4 research outputs found
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
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THE PHYSIOLOGICAL AND MENTAL EFFECTS OF DANCE ON HEALTH AND REHABILITATIVE THERAPY
Dance/movement therapy has been shown to be a viable therapy for those with a range of conditions. Focusing on the mind/body connection can enhance and help the healing process while doing so in a creative manner. Since dance relies on both mental and physical capacities, it can promote improvement in both areas of health and even reverse symptoms associated with those who may have debilitating problems. To explore this, surveys and interviews were conducted to further learn about the impact of dance on health. The data indicates that dance not only has multiple benefits but can be a viable form of treatment. For example, the results indicated that accessibility of taking a dance class allowed this exercise form to be reached by a wide range of people, from healthy professionals to those seeking alternate exercise options to those with movement disorders such as Parkinson’s Disease because of the safe environment and open structure of the classroom. Furthermore, the classes also offer the activity to many people at one time, providing social interactions for those who participate, thereby fostering a network of people that can encourage them to continue going to classes and have a stable workout routine
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