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了解创伤性脑损伤相关的液体生物标志物变化如何影响退伍军人的生活质量结局:一项前瞻性观察性试验方案(UNTANGLE)。

Understanding how traumatic brain injury-related changes in fluid biomarkers affect quality of life outcomes in veterans: a prospective observational trial protocol (UNTANGLE).

机构信息

Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.

Ophthalmology Department, Queen Elizabeth Hospital Birmingham, Birmingham, UK.

出版信息

BMJ Open. 2024 Aug 19;14(8):e084818. doi: 10.1136/bmjopen-2024-084818.

DOI:10.1136/bmjopen-2024-084818
PMID:39160095
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11337664/
Abstract

INTRODUCTION

Traumatic brain injury (TBI) is a major cause of disability, with annual global incidence estimated as 69 million people. Survivors can experience long-term visual changes, altered mental state, neurological deficits and long-term effects that may be associated with mental illness. TBI is prevalent in military personnel due to gunshot wounds, and blast injury. This study aims to evaluate the relationship between evolving visual, biochemical and mental health changes in both military veterans and civilians, suffering from TBI, and detect preliminary indicators of prognosis for TBI recovery, and quality-of-life outcomes.

METHODS AND ANALYSIS

UNTANGLE is a 24-month prospective observational pilot study recruiting three patient groups: civilians with acute moderate-severe TBI, military veterans with diagnosis of a previous TBI and a control group of civilians or veterans with no history of a previous TBI. Patients will undergo visual, biochemical and mental health assessments, as well as patient-reported quality of life outcome measures over the course of a 1-year follow-up period.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales with a REC reference number of 23/NW/0203. The results of the study will be presented at scientific meetings and published in peer-reviewed journals, including both civilian and military-related publications. We will also present our findings at national and international meetings of learnt neuroscience and neuropsychiatry and military societies. We anticipate that our pilot study will inform a larger study on the long-term outcomes of TBI and quality of life, specific to military veterans, such that potential interventions may be accessed as quickly as possible.

TRIAL REGISTRATION NUMBER

ISRCTN13276511.

摘要

简介

创伤性脑损伤(TBI)是残疾的主要原因,全球每年的发病率估计为 6900 万人。幸存者可能会经历长期的视觉变化、精神状态改变、神经功能缺损和长期影响,这些可能与精神疾病有关。由于枪伤和爆炸伤,军人中 TBI 较为常见。本研究旨在评估患有 TBI 的退伍军人和平民中不断变化的视觉、生化和心理健康变化之间的关系,并发现 TBI 恢复和生活质量预后的初步指标。

方法和分析

UNTANGLE 是一项为期 24 个月的前瞻性观察性试点研究,招募了三组患者:急性中度至重度 TBI 的平民、以前诊断为 TBI 的退伍军人和无 TBI 既往史的平民或退伍军人对照组。患者将接受视觉、生化和心理健康评估,以及患者报告的 1 年随访期间的生活质量结果测量。

伦理和传播

该研究已获得英国健康研究局和威尔士健康和护理研究伦理委员会的批准,注册号为 23/NW/0203。该研究的结果将在科学会议上公布,并在同行评议的期刊上发表,包括与平民和军人相关的出版物。我们还将在神经科学和神经精神病学以及军人协会的国家和国际会议上介绍我们的研究结果。我们预计我们的试点研究将为针对退伍军人的 TBI 和生活质量的长期结果提供更大规模的研究,以便尽快获得潜在的干预措施。

试验注册号

ISRCTN83540369。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1d3/11337664/4cfcd0856dbd/bmjopen-14-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1d3/11337664/4cfcd0856dbd/bmjopen-14-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1d3/11337664/4cfcd0856dbd/bmjopen-14-8-g001.jpg

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