7%) had undiagnosed prevalent TB, and characteristics were similar between internal derivation and validation datasets. Among XPHACTOR, TBFT, and Gugulethu cohorts, median CD4 was 400, 73, and 167 cells/μL, and prevalence of TB was 5%, 10%, and 18%, respectively. Factors predictive of TB in the derivation dataset and selected for the clinical score included male sex (1 point), ≥1 WHO TB symptom (7 points), smoking history (1 point), temperature >37.5°C (6 points), body mass index (BMI) <18.5kg/m2 (2 points), and severe anemia (hemoglobin <8g/dL) (3 points). Sensitivity using WHO 4-symptom TB screen was 73%, 80%, 94%, and 94% in XPRES, XPHACTOR, TBFT, and Gugulethu cohorts, respectively, but increased to 88%, 87%, 97%, and 97%, when a clinical score of ≥2 was used. Negative predictive value (NPV) also increased 1%, 0.3%, 1.6%, and 1.7% in XPRES, XPHACTOR, TBFT, and Gugulethu cohorts, respectively, when the clinical score of ≥2 replaced WHO 4-symptom TB screen. Categorizing risk scores into low (<2), moderate (2 to 10), and high-risk categories (>10) yielded TB prevalence of 1%, 1%, 2%, and 6% in the lowest risk group and 33%, 22%, 26%, and 32% in the highest risk group for XPRES, XPHACTOR, TBFT, and Gugulethu cohorts, respectively. At clinical score ≥2, the number needed to screen (NNS) ranged from 5.0 in Gugulethu to 11.0 in XPHACTOR. Limitations include that the risk score has not been validated in resource-rich settings and needs further evaluation and validation in contemporary cohorts in Africa and other resource-constrained settings.Conclusions: The simple and feasible clinical score allowed for prioritization of sensitivity and NPV, which could facilitate reductions in mortality from undiagnosed TB and safer administration of TPT during proposed global scale-up efforts. Differentiation of risk by clinical score cutoff allows flexibility in designing differentiated HIV-TB care to maximize impact of available resources. [ABSTRACT FROM AUTHOR]

Background: No clinical studies to date have compared the inspiratory and expiratory airway lumen area between supine and standing positions. Thus, the aims of this study were twofold: (1) to compare inspiratory and expiratory airway lumen area (IAA and EAA, respectively) on computed tomography (CT) among supine and standing positions; and (2) to investigate if IAA and EAA are associated with lung function abnormality in patients with chronic obstructive pulmonary disease (COPD).Methods: Forty-eight patients with COPD underwent both low-dose conventional (supine position) and upright CT (standing position) during inspiration and expiration breath-holds and a pulmonary function test (PFT) on the same day. We measured the IAA and EAA in each position.Results: For the trachea to the third-generation bronchi, the IAA was significantly larger in the standing position than in the supine position (4.1-4.9% increase, all p < 0.05). The EAA of all bronchi was significantly larger in the standing position than in the supine position (9.7-62.5% increases, all p < 0.001). The correlation coefficients of IAA in the standing position and forced expiratory volume in 1 s were slightly higher than those in the supine position. The correlation coefficients of EAA or EAA/IAA in the standing position and residual volume, and the inspiratory capacity/total lung capacity ratio were higher than those in the supine position.Conclusions: Airway lumen areas were larger in the standing position than in the supine position. IAAs reflect airway obstruction, and EAAs reflect lung hyperinflation. Upright CT might reveal these abnormalities more precisely. Trial registration University Hospital Medical Information Network (UMIN 000026587), Registered 17 March 2017. URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030456 . [ABSTRACT FROM AUTHOR]

Aims: To evaluate diagnostic performance of glomerular filtration rate (GFR) estimated by modification of diet in renal disease (MDRD), chronic kidney disease epidemiology collaboration (CKD-EPI), full age spectrum (FAS), and revised Lund-Malmö (r-LM) equations in adults with diabetes.Methods: Individuals were included in this cross-sectional study if they had at least 1 measurement of technetium-99m diethylenetriamine-pentaacetic acid (99mTc-DTPA) GFR (mGFR) and serum creatinine (1487 patients with 2703 measures). GFR calculated by estimation equations was compared with mGFR. Diagnostic performance was assessed using concordance correlation coefficient (CCC), bias, precision, accuracy, reduced major axis regression (RMAR), and Bland-Altman plot. Analysis was repeated in subgroups based on sex, diabetes type, Hemoglobin A1C, and GFR level.Results: Of all patients, 1189 (86%) had type 2 diabetes. Mean mGFR, MDRD, CKD-EPI, FAS, and revised Lund-Malmö eGFR were 66, 72, 74, 71, and 67 mL/min/1.73m2, respectively. Overall, the r-LM had the highest CCC (0.83), lowest bias (-1.4 mL/min/1.73 m2), highest precision (16.2 mL/min/1.73 m2), and highest accuracy (P10 = 39%). The RMAR (slope, intercept) in r-LM, FAS, MDRD, and CKD-EPI was 1.18, -13.35; 0.97, -2.9; 1, -6.4, and 1.04, -11.3, respectively. The Bland-Altman plot showed that r-LM had the lowest mean difference and the narrowest 95% limit of agreement (-1.0, 54.1 mL/min/1.73 m2), while mean difference was more than 5-fold higher in FAS, MDRD, and CKD-EPI (-5.2, -6.3, and -8.2, respectively).Conclusions: In adults with diabetes the revised Lund-Malmö performs better than MDRD, CKD-EPI, and FAS in calculating point estimates of GFR. [ABSTRACT FROM AUTHOR]

Objective: To compare the value of using one-stop magnetic resonance imaging (MRI) vs standard radiological imaging as a supplement to transvaginal ultrasonography (TVS) for the preoperative assessment of patients with endometriosis referred for surgery in a tertiary care academic center.Methods: This prospective observational study compared the diagnostic value of the standard preoperative imaging practice of our center, which involves expert TVS complemented by intravenous urography (IVU) for the evaluation of the ureters and double-contrast barium enema (DCBE) for the evaluation of the rectum, sigmoid and cecum, with that of expert TVS complemented by a 'one-stop' MRI examination evaluating the upper abdomen, pelvis, kidneys and ureters as well as rectum and sigmoid on the same day, for the preoperative triaging of 74 women with clinically suspected deep endometriosis. The findings at laparoscopy were considered the reference standard. Patients were stratified according to their need for monodisciplinary surgical approach, carried out by gynecologists only, or multidisciplinary surgical approach, involving abdominal surgeons and/or urologists, based on the extent to which endometriosis affected the reproductive organs, bowel, ureters, bladder or other abdominal organs.Results: Our standard preoperative imaging approach and the combined findings of TVS and MRI had similar diagnostic performance, resulting in correct stratification for a monodisciplinary or a multidisciplinary surgical approach of 67/74 (90.5%) patients. However, there were differences between the estimation of the severity of disease by DCBE and MRI. The severity of rectal involvement was underestimated in 2.7% of the patients by both TVS and DCBE, whereas it was overestimated in 6.8% of the patients by TVS and/or DCBE.Conclusions: Complementary to expert TVS, 'one-stop' MRI can predict intraoperative findings equally well as standard radiological imaging (IVU and DCBE) in patients referred for endometriosis surgery in a tertiary care academic center. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: Commercially available business (CAB) datasets for food environments have been investigated for error in large urban contexts and some rural areas, but there is a relative dearth of literature that reports error across regions of variable rurality. The objective of the current study was to assess the validity of a CAB dataset using a government dataset at the provincial scale.Design: A ground-truthed dataset provided by the government of Newfoundland and Labrador (NL) was used to assess a popular commercial dataset. Concordance, sensitivity, positive-predictive value (PPV) and geocoding errors were calculated. Measures were stratified by store types and rurality to investigate any association between these variables and database accuracy.Setting: NL, Canada.Participants: The current analysis used store-level (ecological) data.Results: Of 1125 stores, there were 380 stores that existed in both datasets and were considered true-positive stores. The mean positional error between a ground-truthed and test point was 17·72 km. When compared with the provincial dataset of businesses, grocery stores had the greatest agreement, sensitivity = 0·64, PPV = 0·60 and concordance = 0·45. Gas stations had the least agreement, sensitivity = 0·26, PPV = 0·32 and concordance = 0·17. Only 4 % of commercial data points in rural areas matched every criterion examined.Conclusions: The commercial dataset exhibits a low level of agreement with the ground-truthed provincial data. Particularly retailers in rural areas or belonging to the gas station category suffered from misclassification and/or geocoding errors. Taken together, the commercial dataset is differentially representative of the ground-truthed reality based on store-type and rurality/urbanity. [ABSTRACT FROM AUTHOR]

Background: The onset of venous thromboembolism is insidious and the prognosis is poor. In this study, we aimed to construct a VTE risk warning model and testified its clinical application value.Methods: Preliminary construction of the VTE risk warning model was carried out according to the independent risk warning indicators of VTE screened by Logistic regression analysis. The truncated value of screening VTE was obtained and the model was evaluated. ROC curve analysis was used to compare the test of Caprini risk assessment scale and VTE risk warning model. The cut-off value of the VTE risk warning model was used to evaluate the test effectiveness of the model for VTE patients with validation data set.Results: The VTE risk warning model is p = ex / (1+ ex), x = - 4.840 + 2.557 • X10(1) + 1.432 • X14(1) + 2.977 • X15(1) + 3.445 • X18(1) + 1.086 • X25(1) + 0.249 • X34 + 0.282 • X41. ROC curve results show that: AUC (95%CI), cutoff value, sensitivity, specificity, accuracy, Youden index, Caprini risk assessment scale is 0.596 (0.552, 0.638), 5, 26.07, 96.50, 61.3%, 0.226, VTE risk warning model is 0.960 (0.940, 0.976), 0.438, 92.61, 91.83, 92.2%, 0.844, respectively, with statistically significant differences (Z = 14.521, P < 0.0001). The accuracy and Youden index of VTE screening using VTE risk warning model were 81.8 and 62.5%, respectively.Conclusions: VTE risk warning model had high accuracy in predicting VTE occurrence in hospitalized patients. Its test performance was better than Caprini risk assessment scale. It also had high test performance in external population. [ABSTRACT FROM AUTHOR]

Objective: The present study was undertaken to assess the comparative responsiveness of outcome measures used for the assessment of pain and function in individuals with osteoarthritis (OA) of the first metatarsophalangeal (MTP) joint.Methods: Eighty-eight patients (mean ± SD age 57.2 ± 10.2 years) with OA of the first MTP joint who participated in a randomized trial completed the Foot Health Status Questionnaire (FHSQ), the Foot Function Index Revised Short Form (FFI-RS), and 100-mm visual analog scales (VAS) of pain and stiffness at baseline and 12 weeks. Responsiveness of the subscales for each outcome measure was determined using paired t-tests, Cohen's d coefficient, the standardized response mean (SRM), and the Guyatt index (GI). Sample size estimations were calculated based on minimal important differences (MIDs).Results: All outcome measures were sensitive to change and demonstrated at least medium effect sizes. Three outcome measures exhibited large or very large effect sizes for Cohen's d coefficient, the SRM, and the GI: the FHSQ pain subscale (d = 1.03; SRM 1.10, GI score 1.30), the FFI-RS pain subscale (d = 1.09; SRM 1.05, GI score 1.73), and the 100-mm VAS of pain severity while walking (d = 1.22; SRM 1.07, GI score 1.78). Sample size calculations indicated that between 20 and 33 participants per group would be required to detect MIDs using these measures.Conclusion: The FHSQ pain subscale, FFI-RS pain subscale, and the 100-mm VAS of pain severity while walking are the most responsive outcome measures for the assessment of pain and function in individuals with OA of the first MTP joint. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials. [ABSTRACT FROM AUTHOR]

Rationale: Although proposed as a clinical prompt to sepsis based on predictive validity for mortality, the Quick Sepsis-related Organ Failure Assessment (qSOFA) score is often used as a screening tool, which requires high sensitivity.Objectives: To assess the predictive accuracy of qSOFA for mortality in Brazil, focusing on sensitivity.Methods: We prospectively collected data from two cohorts of emergency department and ward patients. Cohort 1 included patients with suspected infection but without organ dysfunction or sepsis (22 hospitals: 3 public and 19 private). Cohort 2 included patients with sepsis (54 hospitals: 24 public and 28 private). The primary outcome was in-hospital mortality. The predictive accuracy of qSOFA was examined considering only the worst values before the suspicion of infection or sepsis.Measurements and Main Results: Cohort 1 contained 5,460 patients (mortality rate, 14.0%; 95% confidence interval [CI], 13.1-15.0), among whom 78.3% had a qSOFA score less than or equal to 1 (mortality rate, 8.3%; 95% CI, 7.5-9.1). The sensitivity of a qSOFA score greater than or equal to 2 for predicting mortality was 53.9% and the 95% CI was 50.3 to 57.5. The sensitivity was higher for a qSOFA greater than or equal to 1 (84.9%; 95% CI, 82.1-87.3), a qSOFA score greater than or equal to 1 or lactate greater than 2 mmol/L (91.3%; 95% CI, 89.0-93.2), and systemic inflammatory response syndrome plus organ dysfunction (68.7%; 95% CI, 65.2-71.9). Cohort 2 contained 4,711 patients, among whom 62.3% had a qSOFA score less than or equal to 1 (mortality rate, 17.3%; 95% CI, 15.9-18.7), whereas in public hospitals the mortality rate was 39.3% (95% CI, 35.5-43.3).Conclusions: A qSOFA score greater than or equal to 2 has low sensitivity for predicting death in patients with suspected infection in a developing country. Using a qSOFA score greater than or equal to 2 as a screening tool for sepsis may miss patients who ultimately die. Using a qSOFA score greater than or equal to 1 or adding lactate to a qSOFA score greater than or equal to 1 may improve sensitivity.Clinical trial registered with www.clinicaltrials.gov (NCT03158493). [ABSTRACT FROM AUTHOR]

Accurate seizure prediction will transform epilepsy management by offering warnings to patients or triggering interventions. However, state-of-the-art algorithm design relies on accessing adequate long-term data. Crowd-sourcing ecosystems leverage quality data to enable cost-effective, rapid development of predictive algorithms. A crowd-sourcing ecosystem for seizure prediction is presented involving an international competition, a follow-up held-out data evaluation, and an online platform, Epilepsyecosystem.org, for yielding further improvements in prediction performance. Crowd-sourced algorithms were obtained via the 'Melbourne-University AES-MathWorks-NIH Seizure Prediction Challenge' conducted at kaggle.com. Long-term continuous intracranial electroencephalography (iEEG) data (442 days of recordings and 211 lead seizures per patient) from prediction-resistant patients who had the lowest seizure prediction performances from the NeuroVista Seizure Advisory System clinical trial were analysed. Contestants (646 individuals in 478 teams) from around the world developed algorithms to distinguish between 10-min inter-seizure versus pre-seizure data clips. Over 10 000 algorithms were submitted. The top algorithms as determined by using the contest data were evaluated on a much larger held-out dataset. The data and top algorithms are available online for further investigation and development. The top performing contest entry scored 0.81 area under the classification curve. The performance reduced by only 6.7% on held-out data. Many other teams also showed high prediction reproducibility. Pseudo-prospective evaluation demonstrated that many algorithms, when used alone or weighted by circadian information, performed better than the benchmarks, including an average increase in sensitivity of 1.9 times the original clinical trial sensitivity for matched time in warning. These results indicate that clinically-relevant seizure prediction is possible in a wider range of patients than previously thought possible. Moreover, different algorithms performed best for different patients, supporting the use of patient-specific algorithms and long-term monitoring. The crowd-sourcing ecosystem for seizure prediction will enable further worldwide community study of the data to yield greater improvements in prediction performance by way of competition, collaboration and synergism.10.1093/brain/awy210_video1awy210media15817489051001. [ABSTRACT FROM AUTHOR]

Background: To investigate the diagnostic value of dual-source computed tomography (DSCT) in the evaluation of tetralogy of Fallot (TOF)-associated extracardiac vascular abnormalities in pediatric patients compared with transthoracic echocardiography (TTE).Methods: One hundred and twenty-three pediatric patients diagnosed with TOF were included in this retrospective study. All patients underwent DSCT and TTE preoperatively. All associated extracardiac vascular abnormalities and their percentages were recorded. The diagnostic performances of DSCT and TTE were compared based on the surgical results. The image quality of DSCT was rated, and the effective radiation dose (ED) was calculated.Results: A total of 159 associated extracardiac vascular deformities were confirmed by surgery. Patent ductus arteriosus (36, 22.64%), right-sided aortic arch (29, 18.24%), and pulmonary valve stenosis (23, 14.47%) were the most common associated extracardiac vascular abnormalities. DSCT was superior to TTE in demonstrating associated extracardiac anomalies (diagnostic accuracy: 99.13% vs. 97.39%; sensitivity: 92.45% vs. 77.07%; specificity: 99.81% vs. 99.42%). The agreement on grading the image quality of DSCT was excellent (κ = 0.80), and the mean score of the image quality was 3.39 ± 0.50. The mean ED of DSCT was 0.86 ± 0.47 mSv.Conclusions: Compared to TTE, low-dose DSCT has high diagnostic accuracy in the depiction of associated extracardiac vascular anomalies in pediatric patients with TOF, and could provide more morphological details for surgeons. [ABSTRACT FROM AUTHOR]

Objective: The present study assessed systematic bias and the effects of data set error on the validity of food environment measures in two municipal and two commercial secondary data sets.Design: Sensitivity, positive predictive value (PPV) and concordance were calculated by comparing two municipal and two commercial secondary data sets with ground-truthed data collected within 800 m buffers surrounding twenty-six schools. Logistic regression examined associations of sensitivity and PPV with commercial density and neighbourhood socio-economic deprivation. Kendall's τ estimated correlations between density and proximity of food outlets near schools constructed with secondary data sets v. ground-truthed data.Setting: Vancouver, Canada.Subjects: Food retailers located within 800 m of twenty-six schools RESULTS: All data sets scored relatively poorly across validity measures, although, overall, municipal data sets had higher levels of validity than did commercial data sets. Food outlets were more likely to be missing from municipal health inspections lists and commercial data sets in neighbourhoods with higher commercial density. Still, both proximity and density measures constructed from all secondary data sets were highly correlated (Kendall's τ>0·70) with measures constructed from ground-truthed data.Conclusions: Despite relatively low levels of validity in all secondary data sets examined, food environment measures constructed from secondary data sets remained highly correlated with ground-truthed data. Findings suggest that secondary data sets can be used to measure the food environment, although estimates should be treated with caution in areas with high commercial density. [ABSTRACT FROM AUTHOR]

Objective: Patient-physician discordance in global assessment of disease activity concerns one-third of patients, but what does it reflect? We aimed to assess patient-physician discordance in psoriatic arthritis (PsA) and patient-reported domains of health (physical and psychological) associated with discordance.Methods: We analyzed the PsAID (Psoriatic Arthritis Impact of Disease), a cross-sectional, multicenter European study of patients with PsA according to expert opinion. Patient global assessment (PGA) and physician global assessment (PhGA) were rated on a 0-10 numeric rating scale. Discordance was defined as the difference (PGA-PhGA) and as the absolute difference |PGA-PhGA| ≥3 points. Determinants of PGA-PhGA were assessed by a stepwise multivariate linear regression among 12 physical and psychological aspects of impact: pain, skin problems, fatigue, ability to work/leisure, functional incapacity, feeling of discomfort, sleep disturbance, anxiety/fear, coping, embarrassment/shame, social participation, and depressive affects.Results: In 460 patients (mean ± SD age 50.6 ± 12.9 years, 52.2% female, mean ± SD disease duration 9.5 ± 9.5 years, mean ± SD Disease Activity Index for Psoriatic Arthritis score 30.8 ± 32.4, and 40.4% undergoing treatment with biologic agents), the mean ± SD PGA was higher than the mean PhGA, with a mean absolute difference of 1.9 ± 1.8 points. Discordance defined by |PGA-PhGA| ≥3 of 10 concerned 134 patients (29.1%), and 115 patients (85.8% of the patients with discordance) had PGA>PhGA. Higher fatigue (β = 0.14), lower self-perceived coping (β = 0.23), and impaired social participation (β = 0.16) were independently associated with a higher difference (PGA-PhGA).Conclusion: Discordance concerned 29.1% of these patient/physician dyads, mainly by PGA>PhGA. Factors associated with discordance were psychological rather than physical domains of health. Discordance was more frequent in patients in remission, indicating more work is needed on the patient perspective regarding disease activity. [ABSTRACT FROM AUTHOR]

Aims: Complex ablation procedures are supported by accurate representation of an increasing variety of electrophysiological and imaging data within electroanatomic mapping systems (EMS). This study aims to develop a novel method for representing multiple complementary datasets on a single cardiac chamber model. Validation of the system and its application to both atrial and ventricular arrhythmias is examined.Methods and Results: Dot mapping was conceived to display multiple datasets by utilizing quantitative surface shading to represent one dataset and finely spaced dots to represent others. Dot positions are randomized within triangular (surface meshes) or tetrahedral (volumetric meshes) simplices making the approach directly transferrable to contemporary EMS. Test data representing uniform electrical activation (n = 10) and focal scarring (n = 10) were used to test dot mapping data perception accuracy. User experience of dot mapping with atrial and ventricular clinical data is evaluated. Dot mapping ensured constant screen dot density for regions of uniform dataset values, regardless of user manipulation of the cardiac chamber. Perception accuracy of dot mapping was equivalent to colour mapping for both propagation direction (1.5 ± 1.8 vs. 4.8 ± 5.3°, P = 0.24) and focal source localization (1.1 ± 0.7 vs. 1.4 ± 0.5 mm, P = 0.88). User acceptance testing revealed equivalent diagnostic accuracy and display fidelity when compared with colour mapping.Conclusion: Dot mapping provides the unique ability to display multiple datasets from multiple sources on a single cardiac chamber model. The visual combination of multiple datasets may facilitate interpretation of complex electrophysiological and imaging data. [ABSTRACT FROM AUTHOR]

Aims: In persistent atrial fibrillation (AF), left atrial low-voltage areas and complex fractionated atrial electrograms (CFAEs) have been thoroughly discussed as critical substrate points for AF perpetuation. Thus, in patients undergoing pulmonary vein isolation, these sites are often considered additional ablation targets. Currently, mapping techniques for these substrate indicators are still under discussion. The aim of this study was to evaluate the impact of different mapping catheters on the detection of low-voltage areas and CFAE.Methods and Results: Two bipolar voltage maps and two CFAE left atrial maps were obtained each in 30 patients undergoing catheter ablation of AF using the following two different catheters: A four-pole ablation catheter (MAP, mapping and ablation catheter) (electrode size: tip: 4 mm, band: 1 mm; inter-electrode spacing: 0.5-5-2 mm) and a 10-pole circular pulmonary vein mapping catheter (CMC) (electrode size: 1 mm; inter-electrode spacing: 7-7-7 mm). Successively, low-voltage and CFAE area sizes were then compared between the two catheters. Areas with a bipolar voltage of <0.5 mV were significantly smaller when obtained with the CMC compared with the MAP (8.9 ± 8.9 vs. 17.4 ± 11.7 cm², P < 0.001). This was also significantly different for a bipolar voltage of <0.2 mV (2.3 ± 4.6 vs. 6.2 ± 9.6 cm², P < 0.001). Complex fractionated atrial electrogram area sizes were significantly larger when obtained with the CMC compared with the MAP group (14.6 ± 10.9 vs. 19.4 ± 9.4 cm², P = 0.011).Conclusion: Low-voltage and CFAE area size varies significantly between different mapping catheters. Mapping electrode settings have to be taken into consideration for the assessment of electroanatomical substrate of AF. [ABSTRACT FROM AUTHOR]

Objective: To examine the diagnostic accuracy of a previously developed model for the first-trimester combined test in screening for trisomies 21, 18 and 13.Methods: This was a prospective validation study of screening for trisomies 21, 18 and 13 by assessment of a combination of maternal age, fetal nuchal translucency, fetal heart rate and serum free β-human chorionic gonadotropin (β-hCG) and pregnancy-associated plasma protein-A (PAPP-A) at 11 + 0 to 13 + 6 weeks' gestation in 108 982 singleton pregnancies undergoing routine care in three maternity hospitals. A previously published algorithm was used to calculate patient-specific risks for trisomy 21, 18 and 13 in each patient. The detection rate (DR) and false-positive rate (FPR) at estimated risk cut-offs from 1 in 2 to 1 in 1000 were determined. The proportions of trisomies detected were compared to their expected values in different risk groups.Results: In the study population, there were 108 112 (99.2%) cases with normal fetal karyotype or birth of a phenotypically normal neonate and 870 (0.8%) cases with abnormal karyotype, including trisomy 21 (n = 432), trisomy 18 (n = 166), trisomy 13 (n = 56), monosomy X (n = 63), triploidy (n = 35) or other aneuploidy (n = 118). The screen-positive rates, standardized according to the maternal age distribution in England and Wales in 2011, of fetuses with abnormal or normal karyotype were compatible with those predicted from the previous model; at a risk cut-off of 1 in 100, the FPR was about 4% and the DRs for trisomies 21, 18 and 13 were 90%, 97% and 92%, respectively. There was evidence that the algorithm overestimated risk. This could, to some degree, reflect under-ascertainment in pregnancies ending in miscarriage or stillbirth.Conclusion: In a prospective validation study, the first-trimester combined test detected 90%, 97% and 92% of trisomies 21, 18 and 13, respectively, as well as > 95% of cases of monosomy X and triploidies and > 50% of other chromosomal abnormalities, at a FPR of 4%. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Objective: This Phase 2 study assessed the performance of positron emission tomography (PET) brain images made with Flutemetamol F 18 Injection in detecting β-amyloid neuritic plaques in Japanese subjects.Methods: Seventy subjects (25 with probable Alzheimer's disease (pAD), 20 with amnestic mild cognitive impairment (aMCI), and 25 cognitively normal healthy volunteers[HVs]) underwent PET brain imaging after intravenous Flutemetamol F 18 Injection (185 MBq). Images were interpreted as normal or abnormal for neuritic plaque density by each of five non-Japanese and five Japanese readers who were blinded to clinical data. The primary efficacy analysis (based on HV and pAD data) was the agreement of the non-Japanese readers' image interpretations with the clinical diagnosis, resulting in estimates of positive percent agreement (PPA; based on AD subjects; similar to sensitivity) and negative percent agreement (NPA; based on HVs; similar to specificity). Secondary analyses included PPA and NPA for the Japanese readers; inter-reader agreement (IRA); intra-reader reproducibility (IRR); quantitative image interpretations (standardized uptake value ratios [SUVRs]) by diagnostic subgroup; test-retest variability in five pAD subjects; and safety.Results: PPA was 92% for all non-Japanese readers and ranged from 88 to 92% for the Japanese readers. NPA ranged from 96 to 100% for both the non-Japanese readers and the Japanese readers. The majority image interpretations (the interpretations made independently by ≥3 of 5 readers) resulted in PPA values of 92 and 92% and NPA values of 100 and 96% for the non-Japanese and Japanese readers, respectively. IRA and IRR were strong. Composite SUVR values (mean of multiple regional values) allowed clear differentiation between pAD subjects and HVs. Test-retest variability ranged from 1.14 to 2.27%, and test-retest agreement of the blinded visual interpretations was 100% for all readers. Flutemetamol F 18 Injection was generally well tolerated.Conclusions: The detection of brain neuritic plaques in Japanese subjects using [18F]Flutemetamol PET images gave results highly consistent with clinical diagnosis, with non-Japanese and Japanese readers giving similar results. Inter-reader agreement and intra-reader reproducibility were high for both sets of readers. Visual delineation of abnormal and normal scans was corroborated by quantitative assessment, with low test-retest variability.Trial Registration: Clinicaltrials.gov registration number NCT02813070. [ABSTRACT FROM AUTHOR]

Background: The aim of our study was to investigate the reliability of automated oscillometric blood pressure (BP) monitoring in the presence and absence of atrial fibrillation (AF) in hypertensive patients.Methods: BP was measured and compared in 71 randomly selected patients with AF and arterial hypertension diagnosis, 4 times each by auscultatory and oscillometric (Microlife BP A6 PC with AF detection system) methods.Results: Study included 71 patients: 36 males (mean age 67.4 years) and 35 females (70.2 years). At the time of BP measuring procedure, 36 patients were in sinus rhythm (SR) and 35 in AF. In SR patients mean systolic blood pressure (SBP) was 132 ± 17.9 mmHg with auscultatory method (AM), 137.4 ± 19.4 mmHg with oscillometric method (OM); mean diastolic BP was 77.1 ± 10.9 mmHg (AM), 78.5 ± 12.2 mmHg (OM), in AF patients mean SBP was 127.5 ± 15.1 mmHg (AM), 133.6 ± 17.4 mmHg (OM); mean diastolic BP was 81.4 ± 9.9 mmHg (AM), 83.5 ± 11.8 mmHg (OM), p = 0.037. The averages of differences for SBP and DBP in sinus rhythm group were (-5.3 mmHg (95% limits of agreement -27.2 - 16.6)) and (-1.4 mmHg (95% limits of agreement -12.8 - 10.0)), respectively. In patients with AF the averages of differences for SBP and DBP were (-6.1 mmHg (95% limits of agreement -23.9 - 11.7)) and (-2.1 mmHg (95% limits of agreement -12.9 - 8.7)), respectively.Conclusions: The oscillometric device validated for patients with AF on average gives 5.3 mmHg higher systolic BP values for patients with SR and 6.3 mmHg higher BP values for patients with AF. However, the limits of agreement between two methods reveal wide range of random error rates which is a questionable topic in clinical practice, as it could possibly affect the treatment of arterial hypertension in patients with AF. [ABSTRACT FROM AUTHOR]

Background: PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development of a Category ≥2 pressure ulcer. The current 'gold standard' for the identification of a Category ≥2 pressure ulcer is expert clinical assessment. Due to the appearance of the bed, it is not possible to achieve blinding of the endpoint. This therefore poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including whether patients would agree to photographs; the burden of data collection; the quality of photographs; the completeness of data; and how the use of photographs compares with the current 'gold standard'. This validation sub-study aims to assess and quantify potential bias in the reporting of the trial endpoint.Methods/design: Patients will be specifically asked to consent to photographs being taken of their skin sites. Photographs will be taken at first observation or when patients develop a new Category ≥2 pressure ulcer (to assess over-reporting). A 10% random sample of patients will be identified for additional photographs of two skin sites (one torso and one limb) with and without a pressure ulcer (if present) by an independent assessor (to assess the potential for under-reporting). Staff will be trained to take photographs using a standardised camera and photographic technique. A 'grey scale' will be included in the photo to correct white balance. Photographs will be securely transferred for central review. Photographs will have white balance corrected, and the computer monitor will be calibrated prior to review. Analysis will include assessment of under- and over-reporting, acceptability of photography to patients, secure transfer of data, quality of and confidence in blinded photograph review and sensitivity analysis using photograph assessment of primary outcome.Discussion: This study will use photographs to contribute to the primary outcome of the trial. It will inform our understanding of the acceptability of photography for prevention trials and the possibility of other uses of photographic data in clinical work and research.Trial Registration: ISRCTN, ISRCTN01151335 . Registered on 14 May 2013. [ABSTRACT FROM AUTHOR]

Background: Wireless, wearable, inertial motion sensor technology introduces new possibilities for monitoring spinal motion and pain in people during their daily activities of work, rest and play. There are many types of these wireless devices currently available but the precision in measurement and the magnitude of measurement error from such devices is often unknown. This study investigated the concurrent validity of one inertial motion sensor system (ViMove) for its ability to measure lumbar inclination motion, compared with the Vicon motion capture system.Methods: To mimic the variability of movement patterns in a clinical population, a sample of 34 people were included - 18 with low back pain and 16 without low back pain. ViMove sensors were attached to each participant's skin at spinal levels T12 and S2, and Vicon surface markers were attached to the ViMove sensors. Three repetitions of end-range flexion inclination, extension inclination and lateral flexion inclination to both sides while standing were measured by both systems concurrently with short rest periods in between. Measurement agreement through the whole movement range was analysed using a multilevel mixed-effects regression model to calculate the root mean squared errors and the limits of agreement were calculated using the Bland Altman method.Results: We calculated root mean squared errors (standard deviation) of 1.82° (±1.00°) in flexion inclination, 0.71° (±0.34°) in extension inclination, 0.77° (±0.24°) in right lateral flexion inclination and 0.98° (±0.69°) in left lateral flexion inclination. 95% limits of agreement ranged between -3.86° and 4.69° in flexion inclination, -2.15° and 1.91° in extension inclination, -2.37° and 2.05° in right lateral flexion inclination and -3.11° and 2.96° in left lateral flexion inclination.Conclusions: We found a clinically acceptable level of agreement between these two methods for measuring standing lumbar inclination motion in these two cardinal movement planes. Further research should investigate the ViMove system's ability to measure lumbar motion in more complex 3D functional movements and to measure changes of movement patterns related to treatment effects. [ABSTRACT FROM AUTHOR]

Objective: We assessed implementation of the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) physical function form (PF-10a) in routine practice in a racially and ethnically diverse population with rheumatoid arthritis (RA). Objectives were to determine feasibility of implementing PF-10a in the electronic health record (EHR) and PF-10a validity and longitudinal responsiveness.Methods: Clinical and demographic data were abstracted from EHRs for all RA patients seen at a university-based rheumatology clinic between February 2013 and February 2015. We evaluated floor and ceiling (edge) effects and construct validity of PF-10a in a subgroup of patients with Health Assessment Questionnaire (HAQ) scores (n = 189). We used linear mixed-effects models to assess responsiveness of PF-10a to longitudinal changes in the Clinical Disease Activity Index (CDAI) for patients in the entire clinical cohort, with both scores recorded on at least 2 encounters (n = 326).Results: Half of the patients were nonwhite, and 15% were non-English speakers. Over a 2-year period, PF10a was successfully implemented; 97% of patients and 89% of encounters had at least 1 measurement performed. PF-10a had fewer ceiling (defined as best) effects than the HAQ (8% versus 22%), and convergent validity was high (r = -0.85). PF-10a was sensitive to expected differences (older versus younger patients, more versus less active disease). Longitudinal changes in PF-10a were highly associated with changes in the CDAI score (P < 0.0001).Conclusion: PF-10a was feasible to implement in a diverse RA population. It strongly correlates with the HAQ but has fewer ceiling effects and is responsive to changes in RA disease activity, suggesting its validity for use in routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Hypertension is a major risk factor for cardiovascular disease and prevalence varies by ethnic group. The diagnosis and management of blood pressure are informed by guidelines largely based on data from white populations. This study addressed whether accuracy of blood pressure measurement in terms of diagnosis of hypertension varies by ethnicity by comparing two measurement modalities (clinic blood pressure and home monitoring) with a reference standard of ambulatory BP monitoring in three ethnic groups.Methods: Cross-sectional population study (June 2010 - December 2012) with patients (40-75 years) of white British, South Asian and African Caribbean background with and without a previous diagnosis of hypertension recruited from 28 primary care practices. The study compared the test performance of clinic BP (using various protocols) and home-monitoring (1 week) with a reference standard of mean daytime ambulatory measurements using a threshold of 140/90 mmHg for clinic and 135/85 mmHg for out of office measurement.Results: A total of 551 participants had complete data of whom 246 were white British, 147 South Asian and 158 African Caribbean. No consistent difference in accuracy of methods of blood pressure measurement was observed between ethnic groups with or without a prior diagnosis of hypertension: for people without hypertension, clinic measurement using three different methodologies had high specificity (75-97%) but variable sensitivity (33-65%) whereas home monitoring had sensitivity of 68-88% and specificity of 64-80%. For people with hypertension, detection of a raised blood pressure using clinic measurements had sensitivities of 34-69% with specificity of 73-92% and home monitoring had sensitivity (81-88%) and specificity (55-65%).Conclusions: For people without hypertension, ABPM remains the choice for diagnosing hypertension compared to the other modes of BP measurement regardless of ethnicity. Differences in accuracy of home monitoring and clinic monitoring (higher sensitivity of the former; higher specificity of the latter) were also not affected by ethnicity. [ABSTRACT FROM AUTHOR]

Objective: Two oscillometric devices, the Microlife WatchBP O3® and the Omron RS6®, designed for self-blood pressure measurement were evaluated according to the European Society of Hypertension (ESH)-International Protocol (IP) Revision 2010 in the obese population.Methods: The Microlife WatchBP O3 measures blood pressure (BP) at the brachial level and the Omron RS6 measures BP at the wrist level. The ESH-IP revision 2010 includes a total of 33 subjects. The difference between observers' and device BP values was calculated for each measure. A total of 99 pairs of BP differences were classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely in each of the two studies.Results: Microlife WatchBP O3 and Omron RS6 failed to fulfill the criteria of the ESH-IP. The mean differences between the device and the mercury readings were: 0.3±7.8 mmHg and -1.9±6.4 mmHg for systolic BP and diastolic BP, respectively, for Microlife WatchBP O3, and 2.7±9.9 mmHg for SBP and 3.5±11.1 mmHg for diastolic BP for Omron RS6.Conclusion: Microlife WatchBP O3 and Omron RS6 readings differing from the mercury standard by more than 5, 10, and 15 mmHg failed to fulfill the ESH-IP revision 2010 requirements in obese subjects. Therefore, the two devices cannot be recommended for use in obese subjects. [ABSTRACT FROM AUTHOR]

Background: To determine if global strain parameters measured by cardiovascular magnetic resonance (CMR) acutely following ST-segment Elevation Myocardial Infarction (STEMI) predict adverse left ventricular (LV) remodelling independent of infarct size (IS).Methods: Sixty-five patients with acute STEMI (mean age 60 ± 11 years) underwent CMR at 1-3 days post-reperfusion (baseline) and at 4 months. Global peak systolic circumferential strain (GCS), measured by tagging and Feature Tracking (FT), and global peak systolic longitudinal strain (GLS), measured by FT, were calculated at baseline, along with IS. On follow up scans, volumetric analysis was performed to determine the development of adverse remodelling - a composite score based on development of either end-diastolic volume index [EDVI] ≥20% or end-systolic volume index [ESVI] ≥15% at follow-up compared to baseline.Results: The magnitude of GCS was higher when measured using FT (-21.1 ± 6.3%) than with tagging (-12.1 ± 4.3; p < 0.001 for difference). There was good correlation of strain with baseline LVEF (r 0.64-to 0.71) and IS (ρ -0.62 to-0.72). Baseline strain parameters were unable to predict development of adverse LV remodelling. Only baseline IS predicted adverse remodelling - Odds Ratio 1.05 (95% CI 1.01-1.10, p = 0.03), area under the ROC curve 0.70 (95% CI 0.52-0.87, p = 0.04).Conclusion: Baseline global strain by CMR does not predict the development of adverse LV remodelling following STEMI. [ABSTRACT FROM AUTHOR]

Aims: Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models.Methods and Results: All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7-33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5-27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: -8 to 14%), P = 0.60].Conclusion: The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment. [ABSTRACT FROM AUTHOR]

Background: The aims of this report were 1) to describe the duration of moderate to vigorous physical activity (MVPA) and the proportion of participants meeting the recommended criterion of at least 150 min of MVPA per week as measured by the 7 Day Physical Activity Recall Questionnaire (7D-PAR) and accelerometer among women who were enrolled in the mPED trial; 2) to assess the level of agreement of the two measures using a Bland-Altman plot; and 3) to describe the positive and negative predictive values (PPV and NPV, respectively) of meeting the guidelines by calculating the percentage of women meeting the physical activity recommendation by the 7D-PAR who also met this recommendation based on data from the accelerometer.Methods: Baseline data on duration of MVPA from the mPED trial were analyzed for 215 women. Among the women who met the recommended criterion by the 7D-PAR (self-report), we calculated the proportion of individuals who also met it by the accelerometer (objective measure). A Bland Altman Plot was used to assess concordance between the two measures.Results: The mean age was 52.4 (±11.2) years; 54.4 % were white; and 48.8 % were single or divorced. While median MVPA was 160 min/week by the 7D-PAR, it was only 24 min/week in the accelerometer. A total of 117 women met the 150-min criterion by the 7D-PAR. Of these, only 18 also met the criterion by the objective measure (PPV 15.4 %, 95 % CI 9.4-23.2 %). Among the 98 women who did not meet the criterion by the 7D-PAR, none met it by the accelerometer (NPV 100 %). A Bland Altman plot showed the mean difference of +145 min between the two measures with a 95 % limit of agreement at + 471 to -181 min.Conclusions: The large discrepancy between the self-reported and objective measures of MVPA meeting the 150-min criterion suggests that self-reported physical activity measures should be used with caution in intervention studies. While our data suggest that self-report could be used to identify a physically inactive sample, it would be likely to over-estimate the proportions of women who become active in one or both arms of trials of interventions promoting MVPA.Trial Registration: ClinicalTrials.gov NCT01280812. [ABSTRACT FROM AUTHOR]

Background: Evaluating different approaches to identifying frail home care clients at heightened risk for adverse health outcomes is an important but understudied area. Our objectives were to determine the prevalence and correlates of frailty (as operationally defined by three measures) in a home care cohort, the agreement between these measures, and their predictive validity for several outcomes assessed over one year.Methods: We conducted a retrospective cohort study with linked population-based administrative and clinical (Resident Assessment Instrument [RAI]) data for all long-stay home care clients (aged 66+) assessed between April 2010-2013 in Ontario, Canada (n = 234,552). We examined two versions of a frailty index (FI), a full and modified FI, and the CHESS scale, compared their baseline characteristics and their predictive accuracy (by calculating the area under the ROC curve [AUC]) for death, long-term care (LTC) admission, and hospitalization endpoints in models adjusted for age, sex and comorbidity.Results: Frailty prevalence varied by measure (19.5, 24.4 and 44.1 %, for full FI, modified FI and CHESS, respectively) and was similar among female and male clients. All three measures were associated with a significantly increased risk of death, LTC admission and hospitalization endpoints in adjusted analyses but their addition to base models resulted in modest improvement for most AUC estimates. There were significant differences between measures in predictive accuracy, with the full FI demonstrating a higher AUC for LTC admission and CHESS a higher AUC for hospitalization - although none of the measures performed well for the hospitalization endpoints.Conclusions: The different approaches to detecting vulnerability resulted in different estimates of frailty prevalence among home care clients in Ontario. Although all three measures were significant predictors of the health outcomes examined, the gains in predictive accuracy were often modest with the exception of the full FI in predicting LTC admission. Our findings provide some support for the clinical utility of a comprehensive FI measure and also illustrate that it is feasible to derive such a measure at the population level using routinely collected data. This may facilitate further research on frailty in this setting, including the development and evaluation of interventions for frailty. [ABSTRACT FROM AUTHOR]

In occidental countries, peripheral arterial disease (PAD) is an important health issue; however, most subjects are asymptomatic (~50%) and therefore undiagnosed and untreated. Current guidelines recommend screening for PAD in primary care setting using ankle brachial index (ABI) in all patients with cardiovascular risks. This is, however, not performed strictly because the standard Doppler method is cumbersome and time-consuming. Here, we evaluate the accuracy and reproducibility of ABI measurements obtained by an improved automated oscillometric device, the MESI ABPI MD(®) device, and the standard Doppler method. ABI was measured in random order in a general practice with Doppler probes by two operators separately (ABI_dop) and twice with the MESI ABPI MD device (ABI_mesi). ABI_dop was calculated dividing the highest systolic blood pressure from both tibial and dorsalis pedis arteries by the highest systolic blood pressure of both brachial arteries. ABI_mesi was obtained automatically with simultaneous measurements on three extremities. According to ABI_dop, PAD was present in 10% of the 136 screened subjects (68.2±7.4 years). Interoperator coefficient of variation was 5.5% for ABI_dop, while the intrasubject coefficient of variation for ABI_mesi was 3.0%. ABI_mesi was correlated with ABI_dop (R=0.61, P<0.0001). The difference between the two techniques was 0.06±0.14 with ABI_mesi providing slightly higher values (P<0.0001) and negligible bias across the range (R=0.19, P<0.0001). Therefore, ABI_mesi ≤1 had a sensitivity of 85% and specificity of 96% to detect ABI_dop ≤0.9 and hence PAD. Doppler measurements took seven times longer than MESI ABPI MD measurements to be performed. In conclusion, MESI improved automated oscillometric method and offered a faster and repeatable measurement of ABI with only a small, clinically irrelevant overestimation of ABI value. The tested MESI ABPI MD-improved oscillometric system can be used as a screening tool for patients in general practice and would enable family doctors to comply with current guidelines for PAD. [ABSTRACT FROM AUTHOR]

Background: Prognostic assessment in patients with hepatocellular carcinoma (HCC) remains controversial. Using the Italian Liver Cancer (ITA.LI.CA) database as a training set, we sought to develop and validate a new prognostic system for patients with HCC.Methods and Findings: Prospective collected databases from Italy (training cohort, n = 3,628; internal validation cohort, n = 1,555) and Taiwan (external validation cohort, n = 2,651) were used to develop the ITA.LI.CA prognostic system. We first defined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics (largest tumor diameter, number of nodules, intra- and extrahepatic macroscopic vascular invasion, extrahepatic metastases). A parametric multivariable survival model was then used to calculate the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group (ECOG) performance status, Child-Pugh score (CPS), and alpha-fetoprotein (AFP) in predicting individual survival. Based on the model results, an ITA.LI.CA integrated prognostic score (from 0 to 13 points) was constructed, and its prognostic power compared with that of other integrated systems (BCLC, HKLC, MESIAH, CLIP, JIS). Median follow-up was 58 mo for Italian patients (interquartile range, 26-106 mo) and 39 mo for Taiwanese patients (interquartile range, 12-61 mo). The ITA.LI.CA integrated prognostic score showed optimal discrimination and calibration abilities in Italian patients. Observed median survival in the training and internal validation sets was 57 and 61 mo, respectively, in quartile 1 (ITA.LI.CA score ≤ 1), 43 and 38 mo in quartile 2 (ITA.LI.CA score 2-3), 23 and 23 mo in quartile 3 (ITA.LI.CA score 4-5), and 9 and 8 mo in quartile 4 (ITA.LI.CA score > 5). Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower (log-rank test, p < 0.001) in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort. The concordance index (C index) of the ITA.LI.CA score in the internal and external validation cohorts was 0.71 and 0.78, respectively. The ITA.LI.CA score's prognostic ability was significantly better (p < 0.001) than that of BCLC stage (respective C indexes of 0.64 and 0.73), CLIP score (0.68 and 0.75), JIS stage (0.67 and 0.70), MESIAH score (0.69 and 0.77), and HKLC stage (0.68 and 0.75). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups.Conclusions: The ITA.LI.CA prognostic system includes both a tumor staging-stratifying patients with HCC into six main stages (0, A, B1, B2, B3, and C)-and a prognostic score-integrating ITA.LI.CA tumor staging, CPS, ECOG performance status, and AFP. The ITA.LI.CA prognostic system shows a strong ability to predict individual survival in European and Asian populations. [ABSTRACT FROM AUTHOR]

Aims: Electrocardiographic diagnosis of wide QRS complex tachycardia (WCT) continues to be challenging as none one of the available methods is specific for ventricular tachycardia (VT) diagnosis. We aimed to construct a method for WCT differentiation based on a scoring system, in which ECGs are graded according to the number of VT-specific features. This novel method was validated and compared with Brugada algorithm and other methods.Methods and Results: A total of 786 WCTs (512 VTs) from 587 consecutive patients with a proven diagnosis were analysed by two blinded observers. The VT score method was based on seven ECG features: initial R wave in V1, initial r > 40 ms in V1/V2, notched S in V1, initial R in aVR, lead II R wave peak time ≥50 ms, no RS in V1-V6, and atrioventricular dissociation. Atrioventricular dissociation was assigned two points, and each of the other features was assigned one point. The overall accuracy of VT score ≥1 for VT diagnosis (83%) was higher than that of the aVR (72%, P = 0.001) and Brugada (81%) algorithms. Ventricular tachycardia score ≥3 was present in 66% of VTs and was more specific (99.6%) than any other algorithm/criterion for VT diagnosis. Ventricular tachycardia score ≥4 was present in 33% of VTs and was 100% specific for VT.Conclusion: The new ECG-based method provides a certain diagnosis of VT in the majority of patients with VT, identifies unequivocal ECGs, and has superior overall diagnostic accuracy to other ECG methods. [ABSTRACT FROM AUTHOR]

Background: 3 T MRI has been adopted by some centers as the primary choice for assessment of myocardial perfusion over conventional 1.5 T MRI. However, there is no data published on the potential additional value of incorporating semi-quantitative data from 3 T MRI. This study sought to determine the performance of qualitative 3 T stress magnetic resonance myocardial perfusion imaging (3 T-MRMPI) and the potential incremental benefit of using a semi-quantitative perfusion technique in patients with suspected coronary artery disease (CAD).Methods: Fifty eight patients (41 men; mean age: 59 years) referred for elective diagnostic angiography underwent stress 3 T MRMPI with a 32-channel cardiac receiver coil. The MR protocol included gadolinium-enhanced stress first-pass perfusion (0.56 mg/kg, dipyridamole), rest perfusion, and delayed enhancement (DE). Visual analysis was performed in two steps. Ischemia was defined as a territory with perfusion defect at stress study but no DE or a territory with DE but additional peri-infarcted perfusion defect at stress study. Semi-quantitative analysis was calculated by using the upslope of the signal intensity-time curve during the first pass of contrast medium during dipyridamole stress and at rest. ROC analysis was used to determine the MPRI threshold that maximized sensitivity. Quantitative coronary angiography served as the reference standard with significant stenosis defined as >70 % diameter stenosis. Diagnostic performance was determined on a per-patient and per-vessel basis.Results: Qualitative assessment had an overall sensitivity and specificity for detecting significant stenoses of 77 % and 80 %, respectively. By adding MPRI analysis, in cases with negative qualitative assessment, the overall sensitivity increased to 83 %. The impact of MPRI differed depending on the territory; with the sensitivity for detection of left circumflex (LCx) stenosis improving the most after semi-quantification analysis, (66 % versus 83 %).Conclusions: Pure qualitative assessment of 3 T MRI had acceptable performance in detecting severe CAD. There is no overall benefit of incorporating semi-quantitative data; however a higher sensitivity can be obtained by adding MPRI, especially in the detection of LCx lesions. [ABSTRACT FROM AUTHOR]

Background: Although cardiovascular disease is the major cause of premature death among Indigenous peoples in several advanced economies, no acute coronary syndrome (ACS) risk models have been validated in Indigenous populations. We tested the validity and calibration of three Global Registry of Acute Coronary Events (GRACE) scores among Aboriginal and non-Aboriginal Australians.Methods: GRACE scores were calculated at admission or discharge using clinical data, with all-cause deaths obtained from data linkage. Scores for GRACE models were validated for; 1) in-hospital death, 2) death within 6 months from admission or 3) death within 6 months of discharge (this also for 1 and 5-years mortality).Results: Aboriginal patient were younger (62 % aged <55 years versus 15 % non-Aboriginal) and their median GRACE scores lower than non-Aboriginal patients, as was crude mortality at 6 months from admission (6 % vs 10 %) and at 1 and 5 years. After age stratification, risk scores for Aboriginal patients were equivalent or higher, especially among those aged <55 years. There was a trend to more deaths after discharge among Aboriginal patients in each age group, suggesting an age-related under-estimation of risk. The c-statistics for the three GRACE models within both groups were between 0.75 and 0.79.Conclusions: We demonstrated for the first time that while the discriminatory capacity of GRACE risk scores among Indigenous Australians is good, the models may need re-calibrating to improve risk stratification in this and other Indigenous groups, where age of onset of coronary disease is much younger than among the original reference population. [ABSTRACT FROM AUTHOR]

Rationale: Estimates of idiopathic pulmonary fibrosis (IPF) incidence and prevalence from electronic databases without case validation may be inaccurate.Objectives: Develop claims algorithms to identify IPF and assess their positive predictive value (PPV) to estimate incidence and prevalence in the United States.Methods: We developed three algorithms to identify IPF cases in the HealthCore Integrated Research Database. Sensitive and specific algorithms were developed based on literature review and consultation with clinical experts. PPVs were assessed using medical records. A third algorithm used logistic regression modeling to generate an IPF score and was validated using a separate set of medical records. We estimated incidence and prevalence of IPF using the sensitive algorithm corrected for the PPV.Measurements and Main Results: We identified 4,598 patients using the sensitive algorithm and 2,052 patients using the specific algorithm. After medical record review, the PPVs of these algorithms using the treating clinician's diagnosis were 44.4 and 61.7%, respectively. For the IPF score, the PPV was 76.2%. Using the clinical adjudicator's diagnosis, the PPVs were 54 and 57.6%, respectively, and for the IPF score, the PPV was 83.3%. The incidence and period prevalences of IPF, corrected for the PPV, were 14.6 per 100,000 person-years and 58.7 per 100,000 persons, respectively.Conclusions: Sensitive algorithms without correction for false positive errors overestimated incidence and prevalence of IPF. An IPF score offered the greatest PPV, but it requires further validation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the diagnostic accuracy of middle cerebral artery peak systolic velocity (MCA-PSV) Doppler measurements in prediction of hemoglobin levels in twin anemia-polycythemia sequence (TAPS).Methods: This study involved a consecutive cohort comprising monochorionic twin pregnancies complicated by TAPS managed at three European fetal medicine centers between 2005 and 2013. The accuracy of MCA-PSV, measured immediately prior to fetal hemoglobin (Hb) measurement by fetal or cord blood sampling, for prediction of anemia and polycythemia was assessed using 2 × 2 tables.Results: A total of 116 measurements (74 recorded in donors and 42 in recipients) from 43 twin pregnancies complicated by TAPS were available for analysis. MCA-PSV multiples of the median (MoM) values correlated well with Hb levels (r = - 0.86; P < 0.001). The sensitivity of MCA-PSV ≥ 1.5 MoM to predict severe anemia (Hb deficit > 5 SD below the mean) in TAPS donors was 94% (95% CI, 85-98%); specificity was 74% (95% CI, 62-83%); positive and negative predictive values were 76% (95% CI, 65-85%) and 94% (95% CI, 83-98%), respectively. The sensitivity of MCA-PSV ≤ 1.0 MoM to predict polycythemia (Hb level > 5 SD above the mean) in TAPS recipients was 97% (95% CI, 87-99%); specificity was 96% (95% CI, 89-99%); positive and negative predictive values were 93% (95% CI, 81-97%) and 99% (95% CI, 93-100%), respectively.Conclusion: MCA-PSV measurement has high diagnostic accuracy for predicting abnormal Hb levels in fetuses with TAPS. [ABSTRACT FROM AUTHOR]

Background: Molecular diagnosis has been proposed to enhance the intra-operative diagnosis of sentinel lymph node (SLN) invasion in head and neck squamous cell carcinoma (HNSCC). Although cytokeratin (CK) mRNA quantification with real-time reverse transcriptase-PCR (QRT-PCR) has produced encouraging results, the more discriminating markers remain to be identified.Methods: Pemphigus vulgaris antigen (PVA), squamous cell carcinoma antigen (SCCA), and CK17 mRNA were quantified using QRT-PCR, and the results were compared with an extensive histopathological examination of the entire SLNs on 78 SLNs harvested from 22 patients with HNSCC.Results: SCCA and CK17 quantification showed significantly higher mRNA values for macrometastases (MAs) than for either negative or isolated tumour cell (ITC) SLNs (P<0.01). Pemphigus vulgaris antigen allowed the discrimination of all MAs and micrometastases from both negative and ITC SLNs (P<0.001). For the neck staging of patients, considering metastatic vs non-metastatic status, receiver-operating characteristic curve analysis found areas under the curve of 93.8, 97.9, and 100% for CK17, SCCA, and PVA, respectively. With PVA, a cutoff value of 562 copies per 100 ng of cDNA permitted the correct distinction between patients with positive as opposed to negative neck nodes in all cases.Conclusion: PVA seems to be a highly promising marker for accurate intra-operative SLN staging in HNSCC by QRT-PCR. [ABSTRACT FROM AUTHOR]

Objective: To define the prevalence of and factors associated with having a negative purified protein derivative (PPD) among persons who self-report a prior positive PPD and to define the safety of repeat testing in such persons.Design: Observational cohort study.Setting: Methadone maintenance program with onsite primary care.Patients/participants: Current or former drug users enrolled in methadone maintenance treatment.Interventions: Structured interview, tuberculin skin testing regardless of self-reported PPD status, and anergy testing.Measurements and Main Results: Nearly one third (31%) of participants who self-reported a prior positive PPD had a negative measured PPD, despite receipt of a "booster" PPD. A single participant (0.5%) blistered in response to the PPD without lasting ill effect. Participants with PPD results discordant from their history were more likely to be HIV-seropositive and nonreactive to the anergy panel. The discordance rate among HIV-infected participants was 43%, and was largely attributable to immune dysfunction. Among HIV-seronegative participants, the discordance rate was 27%. Recent crack-cocaine use was independently associated with discordance in the absence of HIV infection.Conclusions: We confirmed that planting a PPD in patients who self-report a positive PPD history confers minimal risk. Substantial rates of discordance exist between self-reported history of a positive PPD and measured PPD status. Further research is needed to define the optimal management of PPD-negative patients who self-report a prior positive PPD and who have not received prior treatment for latent tuberculosis. [ABSTRACT FROM AUTHOR]

Background: There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.Methods and Materials: This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48 months; however, this has now been extended to 66 months. A sample size of 600 participants is required.Discussion: The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.Trial Registration: ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016. [ABSTRACT FROM AUTHOR]

Aims: Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This study analyses the accuracy of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram compared with conventional manual annotation during PVC ablation procedures.Methods and results: Forty patients with successful ablation of focal PVC in three centres were included. Electroanatomical activation maps obtained with the automatic system (WF-map) were compared with manual annotation maps (M-map). Correlation and concordance of LAT obtained with both methods were assessed at 3536 points. The distance between the earliest activation site (EAS) and the effective radiofrequency application point (e-RFp) were determined in M-map and WF-map. The distance between WF-EAS and M-EAS was assessed. Successful ablation sites included left ventricular outflow tract (LVOT; 55%), right ventricular outflow tract (40%), and tricuspid annulus (5%). Good correlation was observed between the two annotation approaches (r = 0.655; P < 0.0001). Bland-Altman analysis revealed a systematic delayed detection of LAT by WF-map (bias 33.8 ± 30.9 ms), being higher in LVOT than in the right ventricle (42.6 ± 29.2 vs. 27.2 ± 30.5 ms, respectively; P < 0.0001). No difference in EAS-eRFp distance was observed between M-map and WF-map (1.8 ± 2.8 vs. 1.8 ± 3.4 mm, respectively; P = 0.986). The median (interquartile range) distance between WF-EAS and M-EAS was 2.2(0-6) mm.Conclusion: Good correlation was found between M-map and WF-map. Local activation time detection was systematically delayed in WF-map, especially in LVOT. Accurate identification of e-RFp was achieved with both annotation approaches. [ABSTRACT FROM AUTHOR]