In 2007, SRC developed a proprietary longitudinal outcomes database (known as “BOLD™”) created for the bariatric and metabolic surgery specialty. Today, BOLD has expanded to multiple specialties and is regarded as the world’s largest and most comprehensive repository of surgical outcomes information.
SRC’s multispecialty database provides participating surgeons with real-time access to individual patient information that guides clinical decisions. Providers can also obtain meaningful information through numerous reports that are based on information from the surgeon’s individual practice. National International summary reports enable participants to compare their individual outcomes to aggregate data and assess their approach to care.
SRC uses a comprehensive Data Quality Program to ensure the integrity of the information collected and derived from its database. A number of safeguards are included in the software and all data collected is validated during site inspections for SRC’s accreditation program participants.
Surgeons not participating in an SRC accreditation program may use SRC’s Database by paying a database license fee of $650 per surgeon.
Data Access and Dissemination Summary
All SRC data used in publication or presentation must be approved by SRC prior to submission.
SRC encourages and supports broad access to information from its outcomes databases. SRC’s Data Access and Dissemination Policy (D2P2) were developed to govern the use and sharing of outcomes database information with Center of Excellence and Master Surgeon program participants, outside investigators and other third parties. The D2P2 protects the integrity of outcomes database information, safeguards participants and patient information, and promotes timely and scientifically accurate presentation and publication of data.
The D2P2 describes the process by which database participants and others can submit data access requests for use and dissemination.
Click here to review the detailed Data Access and Dissemination Policy (D2P2).
Use of Information by Database Participants
Database participants may use their own program outcomes data for the following purposes without submitting a request for approval by SRC:
- Monitoring internal quality assurance and quality improvement processes to satisfy institutional requirements
- Reporting their own statistics and outcomes to inform individual referring physicians, help counsel patients and families, as well as strengthen collaborative decision-making with surgical and nonsurgical colleagues
- Aiding managed care, hospital-surgeon and other contract negotiations
- Promoting and marketing their program
Database participants seeking additional information on their own programs that is not contained in the standard outcomes database reports or data needed for publication, presentation, research or general information purposes must submit a formal Data Access Request. This process provides the necessary checks and balances for the use of SRC’s outcomes database information.
SRC welcomes the use of database information by researchers, payors, government and other stakeholders.
Parties interested in using database information for publication, presentation, research or commercial purposes must submit a formal Data Access Request for approval from SRC. This process provides the necessary checks and balances for the use of SRC’s database information.
Journalists may request limited data for general information purposes. These requests are not intended for use in original research or data analysis projects. Media requests should be directed to email@example.com.
SRC’s Database is used as a tool to collect and monitor volume and outcomes information required for Accreditation program compliance and can also can be used to develop general knowledge about optimal surgery practices. Each purpose necessitates a different level of Institutional Review Board (IRB) oversight.
- Accreditation Program Compliance – Data collected in SRC’s Database can be used to ensure ongoing compliance with Accreditation program requirements. National summary reports, consisting of database aggregate information, are provided to participants so they can assess their own patterns of care and outcomes relative to national norms. These activities are implemented solely for the purpose of assessing the quality of care and do not require review by an IRB, according to 45 CFR Part 164.501, 506.
- General Knowledge: The BOLD Study – SRC’s Database information is also used to advance general knowledge about optimal surgery and patient care practices, which is referred to as the “BOLD Study”. This is considered human subject research and requires IRB review. The Copernicus Group Independent Review Board (CGIRB) provides IRB oversight of the BOLD Study:
- IRB Oversight: CGIRB determined that SRC’s research staff is the only group engaged in the analysis of database information for general knowledge purposes. Therefore, SRC is the only entity required to have IRB oversight. More specifically, participating facilities are not required to have IRB approval and/or oversight if their surgeons do not conduct research using data collected in the BOLD Study. While not required by SRC, a facility may elect to have its local IRB review its participation in the Study. This optional oversight is sometimes necessary because the facility has a policy requiring its IRB to review all studies conducted at the institution, even if only to determine that the facility is not engaged in research.
- Waiver of Informed Consent: No patient-identifying information (e.g., names, medical record or social security number) is collected in SRC’s research datasets, and SRC has safeguards in place to ensure the confidentiality of the protected health information described in the Study protocol. CGIRB concluded that the BOLD Study poses minimal risk to patients and granted approval for SRC to engage in research with a waiver of informed consent. Therefore, surgeons and facilities do not need to ask their patients to sign an informed consent document to participate in the Study – instead, a Patient Information Sheet must be provided to each patient prior to their surgery.