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Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method.
- Source :
-
Cerebrovascular diseases extra [Cerebrovasc Dis Extra] 2019; Vol. 9 (2), pp. 72-76. Date of Electronic Publication: 2019 Jul 25. - Publication Year :
- 2019
-
Abstract
- Background and Purpose: 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.<br />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.<br />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%.<br />Conclusion: There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.<br /> (© 2019 The Author(s) Published by S. Karger AG, Basel.)
- Subjects :
- California
Humans
Magnesium Sulfate administration & dosage
Neuroprotective Agents administration & dosage
Patient Dropouts
Stroke diagnosis
Stroke physiopathology
Time Factors
Treatment Outcome
Ambulances
Cell Phone
Emergency Medical Services methods
Emergency Medical Technicians
Informed Consent
Patient Selection
Research Personnel
Stroke drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1664-5456
- Volume :
- 9
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Cerebrovascular diseases extra
- Publication Type :
- Academic Journal
- Accession number :
- 31344699
- Full Text :
- https://doi.org/10.1159/000500851