학술논문
Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
Document Type
article
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; Cindy Sparrow
Source
Contemporary Clinical Trials Communications, Vol 22, Iss , Pp 100787- (2021)
Subject
Language
English
ISSN
2451-8654
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.