Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials
| Autor: | 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, PREP-IT Investigators, Wells, Jeffrey, Bhandari, Mohit, Steering Committee, Adjudication Committee, Data and Safety Monitoring Committee, Research Methodology Core, Patient Centred Outcomes Core, Orthopaedic Surgery Core, Operating Room Core, Infectious Disease Core, Military Core, PREP-IT Clinical Sites, 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, Degani, Yasmin, O'Hara, Nathan N, Joseph, Katherine, Camara, Megan, Aqueous-PREP and PREPARE, Aqueous-PREP, PREPARE |
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| Rok vydání: | 2021 |
| Předmět: |
Trial design
Patient advisors Clinical Trials and Supportive Activities education PREP-IT Clinical Sites Stakeholder engagement Consent Clinical Research Infectious Disease Core Patient Centred Outcomes Core Data and Safety Monitoring Committee Orthopaedic Surgery Core PREPARE PREP-IT Investigators Steering Committee Cluster randomized crossover Adjudication Committee humanities 8.4 Research design and methodologies (health services) Operating Room Core Research Methodology Core Deferred consent Patient Safety Aqueous-PREP and PREPARE Military Core Health and social care services research Aqueous-PREP |
| Popis: | IntroductionCluster 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.MethodsThe 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.ResultsPatient 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.DiscussionInvolvement 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. |
| Databáze: | OpenAIRE |
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