Dr. William Whitehead, Hydrocephalus Clinical Research Network (HCRN) investigator and Principal Investigator (PI) on the Entry Site Trial funded by the Patient Centered Outcomes Research Institute (PCORI), shared the benefits of patient involvement in research planning in a recent meeting of the study’s Patient Partner Committee (PPC) review of milestones.
The CSF Shunt Entry Site Trial aims to determine the most effective entry site for placing a shunt through a randomized control trial. The study currently has an 81% consent rate by parents allowing for their children to participate in the trial.
“I believe our higher consent rate is a direct result of patient partners’ involvement in the consent process,” said Dr. Whitehead during the call. “Surgical trials usually have a much lower consent rate.”
The consent rate for this type of clinical trial is typically around 50%. Dr. Whitehead ascribed the Entry Site Trial’s high rate of participation to the accessibility of information about the trial on the HA and HCRN websites, the content of the consent form, which was reviewed by the PPC, and the overall involvement of HA in the trial.
During the meeting, Dr. Whitehead emphasized the value provided by the Hydrocephalus Association and the Patient Partner Committee in the planning and execution of this study.
The study, which compares anterior and posterior entry sites for first time shunt placements, is enrolling patients at all nine HCRN centers in North America. Thirty-seven neurosurgeons across those nine sites are participating in the randomized selection of shunt entry sites for the eligible, consented patients in the study. The PCORI award began in January 2015.