Brain Donation Program Database
Prior to 1998, records were kept on paper in binders. With the initiation of the computerized database, the essential aspects of these records, including demographic, medical history and neuropathological findings, were abstracted and entered into the computerized database. Since 1998, the Institute has developed a sophisticated database and database management protocols, largely engineered by a contracted professional industrial database consultant. The clinical and neuropathology components of the Brain Donation Program Database were designed together and are completely integrated. The Database is a customized elaboration of Microsoft Access and My Sequel off-the-shelf programs. The current combined clinical and neuropathology components take up 218 megabytes. The Database is composed of 51 matrices with 1905 fields (separate data categories) which collectively contain data pertaining to basic demographic information, medical history, results of standardized clinical assessments and, for autopsied subjects, neuropathologic data, tissue inventory and records of tissue requests and shipments. The Database contains 53 forms to facilitate data entry and 75 different standing data reports that can be generated with a single keystroke. The Database is also used to ensure that scheduling of clinical assessments is done at appropriate intervals. The current neuropathology subsection of the Database has 330 fields, of which the National Alzheimer’s Coordinating Center (NACC) Neuropathology Data Set is a subset. Numerous additional fields beyond the latter include in-house grading methods for plaques, tangles, Lewy bodies and white matter rarefaction, as well as fixed tissue quality, RNA quality and current inventory of 160 fields for fixed tissue, frozen tissue, CSF and blood serum. The Neuropathology Database tracks tissue requests and requestors.
The Database is backed up automatically every day on two servers administered by Sun Health Information Services, located at two sites about 5 miles apart. Storage of data in both locations ensures that structural damage to one server (e.g. fire) does not result in irretrievable loss. Both servers store daily copies of databases for the preceding 30 days; older copies are sent to a commercial server contracted for this purpose. Storage of older database copies allows the recovery of an intact database in the event of inadvertent errors in database operation, hardware malfunction or software malfunction.
The SHRI Brain Donation Program Database has been managed by informal groups that have included the database designer, a statistician, the directors of the clinical and neuropathology cores and the major database operators. This arrangement has worked very well as it includes the individuals who use the database day-to-day, the physician–scientists that will be collecting the data, and the database designer, who can make changes to the database as necessary.
Confidentiality of human subject data in the Database is assured by multiple safeguards which restrict access to personal identifying information such as name, date of birth, date of death, address and gender. Data entry is restricted to as few personnel as possible. Access to the Database requires a unique user name and password, and all transactions are tracked and stored in an electronic log, allowing identification of inappropriate or incorrect usage by any individual. Access to the Sun Health local area network is protected by a firewall maintained by Sun Health Information Services. Paper copies of subject records are kept in locked filing cabinets in the offices of the major database operators. Sun Health Research Institute has been issued a Certificate of Confidentiality by the US Secretary of Health and Human Services, protecting human subjects’ data from court subpoena.
Institute researchers are able to obtain an up-to-date copy of the Database, minus personal identifying information, at any time upon request. A standing query is used to produce this, following which the database copy is copied onto a portable memory storage device which the researcher may then load onto his/her own computer. Standard Microsoft Access software, which is provided by Sun Health, will run the database copy. For database queries involving detailed knowledge of clinical or neuropathologic criteria, the directors of neurology and neuropathology assist the researchers with query design.
All data are subjected automatically to an error checking program that identifies out of range, illogical and missing data. In addition, a random sample of subject records is compared directly with data forms (paper copy) on a periodic basis to reduce data entry mistakes.