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Abstract
There is urgent need for clinical trials of novel interventions to reduce the burden of acute ischemic stroke. A key impediment to such trials is slow recruitment. Since obtaining written informed consent in the setting of acute stroke is especially challenging, some experts have endorsed relaxing the requirement for informed consent by permitting verbal consent or waivers to facilitate recruitment. This systematic review of 36 randomized controlled trials of acute interventions for ischemic stroke assesses whether alternatives to written informed consent are associated with increased recruitment rates. After the exclusion of 2 outlier trials that differed from other trials in conduct and interventions studied, no association was observed on univariable analysis (8.9 participants/month in trials requiring written consent vs 6.1 participants/month in trials with alternatives, p = 0.43) or multivariable analysis (when adjusting for the number of centers, number of countries, and exclusions based on modified Rankin Scale scores). Alternatives to written informed consent in acute stroke trials may enable trial designs that would not be feasible otherwise. However, we did not find evidence that, within traditional trial designs, such alternatives are associated with faster recruitment.
GLOSSARY
- EFIC=
- Exception from Informed Consent;
- HASTA=
- Hyper Acute Stroke Alarm Study;
- mRS=
- modified Rankin Scale;
- NIHSS=
- NIH Stroke Scale;
- PHANTOM-S=
- The Pre-Hospital Acute Neurological Therapy and Optimization of Medical Care in Stroke Patients Study;
- PRISMA=
- Preferred Reporting Items for Systematic Reviews and Meta-Analysis;
- tPA=
- tissue plasminogen activator
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 1472
- Received July 10, 2015.
- Accepted in final form November 16, 2015.
- © 2016 American Academy of Neurology
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