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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 LU ; Nielsen, Niklas LU ; Ullén, Susann LU ; Blennow Nordstrom, Erik LU orcid ; Dankiewicz, Josef LU orcid ; Friberg, Hans LU ; Heimburg, Katarina LU ; Jakobsen, Janus Christian ; Levin, Helena LU and Callaway, Clifton , et al. (2020) In Resuscitation 150. p.104-112
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Cardiac arrest, Cognitive function, Patient Reported Outcome Measures, Quality of life, Treatment outcome
in
Resuscitation
volume
150
pages
9 pages
publisher
Elsevier
external identifiers
  • pmid:32205155
  • scopus:85083012198
ISSN
0300-9572
DOI
10.1016/j.resuscitation.2020.03.004
language
English
LU publication?
yes
id
59dff426-97fc-4f02-9280-e7b368ab814f
date added to LUP
2020-04-30 07:39:34
date last changed
2024-06-12 12:49:33
@article{59dff426-97fc-4f02-9280-e7b368ab814f,
  abstract     = {{<p>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.</p>}},
  author       = {{Lilja, Gisela and Nielsen, Niklas and Ullén, Susann and Blennow Nordstrom, Erik and Dankiewicz, Josef and Friberg, Hans and Heimburg, Katarina and Jakobsen, Janus Christian and Levin, Helena and Callaway, Clifton and Cariou, Alain and Eastwood, Glenn M. and Helbok, Raimund and Hovdenes, Jan and Kirkegaard, Hans and Leithner, Christoph and Morgan, Matt P.G. and Nordberg, Per and Oddo, Mauro and Pelosi, Paolo and Rylander, Christian and Saxena, Manoj and Taccone, Fabio Silvio and Siranec, Michal and Wise, Matthew P. and Young, Paul J. and Cronberg, Tobias}},
  issn         = {{0300-9572}},
  keywords     = {{Cardiac arrest; Cognitive function; Patient Reported Outcome Measures; Quality of life; Treatment outcome}},
  language     = {{eng}},
  pages        = {{104--112}},
  publisher    = {{Elsevier}},
  series       = {{Resuscitation}},
  title        = {{Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)}},
  url          = {{http://dx.doi.org/10.1016/j.resuscitation.2020.03.004}},
  doi          = {{10.1016/j.resuscitation.2020.03.004}},
  volume       = {{150}},
  year         = {{2020}},
}