Domains, Trends, and Uptake of Common Data Elements in Intervention Studies Focused on Recovery of Consciousness in Severe Brain Injury from 1986 to 2020: A Scoping Review.

IF 3.7 2区 医学 Q1 REHABILITATION
Jennifer A Weaver, Alison M Cogan, Vera Pertsovskaya, Parie Bhandari, Bint-E Z Awan, Sara Lewis, Angela Hartman, Kristen Maisano, Tom Harrod
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Abstract

Objective: The primary purpose of our scoping review was to evaluate the range and typology of primary clinical outcome assessments used in intervention studies promoting recovery of consciousness for patients with disorders of consciousness (DoC). A secondary aim was to examine the extent to which the introduction of common data elements (CDE) has reduced the heterogeneity of primary clinical outcome assessments in DoC studies.

Data sources: We searched for articles across five databases: Cochrane, Embase, PsycInfo, PubMed, and Scopus.

Study selection: We selected articles that focused on facilitating recovery of consciousness among adults with DoC following severe traumatic brain injury.

Data extraction: We extracted the study year, primary clinical outcome assessment, and funding source.

Data synthesis: We classified the primary clinical outcome by International Classification of Functioning, Disability and Health (ICF) domain and CDE status. 75 primary clinical outcome assessments were extracted from 307 included articles; 45 primary clinical outcome assessments (60%) aligned with the ICF Body Function domain. The proportion of articles with US federal funding that reported a CDE as the clinical outcome assessment did not differ by year published.

Conclusion: Implementation of CDEs in 2010 did not substantively change the utilization of clinical outcome assessments that are CDEs because these were already more likely to be reported than non-CDEs. Overall, the wide variation in primary clinical outcome assessments utilized in intervention studies facilitating recovery of consciousness limits the ability to conduct meta-analyses, which are needed to increase the strength of evidence for DoC interventions.

1986年至2020年重度脑损伤患者意识恢复干预研究的领域、趋势和共同数据元素的吸收:范围综述
目的:我们的范围综述的主要目的是评估用于促进意识障碍(DoC)患者意识恢复的干预研究的主要临床结果评估的范围和类型。第二个目的是检查引入公共数据元素(CDE)在多大程度上降低了DoC研究中主要临床结果评估的异质性。数据来源:我们搜索了五个数据库中的文章:Cochrane、Embase、PsycInfo、PubMed和Scopus。研究选择:我们选择了关注于促进严重创伤性脑损伤后成人DoC患者意识恢复的文章。资料提取:我们提取了研究年份、主要临床结果评估和资金来源。数据综合:我们根据国际功能、残疾和健康分类(ICF)领域和CDE状态对主要临床结局进行分类。从307篇纳入的文章中提取了75项主要临床结局评估;45项主要临床结果评估(60%)与ICF机体功能域一致。在美国联邦资助的文章中,将CDE作为临床结果评估的比例在发表年份之间没有差异。结论:2010年CDEs的实施并没有实质性地改变CDEs临床结果评估的使用,因为这些已经比非CDEs更有可能被报道。总的来说,促进意识恢复的干预研究中使用的主要临床结果评估差异很大,限制了进行meta分析的能力,而meta分析是增加DoC干预证据强度所必需的。
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来源期刊
CiteScore
6.20
自引率
4.70%
发文量
495
审稿时长
38 days
期刊介绍: The Archives of Physical Medicine and Rehabilitation publishes original, peer-reviewed research and clinical reports on important trends and developments in physical medicine and rehabilitation and related fields. This international journal brings researchers and clinicians authoritative information on the therapeutic utilization of physical, behavioral and pharmaceutical agents in providing comprehensive care for individuals with chronic illness and disabilities. Archives began publication in 1920, publishes monthly, and is the official journal of the American Congress of Rehabilitation Medicine. Its papers are cited more often than any other rehabilitation journal.
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