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Resuscitation. 2020 Mar 20. pii: S0300-9572(20)30113-1. doi: 10.1016/j.resuscitation.2020.03.004. [Epub ahead of print]

Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2).

Author information

1
Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Neurology, Lund, Sweden.
2
Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Helsingborg, Sweden.
3
Clinical Studies Sweden - Forum South, Skane University Hospital, Lund, Sweden.
4
Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Cardiology, Lund, Sweden.
5
Lund University, Skane University Hospital, Department of Clinical Sciences Lund, Anesthesiology and Intensive Care, Malmö, Sweden.
6
Copenhagen Trial Unit, Copenhagen, Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Department of Cardiology, Holbæk Hospital, Denmark.
7
Lund University, Skane University Hospital, Department of Clinical Sciences, Research and Education, Lund, Sweden.
8
Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
9
Cochin University Hospital (APHP) and Paris Descartes University, France.
10
Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
11
Department of Neurology, Neurological Intensive Care Unit, Medical University Innsbruck, Innsbruck, Austria.
12
Department of Anesthesiology, Rikshospitalet, Oslo University Hospital, Norway.
13
Research Center for Emergency Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.
14
Department of Neurology, Charité University Medicine, Berlin, Germany.
15
Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.
16
Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.
17
Department of Intensive Care Medicine, CHUV, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
18
Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy; San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.
19
Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
20
Bankstown Hospital, South Western Sydney Local Health District, Sydney, Australia; Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, Australia.
21
Erasme Hospital, Université Libre de Bruxelles, Department of Intensive Care, Brussels, Belgium.
22
Department of Medicine - Department of Cardiovascular Medicine, Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech republic.
23
Medical Research Institute of New Zealand, Wellington, New Zealand.

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-5 L), 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.

KEYWORDS:

Cardiac arrest; Cognitive function; Patient Reported Outcome Measures; Quality of life; Treatment outcome

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