المؤلفون: Carlson, Laura M, Christensen, Krista, Sagiv, Sharon K, Rajan, Pradeep, Klocke, Carolyn R, Lein, Pamela J, Coffman, Evan, Shaffer, Rachel M, Yost, Erin E, Arzuaga, Xabier, Factor-Litvak, Pam, Sergeev, Alexander, Toborek, Michal, Bloom, Michael S, Trgovcich, Joanne, Jusko, Todd A, Robertson, Larry, Meeker, John D, Keating, Aileen F, Blain, Robyn, Silva, Raquel A, Snow, Samantha, Lin, Cynthia, Shipkowski, Kelly, Ingle, Brandall, Lehmann, Geniece M

مصطلحات موضوعية: Biological Sciences, Environmental Sciences, Chemical Sciences, Endocrine Disruptors, Generic health relevance, Animals, Humans, Carcinogens, Mammals, Polychlorinated Biphenyls, Uncertainty, Evidence map, Polychlorinated biphenyl, Systematic review, Risk assessment, Hazard identification, Toxicology, Biological sciences, Chemical sciences, Environmental sciences

الوصف: Assessing health outcomes associated with exposure to polychlorinated biphenyls (PCBs) is important given their persistent and ubiquitous nature. PCBs are classified as a Group 1 carcinogen, but the full range of potential noncancer health effects from exposure to PCBs has not been systematically summarized and evaluated. We used systematic review methods to identify and screen the literature using combined manual review and machine learning approaches. A protocol was developed that describes the literature search strategy and Populations, Exposures, Comparators, and Outcomes (PECO) criteria used to facilitate subsequent screening and categorization of literature into a systematic evidence map of PCB exposure and noncancer health endpoints across 15 organs/systems. A comprehensive literature search yielded 62,599 records. After electronic prioritization steps, 17,037 studies were manually screened at the title and abstract level. An additional 900 studies identified by experts or supplemental searches were also included. After full-text screening of 3889 references, 1586 studies met the PECO criteria. Relevant study details such as the endpoints assessed, exposure duration, and species were extracted into literature summary tables. This review compiles and organizes the human and mammalian studies from these tables into an evidence map for noncancer health endpoints and PCB mixture exposure to identify areas of robust research as well as areas of uncertainty that would benefit from future investigation. Summary data are available online as interactive visuals with downloadable metadata. Sufficient research is available to inform PCB hazard assessments for most organs/systems, but the amount of data to inform associations with specific endpoints differs. Furthermore, despite many years of research, sparse data exist for inhalation and dermal exposures, which are highly relevant human exposure routes. This evidence map provides a foundation for future systematic reviews and noncancer hazard assessments of PCB mixtures and for strategic planning of research to inform areas of greater uncertainty.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/4s17623sTest
https://escholarship.org/content/qt4s17623s/qt4s17623s.pdfTest

المؤلفون: Walker, Vickie R., Lemeris, Courtney R., Magnuson, Kristen, Sibrizzi, Christopher A., Shipkowski, Kelly A., Taylor, Kyla W., Rooney, Andrew A.

المصدر: Systematic Reviews ; volume 13, issue 1 ; ISSN 2046-4053

مصطلحات موضوعية: Medicine (miscellaneous)

الوصف: Systematic review methods are recognized for their rigor and transparency and are widely adapted to frameworks that cover review types such as systematic reviews, scoping reviews, and systematic evidence maps. Reporting guidelines help promote better systematic review practices and detailed documentation of the review process for different types of health research (e.g., PRISMA—Preferred Reporting Items for Systematic Reviews and Meta-Analyses; CONSORT—Consolidated Standards of Reporting Trials; and STROBE—Strengthening the Reporting of Observational Studies in Epidemiology). Transparency in the systematic review process and reporting of results is one of the key advantages of the methods and particularly important for hazard and risk assessments due to the high level of scrutiny these reviews face from scientific, political, and public communities. Data visualizations are important to clearly convey information from a review by helping readers perceive, understand, and assess the displayed information easily and quickly. The study flow diagram is a required element of a systematic review and maps out the number of included and excluded records identified, and the reasons for exclusion. Static literature flow diagrams help viewers readily understand the general review methodology and summarize the number of records included or excluded at each stage of the review. However, such diagrams can be time-consuming to develop and maintain during a systematic review or scoping review, and they provide limited summary-level information. We explored how the use of online systematic review tools such as DistillerSR coupled with visualization software such as Tableau can efficiently generate an Interactive REFerence Flow (I-REFF) diagram that is linked to the literature screening data, thus requiring minimal preparation, and resulting in a simplified process for updating the diagram. Furthermore, I-REFF diagrams enhance transparency and traceability by not only summarizing the records in the review but also ...

الإتاحة: https://doi.org/10.1186/s13643-023-02420-0Test

المؤلفون: Berridge, Brian R, Bucher, John R, Sistare, Frank, Stevens, James L, Chappell, Grace A, Clemons, Meredith, Snow, Samantha, Wignall, Jessica, Shipkowski, Kelly A

المساهمون: National Institute of Environmental Health Sciences, National Institutes of Health, U.S. Department of the Interior

المصدر: Toxicological Sciences ; volume 198, issue 1, page 4-13 ; ISSN 1096-6080 1096-0929

مصطلحات موضوعية: Toxicology

الوصف: Throughput needs, costs of time and resources, and concerns about the use of animals in hazard and safety assessment studies are fueling a growing interest in adopting new approach methodologies for use in product development and risk assessment. However, current efforts to define “next-generation risk assessment” vary considerably across commercial and regulatory sectors, and an a priori definition of the biological scope of data needed to assess hazards is generally lacking. We propose that the absence of clearly defined questions that can be answered during hazard assessment is the primary barrier to the generation of a paradigm flexible enough to be used across varying product development and approval decision contexts. Herein, we propose a biological questions-based approach (BQBA) for hazard and safety assessment to facilitate fit-for-purpose method selection and more efficient evidence-based decision-making. The key pillars of this novel approach are bioavailability, bioactivity, adversity, and susceptibility. This BQBA is compared with current hazard approaches and is applied in scenarios of varying pathobiological understanding and/or regulatory testing requirements. To further define the paradigm and key questions that allow better prediction and characterization of human health hazard, a multidisciplinary collaboration among stakeholder groups should be initiated.

الإتاحة: https://doi.org/10.1093/toxsci/kfad124Test
https://academic.oup.com/toxsci/article-pdf/198/1/4/57160273/kfad124.pdfTest

المؤلفون: Shipkowski, Kelly A., Hubbard, Troy D., Ryan, Kristen, Waidyanatha, Suramya, Cunny, Helen, Shockley, Keith R., Allen, Joshua L., Toy, Heather, Levine, Keith, Harrington, James, Betz, Laura, Sparrow, Barney, Roberts, Georgia K.

المساهمون: National Institutes of Health, National Institute of Environmental Health Sciences

المصدر: Toxicology Reports ; volume 10, page 621-632 ; ISSN 2214-7500

مصطلحات موضوعية: Health, Toxicology and Mutagenesis, Toxicology

الإتاحة: https://doi.org/10.1016/j.toxrep.2023.05.003Test
https://api.elsevier.com/content/article/PII:S2214750023000550?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2214750023000550?httpAccept=text/plainTest

المؤلفون: Carlson, Laura M., Christensen, Krista, Sagiv, Sharon K., Rajan, Pradeep, Klocke, Carolyn R., Lein, Pamela J., Coffman, Evan, Shaffer, Rachel M., Yost, Erin E., Arzuaga, Xabier, Factor-Litvak, Pam, Sergeev, Alexander, Toborek, Michal, Bloom, Michael S., Trgovcich, Joanne, Jusko, Todd A., Robertson, Larry, Meeker, John D., Keating, Aileen F., Blain, Robyn, Silva, Raquel A., Snow, Samantha, Lin, Cynthia, Shipkowski, Kelly, Ingle, Brandall, Lehmann, Geniece M.

المصدر: Environmental Research ; volume 220, page 115148 ; ISSN 0013-9351

مصطلحات موضوعية: General Environmental Science, Biochemistry

الإتاحة: https://doi.org/10.1016/j.envres.2022.115148Test
https://api.elsevier.com/content/article/PII:S0013935122024756?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0013935122024756?httpAccept=text/plainTest

المؤلفون: Berridge, Brian R, Bucher, John R, Sistare, Frank, Stevens, James L, Chappell, Grace A, Clemons, Meredith, Snow, Samantha, Wignall, Jessica, Shipkowski, Kelly A

المصدر: Toxicological Sciences; Mar2024, Vol. 198 Issue 1, p4-13, 10p

مصطلحات موضوعية: MEDICATION safety, RISK assessment, HAZARDS, NEW product development, HUMAN beings

مستخلص: Throughput needs, costs of time and resources, and concerns about the use of animals in hazard and safety assessment studies are fueling a growing interest in adopting new approach methodologies for use in product development and risk assessment. However, current efforts to define "next-generation risk assessment" vary considerably across commercial and regulatory sectors, and an a priori definition of the biological scope of data needed to assess hazards is generally lacking. We propose that the absence of clearly defined questions that can be answered during hazard assessment is the primary barrier to the generation of a paradigm flexible enough to be used across varying product development and approval decision contexts. Herein, we propose a biological questions-based approach (BQBA) for hazard and safety assessment to facilitate fit-for-purpose method selection and more efficient evidence-based decision-making. The key pillars of this novel approach are bioavailability, bioactivity, adversity, and susceptibility. This BQBA is compared with current hazard approaches and is applied in scenarios of varying pathobiological understanding and/or regulatory testing requirements. To further define the paradigm and key questions that allow better prediction and characterization of human health hazard, a multidisciplinary collaboration among stakeholder groups should be initiated. [ABSTRACT FROM AUTHOR]

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المؤلفون: Walker, Vickie R., Schmitt, Charles P., Wolfe, Mary S., Nowak, Artur J., Kulesza, Kuba, Williams, Ashley R., Shin, Rob, Cohen, Jonathan, Burch, Dave, Stout, Matthew D., Shipkowski, Kelly A., Rooney, Andrew A.

المساهمون: Intensive Care Foundation, National Institutes of Health, National Institute of Environmental Health Sciences

المصدر: Environment International ; volume 159, page 107025 ; ISSN 0160-4120

مصطلحات موضوعية: General Environmental Science

الإتاحة: https://doi.org/10.1016/j.envint.2021.107025Test
https://api.elsevier.com/content/article/PII:S0160412021006504?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0160412021006504?httpAccept=text/plainTest

المؤلفون: Shipkowski, Kelly A., Betz, Joseph M., Birnbaum, Linda S., Bucher, John R., Coates, Paul M., Hopp, D. Craig, MacKay, Duffy, Oketch-Rabah, Hellen, Walker, Nigel J., Welch, Cara, Rider, Cynthia V.

المساهمون: National Institute of Environmental Health Sciences, National Institutes of Health

المصدر: Food and Chemical Toxicology ; volume 118, page 963-971 ; ISSN 0278-6915

مصطلحات موضوعية: Toxicology, General Medicine, Food Science

الإتاحة: https://doi.org/10.1016/j.fct.2018.04.007Test
https://api.elsevier.com/content/article/PII:S0278691518302096?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0278691518302096?httpAccept=text/plainTest

المؤلفون: Duke, Katherine S., Taylor-Just, Alexia J., Ihrie, Mark D., Shipkowski, Kelly A., Thompson, Elizabeth A., Dandley, Erinn C., Parsons, Gregory N., Bonner, James C.

المساهمون: National Institute of Environmental Health Sciences

المصدر: Particle and Fibre Toxicology ; volume 14, issue 1 ; ISSN 1743-8977

مصطلحات موضوعية: Health, Toxicology and Mutagenesis, Toxicology, General Medicine

الإتاحة: https://doi.org/10.1186/s12989-017-0207-3Test

المؤلفون: Shipkowski, Kelly A., Sheth, Christopher M., Smith, Matthew J., Hooth, Michelle J., White, Kimber L., Germolec, Dori R.

المساهمون: National Institutes of Health, National Institute of Environmental Health Sciences

المصدر: Journal of Immunotoxicology ; volume 14, issue 1, page 215-227 ; ISSN 1547-691X 1547-6901

الإتاحة: https://doi.org/10.1080/1547691x.2017.1394932Test