July 27, 2007

To the Members of the ASMBS:

We at Surgical Review Corporation (SRC) thought that you might be interested in some of the inquiries we have received since the release of BOLD™ several weeks ago and our responses.

How was BOLD™ designed?

The development of BOLD was guided by SRC’s Research Advisory Committee (RAC). The RAC consists of noted bariatric surgeons Eric DeMaria, M.D. (Duke University), Bruce Wolfe, M.D. (Oregon Health and Science University), Harvey Sugerman, M.D. (Chairman, SRC’s Bariatric Surgery Review Committee and Editor-in-Chief, SOARD), Walter Pories, M.D. (Chairman, SRC’s Board of Directors) and is chaired by Gail Hughes, Dr.P.H., M.P.H (Vice President, SRC’s Research Division). Other bariatric surgeons, as well as scientists from other specialties are in the process of being added to the RAC.

The development of BOLD 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.

What is the purpose of BOLD?

BOLD has three primary goals:

1. To offer Centers a real-time tool to monitor their compliance with the Bariatric Surgery Centers of Excellence® (BSCOE) requirements.
   
2. To provide SRC with credible data that can be used to convince the public, our colleagues 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.
3. To collect the information needed to improve patient outcomes. The data will guide us in choosing the right operation for our 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.

What is the 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 that was 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 longitudinally (over time). The scale will be used to guide SRC in setting new standards for its BSCOE program. It will also be used to convince payors and legislators of the value and efficacy of bariatric surgery.

Who has access to BOLD?

BOLD is currently available to all Fully Approved BSCOE surgeons and soon to be available to those with Provisional Status and ASMBS Fellows.

What is the purpose of the Participation Agreement?

The Participant Agreement was prepared by Michael Hartney, legal counsel for the ASMBS and SRC, in consultation with other industry experts. The Agreement, albeit lengthy, is intended to protect surgeons, hospitals and patients and to meet the various requirements of HIPAA and privacy of human subjects. Admittedly, it is necessarily voluminous in order to cover all areas. Once the appropriate information is completed and sent to SRC, users will be given access to BOLD.

Is there a charge for BOLD?

BOLD does not require a software purchase. Users pay a one-time fee of $8.75 per patient for as long as the patient is followed in BOLD. The fee specifically covers costs for data management, storage, and security, as well as compilation, analysis, reporting and dissemination of data. BOLD fees are pre-billed in blocks of 100 patients ($875) to minimize bookkeeping for your office as well as SRC. The fee is charged even if your office uses a third-party software system to capture information for BOLD.

And as a reminder, you only are required to enter new patients into BOLD who have signed their informed consent agreement. No data mining on old charts is required.

Will BOLD work with third-party software?

We are in the final developmental stages of an interface. If your program is 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. Until vendors have developed an interface, users will be required to enter data directly into BOLD. Parallel processing is not a bad idea, and a common approach with new software systems to ensure that the data in the new system matches that in the old.

We also understand that a number of centers and surgeons do not use a third-party software system. That is why we have tried to make BOLD as user-friendly as possible.

What about future changes to BOLD?

Obviously, the first release of BOLD will not be perfect — no new software offering is. We ask for your patience and support during the introductory period. Your constructive input is important to the continued evolution of BOLD. If you have suggestions for improvement, they will be considered by SRC’s research staff and our information services team. All changes will be approved by the RAC. It is likely that approved changes will be made on a standard basis, perhaps once per quarter.

We hope that you will find this information useful, and we look forward to BOLD helping ASMBS members successfully achieve the best information and guidance for treating their patients, now and in the future.

Sincerely,

Walter J. Pories, M.D., FACS
Chairman of the Board