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Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
- Pechero, Guillermo;
- Pfaff, Branden;
- Rao, Mayank;
- Pogorzelski, David;
- McKay, Paula;
- Spicer, Ella;
- Howe, Andrea;
- Demyanovich, Haley K;
- Sietsema, Debra L;
- McTague, Michael F;
- Ramsey, Lolita;
- Holden, Martha;
- Rudnicki, Joshua;
- Wells, Jeff;
- Medeiros, Michelle;
- Slobogean, Gerard P;
- Sprague, Sheila;
- Investigators, PREP-IT;
- Slobogean, Gerard P;
- Sprague, Sheila;
- Wells, Jeffrey;
- Bhandari, Mohit;
- Committee, Steering;
- Bhandari, Mohit;
- Sprague, Sheila;
- D'Alleyrand, Jean-Claude;
- Harris, Anthony D;
- Mullins, Daniel C;
- Thabane, Lehana;
- Wood, Amber;
- Committee, Adjudication;
- Della Rocca, Gregory J;
- Hebden, Joan;
- Jeray, Kyle J;
- Marchand, Lucas;
- O'Hara, Lyndsay M;
- Zura, Robert;
- Committee, Data and Safety Monitoring;
- Gardner, Michael J;
- Blasman, Jenna;
- Davies, Jonah;
- Liang, Stephen;
- Taljaard, Monica;
- Core, Research Methodology;
- Devereaux, PJ;
- Guyatt, Gordon H;
- Thabane, Lehana;
- Heels-Ansdell, Diane;
- Core, Patient Centred Outcomes;
- Marvel, Debra;
- Palmer, Jana;
- Friedrich, Jeff;
- O'Hara, Nathan N;
- Grissom, Frances;
- Core, Orthopaedic Surgery;
- Gitajn, I Leah;
- Morshed, Saam;
- O'Toole, Robert V;
- Petrisor, Bradley A;
- Core, Room;
- Camara, Megan;
- Mossuto, Franca;
- Core, Infectious Disease;
- Joshi, Manjari G;
- Core;
- Fowler, Justin;
- Rivera, Jessica;
- Talbot, Max;
- Sprague, Sheila;
- Bhandari, Mohit;
- Dodds, Shannon;
- Garibaldi, Alisha;
- Li, Silvia;
- Nguyen, Uyen;
- Pogorzelski, David;
- Rojas, Alejandra;
- Scott, Taryn;
- Del Fabbro, Gina;
- Szasz, Olivia Paige;
- Heels-Ansdell, Diane;
- McKay, Paula;
- Slobogean, Gerard P;
- O'Hara, Nathan N;
- Howe, Andrea;
- Rudnicki, Joshua;
- Demyanovich, Haley;
- Little, Kelly;
- Mullins, C Daniel;
- Medeiros, Michelle;
- Kettering, Eric;
- Hale, Diamond;
- Sites, PREP-IT Clinical;
- O'Toole, Robert V;
- D'Alleyrand, Jean-Claude;
- Eglseder, Andrew;
- Johnson, Aaron;
- Langhammer, Christopher;
- Lebrun, Christopher;
- Manson, Theodore;
- Nascone, Jason;
- Paryavi, Ebrahim;
- Pensy, Raymond;
- Pollak, Andrew;
- Sciadini, Marcus;
- Slobogean, Gerard P;
- Degani, Yasmin;
- Demyanovich, Haley K;
- Howe, Andrea;
- O'Hara, Nathan N;
- Joseph, Katherine;
- Rudnicki, Joshua;
- Camara, Megan;
- Aqueous-PREP and PREPARE;
- Petrisor, Brad A;
- Johal, Herman;
- Ristevski, Bill;
- Williams, Dale;
- Denkers, Matthew;
- Rajaratnam, Krishan;
- Al-Asiri, Jamal;
- Leonard, Jordan;
- Marcano-Fernández, Francesc A;
- Gallant, Jodi;
- Persico, Federico;
- Gjorgjievski, Marko;
- George, Annie;
- Natoli, Roman M;
- Gaski, Greg E;
- McKinley, Todd O;
- Virkus, Walter W;
- Sorkin, Anthony T;
- Szatkowski, Jan P;
- Baele, Joseph R;
- Mullis, Brian H;
- Hill, Lauren C;
- Hudgins, Andrea;
- Osborn, Patrick;
- Fowler, Justin;
- Pierrie, Sarah;
- Martinez, Eric;
- Kimmel, Joseph;
- Jeray, Kyle J;
- Adams, John D;
- Beckish, Michael L;
- Bray, Christopher C;
- Brown, Timothy R;
- Cross, Andrew W;
- Dew, Timothy;
- Faucher, Gregory K;
- Gurich, Richard W;
- Lazarus, David E;
- Millon, S John;
- Palmer, M Jason;
- Porter, Scott E;
- Schaller, Thomas M;
- Sridhar, Michael S;
- Sanders, John L;
- Rudisill, L Edwin;
- Garitty, Michael J;
- Poole, Andrew S;
- Sims, Michael L;
- Walker, Clark M;
- Carlisle, Robert M;
- Hofer, Erin Adams;
- Huggins, Brandon S;
- Hunter, Michael D;
- Marshall, William A;
- Ray, Shea Bielby;
- Smith, Cory D;
- Altman, Kyle M;
- Bedard, Julia C;
- Loeffler, Markus F;
- Pichiotino, Erin R;
- Cole, Austin A;
- Maltz, Ethan J;
- Parker, Wesley;
- Ramsey, T Bennett;
- Burnikel, Alex;
- Colello, Michael;
- Stewart, Russell;
- Wise, Jeremy;
- Moody, M Christian;
- Tanner, Stephanie L;
- Snider, Rebecca G;
- Townsend, Christine E;
- Pham, Kayla H;
- Martin, Abigail;
- Robertson, Emily;
- Morshed, Saam;
- Miclau, Theodore;
- Kandemir, Utku;
- Marmor, Meir;
- Matityahu, Amir;
- McClellan, R Trigg;
- Meinberg, Eric;
- Shearer, David;
- Toogood, Paul;
- Ding, Anthony;
- Donohoe, Erin;
- Murali, Jothi;
- Belaye, Tigist;
- Berhaneselase, Eleni;
- Paul, Alexandra;
- Garg, Kartik;
- Aqueous-PREP;
- Gary, Joshua L;
- Warner, Stephen J;
- Munz, John W;
- Choo, Andrew M;
- Achor, Timothy S;
- Routt, Milton L Chip;
- Rao, Mayank;
- Pechero, Guillermo;
- Miller, Adam;
- Hagen, Jennifer E;
- Patrick, Matthew;
- Vlasak, Richard;
- Krupko, Thomas;
- Sadasivan, Kalia;
- Koenig, Chris;
- Bailey, Daniel;
- Wentworth, Daniel;
- Van, Chi;
- Schwartz, Justin;
- Dehghan, Niloofar;
- Jones, Clifford B;
- Watson, J Tracy;
- McKee, Michael;
- Karim, Ammar;
- Talerico, Michael;
- Sietsema, Debra L;
- Williams, Alyse;
- Dykes, Tayler;
- Obremskey, William T;
- Jahangir, Amir Alex;
- Sethi, Manish;
- Boyce, Robert;
- Stinner, Daniel J;
- Mitchell, Phillip;
- Trochez, Karen;
- Rodriguez, Andres;
- Gajari, Vamshi;
- Rodriguez, Elsa;
- Pritchett, Charles;
- Boulton, Christina;
- Lowe, Jason;
- Wild, Jason;
- Ruth, John T;
- Taylor, Michel;
- Seach, Andrea;
- Saeed, Sabina;
- Culbert, Hunter;
- Cruz, Alejandro;
- Knapp, Thomas;
- Hurkett, Colin;
- Lowney, Maya;
- Prayson, Michael;
- Venkatarayappa, Indresh;
- Horne, Brandon;
- Jerele, Jennifer;
- Clark, Linda;
- Marcano-Fernández, Francesc;
- Jornet-Gibert, Montsant;
- Martínez-Carreres, Laia;
- Martí-Garín, David;
- Serrano-Sanz, Jorge;
- Sánchez-Fernández, Joel;
- Sanz-Molero, Matsuyama;
- Carballo, Alejandro;
- Pelfort, Xavier;
- Acerboni-Flores, Francesc;
- Alavedra-Massana, Anna;
- Anglada-Torres, Neus;
- Berenguer, Alexandre;
- Cámara-Cabrera, Jaume;
- Caparros-García, Ariadna;
- Fillat-Gomà, Ferran;
- Fuentes-López, Ruben;
- Garcia-Rodriguez, Ramona;
- Gimeno-Calavia, Nuria;
- Graells-Alonso, Guillem;
- Martínez-Álvarez, Marta;
- Martínez-Grau, Patricia;
- Pellejero-García, Raúl;
- Ràfols-Perramon, Ona;
- Peñalver, Juan Manuel;
- Domènech, Mònica Salomó;
- Soler-Cano, Albert;
- Velasco-Barrera, Aldo;
- Yela-Verdú, Christian;
- Bueno-Ruiz, Mercedes;
- Sánchez-Palomino, Estrella;
- Guerra-Farfan, Ernesto;
- Tomas-Hernandez, Jordi;
- Teixidor-Serra, Jordi;
- Molero-Garcia, Vicente;
- Selga-Marsa, Jordi;
- Porcel-Vasquez, Juan Antonio;
- Andres-Peiro, Jose Vicente;
- Minguell-Monyart, Joan;
- Garcia-Sanchez, Yaiza;
- Nuñez-Camarena, Jorge;
- Tauste-Rubio, Eladia;
- Gonzalez-Amigo, Marta;
- PREPARE;
- Romeo, Nicholas M;
- Vallier, Heather A;
- Breslin, Mary A;
- Fraifogl, Joanne;
- Wilson, Eleanor S;
- Wadenpfuhl, Leanne K;
- Halliday, Paul G;
- Viskontas, Darius G;
- Apostle, Kelly L;
- Boyer, Dory S;
- Moola, Farhad O;
- Perey, Bertrand H;
- Stone, Trevor B;
- Lemke, H Michael;
- Zomar, Mauri;
- Spicer, Ella;
- Fan, Chen Brenda;
- Payne, Kyrsten;
- Phelps, Kevin;
- Bosse, Michael;
- Karunakar, Madhav;
- Kempton, Laurence;
- Sims, Stephen;
- Hsu, Joseph;
- Seymour, Rachel;
- Churchill, Christine;
- Bartel, Claire;
- Mayberry, Robert Miles;
- Brownrigg, Maggie;
- Girardi, Cara;
- Mayfield, Ada;
- Hymes, Robert A;
- Schwartzbach, Cary C;
- Schulman, Jeff E;
- Malekzadeh, A Stephen;
- Holzman, Michael A;
- Ramsey, Lolita;
- Ahn, James S;
- Panjshiri, Farhanaz;
- Das, Sharmistha;
- English, Antoinisha D;
- Haaser, Sharon M;
- Cuff, Jaslynn AN;
- Pilson, Holly;
- Carroll, Eben A;
- Halvorson, Jason J;
- Babcock, Sharon;
- Goodman, J Brett;
- Holden, Martha B;
- Bullard, Debra;
- Williams, Wendy;
- Higgins, Thomas F;
- Haller, Justin M;
- Rothberg, David L;
- Marchand, Lucas S;
- Neese, Ashley;
- Russell, Mark;
- Olsen, Zachary M;
- Gitajn, I Leah;
- Coe, Marcus;
- Dwyer, Kevin;
- Mullin, Devin S;
- Reilly, Clifford A;
- DePalo, Peter;
- Hall, Amy E;
- Heng, Marilyn;
- Harris, Mitchel B;
- Smith, R Malcolm;
- Lhowe, David W;
- Esposito, John G;
- Bansal, Mira;
- Bergin, Patrick F;
- Russell, George V;
- Graves, Matthew L;
- Morellato, John;
- Champion, Heather K;
- Johnson, Leslie N;
- McGee, Sheketha L;
- Bhanat, Eldrin L;
- Mehta, Samir;
- Donegan, Derek;
- Ahn, Jaimo;
- Horan, Annamarie;
- Dooley, Mary;
- Kuczinski, Ashley;
- Iwu, Ashley;
- Potter, David;
- VanDemark, Robert;
- Pfaff, Branden;
- Hollinsworth, Troy;
- Weaver, Michael J;
- von Keudell, Arvind G;
- McTague, Michael F;
- Allen, Elizabeth M;
- Jaeblon, Todd;
- Beer, Robert;
- Demyanovich, Haley K;
- Gage, Mark J;
- Reilly, Rachel M;
- Sparrow, Cindy
- et al.
Published Web Location
https://doi.org/10.1016/j.conctc.2021.100787Abstract
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.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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