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Protocol for outcome reporting and follow-up in the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2)

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. and Cronberg, Tobias 2020. Protocol for outcome reporting and follow-up in the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2). Resuscitation 150 , pp. 104-112. 10.1016/j.resuscitation.2020.03.004

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Abstract

Aims 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. Methods 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. Discussion 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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Elsevier
ISSN: 0300-9572
Date of First Compliant Deposit: 18 May 2020
Date of Acceptance: 9 March 2020
Last Modified: 18 May 2020 14:45
URI: http://orca-mwe.cf.ac.uk/id/eprint/131698

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