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Ann Thorac Surg 1995;60:1526-1529
© 1995 The Society of Thoracic Surgeons
Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri
Abstract
Many efforts to improve the quality of care focus on information drawn from databases. Such information can be very useful; however, the acquisition and analysis of data must be undertaken with caution. Six issues related to quality of care and the acquisition and analysis of data that pose problems for thoracic surgeons are the limitations and dangers of the right to know, the inadequacy of current databases, outcomes analysis and whether they help or hurt us, increased scrutiny of our practices, practice guidelines and the standards of care, and credentialing. To maximize the benefits of databases, physicians must participate in the process of data acquisition and analysis and the formulation of practice guidelines. Speaking out against the misuse of incomplete or inaccurate data and supporting Society initiatives that address these concerns will help us as we strive to maintain a strong physician-patient relationship and to deliver optimal care to our patients.
The charge given to me by the organizers of this symposium is to present an overview of where we, as practicing thoracic surgeons, stand with regard to quality initiatives and the power of our databases. I will address six specific issues related to quality of care and the acquisition and analysis of data that are posing problems for us now and likely will in the future.
Limitations and Dangers of Right to Know
In his presentation, Hartzell Schaff, MD, discussed some of the important issues surrounding the public's right to know. There are clear limitations and dangers associated with this right. Consumers of healthcare are being increasingly exposed to outcomes data that will presumably permit them to make more informed choices about the quality of care they receive. Examples of this phenomenon relevant to our specialty include the mortality rates for coronary artery bypass grafting at individual hospitals that have been accumulated and published by the Health Care Finance Administration, and mortality data from hospitals and for individual surgeons released to the public in New York and Pennsylvania [1]. The Clinton health plan would have made data on quality available to consumers with respect to health insurance plans and, where feasible, with respect to providers as well [2]. One likely outcome of this information-rich environment is information overload, where consumers could be overwhelmed by the sheer volume of information available to them and by the inability to make truly informed choices [24].
As the amount of outcomes data increases and the data are aggregated into smaller units, reliability of the data may decline. Defining and measuring indicators of quality such as functional status and increased quality of life are much more problematic and costly than determining mortality rates, which are easily definable. Furthermore, collection and analysis of such large amounts of data is expensive, and the results obtained may not demonstrate meaningful differences. As an example, the Greater Cleveland Health Quality Choice Project obtained information on cardiac surgical procedures performed at hospitals in that geographic area. This study cost millions of dollars. Yet differences in performance among most hospitals were small and were not consistent [5]. Thus, as pointed out by Jost [2], it is possible that consumer decisions could be based on differences that are statistically meaningless, especially if consumers are not carefully educated and are unable to analyze and interpret the data.
Inadequate Current Databases
Fred Grover, MD, described the uses, quality, and limitations of available databases and emphasized the critical importance of risk stratification. However, it is becoming increasingly apparent that the databases cardiothoracic surgeons rely on most heavily, such as The Society of Thoracic Surgeons' database, may be inadequate to satisfy the consumers and providers of healthcare. Timothy Denton, MD, emphasized the need to upgrade these databases to encompass other outcomes that would include quality of life and patient satisfaction. Quality of life encompasses such variables as overall well-being, physical capacity, psychological status, and social status. These end points are ``soft'' when compared to the end points we have become accustomed to dealing with, such as mortality and specific morbid events such as myocardial infarction, stroke, renal failure, and so on. When these softer end points are used, it will be more difficult and expensive to collect meaningful and statistically valid data. The Society of Thoracic Surgeons is adding supplemental programs to its database that will encompass some of these variables. There are other variables that will also require more careful analysis in the future. These include the quality and cost of the resources used to deliver specific therapies such as cardiac surgery, the efficiency with which this care is delivered, and the appropriateness of care.
Outcomes Analysis: Friend or Foe?
Outcomes analysis is not an unfamiliar term to cardiothoracic surgeons. Mortality and morbidity data obtained for patients undergoing cardiac surgical procedures represent some of the earliest published outcomes information, and enormous amounts of data relative to these outcomes after coronary artery bypass grafting and other cardiac operations have been generated over the last 25 years. The Society of Thoracic Surgeons' database will soon have outcomes data encompassing a number of important variables in more than 400,000 patients.
The importance of outcomes analysis is evidenced by the commitment of funds by the federal government for this activity. The projected budget of the Agency for Health Care Policy Research for 1995 approaches $175 million, and 28% of this amount, or approximately $50 million, will be used for outcomes research. Although nearly $200 million has been spent on outcomes research since the Agency for Health Care Policy Research was established in 1990, critics have argued that this research has yielded few data clinicians and healthcare policy makers can use to make rational decisions about healthcare [6]. They suggest the Agency for Health Care Policy Research cannot point to a single instance in which its database studies have altered general clinical practice. The majority of the studies have relied on data that were accumulated by hospitals, insurers, and government health programs and analyzed retrospectively. Because of hidden biases and lack of randomization, it has been argued that the data are less informative than those obtained from formal prospective clinical trials. Jerome Kassirer, MD, editor of The New England Journal of Medicine, stated in a recent editorial that ``We [physicians] should resist the argument, fostered largely by the business community, that some data are better than none at all'' [7]. Despite these and other criticisms, outcomes research will likely continue on a large scale. It is also likely that conditions affecting large segments of our population, such as coronary artery disease, will continue to be examined using this methodology.
There is a potential for misuse of such data, as occurred in New York and Pennsylvania, when hospital and physician mortality rates were released to the public despite concerns raised by cardiothoracic surgeons. A result of the release of such information was the inappropriate use of the data by physicians and hospitals to capitalize on their rankings [1]. Furthermore, with this approach there is the potential to punish the outliers rather than reward the best providers, a notion that must be strongly resisted. If these trends continue, patients may lose freedom of choice of a particular physician or hospital; physicians could lose more of their autonomy. Competition among hospitals and physicians will become more public and more abrasive.
Increasing Scrutiny of Our Practices
A fundamental requirement of managed competition, which is rapidly pervading the practice of medicine in the United States, is the ability to make reliable and valid comparisons of the quality of care delivered by healthcare providers, the so-called report cards. This will include performance-based assessment of individual physicians or groups. Specialists in cardiovascular disease will be closely scrutinized because of the high cost of cardiac procedures and because of the large volume of data available from outcome studies evaluating various methods of diagnosis and therapy for cardiovascular disorders. Practice profiles (data on patients of physicians or groups of physicians) are extracted from local, national, or proprietary databases and are compared with established standards. The limitations and hazards of such comparisons are well documented [1 , 2, 7, 8]. We could, on the basis of these criticisms, resist all profiling efforts, but this would not be a realistic approach. We should, however, as suggested by Kassirer [7], become more actively involved in the processes that define and develop the methodology used to assess the value of practice profiles and their cost-effectiveness. We should also publicly express our concerns about the businesses that collect data from various sources, assess the performance of individual practitioners or group practices, and sell the data to third-party payers and employers. As pointed out by Kassirer, ``Companies in the business of producing profiles are monitoring physicians, but at present nobody is monitoring them'' [7].
Practice Guidelines and Standards of Care
Practice guidelines have been touted as a great hope for reform of the healthcare system. In 1990, $2 million of the Agency for Health Care Policy Research's appropriation of nearly $100 million was obligated for practice guidelines [9]. These federally mandated guidelines are targeted to the primary care physician and to the consumer. The American College of Cardiology, the American Heart Association, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery have been proactive in the development of practice guidelines. The first guidelines compiled by the American College of Cardiology/American Heart Association relating to implantation of cardiac pacemakers and antiarrhythmia devices and to the use of exercise testing and cardiac radionuclide imaging were published in the mid-1980s. These documents, and those relating to cardiothoracic surgical procedures compiled by The Society of Thoracic Surgeons and The American Association for Thoracic Surgery, have been written by physicians for physicians. Preparation of such guidelines is a costly and labor-intensive process. The cost to American taxpayers for the recently published practice guidelines for the diagnosis and management of unstable angina was $927,000 [9]! The guidelines were prepared by 19 experts who reviewed more than 1,800 publications [10].
Although such guidelines improve the practice of medicine and may serve as yardsticks by which to measure physician performance, many uncertainties regarding their usefulness remain. Most guidelines are static and will require continuous updating as new information becomes available. The validity of practice guidelines has been questioned, and their cost/benefit ratios have yet to be determined. Studies evaluating compliance with such guidelines and the importance of guidelines on outcomes, cost of healthcare, utilization of resources, malpractice litigation, and other important issues are necessary. It is clear that physicians must actively participate in the formulation of such guidelines and must resist the intrusion by governmental agencies and healthcare providers who may wish to play a major role in this process.
Credentialing
In a recent editorial, Benson Wilcox, MD, president of The Society of Thoracic Surgeons, stated that the ``time-tested exceedingly effective system of responsible self-regulation [by physicians] is in danger of being dismantled in the name of `healthcare reform''' [11]. He pointed to the increasing number of examples where hospital boards, insurance companies, or other management groups have based credentialing decisions on factors other than professional qualifications. Healthcare providers are implementing various techniques that fall under the title of economic credentialing that could restrict access to individual physicians based on criteria other than professional competence [12]. This is potentially harmful to both physicians and patients, and must be strongly resisted.
The Future Is HereWhat Can We Do?
In his address to this symposium, Robert Jamplis, MD, indicated that the future is here [13]. What can we, as cardiothoracic surgeons, do to address these and other issues that will confront us as we strive to maintain a strong physician-patient relationship and to deliver optimal care to our patients?
The Society of Thoracic Surgeons represents our most important and valuable resource. By virtue of its broad membership, it best represents our specialty. It has committed leadership that has addressed, through various committees, important issues such as standards and ethics, mortality statistics, practice guidelines, clinical privileges, and credentialing. It has also established a national database, an invaluable resource that contains an enormous amount of information relating to the type and quality of cardiothoracic surgical services provided to our patients. It has become an important counterbalance to other databases that are being used and will continue to be used by governmental agencies and third-party payers to evaluate the surgical services provided to the American public. It is our obligation as members of The Society of Thoracic Surgeons to participate actively in the activities of The Society that relate to these issues. We must be willing to serve as members of the various committees noted above or to make our opinions and concerns known to the members of these committees.
What can we, as practicing cardiothoracic surgeons, do to assure our patients will receive the best, most appropriate, and the most cost-effective services? Clearly, we must all become more involved in the aspects of our practices that do not relate directly to patient care. We must strive to improve the quality of care delivered in our offices, in our hospitals, in our communities, and at the regional and national levels. We must continue to collect and analyze meaningful data that relate to the care of our patients. Participation in The Society of Thoracic Surgeons' database is clearly one important way to achieve this goal. We must become more familiar with outcomes analysis and continuous quality improvement, which will be increasingly used to evaluate our practice patterns. These are buzzwords for the future. We must actively participate in the formulation of guidelines for patient care at the local, regional, and national levels. We must more critically monitor our practice patterns and change them if necessary, because if this is not done by physicians, other healthcare providers and governmental agencies will assume this responsibility.
But we must continue to put the patient first. We must speak out against the misuse of incomplete or inaccurate data that are being and will continue to be used to make decisions about healthcare delivery. We must publicly criticize improper methods of data analysis and reporting, and we must continue to actively oppose economic credentialing and other types of regulation based on considerations other than professional qualifications. And, finally, we must support the initiatives of The Society of Thoracic Surgeons that address these issues.
Footnotes
Presented at Preparing Your Practice for Change: Thoracic Surgery Into the Next Decade, Atlanta, GA, Sep 2425, 1994.
Address reprint requests to Dr Kouchoukos, Division of Cardiothoracic Surgery, Washington University School of Medicine, The Jewish Hospital of St. Louis, 216 S Kingshighway, St. Louis, MO 63110.
References
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