By Dr. Jay Wellons
Posted with permission from the HCRN website.
Original post January 21, 2015
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 Hydrocephalus Clinical Research Network (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.