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4. 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, Investigators, PREP-IT, Wells, Jeffrey, Bhandari, Mohit, Committee, Steering, D'Alleyrand, Jean-Claude, Harris, Anthony D, Mullins, Daniel C, Thabane, Lehana, Wood, Amber, Committee, Adjudication, Della Rocca, Gregory J, Hebden, Joan, Jeray, Kyle J, Marchand, Lucas, O'Hara, Lyndsay M, Zura, Robert, Committee, Data and Safety Monitoring, Gardner, Michael J, Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Core, Research Methodology, Devereaux, PJ, Guyatt, Gordon H, Heels-Ansdell, Diane, Core, Patient Centred Outcomes, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N, Grissom, Frances, Core, Orthopaedic Surgery, Gitajn, I Leah, Morshed, Saam, O'Toole, Robert V, Petrisor, Bradley A, Core, Room, Camara, Megan, Mossuto, Franca, Core, Infectious Disease, Joshi, Manjari G, Core, Fowler, Justin, Rivera, Jessica, Talbot, Max, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Nguyen, Uyen, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, Demyanovich, Haley, Little, Kelly, Mullins, C Daniel, Kettering, Eric, Hale, Diamond, Sites, PREP-IT Clinical, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, and Nascone, Jason

Subjects
Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Health and social care services research, 8.4 Research design and methodologies (health services), 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

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

Author

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, Committee:, on behalf of the PREP-IT Investigators Executive, Wells, Jeffrey, Committee, Steering, D'Alleyrand, Jean-Claude, Harris, Anthony D, Mullins, Daniel C, Wood, Amber, Committee, Adjudication, Della Rocca, Gregory J, Hebden, Joan, Jeray, Kyle J, Marchand, Lucas, O'Hara, Lyndsay M, Zura, Robert, Committee, Data and Safety Monitoring, Gardner, Michael J, Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Core, Research Methodology, Devereaux, PJ, Guyatt, Gordon H, Heels-Ansdell, Diane, Core, Patient Centred Outcomes, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N, Grissom, Frances, Core, Orthopaedic Surgery, Gitajn, I Leah, Morshed, Saam, O'Toole, Robert V, Petrisor, Bradley A, Core, Room, Mossuto, Franca, Core, Infectious Disease, Joshi, Manjari G, Core, Fowler, Justin, Rivera, Jessica, Talbot, Max, Center, McMaster University Methods, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, Center, University of Maryland School of Medicine Administrative, Howe, Andrea, Rudnicki, Joshua, Demyanovich, Haley, Little, Kelly, School of Pharmacy, The PATIENTS Program University of Maryland, Mullins, C Daniel, Medeiros, Michelle, Kettering, Eric, Hale, Diamond, Site, PREP-IT Clinical Sites Lead Clinical, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, and Pensy, Raymond

Subjects
Health Services, Clinical Trials and Supportive Activities, Clinical Research, Good Health and Well Being, 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, PREPARE, PREP-IT Investigators Executive Committee, Cluster crossover, Pragmatic, Sampling, Sampling framework, Sampling strategy, Work flow
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

Published
2021

6. 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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8. 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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9. Direct oral anticoagulants versus low-molecular-weight heparin in patients with cancer-associated venous thrombosis: a cost-effectiveness analysis.

Author

Kang, Wei, Peng, Kuan, Yan, Vincent K.C., Al-Badriyeh, Daoud, Lee, Shing Fung, Yiu, Hei Hang Edmund, Wei, Yue, Li, Silvia T. H., Ye, Xuxiao, El Helali, Aya, Lam, Ka On, Lee, Victor H. F., Wong, Ian C. K., and Chan, Esther W.

Subjects
LOW-molecular-weight heparin, ORAL medication, VENOUS thrombosis, PATIENT compliance, QUALITY-adjusted life years
Abstract

Background: Direct oral anticoagulants (DOACs) have demonstrated clinical benefits and better patient adherence over low-molecular-weight heparin (LMWH) in treating patients with cancer-associated venous thrombosis (CAT). We aimed to compare the cost-effectiveness of DOACs against LMWH in patients with CAT from the perspective of the Hong Kong healthcare system. Methods: A Markov state-transition model was performed to estimate the incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALYs) for DOACs and LMWH in a hypothetical cohort of 10,000 patients with CAT over a 5-year lifetime horizon. The model was primarily based on the health states of no event, recurrent venous thromboembolism, bleeding, and death. Transition probabilities, relative risks, and utilities were derived from the literature. Resource cost data were obtained from the Hong Kong Hospital Authority. Deterministic and probabilistic sensitivity analyses tested the robustness of the results. Results: Relative to LMWH, DOACs were associated with increased QALYs (1.52 versus 1.50) at a lower medical cost of USD 2,232 versus 8,224 in five years. The cost of LMWH was the main contributor to the outcome. Out of 10,000 simulated cases, DOACs were dominant in 15.8% and cost-effective in 42.1%, at the willingness-to-pay threshold of USD 148,392 per additional QALY. Conclusions: DOACs were associated with greater QALY improvements and lower overall costs compared to LMWH. Accounting for uncertainty, DOACs were between cost-effective and dominant in 57.9% of cases. DOACs are a cost-effective alternative to LMWH in the management of CAT in Hong Kong. [ABSTRACT FROM AUTHOR]

Published
2024
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10. 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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11. 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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14. COVID-19 Vaccination Preferences of University Students and Staff in Hong Kong

Author

Fung, Lydia W. Y., primary, Zhao, Jiaxi, additional, Yan, Vincent K. C., additional, Blais, Joseph E., additional, Chan, Jacky C. H., additional, Li, Silvia T. H., additional, Shami, Jessica J. P., additional, Kwan, Christine, additional, Wei, Yue, additional, Wong, Carlos K. H., additional, Li, Xue, additional, Chui, Celine S. L., additional, Wan, Eric Y. F., additional, Lai, Francisco T. T., additional, Tse, Samson, additional, Cowling, Benjamin J., additional, Wong, Ian C. K., additional, and Chan, Esther W., additional

Published
2022
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15. 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
Full Text
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16. 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

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

Author

Medeiros, Michelle, primary, Love, T Rosie, additional, Slobogean, Gerard P., additional, Sprague, Sheila, additional, Perfetto, Eleanor M., additional, O'Hara, Nathan N., additional, Mullins, C. Daniel, additional, Wells, Jeffrey, additional, Bhandari, Mohit, additional, D'alleyrand, Jean-Claude, additional, Harris, Anthony, 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, PJ, additional, Guyatt, Gordon H., additional, Heels-Ansdell, Dianne, additional, Marvel, Debra, additional, Palmer, Jana, additional, Friedrich, Jeff, additional, O'Hara, Nathan, additional, Grissom, Frances, additional, Gitajn, Leah, additional, Morshed, Saam, additional, O'Toole, Robert, additional, Petrisor, Bradley A., additional, Camara, Megan, 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, Pogorzelski, David, additional, Rojas, Alejandra, additional, Scott, Taryn, additional, Del Fabbro, Gina, additional, Szasz, Olivia Page, additional, McKay, Paula, additional, Howe, Andrea, additional, Rudnicki, Joshua, additional, Demyanovich, Haley, additional, Little, Kelly, additional, Boissonneault, Adam, additional, Medeiros, Michellic, additional, Kettering, Eric, additional, Hale, Diamond, additional, Mahal, Nirmen, 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, Pollack, Andrew, additional, Sciadini, Marcus, additional, Degani, Yasmin, additional, Joseph, Katherine, additional, S. Marchand, Lucas, additional, Phipps, Heather, additional, Hempen, Eric, additional, Johal, Herman, additional, Risteyski, 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, McGaugh, Sarah M., additional, Pusztai, Kaitlyn, additional, Piekarski, Sarah, additional, Lyons, Mavis, additional, Gennaccaro, Julia, 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, Jang, Yohan, additional, Lopas, Luke A., additional, Hill, Lauren C., additional, Hudgins, Andrea, additional, Fentz, Courteney L., additional, Diaz, Maricela M., additional, Garst, Katelyn M., additional, Denari, Emma W., additional, Osborn, Patrick, additional, Pierrie, Sarah, additional, Martinez, Eric, additional, Kimmel, Joseph, additional, Herrera, Maria, additional, Adams, John D., additional, Beckish, Michael, additional, Bray, Christopher, additional, Brown, Timothy R., additional, Cross, Andrew W., additional, Dew, Timothy, additional, Faucher, Gregory, additional, Gurich Jr, 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 Jr, Edwin L., additional, Garitty, Michael J., additional, Poole, Andrew S., additional, Sims, Michael L., additional, Walker, Clark M., additional, Carlisle II, 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, Anderson, Matthew, additional, Eskew, Joshua, additional, Judkins, Benjamin, additional, Miller, James M., additional, Tanner, Stephanie L., additional, Snider, Rebecca G., additional, Townsend, Christine E., additional, Pham, Kayla H., additional, Martin, Abigail, additional, Robertson, Emily, additional, Wilson Sykes, John, 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, Murali, Jothi, additional, El Naga, Ashraf, additional, Tangtiphaiboontana, Jennifer, additional, Belaye, Tigist, additional, Berhaneselase, Eleni, additional, Paul, Alexandra, additional, Garg, Kartik, additional, Pokhvashchev, Dmitry, additional, Gary, Joshua L., additional, Warner, Stephen J., additional, Munz, John W., additional, Choo, Andrew M., additional, Achor, Timothy, additional, Routt, Milton L. "Chip", additional, Rao, Mayank, additional, Pechero, Guillermo, additional, Miller, Adam, additional, Kutzler, Michael, additional, Boutte, Sterling, additional, Warth, Ryan J., additional, Hagen, Jennifer E., additional, Patrick, Matthew, additional, Vlasak, Richard, additional, Krupko, Thomas, additional, Sadasivan, Kalia, additional, Talerico, Michael, additional, Horodyski, Marybeth, additional, Koenig, Chris, additional, Bailey, Daniel, additional, Wentworth, Daniel, additional, Van, Chi, additional, Schwartz, Justin, additional, Pazik, Marissa, additional, Lossada-Soto, Elizabeth, additional, Dehghan, Niloofar, additional, Jones, Clifford B., additional, Watson, J. Tracy, additional, McKee, Michael, additional, Karim, Ammar, additional, Sietsema, Debra L., additional, William, 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, Chris, additional, Hogan, Natalie, additional, Moreno, Fidel A., additional, Boulton, Christina, additional, Lowe, Jason, additional, Wild, Jason, additional, Ruth, John T., additional, Taylor, Michel, additional, Askam, Brad, additional, Seach, Andrea, additional, Saeed, Sabina, additional, Culbert, Hunter, additional, Crus, Alejandro, additional, Knapp, Thomas, additional, Hurkett, Colin, additional, Lowney, Maya, additional, Featherston, Breanna, additional, Carlson, Robin, additional, Romero, Iliana, additional, Zarif, Isaac, 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-Clavia, 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, Salomò Domènech, Mònica, additional, Soler-Cano, Albert, additional, Velasco-Barrera, Aldo, additional, Yela-Verdú, Christian, additional, Bueno-Ruiz, Mercedes, additional, Sánchez-Palomino, Estrella, additional, Andriola, Vito, additional, Molina-Corbacho, Matilde, additional, Maldonado-Sotoca, Yeray, additional, Gasset-Teixidor, Alfons, additional, Blasco-Moreu, Jorge, additional, Fernández-Poch, Núria, additional, Rodoreda-Puigdemasa, Josep, additional, Verdaguer-Figuerola, Arnau, additional, Enrique Cueva-Sevieri, Heber, additional, Garcia-Gimenez, Santiago, additional, Guerra-Farfán, Ernesto, additional, Tomas-Hernandez, Jordi, additional, Teixidor-Serra, Jordi, additional, Molero-Garcia, Vicente, additional, Selga-Marsa, Jordi, additional, Porcel-Vazquez, Juan Antonio, additional, Andres-Peiro, Jose Vicente, additional, Minguell-Monyart, Joan, additional, Nuñez-Camarena, Jorge, additional, del Mar Villar-Casares, Maria, additional, Mestre-Torres, Jaume, additional, Lalueza-Broto, Pilar, additional, Moreira-Borim, Felipe, additional, García, Yaiza, 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, Heimke, Isabella, 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, Seymour, Rachel, additional, Churchill, Christine, additional, Bartel, Claire, additional, Mayberry, Robert Miles, additional, Brownrigg, Maggie, additional, Girardi, Cara, additional, Mayfield, Ada, additional, Sweeney, Juliette, additional, Pollock, Hannah, additional, Hymes, Robert A., additional, Schwartzbach, Cary C., additional, Schulman, Jeff E., additional, Malekzadeh, A. Stephen, additional, Holzman, Michael A., additional, Wills, Jonathan, additional, Ramsey, Lolita, 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, Hill, Taylor, additional, Brotherton, Ariel, additional, Higgins, Thomas F., additional, Haller, Justin M., additional, Rothberg, David L., additional, Neese, Ashley, additional, Russell, Mark, additional, Olsen, Zachary M., additional, McGowan, Abby V., additional, Hill, Sophia, additional, Coe, Marcus, additional, Dwyer, Kevin, additional, Mullin, Devin S., additional, Reily, Clifford A, additional, DePalo, Peter, additional, Hall, Amy E., additional, Dabrowski, Rebecca E., additional, Chockbengboun, Theresa A., additional, Heng, Marilyn, additional, Harris, Mitchel B., additional, Smith, R. Malcolm, additional, Lhowe, David W., additional, Esposito, John, additional, Bansal, Mira, additional, McTague, Michael, additional, Alnasser, Ahmad, 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, Skeketha L., additional, Bhanat, Eldrin L., additional, Thimothee, Josny, additional, Serrano, Jackie, 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 II, Robert, additional, Pfaff, Branden, additional, Hollinsworth, Troy, additional, Atkins, Kristi, additional, Weaver, Michael J., additional, von Keudel, Arvind G., additional, McTague, Michael F., additional, Allen, Elizabeth M., additional, Sagona, Abigail E., additional, Jaeblon, Todd, additional, Beer, Robert, additional, Bauer, Brent, additional, Meredith, Sean, additional, Stone, Autumn, additional, Gage, Mark J., additional, Reilly, Rachel M., additional, Sparrow, Cindy, additional, Paniagua, Ariana, additional, Domes, Christopher M., additional, Johnson, Kristina P., additional, Shannon, Steven F., additional, Scott, Alesha N., additional, Clinch, Bobbi, additional, Lin, Carol A., additional, Vrahas, Mark S., additional, Moon, Charles N., additional, Marecek, Geoffrey S., additional, Dubuclet, Denice, additional, Scolaro, John A., additional, Learned, James R., additional, Lim, Philip K., additional, Demas, Susan, additional, Beltran, Michael J., additional, Archdeacon, Michael T., additional, Claude Sagi, Henry, additional, Wyrick, John D., additional, Toan Le, Theodore, additional, Laughlin, Richard T., additional, and Thomson, Cameron G., additional

Published
2021
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18. 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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19. 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. 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, Fowler, Justin, Pierrie, Sarah, Herrera, Maria, Morshed, Saam, Miclau, Theodore, Marmor, Meir, 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, 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, Mar Villar-Casares, Maria del, 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., Marchand, Lucas S., 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, Robert, Seabold, Kyle, Staudenmier, Nicholas, Gitajn, I. Leah, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo, 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, Demyanovich, Haley K., 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 Cruz, Yan Marco Dela

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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20. Role of 5-aminosalicylic acid in ulcerative colitis management in 8 Asian territories: a physician survey.

Author

Limsrivilai J, Lai AY, Li STH, Abdullah M, Ali RAR, Aniwan S, Bui HH, Chou JW, Hilmi IN, Lim WC, Sollano J, Teo MMH, Wei SC, and Leung WK

Abstract

Clinical guidelines typically endorse conventional therapies such as 5-aminosalicylic acid (5-ASA) as the mainstay of ulcerative colitis management. However, the degree of adoption and application of guideline recommendations by physicians within Asia remains unclear. This study aims to understand the prescribing patterns of 5-ASA and implementation of current guideline recommendations across Asian clinical practice. A physician survey was conducted among inflammatory bowel disease specialists in 8 Asian territories to understand practices and preferences in ulcerative colitis management, focusing on the use of 5-ASA and concordance with guideline recommendations. Survey findings were validated by country experts in diverse healthcare settings. Subgroup analyses stratified data by income levels and treatment reimbursement status. Ninety-eight valid responses were received from inflammatory bowel disease specialists or gastroenterologists among 8 economic entities. Significant differences were found in clinical practices and treatment preferences for ulcerative colitis management among different income-level and government-subsidy groups. Survey results are summarized in 8 findings that illustrate trends in 5-ASA use and guideline implementation across Asian territories. This study emphasizes socioeconomic factors that impact the adoption of guideline recommendations in real-world practice. Our findings indicate an eclectic approach to guideline implementation across Asia, based on resource availability and feasibility of treatment goals.

Published
2025
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21. A Quality Analysis of Systematic Reviews in Dentistry, Part 1: Meta-Analyses of Randomized Controlled Trials.

Author

El-Rabbany M, Li S, Bui S, Muir JM, Bhandari M, and Azarpazhooh A

Subjects
Checklist, Humans, Publication Bias, Randomized Controlled Trials as Topic, Dentistry, Research Design
Abstract

Objectives: As the volume of publications in dentistry continues to increase, clinicians are becoming increasingly reliant on systematic reviews and meta-analyses as their primary source of evidence. With an increase in the dependence on dental metaanalyses, it is important to ensure that they are being conducted with as little bias as possible. The objective of this systematic review is to assess the quality of therapeutic meta-analyses of randomized controlled trials (RCTs) on dental-related topics and to analyze how quality has changed over time., Methods: All relevant studies were searched for through MEDLINE, Embase, PsycINFO, and the Cochrane Library. Title, abstract, and full-text review, as well as data extraction and quality assessment, were all conducted in duplicate. All reviewers used a pilot-tested extraction form that included the AMSTAR checklist to assess quality of systematic reviews. A logit link function ordinal regression was conducted to evaluate quality improvement trends over time., Results: Of the 3832 studies identified, 208 studies were selected for review. Of these, 13% provided an a priori design, 53% screened and extracted data in duplicate, 29% included gray literature, 63% assessed the quality of included studies, and 39% assessed publication bias. As was indicated by the ordinal regression, the quality of meta-analyses, as per the AMSTAR criteria, has increased significantly with time (P < .001)., Conclusions: This investigation illustrates that although the quality of meta-analyses of RCTs has been increasing since the start of the millennium, there remains substantial room for improvement within all aspects of systematic review reporting and methodology. Therefore, it is critical for clinicians to take caution when reading systematic reviews and meta-analyses, ensuring that the principals of critical appraisal are applied when interpreting meta-analyses of RCTs., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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