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Aimun A. B. Jamjoom, Angus B. Gane, and Andreas K. Demetriades

OBJECTIVE

This study aimed to determine the trial discontinuation and publication rate of randomized controlled trials (RCTs) in neurosurgery.

METHODS

Trials registered from 2000 to 2012 were identified on the website clinicaltrials.gov using a range of key words related to neurosurgery. Any trials that were actively recruiting or had unknown status were excluded. Included trials were assessed for whether they were discontinued early on the clinicaltrials.gov database; this included trials identified as withdrawn, suspended, or terminated in the database. For included trials, a range of parameters was identified including the subspecialty, primary country, study start date, type of intervention, number of centers, and funding status. Subsequently, a systematic search for published peer-reviewed articles was undertaken. For trials that were discontinued early or were found to be unpublished, principal investigators were sent a querying email.

RESULTS

Sixty-four neurosurgical trials fulfilled our inclusion criteria. Of these 64, 26.6% were discontinued early, with slow or insufficient recruitment cited as the major reason (57%). Of the 47 completed trials, 14 (30%) remained unpublished. Discontinued trials showed a statistically significant higher chance of remaining unpublished (88%) compared with completed trials (p = 0.0002). Industry-funded trials had a higher discontinuation rate (31%) compared with non–industry-funded trials (23%), but this result did not reach significance (p = 0.57). Reporting of primary outcome measures was complete in 20 (61%) of 33 trials. For secondary outcome measures, complete reporting occurred in only 11 (33.3%) of 33.

CONCLUSIONS

More than a fifth (26.6%) of neurosurgical RCTs are discontinued early and almost a third of those that are completed remain unpublished. This result highlights significant waste of financial resources and clinical data.

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Aaron Lawson McLean, Aimun A. B. Jamjoom, Michael T. C. Poon, Difei Wang, Isaac Phang, Mohamed Okasha, Matthew Boissaud-Cooke, Adam P. Williams, and Aminul I. Ahmed

OBJECTIVE

Freehand external ventricular drain (EVD) insertion is associated with a high rate of catheter misplacement. Image-guided EVD placement with neuronavigation or ultrasound has been proposed as a safer, more accurate alternative with potential to facilitate proper placement and reduce catheter malfunction risk. This study aimed to determine the impact of image-guided EVD placement on catheter tip position and drain functionality.

METHODS

This study is a secondary analysis of a data set from a prospective, multicenter study. Data were collated for EVD placements undertaken in the United Kingdom and Ireland from November 2014 to April 2015. In total, 21 large tertiary care academic medical centers were included.

RESULTS

Over the study period, 632 EVDs were inserted and 65.9% had tips lying free-floating in the CSF. Only 19.6% of insertions took place under image guidance. The use of image guidance did not significantly improve the position of the catheter tip on postoperative imaging, even when stratified by ventricular size. There was also no association between navigation use and drain blockage.

CONCLUSIONS

Image-guided EVD placement was not associated with an increased likelihood of achieving optimal catheter position or with a lower rate of catheter blockage. Educational efforts should aim to enhance surgeons’ ability to apply the technique correctly in cases of disturbed cerebral anatomy or small ventricles to reduce procedural risks and facilitate effective catheter positioning.