A Systematic Review of Informed Consent in Acute Stroke Trials (P5.136)

Abstract

Objective: To characterize how investigators have addressed barriers to informed consent in acute stroke trials. Background: Stroke trial investigators face the challenge of obtaining consent from cognitively altered or aphasic subjects for potentially risky interventions that must be administered quickly. This challenge has grown particularly stark as investigators have begun to test interventions such as thrombolysis delivered in the pre-hospital setting. Design/Methods: We searched PUBMED, MEDLINE, DORIS, and the Stroke Trials Registry for randomized controlled trials of interventions for ischemic stroke within 12 hours of symptom onset, published between 2010 and 2014 (protocol online at: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014010204). We screened 736 articles, yielding 46 trials (with 17,793 patients) that met our inclusion criteria. Results: Thrombolysis was the primary intervention in 9 of the trials; the remainder investigated adjunctive therapy to thrombolysis. Written informed consent prior to randomization was required in 26 trials (62[percnt]); verbal consent was permitted in 7 (17[percnt]); neither written nor verbal consent was required prior to randomization in 9 trials (21[percnt]). Six trials tested pre-hospital interventions that relied upon physicians or paramedics to obtain consent in the field. The mean time to thrombolysis for trials with consent prior to thrombolysis (both pre-hospital and hospital-based) was 199.1 minutes (2,579 patients) versus 129.9 minutes (1,709 patients) for those with consent during or after thrombolysis. Among trials that permitted investigators to waive consent, a variety of justifications were offered including exception from informed consent (EFIC), approval by an Ethics Board, consistency with local regulations and laws, the ability of medical professionals to provide proxy-consent, and the need for rapid treatment. Conclusions: Stroke trial investigators have adopted heterogeneous approaches to informed consent that highlight the balance between patient autonomy and expeditious treatment. Consistent policies regarding consent are needed both for the protection of patients and for the comparison of interventions across trials.

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