Preferences for return of incidental findings from genome sequencing among women diagnosed with breast cancer at a young age.

While experts have made recommendations, information is needed regarding what genome sequencing results patients would want returned. We investigated what results women diagnosed with breast cancer at a young age would want returned and why. We conducted 60 semi-structured, in-person individual interviews with women diagnosed with breast cancer at age 40 or younger. We examined interest in six types of incidental findings and reasons for interest or disinterest in each type. Two coders independently coded interview transcripts; analysis was conducted using NVivo 10. Most participants were at least somewhat interested in all six result types, but strongest interest was in actionable results (i.e. variants affecting risk of a preventable or treatable disease and treatment response). Reasons for interest varied between different result types. Some participants were not interested or ambivalent about results not seen as currently actionable. Participants wanted to be able to choose what results are returned. Participants distinguished between types of individual genome sequencing results, with different reasons for wanting different types of information. The findings suggest that a focus on actionable results can be a common ground for all stakeholders in developing a policy for returning individual genome sequencing results.

Withholding medical treatment from the severely demented patient. Decisional processes and cost implications.

We performed an observational study to determine the prevalence of severe dementia in a general medicine unit, the categories of acute medical care provided to these patients, the process by which treatment decisions are made, and their cost implications. The prevalence of severe dementia was 4.4%. The patients from whom some form of acute medical care was withheld (26 [45.6%] of 57) were more severely ill at admission and had a mortality rate five times higher than those who received full care. Physicians cited family wishes in 75.9% of the decisions to limit care but in only 10.9% of the decisions to give full care. The only differences in charges incurred were due to differential mortality rates in individuals from whom care was withheld. We recommend that hospitals develop and implement protocols for decision making in the care of the severely demented to promote open discussions among providers and families and to increase family contributions to decision making. We believe that the extension of this consultative approach to decisions involving severely demented patients may have the virtue of combining more humane care with more cost-effective care.

Advance directives as acts of communication: a randomized controlled trial.

BACKGROUND: Instructional advance directives are widely advocated as a means of preserving patient self-determination at the end of life based on the assumption that they improve surrogates' understanding of patients' life-sustaining treatment wishes. However, no research has examined whether instructional directives are effective in improving the accuracy of surrogate decisions. PARTICIPANTS AND METHODS: A total of 401 outpatients aged 65 years or older and their self-designated surrogate decision makers (62% spouses, 29% children) were randomized to 1 of 5 experimental conditions. In the control condition, surrogates predicted patients' preferences for 4 life-sustaining medical treatments in 9 illness scenarios without the benefit of a patient-completed advance directive. Accuracy in this condition was compared with that in 4 intervention conditions in which surrogates made predictions after reviewing either a scenario-based or a value-based directive completed by the patient and either discussing or not discussing the contents of the directive with the patient. Perceived benefits of advance directive completion were also measured. RESULTS: None of the interventions produced significant improvements in the accuracy of surrogate substituted judgment in any illness scenario or for any medical treatment. Discussion interventions improved perceived surrogate understanding and comfort for patient-surrogate pairs in which the patient had not completed an advance directive prior to study participation. CONCLUSIONS: Our results challenge current policy and law advocating instructional advance directives as a means of honoring specific patient wishes at the end of life. Future research should explore other methods of improving surrogate decision making and consider the value of other outcomes in evaluating the effectiveness of advance care planning.

When patients resist feeding. Medical, ethical, and legal considerations.

In the recent past, public and professional attention has focused on the question of whether and when it is appropriate to discontinue nutritional support from patients unable or unwilling to ingest food orally. This article addresses the special problems raised by patients who resist medical feeding. It discusses the following issues relevant to this patient group: competency to make treatment choices, decision making on behalf of incompetent patients, the competent patient's right of self-determination, and procedures for reviewing treatment decisions. Legal decisions bearing on the nourishment question are analyzed as well. Although the author concludes that cessation of nourishment is morally and legally permissible in a few cases, she also cautions that the option should be carefully and narrowly applied.

Sanctions for research misconduct: a legal perspective.

The author discusses the legal principles that could assist in the design and administration of the official response to conduct found to threaten the integrity of the scientific process. The primary emphasis is on the principles that shape decisions about punishment. In the present climate of uncertainty about misconduct, it is difficult to adopt fair and consistent approaches to the selection of sanctions and other remedial actions. Officials have taken a variety of actions in response to unacceptable research behavior. Some federal actions have involved proceedings to recover the offending grant recipients' federal funds, prohibiting them from receiving federal grants or contracts for a set period, terminating or withholding ongoing grant support, and mandating future supervision of the offenders' research conduct; and universities have denied or revoked tenure, required or accepted retirement, and disclosed misconduct findings to potential future employers. Three types of legal remedies seem to have influenced the selection of sanctions in past cases: (1) the quasi-contractual legal remedy of restitution, (2) the philosophy of "just deserts," or retribution, based on the largely intuitive idea that the individual who engages in criminal conduct deserves punishment, and (3) deterrence of misconduct. Each type has a range of considerations and implications, and officials should thoughtfully consider the appropriate role of each, because their selection of sanctions will probably have a significant effect on the research community's perceptions of the system's fairness and efficacy.

Psychiatric patients who refuse nourishment.

Recently publicized court cases focused attention on two individuals who wished to be permitted to starve themselves to death in health care facilities. These cases constitute one variation of a more common event arising in medical practice: the patient's refusal to take nourishment voluntarily. The authors discuss medical, ethical, and legal considerations relevant to such refusals and analyze two clinical examples of patients who refused nourishment. The authors suggest that physicians restrict coercive feeding to individuals who are incompetent or suffering from serious mental disorders and adamantly refuse nourishment, as for these individuals the benefits of involuntary nourishment outweigh its risks.

Hypercalcemia of advanced malignancy: decision making and the quality of death.

Hypercalcemia is a common complication of certain advanced malignancies and although not therapeutically difficult, its presence raises complex ethical issues. Treatment of this condition is most easily justified when the patient is not terminal, the benefits are tangible, and the patient agrees with therapy. Withholding treatment is defensible medically, legally, and morally when a terminal situation is present, when drawbacks exceed the benefits, and when an informed patient declines therapy. Hypercalcemia is one of a number of conditions of dying that can be controlled by the physician. The physician's decision to treat such a condition, in part, depends upon his or her view of a good death. Further study is needed to clarify and avoid those situations of dying which involve suffering. Physicians must begin this difficult analysis and dialogue if they are to fulfill their obligation to minimize suffering in all patients.

Freedom of conscience, professional responsibility, and access to abortion.

PIP: The current shortage of US physicians willing to perform induced abortions has created a conflict between women's legal right to access to pregnancy termination and physicians' right to refuse participation in a procedure they regard as morally objectionable. According to a 1993 survey, 84% of US counties (housing 30% of women of reproductive age) had no abortion provider. This situation has been exacerbated by a trend to isolate abortion from other medical procedures; in 1992, only 12% of residency programs in obstetrics and gynecology routinely offered training on first-trimester abortion. Also contributing to physician reluctance to become abortion providers have been the violence, death threats, property damage, and harassment of abortion seekers perpetrated by anti-abortion groups. To ameliorate the abortion access crisis, without intruding on the religious convictions of individual physicians, there must be greater collaboration between professional and community groups. Local community officials and pro-choice supporters are urged to use their influence to protect abortion providers from harassment. Professional organizations should provide both symbolic and practical support, e.g. increased status and remuneration, to physicians who commit to the hardship of abortion provision. Older physicians, most aware of the threat to women's health posed by any erosion of abortion rights, should educate their younger colleagues about the importance of safe abortion. Finally, training on abortion techniques should be integrated into the medical school curriculum and rotations should be established at local abortion clinics.^ieng

Developing standards in animal research review.

Thirty-two institutional animal care and use committees reviewed 4 hypothetic protocols involving experimental procedures frequently conducted on animals. Committees were in general agreement on the need to refine hypothetic protocols to minimize pain, distress, and other harm to laboratory animals. All but 2 committees sought modifications in each protocol, and in numerous instances, committees would not approve a protocol without major modifications. The committee responses delineated emerging standards governing specific areas of animal use, such as antibody production, induced disease, surgery, physical restraint, and behavioral conditioning. Committees had less consensus in their approach to assessing the justification for laboratory animal use. Apparently, this component of committee responsibilities presented the major conceptual and practical difficulties for committees engaged in animal research review.

Bound to treatment: the Ulysses contract.

KIE: Several commentators have proposed a novel legal mechanism, the "Ulysses contract" or "voluntary commitment contract," to permit mental patients with recurrent treatable disorders to consent in advance to treatment which they might reject at a time when their cognitive abilities are impaired. Dresser discusses the legal ramifications of precommitment, the implications of basing consent on a patient's past rather than current wishes, problems of enforcing Ulysses contracts given the uncertainties of psychiatric diagnosis, and the inherent paternalism of these precommitment agreements.^ieng

The incompetent patient on the slippery slope.

Most patients suffering from progressive dementia have thoughts, emotions, perspectives, and perceptions of a world of experience. Decisions about life-sustaining treatment should incorporate a principled approach to evaluating what life is like for these patients.

A pragmatic look at hospital reengineering. Successful reengineering requires the right leadership.

The market turbulence of recent years has made healthcare leaders particularly open to the management tool called "reengineering." Unfortunately, many such efforts fail because they do not go beyond simple cost cutting to create processes that, by adding value to product, attract customers. A healthcare organization planning reengineering should: Find leaders who will educate themselves in reengineering tools and techniques, talk to both proponents and opponents of reengineering, consult those staff members who are most knowledgeable about the organization's processes, and skillfully communicate the organization's vision for the future. Determine its customers' needs by, first, learning who its customers actually are and, second, consulting with them. Reengineered processes should have the built-in data-collecting and reporting mechanisms that will help the organization meet customers' standards. Get the organizations' managers on board. Since satisfying customers' needs is the reason for reengineering, the organization must not let hidden agendas torpedo the effort. Redesign its processes. To accomplish this, the organization must allocate sufficient resources for the redesign effort, assign talented employees to it, and overcome such organizational limitations as "innumeracy" among its work force.