中度至重度获得性脑损伤急性住院后全面康复的康复结果——基于常规收集的健康数据的总体预后研究方案

Uwe M Pommerich, Peter W Stubbs, Jørgen Feldbæk Nielsen
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引用次数: 0

摘要

背景:预后研究进展框架的最初主题被称为整体预后研究。其目的是描述在当前护理情况下最可能出现的健康状况。这些平均组水平的预后可用于告知患者、卫生政策、试验设计或进一步的预后研究。获得性脑损伤,如中风、创伤性脑损伤或脑病,是全世界残疾和功能限制的主要原因。康复旨在最大限度地提高受伤后的独立功能和有意义的社会参与。虽然一些观察性研究可以推断独立功能水平的总体预后,但提供康复的背景很少被描述。本协议的目的是提供临床背景的详细描述,以帮助解释我们即将进行的整体预后研究。方法:该研究将在丹麦的急性住院康复机构进行,该机构为中度至重度获得性脑损伤患者提供专门的住院康复。常规收集的电子健康数据将从医疗保健提供者的数据库中提取,并在个体水平上确定地联系起来,以构建研究队列。研究时间为2011年3月至2022年12月。四个结果将衡量功能水平。还将描述康复需要。将描述整个队列的结果和康复需求,跨越康复复杂性水平,并根据相关的人口统计学和临床参数分层。描述性统计将用于估计急性康复后出院时功能水平的平均预后。缺失数据的模式将被调查。讨论:本方案旨在为我们即将开展的基于常规收集的临床数据的研究提供透明度。这将有助于在我们当前临床实践的背景下解释总体预后估计,并独立评估潜在的偏倚来源。
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Rehabilitation outcomes after comprehensive post-acute inpatient rehabilitation following moderate to severe acquired brain injury-study protocol for an overall prognosis study based on routinely collected health data.

Background: The initial theme of the PROGRESS framework for prognosis research is termed overall prognosis research. Its aim is to describe the most likely course of health conditions in the context of current care. These average group-level prognoses may be used to inform patients, health policies, trial designs, or further prognosis research. Acquired brain injury, such as stroke, traumatic brain injury or encephalopathy, is a major cause of disability and functional limitations, worldwide. Rehabilitation aims to maximize independent functioning and meaningful participation in society post-injury. While some observational studies can allow for an inference of the overall prognosis of the level of independent functioning, the context for the provision of rehabilitation is rarely described. The aim of this protocol is to provide a detailed account of the clinical context to aid the interpretation of our upcoming overall prognosis study.

Methods: The study will occur at a Danish post-acute inpatient rehabilitation facility providing specialised inpatient rehabilitation for individuals with moderate to severe acquired brain injury. Routinely collected electronic health data will be extracted from the healthcare provider's database and deterministically linked on an individual level to construct the study cohort. The study period spans from March 2011 to December 2022. Four outcomes will measure the level of functioning. Rehabilitation needs will also be described. Outcomes and rehabilitation needs will be described for the entire cohort, across rehabilitation complexity levels and stratified for relevant demographic and clinical parameters. Descriptive statistics will be used to estimate average prognoses for the level of functioning at discharge from post-acute rehabilitation. The patterns of missing data will be investigated.

Discussion: This protocol is intended to provide transparency in our upcoming study based on routinely collected clinical data. It will aid in the interpretation of the overall prognosis estimates within the context of our current clinical practice and the assessment of potential sources of bias independently.

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