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Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.

J Trauma Acute Care Surg

October 2024

From the Department of Surgery (S.W.S., C.R.C.-L., S.D., T.W.C., M.A.N., J.R., J.B.H., J.O.J.), Center for Injury Science, and Department of Epidemiology (R.L.G.), University of Alabama at Birmingham, Birmingham, Alabama; Avania Clinical (S.G.), Marlborough, Massachusetts; CSL Behring (A.S., J.C., S.R.S., B.G., J.R., J.D.), King of Prussia, Pennsylvania; Office of Institutional Review Board (A.J.M.), University of Alabama at Birmingham, Birmingham, Alabama; Advarra (L.G., A.H.), Columbia, Maryland; and Department of Surgery (B.J.), University of Arizona, Tucson, Arizona.

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

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Background: Vertebral body tethering (VBT) is a nonfusion surgical treatment for scoliosis. Recent data have shown that intraoperative correction is critical for successful curve correction over time. This study aims to evaluate the relationship between preoperative, intraoperative, and postoperative correction.

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Objectives: Acute respiratory illnesses have a disproportionate impact on older people, and especially those living in residential aged care facilities where transmission risks are heightened. Additionally, staff in these facilities have been working under challenging conditions, often ill-equipped in terms of both training and resources to successfully manage the outbreaks of these illnesses. This paper examines the actions of an Australian public health unit to improve influenza outbreak management in residential aged care facilities and critiques the outcomes through a contemporary lens.

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Clear and accurate pronunciation plays an essential role in communicating effectively and significantly affects English learners' proficiency. ELSA Speak has been used in some schools due to its benefits to help learners improve English pronunciation. However, to optimize the application, a better understanding of EFL learners' satisfaction with ELSA Speak is essential.

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Background And Aims: Previous studies in lumbar spine surgery have mainly studied functioning and pain by comparing average scores from Patient Reported Outcome Measures (PROMs) at different time points. Less is known about these changes in different subgroups. It is self-evident that, while most patients may demonstrate trajectories of these changes close to the average one, some groups may follow more or less different trends.

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