Rimmele D Leander, Lebherz Lisa, Frese Marc, Appelbohm Hannes, Bartz Hans-Jürgen, Kriston Levente, Gerloff Christian, Härter Martin, Thomalla Götz
Department of Neurology, University Medical Centre Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.
Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.
Neurol Res Pract. 2019 Nov 1;1:28. doi: 10.1186/s42466-019-0034-0. eCollection 2019.
The impact of stroke-related impairment on activities of daily living may vary between patients, and can only be estimated by applying patient-reported outcome measures. The International Consortium for Health Outcome Measurement has developed a standard set of instruments that combine clinical and longitudinal patient-reported outcome measures for stroke. The present study was designed (1) to implement and evaluate the feasibility of the use of it as a consistent outcome measure in clinical routine at the stroke center of a German university hospital, (2) to characterize impairment in everyday life caused by stroke, and (3) to identify predictive factors associated with patient-relevant outcomes.
We plan to enroll 1040 consecutive patients with the diagnosis of acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage in a prospective observational study. Demographics, cardiovascular risk factors, and living situation are assessed at inpatient surveillance. At 90 days and 12 months after inclusion, follow-up assessments take place including the Patient-reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10), the Patient- Health Questionnaire-4, and the simplified modified Ranking Scale questionnaire. The acceptance and feasibility (1) will be assessed by a process evaluation through qualitative semi-structured interviews with clinical staff and patients and quantitative analyses of the data quality evaluating practicability, acceptance, adoption, and fidelity to protocol. The primary outcome of objective 2 and 3 is health-related quality of life measured with the PROMIS-10. Additional outcomes are depressive and anxiety symptoms and patient participation in their social roles. Patient-reported outcomes will be assessed in their longitudinal course using (generalized) mixed regressions. Exploratory descriptive and inference statistical analyses will be used to find patterns of patient characteristics and predictive factors of the outcome domains.
The results will describe and further establish the evaluation of stroke patients of a stroke center by standardized PROMs in everyday life.
The trial is registered at ClinicalTrials.gov (NCT03795948). Approval of the local ethics committee (Ethik-Kommission der Ärztekammer Hamburg) has been obtained.
中风相关损伤对日常生活活动的影响在患者之间可能存在差异，并且只能通过应用患者报告的结局指标来估计。国际健康结局测量协会已经开发了一套标准工具，将临床和纵向患者报告的中风结局指标结合起来。本研究旨在：（1）在德国大学医院的中风中心实施并评估将其用作临床常规中一致结局指标的可行性；（2）描述中风导致的日常生活损伤；（3）确定与患者相关结局相关的预测因素。
我们计划在前瞻性观察研究中纳入1040例连续诊断为急性缺血性中风、短暂性脑缺血发作或脑出血的患者。在住院监测时评估人口统计学、心血管危险因素和生活状况。纳入后90天和12个月进行随访评估，包括患者报告结局测量信息系统10项简表（PROMIS - 10）、患者健康问卷 - 4和简化改良Rankin量表问卷。接受度和可行性（1）将通过对临床工作人员和患者进行定性半结构化访谈的过程评估以及对数据质量进行定量分析来评估，数据质量评估包括实用性、接受度、采用率和对方案的依从性。目标2和3的主要结局是用PROMIS - 10测量的健康相关生活质量。其他结局是抑郁和焦虑症状以及患者参与社会角色的情况。将使用（广义）混合回归对患者报告的结局进行纵向评估。探索性描述性和推断性统计分析将用于发现患者特征模式和结局领域的预测因素。
结果将描述并进一步确立在日常生活中通过标准化患者报告结局量表对中风中心的中风患者进行评估。
该试验已在ClinicalTrials.gov（NCT03795948）注册。已获得当地伦理委员会（汉堡医师协会伦理委员会）的批准。
