Elsevier

The Lancet

Volume 384, Issue 9937, 5–11 July 2014, Pages 27-28
The Lancet

Correspondence
Is cerebrovascular neurosurgery sacrificed on the altar of RCTs?

https://doi.org/10.1016/S0140-6736(14)61109-0Get rights and content

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    On the other hand, errors in the study design, misrepresentation of the study population, lacking information regarding the employed treatment interventions, limited study size, and unfairly defined data may undermine the validity of the produced conclusions. This problem is intensified when we are called to interpret these results and apply them to our daily clinical practice.45 Poorly designed studies with a high risk of bias may be associated with inaccurate results and misleading conclusions, particularly for younger or less experienced neurosurgeons.

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    Establishing complications for bAVM management related to an intention to treat is presently limited to a single randomized control trial of unruptured bAVM (ARUBA) in which 18 cases had surgery as part of management, of whom only 5 cases were treated exclusively by surgery (Mohr et al., 2014). These small numbers prevent the ability to generalize outcomes from surgery and therefore ARUBA cannot be easily used as a guideline for treatment of unruptured bAVM (Korja et al., 2014b). Whether or not embolization is utilized prior to surgery may not influence outcomes in surgical series (Morgan et al., 2013; Korja et al., 2014a).

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    Which is the better treatment option, clipping or coiling? The answers to these questions are more complex, and one might easily find him or herself in the middle of the battle of randomized controlled trials (8). For many years, it seemed that size of an aneurysm was the only factor affecting rupture rate.

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    However, based on the disparity in outcome events between the 2 arms in the trial, study statisticians calculated a range of 12 to 30 years might be needed for events in the medical arm to reach that of the intervention group, assuming no further events occur in the intervention group.78 We offer no comment on a recent complaint that neurosurgeons are being referred fewer cases for neurovascular surgery, and for the inference that the large number of cases eligible but treated outside for a trial presumably had satisfactory results.79 Reluctant to report data from small subsets in our trial, we have recently responded to postpublication criticism that the reported stroke outcomes in the interventional arm might contain a large number of clinically minor events, for example, headache with a positive MR. Such events would have been counted as stroke because a new symptom was associated with a new infarct or hemorrhage documented by MR (ARUBA clinical protocol).66

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