Show simple item record

dc.contributor.authorPechero, Guillermo
dc.contributor.authorPfaff, Branden
dc.contributor.authorRao, Mayank
dc.contributor.authorPogorzelski, David
dc.contributor.authorMcKay, Paula
dc.contributor.authorSpicer, Ella
dc.contributor.authorHowe, Andrea
dc.contributor.authorDemyanovich, Haley K
dc.contributor.authorSietsema, Debra L
dc.contributor.authorMcTague, Michael F
dc.contributor.authorRamsey, Lolita
dc.contributor.authorHolden, Martha
dc.contributor.authorRudnicki, Joshua
dc.contributor.authorWells, Jeff
dc.contributor.authorMedeiros, Michelle
dc.contributor.authorSlobogean, Gerard P
dc.contributor.authorSprague, Sheila
dc.contributor.authorSlobogean, Gerard P
dc.contributor.authorSprague, Sheila
dc.contributor.authorWells, Jeffrey
dc.contributor.authorBhandari, Mohit
dc.contributor.authorO'Toole, Robert V
dc.contributor.authorD'Alleyrand, Jean-Claude
dc.contributor.authorEglseder, Andrew
dc.contributor.authorJohnson, Aaron
dc.contributor.authorLanghammer, Christopher
dc.contributor.authorLebrun, Christopher
dc.contributor.authorManson, Theodore
dc.contributor.authorNascone, Jason
dc.contributor.authorParyavi, Ebrahim
dc.contributor.authorPensy, Raymond
dc.contributor.authorPollak, Andrew
dc.contributor.authorSciadini, Marcus
dc.contributor.authorSlobogean, Gerard P
dc.contributor.authorDegani, Yasmin
dc.contributor.authorDemyanovich, Haley K
dc.contributor.authorHowe, Andrea
dc.contributor.authorO'Hara, Nathan N
dc.contributor.authorJoseph, Katherine
dc.contributor.authorRudnicki, Joshua
dc.contributor.authorCamara, Megan
dc.date.accessioned2021-07-06T14:36:36Z
dc.date.available2021-07-06T14:36:36Z
dc.date.issued2021-06-14
dc.identifier.urihttp://hdl.handle.net/10713/16138
dc.description.abstractIntroduction: 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.en_US
dc.description.urihttps://doi.org/10.1016/j.conctc.2021.100787en_US
dc.language.isoenen_US
dc.publisherElsevier Ltd.en_US
dc.relation.ispartofContemporary Clinical Trials Communicationsen_US
dc.rights© 2021 The Authors.en_US
dc.subjectCluster randomized crossoveren_US
dc.subjectConsenten_US
dc.subjectDeferred consenten_US
dc.subjectPatient advisorsen_US
dc.subjectStakeholder engagementen_US
dc.subjectTrial designen_US
dc.titleImplementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trialsen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.conctc.2021.100787
dc.identifier.pmid34195467
dc.source.volume22
dc.source.beginpage100787
dc.source.endpage
dc.source.countryNetherlands


Files in this item

Thumbnail
Name:
Publisher version

This item appears in the following Collection(s)

Show simple item record