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

Author

Pechero, Guillermo, Pfaff, Branden, Rao, Mayank, Pogorzelski, David, McKay, Paula, Spicer, Ella, Howe, Andrea, Demyanovich, Haley K, Sietsema, Debra L, McTague, Michael F, Ramsey, Lolita, Holden, Martha, Rudnicki, Joshua, Wells, Jeff, Medeiros, Michelle, Slobogean, Gerard P, Sprague, Sheila, PREP-IT Investigators, Wells, Jeffrey, Bhandari, Mohit, 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, PREP-IT Clinical Sites, O'Toole, Robert V, D'Alleyrand, Jean-Claude, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, O'Hara, Nathan N, Joseph, Katherine, Camara, Megan, Aqueous-PREP and PREPARE, Aqueous-PREP, and PREPARE

Subjects
PREP-IT Investigators, 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, PREP-IT Clinical Sites, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE, Cluster randomized crossover, Consent, Deferred consent, Patient advisors, Stakeholder engagement, Trial design
Abstract

IntroductionCluster 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.MethodsThe 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.ResultsPatient 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.DiscussionInvolvement 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

2. Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial

Author

O’Hara, Nathan N., Frey, Katherine P., Stein, Deborah M., Levy, Joseph F., Slobogean, Gerard P., Castillo, Renan, Firoozabadi, Reza, Karunakar, Madhav A., Gary, Joshua L., Obremskey, William T., Seymour, Rachel B., Cuschieri, Joseph, Mullins, C. Daniel, O’Toole, Robert V., Carlini, Anthony R., Fowler, Brianna E., Taylor, Tara J., Wegener, Stephen T., Weston-Farber, Elias, Herndon, Steven Craig, Marvel, Debra, Jurkovich, Gregory J., Lee, Christopher, Malhotra, Ajai K., Riedel, Matthew D., DeCoster, Thomas A., Vercellotti, Gregory M., Wells, Jeffrey L., Westrick, Edward R., Bosse, Michael J., Christmas, A. Britton, Cunningham, Kyle William, Hsu, Joseph R., Huynh, Toan, Jacobs, David George, Kempton, Laurence B., Sims, Stephen H., Churchill, Christine, Carroll, Eben A., Babcock, Sharon, Miller, Preston R., Pilson, Holly T., Goodman, James Brett, Holden, Martha B., Weaver, Michael J., Esposito, John G., Goldhaber, Samuel Z., Heng, Marilyn, McGovern, Madeline M., Velmahos, George C., von Keudell, Arvind, Rivera, Jessica C., Gitajn, Ida Leah, Schneider, Prism S., Buckley, Richard E., Gallant, Jodi, McKay, Paula, Kleweno, Conor P., Agel, Julie, Natoli, Roman M., Gaski, Greg E., Heincelman, Carrie L., Jang, Yohan, Lopas, Luke A., McKinley, Todd O., Richard, Raveesh Daniel, Sorkin, Anthony T., Virkus, Walter, Hill, Lauren C., Hymes, Robert A., Holzman, Michael, Panjshiri, Farhanaz, Schulman, Jeff E., Ramsey, Lolita, Cuff, Jaslynn A.N., Haut, Elliott R., Warner, Stephen J., Cotton, Bryan A., Guevara, Keyla D., Claridge, Jeffrey A., Vallier, Heather A., Breslin, Mary A., Connelly, Daniel, Ghulam, Qasim M., Haac, Bryce E., LeBrun, Christopher T., Manson, Theodore T., Nascone, Jason, Pensy, Raymond A., Pollak, Andrew N., Udogwu, Ugochukwu N., Burke, Cynthia Elaine, Degani, Yasmin, DeLeon, Genaro A., Hannan, Zachary D., Healey, Kathleen M., Howe, Andrea L., Marinos, Dimitrius P., McKegg, Phillip C., McKibben, Natasha S., Zingas, Nicolas H., Evans, Andrew R., Askam, Brad M., Boulton, Christina, Weinlein, John C., Bergin, Patrick F., Bergin, Patrick F., Kutcher, Matthew E., Morellato, John, Nehete, Priyanka V., Yener, Ugur, Whiting, Paul S., Domes, Christopher, Kuhn, Gabrielle R., Gajari, Vamshi, Moreno-Diaz, Andres Fidel, Rodriguez-Baron, Elsa B., Rodriguez-Buitrago, Andres, Stinner, Daniel J., Trochez, Karen M., DePalo, Peter, Kennedy, Leah C., Lienhard, Karin, Martin, Ryan, Yee, Stephanie C., Leonard, Jordan, Arif, Hikmatullah, Brown, Krista, Deeter, Lakye Lenee, Sardesai, Neil, Bangura, Abdulai T., Demyanovich, Haley K., Eglseder, W. Andrew, Gupta, Jayesh, Isaac, Marckenley, Mulliken, Alexandra, Crisco, MJ., Lueckel, Stephanie N., Brown, Gregory A., Breazeale, Stephen, Fisher, Stephen N., Wild, Jason R., Beebe, Michael J., Khanna, Rajinder M., Brauer, Deborah, and Boyce, Robert H.

Published
2024
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4. The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey, Bhandari, Mohit, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wood, Amber, Rocca, Gregory J. Della, Hebden, Joan, Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert, Lee, Christopher, Patterson, Joseph, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, PJ, Guyatt, Gordon H., Heels-Ansdell, Diane, Marvel, Debra, Wells, Jana Palmer Jeffrey, Friedrich, Jeff, O'Hara, Nathan N., Grissom, Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Mossuto, Franca, Joshi, Manjari G., D'Alleyrand, Jean-Claude, Fowler, Justin, Rivera, Jessica, Talbot, Max, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Rojas, Alejandra, Fabbro, Gina Del, Szasz, Olivia Paige, McKay, Paula, Minea, Alexandra, Howe, Andrea, Demyanovich, Haley, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Demyanovich, Haley K., Phipps, Heather, Hempen, Eric, Holler, Christine, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi, Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Jr, Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Jr, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin, Quirion, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. Wilson, Yoder, Krystina, Conner, Kelsey, Abbott, Harper, Natoli, Roman M., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Mullis, Brian H., Jang, Yohan, Lopas, Luke A., Hill, Lauren C., Fentz, Courteney L., Diaz, Maricela M., Brown, Krista, Garst, Katelyn M., Denari, Emma W., Osborn, Patrick, Pierrie, Sarah, Herrera, Maria, Miclau, Theodore, Marmor, Meir, Matityahu, Amir, McClellan, R. Trigg, Shearer, David, Toogood, Paul, Ding, Anthony, Murali, Jothi, Naga, Ashraf El, Tangtiphaiboontana, Jennifer, Belaye, Tigist, Berhaneselase, Eleni, Pokhvashchev, Dmitry, Obremskey, William T, Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip, Trochez, Karen, Rodriguez, Elsa, Pritchett, Charles, Hogan, Natalie, Moreno, A. Fidel, Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Talerico, Michael, Horodyski, Marybeth, Pazik, Marissa, Lossada-Soto, Elizabeth, Gary, Joshua L., Warner, Stephen J, Munz, John W., Choo, Andrew M., Achor, Timothy S., Routt, Milton L. “Chip”, Kutzler, Michael, Boutte, Sterling, Warth, Ryan J., Prayson, Michael, Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Boulton, Christina, Lowe, Jason, Ruth, John T., Askam, Brad, Seach, Andrea, Cruz, Alejandro, Featherston, Breanna, Carlson, Robin, Romero, Iliana, Zarif, Isaac, Dehghan, Niloofar, McKee, Michael, Jones, Clifford B, Sietsema, Debra L, Williams, Alyse, Dykes, Tayler, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vazquez, Juan Antonio, Andres-Peiro, Jose Vicente, Esteban-Feliu, Ignacio, Vidal-Tarrason, Nuria, Serracanta, Jordi, Nuñez-Camarena, Jorge, del Mar Villar-Casares, Maria, Mestre-Torres, Jaume, Lalueza-Broto, Pilar, Moreira-Borim, Felipe, Garcia-Sanchez, Yaiza, Marcano-Fernández, Francesc, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Andriola, Vito, Molina-Corbacho, Matilde, Maldonado-Sotoca, Yeray, Gasset-Teixidor, Alfons, Blasco-Moreu, Jorge, Fernández-Poch, Núria, Rodoreda-Puigdemasa, Josep, Verdaguer-Figuerola, Arnau, Cueva-Sevieri, Heber Enrique, Garcia-Gimenez, Santiago, Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Spicer, Ella, Payne, Kyrsten, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Gaski, Greg E., Wills, Jonathan, Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Williams, Wendy, Hill, Taylor, Brotherton, Ariel, Romeo, Nicholas M., Vallier, Heather A, Vergon, Anna, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Olsen, Zachary M., McGowan, Abby V., Hill, Sophia, Dauk, Morgan K., Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, McGee, Sheketha L., Bhanat, Eldrin L., Yener, Ugur, Khanna, Rajinder, Nehete, Priyanka, Potter, Dr. David, VanDemark, Dr. Robert, III, Seabold, Kyle, Staudenmier, Nicholas, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo, Peter A., Sr., Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Mayfield, Ada, Sweeney, Juliette, Jaeblon, Todd, Beer, Robert, Bauer, Brent, Meredith, Sean, Talwar, Sneh, Domes, Christopher M., Gage, Mark J., Reilly, Rachel M., Paniagua, Ariana, Dupree, JaNell, Weaver, Michael J., von Keudell, Arvind G., Sagona, Abigail E., Mehta, Samir, Donegan, Derek, Horan, Annamarie, Dooley, Mary, Heng, Marilyn, Harris, Mitchel B., Lhowe, David W., Esposito, John G., Alnasser, Ahmad, Shannon, Steven F., Scott, Alesha N., Clinch, Bobbi, Weber, Becky, Beltran, Michael J., Archdeacon, Michael T., Sagi, Henry Claude, Wyrick, John D., Le, Theodore Toan, Laughlin, Richard T., Thomson, Cameron G., Hasselfeld, Kimberly, Lin, Carol A., Vrahas, Mark S., Moon, Charles N., Little, Milton T., Marecek, Geoffrey S., Dubuclet, Denice M., Scolaro, John A., Learned, James R., Lim, Philip K., Demas, Susan, Amirhekmat, Arya, Dela Cruz, Yan Marco, Boissonneault, Adam, O Hara, Nathan, Marchand, Lucas, Higgins, Thomas, Gitajn, Leah, Sharma, Ishani, O’Toole, Robert V, and Slobogean, Gerard

Published
2023
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5. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey L., Bhandari, Mohit, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan N., Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert D., Lee, Christopher, Patterson, Joseph T., Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, PJ, Guyatt, Gordon, Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana E., Friedrich, Jeff, O'Hara, Nathan N., Grissom, Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley, Mossuto, Franca, Joshi, Manjari G., D'Alleyrand, Jean-Claude G., Fowler, Justin, Rivera, Jessica C., Talbot, Max, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Del Fabbro, Gina, Szasz, Olivia Paige, Bzovsky, Sofia, McKay, Paula, Minea, Alexandra, Murphy, Kevin, Howe, Andrea L., Demyanovich, Haley K., Hoskins, Wayne, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Phipps, Heather, Hempen, Eric, Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi L., Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich Jr, Richard W., Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill Jr, L. Edwin, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin R., Quirion, Julia C., Loeffler, Markus F., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. Wilson, Yoder, Krystina, Conner, Kelsey, Abbott, Harper, Natoli, Roman M., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Mullis, Brian H., Jang, Yohan, Lopas, Luke A., Hill, Lauren C., Fentz, Courteney L., Diaz, Maricela M., Brown, Krista, Garst, Katelyn M., Denari, Emma W., Osborn, Patrick, Pierrie, Sarah N., Kessler, Bradley, Herrera, Maria, Miclau, Theodore, Marmor, Meir T., Matityahu, Amir, McClellan, R. Trigg, Shearer, David, Toogood, Paul, Ding, Anthony, Murali, Jothi, El Naga, Ashraf, Tangtiphaiboontana, Jennifer, Belaye, Tigist, Berhaneselase, Eleni, Pokhvashchev, Dmitry, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip P., Trochez, Karen, Rodriguez, Elsa, Pritchett, Charles, Hogan, Natalie, Fidel Moreno, A., Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Talerico, Michael, Horodyski, Marybeth, Pazik, Marissa, Lossada-Soto, Elizabeth, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., Routt, Milton L. “Chip”, Kutzler, Michael, Boutte, Sterling, Warth, Ryan J., Prayson, Michael J., Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Boulton, Christina, Lowe, Jason, Ruth, John T., Askam, Brad, Seach, Andrea, Cruz, Alejandro, Featherston, Breanna, Carlson, Robin, Romero, Iliana, Zarif, Isaac, Dehghan, Niloofar, McKee, Michael, Jones, Clifford B., Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vazquez, Juan Antonio, Andres-Peiro, Jose Vicente, Esteban-Feliu, Ignacio, Vidal-Tarrason, Nuria, Serracanta, Jordi, Nuñez-Camarena, Jorge, del Mar Villar-Casares, Maria, Mestre-Torres, Jaume, Lalueza-Broto, Pilar, Moreira-Borim, Felipe, Garcia-Sanchez, Yaiza, Marcano-Fernández, Francesc, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Salomó Domènech, Mònica, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Andriola, Vito, Molina-Corbacho, Matilde, Maldonado-Sotoca, Yeray, Gasset-Teixidor, Alfons, Blasco-Moreu, Jorge, Fernández-Poch, Núria, Rodoreda-Puigdemasa, Josep, Verdaguer-Figuerola, Arnau, Cueva-Sevieri, Heber Enrique, Garcia-Gimenez, Santiago, Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Spicer, Ella, Payne, Kyrsten, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Gaski, Greg E., Wills, Jonathan, Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Williams, Wendy, Hill, Taylor, Brotherton, Ariel, Romeo, Nicholas M., Vallier, Heather A., Vergon, Anna, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Olsen, Zachary M., McGowan, Abby V., Hill, Sophia, Dauk, Morgan K., Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, McGee, Sheketha L., Bhanat, Eldrin L., Yener, Ugur, Khanna, Rajinder, Nehete, Priyanka, Potter, David, VanDemark III, Robert, Seabold, Kyle, Staudenmier, Nicholas, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo Sr., Peter A., Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Mayfield, Ada, Sweeney, Juliette, Jaeblon, Todd, Beer, Robert, Bauer, Brent, Meredith, Sean, Talwar, Sneh, Domes, Christopher M., Gage, Mark J., Reilly, Rachel M., Paniagua, Ariana, Dupree, JaNell, Weaver, Michael J., von Keudell, Arvind G., Sagona, Abigail E., Mehta, Samir, Donegan, Derek, Horan, Annamarie, Dooley, Mary, Heng, Marilyn, Harris, Mitchel B., Lhowe, David W., Esposito, John G., Alnasser, Ahmad, Shannon, Steven F., Scott, Alesha N., Clinch, Bobbi, Weber, Becky, Beltran, Michael J., Archdeacon, Michael T., Sagi, Henry Claude, Wyrick, John D., Le, Theodore Toan, Laughlin, Richard T., Thomson, Cameron G., Hasselfeld, Kimberly, Lin, Carol A., Vrahas, Mark S., Moon, Charles N., Little, Milton T., Marecek, Geoffrey S., Dubuclet, Denice M., Scolaro, John A., Learned, James R., Lim, Philip K., Demas, Susan, Amirhekmat, Arya, and Dela Cruz, Yan Marco

Published
2022
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6. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

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

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

Author

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

Published
2021
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8. Randomized controlled trial of a gluten-free diet in patients with schizophrenia positive for antigliadin antibodies (AGA IgG): a pilot feasibility study

Author

Kelly, Deanna L., Demyanovich, Haley K., Rodriguez, Katrina M., Cihakova, Daniela, Talor, Monica V., McMahon, Robert P., Richardson, Charles M., Vyas, Gopal, Adams, Heather A., August, Sharon M., Fasano, Alessio, Cascella, Nicola G., Feldman, Stephanie M., Liu, Fang, Sayer, MacKenzie A., Powell, Megan M., Wehring, Heidi J., Buchanan, Robert W., Gold, James M., Carpenter, William T., Jr., and Eaton, William W.

Subjects
Clinical trials, Gluten, Schizophrenia -- Research -- Care and treatment, Immunoglobulin G, Gluten-free diet, Schizoaffective disorder, Immunoglobulins, Antibodies, Diet, Celiac disease, Health, Psychology and mental health, University of Maryland, Baltimore. School of Medicine
Abstract

Background: Approximately one-third of people with schizophrenia have elevated levels of antigliadin antibodies of the immunoglobulin G type (AGA IgG)--a higher rate than seen in healthy controls. We performed the first double-blind clinical trial of gluten-free versus gluten-containing diets in a subset of patients with schizophrenia who were positive for AGA IgG. Methods: In this pilot feasibility study, 16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG ([greater than or equal to] 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial. All participants received standardized gluten-free meals and were randomized in a double-blind fashion to receive a shake containing 10 g of gluten flour or 10 g of rice flour each day. Participants were rated for psychiatric, cognitive and gastrointestinal symptoms at baseline and end point. Results: Of the 16 participants, 14 completed the 5- week trial (2 discontinued early for administrative reasons). Compared with participants on the gluten-containing diet, participants on the gluten-free diet showed improvement on the Clinical Global Impressions scale (Cohen d = -0.75) and in negative symptoms (Cohen d = -0.53). We noted no improvement in positive or global cognitive symptoms, but did observe an improvement in attention favouring the gluten-free diet (Cohen d = 0.60). Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the gluten-containing group. Adverse effects were similar between groups. Limitations: This study was limited by its small sample size; larger studies are needed. Conclusion: This feasibility study suggests that removal of gluten from the diet is associated with improvement in psychiatric and gastrointestinal symptoms in people with schizophrenia or schizoaffective disorder., Introduction A connection between schizophrenia and inflammation is emerging in the literature, supported by many research approaches. (1,2) Research also supports the idea that individual risk for schizophrenia is increased [...]

Published
2019
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10. Effect of Vitamin D3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial.

Author

Slobogean, Gerard P., Bzovsky, Sofia, O'Hara, Nathan N., Marchand, Lucas S., Hannan, Zachary D., Demyanovich, Haley K., Connelly, Daniel W., Adachi, Jonathan D., Thabane, Lehana, and Sprague, Sheila

Subjects
FRACTURE healing, DIETARY supplements, FEMORAL fractures, CHOLECALCIFEROL, VITAMIN D, TIBIAL fractures
Abstract

Nearly half of adult fracture patients are vitamin D deficient (serum 25‐hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D3 supplementation for improving tibia and femur fracture healing. We conducted a single‐center, double‐blinded phase II screening randomized controlled trial with a 12‐month follow‐up. Patients aged 18–50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D3 at injury and 6 weeks (n = 27); (ii) 4000 IU vitamin D3 daily (n = 24); (iii) 600 IU vitamin D3 daily (n = 24); or (iv) placebo (n = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX‐IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D3 deficient at baseline. Ninety‐nine patients completed the 3‐month follow‐up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX‐IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D3 supplementation in improving acute fracture healing. Vitamin D3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita‐Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research. [ABSTRACT FROM AUTHOR]

Published
2023
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11. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

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

Published
2021
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12. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey, Bhandari, Mohit, Rojas, Alejandra, Garibaldi, Alisha, Wood, Amber, Howe, Andrea, Harris, Anthony D., Petrisor, Bradley A., Mullins, Daniel C., Pogorzelski, David, Marvel, Debra, Heels-Ansdell, Diane, Mossuto, Franca, Grissom, Frances, Del Fabbro, Gina, Guyatt, Gordon H., Della Rocca, Gregory J., Demyanovich, Haley K., Gitajn, I. Leah, Palmer, Jana, D’Alleyrand, Jean-Claude, Friedrich, Jeff, Rivera, Jessica, Hebden, Joan, Rudnicki, Joshua, Fowler, Justin, Jeray, Kyle J., Thabane, Lehana, Marchand, Lucas, O’Hara, Lyndsay M., Joshi, Manjari G., Talbot, Max, Camara, Megan, Szasz, Olivia Paige, O’Hara, Nathan N., McKay, Paula, Devereaux, P. J., O’Toole, Robert V., Zura, Robert, Morshed, Saam, Dodds, Shannon, Li, Silvia, Tanner, Stephanie L., Scott, Taryn, and Nguyen, Uyen

Subjects
Online Only, Orthopedics, Research, Original Investigation
Abstract

Key Points Question What is the effectiveness of surgical skin preparation with iodophor solutions vs chlorhexidine solutions at reducing 90-day surgical site infections and unplanned fracture-related reoperations within 1 year of injury? Findings This trial master protocol describes 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous and Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities), which seek to compare the effectiveness of iodophor and chlorhexidine surgical skin preparation solutions at reducing surgical site infections and unplanned fracture-related reoperations. Meaning Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results are poised to inform clinical guidelines and bring about change in clinical practice., Importance The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962, This trial protocol describes 2 multicenter pragmatic cluster randomized crossover trials comparing the effectiveness of iodophor and chlorhexidine surgical skin preparation solutions at reducing surgical site infections (SSIs) and unplanned fracture-related reoperations.

Published
2020

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

Author

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

Published
2021
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15. Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study.

Author

Sprague, Sheila, Guyatt, Paige, Bzovsky, Sofia, Nguyen, Uyen, Bhandari, Mohit, Thabane, Lehana, Petrisor, Brad, Johal, Herman S., Leonard, Jordan, Dodds, Shannon, Mossuto, Franca, O'Toole, Robert V., Howe, Andrea, Demyanovich, Haley K., Camara, Megan, O'Hara, Nathan N., Slobogean, Gerard P., The PREP-IT Investigators, Wells, Jeffrey, and D'Alleyrand, Jean-Claude

Subjects
PRAGMATICS, COMPOUND fractures, SURGICAL site infections, CLUSTER randomized controlled trials, MUSCULOSKELETAL system injuries, ANTISEPTICS, SKIN permeability
Abstract

Background: Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. Methods: Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. Results: All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. Conclusions: These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. Trial registration: ClincialTrials.gov, number NCT03385304. Registered December 28, 2017. [ABSTRACT FROM AUTHOR]

Published
2021
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16. Gliadin-related antibodies in schizophrenia

Author

Čiháková, Daniela, primary, Eaton, William W., additional, Talor, Monica V., additional, Harkus, Uasim H., additional, Demyanovich, Haley K., additional, Rodriguez, Katrina, additional, Feldman, Stephanie, additional, and Kelly, Deanna L., additional

Published
2018
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17. Antigliadin Antibodies (AGA IgG) Are Related to Neurochemistry in Schizophrenia

Author

Rowland, Laura M., primary, Demyanovich, Haley K., additional, Wijtenburg, S. Andrea, additional, Eaton, William W., additional, Rodriguez, Katrina, additional, Gaston, Frank, additional, Cihakova, Daniela, additional, Talor, Monica V., additional, Liu, Fang, additional, McMahon, Robert R., additional, Hong, L. Elliot, additional, and Kelly, Deanna L., additional

Published
2017
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18. The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial

Author

Pogorzelski, David, McKay, Paula, Weaver, Michael J., Jaeblon, Todd, Hymes, Robert A., Gaski, Greg E., Fraifogl, Joanne, Ahn, James S., Bzovsky, Sofia, Slobogean, Gerard, Sprague, Sheila, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey, Bhandari, Mohit, Slobogean, Gerard P., Bhandari, Mohit, Sprague, Sheila, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wells, Jeffrey, Wood, Amber, Della Rocca, Gregory J., Harris, Anthony D., Hebden, Joan, Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert, Lee, Christopher, Patterson, Joseph, Devereaux, P.J., Guyatt, Gordon H., Thabane, Lehana, Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana, Wells, Jeffrey, Friedrich, Jeff, Mullins, C. Daniel, O'Hara, Nathan N., Grissom, Ms Frances, Della Rocca, Gregory J., Gitajn, I. Leah, Jeray, Kyle J., Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Mossuto, Franca, Harris, Anthony D., Joshi, Manjari G., D'Alleyrand, Jean-Claude, Fowler, Justin, Rivera, Jessica, Talbot, Max, Sprague, Sheila, Bhandari, Mohit, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Rojas, Alejandra, Del Fabbro, Gina, Szasz, Olivia Paige, Heels-Ansdell, Diane, McKay, Paula, Minea, Alexandra, Murphy, Kevin, Slobogean, Gerard P., O'Hara, Nathan N., Howe, Andrea, Demyanovich, Haley, Mullins, C. Daniel, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, O'Toole, Robert V., D'Alleyrand, Jean-Claude, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Slobogean, Gerard P., Degani, Yasmin, Demyanovich, Haley K., Howe, Andrea, O'Hara, Nathan N., Phipps, Heather, Hempen, Eric, Holler, Christine, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi, Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Jeray, Kyle J., Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin, Quirion, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. 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Abstract

At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment.

Published
2022
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19. Skin Antisepsis before Surgical Fixation of Extremity Fractures.

Author

Sprague S, Slobogean G, Wells JL, O'Hara NN, Thabane L, Mullins CD, Harris AD, Wood A, Viskontas D, Apostle KL, O'Toole RV, Joshi M, Johal H, Al-Asiri J, Hymes RA, Gaski GE, Pilson HT, Carroll EA, Babcock S, Halvorson JJ, Romeo NM, Matson CA, Higgins TF, Marchand LS, Bergin PF, Morellato J, Van Demark RE 3rd, Potter GD, Gitajn IL, Chang G, Phelps KD, Kempton LB, Karunakar M, Jaeblon T, Demyanovich HK, Domes CM, Kuhn GR, Reilly RM, Gage MJ, Weaver MJ, von Keudell AG, Heng M, McTague MF, Alnasser A, Mehta S, Donegan DJ, Natoli RM, Szatkowski J, Scott AN, Shannon SF, Jeray KJ, Tanner SL, Marmor MT, Matityahu A, Fowler JT, Pierrie SN, Beltran MJ, Thomson CG, Lin CA, Moon CN, Scolaro JA, Amirhekmat A, Leonard J, Pogorzelski D, Bzovsky S, Heels-Ansdell D, Szasz OP, Gallant JL, Della Rocca GJ, Zura RD, Hebden JN, Patterson JT, Lee C, O'Hara LM, Marvel D, Palmer JE, Friedrich J, D'Alleyrand JG, Rivera JC, Mossuto F, Schrank GM, Guyatt G, Devereaux PJ, and Bhandari M

Subjects
Humans, 2-Propanol administration & dosage, 2-Propanol adverse effects, 2-Propanol therapeutic use, Antisepsis methods, Canada, Ethanol, Extremities injuries, Extremities microbiology, Extremities surgery, Preoperative Care adverse effects, Preoperative Care methods, Skin microbiology, Cross-Over Studies, United States, Anti-Infective Agents, Local administration & dosage, Anti-Infective Agents, Local adverse effects, Anti-Infective Agents, Local therapeutic use, Chlorhexidine administration & dosage, Chlorhexidine adverse effects, Chlorhexidine therapeutic use, Iodine administration & dosage, Iodine adverse effects, Iodine therapeutic use, Surgical Wound Infection etiology, Surgical Wound Infection prevention & control, Fractures, Bone surgery, Fracture Fixation
Abstract

Background: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture)., Methods: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications., Results: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups., Conclusions: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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20. Effect of Vitamin D 3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double-Blind Controlled Trial.

Author

Slobogean GP, Bzovsky S, O'Hara NN, Marchand LS, Hannan ZD, Demyanovich HK, Connelly DW, Adachi JD, Thabane L, and Sprague S

Abstract

Nearly half of adult fracture patients are vitamin D deficient (serum 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D 3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D 3 supplementation for improving tibia and femur fracture healing. We conducted a single-center, double - blinded phase II screening randomized controlled trial with a 12-month follow-up. Patients aged 18-50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D 3 at injury and 6 weeks ( n  = 27); (ii) 4000 IU vitamin D 3 daily ( n  = 24); (iii) 600 IU vitamin D 3 daily ( n  = 24); or (iv) placebo ( n  = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX-IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D 3 deficient at baseline . Ninety-nine patients completed the 3-month follow-up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX-IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D 3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p  = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p  = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D 3 supplementation in improving acute fracture healing. Vitamin D 3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita-Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research., Competing Interests: Dr. Slobogean sits on the editorial or governing board of the Journal of Orthopedic Trauma, serves as a paid consultant for Nuvasive, is a board or committee member for the Orthopedic Trauma Association, receives research support from the Patient Centered Outcomes Research Institute, serves as a paid consultant for Smith & Nephew, receives research support from the US Department of Defense, and serves as a paid consultant for Zimmer, outside the submitted work. Dr. O'Hara reports stock or stock options from Arbutus Medical Inc., outside the submitted work. Dr. Adachi reports personal fees and research support from Amgen Co., serves as a board or committee member for the International Osteoporosis Foundation, sits on the editorial or governing board for Osteoporosis International, and receives research support from Radius, outside the submitted work. Dr. Sprague serves as a board or committee member for the Orthopedic Trauma Association, is employed by Global Research Solutions Inc., and receives consultant fees from the University of Sherbrooke and Platform Life Sciences, all outside the submitted work. All other coauthors have nothing to disclose., (© 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.)

Published
2022
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