THE ETHICS OF USING QUALITY IMPROVEMENT METHODS IN HEALTH CARE

Americans expect high-quality health caresafe, effective, patient-centered, timely, equitable, and efficient (1). Unfortunately, reality falls short of this ideal. A growing literature documents serious problems, such as unnecessary surgery, inappropriate use of medications, inadequate prevention, avoidable exacerbations of chronic conditions, and long delays before important research findings become standard (14). We discuss deliberate efforts of providers to meet their obligations to improve the quality of patient care through clinical and managerial changes in the processes of care. Health care practices have always evolved, but mostly in a scattershot way. In recent years, providers have initiated new methods, some of which were modeled first in manufacturing to make ongoing improvements more systematic, data-guided, and efficient (5, 6). These continuous quality improvement methods are commonly referred to as QI. Ethical issues arise in QI because attempts to improve quality may inadvertently cause harm, waste scarce resources, or affect some patients unfairly. For example, efforts at earlier administration of antibiotics for pneumonia may lead to overuse, or efforts to encourage cancer screening may prompt useless, risky, and expensive tests in people who are too near death to benefit. In addition, some activities using QI methods have been categorized as research that uses patients as subjects, which brings the activities under the ethical and regulatory requirements governing human subjects research, including review by institutional review boards (IRBs) (7). Putting improvement activities under research regulations can precipitate substantial delays, costs, and conflicts (811). Key federal agencies have disagreed about the boundaries between research and QI, and QI practitioners, health care organizations, agencies that fund research, policymakers, and IRB members are uncertain about ethical and legal requirements. The situation has already generated disincentives to engage in QI. Beginning in 2003, The Hastings Center convened a group of experts to address the ethical issues associated with QI methods in health care. Ethicists, clinician leaders, experienced managers, regulators, authors of relevant publications, and others met repeatedly, considered published and newly commissioned scholarly papers, and discussed options with experts and affected parties. The project presented interim findings at national meetings on research ethics, general internal medicine, health services research, and quality improvement, and the project sponsored a listserv to share progress and issues with everyone who expressed interest in the work. The project has published a comprehensive report (8) and a set of commissioned papers (12). We present a summary and explanation of the report’s main conclusions, along with recommendations for developing policy and practices to protect patients from both the harm that QI activities might cause and the harm that quality and safety deficits do cause. The full report contains more details on the process, the arguments, and our conclusions. QI Activities: Part of Normal Health Care Operations The project group addressed 3 questions: What is QI, and what role does it play in health care? What ethical requirements should QI activities meet? What arrangements do we need to ensure the ethical conduct of QI? Defining QI The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings. Quality improvement uses an array of methods and can look like practical problem solving, an evidence-based management style, or an application of a theory-driven science of system change. Quality improvement methods often encourage health care workers to use their experience, along with insights from others, to identify promising improvements, implement changes on a small scale, monitor and interpret effects, and decide about additional changes and wider implementation. Alternatively, a QI activity might start with management review of the organization’s performance from aggregate data or with similar analyses of data across multiple organizations. At its heart, QI is a form of experiential learning that regards improvement to be part of the work process and always involves deliberate actions expected to improve care, guided by data reflecting the effects. Quality improvement is an intrinsic part of good clinical care, in which data from clinicians’ own settings guide them in improving their practices. Quality improvement assumes that quality and safety are largely characteristics of systems, and its methods enable workers to gain insight about their system’s relationships and functions. Many QI activities rely on groups of clinicians, managers, and staff cooperating to improve procedures, such as scheduling, medication handling, and record keeping. Organizations that accredit the education and certify the competence of health care professionals have come to require practitioners to be competent in improving their own practices (13, 14). As health care workers engage in QI, they deepen their understanding of their processes of care and how to improve those processes. Over time, successful QI transforms organizational culture so that everyone is committed to continuous quality improvement and everyone has the requisite skills. In sum, QI is a structured, data-guided form of the innovation and adaptation that has always been part of normal health care operations, and it has proven to be effective in improving U.S. health care (1519). Requirements for the Ethical Conduct of QI The project group began by examining how the existing ethical framework that governs research on human subjects might apply (20). Table 1 shows the group’s conclusions, organized under 7 topics considered important for ethical research (21). This analysis highlights the responsibility that health care providers have to improve quality and the responsibility that patients have to cooperate with improvement efforts. Physicians, nurses, and other clinicians have long professed a special ethical responsibility to serve the interests of their patients, including the responsibility to maintain and continually strive to improve the quality of care (22, 23). As health care delivery has come to require complex interdependent systems, a similar ethical responsibility falls on health care organizations and their managers (24). Participation in QI activities is a systematic way to fulfill this responsibility. Table 1. Ethical Requirements for the Protection of Human Participants in Quality Improvement Activities* Because QI activities are, and should be, part of normal health care operations, patients also have a responsibility to participate in quality improvement, which often requires direct cooperation (for example, permitting collection and use of data about their medical conditions, treatments, and outcomes) (25). A patient who will not be involved in QI constrains the efforts of that care system to improve itself and thereby jeopardizes the very benefits sought. The interests of patients in receiving reliably high-quality health care depend on all patients cooperating with QI activities. Hence, the responsibility to cooperate need not turn on whether the particular patient directly benefits from a particular QI activity (although this is often the case); rather, it is justified ethically by the benefits that each patient receives because all are cooperating in the overall QI enterprise. Reaping the benefits of the QI enterprise without participation would be unfair. Of course, the patient’s responsibility to cooperate is subject to standards of reasonableness, which require that patients have access to general information about QI activities and be kept safe from harms and from violations of their rights. For example, patients should be able to count on the confidentiality of their personal health information and on the opportunity to choose whether to participate in a QI activity that exposes them to more than minimal incremental risk (measured relative to the risks of usual medical care). Health care workers (employees and non-employee professionals who provide care within an organization) who participate in QI activities should also be able to count on confidentiality and the opportunity to opt out of QI activities that present more than minimal incremental risk to themselves. In the case of workers, however, confidentiality and risk are measured relative to the normal work situation; an organization has no ethical requirement to allow a worker to opt out of a QI activity because that activity might reveal that the worker is incompetent or unnecessary (Table 1). The ethical responsibility to cooperate with QI activities contrasts with the fundamental ethical claim that research is voluntary (26). Health care professionals and organizations have no ethical responsibility to do research, and every person is entitled to choose whether to be a research subject. This ethical claim emerged in response to research that imposed substantial risk on nonconsenting persons without offering them any direct benefit (27, 28). Research ethics springs from society’s conclusion that the interests of researchers often conflict with those of subjects and that research is conceptually distinct from health care delivery. Indeed, most published clinical research results have been found to be of little relevance to clinical practice (29). A person’s decision to be a subject in research must be voluntary and fully informed to prevent exploitation. To ensure that researchers meet their ethical obligations to human subjects, representatives of the relevant community (IRBs) should review the design, sample, informed consent process, and riskbenefit relationship of most research projects involving human subjects. In contrast, QI generally aligns with patients’ interests, presents