Derivation of the uncontrolled donation after circulatory determination of death protocol for New York city.

Evidence from Europe suggests establishing out-of-hospital, uncontrolled donation after circulatory determination of death (UDCDD) protocols has potential to substantially increase organ availability. The study objective was to derive an out-of-hospital UDCDD protocol that would be acceptable to New York City (NYC) residents. Participatory action research and the SEED-SCALE process for social change guided protocol development in NYC from July 2007 to September 2010. A coalition of government officials, subject experts and communities necessary to achieve support was formed. Authorized NY State and NYC government officials and their legal representatives collaboratively investigated how the program could be implemented under current law and regulations. Community stakeholders (secular and religious organizations) were engaged in town hall style meetings. Ethnographic data (meeting minutes, field notes, quantitative surveys) were collected and posted in a collaborative internet environment. Data were analyzed using an iterative coding scheme to discern themes, theoretical constructs and a summary narrative to guide protocol development. A clinically appropriate, ethically sound UDCDD protocol for out-of-hospital settings has been derived. This program is likely to be accepted by NYC residents since the protocol was derived through partnership with government officials, subject experts and community participants.

The quality improvement-research divide and the need for external oversight.

Historically, quality assurance studies have received scant ethical attention. The advent of information systems capable of supporting research-grade continuous quality improvement projects demands that we clearly define how these projects differ from research and when they require external review. The ethical obligation for the performance of quality assurance projects, with its emphasis on identifiable immediate action for a served population, is a critical distinction. The obligation to perform continuous quality improvement is a deliverable of the social contract entered into implicitly by patients and health care providers and systems. In this article, the authors review the ethical framework that requires these studies, evaluate the differences between quality assurance studies and classic research, and propose criteria for requiring external review.

A new paradigm for HIV care: ethical and clinical considerations.

Although dramatic advances in clinical treatment have greatly improved the lives of many people with HIV/AIDS, many other patients do not have information about or access to these treatments because of health care providers' presumptive judgments about patients' ability to adhere to medical regimens. The authors contend that with sufficient support and education most patients, even those with difficult social and medical problems, can be helped to initiate and maintain HIV treatment in accordance with current clinical standards. This commentary delineates a new paradigm for HIV care in which patients and providers collaborate on individualized plans to establish patients' readiness for treatment, ensure maintenance of treatment, and make use of the social services necessary to accomplish these goals. Providers have an ethical responsibility to do everything possible to see that patients who might benefit from new HIV treatments have a fair opportunity to do so, and health systems have a responsibility to facilitate this process. Substantial progress toward meeting these responsibilities can be made within the current health care environment.

The difficult, demanding, and demented AIDS patient in long-term care.

Demented AIDS patients in long-term care present interconnected medical, ethical, and management problems. The patient's right to care must be considered in the context of the obligations owed to other residents and to staff members. A principled analysis should focus on substantive and procedural issues: the concept of autonomy must be modified by notions of accommodation to the needs of others; procedural fairness should guide discussions. A dynamic analysis should identify the various parties, their conflicting interests, and possible routes for resolving differences.

Self-reported legal needs of women with or at risk for HIV infection. The Her Study Group.

Women at risk for human immunodeficiency virus (HIV) infection are often poor and members of racial or ethnic minorities. In addition to legal concerns that might be common among persons with similar sociodemographic characteristics, HIV infection adds the potential of possible stigma and discrimination, as well as the prospect of illness and increased mortality. To determine women's perceptions of need for and access to legal services and whether such perceptions are affected by HIV infection, from November 1993 through September 1995 we interviewed 509 women with or at risk for HIV infection by virtue of injection drug use or high-risk sexual behaviors in New York and Baltimore, Maryland. A majority of women, regardless of HIV serostatus, reported current or future needs for legal assistance with government benefits. More than 25% reported needing current or future legal help with housing, debts, arrangements for care of children, a will, and advance directives. Substantial minorities of women reported other legal needs. HIV-positive women were significantly more likely to report anticipated future need for help with paternal custody or visitation, current need in making a will, and anticipated future assistance with advance directives. For most items, a majority of women thought they knew where to receive help. However, among women reporting a current need, only a minority actually were receiving legal assistance. This study suggests that the extent of legal needs among women with or at risk for HIV infection is substantial, and that few receive legal assistance. With few exceptions, at least for women early in the course of illness, HIV infection does not appear to alter the pattern or extent of legal needs. There are dramatic differences, regardless of HIV status, between expectation and reality in women's access to legal services.

A noncompliant patient with fluctuating capacity.

Because of intermittent refusal of both dialysis and medications, serial capacity assessments were made on a 38-year-old male on hemodialysis and receiving TB treatment. His capacity to make an informed treatment decision appeared to fluctuate and despite multidisciplinary involvement and a court determination that treatment should take place, questions remained as to how such a case should be managed in the patient's best interest. The process of making a capacity determination was reviewed from both a psychiatric and legal viewpoint and alternative strategies presented.

Rethinking nonadherence: historical perspectives on triple-drug therapy for HIV disease.

The advent of triple-drug therapy for HIV disease has raised the concern that disadvantaged patients with multiple social problems may be nonadherent to treatment. Fearing that partial adherence will lead to drug resistance, some clinicians are withholding these powerful new drugs from such patients. The historical record demonstrates that labeling patients as nonadherent may be both stigmatizing and inaccurate. Since 1900, such adjectives as ignorant, vicious, and recalcitrant have been used to describe patients who do not follow medical advice. Less judgmental terms, such as nonadherent and noncompliant, are now used, but these terms still imply that patients should obey physician-imposed regimens. Studies of nonadherence have consistently shown that the problem is widespread among all persons and cannot reliably be predicted on the basis of patient characteristics. This paper argues that physicians should deemphasize the standard approach of predicting and correcting nonadherent behavior in certain patients. Rather, clinicians should encourage all HIV-positive patients to devise individualized treatment plans that can facilitate reliable ingestion of medication. Although the potential development of resistance to triple-drug therapy remains an important public health issue, concern about this possibility must be balanced with respect for patients' rights. Encouraging the active participation of HIV-positive persons in their own treatment will help avoid judgmental and inaccurate assessments of patient behavior and may help patients take medications more successfully.

The medical psychiatrist as physician for the chronically mentally ill.

A 60-year-old black female with chronic paranoid schizophrenia was admitted to the Medical Service for a workup because of severe iron deficiency anemia; she refused the workup. She was found to be acutely psychotic and incapable of informed medical decision making. The management of her medical workup by her medical/C-L psychiatrist led to a diagnosis of colon cancer, and subsequent surgery. The case is discussed here by a consultation-liaison psychiatrist and a lawyer bioethicist. It illustrates the role of medical/C-L psychiatrists as physicians for chronically mentally ill patients with serious medical illness in the general hospital, who guide the medical/surgical care of these patients without powerful negative countertransference bias, thus balancing respect for patient autonomy with advocacy for medical "best interests."

Mediation and managed care.

Managed care has not only intensified existing conflicts between patient and provider, it has, by its very nature, changed the shape and scope of the healthcare enterprise and introduced an entirely new set of disputes. The decision-making dynamics have been altered, and the cast of players has expanded. Traditionally, the therapeutic interaction took place between the physician and the patient although it occasionally included the patient's family. Whatever obligations existed, such as fidelity, confidentiality, and standard of care, they bound only those parties. Now, as the managed care organization has interposed itself between the patient and the physician, the dyad has become a triad. The power balance has shifted, and a new set of rights and responsibilities now flows between and among the players, each of whom has interests that may or may not coincide. This article argues that, because of its cost containment origins and orientation, managed care increases the likelihood that misunderstandings, disagreements and disputes will develop into full-blown conflicts. If managed care is to succeed financially and operate with integrity, it must develop techniques for managing the increasing conflicts that arise inevitably between and among the organizations, physicians, and patients. It is clear that the voice of the patient needs to be strengthened within the new complex decision-making, review, and appeal procedures. Mediation is the most appropriate method of dispute resolution for the managed care setting because it balances the disparities in power endemic to the bureaucratization of medicine and refocuses the interests of the various parties. Using bioethics consultation as a model for dispute mediation provides a set of principles and guideline tasks that can be applied effectively to managed care.

The Health Care Provider's Role in Adolescent Medical Decision-Making.

In caring for adolescent patients, health care providers often face problems other than their medical conditions. This chapter presents three case studies that illustrate a diversity of ethical questions that arise in the context of adolescent health care. The investigators present and define the basic ethical principles that should govern a health care provider's approach to treating an adolescent. Even though this study was primarily directed toward adolescents who live without proper adult supervision, the principles and guidelines derived from this study can apply to the health care of all adolescents.

Guidelines for adolescent health research: a position paper of the society for adolescent medicine.

Their ambiguous legal and ethical status has become a barrier to adolescents' appropriate involvement in research from which they may benefit and which is needed to improve adolescent health care and to inform health policy. Involvement of adolescents in research should be based on a scientific and empathetic understanding of their developing capabilities and a careful assessment of risks and benefits. The important role of parents and communities as protectors of adolescents should be respected and enhanced as we acknowledge and respect developing adolescent autonomy. These guidelines provide a framework to interpret the federal regulations for protection of human subjects in light of the unique legal, ethical, developmental, contextual, and racial issues that affect adolescents. The guidelines are designed to protect individual adolescent research subjects and to facilitate important youth research that would promote the health of adolescents.

The doctor-proxy relationship: the neglected connection.

Advance directives have been lauded by scholars and supported by professional organizations, Congress, and the United States Supreme Court. Despite this encouragement, only a small number of capable patients execute living wills or appoint health care agents. When patients do empower proxies, doctors may be uncertain about the scope of their duties and obligations to these persons who, in theory, stand in the shoes of the patient. This article argues for a conscious focus on the ethical duties, emotional supports, and guidance owed by physicians to health care agents.

Preserving the physician-patient relationship in the era of managed care.

Even without comprehensive health care reform legislation, the US health care system is undergoing significant changes. Probably the most important change is the expansion of managed care with significant price competition. One of the major concerns about this change is the effect of managed care on the physician-patient relationship. To provide a normative standard for evaluating the effect of changes, we need an ideal conception of the physician-patient relationship. This ideal can be summarized by six C's: choice, competence, communication, compassion, continuity, and (no) conflict of interest. For the 37 million uninsured Americans there is little chance of realizing the ideal physician-patient relationship, since they lack the choice of practice setting and physician, receive care in a rushed atmosphere that undermines communication and compassion, and have no continuity of care. While many insured Americans may believe they have an ideal physician-patient relationship, the relationship is threatened by lack of a regular assessment of competence, by financial incentives that undermine good communication, and by the persistence of conflict of interest. The shift to managed care may improve the choice of practice settings, especially in sections of the country that currently lack managed care; increase choice of preventive services; make quality assessments more routine; and improve communication by making greater use of primary care physicians and nonphysician providers. However, the expansion of managed care and the imposition of significant cost control have the potential to undermine all aspects of the ideal physician-patient relationship. Choice could be restricted by employers and by managed care selection of physicians; poor quality indicators could undermine assessments of competence; conductivity requirements could eliminate time necessary for communication; changing from one to another managed care plan to secure the lowest costs could produce significant disruption in continuity of care; and use of salary schemes that reward physicians for not using medical services could increase conflict of interest.