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Ann Thorac Surg 1997;64:1245-1249
© 1997 The Society of Thoracic Surgeons


Original Articles: Cardiovascular

Establishing and Using a Local/Regional Cardiac Surgery Database

Kit V. Arom, MD, PhD, Rebecca J. Petersen, RN, Thomas A. Orszulak, MD, R. Morton Bolman, III, MD, Per H. Wickstrom, MD, Lyle D. Joyce, MD, PhD, Theodore H. Spooner, MD, Brian L. Tell, MD, Patricia A. Janey, RN

Minnesota Society of Thoracic Surgeons, Minneapolis, Minnesota


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
Background. In 1993, the Minnesota Society of Thoracic Surgeons and the Minnesota Cardiac Surgery Database were organized in response to a third-party payer demand for data about practice protocols and patient outcomes. It has matured to an active organization of 46 cardiothoracic surgeons, 14 institutions, and more than 7,000 patients who have undergone coronary artery bypass grafting.

Methods. Data are validated for completeness and accuracy through a statewide auditing process. They are coded by hospital, analyzed using the standard Society of Thoracic Surgeons National Cardiac Surgery Database format and definitions, and reviewed quarterly in a continuous quality improvement process.

Results. Through data review and exchange site visits, variations in practice protocols and outcomes have been identified. For example, our statewide data review and continuous quality improvement process identified prolonged ventilation (more than 24 hours) as one variation. Multidisciplinary teams were defined, and statewide exchange site visits led by cardiovascular surgeons were implemented. An example of the improvement in the accuracy and completeness of the data used to study procedure outcomes is represented by the improved reporting of ejection fraction values that has resulted from this process.

Conclusions. Using the standardized Society of Thoracic Surgeons National Cardiac Surgery Database and the Minnesota Society of Thoracic Surgeons organizational structure to establish a high-quality database will allow for statewide peer review, exchange of practice guidelines, and promotion of standardization, which eventually can improve outcomes and reduce costs. This organization or model can be replicated at any local, state, or regional level. Thoracic surgeons faced with similar challenges for public disclosure of surgical results can learn much from the successful development of the Minnesota Cardiac Surgery Database.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
See also pages 1249.

In 1993, cardiothoracic surgeons in Minnesota were confronted with a request for patient-specific data for use by third-party payers to compare clinical outcomes among institutions and physicians. Circumstances in Minnesota could have unfolded as they did for physicians in New York and Pennsylvania in 1989 and 1992, with publicized physician- and hospital-specific report cards [13]. Instead, cardiothoracic surgeons in Minnesota took a proactive position and organized an all-inclusive statewide initiative to collect, analyze, and report reliable, statistically significant data.

Society has demanded specific changes to the care delivery process, and physicians and health care systems need to respond. The required changes vary from region to region as a result of differences in health care environments, delivery systems, patient socioeconomic status, and comorbid conditions, all of which affect patient outcomes. The goal for all participants of the Minnesota Society of Thoracic Surgeons (MNSTS) is to benchmark local/regional patient outcomes against the Society of Thoracic Surgeons National Cardiac Surgery Database. The MNSTS believes strongly that, in spite of differences in geographic location, the comparison of MNSTS outcomes to the standard of the Society of Thoracic Surgeons National Cardiac Surgery Database is essential. All physicians must work together as a health care delivery team to effect and implement improved outcomes, which also should be cost-effective.

The MNSTS gathered members of the health care delivery team together and developed a mechanism for monitoring clinical outcomes among patients undergoing coronary artery bypass grafting by implementing a statewide continuous quality improvement (CQI) initiative. This article identifies the key steps in developing a local, state, or regional clinical database and in managing a statewide CQI process. The MNSTS is committed to the statewide approach to a more efficient care delivery system. Our approach and the lessons we learned will provide a valuable tool for other medical professionals faced with similar challenges.


    Organizational Structure
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
Cardiothoracic surgeons were determined to be the connecting link in the information exchange among providers, payers, and consumers. They mobilized their knowledge and experience in analyzing data into an organization with a vision and strategy to show voluntarily the public and private sector their commitment to providing efficient and cost-effective care through a peer review process. In February 1994, after much legal counsel, the MNSTS submitted an application for a nonprofit 501 C-4 peer review organization. By forming a structure under the peer review guidelines, the data and discussions pertaining to clinical outcomes are provided certain legal protection. The data that are collected, analyzed, and reviewed may be held in confidence and are not subject to subpoena or discovery.

Organizational bylaws and articles of incorporation were designed, and a tax-exempt status was obtained. The focus and purpose of the MNSTS as stated in the Articles of Incorporation are to document health care outcomes on all patients who undergo cardiac operations in the state of Minnesota and to analyze clinical data that are statistically and clinically significant. In addition, the MNSTS will provide risk-adjusted data to those parties designated in the corporation's bylaws or policies to facilitate a change in clinical practice. This will promote quality and efficiency in the field of thoracic and cardiovascular surgery in Minnesota.

Officers (president, vice-president, and secretary/treasurer) were elected by ballot from the membership of 46 surgeons practicing at 14 institutions. To ensure equal representation and voice in decision-making, the board of directors also was elected by ballot, with one to three members selected from each group, depending on the group size. Business managers were chosen from the data managers group to assist the officers in managing the day-to-day operations. Monthly meetings were held during the first year as organizational infrastructure was established, goals were set, and data collection management was refined. Presently, the board of directors meets quarterly to deal with business issues and decisions regarding the organization's future direction. Each board member serves as a spokesperson for his or her group.

Administration and management of the organization has been strictly voluntary. The business managers are responsible for administrative, secretarial, and financial duties under the direction and supervision of the officers. Time involved in the management and facilitation of meetings, site visits, and annual meetings is equivalent to a three-quarter full-time equivalent, or an annual salary of approximately $60,000. Each surgeon member is assessed $150 for annual membership dues. Distribution of these funds supports postage, office supplies, printing, and activities related to site visits and quarterly and annual meetings.

Establishing a level of trust among the surgeons, where they were comfortable with the review of institution-specific—and now group-specific—data was a gradual process. For the first year, compiled data were presented for discussion and review to the cardiothoracic surgeons and data managers by outside biostatisticians. In October 1995, at the second annual meeting and data review, hospital administrators were invited to participate. Presently, all hospital administrators and directors of the hospitals' cardiovascular departments are involved in the CQI meetings.


    Organizational Objectives
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
To meet the demands of managed care payers and consumers, the MNSTS has focused on several key concerns. A primary goal is to collect accurate and valid data in a cost-effective manner. To support this goal, we have developed common collection processes using definitions already established and supported by The Society of Thoracic Surgeons National Cardiac Surgery Database Committee. In addition, we have strived to use only those data points that measure quality. We have collaborated with the state of Minnesota and other private and public parties to minimize the duplication of resources and to maintain patient confidentiality. Statistical methodologies used to analyze data are monitored to ensure statistically significant local, state, and regional outcomes.


    Exchange Site Visits
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
Data have been collected, analyzed, and reviewed by cardiothoracic surgeons, hospital administrators, and directors of cardiovascular departments over the past 3 years. The next step in the progression of CQI, as it relates to clinical outcomes, was to examine the processes that affect those outcomes.

The steps in measuring improvement include data analysis, identification of variations, study of process components, redesign of processes, data analysis, and reevaluation. A goal of the MNSTS CQI process is to promote data-driven, process-based improvement instead of a reactive approach to specific situations. Creating a dynamic, systematic approach to providing efficient, cost-effective care requires the combination of all the steps of measurement. Providing the opportunity for institutions to share these steps and components with each other undoubtedly can improve clinical outcomes. Therefore, an action-based initiative in the form of statewide exchange site visits began in the summer of 1996.

Each institution was paired with another and a lead surgeon was assigned. With the assistance of the data managers, specialty team members were selected. Each site provided a cardiothoracic surgeon, anesthesiologist, perfusionist, physician's assistant/surgical technician, nurse practitioner/nurse clinician, intensive care unit nurse, operating nurse, and step-down unit or intermediate care nurse. Hospital teams participated in building a multidisciplinary approach to study processes of care and their effect on clinical outcomes.

During the site visit, host team members are paired with the visiting team member. The objectives of exchange site visits include determining an outcome specific to coronary artery bypass grafting and its relation to cost, patient health status, and satisfaction. In addition, points of measurement are identified and guidelines and protocols are shared. Participants observe the flow process and generate ideas for improvement by identifying inefficient practices.

Before the scheduled site visit, each team member is provided with a manual to review. The manual includes a program agenda, participant names and titles, program ground rules, objectives, member responsibilities, and articles pertaining to outcome measurement and flow charting. After each exchange visit, participants return to their home sites to share with, teach, and train co-workers.

The day of the exchange site visit begins with an overview of the team's responsibilities and objectives. Each member is to be an active observer of communication pathways, patient transfers, systems inefficiency, and general system processes. All team member pairs report to their designated area (eg, operating room, intensive care unit, step-down unit) to observe the day's routine. At the conclusion of the site visit, the participants summarize and evaluate the events of the day. Key variations in job responsibilities, protocol, and pathways are shared, and one or two outcomes are identified as a team project for study. Developing flow charts assists team members in evaluating processes of care (Fig 1Go).



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Fig 1. . Two flow charts showing the plans for extubation after coronary artery bypass grafting at two different site visits. Flow charts help team members evaluate and change methods of care at any specific reference. (I = first case of the day; II = second and later cases of the day; P = extubation protocol met; Tx to OR w/NC O2 = transfer to operating room with nasal cannula oxygen; Tx to preop = transfer to preoperative area; Vent = ventilation.)

 
Hospital administrators also have received a resource manual pertaining to the site visits. It outlines the program objectives, personnel involved, and host and visiting site responsibilities. Hospital administrators also are invited to the briefing or evaluation session at the end of each site visit.

The improved efficiency and patient care that can result from these visits is illustrated by our experience with prolonged ventilation. Prolonged ventilation was found to have significant variations in the early data review, and it became an area on which to focus improvement efforts. At the time of the site visit, implementation of patient protocols had been in place for several months; however, any clinical improvement had not been documented with data because of the time intervals between collecting and reporting data at the state level.

Completion of all exchange visits requires 12 months, then repeated visits occur to reevaluate any changes that have been implemented. An avenue for networking among peers has been a direct benefit of the site visits.

Data Integrity and Auditing
Data managers have played a significant role in the success of the MNSTS. A data managers committee was designed to bring all those who had direct responsibility for data abstraction together on a regular basis to discuss issues pertaining to data acquisition, data keypunch, and interpretation of definitions. Meetings are scheduled quarterly to coincide with the board of directors and CQI meetings.

Certain definitions continue to require clarification, such as ejection fraction (EF), unstable angina, perioperative myocardial infarction, and operative status. These are a few of the data elements that in the early review represented significant variations in reporting or a high percentage of incompletion. For example, the EF data point, which is a core data point in the risk model, had a range of 0% to 58% missing across institutions. Were these variations due to a collection process or definition interpretation, or were they a true reflection of clinical outcomes? In response, those centers reporting missing EF values above or below the state standard deviation were asked to reabstract all records and report back to the committee. Several factors were uncovered that contributed to missing data. For example, no angiography report was available on the chart or EF was reported in text description only. Numerically assigned values representing an EF also vary among cardiologists, radiologists, and surgeons, as well as among tests performed (eg, angiography versus echocardiography).

After lengthy discussion among the board of directors, a unanimous decision was made to assign the value of 0.60 to a normal EF, and a decision hierarchy was designed for the data managers to use for source documentation. In conjunction with the recognition of an incomplete data point and discussion of the issue and problem-solving process, the statewide mean for missing EF has been reduced to 6% compared with 23% before implementation of the data managers committee and statewide auditing and data integrity checks.

External audits that involve site visits by the data managers at all participating institutions occur on a quarterly rotational schedule. These site visits emphasize data abstraction reliability and ensure inclusion of all eligible patients in the registry. The following steps are involved in the statewide round-robin audits. First, data managers from the host site randomly select three records per quarter for audit. The patient records are printed from the document processor in The Society of Thoracic Surgeons software. The host site requests the in-hospital patient chart for reauditing. At this point, the visiting data manager reabstracts the patient record using the interrater reliability score form to document collection of the core data fields and compliance with data definitions. The host and visiting data managers then review the results and clarify discrepancies. This process is repeated at all sites, and the interrater reliability score forms then are returned to the chairperson of the data managers committee for scoring. Completeness and accuracy are measured, graphed, and reported to each data manager, physician group, and board of directors on a quarterly basis. The percentage of completeness varies slightly from quarter to quarter, but the completion rate always has been greater than 95%. (The statewide benchmark has been set at a 95% threshold.)

Internal data integrity criteria and data field checks also are emphasized. Working with Summit Medical, Inc (Minneapolis, MN), we identified the core elements and incorporated them into numeric field tallies and data reports. These reports are required to be executed by each group on their own database before the quarterly harvest. To ensure internal data integrity, each physician group also cross-checks their practice volume and mortality rates against that of the hospital census report—ensuring 100% capture of the patient population. Data managers then sign and return a verification of data integrity document to Summit Medical, Inc. with their quarterly data. Data then are stripped of patient identifiers to maintain confidentiality before being analyzed and coded by hospital.

Summit Medical, Inc, acts as a repository for the MNSTS data, duplicating its role and function as with the National Society of Thoracic Surgeons Cardiac Surgery Database Registry and annual harvesting process. Each site submits all current and past data to Summit Medical on a quarterly basis. The aggregate data are analyzed and compiled into specified coded reports. The formats for these reports are specified by the business managers and may vary from quarter to quarter depending on various interests or CQI initiatives. Each board member receives a final version of the report before the CQI meeting for review and evaluation of discrepancies.


    Conclusion
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
The MNSTS has developed a standardized process for the collection of data and has created a complete and accurate risk-adjusted statewide database. With this accomplishment, cardiothoracic surgeons have become proactive change agents in the development of a statewide cardiothoracic database, representing a greater role of accountability for the appropriateness and cost-effectiveness of care. This initiative is successful because of the high level of trust among the surgeons and excellent cooperation from the participating institutions. Surgeons who can put aside competitiveness and general feelings of mistrust for other professionals, and who are able to effect change and identify areas of improvement and act on them, will be the reformers of our current system, rather than those being reformed. The MNSTS organizational model can be replicated at any local, state, or regional level. Thoracic surgeons faced with similar challenges for public disclosure of surgical results can learn much from the successful development of the Minnesota Cardiac Surgery Database.


    Acknowledgments
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
We thank the data managers for their commitment and dedication to this process. They have contributed greatly to the success of this organization. We acknowledge and appreciate the assistance of Dr Gerald O'Connor, Marc Schwartz, and Joseph W. Bero.

Minnesota Society of Thoracic Surgeons Cardiothoracic Surgeon Membership includes Gregg W. Anderson, Orn Arnar, Kit V. Arom, David P. Blake, R. Morton Bolman III, Mary J. Boylan, James Burdine, Richard C. Daly, Gordon K. Danielson, Joseph A. Dearani, Peter E. Dyrud, Frazier Eales, Robert W. Emery, Thomas F. Flavin, Paul G. Gannon, Christopher Heck, Arlen R. Holter, Terrence P. Horrigan, Lyle D. Joyce, Thomas E. Kersten, R. Michael King, Joseph C. Kiser*, Vibhu R. Kshettry, Theodore J. Lillehei, William G. Lindsay*, Michael F. Lynch*, Christopher McGregory, J. Ernesto Molina, Bjorn K. Monson, Charles J. Mullany, Demetre M. Nicoloff, William F. Northrup III, Thomas A. Orszulak, John W. Overton, Soon J. Park, Edgar A. Pineda, Francisco J. Puga, John R. Satterfield, Hartzell V. Schaff, Sara J. Shumway, Theodore H. Spooner, John M. Streitz, Brian L. Tell, John M. Teskey, Neil Vanstrom*, Thomas J. Von Rueden, Herbert B. Ward, and Per H. Wickstrom.

Participating institutions include Abbott Northwestern Hospital, Fairview Southdale Hospital, Fairview Riverside Medical Center, Mercy Hospital, North Memorial Hospital, St. Joseph's Hospital-HealthEast, United Hospital, Duluth Clinic and Hospital, Ramsey Medical Center, St. Mary's Hospital-Mayo, Methodist Hospital, St. Cloud Hospital, St. Mary's Hospital-Duluth, and University Hospital and Clinics.


    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 
Presented at the Poster Session of the Thirty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Feb 3-5, 1997.

Address reprint requests to Dr Arom, Minnesota Society of Thoracic Surgeons, 920 E 28th St, Suite 420, Minneapolis, MN 55407.


    References
 Top
 Footnotes
 Abstract
 Introduction
 Organizational Structure
 Organizational Objectives
 Exchange Site Visits
 Conclusion
 Acknowledgments
 References
 

  1. Goldfarb B. Making the grade: validity of scoring systems for doctors and hospitals under fire. Medical World News 1993;34:46–7.
  2. Darby M. Pennsylvania report discloses surgeon specific death rates. Report on Medical Guidelines and Outcomes Research 1992;3:1–2.
  3. Schneiderman D. The public dissemination of physician-specific mortality data: who has a right to know? Bull Am Coll Surg 1993;78:31–7.

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