Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method.
Ambulances
California
Cell Phone
Emergency Medical Services
/ methods
Emergency Medical Technicians
Humans
Informed Consent
Magnesium Sulfate
/ administration & dosage
Neuroprotective Agents
/ administration & dosage
Patient Dropouts
Patient Selection
Research Personnel
Stroke
/ diagnosis
Time Factors
Treatment Outcome
Consent
Emergency medical services
Stroke
Journal
Cerebrovascular diseases extra
ISSN: 1664-5456
Titre abrégé: Cerebrovasc Dis Extra
Pays: Switzerland
ID NLM: 101577885
Informations de publication
Date de publication:
2019
2019
Historique:
received:
11
04
2019
accepted:
09
05
2019
pubmed:
26
7
2019
medline:
12
2
2020
entrez:
26
7
2019
Statut:
ppublish
Résumé
Subject 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. All 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. There 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%. There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.
Sections du résumé
BACKGROUND AND PURPOSE
OBJECTIVE
Subject 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.
METHODS
METHODS
All 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.
RESULTS
RESULTS
There 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%.
CONCLUSION
CONCLUSIONS
There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.
Identifiants
pubmed: 31344699
pii: 000500851
doi: 10.1159/000500851
pmc: PMC6738216
doi:
Substances chimiques
Neuroprotective Agents
0
Magnesium Sulfate
7487-88-9
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
72-76Informations de copyright
© 2019 The Author(s) Published by S. Karger AG, Basel.
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