Evidence map›Paper›PMID 34757439›Full record

Trial reportIntensive care medicine2022

Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial.

Anders Granholm, Marie Warrer Munch, Sheila Nainan Myatra, Bharath Kumar Tirupakuzhi Vijayaraghavan, Maria Cronhjort, Rebecka Rubenson Wahlin, Stephan M Jakob, Luca Cioccari, Maj-Brit Nørregaard Kjær, Gitte Kingo Vesterlund and 36 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Intensive care medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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

63 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors.

Anders GranholmDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. andersgran@gmail.com.ORCID http://orcid.org/0000-0001-5799-7655
Marie Warrer MunchDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Sheila Nainan MyatraDepartment of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Bharath Kumar Tirupakuzhi VijayaraghavanDepartment of Critical Care, Apollo Hospitals, Chennai, India.
Maria CronhjortDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Rebecka Rubenson WahlinDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Stephan M JakobDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Luca CioccariDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Maj-Brit Nørregaard KjærDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Gitte Kingo VesterlundDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Tine Sylvest MeyhoffDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Marie HellebergDepartment of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Morten Hylander MøllerDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Thomas BenfieldCenter of Research & Disruption of Infectious Diseases, Department of Infectious Diseases, Copenhagen University Hospital-Amager and Hvidovre, Hvidovre, Denmark.
Balasubramanian VenkateshThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Naomi E HammondThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Sharon MicallefThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Abhinav BassiThe George Institute for Global Health, New Delhi, India.
Oommen JohnThe George Institute for Global Health, New Delhi, India.
Vivekanand JhaThe George Institute for Global Health, New Delhi, India.
Klaus Tjelle KristiansenDepartment of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.
Charlotte Suppli UlrikDepartment of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Vibeke Lind JørgensenDepartment of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Margit SmittDepartment of Neuroanaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Morten H BestleDepartment of Anaesthesia and Intensive Care, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Anne Sofie AndreasenDepartment of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
Lone Musaeus PoulsenDepartment of Anaesthesiology, Zealand University Hospital, Køge, Denmark.
Bodil Steen RasmussenCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Anne Craveiro BrøchnerCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Thomas StrømDepartment of Anaesthesia and Critical Care Medicine, Odense University Hospital, Odense C, Denmark.
Anders MøllerDepartment of Anaesthesia and Intensive Care, Næstved-Slagelse-Ringsted Hospital, Slagelse, Denmark.
Mohd Saif KhanDepartment of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, India.
Ajay PadmanabanDepartment of Critical Care, Apollo Hospitals, Chennai, India.
Jigeeshu Vasishtha DivatiaDepartment of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
Sanjith SaseedharanDepartment of Intensive Care, SL Raheja Hospital, Mumbai, Maharashtra, India.
Kapil BorawakeDepartment of Intensive Care, Vishwaraj Hospital, Pune, India.
Farhad KapadiaSection of Critical Care, Department of Medicine, Hinduja Hospital, Mahim, Mumbai, India.
Subhal DixitDepartment of Critical Care Medicine, Sanjeevan Hospital, Pune, Maharashtra, India.
Rajesh ChawlaDepartment of Respiratory and Critical Care Medicine, Indraprastha Apollo Hospital, New Delhi, India.
Urvi ShuklaIntensive Care Unit and Emergency Services, Symbiosis University Hospital and Research Centre, Lavale, Pune, India.
Pravin AminDepartment of Critical Care Medicine, Bombay Hospital Institute of Medical Sciences, Mumbai, India.
Michelle S ChewDepartment of Anesthesiology and Intensive Care, Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Christian Aage WambergDepartment of Anaesthesia and Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark.
Christian GluudCentre for Clinical Intervention Research, Copenhagen Trial Unit, Capital Region of Denmark, Copenhagen University Hospital -Rigshospitalet, Copenhagen, Denmark.
Theis LangeDepartment of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Anders PernerDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Funding

Rigshospitalet's Research Council E-22703-06The Novo Nordisk Foundation 0062998
6 · The paper itself

Abstract

purposeWe compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation.

methodsWe analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone.

resultsThe adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI -0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses.

conclusionWe found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.

Indexed as

COVID-19 Drug TreatmentBayes TheoremDexamethasoneHumansHypoxiaSARS-CoV-2SteroidsDexamethasoneSteroidsBayesian analysisCorticosteroidsCOVID-19Critical illnessHypoxaemia

Identifiers

PMID34757439
PMCPMC8579417

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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.