A Model for Efficient Review of Clinical Data by Researchers
within the STRIDE Clinical Data Warehouse
Henry J. Lowe MD, Susan Weber PhD, Narasiman Ramamoorthy,
Todd Ferris MD, MS, Penni Hernandez ND, RN
Stanford Center for Clinical Informatics, Stanford University, Stanford CA
Abstract clinical data are adjudicated by the Privacy Officer.
STRIDE (Stanford Translational Research Integrated The Cohort Clinical Data Review Tool supports
Database Environment) is a standards-based either fully identified or de-identified review as
informatics platform supporting clinical and determined by the adjudication process.
translational research at Stanford University.
Workflow in this environment often consists of The application provides two views of the cohort
research patient cohort identification, cohort clinical data: (1) the patient cohort list and (2) the clinical
data review and extraction of clinical data for data related to a specific patient in the cohort. The
research use. To facilitate an efficient HIPAA- former view displays a tabular list of patients, a
compliant model for patient cohort clinical data graphical dashboard of cohort demographics and
review we have developed an application called the inclusion/exclusion status. Selecting a specific patient
STRIDE Patient Cohort Clinical Data Review Tool switches to a view that allows the user to select
that provides researchers with a patient cohort which clinical data should be displayed, using a
dashboard, clinical data filtering and enhanced hierarchical list of elements. For example, under
regular expression-based searching. Clinical Documents, one may quickly choose to
review all, none or a selected subset of document
Introduction types. The data to be reviewed is presented in a
Review of clinical data is an important step in tabular format, sorted by a variety of criteria.
determining if patients are eligible or suitable for
clinical research studies and in the performance of The application contains a regular expression (RE)
retrospective chart review studies. Electronic Health parser that supports rapid and granular searches
Record (EHR) interfaces are designed to support within a cohort patient’s clinical data. On executing a
patient care and may not be well suited for use in RE search the application displays only the clinical
research-oriented chart review. To address this data that contains a match while automatically
barrier in the STRIDE1 system we have developed an highlighting the matching data. We have extended
application specifically designed to support efficient the RE parser to support additional syntax such as
review of clinical data on research patient cohorts “INLINE”, which returns matches only in the same
derived from the STRIDE Clinical Data Warehouse. line of text. For example, the expressions “A1C
The major design criteria for this application INLINE HIGH” will display all HBA1c test results
included: (1) support of clinical data review in a that have been reported as high. Another extension is
HIPAA-compliant fashion; (2) automated creation of a high level NEAR() operator that allows the user to
the clinical data sets to be reviewed; (3) allowing specify a word proximity constraint, as in
reviewers to easily include/exclude patients from a “ACCIDENT NEAR(10) FALL”.
research cohort during data review while providing a Results and Discussion
dashboard that continuously updates the The STRIDE Patient Cohort Clinical Data Review
demographics of the current cohort; (4) support for Tool has been in use for over a year and has been
user-controlled filtering of clinical data elements to well received by researchers at Stanford.
simplify the data review task and (5) inclusion of a Approximately 60% of STRIDE patient cohort
powerful search function that instantly finds and searches lead to clinical data review. The tool is
highlights data in a patient’s record. viewed as providing a more efficient model for
research-related clinical data review than the
Methods Electronic Health Record, while being more tightly
The STRIDE Patient Cohort Clinical Data Review integrated into clinical and translational research
Tool is a cross-platform application written in Java. workflow.
Researchers who have used the STRIDE Patient
Cohort Discovery Tool to identify potential research References
patient cohorts can request permission to review 1. Lowe HJ, Ferris TA, Hernandez PM, Weber SC
associated clinical data on a cohort under HIPAA’s STRIDE - An Integrated Standards-Based
“preparatory to research review” policy or as part of Translational Research Platform
an IRB-approved study. All requests to review AMIA Annu Symp Proc. 2009:386-90
34
A Model for Efficient Review of Clinical Data by Researchers
within the STRIDE Clinical Data Warehouse
Henry J. Lowe MD, Susan Weber PhD, Narasiman Ramamoorthy,
Todd Ferris MD, MS, Penni Hernandez ND, RN
Stanford Center for Clinical Informatics, Stanford University, Stanford CA
Abstract clinical data are adjudicated by the Privacy Officer.
STRIDE (Stanford Translational Research Integrated The Cohort Clinical Data Review Tool supports
Database Environment) is a standards-based either fully identified or de-identified review as
informatics platform supporting clinical and determined by the adjudication process.
translational research at Stanford University.
Workflow in this environment often consists of The application provides two views of the cohort
research patient cohort identification, cohort clinical data: (1) the patient cohort list and (2) the clinical
data review and extraction of clinical data for data related to a specific patient in the cohort. The
research use. To facilitate an efficient HIPAA- former view displays a tabular list of patients, a
compliant model for patient cohort clinical data graphical dashboard of cohort demographics and
review we have developed an application called the inclusion/exclusion status. Selecting a specific patient
STRIDE Patient Cohort Clinical Data Review Tool switches to a view that allows the user to select
that provides researchers with a patient cohort which clinical data should be displayed, using a
dashboard, clinical data filtering and enhanced hierarchical list of elements. For example, under
regular expression-based searching. Clinical Documents, one may quickly choose to
review all, none or a selected subset of document
Introduction types. The data to be reviewed is presented in a
Review of clinical data is an important step in tabular format, sorted by a variety of criteria.
determining if patients are eligible or suitable for
clinical research studies and in the performance of The application contains a regular expression (RE)
retrospective chart review studies. Electronic Health parser that supports rapid and granular searches
Record (EHR) interfaces are designed to support within a cohort patient’s clinical data. On executing a
patient care and may not be well suited for use in RE search the application displays only the clinical
research-oriented chart review. To address this data that contains a match while automatically
barrier in the STRIDE1 system we have developed an highlighting the matching data. We have extended
application specifically designed to support efficient the RE parser to support additional syntax such as
review of clinical data on research patient cohorts “INLINE”, which returns matches only in the same
derived from the STRIDE Clinical Data Warehouse. line of text. For example, the expressions “A1C
The major design criteria for this application INLINE HIGH” will display all HBA1c test results
included: (1) support of clinical data review in a that have been reported as high. Another extension is
HIPAA-compliant fashion; (2) automated creation of a high level NEAR() operator that allows the user to
the clinical data sets to be reviewed; (3) allowing specify a word proximity constraint, as in
reviewers to easily include/exclude patients from a “ACCIDENT NEAR(10) FALL”.
research cohort during data review while providing a Results and Discussion
dashboard that continuously updates the The STRIDE Patient Cohort Clinical Data Review
demographics of the current cohort; (4) support for Tool has been in use for over a year and has been
user-controlled filtering of clinical data elements to well received by researchers at Stanford.
simplify the data review task and (5) inclusion of a Approximately 60% of STRIDE patient cohort
powerful search function that instantly finds and searches lead to clinical data review. The tool is
highlights data in a patient’s record. viewed as providing a more efficient model for
research-related clinical data review than the
Methods Electronic Health Record, while being more tightly
The STRIDE Patient Cohort Clinical Data Review integrated into clinical and translational research
Tool is a cross-platform application written in Java. workflow.
Researchers who have used the STRIDE Patient
Cohort Discovery Tool to identify potential research References
patient cohorts can request permission to review 1. Lowe HJ, Ferris TA, Hernandez PM, Weber SC
associated clinical data on a cohort under HIPAA’s STRIDE - An Integrated Standards-Based
“preparatory to research review” policy or as part of Translational Research Platform
an IRB-approved study. All requests to review AMIA Annu Symp Proc. 2009:386-90
34
