The Creation of a Pilot Database of EEG Recordings and de- Identified Medical Records From Patients Internally Referred Within the UNMH Comprehensive Epilepsy Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- UNMH EEG Corpus
研究概览
简要总结
This proposal outlines the steps required for the creation of a pilot database of EEG recordings and de-identified medical records from patients internally referred within the UNMH Comprehensive Epilepsy Center. The UNMH EEG Corpus would be the first database of its kind. Other public databases contain either patient EEG signals or medical records, but without both kinds of information, it is impossible to relate pre-treatment neurobiomarkers with post-treatment prognosis. The database will also contain information that can improve seizure localization based off of scalp and intracranial EEG, and the requisite data for the creation of algorithms that forecast seizure activity; a development that could ultimately lead to novel responsive neural stimulation procedures that suppress seizures before they begin.
详细描述
Retrospective De-identified EEG and Clinical Database Creation:
The proposed database (UNMH EEG corpus) will be created in stages and designed to increase in complexity and functionality given future funding and tool development. The initial scope for this project includes the construction of a relational database that links patient demographic data (medical records, EEG study number, date of birth) which will be linked to the study number. This list will be kept for 6 years from the completion of study and will be stored in locked office cabinet as a paper form (source documentation) and password protected computer in locked office (electronic version). Then, the rest of the data collection will include algorithmically de-identified clinical reports (e.g. progress notes), recording meta-data (e.g. montage configuration), and de-identified clinical EEG with only study number without PHI. Future work beyond the scope of this pilot project will involve: annotating the EEG trace with the timing and type of seizure (or artifact), extracting medication history from the patient records, standardizing notes on treatment history and outcome, review that ePHI has been removed, and dissemination. A full patient assessment can also include MRI, MEG and PET scans and a final database should also include these valuable images. The creation of the pilot UNMH EEG corpus will focus on the subset of patients internally referred within UNMH for whom an EEG was performed, a treatment was provided, and a follow up assessment occurred. This inclusion criteria will guarantee that the minimum data is present to statistically relate pre-treatment EEG with post-treatment prognosis.
Collection of De-identified Data Retrospectively:
Time Frame: 1) from current up to August 8, 2007 when Nihon Kodhen Neuroworkbench was started at UNM, 2) From the start of study, each year, the investigator will add previous year's de-identified data to the database until the last dataset of 2027. For example, in January to February 2023, the investigator will add 2022 data to the database. The investigator will add previous year's data to the database until 2028 with the last dataset till 2027.
The investigator will generate randomized de-identified study number by computer programing. The investigator will create the secure table of de-identified study number to link patient's PHI (medical record number, EEG study number, Date of Birth). This table will be stored in the locked cabinet in PIs' office. Also, the electronic version will be stored in HSC password protected computer under HSC IT secured drive with only access by PIs and study coordinator.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will screen with UNMH EEG database, Nihon Kohden Neuroworkbench first. After meeting all the inclusion and
排除标准
- •, we will access the Cerner Powerchart (UNMH EMR) for the rest of the clinical information.
- •18 years old or older. If the patient's age is over 89, we will aggregated them to age 90 or older so that the patient cannot be identified. Also, all the EEG data will be de-identified and only show the year of the study performed instead of the exact study date to reduce the risk of identification. Of note, we perform over few thousands of EEG studies per year and it will be almost impossible to identify the patient based on the study year.
- •Exclusion Criteria:
- •Children under age of 18 years old will be excluded.
- •Mismatched patients between EEG database and EMR
结局指标
主要结局
UNMH EEG Corpus
时间窗: 2007-2027
Fully de-identified database creation matching between EEG and clinical data for adult patients of 18 years or older who underwent EEG study at UNMH from 2007 till 2027
次要结局
未报告次要终点
