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

Author

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

Published
2024
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7. 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

8. PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.

Author

O'Toole, Robert V, Stein, Deborah M, Frey, Katherine P, O'Hara, Nathan N, Scharfstein, Daniel O, Slobogean, Gerard P, Taylor, Tara J, Haac, Bryce E, Carlini, Anthony R, Manson, Theodore T, Sudini, Kuladeep, Mullins, C Daniel, Wegener, Stephen T, Firoozabadi, Reza, Haut, Elliott R, Bosse, Michael J, Seymour, Rachel B, Holden, Martha B, Gitajn, Ida Leah, Goldhaber, Samuel Z, Eastman, Alexander L, Jurkovich, Gregory J, Vallier, Heather A, Gary, Joshua L, Kleweno, Conor P, Cuschieri, Joseph, Marvel, Debra, Castillo, Renan C, and METRC

Subjects
METRC, orthopaedic & trauma surgery, thromboembolism, trauma management, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

IntroductionPatients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients.Methods and analysisPREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections.Ethics and disseminationThe PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients.Trial registration numberNCT02984384.

Published
2021

9. 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

12. 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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17. 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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19. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force

Author

Husereau, Don, Drummond, Michael, Augustovski, Federico, de Bekker-Grob, Esther, Briggs, Andrew H., Carswell, Chris, Caulley, Lisa, Chaiyakunapruk, Nathorn, Greenberg, Dan, Loder, Elizabeth, Mauskopf, Josephine, Mullins, C. Daniel, Petrou, Stavros, Pwu, Raoh-Fang, and Staniszewska, Sophie

Published
2022
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21. 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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22. 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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23. Correction to: Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations

Author

Husereau, Don, Drummond, Michael, Augustovski, Federico, de Bekker-Grob, Esther, Briggs, Andrew H., Carswell, Chris, Caulley, Lisa, Chaiyakunapruk, Nathorn, Greenberg, Dan, Loder, Elizabeth, Mauskopf, Josephine, Mullins, C. Daniel, Petrou, Stavros, Pwu, Raoh-Fang, and Staniszewska, Sophie

Published
2022
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25. Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial.

Author

O'Hara, Nathan N., Frey, Katherine P., Stein, Deborah M., Levy, Joseph F., Slobogean, Gerard P., Castillo, Renan, Firoozabadi, Reza, Karunakar, Madhav A., Gary, Joshua L., Obremskey, William T., Seymour, Rachel B., Cuschieri, Joseph, Mullins, C. Daniel, O'Toole, Robert V., Carlini, Anthony R., Fowler, Brianna E., Taylor, Tara J., Wegener, Stephen T., Weston-Farber, Elias, and Herndon, Steven Craig

Subjects
ASPIRIN, HEPARIN, ENOXAPARIN, LOW-molecular-weight heparin, PATIENTS' attitudes, CLINICAL trials, COST analysis, PATIENT experience
Abstract

Background: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients' experiences with these medications, we compared patients' satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin. Methods: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales. Results: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p < 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p < 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least $25 (OR: 0.15; 95% CI: 0.12 to 0.18; p < 0.001). Conclusions: Use of aspirin substantially improved patients' satisfaction with their medication after orthopaedic trauma. While aspirin use increased the odds of incurring any out-of-pocket costs, it protected against costs of ≥$25, potentially improving health equity for thromboprophylaxis. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative

Author

Orsini, Lucinda S., Berger, Marc, Crown, William, Daniel, Gregory, Eichler, Hans-Georg, Goettsch, Wim, Graff, Jennifer, Guerino, John, Jonsson, Pall, Lederer, Nirosha Mahendraratnam, Monz, Brigitta, Mullins, C. Daniel, Schneeweiss, Sebastian, Brunt, David Van, Wang, Shirley V., and Willke, Richard J.

Published
2020
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29. Ability of Caprini and Padua risk-assessment models to predict venous thromboembolism in a nationwide Veterans Affairs study

Author

Hayssen, Hilary, primary, Sahoo, Shalini, additional, Nguyen, Phuong, additional, Mayorga-Carlin, Minerva, additional, Siddiqui, Tariq, additional, Englum, Brian, additional, Slejko, Julia F., additional, Mullins, C. Daniel, additional, Yesha, Yelena, additional, Sorkin, John D., additional, and Lal, Brajesh K., additional

Published
2023
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33. Methodological Comparison of Mapping the Expanded Prostate Cancer Index Composite to EuroQoL-5D-3L Using Cross-Sectional and Longitudinal Data: Secondary Analysis of NRG/RTOG 0415

Author

Khairnar, Rahul, DeMora, Lyudmila, Sandler, Howard M., Lee, W. Robert, Villalonga-Olives, Ester, Mullins, C. Daniel, Palumbo, Francis B., Bruner, Deborah W., Shaya, Fadia T., Bentzen, Soren M., Shah, Amit B., Malone, Shawn, Michalski, Jeff M., Dayes, Ian S., Seaward, Samantha A., Albert, Michele, Currey, Adam D., Pisansky, Thomas M., Chen, Yuhchyau, Horwitz, Eric M., DeNittis, Albert S., Feng, Felix, and Mishra, Mark V.

Published
2022
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45. Good Practices for Real‐World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐World Evidence in Health Care Decision Making

Author

Berger, Marc L., Sox, Harold, Willke, Richard J., Brixner, Diana L., Eichler, Hans‐Georg, Goettsch, Wim, Madigan, David, Makady, Amr, Schneeweiss, Sebastian, Tarricone, Rosanna, Wang, Shirley V., Watkins, John, and Mullins, C. Daniel

Published
2017
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