The explosion of interest in the broad area of outcome studies has brought with it a significant amount of confusion both as to the foundational concepts behind outcomes and the terminology used. The following discussion is brought forward to provide some clarity and definitions.
Historical Perspective
Before defining where we are in terms of outcomes, it is helpful to see where we have been. The measurement of outcomes is not a new concept in medicine. Physicians have always noted the outcomes of care and treatment, albeit informally. The patient died or lived, got better or worse.
There are also many examples of efforts to develop a more organized approach toward collecting outcomes. Nearly 100 years ago, at the beginning of the 20th century, Dr. E. A. Codman, a Boston surgeon, brought forward the then new concept of recording the results of surgical treatment. His goal of using data to compare surgeons and hospitals was not warmly greeted by his colleagues. Likewise, Florence Nightingale’s efforts to create methods to measure the effectiveness of care provided by hospitals also met resistance.
The current outcomes movement is being somewhat more readily accepted. Several compelling factors have led to the current emphasis on the importance of measuring the outcomes of treatment.
Small area Variations
In the 1970’s, John Wennberg, MD, and his colleagues developed and refined small area analysis of variations in healthcare utilization. This methodology calculated population based rates of medical care utilization by patients, hospitals and health care providers. By defining hospital service areas through the use of zip codes, Wennberg developed per capita utilization rates for medical and surgical procedures.
Prior to Wennberg’s research, the consensus among health care providers was that, once adjustments were made for age, gender and co-morbidities, utilization rates across geographic regions would be consistent. What the result of Wennberg’s work disclosed, however, was the opposite. In almost all of the medical and surgical care studied, significant variations in utilization rates for elective procedures emerged. After factoring out other variables, it was determined that this variation arose because of differences in belief among physicians relative to the optimal way to treat certain conditions. For example, the highest rate for hysterectomies was 4 times greater than the lowest rate. Prostatectomy also showed a 4 times difference between the high and the low; and tonsillectomies showed a 6 time difference in rates.
The Dartmouth Atlas of Health Care, recently published in 1996, for which Dr. Wennberg was the Chief Investigator, shows little improvement in the rate of variation for common procedures. This has significant ramifications from both a quality of care as well as a cost perspective. The inherent uncertainty about which rate is the correct rate has been a major driver of the outcomes movement.
RAND Studies
The RAND study on the appropriateness of care also commenced in the 1970’s. These studies focused on the appropriateness of surgical interventions for selected high volume procedures. Despite criticisms regarding the methodology used, the results are still noteworthy. Using a method developed by RAND researches, all possible criteria for performing certain procedures was developed. Retrospective chart reviews using the established criteria showed that 14 to 38 percent of targeted procedures were inappropriate. These findings added to the growing concerns relative to “which rate is the correct rate.”
Outcomes Management
In 1996, Paul Ellwood, MD, delivered the Shattuck lecture during which he described our health care system as one “driven by misguided choices, filled with instability and in need of a ‘central nervous system’ which could address and cope with complexities of modern medicine.” Dr. Ellwood defined the problem as arising from the “inability to measure and understand the effect of choices made by patients, payers and physicians on the patient’s desire for a better quality of life.” Dr. Ellwood proposed that the solution was the creation of a “technology of patient experience” to allow patients, payers and providers to make rational medical care related choices based on data which shows the effect of those choices on the patient. His vision was to weave together those differing perspectives through a collaborative effort he labeled as “outcomes management.” The outcomes movement as it exists today arose in great part from Ellwood’s vision. [Ellwood, 1998]
Assessment and Accountability
Despite the mounting evidence that variations in utilization and patterns of care existed, clearly the strongest force behind the outcomes movement has been the emergence of managed care. In an increasingly competitive health care environment, reducing costs while maintaining quality has become critical. In 1988, Arnold Relman, MD, former Editor of the New England Journal of Medicine, described the health care system as entering into the third revolution of medical care “assessment and accountability” [Relman 1988]. He sounded the call to arms for physicians to become involved in determining the cost, safety and effectiveness of all things physicians do or employ in diagnosing, treating and preventing disease. Organized medicine is being called upon to define quality and reduce the variations which lead to inappropriate treatment and unnecessary resource consumption.
Outcomes: Concepts and Definitions
Despite the growing interest in outcomes assessment and management, there is considerable confusion regarding the terms, concepts and their meaning. There are four outcomes of any medical intervention:
- clinical indicators such as reduction of tumor size, mortality, recurrence rates;
- quality of life which measures the impact of treatment from the perspective of the patient;
- patient satisfaction which measures the satisfaction of the patient with the process and structure of care; and,
- cost or charge for the procedure or intervention.
Clinical Indicators
The observation of the clinical impact of medical interventions is not a new concept. Historically, whether the intervention of a medical treatment was clinically successful (i.e the patient lived or died, the tumor was removed, an infection was controlled with antibiotic) has been a central focus for health care providers. As the critical mass of potential treatment interventions and medical technology has increased, so have the differences in the approach to managing a disease process. The increasingly sophisticated array of treatment possibilities has also led to increased variation in utilization and cost. Be that as it may, however, the primary focus of any health care provider is to improve the health of his or her patient. Until recently, the “success” of any treatment intervention has been judged solely on whether clinically significant changes have occurred in the health of the patient.
Quality of Life
Within the past two decades, there has been an increasing emphasis on the impact of treatment from the perspective of the patient. This desire to scientifically measure the patient’s quality of life prior to and following a treatment intervention has arisen from a combination of factors which include:
- increased involvement by patients as part of the healthcare team;
- increased emphasis on disease management as a way to control practice variation and costs;
- the need to assure an improved quality of life for the patient undergoing increasingly sophisticated medical interventions; and
- the need to collect data to assure quality and promote accountability.
The increasing emphasis on patient centered care is reflective of a growing concern relative to the impact of treatment from the perspective of the patient. It is no longer enough to “cure” the patient in a way which significantly impairs future quality of life and functional status. In addition, factoring in an assessment of the patient’s quality of life, while determining the medical effectiveness of any treatment intervention, assures the maintenance of a high level of quality in the face of continued cost containment efforts. To borrow from the industrial model, the patient is the “customer”, and must be kept in the center of any quality assurance or improvement efforts. In an increasingly competitive healthcare environment, reduction of costs will remain unacceptable if they result in a detrimental impact on the patient’s quality of life and his or her ability to maintain or improve functional status.
Quality of life can be thought of as an umbrella term encompassing the overall health related quality of life as perceived by the patient. Broad domains routinely measured include:
- physical function, which refers to the patient’s ability to perform daily activities as well as more strenuous activities;
- mental or psychological functional status which assess the patient’s psychological well being and levels of cognitive functioning;
- social and role function which refers to both a social component (such as the ability to maintain contact with family and friends) and the quality of one’s work (whether in home, school or work);
- general health perceptions which focus on the patient’s self-rating of overall health. Research has shown that the patient’s assessment of global health status is an important determinant of the outcome of treatment;
- symptom perception usually refers to self-reported levels of pain; and,
- sexuality which refers to the impact of treatment on the patient’s body image and sexual functioning.
The hallmark feature of the measurement of quality of life is that it is longitudinal. Collection takes place prior to treatment, if possible, and continues at set points along the treatment continuum. This provides rich and useful data when used with the measurement of appropriate clinical indicators. As the trend toward looking at overall medical effectiveness from both a quality and cost perspective continues, looking at the impact of treatment from the perspective of the patient through systematically measuring quality of life will be essential.
Patient satisfaction
The topic of patient satisfaction has received greater attention as healthcare has become more competitive. It has also been the subject of increased debates about its utility. Total quality improvement efforts are organized, in part, to enhance the ability of healthcare providers to compete. Emphasizing patient satisfaction assists healthcare providers to make business and management decisions that will enable their practice to survive and grow. As part of the increasing climate of accountability, managed care organizations must demonstrate to purchasers that their patients are satisfied with the process of care provided. Employers must justify their decisions to contract with certain managed care organizations to their employees. Physicians must be able to prove that their patients are equally satisfied with the process and structure of care being provided.
More importantly, research has shown that increased levels of patient satisfaction leads to greater compliance on the part of the patient, which leads to better outcomes. This synergy is beneficial to patients, providers, employers and third party payers. A less than satisfied patient will have a slower rate of recovery (and return to work), consume disportionately more resources and have cost ramifications for both the provider and the managed care organization.
The purpose of any patient satisfaction survey is to assess the overall medical care as well as to obtain an evaluation of specific features of care. The features, or attributes, of healthcare typically measured through patient satisfaction surveys include [Ware, 1983]:
- accessibility and availability of services and providers;
- choice and continuity;
- communication;
- financial arrangements;
- interpersonal aspects of care;
- outcomes of care;
- technical quality of care; and
- time spent with providers.
Cost or Charge
The cost for any treatment intervention has become increasingly more important as cost containment has become the primary goal in the era of managed care. Most recently, the cost or charges for care have been used as a surrogate for quality by third party payers making decisions about contracting with selected providers. Cost is also a significant factor in physician profiling efforts which are often tied to compensation rates.
The actual costs involved in a treatment intervention (i.e. physician time, allied health care provider time, drugs, etc.) involves a complex formula which is difficult, but not impossible to derive. More frequently, charges (i.e. fees for services, hospital stays, diagnostic tests) are used to evaluate the overall cost of treatment for a particular patient. Capitated contracts and mechanisms implemented by governmental payers have significantly limited reimbursement for many services provided patients. Cost or charge of treatment is an important component in determining the overall medical effectiveness of a treatment protocol or procedure. However, the deep cost containment efforts currently in place have impacted on patient care at a local level through layoffs of nursing and other support personnel and the reduction of time spent with the patient by the provider. In addition, the patient’s quality of care is often impacted through “watchful waiting” prior to implementing treatment by an appropriate specialist. This has the effect of increasing the total length of the episode of care, which ultimately impacts on both quality and cost.
The research is clear that by improving the quality and effectiveness of care by reduction of variations through implementation of guidelines and effective outcomes management, costs of care are commensurately reduced. The implication of this research is an important factor in the emerging importance of outcomes management.
Outcomes Management
In essence, outcomes management is a systematic way to answer the questions asked to all patients “How do you feel?” and “How are you?”. Outcomes management also seeks to answer the question: “What did treatment cost?” The primary goal of outcomes management is to:
- use information and knowledge obtained through monitoring outcomes
- to achieve optimal patient outcomes; through improved clinical decision, and
- making and service delivery. [JCAHO, 1994]
By longitudinally measuring the impact of treatment from the perspective of the patient through measuring quality of life and patient satisfaction, as well as collecting clinically significant outcome data and the cost (or charge) for treatment, a picture of the most medically effective treatment intervention for a disease process can be developed. The goal for all healthcare providers is to provide the highest quality of care in the most cost effective manner based upon evidence which assists the provider and the patient to make the most appropriate healthcare decisions. By developing decision tools through the analysis of outcome data, such as guidelines and pathways for use by healthcare providers and patients, the highest quality of care, based upon accurate data, rather than intuitive decision making, is possible on a consistent and cost effective basis.
Summary
There are a number of compelling and significant reasons for implementing an outcomes management initiative. These include:
- the need to prove and improve the quality of care provided;
- the need to demonstrate a continued commitment to quality assessment;
- the need to negotiate effectively with managed care organizations;
- the need to determine the most medically effective interventions from both a quality of care and cost perspective;
- the need to have decision tools based upon data which will aid in clinical decision making; and
- the need for healthcare providers to have mechanisms in place to assess areas within their own practice requiring improvement.
In the current healthcare environment, with its increased emphasis on quality and accountability, organized medicine must express support for and leadership in the development of quality measures. Outcomes management is a natural outgrowth of that support.
The American Association of Neurological Surgeons and the Congress of Neurological Surgeons, through its Joint Committee on Outcomes, have committed support to providing tools to its membership for the collection of outcome data. Information about the work of the Committee is available through NEUROSURGERY://ON-CALL®. Members are also encouraged to contact Robert Harbaugh, MD, (603) 650-8732; e-mail [email protected] or Megan Morgan, Project Manager (815) 574-8242; [email protected] for help with individual outcome related projects or questions.
References
Ellwood, P: Shattuck Lecture: “Outcomes management, a technology of patient experience.” N.Engl J Med, 319(23): 1549-1556, 1988
Relman A: “Assessment and accountability: The third revolution in medical care.” N.Engl J Med, 319(19), 1220-1222, 1988
Wennberg, J, et al., Small area variations in health care delivery. American Association for the Advancement of Science, 1973
Wennberg, J, et al., “Are hospital services rationed in New Haven or over-utilized in Boston?” The Lancet, May 23, 1987
Wennberg, J, “Which rate is right?” N.Engl J Med, 314 (5) , 310-311 1986
The Dartmouth Atlas of Health Care, American Hospital Publishing, 1996
A Guide to Establishing Programs for Assessing Outcomes in Clinical Settings, Joint Commission on Accreditation of Healthcare Organizations, 1994
Measuring Medicine: An Introduction to Health Status Assessment and a Framework for Application, Faulkner & Grey, 1994