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

Author

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

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

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

Published
2021
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2. Bone healing: Advances in biology and technology

Author

Brian H. Mullis, MD, Andrew S. Gudeman, MD, Joseph Borrelli, Jr, MD, Brett D. Crist, MD, Mark A. Lee, MD, and Andrew R. Evans, MD

Subjects
Orthopedic surgery, RD701-811
Abstract

Abstract. Fracture healing is a complex cascade of cellular and molecular processes. These processes require the appropriate cellular and molecular environment to ensure the restoration of skeletal stability and resolution of inflammation. In order for fracture healing to occur, the necessary building blocks for bone metabolism and synthesis must be supplied through proper nutrition. Pharmacologic therapies aimed at modulating the inflammatory response to fractures have the potential to interfere with the synthesis of molecules needed for the production of bone. Infection can interfere with, and even prevent normal fracture healing from occurring. Cellular and genetic treatment strategies are actively being developed to target deficiencies, and bridge gaps that can influence how fractures heal. Evolving technologies, including nutritional supplementation, pharmacotherapies, antibiotics, surgical techniques, as well as genetic and cellular therapies, have the potential to enhance, optimize, and even revolutionize the process of fracture healing.

Published
2021
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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
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4. Arthroscopy Should be Used With Caution for Gunshot Wounds to the Hip

Author

Brian H. Mullis, Marcus V. Trotter, Jorge Figueras, and Jan P. Ertl

Subjects
medicine.medical_specialty, Abdominal compartment syndrome, medicine.diagnostic_test, business.industry, Exploratory laparotomy, medicine.medical_treatment, Rehabilitation, Trauma center, Arthroscopy, Public Health, Environmental and Occupational Health, Physical Therapy, Sports Therapy and Rehabilitation, medicine.disease, Surgery, Hematoma, medicine, Current Procedural Terminology, Original Article, Orthopedics and Sports Medicine, Hip arthroscopy, Gunshot wound, business
Abstract

Purpose To evaluate the safety and efficacy of hip arthroscopy immediately following gunshot wound (GSW) to the hip. Methods Patients who received hip arthroscopy for GSWs from 2006 to 2020 by 2 surgeons at a level I trauma center were identified by Current Procedural Terminology codes. Inclusion criteria were those patients who suffered a GSW to the hip, received hip arthroscopy for treatment, and had a minimum follow-up of 2 months. The exclusion criteria were any patients younger than 18 years of age. Medical records were reviewed for patient demographics, surgical details, clinical outcomes, and complications. Results A total of 50 hip arthroscopy cases were identified by Current Procedural Terminology codes. Of the 50 cases identified, 8 patients met the inclusion criteria. All 8 patients were male, African-American, and the mean age was 31 years (range, 19-54 years) with mean follow-up of 14 months. Five of 8 cases were noted to have poor visualization with arthroscopy. Common reasons for poor visualization were difficult access to the bullet fragments, morbid obesity, hematoma formation, and pre-existing arthritis. Of these 5 cases, 2 were converted to open procedures to retrieve the remaining bullet fragments. One patient developed abdominal compartment syndrome, most likely due to increased pulse pressure over a prolonged operative period and involvement of the acetabular fovea. Emergent exploratory laparotomy and abdominal compartment fluid release were performed, and the patient had an otherwise unremarkable hospital course. Conclusions There are risks with the use of arthroscopic methods to remove GSW fragments, which may be greater than elective hip arthroscopy. Certain factors, such as the surgeon’s arthroscopic experience, locations of bullets fragments, visual quality, length of procedure, and concomitant acetabular fractures, must be considered before proceeding with arthroscopy. Level of Evidence Therapeutic case series.

Published
2021

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

Author

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

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

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

Author

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

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

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

Published
2020

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