Surgical Review Corporation is pleased to announce that the Bariatric Outcomes Longitudinal Database™ (BOLD™) is ready for use. Packets with information and specific documentation have been mailed to the Bariatric Surgery Centers of Excellence® surgical groups and Provisional Status applicants.

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 is designed to collect outcomes data. Information from BOLD will be given back to those providers who can benefit from it. BOLD provides the ability to determine best practices. The database is expected to grow in a modular design with additional modules to enhance and supplement SRC's research initiatives. While the basic 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.

BOLD has three primary goals:

• To offer Centers a real-time tool to monitor their compliance with the Bariatric Surgery Centers of Excellence (BSCOE) requirements.

• To provide SRC with credible data that can be used to convince consumers, employers, medical professionals, legislators and payors of the value and efficacy of bariatric surgery. Clinical series, although helpful, represent only selective data. The information collected by payors in the past has not been shared with the providers.

• To collect the information needed to improve patient outcomes. The data will guide surgeons in choosing the right operation for patients (i.e. "Is the effectiveness of a banded RYGB dependent upon BMI?" or "Which anticoagulant is most protective?"). 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 LABS program and other national databases, such as the Society of Thoracic Surgeons.

Initial data elements were posted approximately one year ago for review and comment by all BSCOE program applicants. Beta testing was done by SRC's Bariatric Surgery Review Committee and the RAC.

Access to BOLD

BOLD is currently available to all Fully Approved BSCOE surgeons. It is now available on an optional basis to Provisional Status applicants and will soon be available to ASMBS Fellows. 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 is in the final developmental stages toward an interface designed to work with third-party software systems. For participants currently using a third-party software system, SRC's intent is for the data to be automatically transmitted into BOLD to minimize or eliminate duplicate data entry. SRC has met with vendors and shared the data elements necessary to begin work on their interfaces.

SRC is pleased to announce that the following vendors have been approved as an external source that will transmit outcomes data into BOLD.

• RemedyMD
• Exemplo Medical
• PatientHub™
• Patient Relationship Management, LLC
• Raintree Systems, Inc.
• Bariatric Office Products

BOLD Fees

Effective February 18, 2008, SRC changed the fee structure for BOLD as follows:

• 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.

• 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.

• 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, users will be given access to BOLD.

Future Changes to BOLD

This is the first release of BOLD and SRC appreciates your patience and support during the introductory period. Constructive input from users is important to the continued evolution of BOLD. Suggestions for changes to improve BOLD will be considered by SRC's research staff and information services team. All changes must be approved by the RAC. It is likely that approved changes will be made on a standard basis, perhaps once per quarter.