William Whitehead, MD, Hydrocephalus Clinical Research Network (HCRN) investigator and Primary Investigator (PI) on the study, 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 studyâ€™s Patient Partner Committee review of milestones.
â€œI believe our higher consent rate is a direct result of patient partnersâ€™ involvement in consent process,â€ said Dr. Whitehead during the call. â€œSurgical trials usually have a much lower consent rate.â€ He ascribed the 81% consent rate for randomization to the accessibility of information about the study to the participant families. In particular, he said the documentation provided helped to explain the need to randomize the surgical procedure and provided clear, comprehensive information on the HCRN and Hydrocephalus Association websites. Dr. Whitehead emphasized the value that the Hydrocephalus Association and the Patient Partner Committee provided in planning and executing the 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.