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

Fracture of the radial styloid and concomitant first dorsal compartment musculotendinous injuries

In the absence of preexisting inflammatory conditions, pure traumatic rupture of the extensor pollicis brevis (EPB) and abductor pollicis longus (APL) tendons are rare injuries. We present a report of 2 cases of extensor tendon ruptures at the musculotendinous junction occurring after concomitant fractures of the radial styloid in patients who were involved in high-energy trauma. The presence of a radial styloid fracture should raise suspicion for a greater spectrum of injury that can contribute to multidirectional instability. The spectrum might even include proximal damage to the EPB and APL tendons. Although the associated tendon injuries might or might not contribute to functional loss, their presence should be noted when evaluating a patient with this injury pattern

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