Anni Jeppesen

A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Standard

A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. / Kirkegaard, Hans; Pedersen, Asger Roer; Pettilä, Ville; Hjort, Jakob; Rasmussen, Bodil Steen; de Haas, Inge; Nielsen, Jørgen Feldbæk; Ilkjær, Susanne; Kaltoft, Anne; Jeppesen, Anni Nørgaard; Grejs, Anders Morten; Duez, Christophe Henri Valdemar; Larsen, Alf Inge; Toome, Valdo; Arus, Urmet; Taccone, Fabio Silvio; Storm, Christian; Laitio, Timo; Skrifvars, Markus B; Søreide, Eldar.

I: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, Bind 24, Nr. 1, 28.11.2016, s. 138.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Kirkegaard, H, Pedersen, AR, Pettilä, V, Hjort, J, Rasmussen, BS, de Haas, I, Nielsen, JF, Ilkjær, S, Kaltoft, A, Jeppesen, AN, Grejs, AM, Duez, CHV, Larsen, AI, Toome, V, Arus, U, Taccone, FS, Storm, C, Laitio, T, Skrifvars, MB & Søreide, E 2016, 'A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial', Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, bind 24, nr. 1, s. 138. https://doi.org/10.1186/s13049-016-0334-0

APA

Kirkegaard, H., Pedersen, A. R., Pettilä, V., Hjort, J., Rasmussen, B. S., de Haas, I., Nielsen, J. F., Ilkjær, S., Kaltoft, A., Jeppesen, A. N., Grejs, A. M., Duez, C. H. V., Larsen, A. I., Toome, V., Arus, U., Taccone, F. S., Storm, C., Laitio, T., Skrifvars, M. B., & Søreide, E. (2016). A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, 24(1), 138. https://doi.org/10.1186/s13049-016-0334-0

CBE

Kirkegaard H, Pedersen AR, Pettilä V, Hjort J, Rasmussen BS, de Haas I, Nielsen JF, Ilkjær S, Kaltoft A, Jeppesen AN, Grejs AM, Duez CHV, Larsen AI, Toome V, Arus U, Taccone FS, Storm C, Laitio T, Skrifvars MB, Søreide E. 2016. A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine. 24(1):138. https://doi.org/10.1186/s13049-016-0334-0

MLA

Vancouver

Author

Kirkegaard, Hans ; Pedersen, Asger Roer ; Pettilä, Ville ; Hjort, Jakob ; Rasmussen, Bodil Steen ; de Haas, Inge ; Nielsen, Jørgen Feldbæk ; Ilkjær, Susanne ; Kaltoft, Anne ; Jeppesen, Anni Nørgaard ; Grejs, Anders Morten ; Duez, Christophe Henri Valdemar ; Larsen, Alf Inge ; Toome, Valdo ; Arus, Urmet ; Taccone, Fabio Silvio ; Storm, Christian ; Laitio, Timo ; Skrifvars, Markus B ; Søreide, Eldar. / A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. I: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine. 2016 ; Bind 24, Nr. 1. s. 138.

Bibtex

@article{de0d25efca104992a6d3c26b5dd2f1df,
title = "A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial",
abstract = "BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients.METHODS: TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%.DISCUSSION: We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01689077 , 17 September 2012.",
author = "Hans Kirkegaard and Pedersen, {Asger Roer} and Ville Pettil{\"a} and Jakob Hjort and Rasmussen, {Bodil Steen} and {de Haas}, Inge and Nielsen, {J{\o}rgen Feldb{\ae}k} and Susanne Ilkj{\ae}r and Anne Kaltoft and Jeppesen, {Anni N{\o}rgaard} and Grejs, {Anders Morten} and Duez, {Christophe Henri Valdemar} and Larsen, {Alf Inge} and Valdo Toome and Urmet Arus and Taccone, {Fabio Silvio} and Christian Storm and Timo Laitio and Skrifvars, {Markus B} and Eldar S{\o}reide",
year = "2016",
month = nov,
day = "28",
doi = "10.1186/s13049-016-0334-0",
language = "English",
volume = "24",
pages = "138",
journal = "Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine",
issn = "1757-7241",
publisher = "BioMed Central",
number = "1",

}

RIS

TY - JOUR

T1 - A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial

AU - Kirkegaard, Hans

AU - Pedersen, Asger Roer

AU - Pettilä, Ville

AU - Hjort, Jakob

AU - Rasmussen, Bodil Steen

AU - de Haas, Inge

AU - Nielsen, Jørgen Feldbæk

AU - Ilkjær, Susanne

AU - Kaltoft, Anne

AU - Jeppesen, Anni Nørgaard

AU - Grejs, Anders Morten

AU - Duez, Christophe Henri Valdemar

AU - Larsen, Alf Inge

AU - Toome, Valdo

AU - Arus, Urmet

AU - Taccone, Fabio Silvio

AU - Storm, Christian

AU - Laitio, Timo

AU - Skrifvars, Markus B

AU - Søreide, Eldar

PY - 2016/11/28

Y1 - 2016/11/28

N2 - BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients.METHODS: TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%.DISCUSSION: We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01689077 , 17 September 2012.

AB - BACKGROUND: The TTH48 trial aims to determine whether prolonged duration (48 hours) of targeted temperature management (TTM) at 33 (±1) °C results in better neurological outcomes compared to standard duration (24 hours) after six months in comatose out-of-hospital cardiac arrest (OHCA) patients.METHODS: TTH48 is an investigator-initiated, multicentre, assessor-blinded, randomised, controlled superiority trial of 24 and 48 hours of TTM at 33 (±1) ° C performed in 355 comatose OHCA patients aged 18 to 80 years who were admitted to ten intensive care units (ICUs) in six Northern European countries. The primary outcome of the study is the Cerebral Performance Category (CPC) score observed at six months after cardiac arrest. CPC scores of 1 and 2 are defined as good neurological outcomes, and CPC scores of 3, 4 and 5 are defined as poor neurological outcomes. The secondary outcomes are as follows: mortality within six months after cardiac arrest, CPC at hospital discharge, Glasgow Coma Scale (GCS) score on day 4, length of stay in ICU and at hospital and the presence of any adverse events such as cerebral, circulatory, respiratory, gastrointestinal, renal, metabolic measures, infection or bleeding. With the planned sample size, we have 80% power to detect a 15% improvement in good neurological outcomes at a two-sided statistical significance level of 5%.DISCUSSION: We present a detailed statistical analysis protocol (SAP) that specifies how primary and secondary outcomes should be evaluated. We also predetermine covariates for adjusted analyses and pre-specify sub-groups for sensitivity analyses. This pre-planned SAP will reduce analysis bias and add validity to the findings of this trial on the effect of length of TTM on important clinical outcomes after cardiac arrest.TRIAL REGISTRATION: ClinicalTrials.gov: NCT01689077 , 17 September 2012.

U2 - 10.1186/s13049-016-0334-0

DO - 10.1186/s13049-016-0334-0

M3 - Journal article

C2 - 27894327

VL - 24

SP - 138

JO - Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

JF - Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

SN - 1757-7241

IS - 1

ER -