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Outcomes research and the politics of health care: Where have we been and where are we going?
Outcomes Research and the Politics of Health Care: Where Have We Been and Where Are We Going? William J. Sibbald
HE “POLITICS” of health care has been characterized by interest groups and individuals competing for power and leadership. In the 1960s and 1970s, critical care matured into a discipline with a well-defined body of knowledge. The size of critical care units grew in parallel to advances in technology with a belief that intensive monitoring and care of acutely ill patients improved outcomes. Once established as an essential part of the hospital and professional landscape, politics then emerged as a confounding factor in the growth of critical care. Not surprisingly, its maturation throughout the 1980s and 1990s was accompanied by the emergence of political competition between different critical care organizations, between different countries, within individual countries, and, occasionally, within well-defined geographic areas. Critical care clinicians and scientists occasionally sought control and power in some of the domains of this discipline, particularly in activities that evaluated different approaches to measuring critical care outcomes. Remember the many scoring systems developed to describe illness severity in the intensive care unit (ICU) and then organ dysfunction? Although they differed in substantive ways according to their proponents, practically speaking, there was a paucity of clear and meaningful clinical distinctions. The many debates over what scoring system had the greatest validity under specific circumstances lost sight of the bigger picture—the simple need to measure what was happening in our ICUs. Although scientific competition has its place, we need to be cognizant of the possibility that it can lead to the misfortune of political processes, a slowing of progress.
T
HEALTH CARE REFORM AND OUTCOMES RESEARCH
In the 1990s, Critical Care met head-on with health care reform. Until that point, there had been little understanding of the importance of measuring, or of being held accountable, for outcomes achieved during an intensive care hospitalization, or for the resources expended to achieve such outcomes. Health care reform therefore introduced the words measurement and accountability to the ICU lexicon. In retrospect, our goal in the 1990s was Journal of Critical Care, Vol 16, No 4 (December), 2001: pp 133-135
primarily focused on developing the structures (more ICUs) and processes (antisepsis treatments) that might improve care for acutely ill patients. We promoted basic research of ICU care processes, particularly related to sepsis, to improve our understanding of the clinical syndromes describing a critically ill patient. Meanwhile, the need for health care reform was driven by a combination of innovations in technology, of which the ICU was a visible hospital example, an aging population and health care inflation. Governments worldwide, regardless of the mechanism used to fund health care, determined that increasing cost pressures could not be sustained and that changes to how health care was organized and managed were necessary. Physicians learned they could no longer presume a dominant position in hospital decision making. Cost cutting, restructuring, hospital mergers, and outcomes measurement, were the early response to the need to reduce escalating health care budgets. Physicians sometimes became managers, thus, partners in the process of designing, delivering, measuring, and reorganizing both the structure and the process of care delivery. In critical care, we disseminated our early tools for measuring illness severity, added to them a process of looking at the results of our interventions, and then began to undertake studies that described ICU activities, processes, and outcomes. At the outset, outcomes research in the ICU was primarily an academic activity. Although we continued to pursue understandings of the pathogenesis and treatment of sepsis, and other clinical challenges, some critical care researchers began to focus on ICU-related outcomes, and how they might be influenced by altering the structure and
From the Journal of Critical Care Editorial Office, Department of Medicine, Sunnybrook & Women’s College Health Sciences Centre, Toronto, Ontario, Canada. Address reprint requests to William J. Sibbald, MD, Editor-inChief, Journal of Critical Care, Department of Medicine, Sunnybrook & Women’s College Health Sciences Centre, 2075 Bayview Ave, Room D4 74, Toronto, Ontario, Canada M4N 3M5. Copyright © 2002 by W.B. Saunders Company 0883-9441/01/1604-0002$35.00/0 doi:10.1053/jcrc.2001.31437 133
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WILLIAM J. SIBBALD
processes of ICU care. However, their activity generally remained within academic centers, with little evidence that this measurement approach was generalized to the broader community. And, there was little systematic evidence that benchmarking between peer hospital ICUs was used to describe where improvements could occur, and how changes could be promoted to create such improvements. In North America, we measured—as good managers should. However, we showed little of the leadership required to challenge traditional structures and processes especially needed to ensure good benchmarking and change strategies. MANAGING OUTCOME MEASUREMENT IN THE ICU
It is the way we have organized and managed ICU-related outcomes research, or rather, have not organized, that leads some to believe critical care as a discipline, and as a hospital service, is now at a crucial juncture. We now understand that ongoing measurement is an important component of critical care. We have begun to measure both the quality and effectiveness of the care we provide against specific end results or outcomes. However, the initiatives to promote improvements in ICU performance are increasingly being created by organizations external to the academic process. In the United States, for example, a group of Fortune 500 companies partnered with large health care purchasers to create The Leapfrog Group, whose stated goal is “to mobilize employer purchasing power and initiate breakthrough improvements in the safety and overall value of health care to American consumers” (http://www.leapfroggroup.org/). Solucient in partnership with VISICU authored the report “100 Top Hospitals: ICU Benchmarks for Success” (http://www.100tophospitals.com/Studies/ icu00/ default.htm). This report “identifies industry benchmarks for intensive care by recognizing hospitals and their management teams that demonstrate superior clinical, operational, and financial performance.”1 Perhaps our inability to move quickly enough from simply measuring outcomes, to comparing outcomes between hospitals, to creating an atmosphere of utilization management, created the gap that allowed industry to develop initiatives for private measurement and public reporting on ICU performance in the United States. Notwithstanding the apparent need and capacity to move in this direction, when ICU performance is measured by ex-
ternal organizations, we need to be diligent that appropriate processes are in place to ensure the validity of the data gathering, interpretation, and reporting activities. What are the important lessons in this instance? I suggest that critical care failed to understand the importance of managing its outcome measurement activities—a failure perhaps explained by our preoccupation, in part, with the political processes. How did it happen that we failed to understand, at least in some health care jurisdictions, the importance of owning the databases describing what we do in our ICUs, and, even more importantly, leading to the publication of our performance data in a public forum? There are alternatives to the approach adopted in the United States for the development and reporting of ICU performance data. Some health care jurisdictions have successfully created a shared process to develop, compare, and report on ICU performance between government and societies directly representing the critical care workforce.2 There is also good evidence that how ICUs are structured will impact on outcome.3,4 An Agency for Health Care Policy and Research (AHCPR)commissioned study (http://www.ahcpr.gov/clinic/ ptsafety/) reports on “11 highly proven practices” that will improve patient safety—many of which are applicable to the ICU. They include: giving patients antibiotics just before surgery to prevent infections, using ultrasound to help guide the insertion of central intravenous lines and prevent punctured arteries and other complications, and giving surgery patients -blockers to prevent heart attacks during or after the surgery. MEDICAL ERROR
A search of Medline reveals that our critical care researchers have yet to adopt an understanding of the role of medical error as a core competency. A review of data suggests return on investment in this area could be much greater than the considerable resources, intellect and otherwise, expanded on the many studies of sepsis. In their review of the Intersept trial, Sprung et al5 noted that 48 of 553 trial patients received inappropriate antimicrobial therapy or inadequate medical or surgical management. This is an excellent example of where a critical analysis of our care processes can identify the importance of medical error—even in an area we have studied so completely over the past 20 years. We
OUTCOMES RESEARCH AND ICU POLITICS
135
cannot ignore our imperfections, yet we need to understand medical error as a system-related process failure, and begin to create infrastructure to measure its occurrence, and respond with appropriate changes. Our failure to respond urgently to this challenge will mean intervention from outside our professional groups to impose standards and processes on our practice. There are other areas that ICU outcomes research needs to address. The lay press has been replete with stories of imbalances between ICU resources and patient-related need. In many North American metropolitan areas, ICUs can be so full that ambulances are redirected to other hospitals. In a recent Canadian study, data was presented to argue that hospital restructuring has been associated with increased emergency department overcrowding, even after controlling for use and patient demographics.6 Outcomes researchers need to address and describe how it is that critically ill patients can be triaged away from a primary hospital, whereas elective surgery continues. At the same time, there is con-
cern in many areas for the immediate future of our critical care workforce. The increasing activity in our ICUs coupled with a workforce that cannot support existing needs leads to excessive reliance on a core workforce that we may be pushing into a burnout situation. CONCLUSION
There are some very real and significant issues that early approaches to outcomes research in critical care have identified. We know that doctors in different ICUs use different processes for the same class of patients. We know that patients die at measurably different rates in ICUs in the same country. We know that patients die at measurably different rates in different countries. Patients are dying from a lack of critical care resources. Medical error exists in the ICU, but who among us is talking about it? What are we doing for our staff, our nurses, physicians, and allied health care workers who are being overworked? Where is our advocacy for those people?
REFERENCES 1. Solucient: www.100tophospitals.com/Studies/icu00/default. htm 2. Rowan K: Intensive Care Society has set up a centre for national audit. BMJ 313:1007-1008, 1996 3. Carmel S, Rowan K: Variation in intensive care unit outcomes: A search for the evidence on organizational factors. Curr Opin Crit Care 7:284-296, 2001 4. Pronovost PJ, Jenckes MW, Dorman T, et al: Organizational characteristics of intensive care units related to out-
comes of abdominal aortic surgery. JAMA 281:1310-1317, 1999 5. Sprung CL, Finch RG, Thijs LG, et al: International sepsis trial (INTERSEPT): Role and impact of a clinical evaluation committee. Crit Care Med 24:1441-1447, 1996 5. Schull MJ, Szalai JP, Schwartz B, et al: Emergency department overcrowding following systematic hospital restructuring: Trends at twenty hospitals over ten years. Acad Emerg Med 8:1037-1043, 2001
HE “POLITICS” of health care has been characterized by interest groups and individuals competing for power and leadership. In the 1960s and 1970s, critical care matured into a discipline with a well-defined body of knowledge. The size of critical care units grew in parallel to advances in technology with a belief that intensive monitoring and care of acutely ill patients improved outcomes. Once established as an essential part of the hospital and professional landscape, politics then emerged as a confounding factor in the growth of critical care. Not surprisingly, its maturation throughout the 1980s and 1990s was accompanied by the emergence of political competition between different critical care organizations, between different countries, within individual countries, and, occasionally, within well-defined geographic areas. Critical care clinicians and scientists occasionally sought control and power in some of the domains of this discipline, particularly in activities that evaluated different approaches to measuring critical care outcomes. Remember the many scoring systems developed to describe illness severity in the intensive care unit (ICU) and then organ dysfunction? Although they differed in substantive ways according to their proponents, practically speaking, there was a paucity of clear and meaningful clinical distinctions. The many debates over what scoring system had the greatest validity under specific circumstances lost sight of the bigger picture—the simple need to measure what was happening in our ICUs. Although scientific competition has its place, we need to be cognizant of the possibility that it can lead to the misfortune of political processes, a slowing of progress.
T
HEALTH CARE REFORM AND OUTCOMES RESEARCH
In the 1990s, Critical Care met head-on with health care reform. Until that point, there had been little understanding of the importance of measuring, or of being held accountable, for outcomes achieved during an intensive care hospitalization, or for the resources expended to achieve such outcomes. Health care reform therefore introduced the words measurement and accountability to the ICU lexicon. In retrospect, our goal in the 1990s was Journal of Critical Care, Vol 16, No 4 (December), 2001: pp 133-135
primarily focused on developing the structures (more ICUs) and processes (antisepsis treatments) that might improve care for acutely ill patients. We promoted basic research of ICU care processes, particularly related to sepsis, to improve our understanding of the clinical syndromes describing a critically ill patient. Meanwhile, the need for health care reform was driven by a combination of innovations in technology, of which the ICU was a visible hospital example, an aging population and health care inflation. Governments worldwide, regardless of the mechanism used to fund health care, determined that increasing cost pressures could not be sustained and that changes to how health care was organized and managed were necessary. Physicians learned they could no longer presume a dominant position in hospital decision making. Cost cutting, restructuring, hospital mergers, and outcomes measurement, were the early response to the need to reduce escalating health care budgets. Physicians sometimes became managers, thus, partners in the process of designing, delivering, measuring, and reorganizing both the structure and the process of care delivery. In critical care, we disseminated our early tools for measuring illness severity, added to them a process of looking at the results of our interventions, and then began to undertake studies that described ICU activities, processes, and outcomes. At the outset, outcomes research in the ICU was primarily an academic activity. Although we continued to pursue understandings of the pathogenesis and treatment of sepsis, and other clinical challenges, some critical care researchers began to focus on ICU-related outcomes, and how they might be influenced by altering the structure and
From the Journal of Critical Care Editorial Office, Department of Medicine, Sunnybrook & Women’s College Health Sciences Centre, Toronto, Ontario, Canada. Address reprint requests to William J. Sibbald, MD, Editor-inChief, Journal of Critical Care, Department of Medicine, Sunnybrook & Women’s College Health Sciences Centre, 2075 Bayview Ave, Room D4 74, Toronto, Ontario, Canada M4N 3M5. Copyright © 2002 by W.B. Saunders Company 0883-9441/01/1604-0002$35.00/0 doi:10.1053/jcrc.2001.31437 133
134
WILLIAM J. SIBBALD
processes of ICU care. However, their activity generally remained within academic centers, with little evidence that this measurement approach was generalized to the broader community. And, there was little systematic evidence that benchmarking between peer hospital ICUs was used to describe where improvements could occur, and how changes could be promoted to create such improvements. In North America, we measured—as good managers should. However, we showed little of the leadership required to challenge traditional structures and processes especially needed to ensure good benchmarking and change strategies. MANAGING OUTCOME MEASUREMENT IN THE ICU
It is the way we have organized and managed ICU-related outcomes research, or rather, have not organized, that leads some to believe critical care as a discipline, and as a hospital service, is now at a crucial juncture. We now understand that ongoing measurement is an important component of critical care. We have begun to measure both the quality and effectiveness of the care we provide against specific end results or outcomes. However, the initiatives to promote improvements in ICU performance are increasingly being created by organizations external to the academic process. In the United States, for example, a group of Fortune 500 companies partnered with large health care purchasers to create The Leapfrog Group, whose stated goal is “to mobilize employer purchasing power and initiate breakthrough improvements in the safety and overall value of health care to American consumers” (http://www.leapfroggroup.org/). Solucient in partnership with VISICU authored the report “100 Top Hospitals: ICU Benchmarks for Success” (http://www.100tophospitals.com/Studies/ icu00/ default.htm). This report “identifies industry benchmarks for intensive care by recognizing hospitals and their management teams that demonstrate superior clinical, operational, and financial performance.”1 Perhaps our inability to move quickly enough from simply measuring outcomes, to comparing outcomes between hospitals, to creating an atmosphere of utilization management, created the gap that allowed industry to develop initiatives for private measurement and public reporting on ICU performance in the United States. Notwithstanding the apparent need and capacity to move in this direction, when ICU performance is measured by ex-
ternal organizations, we need to be diligent that appropriate processes are in place to ensure the validity of the data gathering, interpretation, and reporting activities. What are the important lessons in this instance? I suggest that critical care failed to understand the importance of managing its outcome measurement activities—a failure perhaps explained by our preoccupation, in part, with the political processes. How did it happen that we failed to understand, at least in some health care jurisdictions, the importance of owning the databases describing what we do in our ICUs, and, even more importantly, leading to the publication of our performance data in a public forum? There are alternatives to the approach adopted in the United States for the development and reporting of ICU performance data. Some health care jurisdictions have successfully created a shared process to develop, compare, and report on ICU performance between government and societies directly representing the critical care workforce.2 There is also good evidence that how ICUs are structured will impact on outcome.3,4 An Agency for Health Care Policy and Research (AHCPR)commissioned study (http://www.ahcpr.gov/clinic/ ptsafety/) reports on “11 highly proven practices” that will improve patient safety—many of which are applicable to the ICU. They include: giving patients antibiotics just before surgery to prevent infections, using ultrasound to help guide the insertion of central intravenous lines and prevent punctured arteries and other complications, and giving surgery patients -blockers to prevent heart attacks during or after the surgery. MEDICAL ERROR
A search of Medline reveals that our critical care researchers have yet to adopt an understanding of the role of medical error as a core competency. A review of data suggests return on investment in this area could be much greater than the considerable resources, intellect and otherwise, expanded on the many studies of sepsis. In their review of the Intersept trial, Sprung et al5 noted that 48 of 553 trial patients received inappropriate antimicrobial therapy or inadequate medical or surgical management. This is an excellent example of where a critical analysis of our care processes can identify the importance of medical error—even in an area we have studied so completely over the past 20 years. We
OUTCOMES RESEARCH AND ICU POLITICS
135
cannot ignore our imperfections, yet we need to understand medical error as a system-related process failure, and begin to create infrastructure to measure its occurrence, and respond with appropriate changes. Our failure to respond urgently to this challenge will mean intervention from outside our professional groups to impose standards and processes on our practice. There are other areas that ICU outcomes research needs to address. The lay press has been replete with stories of imbalances between ICU resources and patient-related need. In many North American metropolitan areas, ICUs can be so full that ambulances are redirected to other hospitals. In a recent Canadian study, data was presented to argue that hospital restructuring has been associated with increased emergency department overcrowding, even after controlling for use and patient demographics.6 Outcomes researchers need to address and describe how it is that critically ill patients can be triaged away from a primary hospital, whereas elective surgery continues. At the same time, there is con-
cern in many areas for the immediate future of our critical care workforce. The increasing activity in our ICUs coupled with a workforce that cannot support existing needs leads to excessive reliance on a core workforce that we may be pushing into a burnout situation. CONCLUSION
There are some very real and significant issues that early approaches to outcomes research in critical care have identified. We know that doctors in different ICUs use different processes for the same class of patients. We know that patients die at measurably different rates in ICUs in the same country. We know that patients die at measurably different rates in different countries. Patients are dying from a lack of critical care resources. Medical error exists in the ICU, but who among us is talking about it? What are we doing for our staff, our nurses, physicians, and allied health care workers who are being overworked? Where is our advocacy for those people?
REFERENCES 1. Solucient: www.100tophospitals.com/Studies/icu00/default. htm 2. Rowan K: Intensive Care Society has set up a centre for national audit. BMJ 313:1007-1008, 1996 3. Carmel S, Rowan K: Variation in intensive care unit outcomes: A search for the evidence on organizational factors. Curr Opin Crit Care 7:284-296, 2001 4. Pronovost PJ, Jenckes MW, Dorman T, et al: Organizational characteristics of intensive care units related to out-
comes of abdominal aortic surgery. JAMA 281:1310-1317, 1999 5. Sprung CL, Finch RG, Thijs LG, et al: International sepsis trial (INTERSEPT): Role and impact of a clinical evaluation committee. Crit Care Med 24:1441-1447, 1996 5. Schull MJ, Szalai JP, Schwartz B, et al: Emergency department overcrowding following systematic hospital restructuring: Trends at twenty hospitals over ten years. Acad Emerg Med 8:1037-1043, 2001