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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. 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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3. Comparison of 24-Month Outcomes After Treatment for Distal Radius Fracture: The WRIST Randomized Clinical Trial

Author

Kevin C, Chung, Hyungjin Myra, Kim, Sunitha, Malay, Melissa J, Shauver, and Debra, Bullard

Subjects
Male, medicine.medical_specialty, Canada, medicine.medical_treatment, Wrist, law.invention, Upper Extremity, External fixation, Randomized controlled trial, law, Hand strength, Multicenter trial, medicine, Humans, Malunion, Aged, Aged, 80 and over, Singapore, business.industry, General Medicine, Middle Aged, medicine.disease, Wrist Injuries, United States, Percutaneous pinning, Casts, Surgical, medicine.anatomical_structure, Treatment Outcome, Relative risk, Physical therapy, Female, business, Radius Fractures, Bone Plates, Follow-Up Studies
Abstract

Importance Distal radius fractures (DRFs) are common injuries among older adults and can result in substantial disability. Current evidence regarding long-term outcomes in older adults is scarce. Objective To compare outcomes across treatment groups at 24 months among adults with DRFs who participated in the WRIST trial. Design, Setting, and Participants The Wrist and Radius Injury Surgical Trial (WRIST) randomized, international, multicenter trial was conducted from April 1, 2012, through December 31, 2016. Participants were adults aged 60 years or older with isolated, unstable DRFs at 24 health systems in the US, Canada, and Singapore. Data analysis was performed from March 2019 to March 2021. Interventions Participants were randomized to open reduction and volar locking plate system (VLPS), external fixation with or without supplementary pinning (EFP), and percutaneous pinning (CRPP). The remaining participants chose closed reduction and casting. Main Outcomes and Measures The primary outcome was the 24-month Michigan Hand Outcomes Questionnaire (MHQ) summary score. Secondary outcomes were scores on the MHQ subdomains hand strength and wrist motion. Results A total of 304 adults were recruited for the study, and 187 were randomized to undergo surgery, 65 to VLPS, 64 to EFP, and 58 to CRPP; 117 participants opted for closed reduction and casting. Assessments were completed at 24 months for 182 participants (160 women [87.9%]; mean [SD] age, 70.1 [8.5] years). Mean MHQ summary scores at 24 months were 88 (95% CI, 83-92) for VLPS, 83 (95% CI, 78-88) for EFP, 85 (95% CI, 79-90) for CRPP, and 85 (95% CI, 79-90) for casting, with no clinically meaningful difference across groups after adjusting for covariates (χ23 = 1.44; P = .70). Pain scores also did not differ across groups at 24 months (χ23 = 2.64; P = .45). MHQ summary scores changed from 82 (95% CI, 80-85) to 85 (95% CI, 83-88) (P = .12) between 12 and 24 months across groups. The rate of malunion was higher in the casting group (26 participants [59.1%]) than in the other groups (4 participants [8.0%] for VLPS, 8 participants [17.0%] for EFP, and 4 participants [9.8%] for CRPP; χ23 = 43.6; P

Published
2021

4. Predicting Outcomes After Distal Radius Fracture: A 24-Center International Clinical Trial of Older Adults

Author

Kevin C. Chung, H. Myra Kim, Sunitha Malay, Melissa J. Shauver, Steven C. Haase, Jeffrey N. Lawton, John R. Lien, Adeyiza O. Momoh, Kagan Ozer, Erika D. Sears, Jennifer F. Waljee, Matthew S. Brown, Hoyune E. Cho, Brett F. Michelotti, Tamara D. Rozental, Paul T. Appleton, Edward K. Rodriguez, Laura N. Deschamps, Lindsay Mattfolk, Katiri Wagner, Philip Blazar, Brandon E. Earp, W. Emerson Floyd, Dexter L. Louie, Fraser J. Leversedge, Marc J. Richard, David S. Ruch, Suzanne Finley, Cameron Howe, Maria Manson, Janna Whitfield, Bertrand H. Perey, Kelly Apostle, Dory Boyer, Farhad Moola, Trevor Stone, Darius Viskontas, Mauri Zomar, Karyn Moon, Raely Moon, Loree K. Kalliainen, Christina M. Ward, James W. Fletcher, Cherrie A. Heinrich, Katharine S. Pico, Ashish Y. Mahajan, Brian W. Hill, Sandy Vang, Dawn M. Laporte, Erik A. Hasenboehler, Scott D. Lifchez, Greg M. Osgood, Babar Shafiq, Jaimie T. Shores, Vaishali Laljani, H. Brent Bamberger, Timothy W. Harman, David W. Martineau, Carla Robinson, Brandi Palmer, Ruby Grewal, Ken A. Faber, Joy C. MacDermid, Kate Kelly, Katrina Munro, Joshua I. Vincent, David Ring, Jesse B. Jupiter, Abigail Finger, Jillian S. Gruber, Rajesh K. Reddy, Taylor M. Pong, Emily R. Thornton, David G. Dennison, Sanjeev Kakar, Marco Rizzo, Alexander Y. Shin, Tyson L. Scrabeck, Kyle Chepla, Kevin Malone, Harry A. Hoyen, Blaine Todd Bafus, Roderick B. Jordan, Bram Kaufman, Ali Totonchil, Dana R. Hromyak, Lisa Humbert, Sandeep Sebastin, Sally Tay, Kate W. Nellans, Sara L. Merwin, Ethan W. Blackburn, Sandra J. Hanlin, Barbara Patterson, R. Glenn Gaston, R. Christopher Cadderdon, Erika Gordon Gantt, John S. Gaul, Daniel R. Lewis, Bryan J. Loeffler, Lois K. Osier, Paul C. Perlik, W. Alan Ward, Benjamin Connell, Pricilla Haug, Caleb Michalek, Tod A. Clark, Sheila McRae, Jennifer Moriatis Wolf, Craig M. Rodner, Katy Coyle, Thomas P. Lehman, Yuri C. Lansinger, Gavin D. O’Mahony, Kathy Carl, Janet Wells, David J. Bozentka, L. Scott Levin, David P. Steinberg, Annamarie D. Horan, Denise Knox, Kara Napolitano, John Fowler, Robert Goitz, Cathy A. Naccarelli, Joelle Tighe, Warren C. Hammert, Allison W. McIntyre, Krista L. Noble, Kaili Waldrick, Jeffery B. Friedrich, David Bowman, Angela Wilson, Zhongyu Li, L. Andrew Koman, Benjamin R. Graves, Beth P. Smith, and Debra Bullard

Subjects
Male, medicine.medical_specialty, predictors of outcomes, Recursive partitioning, Comorbidity, 030230 surgery, Wrist, Affect (psychology), law.invention, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Surveys and Questionnaires, Outcome Assessment, Health Care, Medicine and Health Sciences, Humans, Medicine, Orthopedics and Sports Medicine, older adults, Aged, Pain Measurement, Aged, 80 and over, 030222 orthopedics, business.industry, Secondary data, Evidence-based medicine, Middle Aged, Prognosis, Identified patient, Clinical trial, medicine.anatomical_structure, Physical therapy, Female, Surgery, Radius Fractures, business, Distal radius fracture
Abstract

© 2019 American Society for Surgery of the Hand Purpose: Current evidence on predictors of outcomes after distal radius fracture is often based on retrospective analyses or may be confounded by fracture type. Using data from the Wrist and Radius Injury Surgical Trial (WRIST), a 24-site randomized study of distal radius fracture treatment, in which all fractures are severe enough to warrant surgery, we set out to perform a secondary data analysis to explore predictors of better or worse hand outcomes. Methods: The primary outcome measure was the Michigan Hand Outcomes Questionnaire (MHQ) summary score 12 months after treatment. We used a regression tree analysis with recursive partitioning to identify subgroups of participants who experienced similar outcomes (ie, MHQ score) and to determine which baseline or treatment factors they had in common. Results: Factors most predictive of 12-month MHQ score were pain at enrollment, education, age, and number of comorbidities. Specifically, participants who had a high school education or less and also reported severe pain had the lowest MHQ scores. Conversely, participants with less pain and more education and who were age 87 years or younger with one or no comorbid condition had the highest MHQ scores. Treatment type or radiographic measurements assessed on post-reduction films did not affect 12-month outcomes. Conclusions: These results identified patient characteristics that can be used by surgeons to identify subgroups of patients who may experience similar hand outcomes. Type of study/level of evidence: Prognostic III.

Published
2019

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

7. Reflections 1 Year Into the 21-Center National Institutes of Health–Funded WRIST Study: A Primer on Conducting a Multicenter Clinical Trial

Author

Mauri Zomar, Suzanne Finley, Tyson L. Scrabeck, Annamarie D. Horan, W. Emerson Floyd, Bertrand Perey, David Boman, Carla Robinson, Sanjeev Kakar, Claudette L. Cooper, Lindsay M Herder, Kristie Millman, Joy C. MacDermid, James W. Fletcher, Jennifer Moriatis Wolf, Jerry I. Huang, David S. Ruch, Jennifer F. Waljee, David Ring, Reuben A. Bueno, Beth P. Smith, Mark McAndrew, Zhongyu Li, Kathy Carl, Edward K. Rodriguez, Jason H. Ko, Jeffrey N. Lawton, Brent Bamberger, Kagan Ozer, Scott Levin, Katherine S. Pico, Sandeep J. Sebastin, Brian W. Hill, Andrew Koman, Jennifer Koechle, Tamara D. Rozental, Tod A. Clark, Thomas P. Lehman, Debra Bullard, Jeffrey B. Friedrich, Paul T. Appleton, Poh Ling Tay, Allison W. McIntyre, Rajesh K. Reddy, Benjamin Connell, David J. Bozentka, Kate W. Nellans, Mark P. Cote, Brandi Palmer, Kevin J. Malone, Michael W. Neumeister, Christian M. Ward, Douglas P. Hanel, Kevin C. Chung, Katiri Wagner, Marc J. Richards, Melissa J. Shauver, Denise Knox, Steven C. Haase, Loree K. Kalliainen, Cherrie A. Heinrich, Ruby Grewal, David R. Steinberg, Glenn Gaston, David G. Dennison, Harry A. Hoyen, Warren C. Hammert, Alexander Y. Shin, Philip E. Blazar, H. Myra Kim, Nicholas B. Vedder, Nada N. Berry, Sunitha Malay, Christopher H. Allan, Kate Kelly, Craig M. Rodner, Brandon E. Earp, and Jesse B. Jupiter

Subjects
medicine.medical_specialty, business.industry, Wrist, law.invention, Clinical trial, medicine.anatomical_structure, Randomized controlled trial, law, Physical therapy, Medicine, Orthopedics and Sports Medicine, Surgery, Center (algebra and category theory), Distal radius fracture, business, Primer (cosmetics)
Published
2013

8. Human leukocyte antigen sensitization after structural cortical allograft implantations

Author

Michael D. Gautreaux, David F. Kiger, Eugene Heise, William G. Ward, Beth P. Smith, Debra Bullard, Julia Rushing, and Carol A. Boles

Subjects
Adult, Male, Pathology, medicine.medical_specialty, Adolescent, Human leukocyte antigen, HLA Antigens, Transplantation Immunology, medicine, Humans, Transplantation, Homologous, Orthopedics and Sports Medicine, Prospective Studies, Risk factor, Sensitization, Survival analysis, Autoantibodies, Proportional Hazards Models, Bone Transplantation, Chi-Square Distribution, biology, business.industry, Incidence (epidemiology), Human Leukocyte Antigen Sensitization, General Medicine, Middle Aged, medicine.anatomical_structure, Cohort, Immunology, biology.protein, Surgery, Female, Antibody, business
Abstract

UNLABELLED The incidence and significance of a donor-specific human leukocyte antigen antibody response to massive fresh-frozen human bone allograft implantation is not established. This study was a prospective, multicenter study of a cohort of consecutive patients who self-randomized themselves into two groups based on their alloantibody response to allograft bone transplant. The study hypothesis was that donor-directed antibodies are an independent risk factor influencing incorporation of massive frozen bone allografts. Pretransplant and posttransplant human leukocyte antigen alloantibody analysis was performed and correlated to determine pre-existing and graft-induced antibodies. The surgical outcomes of the two groups of patients were compared to determine the relationship between alloantibody response and bone graft incorporation. Preliminary results revealed that donor-specific human leukocyte antigen sensitization occurred in 17 of 32 (53%) of previously nonsensitized patients. A survival analysis of time to healing based on human leukocyte antigen status showed no evidence of an association between human leukocyte antigen status and time to healing. Longer followup in additional patients will be required to determine if this sensitization is correlated with an alteration in the time to union or with the quality or type of bone graft incorporation. LEVEL OF EVIDENCE Therapeutic study, Level II. See the Guidelines for Authors for a complete description of levels of evidence.

Published
2005

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