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

Gisela Lilja; Niklas Nielsen; Susann Ullén; Erik Blennow Nordstrom; Josef Dankiewicz; Hans Friberg; Katarina Heimburg; 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; Tobias Cronberg

doi:10.1016/j.resuscitation.2020.03.004

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

Gisela Lilja, Niklas Nielsen, Susann Ullén, Erik Blennow Nordstrom, Josef Dankiewicz, Hans Friberg, Katarina Heimburg, 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 PelosiChristian Rylander, Manoj Saxena, Fabio Silvio Taccone, Michal Siranec, Matthew P Wise, Paul J Young, Tobias Cronberg

Medicinsk Afdeling

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

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.

Originalsprog	Engelsk
Sider (fra-til)	104-112
Antal sider	9
Tidsskrift	Resuscitation
Vol/bind	150
Tidlig onlinedato	20 mar. 2020
DOI	https://doi.org/10.1016/j.resuscitation.2020.03.004
Status	Udgivet - maj 2020

Adgang til dokumentet

10.1016/j.resuscitation.2020.03.004

Citationsformater

Lilja, G., Nielsen, N., Ullén, S., Nordstrom, E. B., Dankiewicz, J., Friberg, H., Heimburg, K., Jakobsen, J. C., Levin, H., Callaway, C., Cariou, A., Eastwood, G. M., Helbok, R., Hovdenes, J., Kirkegaard, H., Leithner, C., Morgan, M. P. G., Nordberg, P., Oddo, M., ... 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

@article{2289b9787ed14cc7a0b4fd9fb5f5e258,

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.",

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",

year = "2020",

month = may,

doi = "10.1016/j.resuscitation.2020.03.004",

language = "English",

volume = "150",

pages = "104--112",

journal = "Resuscitation",

issn = "0300-9572",

publisher = "Elsevier Ireland Ltd",

}

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

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

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.

U2 - 10.1016/j.resuscitation.2020.03.004

DO - 10.1016/j.resuscitation.2020.03.004

M3 - Article

C2 - 32205155

SN - 0300-9572

VL - 150

SP - 104

EP - 112

JO - Resuscitation

JF - Resuscitation

ER -

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

Abstract

Adgang til dokumentet

Fingeraftryk

Citationsformater