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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)

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Lilja, G, Nielsen, N, Ullén, S, Nordstrom, EB, Dankiewicz, J, Friberg, H, Heimburg, K, Jakobsen, JC, Levin, H, Callaway, C, Cariou, A, Eastwood, GM, Helbok, R, Hovdenes, J, Kirkegaard, H, Leithner, C, Morgan, MPG, Nordberg, P, Oddo, M, Pelosi, P, Rylander, C, Saxena, M, Taccone, FS, Siranec, M, Wise, MP, Young, PJ & Cronberg, T 2020, 'Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)' Resuscitation, bind 150, s. 104-112. https://doi.org/10.1016/j.resuscitation.2020.03.004

APA

CBE

Lilja G, Nielsen N, Ullén S, Nordstrom EB, Dankiewicz J, Friberg H, Heimburg K, Jakobsen JC, Levin H, Callaway C, Cariou A, Eastwood GM, Helbok R, Hovdenes J, Kirkegaard H, Leithner C, Morgan MPG, Nordberg P, Oddo M, Pelosi P, Rylander C, Saxena M, Taccone FS, Siranec M, Wise MP, Young PJ, Cronberg T. 2020. Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2). Resuscitation. 150:104-112. https://doi.org/10.1016/j.resuscitation.2020.03.004

MLA

Vancouver

Author

Lilja, Gisela ; Nielsen, Niklas ; Ullén, Susann ; Nordstrom, Erik Blennow ; 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. / Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2). I: Resuscitation. 2020 ; Bind 150. s. 104-112.

Bibtex

@article{6410332fc797458481d28d0261097ec5,
title = "Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)",
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",
author = "Gisela Lilja and Niklas Nielsen and Susann Ull{\'e}n and Nordstrom, {Erik Blennow} and Josef Dankiewicz and Hans Friberg and Katarina Heimburg and Jakobsen, {Janus Christian} and Helena Levin and Clifton Callaway and Alain Cariou and Eastwood, {Glenn M} and Raimund Helbok and Jan Hovdenes and Hans Kirkegaard and Christoph Leithner and Morgan, {Matt P G} and Per Nordberg and Mauro Oddo and Paolo Pelosi and Christian Rylander and Manoj Saxena and Taccone, {Fabio Silvio} and Michal Siranec and Wise, {Matthew P} and Young, {Paul J} and Tobias Cronberg",
note = "Copyright {\circledC} 2020 The Authors. Published by Elsevier B.V. All rights reserved.",
year = "2020",
month = "5",
doi = "10.1016/j.resuscitation.2020.03.004",
language = "English",
volume = "150",
pages = "104--112",
journal = "Resuscitation",
issn = "0300-9572",
publisher = "Elsevier Ireland Ltd",

}

RIS

TY - JOUR

T1 - Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2)

AU - Lilja, Gisela

AU - Nielsen, Niklas

AU - Ullén, Susann

AU - Nordstrom, Erik Blennow

AU - Dankiewicz, Josef

AU - Friberg, Hans

AU - Heimburg, Katarina

AU - Jakobsen, Janus Christian

AU - Levin, Helena

AU - Callaway, Clifton

AU - Cariou, Alain

AU - Eastwood, Glenn M

AU - Helbok, Raimund

AU - Hovdenes, Jan

AU - Kirkegaard, Hans

AU - Leithner, Christoph

AU - Morgan, Matt P G

AU - Nordberg, Per

AU - Oddo, Mauro

AU - Pelosi, Paolo

AU - Rylander, Christian

AU - Saxena, Manoj

AU - Taccone, Fabio Silvio

AU - Siranec, Michal

AU - Wise, Matthew P

AU - Young, Paul J

AU - Cronberg, Tobias

N1 - Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.

PY - 2020/5

Y1 - 2020/5

N2 - 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.

AB - 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.

KW - Cardiac arrest

KW - Cognitive function

KW - Patient Reported Outcome Measures

KW - Quality of life

KW - Treatment outcome

U2 - 10.1016/j.resuscitation.2020.03.004

DO - 10.1016/j.resuscitation.2020.03.004

M3 - Journal article

VL - 150

SP - 104

EP - 112

JO - Resuscitation

JF - Resuscitation

SN - 0300-9572

ER -

ID: 59623247