Evidence map›Paper›PMID 18689583›Full record

ArticleChest2008

Reasons for nonenrollment in a clinical trial of acute lung injury.

Andrea E Glassberg, John M Luce, Michael A Matthay, National Heart, Lung, and Blood Institute Clinical Trials Network

Abstract read
In one paragraph

Article in Chest, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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

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

  1. Pooled it
  2. Alternative Tobacco Product Use in Critically Ill Patients.International journal of environmental research and public health · 2020
    Article
  3. Review
  4. Enrollment Challenges in Critical Care Nursing Research.American journal of critical care : an official publication, American Association of Critical-Care Nurses · 2017
    Article
  5. Strategies to Maximize Enrollment in a Prospective Study of Comatose Children in the PICU.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

4 authors.

Andrea E GlassbergPermanente Medical Group, Fremont, San Francisco, San Francisco, CA. Electronic address: andrea.e.glassberg@kp.org.
John M LuceUniversity of California, San Francisco, San Francisco, CA.
Michael A MatthayUniversity of California, San Francisco, San Francisco, CA.
National Heart, Lung, and Blood Institute Clinical Trials Network

Funding

Therapy for Clinical Acute Lung Injury with APCP50HL074005 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PITTET, JEAN-FRANCOIS · 2003 to 2007
$9.6M
Resolution of Clinical Lung InjuryR37HL051856 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MATTHAY, MICHAEL A. · 2006 to 2015
$3.9M
RESOLUTION OF CLINICAL LUNG INJURYR01HL051856 · NHLBI · UNIVERSITY OF CALIFORNIA SAN FRANCISCO · PI MATTHAY, MICHAEL A. · 1996 to 2005
$1.7M
NHLBI NIH HHS HL51856NHLBI NIH HHS N01-HR746059NHLBI NIH HHS P50 HL074005NHLBI NIH HHS P50 HL74005NHLBI NIH HHS R01 HL051856NHLBI NIH HHS R37 HL051856
6 · The paper itself

Abstract

backgroundEnrolling critically ill patients in clinical trials is challenging. We observed that eligible patients at San Francisco General Hospital (SFGH), a public hospital that cares largely for indigent patients, were less likely to be enrolled in a clinical trial of acute lung injury (ALI) than eligible patients at the University of California, San Francisco (UCSF), a university referral center. We examined the reasons for nonenrollment and the impact of the availability of a surrogate decision maker on critical care clinical trials enrollment.

methodsData collected from the ARDS Network trial of lower vs traditional tidal volume ventilation for patients with ALI was analyzed. Patient demographics and reasons for nonenrollment were analyzed among 531 consecutively screened patients at the two hospitals: UCSF and SFGH.

resultsAt UCSF, 1% of screened patients were not enrolled because they lacked surrogates, whereas 18% of screened patients were not enrolled at SFGH because they lacked surrogates. Lack of surrogate was the most common reason for nonenrollment among eligible patients at SFGH.

conclusionsCritically ill patients with ALI at a public hospital were less likely to be enrolled in a clinical trial than patients at a university hospital primarily because they lacked surrogates. Lack of a surrogate also was a major factor in nonenrollment in other ARDS Network hospitals. In order to provide all affected patients an opportunity to participate in research, innovative strategies for increasing enrollment in critical care research without compromising protection from research risks are needed.

Indexed as

Hospitals, GeneralHospitals, PublicHospitals, UniversityPatient SelectionAdultAgedBiomarkersClinical Trials as TopicFemaleHumansMaleMiddle AgedReferral and ConsultationRespiration, ArtificialRespiratory Distress SyndromeRetrospective StudiesBiomarkers

Identifiers

PMID18689583
PMCPMC2789486

What OpenQuestion holds

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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.