Introduction: Intracranial aneurysm coiling trials commonly report only operator interpretations of angiographic outcomes. Individual studies have shown that self assessments tend to report more favorable outcomes when compared with assessments made by independent evaluators. in the current study, we aim to compare the difference between self-report and Core Laboratory assessments of angiographic outcomes within the same trials.
Methods: We conducted a thorough search of the literature in Ovid MEDLINE and EMBASE, using the search terms “subarachnoid hemorrhage”, “intracranial aneurysms”, “endovascular treatment”, “coiling”, and “trials”. The search covered from 2002-2016. Inclusion criteria were clinical trial, >50 aneurysms treated, and reporting of both independent core imaging facility and operator interpretations of angiographic results. Differences between and the Core Laboratory and the operator assessments were analyzed for statistical significance.
Results: The search yielded 356 studies, out of which four fulfilled our inclusion criteria: GREAT, Cerebryte, CLARITY series, and the Endovascular Treatment of Intracranial Aneurysms with Matrix Detachable Coils registry. These four studies included data on a total of 1,935 aneurysms for analysis. Angiographic outcomes were all graded by using the Raymond Grading Scale (complete occlusion, residual neck, residual aneurysms). All four studies reported more favorable results by operator self-assessment compared with Core Laboratory assessments, with odd ratios of 1.74 (CI 1.33-2.28), 1.99 (CI 1.38-2.87), 3.49 (CI 2.81-4.33), and 2.14 (CI 1.64-2.78) . The combined odds ratio of favorable outcomes by self-report is 2.42 (CI 2.12-2.76).
Conclusions: Self-reported interpretations tend to report higher rates of favorable outcomes compared with Core Laboratory assessments. Interpretations of self-report only trials should be aware of this bias, and decision making for device approvals should take into account our findings.
Patient Care: Our study may impact interpretation of trials of new devices and whether they should be approved for patient use.
Learning Objectives: Trials of intracranial aneurysm coiling commonly only report operator evaluations.
Self-reported results tend to have more favorable outcomes when compared with Core Laboratory evaluations.
This bias should be kept in mind when interpreting results from these trials.