Evidence map›Paper›PMID 33028425›Full record

Trial reportTrials2020

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

Janus Christian Jakobsen, Josef Dankiewicz, Theis Lange, Tobias Cronberg, Gisela Lilja, Helena Levin, Jan Bělohlávek, Clifton Callaway, Alain Cariou, David Erlinge and 18 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 20 institutions in 15 countries.

Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Tagensvej 22, Copenhagen, Denmark. jcj@ctu.dk.ORCID http://orcid.org/0000-0002-3642-2120
Josef DankiewiczDepartment of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
Theis LangeSection of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Tobias CronbergDepartment of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.
Gisela LiljaDepartment of Clinical Sciences, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.
Helena LevinDepartment of Clinical Sciences, Research and Education, Lund University, Skåne University Hospital, Lund, Sweden.
Jan Bělohlávek2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.
Clifton CallawayDepartment of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Alain CariouMedical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France.
David ErlingeDepartment of Clinical Sciences, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
Jan HovdenesDepartment of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Michael JoannidisDivision of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria.
Per NordbergDepartment of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.
Mauro OddoDepartment of Intensive Care Medicine, Faculty of Biology and Medicine, Centre Hospitalier Universitaire Vaudois (CHUV) - University Hospital, University of Lausanne, Lausanne, Switzerland.
Paolo PelosiDepartment of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.
Hans KirkegaardResearch Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark.
Glenn EastwoodDepartment of Intensive Care, Austin Hospital, Heidelberg, Australia.
Christian RylanderDepartment of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Manoj SaxenaBankstown Hospital Clinical School and The George Institute for Global Health, University of New South Wales, Kensington, Australia.
Christian StormDepartment of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Fabio Silvio TacconeDepartment of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Matthew P WiseAdult Critical Care, University Hospital of Wales, Cardiff, UK.
Matt P G MorganAdult Critical Care, University Hospital of Wales, Cardiff, UK.
Paul YoungMedical Research Institute of New Zealand, Wellington, New Zealand.
Alistair NicholUniversity Collage Dublin-Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.
Hans FribergDepartment of Clinical Sciences, Anesthesia & Intensive Care, Lund University, Skåne University Hospital, Lund, Sweden.
Susann UllénClinical Studies Sweden, Skåne University Hospital, Lund, Sweden.
Niklas NielsenDepartment of Clinical Sciences Lund, Anesthesia & Intensive Care, Lund University, Helsingborg Hospital, Lund, Sweden.
Lund University · SEUniversity Hospital of Wales · GBAarhus University Hospital · DKAustin Hospital · AUCharles University · CZDélégation Paris 5 · FRInnsbruck Medical University · ATJohns Hopkins University · USKarolinska Institutet · SEMedical Research Institute of New Zealand · NZOslo University Hospital · NOOspedale Policlinico San Martino · ITSkåne University Hospital · SEThe Alfred Hospital · AUUniversité Libre de Bruxelles · BEUniversity Hospital of Lausanne · CHUniversity of Copenhagen · DKUniversity of Gothenburg · SEUniversity of Pittsburgh · USUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo 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/

designThe 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.

Indexed as

Cardiopulmonary ResuscitationHypothermiaHypothermia, InducedOut-of-Hospital Cardiac ArrestBody TemperatureFeverHumansTreatment Outcome

Identifiers

PMID33028425
PMCPMC7542893
OpenAlexW3092309381

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.