Guidelines on Use of STS National Database and Database-Derived Information
Guidelines on Use of STS National Database and Database-derived Information
STS National Database “Participants” (which may consist solely of one or more cardiothoracic surgeons, or may consist of one or more cardiothoracic surgeons plus their hospital, at the surgeons’ election) engage in the process of collecting STS data and utilization of Database-derived information for the purpose of local and national improvement in the quality of cardiothoracic surgical care. This Guideline provides information on the specific and accepted professional use of data and Database-derived information from the three STS National Databases – Adult Cardiac, General Thoracic and Congenital Heart (collectively referred to herein as the “STS National Database”). Use of these data may take one of several forms, as outlined below.
Clinical outcomes research
The standard STS National Database Participation Agreement provides, in part, as follows:
Participant may submit to STS for analysis by the independent data warehouse service provider such requests for ad hoc queries (requiring access to and analysis of aggregate data from the STS National Database) as Participant may desire. All such requests for ad hoc queries shall be subject to prior approval by STS, in accordance with such procedures and other requirements as it may reasonably establish, before efforts are undertaken by the independent data warehouse service provider to respond thereto. In its response to each of Participant’s ad hoc queries, STS shall give due consideration to scientific merit, the funds and other resources available to address ad hoc queries and other pertinent factors; provided, however, that if adequate funding is not otherwise available, STS may condition its approval of a request for an ad hoc query upon Participant’s agreement to pay the fees required by the independent data warehouse and any other service providers required in order to appropriately address Participant’s ad hoc query. As a part of its efforts to promote the use of the National Database as a tool for the development of beneficial scientific information, STS will provide reasonable assistance to Participant in refining Participant’s requests for ad hoc queries so as to enhance their potential for approval in light of the pertinent factors noted above.
Since individual Participants own their local data, both before and after harvesting of the data by the independent data warehouse service provider, individual Participant-specific data may be used for clinical research by that Participant. The particular research hypothesis and methods must be evaluated for scientific merit and ethical propriety by the appropriate Institutional Review Board.
Clinical research on aggregated national or Participant-level data may be used to produce one or more of the following forms for reporting and dissemination of information: abstract, scientific meeting presentation, manuscript for publication in the medical literature. Reviews by abstract selection committees and journal peer review panels provide vehicles for the necessary and appropriate critique of the proposed hypothesis and science used to derive the conclusions and recommendations.
Industry use of data
Individual corporate entities in the medical product and pharmaceutical industries may submit ad hoc queries to the STS for data analysis by the independent data warehouse service provider. All such ad hoc queries shall be subject to prior approval by the STS, in accordance with such procedures and other requirements as it may reasonably establish, before efforts are undertaken by the independent data warehouse service provider to respond thereto. This assessment will be made in keeping with Participation Agreement (Adult Cardiac) paragraph 6.2, which provides that “all data submitted . . . for purposes of inclusion in the STS National Database may be used by STS . . . as it sees fit for the purposes of promoting medical research, surgeon self-assessment and the other interests of the STS National Database . . .”
Industry use of data may be applied broadly to national trends in practice patterns, as required for research and development decision-making. Specific product use trends as reported to the STS National Database may be used for tracking outcomes of newly implemented products and procedures, and monitoring safety and effectiveness on newly approved products. Data analysis and reporting back to the requesting entity on product-specific utilization and trends will be carried out with appropriate and necessary “blinding”, so the requesting entity can compare itself and its product utilization (as required) only to “all other entities.”
Organization/specialty use of data
STS Participants may apply for and conduct, if funded, approved health services research utilizing the Database to address quality of care and patient safety, and to create clinical registries. Such funded research may, for example, be done as an institution or as a multi-center collaborative to demonstrate impact of specific practice patterns or changes on clinical outcomes using the National Database information. All such work and use of data, as done in collaboration with the independent data warehouse service provider, shall undergo the necessary and appropriate peer-review process, to determine the scientific merit and ethical appropriateness of the research as required to qualify for such external funding.
Participant use of data
Individual Participants may use their own data, as collected for and by the National Database submission process, for their internal quality assurance and monitoring of quality improvement processes. Such internal utilization may satisfy institution quality assurance requirements such as mortality and morbidity review and confidential service conference discussions. Process improvement within an institution may be monitored for continuous quality improvement impact, using the data and outcomes as reported for and by the STS National Database.
Participants may use their data, as tracked by them and/or as reported by the independent data warehouse service provider, to provide validated data for internal processes beyond quality assurance as described herein. Relative to care delivery, Participants may report Participant-specific statistics and outcomes as part of 1) informing individual referring physicians, 2) counseling patients and families, and 3) collaborative decision-making with surgical and non-surgical colleagues. Participant data may also be used as a statistical aid for managed care contract negotiations, as conducted by the Participant.
As a tool for service-building, Participants may use their data, as tracked by them and/or as reported by the independent data warehouse service provider, to participate in certain approved activities for purposes of promotion and marketing of the specialty program. Participation Agreement (Adult Cardiac) paragraph 6.4 provides, in part, “that Participant may use aggregated data from the STS National Database that have been previously released to the public by STS (e.g., in published reports and slide sets) without first obtaining [the Society’s] written consent.” Participants are encouraged to report their own statistics and outcomes in comparison with the STS national mean or average, as a benchmark assessment. Such Participant-specific data reporting shall, as often as possible, be reported as trends over time, ideally to encompass at least 3-5 years of data, whenever sufficient data is available.
Statements regarding Participant data or outcomes should comply with theSTSAdvertising and Publicity Policy,and therefore “shall not contain any false or misleading statement, or shall not otherwise operate to deceive.” This includes use of qualitative terms such as “significantly better than”, if statistically unfounded, or reporting of results without reference to the source of data. The display of isolated data points, without frame of reference over time or context for defining statistical significance of claim(s) made is discouraged. Any report of noncompliance or question of apparent impropriety in the use and reporting of STS data shall be referred to the STS Standards and Ethics Committee.
Special reports generated for third parties
The STS may arrange for the generation of special reports for third parties. Paragraph 6.1 of the Participation Agreement provides that Participant data “may be used by STS and its designees only in accordance with the [Agreement terms] and any subsequent instruction from Participant …” These special reports require the consent and instruction of the involved Participants. Examples of these special reports include:
Regional reports as a consequence of data collection efforts of geographically based groups of cardiothoracic surgeons for the purpose of quality evaluation and quality improvement on a regional basis.
Reports for other non-STS third parties (medical product and pharmaceutical entities, purchasers and payers of cardiothoracic surgical healthcare services, or other medical care delivery stakeholders). These report requests will be evaluated separately and in accordance with STS-imposed restrictions on the use of Database-derived information by these third party entities.
In conclusion, the STS National Database data and data-derived information are a valuable resource for a variety of stakeholders in cardiothoracic surgical care. All are accountable for the responsible use of this resource. Participants own their own data, and are encouraged to use the data to evaluate local care delivery and to improve the quality of care delivered to their patients. The STS owns the aggregate data, and has the charge to responsibly make these data available for patient health and safety and the promotion of quality improvement in cardiothoracic surgical care.
Adopted by the Board of Directors of The Society of Thoracic Surgeons: October 10, 2004