Surgical Review Corporation expects more than 100,000 patients to be entered annually into its Bariatric Outcomes Longitudinal Database™ (BOLD™), thus making it the largest bariatric surgery database registry in the world. Each participant in the BSCOE program is required to submit detailed patient information on every patient that has bariatric surgery.
Bariatric Outcomes Longitudinal Database (BOLD™)
BOLD is an efficient, user-friendly,
Internet-based patient outcomes tracking and reporting database that is IRB
approved and fully compliant with HIPAA and other patient privacy requirements. Click here to view an online
presentation of BOLD.
Purpose of BOLD
BOLD captures real-time information on each patient during pre-, intra- and all postoperative visits. BOLD also obtains information on intraoperative, pre- and postdischarge adverse events. BOLD captures detailed information regarding each patient’s co-morbidities before and after surgery using a severity scale. Users of BOLD have access to all of their information at no additional charge and will be able to compare their results against national aggregates. BOLD
provides the ability to establish criteria for best practices.
BOLD has three primary goals:
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To offer Centers a real-time tool to monitor their compliance
with the Bariatric Surgery Centers of Excellence (BSCOE) requirements.
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To provide SRC with credible data that can be used to demonstrate to consumers, employers, medical professionals and payors of the value and efficacy of bariatric surgery. Clinical series, although helpful, represent only selective data. Claims data collected by payors is often inaccurate due to the nature of billing codes.
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To collect the information needed to improve patient outcomes. The data will guide surgeons in choosing the right operation for patients. BOLD is a unique platform for evidence-based medicine, tracking complications and improvement or resolution of co-morbidities longitudinally in an effort to develop risk stratification guidelines that will promote improved patient care and outcomes.
BOLD Design
The development of BOLD was guided by SRC's
Research Advisory Committee (RAC) and began during the fourth quarter
of 2005. All software development was performed by SRC. Efforts were made to
keep data elements and data definitions common with the NIH Longitudinal Assessment of Bariatric Surgery (LABS) program and other national databases.
Initial data elements were posted
for review and comment by all BSCOE program applicants. Beta testing was done
by SRC's Bariatric Surgery Review Committee and RAC.
Access to BOLD
As of February 1, 2008, all Provisional Status designees are required to participate in BOLD and compliance is required within 90 days of the Provisional Status designation. After receiving BOLD access, Provisional Status designees must begin entering all new bariatric surgery patients. BOLD compliance is required to be able to receive Full Approval designation as a BSCOE. Participants are
required to enter their information in the BOLD format. Accuracy is required
and the data is audited and verified. Inaccurate reporting can mean loss of
BSCOE status.
Interface with Third-party Software
SRC developed an interface designed to import data from interested third-party software systems. Participants currently using a participating third-party software system may transmit their data directly into BOLD to minimize or eliminate duplicate data entry. SRC has shared the data elements and integration instructions with several vendors and hospitals interested in developing an interface with BOLD. (Vendors are listed in order of interface completion date.)
SRC is pleased to announce that the following vendors have been approved as a third-party provider source that will transmit outcomes data into BOLD.
BOLD Fees
Effective February 18, 2008, SRC changed the fee structure for BOLD as follows:
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All surgical groups — Provisional Status and Full Approval designees — will pay a one-time BOLD activation fee of $875 with the submission of the BOLD Participation Agreement. Payments for the initial block of 100 patients from designees already signed up to use BOLD will be credited as the BOLD activation fee.
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Provisional Status Centers (hospitals and freestanding outpatient centers) will be billed an annual BOLD data submission fee of $875, regardless of the number of patients entered into BOLD.
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Fully Approved BSCOE Centers (hospitals and freestanding outpatient centers) designated before January 1, 2008, will be billed an annual BOLD data submission fee of $1,250 until they enter their renewal year, regardless of the number of patients entered into BOLD. Starting in 2008, Centers renewing their BSCOE designation will not be charged a separate BOLD fee as it is included in the annual BSCOE Participation Fee.
BOLD does not require a software purchase. The fee specifically covers costs for program activation, data management, storage and security, as well as compilation, analysis, reporting and dissemination of data. These fees are charged even if a third-party software system is used to transmit data to BOLD.
IRB Approval
BOLD utilizes information on living patients from the
preoperative stage through five years or more following surgery. It also asks
for some information which is considered Protected Health Information under
HIPAA. For these reasons, the BOLD research study is considered human subject
research and subject to various federal laws, including the requirement to
receive Institutional Review Board (IRB) approval.
The University and Medical Center Institutional
Review Board (UMCIRB) at East Carolina University approved SRC’s IRB
application, along with a short-form protocol and informed consent document.
BOLD users will receive a package with the IRB approval letter, the approved
patient informed consent form, study protocol and consent to have UMCIRB
provide oversight for the BOLD research study. Institutions that are required
or elect to have a local IRB provide oversight will be permitted to do so with
appropriate documentation. IRB approval is required before users can enter
data.
Purpose of the BOLD Co-morbidity Scale
The co-morbidity scale used in BOLD was created by the RAC and
is based upon a schema originally published by noted bariatric surgeons, Bruce
Wolfe, M.D. and Mohamed Ali, M.D., in consultation with others such as
NIH/NIDDK/LABS co-investigators and representatives from national health plans.
The co-morbidity scale provides a quantifiable measure of the effect of
bariatric surgery on co-morbidities over time. The scale will be used to guide
SRC in setting new standards for its BSCOE program. It will also be used to
demonstrate the value and efficacy of bariatric surgery.
Purpose of the Participation Agreement
The Participant Agreement was prepared by legal counsel in consultation with other industry
experts. The Agreement covers all areas and is intended
to protect surgeons, hospitals and patients, as well as meet the various
requirements of HIPAA and privacy of human subjects. Once the agreement is
completed, signed and returned to SRC (along with the other required documentation), users will be given access to BOLD.
Future Changes to BOLD
BOLD is expected to
grow in a modular design with additional modules to enhance and supplement
SRC’s research initiatives. While the current data collected in BOLD is required
for all BSCOE participants, the supplemental data collected in the additional
modules will be optional for Research Consortium participants. Constructive input from
users is important to the continued evolution of BOLD. Suggestions for changes
to improve BOLD are considered by SRC’s research staff and RAC. Your input is valuable. Please feel free to send comments or suggestions regarding BOLD to .
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