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The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?
- Joan E. Adamo, Robert V. Bienvenu II, F. Owen Fields, Soma Ghosh, Christina M. Jones, Michael Liebman, Mark S. Lowenthal, Scott J. Steele
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- Journal:
- Journal of Clinical and Translational Science / Volume 2 / Issue 5 / October 2018
- Published online by Cambridge University Press:
- 06 December 2018, pp. 295-300
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Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.
Effects of Additives on Efficacy, Uptake, and Translocation of Chlorimuron Ethyl Ester
- Robert J. Fielding, Edward W. Stoller
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- Journal:
- Weed Technology / Volume 4 / Issue 2 / June 1990
- Published online by Cambridge University Press:
- 12 June 2017, pp. 264-271
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Effects of a 28% N solution containing urea and ammonium nitrate (28% UAN) and a nonionic surfactant on efficacy, uptake, and translocation of chlorimuron ethyl ester in soybean and broadleaf weeds were investigated. Chlorimuron applied postemergence at 8.8 and 13 g ai/ha with either nonionic surfactant at 0.25% (v/v), 28% UAN at 9.4 L/ha, or nonionic surfactant plus 28% UAN controlled weeds better than without additives. Chlorimuron with nonionic surfactant and with 28% UAN controlled weeds similarly but with 28% UAN injured soybeans least. Chlorimuron with nonionic surfactant plus 28% UAN controlled velvetleaf best but injured soybeans most. Less than 2% of applied 14C-chlorimuron was absorbed in velvetleaf 84 h after treatment (HAT) when no additive was present, but adding nonionic surfactant, 28% UAN, and nonionic surfactant plus 28% UAN resulted in 21, 9, and 32% uptake, respectively, 84 HAT. Nonionic surfactant plus 28% UAN also increased translocation (primarily acropetal) of the 14C. Adding 28% UAN increased 14C-chlorimuron uptake in velvetleaf grown at low fertility but had no effect under high fertility.
Effects of Additives on the Efficacy, Uptake, and Translocation of the Methyl Ester of Thifensulfuron
- Robert J. Fielding, Edward W. Stoller
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- Journal:
- Weed Science / Volume 38 / Issue 2 / March 1990
- Published online by Cambridge University Press:
- 12 June 2017, pp. 172-178
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Effects of a 28% N solution containing urea and ammonium nitrate (28% UAN) on field efficacy of the methyl ester of thifensulfuron and combinations of thifensulfuron and the methyl ester of chlorimuron were investigated. Velvetleaf control and soybean injury increased as rates of thifensulfuron increased (0, 2.2, 4.4, and 5.8 g ai/ha) and as rates of chlorimuron increased (0, 4.4, and 8.8 g ai/ha). Treatments that included 28% UAN at 9 L/ha controlled velvetleaf 9% better, averaged across herbicides and rates 21 days after treatment (DAT), but also increased soybean injury. Thifensulfuron applications controlled common lambsquarters well, but control was not affected by additions of 28% UAN. In studies where 14C-thifensulfuron was applied without an additive to the second true leaf of growth-chamber-grown velvetleaf, less than 4% of that applied was absorbed 84 h after treatment (HAT), whereas treatments that included nonionic surfactant or 28% UAN absorbed 33 and 45%, respectively. When both nonionic surfactant and 28% UAN were added, plants absorbed 76% 84 HAT. Translocation 84 HAT was also greatest with both additives and the majority moved to tissues above treated leaves. The 28% UAN increased uptake of thiameturon regardless of soil fertility level.
An Environmental Scan of Academic Emergency Medicine at the 17 Canadian Medical Schools: Why Does this Matter to Emergency Physicians?
- Ian G. Stiell, Jennifer D. Artz, Eddy S. Lang, Jonathan Sherbino, Laurie J. Morrison, James Christenson, Jeffrey J. Perry, Claude Topping, Robert Woods, Robert S. Green, Rodrick Lim, Kirk Magee, John Foote, Garth Meckler, Mark Mensour, Simon Field, Brian Chung, Martin Kuuskne, James Ducharme, Vera Klein, Jill McEwen
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- Journal:
- Canadian Journal of Emergency Medicine / Volume 19 / Issue 1 / January 2017
- Published online by Cambridge University Press:
- 21 July 2016, pp. 39-46
- Print publication:
- January 2017
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Objective
We sought to conduct a major objective of the CAEP Academic Section, an environmental scan of the academic emergency medicine programs across the 17 Canadian medical schools.
MethodsWe developed an 84-question questionnaire, which was distributed to academic heads. The responses were validated by phone by the lead author to ensure that the questions were answered completely and consistently. Details of pediatric emergency medicine units were excluded from the scan.
ResultsAt eight of 17 universities, emergency medicine has full departmental status and at two it has no official academic status. Canadian academic emergency medicine is practiced at 46 major teaching hospitals and 13 specialized pediatric hospitals. Another 69 Canadian hospital EDs regularly take clinical clerks and emergency medicine residents. There are 31 full professors of emergency medicine in Canada. Teaching programs are strong with clerkships offered at 16/17 universities, CCFP(EM) programs at 17/17, and RCPSC residency programs at 14/17. Fourteen sites have at least one physician with a Master’s degree in education. There are 55 clinical researchers with salary support at 13 universities. Sixteen sites have published peer-reviewed papers in the past five years, ranging from four to 235 per site. Annual budgets range from $200,000 to $5,900,000.
ConclusionThis comprehensive review of academic activities in emergency medicine across Canada identifies areas of strengths as well as opportunities for improvement. CAEP and the Academic Section hope we can ultimately improve ED patient care by sharing best academic practices and becoming better teachers, educators, and researchers.
Contributors
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- By Zachary W. Adams, Margarita Alegría, Atalay Alem, Jordi Alonso, Victor Aparicio, Rifat Atun, Florence Baingana, Emily Baron, Marco Bertelli, Dinesh Bhugra, Sanchita Biswas, José Miguel Caldas de Almeida, Edwin Cameron, Somnath Chatterji, Erminia Colucci, Janice L. Cooper, Carla Kmett Danielson, Diego De Leo, Mary-Jo DelVecchio Good, Marten W. de Vries, Maureen S. Durkin, Xiangming Fang, Julia W. Felton, Sally Field, Andrea Fiorillo, Lance Gable, Teddy Gafna, Sandro Galea, Patrick Gatonga, Sofia Halperin-Goldstein, Yanling He, Grace A. Herbert, Sabrina Hermosilla, Simone Honikman, Takashi Izutsu, Ruwan M. Jayatunge, Janis H. Jenkins, Rachel Jenkins, Lynne Jones, Jayanthi Karunaratne, Ronald C. Kessler, Rob Keukens, Lincoln I. Khasakhala, Hanna Kienzler, Sarah Kippen Wood, M. Thomas Kishore, Robert Kohn, Natasja Koitzsch Jensen, Sheri Lapatin, Anna Lessios, Isabel Louro Bernal, Feijun Luo, Laura MacPherson, Matthew J. Maenner, Anne W. Mbwayo, David McDaid, Ingrid Meintjes, Victoria N. Mutiso, David M. Ndetei, Samuel O. Okpaku, Lijing Ouyang, Ramachandran Padmavati, Clare Pain, Duncan Pedersen, Jordan Pfau, Felipe Picon, Rodney D. Presley, Reima Pryor, Shoba Raja, Thara Rangaswamy, Jorge Rodriguez, Diana Rose, Moosa Salie, Norman Sartorius, Ester Shapiro, Manuela Silva, Daya Somasundaram, Katherine Sorsdahl, Dan J. Stein, Deborah M. Stone, Heather Stuart, Athula Sumathipala, Hema Tharoor, Rita Thom, Lay San Too, Atsuro Tsutsumi, Chris Underhill, Anne Valentine, Claire van der Westhuizen, Thandi van Heyningen, Robert van Voren, Inka Weissbecker, Gail Wyatt
- Edited by Samuel O. Okpaku
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- Book:
- Essentials of Global Mental Health
- Published online:
- 05 March 2014
- Print publication:
- 27 February 2014, pp x-xiv
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- By Aakash Agarwala, Linda S. Aglio, Rae M. Allain, Paul D. Allen, Houman Amirfarzan, Yasodananda Kumar Areti, Amit Asopa, Edwin G. Avery, Patricia R. Bachiller, Angela M. Bader, Rana Badr, Sibinka Bajic, David J. Baker, Sheila R. Barnett, Rena Beckerly, Lorenzo Berra, Walter Bethune, Sascha S. Beutler, Tarun Bhalla, Edward A. Bittner, Jonathan D. Bloom, Alina V. Bodas, Lina M. Bolanos-Diaz, Ruma R. Bose, Jan Boublik, John P. Broadnax, Jason C. Brookman, Meredith R. Brooks, Roland Brusseau, Ethan O. Bryson, Linda A. Bulich, Kenji Butterfield, William R. Camann, Denise M. Chan, Theresa S. Chang, Jonathan E. Charnin, Mark Chrostowski, Fred Cobey, Adam B. Collins, Mercedes A. Concepcion, Christopher W. Connor, Bronwyn Cooper, Jeffrey B. Cooper, Martha Cordoba-Amorocho, Stephen B. Corn, Darin J. Correll, Gregory J. Crosby, Lisa J. Crossley, Deborah J. Culley, Tomas Cvrk, Michael N. D'Ambra, Michael Decker, Daniel F. Dedrick, Mark Dershwitz, Francis X. Dillon, Pradeep Dinakar, Alimorad G. Djalali, D. John Doyle, Lambertus Drop, Ian F. Dunn, Theodore E. Dushane, Sunil Eappen, Thomas Edrich, Jesse M. Ehrenfeld, Jason M. Erlich, Lucinda L. Everett, Elliott S. Farber, Khaldoun Faris, Eddy M. Feliz, Massimo Ferrigno, Richard S. Field, Michael G. Fitzsimons, Hugh L. Flanagan Jr., Vladimir Formanek, Amanda A. Fox, John A. Fox, Gyorgy Frendl, Tanja S. Frey, Samuel M. Galvagno Jr., Edward R. Garcia, Jonathan D. Gates, Cosmin Gauran, Brian J. Gelfand, Simon Gelman, Alexander C. Gerhart, Peter Gerner, Omid Ghalambor, Christopher J. Gilligan, Christian D. Gonzalez, Noah E. Gordon, William B. Gormley, Thomas J. Graetz, Wendy L. Gross, Amit Gupta, James P. Hardy, Seetharaman Hariharan, Miriam Harnett, Philip M. Hartigan, Joaquim M. Havens, Bishr Haydar, Stephen O. Heard, James L. Helstrom, David L. Hepner, McCallum R. Hoyt, Robert N. Jamison, Karinne Jervis, Stephanie B. Jones, Swaminathan Karthik, Richard M. Kaufman, Shubjeet Kaur, Lee A. Kearse Jr., John C. Keel, Scott D. Kelley, Albert H. Kim, Amy L. Kim, Grace Y. Kim, Robert J. Klickovich, Robert M. Knapp, Bhavani S. Kodali, Rahul Koka, Alina Lazar, Laura H. Leduc, Stanley Leeson, Lisa R. Leffert, Scott A. LeGrand, Patricio Leyton, J. Lance Lichtor, John Lin, Alvaro A. Macias, Karan Madan, Sohail K. Mahboobi, Devi Mahendran, Christine Mai, Sayeed Malek, S. Rao Mallampati, Thomas J. Mancuso, Ramon Martin, Matthew C. Martinez, J. A. Jeevendra Martyn, Kai Matthes, Tommaso Mauri, Mary Ellen McCann, Shannon S. McKenna, Dennis J. McNicholl, Abdel-Kader Mehio, Thor C. Milland, Tonya L. K. Miller, John D. Mitchell, K. Annette Mizuguchi, Naila Moghul, David R. Moss, Ross J. Musumeci, Naveen Nathan, Ju-Mei Ng, Liem C. Nguyen, Ervant Nishanian, Martina Nowak, Ala Nozari, Michael Nurok, Arti Ori, Rafael A. Ortega, Amy J. Ortman, David Oxman, Arvind Palanisamy, Carlo Pancaro, Lisbeth Lopez Pappas, Benjamin Parish, Samuel Park, Deborah S. Pederson, Beverly K. Philip, James H. Philip, Silvia Pivi, Stephen D. Pratt, Douglas E. Raines, Stephen L. Ratcliff, James P. Rathmell, J. Taylor Reed, Elizabeth M. Rickerson, Selwyn O. Rogers Jr., Thomas M. Romanelli, William H. Rosenblatt, Carl E. Rosow, Edgar L. Ross, J. Victor Ryckman, Mônica M. Sá Rêgo, Nicholas Sadovnikoff, Warren S. Sandberg, Annette Y. Schure, B. Scott Segal, Navil F. Sethna, Swapneel K. Shah, Shaheen F. Shaikh, Fred E. Shapiro, Torin D. Shear, Prem S. Shekar, Stanton K. Shernan, Naomi Shimizu, Douglas C. Shook, Kamal K. Sikka, Pankaj K. Sikka, David A. Silver, Jeffrey H. Silverstein, Emily A. Singer, Ken Solt, Spiro G. Spanakis, Wolfgang Steudel, Matthias Stopfkuchen-Evans, Michael P. Storey, Gary R. Strichartz, Balachundhar Subramaniam, Wariya Sukhupragarn, John Summers, Shine Sun, Eswar Sundar, Sugantha Sundar, Neelakantan Sunder, Faraz Syed, Usha B. Tedrow, Nelson L. Thaemert, George P. Topulos, Lawrence C. Tsen, Richard D. Urman, Charles A. Vacanti, Francis X. Vacanti, Joshua C. Vacanti, Assia Valovska, Ivan T. Valovski, Mary Ann Vann, Susan Vassallo, Anasuya Vasudevan, Kamen V. Vlassakov, Gian Paolo Volpato, Essi M. Vulli, J. Matthias Walz, Jingping Wang, James F. Watkins, Maxwell Weinmann, Sharon L. Wetherall, Mallory Williams, Sarah H. Wiser, Zhiling Xiong, Warren M. Zapol, Jie Zhou
- Edited by Charles Vacanti, Scott Segal, Pankaj Sikka, Richard Urman
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- Book:
- Essential Clinical Anesthesia
- Published online:
- 05 January 2012
- Print publication:
- 11 July 2011, pp xv-xxviii
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Standardized Emergency Management System and Response to a Smallpox Emergency
- Robert J. Kim-Farley, John T. Celentano, Carol Gunter, Jessica W. Jones, Rogelio A. Stone, Raymond D. Aller, Laurene Mascola, Sharon F. Grigsby, Jonathan E. Fielding
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- Journal:
- Prehospital and Disaster Medicine / Volume 18 / Issue 4 / December 2003
- Published online by Cambridge University Press:
- 28 June 2012, pp. 313-320
- Print publication:
- December 2003
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The smallpox virus is a high-priority, Category-A agent that poses a global, terrorism security risk because it: (1) easily can be disseminated and transmitted from person to person; (2) results in high mortality rates and has the potential for a major public health impact; (3) might cause public panic and social disruption; and (4) requires special action for public health preparedness. In recognition of this risk, the Los Angeles County Department of Health Services (LAC-DHS) developed the Smallpox Preparedness, Response, and Recovery Plan for LAC to prepare for the possibility of an outbreak of smallpox.
A unique feature of the LAC-DHS plan is its explicit use of the Standardized Emergency Management System (SEMS) framework for detailing the functions needed to respond to a smallpox emergency. The SEMS includes the Incident Command System (ICS) structure (management, operations, planning/intelligence, logistics, and finance/administration), the mutual-aid system, and the multi/interagency coordination required during a smallpox emergency. Management for incident command includes setting objectives and priorities, information (risk communications), safety, and liaison. Operations includes control and containment of a smallpox outbreak including ring vaccination, mass vaccination, adverse events monitoring and assessment, management of confirmed and suspected smallpox cases, contact tracing, active surveillance teams and enhanced hospital-based surveillance, and decontamination. Planning/intelligence functions include developing the incident action plan, epidemiological investigation and analysis of smallpox cases, and epidemiological assessment of the vaccination coverage status of populations at risk. Logistics functions include receiving, handling, inventorying, and distributing smallpox vaccine and vaccination clinic supplies; personnel; transportation; communications; and health care of personnel. Finally, finance/administration functions include monitoring costs related to the smallpox emergency, procurement, and administrative aspects that are not handled by other functional divisions of incident command systems.
The plan was developed and is under frequent review by the LAC-DHS Smallpox Planning Working Group, and is reviewed periodically by the LAC Bioterrorism Advisory Committee, and draws upon the Smallpox Response Plan and Guidelines of the Centers for Disease Control and Prevention (CDC) and recommendations of the Advisory Committee on Immunization Practices (ACIP). The Smallpox Preparedness, Response, and Recovery Plan, with its SEMS framework and ICS structure, now is serving as a model for the development of LAC-DHS plans for responses to other terrorist or natural-outbreak responses.
Effects of the acanthocephalan parasite Echinorhynchus truttae on the feeding ecology of Gammarus pulex (Crustacea: Amphipoda)
- Nina J. Fielding, Calum MacNeil, Jaimie T. A. Dick, Robert W. Elwood, Gillian E. Riddell, Alison M. Dunn
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- Journal:
- Journal of Zoology / Volume 261 / Issue 3 / November 2003
- Published online by Cambridge University Press:
- 22 October 2003, pp. 321-325
- Print publication:
- November 2003
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The amphipod Gammarus pulex is an intermediate host to the acanthocephalan fish parasite Echinorhynchus truttae. Gammarus pulex has a wide trophic repertoire, feeding as a herbivore, detritivore and predator. In this study an examination was made of the effects of E. truttae parasitism on components of the G. pulex diet: stream-conditioned leaves, dead chironomids and live juvenile isopods Asellus aquaticus. Over 21 days, parasitism had no effect on daily feeding rates or wet weights of G. pulex fed on leaves or chironomids. Parasitism had a significant effect on the number of A. aquaticus killed by G. pulex, with parasitized individuals killing significantly fewer than their unparasitized counterparts. In addition, unparasitized amphipods killed all size classes of A. aquaticus indiscriminately, whereas parasitized animals tended to kill the smaller size classes. The impacts of the parasitism of G. pulex throughout the wider freshwater community are discussed.
Hospital Characteristics Associated With Colonization of Water Systems by Legionella and Risk of Nosocomial Legionnaires' Disease: A Cohort Study of 15 Hospitals
- Jacob L. Kool, David Bergmire-Sweat, Jay C. Butler, Ellen W. Brown, Deborah J. Peabody, Daniel S. Massi, Joseph C. Carpenter, Janet M. Pruckler, Robert F. Benson, Barry S. Fields
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- Journal:
- Infection Control & Hospital Epidemiology / Volume 20 / Issue 12 / December 1999
- Published online by Cambridge University Press:
- 02 January 2015, pp. 798-805
- Print publication:
- December 1999
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Objective:
To investigate an increase in reports of legionnaires' disease by multiple hospitals in San Antonio, Texas, and to study risk factors for nosocomial transmission of legionnaires' disease and determinants for Legionella colonization of hospital hot-water systems.
Setting:The 16 largest hospitals in the cities of San Antonio, Temple, and Austin, Texas.
Design:Review of laboratory databases to identify patients with legionnaires' disease in the 3 years prior to the investigation and to determine the number of diagnostic tests for Legionella performed; measurement of hot-water temperature and chlorine concentration and culture of potable water for Legionella. Exact univariate calculations, Poisson regression, and linear regression were used to determine factors associated with water-system colonization and transmission of Legionella.
Results:Twelve cases of nosocomial legionnaires' disease were identified; eight of these occurred in 1996. The rise in cases occurred shortly after physicians started requesting Legionella urinary antigen tests. Hospitals that frequently used Legionella urinary antigen tests tended to detect more cases of legionnaires' disease. Legionella was isolated from the water systems of 11 of 12 hospitals in San Antonio; the 12th had just experienced an outbreak of legionnaires' disease and had implemented control measures. Nosocomial legionellosis cases probably occurred in 5 hospitals. The number of nosocomial legionnaires' disease cases in each hospital correlated better with the proportion of water-system sites that tested positive for Legionella (P=.07) than with the concentration of Legionella bacteria in water samples (P=.23). Hospitals in municipalities where the water treatment plant used monochloramine as a residual disinfectant (n=4) and the hospital that had implemented control measures were Legionella-free. The hot-water systems of all other hospitals (n=11) were colonized with Legionella. These were all supplied with municipal drinking water that contained free chlorine as a residual disinfectant. In these contaminated hospitals, the proportion of sites testing positive was inversely correlated with free residual chlorine concentration (P=.01). In all hospitals, hot-water temperatures were too low to inhibit Legionella growth.
Conclusions:The increase in reporting of nosocomial legionnaires' disease was attributable to increased use of urinary antigen tests; prior cases may have gone unrecognized. Risk of legionnaires' disease in hospital patients was better predicted by the proportion of water-system sites testing positive for Legionella than by the measured concentration of Legionella bacteria. Use of monochloramine by municipalities for residual drinking water disinfection may help prevent legionnaires' disease.
13 - Ground-Truth Studies of West Coast and Gulf of Mexico Submarine Fans
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- By Homa J. Lee, U.S. Geological Survey, Menlo Park, California, Robert E. Kayen, U.S. Geological Survey, Menlo Park, California, Brian D. Edwards, U.S. Geological Survey, Menlo Park, California, Michael E. Field, U.S. Geological Survey, Menlo Park, California, James V. Gardner, U.S. Geological Survey, Menlo Park, California, William C. Schwab, U.S. Geological Survey, Woods Hole, Massachusetts, David C. Twichell, U.S. Geological Survey, Woods Hole, Massachusetts
- Edited by James V. Gardner, United States Geological Survey, California, Michael E. Field, United States Geological Survey, California, David C. Twichell
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- Book:
- Geology of the United States' Seafloor
- Published online:
- 25 January 2010
- Print publication:
- 13 August 1996, pp 221-234
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Summary
Introduction
The use of sidescan sonar technology has greatly expanded in recent years. One impediment to interpreting sidescan sonar images, which are a representation of the amount of sound backscattered from the seafloor, is the incomplete understanding of the physical meaning of acoustic backscatter intensity variations. Ground-truth studies can help us to understand the causes of variations in backscatter. We need to measure physical and geometric properties of seafloor sediment and correlate them with variations in sidescan sonar acoustic backscatter. We present in this paper comparative ground-truth studies of two deep-sea fan depositional lobes. We show that sediment lithology influences sidescan sonar images, but that the relation between backscatter intensity and sediment grain size is not uniquely defined.
Some of the seafloor characteristics that are potential causes of variations in acoustic backscatter intensity are surface roughness, variations in sediment composition, grazing angle of insonification, and seafloor slope, including topographic variability (Urick 1983). The influence of each of these and the subbottom depth range over which sediment compositional variations are important will vary with the characteristics of the sidescan system, including frequency, pulse length, bandwidth, time-varying gains, and footprint size. The number of variables needs to be kept to a minimum in order to simplify a ground-truth study. The distal parts of deep-sea fans are good locations for such studies because they tend to have nearly horizontal seafloor surfaces. Thus, the topographic variability – bottom slope effect can be ignored.
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