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1. Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults

Author

Jennifer Hruslinski, Diane A. Menio, Robert A. Hymes, J. Douglas Jaffe, Christine Langlois, Lolita Ramsey, Lakisha J. Gaskins, Mark D. Neuman, Thomas Looke, Sandra Bent, Ariana Franco-Mora, Pamela Hedrick, Matthew Newbern, Rafik Tadros, Karen Pealer, Edward Marcantonio, Kamen Vlassakov, Carolyn Buckley, Svetlana Gorbatov, James Gosnell, Talora Steen, Avery Vafai, Jose Zeballos, Louis Cardenas, Ashley Berry, John Getchell, Nicholas Quercetti, Daniel I. Sessler, Sabry Ayad, Manal Hassan, Assad Ali, Gauasan Bajracharya, Damien Billow, Michael Bloomfield, Kavita Elliott, Robert Hampton, Linda He, Hooman Honar, Dilara Khoshknabi, Daniel Kim, Paul Minko, Adam Morris, Azfar Niazi, Tara Nutcharoen, Jeffrey Roberts, Partha Saha, Ahmed Salih, Alexis Skolaris, Taylor Stang, Victor Strimbu, Jesse Templeton, Andrew Volio, Jiayi Wang, Kelly Bolkus, Matthew DeAngelis, Gregory Dodson, Jeffrey Gerritsen, Brian McEniry, Ludmil Mitrev, Kwesi Kwofie, Flynn Bonazza, Vera Lloyd, Izabela Panek, Jared Dabiri, Chris Chavez, Jason Craig, Todd Davidson, Chad Dietrichs, Cheryl Fleetwood, Mike Foley, Chris Getto, Susie Hailes, Sarah Hermes, Andy Hooper, Greg Koener, Kate Kohls, Leslie Law, Adam Lipp, Allison Losey, William Nelson, Mario Nieto, Pam Rogers, Steve Rutman, Garrett Scales, Barbara Sebastian, Tom Stanciu, Gregg Lobel, Michelle Giampiccolo, Dara Herman, Margit Kaufman, Bryan Murphy, Clara Pau, Thomas Puzio, Marlene Veselsky, Trevor Stone, Kelly Apostle, Dory Boyer, Brenda Chen Fan, Susan Lee, Mike Lemke, Richard Merchant, Farhad Moola, Kyrsten Payne, Bertrand Perey, Darius Viskontas, Mark Poler, Patricia D'Antonio, Richard Sheppard, Amer Abdullah, Jamie Fish-Fuhrmann, Mark Giska, Christina Fidkowski, Trent Guthrie, William Hakeos, Lillian Hayes, Joseph Hoegler, Katherine Nowak, Robert Hymes, Jeffery Beck, Jaslynn Cuff, Greg Gaski, Sharon Haaser, Michael Holzman, A. Stephen Malekzadeh, Jeff Schulman, Cary Schwartzbach, Frederick Sieber, Tangwan Azefor, Charles Brown, Arman Davani, Mahmood Jaberi, Courtney Masear, Balram Sharma, Syed Basit Haider, Carolyn Chungu, Ali Ebrahimi, Karim Fikry, Kerri Gannon, Andrew Marcantonio, Meredith Pace, David Sanders, Collin Clarke, Abdel Lawendy, Gary Schwartz, Mohit Garg, Joseph Kim, Mitchell Marshall, Juan Caurci, Ekow Commeh, Randy Cuevas, Germaine Cuff, Lola Franco, David Furguiele, Matthew Giuca, Melissa Allman, Omid Barzideh, James Cossaro, Armando D'Arduini, Anita Farhi, Jason Gould, John Kafel, Anuj Patel, Abraham Peller, Hadas Reshef, Mohammed Safur, Fiore Toscano, Tiffany Tedore, Michael Akerman, Eric Brumberger, Sunday Clark, Rachel Friedlander, Anita Jegarl, Joseph Lane, John P. Lyden, Nili Mehta, Matthew T. Murrell, Nathan Painter, William Ricci, Kaitlyn Sbrollini, Rahul Sharma, Peter A.D. Steel, Michele Steinkamp, Roniel Weinberg, David Stephenson Wellman, Antoun Nader, Paul Fitzgerald, Michaela Ritz, Steven Papp, Greg Bryson, Alexandra Craig, Cassandra Farhat, Braden Gammon, Wade Gofton, Nicole Harris, Karl Lalonde, Allan Liew, Bradley Meulenkamp, Kendra Sonnenburg, Eugene Wai, Geoffrey Wilkin, Derek Donegan, Cassandra Dinh, Nabil Elkassabany, Annamarie Horan, Samir Mehta, Karen Troxell, Mary Ellen Alderfer, Jason Brannen, Christopher Cupitt, Stacy Gerhart, Renee McLin, Julie Sheidy, Katherine Yurick, Jeffrey Carson, Fei Chen, Karen Dragert, Geza Kiss, Halina Malveaux, Deborah McCloskey, Scott Mellender, Sagar S. Mungekar, Helaine Noveck, Carlos Sagebien, Barry Perlman, Luat Biby, Gail McKelvy, Anna Richards, Syed Azim, Ramon Abola, Brittney Ayala, Darcy Halper, Ana Mavarez, Stephen Choi, Imad Awad, Brendan Flynn, Patrick Henry, Richard Jenkinson, Lilia Kaustov, Elizabeth Lappin, Paul McHardy, Amara Singh, Ellen Hauck, Joanne Donnelly, Meera Gonzalez, Christopher Haydel, Jon Livelsberger, Theresa Pazionis, Bridget Slattery, Maritza Vazquez-Trejo, Eric Schwenk, Jaime Baratta, Brittany Deiling, Laura Deschamps, Michael Glick, Daniel Katz, James Krieg, Jennifer Lessin, Marc Torjman, Ki Jinn Chin, Rongyu Jin, Mary Jane Salpeter, Mark Powell, Jeffrey Simmons, Prentiss Lawson, Promil Kukreja, Shanna Graves, Adam Sturdivant, Ayesha Bryant, Sandra Joyce Crump, Derek Dillane, Michael Taylor, Michelle Verrier, Richard Applegate, Ana Arias, Natasha Pineiro, Jeffrey Uppington, Phillip Wolinsky, Joshua Sappenfield, Amy Gunnett, Jennifer Hagen, Sara Harris, Kevin Hollen, Brian Holloway, Mary Beth Horodyski, Trevor Pogue, Ramachandran Ramani, Cameron Smith, Anna Woods, Matthew Warrick, Kelly Flynn, Paul Mongan, Yatish Ranganath, Sean Fernholz, Esperanza Ingersoll-Weng, Anil Marian, Melinda Seering, Zita Sibenaller, Lori Stout, Allison Wagner, Alicia Walter, Cynthia Wong, Jay Magaziner, Denise Orwig, Trina Brown, Jim Dattilo, Susan Ellenberg, Rui Feng, Lee Fleisher, Lakisha Gaskins, Maithri Goud, Chris Helker, Lydia Mezenghie, Brittany Montgomery, Peter Preston, Alisa Stephens, J. Sanford Schwartz, Ann Tierney, Ramona Weber, Jacques Chelly, Shiv Goel, Wende Goncz, Touichi Kawabe, Sharad Khetarpal, Kevin King, Frank Kunkel, Charles Luke, Amy Monroe, Vladislav Shick, Anthony Silipo, Caroline Stehle, Katherine Szabo, Sudhakar Yennam, Mark Hoeft, Max Breidenstein, Timothy Dominick, Alexander Friend, Donald Mathews, Richard Lennertz, Helen Akere, Tyler Balweg, Amber Bo, Christopher Doro, David Goodspeed, Gerald Lang, Maggie Parker, Amy Rettammel, Mary Roth, Robert Sanders, Marissa White, Paul Whiting, Brian Allen, Tracie Baker, Debra Craven, Matt McEvoy, Teresa Turnbo, Stephen Kates, Melanie Morgan, Teresa Willoughby, Wade Weigel, David Auyong, Ellie Fox, Tina Welsh, Bruce Cusson, Sean Dobson, Christopher Edwards, Lynette Harris, Daryl Henshaw, Kathleen Johnson, Glen McKinney, Scott Miller, Jon Reynolds, Jimmy Turner, David VanEenenaam, Robert Weller, Shamsuddin Akhtar, Marcelle Blessing, Chanel Johnson, Michael Kampp, Kimberly Kunze, Jinlei Li, Mary O'Connor, and Miriam Treggiari

Subjects
medicine.medical_specialty, Canada, Research Subjects, Patient engagement, Hip fracture surgery, Patient Advocacy, Anesthesia, General, Patient advocacy, Anesthesia, Spinal, 03 medical and health sciences, 0302 clinical medicine, Nursing, 030202 anesthesiology, Fracture Fixation, Medicine, Humans, General anaesthesia, Cooperative Behavior, Geriatrics, Hip fracture, business.industry, Hip Fractures, Lived experience, Age Factors, Research process, medicine.disease, United States, Anesthesiology and Pain Medicine, Research Design, Patient Participation, business, Decision Making, Shared
Abstract

Summary Engaging patients—defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them—as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Published
2020

2. Durability of Response to Treatment among Antiretroviral‐Experienced Subjects: 48‐Week Results from AIDS Clinical Trials Group Protocol 359

Author

Jon Cook, Charles B. Hicks, Bruce Coon, Richard Hutt, Margaret A. Fischl, David Pearson, Jan Clark, Candida T. Talabucon, Carol L. Brosgart, Joan Dragavon, Laura Ponticello, Janet Devine, Eugene Sun, Melissa Kerkau, Daniel C. Rodrigue, Donna Thee, Jeanne Berg, Mario Guerrero, Lyle Oshita, Jane L. Norris, Judy Aberg, Mark I. Becker, John Fuchs, Pablo Tebas, Guillermo J. Vázquez, Pamposh Kaul, Antoinette Kenton, Phyllis Barnett, Pascal J. de Caprariis, Michael Royal, Michelle Jack, Ann Walawander, Harold A. Kessler, Scott Souza, Sharon Shriver, Genice Hamilton, Susan E. Cohn, Hailong Cheng, John G. Gerber, Monica Millard, Sherree Wright, Linh Ngo, Gildon N. Beall, Debra Ogata-Arakaki, John Mc Neil, David M. Mushatt, Courtney V. Fletcher, Charles van der Horst, Karen Waterman, Ileana Lopez, David Katzenstein, Robert J. Fass, Joseph J. Eron, Edward P. Acosta, Stephen W. Lagakos, Hilda Mendoza, Jim Bruce, Michael F. Para, Sally Snyder, Mary Shoemaker, Mark A. Beilke, Tammy Powell, Margaret Nelson, Juan J.L. Lertora, Liliana Aguinada, Virginia Ramirez, M. Graham Ray, William W. Freimuth, Brenda Greenhill, Beverly Putnam, Aouie Carrera, Mary Albrecht, Michael F. Giordano, Stuart Carr, John M. Leedom, Charlotte Mills, Charles J. Gonzalez, Rebecca Becker, Richard Haubrich, Elizabeth Gimbel, D. Baker, Vivian Yuan, Andrea Weiss, Hongyu Jiang, Cheryl N. Karol, Kim Ingersol, Russell Strada, Paulette Mac Dougall, Carla Pettinelli, Glenna M. Auerback, Alice F. Mercado, Frances Canchola, Chris Helker, Susan A. Fiscus, X. Joan Hu, Janine R. Maenza, Henry S. Sacks, Robert Kalajian, Debbie Slamowitz, Robin Shepard, Margo Heath-Chiozzi, Michael J. Borucki, Ana Martinez, Olivia T. Ortiz, Suzanne Fiorillo, Jorge Santana, Michael S. Saag, Dena Duran, Steve Nowling, Jeff Taylor, Kristine Todd, Robert W. Coombs, Douglas D. Richman, Thomas C. Merigan, Robert Delapenha, Kenneth Wood, Harvey M. Friedman, Joseph Pulvirenti, Don Craven, Timothy W. Schacker, Ronald Swanstrom, Neel French, Judith Feinberg, Mark A. Jacobson, Judith Brown, Joseph Wheat, Ross G. Hewitt, James F. Rooney, Scott A. Smith, Bruce Peel, Doris Shank, Lisa Alexis, Roy M. Gulick, Andrea Christopher Belschner, and Linda Meixner

Subjects
medicine.medical_specialty, HIV Infections, Antiviral Agents, Double-Blind Method, Acquired immunodeficiency syndrome (AIDS), Indinavir, Internal medicine, medicine, Adefovir, Humans, Immunology and Allergy, Delavirdine, Prospective Studies, Saquinavir, Salvage Therapy, Ritonavir, Nucleoside analogue, business.industry, HIV, HIV Protease Inhibitors, medicine.disease, CD4 Lymphocyte Count, Surgery, Infectious Diseases, Nelfinavir, RNA, Viral, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, business, medicine.drug
Abstract

The 24-week extension of AIDS Clinical Trials Group Protocol 359, a study of human immunodeficiency virus (HIV)‐infected, indinavir-experienced patients, was designed to study the durability of “salvage” treatment regimens. Patients received saquinavir in combination with either ritonavir or nelfinavir and, in addition, delavirdine, adefovir, or both. Patients who demonstrated a virologic response at weeks 12‐16 were eligible to continue therapy in the extension through week 48. Of the 105 eligible subjects who were enrolled in the extension, 86 (82%) completed 48 weeks, and 49 (57%) of those 86 had HIV RNA levels 500 copies/ mL at week 48. For these 86 subjects who completed 48 weeks, the median change in CD4 cell count from baseline was +72 cells/mm 3 . Greater body weight, higher CD4 cell count, and greater degree of phenotypic susceptibility to indinavir and saquinavir at baseline were significantly associated with durable virologic suppression. These results show that some patients who experience treatment failure can demonstrate durable virologic and immunologic responses with salvage antiretroviral regimens. Current treatment guidelines recommend starting therapy for human immunodeficiency virus (HIV) infection with 2 nucleoside analogue reverse-transcriptase inhibitors in combination with 1 or 2 protease inhibitors or a nonnucleoside analogue reversetranscriptase inhibitor [1, 2]. However, 20%‐63% of patients from clinical cohorts experience virologic treatment failure while receiving combination antiretroviral therapy [3‐7]. Recent prospective studies have attempted to identify strategies for treatment of the treatment-experienced patient [8‐13], but these studies have focused primarily on 8‐24-week virologic responses to treatment. The durability of virologic and immunologic re

Published
2002
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