On the last day of Hydrocephalus Awareness Month, the Patient-Centered Outcomes Research Institute (PCORI) announced it is awarding a $1.8 million grant in support of a Hydrocephalus Clinical Research Network (HCRN) proposed randomized control trial to determine the most effective entry site for placing a shunt. The Hydrocephalus Association partnered with HCRN to involve patients and caregivers in the initial study selection and development, and now in the continued execution and results dissemination. For those of you that responded to our research survey in late April, thank you. You helped identify the priorities for research funding for our community.
The study, A Randomized Controlled Trial of Anterior Versus Posterior Entry Site for Cerebrospinal Fluid Shunt Insertion, is a three-year randomized control trial with the goal to determine which entry point decreases the need for repeated brain surgeries due to device failure. The study will look at entry points in both the anterior (front/top) and posterior (back) areas of the brain. Dr. William Whitehead of Texas Children’s Hospital and Baylor College of Medicine, a principal investigator for HCRN, developed and will oversee the trail which will accrue patients at all nine HCRN-participating pediatric hospitals.
As members of our community know, placement of a CSF shunt is the most common treatment for hydrocephalus. Shunts experience a high failure rate due to obstruction, and approximately 50 percent fail within two years of surgical implantation in children. This is a significant cause of pain, suffering, anxiety, and sometimes death in both children and adults living with hydrocephalus, thereby making it a subject of paramount concern to the hydrocephalus patient and caregiver population. By determining which entry site for shunt placement increases the long-term survival rate of the shunt, the findings can inform decisions in the operating room and help improve the quality of life for the patient by reducing the risk of repeated brain surgery and shunt infection, as well as reducing the number of hospitalizations, diagnostic tests, and days off from school and work.
The funding organization, PCORI, is a nonprofit, nongovernmental organization established by Congress under the Patient Protection and Affordable Care Act of 2010. PCORI aims to fund research that is most relevant to patients and its funded grants require involvement by the patient community throughout the entire lifecycle of a project. To organize patient representation in the study, HA facilitated the creation of the Patient Partner Committee (PPC). This group consists of 12 patients and caregivers, and 2 HA staff members that will engage at each key milestone over the next three years and will work with HA to disseminate the study results at the end of the grant. The study will begin accruing patients in 2015.