Lilja Gisela, Nielsen Niklas, Ullén Susann, Blennow Nordstrom Erik, Dankiewicz Josef, Friberg Hans, Heimburg Katarina, Jakobsen Janus Christian, Levin Helena, Callaway Clifton, Cariou Alain, Eastwood Glenn M, Helbok Raimund, Hovdenes Jan, Kirkegaard Hans, Leithner Christoph, Morgan Matt P G, Nordberg Per, Oddo Mauro, Pelosi Paolo, Rylander Christian, Saxena Manoj, Taccone Fabio Silvio, Siranec Michal, Wise Matthew P, Young Paul J, Cronberg Tobias
Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden.
Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Helsingborg, Sweden.
Resuscitation. 2020 May;150:104-112. doi: 10.1016/j.resuscitation.2020.03.004. Epub 2020 Mar 20.
The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.
Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.
The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation.
TTM2试验是一项多中心随机临床试验，将比较院外心脏骤停（OHCA）后33°C的目标温度管理（TTM）与正常体温以及发热（≥37.8°C）的早期治疗。本文介绍了TTM2试验随访的设计和基本原理，将收集次要和探索性结局的信息。我们还介绍了探索性结局分析，其将聚焦于OHCA幸存者的神经认知功能和社会参与度。
盲法结局评估者将在OHCA后30天进行电话随访，包括改良Rankin量表（mRS）和扩展格拉斯哥结局量表（GOSE）。将在6个月和24个月时进行面对面会议，包括来自多个信息源的结局报告：临床医生报告：mRS、GOSE；患者报告：欧洲五维健康量表-5水平反应版（EQ-5D-5L）、生活满意度、两个简单问题；观察者报告：老年人心脏骤停认知衰退 informant问卷（IQCODE-CA）和神经认知表现测量：蒙特利尔认知评估（MoCA）、符号数字模态测验（SDMT）。将进行探索性分析，重点关注幸存者的脑损伤，比较两个干预组在神经认知功能（MoCA、SDMT）和社会参与度（GOSE）方面的潜在差异。描述了提高评分者间信度和减少缺失数据的策略。
TTM2试验随访是对患者结局进行的务实但详细的预先计划和标准化评估，旨在确保数据质量、减少缺失数据，并为研究TTM的临床相关效应提供最佳条件，包括OHCA幸存者的神经认知功能和社会参与度。
