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

Research output: Contribution to journalArticle

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.

Details

Authors
  • Susann Ullén
  • Janus Christian Jakobsen
  • Helena Levin
  • Clifton Callaway
  • Alain Cariou
  • Glenn M. Eastwood
  • Raimund Helbok
  • Jan Hovdenes
  • Hans Kirkegaard
  • Christoph Leithner
  • Matt P.G. Morgan
  • Per Nordberg
  • Mauro Oddo
  • Paolo Pelosi
  • Christian Rylander
  • Manoj Saxena
  • Fabio Silvio Taccone
  • Michal Siranec
  • Matthew P. Wise
  • Paul J. Young
Organisations
External organisations
  • Skåne University Hospital
  • Helsingborg Hospital
  • University of Southern Denmark
  • University of Pittsburgh
  • Monash University
  • Medical University of Innsbruck
  • Aarhus University Hospital
  • Charité - University Medicine Berlin
  • University Hospital of Wales
  • Karolinska Institutet
  • Lausanne University Hospital
  • University of Genoa
  • Ospedale Policlinico San Martino
  • Sahlgrenska University Hospital
  • Bankstown-Lidcombe Hospital
  • University of New South Wales
  • Free University of Brussels (ULB)
  • General University Hospital in Prague
  • Medical Research Institute of New Zealand
  • Holbæk Hospital
  • Cochin Hospital
  • Paris Descartes University
  • Oslo university hospital
  • Aarhus University
  • University of Lausanne
  • University of Gothenburg
  • Hospital Erasme
  • Charles University in Prague
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Neurology
  • Cardiac and Cardiovascular Systems

Keywords

  • Cardiac arrest, Cognitive function, Patient Reported Outcome Measures, Quality of life, Treatment outcome
Original languageEnglish
Pages (from-to)104-112
Number of pages9
JournalResuscitation
Volume150
Publication statusPublished - 2020
Publication categoryResearch
Peer-reviewedYes