Evidence map›Paper›PMID 31344699›Full record

Trial reportCerebrovascular diseases extra2019

Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method.

Bryant J Rosell, Kristina Shkirkova, Jeffrey L Saver, David S Liebeskind, Sidney Starkman, May Kim-Tenser, Marc Eckstein, Latisha Sharma, Robin Conwit, Scott Hamilton and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cerebrovascular diseases extra, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Bryant J RosellKeck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.
Kristina ShkirkovaKeck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA, kristina.shkirkova@usc.edu.
Jeffrey L SaverStroke Center, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
David S LiebeskindStroke Center, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
Sidney StarkmanStroke Center, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
May Kim-TenserKeck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.
Marc EcksteinKeck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.
Latisha SharmaStroke Center, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
Robin ConwitNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Massachusetts, USA.
Scott HamiltonDepartment of Neurology, Stanford University, Palo Alto, California, USA.
Nerses SanossianKeck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeSubject retention into clinical trials is vital, and prehospital enrollment may be associated with higher rates of subject withdrawal than more traditional methods of enrollment. We describe rates of subject retention in a prehospital trial of acute stroke therapy.

methodsAll subjects were enrolled into the NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) phase 3 clinical trial. Paramedics screened eligible subjects and contacted the physician-investigator using a dedicated in-ambulance cellular phone. Physician-investigators obtained explicit informed consent from the subject or on-scene legally authorized representative (LAR) who reviewed and signed a consent form. Exception from informed consent (EFIC) was utilized in later stages of the study.

resultsThere were 1,700 subjects enrolled; 1,017 provided consent (60%), 662 were enrolled via LAR (39%), and 21 were enrolled via EFIC (1%). Of the 1,700 patients, 1,413 (83%) completed the 90-day visit, 265 (16%) died prior to the 90-day visit, and 22 (1.3%) withdrew from the study before completion. There were no differences in rates of withdrawal by method of study enrolment, i.e., self-consent (n = 14), 1.4%; LAR (n = 8), 1.2%; EFIC (n = 0) 0%.

conclusionThere was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.

Indexed as

AmbulancesCell PhoneEmergency Medical TechniciansInformed ConsentPatient SelectionResearch PersonnelCaliforniaEmergency Medical ServicesHumansMagnesium SulfateNeuroprotective AgentsPatient DropoutsStrokeTime FactorsTreatment OutcomeMagnesium SulfateNeuroprotective AgentsConsentEmergency medical servicesStroke

Identifiers

PMID31344699
PMCPMC6738216

What OpenQuestion holds

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Registered trials

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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.