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Wiley W. Souba, M.D., SC.D., F.A.C.S. 1 PROFESSIONALISM IN SURGERY Over the past decade, the American health care system has had to cope with and manage an unprecedented amount of change. As a consequence, the medical profession has been challenged along the entire range of its cultural values and its traditional roles and responsibilities. It would be difficult, if not impossible, to find another social issue directly affecting all Americans that has under- gone as rapid and remarkable a transformation—and oddly, a transformation in which the most important protagonists (i.e., the patients and the doctors) remain dissatisfied.1 Nowhere is this metamorphosis more evident than in the field of surgery. Marked reductions in reimbursement, explosions in surgical device biotechnology, a national medical malpractice cri- sis, and the disturbing emphasis on commercialized medicine have forever changed the surgical landscape, or so it seems. The very foundation of patient care—the doctor-patient relationship—is in jeopardy. Surgeons find it increasingly difficult to meet their responsibilities to patients and to society as a whole. In these cir- cumstances, it is critical for us to reaffirm our commitment to the fundamental and universal principles and values of medical professionalism. The concept of medicine as a profession grounded in com- passion and sympathy for the sick has come under serious chal- lenge.2 One eroding force has been the growth and sovereignty of biomedical research. Given the high position of science and technology in our societal hierarchy, we may be headed for a form of medicine that includes little caring but becomes exclu- sively focused on the mechanics of treatment, so that we deal with sick patients much as we would a flat tire or a leaky faucet. In such a form of medicine, healing becomes little more than a technical exercise, and any talk of morality that is unsubstantiat- ed by hard facts is considered mere opinion and therefore car- ries little weight. The rise of entrepreneurialism and the growing corporatization of medicine also challenge the traditions of virtue-based medical care. When these processes are allowed to dominate medicine, health care becomes a commodity. As Pellegrino and Thomasma remark, “When economics and entrepreneurism drive the profes- sions, they admit only self-interest and the working of the market- place as the motives for professional activity. In a free-market economy, effacement of self-interest, or any conduct shaped pri- marily by the idea of altruism or virtue, is simply inconsistent with survival.”2 These changes have caused a great deal of anxiety and fear among both patients and surgeons nationwide. The risk to the profession is that it will lose its sovereignty, becoming a passive rather than an active participant in shaping and formulating health policy in the future.The risks to the public are that issues of cost will take precedence over issues of quality and access to care and that health care will be treated as a commodity—that is, as a priv- ilege rather than a right. The Meaning of Professionalism A profession is a collegial discipline that regulates itself by means of mandatory, systematic training. It has a base in a body of technical and specialized knowledge that it both teaches and advances; it sets and enforces its own standards; and it has a ser- vice orientation, rather than a profit orientation, enshrined in a code of ethics.3-5To put it more succinctly, a profession has cogni- tive, collegial, and moral attributes. These qualities are well expressed in the familiar sentence from the Hippocratic oath: “I will practice my art with purity and holiness and for the benefit of the sick.” The escalating commercialization and secularization of medicine have evoked in many physicians a passionate desire to reconnect with the core values, practices, and behaviors that they see as exem- plifying the very best of what medicine is about. This tension between commercialism on the one hand and humanism and altruism on the other is a central part of the professionalism chal- lenge we face today.6 As the journalist Loretta McLaughlin once wrote, “The rush to transform patients into units on an assembly line demeans medicine as a caring as well as curative field, demeans the respect due every patient and ultimately demeans illness itself as a significant human condition.”7 Historically, the legitimacy of medical authority is based on three distinct claims2,8: first, that the knowledge and competence of the professional have been validated by a community of peers; second, that this knowledge has a scientific basis; and third, that the professional’s judgment and advice are oriented toward a set of values.These aspects of legitimacy correspond to the collegial, cognitive, and moral attributes that define a profession. Competence and expertise are certainly the basis of patient care, but other characteristics of a profession are equally important [see Table 1]. Being a professional implies a commitment to excel- lence and integrity in all undertakings. It places the responsibility to serve (care for) others above self-interest and reward. Accord- ingly, we, as practicing medical professionals, must act as role models by exemplifying this commitment and responsibility, so that medical students and residents are exposed to and learn the kinds of behaviors that constitute professionalism [see Sidebar Elizabeth Blackwell: A Model of Professionalism]. The medical profession is not infrequently referred to as a voca- tion. For most people, this word merely refers to what one does for a living; indeed, its common definition implies income-generating activity. Literally, however, the word vocation means “calling,” and the application of this definition to the medical profession yields a Table 1—Elements of a Profession A profession • Is a learned discipline with high standards of knowledge and performance • Regulates itself via a social contract with society • Places responsibility for serving others above self-interest and reward • Is characterized by a commitment to excellence in all undertakings • Is practiced with unwavering personal integrity and compassion • Requires role-modeling of right behavior • Is more than a job—it is a calling and a privilege © 2005 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 1 Professionalism in Surgery — 1 © 2005 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 1 Professionalism in Surgery — 2 more profound meaning. According to Webster’s Third New International Dictionary,9 a profession may be defined as a calling requiring specialized knowledge and often long acade- mic preparation, including instruction in skills and methods as well as in the scientific, historical, or scholarly principles under- lying such skills and methods, maintaining by force of organiza- tion or concerted opinion high standards of achievement and conduct, and committing its members to continued study and to a kind of work which has for its prime purpose the rendering of a public service[.] Most of us went to medical school because we wanted to help and care for people who are ill. This genuine desire to care is unam- biguously apparent in the vast majority of personal statements that medical students prepare as part of their application process. To quote William Osler, “You are in this profession as a calling, not as a business; as a calling which extracts from you at every turn self-sacrifice, devotion, love and tenderness to your fellow man.We must work in the missionary spirit with a breath of char- ity that raises you far above the petty jealousies of life.”10 To keep medicine a calling, we must explicitly incorporate into the mean- ing of professionalism those nontechnical practices, habits, and attributes that the compassionate, caring, and competent physi- cian exemplifies. We must remind ourselves that a true profes- sional places service to the patient above self-interest and above reward. Professionalism is the basis of our contract with society. To maintain our professionalism, and thus to preserve the contract with society, it is essential to reestablish the doctor-patient rela- tionship as the foundation of patient care. The Surgeon-Patient Relationship The underpinning of medicine as a compassionate, caring pro- fession is the doctor-patient relationship, a relationship that has become jeopardized and sometimes fractured over the past decade. Our individual perceptions of what this relationship is and how it should work will inevitably have a great impact on how we approach the care of our patients.2 The fundamental question to be answered is, what should the surgeon-patient relationship be governed by? If this relationship is viewed solely as a contract for services rendered, it is subject to the law and the courts; if it is viewed simply as an issue of applied biol- ogy, it is governed by science; and if it is viewed exclusively as a commercially driven business transaction, it is regulated by the marketplace. If, however, our relationship with our patients is understood as going beyond basic delivery of care and as consti- tuting a covenant in which we act in the patient’s best interest even if that means providing free care, it is based on the virtue of char- ity. Such a perspective transcends questions of contracts, politics, economics, physiology, and molecular genetics—all of which rightly influence treatment strategies but none of which is any substitute for authentic caring. The view of the physician-patient relationship as a covenant does not demand devotion to medicine at the exclusion of other responsibilities, and it is not inconsistent with the fact that medi- cine is also a science, an art, and a business.2 Nevertheless, in our struggle to remain viable in a health care environment that has become a commercial enterprise, efforts to preserve market share cannot take precedence over the provision of care that is ground- ed in charity and compassion. It is exactly for this reason that med- icine always will be, and should be, a relationship between people. To fracture that relationship by exchanging a covenant based on charity and compassion for a contract based solely on the delivery of goods and services is something none of us would want for our- selves.The nature of the healing relationship is itself the founda- tion of the special obligations of physicians as physicians.2 Translation of Theory into Practice The American College of Surgeons (ACS) Task Force on Pro- fessionalism has developed a Code of Professional Conduct,11 which emphasizes the following four aspects of professionalism: 1. A competent surgeon is more than a competent technician. 2. Whereas ethical practice and professionalism are closely relat- ed, professionalism also incorporates surgeons’ relationships with patients and society. 3. Unprofessional behavior must have consequences. Elizabeth Blackwell: A Model of Professionalism17 Elizabeth Blackwell was born in England in 1821, the daughter of a sug- ar refiner. When she was 10 years old, her family emigrated to New York City. Discovering in herself a strong desire to practice medicine and care for the underserved, she took up residence in a physician’s household, using her time there to study using books in the family’s medical library. As a young woman, Blackwell applied to several prominent medical schools but was snubbed by all of them. After 29 rejections, she sent her second round of applications to smaller colleges, including Geneva Col- lege in New York. She was accepted at Geneva—according to an anec- dote, because the faculty put the matter to a student vote, and the stu- dents thought her application a hoax. She braved the prejudice of some of the professors and students to complete her training, eventually rank- ing first in her class. On January 23, 1849, at the age of 27, Elizabeth Blackwell became the first woman to earn a medical degree in the United States. Her goal was to become a surgeon. After several months in Pennsylvania, during which time she became a naturalized citizen of the United States, Blackwell traveled to Paris, where she hoped to study with one of the leading French surgeons. De- nied access to Parisian hospitals because of her gender, she enrolled in- stead at La Maternité, a highly regarded midwifery school, in the summer of 1849. While attending to a child some 4 months after enrolling, Black- well inadvertently spattered some pus from the child’s eyes into her own left eye. The child was infected with gonorrhea, and Blackwell contracted a severe case of ophthalmia neonatorum, which later necessitated the removal of the infected eye. Although the loss of an eye made it impossi- ble for her to become a surgeon, it did not dampen her passion for be- coming a practicing physician. By mid-1851, when Blackwell returned to the United States, she was well prepared for private practice. However, no male doctor would even consider the idea of a female associate, no matter how well trained. Barred from practice in most hospitals, Blackwell founded her own infir- mary, the New York Infirmary for Indigent Women and Children, in 1857. When the American Civil War began, Blackwell trained nurses, and in 1868 she founded a women’s medical college at the Infirmary so that women could be formally trained as physicians. In 1869, she returned to England and, with Florence Nightingale, opened the Women’s Medical College. Blackwell taught at the newly created London School of Medi- cine for Women and became the first female physician in the United Kingdom Medical Register. She set up a private practice in her own home, where she saw women and children, many of whom were of less- er means and were unable to pay. In addition, Blackwell mentored other women who subsequently pursued careers in medicine. She retired at the age of 86. In short, Elizabeth Blackwell embodied professionalism in her work. In 1889 she wrote, “There is no career nobler than that of the physician. The progress and welfare of society is more intimately bound up with the prevailing tone and influence of the medical profession than with the sta- tus of any other class.” © 2005 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 1 Professionalism in Surgery — 3 4. Professional organizations are responsible for fostering profes- sionalism in their membership. If professionalism is indeed embodied in the principles dis- cussed [see Table 1], the next question that arises is, how do we translate theory into practice? That is,what do these principles look like in action? To begin with, a competent surgeon must possess the medical knowledge, judgment, technical ability, professional- ism, clinical excellence, and communication skills required for pro- vision of high-quality patient-centered care. Furthermore, this expertise must be demonstrated to the satisfaction of the profes- sion as a whole.The Accreditation Council on Graduate Medical Education (ACGME) has identified six competencies that must be demonstrated by the surgeon: (1) patient care, (2) medical knowl- edge, (3) practice-based learning and improvement, (4) interper- sonal and communication skills, (5) professionalism, and (6) sys- tems-based practice.These competencies are now being integrat- ed into the training programs of all accredited surgical residencies. A surgical professional must also be willing and able to take responsibility. Such responsibility includes, but is not necessarily limited to, the following three areas: (1) provision of the highest- quality care, (2) maintenance of the dignity of patients and co- workers, and (3) open, honest communication. Assumption of responsibility as a professional involves leading by example, placing the delivery of quality care above the patient’s ability to pay, and displaying compassion. Cassell reminds us that a sick person is not just “a well person with a knapsack of illness strapped to his back”12 and that whereas “it is possible to know the suffering of others, to help them, and to relieve their distress, [it is not possible] to become one with them in their torment.”13 Illness and suffering are not just biologic problems to be solved by biomedical research and technology: they are also enigmas that can serve to point out the limitations, vulnerabilities, and frailties that we want so much to deny, as well as to reaffirm our links with one another. Most important, professionalism demands unwavering person- al integrity. Regrettably, examples of unprofessional behavior exist. An excerpt from a note from a third-year medical student to the core clerkship director reads as follows: “I have seen attendings make sexist, racist jokes or remarks during surgery. I have met res- idents who joke about deaf patients and female patients with facial hair. [I have encountered] teams joking and counting down the days until patients die.” This kind of exposure to unprofessional conduct and language can influence young people negatively, and it must change. It is encouraging to note that many instances of unprofessional conduct that once were routinely overlooked—such as mistreating medical students, speaking disrespectfully to coworkers, and fraud- ulent behavior—now are being dealt with. Still, from time to time an incident is made public that makes us all feel shame. In March 2003, the Seattle Times carried a story about the chief of neuro- surgery at the University of Washington, who pleaded guilty to a felony charge of obstructing the government’s investigation and admitted that he asked others to lie for him and created an atmos- phere of fear in the neurosurgery department. According to the United States Attorney in Seattle, University of Washington employees destroyed reports revealing that University doctors sub- mitted inflated billings to Medicare and Medicaid.The department chair lost his job, was barred from participation in Medicare, and, as part of his plea bargain, had to pay a $500,000 fine, perform 1,000 hours of community service, and write an article in a med- ical journal about billing errors. The University spent many mil- lions in legal fees and eventually settled the billing issues with the Federal government for one of the highest Physicians at Teaching Hospitals (PATH) settlements ever. Fortunately, such extreme cases of unprofessionalism are quite uncommon. Nevertheless, it remains our responsibility as profes- sionals to prevent such behaviors from developing and from being reinforced. To this end, we must lead by example. A study pub- lished in 2004 demonstrated an association between displays of unprofessional behavior in medical school and subsequent discipli- nary action by a state medical board.14The authors concluded that professionalism is an essential competency that students must demonstrate to graduate from medical school.Who could disagree? The Future of Surgical Professionalism It is often subtly implied—or even candidly stated—that no matter how well we adjust to the changing health care environ- ment, the practice of surgery will never again be quite as reward- ing as it once was. This need not be the case. The ongoing advances in surgical technology, the increasing opportunities for community-based surgeons to enroll their patients into clinical tri- als, and the growing emphasis on lifelong learning as part of main- tenance of certification are factors that not only help satisfy social and organizational demands for quality care but also are in the best interest of our patients. In the near future, maintenance of certification for surgeons will involve much more than taking an examination every decade.The ACS is taking the lead in helping to develop new measures of com- petence.Whatever specific form such measures may take, display- ing professionalism and living up to a set of uncompromisable core values15 will always be central indicators of the performance of the individual surgeon and the integrity of the discipline of surgery as a whole. Although surgeons vary enormously with respect to personali- ty, practice preferences, areas of specialization, and style of relating to others, they all have one role in common: that of healer. Indeed, it is the highest of privileges to be able to care for the sick. As the playwright Howard Sackler once wrote, “To intervene, even briefly, between our fellow creatures and their suffering or death, is our most authentic answer to the question of our humanity.” Inseparable from this privilege is a set of responsibilities that are not to be taken lightly: a pledge to offer our patients the best care possible and a commitment to teach and advance the science and practice of medicine. Commitment to the practice of patient-cen- tered, high-quality, cost-effective care is what gives our work meaning and provides us with a sense of purpose.16We as surgeons must participate actively in the current evolution of integrated health care; by doing so, we help build our own future. © 2005 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 1 Professionalism in Surgery — 4 1. Fein R:The HMO revolution. Dissent, spring 1998, p 29 2. Pellegrino ED,Thomasma DC: Helping and Heal- ing. Georgetown University Press,Washington, DC, 1997 3. Brandeis LD: Familiar medical quotations. Business—A Profession. Maurice Strauss, Ed. Little Brown & Co, Boston, 1986 4. Cogan ML: Toward a definition of profession. Harvard Educational Reviews 23:33, 1953 5. Greenwood E: Attributes of a profession. Social Work 22:44, 1957 6. Souba W, Day D: Leadership values in academic medicine. Acad Med (in press) 7. McLaughlin L:The surgical express. Boston Globe, April 24, 1995 8. Starr PD: The social transformation of American medicine. Basic Books, New York, 1982 9. Webster’s Third New International Dictionary of the English Language, Unabridged. Gove PB, Ed. Merriam-Webster Inc, Springfield, Massachusetts, 1986, p 1811 10. Osler’s “Way of Life” and Other Addresses, with Commentary and Annotations. Hinohara S, Niki H, Eds. Duke University Press, Durham, North Carolina, 2001 11. Gruen RI, Arya J, Cosgrove EM, et al: Profession- alism in surgery. J Am Coll Surg 197:605, 2003 12. Cassell EJ: The function of medicine. Hastings Center Report 7:16, 1977 13. Cassell EJ: Recognizing suffering. Hastings Center Report 21:24, 1991 14. Papadakis M, Hodgson C, Teherani A, et al: Un- professional behavior in medical school is associat- ed with subsequent disciplinary action by a state medical board. Acad Med 79:244, 2004 15. Souba W: Academic medicine’s core values: what do they mean? J Surg Res 115:171, 2003 16. Souba W: Academic medicine and our search for meaning and purpose. Acad Med 77:139, 2002 17. Speigel R: Elizabeth Blackwell: the first woman doctor. Snapshots In Science and Medicine, http://science-education.nih.gov/snapshots. nsf/story?openform&pds~Elizabeth_Blackwell_ Doctor References © 2005 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 1 Professionalism in Surgery — 5 John D. Birkmeyer, M.D., F.A.C.S. 2 PERFORMANCE MEASURES IN SURGICAL PRACTICE With the growing recognition that the quality of surgical care varies widely, there is a rising demand for good measures of surgi- cal performance. Patients and their families need to be able to make better-informed decisions about where to get their surgical care—and from whom.1 Employers and payers need data on which to base their contracting decisions and pay-for-performance initiatives.2 Finally, clinical leaders need tools that can help them identify “best practices”and guide their quality-improvement efforts. To meet these different needs, an ever-broadening array of perfor- mance measures is being developed. The consensus about the general desirability of surgical perfor- mance measurement notwithstanding, there remains considerable uncertainty about which specific measures are most effective in measuring surgical quality. The measures currently in use are remarkably heterogeneous, encompassing a range of different ele- ments. In broad terms, they can be grouped into three main cate- gories: measures of health care structure, process-of-care measures, and measures reflecting patient outcomes. Although each of these three types of performance measure has its unique strengths, each is also associated with conceptual, methodological, or practical problems [see Table 1]. Obviously, the baseline risk and frequency of the procedure are important considerations in weighing the strengths and weaknesses of different measures.3 So too is the un- derlying purpose of performance measurement; for example, mea- sures that work well when the primary intent is to steer patients to the best hospitals or surgeons (selective referral) may not be opti- mal for quality-improvement purposes. Several reviews of performance measurement have been pub- lished in the past few years.3-5 In what follows, I expand on these reviews, providing an overview of the measures commonly used to assess surgical quality, considering their main strengths and limi- tations, and offering recommendations for selecting the optimal quality measure. Overview of Current Performance Measures The number of performance measures that have been devel- oped for the assessment of surgical quality is already large and continues to grow. For present purposes, it should be sufficient to consider a representative list of commonly used quality indicators that have been endorsed by leading quality-measurement organi- zations or have already been applied in hospital accreditation, pay- for-performance, or public reporting efforts [see Table 2]. A more exhaustive list of performance measures is available on the National Quality Measures Clearinghouse (NQMC) Web site, sponsored by the Agency for Healthcare Research and Quality (AHRQ) (http://www.qualitymeasures.ahrq.gov). To date, the National Quality Forum (NQF), the Joint Com- mission on Accreditation of Healthcare Organizations (JCAHO), and the Center for Medicare and Medicaid Services (CMS) have focused primarily on preventive care and hospital-based medical care, with an emphasis on process-of-care variables. In surgery, these groups have all endorsed one process measure—appropriate and timely use of prophylactic antibiotics [see Table 2]—in partner- ship with the Centers for Disease Control and Prevention (CDC). In 2006, CMS, as part of its Surgical Care Improvement Program (SCIP), is also endorsing process measures related to prevention of postoperative cardiac events, venous thromboembolism, and res- piratory complications. The AHRQ has focused primarily on quality measures that take advantage of readily available administrative data. Because little information on process of care is available in these datasets, these Table 1 Primary Strengths and Limitations of Structural, Process, and Outcome Measures Examples Procedure volume Intensivist-managed ICU Appropriate use of prophylactic antibiotics Risk-adjusted mortalities for CABG from state or national registries Type of Measure Structural Process of care Direct outcome Strengths Measures are expedient and inexpensive Measures are efficient—a single one may relate to several outcomes For some procedures, measures predict subse- quent performance better than process or out- come measures do Measures reflect care that patients actually receive—hence, greater buy-in from providers Measures are directly actionable for quality-improve- ment activities For many measures, risk adjustment is unnecessary Face validity Measurement may improve outcomes in and of itself (Hawthorne effect) Limitations Number of measures is limited Measures are generally not actionable Measures do not reflect individual performance and are consid- ered unfair by providers Many measures are hard to define with existing databases Extent of linkage between measures and important patient outcomes is variable High-leverage, procedure-specific measures are lacking Sample sizes are limited Clinical data collection is expensive Concerns exist about risk adjustment with administrative data CABG—coronary artery bypass grafting © 2006 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 2 PERFORMANCE MEASURES IN SURGICAL PRACTICE — 1 © 2006 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 2 PERFORMANCE MEASURES IN SURGICAL PRACTICE — 2 measures are mainly structural (e.g., hospital procedure volume) or outcome-based (e.g., risk-adjusted mortality). The Leapfrog Group (http://www.leapfroggroup.org), a coali- tion of large employers and purchasers, developed perhaps the most visible set of surgical quality indicators for its value-based purchasing initiative.The organization’s original (2000) standards focused exclusively on procedure volume, but these were expand- ed in 2003 to include selected process variables (e.g., the use of beta blockers in patients undergoing abdominal aortic aneurysm repair) and outcome measures. Structural Measures The term health care structure refers to the setting or system in which care is delivered. Many structural performance measures reflect hospital-level attributes, such as the physical plant and resources or the coordination and organization of the staff (e.g., the registered nurse–bed ratio and the designation of a hospital as a level I trauma center). Other structural measures reflect physi- cian-level attributes (e.g., board certification, subspecialty train- ing, and procedure volume). STRENGTHS Structural performance measures have several attractive fea- tures. A strength of such measures is that many of them are strongly related to outcomes. For example, with esophagectomy and pancreatic resection for cancer, operative mortality is as much as 10% lower, in absolute terms, at very high volume hospitals than at lower-volume centers.6,7 In some instances, structural measures (e.g., procedure volume) are better predictors of subse- quent hospital performance than any known process or outcome measures are [see Figure 1].8 A second strength is efficiency. A single structural measure may be associated with numerous outcomes. For example, with some types of cancer surgery,higher hospital or surgeon procedure volume is associated not only with lower operative mortality but also with lower perioperative morbidity and improved late survival.9-11 In- tensivist-staffed intensive care units are linked to shorter lengths of stay and reduced use of resources, as well as to lower mortality.12,13 The third, and perhaps most important, strength of structural measures is expediency. Many such measures can easily be as- sessed with readily available administrative data. Although some structural measures require surveying of hospitals or providers, such data are much less expensive to collect than data obtained through review of individual patients’ medical records. LIMITATIONS Relatively few structural performance measures are strongly linked to patients and thus potentially useful as quality indicators. Another limitation is that most structural measures, unlike most process measures, are not readily actionable. For example, a small hospital can increase the percentage of its surgical patients who receive antibiotic prophylaxis, but it cannot easily make itself a high-volume center. Thus, although some structural measures may be useful for selective referral initiatives, they are of limited value for quality improvement. Whereas some structural measures can identify groups of hospi- tals or providers that perform better on average, they are not ade- quate discriminators of performance among individuals. For ex- ample, in the aggregate, high-volume hospitals have a much lower operative mortality for pancreatic resection than lower-volume centers do. Nevertheless, some individual high-volume hospitals may have a high mortality, and some individual low-volume centers may have a low mortality (though the latter possibility may be difficult to confirm because of the smaller sample sizes involved).14 For this rea- son, many providers view structural performance measures as unfair. Process Measures Processes of care are the clinical interventions and services pro- vided to patients. Process measures have long been the predomi- nant quality indicators for both inpatient and outpatient medical care, and their popularity as quality measures for surgical care is growing rapidly. STRENGTHS A strength of process measures is their direct connection to patient management. Because they reflect the care that physicians actually deliver, they have substantial face validity and hence greater “buy- in” from providers. Such measures are usually directly actionable and thus are a good substrate for quality-improvement activities. A second strength is that risk adjustment, though important for outcome measures, is not required for many process measures. For example, appropriate prophylaxis against postoperative venous thromboembolism is one performance measure in CMS’s ex- panding pay-for-performance initiative and is part of SCIP. Be- cause it is widely agreed that virtually all patients undergoing open abdominal procedures should be offered some form of prophy- laxis, there is little need to collect detailed clinical data about ill- ness severity for the purposes of risk adjustment. Table 2 Performance Measures Currently Used in Surgical Practice Diagnosis or Procedure Critical illness Any surgical procedure Abdominal aneurysm repair Carotid endarterectomy Esophageal resection for cancer Coronary artery bypass grafting Pancreatic resection Pediatric cardiac surgery Hip replacement Craniotomy Cholecystectomy Appendectomy Performance Measure Developer/Endorser Staffing with board-certified intensivists (LF) Appropriate antibiotic prophylaxis (correct approach: give 1 hr preoperatively, discon- tinue within 24 hr) (NQF, JCAHO, CMS) Hospital volume (AHRQ, LF) Risk-adjusted mortality (AHRQ) Prophylactic beta blockers (LF) Hospital volume (AHRQ) Hospital volume (AHRQ) Hospital volume (NQF, AHRQ, LF) Risk-adjusted mortality (NQF, AHRQ, LF) Use of internal mammary artery (NQF, LF) Hospital volume (AHRQ, LF) Risk-adjusted mortality (AHRQ) Hospital volume (AHRQ) Risk-adjusted mortality (AHRQ) Risk-adjusted mortality (AHRQ) Risk-adjusted mortality (AHRQ) Laparoscopic approach (AHRQ) Avoidance of incidental appendectomy (AHRQ) AHRQ—Agency for Healthcare Research and Quality CMS—Center for Medicare and Medicaid Services JCAHO—Joint Commission on Accreditation of Healthcare Organizations LF—Leapfrog Group NQF—National Quality Forum © 2006 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 2 PERFORMANCE MEASURES IN SURGICAL PRACTICE — 3 Another strength is that process measures are generally less con- strained by sample-size problems than outcome measures are. Important outcome measures (e.g., perioperative death) are rela- tively rare, but most targeted process measures are relevant to a much larger proportion of patients. Moreover, because process measures generally target aspects of general perioperative care, they can often be applied to patients who are undergoing numer- ous different procedures, thereby increasing sample sizes and, ulti- mately, improving the precision of the measurements. LIMITATIONS At present, a major limitation of process measures is the lack of a reliable data infrastructure. Administrative datasets do not have the clinical detail and specificity required for close evaluation of process- es of care. Measurement systems based on clinical data, including that of the National Surgical Quality Improvement Program (NSQIP) of the Department of Veterans Affairs (VA),15 focus on patient characteristics and outcomes and do not collect information on processes of care.Currently,most pay-for-performance programs rely on self-reported information from hospitals, but the reliability of such data is uncertain (particularly when reimbursement is at stake). A second limitation is that at present, targeted process measures in surgery pertain primarily to general perioperative care and often relate to secondary rather than primary outcomes. Although the value of antibiotic prophylaxis in reducing the risk of superficial surgical site infection (SSI) should not be underestimated, super- ficial SSI is not among the most important adverse events of major surgery (including death).Thus, improvements in the use of pro- phylactic antibiotics will not address the fundamental problem of variation in the rates of important outcomes from one hospital to another and from one surgeon to another. Except, possibly, in the case of coronary artery bypass grafting (CABG), the processes that determine the success of individual procedures have yet to be identified. Outcome Measures Direct outcome measures reflect the end result of care, either from a clinical perspective or from the patient’s viewpoint. Mor- tality is by far the most commonly used surgical outcome mea- sure, but there are other outcomes that could also be used as qual- ity indicators, including complications, hospital readmission, and various patient-centered measures of satisfaction or health status. Several large-scale initiatives involving direct outcome assess- ment in surgery are currently under way. For example, proprietary health care rating firms (e.g., Healthgrades) and state agencies are assessing risk-adjusted mortalities by using Medicare or state-level administrative datasets. Most of the current outcome-measure- ment initiatives, however, involve the use of large clinical registries, of which the cardiac surgery registries in New York, Pennsylvania, and a growing number of other states are perhaps the most visible examples. At the national level, the Society for Thoracic Surgeons and the American College of Cardiology have implemented sys- tems for tracking the morbidity and mortality associated with car- diac surgery and percutaneous coronary interventions, respective- ly. Although the majority of the outcome-measurement efforts to date have been procedure-specific (and largely limited to cardiac procedures), NSQIP has assessed hospital-specific morbidities and mortalities aggregated across surgical specialties and proce- dures. Efforts to apply the same measurement approach outside the VA are now being implemented.16 STRENGTHS Direct outcome measures have at least two major strengths. First, they have obvious face validity and thus are likely to garner a high degree of support from hospitals and surgeons. Second, out- come measurement, in and of itself, may improve performance— the so-called Hawthorne effect. For example, surgical morbidity and mortality in VA hospitals have fallen dramatically since the implementation of NSQIP in 1991.15 Undoubtedly, many surgical leaders at individual hospitals made specific organizational or process improvements after they began receiving feedback on their hospitals’ performance. However, it is very unlikely that even a full inventory of these specific changes would explain such broad- based and substantial improvements in morbidity and mortality. LIMITATIONS One limitation of hospital- or surgeon-specific outcome mea- sures is that they are severely constrained by small sample sizes. For the large majority of surgical procedures, very few hospitals (or surgeons) have sufficient adverse events (numerators) and cases (denominators) to be able to generate meaningful, proce- Mortality (%), 1998–99 Unadjusted Mortality for Resection of Esophageal Cancer, 1994–1997 Hospital Volume, 1994–1997 Highest Lowest Lowest Highest 12.0 16.0 20.0 4.0 8.0 0 Mortality (%), 1998–99 Unadjusted Mortality for Resection of Pancreatic Cancer, 1994–1997 Hospital Volume, 1994–1997 Highest Lowest Lowest Highest 12.0 16.0 20.0 4.0 8.0 0 b a Figure 1 Illustrated is the relative ability of historical (1994–1997) measures of hospital volume and risk- adjusted mortality to predict subsequent (1998–1999) risk-adjusted mortality in Medicare patients undergoing (a) esophageal or (b) pancreatic resection for cancer.8 © 2006 WebMD, Inc. All rights reserved. ELEMENTS OF CONTEMPORARY PRACTICE ACS Surgery: Principles and Practice 2 PERFORMANCE MEASURES IN SURGICAL PRACTICE — 4 dure-specific measures of morbidity or mortality. For example, a 2004 study used data from the Nationwide Inpatient Sample to study seven procedures for which mortality was advocated as a quality indicator by the AHRQ.17 For six of the seven procedures, only a very small proportion of hospitals in the United States had large enough caseloads to rule out a mortality that was twice the national average. Although identifying poor-quality outliers is an important function of outcome measurement, to focus on this goal alone is to underestimate the problems associated with small sam- ple sizes. Distinguishing among individual hospitals with interme- diate levels of performance is even more difficult. Other limitations of direct outcome assessment depend on whether the assessment is based on administrative data or on clin- ical information abstracted from medical records. For outcome measures based on clinical data, the major problem is expense. For example, it costs more than $100,000 annually for a private-sec- tor hospital to participate in NSQIP. For outcome measures based on administrative data, a major concern is the adequacy of risk adjustment. For outcome mea- sures to have face validity with providers, high-quality risk adjust- ment may be essential. It may also be useful for discouraging gam- ing of the system (e.g., hospitals or providers avoiding high-risk patients to optimize their performance measures). It is unclear, however, to what extent the scientific validity of outcome measures is threatened by imperfect risk adjustment with administrative data. Although administrative data lack clinical detail on many variables related to baseline risk,18-21 the degree to which case mix varies systematically across hospitals or surgeons has not been determined. Among patients who are undergoing the same surgi- cal procedure, there is often surprisingly little variation. For exam- ple, among patients undergoing CABG in New York State, unad- justed hospital mortality and adjusted hospital mortality (as derived from clinical registries) were nearly identical in most years (with correlations exceeding 0.90) [see Figure 2].22 Moreover, hospital rankings based on unadjusted mortality and those based on ad- justed mortality were equally useful in predicting subsequent hos- pital performance. Matching the Performance Measure to the Underlying Goal Performance measures will never be perfect. Certainly, over time, better analytic methods will be developed, and better access to higher-quality data may be gained with the addition of clinical elements to administrative datasets or the broader adoption of electronic medical records. There are, however, some problems with performance measurement (e.g., sample-size limitations) that are inherent and thus not fully correctable. Consequently, clinical leaders, patient advocates, payers, and policy makers will all have to make decisions about when imperfect measures are nonetheless good enough to act on. A measure should be implemented only with the expectation that acting on it will yield a net improvement in health quality. In other words, the direct benefits of implementing a particular mea- sure cannot be outweighed by the indirect harm. Unfortunately, benefits and harm are often difficult to measure. Moreover, mea- surement is heavily influenced by the specific context and by who—patients, payers, or providers—is doing the accounting. For this reason, the question of where to set the bar, so to speak, has no simple answer. It is important to ensure a good match between the perfor- mance measure and the primary goal of measurement. It is par- ticularly important to be clear about whether the underlying goal is (1) quality improvement or (2) selective referral (i.e., directing patients to higher-quality hospitals or providers). Although some pay-for-performance initiatives may have both goals, one usually predominates. For example, the ultimate objective of CMS’s pay- for-performance initiative with prophylactic antibiotics is to im- prove quality at all hospitals, not to direct patients to centers with high compliance rates. Conversely, the Leapfrog Group’s efforts in surgery are primarily aimed at selective referral, though they may indirectly provide incentives for quality improvement. For the purposes of quality improvement, a good performance measure—most often, a process-of-care variable—must be action- able. Measurable improvements in the given process should trans- late into clinically meaningful improvements in patient outcomes. Although quality-improvement activities are rarely actually harm- ful, they do have potential downsides, mainly related to their op- portunity cost. Initiatives that hinge on bad performance measures siphon away resources (e.g., time and focus) from more productive activities. For the purposes of selective referral, a good performance mea- sure is one that steers patients toward better hospitals or physicians Risk-Adjusted Mortality (%) Mortality (%), 2002 Correlation = 0.95 Observed Mortality (%) Unadjusted Mortality Ratings, New York State Hospital Risk-Adjusted Mortality Ratings, New York State Hospitals, 2001 a b 0.5 4.0 3.0 2.0 1.0 3.5 2.5 1.5 0.5 4.0 3.0 2.0 1.0 Best Middle Worst Best Middle Worst 0 0 1 1.5 2 2.5 3 3.5 4 4.5 Figure 2 Shown are mortality figures from CABG in New York State hospitals, based on data from the state’s clinical outcomes registry. (a) Depicted is the correlation between adjusted and unadjusted mortalities for all state hospitals in 2001. (b) Illus- trated is the relative ability of adjusted mortality and unadjusted mortality to predict performance in the subsequent year.

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