Search

Your search keyword '"Eleni Berhaneselase"' showing total 3 results
Start Over Author "Eleni Berhaneselase" Topic medicine (general)
3 results on '"Eleni Berhaneselase"'

1. GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures

Author

Billy T. Haonga, Jamieson M. O’Marr, Patrick Ngunyale, Joshua Ngahyoma, Justin Kessey, Ibrahim Sasillo, Patricia Rodarte, Tigist Belaye, Eleni Berhaneselase, Edmund Eliezer, Travis C. Porco, Saam Morshed, and David W. Shearer

Subjects
Local antibiotics, Fracture-related Infection, Open tibia fractures, Gentamicin, Tanzania, Randomized control, Medicine (General), R5-920
Abstract

Abstract Background The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different. Methods This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up. Discussion This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures. Trial registration Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Published
2023
Full Text
View/download PDF

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

Author

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

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

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

Published
2021
Full Text
View/download PDF

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

Author

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

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

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

Published
2021
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results