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

Teaching Patients How to Reduce a Shoulder Dislocation: A Randomized Clinical Trial Comparing the Boss-Holzach-Matter Self-Assisted Technique and the Spaso Method

BACKGROUND: There are many different techniques for reducing acute anterior dislocations of the shoulder, and their use depends on surgeon preference. The objective of this study was to compare the pain experienced by a patient performing a self-reduction technique with the pain felt during a reduction performed by a trained physician. METHODS: The study was carried out at the emergency department of a tertiary referral center. Patients between 18 and 60 years of age with an acute anterior shoulder dislocation were randomly allocated into 2 groups. In 1 group the emergency doctor actively guided the reduction process with the Spaso technique (Sp group), and in the other group the patient used the Boss-Holzach-Matter (also known as Davos or Aronen) self-reduction technique (BHM group). The pain experienced by the patient during the reduction was recorded by means of a visual analogue scale (VAS) ranging from 0 to 10. Other recorded data included demographic characteristics, reduction time, and success rate. RESULTS: Of 378 patients assessed for eligibility from May 2015 until February 2017, 197 did not meet the inclusion criteria, 58 met exclusion criteria, 22 declined to participate, and 41 withdrew before randomization. Sixty acute anterior shoulder dislocations were randomized into the Sp group (n = 30) or the BHM group (n = 30). The BHM group experienced significantly less pain during reduction than the Sp group (p = 0.047), with mean pain scores of 3.57 (standard deviation [SD] = 2.1]) and 5.26 (SD = 2.9), respectively. No significant difference between groups was found with respect to reduction time (105 seconds [range, 10 to 660 seconds] in the Sp group and 90 seconds [range, 5 to 600 seconds] in the BHM group; p = 0.6) or success rate (67% and 77%, respectively; p = 0.39). CONCLUSIONS: The self-reduction technique results in less pain than, and is as efficient in achieving reduction of anterior shoulder dislocations as, the Spaso technique. These findings favor the use of the self-assisted method as an effective first-line treatment for shoulder dislocations seen in the emergency department as well as its use by patients with recurrent dislocation

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