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A prospective RCT comparing combined chromoendoscopy with water exchange (CWE) vs water exchange (WE) vs air insufflation (AI) in adenoma detection in screening colonoscopy.
Leung, JW, Yen, AW, Jia, H, Opada, C, Melnik, A, Atkins, J, Feller, C, Wilson, MD, Leung, FW
United European gastroenterology journal. 2019;(4):477-487
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Abstract
BACKGROUND A low adenoma detection rate (ADR) increases risks of interval cancers (ICs). Proximal colon flat polyps, e.g. serrated lesions (SLs), are difficult to find. Missed proximal colon flat lesions likely contribute to IC. AIMS We compared chromoendoscopy with water exchange (CWE), water exchange (WE) and air insufflation (AI) in detecting adenomas in screening colonoscopy. METHODS After split-dose preparation, 480 veterans were randomized to AI, WE and CWE. RESULTS Primary outcome of proximal ADR (55.6% vs 53.4% vs 52.2%, respectively) were similar in all groups. Adenoma per colonoscopy (APC) and adenoma per positive colonoscopy (APPC) were comparable. Detection rate of proximal colon SLs was significantly higher for CWE and WE than AI (26.3%, 23.6% and 11.3%, respectively, p = 0.002). Limitations: single operator; SLs only surrogate markers of but not IC. CONCLUSIONS When an endoscopist achieves high-quality AI examinations with overall ADR twice (61.6%) the recommended standard (30%), use of WE and CWE does not produce further improvement in proximal or overall ADR. Comparable APC and APPC confirm equivalent withdrawal inspection techniques. WE alone is sufficient to significantly improve detection of proximal SLs. The impact of increased detection of proximal SLs by WE on prevention of IC deserves to be studied. This study is registered at ClinicalTrial.gov (NCT#01607255).
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New approach for detection of LDL-hypercholesterolemia in the pediatric population: The Fr1dolin-Trial in Lower Saxony, Germany.
Kordonouri, O, Lange, K, Boettcher, I, Christoph, J, Marquardt, E, Tombois, C, Galuschka, L, Stiller, D, Mueller, I, Roloff, F, et al
Atherosclerosis. 2019;:85-91
Abstract
BACKGROUND AND AIMS Lipid disorders are often detected very late, particularly in affected young children. We evaluated the feasibility of a screening for LDL-hypercholesterolemia (highLDL) among toddlers and preschoolers. METHODS Population-based screening has been offered to all children (2-6 years) living in the State of Lower Saxony, Germany, with capillary blood sampling for detection of elevated LDL-cholesterol (LDL-C ≥ 135 mg/dL). Positive results were confirmed by a second measurement. Follow-up in specialized centers, including disease specific counselling and extended diagnostics, as well as evaluation of psychological distress of the parents, is carried out longitudinally. RESULTS Up to March 2018, 5656 children have participated in the screening program. 5069/5656 children have completed the screening for highLDL (52.0% boys; median age: 4.0 years [Interquartile range, IQR 3.0-5.1]; mother age: 35 years [IQR 31-38]; father's age: 37 years; [IQR 33-42]). HighLDL was identified in 112 children (2.2%; 40.2% boys; LDL-C 157.6 ± 29.5 mg/dL, mean ± SD). In the total cohort, parents stated in 40.9% of the cases a positive family history for hyperlipidemia and in 29.9% a premature cardiovascular event. Children with highLDL had more often both risk factors in their family history; however, in 37% of them none of these factors were reported. CONCLUSIONS The first results of the screening program showed its feasibility and revealed high prevalence of highLDL in the general population. Furthermore, a large proportion of families of affected children were not aware about their lipid disorders.
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Screening coronary angiography in patients with long-standing diabetes mellitus undergoing kidney transplant evaluation.
Puttarajappa, CM, Tevar, AD, Hariharan, S, Silver, SJ, Soman, P, Hendrick, S, Mour, G, Wu, CM
Clinical transplantation. 2019;(4):e13501
Abstract
BACKGROUND The utility of coronary angiography in patients with diabetes mellitus undergoing kidney transplant evaluation is unclear. Predictors of critical angiography lesions in these patients will aid in appropriate use of angiography. METHODS Single-center study of 80 patients with ≥15 years of diabetes mellitus who underwent a screening coronary angiography despite a negative cardiac stress test. Risk factors for needing coronary intervention (CI) (percutaneous or bypass grafting) were analyzed. RESULTS Eighteen patients (23%) had a ≥70% occlusion in one or more major coronary vessel(s), with right coronary artery being the most commonly involved (71%). Fifteen patients (19%) underwent coronary intervention: ten percutaneously and five with bypass surgery. Risk factors for needing CI were not being on statin (OR 3.54, P = 0.047) and history of stroke or peripheral vascular disease (PVD; OR 3.5, P = 0.034). A model that included statin use, stroke/PVD history, and glycosylated hemoglobin had a receiver operating characteristic curve area under the curve of 0.8 to predict CI. CONCLUSION Despite a negative stress test, the prevalence of critical coronary lesions was high among kidney transplant candidates with long-standing diabetes. Risk factors for needing coronary intervention were absence of statin use and a history of stroke or peripheral vascular disease.
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Cost-effectiveness of a cascade screening program for the early detection of familial hypercholesterolemia.
Lázaro, P, Pérez de Isla, L, Watts, GF, Alonso, R, Norman, R, Muñiz, O, Fuentes, F, Mata, N, López-Miranda, J, González-Juanatey, JR, et al
Journal of clinical lipidology. 2017;(1):260-271
Abstract
BACKGROUND Although familial hypercholesterolemia (FH) confers a high risk of coronary artery disease, most patients are undiagnosed, and little is known about the efficiency of genetic cascade screening programs at national level. OBJECTIVE The aim of the study was to estimate the cost-effectiveness of a national genetic cascade screening program in Spain. METHODS An economic evaluation was performed using a decision tree analysis. The choice in the decision tree was between implementation of the national program for FH (NPFH) or keeping the usual clinical care. The NPFH detects FH patients through total cholesterol measurement at primary care level and use of genetic testing in index cases and relatives. The payer (National Health System) and social (including the productivity lost) perspectives were considered. The outcome variables were coronary events avoided, deaths avoided, and quality-adjusted life years (QALYs) gained. RESULTS From the payer perspective, the application of the NPFH during 1 year prevents 847 coronary events and 203 deaths in the 9000 FH patients cohort during a 10-year follow-up, yielding an extra 767 QALYs, at a cost of €29,608 per QALY gained. From the social perspective, the NPFH is dominant over the control (the cost decreases and the effectiveness increases). The sensitivity analysis confirms the robustness of the findings. CONCLUSION The NPFH based on molecular testing is a cost-effective diagnostic and management strategy that supports government expenditure aimed at preventing coronary artery disease in FH patients in Spain. Implementation of such a strategy is likely to be also cost-effective in countries with similar developed healthcare systems.
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Screening for Diabetic Retinopathy Using a Portable, Noncontact, Nonmydriatic Handheld Retinal Camera.
Zhang, W, Nicholas, P, Schuman, SG, Allingham, MJ, Faridi, A, Suthar, T, Cousins, SW, Prakalapakorn, SG
Journal of diabetes science and technology. 2017;(1):128-134
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Abstract
BACKGROUND Diabetic retinopathy (DR) is a leading cause of low vision and blindness. We evaluated the feasibility of using a handheld, noncontact digital retinal camera, Pictor, to obtain retinal images in dilated and undilated eyes for DR screening. We also evaluated the accuracy of ophthalmologists with different levels of training/experience in grading these images to identify eyes with vision-threatening DR. METHODS A prospective study of diabetic adults scheduled to have dilated eye exams at Duke Eye Center from January to May 2014 was conducted. An imager acquired retinal images pre- and postdilation with Pictor and selected 1 pre- and 1 postdilation image per eye. Five masked ophthalmologists graded images for gradability (based on image focus and centration) and the presence of no, mild, moderate, or severe nonproliferative DR (NPDR) or proliferative DR (PDR). Referable disease was defined as moderate or severe NPDR or PDR on image grading. We evaluated feasibility based on the graders' evaluation of image gradability. We evaluated accuracy of identifying vision-threatening disease (severe NPDR or PDR documented on dilated clinical examination) based on the graders' sensitivity and specificity of grading referable disease. RESULTS Images were gradable in 86-94% of predilation and 94-97% of postdilation photos. Compared to the dilated clinical exam, overall sensitivity for identifying vision-threatening DR was 64-88% and specificity was 71-90%. CONCLUSIONS Pictor can capture retinal images of sufficient quality to screen for DR with and without dilation. Single retinal images obtained using Pictor can identify eyes with vision-threatening DR with high sensitivity and acceptable specificity compared to clinical exam.
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Evaluating FINDRISC as a screening tool for type 2 diabetes among overweight adults in the PREVIEW:NZ cohort.
Silvestre, MP, Jiang, Y, Volkova, K, Chisholm, H, Lee, W, Poppitt, SD
Primary care diabetes. 2017;(6):561-569
Abstract
AIMS: This study aimed to evaluate the efficacy of a high (≥12) Finnish diabetes risk (FINDRISC) score in identifying undiagnosed prediabetes and type 2 diabetes (T2D) in an New Zealand population of overweight and obese individuals, across a variety of ethnic groups. METHODS We estimated the efficacy of elevated FINDRISC scores in predicting prediabetes and T2D in 424 overweight adults with no prior diagnosis recruited for the PREVention of diabetes through lifestyle Interventions in Europe and Worldwide (PREVIEW) study. All participants who completed the FINDRISC questionnaire during a pre-screening phase with a score of ≥12 were then screened using a 2h oral glucose tolerance test (2h-OGTT) to identify undiagnosed dysglycaemia. RESULTS Of the 424 participants, 65% (n=280) were pre-diabetic and 7% (n=32) had undiagnosed T2D. A higher FINDRISC score was significantly associated with prediabetes and T2D (P=0.02). There was a significant association between ethnicity and glycaemic status (normal vs prediabetes/T2D, P=0.02). Increasing the FINDRISC cut-off to ≥15 resulted in a non-significant increase in the proportion of participants correctly classified with dysglycaemia. ROC-AUC=0.6 with sensitivity=0.6026 (95% CI: 0.5459-0.6573) and specificity=0.5536 (95% CI: 0.4567-0.6476). Isolated impaired fasting glucose (IFG) was more efficient in predicting dysglycaemia than isolated impaired glucose tolerance (IGT). CONCLUSIONS The FINDRISC questionnaire is a useful and efficacious screening tool to identify unknown prediabetes and T2D in overweight New Zealanders, particularly in Maori individuals.
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Evaluation of non-invasive screening measures to identify individuals with prediabetes.
Vanderwood, KK, Kramer, MK, Miller, RG, Arena, VC, Kriska, AM
Diabetes research and clinical practice. 2015;(1):194-201
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AIMS: Because blood-based screening to identify those with prediabetes to take part in Diabetes Prevention Program (DPP) translation efforts can be costly and time-consuming, non-invasive methods are needed. The aims of this paper are to evaluate the ability of the American Diabetes Association (ADA) risk test in identifying individuals with prediabetes, as well as the use of body composition measures for this purpose. In addition the utility of these alternate methods to ascertain the presence of the metabolic syndrome was assessed. METHODS Potential participants were recruited from a worksite and three community centers to take part in a DPP translation study. Participants completed onsite screening where anthropometric measures, fasting lipids and glucose, and hemoglobin A1c were assessed. Those with a BMI ≥24 kg/m(2) and prediabetes and/or the metabolic syndrome were eligible to participate. Non-invasive screening methods were evaluated for their ability to identify those with prediabetes and the metabolic syndrome based on clinically measured values. RESULTS All non-invasive methods were highly sensitive (68.9% to 98.5%) in the detection of prediabetes, but specificity was low (6.7% to 44.5%). None of the alternatives evaluated achieved acceptable discrimination levels in ROC analysis. Similar results were noted in identifying the metabolic syndrome. CONCLUSIONS The non-invasive methods evaluated in this study effectively identify participants with prediabetes, but would also allow for enrollment of a large number of individuals who do not have prediabetes. Deciding whether to use these alternatives, blood-based measures, or a combination of both will ultimately depend on the purpose of the program and the level of flexibility regarding participant eligibility.
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[TSH-reference range of adults: results from the population-based study KORA F4].
Burkhardt, K, Ittermann, T, Heier, M, Kirchberger, I, Völzke, H, Wallaschofski, H, Below, H, Nauck, M, Meisinger, C
Deutsche medizinische Wochenschrift (1946). 2014;(7):317-22
Abstract
INTRODUCTION There is no valid nationwide reference value for Thyroid-stimulating hormone (TSH) for German adults because of different iodine supply and different laboratory equipment, however, reference values for single regions of Germany have been defined. The aim of this study was to find a reference value for South Germany and to compare this with results of other population-based studies. METHODS 3080 individuals from the KORA-F4 study (Cooperative Health Research in the Region of Augsburg) at the age range of 32 to 81 years were examined regarding their thyroid characteristics (anamnesis, sonography and clinical chemistry). After excluding individuals with known as well as unknown thyroid disorders revealed by the KORA study, there were 710 thyroid-healthy individuals left to evaluate TSH-, fT3- and fT4-reference ranges. RESULTS For thyroid-healthy men and women we evaluated a TSH-reference range of 0.52-3.60 mIU/l on Siemens Vista Analysers with a median of 1.49 mIU/l. We could not find any statistically significant influence of age or sex. Median iodine excretion in urine was 118.6 µg/g creatinine in our healthy population which is above the recommended target value of 100 µg/g. DISCUSSION The TSH-reference value of the South German population is higher than the one assessed in the Northeast-German SHIP-study 10 years ago. For the definition of a TSH-reference value, population-based and apparatus-specific examinations are necessary.
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Noninvasive skin fluorescence spectroscopy is comparable to hemoglobin A1c and fasting plasma glucose for detection of abnormal glucose tolerance.
Olson, BP, Matter, NI, Ediger, MN, Hull, EL, Maynard, JD
Journal of diabetes science and technology. 2013;(4):990-1000
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AIM: We compare performance of noninvasive skin fluorescence spectroscopy (SFS), fasting plasma glucose (FPG), and hemoglobin A1c (A1C) for detection of abnormal glucose tolerance (AGT). METHODS The NSEEDS trial evaluated SFS, FPG, and A1C in an at-risk population of 479 previously undiagnosed subjects from nine US centers, each of whom received a 75 g, 2 h oral glucose tolerance test (OGTT). Skin fluorescence spectra were collected and analyzed with SCOUT DS® devices. Disease truth was AGT, defined as OGTT ≥140 mg/dl. Abnormal glucose tolerance sensitivity, false positive rate (FPR), and receiver operating characteristic (ROC) curves were computed for each measurement technique. Skin fluorescence spectroscopy reproducibility was also assessed. RESULTS The AGT sensitivity of SFS was 68.2%, higher than that of FPG (thresholds of 100 and 110 mg/dl) and A1C (thresholds of 5.7% and 6.0%). The FPR of SFS was 37.7%, comparable to A1C at the 5.7% threshold (30.7%). Partial ROC areas of SFS, FPG, and A1C were similar for FPRs of 20-50% (average sensitivities of 64.0%, 59.0%, and 68.6%, respectively). The interday coefficient of variation for SFS was 7.6%. CONCLUSIONS Skin fluorescence spectroscopy has similar screening performance to FPG and A1C and is a viable approach for detection of AGT.
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Autofluorescence imaging endoscopy for screening of esophageal squamous mucosal high-grade neoplasia: a phase II study.
Ishihara, R, Inoue, T, Hanaoka, N, Takeuchi, Y, Tsujii, Y, Kanzaki, H, Oota, T, Hanafusa, M, Yamamoto, S, Nagai, K, et al
Journal of gastroenterology and hepatology. 2012;(1):86-90
Abstract
BACKGROUND AND AIM Few prospective studies examining the efficacy of autofluorescence imaging (AFI) screening for esophageal cancer have been reported. This study aimed to investigate the diagnostic value of AFI endoscopy for the screening of squamous mucosal high-grade neoplasia of the esophagus, performed by experienced and less-experienced endoscopists. METHODS Patients with a history of esophageal neoplasia or head and neck cancer underwent AFI endoscopic screening, followed by chromoendoscopy using iodine staining as the reference standard. The primary outcome was the sensitivity of AFI for detecting new squamous mucosal high-grade neoplasias. The secondary outcome was the positive predictive value (PPV) of AFI. RESULTS Of a total 364 patients who underwent endoscopic examination, 43 new mucosal high-grade neoplasias were detected. The sensitivities of AFI in the experienced and less-experienced endoscopist groups were 71% (95% confidence interval [CI]: 55-87%) and 50% (95% CI: 32-68%), respectively. The PPV of AFI in the experienced and the less-experienced endoscopist groups were 25% (95% CI: 16-34%) and 26% (95% CI: 15-37%), respectively. The sensitivity of AFI in lesions ≤ 10 mm (31%, 5/16 lesions) was significantly lower than that in lesions > 10 mm (78%, 21/27 lesions) (P = 0.003). CONCLUSIONS The sensitivity of AFI for the detection of new squamous mucosal high-grade neoplasias, and its PPV, were both low. Based on these results, a randomized study to compare AFI with standard techniques is not justified.