Researchers' preferences and attitudes on ethical aspects of genomics research: a comparative study between the USA and Spain.

INTRODUCTION: The use of human samples in genomic research has increased ethical debate about informed consent (IC) requirements and the information that subjects should receive regarding the results of the research. However, there are no quantitative data regarding researchers' attitudes about these issues. METHODS: We present the results of a survey of 104 US and 100 Spanish researchers who had published genomic epidemiology studies in 61 journals during 2006. RESULTS: Researchers preferred a broader IC than the IC they had actually obtained in their published papers. US authors were more likely than their Spanish colleagues to support obtaining a broad IC, covering either any future research project or any projects related to a group of diseases (67.6% vs 43%; adjusted OR = 4.84, 95% CI, 2.32 to 10.12). A slight majority of researchers (55.8%) supported informing participants about individual genomic results only if the reliability and clinical validity of the information had been established. Men were more likely than women to believe that patients should be informed of research results even if these conditions were not met (adjusted OR = 2.89, 95% CI = 1.46 to 5.72). CONCLUSIONS: This study provides evidence of a wide range of views among scientists regarding some controversial ethical issues related to genomic research, suggesting the need for more study, debate and education. In the interim, journals might consider including the investigators' policies regarding these ethical issues in the papers they publish in the field of genomic epidemiology.

Decision-making in patients with advanced cancer compared with amyotrophic lateral sclerosis.

AIM: Patients with advanced cancer need information about end-of-life treatment options in order to make informed decisions. Clinicians vary in the frequency with which they initiate these discussions. PATIENTS AND METHODS: As part of a long-term longitudinal study, patients with an expected 2-year survival of less than 50% who had advanced gastrointestinal or lung cancer or amyotrophic lateral sclerosis (ALS) were interviewed. Each patient's medical record was reviewed at enrollment and at 3 months for evidence of the discussion of patient wishes concerning ventilator support, artificial nutrition and hydration (ANH), resuscitation (DNR) and hospice care. A Kaplan-Meier analysis was also performed and 2-year survival calculated. RESULTS: 60 cancer and 32 ALS patients were enrolled. ALS patients were more likely than cancer patients to have evidence of discussion about their wishes for ventilator support (31% vs 0%, p<0.001), ANH (38% vs 0%, p<0.001), DNR (25% vs 0%, p<0.001) and hospice care (22% vs 5%, p = 0.03). At 6 months, 91% of ALS patients were alive compared with 62% of cancer patients; at 2 years, 63% of ALS patients were alive compared with 23% of cancer patients (p<0.001). CONCLUSIONS: Cancer patients were less likely than ALS patients to have had documented advanced care planning discussions despite worse survival. This may reflect perceptions that ALS has a more predictable course, that advanced cancer has a greater number of treatment options, or differing views about hope. Nevertheless, cancer patients may be less adequately prepared for end-of-life decision-making.

Physicians' confidence in discussing do not resuscitate orders with patients and surrogates.

PURPOSE: Physicians are often reluctant to discuss "Do Not Resuscitate" (DNR) orders with patients. Although perceived self-efficacy (confidence) is a known prerequisite for behavioural change, little is understood about the confidence of physicians regarding DNR discussions. SUBJECTS AND METHODS: A survey of 217 internal medicine attendings and 132 housestaff at two teaching hospitals about their attitudes and confidence regarding DNR discussions. RESULTS: Participants were significantly less confident about their ability to discuss DNR orders than to discuss consent for medical procedures (p<0.001), and this was true for both attendings (p = 0.002) and housestaff (p<0.001). In a multivariate logistic model of confidence regarding DNR discussions, women were less confident than men (OR = 0.52, CI = 0.29 to 0.92); house officers were less confident than attendings (OR = 0.35, CI = 0.20 to 0.61), those who were less confident of their ability to discuss medical procedures were less confident discussing DNR (OR = 0.12, CI = 0.06 to 0.25), and those who found talking to patients about DNR orders very difficult reported less confidence than those who did not (OR = 0.06, CI = 0.02 to 0.16). CONCLUSION: We conclude that physicians' confidence regarding DNR discussions is low compared with their confidence regarding other medical discussions and that confidence varies by sex and perceived difficulty of the task. Efforts to improve DNR discussions should explore the need to tailor educational interventions to fit these characteristics.

Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception.

The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.

I was sick and you came to visit me: time spent at the bedsides of seriously ill patients with poor prognoses.

PURPOSE: To learn how much time hospital staff and families spend at the bedsides of seriously ill patients with poor prognoses. SUBJECTS AND METHODS: An observational study was made of 58 inpatients with cancer, acquired immunodeficiency syndrome, heart failure, obstructive lung disease, or advanced dementia, along with their families and the physicians and nurses working on the medical floors of a university hospital, using direct videotape surveillance of patients' doorways. RESULTS: The mean (+/-SD) total visitor-minutes spent in the rooms of these patients was 321 +/- 297 minutes per day. On average, patients spent 18 hours 39 minutes per day alone. Mean visit durations were 3 +/- 3 minutes for attending physicians (including consultants), 3 +/- 2 minutes for house officers, 2 +/- 1 minutes for nurses, and 24 +/- 51 minutes for family. The total person-visits per patient per day were 3 +/- 3 for attending physicians, 9 +/- 8 for house officers, 45 +/- 23 for nurses, and 13 +/- 21 for family. Patient sex and age were not significantly associated with total visitor-minutes. In a repeated-measures analysis of variance model, nonwhite patients received fewer total visitor-minutes than did white patients, and patients with dementia received fewer total visitor-minutes than did patients with other diagnoses, especially those with malignancy. Do-not-resuscitate orders were associated with slightly more total visitor-minutes. CONCLUSIONS: These seriously ill patients with poor prognoses spent most of their time in the hospital alone. Staff visits were frequent but brief. These data do not confirm anecdotal reports that staff members spend less time at the bedsides of patients with do-not-resuscitate orders. Patients with advanced dementia and minority patients appear to have less bedside contact. Further study is required to confirm these findings and to understand optimal visit time for medical inpatients with poor prognoses.

Physician-assisted suicide.

Medical professional codes have long prohibited physician involvement in assisting a patient's suicide. However, despite ethical and legal prohibitions, calls for the liberalization of this ban have grown in recent years. The medical profession should articulate its views on the arguments for and against changes in public policy and decide whether changes are prudent. In addressing such a contentious issue, physicians, policymakers, and society must fully consider the needs of patients, the vulnerability of particular patient groups, issues of trust and professionalism, and the complexities of end-of-life health care. Physician-assisted suicide is prominent among the issues that define our professional norms and codes of ethics. The American College of Physicians-American Society of Internal Medicine (ACP-ASIM) does not support the legalization of physician-assisted suicide. The routine practice of physician-assisted suicide raises serious ethical and other concerns. Legalization would undermine the patient-physician relationship and the trust necessary to sustain it; alter the medical profession's role in society; and endanger the value our society places on life, especially on the lives of disabled, incompetent, and vulnerable individuals. The ACP-ASIM remains thoroughly committed to improving care for patients at the end of life.

At wit's end: forgiveness, dignity, and the care of the dying.

Medical commentators on the play W;t by Margaret Edson, have tended to highlight the play's medical themes in the hope that this will help to improve the care of the dying. In this essay, the author argues that a close reading of the play suggests an alternative approach. This approach would require physicians to become personally engaged with the play's broad underlying themes, in particular the themes of dignity, relationship, and forgiveness. Physicians who do this might be able to undergo the sort of personal transformation that could allow them to relate to dying patients more fully as fellow human beings. Such a reaction to the play by physicians might truly and radically improve the care of the dying.

On the current state of clinical ethics.

Practitioners of pain medicine and palliative care may already be quite familiar with clinical ethics, yet still uncertain about the precise nature of the field and the scope of its activities. Clinical ethics is centrally concerned with the ethics of the encounter between the healthcare professional and the patient in clinical care settings. It is thus a subset of bioethics, and distinct from research ethics and organizational ethics. The various ways of organizing teaching activities, research programs, and case consultations in clinical ethics are described and critiqued. The author describes some new and emerging ideas and practices in clinical ethics, speculates about future directions for the field, and concludes with a call for greater collaboration between practitioners of pain medicine and clinical ethicists.

Commentary: double effect--intention is the solution, not the problem.

While the author believes that Nuccetelli and Seay have not succeeded in replacing the Rule of Double Effect with a more workable and practical moral principle, he believes they have emphasized a frequently overlooked element: that certain clear conditions must first be met before the Rule can be applied.

Measuring the effects of managed care on physicians' perceptions of their personal financial incentives.

Using data from the 1997 Resurvey of Young Physicians (N = 1,549), this study examines whether several measures of physicians' contractual arrangements with health plans are associated with their perceptions of overall financial incentives to either decrease or increase the volume of services to patients. Results indicate the following factors were significantly associated with an increased likelihood of reporting an incentive to decrease services: a gatekeeper arrangement with a compensation incentive; the perception of a high risk of plan deselection for physicians with high costs; the perception that referrals received depended on the costs of care provided; communication prohibiting or discouraging the disclosure to patients of the physician's financial relationship with the health plan; receiving capitation payments from at least one plan; and employment in a health maintenance organization. Being compensated on a fee-for-service basis or receiving a salary with incentive or bonus provisions (compared to straight salary) were associated with an increased likelihood of reporting an incentive to increase services to patients. Physicians' overall methods of compensation had a relatively small impact on their perceived financial incentives compared to other statistically significant factors. Our findings suggest that physicians' self-reported, overall personal financial incentives within their practices are a valid summary measure of the heterogeneous mix of specific financial arrangements faced by most physicians.

Physicians' ethical beliefs about cost-control arrangements.

BACKGROUND: Although much has been written about the ethics of new methods of health care financing, little is known about the extent to which physicians experience these cost-control arrangements as ethical problems. METHOD: A cross-sectional telephone survey of 1,549 physicians, 8 to 17 years after residency, randomly selected from 75 US metropolitan service areas (response rate, 74.0%). RESULTS: Only 17.0% believed that financial incentives to limit services are ethically acceptable. Although 52.9% thought that physicians should try to abide by guidelines discouraging the use of interventions with possible but unproven benefit, only 14.5% thought such guidelines should be enforced by payers. Only 5.7% thought that it was morally acceptable for payers to discourage physicians from telling patients about their personal financial incentives, and only 9.1% found compliance with such restrictions morally acceptable. Changes in the health care system in the past 5 years were believed to have had a negative impact on their own patients' trust in them by 50.6%, and 80.8% believed that changes in the health care system in the past decade have diminished physicians' commitment to an ethic of undivided loyalty to patients. In multiple regression analysis, physicians who reported that the overall personal financial incentives in their practices encouraged them to reduce services were significantly more likely to have ethical objections to such incentives, to believe their own patients' trust in them had diminished, and to believe that the ethic of undivided loyalty to patients had diminished. CONCLUSIONS: Many of the methods now commonly used to influence medical decision making are considered ethically objectionable by most midcareer physicians. Whether their ethical disquiet about these arrangements is justified cannot be answered from these data.