The Urgent Need to Improve Health Care Quality: Title and subTitle BreakInstitute of Medicine National Roundtable on Health Care Quality

FEW ISSUES are more central to the ongoing debate about health care in the United States than quality of care. The Institute of Medicine (IOM), a component of the National Academy of Sciences, Washington, DC, convened the National Roundtable on Health Care Quality to bring together a wide variety of individuals to engage in a series of discussions about health care quality, a process that took place over a 2-year period. The roundtable solicited presentations from experts, convened conferences, and initiated a parallel set of detailed discussions about managed care and quality. (Additional information about the roundtable's work is available at http://www.nap.edu/readingroom/books/statement/.)

The roundtable, which met 6 times between February 1996 and January 1998, reached consensus on the conclusions delineated here by a process of examining the information it received from these processes and the experience of its members. The consensus evolved during the final meetings of the roundtable. The first draft of a document reflecting these conclusions was created by the listed authors and the IOM project director. Revisions were made in accordance with discussion at roundtable meetings and comments from individual members. The final document was approved following the formal report review process of the National Research Council of the National Academy of Sciences.

The roundtable concluded that, following a period of appropriate and intense concern about health care costs, a national focus on improving the quality of health care is imperative. The roundtable reached this conclusion by the following reasoning:

The IOM council addressed these quality-of-care issues in 1994.¹ The roundtable concurs with the council's view that the IOM's definition of quality, developed in 1990, has been widely accepted and is still robust today: "Quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."²

Several ideas in the definition deserve elaboration. The term health services refers to a wide array of services that affect health, including those for physical and mental illnesses. It includes services aimed at preventing disease and promoting health and well-being as well as acute, long-term, rehabilitative, and palliative care. Furthermore, the definition applies to many types of health care practitioners (eg, physicians, nurses, various other health care professionals) and to all settings of care (from hospitals and nursing homes to physicians' offices, community sites, and even private homes).

Including both individuals and populations draws attention to the different perspectives that need to be addressed. On one hand, we are concerned with the quality of care that individual health plans and clinicians deliver to individuals in specific episodes of care. On the other hand, we must direct attention to the quality of care across the entire system. In particular, we must ask whether all parts of the population have access to needed and appropriate services and whether their health status is improving.

The phrase desired health outcomes refers to health outcomes that patients desire and highlights the crucial link between how care is provided and its effects on health, as well as the need to ensure that patients and their families are well informed about alternative health care interventions and their expected outcomes. It underscores the importance of being mindful of people's ability to function as well as possible in their daily lives in addition to attending to more narrowly defined medical outcomes of disease. It also includes a consideration of patient and family satisfaction with health care services.

The definition emphasizes that high-quality care increases the likelihood of beneficial outcomes. It reminds us that quality is not identical to positive outcomes. Poor outcomes occur despite the best possible health care because disease often defeats our best efforts. Conversely, patients may do well despite poor quality care because humans are resilient. Assessing quality thus requires attention to both processes and outcomes of care.

Current professional knowledge emphasizes that health care professionals must stay abreast of the dynamic knowledge base in their professions and use that knowledge appropriately. No matter how good our understanding or measures of quality are today, we must always be prepared to revise them as new knowledge is generated about what works and what does not in health care to produce positive outcomes for patients. Although the knowledge and practices of individual clinicians are important for high-quality care, today we realize that no health care professional can deliver high quality alone. Increasingly, health care professionals practice within groups and systems of care. The functioning of those systems in preventing and minimizing errors and the harm such errors may cause, coordinating care among settings and various practitioners, and ensuring that relevant and accurate health care information is available when needed are critical factors in ensuring high-quality care.

For more than 25 years, experts have worked to create reliable and valid measures with which to assess the quality of health care over a wide range of diagnostic and therapeutic services and for a broad array of health and medical problems. For some health care fields, such measurement tools can be put to immediate, widespread use, but in others, the science of quality measurement is in an early stage of development. There have been many advances as well as refinements in the field of quality measurement. As the acceptance of these measures has increased, so has the audience for them. With this wider attention has come the need to broaden the domain of measures to include outcomes as well as processes of care and to speak to the concerns of consumers by developing outcome measures that go beyond immediate morbidity and mortality to include various kinds of functional status.

In general, either processes or outcomes may be valid measures of quality. For an outcome to be a valid measure, it must be closely related to processes of care that can be modified to affect the outcome. For example, the proportion of patients with inoperable lung cancer who develop metastases within 6 months of diagnosis is an important outcome measure but not a valid quality measure, because no known processes of care can influence this outcome. For a process to be a valid measure, it must be closely related to an outcome that we care about. Thus, controlling hypertension is a process that is a valid measure of quality because it has been shown to reduce the occurrence of strokes and death.

A number of specific examples of different types of quality measures and their uses were discussed at the September 1996 IOM conference, Measuring the Quality of Health Care: State of the Art. As this experience made clear, quality of care for a great variety of specific clinical conditions and procedures can be measured with sufficient precision to make judgments and take needed actions to bring about improvement. The inventory of useful measures continues to grow. The Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, Ill, and the National Committee for Quality Assurance, Washington, DC, have stimulated interest in developing quality measures and in quality measurement. A large number of valid measures have been used to assess the magnitude of various quality problems.

Health care quality problems may be classified into 3 categories, underuse, overuse, and misuse. Underuse is the failure to provide a health care service when it would have produced a favorable outcome for a patient. Missing a childhood immunization for measles or polio is an example of underuse. Overuse occurs when a health care service is provided under circumstances in which its potential for harm exceeds the possible benefit. Prescribing an antibiotic for a viral infection like a cold, for which antibiotics are ineffective, constitutes overuse. Misuse occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service. Avoidable complications of surgery or medication use are important misuse problems. A patient who suffers a rash after receiving penicillin for strep throat despite having a known allergy to that antibiotic is an example of misuse. Evidence from careful research studies demonstrates a large number of serious problems in each of these categories. A recent review of quality research published from 1993 to 1997 reached the same conclusion,^{6 - 7} as did the report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry.⁸

Underuse of proven effective interventions leads to major foregone opportunities to improve health and function. Undetected and untreated hypertension or depression, failure to immunize children, and prenatal care begun too late in pregnancy are examples of important underuse problems. The magnitude of these problems is considerable. Failure to use effective treatments (eg, thrombolytics, β-blockers, aspirin, and angiotensin-converting enzyme inhibitors) for acute myocardial infarction for all patients who could benefit from these interventions may lead to as many as 18000 preventable deaths each year in the United States.⁹ One recent study showed that in one group of elderly acute myocardial infarction patients, 79% of eligible patients did not receive β-blockers; their subsequent mortality at 2 years was 75% greater than those who had received β-blockers.¹⁰

Underuse is by no means confined to managed health care plans, which have financial incentives to reduce the amount of care they provide. Several studies have shown that between 40% and 60% of patients in selected health maintenance organization and fee-for-service populations do not receive needed care for specific effective services. One study, for example, showed that 59% of hypertensive patients did not have controlled blood pressures in fee-for-service plans compared with 46% in managed care plans.¹¹ The same study also documented that 65% of women treated in fee-for-service settings did not receive scheduled mammograms compared with 45% of those in managed care plans. Another study showed a failure to detect and treat depression by general medical clinicians in 58% of managed care patients compared with 46% of fee-for-service patients.¹² These data and others like them led roundtable members to conclude that quality is the problem, not managed care.

Underuse problems are exacerbated when people lack health insurance, a problem that is faced by more than 41 million Americans. The net health effect of the barrier to access to care that results from being uninsured is measured in shortened lives and increased disability. One study found that those without health insurance had a 25% greater chance of dying within 12 years, controlling for age, race, education, income, and comorbidity.¹³ Other work has confirmed these findings and extended them to show that lack of insurance is associated with poor functional status and that loss of health insurance, particularly Medicaid, can be associated with deterioration in chronic disease secondary to reduced access to effective care.^{14 - 17}

Overuse is also common in US medicine. Two recent studies showed that 21% of all antibiotic prescriptions (a total of 23.8 million prescriptions) given to ambulatory adults or children in 1992 were used to treat colds, other upper respiratory tract infections, or bronchitis, conditions for which antibiotics are ineffective and pose the risk of life-threatening adverse drug reactions and an increase in antibiotic resistance.^{18 - 19} The RAND Health Services Utilization Study, the results of which are now 17 years old, is the largest study of overuse and, to our knowledge, the only one that examined multiple regions of the country. It showed that 17% of coronary angiographies, 32% of carotid endarterectomies, and 17% of upper gastrointestinal tract endoscopies were performed for clearly inappropriate indications in a nationally representative sample of Medicare beneficiaries in 1981.²⁰ No data have been published subsequently that suggest significant improvements have occurred. Other studies have found that 16% of hysterectomies in a group of 7 health maintenance organizations were inappropriate, with individual plan rates varying between 10% and 27%²¹ ; that 23% of children were proposed for tympanostomy tube insertion (the most common surgical procedure in childhood) for inappropriate reasons²² ; and that 20% of cardiac pacemakers were inserted for clearly inappropriate indications.²³

Misuse problems (that is, the preventable complications of treatment) also occur with great frequency. Misuse is not the same as error because not all errors result in adverse events or injury. Many errors, such as the wrong dose of medication or misdiagnosis, may be identified before harm occurs. If not identified and corrected, however, many errors do cause injury. Recent research indicates that patient injuries resulting from the administration of medications occur at the rate of about 2000 per year in each large teaching hospital; about 28% are preventable given current knowledge.²⁴ Each of these preventable injuries adds nearly $5000 to the cost of the hospital stay during which it occurs.²⁵ The Harvard Medical Practice Study estimated that more than 27000 patient injuries due to negligent care occurred among patients hospitalized in New York State in 1984.²⁶ The RAND study of prospective payment for hospitals showed that Medicare patients who received poor-quality care while hospitalized for congestive heart failure, as judged by adherence to objectively defined criteria, experienced a 74% greater mortality rate within 30 days of hospital admission compared with patients who received good-quality care.²⁷

This tripartite classification of quality problems illuminates the relationship between quality and cost. It also helps answer the question of whether improving quality leads to increased or decreased costs. Reducing overuse improves quality (by sparing patients the unnecessary risk that attends to inappropriate health services) and reduces costs at the same time. Solving misuse problems also improves quality (by reducing the number of complications) and decreases costs (by eliminating the cost of treating complications). Fixing underuse problems, however, nearly always results in both increased costs and increased quality. This relationship arises from the fact that, except for immunizations and prenatal care, effective health care services generally do not save money.²⁸ If they are effective, they improve health and result in increased quality, but only at increased cost. The principal exception to this rule arises when services are narrowly targeted at very high-risk subgroups of people for whom expensive complications of disease are prevented with high frequency.²⁹ Such circumstances are unusual because we typically cannot predict with accuracy which individuals will suffer particular complications in the short term (eg, which patients with hypertension will suffer strokes in the next year).

These relationships also identify the most effective ways to improve the value of health care services, which may be defined as the health benefit per dollar spent. The largest improvements in value occur when the same action increases the numerator of the ratio while decreasing the denominator. If we improve quality by fixing overuse or misuse problems, we have exactly this impact on value. The impact on value of remedying underuse problems is less clear because both the numerator and the denominator of the ratio increase.

The evidence is compelling. Millions of Americans are not reached by proven effective interventions that can save lives and prevent disability. Perhaps an equal number suffer needlessly because they are exposed to the harms of unnecessary health services. Large numbers are injured because preventable complications of medical treatment are not averted. These problems exist in managed care and fee-for-service systems, in large and small communities, and in all parts of the country. Substantial opportunities exist to increase quality and decrease cost simultaneously by ameliorating problems of overuse and misuse.

In discussing quality problems in terms of underuse, overuse, and misuse, this statement does not attempt to address all the issues that might relate to quality. Such issues include geographic variations in the rates of use of health services, generalist and specialist physician training, the makeup of the nonphysician health care workforce, and the effect of organization of medical services as a determinant of quality, for which there is an emerging literature.^{30 - 32} These and other relevant issues may be causal or explanatory factors leading to a better understanding of quality problems; that is, they will be related to specific underuse, overuse, or misuse problems.

The statement that our health care system faces quality problems of serious magnitude should not be taken as an indictment of the skill or motivation of the men and women who provide those health care services. Indeed, these people, who represent a host of different disciplines, are among the most highly trained, technically proficient, and best motivated of professionals. In the vast majority of specific instances of problems in health care quality, individuals are not to blame. The answers are not simple and often involve shortcomings in the complex systems in which health care is delivered.

In part, the problems we face represent the obverse side of an extraordinary success story. In the past 25 years, we have generated an immense amount of new knowledge about what works to improve health and what does not. One crude index of the pace of this change is illuminating. The randomized controlled trial has become the "gold standard" for evaluating the efficacy of health care interventions of all sorts. Yet it is a relatively recent phenomenon; the first one was published in 1952. In the 30 years from 1966 through 1995, more than 76000 journal articles were published from randomized controlled trials (as registered in the automated database MEDLINE). The first 5 years of that period contributed less than 1% of the total, whereas the last half decade contributed more than the previous 25 years combined. In the face of this avalanche of rigorous data on efficacy, our methods of training physicians and other clinicians and our systems for supporting them in the delivery of health care services have not kept pace. Their rigorous clinical training has not equipped them to make maximal use of a variety of methods to assess and improve their own practices. Principles of quality measurement and improvement could be included in the education and training of future practitioners to better prepare them for this ongoing responsibility.

Whether they are organized in solo practice, in small single-specialty partnerships, or in large multispecialty groups, too few physicians have ready access to all the data that would be useful to them as they care for patients. Too few hospitals take maximum advantage of all of their data in facilitating efficient patient care while systematically avoiding preventable complications. One hospital has given us a glimpse of what may be possible. Researchers at LDS Hospital in Salt Lake City, Utah, published their experience in reducing the frequency and impact of adverse drug events due to antibiotics. They assisted physicians in prescribing prophylactic antibiotic regimens in surgery and therapeutic treatments using a powerful set of computer-assisted guidelines. The results were impressive: a 30% decrease in the frequency of patient injuries due to antibiotics, a 27% decrease in the mortality of antibiotic-treated patients, and a 58% decrease in antibiotic costs per treated patient.³ However, this example stands out starkly because it is so exceptional compared with the experience of the vast majority of other institutions.

A notable constraint to quality improvement is posed by the lack of an information infrastructure to support it in almost all health care delivery settings and the substantial investment needed to build such an infrastructure. Engaging clinicians actively and enthusiastically in quality improvement requires providing them with timely and detailed clinical information they believe and can use to judge quality of care. Collecting and analyzing these data, whether manually by record review or by sophisticated automated systems, are extremely expensive.³³

At present, quality improvement efforts are sporadic at best. They are typically limited to single, large institutions, usually hospitals. Long-term, multi-institutional quality improvement programs are infrequent, and regional attempts to improve quality across an entire delivery system are very rare. However, the exceptions are noteworthy. New York State's program of collecting standardized clinical data for coronary artery bypass surgery (CABS) patients, producing and publishing risk-adjusted mortality rates for hospitals and surgeons, and using these data to facilitate quality improvement efforts has resulted in lower statewide mortality following this procedure.^{34 - 35} This ongoing program now also produces risk-adjusted mortality data on percutaneous transluminal coronary angioplasty. The 5 hospitals in northern New England at which CABS is performed have used continuous quality improvement techniques to achieve reductions in mortality as well.⁵ Pennsylvania has published data on risk-adjusted mortality following CABS and acute myocardial infarction, but their impact on inducing improvement is not clear.^{36 - 37} Some other states are beginning to experiment with compiling and publishing less complicated data on hospital performance.³⁸ The large majority of these efforts, including a few regional efforts to publish performance data for managed care plans, consist only of compiling and reporting data. Improvement is left to individual hospitals or plans and is rarely documented.

The Joint Commission on Accreditation of Healthcare Organizations, the National Committee for Quality Assurance, and the Peer Review Organizations of the Health Care Financing Administration are encouraging organizations to use methods of continuous improvement but the effectiveness of these efforts remains to be documented.

Four major strategies have been advocated to move the health care delivery system toward improving quality. Whether one believes in regulation, continuous quality improvement, marketplace competition, or payment incentives as the most effective way to improve quality of care, evidence and experience to date suggest that none of these taken alone will prove up to the challenges we face. The challenges may be stated simply: (1) to always provide effective care to those who could benefit from it, (2) to always refrain from providing inappropriate services, and (3) to eliminate all preventable complications.

Although regulation is not currently fashionable, states are pursuing it vigorously as a means to control perceived abuses in managed care. Regulation is the only mechanism we have to protect the public from egregiously poor providers. Another of its advantages is that it can reach every corner of the delivery system as compared with improvements made by a single hospital or health plan. Although it can establish minimum standards of performance reasonably well, uniform enforcement of those standards has proved far more problematic. In addition, regulation is inflexible, difficult to modify quickly as knowledge changes, and not well suited to motivate those already performing well to strive for even greater achievement.

Continuous quality improvement emerged from the industrial sector as an effective package of theory and practical tools to reduce errors in the production process. Although widely praised in business circles, it is far less widely adopted. As applied to health care, it has been similarly praised but has also spread slowly. Its most exemplary practitioners, who have achieved notable successes,^{3 - 5} emphasize that it is most effective when used as an integral part of a scientific approach to improving clinical practice. Very few data document the effectiveness of continuous quality improvement, however,³⁹ and even exemplary practitioners have had difficulty in disseminating its benefits uniformly throughout their institutions. Among its potential strengths are an ability to motivate good performers to excel and an emphasis on generating new methods for achieving improvement. Among its limitations are a too narrow focus on administrative (as opposed to clinical) aspects of care and a lack of attention to problems of overuse or underuse. Future experience may yield increased effectiveness. Current experience in both health care and other sectors of the economy suggests that its impact will be useful but may be limited.⁴⁰

Marketplace competition is the engine driving many changes in health care. Market advocates believe that providing more information about quality to the public will induce health plans, hospitals, and physicians to compete by improving the quality of their care in the expectations of increasing market share. Skeptics point out that no health care market currently competes on the basis of improving quality and there is little theoretical basis in economics to predict that this change will occur.⁴¹

Many experts believe that payment incentives (to health plans, hospitals, or physicians) can be powerful forces to drive improved quality. Unfortunately, the dominant methods of payment in use today do not achieve this goal. Unadorned fee-for-service payments encourage overuse, whereas capitation payments encourage underuse. No current payment system systematically rewards excellence in quality. The immediate prospects for change are not bright, although some health plans have begun to develop performance-based payment systems as incentives to improve quality. These efforts have yet to be evaluated. In another area, the difficulties of assembling sufficient data with which to construct risk-adjustment methods have hobbled efforts to counteract the powerful incentives health plans now face to avoid sick individuals and market their services only to healthy people.

Furthermore, and perhaps most important, even if the right set of strategies could be devised to encourage quality improvement, there are no clear role models of exemplary delivery systems to emulate. Whether one examines hospitals, medical groups, health plans, or integrated delivery systems, no institution in any of these categories can provide a blueprint for solving the multitude of current quality problems. Neither has academic medicine met its part of the challenge to modernize its education and training methods so young physicians can begin practice with an understanding of health care quality and the tools needed to engage in a career-long effort to assess and improve the quality of care they provide.

Who should be concerned about health care quality problems and who should be involved in their solution? The answer is everyone: health care professionals, patients and their families, consumer advocates, health care administrators (whether serving in health care plans, hospitals, medical groups, nursing homes, or other facilities), private and public purchasers of health care services, and policymakers at the national, state, and local levels.

The roundtable believes that health care professionals should take the lead in improving quality, and it strongly urges leaders in the health care professions as well as practicing clinicians to actively do so. Leadership in quality improvement is also a joint responsibility of all who serve in health care organizations, including managers, data and information specialists, laboratory technicians, housekeeping staff, dietary personnel, nurses, and physicians. Individual patients must have the opportunity and the information they need to participate in their own care and to take responsibility, where necessary and appropriate, for their own health. Consumer advocates and purchasers can press to keep quality of care at the top of the agenda as an issue of concern throughout the health care system and to seek effective ways for health care professionals, administrators, and others to be accountable to patients and to society for the quality of care. Policymakers at all levels of government can foster opportunities for communication of best practices and other innovations, increase research on quality measurement and improvement, and assist the development of more effective information and delivery systems. We should all strive for such fundamental improvement that health care becomes not only technologically dazzling but also compassionate, reliable, appropriate to a patient's needs, and safe.

The burden of harm conveyed by the collective impact of all of our health care quality problems is staggering. It requires the urgent attention of all the stakeholders: the health care professions, health care policymakers, consumer advocates, and purchasers of care. The challenge is to bring the full potential benefit of effective health care to all Americans while avoiding unneeded and harmful interventions and eliminating preventable complications of care. Meeting this challenge demands a readiness to think in radically new ways about how to deliver health care services and how to assess and improve their quality. Our present efforts resemble a team of engineers trying to break the sound barrier by tinkering with a Model T Ford. We need a new vehicle or, perhaps, many new vehicles. The only unacceptable alternative is not to change.