6 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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Retrospective Analysis of Low-Molecular-Weight Heparin and Unfractionated Heparin in Pediatric Trauma Patients: A Comparative Analysis
Background: Chemoprophylaxis with either unfractionated heparin (UFH) or Low-Molecular-Weight Heparin (LMWH) are recommended to prevent Venous Thromboembolism (VTE) after trauma. Experimental work has shown beneficial effects of LMWH in animal models, but it is unknown if similar effects exist in humans. We hypothesized that treatment with LMWH is associated with a survival benefit when compared to UFH. Methods: We performed a retrospective analysis of our level I trauma center database from January 2009 to June 2018. Pediatric patients (age < 18) were included if they received either LMWH or UFH during their stay. Outcome measures included mortality, VTE complications, and hospital length of stay (HLOS). Results: A total of 354 patients were included. Patients who received LMWH had lower mortality compared to those who received UFH. After multivariate logistic regression, LMWH was still independently associated with improved survival. No association was found between LMWH and UFH regarding deep vein thrombosis (DVT) or pulmonary embolism (PE) rates. No association was found between LMWH with HLOS. Conclusions: LMWH was associated with improved survival compared to UFH in our pediatric trauma patients. This was independent of injury severity or VTE complications. Further studies are required to understand better the mechanisms by which LMWH improves survival. (C) 2019 Elsevier Inc. All rights reserved.12 month embargo; published online: 10 January 2020This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]
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Additional Burden of Esophageal and Gastric Varices on Hospitalized Patients With Moderate or Severe Congenital Heart Disease
12 month embargo; first published: 23 October 2023This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]
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Incidence of Radiation-Associated Cancer in Patients With Congenital Heart Disease
12 month embargo; first published: 14 October 2023This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]
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