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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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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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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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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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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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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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Iron homeostasis and distal colorectal adenoma risk in the prostate, lung, colorectal, and ovarian cancer screening trial.
Cross, AJ, Sinha, R, Wood, RJ, Xue, X, Huang, WY, Yeager, M, Hayes, RB, Gunter, MJ
Cancer prevention research (Philadelphia, Pa.). 2011;(9):1465-75
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Red meat consumption has been positively associated with colorectal cancer; however, the biological mechanism underlying this relationship is not understood. Red meat is a major source of iron, which may play a role in colorectal carcinogenesis via increased crypt cell proliferation, cytotoxicity, and endogenous N-nitrosation. In a nested case-control study within the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, we prospectively evaluated multiple iron exposure parameters, including dietary intake and serum measures of iron, ferritin, transferrin, total iron binding capacity (TIBC), and unsaturated iron binding capacity (UIBC) in relation to incident colorectal adenoma in 356 cases and 396 matched polyp-free controls. We also investigated variation in eight key genes involved in iron homeostasis in relation to colorectal adenoma in an additional series totaling 1,126 cases and 1,173 matched controls. We observed a positive association between red meat intake and colorectal adenoma [OR comparing extreme quartiles (OR(q4-q1)) = 1.59, 95% CI = 1.02-2.49, P(trend) = 0.03]. Serum TIBC and UIBC were inversely associated with colorectal adenoma (OR(q4-q1) = 0.57, 95% CI = 0.37-0.88, P(trend) = 0.03; and OR(q4-q1) = 0.62, 95% CI = 0.40-0.95, P(trend) = 0.04, respectively). Colorectal adenoma was not associated with serum ferritin, iron, or transferrin saturation or with polymorphisms in genes involved in iron homeostasis. Serum TIBC and UIBC, parameters that have a reciprocal relationship with overall iron load, were inversely related to colorectal adenoma, suggesting that individuals with lower iron status have a reduced risk of developing colorectal adenoma.
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Comparing PAP smear cytology, aided visual inspection, screening colposcopy, cervicography and HPV testing as optional screening tools in Latin America. Study design and baseline data of the LAMS study.
Syrjänen, K, Naud, P, Derchain, S, Roteli-Martins, C, Longatto-Filho, A, Tatti, S, Branca, M, Erzen, M, Hammes, LS, Matos, J, et al
Anticancer research. 2005;(5):3469-80
Abstract
OBJECTIVES This is a European Commission (EC)-funded ongoing study known as the LAMS (Latin American Screening) study, where PAP smear/liquid-based cytology and screening colposcopy were compared with i) three optional screening tools [visual inspection with acetic acid (VIA), or Lugol's iodine (VILI), cervicography] and with ii) Hybrid Capture II from a) conventional samples and from b) self-samples, in women at different risk for cervical cancer in Brazil and Argentina. STUDY DESIGN During 2002-2003, a cohort of 12,107 women attending four clinics: Campinas (CA), Sao Paulo (SP), Porto Alegre (PA) and Buenos Aires (BA), were interviewed for risk factors, and examined using the 8 diagnostic arms. Colposcopy was performed for women positive in any test and for 5% of women with baseline PAP-negative and 20% of HCII-negatives. All high-grade lesions (CIN2/3) were treated, and low-grade CIN are prospectively followed-up. RESULTS Of the 12,107 women, the following baseline data are available: epidemiological data (n=11,996), conventional PAP smears (n=10,363), LBC, SurePATH (n=320), LBC, DNA-Citoliq (n=1,346), VIA (n=12.067), VILI (n=3,061), cervicography (n=279), screening colposcopy (n=3,437), HCII conventional (n=4,710), HCII self-sampling (n=246) and cervical biopsies (n=1,524). The four sub-cohorts differ significantly in all their baseline data on the implicated risk factors of cervical cancer, consonant with their origin from regions with different cancer incidence. Around 95% of all PAP smears were negative, with slight variations in the prevalence of LSIL and HSIL between the four centers. Significant differences were found in the detection rates of abnormal findings in VIA, VILI and colposcopy between the four centers (p=0.0001). The prevalence of HPV was practically identical (16.5-18.8%) in all four cohorts (p=0.486), with no differences in the relative viral loads. Biopsy results were different depending on whether the women underwent screening colposcopy (BA) or elective colposcopy (others). CONCLUSION Four cohorts with significantly different baseline data are available, and prospective follow-up of these women permits analysis of whether variations in cervical cancer incidence in these regions is due to i) different natural history of the precursor lesions, or ii) due to different levels of exposure to the known risk factors.
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Life-style intervention at the worksite--reduction of cardiovascular risk factors in a randomized study.
Nilsson, PM, Klasson, EB, Nyberg, P
Scandinavian journal of work, environment & health. 2001;(1):57-62
Abstract
OBJECTIVES This study tested a feasible method for screening for cardiovascular risk at the worksite and investigated the effects of a long-term comprehensive program of life-style intervention to prevent cardiovascular disease. METHODS Employees in the public sector filled out a self-administered questionnaire with questions on social, medical, and work-related factors. The respondents numbered 454 (80%). A score sum for cardiovascular risk was calculated (range 1-20, median 7.0), and the 128 subjects with a sum above 8 were invited to a health examination including blood sampling. Thereafter the subjects were invited to participate, following randomization, in a comprehensive, 18-month, life-style intervention program to improve cardiovascular risk or in a control group. RESULTS The intervention group significantly decreased body mass index, diastolic blood pressure, heart rate, low-density lipoprotein (LDL) cholesterol, and smoking habits during the intervention. The initially elevated serum cortisol, as a marker of stress reaction, normalized in the intervention group. In the control group LDL cholesterol also decreased, but the glucose and triglyceride levels increased, and smoking habits were unchanged. Sick days for a given period decreased after 1 year in the intervention group but not in the control group. CONCLUSIONS Several cardiovascular risk factors can be improved and morning serum cortisol normalized during a long-term life-style intervention program with a randomized design using a worksite population of middle-aged subjects. The use of a 2-step screening program, with an initial questionnaire followed by a health check of subjects with elevated risk, is feasible for worksite settings.
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Lipid screening to prevent coronary artery disease: a quantitative evaluation of evolving guidelines.
Grover, SA, Dorais, M, Paradis, G, Fodor, JG, Frohlich, JJ, McPherson, R, Coupal, L, Zowall, H
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2000;(10):1263-9
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BACKGROUND There is strong evidence to support the treatment of abnormal blood lipid levels among people with cardiovascular disease. Primary prevention is problematic because many individuals with lipid abnormalities may never actually develop cardiovascular disease. We evaluated the 1998 Canadian lipid guidelines to determine whether they accurately identify high-risk adults for primary prevention. METHODS Using data from the Lipid Research Clinics and receiver operating characteristic (ROC) curves, we compared the diagnostic performance of the 1998 lipid guidelines when risk factors for coronary artery disease (CAD) were counted versus calculating risk using Framingham risk equations. We also compared the diagnostic accuracy of the 1998 guidelines with guidelines previously published by the National Cholesterol Education Program in the United States and the 1988 Canadian Consensus Conference on Cholesterol and then used Canadian Heart Health Survey data to forecast lipid screening and treatment rates for the Canadian population. RESULTS The Framingham risk equations were more accurate than counting risk factors for predicting CAD risk (areas under the ROC curves, 0.83 [standard deviation (SD) 0.02] v. 0.77 [SD 0.03], p < 0.05). Risk counting was a particularly poor method for predicting risk for women. The 1998 Canadian guidelines identified high-risk individuals more accurately than the earlier guidelines, but the increased accuracy was largely due to a lower false-positive rate or a higher true-negative rate (i.e., increased test specificity). Using the 1998 lipid guidelines we estimate that 5.9 million Canadians currently free of cardiovascular disease would be eligible for lipid screening and 322,705 (5.5%) would require therapy. INTERPRETATION Calculating risk using risk equations is a more accurate method to identify people at high risk for CAD than counting the number of risk factors present, especially for women, and the 1998 Canadian lipid screening guidelines are significantly better at identifying high-risk patients than the 1988 guidelines. Many of our findings were incorporated into the new 2000 guidelines.
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A controlled time-series trial of clinical reminders: using computerized firm systems to make quality improvement research a routine part of mainstream practice.
Goldberg, HI, Neighbor, WE, Cheadle, AD, Ramsey, SD, Diehr, P, Gore, E
Health services research. 2000;(7):1519-34
Abstract
OBJECTIVE To explore the feasibility of conducting unobtrusive interventional research in community practice settings by integrating firm-system techniques with time-series analysis of relational-repository data. STUDY SETTING A satellite teaching clinic divided into two similar, but geographically separated, primary care group practices called firms. One firm was selected by chance to receive the study intervention. Forty-two providers and 2,655 patients participated. STUDY DESIGN A nonrandomized controlled trial of computer-generated preventive reminders. Net effects were determined by quantitatively combining population-level data from parallel experimental and control interrupted time series extending over two-month baseline and intervention periods. DATA COLLECTION Mean rates at which mammography, colorectal cancer screening, and cholesterol testing were performed on patients due to receive each maneuver at clinic visits were the trial's outcome measures. PRINCIPAL FINDINGS Mammography performance increased on the experimental firm by 154 percent (0.24 versus 0.61, p = .03). No effect on fecal occult blood testing was observed. Cholesterol ordering decreased on both the experimental (0.18 versus 0.1 1, p = .02) and control firms (0.13 versus 0.07, p = .03) coincident with national guidelines retreating from recommending screening for young adults. A traditional uncontrolled interrupted time-series design would have incorrectly attributed the experimental-firm decrease to the introduction of reminders. The combined analysis properly indicated that no net prompting effect had occurred, as the difference between firms in cholesterol testing remained stochastically stable over time (0.05 versus 0.04, p = .75). A logistic-regression analysis applied to individual-level data produced equivalent findings. The trial incurred no supplementary data collection costs. CONCLUSIONS The apparent validity and practicability of our reminder implementation study should encourage others to develop computerized firm systems capable of conducting controlled time-series trials.