Department of Occupational Therapy, Colorado State University College of Health and Human Sciences, Fort Collins, Colorado, USA
Department of Clinical Research and Leadership, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.
BMJ Open. 2022 Jun 30;12(6):e056538. doi: 10.1136/bmjopen-2021-056538.
Historically, heterogeneous outcome assessments have been used to measure recovery of consciousness in patients with disorders of consciousness (DoC) following traumatic brain injury (TBI), making it difficult to compare across studies. To date, however, there is no comprehensive review of clinical outcome assessments that are used in intervention studies of adults with DoC. The objective of this scoping review is to develop a comprehensive inventory of clinical outcome assessments for recovery of consciousness that have been used in clinical studies of adults with DoC following TBI.
The methodological framework for this review is: (1) identify the research questions, (2) identify relevant studies, (3) select studies, (4) chart the data, (5) collate, summarise and report results and (6) consult stakeholders to drive knowledge translation. We will identify relevant studies by searching the following electronic bibliographic databases: PubMed, Scopus, EMBASE, PsycINFO and The Cochrane Library (including Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Cochrane Methodology Register). Criteria for article inclusion are published in the English-language, peer-reviewed studies of interventions aimed at facilitating recovery of consciousness among adults (> 18 years) with DoC following a severe TBI, published from January 1986 to December 2020. Articles meeting inclusion criteria at this stage will undergo a full text review. We will chart the data by applying the WHO International Classification of Functioning, Disability and Health Framework to identify the content areas of clinical outcome assessments. To support knowledge translation efforts, we will involve clinicians and researchers experienced in TBI care throughout the project from conceptualisation of the study through dissemination of results.
No ethical approval is required for this study as it is not determined to be human subjects research. Results will be presented at national conferences and published in peer-reviewed journals.
CRD42017058383.
从历史上看,在创伤性脑损伤(TBI)后患有意识障碍(DOC)的患者中,使用异质的结果评估来衡量意识的恢复,这使得难以在研究之间进行比较。然而,迄今为止,尚无针对 TBI 后成人意识障碍干预研究中使用的临床结果评估的综合综述。本范围综述的目的是开发一个全面的意识恢复临床结果评估清单,这些评估已在 TBI 后成人意识障碍的临床研究中使用。
本综述的方法论框架为:(1)确定研究问题,(2)确定相关研究,(3)选择研究,(4)绘制数据,(5)整理、总结和报告结果,(6)咨询利益相关者以推动知识转化。我们将通过搜索以下电子书目数据库来确定相关研究:PubMed、Scopus、EMBASE、PsycINFO 和 Cochrane 图书馆(包括 Cochrane 系统评价数据库、Cochrane 对照试验中心注册库和 Cochrane 方法学注册库)。纳入文章的标准是发表在英文同行评议研究中,研究对象为患有严重 TBI 后意识障碍的成年人(>18 岁)的干预措施,研究时间为 1986 年 1 月至 2020 年 12 月。在这一阶段符合纳入标准的文章将进行全文审查。我们将通过应用世界卫生组织国际功能、残疾和健康分类框架来绘制数据,以确定临床结果评估的内容领域。为了支持知识转化工作,我们将在整个项目中让有 TBI 护理经验的临床医生和研究人员参与,从研究概念化到结果传播。
由于本研究被确定为不属于人体研究,因此不需要伦理批准。研究结果将在全国会议上展示,并发表在同行评议期刊上。
CRD42017058383。