Made to Measure: The Ethics of Routine Measurement for Healthcare Improvement.

This paper analyses the ethics of routine measurement for healthcare improvement. Routine measurement is an increasingly central part of healthcare system design and is taken to be necessary for successful healthcare improvement efforts. It is widely recognised that the effectiveness of routine measurement in bringing about improvement is limited-it often produces only modest effects or fails to generate anticipated improvements at all. We seek to show that these concerns do not exhaust the ethics of routine measurement. Even if routine measurement does lead to healthcare improvements, it has associated ethical costs which are not necessarily justified by its benefits. We argue that the practice of routine measurement changes the function of the healthcare system, resulting in an unintended and ethically significant transformation of the sector. It is difficult to determine whether such changes are justified or offset by the benefits of routine measurement because there may be no shared understanding of what is 'good' in healthcare by which to compare the benefits of routine measurement with the goods that are precluded by it. We counsel that the practice of routine measurement should proceed with caution and should be recognised to be an ethically significant choice, rather than an inevitability.

What does 'quality' add? Towards an ethics of healthcare improvement.

In this paper, we argue that there are important ethical questions about healthcare improvement which are underexplored. We start by drawing on two existing literatures: first, the prevailing, primarily governance-oriented, application of ethics to healthcare 'quality improvement' (QI), and second, the application of QI to healthcare ethics. We show that these are insufficient for ethical analysis of healthcare improvement. In pursuit of a broader agenda for an ethics of healthcare improvement, we note that QI and ethics can, in some respects, be treated as closely related concerns and not simply as externally related agendas. To support our argument, we explore the gap between 'quality' and 'ethics' discourses and ask about the possible differences between 'good quality healthcare' and 'good healthcare'. We suggest that the word 'quality' both adds to and subtracts from the idea of 'good healthcare', and in particular that the technicist inflection of quality discourses needs to be set in the context of broader conceptualisations of healthcare improvement. We introduce the distinction between quality as a measurable property and quality as an evaluative judgement, suggesting that a core, but neglected, question for an ethics of healthcare improvement is striking the balance between these two conceptions of quality.

Ethics and Collateral Findings in Pragmatic Clinical Trials.

Pragmatic clinical trials (PCTs) offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question(s), yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as ?pragmatic clinical trial collateral findings,? or ?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice.

Value based competition in health care's ethical drawbacks and the need for a values-driven approach.

Value Based competition in Health Care (VBHC) has become a guiding principle in the quest for high quality health care for acceptable costs. Current literature lacks substantial ethical evaluation of VBHC.In this paper we describe how a single-minded focus on VBHC may cause serious infringements upon at least four medical ethical principles: 1) it tends to neglect patients' personal values; 2) it ignores the intrinsic value of the caring act; 3) it disproportionately replaces trust in professionals with accountability, and 4) it undermines solidarity.Health care needs a next step in VBHC. We suggest a 'Values-Driven Health Care' (VDHC) approach that a) takes patients' personal values as prescriptive and guiding; b) holds a value account that encompasses health care's intrinsic (gift) values; c) is based upon intelligent accountability that supports trust in trustworthy professionals, and d) encourages patients to raise their voices for the shared good of health care.

The ethical oversight of learning health care activities in Switzerland: a qualitative study.

OBJECTIVE: This study aims to identify the key issues regarding the ethical oversight of health care improvement activities in Switzerland. DESIGN: Individual semi-structured qualitative interviews, analysed using conventional content analysis. SETTING: Interviews were conducted in Switzerland between July 2017 and February 2018. PARTICIPANTS: A purposive sample of 38 key stakeholders from four different groups: health care improvement researchers and practitioners (n = 19), representatives of clinical trial units (n = 3), clinical ethicists (n = 5), quality heads of university hospitals (n = 5), and cantonal ethics committee members (n = 6). RESULTS: There appears to be widespread uncertainty regarding when certain learning health care activities require ethical review by a research ethics committee in Switzerland. This situation is exacerbated by legislative ambiguity and limited guidance. It was reported that the lack of other oversight mechanisms for activities outside of the Human Research Act is also leading many investigators to submit projects to research ethics committees to avoid barriers to publication. CONCLUSIONS: The continuous, integrated, and dynamic nature of learning health care poses significant challenges to the current regulatory framework. It will be important that more clarification and guidance is provided regarding which activities require ethical review, and that it is considered how the ethical oversight of activities falling outside human research legislation can be strengthened. However, the traditional model of ethical oversight is poorly suited to learning health care and may need to be replaced with new systemic oversight approaches.

Kenyan health stakeholder views on individual consent, general notification and governance processes for the re-use of hospital inpatient data to support learning on healthcare systems.

BACKGROUND: Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. METHODS: We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. RESULTS: Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. CONCLUSIONS: As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs.

Philosophy of Healthcare Ethics Practice Statements: Quality Attestation and Beyond.

One element of the American Society for Bioethics and Humanities' recently-piloted quality attestation portfolio for clinical ethics consultants is a "philosophy of clinical ethics consultation statement" describing the candidate's approach to clinical ethics consultation. To date, these statements have been under-explored in the literature, in contrast to philosophy statements in other fields such as academic teaching. In this article, I argue there is merit in expanding the content of these statements beyond clinical ethics consultation alone to describe the author's approach to other important "domains" of healthcare ethics practice (e.g., organizational policy development/review and ethics teaching). I also claim such statements have at least three additional uses outside quality attestation: (1) as a reflective practice learning tool to increase role clarity among practicing healthcare ethicists and bioethics fellows; (2) assisting practicing healthcare ethicists in clarifying role expectations with those they work with; and (3) helping inform developing professional practice standards.

Ethics Review of Projects (ERoP): A Conceptual Framework.

Ethical risks are routinely assessed and mitigated in research studies. The same risks can exist in program evaluations and quality improvement initiatives and yet may not be routinely and comprehensively addressed. The authors present a conceptual framework that can help organizations develop comprehensive ethics review processes for non-research knowledge-generating projects (NRKGPs). They provide strategies that can be implemented in three progressive domains and illustrate the framework's application using two examples of health organizations with existing NRKGP ethics review processes. They conclude the article by discussing some lessons learned.

What Patients Value About Reading Visit Notes: A Qualitative Inquiry of Patient Experiences With Their Health Information.

BACKGROUND: Patients are increasingly asking for their health data. Yet, little is known about what motivates patients to engage with the electronic health record (EHR). Furthermore, quality-focused mechanisms for patients to comment about their records are lacking. OBJECTIVE: We aimed to learn more about patient experiences with reading and providing feedback on their visit notes. METHODS: We developed a patient feedback tool linked to OpenNotes as part of a pilot quality improvement initiative focused on patient engagement. Patients who had appointments with members of 2 primary care teams piloting the program between August 2014-2015 were eligible to participate. We asked patients what they liked about reading notes and about using a feedback tool and analyzed all patient reports submitted during the pilot period. Two researchers coded the qualitative responses (κ=.74). RESULTS: Patients and care partners submitted 260 reports. Among these, 98.5% (256/260) of reports indicated that the reporting tool was valuable, and 68.8% (179/260) highlighted what patients liked about reading notes and the OpenNotes patient reporting tool process. We identified 4 themes describing what patients value about note content: confirm and remember next steps, quicker access and results, positive emotions, and sharing information with care partners; and 4 themes about both patients' use of notes and the feedback tool: accuracy and correcting mistakes, partnership and engagement, bidirectional communication and enhanced education, and importance of feedback. CONCLUSIONS: Patients and care partners who read notes and submitted feedback reported greater engagement and the desire to help clinicians improve note accuracy. Aspects of what patients like about using both notes as well as a feedback tool highlight personal, relational, and safety benefits. Future efforts to engage patients through the EHR may be guided by what patients value, offering opportunities to strengthen care partnerships between patients and clinicians.

The PoET (Prevention of Error-Based Transfers) Project.

The PoET (Prevention of Error-based Transfers) Project is one of the Ethics Quality Improvement Projects (EQIPs) taking place at William Osler Health System. This specific project is designed to reduce transfers from long-term care to hospital that are caused by legal and ethical errors related to consent, capacity and substitute decision-making. The project is currently operating in eight long-term care homes in the Central West Local Health Integration Network and has seen a 56% reduction in multiple transfers before death in hospital.

Snakes and ladders: state interventions and the place of liberty in public health policy.

In this paper I outline and explore some problems in the way that the Nuffield Council of Bioethics' report Public Health: Ethical Issues (2007) presents its 'Intervention Ladder'. They see the metaphor of a ladder both as capturing key normative priorities and as making a real and important contribution to ethical policymaking in public health. In this paper I argue that the intervention ladder is not a useful model for thinking about policy decisions, that it is likely to produce poor decisions and that it is incompatible with the report's stated approach to relevant public health policy values.

When and Why Is Research without Consent Permissible?

The purpose of consent is to let a person waive her rights of control over some aspects of her life. But becoming part of a research study does not always seriously undermine one's control.

The Puck Stops Here: Taking Organizational Accountability Seriously.

This commentary presents an ethical argument and practical suggestions for holding health administrators accountable for quality improvement efforts and results. Using hockey analogies and drawing on evidence from various studies and literature in organizational ethics, it argues that health leaders must promote system performance by ensuring that there is a well-organized delivery system around patients' episodes of care and that all personnel are performing at an acceptable level. Informed by system transformation and successes in the UK, this commentary proposes four strategies to hold leaders accountable: require leaders to be familiar with front-line operations, adopt a service-line approach, evaluate organizational performance by analyzing and publicizing outcome metrics and utilize outcome-based incentives.

Oversight on the borderline: Quality improvement and pragmatic research.

Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local quality improvement to first determine whether such non-routine activities constitute research or quality improvement and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients' and clinicians' rights, well-being, and privacy in all such activities. Specifically, we recommend that (1) health care organizations should have systematic policies and processes for designating activities as routine quality improvement, non-routine quality improvement, or quality improvement research and determining what oversight each will receive. (2) Health care organizations should have formal and explicit oversight processes for non-routine quality improvement activities that may include input from institutional quality improvement experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. (3) Quality improvement research requires review by an institutional review board; for such review to be effective, institutional review boards should develop particular expertise in assessing quality improvement research. (4) Stakeholders should be included in the review of non-routine quality improvement and quality improvement-related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through quality improvement as complementary activities for improving health.

Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.

BACKGROUND: Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.