Brindis, Ralph G. MD, MPH; Spertus, John MD, MPH
Fundamental changes are needed in the organization and delivery of health care in the United States. - —Crossing the Quality Chasm, 2001
Perhaps no effort has better crystallized the challenge to today’s health care system than the Institute of Medicine’s report, Crossing the Quality Chasm. The Institute clearly articulates that the American health care system has fallen far short of its potential to deliver high-quality care that is defined as safe, effective, evidence-based, timely, equitable, and patient-centered.1 Although payers, purchasers, consumers, and an entire industry of health care performance and outcomes graders are seeking to compare and shape the quality of care, there is an imperative that this initiative needs to be led by physicians themselves, ideally under the banner of academic medicine. The physician expertise typically concentrated in our academic medical centers is best suited to define and determine “quality” in the delivery of medical care as opposed to web-based health grader’s “report cards” or various insurance industry-derived metrics.
Current efforts to meet this challenge have been sporadic and largely driven by specific specialties within medicine. Yet the time has come for a more broad-based and coordinated effort. In this paper, we highlight the joint efforts of the principal physician organizations in cardiology to systematically create a foundation for improving the quality of cardiovascular care. We focus on effectiveness and efficiency because other dimensions of quality are covered in other articles in this issue. The progress of the American College of Cardiology (ACC) and the American Heart Association (AHA) can serve as an important example through which academic medicine can play a leadership role in improving the quality of American health care.
Prior to measuring quality, one first needs to know both how and what to measure. Initiating a process of selecting what to measure entails synthesizing the data and then defining what actually works in medicine to improve a patient’s outcome. By systematically evaluating and synthesizing the available data, clinical practice guidelines can be created.
Clinical practice guidelines
Clinical practice guidelines are written in the spirit of suggesting diagnostic or therapeutic interventions that appear to be effective for patients in most circumstances. Ideally, these recommendations are based upon multiple large randomized controlled trials. When such data is lacking, however, observational data, smaller clinical trials, or even “expert opinion” can be used. Over the past 25 years, the ACC and the AHA have published multiple cardiovascular clinical practice guidelines, continuously updating them as clinical advances dictates. Guidelines that have been revised due to clinical advances include: acute myocardial infarction, chronic stable angina, chronic heart failure, coronary artery bypass surgery, percutaneous coronary intervention (PCI), management of supraventricular arrhythmias, and implantation of pacemakers and antiarrhythmia devices. These guidelines are intended to assist health care providers in clinical decision making by describing generally acceptable approaches for the detection, management, and/or prevention of cardiovascular disease.
To assist readers in understanding specific guideline recommendations, the evidence is transparently communicated through both the directionality and confidence of such recommendations. Parallel to other professional organizations current ACC/AHA classifications are: Class I (strongly indicated), Class IIA (probably indicated), Class IIB (possibly indicated), or Class III (not indicated). In addition, the strength of the evidence is also communicated by being explicitly described as an A, B, or C level of data. Level A evidence implies that the data are derived from multiple randomized trials, whereas Level C evidence reflects consensus opinion of experts, case studies, or “standard-of-care.”2
An example of a Class I recommendation in the treatment of an acute myocardial infarction would be administration of aspirin within 24 hours of admission to the hospital. A Class III recommendation might be the performance of angioplasty on a stenotic lesion in a “nonculprit” coronary artery in the management of an acute myocardial infarction. The acceptance of the role of clinical practice guidelines has succeeded only through the remarkable commitment of numerous clinicians, researchers, and academics that have devoted countless hours of volunteer time to this process.
Occasionally the evidence supporting a particular structural aspect or process of care is so strong that failure to perform such actions reduces the likelihood that optimal patient outcomes will occur. Creating a mechanism for quantifying these opportunities to improve the outcomes of care is accomplished by the creation of performance measures. Performance measurements are distilled from clinical guidelines and typically emanate from strong, evidenced-based care (a Class I indication) that also lends itself to both measurement and improvement.3 For example, performance measures in the management of acute myocardial infarction include aspirin and beta-blocker use. For those patients with ST-elevation myocardial infarction (STEMI), an additional important performance measure includes the timely use of reperfusion strategies such as delivering thrombolytic therapy within 30 minutes after arriving in the emergency room or, alternatively, performing a primary angioplasty within 90 minutes of first medical contact. These performance measures have been shown to be so beneficial in saving lives that collecting and assessing their adherence during the treatment of acute myocardial infarctions and STEMIs are core measures of the Joint Commission on Accreditation of Health Care Organizations (JCAHO). Clinicians and trialists from the academic outcomes community have worked tirelessly on behalf of the ACC and AHA to coordinate the development of these cardiovascular performance measures with various health care stakeholders, such as Center for Medicare and Medicaid Services, the National Quality Forum, the National Committee on Quality Assurance, and JCAHO so that these entities may pursue the quantification of quality using the most valid assessments available.
Through the development of guidelines and performance measures, the ACC and AHA have learned that the medical establishment needs to communicate patient characteristics in a clear and unambiguous fashion. Furthermore, the generation of data itself should use similar standardized definitions so that the accumulation of data across individual studies may be conducted in a more valid manner. The ACC and AHA have therefore convened a series of committees to develop data standards for common clinical conditions and treatments. Standardized sets of definitions, nomenclature, and data elements facilitate accurate communication and help avoid the potential and real phenomena of the “Tower of Babel” syndrome with the inability to accurately compare clinical trials and other outcomes assessments due to differing definitions of clinical status, adverse outcomes, and even, for example, differing definitions of what constitutes myocardial infarction or death! The ACC and AHA have now developed the lexicon needed to achieve commonality and consistency in definitions for acute coronary syndromes, congestive heart failure, electrophysiology, atrial fibrillation, and PCI. While also benefiting from the extraordinary commitment of dedicated cardiologists and methodological experts, the entire community of academic medicine, with its natural leadership in creating and overseeing randomized clinical trials (RCTs), can now ensure that such trials embrace and use these data standards to ensure accurate RCT comparisons.
Improving Quality: The Cycle of Clinical Therapeutic Effectiveness
The Cycle of Clinical Therapeutic Effectiveness4 requires that an “infrastructure engine” exist that can systematically measure practice patterns and clinical outcomes (see Figure 1). These clinical data, including outcomes, should be available to clinicians and other stakeholders in a risk-adjusted and “benchmarked” format so as to best identify opportunities for implementation of local continuous quality improvement (CQI) initiatives. National Registries, such as the ACC’s National Cardiovascular Registry (ACC-NCDR), can offer data collection and feedback mechanisms that are timely, relevant, credible, and actionable, thereby allowing opportunities for improving care at the local and national level. Since its inception in 1998, the ACC-NCDR has collected and analyzed more than 3.7 million patient hospitalizations from 750 participating U.S. hospitals.5 The ACC-NCDR has developed specific clinical modules for cardiac catheterization and PCI, implantable defibrillators, and carotid artery stenting. These modules have been developed through the use of explicitly established clinical data standards, coupled with advanced risk-adjustment methodologies and benchmarking. Recent improvements to the program include the establishment of mechanisms to ensure data veracity and quality through internal data quality checks along with external auditing. The directors of catheterization labs at participating hospitals identify benchmarked performance outliers for their own institutions, such as increased groin bleeding complications or prolonged “door-to-balloon” times in their PCI management of STEMI. Through this outcomes feedback, implementation of changes in local systems processes can be monitored over time to assess changes in performance.6–8
National registries not only have the potential to improve quality at the local level, but also to support efforts in monitoring drugs and devices on the market. Low-frequency, adverse events are best discovered through a registry format, rather than through clinical trials. Based upon the huge volume of patients tracked through registries, as opposed to the more modest numbers needed to demonstrate efficacy in a clinical trial, registries can identify important signals against the background of random noise. The enhanced value of a registry that collects longitudinal patient follow-up data is that it can also be used to further evaluate the true benefits and effectiveness of treatment strategies.
For example, using a registry such as the ACC-NCDR to assess the long-term efficacy of drug eluting stents (e.g., morbidity, mortality, and quality of life through assessment of angina burden) in the management of coronary artery disease could provide important “real world” experience of the effectiveness of these new innovations and insight that can supplement the efficacy established in clinical trials. Furthermore, the ability of registries to assess clinical outcomes of vast numbers of patients in the “real world” environment can: (1) provide important feedback to influence clinical guidelines recommendations, (2) lead to the generation of new concepts for additional clinical trials, and (3) help set state and national regulatory standards and policies based on quality assessment rather than simple “volume criteria” or limited administrative data. Data from registries can also provide performance metrics to payers to help implement increasingly popular “pay for performance” programs, which differentially reimburse health care providers according to their adherence to specific outcome measures. For example, Virginia’s Quality In-Sights Hospital Incentive Program is using performance metrics derived from the ACC-NCDR cardiac catheterization PCI registry to quantify and reward the demonstrated delivery of excellent cardiovascular quality of care.9
In addition to the established use of guidelines and performance measures to facilitate quality improvement through registry and local quality improvement efforts, there are new and emerging pressures on the field. Outcomes researchers, along with other investigators, have clearly documented inexplicable variations in care that are clearly associated with costs, but not necessarily with outcomes.10–12 In fact, Jencks and colleagues offer evidence that more use of expensive medical care is actually associated with worse quality and outcomes.13 Consequently, it is critical that the medical profession begin to develop clinically and scientifically valid methods for quantifying the appropriateness of care. The ACC has recently initiated a critical new program to develop such methods and measures of appropriateness in cardiovascular care. Starting with diagnostic imaging, a broad portfolio of appropriateness criteria will be developed. For example, performing a noninvasive evaluation for presence of coronary artery disease using the single-photon emission computed tomography-myocardial perfusion imaging testing (SPECT-MPI) would be deemed appropriate in a patient who had a chest pain syndrome and a moderate pretest probability of disease and a left bundle branch block on their resting electrocardiogram. Performing a SPECT-MPI examination in an asymptomatic patient the first year after successful coronary artery bypass surgery or PCI whom had been previously symptomatic prior to revascularization would usually be deemed inappropriate care.
After a portfolio of broad-based appropriateness criteria are created, an explicit effort should be made to compare different modalities available for common clinical conditions so that measures of efficiency can ultimately be developed. In so doing, it is hoped that a physician-led effort cannot only model shared responsibility and accountability for the spending of scarce societal resources, but that it could also inform payers in the rational use of care so that patients can benefit most from the inevitable implementation of methods for cost containment.11,14,15 The adherence to the projected development of these broad-based appropriateness criteria will help achieve the Institute of Medicine’s mandate of efficiency and also to minimize the well documented disparities in the delivery of health care.
The Role of Academic Medicine
Medical knowledge continues to advance at a rapid pace, and there is a demand to translate this knowledge into clinical medicine. Currently, the process of quality assessment and improvement has largely fallen upon the shoulders of professional organizations. The challenge before organized academic medicine is to embrace the rapid evolution of clinical care and to take a leadership role in its further development beyond the role that academicians may play in their professional societies. Accordingly, there are several clear opportunities for academic medicine to support the science of quality.
Support fundamental research in the activities of quality improvement
Whether it is guideline or performance development, creation of data standards, defining and testing methods of appropriateness, or determining how to validly measure efficiency, much research is needed in the field of quality. New techniques and methods of measurement, analysis, and interpretation are needed to define how best to translate new knowledge into practice. Currently, academic institutions heavily reward scientists for studying the basic processes of life, yet not enough support and respect seem to be garnered upon those studying the processes and outcomes of patient care. By visibly rewarding those who invest their careers in quality assessment and improvement, new trainees and faculty can identify the value and import of devoting their careers to this important discipline. It is this new generation that will be positioned to determine how best to continually improve our current processes of quality assessment so that future patients can more clearly benefit from the inevitable progress in medicine.
Provide support for academicians to lead and improve quality at their own institution
Improving quality is not a night and weekend job. In fact, research has clearly demonstrated that one of the most important features of programs that are successful in quality improvement is tangible support and commitment from senior leadership.16 It therefore looms as an important challenge for the culture of academic medicine to recognize and embrace the commitment of junior faculty who assume a leadership role in local quality improvement efforts. This is yet another opportunity to emphasize the importance of such activities to trainees as well as current providers.
Develop discrete educational models and practicums for trainees in quality assessment and improvement
Learning the language and methods of quality improvement cannot be left to happenstance. Academic medicine needs to insure that no trainee can graduate without having a deep understanding of quality assessment and improvement. Six sigma, CQI, rapid cycle improvement, PDSA (plan, do, study, act), best practices, performance measurement, benchmarking, pay for performance, and appropriateness criteria should not be foreign terms that incite fear and mistrust. Rather, these should become components of a clinician’s toolkit so that they are equipped to systematically assess and improve care throughout their careers. Fulfilling this obligation will require the creative development of new educational and training opportunities throughout the domains of academic medicine.
The institution of academic medicine needs to give back to their community in the quality arena
As emphasized throughout this article, the field of quality assessment is complex and growing more advanced all the time. This creates an important opportunity for academic medicine to serve as a conduit for the dissemination of this information throughout their communities. Novel opportunities for community-wide assessment and improvement efforts clearly exist. Yet the expertise required for data collection and analyses are not readily available in many community hospitals. By assisting other centers in these important activities, academic medicine can further help disseminate this emerging science and, through collaboration, accelerate the improvement in health care quality demanded by the Institute of Medicine, health care purchasers, and the public at large.
Academic medicine should actively participate in the design and implementation of data registries
Although to some extent this occurs through the membership of academicians in national professional organizations, a much broader embrace of current registries among academic medicine is needed. Furthermore, academic medicine needs to be firmly committed to improving the design and analysis of such registries so as to accelerate the generation of important clinical evidence. Furthermore, the data collected by registries needs to expand to collect data about the transitions of care from inpatient to outpatient care and to include long-term clinical outcomes. Expanding the outcomes of such registries to include data that are meaningful to patients and society, such as the analysis and descriptions of the patient’s health status (e.g., Seattle Angina Questionnaire [SAQ], assessing patients’ cardiovascular symptoms, daily function, and quality of life) is critically important. Designing parsimonious data sets that include additional predictors of these outcomes (e.g., psychosocial, physician–patient communication, and economic predictors of outcome) is also needed. Such efforts by the institution of academic medicine will clearly accelerate the entire field.
In conclusion, academic medicine has a major responsibility in providing services to our medical community and the nation through a number of venues in the pursuit of high standards in quality of health care. Participation on academic advisory committees, national expert panels, and membership in professional societies is not enough. Academic medicine needs to actively embrace and promote the quality agenda. Service on clinical practice guidelines committees and active participation in the increasingly valuable network of registries offers great opportunities in converting known clinically efficacious therapy into clinical effectiveness at the bedside. Our academic leaders are also called upon by our nation’s policy makers to help shape health policy decisions in determining how and where our health care dollars should be spent. Academic medicine should accelerate its commitment to translating research findings into policy—both in terms of improving quality of care, as well as implications for general population health issues. Academic medicine, with its skills in research, education, and service to the community at large, is ideally suited to play a leadership role in implementing the Institute of Medicine’s guiding principles of quality that assure safe, effective, patient-centered, timely, efficient, and equitable care.
The authors want to acknowledge the contributions of Drs. Claire Brindis, Harlan Krumholz, Richard Levin, Costas Lambrew, and David Reuben.
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