TY - JOUR
T1 - Implementing stakeholder engagement to explore alternative models of consent
T2 - An example from the PREP-IT trials
AU - PREP-IT Investigators
AU - Steering Committee
AU - Adjudication Committee
AU - Data and Safety Monitoring Committee
AU - Research Methodology Core
AU - Patient Centred Outcomes Core
AU - Orthopaedic Surgery Core
AU - Operating Room Core
AU - Infectious Disease Core
AU - Military Core
AU - PREP-IT Clinical Sites
AU - Aqueous-PREP and PREPARE
AU - Aqueous-PREP
AU - PREPARE
AU - Pechero, Guillermo
AU - Pfaff, Branden
AU - Rao, Mayank
AU - Pogorzelski, David
AU - McKay, Paula
AU - Spicer, Ella
AU - Howe, Andrea
AU - Demyanovich, Haley K.
AU - Sietsema, Debra L.
AU - McTague, Michael F.
AU - Ramsey, Lolita
AU - Holden, Martha
AU - Rudnicki, Joshua
AU - Wells, Jeff
AU - Medeiros, Michelle
AU - Slobogean, Gerard P.
AU - Sprague, Sheila
AU - Wells, Jeffrey
AU - Bhandari, Mohit
AU - D'Alleyrand, Jean Claude
AU - Harris, Anthony D.
AU - Mullins, Daniel C.
AU - Thabane, Lehana
AU - Wood, Amber
AU - Della Rocca, Gregory J.
AU - Hebden, Joan
AU - Jeray, Kyle J.
AU - Marchand, Lucas
AU - O'Hara, Lyndsay M.
AU - Zura, Robert
AU - Gardner, Michael J.
AU - Blasman, Jenna
AU - Davies, Jonah
AU - Liang, Stephen
AU - Taljaard, Monica
AU - Devereaux, P. J.
AU - Guyatt, Gordon H.
AU - Heels-Ansdell, Diane
AU - Marvel, Debra
AU - Palmer, Jana
AU - Friedrich, Jeff
AU - O'Hara, Nathan N.
AU - Grissom, Ms Frances
AU - Gitajn, I. Leah
AU - Morshed, Saam
AU - O'Toole, Robert V.
AU - Petrisor, Bradley A.
AU - Camara, Megan
AU - Mossuto, Franca
AU - Joshi, Manjari G.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Cluster randomized crossover
KW - Consent
KW - Deferred consent
KW - Patient advisors
KW - Stakeholder engagement
KW - Trial design
UR - http://www.scopus.com/inward/record.url?scp=85109375394&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100787
DO - 10.1016/j.conctc.2021.100787
M3 - Article
AN - SCOPUS:85109375394
SN - 2451-8654
VL - 22
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100787
ER -