American Journal of Law & Medicine

Quality assessment of ethics in health care: the accountability revolution. (Quality of Care and Health Reform: Complementary or Conflicting)

I. INTRODUCTION

Writing in 1988, Arnold Relman heralded the dawning of the "third revolution" in medical care.(1) The first revolution, at the end of World War II, had inaugurated an Era of Expansion, with an explosion of hospitals, physicians, and research. Medicare and Medicaid were passed, and medicine experienced a golden age of growth. Inevitably, according to Relman, this yielded to an Era of Cost Containment starting in the 1970s. The federal government and private employers revolted against soaring costs, brandishing the weapons of prospective payment, managed care, and global budgeting. Yet these blunt instruments of cost-cutting eventually produced concern over how to evaluate the quality of health care, to promote the good while trimming the bad. Thus Relman announced the arrival of the Era of Assessment and Accountability.

This chronology helps explain the current importance of quality. Quality assessment and more recently, quality improvement techniques, occupy a central place in this new era.(2) If the first revolution was fueled by a therapeutic optimism borne of biomedical breakthroughs; and the second driven by financial anxiety at the cost of progress; the third is built on the hope that the tools of quality assessment will help separate the gold from the dross, the valuable health care from the useless. There is much still controversial and under development in quality assessment. But the notion is that if we can specify what constitutes good quality in health care, we can assess how closely current practice approximates that ideal, and then convey that data to all concerned. This "feedback loop" then has the potential to move practice closer to the ideal, or to catalyze interventions to do so.

In pursuing this strategy, the quality revolution aims to render health care organizations and professionals accountable in profoundly new ways. Quality assessment requires specification of what constitutes good quality, then the formulation of measures to gauge quality, their application to generate data on how closely real practices approximate good quality, and reporting of that data to allow feedback and change. This is new in two ways. First, those setting standards (be they regulators, administrators, or others) are no longer simply preaching; they and those being regulated can tell through an ongoing feedback process how standards are (or are not) being translated into action. Second, and even more significantly, the range of people receiving data on practices within health plans may now be expanded. Certainly, administrators, regulators, and health professionals themselves, will be important recipients of this data, able to respond with efforts to effect change. But patients, potential patients, and employers choosing health plans may now also get data revealing comparative quality, as shown, for example, by morbidity and mortality statistics and patient satisfaction measures. And if they do not like what the data reveal, they can protest or reject a health plan. This entire process thus has the potential to render health plans and professionals accountable to consumers directly.(3)

This vision of a future of direct public accountability represents a profound change. Each of the two prior eras has had a characteristic vision of the relationship between the medical profession and society at large.(4) In the Era of Expansion the man in the white coat ruled, be he physician or scientist.(5) There was little consumer accountability. In the U.S. this was the last hurrah for Hippocratic paternalism.(6) Physician authority was at its height, and doctor knew best. Though the stray theologian would call for "our right to know the truth" from doctors,(7) and the stray judge would offer ambivalent musings about "an informed consent,"(8) in the clinic physicians called the shots.

The Era of Cost Containment was another story. Payer revolt was part of a broader revolt against the medical profession's authority to write its own check in every sense. The 1970s produced a sea-change in the medical profession's relationship to society, announced most tellingly by two outsiders to medicine -- a theologian and a judge. In 1970 Paul Ramsey published The Patient as Person,(9) playing a significant part in inaugurating the new field of biomedical ethics, a modern reexamination of the ancient domain of medical ethics. And in 1972 Judge Spottswood Robinson produced an opinion that remains the high-water mark of informed consent, concluding that the court -- not the medical profession -- would determine physicians' obligations to disclose risks and obtain consent.(10)

Yet this revolt produced new professionals and a new literature to champion "patients' rights;" for the most part it did not produce direct accountability to patients and consumers themselves. Thus in the early 1970s an assortment of lawyers, philosophers, theologians, and other professionals -- some calling themselves "bioethicists"(11) -- rose to advocate patients' moral and legal rights.(12) These professionals fought to reveal the value judgments in medicine and to transform medical decision making from a site of physician control and discretion to a site of patient control and self-determination. They labored in professional journals and national commissions.(13) They attempted to influence the work of judges(14) and state legislatures.(15) Some took their work into clinical settings, acting as educators and consultants to physicians and others. A robust but professional dialogue ensued; rarely did bioethicists report to patients directly.

It is the shift we now see, with the Era of Assessment and Accountability, that finally promises a genuine revolution. With the rise of assessment techniques to measure clinical reality, not just rhetoric, we see the possibility of direct public accountability.(16) To be sure, it is not yet certain that assessment techniques will be used that way. The federal Health Care Quality Improvement Act of 1986, for example, focuses on supporting physician peer review, with very limited public access to the information generated.(17) Indeed, public disclosure of quality data has been hotly contested.(18) Moreover, quality assessment can be statistically sophisticated and arcane work. Thus quality assessment too can devolve into a dialogue among professionals, even if one camp or another claims to be representing patients' interests.(19) Yet there are signs of something bigger -- opening the doors of the hospital, the doctor's office, and the HMO to public scrutiny and choice through quality assessment.(20) Prominent federal proposals for health care reform hinge on doing exactly that. Consumers would get a "report card" on the quality of competing health plans, and then choose.(21)

This movement toward direct reporting to the public on the quality of medical care seems supported by a larger movement toward direct public accountability in other medical spheres too. In the research context, the HIV and AIDS epidemics have produced an unusually informed group of patients, who have demanded changes in drug testing and approval, created community-based IRBs, and subjected providers to tough scrutiny.(22) Breast cancer survivors, among others, have seized on this as a model of consumer action to ensure professional accountability.(23) Meanwhile, in the domain of health care coverage and insurance, employers and workers have entered into a struggle for good but affordable health care, a struggle that cannot be waged without some means of comparing health plans. The process of comparing and negotiating with health plans forces those plans to report their practices and to be accountable.

Quality assessment is thus a linchpin of the revolutionary Third Era in medicine. It is a way of reporting on actual practice to a wide range of decision makers, including patients and other consumers. This is a potent development, allowing patients and consumers to share control -- not just physicians claiming to know what is in the patient's best interests, not just bioethicists claiming to know what patients want, but patients themselves. And indeed, quality assessment is everywhere, commanded by statute, performed by credentialing organizations, institutionalized by health care organizations, and urged for individual physicians.(24)

Against this background it becomes startling that there has been near silence on the possibility of applying quality assessment techniques to ethics practices within health plans.(25) This might take three forms: evaluating the ethical behavior of health professionals; the ethics policies and mechanisms embraced by the organization; and, as a subset of the latter, the particular competence of the committees or consultant specializing in ethical questions. Thus, consumers might first want to know whether they can expect the physicians in Health Plan A to be conversant with current thinking about ethics, to respect patients' autonomy by sharing adequate information and supporting patient decision making, to honor patients' wishes to forgo unwanted lifesustaining treatments, and to protect the confidentiality of patient information. Second, does the health care organization offering Plan A have written policies on problems such as assessing patients' decisional capacity, forgoing life-sustaining treatment, honoring patients' advance directives? Third, does the organization have a mechanism for obtaining advice on ethically difficult cases, and is that mechanism (be it a committee, an ethics consultant, or something else) competent, as well as open and accountable to patients? How does Plan A compare to competing Plan B on all these points?

To be sure, the last of these three questions has begun to prompt discussion among bioethicists. We see an emerging debate on what constitutes competence in an ethicist consulting in the clinic. Thus there are articles on the ethics of doing bioethics, on credentialing bioethicists, and on recommended consulting protocols.(26) Yet this is not situated in a broader call for the application of quality assessment to ethical behavior, policies, and mechanisms within a health care organization generally.

What ethical commentary there is on quality assessment is largely on something else -- the ethical questions involved in assessing the quality of health care interventions.(27) Thus we see a literature starting to urge assessment of treatments from the viewpoint of what patients themselves value.(28) Moreover, emphasis on assessing outcomes rather than structure or process,(29) stresses that the bottom line is the health outcomes of patients. Avedis Donabedian has argued that one feature of quality health care is its "legitimacy," "[c]onformity to social preferences as expressed in ethical principles, values, norms, mores, laws, and regulations."(30) Finally, some urge great caution in using the results of quality assessment to ration and so deny certain care to patients.(31)

Yet this ethics literature on quality, as important as it is, misses a bigger story -- the potential of quality assessment, as an instrument of direct public accountability, to transform ethics itself. Patients' rights and health care professionals' duties have been passionately championed by modern bioethics for the last quarter-century. Bioethicists have urged a radical reorganization of medical practice so that patients' values govern and medical decision making is patient-centered. But patients and consumers themselves have yet to assert real influence over the kind of ethical practices they encounter. Quality assessment has the potential to become a way of their doing so. If quality assessment tools are to be used to assess medical practice and health care organizations, patients have an enormous stake in making sure that those tools assess not just technical medical care, but ethical behavior as well.

This Article is an argument for including ethics in the accountability revolution. Ethics should be more than rhetoric, however passionately declaimed; it should be behavior that is assessed and promoted. This means using quality assessment techniques to evaluate ethical behavior within health care organizations.(32) Yet that must be undertaken carefully. In some domains of medical ethics the obligations are wellestablished; in others they are not. Assessment techniques will be more useful in the former. Moreover, quality assessment applied to ethics should provide a floor not a ceiling. There are limits to what the often quantitative techniques of quality assessment can tell us about ethical practice. Thirdly, quality assessment will often more readily be applied to the assessment of ethics process than achievement of a specific ethics outcome; there remains too much controversy over outcomes to permit designating one as ethical in many cases. Finally, quality assessment techniques are still in development and a matter of debate.(33)

Yet to cordon off ethics as an aspect of practice too "soft" or imprecise for assessment is to give up the effort to transform medical practice. That effort began in the courts earlier in this century. It then spread into a multi-disciplinary ethics literature and the professional societies. By now it has extended into the state and federal legislatures, the regulatory bodies, medical boards, and accrediting organizations. In an era of statistics, computerization, and probabilistic expertise, the next arena for that effort is the world of quality.

To make this argument, Part II begins by analyzing the ascendancy of quality assessment as a mechanism of accountability, as evidenced by its prominent place in current federal health care reform proposals. Part III goes on to ask what role quality might play in assuring public accountability in ethics. Part IV traces the development of empirical work in ethics to suggest the feasibility of quality assessment. Part V considers pitfalls and limitations, including potential uses in law of quality assessment data on ethics. Finally, Part VI concludes by showing the potential for quality assessment to perform a kind of technology-forcing function in bioethics. It will force us to make good on the rhetoric of patients' authority to decide, while narrowing the gap between ethics proclamations and clinical practice, and propelling the development of institutional ethics. The assessment and accountability revolution can transform bioethics itself.

II. THE RISE OF QUALITY ASSESSMENT

The 1980s saw an upsurge of interest in health care quality. Donabedian and other theorists began to discuss how to specify quality and assess it. The federal government and other major purchasers of health care began efforts to include quality evaluations in Medicare and other programs. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) added quality assessment to its accrediting procedures. Health care organizations themselves began programs of quality assessment or "QA," and efforts aimed at quality improvement.

All of this yielded a burgeoning literature on how to conceptualize, asses, and promote quality. There was controversy on what constituted good quality, how to measure it, and what the numbers revealed. As Troyen Brennan recounts, mortality rates, "care scales," physician surveys, patient surveys and satisfaction measures, various outcome measures, and still other gauges have been proposed. …

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