Evidence map›Paper›PMID 30663498›Full record

ArticleJournal of the American Heart Association2019

Emergency Consent: Patients' and Surrogates' Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction.

Neal W Dickert, Victoria M Scicluna, Opeolu Adeoye, Dominick J Angiolillo, James C Blankenship, Chandan M Devireddy, Michael R Frankel, Sara F Goldkind, Gautam Kumar, Yi-An Ko and 10 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Journal of the American Heart Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 9% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
  7. 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

20 authors at 9 institutions in 1 country.

Neal W Dickert1 Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.
Victoria M Scicluna4 University of Michigan School of Medicine Ann Arbor MI.
Opeolu Adeoye5 Department of Emergency Medicine University of Cincinnati College of Medicine Cincinnati OH.
Dominick J Angiolillo6 Division of Cardiology Department of Medicine University of Florida College of Medicine-Jacksonville Jacksonville FL.
James C Blankenship7 Department of Cardiology Geisinger Medical Center Danville PA.
Chandan M Devireddy1 Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.
Michael R Frankel2 Department of Neurology Emory University School of Medicine Atlanta GA.
Sara F Goldkind8 Research and Clinical Bioethics Consultant Goldkind Consulting LLC Potomac MD.
Gautam Kumar1 Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.
Yi-An Ko10 Department of Biostatistics and Bioinformatics Emory University Rollins School of Public Health Atlanta GA.
Andrea R Mitchell1 Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.
Raul G Nogueria2 Department of Neurology Emory University School of Medicine Atlanta GA.
Ruth M Parker11 Department of Medicine Emory University School of Medicine Atlanta GA.
Manesh R Patel12 Division of Cardiology Department of Medicine Duke University School of Medicine Durham NC.
Michele Riedford14 Emory Healthcare Patient and Family Advisory Council Atlanta GA.
Robert Silbergleit15 Department of Emergency Medicine University of Michigan Medical School Ann Arbor MI.
Candace D Speight1 Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.
Ilana Spokoyny16 Department of Neurology California Pacific Medical Center San Francisco CA.
Kevin P Weinfurt13 Department of Population Health Sciences Duke University School of Medicine Durham NC.
Rebecca D Pentz3 Winship Cancer Institute Emory University School of Medicine Atlanta GA.
Emory University · USDuke University · USUniversity of Michigan–Ann Arbor · USCalifornia Pacific Medical Center · USEmory Healthcare · USFlorida College · USGeisinger Medical Center · USParker Hannifin (United States) · USUniversity of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.

Indexed as

Decision MakingEmergenciesInformed ConsentInterviews as TopicCross-Sectional StudiesEmergency Service, HospitalFemaleHumansMaleMiddle AgedMyocardial InfarctionRandomized Controlled Trials as TopicRetrospective StudiesStrokeacute myocardial infarctionclinical trialethicsinformed consentstroke

Identifiers

PMID30663498
PMCPMC6497349
OpenAlexW2909873882

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.