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1. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

Guillermo Pechero, Jr., MD, Branden Pfaff, Mayank Rao, David Pogorzelski, Paula McKay, Ella Spicer, Andrea Howe, Haley K. Demyanovich, Debra L. Sietsema, Michael F. McTague, Lolita Ramsey, Martha Holden, Joshua Rudnicki, Jeff Wells, Michelle Medeiros, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Mohit Bhandari, Robert V. O'Toole, Jean-Claude D'Alleyrand, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Nathan N. O'Hara, Katherine Joseph, Megan Camara, Anthony D. Harris, Daniel C. Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Ms Frances Grissom, I. Leah Gitajn, Saam Morshed, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Eric Kettering, Diamond Hale, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Andrea Hudgins, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, Jr., David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Jr., Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohoe, Jothi Murali, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. “Chip” Routt, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J. Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vasquez, Jose Vicente Andres-Peiro, Joan Minguell-Monyart, Yaiza Garcia-Sanchez, Jorge Nuñez-Camarena, Eladia Tauste-Rubio, Marta Gonzalez-Amigo, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Joanne Fraifogl, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Chen “Brenda” Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Lucas S. Marchand, Ashley Neese, Mark Russell, Zachary M. Olsen, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, III, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Cluster randomized crossover, Stakeholder engagement, Consent, Deferred consent, Trial design, Patient advisors, Medicine (General), R5-920
Abstract

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Published
2021
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2. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, Jr., David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Jr., Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. “Chip” Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen “Brenda” Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, III, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Sampling, Pragmatic, Cluster crossover, Sampling framework, Work flow, Sampling strategy, Medicine (General), R5-920
Abstract

Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Published
2021
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5. Wound care practices after orthopaedic trauma surgery are highly variable and not evidence based

Author

Jeff E. Schulman, Stephen D. Lockey, Youssef M. Khalafallah, Lolita Ramsey, and Robert A. Hymes

Subjects
Financial costs, 030222 orthopedics, medicine.medical_specialty, Future studies, Evidence-based practice, Sutures, business.industry, Trauma center, 030208 emergency & critical care medicine, Surgery, 03 medical and health sciences, Wound care, Orthopedics, 0302 clinical medicine, Trauma Centers, Wound management, Surgical site, medicine, Humans, Surgical Wound Infection, General Earth and Planetary Sciences, Orthopedic Procedures, Orthopaedic trauma, business, General Environmental Science
Abstract

Objective Given the tremendous medical, social and financial costs of surgical site infections, the pressure to minimize these complications has been mounting. There remains a substantial gap in evidence-based practice for postoperative wound care after orthopaedic trauma surgery. The purpose of this study is to determine what standards are currently in practice for postoperative wound management. Methods A 16-question web-based survey was published on the Orthopaedic Trauma Association website and disseminated to members through the association's quarterly email. The survey gathered data on postoperative wound care practices; specifically, when wound checks are performed, and when providers allow patients to get the incisions wet. Results 102 Orthopaedic surgeons completed the survey. Ninety-one percent were trauma fellowship trained, and 95% worked at either a Level I (76%) or Level II (19%) trauma center. There were over 100 different proposed protocols captured by the survey. The majority of surgeons (54%) perform a wound check within the first three days after surgery. Additionally, half of surgeons (50%) do not permit patients to get their incisions wet until sutures and staples are removed. Conclusion Wound care routines following surgical management of orthopaedic trauma injuries are highly variable. Diverse protocols are performed at the discretion of the treating surgeon without scientific basis. This study defines immense variability in one aspect of peri-operative care that could play an important role in surgical site infections and provides a foundation for future studies to explore the potential influence of standardized wound care routines on post-operative infections and wound healing.

Published
2021

6. Pain, Analgesic Use, and Patient Satisfaction With Spinal Versus General Anesthesia for Hip Fracture Surgery : A Randomized Clinical Trial

Author

Mark D, Neuman, Rui, Feng, Susan S, Ellenberg, Frederick, Sieber, Daniel I, Sessler, Jay, Magaziner, Nabil, Elkassabany, Eric S, Schwenk, Derek, Dillane, Edward R, Marcantonio, Diane, Menio, Sabry, Ayad, Manal, Hassan, Trevor, Stone, Steven, Papp, Derek, Donegan, Mitchell, Marshall, J Douglas, Jaffe, Charles, Luke, Balram, Sharma, Syed, Azim, Robert, Hymes, Ki-Jinn, Chin, Richard, Sheppard, Barry, Perlman, Joshua, Sappenfield, Ellen, Hauck, Mark A, Hoeft, Ann, Tierney, Lakisha J, Gaskins, Annamarie D, Horan, Trina, Brown, James, Dattilo, Jeffrey L, Carson, Thomas, Looke, Sandra, Bent, Ariana, Franco-Mora, Pamela, Hedrick, Matthew, Newbern, Rafik, Tadros, Karen, Pealer, Kamen, Vlassakov, Carolyn, Buckley, Lauren, Gavin, Svetlana, Gorbatov, James, Gosnell, Talora, Steen, Avery, Vafai, Jose, Zeballos, Jennifer, Hruslinski, Louis, Cardenas, Ashley, Berry, John, Getchell, Nicholas, Quercetti, Gauasan, Bajracharya, Damien, Billow, Michael, Bloomfield, Evis, Cuko, Mehrun K, Elyaderani, Robert, Hampton, Hooman, Honar, Dilara, Khoshknabi, Daniel, Kim, David, Krahe, Michael M, Lew, Conjeevram B, Maheshwer, Azfar, Niazi, Partha, Saha, Ahmed, Salih, Robert J, de Swart, Andrew, Volio, Kelly, Bolkus, Matthew, DeAngelis, Gregory, Dodson, Jeffrey, Gerritsen, Brian, McEniry, Ludmil, Mitrev, M Kwesi, Kwofie, Anne, Belliveau, 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, 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, Greg, O'Neill, Amer, Abdullah, Jamie, Fish-Fuhrmann, Mark, Giska, Christina, Fidkowski, Stuart Trent, Guthrie, William, Hakeos, Lillian, Hayes, Joseph, Hoegler, Katherine, Nowak, Jeffery, Beck, Jaslynn, Cuff, Greg, Gaski, Sharon, Haaser, Michael, Holzman, A Stephen, Malekzadeh, Lolita, Ramsey, Jeff, Schulman, Cary, Schwartzbach, Tangwan, Azefor, Arman, Davani, Mahmood, Jaberi, Courtney, Masear, Syed Basit, Haider, Carolyn, Chungu, Ali, Ebrahimi, Karim, Fikry, Andrew, Marcantonio, Anitha, Shelvan, David, Sanders, Collin, Clarke, Abdel, Lawendy, Gary, Schwartz, Mohit, Garg, Joseph, Kim, Juan, Caruci, Ekow, Commeh, Randy, Cuevas, Germaine, Cuff, Lola, Franco, David, Furgiuele, 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, Greg, Bryson, Alexandra, Craig, Cassandra, Farhat, Braden, Gammon, Wade, Gofton, Nicole, Harris, Karl, Lalonde, Allan, Liew, Bradley, Meulenkamp, Kendra, Sonnenburg, Eugene, Wai, Geoffrey, Wilkin, Karen, Troxell, Mary Ellen, Alderfer, Jason, Brannen, Christopher, Cupitt, Stacy, Gerhart, Renee, McLin, Julie, Sheidy, Katherine, Yurick, Fei, Chen, Karen, Dragert, Geza, Kiss, Halina, Malveaux, Deborah, McCloskey, Scott, Mellender, Sagar S, Mungekar, Helaine, Noveck, Carlos, Sagebien, Luat, Biby, Gail, McKelvy, Anna, Richards, Ramon, Abola, Brittney, Ayala, Darcy, Halper, Ana, Mavarez, Sabeen, Rizwan, Stephen, Choi, Imad, Awad, Brendan, Flynn, Patrick, Henry, Richard, Jenkinson, Lilia, Kaustov, Elizabeth, Lappin, Paul, McHardy, Amara, Singh, Joanne, Donnelly, Meera, Gonzalez, Christopher, Haydel, Jon, Livelsberger, Theresa, Pazionis, Bridget, Slattery, Maritza, Vazquez-Trejo, Jaime, Baratta, Michael, Cirullo, Brittany, Deiling, Laura, Deschamps, Michael, Glick, Daniel, Katz, James, Krieg, Jennifer, Lessin, Jeffrey, Mojica, Marc, Torjman, Rongyu, Jin, Mary Jane, Salpeter, Mark, Powell, Jeffrey, Simmons, Prentiss, Lawson, Promil, Kukreja, Shanna, Graves, Adam, Sturdivant, Ayesha, Bryant, Sandra Joyce, Crump, Michelle, Verrier, James, Green, Matthew, Menon, Richard, Applegate, Ana, Arias, Natasha, Pineiro, Jeffrey, Uppington, Phillip, Wolinsky, 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, Denise, Orwig, Maithri, Goud, Chris, Helker, Lydia, Mezenghie, Brittany, Montgomery, Peter, Preston, J Sanford, Schwartz, Ramona, Weber, Lee A, Fleisher, Samir, Mehta, Alisa J, Stephens-Shields, Cassandra, Dinh, Jacques E, Chelly, Shiv, Goel, Wende, Goncz, Touichi, Kawabe, Sharad, Khetarpal, Amy, Monroe, Vladislav, Shick, Max, Breidenstein, Timothy, Dominick, Alexander, Friend, Donald, Mathews, Richard, Lennertz, Robert, Sanders, Helen, Akere, Tyler, Balweg, Amber, Bo, Christopher, Doro, David, Goodspeed, Gerald, Lang, Maggie, Parker, Amy, Rettammel, Mary, Roth, Marissa, White, Paul, Whiting, Brian F S, 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, B Scott, Segal, Jimmy, Turner, David, VanEenenaam, Robert, Weller, Jineli, Lei, Miriam, Treggiari, Shamsuddin, Akhtar, Marcelle, Blessing, Chanel, Johnson, Michael, Kampp, Kimberly, Kunze, Mary, O'Connor, Jinlei, Li, Duminda N, Wijeysundera, Sachin, Kheterpal, Reneé H, Moore, Alexander K, Smith, Laura L, Tosi, Lee, Fleisher, Christine, Langlois, Samuel, Oduwole, and Thomas, Rose

Subjects
Male, Analgesics, Canada, Pain, Postoperative, Hip Fractures, Pain, General Medicine, Anesthesia, General, Anesthesia, Spinal, Patient Satisfaction, Internal Medicine, Humans, Female, Aged
Abstract

The REGAIN (Regional versus General Anesthesia for Promoting Independence after Hip Fracture) trial found similar ambulation and survival at 60 days with spinal versus general anesthesia for hip fracture surgery. Trial outcomes evaluating pain, prescription analgesic use, and patient satisfaction have not yet been reported.To compare pain, analgesic use, and satisfaction after hip fracture surgery with spinal versus general anesthesia.Preplanned secondary analysis of a pragmatic randomized trial. (ClinicalTrials.gov: NCT02507505).46 U.S. and Canadian hospitals.Patients aged 50 years or older undergoing hip fracture surgery.Spinal or general anesthesia.Pain on postoperative days 1 through 3; 60-, 180-, and 365-day pain and prescription analgesic use; and satisfaction with care.A total of 1600 patients were enrolled. The average age was 78 years, and 77% were women. A total of 73.5% (1050 of 1428) of patients reported severe pain during the first 24 hours after surgery. Worst pain over the first 24 hours after surgery was greater with spinal anesthesia (rated from 0 [no pain] to 10 [worst pain imaginable]; mean difference, 0.40 [95% CI, 0.12 to 0.68]). Pain did not differ across groups at other time points. Prescription analgesic use at 60 days occurred in 25% (141 of 563) and 18.8% (108 of 574) of patients assigned to spinal and general anesthesia, respectively (relative risk, 1.33 [CI, 1.06 to 1.65]). Satisfaction was similar across groups.Missing outcome data and multiple outcomes assessed.Severe pain is common after hip fracture. Spinal anesthesia was associated with more pain in the first 24 hours after surgery and more prescription analgesic use at 60 days compared with general anesthesia.Patient-Centered Outcomes Research Institute

Published
2022

9. Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial

Author

Michael J. Bosse, Joanne Donnelly, Robert D. Zura, Heather A. Vallier, William T. Obremskey, Reza Firoozabadi, Yasmin Degani, Christine Churchill, Peter Z. Berger, Lauren C. Hill, Christina L. Boulton, Rachel B. Seymour, M. J. Crisco, Seth R. Yarboro, Jerald R. Westberg, Christopher M. McAndrew, Christina Riggsbee, Carrie Schoonover, Joshua L. Gary, Marcus F. Sciadini, Vamshi Gajari, Jason J. Halvorson, John C. Weinlein, Greg Osgood, Gele B. Moloney, Babar Shafiq, Sterling J. Boutte, Daniel O. Scharfstein, Olivia C. Lee, Thomas M. Large, Daniel Connelly, David L. Rothberg, Angela Mullins, Walter W Virkus, Drew Sanders, Christopher S. Smith, Cyrus Caroom, William M. Ricci, Animesh Agarwal, Vaishali Laljani, Thomas R Wojda, Medardo Maroto, Josie M. Hydrick, Lisa K. Schroder, Colette Hilliard, Joseph Kimmel, Boris A. Zelle, Stanislaw P Stawicki, Matthew L Graves, Mary A. Breslin, Ravi A. Karia, Susan C J Collins, Lauren E. Allen, James Brett Goodman, Debra L. Sietsema, Eric D. McVey, Anthony R. Carlini, Emily Wagstrom, Yanjie Huang, Patrick M. Osborn, Cara J. Rowe, Elizabeth Sheridan, Roman A. Hayda, Cameron Howes, Christopher T. LeBrun, Mary Zadnik, Laura S. Phieffer, Jessica C. Rivera, Andrew R. Evans, Sharon Haaser, Andrew M Choo, Greg E. Gaski, Justin M. Haller, Jeff E. Schulman, Jaslynn A.N. Cuff, J. Spence Reid, David Teague, Basem Attum, Tara J. Taylor, Cesar S. Molina, Julius A. Bishop, Peter C. Krause, Laurence B. Kempton, Timothy S. Achor, Colin V. Crickard, Lindsay E. Hickerson, Clay A. Spitler, Hassan R. Mir, Veronica Lester-Ballard, Michael L. Brennan, Ryan N Montalvo, Theodore T. Manson, Jason W. Nascone, Chinenye O. Nwachuku, Anna N. Miller, Rachel M. Reilly, Timothy Costales, A. Stephen Malekzadeh, Renan C. Castillo, Kathy Ringenbach, Paul S. Whiting, A. Alex Jahangir, Michael D. Holzman, Michael J. Gardner, Andres Rodriguez-Buitrago, Andrew N. Pollak, George V Russell, Gerald J. Lang, Massimo Max Morandi, Gerard P. Slobogean, John W. Munz, Brigham Au, Andrea Howe, Clinton K. Murray, Saqib Rehman, Ashoke K. Sathy, Alexander B. Siy, Daniel Mascarenhas, Adam M. Kaufman, Anthony T. Sorkin, Stephen H. Sims, Karen M. Trochez, Gabriela Gonzales, H. Michael Frisch, Manjari Joshi, Thomas F. Higgins, G Bradley Reahl, Roman M. Natoli, C. Michael Lecroy, William J.J. Ertl, Nathan N O'Hara, Madhav A. Karunakar, Patrick F. Bergin, Sandy Vang, Joseph R. Hsu, Martha B. Holden, Eduardo J. Burgos, Lolita Ramsey, David B. Weiss, Amanda Spraggs-Hughes, Clifford B. Jones, Mark D. Jenkins, Michael J. Weaver, Robert A. Hymes, David C. Goodspeed, Robert V O'Toole, and Dimitrius Marinos

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Intra-Articular Fractures, 030230 surgery, Pilon fracture, law.invention, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Vancomycin, Post-hoc analysis, Fracture fixation, Surgical Wound Dehiscence, medicine, Infection control, Humans, Surgical Wound Infection, Prospective Studies, Gram-Positive Bacterial Infections, Probability, Wound dehiscence, business.industry, Absolute risk reduction, Middle Aged, medicine.disease, Surgery, Anti-Bacterial Agents, Tibial Fractures, 030220 oncology & carcinogenesis, Fractures, Ununited, Female, Powders, business, Gram-Negative Bacterial Infections, medicine.drug
Abstract

Importance Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, –3.4%; 95% CI, –6.9% to 0.1%;P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, –3.7%; 95% CI, –6.7% to –0.8%;P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, –1.6% to 2.1%;P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration ClinicalTrials.gov Identifier:NCT02227446

Published
2021

10. Patient and stakeholder engagement learnings: PREP-IT as a case study

Author

Michelle Medeiros, T Rosie Love, Gerard P. Slobogean, Sheila Sprague, Eleanor M. Perfetto, Nathan N. O'Hara, C. Daniel Mullins, Jeffrey Wells, Mohit Bhandari, Jean-Claude D'alleyrand, Anthony Harris, Daniel C. Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon H. Guyatt, Dianne Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan O'Hara, Frances Grissom, Leah Gitajn, Saam Morshed, Robert O'Toole, Bradley A. Petrisor, Megan Camara, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, David Pogorzelski, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Page Szasz, Paula McKay, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, Adam Boissonneault, Michellic Medeiros, Eric Kettering, Diamond Hale, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollack, Marcus Sciadini, Yasmin Degani, Katherine Joseph, Lucas S. Marchand, Heather Phipps, Eric Hempen, Herman Johal, Bill Risteyski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Sarah M. McGaugh, Kaitlyn Pusztai, Sarah Piekarski, Mavis Lyons, Julia Gennaccaro, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Andrea Hudgins, Courteney L. Fentz, Maricela M. Diaz, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, Maria Herrera, John D. Adams, Michael Beckish, Christopher Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, Edwin L. Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, John Wilson Sykes, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Dmitry Pokhvashchev, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy Achor, Milton L. \\'Chip\\' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Michael Talerico, Marybeth Horodyski, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Marissa Pazik, Elizabeth Lossada-Soto, Niloofar Dehghan, Clifford B. Jones, J. Tracy Watson, Michael McKee, Ammar Karim, Debra L. Sietsema, Alyse William, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Chris Pritchett, Natalie Hogan, Fidel A. Moreno, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Brad Askam, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Crus, Thomas Knapp, Colin Hurkett, Maya Lowney, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Clavia, Guillem Graells-Alonso, Marta Martínez-álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomò Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Ernesto Guerra-Farfán, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Joan Minguell-Monyart, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Joanne Fraifogl, Eleanor S. Wilson, Leanne K Wadenpfuhl, Paul G. Halliday, Isabella Heimke, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen \\'Brenda\\' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Juliette Sweeney, Hannah Pollock, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Jonathan Wills, Lolita Ramsey, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Debra Bullard, Wendy Williams, Taylor Hill, Ariel Brotherton, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A Reily, Peter DePalo, Amy E. Hall, Rebecca E. Dabrowski, Theresa A. Chockbengboun, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John Esposito, Mira Bansal, Michael McTague, Ahmad Alnasser, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Skeketha L. McGee, Eldrin L. Bhanat, Josny Thimothee, Jackie Serrano, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark II, Branden Pfaff, Troy Hollinsworth, Kristi Atkins, Michael J. Weaver, Arvind G. von Keudel, Michael F. McTague, Elizabeth M. Allen, Abigail E. Sagona, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Autumn Stone, Mark J. Gage, Rachel M. Reilly, Cindy Sparrow, Ariana Paniagua, Christopher M. Domes, Kristina P. Johnson, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Geoffrey S. Marecek, Denice Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, and Cameron G. Thomson

Subjects
Patient Outcome Assessment, Medical education, business.industry, Stakeholder Participation, Health Policy, Patient-Centered Care, Stakeholder engagement, Medicine, Humans, Multi stakeholder, business, Patient centered
Published
2021

11. 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

12. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen 'Brenda' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Pragmatic, medicine.medical_specialty, Comparative effectiveness research, Pharmacy, Sampling framework, Cluster crossover, Sampling strategy, Article, Odds, 03 medical and health sciences, 0302 clinical medicine, Health care, medicine, 030212 general & internal medicine, Sampling, Pharmacology, lcsh:R5-920, Descriptive statistics, business.industry, Sampling (statistics), General Medicine, Test (assessment), Work flow, Family medicine, business, lcsh:Medicine (General), 030217 neurology & neurosurgery
Abstract

Author(s): Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | Abstract: IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Published
2020

13. Examining the Health Information–Seeking Behaviors of Korean Americans

Author

Lolita Ramsey, Elizabeth S Chong, Gary L. Kreps, Kyeung Mi Oh, and Jungmi Jun

Subjects
Adult, Male, Gerontology, Health (social science), Cross-sectional study, Health Behavior, Information Seeking Behavior, MEDLINE, Ethnic group, Library and Information Sciences, Trust, Neoplasms, Information seeking behavior, Korean americans, Environmental health, Cancer screening, Humans, Medicine, Mass Media, Early Detection of Cancer, Mass media, Internet, Physician-Patient Relations, Asian, business.industry, Communication, Public Health, Environmental and Occupational Health, Newspapers as Topic, Middle Aged, Metropolitan area, Cross-Sectional Studies, Socioeconomic Factors, Female, Periodicals as Topic, business
Abstract

Many Korean Americans suffer from high levels of cancer incidence and have low cancer screening rates. A significant number of Korean Americans lack adequate information about cancer screening tests. However, little is known about their health behaviors. This article examines exposure to mass media and health information-seeking behaviors for Korean Americans, and their associations with demographic characteristics influencing variations in exposure to the different health information and trust in health information sources. The authors gathered data for this study using a cross-sectional, community-based survey conducted in the Washington, DC, metropolitan area during 2006 and 2007. It was administered to 254 Korean Americans who were 40 years of age or older. This study is part of the first health-related program of research to study exposure to mass media, health and cancer information sources, and seeking preferences and experiences of Korean Americans. Results indicated that Korean ethnic media sources and Internet are important sources used regularly. Age, years of education completed, and English proficiency levels for Korean Americans significantly predicted the likelihood of their Internet use. Low-income Korean Americans with less education were more likely to seek health information in Korean ethnic magazines and newspapers, whereas Korean Americans with higher education and English proficiency were more likely to seek information online. The most trusted source of health information among respondents was from a doctor or other health care professional. Future research should be conducted to determine whether physicians are actually used as a primary source for health information.

Published
2012

14. Intramedullary Nailing of Open Tibial Fractures: Provisional Plate Fixation

Author

Meryl R Ludwig, Lolita Ramsey, Robert A. Hymes, Michael Pitta, and Jeff E. Schulman

Subjects
Adult, Male, medicine.medical_specialty, Prosthesis-Related Infections, medicine.medical_treatment, Tibia Fracture, Bone Nails, law.invention, Intramedullary rod, 03 medical and health sciences, Fractures, Open, 0302 clinical medicine, Postoperative Complications, law, Medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Tibia, Reduction (orthopedic surgery), Retrospective Studies, 030222 orthopedics, business.industry, Trauma center, Odds ratio, Confidence interval, Surgery, Fracture Fixation, Intramedullary, Tibial Fractures, Treatment Outcome, Orthopedic surgery, Female, business, Bone Plates
Abstract

Tibia fracture is the most common type of long bone fracture, and intramedullary nailing is the preferred treatment. In open fractures, a provisional plate is often used to maintain reduction. It is unknown whether this practice increases the risk of infection or other complications. This study retrospectively compared patients who were treated at a level 1 trauma center with intramedullary nailing of an open tibia fracture. Patients who were included: (1) were 18 years or older; (2) were treated between January 1, 2005, and June 30, 2013; (3) had an open fracture of the tibia; and (4) were treated operatively with intramedullary nailing, with or without provisional plate fixation. Patient sex, history of diabetes, history of smoking, mechanism of injury, and side of injury were analyzed. Postoperative complications included infection, delayed union or non-union, compartment syndrome, and death. After the authors controlled for age, Gustilo-Anderson type, and AO/Orthopaedic Trauma Association classification, they found that provisional plate use did not significantly increase the risk of infection (adjusted odds ratio, 1.64; 95% confidence interval, 0.51–5.32; P =.41) or any other complications (adjusted odds ratio, 1.24; 95% confidence interval, 0.46–3.35; P =.67). In the subgroup of patients who had a provisional plate (n=35), removal of the plate did not significantly decrease the risk of infection (adjusted odds ratio, 0.43; 95% confidence interval, 0.07–2.69; P =.36) or other complications (adjusted odds ratio, 0.55; 95% confidence interval, 0.12–2.46; P =.44). In open tibia fractures treated with intramedullary nailing, provisional plate stabilization, a valuable reduction aid, did not increase the risk of infection or other complications. Because of the small subgroup size, however, definitive conclusions cannot be drawn about removal of these provisional plates. [ Orthopedics. 2016; 39(5):e931–e936.]

Published
2015

15. Cancer Information Seeking and Awareness of Cancer Information Sources among Korean Americans

Author

Lolita Ramsey, Gary L. Kreps, Jungmi Jun, and Kyeung Mi Oh

Subjects
Adult, Male, Gerontology, Health Knowledge, Attitudes, Practice, Cross-sectional study, Health Behavior, Information Seeking Behavior, Ethnic group, MEDLINE, Neoplasms, Surveys and Questionnaires, Information seeking behavior, Cancer screening, medicine, Humans, Information Services, Asian, Information seeking, business.industry, Public Health, Environmental and Occupational Health, Cancer, Middle Aged, medicine.disease, National Cancer Institute (U.S.), United States, Cross-Sectional Studies, Oncology, Information source, Female, business, Social psychology
Abstract

Many Korean Americans (KAs) suffer high cancer incidence levels and have low cancer screening rates. A significant number of KAs lack adequate information about cancer screening tests. However, little is known about the health information seeking behaviors of KAs. This study examines the types of cancer information searched for, the cancer information seeking experiences, and the awareness of major cancer information sources, such as the National Cancer Institutes (NCI) and the NCI's Cancer Information Service, among KAs. It also examines associations with demographic characteristics and media use influencing variations in the awareness of cancer information sources. Data for this study were gathered with a cross-sectional, community-based survey (254 KAs). The survey results indicated that KA's involvement in cancer information seeking is relatively low, and they have somewhat negative experiences in seeking cancer information. In addition, their awareness of cancer information sources was limited. Despite of the heavy use of Korean ethnic media, it did not connect to cancer information source awareness. Rather, use of US mainstream media was significantly related with awareness. Campaigns using the Korean language through partnerships with Korean ethnic media to inform KAs about credible sources of health information appear to be warranted by our findings.

Published
2011

16. Health-related quality of life in patients with chronic hepatitis B

Author

Zahra Younoszai, Jillian Kallman, Zobair M. Younossi, Amy A. Dan, Lolita Ramsey, Fatema Nader, and Silvia Bondini

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Cirrhosis, Population, Chronic liver disease, Hepatitis B, Chronic, Primary biliary cirrhosis, Cost of Illness, Quality of life, Surveys and Questionnaires, medicine, Humans, Prospective Studies, education, Prospective cohort study, education.field_of_study, Hepatology, Liver Cirrhosis, Biliary, business.industry, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Hepatitis B, medicine.disease, Health Surveys, humanities, Quality of Life, Female, business
Abstract

Although chronic hepatitis C (CH-C) has consistently been shown to impair patients' health-related quality of life (HRQL), the impact of chronic hepatitis B (CH-B) on HRQL has not been fully explored. Aim: Compare HRQL between patients with CH-B, CH-C, primary biliary cirrhosis (PBC) and healthy controls. Design: Three HRQL questionnaires [Chronic Liver Disease Questionnaire (CLDQ), Short Form 36 (SF-36) and the Health Utility Index (HUI Mark-2 and Mark-3)] were administered prospectively. Additional clinical and laboratory data and normative data for healthy individuals, were available. Analysis: Scores were compared using analysis of variance and multiple regression. Results: One hundred and forty-six patients with CH-B, CH-C and PBC were included [mean age 47.1 years (±11.6), 41% female, 33% cirrhosis]. CH-C and PBC patients scored the lowest on all CLDQ, SF-36 and HUI domains compared with CH-B patients and healthy controls. CH-B patients had scores similar to the healthy population, measured by most CLDQ and SF-36 scales. However, the HUI scores for CH-B patients showed more impairment than population norms. Having CH-B and not having cirrhosis were predictive of utility and HRQL scores in multivariate models. Conclusions: CH-B patients have better HRQL than CH-C, PBC and population norms. CH-B patients' overall utility scores are lower than population norms.

Published
2007

17. Screening for chlamydial infection

Author

Kenneth W, Lin and Lolita, Ramsey

Subjects
Young Adult, Pregnancy, Humans, Female, Chlamydia Infections, Pregnancy Complications, Infectious
Published
2009

18. A phase II dose finding study of darbepoetin alpha and filgrastim for the management of anaemia and neutropenia in chronic hepatitis C treatment

Author

M. Sjogren, Rochelle Collantes, K. Terra, C. Gurung, Manirath K. Srishord, Zobair M. Younossi, H. Gujral, Yun Fang, Fatema Nader, Lolita Ramsey, D. Farmer, J. P. Ong, R. Sjogren, and Chunhong Bai

Subjects
Adult, Male, medicine.medical_specialty, Neutropenia, Darbepoetin alfa, Filgrastim, Alpha interferon, Interferon alpha-2, Gastroenterology, Antiviral Agents, Polyethylene Glycols, chemistry.chemical_compound, Hemoglobins, Pegylated interferon, Virology, Internal medicine, Granulocyte Colony-Stimulating Factor, Ribavirin, Medicine, Humans, Erythropoietin, Hepatology, business.industry, Interferon-alpha, Anemia, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, Recombinant Proteins, Granulocyte colony-stimulating factor, Infectious Diseases, Treatment Outcome, chemistry, Immunology, Hematinics, Quality of Life, Female, business, medicine.drug
Abstract

Dose reductions of pegylated interferon alpha and ribavirin may be avoided by using growth factors. This phase II clinical trial assesses the dose, efficacy and safety of darbepoetin alpha and filgrastim for treatment of anaemia and neutropenia associated with combination therapy for hepatitis C virus (HCV). Chronic hepatitis C patients (n = 101) received pegylated interferon alpha-2b (1.5 mug/kg once weekly) and ribavirin (800-1400 mg once daily). Patients with anaemia [haemoglobin (Hb)/= 10.5 g/dL] received darbepoetin alpha (3 mug/kg once every 2 weeks); the dose was titrated to achieve a Hb level of 12.0 g/dL. Patients with neutropenia [absolute neutrophil count (ANC)/= 0.75 x 10(9)/L] received filgrastim with the dose titrated from 150 mug QW to 300 mug thrice weekly to maintain ANC/= 0.75 x 10(9)/L and10 x 10(9)/L. During antiviral therapy, 52% of patients required darbepoetin alpha, filgrastim or both. Hb at the time of darbepoetin alpha initiation was 10.2 +/- 0.4 g/dL. After 81 days of darbepoetin alpha, Hb increased by 1.9 +/- 1.0 g/dL to 12.1 +/- 1.1 g/dL (P0.0001). Filgrastim resulted in a significant increase in ANC [0.75 +/- 0.16 x 109/L to 8.28 +/- 5.67 x 10(9)/L (P0.0001)]. In treatment-naïve patients, 48% achieved sustained virological response (SVR), whereas 27% of patients previously treated with a course of pegylated interferon alpha achieved SVR. Low viral load, nongenotype 1 and treatment with growth factors were independently associated with SVR. Mild and severe anaemia were associated with quality of life impairments. Darbepoetin alpha resulted in an improvement in the Vitality domain of Short Form-36. No significant adverse events were related to growth factors. During anti-HCV therapy, filgrastim improved neutropenia and darbepoetin alpha improved both anaemia and quality of life. Future randomized clinical trials are needed to establish the impact of growth factors in improving sustained virological response.

Published
2008

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