15 results
Early technology review: towards an expedited pathway
- Leslie Levin, Murray Sheldon, Robert S. McDonough, Naomi Aronson, Maroeska Rovers, C. Michael Gibson, Sean Robert Tunis, Richard E. Kuntz
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 40 / Issue 1 / 2024
- Published online by Cambridge University Press:
- 29 January 2024, e13
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Objectives
Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.
MethodsAn example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.
ResultsAdvice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.
ConclusionsEarly engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.
The Congressionally Directed Medical Research Programs’ Ovarian Cancer Academy: a new approach to training in biomedical research
- Tasha R. Wyatt, Lara Stepleman, Taylor Coleman, Leslie Robinson, Karen Wylie, Douglas A. Levine, Nita J. Maihle
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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, e79
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Introduction:
Researchers have begun to change their approach to training in the biomedical sciences through the development of communities of practice (CoPs). CoPs share knowledge across clinical and laboratory contexts to promote the progress of clinical and translational science. The Congressionally Directed Medical Research Programs’ (CDMRP) Ovarian Cancer Academy (OCA) was designed as a virtual CoP to promote interactions among early career investigators (ECIs) and their mentors with the goal of eliminating ovarian cancer.
Methods:A mixed-methods approach (surveys and interviews) was used to evaluate the effectiveness of the OCA for the eight ECIs and five mentors. Quantitative analysis included internal reliability of scales and descriptive statistics for each measure, as well as paired sample t-tests for Time 1 and Time 2. Qualitative data were analyzed for themes to discern which aspects of the program were useful and where more attention is needed.
Results:Preliminary analyses reveal several trends, including the importance of training in grant writing to the ECI’s productivity, as well as the value of peer mentorship.
Conclusion:The results show that the OCA was an innovative and effective way to create a CoP with broad implications for the field of ovarian cancer research, as well as for the future of biomedical research training.
The Questionable Character of the Bar's Character and Fitness Inquiry
- Leslie C. Levin, Christine Zozula, Peter Siegelman
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- Journal:
- Law & Social Inquiry / Volume 40 / Issue 1 / Winter 2015
- Published online by Cambridge University Press:
- 27 December 2018, pp. 51-85
- Print publication:
- Winter 2015
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Lawyers who engage in misconduct can do substantial harm. To screen out “unfit” lawyers, bar examining authorities collect detailed personal information from bar applicants. The rationale for this “character and fitness” inquiry is to identify who is likely to become a problematic lawyer. Despite the history of discrimination associated with this inquiry and the highly personal information requested, there has been no rigorous test of whether such predictions are possible. This article examines the information disclosed by 1,343 Connecticut bar applicants and their subsequent disciplinary records. It reveals that while some bar application data are associated with an elevated risk of future discipline, the predictive power of the data is extremely low. Moreover, several variables are more strongly associated with less severe discipline than with more severe discipline. We argue that some of the causal mechanisms linking application data to subsequent discipline may have more to do with career trajectory than with an underlying propensity to engage in misconduct.
EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES
- Leslie Levin
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 31 / Issue 4 / 2015
- Published online by Cambridge University Press:
- 11 November 2015, pp. 207-209
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With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.
Polychrome Pottery Economics and Ritual Life in Postclassic Oaxaca, Mexico
- Marc N. Levine, Lane F. Fargher, Leslie G. Cecil, Jamie E. Forde
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- Journal:
- Latin American Antiquity / Volume 26 / Issue 3 / September 2015
- Published online by Cambridge University Press:
- 20 January 2017, pp. 319-340
- Print publication:
- September 2015
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Tututepec was a regional capital that dominated much of southern Oaxaca, Mexico, during the Late Postclassic period (A.D. 1100-1522). This article synthesizes the results of compositional (neutron activation and petrography), stylistic, and iconographic analyses of pottery from commoner household excavations at Tututepec to address questions concerning ceramic production and distribution and also to shed light on aspects of political economy and domestic ritual at the capital. The study focuses primarily on Mixteca-Puebla polychromes, painted serving vessels bearing complex decorative motifs. Our compositional analyses, interpreted in light of the bedrock geology of the region, indicate that commoners obtained at least six to ten distinct varieties of pottery made from raw materials available locally within greater Tututepec. We argue that households probably acquired pottery through a central marketplace at the capital. In addition, our study demonstrates that commoners had regular access to polychromes from multiple producers, challenging the widespread notion that these vessels were restricted to elites who controlled their production. We argue that polychrome serving vessels played a prominent role in commonly occurring domestic rituals. Furthermore, commoners appear to have consciously selected vessels painted with imagery associated with warfare and sacrifice, suggesting that they actively supported the official imperial ideology of Tututepec.
Contributors
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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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- Book:
- The Cambridge Dictionary of Philosophy
- Published online:
- 05 August 2015
- Print publication:
- 27 April 2015, pp ix-xxx
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Randomized Controlled Trial of Yogic Meditation Techniques for Patients With Obsessive-Compulsive Disorder
- David S. Shannahoff-Khalsa, Leslie E. Ray, Saul Levine, Christopher C. Gallen, Barry J. Schwartz, John J. Sidorowich
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- Journal:
- CNS Spectrums / Volume 4 / Issue 12 / December 1999
- Published online by Cambridge University Press:
- 07 November 2014, pp. 34-47
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The objective of this study was to compare efficacy of two meditation protocols for treating patients with obsessive-compulsive disorder (OCD). Patients were randomized to two groups—matched for sex, age, and medication status—and blinded to the comparison protocol. They were told the trial would last for 12 months, unless one protocol proved to be more efficacious. If so, groups would merge, and the group that received the less efficacious treatment would also be afforded 12 months of the more effective one. The study was conducted at Children's Hospital, San Diego, Calif. Patients were selected according to Diagnostic and Statistical Manual of Mental Disorders, Third Edition-Revised (DSM-III-R) criteria and recruited by advertisements and referral. At baseline, Group 1 included 11 adults and 1 adolescent, and Group 2 included 10 adults. Group 1 employed a kundalini yoga meditation protocol and Group 2 employed the Relaxation Response plus Mindfulness Meditation technique. Baseline and 3-month interval testing was conducted using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Symptoms Checklist-90-Revised Obsessive Compulsive (SCL-90-R OC) and Global Severity Index (SCL-90-R GSI) scales, Profile of Moods scale (POMS), Perceived Stress Scale (PSS), and Purpose in Life (PIL) test. Seven adults in each group completed 3 months of therapy. At 3 months, Group 1 demonstrated greater improvements (Student's independent groups t-test) on the Y-BOCS, SCL-90-R OC and GSI scales, and POMS, and greater but nonsignificant improvements on the PSS and PIL test. An intent-to-treat analysis (Y-BOCS) for the baseline and 3-month tests showed that only Group 1 improved. Within-group statistics (Students paired t-tests) showed that Group 1 significantly improved on all six scales, but Group 2 had no improvements. Groups were merged for an additional year using Group 1 techniques. At 15 months, the final group (N=11) improved 71%, 62%, 66%, 74%, 39%, and 23%, respectively, on the Y-BOCS, SCL-90-R OC SCL-90-R GSI, POMS, PSS, and PIL; P<0.003 (analysis of variance). This study demonstrates that kundalini yoga techniques are effective in the treatment of OCD.
The Roles and Responsibilities of Physicians in Patients' Decisions about Unproven Stem Cell Therapies
- Aaron D. Levine, Leslie E. Wolf
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- Journal:
- Journal of Law, Medicine & Ethics / Volume 40 / Issue 1 / Spring 2012
- Published online by Cambridge University Press:
- 01 January 2021, pp. 122-134
- Print publication:
- Spring 2012
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Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused on safety, and novel effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions (SCBIs) is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy.
Contributors
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- By Carmel Armon, Maria Baldwin, Kevin M. Barrett, José Biller, David J. Blacker, Thomas G. Brott, Ira Chang, Winston Chiong, Todd Czartoski, Arielle Davis, Janavi Dunuwille, John W. Engstrom, W. David Freeman, Leslie A. Gillum, Jeffrey J. Glasheen, David M. Greer, John W. Henson, S. Andrew Josephson, Sandeep Khot, Dimitriy Levin, David J. Likosky, Edward M. Manno, Glenn R. Markenson, David McCollum, Sarkis Morales-Vidal, David Palestrant, Alejandro A. Rabinstein, Michael J. Schneck, Brian J. Scott, Patricia D. Scripko, Macarena Cabrera Serrano, William O. Tatum, Jennifer Wulff
- Edited by S. Andrew Josephson, University of California, San Francisco, W. David Freeman, David J. Likosky
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- Book:
- Neurohospitalist Medicine
- Published online:
- 07 October 2011
- Print publication:
- 29 September 2011, pp x-xii
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Coverage with evidence development: The Ontario experience
- Leslie Levin, Ron Goeree, Mark Levine, Murray Krahn, Tony Easty, Adalstein Brown, David Henry
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 27 / Issue 2 / April 2011
- Published online by Cambridge University Press:
- 08 April 2011, pp. 159-168
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Background: For non-drug technologies, there is often residual uncertainty following systematic review, mainly due to inadequate evidence of efficacy. The unwillingness to make decisions in the presence of uncertainty may lead to passive diffusion and intuitive decision making with or without public pressure. This may affect health system sustainability. There is increasing interest in post-market evaluation through processes that include coverage with evidence development (CED) to address residual uncertainty regarding effectiveness and cost-effectiveness. Global experience of CED has been slow to develop despite their potential contribution to decision making.
Methods: Ontario's field evaluation program to better inform decision making represents a collaboration between physicians, policy decision makers and academic centers. We report results of the first ten CEDs from this program to assess whether they achieved their objective of influencing policy by addressing residual uncertainty following systematic review.
Results: Since 2003, nineteen field evaluation studies to resolve residual uncertainty following systematic review have been completed, ten of which met the criteria of CED and are the focus of this report. There was more than one patient subgroup or intervention in three of the CEDs. This provided the basis for evaluating thirteen outcomes. In each case, the CED addressed the uncertainty and led to a decision based on the systematic review and CED result. The CEDs led to adoption of the technology in six instances, modified adoption in three instances and withdrawal in four instances.
Conclusions: CED makes an important contribution to translating evidence to decision making. Methodologies are needed to increase the scope and reduce timelines for CEDs, such as the use of linked comprehensive and robust data sets and collaborative studies with other jurisdictions. CED before making long-term funding decisions, especially where there is uncertainty of effectiveness, safety or cost-effectiveness, should be increasingly funded by health systems.
Contributors
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- By Shamsuddin Akhtar, Greg Albert, Sidney Allison, Muhammad Anwar, Haruo Arita, Amanda Barker, Mary Hanna Bekhit, Jeanna Blitz, Tyson Bolinske, David Burbulys, Asokumar Buvanendran, Gregory Cain, Keith A. Candiotti, Daniel B. Carr, Derek Chalmers, John Charney, Rex Cheng, Roger Chou, Keun Sam Chung, Anna Clebone, Frederick Conlin, Susan Dabu-Bondoc, Tiffany Denepitiya-Balicki, Jeanette Derdemezi, Anahat Kaur Dhillon, Ho Dzung, Juan Jose Egas, Stephen M. Eskaros, Zhuang T. Fang, Claudia R. Fernandez Robles, Victor A. Filadora, Ellen Flanagan, Dan Froicu, Allison Gandey, Nehal Gatha, Boris Gelman, Christopher Gharibo, Muhammad K. Ghori, Brian Ginsberg, Michael E. Goldberg, Jeff Gudin, Thomas Halaszynski, Martin Hale, Dorothea Hall, Craig T. Hartrick, Justin Hata, Lars E. Helgeson, Joe C. Hong, Richard W. Hong, Balazs Horvath, Eric S. Hsu, Gabriel Jacobs, Jonathan S. Jahr, Rongjie Jaing, Inderjeet Singh Julka, Zeev N. Kain, Clinton Kakazu, Kianusch Kiai, Mary Keyes, Michael M. Kim, Peter G. Lacouture, Ryan Lanier, Vivian K. Lee, Mark J. Lema, Oscar A. de Leon-Casasola, Imanuel Lerman, Philip Levin, Steven Levin, JinLei Li, Eric C. Lin, Sharon Lin, David A. Lindley, Ana M. Lobo, Marisa Lomanto, Mirjana Lovrincevic, Brenda C. McClain, Tariq Malik, Jure Marijic, Joseph Marino, Laura Mechtler, Alan Miller, Carly Miller, Amit Mirchandani, Sukanya Mitra, Fleurise Montecillo, James M. Moore, Debra E. Morrison, Philip F. Morway, Carsten Nadjat-Haiem, Hamid Nourmand, Dana Oprea, Sunil J. Panchal, Edward J. Park, Kathleen Ji Park, Kellie Park, Parisa Partownavid, Akta Patel, Bijal Patel, Komal D. Patel, Neesa Patel, Swati Patel, Paul M. Peloso, Danielle Perret, Anthony DePlato, Marjorie Podraza Stiegler, Despina Psillides, Mamatha Punjala, Johan Raeder, Siamak Rahman, Aziz M. Razzuk, Maggy G. Riad, Kristin L. Richards, R. Todd Rinnier, Ian W. Rodger, Joseph Rosa, Abraham Rosenbaum, Alireza Sadoughi, Veena Salgar, Leslie Schechter, Michael Seneca, Yasser F. Shaheen, James H. Shull, Elizabeth Sinatra, Raymond S. Sinatra, Neil Singla, Neil Sinha, Denis V. Snegovskikh, Dmitri Souzdalnitski, Julie Sramcik, Zoreh Steffens, Alexander Timchenko, Vadim Tokhner, Marc C. Torjman, Co T. Truong, Nalini Vadivelu, Ashley Vaughn, Anjali Vira, Eugene R. Viscusi, Dajie Wang, Shu-ming Wang, J. Michael Watkins-Pitchford, Steven J. Weisman, Ira Whitten, Bryan S. Williams, Jeremy M. Wong, Thomas Wong, Christopher Wray, Yaw Wu, Anthony T. Yarussi, Laurie Yonemoto, Bita H. Zadeh, Jill Zafar, Martha Zegarra, Keren Ziv
- Edited by Raymond S. Sinatra, Jonathan S. Jahr, University of California, Los Angeles, School of Medicine, J. Michael Watkins-Pitchford
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- Book:
- The Essence of Analgesia and Analgesics
- Published online:
- 06 December 2010
- Print publication:
- 14 October 2010, pp xi-xviii
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Guardians at the Gate: The Backgrounds, Career Paths, and Professional Development of Private US Immigration Lawyers
- Leslie C. Levin
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- Journal:
- Law & Social Inquiry / Volume 34 / Issue 2 / Spring 2009
- Published online by Cambridge University Press:
- 27 December 2018, pp. 399-436
- Print publication:
- Spring 2009
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This article presents findings from a qualitative study of seventy‐one New York immigration lawyers who are engaged in private practice. It focuses on the lawyers' backgrounds, career paths, and early professional training and describes, inter alia, the unusual diversity of this bar, the lawyers' reasons for practicing immigration law, the ways in which they learn to practice law, and the strong sense of community within the private immigration bar. It uses the idea of communities of practice to help understand how lawyers learn from their colleagues and are influenced by them. The article identifies several factors that may contribute to the supportiveness of the bar and the strong sense of community within that practice specialty, notwithstanding its great diversity. It concludes by making some preliminary comparisons between immigration lawyers and lawyers in other practice specialties and by identifying some questions for future study.
Contributors
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- By Claude Alain, Amy F. T. Arnsten, Lars Bäckman, Malcolm A. Binns, Sandra E. Black, S. Thomas Carmichael, Keith D. Cicerone, Maurizio Corbetta, Bruce Crosson, Jeffrey L. Cummings, Deirdre R. Dawson, Michael deRiesthal, Roger A. Dixon, Laura Eggermont, Kirk I. Erickson, Anthony Feinstein, Susan M. Fitzpatrick, Fu Qiang Gao, Douglas D. Garrett, Omar Ghaffar, Robbin Gibb, Elizabeth L. Glisky, Martha L. Glisky, Leslie J. Gonzalez Rothi, Cheryl L. Grady, Carol Greenwood, Gerri Hanten, Richard G. Hunter, Masud Husain, Narinder Kapur, Bryan Kolb, Arthur F. Kramer, Susan A. Leon, Harvey S. Levin, Brian Levine, Nadina Lincoln, Thomas W. McAllister, Edward McAuley, Bruce S. McEwen, David M. Morris, Stephen E. Nadeau, Roshan das Nair, Matthew Parrott, Jennie Ponsford, George P. Prigatano, Joel Ramirez, John M. Ringman, Ian H. Robertson, Amy D. Rodriguez, John C. Rosenbek, Bernhard Ross, Erik Scherder, Victoria Singh-Curry, Trudi Stickland, Donald T. Stuss, Edward Taub, Gary R. Turner, Harry V. Vinters, Samuel Weiss, John Whyte, Barbara A. Wilson, Gordon Winocur, J. Martin Wojtowicz
- Edited by Donald T. Stuss, University of Toronto, Gordon Winocur, University of Toronto, Ian H. Robertson, Trinity College, Dublin
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- Book:
- Cognitive Neurorehabilitation
- Published online:
- 05 September 2015
- Print publication:
- 11 September 2008, pp ix-xiv
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Establishing a comprehensive continuum from an evidentiary base to policy development for health technologies: The Ontario experience
- Leslie Levin, Ron Goeree, Nancy Sikich, Birthe Jorgensen, Melissa C. Brouwers, Tony Easty, Catherine Zahn
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 23 / Issue 3 / July 2007
- Published online by Cambridge University Press:
- 19 June 2007, pp. 299-309
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- Article
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Objectives: The aim of this study was to describe a comprehensive continuum that has developed in Ontario between government and key stakeholder groups, including hospitals, physicians, academic institutions, clinical epidemiologists, health economists, industry, and bioethicists to achieve evidence-based recommendations for policy development.
Methods: The various components of the comprehensive model that has evolved to develop an evidentiary platform for policy development are summarized, and the flow between these components is described.
Results: The development of the Ontario Health Technology Advisory Committee (OHTAC) and associated programs demonstrate the need to go beyond the traditional steps taken within most health technology assessment paradigms. These components include pragmatic postmarketing studies, human factors, and safety analyses, and formalized interactions with a broad spectrum of potential end-users of each technology, experts, and industry. These components, taken together with an expanded systematic review to include a range of economic analyses, and societal impacts augment the traditional systematic review processes. This approach has been found to be important in assisting decision making and has resulted in an 81 percent conversion from evidence to policy consideration for eighty-three technologies that had been assessed at the time this article was submitted.
Conclusions: The comprehensive model, centered around OHTAC, has added important new dimensions to health policy by improving its relevance to decision makers and providing an accountable and transparent basis for government to invest appropriately in health technologies. This study could also form a basis for further research into appropriate methodologies and outcome measurements as they relate to each component of this approach.
Acquired aphasia in children after surgical resection of left-thalamic tumors
- Ruth Nass, Leslie Boyce, Fern Leventhal, Beth Levine, Jeffrey Allen, Carol Maxfield, David Salsberg, Martha Sarno, Ajax George
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- Journal:
- Developmental Medicine and Child Neurology / Volume 42 / Issue 9 / September 2000
- Published online by Cambridge University Press:
- 03 October 2000, pp. 580-590
- Print publication:
- September 2000
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- Article
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Five children (three males, two females; four right-, one left-handed; age range 6 to 14 years) who developed aphasia after gross-total excision of left predominantly thalamic tumors are reported. Three patients had Broca aphasia, one had mixed transcortical aphasia, and one patient had conduction aphasia. In the months after surgery three children improved while receiving radiation and/or chemotherapy, although none recovered completely. Two patients with malignant tumors developed worsening aphasia when the tumor recurred and later died. Two patients (of three tested) had visuospatial difficulties in addition to language deficits. Attention and executive functioning were affected in three of three patients tested. Memory, verbal and/or visual functioning, were affected in four of four patients tested. Both patients who were tested showed transient right hemineglect. Two (of two tested) were probably apraxic. The wide range of deficits in these children highlights the importance of the thalamus and other subcortical structures in developing cognition.