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

Détails

ID Serval
serval:BIB_C8D7AD822BF2
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Protocol for outcome reporting and follow-up in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2).
Périodique
Resuscitation
Auteur(s)
Lilja G., Nielsen N., Ullén S., Blennow Nordstrom E., 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 MPG, Nordberg P., Oddo M., Pelosi P., Rylander C., Saxena M., Taccone F.S., Siranec M., Wise M.P., Young P.J., Cronberg T.
ISSN
1873-1570 (Electronic)
ISSN-L
0300-9572
Statut éditorial
Publié
Date de publication
05/2020
Peer-reviewed
Oui
Volume
150
Pages
104-112
Langue
anglais
Notes
Publication types: Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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.
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.
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.
Mots-clé
Aged, Follow-Up Studies, Humans, Hypothermia, Hypothermia, Induced, Multicenter Studies as Topic, Out-of-Hospital Cardiac Arrest/therapy, Randomized Controlled Trials as Topic, Reproducibility of Results, Treatment Outcome, Cardiac arrest, Cognitive function, Patient Reported Outcome Measures, Quality of life, Treatment outcome
Pubmed
Web of science
Open Access
Oui
Création de la notice
01/04/2020 19:52
Dernière modification de la notice
07/07/2021 6:36
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