Статті в журналах: "GM risk assessment"

1

Sparrow, P. A. C. "GM Risk Assessment." Molecular Biotechnology 44, no. 3 (January 20, 2010): 267–75. http://dx.doi.org/10.1007/s12033-009-9237-x.

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2

Wilkinson, Mike J. "Abandoning ‘responsive’ GM risk assessment." Trends in Biotechnology 22, no. 9 (September 2004): 438–39. http://dx.doi.org/10.1016/j.tibtech.2004.07.006.

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3

Gregory, P. "Risk Assessment Data for GM Crops." Science 292, no. 5517 (April 27, 2001): 638–39. http://dx.doi.org/10.1126/science.292.5517.638.

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4

Lack, Gideon. "Clinical risk assessment of GM foods." Toxicology Letters 127, no. 1-3 (February 2002): 337–40. http://dx.doi.org/10.1016/s0378-4274(01)00517-3.

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5

Nodari, Rubens Onofre. "Risk assessment for Brazil's GM bean." Nature 479, no. 7373 (November 2011): 299. http://dx.doi.org/10.1038/479299e.

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6

Wilkinson, Mike J., Jeremy Sweet, and Guy M. Poppy. "Risk assessment of GM plants: avoiding gridlock?" Trends in Plant Science 8, no. 5 (May 2003): 208–12. http://dx.doi.org/10.1016/s1360-1385(03)00057-8.

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7

De Schrijver, A., Y. Devos, M. Van den Bulcke, P. Cadot, M. De Loose, D. Reheul, and M. Sneyers. "Risk assessment of GM stacked events obtained from crosses between GM events." Trends in Food Science & Technology 18, no. 2 (February 2007): 101–9. http://dx.doi.org/10.1016/j.tifs.2006.09.002.

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8

Miller, Henry I. "The tarnished gold standard for GM risk assessment." GM Crops 1, no. 2 (March 1, 2010): 2–4. http://dx.doi.org/10.4161/gmcr.1.2.10861.

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9

Keese, Paul K., Andrea V. Robold, Ruth C. Myers, Sarah Weisman, and Joe Smith. "Applying a weed risk assessment approach to GM crops." Transgenic Research 23, no. 6 (September 18, 2013): 957–69. http://dx.doi.org/10.1007/s11248-013-9745-0.

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10

Schiemann, J. "ENVIRONMENTAL RISK ASSESSMENT OF GM PLANTS AT THE EUROPEAN LEVEL." Acta Horticulturae, no. 839 (July 2009): 717–18. http://dx.doi.org/10.17660/actahortic.2009.839.98.

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11

Liu, Yongbo, and Charles Neal Stewart. "An exposure pathway‐based risk assessment system for GM plants." Plant Biotechnology Journal 17, no. 10 (May 17, 2019): 1859–61. http://dx.doi.org/10.1111/pbi.13146.

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12

Poppy, Guy M. "Geneflow from GM plants – towards a more quantitative risk assessment." Trends in Biotechnology 22, no. 9 (September 2004): 436–38. http://dx.doi.org/10.1016/j.tibtech.2004.07.005.

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13

Levidow, Les. "Ignorance-Based Risk Assessment? Scientific Controversy over GM Food Safety." Science as Culture 11, no. 1 (March 2002): 61–67. http://dx.doi.org/10.1080/09505430120115725.

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14

Davies, Howard V. "GM organisms and the EU regulatory environment: allergenicity as a risk component." Proceedings of the Nutrition Society 64, no. 4 (November 2005): 481–86. http://dx.doi.org/10.1079/pns2005462.

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The European Food Safety Authority, following a request from the European Commission, has published a guidance document for the risk assessment of GM plants and derived food and feed to assist in the implementation of provisions of Regulation (EC) 1829/2003 of the European Parliament and Council on GM food and feed. This regulation has applied since 18 April 2004. In principle, hazard identification and characterisation of GM crops is conducted in four steps: characterisation of the parent crop and any hazards associated with it; characterisation of the transformation process and of the inserted recombinant DNA, including an assessment of the possible production of new fusion proteins or allergens; assessment of the introduced proteins (toxicity, allergenicity) and metabolites; identification of any other targetted and unexpected alterations in the GM crop, including changes in the plant metabolism resulting in compositional changes and assessment of their toxicological, allergenic or nutritional impact. In relation to allergenicity specifically, it is clear that this property of a given protein is not intrinsic and fully predictable but is a biological activity requiring an interaction with individuals with a predisposed genetic background. Allergenicity, therefore, depends on the genetic diversity and variability in atopic human subjects. Given this lack of complete predictability it is necessary to obtain, from several steps in the risk-assessment process, a cumulative body of evidence that minimises any uncertainty about the protein(s) in question.

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15

JOHNSON, K., A. RAYBOULD, M. HUDSON, and G. POPPY. "How does scientific risk assessment of GM crops fit within the wider risk analysis?" Trends in Plant Science 12, no. 1 (January 2007): 1–5. http://dx.doi.org/10.1016/j.tplants.2006.11.004.

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16

Meredith, Clive. "Allergenic potential of novel foods." Proceedings of the Nutrition Society 64, no. 4 (November 2005): 487–90. http://dx.doi.org/10.1079/pns2005463.

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Concerns have been expressed that the introduction of novel foods into the diet might lead to the development of new food allergies in consumers. Novel foods can be conveniently divided into GM and non-GM categories. Decision-tree approaches (e.g. International Life Sciences Institute-International Food Biotechnology Council and WHO/FAO) to assess the allergenic potential of GM foods were developed following the discovery, during product development, of the allergenic potential of GM soyabean expressing a gene encoding a storage protein from Brazil nut (Bertolletia excelsa). Within these decision trees considerations include: the source of the transgene; amino acid homology with known allergens; cross-reactivity with IgE from food-allergic individuals; resistance to proteolysis; prediction using animal models of food allergy. Such decision trees are under constant review as new knowledge and improved models emerge, but they provide a useful framework for the assessment of the allergenic potential of GM foods. For novel non-GM foods the assessment of allergenic potential is more subjective; some foods or food ingredients will need no assessment other than a robust protein assay to demonstrate the absence of protein. Where protein is present in the novel non-GM food, hazard and risk assessments need to be made in terms of the quantity of protein that might be consumed, the identity of individual protein components and their relationships to known food allergens. Where necessary, this assessment would extend to serum screening for potential cross-reactivities, skin-prick tests in previously-sensitised individuals and double-blind placebo-controlled food challenges.

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17

Santoso, B., R. Romadoni, S. Suzdayan, and P. Nasution. "Risk Assessment Fishing Vessel Based for the Intact Ship Stability." IOP Conference Series: Earth and Environmental Science 934, no. 1 (November 1, 2021): 012062. http://dx.doi.org/10.1088/1755-1315/934/1/012062.

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Abstract Application of safety assessment and risk analysis using a risk-based approach for ship stability in ship operations at sea. However, there are currently no specific criteria and computational methods for risk assessment of ship stability. Based on the stability requirements for fishing activities at sea, the ship stability criteria will be explained in detail in this study. Calculation of stability used to obtain the GZ enforcement arm is carried out with the help of software for the shaking period using the International Maritime Organization (IMO) formula. Next, how to calculate parameters and determine certain coefficients for risk assessment of ship stability, and how to redraw the stability curve. Finally, proposed method is applied to ship model with comments and recommendations for monitoring to provide and overview. The study result indicate that the five loading conditions that occur on the ship have good stability by the criteria set by the International Maritime Organization (IMO). The value of GMt in each condition includes condition 1 and so on, 0.48; 0.48; 0.47; 0.46; 0.43. The results are presented in the form of F-N. Finally the sensitivity of the model is evaluated along with the assessment of associated uncertainties. The FN graph represents acceptable areas and unacceptable areas. Based on the results of data processing, the highest GM at GM Load-case 5 0.638 meters is in the Acceptable area. While Load-case 1 to Load-case 4 GM values sequentially Load-case 1: 0.487 meters; Load-case 2: 0.488 meters; Load-case 3: 0.47 meters; Load-case 4: 0.468 meters; is in an unacceptable area Unacceptable.

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18

Delaney, Bryan, Jan Hazebroek, Rod Herman, Daland Juberg, and Nicholas P. Storer. "Untargeted Metabolomics Are Not Useful in the Risk Assessment of GM Crops." Trends in Plant Science 24, no. 5 (May 2019): 383–84. http://dx.doi.org/10.1016/j.tplants.2019.03.002.

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19

Herman, Rod A., and Alan Raybould. "Invoking ideology in the promotion of ecological risk assessment for GM crops." Trends in Biotechnology 31, no. 4 (April 2013): 217–18. http://dx.doi.org/10.1016/j.tibtech.2013.01.007.

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20

Dualde, Pablo, Nuria León, Yovana Sanchis, Francisca Corpas-Burgos, Sandra F. Fernández, Cristina S. Hernández, Guillermo Saez, et al. "Biomonitoring of Phthalates, Bisphenols and Parabens in Children: Exposure, Predictors and Risk Assessment." International Journal of Environmental Research and Public Health 18, no. 17 (August 24, 2021): 8909. http://dx.doi.org/10.3390/ijerph18178909.

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Exposure to emerging contaminants, such as phthalates, bisphenols and parabens in children has been associated with possible neurodevelopment and endocrine alterations. In the present study, the biomonitoring of biomarkers in children (5–12 years old) from the Valencia Region (Spain) have been implemented using urines from the BIOVAL program. More than 75% of the children studied (n = 562) were internally exposed (>LOQ) to bisphenols and parabens, and the whole population assessed (n = 557) were exposed to at least one phthalate. The geometric means (GM) of the concentrations of bisphenol A, methyl paraben and propyl paraben were 0.9, 1.4 and 0.39 ng/mL, respectively. Regarding phthalates, monoethyl phthalate GM was 55.0 ng/mL and diethyl hexyl phthalate (as the sum of five metabolites) GM was 60.6 ng/mL. Despite the studied population being widely exposed, the detection frequencies and concentrations were in general lower than in previous studies involving children in Spain and in other countries in recent years. Furthermore, the risk assessment study concluded that the internal exposure to phthalates, bisphenols and parabens is lower than the guidance values established, and, therefore, a health risk derived from the exposure to these compounds in the studied population is not expected.

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21

Pusztai, Arpad. "Can Science Give Us the Tools for Recognizing Possible Health Risks of GM Food?" Nutrition and Health 16, no. 2 (April 2002): 73–84. http://dx.doi.org/10.1177/026010600201600202.

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Nearly ten years after the introduction of GM foodcrops there are still only a handful of published studies about their safety. Independent studies are even fewer, moreover, no peer-reviewed publications exist in which the results of clinical investigations on the possible effects of GM food on human health are described. Even though the evaluation of the safety or possible toxicity of GM foodstuffs is more difficult than that of drugs or food additives, this scarcity of data and the lack of a scientific database is curious particularly as descriptions of the results of chemical, nutritional and biological testing in some early (unpublished) studies or some more recent publications demonstrate the feasibility of carrying out proper and scientifically valid health risk assessment on GM foods. In this review, after critically examining some of the basic principles, past results and possible novel methods of future health safety assessment of GM foodstuffs, the conclusion appears to be that as the tools for the recognition and indeed for the elimination of the risks GM foods may present for us are available or can be developed, it is the will and the funding for such work that needs to be found.

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22

Chlebowski, R. T., G. L. Anderson, D. S. Lane, A. Aragaki, T. Rohan, S. Yasmeen, G. Sato, C. A. Rosenberg, and F. A. Hubbell. "Predicting risk of estrogen receptor positive breast cancers in postmenopausal women." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 1507. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.1507.

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1507 Background: Chemoprevention strategies for estrogen receptor positive (ER+) breast cancers are emerging, especially for postmenopausal women, but require methods of targeting appropriate populations. Our objective was to improve the Breast Cancer Risk Assessment Tool [Gail Model (GM)] for estimating ER+ breast cancer risk. Methods: A prospective cohort involving 161,809 postmenopausal women aged 50–79 years, (93,676 in the observational study (OS) and 68,132 in clinical trials (CT)) at Women’s Health Initiative (WHI) Clinical Centers had comprehensive assessment of lifestyle, medication use and breast cancer risk factors. Breast cancer risk from the GM and other models incorporating additional or fewer risk factors and five year incidence of ER + and ER negative (ER-) invasive breast cancers were determined. Main outcome measures were concordance statistics for models predicting breast cancer risk. Results: Of 148,266 women meeting eligibility criteria, (no prior breast cancer and/or mastectomy), 3,236 developed breast cancer. Chronological age and age at menopause, both GM components, were significantly associated with only ER+ but not ER- breast cancer risk (p<0.05 for heterogeneity test). The GM predicted population-based ER+ cancer risk with reasonable accuracy (concordance statistic 0.60, 95% confidence interval (CI) 0.58 to 0.62) but for ER- cancers, the results were equivalent to chance allocation (concordance statistic 0.49, 95% CI 0.45 to 0.54). For ER+ cancers, no additional risk factors improved the GM prediction. However, a simpler model, developed in the OS and tested in the CT population, including only age, family history, and benign breast biopsy was comparable to GM in ER+ breast cancer prediction (concordance statistics 0.58, 95% CI 0.56 to 0.60). Using this model, all women ≥ 55 years old (or ≥ 60 year old if African American) with either a prior breast biopsy or first degree breast cancer family history had five year breast cancer risk of ≥ 1.8%. Conclusions: In postmenopausal women with comprehensive mammography use, the GM identifies populations at increased risk for ER+ breast cancer but not for ER- cancer. A model with fewer variables provides a simpler alternative for identifying populations appropriate for breast cancer chemoprevention interventions. No significant financial relationships to disclose.

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23

Zaker Esteghamati, Mohsen. "A Holistic Review of GM/IM Selection Methods from a Structural Performance-Based Perspective." Sustainability 14, no. 20 (October 11, 2022): 12994. http://dx.doi.org/10.3390/su142012994.

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Current fully probabilistic approaches to performance-based earthquake engineering describe structures’ behavior under a wide range of seismic hazard levels. These approaches require a detailed representation of ground motion (GM) uncertainty at all considered hazard levels, yet different GM selection methods lead to different estimations of structural performance. This paper presents a holistic review of the current practices in GM representation and selection for structural demand analysis through a performance-based lens. The multidisciplinary nature of GM selection, ranging from earth science to engineering seismology and statistics, has created a preponderance of literature to find the best practice for probabilistic assessment of structures in terms of computational efficiency and statistical accuracy. Many of these studies focus individually on GM selection or structural analysis, and the relatively scarce review papers either focus on code-based GM selection or do not specifically address risk-based evaluations by overlooking the interaction between GM selection and structural analysis. This paper aims to aid researchers in selecting appropriate GMs as part of a statistically valid and robust probabilistic demand analysis without performing an exhaustive literature review. Discussion on the available computational tools and their trade-offs for risk-based assessment of single structures is provided. While the problem-specific nature of GM selection means that no pre-selected set of GM/IM is applicable to all cases, the comprehensive narrative of this paper is expected to aid analysts in reaching a more informed decision.

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24

LIU, F. X., C. P. BU, T. TANG, G. M. CHEN, S. K. GU, Y. N. WANG, and X. X. ZHAO. "Effects of Chinese honeybee foraging on oilseed rape gene flow and honey ingredients." Journal of Agricultural Science 155, no. 10 (November 16, 2017): 1623–32. http://dx.doi.org/10.1017/s0021859617000776.

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SUMMARYHoneybee foraging can transfer exogenous genes from genetically modified (GM) oilseed rape (Brassica napusL.) to closely related plants, which not only induces potential ecological risks but also contaminates non-GM seeds or honey products with GM ingredients. These events may lead to international trade disputes. Chinese honeybees (Apis cerana ceranaFabricius) and a herbicide (glufosinate)-resistant GM strain ofB. napus(Z7B10) were studied to examine the effects of honeybee short-range foraging on oilseed rape gene flow and honey ingredients. Results showed variable frequencies of gene flow between GM and non-GM oilseed rape cultivars, with the highest frequency under nylon net isolation with artificially stocked honeybees, the lowest frequency under nylon net isolation alone, and an intermediate frequency under natural pollination, suggesting the important role of honeybee foraging in gene flow frequency. Additionally, GM pollen grains were found in honey collected from honeybees foraging on both GM and non-GM oilseed rape cultivars. The phosphinothricin acetyltransferase protein was also detected in both unbroken pollen-containing and pollen-free honey by protein testing strips, suggesting that honeybee foraging on GM oilseed rape could lead to contamination with GM ingredients. Overall, the results provide a direct scientific basis for the ecological risk assessment and safety management of GM oilseed rape.

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25

Kirby, Cindy, and Carol Trotter. "Pneumothorax in the Neonate: Assessment and Diagnosis." Neonatal Network 24, no. 5 (September 2005): 49–55. http://dx.doi.org/10.1891/0730-0832.24.5.49.

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PNEUMOTHORAX OCCURS MORE often in the neonatal period than at any other time of life.1 It can happen spontaneously, secondary to mechanical ventilation, as a complication following certain procedures, or as a result of pneumonia or aspiration.2 The frequency of spontaneous pneumothorax is approximately 1 percent of all live births.1 Horbar and colleagues reported data on 118,448 very low birth weight newborns (410–1,500 gm) followed through the Vermont Oxford Network from 1991 to 1999. They documented an increasing risk for pneumothorax with time. Rates of pneumothorax for neonates with birth weights of 501–750 gm were as high as 14 percent in 1999.3 The following case study summarizes the course of a neonate with a recurrent tension pneumothorax.

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26

Pires, Carmen Sílvia Soares, Fernando Amaral Silveira, Carolina Ferreira Cardoso, Edison Ryotii Sujii, Débora Pires Paula, Eliana Maria Gouveira Fontes, Joseane Padilha da Silva, Sandra Maria Morais Rodrigues, and David Alan Andow. "Selection of bee species for environmental risk assessment of GM cotton in the Brazilian Cerrado." Pesquisa Agropecuária Brasileira 49, no. 8 (August 2014): 573–86. http://dx.doi.org/10.1590/s0100-204x2014000800001.

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The objective of this work was to list potential candidate bee species for environmental risk assessment (ERA) of genetically modified (GM) cotton and to identify the most suited bee species for this task, according to their abundance and geographical distribution. Field inventories of bee on cotton flowers were performed in the states of Bahia and Mato Grosso, and in Distrito Federal, Brazil. During a 344 hour sampling, 3,470 bees from 74 species were recovered, at eight sites. Apis mellifera dominated the bee assemblages at all sites. Sampling at two sites that received no insecticide application was sufficient to identify the three most common and geographically widespread wild species: Paratrigona lineata, Melissoptila cnecomola, and Trigona spinipes, which could be useful indicators of pollination services in the ERA. Indirect ordination of common wild species revealed that insecticides reduced the number of native bee species and that interannual variation in bee assemblages may be low. Accumulation curves of rare bee species did not saturate, as expected in tropical and megadiverse regions. Species-based approaches are limited to analyze negative impacts of GM cotton on pollinator biological diversity. The accumulation rate of rare bee species, however, may be useful for evaluating possible negative effects of GM cotton on bee diversity.

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27

Aguilera, J., K. Nielsen, and J. Sweet. "Risk assessment of GM trees in the EU: current regulatory framework and guidance." iForest - Biogeosciences and Forestry 6, no. 3 (June 1, 2013): 127–31. http://dx.doi.org/10.3832/ifor0101-006.

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28

Henley, William J., R. Wayne Litaker, Lucie Novoveská, Clifford S. Duke, Hector D. Quemada, and Richard T. Sayre. "Initial risk assessment of genetically modified (GM) microalgae for commodity-scale biofuel cultivation." Algal Research 2, no. 1 (January 2013): 66–77. http://dx.doi.org/10.1016/j.algal.2012.11.001.

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29

Schoeman, Heidi, Gideon M. Wolfaardt, Alfred Botha, Pierre van Rensburg, and Isak S. Pretorius. "Establishing a risk-assessment process for release of genetically modified wine yeast into the environment." Canadian Journal of Microbiology 55, no. 8 (August 2009): 990–1002. http://dx.doi.org/10.1139/w09-039.

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The use and release of genetically modified organisms (GMOs) is an issue of intense public concern and, in the case of food and beverages, products containing GMOs or products thereof carry the risk of consumer rejection. The recent commercialization of 2 GM wine yeasts in the United States and Canada has made research and development of risk assessments for GM microorganisms a priority. The purpose of this study was to take a first step in establishing a risk-assessment process for future use and potential release of GM wine yeasts into the environment. The behaviour and spread of a GM wine yeast was monitored in saturated sand columns, saturated sand flow cells, and conventional flow cells. A widely used commercial Saccharomyces cerevisiae wine yeast, VIN13, a VIN13 transgenic strain (LKA1, which carries the LKA1 α-amylase gene of Lipomyces kononenkoae ), a soil bacterium ( Dyadobacter fermentens ), and a nonwine soil-borne yeast ( Cryptococcus laurentii ) were compared in laboratory-scale microcosm systems designed to monitor microbial mobility behaviour, survival, and attachment to surfaces. It was found that LKA1 cells survived in saturated sand columns, but showed little mobility in the porous matrix, suggesting that the cells attached with high efficiency to sand. There was no significant difference between the mobility patterns of LKA1 and VIN13. All 3 yeasts (VIN13, LKA1, and C. laurentii) were shown to form stable biofilms; the 2 S. cerevisiae strains either had no difference in biofilm density or the LKA1 biofilm was less dense than that of VIN13. When co-inoculated with C. laurentii, LKA1 had no negative influence on the breakthrough of the Cryptococcus yeast in a sand column or on its ability to form biofilms. In addition, LKA1 did not successfully integrate into a stable mixed-biofilm community, nor did it disrupt the biofilm community. Overall, it was concluded that the LKA1 transgenic yeast had the same reproductive success as VIN13 in these 3 microcosms and had no selective advantage over the untransformed parental strain.

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Lim, Jin Hee, Myung Syun Shim, Kwan Hun Oh, Ji Yeon Seo, Su Young Lee, Sang Kun Park, Hak Ki Shin, and Myoung Rae Cho. "Assessment of Substantial Equivalence and Environmental Risk for Event Selection of Genetically Modified Chrysanthemum." Korean Journal of Horticultural Science and Technology 32, no. 4 (September 30, 2014): 517–24. http://dx.doi.org/10.7235/hort.2014.13149.

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31

Herman, Rod A., Patricia A. Bauman, Laurie Goodwin, Emir Islamovic, Eric H. Ma, Hector Serrano, Andre Silvanovich, et al. "Mass spectrometric analysis of digesta does not improve the allergenicity assessment of GM crops." Transgenic Research 30, no. 3 (April 16, 2021): 283–88. http://dx.doi.org/10.1007/s11248-021-00254-x.

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AbstractAn investigation of the potential allergenicity of newly expressed proteins in genetically modified (GM) crops comprises part of the assessment of GM crop safety. However, allergenicity is not completely predictable from a definitive assay result or set of protein characteristics, and scientific opinions regarding the data that should be used to assess allergenicity are continuously evolving. Early studies supported a correlation between the stability of a protein exposed to digestive enzymes such as pepsin and the protein’s status as a potential allergen, but over time the conclusions of these earlier studies were not confirmed. Nonetheless, many regulatory authorities, including the European Food Safety Authority (EFSA), continue to require digestibility analyses as a component of GM crop risk assessments. Moreover, EFSA has recently investigated the use of mass spectrometry (MS), to make digestion assays more predictive of allergy risk, because it can detect and identify small undigested peptides. However, the utility of MS is questionable in this context, since known allergenic peptides are unlikely to exist in protein candidates intended for commercial development. These protein candidates are pre-screened by the same bioinformatics processes that are normally used to identify MS targets. Therefore, MS is not a standalone allergen identification method and also cannot be used to predict previously unknown allergenic epitopes. Thus, the suggested application of MS for analysis of digesta does not improve the poor predictive power of digestion assays in identifying allergenic risk.

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32

Willand, Achim, and Georg Buchholz. "Environmental Risk Assessment of gmo – Notes on a Draft Commission Directive to Adapt Directive 2001/18/ec." Journal for European Environmental & Planning Law 15, no. 1 (April 6, 2018): 69–83. http://dx.doi.org/10.1163/18760104-01501005.

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The article discusses the scope of the environmental risk assessment of genetically modified organisms (gmo). As environmental risks of the combination of gmo and herbicide application are not assessed on a case-by-case basis in the authorisation procedure of a plant protection product, the environmental risk assessment of gmo has to take account of the risks arising from herbicides against which the gm plants are engineered to be tolerant. As regards the scope of the environmental risk assessment of gmos, the Commission now moves in legislative ‘grey areas’. In 2017 the Commission has drafted a Directive to adapt the Annexes to Directive 2001/18/ec. Concerning the scope of the environmental risk assessment, the authors wish to highlight that the Commission is not empowered to answer questions of interpretation – be it even by a recital – as they do not fall within the scope of its regulatory powers (here: technical adaptations).

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Harricharan, S., K. Biederman, A. M. Bombassaro, A. Lazo-Langner, S. Elsayed, A. Fulford, J. A. Delport, and A. Xenocostas. "Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients." Current Oncology 25, no. 2 (April 30, 2018): 139. http://dx.doi.org/10.3747/co.25.3848.

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Background A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes.Methods This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf).Results Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001).Conclusions Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

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Delaney, Bryan. "Strategies to Evaluate the Safety of Bioengineered Foods." International Journal of Toxicology 26, no. 5 (September 2007): 389–99. http://dx.doi.org/10.1080/10915810701582855.

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A number of genetically modified (GM) crops bioengineered to express agronomic traits including herbicide resistance and insect tolerance have been commercialized. Safety studies conducted for the whole grains and food and feed fractions obtained from GM crops (i.e., bioengineered foods) bear similarities to and distinctive differences from those applied to substances intentionally added to foods (e.g., food ingredients). Similarities are apparent in common animal models, route of exposure, duration, and response variables typically assessed in toxicology studies. However, because of differences in the nutritional and physical properties of food ingredients and bioengineered foods and in the fundamental goals of the overall safety assessment strategies for these different classes of substances, there are recognizable differences in the individual components of the safety assessment process. The fundamental strategic difference is that the process for food ingredients is structured toward quantitative risk assessment whereas that for bioengineered foods is structured for the purpose of qualitative risk assessment. The strategy for safety assessment of bioengineered foods focuses on evaluating the safety of the transgenic proteins used to impart the desired trait or traits and to demonstrate compositional similarity between the grains of GM and non-GM comparator crops using analytical chemistry and, in some cases, feeding studies. Despite these differences, the similarities in the design of safety studies conducted with bioengineered foods should be recognized by toxicologists. The current paper reviews the basic principles of safety assessment for bioengineered foods and compares them with the testing strategies applied to typical food ingredients. From this comparison it can be seen that the strategies used to assess the safety of bioengineered foods are at least as robust as that used to assess the safety of typical food ingredients.

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Edrington, Thomas, Rong Wang, Lucas McKinnon, Colton Kessenich, Kimberly Hodge-Bell, Wenze Li, Jianguo Tan, et al. "Food and feed safety of the Bacillus thuringiensis derived protein Vpb4Da2, a novel protein for control of western corn rootworm." PLOS ONE 17, no. 8 (August 3, 2022): e0272311. http://dx.doi.org/10.1371/journal.pone.0272311.

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Western corn rootworm (WCR), Diabrotica virgifera virgifera, LeConte, is an insect pest that poses a significant threat to the productivity of modern agriculture, causing significant economic and crop losses. The development of genetically modified (GM) crops expressing one or more proteins that confer tolerance to specific insect pests, such as WCR, was a historic breakthrough in agricultural biotechnology and continues to serve as an invaluable tool in pest management. Despite this, evolving resistance to existing insect control proteins expressed in current generation GM crops requires continued identification of new proteins with distinct modes of action while retaining targeted insecticidal efficacy. GM crops expressing insecticidal proteins must undergo extensive safety assessments prior to commercialization to ensure that they pose no increased risk to the health of humans or other animals relative to their non-GM conventional counterparts. As part of these safety evaluations, a weight of evidence approach is utilized to assess the safety of the expressed insecticidal proteins to evaluate any potential risk in the context of dietary exposure. This study describes the food and feed safety assessment of Vpb4Da2, a new Bacillus thuringiensis insecticidal protein that confers in planta tolerance to WCR. Vpb4Da2 exhibits structural and functional similarities to other insect control proteins expressed in commercialized GM crops. In addition, the lack of homology to known toxins or allergens, a lack of acute toxicity in mice, inactivation by conditions commonly experienced in the human gut or during cooking/food processing, and the extremely low expected dietary exposure to Vpb4Da2 provide a substantial weight of evidence to demonstrate that the Vpb4Da2 protein poses no indication of a risk to the health of humans or other animals.

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Siopi, Maria, Stamatis Karakatsanis, Christoforos Roumpakis, Konstantinos Korantanis, Elina Eldeik, Helen Sambatakou, Nikolaos V. Sipsas, Panagiotis Tsirigotis, Maria Pagoni, and Joseph Meletiadis. "Performance, Correlation and Kinetic Profile of Circulating Serum Fungal Biomarkers of Invasive Aspergillosis in High-Risk Patients with Hematologic Malignancies." Journal of Fungi 7, no. 3 (March 13, 2021): 211. http://dx.doi.org/10.3390/jof7030211.

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As conventional microbiological documentation of invasive aspergillosis (IA) is difficult to obtain, serum fungal biomarkers are important adjunctive diagnostic tools. Positivity rates and the kinetic profiles of galactomannan (GM), 1,3-β-D-glucan (BDG) and Aspergillus DNA (PCR) were studied in high-risk patients with hematologic malignancies. GM, BDG and PCR data from serial serum specimens (n = 240) from 93 adult hematology patients with probable (n = 8), possible (n = 25) and no (n = 60) IA were retrospectively analyzed. Positivity rates and sensitivity/specificity/positive/negative predictive values (NPV) of each fungal biomarker alone and in combination were estimated. The three markers were compared head-to-head and correlated with various biochemical, demographic and patient characteristics. The positivity rates for patients with probable/possible/no IA were 88%/8%/0% for GM (X2 = 55, p < 0.001), 62%/46%/35% for BDG (X2 = 2.5, p = 0.29), 62%/33%/27% for PCR (X2 = 3.9, p = 0.15), 50%/4%/0% for GM + BDG and GM + PCR (X2 = 31, p < 0.001), 50%/8%/22% for BDG + PCR (X2 = 6.5, p = 0.038) and 38%/4%/0% for GM + BDG + PCR (X2 = 21, p < 0.001). Higher agreement (76%) and negative correlation (rs = −0.47, p = 0.0017) was found between GM index and PCR Ct values. The sensitivity and NPV was 45–55% and 90–92% when biomarkers assessed alone and increased to 75–90% and 93–97%, respectively when combined. Weak significant correlations were found between GM, PCR and BDG results with renal/liver function markers (r = 0.11–0.57) with most GM+ and PCR+ samples found in the first and second week of clinical assessment, respectively and BDG later on. Different positivity rates, time profiles and performances were found for the three biomarkers advocating the combination of GM with PCR for the early diagnosis of IA, whereas the high NPV of combined biomarkerscould help excluding IA.

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Kramer, Catherine, Phil Brune, Justin McDonald, Monique Nesbitt, Alaina Sauve, and Sabine Storck‐Weyhermueller. "Evolution of risk assessment strategies for food and feed uses of stacked GM events." Plant Biotechnology Journal 14, no. 9 (March 28, 2016): 1899–913. http://dx.doi.org/10.1111/pbi.12551.

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Mustonen, Leo, Pirjo Peltonen-Sainio, and Katri Pahkala. "Risk assessment for volunteer and seedling GM potatoes in the northernmost European growing areas." Acta Agriculturae Scandinavica, Section B - Plant Soil Science 59, no. 6 (November 2009): 552–58. http://dx.doi.org/10.1080/09064710802441152.

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Shimada, Kazumasa, and Michiaki Kai. "Lifetime Risk Assessment of Lung Cancer Incidence for Nonsmokers in Japan Considering the Joint Effect of Radiation and Smoking Based on the Life Span Study of Atomic Bomb Survivors." Journal of Radiation Protection and Research 46, no. 3 (September 30, 2021): 83–97. http://dx.doi.org/10.14407/jrpr.2020.00255.

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Background: The lifetime risk of lung cancer incidence due to radiation for nonsmokers is overestimated because of the use of the average cancer baseline risk among a mixed population, including smokers. In recent years, the generalized multiplicative (GM)-excess relative risk (ERR) model has been developed in the life span study of atomic bomb survivors to consider the joint effect of radiation and smoking. Based on this background, this paper discusses the issues of radiation risk assessment considering smoking in two parts.Materials and Methods: In Part 1, we proposed a simple method of estimating the baseline risk for nonsmokers using current smoking data. We performed sensitivity analysis on baseline risk estimation to discuss the birth cohort effects. In Part 2, we applied the GM-ERR model for Japanese smokers to calculate lifetime attributable risk (LAR). We also performed a sensitivity analysis using other ERR models (e.g., simple additive (SA)-ERR model).Results and Discussion: In Part 1, the lifetime baseline risk from mixed population including smokers to nonsmokers decreased by 54% (44%–60%) for males and 24% (18%–29%) for females. In Part 2, comparison of LAR between SA- and GM-ERR models showed that if the radiation dose was ≤200 mGy or less, the difference between these ERR models was within the standard deviation of LAR due to the uncertainty of smoking information.Conclusion: The use of mixed population for baseline risk assessment overestimates the risk for lung cancer due to low-dose radiation exposure in Japanese males.

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Ando, Akira, Chise Suzuki, and Jun Shima. "Survival of Genetically Modified and Self-Cloned Strains of Commercial Baker's Yeast in Simulated Natural Environments: Environmental Risk Assessment." Applied and Environmental Microbiology 71, no. 11 (November 2005): 7075–82. http://dx.doi.org/10.1128/aem.71.11.7075-7082.2005.

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ABSTRACT Although genetic engineering techniques for baker's yeast might improve the yeast's fermentation characteristics, the lack of scientific data on the survival of such strains in natural environments as well as the effects on human health prevent their commercial use. Disruption of acid trehalase gene (ATH1) improves freeze tolerance, which is a crucial characteristic in frozen-dough baking. In this study, ATH1 disruptants constructed by genetic modification (GM) and self-cloning (SC) techniques were used as models to study such effects because these strains have higher freeze tolerance and are expected to be used commercially. Behavior of the strains in simulated natural environments, namely, in soil and water, was studied by measuring the change in the number of viable cells and in the concentration of DNA that contains ATH1 loci. Measurements were made using a real-time PCR method during 40 days of cultivation. Results showed that the number of viable cells of GM and SC strains decreased in a time-dependent manner and that the decrease rate was nearly equal to or higher than that for wild-type (WT) yeast. For all three strains (SC, GM, and WT) in the two simulated natural environments (water and soil), the DNA remained longer than did viable cells but the decrease patterns of either the DNA or the viable cells of SC and GM strains had tendencies similar to those of the WT strain. In conclusion, disruption of ATH1 by genetic engineering apparently does not promote the survival of viable cells and DNA in natural environments.

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Pidgeon, J. D., M. J. May, J. N. Perry, and G. M. Poppy. "Mitigation of indirect environmental effects of GM crops." Proceedings of the Royal Society B: Biological Sciences 274, no. 1617 (April 17, 2007): 1475–79. http://dx.doi.org/10.1098/rspb.2007.0401.

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Currently, the UK has no procedure for the approval of novel agricultural practices that is based on environmental risk management principles. Here, we make a first application of the ‘bow-tie’ risk management approach in agriculture, for assessment of land use changes, in a case study of the introduction of genetically modified herbicide tolerant (GMHT) sugar beet. There are agronomic and economic benefits, but indirect environmental harm from increased weed control is a hazard. The Farm Scale Evaluation (FSE) trials demonstrated reduced broad-leaved weed biomass and seed production at the field scale. The simplest mitigation measure is to leave a proportion of rows unsprayed in each GMHT crop field. Our calculations, based on FSE data, show that a maximum of 2% of field area left unsprayed is required to mitigate weed seed production and 4% to mitigate weed biomass production. Tilled margin effects could simply be mitigated by increasing the margin width from 0.5 to 1.5 m. Such changes are cheap and simple to implement in farming practices. This case study demonstrates the usefulness of the bow-tie risk management approach and the transparency with which hazards can be addressed. If adopted generally, it would help to enable agriculture to adopt new practices with due environmental precaution.

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Parygina, M. N., S. I. Mozgovoi, A. G. Shimanskaya, and A. V. Kononov. "CDX₂ Protein as a Surrogate Marker of Gastric Mucosal Atrophy." Journal of Anatomy and Histopathology 10, no. 3 (September 20, 2021): 60–67. http://dx.doi.org/10.18499/2225-7357-2021-10-3-60-67.

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The aim of the study is to develop an approach to assess the severity of the gastric mucosa (GM) atrophy based on the immunohistochemical (IHC) technique to improve diagnostic quality of the stage of chronic gastritis (CG) and to implement predictive assessment of risk factors of gastric cancer development.Material and methods. The study included 155 cases of CG selected in accordance with Operational Link for Gastritis Assessment (OLGA)-system (2 samples of antral gastric mucosa (GM), 1 sample of angular GM and 2 samples of corpus GM). All biopsy samples were examined using histological and IHC (CDX2) techniques. An expression semi-quantitative index was developed to characterize CDX2. The results obtained were statistically processed using the Mann-Whitney and Kruskal-Wallis tests, the Spearman correlation coefficient, and the construction of logistic regression models.Results. It was found that the value of the CDX2 index assessed within the GM biopsy samples positively correlates with the gradation of atrophy (r=0.665 (p<0.001)). A positive correlation remains between the CDX2sum index, calculated by summing the CDX2 index values at each of the GM points, and the stage of chronic gastritis according to the OLGA classification (r=0.70 (p<0.01)). When assessing the contribution of changes at each point of biopsy sampling and retrospective correlation of the CDX2 index at two points of the GM and the stage of chronic gastritis, the greatest correlation was found for points 3 (stomach angle) and 5 (greater curvature of the gastric body), at three points – for points 1 (greater curvature antrum), 3 and 5 (r=0.592 (p<0.01)). Logistic regression models were built to predict the stage of chronic gastritis based on the CDX2 index in the specified combinations of points. The following model was chosen as the optimal one: to take biopsies at three points (1, 3, 5) and assess their CDX2 index, with sensitivity equal 80.4%, specificity equal 82.8% and diagnostic accuracy equal 83.9%.Conclusion. The CDX2 semi-quantitative index can be used to evaluate GM atrophy. The performed regression analysis demonstrates its predictive role. The constructed regression model based on the CDX2 semi-quantitative index calculation at two/three points of GM allows increasing predictive value of biopsy investigations and accuracy of stratified assessment of the gastric adenocarcinoma risk development in patients with CG.

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Lee, Shin-Woo. "Strategies for the development of GM crops in accordance with the environmental risk assessment (I)." Journal of Plant Biotechnology 38, no. 2 (June 30, 2011): 125–29. http://dx.doi.org/10.5010/jpb.2011.38.2.125.

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Song, Ping, Zhenglin Hou, Shravan Sukumar, and Rod A. Herman. "Template-based peptide modeling for celiac risk assessment of newly expressed proteins in GM crops." Regulatory Toxicology and Pharmacology 116 (October 2020): 104715. http://dx.doi.org/10.1016/j.yrtph.2020.104715.

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Nakai, Shuichi, Kana Hoshikawa, Seiichiro Yamane, Ayako Shimono, and Ryo Ohsawa. "Example of an isolated field study and environmental risk assessment for GM corn in Japan." Breeding Research 17, no. 1 (2015): 1–15. http://dx.doi.org/10.1270/jsbbr.17.1.

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46

Myhr, Anne Ingeborg. "The Challenge of Scientific Uncertainty and Disunity in Risk Assessment and Management of GM Crops." Environmental Values 19, no. 1 (February 1, 2010): 7–31. http://dx.doi.org/10.3197/096327110x485365.

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47

Sweet, Jeremy, and Detlef Bartsch. "Guidance on risk assessment of herbicide tolerant GM plants by the European Food Safety Authority." Journal für Verbraucherschutz und Lebensmittelsicherheit 6, S1 (April 5, 2011): 65–72. http://dx.doi.org/10.1007/s00003-011-0686-3.

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Ronca, Sandra, Joël Allainguillaume, Caroline S. Ford, John Warren, and Mike J. Wilkinson. "GM risk assessment: Pollen carriage from Brassica napus to B. rapa varies widely between pollinators." Basic and Applied Ecology 19 (March 2017): 36–44. http://dx.doi.org/10.1016/j.baae.2017.01.007.

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Bai, Chenghao, Yiguo Xue, Daohong Qiu, Weimin Yang, Maoxin Su, and Xinmin Ma. "Real-Time Updated Risk Assessment Model for the Large Deformation of the Soft Rock Tunnel." International Journal of Geomechanics 21, no. 1 (January 2021): 04020234. http://dx.doi.org/10.1061/(asce)gm.1943-5622.0001887.

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Kumar, Dinesh, Richa Kalia, Satya Bhushan Sharma, and Sunil Kumar Raina. "Validation of Community Based Assessment Checklist for Diabetes Mellitus in tertiary care setting, Himachal Pradesh, India." Journal of Comprehensive Health 7, no. 1 (June 30, 2019): 14–18. http://dx.doi.org/10.53553/jch.v07i01.004.

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Background:Â Government of India has developed a Community Based Assessment Checklist (CBAC) as a screening tool for Hypertension, Diabetes, and Cancers (Oral, Breast, Cervix). The objective was to assess the validity of the CBAC checklist for type-2 DM at a suggested cut off score of four.Â Methods:Â Cross-sectional study was carried out in the central laboratory of medical college in the northern state of India. Total 120 already known cases of DM or had Fasting Blood Glucose (FBG) ofÂ >126 gm/dl and 120 individuals with FBG ofÂ >126 gm/dl, considered as negative for type-2 DM, were recruited. Simultaneously, CBAC checklist was administered to all the 240 participants.Â Results:Â High risk CBAC score (>4) was present in 27.5% patients with diabetes and 12.5% without diabetes (p=0.004). Risk criteria of<4 had a diagnostic accuracy of 80.5% (Sensitivity: 42.9%; Specificity: 87.5%) with positive and negative predictive value of 37.5% and 89.7% respectively. Area under curve based on Receiver Operator Characteristic (AUC-ROC) curve was observed to be 0.62 (95% CI: 0.55-0.69) (p=0.001).Â Conclusion:Â Questionnaire based CBAC risk assessment criteria as a screening tool for blood sugar assessment had poor sensitivity, good specificity and poor discriminatory ability.

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