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一项调查短暂性脑缺血发作后疲劳、心理或认知障碍的回顾性队列研究:方案文件

A retrospective cohort study to investigate fatigue, psychological or cognitive impairment after TIA: protocol paper.

作者信息

Moran Grace M, Calvert Melanie, Feltham Max G, Ryan Ronan, Marshall Tom

机构信息

Primary Care Clinical Sciences, University of Birmingham, Birmingham, UK.

出版信息

BMJ Open. 2015 May 3;5(4):e008149. doi: 10.1136/bmjopen-2015-008149.

Abstract

INTRODUCTION

Transient ischaemic attack (TIA) is defined by short-lasting, stroke-like symptoms, and is recognised as a medical emergency. Symptoms are assumed to completely resolve, and treatment is focused on secondary stroke/TIA prevention. However, evidence suggests that patients with TIA may experience ongoing residual impairments, which they do not receive therapy for as standard practice. TIA-induced sequelae could impact on patients' quality of life and ability to return to work or social activities. We aim to investigate whether TIA is associated with subsequent consultation for fatigue, psychological or cognitive impairment in primary care.

METHODS AND ANALYSIS

A retrospective open cohort study of patients with first-ever TIA and matched controls. Relevant data will be extracted from The Health Improvement Network (THIN) database, an anonymised primary care database which includes data for over 12 million patients and covers approximately 6% of the UK population. Outcomes will be the first consultation for fatigue, anxiety, depression, post-traumatic stress disorder or cognitive impairment. Principal analysis will use Kaplan-Meier survivor functions to estimate time to first consultation, with log-rank tests to compare TIA and control patients. Cox proportional hazard models will predict the effect of demographic and patient characteristics on time to first consultation.

ETHICS AND DISSEMINATION

Approval was granted by a THIN Scientific Review Committee (ref: 14-008). The study's findings will be published in a peer-reviewed journal and disseminated at national and international conferences and through social media.

摘要

引言

短暂性脑缺血发作(TIA)由短暂的、类似中风的症状所定义,被视为一种医疗急症。症状被认为会完全缓解,治疗重点在于二级中风/TIA预防。然而,有证据表明,TIA患者可能会持续存在残留损伤,但按照标准做法,他们并未接受针对这些损伤的治疗。TIA引发的后遗症可能会影响患者的生活质量以及重返工作或社会活动的能力。我们旨在调查TIA是否与随后在初级保健中因疲劳、心理或认知障碍而进行的咨询有关。

方法与分析

一项针对首次发生TIA的患者及匹配对照的回顾性开放队列研究。相关数据将从健康改善网络(THIN)数据库中提取,该数据库是一个匿名的初级保健数据库,包含超过1200万患者的数据,覆盖英国约6%的人口。研究结果将是首次因疲劳、焦虑、抑郁、创伤后应激障碍或认知障碍而进行的咨询。主要分析将使用Kaplan-Meier生存函数来估计首次咨询的时间,并使用对数秩检验来比较TIA患者和对照患者。Cox比例风险模型将预测人口统计学和患者特征对首次咨询时间的影响。

伦理与传播

已获得THIN科学审查委员会的批准(编号:14 - 008)。该研究的结果将发表在同行评审的期刊上,并在国内和国际会议上以及通过社交媒体进行传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fee/4420964/1c706ecc9bf3/bmjopen2015008149f01.jpg

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