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

Guillermo Pechero Jr; 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; PREP-IT Investigators; Gerard P Slobogean; Sheila Sprague; Jeffrey Wells; Mohit Bhandari; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; PREP-IT Clinical Sites; 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; Gerard P Slobogean; Yasmin Degani; Haley K Demyanovich; Andrea Howe; Nathan N O'Hara; Katherine Joseph; Joshua Rudnicki; Megan Camara; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE

doi:10.1016/j.conctc.2021.100787

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

Contemp Clin Trials Commun. 2021 Jun 14:22:100787. doi: 10.1016/j.conctc.2021.100787. eCollection 2021 Jun.

Authors

Guillermo Pechero Jr¹, Branden Pfaff², Mayank Rao¹, David Pogorzelski³, Paula McKay³, Ella Spicer⁴, Andrea Howe⁵, Haley K Demyanovich⁵, Debra L Sietsema⁶, Michael F McTague⁷, Lolita Ramsey⁸, Martha Holden⁹, Joshua Rudnicki⁵, Jeff Wells¹⁰, Michelle Medeiros¹¹, Gerard P Slobogean⁵, Sheila Sprague^{3

12}; PREP-IT Investigators; Gerard P Slobogean¹³, Sheila Sprague¹⁴, Jeffrey Wells¹⁵, Mohit Bhandari¹⁴; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; PREP-IT Clinical Sites; Robert V O'Toole¹⁶, Jean-Claude D'Alleyrand¹⁶, Andrew Eglseder¹⁶, Aaron Johnson¹⁶, Christopher Langhammer¹⁶, Christopher Lebrun¹⁶, Theodore Manson¹⁶, Jason Nascone¹⁶, Ebrahim Paryavi¹⁶, Raymond Pensy¹⁶, Andrew Pollak¹⁶, Marcus Sciadini¹⁶, Gerard P Slobogean¹⁶, Yasmin Degani¹⁶, Haley K Demyanovich¹⁶, Andrea Howe¹⁶, Nathan N O'Hara¹⁶, Katherine Joseph¹⁶, Joshua Rudnicki¹⁶, Megan Camara¹⁶; Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE

Collaborators

Gerard P Slobogean, Mohit Bhandari, Sheila Sprague, Jean-Claude D'Alleyrand, Anthony D Harris, Daniel C Mullins, Lehana Thabane, Jeffrey Wells, Amber Wood, Gregory J Della Rocca, Anthony D Harris, 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, Lehana Thabane, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeffrey Wells, Jeff Friedrich, Daniel C Mullins, Nathan N O'Hara, Ms Frances Grissom, Gregory J Della Rocca, I Leah Gitajn, Kyle J Jeray, Saam Morshed, Robert V O'Toole, Bradley A Petrisor, Megan Camara, Franca Mossuto, Anthony D Harris, Manjari G Joshi, Jean-Claude D'Alleyrand, Justin Fowler, Jessica Rivera, Max Talbot, Sheila Sprague, Mohit Bhandari, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, David Pogorzelski, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Diane Heels-Ansdell, Paula McKay, Gerard P Slobogean, Nathan N O'Hara, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C Daniel Mullins, Michelle Medeiros, 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, Justin Fowler, Sarah Pierrie, Eric Martinez, Joseph Kimmel, Kyle J Jeray, 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 2nd, 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, Saam Morshed, 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, 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-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, 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, Robert A Hymes, Cary C Schwartzbach, Jeff E Schulman, A Stephen Malekzadeh, Michael A Holzman, Lolita Ramsey, James S Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D English, Sharon M Haaser, Jaslynn An 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, I Leah Gitajn, 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 3rd, Branden Pfaff, Troy Hollinsworth, Michael J Weaver, Arvind G von Keudell, Michael F McTague, Elizabeth M Allen, Todd Jaeblon, Robert Beer, Haley K Demyanovich, Mark J Gage, Rachel M Reilly, Cindy Sparrow

Affiliations

¹ McGovern Medical School, The University of Texas Health Science Center at Houston, 7000 Fannin Street, Houston, TX, USA.
² Sanford USD Medical Center and Hospital, 1305 W. 18th St., Sioux Falls, SD, USA.
³ Department of Surgery, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, Canada.
⁴ Fraser Health Authority/Royal Columbian Hospital, 403-233 Nelson's Crescent, New Westminster, BC, Canada.
⁵ Department of Orthopaedic Surgery, University of Maryland School of Medicine, 655 W Baltimore St. S., Baltimore, MD, USA.
⁶ The CORE Institute®, 6501 North 19th Avenue, Phoenix, AZ, USA.
⁷ Department of Orthopaedic Surgery, Harvard Medical School Orthopedic Trauma Initiative, Brigham and Women's Hospital, Boston, USA.
⁸ Inova Fairfax Medical Campus, 3300 Gallows Road, Falls Church, VA, USA.
⁹ Department of Orthopaedic Surgery, Wake Forest Baptist Health, 1 Medical Center Blvd, Winston-Salem, NC, USA.
¹⁰ Trauma Survivors Network, 8110 Gatehouse Road, Falls Church, VA, USA.
¹¹ University of Maryland School of Pharmacy, The PATIENTS Program, 220 Arch Street, Baltimore, MD, USA.
¹² Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main St. W., Hamilton, ON, Canada.
¹³ University of Maryland School of Medicine, Baltimore, MD, USA.
¹⁴ McMaster University, Hamilton, ON, Canada.
¹⁵ Trauma Survivors Network, Falls Church, VA, USA.
¹⁶ University of Maryland School of Medicine, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.

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.

Keywords: Cluster randomized crossover; Consent; Deferred consent; Patient advisors; Stakeholder engagement; Trial design.