Setting Priorities for Patient Safety: Title and subTitle BreakEthics, Accountability, and Public Engagement

Patients continue to experience preventable harms. As a result, policy makers, physicians, and members of the public have intensified their efforts to improve patient safety. Quiz Ref IDThe Joint Commission publishes National Patient Safety Goals, the National Quality Forum recommends safe practices, the Centers for Medicare & Medicaid Services (CMS) will not pay for certain preventable complications, and health care organizations are taking action to reduce preventable harm. Although these actions are welcome, they raise ethical questions about selecting health care areas or patient populations for improvement efforts. In this Commentary, we explore the contentious issue of deciding what warrants a priority in patient safety and offer strategies to guide further discussion, policy, and research.

When patient safety garnered the attention of policy makers with the 1999 To Err Is Human¹ report, resources were scarce, harm was ubiquitous, and the science to reduce harm was immature. A decade later, patient safety resources have increased and effective interventions are more common. Many interventions are patterned after safety efforts in commercial aviation.² Although aviation safety is an important model for health care systems, it offers no guidance for setting priorities.

Quiz Ref IDAviation uses one metric to prioritize efforts—the plane crash type with the greatest number of fatalities. The aviation industry is not required to choose among different kinds or groups of passengers encountering different types of hazards. The flying public is literally in the same aircraft, sharing a common risk. Aviation confronts few if any of the injustices or moral worries about the fair distribution of risk mitigation efforts that health care faces.

Health care must set priorities among different groups of patients facing different kinds of hazards. Should errors that cause fatalities take precedence over errors that cause disability? Should errors that primarily affect patient groups with good prognoses trump errors among patients with poor prognoses? Are errors in pediatric or geriatric populations more important? Are central line–associated bloodstream infections more important than patient falls? These questions are similar to other priority-setting challenges in public health and health care policy. Quiz Ref IDIn these arenas, outcome measures that combine mortality and morbidity into a single metric, such as quality-adjusted life-years, can facilitate priority setting to guide insurance coverage decisions and to help allocate health resources.^{3 - 4} Yet, these measures pose social and ethical challenges such as the relevance of age, the tradeoffs among different disability types, the uniqueness of lifesaving therapies, whether the general public or patients with illnesses and injuries should establish quality-adjusted life-year weights, and what value to place on averting pain and suffering compared with permanent disability or death.⁵ Few efforts have explored these issues in the specific context of health care errors.

It is uncertain whether any moral distinction separates patient safety from access to health care or other public health contexts. There may be good moral and policy reasons for prioritizing some hazards based on human culpability and the egregiousness of ensuing harm rather than the measured burden they inflict. For example, there is anecdotal evidence of public and patient outrage over the relatively rare instances in which healthy limbs or breasts are mistakenly amputated. The public would likely place a higher value on interventions that prevent these errors than on interventions for more commonplace mistakes that over time produce a greater burden of death or morbidity. Public values regarding such issues must be carefully assessed and responsibly incorporated in the formation of a national system to mitigate heath care errors.

Health care is attempting to set priorities for patient safety efforts in the absence of any explicit or robust framework to guide decisions. For example, CMS selects medical complications for which it will not pay, based on whether these complications are important, measurable, and largely preventable.⁶ Like many policies, it is unclear what constitutes an important complication and to whom it is important. Does the federal government or the Joint Commission determine importance based on the cost to payers or the burden placed on an already disadvantaged and vulnerable patient group? Who sets and how patient safety priorities are determined matters greatly. Are regulators, payers, physicians, the members of the public, or stakeholder groups representing patients who have experienced harm controlling these decisions? Most likely, the processes used to set priorities will influence what ranks at the top of the list.

Quiz Ref IDIf public trust, confidence, and support for patient safety efforts are wanted, methods to allocate scarce resources must be ethically defensible and legitimate. Thus, methods to prioritize improvement efforts must include transparency and accountability when setting priority decisions, including the disclosure of ethical and technical rationales for each decision; an ethics framework that identifies and explicates the specific moral principles to guide priority setting; and public engagement and participation in patient safety priorities. Available literature on accountability and a good governance structure could serve the national patient safety effort well.^{7 - 8} Accountability is important to ethically set priorities and monitor results. Once priorities are set, health care organizations should be accountable for achieving the intended improvements in patient safety.

Frameworks and accounts of justice are available to aid health policy decision making.^{9 - 10} Their relevance to the specific context of patient safety policy must be examined, with particular regard to whether distinctive features of patient safety and medical error warrant the development and inclusion of specific midlevel principles. These issues include whether certain injuries occur only or disproportionately as a result of medical errors, whether medical errors generate any special obligations to families and caretakers, and whether dissimilar unintended injuries and errors have a differential effect on the public's confidence in health care organizations and services.

Public engagement is essential to form effective and legitimate public policies that involve moral values and social tradeoffs. Although determining the scientific soundness of safety measures are largely technical judgments, setting priorities are not and should be respectful of public views. Quiz Ref IDPublic engagement efforts could include surveys and focus groups to elicit aggregate information about relevant public values and attitudes and citizen juries and advisory councils to give the public a place at the table when making policy decisions that involve value judgments. These approaches may vary in the degree to which public responses are reflective and informed or reactive and immediate and may vary in the level of confidence generated in the priority-setting process. Internet venues may provide new and efficient means of eliciting the public's opinions in setting patient safety priorities in particular and health care policy in general.

Efforts to improve patient safety have progressed to a point that requires national leadership to develop formal processes and policies to establish priorities for patient safety efforts. To achieve this, the Secretary of Health and Human Services in coordination with the White House Office of Health Reform should develop an ongoing formal process to set priorities that are transparent, accountable, and based on a solid ethics framework and should engage public input in that process. The remit for this process should be entrusted to a new national structure to coordinate the federal investment in patient safety research.