Characterizing Quality – The Opportunity of Outcomes Research

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    Quality assurance for neurosurgical care in the United States is based primarily on the rigors of the neurosurgical certification process. Physicians who desire a career in neurosurgery pursue specialty training designed to credential them for certification by the American Board of Neurological Surgery. Over the last few years the ABNS has been working on ways to document maintenance of competence and quality in neurosurgical care. The ABNS Maintenance of Certification program, which has a July 2005 start date, is intended to assure a sustained high quality of neurosurgical practice once a candidate moves from the environment of a supervised residency program to the relatively unmonitored environment of independent neurosurgical practice. One of the ways being considered for documenting competence in the neurosurgical practice area is evaluation of operative outcomes.

    The need to develop meaningful measures for quality performance has taken on new importance with the emergence of pay-for-performance initiatives, which increasingly have been adopted by private payers in the past few years, and now by Medicare, which is currently piloting pay-for-performance programs for 10 large medical groups. With the specter of government-mandated quality measures looming, neurosurgeons look to organized neurosurgery to develop meaningful methods for measuring quality.

    This article presents a brief review of the concepts of quality assurance and assessment as they are applied in the healthcare system of the United States. A paradigm for evaluating and improving neurosurgical quality is proposed, with the expectation that these quality measures could serve as measures required for documenting MOC and pay-for-performance requirements.

    Defining Quality
    For quality to be measured or assured, a generally agreed-upon definition of the term must exist. Healthcare quality is a social construct that includes the somewhat nebulous concept of “health” in a given society and also involves the various perspectives of those healthcare system participants who are defining the term.

    Healthcare quality is usually defined in terms of benefits to patients, with high quality care defined as care that best maintains and improves patients’ health and satisfaction. Healthcare policy analyst Mark Chassin has provided a simple but compelling definition of quality in healthcare as “care that meets or exceeds the expectations of the patient and the society.” The Institute of Medicine has defined quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”

    Patients define quality in terms of responsiveness to their expectations and needs. However, patient expectations may be unrealistic. For example, medical advances reported in the mass media may inflate patient expectations to unachievable levels. In addition, patient needs might be contrary to what physicians would call good health. For instance, patients seeking narcotics might see neurosurgeons who are willing to fill their prescriptions as providers of high quality care.

    Employers, who frequently purchase healthcare insurance for their employees, are primarily concerned with the efficiency of care as a measure of quality. For them, quality care is low-cost care.

    Physicians believe that professional judgment should be the authoritative criterion for determining the quality of care, and neurosurgical quality assurance in the United States is based on this premise.

    Measuring Quality
    The evaluation of quality medical care usually is based on three factors: structure, process and outcome. These components vary depending on whether one is evaluating quality at the practitioner level, the healthcare institution level, the individual patient level or the population level. Structure and process measures of quality have been used predominantly because they are easier to assess than outcome. For instance, it is easier to determine whether or not an institution has a committee for review of morbidity and mortality or if a patient received preoperative antibiotics than it is to determine the patient’s risk-adjusted outcome.

    The evaluation of quality medical care usually is based on three factors: structure, process and outcome.
    However, quality assessment by either process or outcomes evaluation alone is intrinsically unreliable. For process evaluation to be a valid measure of quality, it is necessary to document a causal relationship between adherence to the process and improved health outcomes. For example, one must show that regular morbidity and mortality conferences result in progressively fewer complications. Proving such a connection can be difficult. Conversely, for outcomes evaluation to be a valid measure of quality, it is necessary to link the outcome measured to a process or processes that can be modified to improve that outcome. As an example, assessing the functional outcomes of patients with ischemic stroke is a valid quality measure if improving the processes involved in early diagnosis and treatment can result in decreased morbidity.

    A Paradigm for Quality Assurance in Neurosurgery
    Quality assurance is an attempt to oversee individual and organizational responsibility for access to and enjoyment of health. Mark Chassin developed a paradigm for assessing quality that categorizes quality problems into overuse, underuse and misuse of healthcare interventions. This paradigm has heuristic value and can be readily applied to neurosurgical practice.

    Overuse of neurosurgical intervention occurs when the risk of harm from providing a neurosurgical service exceeds the potential benefit. A number of factors may lead to overuse of neurosurgical procedures. These include an inadequate knowledge base, unclear indications for treatment, reimbursement for service, enthusiasm for the procedures that can performed, and expectations of patients and referring physicians that “something” needs to be done.

    Underuse of neurosurgical intervention occurs when the neurosurgeon fails to provide a service that would likely have produced a favorable outcome. Factors leading to underuse include an inadequate knowledge base and unclear indications. Capitated payment plans encourage underuse of services as do financial barriers to care such as lack of insurance coverage.

    Misuse of neurosurgical care is defined as the occurrence of avoidable complications from appropriately applied neurosurgical interventions. As for overuse and underuse, an inadequate knowledge base may be responsible for misuse of neurosurgical services. Inadequate surgical training or inadequate surgical skill also can lead to this kind of quality problem. It must be noted that misuse problems are often system-wide problems and not the fault of an individual practitioner.

    Outcomes Data Can Improve Neurosurgical Care
    This paradigm fosters analysis of how the quality of neurosurgical care could be improved. For example, the one causative factor common to overuse, underuse and misuse is an inadequate physician knowledge base. Considering the explosion of relevant clinical data over the last 50 years and the steadily increasing pace of change, it is impossible for physicians in the 21st century to practice the highest quality of medicine based solely on the information carried in their heads. It is, therefore, important to evaluate what and how neurosurgeons are taught. Numerous organizations are active in assuring the quality of education for neurosurgical residents and practitioners. Teaching skills for gathering and critically evaluating information pertinent to a specific clinical setting must be emphasized. Further, neurosurgeons must be convinced of the importance of continuously monitoring the outcomes of care.

    The idea that outcomes research can improve the quality of care is not new, and in fact there is evidence to support a causal relationship. However, the Northern New England Cardiovascular Disease Study Group has demonstrated that meticulous tracking of outcomes data in a nonpunitive environment can result in decreasing misuse, overuse and underuse problems. Neurosurgery might benefit from a similar system.

    Several years ago the Outcomes Committee of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons developed the infrastructure necessary to conduct national and international outcomes studies in neurological surgery. Committee members from each of the clinical sections of the AANS and the CNS were recruited to ensure representation of clinical expertise in all areas of neurosurgery. The committee included neurosurgeons and non-neurosurgical consultants with expertise in clinical epidemiology and information technology.

    A reliable and secure, Internet-based neurosurgical outcomes reporting system was deployed. This system allowed neurosurgeons to download outcomes reporting instruments to their personal computers, submit data electronically to a centralized database, obtain feedback about their outcomes and compare outcomes indicators in their practice to the same indicators in the universal dataset. Data submitted to the central database did not have patient or surgeon identifiers, thus assuring patient and physician confidentiality. Data verification and monitoring could be accomplished, however, by use of the user name and password key, housed at the AANS Executive Office.

    This system was convenient and available at no charge to all members of the AANS and the CNS. Even so, almost no one used it. At the time, the neurosurgical community did not perceive enough benefit in this system to justify the modest amount of time required to collect and submit data.

    The Time Is Right
    The infrastructure exists, and now, with the advent of ABNS Maintenance of Certification and pay for performance, perhaps the time is right to revisit neurosurgical outcomes research. One option would be for each ABNS-certified neurosurgeon to continuously submit outcomes data on one procedure that he or she performs frequently. This would immediately result in the ability to monitor and improve the quality of neurosurgical care. Individual outcomes that differed substantially from the universal database norms would trigger educational intervention. It would then be possible to determine if the intervention had a positive effect on subsequent outcomes. This system would allow the kind of meticulous practice monitoring that results in improved patient care and reduced costs with a minimum investment of time and effort on the part of the neurosurgeon.

    Those unfamiliar with this type of Internet-based data collection may think it would be an onerous, time-consuming process. However, I have been collecting data for a number of years on a procedure I perform frequently, carotid endarterectomy, using a personal database. I consult this data frequently and use it in consultations with my patients and for quality improvement efforts. The data are extremely useful and it takes only a few minutes per patient to record. My own positive personal experience with recording and using outcomes data explains why I have long championed the development of an outcomes reporting system that offers a menu of procedural outcomes studies for all of neurosurgery.

    Such a system would generate data that could be used as a very valuable research tool. Analysis of outcomes and practice variations over wide geographic areas could be conducted efficiently, and neurosurgeons in solo practice would be able to participate in the database as easily as those at academic centers. Data in the central database could be analyzed and hypotheses generated for randomized clinical trials and to determine best clinical practices.

    There is great opportunity for improving neurosurgical outcomes through development and utilization of a system for outcomes research. Quality improvement in neurosurgery needs to come from within the specialty rather than being imposed by government agencies or third party payers. Autonomous, private sector oversight organizations like the ABNS are composed of intelligent and dedicated individuals who have a deep personal interest in assuring the quality of neurosurgical care. No external agent could match the insight and dedication of this group. The ABNS already has developed an Internet-based data collection system called NeuroLog for ABNS resident case log accumulation and is anticipating utilizing the tool for the Maintenance of Certification process, as well. Given the added impetus for quality measurement tools needed for pay-for-performance initiatives, it seems that now is the right time to implement an outcomes system that will truly benefit our patients.

    Robert E. Harbaugh, MD, FACS, FAHA, is the associate editor of the Bulletin. He is professor and chair of the Department of Neurosurgery, Penn State University College of Medicine, Penn State Hershey Medical Center, Hershey, Pa.

    For More Information

    Chassin MR. “Improving the Quality of Care.” New England Journal of Medicine. 1996; 335: 891-894.

    Chassin MR: “Is Health Care Ready for Six Sigma Quality?”
    The Milbank Quarterly. 1998; 76: 565-589.

    Donabedian A. “Criteria, Norms and Standards of Quality: What Do They Mean?” American Journal of Public Health. 1981; 71: 409-412.

    Harbaugh RE. “Quality Assurance in Neurosurgery: United States Concepts.” Acta Neurochirurgica. Supplementum. 2001; 78: 53-58.

    O’Connor GT, Plume SK Wennberg JE. “Regional Organization for Outcomes Research.” Annals of the New York Academy of Sciences. 1993; 703: 44-50. ]]>

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