Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

The Variable Angle Hip Fracture Nail Relative to the Gamma 3: A Finite Element Analysis Illustrating the Same Stiffness and Fatigue Characteristics

Ten percent of the 250,000 proximal femur fractures that occur in the United States each year are malreduced into a varus position after treatment. Currently, there is no cephalomedullary nail available that allows the physician to dynamically change the lag-screw-to-nail angle. The Variable Angle Nail (VAN) was designed to allow movement of the lag screw relative to the shaft of the nail. This study compared the characteristics of the VAN to the Gamma 3 nail via finite element analysis (FEA) in stiffness and fatigue. The results of the FEA model with the same loading parameters showed the Gamma 3 and the VAN with lag-screw-to-nail angle of 120° to have essentially the same stiffness values ranging from 350 to 382 N/mm. The VAN with lag-screw-to-nail angles of 120°, 130°, and 140° should be able to withstand more than 1,000,000 cycles from 1,400 N to 1,500 N loading of the tip of the lag screw. The Gamma 3 should be able to last more than 1,000,000 cycles at 1,400 N. In summary, the VAN is superior or equivalent in stiffness and fatigue when compared to the Gamma 3 using FEA

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

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