2021
DOI: 10.1016/j.conctc.2021.100787
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Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

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 … Show more

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“…Consent in the PREP-IT trials was usually conducted after surgical management of their fracture and before discharge from the hospital. 10 …”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…Consent in the PREP-IT trials was usually conducted after surgical management of their fracture and before discharge from the hospital. 10 …”
Section: Methodsmentioning
confidence: 99%
“…Patient–partner representatives are members of PREP-IT's Patient-Centered Outcomes Core who are involved in many aspects of the trial and drive the trial decisions and activities. 10 Partners include patients who experienced orthopaedic trauma and other medical events and professional association representatives. They work together with the research team and a multidisciplinary health care team to conduct the PREP-IT trials.…”
Section: Methodsmentioning
confidence: 99%