Research and Application: Examples - Biomedical Informatics in Translational Research - page 216

Health Program at WRAMC and the Dr. Dean Ornish Program for Reversing Heart
Disease at Windber Medical Center. To be eligible to participate in this program,
patients must have either a diagnosis of coronary artery disease or two or more risk
factors for heart disease. Currently more than 290 patients have been recruited into
the ICMHP research protocols.
As part of the Ornish program, participants make comprehensive lifestyle
changes designed to successfully manage heart disease without relying on lipid-low-
ering drugs or surgical procedures. The program lasts for an entire year and is
divided into two parts. The first part is an intensive 12-week intervention during
which participants learn how to effectively change their lifestyles. Once the first part
of the program is complete, the participants transition to the second phase, where
they have less interaction with program staff but are still expected to meet the
program guidelines.
Extensive data are collected from participants enrolled in the lifestyle change
program at three examinations: baseline, after 3 months, and at the conclusion of
the program (1 year). Interviews are conducted with participants to collect informa-
tion on demographic factors such as age, ethnicity, gender, cardiovascular history,
and medication use. A thorough physical examination includes height and weight
measurements to calculate BMI, a graded exercise test to assess cardiovascular fit-
ness, blood lipid profiles, systolic and diastolic blood pressure, and psychological
screening to evaluate mental health. In addition, each participant is asked to keep a
weekly Personal Awareness Log, which includes daily documentation of diet, exer-
cise frequency and duration, stress management frequency and duration, and group
attendance, to collect information on their adherence to the guidelines of the lifestyle
change program. Currently, 219 ICMHP participants have completed the 1-year
program.
10.3.2 Data Tracking
In Chapter 7, three approaches for establishing a data tracking system were dis-
cussed. WRI opted for the hybrid approach: off-the-shelf software, purchased from
Cimarron Software, to track laboratory data from microarray, genotyping, and
proteomics platforms and codevelopment with Cimarron Software, of a module to
track clinical data and tissue banking activity. In the past couple of years, WRI wit-
nessed the dynamic nature of biomedical informatics research as several experimen-
tal platforms evolved or were phased out. This posed serious challenges to the
maintenance of the laboratory data tracking system that could effectively support all
the data platforms.
The clinical data collection and tissue banking activities are tracked by a module
called CLWS (Clinical Laboratory Workflow System) codeveloped with Cimarron
Software. A screenshot of the CLWS is shown in Chapter 7. Because this data tracking
system was codeveloped by WRI, the institute could place multiple quality control
measures on clinical data tracking including data collection through nurse interviews
(core questionnaire) or directly by a pathologist (pathology checklist), double data
entry into the database, and the planned implementation of a QA metric to flag suspi-
cious entries. Another application, the QA Issue Tracking System (QAIT), has been