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Biomedical subjects

M Siegler

Publications and source records attributed to M Siegler.

At least 19 recordsLinked to original sources

Perceptions of cancer patients and their physicians involved in phase I trials.

PURPOSE: In an attempt to understand some of the complex issues related to the participation of cancer patients in phase I trials, and the perceptions of patients toward these trials, we conducted a pilot survey study of 30 cancer patients who had given informed consent to participate in a phase I trial at our institution. Concurrently, the oncologists identified by the surveyed patients as responsible for their care were surveyed as well. PATIENTS AND METHODS: Twenty-seven of 30 consecutive patients agreed to and completed the survey. Patients were surveyed before they received any investigational agents. Eighteen oncologists participated in this survey study. RESULTS: Eighty-five percent of patients decided to participate in a phase I trial for reasons of possible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that they understood all (33%) or most (60%) of the information provided about the trials in which they had decided to participate. Only 33% were able to state the purpose of the trial in which they were participating, with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs regarding expectations of possible benefits and toxicities for their patients participating in phase I trials. CONCLUSION: Cancer patients who participate in phase I trials are strongly motivated by the hope of therapeutic benefit. Altruistic feelings appear to have a limited and inconsequential role in motivating patients to participate in these trials. Cancer patients who participate in phase I trials appear to have an adequate self-perceived knowledge of the risks of investigational agents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose-determination studies.

Adult

Redefining the emergency physician's role in do-not-resuscitate decision-making.

In summary, Wrenn and Brody's [14] study raises important questions about the appropriate role of emergency physicians in discussing DNR decisions in the emergency setting. Their approach to DNR orders expands, appropriately we believe, the traditional role of emergency physicians. We suggest that it is desirable for emergency physicians to give patients and family members the option of DNR status when there is a significant likelihood that the patient will experience cardiopulmonary arrest before the admitting physician can address the DNR issue and the patient is profoundly debilitated or terminally ill. In addition, emergency physicians have a heightened obligation to promptly address DNR status when appropriate decisions about resuscitation have been reached previously, as in the following cases: (1) when a clearly valid portable prehospital DNR order is in effect; (2) when the patient's primary physician clearly indicates to the emergency physician that the patient is DNR; (3) when an incompetent patient has an advance directive that explicitly precludes CPR and unquestionably applies to the current situation; (4) when a clearly competent, informed patient requests that a DNR order be entered. Finally, we advise emergency physicians against using the principle of futility as sole justification for DNR orders except in situations in which cardiopulmonary arrest is expected, and outcome data suggest that survival is virtually unprecedented.

Decision Making

Community hospital ethics consultation: evaluation and comparison with a university hospital service.

BACKGROUND: Ethics consultants may improve patient care by responding to physician requests for assistance with problems they identify as ethical issues. OBJECTIVE: To examine three aspects of ethics consultation: the clinical questions asked; the helpfulness of the consultation to requesting physicians; and the differences between consultations performed at a community teaching hospital and those performed at a university hospital. SETTINGS: A community teaching hospital and a university teaching hospital. SUBJECTS: Physicians who formally requested ethics consultations in both hospitals and the patients for whom they requested them. METHODS: Over 2 years (January 1, 1988, to December 31, 1989), we prospectively evaluated a newly established clinical ethics consultation service in a community teaching hospital using confidentially completed, pretested, structured questionnaires, and compared our data with previously reported university hospital data. RESULTS: During the 2-year study, 104 consultation requests were received from 68 physicians in eight departments. Requesters most often requested consultation about deciding to forego life-sustaining treatment (74%), resolving disagreements (46%), and assessing patient competence (30%). Requesters found the consultation "very helpful" or "helpful" in one or more aspects of patient care in 86% of cases, or in one or more aspects of physician education in 86% of cases. These data are similar to university hospital data.

Adolescent

Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.

PURPOSE: Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country. METHODS: Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group. RESULTS: The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials. CONCLUSION: Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

Adult

Bone marrow transplantation for sickle cell disease. A study of parents' decisions.

BACKGROUND: Bone marrow transplantation has been shown to cure sickle cell disease, but it carries a 15 percent mortality risk. To determine whether parents would accept this risk to cure their children of sickle cell disease, we interviewed parents of children with sickle cell disease who were being followed in a university hospital clinic. METHODS: We assessed parents' attitudes by using questions based on the standard reference-gamble paradigm. After we gave them descriptions of bone marrow transplantation and graft-versus-host disease (GVHD), the parents were presented with a series of hypothetical situations. In the first situation, bone marrow transplantation was described as offering certain (100 percent) survival with cure of sickle cell disease. In subsequent descriptions, the mortality rate associated with bone marrow transplantation was increased by 5 percent increments. The parents indicated the highest mortality risk at which they would consent to the procedure in order to cure their children. RESULTS: In order to obtain a cure for their children, 36 of 67 parents (54 percent) were willing to accept some risk of short-term mortality, 25 of 67 (37 percent) were willing to accept at least the 15 percent short-term mortality risk we estimate to be the current figure for bone marrow transplantation, and 8 of 67 (12 percent) were willing to accept a short-term mortality risk of 50 percent or more. Nine parents (13 percent) said they would accept both a mortality risk of 15 percent or more and an additional 15 percent risk of GVHD. The parents' decisions were not related to the clinical severity of their children's illness. CONCLUSIONS: At current rates of mortality and morbidity with bone marrow transplantation, a substantial minority of the parents of children with sickle cell disease may consent to bone marrow transplantation for their children. Parental attitudes should be factored into decisions about whether to offer bone marrow transplantation to children with sickle cell disease.

Adolescent

Should alcoholics compete equally for liver transplantation?

The circumstances of liver transplantation are unique among organ transplantation because of the dire, absolute scarcity of donor livers and the predominance of one disease--alcohol-related end-stage liver disease--as the principal cause of liver failure. We propose that patients who develop end-stage liver disease through no fault of their own should have higher priority for receiving a liver transplant than those whose end-stage liver disease results from failure to obtain treatment for alcoholism. We base our proposal on considerations of fairness and on whether public support for liver transplantation can be maintained if, as a result of a first-come, first-served approach, patients with alcohol-related end-stage liver disease receive more than half the available donor livers. We conclude that since not all can live, priorities must be established for the use of scarce health care resources.

Adult

Amyotrophic lateral sclerosis and life-sustaining therapy: patients' desires for information, participation in decision making, and life-sustaining therapy.

To identify the wishes of patients with amyotrophic lateral sclerosis (ALS) for information, participation in decision making, and life-sustaining therapy and to determine whether these wishes are stable over time, we conducted a prospective survey (baseline and 6-month follow-up interviews) of 38 consecutive patients with an established diagnosis of ALS at the University of Chicago Motor Neuron Disease Clinic. Demographic data, clinical stage of ALS, illness experience, wishes for information, and desires for participating in decisions about life-sustaining therapy were elicited. Patients readily expressed their wishes for specific information on communication aids and ventilator care for respiratory failure. Demographic, socioeconomic, and clinical characteristics did not predict patients' desires for information and decision making. The preferences for information and participation in decisions were stable during the 6-month study period, whereas preferences for cardiopulmonary resuscitation in two hypothetical circumstances were less stable. Changes were unrelated to demographic or clinical characteristics of the patients. Because many patients with ALS change their preferences for life-sustaining therapy, advance directives for end-of-life care must be reevaluated periodically.

Adult

Sex or survival: trade-offs between quality and quantity of life.

Patients with localized prostate cancer may be treated with either surgery (radical prostatectomy) or radiotherapy. Although controversial, many physicians believe that surgery offers a higher survival rate. However, the surgical treatment may also produce a higher rate of sexual impotency. Our study assessed how men value survival and sexual potency when asked to trade off one for the other. Using the treatment-choice technique, we interviewed 50 men aged 45 to 70 years without known prostate cancer. At hypothetical rates of survival (90% at 5 years for surgery) and impotency (90% for surgery and 40% for radiotherapy) representing published estimates, 32% of respondents were unwilling to trade off any survival, but 68% were willing to trade off a 10% or greater advantage in 5-year survival (by choosing radiotherapy) to maintain sexual potency. The median 5-year survival traded off was 10% (range, 0% to 80%). Willingness to trade off survival for sexual potency was significantly related to level of education, but not to age, interest in sex, frequency of sexual intercourse, or ability to achieve erection. We conclude that some men may choose treatment with lower long-term survival to increase their chance of remaining sexually potent. Because these men may be difficult to identify in clinical practice, physicians should thoroughly discuss both surgery and radiotherapy options with patients who have localized prostate cancer.

Aged