Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine.

IMPORTANCE: Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years. OBJECTIVE: To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers. DESIGN: In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process. FINDINGS: The concept of a "reference case" and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an "impact inventory," which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses. CONCLUSIONS AND RELEVANCE: The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences.

Good medical ethics.

This paper summarises the features of my paper, 'Voluntary Active Euthanasia', and a later jointly authored paper, 'Moral Fictions', which I believe are examples of good medical ethics.

Reflections on the patient preference predictor proposal.

There are substantial data establishing that surrogates are often mistaken in predicting what treatments incompetent patients would have wanted and that supplements such as advance directives have not resulted in significant improvements. Rid and Wendler's Patient Preference Predictor (PPP) proposal will attempt to gather data about what similar patients would prefer in a variety of treatment choices. It accepts the usual goal of patient autonomy and the Substituted Judgment principle for surrogate decisions. I provide reasons for questioning sole reliance on autonomy when surrogates, not patients, are deciding and for giving some independent weight to patient well-being. Moreover, that family members, typical surrogates, will know best what the patient if incompetent would have wanted is not the only reason why they are chosen. The more pressing problem is that the PPP would fail to remove the more serious mistakes that empirical psychology over the last few decades has shown to infect such decision making.

Deactivation of pacemakers and implantable cardioverter-defibrillators.

Cardiac implantable electrical devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs), are the most effective treatment for life-threatening arrhythmias. Patients or their surrogates may request device deactivation to avoid prolongation of the dying process or in other settings, such as after device-related complications or with changes in health care goals. Despite published guidelines outlining theoretical and practical aspects of this common clinical scenario, significant uncertainty remains for both patients and health care providers regarding the ethical and legal status of CIED deactivation. This review outlines the ethical and legal principles supporting CIED deactivation, centered upon patient autonomy and authority over their own medical treatment. The empirical literature describing stakeholder views and experiences surrounding CIED deactivation is described, along with implications of these studies for future research surrounding the care of patients with CIEDs.

Prioritizing registered donors in organ allocation: an ethical appraisal of the Israeli organ transplant law.

PURPOSE OF REVIEW: A new organ transplant law in Israel, which gives priority in organ allocation to candidates who in various ways support organ donation, has resulted in a significant increase in organ donation in 2011. We provide an ethical analysis of the new law. RECENT FINDINGS: We note that by continuing to require opt-in consent, the Israeli law has an ethical advantage over opt-out laws, which may result in some use of organs from donors who have not consented. We discuss the fair response to 'free-riding' candidates who, usually for religious reasons, are opposed to donation, but nevertheless seek a transplant, who will not receive any priority over candidates who have been registered donors for at least 3 years before listing. We spell out several reasons why it is potentially unfair to prioritize patients whose first-degree relatives are registered donors, whereas it is fair to prioritize candidates who have been living directed or nondirected donors. Finally, we note the difficulty of ensuring public awareness of the priority system, which is necessary for its fairness. SUMMARY: Athough needing some modifications, the new Israeli law is based on sound ethical approach that seems to begin already to bear fruits.

Should patients receive general anesthesia prior to extubation at the end of life?.

Billings has proposed that any potentially conscious and imminently dying patient who is undergoing withdrawal of ventilator support should be offered general anesthesia to fully protect against suffering. Here we examine whether his proposal is compatible with the doctrine of double effect, a philosophical construct that is generally in accord with the legal requirements for palliative care in the United States. We review the essential elements of the doctrine of double effect, and emphasize the importance of pre-medicating patients before ventilator withdrawal (anticipatory dosing) and of titrating medications to the needs of the patient. The doctrine of double effect requires physicians to balance the risk of the patient suffering against the risk of hastening the patient's deathwhen titrating the medications used to provide comfort. We argue that the values and preferences of the patient should determine how these risks are balanced. We therefore agree with Billings that general anesthesia may be indicated for patients who prefer to minimize the risk of suffering while accepting a greater risk of having their death hastened. This approach would not be appropriate, however, for patients who place a higher value upon avoiding the risk of hastening death, even when this involves a greater risk of potential suffering.

Ethical and legal views regarding deactivation of cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy.

Little is known about patients' views surrounding the ethical and legal aspects of managing pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) near the end of life. Patients with hypertrophic cardiomyopathy (HC) are at heightened risk of sudden cardiac death and are common recipients of such devices. Patients with HC recruited from the membership of the Hypertrophic Cardiomyopathy Association were surveyed about their clinical histories, advance care planning, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy. The mean age of the 546 patients was 49.1 years, 47% were women, and 57% had ICDs. Only 46% of the respondents had completed an advance directive, only 51% had a healthcare proxy, and cardiac implantable electrical devices (CIEDs) were commonly not addressed in either (92% and 58%, respectively). Many patients characterized deactivating PMs or ICDs as euthanasia or physician-assisted suicide (29% for PMs and 17% for ICDs), and >50% expressed uncertainty regarding the legality of device deactivation. Patients viewed deactivation of ICDs and PMs as morally different from other life-sustaining therapies such as mechanical ventilation and dialysis, and these views varied substantially according to the CIED type (p <0.0001). The respondents expressed concerns regarding clinical conflicts related to religion, ethical and legal uncertainty, and informed consent. In conclusion, patients who have, or are eligible to receive, CIEDs might require improved advance care planning and education regarding the ethical and legal options for managing CIEDs at the end of life.

Value and cancer care: toward an equitable future.

Health care expenses in the United States are increasing inexorably. At the current rate of growth, it is anticipated that 20% of the gross national product will consist of health-related expenditures within the next decade. Cancer is the second leading cause of death in the United States, and it is increasing in prevalence because of the aging of the population and the limited number of successful prevention strategies. As the biological characteristics of cancer come into sharper focus, targeted therapies are being developed that offer the promise of increased clinical benefit with fewer toxicities than are associated with conventional treatment. Although spectacular successes are infrequent with this approach, to date, the majority of targeted therapies are modestly effective at best, and extremely costly. This observation suggests that a broadly acceptable definition of value in a cancer therapeutic agent is not at hand, but is sorely needed from the vantage points of the patient and society. A corollary issue of enormous import is how to equitably distribute the health care dollar in the service of achieving the greatest good for the greatest number. Although cancer is responsible for only 5% of the health care budget, its cost is increasing and it can be viewed as paradigmatic when contemplating the problem of equity in health care. Here, a number of concepts are discussed that focus on this goal and its implications for the cancer patient and society at large.

Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: a quantitative assessment.

BACKGROUND: Despite the high prevalence of pacemakers and implantable cardioverter-defibrillators, little is known about physicians' views surrounding the ethical and legal aspects of managing these devices at the end of life. OBJECTIVE: The purpose of this study was to identify physicians' experiences and views surrounding the ethical and legal aspects of managing cardiac devices at the end of life. METHODS: Survey questions were administered to internal medicine physicians and subspecialists at a tertiary care center. Physicians were surveyed about their clinical experience, legal knowledge, and ethical beliefs relating to the withdrawal of PM and ICD therapy in comparison to other life-sustaining therapies. RESULTS: Responses were obtained from 185 physicians. Compared to withdrawal of PMs and ICDs, physicians more often reported having participated in the withdrawal or removal of mechanical ventilation (86.1% vs 33.9%, P <.0001), dialysis (60.6% vs 33.9%, P <.001), and feeding tubes (73.8% vs 33.9%, P <.0001). Physicians were consistently less comfortable discussing cessation of PMs and ICDs compared to other life-sustaining therapies (P <.005). Only 65% of physicians correctly identified the legal status of euthanasia in the United States, and 20% accurately reported the legal status of physician-assisted suicide in the United States. Compared to deactivation of an ICD, physicians more often characterized deactivation of a PM in a pacemaker-dependent patient as physician-assisted suicide (19% vs 10%, P = .027) or euthanasia (9% vs 1%, P <.001). CONCLUSION: In this single-center study, internists were less comfortable discussing cessation of PM and ICD therapy compared to other life-sustaining therapies and lacked experience with this practice. Education regarding the legal and ethical parameters of device deactivation is needed.

Creating embryos for use in stem cell research.

In this paper I will address whether the restriction on the creation of human embryos solely for the purpose of research in which they will be used and destroyed in the creation of human stem cell lines is ethically justified. Of course, a cynical but perhaps accurate reading of the new Obama policy is that leaving this restriction in place was done for political, not ethical, reasons, in light of the apparent public opposition to creating embryos for use in this research. But the issue of whether the restriction is ethically justified remains important, even if only for another day in the policy arena.

The dead donor rule: can it withstand critical scrutiny?

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)-the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured.

Ethical and value issues in insurance coverage for cancer treatment.

Many new cancer drugs provide only limited benefits, but at very great cost, for example, $200,000-$300,000 per quality-adjusted life year produced. By most standards of value or cost-effectiveness, this does not represent good value. I first review several of the causes of this value failure, including monopoly patents, prohibitions on Medicare's negotiating on drug prices, health insurance protecting patients from costs, and financial incentives of physicians to use these drugs. Besides value or cost-effectiveness, the other principal aim in health care resource allocation should be equity among the population served. I examine several equity considerations-priority to the worse off, aggregation and special priority to life extension, and the rule of rescue-and argue that none justifies greater priority for cancer treatment on the grounds of equity. Finally, I conclude by noting two recent policy changes that are in the wrong direction for achieving value in cancer care, and suggesting some small steps that could take us in the right direction.

Moral fictions and medical ethics.

Conventional medical ethics and the law draw a bright line distinguishing the permitted practice of withdrawing life-sustaining treatment from the forbidden practice of active euthanasia by means of a lethal injection. When clinicians justifiably withdraw life-sustaining treatment, they allow patients to die but do not cause, intend, or have moral responsibility for, the patient's death. In contrast, physicians unjustifiably kill patients whenever they intentionally administer a lethal dose of medication. We argue that the differential moral assessment of these two practices is based on a series of moral fictions - motivated false beliefs that erroneously characterize withdrawing life-sustaining treatment in order to bring accepted end-of-life practices in line with the prevailing moral norm that doctors must never kill patients. When these moral fictions are exposed, it becomes apparent that conventional medical ethics relating to end-of-life decisions is radically mistaken.

Ethical challenges in long-term funding for HIV/AIDS.

The global response to the AIDS pandemic aims for universal access to treatment and for pursuing every possible avenue to prevention. Skeptics, doubting that the huge increases in current funding levels needed for universal treatment will ever happen, would scale back antiretroviral treatment in favor of more cost-effective preventive interventions. Economics, politics, and science figure in this debate. But there is also a question of ethical principle: Is there a moral imperative to emphasize treatment, even if emphasizing prevention would save more lives? The authors examine moral arguments that address this question, and come down on the side of saving the most lives via prevention.

Last-resort options for palliative sedation.

Despite receiving state-of-the-art palliative care, some patients still experience severe suffering toward the end of life. Palliative sedation is a potential way to respond to such suffering, but access is uneven and unpredictable, in part because of confusion about different kinds of sedation. Proportionate palliative sedation (PPS) uses the minimum amount of sedation necessary to relieve refractory physical symptoms at the very end of life. To relieve suffering may require progressive increases in sedation, sometimes to the point of unconsciousness, but consciousness is maintained if possible. Palliative sedation with the intended end point of unconsciousness (PSU) is a more controversial practice that may be considered for much fewer refractory cases. There is more ethical consensus about PPS than PSU. In this article, the authors explore the clinical, ethical, and legal issues associated with these practices. They recommend that palliative care and hospice programs develop clear policies about PPS and PSU, including mechanisms for training and ensuring competency for clinicians, and approaching situations where individuals or institutions may conscientiously object.

Conscientious refusal by physicians and pharmacists: who is obligated to do what, and why?

Some medical services have long generated deep moral controversy within the medical profession as well as in broader society and have led to conscientious refusals by some physicians to provide those services to their patients. More recently, pharmacists in a number of states have refused on grounds of conscience to fill legal prescriptions for their customers. This paper assesses these controversies. First, I offer a brief account of the basis and limits of the claim to be free to act on one's conscience. Second, I sketch an account of the basis of the medical and pharmacy professions' responsibilities and the process by which they are specified and change over time. Third, I then set out and defend what I call the "conventional compromise" as a reasonable accommodation to conflicts between these professions' responsibilities and the moral integrity of their individual members. Finally, I take up and reject the complicity objection to the conventional compromise. Put together, this provides my answer to the question posed in the title of my paper: "Conscientious refusal by physicians and pharmacists: who is obligated to do what, and why?".