6 results
Improving readability of informed consents for research at an academic medical institution
- Kristie B. Hadden, Latrina Y. Prince, Tina D. Moore, Laura P. James, Jennifer R. Holland, Christopher R. Trudeau
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- Journal:
- Journal of Clinical and Translational Science / Volume 1 / Issue 6 / December 2017
- Published online by Cambridge University Press:
- 23 April 2018, pp. 361-365
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Introduction
The final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.
MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.
ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.
ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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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An Open-Label Trial of Venlafaxine in Body Dysmorphic Disorder
- Andrea Allen, Sallie Jo Hadley, Alicia Kaplan, Daphne Simeon, Jennifer Friedberg, Lauren Priday, Bryann R. Baker, Jennifer L. Greenberg, Eric Hollander
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- Journal:
- CNS Spectrums / Volume 13 / Issue 2 / February 2008
- Published online by Cambridge University Press:
- 07 November 2014, pp. 138-144
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Objective:
Body dysmorphic disorder (BDD), a preoccupation with imagined ugliness, is a disabling condition that seems to respond preferentially to selective serotonin reuptake inhibitors. This open-label trial examines venlafaxine's efficacy in BDD and is the first known study of this serotonin-norepinephrine reuptake inhibitor in BDD.
Methods:A total of 17 BDD patients 16–65 years of age entered and 11 completed a 12–16 week open-label trial of venlafaxine. Participants were treated with venlafaxine until a therapeutic dose (minimum of 150 mg/day) was reached and then maintained at that dose for 8 weeks. Key outcome measures were the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder and Clinical Global Impressions-Improvement scale.
Results:Venlafaxine was found to be effective in lessening the specific symptoms and global severity of BDD. Paired t-tests were used to compare baseline and final ratings on the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder total, obsessions, and compulsions scores; by this measure venlafaxine significantly reduced BDD symptoms overall (P=.012), as well as obsessions (P=.034) and compulsions specifically (P=.021). A single sample t-test, comparing final Clinical Global Impressions-Improvement scale ratings to “no change” (score: 4) found significant improvement following treatment.
Conclusion:Venlafaxine may be an effective treatment for BDD, including both obsessive and compulsive symptoms. Controlled research on venlafaxine in BDD is recommended.
Contributors
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- By Michael H. Allen, Leora Amira, Victoria Arango, David W. Ayer, Helene Bach, Christopher R. Bailey, Ross J. Baldessarini, Kelsey Ball, Alan L. Berman, Marian E. Betz, Emily A. Biggs, R. Warwick Blood, Kathleen T. Brady, David A. Brent, Jeffrey A. Bridge, Gregory K. Brown, Anat Brunstein Klomek, A. Jacqueline Buchanan, Michelle J. Chandley, Tim Coffey, Jessica Coker, Yeates Conwell, Scott J. Crow, Collin L. Davidson, Yogesh Dwivedi, Stacey Espaillat, Jan Fawcett, Steven J. Garlow, Robert D. Gibbons, Catherine R. Glenn, Deborah Goebert, Erica Goldstein, Tina R. Goldstein, Madelyn S. Gould, Kelly L. Green, Alison M. Greene, Philip D. Harvey, Robert M. A. Hirschfeld, Donna Holland Barnes, Andres M. Kanner, Gary J. Kennedy, Stephen H. Koslow, Benoit Labonté, Alison M. Lake, William B. Lawson, Steve Leifman, Adam Lesser, Timothy W. Lineberry, Amanda L. McMillan, Herbert Y. Meltzer, Michael Craig Miller, Michael J. Miller, James A. Naifeh, Katharine J. Nelson, Charles B. Nemeroff, Alexander Neumeister, Matthew K. Nock, Jennifer H. Olson-Madden, Gregory A. Ordway, Michael W. Otto, Ghanshyam N. Pandey, Giampaolo Perna, Jane Pirkis, Kelly Posner, Anne Rohs, Pedro Ruiz, Molly Ryan, Alan F. Schatzberg, S. Charles Schulz, M. Katherine Shear, Morton M. Silverman, April R. Smith, Marcus Sokolowski, Barbara Stanley, Zachary N. Stowe, Sarah A. Struthers, Leonardo Tondo, Gustavo Turecki, Robert J. Ursano, Kimberly Van Orden, Anne C. Ward, Danuta Wasserman, Jerzy Wasserman, Melinda K. Westlund, Tracy K. Witte, Kseniya Yershova, Alexandra Zagoloff, Sidney Zisook
- Edited by Stephen H. Koslow, University of Miami, Pedro Ruiz, University of Miami, Charles B. Nemeroff, University of Miami
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- Book:
- A Concise Guide to Understanding Suicide
- Published online:
- 05 October 2014
- Print publication:
- 18 September 2014, pp vii-x
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Family evaluation of hospice care: Examining direct and indirect associations with overall satisfaction and caregiver confidence
- Jason M. Holland, Jennifer R. Keene, Abbie Kirkendall, Nora Luna
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- Journal:
- Palliative & Supportive Care / Volume 13 / Issue 4 / August 2015
- Published online by Cambridge University Press:
- 03 July 2014, pp. 901-908
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Objective:
The Family Evaluation of Hospice Care (FEHC) survey is widely employed by hospices, and several studies have examined this information to help inform and enhance end-of-life services. However, these studies have largely focused on examining relatively straightforward associations between variables and have not tested larger models that could reveal more complex effects. The present study aimed to examine the direct and mediating (i.e., via information/education, patient care, and family support) effects of demographic factors, length of stay, timing of referral, patient symptom severity, location of services, and relationship to caregiver on two outcome variables: overall satisfaction and caregiver confidence.
Method:Surveys were collected from 3226 participants who had lost a loved one who received hospice services. Structural equation modeling was employed to examine the direct and mediating effects of the independent variables on the two outcomes of interest.
Results:Participants reporting on racial minority patients, patients with more symptoms, and those referred too late or too early were the most likely to express some discontentment with hospice services. The information/education these individuals received was the only mediating factor significantly associated with caregiver confidence. More positive perceptions of patient care and information/education were both significantly related to greater overall satisfaction.
Significance of Results:These findings help to (1) pinpoint those most at risk for being less satisfied with hospice, (2) identify which aspects of care may be most strongly related to overall outcomes, and (3) provide a model for examining complex associations among FEHC variables that may be employed by other researchers.
Absorption, metabolism and excretion of flavanones from single portions of orange fruit and juice and effects of anthropometric variables and contraceptive pill use on flavanone excretion
- Gary M. Brett, Wendy Hollands, Paul W. Needs, Birgit Teucher, Jack R. Dainty, Barry D. Davis, Jennifer S. Brodbelt, Paul A. Kroon
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- Journal:
- British Journal of Nutrition / Volume 101 / Issue 5 / 14 March 2009
- Published online by Cambridge University Press:
- 19 August 2008, pp. 664-675
- Print publication:
- 14 March 2009
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Oranges are rich sources of flavonoids that are bioactive and may protect against age-related diseases. The absorption of orange flavanones may be affected by factors such as processing and subject anthropometric variables, and the bioactivity of the absorbed phytochemicals depends on how they are metabolised during absorption. In a randomised cross-over study, twenty subjects consumed a single portion of orange fruit (150 g) or juice (300 g) that contained the flavanones narirutin and hesperidin, and an additional 109 subjects across a broad age range (18–80 years) consumed the juice. Flavanone metabolites were measured in regularly collected samples of plasma and urine. After consumption of fruit or juice, flavanone conjugates, but not the aglycones, were detected in plasma and urine. The flavanone conjugates were shown to include the 7- and 4′-O-monoglucuronides of naringenin, the 7- and 3′-O-monoglucuronides of hesperetin, two hesperetin diglucuronides and a hesperetin sulfo-glucuronide, but no aglycones or rutinosides. Analysis of the plasma pharmacokinetic and urinary excretion data on a dose-adjusted basis indicated no difference in absorption or excretion of either flavanone between the fruit and juice matrices. In the extended urinary excretion dataset the individual variation was very large (range 0–59 % urinary yield). There was a small but significant (P < 0·05) decrease in the excretion of hesperetin (but not naringenin) with increasing age (P < 0·05), but the effects of sex, BMI and contraceptive pill use were shown not to be associated with the variation in flavanone excretion.