학술논문
Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
Document Type
Article
Author
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; Slobogean, Gerard P.; Sprague, Sheila; Wells, Jeffrey; Bhandari, Mohit; Slobogean, Gerard P.; Bhandari, Mohit; Sprague, Sheila; D'Alleyrand, Jean-Claude; Harris, Anthony D.; Mullins, Daniel C.; Thabane, Lehana; Wells, Jeffrey; Wood, Amber; Della Rocca, Gregory J.; Harris, Anthony D.; Hebden, Joan; Jeray, Kyle J.; Marchand, Lucas; O'Hara, Lyndsay M.; Zura, Robert; Gardner, Michael J.; Blasman, Jenna; Davies, Jonah; Liang, Stephen; Taljaard, Monica; Devereaux, P.J.; Guyatt, Gordon H.; Thabane, Lehana; Heels-Ansdell, Diane; Marvel, Debra; Palmer, Jana; Wells, Jeffrey; Friedrich, Jeff; Mullins, Daniel C.; O'Hara, Nathan N.; Grissom, Ms Frances; Della Rocca, Gregory J.; Gitajn, I. Leah; Jeray, Kyle J.; Morshed, Saam; O'Toole, Robert V.; Petrisor, Bradley A.; Camara, Megan; Mossuto, Franca; Harris, Anthony D.; Joshi, Manjari G.; D'Alleyrand, Jean-Claude; 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; 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; 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; Gary, Joshua L.; Warner, Stephen J.; Munz, John W.; Choo, Andrew M.; Achor, Timothy S.; “Chip” Routt, Milton L.; 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.; Tracy Watson, J.; 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; 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 A.N.; 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
Source
Contemporary Clinical Trials Communications; June 2021, Vol. 22 Issue: 1
Subject
Language
ISSN
24518654
Abstract
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.