Neurological Surgery & Affiliated Services De-Identified Clinical Outcomes Database
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2005 |
| End Date: | June 2015 |
| Contact: | Stanley Lee |
| Email: | stanley@uci.edu |
| Phone: | 714-456-6966 |
The collection of data from the myriad of services described is significantly impacted by
NIH guidelines defining medical research involving humans as well as the recent
implementation of HIPAA constraints which further complicate the conduct of retrospective
clinical outcomes research. Simple case reports or case series analysis now involve IRB
participation as well as voluminous documentation.
The solution to this dilemma lies in developing and promoting secure, confidential
prospective clinical databases for storing clinical data for subsequent retrospective
de-identified inquiry. These databases function in a way analogous to "tissue banks" for
subsequent basic science research. Patients consent to prospective entry of their clinical
information into the database so long as they continue to be a patient with the Department
of Neurological Surgery or the Departments or Divisions in association with the affiliated
programs briefly described above. The consent is obtained during the patient's first
inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by
request of the patient at any time, but it does not expire unless the patient withdraws it,
or the patient severs their patient care relationship with UCI Neurosurgery or the
affiliated programs. The database is stored on a separate secure server maintained and
backed up by the UCIMC Information Technology Department. Access to the database is
restricted at multiple levels, with the majority of personnel allowed only limited access
for data entry purposes. Only the database programmer/coordinator, the Department
Administrator and the Chairman of the Department will have unrestricted access to the
database. Authority for permission for levels of security clearance and access to the
database, for other individuals, will be vested in the Chairman of the Department of
Neurological Surgery.
A separate IRB proposal will be formulated for individual study related to the acquisition
of data from the de-identified database. Since these future studies will be performed on
data sets derived from the previously consented subjects of this IRB-approved project, the
requirement for additional consent forms are not anticipated. As a result IRB research
proposals utilizing the database can be expedited. Once the specific study is approved, the
investigator(s) are provided with the clinical information from the database in the form of
a de-identified data set.
NIH guidelines defining medical research involving humans as well as the recent
implementation of HIPAA constraints which further complicate the conduct of retrospective
clinical outcomes research. Simple case reports or case series analysis now involve IRB
participation as well as voluminous documentation.
The solution to this dilemma lies in developing and promoting secure, confidential
prospective clinical databases for storing clinical data for subsequent retrospective
de-identified inquiry. These databases function in a way analogous to "tissue banks" for
subsequent basic science research. Patients consent to prospective entry of their clinical
information into the database so long as they continue to be a patient with the Department
of Neurological Surgery or the Departments or Divisions in association with the affiliated
programs briefly described above. The consent is obtained during the patient's first
inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by
request of the patient at any time, but it does not expire unless the patient withdraws it,
or the patient severs their patient care relationship with UCI Neurosurgery or the
affiliated programs. The database is stored on a separate secure server maintained and
backed up by the UCIMC Information Technology Department. Access to the database is
restricted at multiple levels, with the majority of personnel allowed only limited access
for data entry purposes. Only the database programmer/coordinator, the Department
Administrator and the Chairman of the Department will have unrestricted access to the
database. Authority for permission for levels of security clearance and access to the
database, for other individuals, will be vested in the Chairman of the Department of
Neurological Surgery.
A separate IRB proposal will be formulated for individual study related to the acquisition
of data from the de-identified database. Since these future studies will be performed on
data sets derived from the previously consented subjects of this IRB-approved project, the
requirement for additional consent forms are not anticipated. As a result IRB research
proposals utilizing the database can be expedited. Once the specific study is approved, the
investigator(s) are provided with the clinical information from the database in the form of
a de-identified data set.
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.
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.
Inclusion Criteria:
- Patient of one of the investigators mentioned in the IRB Protocol Narrative
- Ability to give informed consent to have health care info collected, stored, analyzed
- Ability to sign HIPAA form
Exclusion Criteria:
- Nonpatient of one of the investigators in the study
- Minors under the age of 7
- Patients without the ability or capacity to give informed consent
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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