Evidence map›Paper›PMID 32072303›Full record

ArticleIntensive care medicine2020

Contemporary strategies to improve clinical trial design for critical care research: insights from the First Critical Care Clinical Trialists Workshop.

Michael O Harhay, Jonathan D Casey, Marina Clement, Sean P Collins, Étienne Gayat, Michelle Ng Gong, Samir Jaber, Pierre-François Laterre, John C Marshall, Michael A Matthay and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Intensive care medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04663555 (Effect of Dexamethasone in Patients With ARDS and COVID-19 - Prospective, Multi-centre, Open-label, Parallel-group, Randomized Controlled Trial), which is not on this map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 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.

NCT04663555 phase4completednot on this mapstarted 2021, after this paper: background citation

Effect of Dexamethasone in Patients With ARDS and COVID-19 - Prospective, Multi-centre, Open-label, Parallel-group, Randomized Controlled Trial (REMED Trial)

TypeinterventionalSponsorBrno University HospitalRan2021 to 2023Enrolled235ConditionsCovid19, ARDSArmsDexamethasone
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. The times are changing: A primer on novel clinical trial designs and endpoints in critical care research.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Elements of Statistical Power in Pediatric Critical Care Trials.Annals of the American Thoracic Society · 2023
    Article
  20. Review
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

15 authors.

Michael O HarhayPalliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, University of Pennsylvania, 304 Blockley Hall, 423 Guardian Drive, Philadelphia, PA, 19104-6021, USA. mharhay@pennmedicine.upenn.edu.ORCID 0000-0002-0553-674X
Jonathan D CaseyDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID 0000-0002-0977-290X
Marina ClementHôpital Privé Jacques Cartier, Massy, France.
Sean P CollinsDepartment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Étienne GayatDepartment of Anesthesia, Burn and Critical Care, University Hospitals Saint-Louis - Lariboisière, AP-HP, Paris, France.
Michelle Ng GongDivision of Critical Care Medicine, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
Samir JaberDepartment of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Teaching Hospital, PhyMed Exp, INSERM U1046, University of Montpellier, Montpellier, France.
Pierre-François LaterreDepartment of Intensive Care, Cliniques St-Luc, Université Catholique de Louvain, Brussels, Belgium.
John C MarshallLi Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health, Toronto, Canada.
Michael A MatthayCardiovascular Research Institute, University of California-San Francisco, San Francisco, CA, USA.
Rhonda E MonroeHeart Failure Society of America (HFSA), HFSA Patient Committee, Rockville, MD, USA.
Todd W RiceDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Eileen RubinARDS Foundation, Northbrook, IL, USA.
Wesley H SelfDepartment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Alexandre MebazaaDepartment of Anesthesia, Burn and Critical Care, University Hospitals Saint-Louis - Lariboisière, AP-HP, Paris, France.

Funding

Clinical and Translational Training Program in Pulmonary MedicineT32HL087738 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Lorraine B Ware · 2007 to 2026
$7.0M
Improving the measurement and analysis of long-term, patient-centered outcomes following acute respiratory failureR00HL141678 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI HARHAY, MICHAEL OSCAR · 2020 to 2022
$747k
Improving the measurement and analysis of long-term, patient-centered outcomes following acute respiratory failureK99HL141678 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI HARHAY, MICHAEL OSCAR · 2018 to 2019
$214k
NHLBI NIH HHS K99 HL141678NHLBI NIH HHS R00 HL141678NHLBI NIH HHS T32 HL087738
6 · The paper itself

Abstract

backgroundConducting research in critically-ill patient populations is challenging, and most randomized trials of critically-ill patients have not achieved pre-specified statistical thresholds to conclude that the intervention being investigated was beneficial.

methodsIn 2019, a diverse group of patient representatives, regulators from the USA and European Union, federal grant managers, industry representatives, clinical trialists, epidemiologists, and clinicians convened the First Critical Care Clinical Trialists (3CT) Workshop to discuss challenges and opportunities in conducting and assessing critical care trials. Herein, we present the advantages and disadvantages of available methodologies for clinical trial design, conduct, and analysis, and a series of recommendations to potentially improve future trials in critical care.

conclusionThe 3CT Workshop participants identified opportunities to improve critical care trials using strategies to optimize sample size calculations, account for patient and disease heterogeneity, increase the efficiency of trial conduct, maximize the use of trial data, and to refine and standardize the collection of patient-centered and patient-informed outcome measures beyond mortality.

Indexed as

Critical CareCritical IllnessClinical Trials as TopicHumansAcute respiratory distress syndromeClinical trialsCritical careSepsis

Identifiers

PMID32072303
PMCPMC7224097

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.