Appendix A
Report of the Technical Panel on the State of Quality to the Quality of Health Care in America Committee

Millions of Americans receive high-quality health care in the United States. Our capacity to provide the most sophisticated and effective care is unrivaled, and there is no evidence that any other system achieves better quality. Yet there is abundant evidence that serious and extensive quality problems exist throughout the U.S. health care system, resulting in harm to many Americans. Opportunities for improvement exist in all areas of clinical practice, across the continuum of care.

As a result of overuse, underuse, and misuse of health care services, our society pays a substantial price. The opportunity costs of poor quality include years of life lost or spent with major or minor impairments, pain and suffering, disability costs, and lost productivity. In many areas, especially those involving overuse and misuse of health care services, that improving quality is also likely to lower health care costs.

BACKGROUND

The Quality of Health Care in America (QHCA) Project, a part of the Institute of Medicine’s Special IOM Initiative on Quality, was established in June 1998 and charged with developing a strategy to produce a significant improvement in quality over the coming decade.

The Committee on the Quality of Health Care in America, chaired by William C.Richardson, Ph.D., was responsible for this 2-year project.

Four advisory groups were established to assist the QHCA Committee in carrying out its charge. To provide a broad base of expertise, these advisory



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Crossing the Quality Chasm: A New Health System for the 21st Century Appendix A Report of the Technical Panel on the State of Quality to the Quality of Health Care in America Committee Millions of Americans receive high-quality health care in the United States. Our capacity to provide the most sophisticated and effective care is unrivaled, and there is no evidence that any other system achieves better quality. Yet there is abundant evidence that serious and extensive quality problems exist throughout the U.S. health care system, resulting in harm to many Americans. Opportunities for improvement exist in all areas of clinical practice, across the continuum of care. As a result of overuse, underuse, and misuse of health care services, our society pays a substantial price. The opportunity costs of poor quality include years of life lost or spent with major or minor impairments, pain and suffering, disability costs, and lost productivity. In many areas, especially those involving overuse and misuse of health care services, that improving quality is also likely to lower health care costs. BACKGROUND The Quality of Health Care in America (QHCA) Project, a part of the Institute of Medicine’s Special IOM Initiative on Quality, was established in June 1998 and charged with developing a strategy to produce a significant improvement in quality over the coming decade. The Committee on the Quality of Health Care in America, chaired by William C.Richardson, Ph.D., was responsible for this 2-year project. Four advisory groups were established to assist the QHCA Committee in carrying out its charge. To provide a broad base of expertise, these advisory

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Crossing the Quality Chasm: A New Health System for the 21st Century groups consisted of both committee members and other distinguished leaders within the health care arena. Each advisory group was chaired by a member(s) of the QHCA Committee. One of these four groups, the Technical Advisory Panel on the State of Quality, chaired by Mark Chassin, M.D., was asked to review and synthesize literature on the state of quality in the health care industry. Other members of this panel included: Arnold Epstein, M.D., M.A.; Brent James, M.D.; James P.Logerfo, M.D.; Harold Luft, Ph.D.; R.Heather Palmer, M.B., B.Ch.; Kenneth B.Wells, M.D. This appendix presents the panel’s findings. REVIEW OF THE LITERATURE In developing its approach to this effort, the State of Quality Panel reviewed an earlier synthesis of the literature on quality that was carried out by investigators at the RAND Corporation (Schuster et al., 1998). This earlier review covered papers that, for the most part, were published between 1993 and mid-1997. To extend that earlier work, the IOM commissioned an updated synthesis from the investigators at RAND. This update covered the literature included in the earlier review with the addition of (1) papers published between July 1997 and August 1998, and (2) selected publications identified by members of the State of Quality Panel. A draft of this commissioned paper was reviewed by the State of Quality Panel at its November 1998 meeting, and subsequently revised in accordance with the panel’s suggestions. The final version, provided at the end of this appendix, was completed in January 1999. DISCUSSION OF FINDINGS A synthesis of findings from the literature on the quality of health care provides abundant evidence of poor quality. There are examples of exemplary care, but the quality of care is not consistent. Thus, the average American cannot assume that he or she will receive the best care modern medicine has to offer. There are many examples of overuse, underuse, and misuse of health care services. Overuse refers to the provision of health services for which the potential risks outweigh the potential benefits. Underuse indicates that a health care service for which the potential benefits outweigh the potential risks was not provided. Misuse occurs when otherwise appropriate care is provided, but in a manner that does or could lead to avoidable complications. Overuse of health care services is common. Examples include the following: performance of major surgery (e.g., hysterectomy, coronary artery bypass graft) without appropriate reasons; provision of antibiotics for the common cold and other viral upper respiratory tract infections for which they are ineffective;

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Crossing the Quality Chasm: A New Health System for the 21st Century insertion of tubes in children’s eardrums in the absence of clinically appropriate indications; and performance of chiropractic spinal manipulation for certain back conditions for which there is no evidence of benefit. Lack of insurance is a major contributing factor to underuse. Even with comprehensive insurance coverage, however, much of the population fails to receive recommended preventive services, and many patients do not receive the full range of clinically indicated services for acute and chronic conditions. Examples include the following: Cardiac care In a study of 3,737 Medicare patients with a diagnosis of heart attack who were eligible for treatment with beta blockers, only 21 percent were found to have received beta blockers within 90 days of discharge. The adjusted mortality rate for patients with treatment was 43 percent below that of patients without treatment (Soumerai et al., 1997). Pneumococcal vaccine In 1989, the U.S. Preventive Services Task Force recommended that people 65 years and older receive a one-time vaccination for pneumonia, and in 1996, this recommendation was modified to apply to all immunocompetent people aged 65 and older. Yet studies of the proportion of elderly who had been vaccinated produced estimates in the range of only 28 to 36 percent (CDC, 1995; Kottke et al., 1997). Acute care for pneumonia Two studies of hospitalized patients with pneumonia found serious shortcomings in the proportion of patients receiving appropriate components of care (Kahn et al., 1990; Meehan et al., 1997). In recent years, increased attention has been focused on misuse. Studies of misuse are particularly challenging because actual or potential adverse events often go undocumented and unreported. But studies of preventable deaths and adverse drug events point to frequent and sometimes serious errors. For example, one study of over 4,000 hospitalized patients found that there were 19 preventable or potential adverse drug events per 1,000 patient days in intensive care units and 10 preventable or potential adverse drug events per 1,000 patient days in general care units (Cullen et al., 1997). LEVEL OF HARM CAUSED BY POOR QUALITY The existing literature does not allow a comprehensive estimate of the burden of harm due to poor quality. The literature on health care quality covers only a portion of the full range of quality concerns. For the most part, published studies focus on individuals who come into contact with the health care system. From a population perspective, the opportunity cost of poor quality must also

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Crossing the Quality Chasm: A New Health System for the 21st Century include the health benefits lost as a result of limited access due to financial or other barriers and poor patient adherence to therapeutic advice. These opportunity costs include years of life lost or spent with major or minor impairments, pain and suffering, disability costs, and lost productivity. The literature also does not reveal how frequently the various types of quality problems occur. For example, some kinds of overuse problems may have a greater likelihood of being documented than some types of misuse or underuse problems because the data necessary to document overuse are more likely to reside in administrative datasets or medical records. From the available literature, it is also not possible to produce estimates of the costs of eliminating certain types of quality problems or the benefits likely to be derived. But there is no doubt that major improvements are possible in many clinical areas and health care settings, across the full continuum of care. NEED FOR FURTHER WORK The panel’s work represents a modest effort to review the state of health care quality. Specifically, the literature review was commissioned for this study limited in the following ways: It focused only on publications in leading peer-reviewed journals. Other sources of information, such as the data and analyses of Medicare Peer Review Organizations (PROs) or analyses using malpractice data, were not included. The Medicare PRO program is a particularly promising source of information on quality because the PROs have been conducting quality review projects involving physicians, hospitals, and health plans for over 10 years. The review did not focus in depth on specific clinical areas. An intensive review by clinical area would provide a more complete picture of the full spectrum of quality problems and their frequency of occurrence. The review did not include the many publications based on reports of patient experience or satisfaction. The review did not include the body of studies reporting the impact of quality improvement activities. Thus it permits only anecdotal observations on the effectiveness of various of attempts to improve quality. Although the publications included in the review appeared in peer-reviewed journals, the panel made no attempt to assess the scientific rigor of the methodologies employed. Despite the above limitations, the panel believes that more in-depth reviews would not change its general conclusions that there are many areas in which quality of care can be improved. At the same time, additional research might be helpful for several reasons:

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Crossing the Quality Chasm: A New Health System for the 21st Century A fuller understanding of quality problems would be useful in identifying specific areas in which those problems are greatest, as well as the most promising opportunities for improvement. Condition-specific analyses would provide better estimates of the potential benefits foregone as a result of poor quality and the best strategies for improvement. Additional work focused in particular clinical areas might also be helpful in raising awareness of practitioners and others who are skeptical about the existence of quality problems in their areas of expertise. Condition-specific analyses of quality that employ rigorous and valid measures could help build stronger support for quality improvement initiatives. Additional reviews of the literature should be conducted to identify factors that contribute to poor quality and effective strategies for improvement. For example, review of the literature on quality substantiates that for certain complex procedures, higher volume leads to better outcomes. But we do not know whether this result is attributable to the greater skill of an experienced surgeon, the greater standardization of processes in high-volume settings, or some other factor. Abundant evidence exists that quality can be improved, and there is much to be learned from the review of various improvement strategies about the roles of patients, clinicians, and systems and the use of various types of incentives. Additional conceptual work, literature and data analysis, and development of measures are needed to improve capacities for quality-of-care assessment in certain key areas of medicine. An example is quality assessment in the areas of mental health, substance abuse, and neurologic disorders, and quality assessment for special populations, such as the frail elderly, poor children, and ethnic minorities. REFERENCES Centers for Disease Control and Prevention. 1995. Influenza and Pneurnococcal Vaccination Coverage Levels among Persons Aged>65 Years—United States, January-December 1995. Morbidity and Mortality Weekly Report 46:176–82. Cullen D.J., et al. 1997. Preventable Adverse Drug Events in Hospitalized Patients: a Comparative Study of Intensive Care and General Care Units. Critical Care Medicine 8:1289–97. Kahn, K.L., W.H.Rogers, L.V.Rubenstein, et al. 1990. Measuring Quality of Care with Explicit Process Criteria before and after Implementation of the DRG-Based Prospective Payment System. Journal of the American Medical Association 264:1969–73. Kottke, T.E., L.I.Solberg, ML. Brekke, et al. 1995, Aspirin in the Treatment of Acute Myocardial Infarction in Elderly Medicare Beneficiaries: Patterns of Use and Outcomes. Circulation 92:2841–7. Meehan, T.P., M.J.Fine, H.M.Krumholz, et al. 1997. Quality of Care, Process and Outcomes in Elderly Patients with Pneumonia. Journal of the American Medical Association 278:2080–4 Schuster, Mark A., Elizabeth A.McGlynn, and Robert H.Brook. 1998. “How Good Is the Quality of Health Care in the United States?” 1998. 76 (4) Milbank Quarterly 517–563. Soumerai, S.B., T.D.McLaughlin, E.Hertzmark, G.Thibault, and L.Goldman. 1997. Adverse Outcomes of Underuse of Beta-Blockers in Elderly Survivors of Acute Myocardial Infarction. Journal of the American Medical Association 277:115–21.

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Crossing the Quality Chasm: A New Health System for the 21st Century The Quality of Health Care in the United States: A Review of Articles Since 1987 Mark A.Schuster, M.D., Ph.D.;1 Elizabeth A.McGlynn, Ph.D.;2 Cung B.Pham, B.A.;3 Myles D.Spar, M.D.;4 and Robert H. Brook, M.D., Sc.D.5 Submitted January 1999 Quality of health care is on the national agenda. In September 1996, President Clinton established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, which has released its final report on how to define, measure, and promote quality of health care (Advisory Commission on Consumer Protection and Quality in the Health Care Industry, 1998). Much of the interest in quality of care has developed in response to the dramatic transformation of the health care system in recent years. New organizational structures and reimbursement strategies have created incentives that may affect quality of care. Although some of the systems are likely to improve quality, concerns about potentially negative consequences have prompted a movement to assure that quality will not be sacrificed to control costs. The concern about quality arises more from fear and anecdote than from facts; there is little systematic evidence about quality of care in the United States. The nation has no mandatory national system and few local systems to track the quality of care delivered to the American people. More information is available on the quality of airlines, restaurants, cars, and VCRs than on the quality of health care. In 1997, the National Coalition on Health Care (NCHC) commissioned us to review the academic literature for articles that provide evidence of the quality of care in the United States (Schuster et al., 1998). The Institute of Medicine’s     Authors’ affiliations: 1Health Sciences, RAND; Department of Pediatrics, UCLA 2Health Sciences, RAND 3Department of Pediatrics, UCLA 4HSR&D Field Program, Sepulveda Veterans Administration Medical Center; and 5Health Sciences, RAND; Department of Medicine, UCLA.

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Crossing the Quality Chasm: A New Health System for the 21st Century Technical Advisory Panel on the State of Quality commissioned an update to include studies published between January 1997 and July 1998. In this report, we summarize our findings from both the original study and the update. In the absence of a national quality tracking system, we believe such a summary is the best way to provide an overview of the quality of care delivered in the United States. We provide examples to illustrate quality in diverse settings, for diverse conditions, and for diverse demographic groups, and to offer insight into the quality that exists nationwide. DEFINING QUALITY 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” (Lohr, 1990). Good quality means providing patients with appropriate services in a technically competent manner, with good communication, shared decision making, and cultural sensitivity. Quality can be evaluated based on structure, process, and outcomes (Donabedian, 1980). Structural quality evaluates health system capacities, process quality assesses interactions between clinicians and patients, and outcomes offer evidence about changes in patients’ health status. The best process measures are those for which there is research evidence that better processes lead to better outcomes. For example, controlling blood pressure reduces mortality from stroke and heart disease; performing routine mammography identifies breast cancer at an earlier stage so that a cure is more likely; prescribing inhaled corticosteroids reduces the likelihood and severity of asthma flare-ups. Similarly, the best outcome measures are those which are tied to processes of care, in other words, those over which the health care system has influence. For example, the survival rate for pancreatic cancer would not be a good outcome measure because we do not yet have treatments that meaningfully affect survival. By contrast, pain level in patients with pancreatic cancer is a reasonable outcome measure. All three dimensions can provide valuable information for measuring quality, but most of the quality-of-care literature focuses on measuring processes of care. Two measurement approaches dominate in the literature: (a) assessing appropriateness of care and (b) adherence to professional standards. An intervention or service (e.g., a lab test, procedure, medication) is considered appropriate if, for individuals with particular clinical and personal characteristics, its expected health benefits (e.g., increased life expectancy, pain relief, decreased anxiety, improved functional capacity) exceed its expected health risks (e.g., mortality, morbidity, anxiety anticipating the intervention, pain caused by the intervention, inaccurate diagnoses) by a wide enough margin to make the intervention or service worth doing (Brook et al., 1986). A subset of appropriate

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Crossing the Quality Chasm: A New Health System for the 21st Century care is necessary or crucial care. Care is considered necessary if there is a reasonable chance of a nontrivial benefit to the patient and if it would be improper not to provide the care—in other words, if it might be considered ethically unacceptable not to provide this care (Kahan et al., 1994; Laouri et al., 1997). Another way to measure process quality is to determine whether care meets or adheres to professional standards. This assessment can be done by creating a list of quality indicators that describe a process of care that should occur for a particular type of patient or clinical circumstance and by evaluating whether patients’ care is consistent with the indicators. Quality indicators are based on standards of care, which are either found in the research literature and in statements of professional medical organizations or determined by an expert panel. Current performance can be compared against a physician’s or a plan’s own prior performance, against the performance of other physicians and plans, or with reference to a benchmark that establishes a goal. Indicators can cover a specific condition (e.g., children with sickle cell disease should be prescribed daily penicillin prophylaxis starting by no later than six months of age, until at least five years of age), or they can cover general aspects of care regardless of condition (e.g., patients prescribed a medication should be asked about medication allergies). HOW WE CONDUCTED OUR LITERATURE SEARCHES This report draws on two searches of the scientific literature. The original NCHC report was based on a search for quality-of-care articles from the MEDLINE PLUS database (1993 to present) conducted in June 1997 and on relevant studies identified from the bibliographies of these articles. This database incorporates both the National Library of Medicine (NLM)’s MEDLINE database and the Health Planning and Administration’s HEALTH database. The NCHC report excluded articles published before 1987. In conducting our literature search, we did not aim to be exhaustive, but rather to find examples that encompass a broad range of conditions and settings. (The inclusion criteria are described in the next section.) For this update, we conducted a systematic search of articles published between January 1, 1997, and July 31, 1998, using the NLM’s Medical Subject Headings (MeSH) to search for appropriate articles. This system is designed so that each MeSH term corresponds to a single concept appearing in the biomedical literature. Trained NLM indexers assign relevant MeSH terms to each database entry (usually about 10–12 per entry) (NLM, 1997a). The more than 17,000 MeSH terms are organized in a tree format, with multiple hierarchical layers of subheadings (NLM, 1997b)(Our search terms appear at the end of the report). We conducted our search on August 24, 1998, and obtained 2,402 entries. Two authors reviewed each entry and its abstract to determine whether the study had potential for inclusion in our summary tables. Based on this initial screening,

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Crossing the Quality Chasm: A New Health System for the 21st Century we retrieved more than 200 articles. Each was reviewed by two authors to determine whether the article was eligible for inclusion in this report. Some articles identified in the literature search were not available from the library by the completion date of the report. Because we did not find any studies of misuse in our update search, we conducted a supplemental search using key words such as “adverse,” “event#,” and “preventable” that produced additional relevant articles. In addition, several studies were recommended by members of the Institute of Medicine’s Technical Advisory Panel on the State of Quality. Criteria for Including Studies We include only data from large or diverse U.S. populations—for example, the nation, an entire state, an entire city, or several hospitals. Studies from multiple offices of a single managed care organization are also considered eligible, but we do not include data from studies that cover only a single hospital or clinic. Although such studies are informative and the cumulative weight of their findings compelling, they are especially subject to concerns that they provide evidence of isolated problems rather than insight into the quality of care delivered more broadly. We include baseline data from quality improvement interventions as well as data for comparison/control/nonintervention groups from such interventions. We report baseline rather than follow-up data because the former are more likely to be representative of the quality of care provided around the country. Quality measurement conducted after a specific intervention shows the potential for interventions to improve quality, but until such interventions are commonplace, these post-intervention results are unlikely to represent what is taking place in most parts of the country. In addition, even the post-intervention results from such studies virtually always show room for further improvement. We report results only from studies for which we can identify a standard of good quality and exclude those for which there is no standard. For example, some studies show variations in practices that may reflect variations in quality. However, the studies cannot determine which hospital or clinic or group of physicians is providing better or worse quality care. Types of Studies Not Included There are several ways to measure quality of care that are not represented among the studies listed in our summary tables. Although these approaches are valuable components of the quality-of-care toolbox, they have not been used in a way that provides an overview of quality in the United States. Studies often compare outcomes across multiple institutions to show which have better and which have worse outcomes, but the studies do not always present

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Crossing the Quality Chasm: A New Health System for the 21st Century a standard against which to compare outcomes. As a consequence, we do not know if the institution with the best outcomes is not nearly as good as it should be, or if the institution with the worst outcomes is nonetheless doing quite well. We only know how they compare with each other. If the outcomes are not risk-adjusted, it can be even more difficult to interpret them. This does not mean that studies cannot use outcomes to shed light on variations in quality. For example, prescription of beta blockers after a heart attack is a frequently used measure of quality. One study found that only about one in five eligible patients with a heart attack received beta blockers within 90 days of hospital discharge and also that those who received the treatment were much less likely to die than those who did not (Soumerai et al., 1997). Another study showed that poorer quality of care for children with asthma was associated with more hospitalizations (Homer et al., 1996). We found a similar limitation with using satisfaction ratings, which some consider a type of outcome. We do not report on levels of satisfaction because it is difficult to determine what is an acceptable level of satisfaction. There is generally no standard to which to compare the results, and we do not know whether the institution with the best satisfaction ratings could and should be doing much better. Studies of access to care are not typically classified as quality-of-care studies, but a person who is unable to obtain health care could hardly be said to be receiving good quality care. Access studies are beyond the scope of this report. However, we need to keep in mind that quality-of-care studies often measure quality only for people who have interacted with the health care system and so tend to overstate quality of care received by the population as a whole (Franks et al., 1993a, 1993b; Lurie et al., 1984, 1986; Sorlie et al., 1994). In general, structural measures have not been consistently shown to relate either to process quality or outcomes, but there are exceptions. For example, volume of care provided (in other words, the number of procedures performed or the number of patients cared for) by an institution or clinician has often been found to relate to quality (Hannan et al., 1989, 1995; Kelly and Hellinger, 1986; Kitahata et al., 1996; Luft et al., 1979; Phibbs et al., 1996; Riley and Lubitz, 1985; Stone et al., 1992). Another type of study does not provide direct evidence of quality of health care but is useful for identifying reasons for poor quality. Studies in which physicians report what they generally do or what they would do for a particular scenario can be informative, especially when physicians report practices that indicate poor quality. Although these studies do not describe care provided to individual patients, they can indicate a need for further education or other efforts to improve clinical practices. Finally, we note that our search mechanism almost certainly missed articles with relevant data. Many studies not intended as quality-of-care studies provide

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Crossing the Quality Chasm: A New Health System for the 21st Century Health Care Servicea Sample Description Data Source Quality of Care Referenceb Cardiovascular Disease Coronary Artery Disease: Coronary Angiography Coronary angiography is a method for evaluating coronary artery anatomy to determine whether a patient is a candidate for coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty. Random sample of 1,335 patients who had coronary angiography. Medical records from 15 nonfederal hospitals providing coronary angiography in New York State, selected through a stratified random sample (for location, volume of coronary angiography, and authorization to perform coronary artery bypass graft surgery), 1990. 4% of coronary angiographies were inappropriate, 20% were equivocal, and 76% were appropriate. Bernstein et al., 1993a Same as above. Random sample of 1,677 cases of coronary angiography. Medicare physician claims from three sites selected from 13 sites in eight states (Arizona, California, Colorado, Iowa, Massachusetts, Montana, Pennsylvania, South Carolina), 1981. 17% of coronary inappropriate, 9% were equivocal, and 74% were appropriate. Chassin et al., 1987

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Crossing the Quality Chasm: A New Health System for the 21st Century Coronary Artery Disease: Coronary Artery Bypass Graft (CABG) In CABG surgery, damaged blood vessels supplying the heart are replaced with vessels from elsewhere in the body. Stratified random sample of 386 patients who underwent CABG surgery in the three hospitals. Medical records from three hospitals (excluding Veterans Administration, other governmental, and specialty hospitals) selected through a stratified random sample (for size and teaching status) in a western state as part of the National Institutes of Health Consensus Development Program, 1979, 1980, and 1982 14% of CABG surgeries were inappropriate, 30% were equivocal, and 56% were appropriate. Winslow et al., 1988 Same as above. Random sample of 1,156 patients who had isolated CABG surgery. Medical records for patients from 12 Academic Medical Center Consortium hospitals in 10 states (California, Iowa, Louisiana, Maryland, Massachusetts, Minnesota, New Hampshire, New York, North Carolina, Pennsylvania), 1990. 1.6% of CABG surgeries were inappropriate, 7% were equivocal, and 92% were appropriate. Leape et al., 1996 Same as above. Random sample of 1,338 patients who had isolated CABG surgery. Medical records from 15 nonfederal hospitals providing CABG procedure in New York State, selected through a stratified random sample (for location and volume of CABG operations), 1990. 2.4% of CABG surgeries were inappropriate, 7% were equivocal, and 91% were appropriate. Leape et al., 1993

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Crossing the Quality Chasm: A New Health System for the 21st Century Health Care Servicea Sample Description Data Source Quality of Care Referenceb Coronary Artery Disease: Percutaneous Transluminal Coronary Angioplasty (PTCA) PTCA uses a miniature balloon catheter to decrease stenosis (blockage) in blood vessels supplying the heart. Random sample of 1,306 patients who had PTCA. Medical records from 15 nonfederal hospitals providing PTCA in New York State, selected through a stratified random sample (for location and volume of PTCA), 1990. 4% of PTCAs were inappropriate, 38% were equivocal, and 58% were appropriate. Hilborne et al., 1993 Myocardial Infarction (MI): Permanent Cardiac Pacemaker Pacemakers help regularize abnormal heart rates and rhythms. Medicare patients who underwent a total of 382 pacemaker implantations. Medical records from six university teaching hospitals, 11 university-affiliated hospitals, and 13 community hospitals in Philadelphia County, January 1, to June 30, 1983. 20% of pacemaker implantations were inappropriate, 36% were equivocal, and 44% were appropriate. Greenspan et al., 1988 MI: Treatment with Lidocaine Lidocaine prophylaxis used to prevent ventricular fibrillation in patients treated for probable MI has been shown to increase mortality. Subset of 2,938 patients with admitting diagnosis of MI. Medical records from sixteen Minnesota hospitals for patients admitted August 1, 1995, to April 30, 1996. The median percentage of patients ineligible for lidocaine who received it in the first 48 hours of hospitalization was 12%. Soumerai et al., 1998

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Crossing the Quality Chasm: A New Health System for the 21st Century MI: Avoidance of Calcium Channel Blockers for Patients with a Contraindication Calcium channel blockers should not be given to patients with certain conditions (e.g., low left ventricular ejection fraction, evidence of shock, or pulmonary edema during hospitalization). 785 patients with clear contraindication to calcium channel blockers from a sample of 16,124 Medicare patients hospitalized with a principal diagnosis of heart attack. Medical records for Medicare beneficiaries who were hospitalized in four states (Alabama, Connecticut, Iowa, Wisconsin), as part of the Cooperative Cardiovascular Project Pilot, June 1, 1992, to February 28, 1993. 21% of those for whom calcium channel blockers were contraindicated received them. Ellerbeck et al., 1995 Same as above. 220 patients with a contraindication for calcium channel blockers (i.e., a left ventricular ejection fraction < 40%) from a sample of 4,300 patients with MI. Medical records from acute care hospitals in Maryland and the District of Columbia in Medicare’s National Claims History File sampled during January 1994, to July 1995. 18% of those for whom calcium blockers were contraindicated received them. Berger et al., 1998 Unstable Angina: Avoidance of Calcium Channel Blockers for Patients with a Contraindication Same as above. 218 patients with contraindications for calcium channel blocking drugs, from a sample of 882 patients ≥ 65 years old with unstable angina. Medical records of Medicare beneficiaries discharged from 16 hospitals in North Carolina between October 1, 1993, and September 30, 1994. 62% of those for whom calcium blockers were contraindicated received them. Simpson et al., 1997

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Crossing the Quality Chasm: A New Health System for the 21st Century Health Care Servicea Sample Description Data Source Quality of Care Referenceb Carotid Arteries Carotid Endarterectomy Carotid endarterectomy is a procedure that opens up stenotic (blocked) carotid arteries (which supply blood to the brain). Random sample of 1,302 cases of carotid endarterectomy. Medicare physician claims data and medical records from three sites selected from thirteen sites in eight states (Arizona, California, Colorado, Iowa, Massachusetts, Montana, Pennsylvania, South Carolina), 1981. 32% of carotid endarterectomies were inappropriate, 32% were equivocal, and 35% were appropriate. Chassin et al., 1987 Gastrointestinal Disease Upper Gastrointestinal Tract Endoscopy Endoscopy enables visualization of the gastrointestinal tract, and permits biopsy and brush cytologic examination. Random sample of 1,585 cases of upper gastrointestinal tract endoscopy. Same as above. 17% of upper gastrointestinal tract endoscopies were inappropriate, 11% were equivocal, and 72% were appropriate. Chassin et al., 1987 Cataracts Cataract Surgery Cataract surgery is a commonly performed surgery in adults ≥ 65 years old. Cataract surgery should not be performed on people with certain conditions (e.g., macular degeneration or diabetic retinopathy). 1,020 patients who underwent a total of 1,139 cataract surgeries. Medical records for patients from 10 academic medical centers, 1990. 2% of cataract surgeries were inappropriate, 7% were equivocal, and 91% were appropriate. Tobacman et al. 1996

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Crossing the Quality Chasm: A New Health System for the 21st Century Low Back Pain Chiropractic Spinal Manipulation AHCPR has concluded that spinal manipulation hastens recovery from acute low back pain not caused by such conditions as fracture, tumor, infection, and cauda equina syndrome (AHCPR, 1994). A random sample of 10 patients per office (920 patients) who sought chiropractic care for low back pain for the first time during the study period. Medical records of patients from 92 chiropractic offices in or near Miami, Florida; Minneapolis-St. Paul, Minnesota; Portland, Oregon; and San Diego, California; who sought care for the first time between January 1, 1985, and December 31, 1991. Initiation of spinal manipulation was inappropriate in 20%–40% of cases, uncertain in 20%– 30% of cases, and appropriate in 40%–54% of cases (depending on city). Shekelle et al., 1998 aIf a description in the first column has no citation, it is covered by the citation in the reference column. bWe contacted the authors of some of the articles to clarify details related to the sample and to the data analysis.

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Crossing the Quality Chasm: A New Health System for the 21st Century TABLE A-3 Examples of Quality of Health Care in the United States Misuse: Did Patients Receive Appropriate Care in a Manner That Could Have Caused Harm? Health Care Servicea Sample Description Data Source Quality of Care Referenceb Preventable Deaths Evaluation of preventable deaths A death is considered preventable when the patient received poor care, and the poor care probably resulted in the patient’s death. 182 patients who died in hospitals from stroke, pneumonia, or heart attack. Medical records for patients from 12 hospitals, 1985. 14% of deaths resulted from inadequate diagnosis or treatment and could have been prevented. Dubois and Brook, 1988 Adverse Events Adverse Events An adverse event is an injury that is caused by medical management rather than the underlying disease and that prolongs hospitalization, produces a disability at   discharge, or both. 30,121 medical records from a weighted sample of 31,429 records of hospitalized patients from a population of 2,671,863 nonpsychiatric discharged patients. 51 randomly selected acute care, nonpsychiatric hospitals in New York State, 1984. There were 1,133 adverse events and 280 negligent events during 1984 admissions, representing a 3.7% statewide incidence rate of adverse events, and a 1.0% statewide incidence rate of adverse events due to negligence. Brennan et al., 1991

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Crossing the Quality Chasm: A New Health System for the 21st Century Same as above. 30,121 medical records from a weighted sample of 31,429 records of hospitalized patients from a population of 2,671,863 nonpsychiatric discharged patients. 51 randomly selected acute care, nonpsychiatric hospitals in New York State, 1984. 17% of adverse events resulting from operations and 37% of other adverse events were due to negligence; 47% of physician errors leading to adverse events were due to negligence. Leape et al., 1991 Adverse Drug Events Same as above. 4,031 adult nonobstetric admissions to a stratified random sample of 11 medical and surgical units in two hospitals. Medical records and reports of hospital staff for 2 tertiary care hospitals in Boston, February to July 1993. There were 1.8 preventable adverse drugs events (ADEs) per 100 admissions (adjusted rate), of which 20% were life threatening, 43% were serious, and 37% were significant. There were an additional 5.5 potential ADEs per 100 admissions (adjusted rate). Bates et al., 1995 Same as above. 4,031 patients admitted to 5 intensive care units (3 medical, 2 surgical) and 6 general care units (4 medical, 2 surgical) selected from a stratified random sample of units in 2 tertiary care hospitals in Boston. Case-investigation reports (including staff interviews, medical record review, etc.) for patients admitted between February and July 1993. There were 19 preventable or potential ADEs per 1000 patient days in the ICUs. There were 10 preventable or potential ADEs per 1000 patient days in general care units. Rates adjusted for number of medications per patient showed no significant differences for the two settings. Cullen et al., 1997

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Crossing the Quality Chasm: A New Health System for the 21st Century Health Care Servicea Sample Description Data Source Quality of Care Referenceb Mental Health Depression: Treatment Includes treatment consistent with prevailing standards of care. 1,198 patients hospitalized with depression, representative of all Medicare elderly patients hospitalized in general medical hospitals with a discharge diagnosis of depression. Medical records for Medicare patients from 297 hospitals in five states (California, Florida, Indiana, Pennsylvania, Texas), July 1, 1985, to June 30, 1986. 33% of patients discharged with antidepressants had doses below recommended level. Wells et al., 1994b Includes treatment consistent with prevailing standards of care. 64 patients with major depression from a sample of 2,592 consecutive primary care patients 18–65 years old who attended one of the study clinics. Patient surveys and interviews, physician surveys, and computerized pharmacy records from 3 primary care clinics of Group Health Cooperative of Puget Sound in Washington. Among patients with major depression who received antidepressant medications, 78% received dosages within the recommended ranges. Simon and VonKorff, 1995

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Crossing the Quality Chasm: A New Health System for the 21st Century Tuberculosis Tuberculosis: Treatment People infected with tuberculosis (TB) in areas with≥4% isoniazid resistance should be treated with a four-drug regimen. 1,230 culture-positive TB patients, 98% of whom were in counties for which a four-drug regimen is recommended. Data from the Tuberculosis Control Program, New Jersey Department of Health and Senior Services, 1994 to 1995. 36% of patients were not initially treated with four or more drugs. Liu et al., 1998 aIf a description in the first column has no citation, it is covered by the citation in the reference column. bWe contacted the authors of some of the articles to clarify details related to the sample and to the data analysis.

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Crossing the Quality Chasm: A New Health System for the 21st Century APPENDIX: Search Strategy for January 1997-July 1998 MEDLINE PLUS Search Search Type Medical Subject Heading (MeSH) Search Term Tree Numbera Boolean Operator Subject Quality of health care N4.761 or Subject Guideline adherence N4.761.337 or Explode exact subjectb Outcome and process assessment, health care N4.761.761.559   Subject Professional review organization N4.761.673 or Subject Quality indicators, health care N4.761.789 and Language English   and Date 1997, 1998     NOTE: As Boolean operators, “or” means that articles with one search term and/or another search term are included, and “and” means that articles must have both search terms (or strings of search terms) to be included. For this search, articles with any of the Medical Subject Headings (MeSH) were included, and only articles in English and from 1997 or 1998 were included. aTree Number is a National Library of Medicine alphanumerical code for indexing MeSH terms. bThe “Explode” search function includes the MeSH category as well as all the subcategorical branches connected to it. It is equivalent to typing out the MeSH term and each of its subcategorical branches separately. The subcategories included when exploding “Outcome and Process Assessment, Health Care” are: Outcome Assessment, Treatment Outcome, Medical Futility, Treatment Failure, and Process Assessment.