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Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan

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Harvard

Jakobsen, JC, Dankiewicz, J, Lange, T, Cronberg, T, Lilja, G, Levin, H, Bělohlávek, J, Callaway, C, Cariou, A, Erlinge, D, Hovdenes, J, Joannidis, M, Nordberg, P, Oddo, M, Pelosi, P, Kirkegaard, H, Eastwood, G, Rylander, C, Saxena, M, Storm, C, Taccone, FS, Wise, MP, Morgan, MPG, Young, P, Nichol, A, Friberg, H, Ullén, S & Nielsen, N 2020, 'Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan' Trials, bind 21, nr. 1, 831, s. 831. https://doi.org/10.1186/s13063-020-04654-y

APA

CBE

Jakobsen JC, Dankiewicz J, Lange T, Cronberg T, Lilja G, Levin H, Bělohlávek J, Callaway C, Cariou A, Erlinge D, Hovdenes J, Joannidis M, Nordberg P, Oddo M, Pelosi P, Kirkegaard H, Eastwood G, Rylander C, Saxena M, Storm C, Taccone FS, Wise MP, Morgan MPG, Young P, Nichol A, Friberg H, Ullén S, Nielsen N. 2020. Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan. Trials. 21(1):831. https://doi.org/10.1186/s13063-020-04654-y

MLA

Vancouver

Author

Jakobsen, Janus Christian ; Dankiewicz, Josef ; Lange, Theis ; Cronberg, Tobias ; Lilja, Gisela ; Levin, Helena ; Bělohlávek, Jan ; Callaway, Clifton ; Cariou, Alain ; Erlinge, David ; Hovdenes, Jan ; Joannidis, Michael ; Nordberg, Per ; Oddo, Mauro ; Pelosi, Paolo ; Kirkegaard, Hans ; Eastwood, Glenn ; Rylander, Christian ; Saxena, Manoj ; Storm, Christian ; Taccone, Fabio Silvio ; Wise, Matthew P ; Morgan, Matt P G ; Young, Paul ; Nichol, Alistair ; Friberg, Hans ; Ullén, Susann ; Nielsen, Niklas. / Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest : a statistical analysis plan. I: Trials. 2020 ; Bind 21, Nr. 1. s. 831.

Bibtex

@article{68f54dafba3a4fd4addc7ea9d0b8549e,
title = "Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan",
abstract = "BACKGROUND: To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.METHODS/DESIGN: The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55{\%} mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5{\%} with an alpha of 0.05 and 90{\%} power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.DISCUSSION: This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.",
author = "Jakobsen, {Janus Christian} and Josef Dankiewicz and Theis Lange and Tobias Cronberg and Gisela Lilja and Helena Levin and Jan Bělohl{\'a}vek and Clifton Callaway and Alain Cariou and David Erlinge and Jan Hovdenes and Michael Joannidis and Per Nordberg and Mauro Oddo and Paolo Pelosi and Hans Kirkegaard and Glenn Eastwood and Christian Rylander and Manoj Saxena and Christian Storm and Taccone, {Fabio Silvio} and Wise, {Matthew P} and Morgan, {Matt P G} and Paul Young and Alistair Nichol and Hans Friberg and Susann Ull{\'e}n and Niklas Nielsen",
year = "2020",
month = "10",
day = "7",
doi = "10.1186/s13063-020-04654-y",
language = "English",
volume = "21",
pages = "831",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest

T2 - a statistical analysis plan

AU - Jakobsen, Janus Christian

AU - Dankiewicz, Josef

AU - Lange, Theis

AU - Cronberg, Tobias

AU - Lilja, Gisela

AU - Levin, Helena

AU - Bělohlávek, Jan

AU - Callaway, Clifton

AU - Cariou, Alain

AU - Erlinge, David

AU - Hovdenes, Jan

AU - Joannidis, Michael

AU - Nordberg, Per

AU - Oddo, Mauro

AU - Pelosi, Paolo

AU - Kirkegaard, Hans

AU - Eastwood, Glenn

AU - Rylander, Christian

AU - Saxena, Manoj

AU - Storm, Christian

AU - Taccone, Fabio Silvio

AU - Wise, Matthew P

AU - Morgan, Matt P G

AU - Young, Paul

AU - Nichol, Alistair

AU - Friberg, Hans

AU - Ullén, Susann

AU - Nielsen, Niklas

PY - 2020/10/7

Y1 - 2020/10/7

N2 - BACKGROUND: To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.METHODS/DESIGN: The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.DISCUSSION: This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.

AB - BACKGROUND: To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear.METHODS/DESIGN: The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4-6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan.DISCUSSION: This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.

UR - http://www.scopus.com/inward/record.url?scp=85092309127&partnerID=8YFLogxK

U2 - 10.1186/s13063-020-04654-y

DO - 10.1186/s13063-020-04654-y

M3 - Journal article

VL - 21

SP - 831

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 831

ER -

ID: 61111596