Patient and Surrogate Postenrollment Perspectives on Research Using the Exception From Informed Consent: An Integrated Survey - 20/08/20
, Michelle Biros, MD b, Deneil K. Harney, MPH a, Elizabeth B. Jones, MD c, Andrea R. Mitchell, MPH d, Rebecca D. Pentz, PhD d, e, Robert Silbergleit, MD a, Candace D. Speight, MPH d, David W. Wright, MD d, Neal W. Dickert, MD, PhD d, fAbstract |
Study objective |
It is important for researchers interested in trials using the exception from informed consent to understand the views and experiences of enrolled individuals. Previous studies have shown that patient and surrogate attitudes are generally positive. These studies were small and did not include pediatric patients, and interviews were often conducted long after trial enrollment. This study sought to explore attitudes toward exception from informed consent in a larger sample and more contemporaneous setting.
Methods |
A 10-item paper-and-pencil survey was integrated into the Established Status Epilepticus Treatment Trial, a randomized trial of 3 treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. Primary domains included attitudes toward trial enrollment, exception from informed consent, and community consultation. Simple descriptive statistics, χ2, and Fisher’s exact tests were conducted.
Results |
Of 317 patients and surrogates, 90% agreed with or were neutral about the statement “I am glad that I/my family member was included in the Established Status Epilepticus Treatment Trial research study,” whereas 10% disagreed. Twenty-seven percent disagreed with enrollment in the study without prospective consent. Black participants were more likely than white, other race, and unknown-race participants to disagree with enrollment without prospective consent (36% versus 23%, 14%, and 14%, respectively). Participants indicated that patients (81%), their families (65%), and those at risk for seizures (51%) were most important to include in community consultation.
Conclusion |
This study aimed to explore attitudes toward exception from informed consent enrollment among participants at all sites in a large, multicenter exception from informed consent trial. General acceptance of trial enrollment was high; acceptance of exception from informed consent specifically was somewhat lower, especially among black participants. Our findings provide further support for targeted community consultation focusing on individuals with connections to the disease under study. Future research should focus on communication in the postenrollment period, especially with individuals who may have concerns about exception from informed consent.
Le texte complet de cet article est disponible en PDF.Plan
| Please see page 344 for the Editor’s Capsule Summary of this article. |
|
| Supervising editor: David L. Schriger, MD, MPH. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
|
| Author contributions: MB, EBJ, RDP, RS, and NWD conceived of the study. VMS, DKH, EBJ, RDP, RS, DWW, and NWD contributed to the design of the survey. DKH, CDS, and NWD supervised the conduct of the study and data collection. VMS, ARM, CDS, and NWD entered and managed the data, including quality control. VMS, CDS, and NWD provided statistical advice and analyzed the data. VMS and NWD drafted the article, and all authors contributed substantially to its revision. VMS takes responsibility for the paper as a whole. |
|
| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
|
| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). This project was part of the Established Status Epilepticus Treatment Trial, which was funded by the National Institutes of Health (NIH) and NINDS (project 1U01NS088034-01). Dr. Dickert reports receiving research support from National Institute of Neurological Disorders and Stroke, National Center for Advancing Translational Sciences, National Institute of Child Health and Human Development, and Patient Centered Outcomes Research Institute. Dr. Silbergleit reports that the institution where his research is conducted receives NIH grants. Dr. Wright reports receiving research support from NIH, the Centers for Disease Control and Prevention, Department of Defense–Tracks TBI, Marcus Foundation–VICTAS trial, and National Highway Traffic Safety Administration Crash Injury Research, as well as participating on scientific advisory boards for Astrocyte Pharma, SENSE Diagnostics, and ISCHEMIX. |
|
| Trial registration number: NCT01960075 |
|
| A podcast for this article is available at www.annemergmed.com. |
Vol 76 - N° 3
P. 343-349 - septembre 2020 Retour au numéro
Article précédent
- Does the Use of High-Flow Nasal Cannula Compared With Conventional Oxygen Therapy in the Peri-intubation Period Reduce Severe Desaturation?
- Drew A. Long, Brit Long, Michael D. April
- Modernizing Informed Consent During Emergency Care
- Mehul D. Patel, Brooke L. Namboodri, Timothy F. Platts-Mills
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?