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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 The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.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.

Key Points Question Were resource constraints due to the COVID-19 pandemic associated with a delay in urgent fracture surgery beyond national time-to-surgery benchmarks? Findings In this cohort pre-post study that included 3589 patients, there was no association between time to surgery and COVID-19 in either open fracture or closed femur/hip fracture cohorts. Meaning Despite concerns that the unprecedented challenges associated with the COVID-19 pandemic would delay acute management of urgent surgery, many hospital systems within the US were able to implement strategies in keeping with time-to-surgery standards for orthopedic trauma.