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Development, implementation, and dissemination of operational innovations across the trial innovation network
- Marisha E. Palm, Terri L. Edwards, Cortney Wieber, Marie T. Kay, Eve Marion, Leslie Boone, Angeline Nanni, Michelle Jones, Eilene Pham, Meghan Hildreth, Karen Lane, Nichol McBee, Daniel K. Benjamin, Jr, Gordon R. Bernard, J. Michael Dean, Jamie P. Dwyer, Daniel E. Ford, Daniel F. Hanley, Paul A. Harris, Consuelo H. Wilkins, Harry P. Selker
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 20 October 2023, e251
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Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned
- Daniel F. Hanley, Jr, Gordon R. Bernard, Consuelo H. Wilkins, Harry P. Selker, Jamie P. Dwyer, J. Michael Dean, Daniel Kelly Benjamin, Jr, Sarah E. Dunsmore, Salina P. Waddy, Kenneth L. Wiley, Jr, Marisha E. Palm, W. Andrew Mould, Daniel F. Ford, Jeri S. Burr, Jacqueline Huvane, Karen Lane, Lori Poole, Terri L. Edwards, Nan Kennedy, Leslie R. Boone, Jasmine Bell, Emily Serdoz, Loretta M. Byrne, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 25 July 2023, e170
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New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network
- Karen Lane, Marisha E. Palm, Eve Marion, Marie T. Kay, Dixie Thompson, Mary Stroud, Helen Boyle, Shannon Hillery, Angeline Nanni, Meghan Hildreth, Sarah Nelson, Jeri S. Burr, Terri Edwards, Lori Poole, Salina P. Waddy, Sarah E. Dunsmore, Paul Harris, Consuelo Wilkins, Gordon R. Bernard, J. Michael Dean, Jamie Dwyer, Daniel K. Benjamin, Jr., Harry P. Selker, Daniel F. Hanley, Daniel E. Ford
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 25 May 2023, e131
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One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
Using gamification to enhance clinical trial start-up activities
- Karen Lane, Ryan Majkowski, Joshua Gruber, Daniel Amirault, Shannon Hillery, Cortney Wieber, Dixie D Thompson, Jacqueline Huvane, Jordan Bridges, E. Paul Ryu, Lindsay M. Eyzaguirre, Marianne Gildea, Richard E. Thompson, Daniel E. Ford, Daniel Hanley
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue 1 / 2022
- Published online by Cambridge University Press:
- 19 May 2022, e75
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Background:
The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community.
Methods:The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance.
Results:Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second.
Conclusion:This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.
Pattern analysis of vegan eating reveals healthy and unhealthy patterns within the vegan diet
- Catherine T Gallagher, Paul Hanley, Katie E Lane
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- Journal:
- Public Health Nutrition / Volume 25 / Issue 5 / May 2022
- Published online by Cambridge University Press:
- 11 May 2021, pp. 1310-1320
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Objective:
This study aimed to identify the types of foods that constitute a vegan diet and establish patterns within the diet. Dietary pattern analysis, a key instrument for exploring the correlation between health and disease, was used to identify patterns within the vegan diet.
Design:A modified version of the EPIC-Norfolk FFQ was created and validated to include vegan foods and launched on social media.
Setting:UK participants, recruited online.
Participants:A convenience sample of 129 vegans voluntarily completed the FFQ. Collected data were converted to reflect weekly consumption to enable factor and cluster analyses.
Results:Factor analysis identified four distinct dietary patterns including: (1) convenience (22 %); (2) health conscious (12 %); (3) unhealthy (9 %) and (4) traditional vegan (7 %). Whilst two healthy patterns were defined, the convenience pattern was the most identifiable pattern with a prominence of vegan convenience meals and snacks, vegan sweets and desserts, sauces, condiments and fats. Cluster analysis identified three clusters, cluster 1 ‘convenience’ (26·8 %), cluster 2 ‘traditional’ (22 %) and cluster 3 ‘health conscious’ (51·2 %). Clusters 1 and 2 consisted of an array of ultraprocessed vegan food items. Together, both clusters represent almost half of the participants and yielding similar results to the predominant dietary pattern, strengthens the factor analysis.
Conclusions:These novel results highlight the need for further dietary pattern studies with full nutrition and blood metabolite analysis in larger samples of vegans to enhance and ratify these results.
Response of the trial innovation network to the COVID-19 pandemic
- Rachel G. Greenberg, Lori Poole, Daniel E. Ford, Daniel Hanley, Harry P. Selker, Karen Lane, J. Michael Dean, Jeri Burr, Paul Harris, Consuelo H. Wilkins, Gordon Bernard, Terri Edwards, Daniel K. Benjamin, Jr
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- Journal:
- Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 20 April 2021, e100
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Introduction:
The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.
Methods:The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned.
Results:The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement.
Conclusions:Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network
- Gordon R. Bernard, Paul A. Harris, Jill M. Pulley, Daniel K. Benjamin, Jonathan Michael Dean, Daniel E. Ford, Daniel F. Hanley, Harry P. Selker, Consuelo H. Wilkins
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- Journal of Clinical and Translational Science / Volume 2 / Issue 4 / August 2018
- Published online by Cambridge University Press:
- 27 November 2018, pp. 187-192
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Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.
Aerobic and Cognitive Exercise (ACE) Pilot Study for Older Adults: Executive Function Improves with Cognitive Challenge While Exergaming
- Nicole Barcelos, Nikita Shah, Katherine Cohen, Michael J. Hogan, Eamon Mulkerrin, Paul J. Arciero, Brian D. Cohen, Arthur F. Kramer, Cay Anderson-Hanley
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- Journal of the International Neuropsychological Society / Volume 21 / Issue 10 / November 2015
- Published online by Cambridge University Press:
- 19 November 2015, pp. 768-779
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Dementia cases are increasing worldwide; thus, investigators seek to identify interventions that might prevent or ameliorate cognitive decline in later life. Extensive research confirms the benefits of physical exercise for brain health, yet only a fraction of older adults exercise regularly. Interactive mental and physical exercise, as in aerobic exergaming, not only motivates, but has also been found to yield cognitive benefit above and beyond traditional exercise. This pilot study sought to investigate whether greater cognitive challenge while exergaming would yield differential outcomes in executive function and generalize to everyday functioning. Sixty-four community based older adults (mean age=82) were randomly assigned to pedal a stationary bike, while interactively engaging on-screen with: (1) a low cognitive demand task (bike tour), or (2) a high cognitive demand task (video game). Executive function (indices from Trails, Stroop and Digit Span) was assessed before and after a single-bout and 3-month exercise intervention. Significant group × time interactions were found after a single-bout (Color Trails) and after 3 months of exergaming (Stroop; among 20 adherents). Those in the high cognitive demand group performed better than those in the low cognitive dose condition. Everyday function improved across both exercise conditions. Pilot data indicate that for older adults, cognitive benefit while exergaming increased concomitantly with higher doses of interactive mental challenge. (JINS, 2015, 21, 768–779)
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- By Mitchell Aboulafia, Frederick Adams, Marilyn McCord Adams, Robert M. Adams, Laird Addis, James W. Allard, David Allison, William P. Alston, Karl Ameriks, C. Anthony Anderson, David Leech Anderson, Lanier Anderson, Roger Ariew, David Armstrong, Denis G. Arnold, E. J. Ashworth, Margaret Atherton, Robin Attfield, Bruce Aune, Edward Wilson Averill, Jody Azzouni, Kent Bach, Andrew Bailey, Lynne Rudder Baker, Thomas R. Baldwin, Jon Barwise, George Bealer, William Bechtel, Lawrence C. Becker, Mark A. Bedau, Ernst Behler, José A. Benardete, Ermanno Bencivenga, Jan Berg, Michael Bergmann, Robert L. Bernasconi, Sven Bernecker, Bernard Berofsky, Rod Bertolet, Charles J. Beyer, Christian Beyer, Joseph Bien, Joseph Bien, Peg Birmingham, Ivan Boh, James Bohman, Daniel Bonevac, Laurence BonJour, William J. Bouwsma, Raymond D. Bradley, Myles Brand, Richard B. Brandt, Michael E. Bratman, Stephen E. Braude, Daniel Breazeale, Angela Breitenbach, Jason Bridges, David O. Brink, Gordon G. Brittan, Justin Broackes, Dan W. Brock, Aaron Bronfman, Jeffrey E. Brower, Bartosz Brozek, Anthony Brueckner, Jeffrey Bub, Lara Buchak, Otavio Bueno, Ann E. Bumpus, Robert W. Burch, John Burgess, Arthur W. Burks, Panayot Butchvarov, Robert E. Butts, Marina Bykova, Patrick Byrne, David Carr, Noël Carroll, Edward S. Casey, Victor Caston, Victor Caston, Albert Casullo, Robert L. Causey, Alan K. L. Chan, Ruth Chang, Deen K. Chatterjee, Andrew Chignell, Roderick M. Chisholm, Kelly J. Clark, E. J. Coffman, Robin Collins, Brian P. Copenhaver, John Corcoran, John Cottingham, Roger Crisp, Frederick J. Crosson, Antonio S. Cua, Phillip D. Cummins, Martin Curd, Adam Cureton, Andrew Cutrofello, Stephen Darwall, Paul Sheldon Davies, Wayne A. Davis, Timothy Joseph Day, Claudio de Almeida, Mario De Caro, Mario De Caro, John Deigh, C. F. Delaney, Daniel C. Dennett, Michael R. DePaul, Michael Detlefsen, Daniel Trent Devereux, Philip E. Devine, John M. Dillon, Martin C. Dillon, Robert DiSalle, Mary Domski, Alan Donagan, Paul Draper, Fred Dretske, Mircea Dumitru, Wilhelm Dupré, Gerald Dworkin, John Earman, Ellery Eells, Catherine Z. Elgin, Berent Enç, Ronald P. Endicott, Edward Erwin, John Etchemendy, C. Stephen Evans, Susan L. Feagin, Solomon Feferman, Richard Feldman, Arthur Fine, Maurice A. Finocchiaro, William FitzPatrick, Richard E. Flathman, Gvozden Flego, Richard Foley, Graeme Forbes, Rainer Forst, Malcolm R. Forster, Daniel Fouke, Patrick Francken, Samuel Freeman, Elizabeth Fricker, Miranda Fricker, Michael Friedman, Michael Fuerstein, Richard A. Fumerton, Alan Gabbey, Pieranna Garavaso, Daniel Garber, Jorge L. A. Garcia, Robert K. Garcia, Don Garrett, Philip Gasper, Gerald Gaus, Berys Gaut, Bernard Gert, Roger F. Gibson, Cody Gilmore, Carl Ginet, Alan H. Goldman, Alvin I. Goldman, Alfonso Gömez-Lobo, Lenn E. Goodman, Robert M. Gordon, Stefan Gosepath, Jorge J. E. Gracia, Daniel W. Graham, George A. Graham, Peter J. Graham, Richard E. Grandy, I. Grattan-Guinness, John Greco, Philip T. Grier, Nicholas Griffin, Nicholas Griffin, David A. Griffiths, Paul J. Griffiths, Stephen R. Grimm, Charles L. Griswold, Charles B. Guignon, Pete A. Y. Gunter, Dimitri Gutas, Gary Gutting, Paul Guyer, Kwame Gyekye, Oscar A. Haac, Raul Hakli, Raul Hakli, Michael Hallett, Edward C. Halper, Jean Hampton, R. James Hankinson, K. R. Hanley, Russell Hardin, Robert M. Harnish, William Harper, David Harrah, Kevin Hart, Ali Hasan, William Hasker, John Haugeland, Roger Hausheer, William Heald, Peter Heath, Richard Heck, John F. Heil, Vincent F. Hendricks, Stephen Hetherington, Francis Heylighen, Kathleen Marie Higgins, Risto Hilpinen, Harold T. Hodes, Joshua Hoffman, Alan Holland, Robert L. Holmes, Richard Holton, Brad W. Hooker, Terence E. Horgan, Tamara Horowitz, Paul Horwich, Vittorio Hösle, Paul Hoβfeld, Daniel Howard-Snyder, Frances Howard-Snyder, Anne Hudson, Deal W. Hudson, Carl A. Huffman, David L. Hull, Patricia Huntington, Thomas Hurka, Paul Hurley, Rosalind Hursthouse, Guillermo Hurtado, Ronald E. Hustwit, Sarah Hutton, Jonathan Jenkins Ichikawa, Harry A. Ide, David Ingram, Philip J. Ivanhoe, Alfred L. Ivry, Frank Jackson, Dale Jacquette, Joseph Jedwab, Richard Jeffrey, David Alan Johnson, Edward Johnson, Mark D. Jordan, Richard Joyce, Hwa Yol Jung, Robert Hillary Kane, Tomis Kapitan, Jacquelyn Ann K. Kegley, James A. Keller, Ralph Kennedy, Sergei Khoruzhii, Jaegwon Kim, Yersu Kim, Nathan L. King, Patricia Kitcher, Peter D. Klein, E. D. Klemke, Virginia Klenk, George L. Kline, Christian Klotz, Simo Knuuttila, Joseph J. Kockelmans, Konstantin Kolenda, Sebastian Tomasz Kołodziejczyk, Isaac Kramnick, Richard Kraut, Fred Kroon, Manfred Kuehn, Steven T. Kuhn, Henry E. Kyburg, John Lachs, Jennifer Lackey, Stephen E. Lahey, Andrea Lavazza, Thomas H. Leahey, Joo Heung Lee, Keith Lehrer, Dorothy Leland, Noah M. Lemos, Ernest LePore, Sarah-Jane Leslie, Isaac Levi, Andrew Levine, Alan E. Lewis, Daniel E. Little, Shu-hsien Liu, Shu-hsien Liu, Alan K. L. Chan, Brian Loar, Lawrence B. Lombard, John Longeway, Dominic McIver Lopes, Michael J. Loux, E. J. Lowe, Steven Luper, Eugene C. Luschei, William G. Lycan, David Lyons, David Macarthur, Danielle Macbeth, Scott MacDonald, Jacob L. Mackey, Louis H. Mackey, Penelope Mackie, Edward H. Madden, Penelope Maddy, G. B. Madison, Bernd Magnus, Pekka Mäkelä, Rudolf A. Makkreel, David Manley, William E. Mann (W.E.M.), Vladimir Marchenkov, Peter Markie, Jean-Pierre Marquis, Ausonio Marras, Mike W. Martin, A. P. Martinich, William L. McBride, David McCabe, Storrs McCall, Hugh J. McCann, Robert N. McCauley, John J. McDermott, Sarah McGrath, Ralph McInerny, Daniel J. McKaughan, Thomas McKay, Michael McKinsey, Brian P. McLaughlin, Ernan McMullin, Anthonie Meijers, Jack W. Meiland, William Jason Melanson, Alfred R. Mele, Joseph R. Mendola, Christopher Menzel, Michael J. Meyer, Christian B. Miller, David W. Miller, Peter Millican, Robert N. Minor, Phillip Mitsis, James A. Montmarquet, Michael S. Moore, Tim Moore, Benjamin Morison, Donald R. Morrison, Stephen J. Morse, Paul K. Moser, Alexander P. D. Mourelatos, Ian Mueller, James Bernard Murphy, Mark C. Murphy, Steven Nadler, Jan Narveson, Alan Nelson, Jerome Neu, Samuel Newlands, Kai Nielsen, Ilkka Niiniluoto, Carlos G. Noreña, Calvin G. Normore, David Fate Norton, Nikolaj Nottelmann, Donald Nute, David S. Oderberg, Steve Odin, Michael O’Rourke, Willard G. Oxtoby, Heinz Paetzold, George S. Pappas, Anthony J. Parel, Lydia Patton, R. P. Peerenboom, Francis Jeffry Pelletier, Adriaan T. Peperzak, Derk Pereboom, Jaroslav Peregrin, Glen Pettigrove, Philip Pettit, Edmund L. Pincoffs, Andrew Pinsent, Robert B. Pippin, Alvin Plantinga, Louis P. Pojman, Richard H. Popkin, John F. Post, Carl J. Posy, William J. Prior, Richard Purtill, Michael Quante, Philip L. Quinn, Philip L. Quinn, Elizabeth S. Radcliffe, Diana Raffman, Gerard Raulet, Stephen L. Read, Andrews Reath, Andrew Reisner, Nicholas Rescher, Henry S. Richardson, Robert C. Richardson, Thomas Ricketts, Wayne D. Riggs, Mark Roberts, Robert C. Roberts, Luke Robinson, Alexander Rosenberg, Gary Rosenkranz, Bernice Glatzer Rosenthal, Adina L. Roskies, William L. Rowe, T. M. Rudavsky, Michael Ruse, Bruce Russell, Lilly-Marlene Russow, Dan Ryder, R. M. Sainsbury, Joseph Salerno, Nathan Salmon, Wesley C. Salmon, Constantine Sandis, David H. Sanford, Marco Santambrogio, David Sapire, Ruth A. Saunders, Geoffrey Sayre-McCord, Charles Sayward, James P. Scanlan, Richard Schacht, Tamar Schapiro, Frederick F. Schmitt, Jerome B. Schneewind, Calvin O. Schrag, Alan D. Schrift, George F. Schumm, Jean-Loup Seban, David N. Sedley, Kenneth Seeskin, Krister Segerberg, Charlene Haddock Seigfried, Dennis M. Senchuk, James F. Sennett, William Lad Sessions, Stewart Shapiro, Tommie Shelby, Donald W. Sherburne, Christopher Shields, Roger A. Shiner, Sydney Shoemaker, Robert K. Shope, Kwong-loi Shun, Wilfried Sieg, A. John Simmons, Robert L. Simon, Marcus G. Singer, Georgette Sinkler, Walter Sinnott-Armstrong, Matti T. Sintonen, Lawrence Sklar, Brian Skyrms, Robert C. Sleigh, Michael Anthony Slote, Hans Sluga, Barry Smith, Michael Smith, Robin Smith, Robert Sokolowski, Robert C. Solomon, Marta Soniewicka, Philip Soper, Ernest Sosa, Nicholas Southwood, Paul Vincent Spade, T. L. S. Sprigge, Eric O. Springsted, George J. Stack, Rebecca Stangl, Jason Stanley, Florian Steinberger, Sören Stenlund, Christopher Stephens, James P. Sterba, Josef Stern, Matthias Steup, M. A. Stewart, Leopold Stubenberg, Edith Dudley Sulla, Frederick Suppe, Jere Paul Surber, David George Sussman, Sigrún Svavarsdóttir, Zeno G. Swijtink, Richard Swinburne, Charles C. Taliaferro, Robert B. Talisse, John Tasioulas, Paul Teller, Larry S. Temkin, Mark Textor, H. S. Thayer, Peter Thielke, Alan Thomas, Amie L. Thomasson, Katherine Thomson-Jones, Joshua C. Thurow, Vzalerie Tiberius, Terrence N. Tice, Paul Tidman, Mark C. Timmons, William Tolhurst, James E. Tomberlin, Rosemarie Tong, Lawrence Torcello, Kelly Trogdon, J. D. Trout, Robert E. Tully, Raimo Tuomela, John Turri, Martin M. Tweedale, Thomas Uebel, Jennifer Uleman, James Van Cleve, Harry van der Linden, Peter van Inwagen, Bryan W. Van Norden, René van Woudenberg, Donald Phillip Verene, Samantha Vice, Thomas Vinci, Donald Wayne Viney, Barbara Von Eckardt, Peter B. M. Vranas, Steven J. Wagner, William J. Wainwright, Paul E. Walker, Robert E. Wall, Craig Walton, Douglas Walton, Eric Watkins, Richard A. Watson, Michael V. Wedin, Rudolph H. Weingartner, Paul Weirich, Paul J. Weithman, Carl Wellman, Howard Wettstein, Samuel C. Wheeler, Stephen A. White, Jennifer Whiting, Edward R. Wierenga, Michael Williams, Fred Wilson, W. Kent Wilson, Kenneth P. Winkler, John F. Wippel, Jan Woleński, Allan B. Wolter, Nicholas P. Wolterstorff, Rega Wood, W. Jay Wood, Paul Woodruff, Alison Wylie, Gideon Yaffe, Takashi Yagisawa, Yutaka Yamamoto, Keith E. Yandell, Xiaomei Yang, Dean Zimmerman, Günter Zoller, Catherine Zuckert, Michael Zuckert, Jack A. Zupko (J.A.Z.)
- Edited by Robert Audi, University of Notre Dame, Indiana
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- The Cambridge Dictionary of Philosophy
- Published online:
- 05 August 2015
- Print publication:
- 27 April 2015, pp ix-xxx
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- By Peter J. D. Andrews, Sandeep Ankolekar, Issam A. Awad, Omar Ayoub, Philip Bath, Jürgen Bardutzky, Alexander Beck, Patrícia Canhão, J. Ricardo Carhuapoma, Winward Choy, Mahua Dey, Rajat Dhar, Michael C. Diringer, Arnd Dörfler, Joshua R. Dusick, Justin A. Dye, Corina Epple, José M. Ferro, Reiner Fietkau, Anthony Frattalone, Philippe Gailloud, Oliver Ganslandt, Anil Gholkar, Philipp Gölitz, Barbara A. Gregson, Daniel Hanley, Thomas M. Hemmen, Dan Holmes, Hagen B. Huttner, Jennifer Jaffe, Olav Jansen, Eric Jüttler, Karl L. Kiening, Martin Köhrmann, Rainer Kollmar, Kara L. Krajewski, Joji B. Kuramatsu, Perttu J. Lindsberg, Andrew Losiniecki, Patrick Lyden, Neil A. Martin, Heinrich P. Mattle, A. David Mendelow, Patrick Mitchell, Daniel T. Nagasawa, Neeraj S. Naval, Jan-Oliver Neumann, Tim Nowe, Berk Orakcioglu, Soenke Peters, Sara Pitoni, François Proust, Adnan I. Qureshi, Martin Radvany, Elise Rowan, Tiina Sairanen, Oliver W. Sakowitz, Edgar Santos, Peter D. Schellinger, Stefan Schwab, Günter Seidel, Sabine Semrau, Louise Sinclair, Dimitre Staykov, Thorsten Steiner, Jeanne Teitelbaum, Wondwossen G. Tekle, Andreas W. Unterberg, Katayoun Vahedi, H. Bart van der Worp, Paul M. Vespa, Raghu Vindlacheruvu, Jens Witsch, Isaac Yang, Wendy C. Ziai, Mario Zuccarello, Klaus Zweckberger
- Edited by Stefan Schwab, Daniel Hanley, A. David Mendelow
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- Book:
- Critical Care of the Stroke Patient
- Published online:
- 05 June 2014
- Print publication:
- 05 June 2014, pp viii-xii
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- By Pierre Amarenco, Adrià Arboix, Marcel Arnold, Robert W. Baloh, John Bamford, Jason J. S. Barton, Claudio L. Bassetti, Christopher F. Bladin, Julien Bogousslavsky, Julian Bösel, Marie-Germaine Bousser, Thomas Brandt, John C. M. Brust, Erica C. S. Camargo, Louis R. Caplan, Emmanuel Carrera, Carlo W. Cereda, Seemant Chaturvedi, Claudia Chaves, Chin-Sang Chung, Isabelle Crassard, Hans Christoph Diener, Marianne Dieterich, Ralf Dittrich, Geoffrey A. Donnan, Paul Eslinger, Conrado J. Estol, Edward Feldmann, José M. Ferro, Joseph Ghika, Daniel Hanley, Ahamad Hassan, Cathy Helgason, Argye E. Hillis, Marc Hommel, Carlos S. Kase, Julia Kejda-Scharler, Jong S. Kim, Rainer Kollmar, Joshua Kornbluth, Sandeep Kumar, Emre Kumral, Hyung Lee, Didier Leys, Eric Logigian, Mauro Manconi, Elisabeth B. Marsh, Randolph S. Marshall, Isabel P. Martins, Josep Lluís Martí-Vilalta, Heinrich P. Mattle, Jérome Mawet, Mikael Mazighi, Patrik Michel, Jay Preston Mohr, Thierry Moulin, Sandra Narayanan, Kwang-Yeol Park, Florence Pasquier, Charles Pierrot-Deseilligny, Nils Petersen, Raymond Reichwein, E. Bernd Ringelstein, Gabriel J. E. Rinkel, Elliott D. Ross, Arnaud Saj, Martin A. Samuels, Jeremy D. Schmahmann, Stefan Schwab, Florian Stögbauer, Mathias Sturzenegger, Laurent Tatu, Pariwat Thaisetthawatkul, Dagmar Timmann, Jan van Gijn, Ana Verdelho, Francois Vingerhoets, Patrik Vuilleumier, Fabrice Vuillier, Eelco F. M. Wijdicks, Shirley H. Wray, Wendy C. Ziai
- Edited by Louis R. Caplan, Jan van Gijn
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- Stroke Syndromes, 3ed
- Published online:
- 05 August 2012
- Print publication:
- 12 July 2012, pp vii-x
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- By Marie-Germaine Bousser, Joseph P. Broderick, Ken Butcher, Louis R. Caplan, J. Ricardo Carhuapoma, José Castillo, Michael Chen, Rush H. Chewning, Frederick Colbourne, Isabelle Crassard, Antoni Dávalos, Stephen M. Davis, Lisa M. DeAngelis, Matthew L. Flaherty, Steven M. Greenberg, Daniel F. Hanley, Ameer E. Hassan, Julian T. Hoff, Andreas F. Hottinger, Hagen B. Huttner, Carlos S. Kase, Richard F. Keep, Crystal MacLellan, Stephan A. Mayer, A. David Mendelow, J. P. Mohr, Kieran P. Murphy, Neeraj S. Naval, Paul A. Nyquist, James Peeling, Adnan I. Qureshi, Manuel Rodriguez-Yáñez, Christian Stapf, Thorsten Steiner, Stanley Tuhrim, Kenneth R. Wagner, Daniel Woo, Guohua Xi, Haralabos Zacharatos, Wendy C. Ziai, Mario Zuccarello
- Edited by J. Ricardo Carhuapoma, Stephan A. Mayer, Columbia University, New York, Daniel F. Hanley
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- Book:
- Intracerebral Hemorrhage
- Published online:
- 04 May 2010
- Print publication:
- 12 November 2009, pp ix-xi
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The acceptability to patients and professionals of remote blood pressure monitoring using mobile phones
- Yvonne Bostock, Janet Hanley, Douglas McGown, Hilary Pinnock, Paul Padfield, Brian McKinstry
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- Journal:
- Primary Health Care Research & Development / Volume 10 / Issue 4 / October 2009
- Published online by Cambridge University Press:
- 01 October 2009, pp. 299-308
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- Article
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Aim
To establish the acceptability of telemetric monitoring of blood pressure to patients and clinicians.
BackgroundTelemetric monitoring of blood pressure (BP) may allow clinicians and patients, in partnership, to more quickly control high BP through medication and lifestyle alterations. However, it is not clear if patients and clinicians would find such a system acceptable.
MethodsQuestionnaire study followed by focus groups of patients with high BP, and clinicians involved in managing BP.
FindingsWe received responses from 25 (50%) practice nurses, 76 (50%) general practitioners and 126 (62%) patients. We ran three focus groups of patients and clinicians. Participants were supportive of the technology, willing to try it, thought it would encourage adherence to medication and lifestyle and felt it would diagnose problems sooner than current methods. However, both groups thought the technology would be more useful for new patients or those whose BP was uncontrolled. They were concerned that individual high readings might provoke anxiety and thought patients would need reassurances about this. Clinicians were concerned about workload and the responsibility to act immediately when faced with a continuous stream of readings, regardless of how inconvenient this may be.
ConclusionParticipants, in general, welcomed this technology and thought it would aid adherence to medication and lifestyle advice, but felt it was most suitable to those with newly diagnosed or uncontrolled hypertension. Patients will need to be educated and reassured about the nature of occasional high readings and the need to consider average BP.
Asymmetrically short tendinous cords causing congenital tricuspid regurgitation: improved understanding of tricuspid valvar dysplasia in the era of color flow echocardiography
- Doff B. McElhinney, Norman H. Silverman, Michael M. Brook, Frank L. Hanley, Paul Stanger
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- Journal:
- Cardiology in the Young / Volume 9 / Issue 3 / May 1999
- Published online by Cambridge University Press:
- 19 August 2008, pp. 300-304
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Background
Tricuspid regurgitation as a manifestation of an isolated congenital anomaly of the tricuspid valve is rare. Cross-sectional and color Doppler echocardiography allow improved evaluation of tricuspid valvar function. As a result, the heterogeneous category of congenital tricuspid valvar dysplasia may be better understood from a functional point of view. We are reporting a distinct entity in which tricuspid valvar regurgitation results from failure of coaptation due to short tendinous cords tethering the septal leaflet.
Patients and ResultsThree children with significant primary tricuspid regurgitation were evaluated, treated, and followed. On echocardiographic evaluation, a central regurgitant jet of moderate or severe degree was directed toward the atrial septum through poorly coapting tricuspid valvar leaflets, which did not approximate due to tethering of the septal leaflet by abnormally short cords. In one patient, the tricuspid valve was otherwise normal; in the other two the leaflets and cords were also thickened. Two patients underwent surgery at 9 and 11 years of age. The cords tethering the septal leaflet were augmented by interposing appropriate lengths of expanded polytetrafluoroethylene suture and performing commissural annuloplasty. Both patients are asymptomatic 33 and 42 months postoperatively, with mild residual tricuspid regurgitation that has not changed since surgery. The other patient, an 8 month-old infant, has not yet undergone surgery.
ConclusionsAsymmetric tendinous cords of the tricuspid valve causing tethering of the septal leaflet is a distinct cause of tricuspid regurgitation that can be recognized with echocardiography. Although rare, the importance of recognizing this lesion lies in its being readily amenable to surgical repair.
Familial absent pulmonary valve syndrome without deletions of chromosome 22q11
- Doff B. McElhinney, Frank L. Hanley, Paul Stanger
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- Journal:
- Cardiology in the Young / Volume 10 / Issue 6 / November 2000
- Published online by Cambridge University Press:
- 19 August 2008, pp. 618-620
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Deletions of chromosome 22q11 are common in patients with tetralogy of Fallot, and in those with absent pulmonary valve syndrome. In this report, we describe a pair of siblings with absent pulmonary valve syndrome, neither of whom had deletions of chromosome 22q11. The finding of familial absent pulmonary valve syndrome without deletion of 22q11 in our patients suggests an alternative genetic basis for this rare condition.
Surgical approach to complicated cervical aortic arch: anatomic, developmental, and surgical considerations
- Doff B. McElhinney, LeNardo D. Thompson, Paul M. Weinberg, Kenneth L. Jue, Frank L. Hanley
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- Journal:
- Cardiology in the Young / Volume 10 / Issue 3 / May 2000
- Published online by Cambridge University Press:
- 19 August 2008, pp. 212-219
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Background
Abnormalities of brachiocephalic arterial branching and arch laterality are common in patients with a cervical aortic arch. In addition, structural anomalies of the arch such as obstruction, aneurysms, and tortuosity are found in a significant number of cases.
MethodsBetween 1990 and 1998, 6 patients underwent surgery for an obstructed right cervical arch. A significant obstruction was present at the transverse or distal arch in all patients, and was recurrent after previous repair in 2. In 1 patient, there was also a multi-lobed aneurysm of the aortic segment contiguous to the obstruction, and in 2 there was marked tortuosity of the arch. In all cases, the order of origin of the head and neck vessels was abnormal, and obstruction of 1 or more brachiocephalic vessels was found in 3. A vascular ring was present in all patients, with a right aortic arch and aberrant left subclavian artery in 4 patients and a double aortic arch with a dominant right cervical arch in 2. The descending aorta was circumflex (left-sided) in 3 patients. Three patients were repaired through a standard right posterolateral thoracotomy, and 3 through a median sternotomy. Patch augmentation aortoplasty was used in 2 patients, a tube graft from the ascending to descending aorta in 2, end to side anastomosis of the descending aorta to the proximal arch in 1, and direct anastomosis to reconstruct an atretic left-sided component of a double arch in 1.
ResultsRepair was successful in all cases, with no perioperative complications. At follow-up ranging from 1 to 9 years, all patients were alive and well, with no recurrence of arch obstruction or other significant complications. Fluorescent in situ hybridization revealed microdeletion of chromosome 22q 11 in 1 patient (not performed in the others).
ConclusionsStructural anomalies of the arch are relatively common in patients with a cervical aortic arch. Such abnormalities may be the result of hemodynamic conditions and/or abnormal vascular tissue related either to the cervical position of the arch or its embryologic precursors. Given the highly variable anatomy of patients with a complicated cervical aortic arch, surgical considerations will vary in kind.