Evidence map›Paper›PMID 32389103›Full record

ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2020

Comparative effectiveness research in critically ill patients: risks associated with mischaracterising usual care.

Willard N Applefeld, Jeffrey Wang, Harvey G Klein, Robert L Danner, Peter Q Eichacker, Charles Natanson

Abstract read
In one paragraph

Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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

7 citing papers in PubMed.

  1. A Framework of Institutional Obligations for Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2026
    Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Research Priorities in Critical Care Cardiology: JACC Expert Panel.Journal of the American College of Cardiology · 2023
    Review
  7. Modeling current practices in critical care comparative effectiveness research.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2022
    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

6 authors.

Willard N Applefeld *Critical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Jeffrey Wang *Critical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Harvey G KleinDepartment of Transfusion Medicine, National Institutes of Health, Bethesda, MD, USA.
Robert L DannerCritical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Peter Q EichackerCritical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Charles NatansonCritical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA. cnatanson@nih.gov.

Funding

Preclinical and Clinical Investigations of Severe Infection and Critical Illness ZIACL008060 · CLC · CLINICAL CENTER · PI DANNER, ROBERT L · 2009 to 2025
$0k
Big Data- Epidemiology of Antimicrobial ResistanceZIACL090046 · CLC · CLINICAL CENTER · PI KADRI, SAMEER · 2017 to 2025
$0k
6 · The paper itself

Abstract

Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. For critically ill subjects in particular, such practice deviations may increase the risk of death or injury and undermine safety monitoring. Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.

Indexed as

Comparative Effectiveness ResearchCritical IllnessResearch SubjectsEthics, ResearchHumansResearch Design

Identifiers

PMID32389103
PMCPMC10692467

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.