Neurological Surgery & Affiliated Services De-Identified Clinical Outcomes Database

The Department of Neurological Surgery is entering a period of rapid growth accompanied by significant investment in its infrastructure. The goals of this effort is to re-establish a full academic mission and for the return of a residency program as part of this paradigm with the target of initiating the program in three to five years. This rebuilding project will be based on the pre-existing neurotrauma and critical care program and three new comprehensive and multidisciplinary clinical programs and medical center product lines. These include neuro-oncology, operative and non-operative spine services and cerebrovascular services. The care and treatment of patients with ischemic stroke is a part of the cerebrovascular program.

Aggressive and accelerated clinical outcomes research and rapid peer-review publication is a mission critical need for successfully applying to re-establish the residency training program. The collection of this data will also strengthen marketing and will promote the advancement of the multidisciplinary programs. While the Neurosurgery Department is central to the multidisciplinary program evolution these affiliated programs and product lines involve multiple departments. These include: Neurology with the stroke service and neurology critical care services; Radiology with the neuroradiology and interventional neuroradiology services; the Hematology/Oncology Services associated with the Chao Family Comprehensive Cancer Center; Radiation Oncology; Otolaryngology Services; Orthopedic Spine Services; and, Physiatry with the Physical and Rehabilitative Medicine Services.

MD Analyze is a commercially available relational data base software program designed to accumulate clinical data for future analysis. It allows the investigators to determine what clinical data they wish to collect, including, but not limited to history, physical, laboratory, radiographic, surgical and follow-up information. It can be programmed to allow data entry from any data collection instrument so desired by the investigators.

Patients treated by the investigators in their practices at UCI will be asked to sign consent and HIPAA forms making them aware of their rights and protection regarding their health care information and giving informed consent to collect and analyze their health care data. Throughout the course of their care they may be asked to complete various surveys or data collection instruments depending on their diagnosis and treatment. See Appendix A for copies of the data collection instruments and surveys. The system allows the personal clinical data to be de-identified (i.e., made anonymous). A full-time data entry clerk will collect and enter clinical data into the MD Analyze data base. This person will also be asked to search and retrieve data based on investigators' research questions after their proposals have been IRB approved. Only the Department Chairman, the Data Base Manager, and the Department Administrator will have access to personal identification data. This information will not be available to the investigators. Potential investigators of the data base will have to provide documentation of IRB approval of their project to the Chair before their requested data set can be harvested from the data base. The chair will then direct the Data Base Manager to generate a report of the requested data. The report of de-identified data will then be securely delivered to the investigator. The Data Base Manager will maintain a file of all requests for data and a copy of the IRB approval for investigators research and data request.

Minors may be asked to complete surveys and questionnaires appropriated to their reading level. Patients may withdraw at any time by making a request to their physician investigator or their staff.