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Surgical Review Corporation developed the Bariatric Outcomes Longitudinal DatabaseSM (BOLD) to collect prospective data on all bariatric surgery patients treated by participants in the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence (BSCOE) program. BOLD is used to help evaluate program compliance and support quality improvement for bariatric and metabolic surgery.
Established in 2007, BOLD is the world’s largest and most comprehensive database of bariatric surgery patient information, containing data on hundreds of thousands of patients. This clinically rich data platform drives SRC’s in-depth analysis across a wide variety of obesity-related parameters and high- and low-frequency occurrences. Created as an ongoing, real-time data capture mechanism, BOLD is uniquely able to contribute to the development of quality benchmarks and best clinical practices.
As of February 1, 2008, BSCOE provisional participants and designees are
required to enter prospective data into BOLD on all of their patients who
undergo bariatric surgery after the date of BOLD activation.
BOLD data is used for two purposes:
1) to ensure compliance with the requirements of the BSCOE program and
2) for data analysis to develop general knowledge about optimal bariatric surgery practices.
Additionally, national summary reports containing BOLD aggregate data are provided to BSCOE
program participants so they can assess their own patterns of care and outcomes relative to national norms.
According to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), healthcare
operations include quality assessment and improvement activities such as outcomes evaluation and
development of clinical guidelines. The use of BOLD data for quality improvement purposes, including
national summary reports, is considered part of healthcare operations under HIPAA and does not
require review by an IRB according to 45 CFR Part 164.501, 506.
The use of BOLD data to develop general knowledge about optimal bariatric surgery
practices is considered human subject research and therefore requires IRB oversight.
This research, which leads to improvements in the quality of patient care, involves
the analysis of BOLD data to evaluate relationships between surgical outcomes and
patient demographics and comorbidities; clinical and surgical characteristics; as well
as preoperative, perioperative and postoperative treatment regimens.
SRC’s research staff is the only entity engaged in the analysis of BOLD
data for general knowledge purposes – BSCOE participants do not conduct
research using BOLD data. Therefore, SRC is the only entity required to
have IRB oversight. The Copernicus Group Independent Review Board (CGIRB)
granted approval for SRC to engage in research using BOLD with a Waiver of Informed Consent.
There are no separate costs for BOLD. Facilities and surgeons participating in the
BSCOE program pay an initial application fee, then an annual BSCOE Participation Fee
for every year of program participation after the first year. Both fees include the
use of BOLD.
To minimize or eliminate duplicate data entry, SRC developed an interface to import data
into BOLD from third-party software systems. The following vendors have now been
approved to transmit data directly into BOLD:
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