Evidence map›Paper›PMID 33938718›Full record

ArticleCritical care medicine2021

Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III.

Denham S Ward, Anthony R Absalom, Leanne M Aitken, Michele C Balas, David L Brown, Lisa Burry, Elizabeth Colantuoni, Douglas Coursin, John W Devlin, Franklin Dexter and 21 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Critical care medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-weighted citation impact, top 10% 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, 23 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Observational
  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

31 authors at 20 institutions in 5 countries.

Denham S WardDepartment of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY.
Anthony R AbsalomUniversity Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Leanne M AitkenSchool of Health Sciences, University of London, London, United Kingdom.
Michele C BalasCenter of Healthy Aging, Self-Management, and Complex Care, The Ohio State University, College of Nursing, Columbus, OH.
David L BrownClear Consults, LLC, Hayward, WI.
Lisa BurryLeslie Dan Faculty of Pharmacy, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
Elizabeth ColantuoniDepartment of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University School of Medicine, Baltimore, MD.
Douglas CoursinDepartments of Anesthesiology and Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI.
John W DevlinSchool of Pharmacy, Northeastern University, Boston, MA.
Franklin DexterDepartment of Anesthesia, University of Iowa, Iowa City, IA.
Robert H DworkinDepartment of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY.
Talmage D EganDepartment of Anesthesiology, University of Utah, Salt Lake City, UT.
Doug ElliottFaculty of Health, University of Technology Sydney, Sydney, NSW, Australia.
Ingrid EgerodIntensive Care Unit, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Pamela FloodDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA.
Gilles L FraserDepartment of Medicine, Tufts University School of Medicine, Maine Medical Center, Portland, ME.
Timothy D GirardDepartment of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
David GozalDivision of Anesthesiology and CCM, Hadassah Medical Center, The Hebrew University School of Medicine, Jerusalem, Israel.
Ramona O HopkinsPsychology Department and Neuroscience Center, Brigham Young University, Provo, UT.
John KressDepartment of Medicine, Section of Pulmonary and Critical Care, The University of Chicago, Chicago, IL.
Mervyn MazeDepartment of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, CA.
Dale M NeedhamDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University, Baltimore, MD.
Pratik PandharipandeDepartment of Anesthesiology and the Critical Illness, Vanderbilt University Medical Center, Nashville, TN.
Richard RikerDepartment of Critical Care Services, Maine Medical Center, Portland, ME.
Daniel I SesslerDepartment of Outcomes Research, Cleveland Clinic, Cleveland, OH.
Steven L ShaferDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA.
Yahya ShehabiMonash Health School of Clinical Sciences - Department of Intensive Care Medicine - Critical Care Research, Melbourne, VIC, Australia.
Claudia SpiesDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Campus Charité Mitte & Campus Virchow-Klinikum, Berlin, Germany.
Lena S SunDepartment of Anesthesiology, Columbia University Medical Center, New York, NY.
Avery TungDepartment of Anesthesia and Critical Care, The University of Chicago, Chicago, IL.
Richard D UrmanDepartment of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Stanford University · USUniversity of Rochester · USBrigham and Women's Hospital · USBrigham Young University · USCleveland Clinic · USColumbia University Irving Medical Center · USJohns Hopkins Medicine · USJohns Hopkins University · USMaine Medical Center · USNortheastern University · USRigshospitalet · DKUniversity Medical Center Groningen · NLUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Iowa · USUniversity of London · GBUniversity of Pittsburgh · USUniversity of Technology Sydney · AUUniversity of Utah · USUniversity of Wisconsin–Madison · US

Funding

Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICUR01HL132887 · NHLBI · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI HEYLAND, DAREN KEITH, NEEDHAM, DALE MURRAY · 2017 to 2021
$3.5M
NHLBI NIH HHS R01 HL132887
6 · The paper itself

Abstract

objectivesClinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.

designA 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.

participantsThirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN

resultsThe final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.

conclusionsThese recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

Indexed as

Congresses as TopicConsensusDelphi TechniqueDistrict of ColumbiaHumansHypnotics and SedativesRespiration, ArtificialTime FactorsHypnotics and Sedatives

Identifiers

PMID33938718
PMCPMC8439670
OpenAlexW3158685742

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.