Sandra H. Johnson

Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana

BACKGROUND Preexposure prophylaxis with antiretroviral agents has been shown to reduce the transmission of human immunodeficiency virus (HIV) among men who have sex with men; however, the efficacy among heterosexuals is uncertain. METHODS We randomly assigned HIV-seronegative men and women to receive either tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or matching placebo once daily. Monthly study visits were scheduled, and participants received a comprehensive package of prevention services, including HIV testing, counseling on adherence to medication, management of sexually transmitted infections, monitoring for adverse events, and individualized counseling on risk reduction; bone mineral density testing was performed semiannually in a subgroup of participants. RESULTS A total of 1219 men and women underwent randomization (45.7% women) and were followed for 1563 person-years (median, 1.1 years; maximum, 3.7 years). Because of low retention and logistic limitations, we concluded the study early and followed enrolled participants through an orderly study closure rather than expanding enrollment. The TDF-FTC group had higher rates of nausea (18.5% vs. 7.1%, P<0.001), vomiting (11.3% vs. 7.1%, P=0.008), and dizziness (15.1% vs. 11.0%, P=0.03) than the placebo group, but the rates of serious adverse events were similar (P=0.90). Participants who received TDF-FTC, as compared with those who received placebo, had a significant decline in bone mineral density. K65R, M184V, and A62V resistance mutations developed in 1 participant in the TDF-FTC group who had had an unrecognized acute HIV infection at enrollment. In a modified intention-to-treat analysis that included the 33 participants who became infected during the study (9 in the TDF-FTC group and 24 in the placebo group; 1.2 and 3.1 infections per 100 person-years, respectively), the efficacy of TDF-FTC was 62.2% (95% confidence interval, 21.5 to 83.4; P=0.03). CONCLUSIONS Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).

Data Elements for Emergency Department Systems, Release 1.0 (DEEDS): A Summary Report

See editorial, p 274. Variations in the way that data are entered in emergency department record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Preventions National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnerships initial product, Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems-such as data incompatibility and high costs of collecting, linking, and using data-can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations. [DEEDS Writing Committee: Data Elements for Emergency Department Systems, Release 1.0 (DEEDS): A summary report. Ann Emerg Med February 1998;31:264-273.].

Disciplinary Actions and Pain Relief: Analysis of the Pain Relief Act

Debilitating pain is a widespread problem that cuts across many patient populations. Despite a recognized ethical duty to relieve pain and effective pain management capabilities, health care professionals continue to undertreat pain. Improved pain management begins with consideration of reasons pain is presently undertreated. Fear of disciplinary action is a central barrier to effective pain management. The Pain Relief Act represents an effort to mitigate this fear by preventing unnecessary investigations, protracted proceedings, and inappropriate legal sanctions for pain treatment.This article begins by recognizing doctors’ legitimate fears of legal sanctions. While few doctors are actually penalized due to pain treatment, the threat of disciplinary action or prosecution is severe because of the substantial burdens imposed by such actions.Next, the article explains how and why a statutory response is specially suited to promote effective pain management. On the state level, “intractable pain” statutes can clearly remove threats of adverse action, promote legal continuity, and provide an external standard by which state medical board policies and actions can be reviewed. The article then addresses the Pain Relief Act, designed to work in conjunction with state statutory frameworks to protect providers who are in substantial compliance with accepted practice guidelines. Finally, the article concludes by comparing areas in which the Act is broader or narrower than current statutes.

The Fear of Liability and the Use of Restraints in Nursing Homes

In nursing homes, restraints are intended to protect residents with mental or physical disabilities from avoidable injuries. However, dangers inherent in the use of restraints on elderly patients - including strangulation, agitation, and unnecessary immobility - weigh strongly against restraints’ protective effects. This article identifies the risk of liability as a factor contributing to the overuse of restraints and argues against such defensive practice on legal, regulatory, and ethical grounds.The article first considers liability sourced in negligence/malpractice litigation on restraints and highlights the often inflated and unreasonable perception of risk here. An examination of the reported cases involving restraints reveals that there are few; that courts are careful to distinguish the circumstances in which facilities are held liable; and that the use of expert testimony can effectively insulate nursing homes from liability. Next, the article identifies legal responses to the overuse of restraints due to claims of liability fear. In addition to encouraging litigation for the overuse of restraints, prohibiting the overuse directly through regulation may help to curb this defensive practice. Comparing two cases involving restraint statutes, the article explains that effective public regulation requires not only sensitivity to physician judgment but also a change in structural biases supporting restraints. The article concludes by analytically assessing the “fear of liability” defense. The overuse of restraints reflects conflict over the most fundamental issues in long-term care. It is a symptom of inadequate models for long-term care, not simply a naive reaction to a fear of liability.

Data elements for emergency department systems, release 1.0 (DEEDS): A summary report

Variations in the way that data are entered in ED record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Preventions (CDC) National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnerships initial product. Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems--such as data incompatibility and high costs of collecting, linking, and using data--can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations.

Making Room for Dying: End of Life Care in Nursing Homes

The cornerstone of contemporary nursing home care is a commitment to patient rehabilitation. Improved care is an important and worthwhile goal, but it is a goal that has yet to make room for the dying. A significant proportion of older people will spend their final days in a nursing home. This article calls for a culture shift in nursing home care to promote improved care for not only those who can be rehabilitated but also those who are dying. This article begins by addressing challenges to achieving this culture that are particular to the nursing home context. It then explains how adjusting the general framework for end of life decision-making to better account for the nursing home context can help make room for the dying. End of life care should be framed around issues that commonly face the dying rather than the extreme scenario of, for example, the person in the vegetative state. Focusing on more common issues may help to reduce incidences of unnecessary hospitalization and improve pain treatment at the end of life. The article concludes by considering three fundamental assumptions in the current structure for end of life decision-making that are particularly ill-suited to the nursing home environment. First, the concept that palliative care is synonymous with “care for the dying” may cause providers to withhold such care until an individual is labeled as “dying.” Second, it is problematic to single-mindedly focus on the autonomy of the patient in end of life decisions when family members and caregivers are integrally involved in long-term care. Third and finally, the legal structure of end of life decisions weighs in favor of medical intervention, and this may affect one’s ability to opt for palliative care.

Providing Relief to Those in Pain: A Retrospective on the Scholarship and Impact of the Mayday Project

cholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better S in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain. With the generous and steadfast support of the Mayday Fund, the American Society of Law, Medicine & Ethics (ASLME) has generated a significant body of scholarship published in the Journal ofLaw;Medicine &Ethics VLME). This research has proven absolutely essential in changing public policy to support better care for those who suffer pain. Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect. If physicians and health care institutions believe, even wrongly, that they cannot do what needs to be done for their patients for example, because the providers believe that they will be at risk for discipline or prosecution or because payment will be denied it seriously decreases the likelihood that patients will receive the care they need. The Mayday Project at ASLME began by listening to health care providers in surveys, in the literature, and at meetings talk about why pain is undertreated and what obstacles they experienced in their own practices. The research, then, mapped out the characteristics of these obstacles and always with an eye toward identifying what reflected reality, what was merely perceived, and what could be done in either case to remove barriers to pain relief.

PSDA in the Nursing Home

As long-term care providers comply with the Patient Self-Determination Act they will confront the substantial differences that exist between nursing homes and hospitals in relation to health care decisionmaking. These differences arise first from the notion that nursing home care is less trustworthy than hospital care and requires more public oversight. Second, the regulatory system applicable to nursing homes is quite different from that applicable to hospitals and other caregivers and has a significant impact on treatment decisionmaking. A third difference between nursing homes and hospitals lies in the structures of caregiving and governance in most nursing homes. Finally, the informed consent model of health care decisionmaking bas not found a precise fit in nursing home care. In Conroy (486 A.2d 1209 [N.J. 1985]), the New Jersey Supreme Court established a special regime for discontinuation of treatment in nursing homes which required, among other things, that a state Nursing Home Ombudsman be notified prior to any discontinuation of treatment. The ombudsman was directed by the court to consider every notification of withdrawal of life-sustaining treatment as a possible abuse and, in consequence, to conduct an investigation. The contrasts between this approach and that of the same court in Quinlan are quite obvious and relate to the courts view that nursing homes require more public scrutiny than do hospitals. More recently, in Greenspan (558 N.E.2d 1194 [Ill. 19901) it was argued that withdrawal of a feeding tube from an incompetent patient would always violate Illinois law requiring nursing homes to provide shelter and assistance with meals and prohibited neglect of nursing home residents. Although the court ultimately rejected this claim, these two cases provide some glimpse of a deeply held assumption concerning nursing home care: that withdrawal of treatment is abusive and illegal. Whether nursing home residents as a group should be treated differently from other individuals in regard to treatment decisions is a public policy question that remains unresolved. Regulations governing quality of care in nursing homes are quite different from those applicable to hospitals, and that too has had an impact on how refusals of treatment are handled. Unlike the regulation of hospitals, nursing home regulation does not initially defer to the judgment of the individual health care providers or to the internal quality assurance mechanisms of the facility. Rather, enforcement is a high priority, capturing the lions share of the budget for enforcing health care regulations in most states. The emphasis on enforcement and supervision by public agencies makes administrators risk averse to any action that would attract investigation. Substantively, the regulatory emphasis on treatment, which tends to view nontreatment as an abuse or violation of standards unless proven otherwise, makes discontinuation of treatments risky. Despite changes that allow withdrawal and withholding of treatment, in practice institutional policies on advance directives may still reflect a fear of nontreatment. Thus in complying with the Patient Self-Determination Act, facilities may communicate a de facto requirement of a written advance directive prior to decisions to discontinue or forgo treatment. …

Customary standard of care: a challenge for regulation and practice.

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physicians performance and measures it against the standard of care. The professions prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the professions custom as the measure against which a physicians performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances. Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high-quality and substandard care. In particular, advocacy for evidence-based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect.

Setting limits on death: a view from the United States.

Assisted suicide is a tragic issue, one of those for which the tools of mere logic are inadequate and in which the power of the individual case is compelling and seductive but not necessarily clarifying. Meaningful dialogue is difficult. Persuasion is limited because the resolution of the issue, on a moral level, must be founded upon fundamental notions of what it means to be human, especially in the midst of suffering or disability or at the point of death.