How do surgeons make decisions? How do they stand by those decisions and evaluate themselves? That was the question that Jay Wellons, MD, MSPH and colleagues in the HCRN set out to answer in their study on compliance during the Shunting Outcomes in Post-Hemorrhagic Hydrocephalus (SOPHH-Compliance) study reviewed at the most recent annual meeting of the AANS/CNS Section of Pediatric Neurosurgery. The primary outcome of the study was to determine which of the two main ways to surgically treat premature infants with hydrocephalus was superior to the other. Indeed, prior studies from the HCRN had resulted in ventriculo-subgaleal shunts leading to less permanent shunt placement than tapping reservoirs, or so it was thought until the investigators identified a major “Center Effect” in the decisions made. One so strong that it clearly affected the results of the study, and one that was mitigated by standardizing the decisions made and the operations performed among all the pediatric neurosurgeons taking part in the HCRN. Ultimately, there was shown to be no difference in the proportion of patients requiring shunt placement between the two groups once decisions were made the same and biases were removed, and Dr. Chevis Shannon, a clinical epidemiologist at Vanderbilt University in the Division of Pediatric Neurosurgery, was awarded funding from the Gerber Foundation to study the highly important neuro-cognitive outcomes between the two groups. Overall, surgeons complied 86% of the time with the complex rubrics as written, an astoundingly high number, and there was no difference found between those surgeons who were considered HCRN investigators in the network and those surgeons at an HCRN center who were not considered investigators but who agreed to follow the standardized care process. These results are felt to be critical in not only studies relating to hydrocephalus in premature infants, but in all of the ongoing and future studies in the HCRN. Making a standardized decision process is critical to sound science, and sticking to it when the rubber hits the road, is the sign of an invested core of surgeon-scientists and colleagues, signaling a commitment to the core mission of the HCRN and the HA, together.
Endoscopic Third Ventriculostomy (ETV) in Children: Prospective, Multicenter Results from the Hydrocephalus Clinical Research Network (HCRN)
This prospective study began as one of the HCRN’s first studies. We started it to thoroughly and critically analyze the success and complications of endoscopic third ventriculostomy (ETV), which remains the only viable alternative to CSF shunts. Since 2007, the HCRN has performed over 400 ETVs, of which we reported our experience with the first 336 in this presentation. This study has set a landmark as the largest prospective, multicenter study of pediatric ETV to date. The main strength of this study was that we were able to collect, in real time, detailed data about what actually took place during surgery, including the amount of bleeding, how successful the surgeon was in creating the hole in the third ventricle, and if the surgeon saw any evidence of injury to the brain. This level of data has not previously been collected on so many patients. Our results were very comforting. We found that very serious complications are exceptionally rare (well less than 1%) and the overall success rate of ETVs was 66%. When we looked for the important factors that predict ETV success, not surprisingly, the “ETV Success Score” (which accounts for the effects of age, hydrocephalus etiology, and whether the child had a previous shunt) was the most important. Interestingly, many of the factors that surgeons assess at surgery (like how big they were able to make the hole in the third ventricle and whether there was bleeding during the operation) were not significant predictors of ETV success. One of the explanations for this rather counter-intuitive finding might be that, perhaps, there were still too few patients in this study for the statistics to show up “significant”. The HCRN, of course, is continuing this study, which will be an on-going component of the HCRN’s research focus in the years to come.