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M Siegler

Publications and source records attributed to M Siegler.

At least 37 records · Page 2Linked to original sources
PubMed1998

Study of cohort-specific consent and patient control in phase I cancer trials.

PURPOSE: To address the challenging ethical dilemmas created from the participation of advanced cancer patients in phase I trials, we assessed the feasibility of a clinical trial design that uses an interactive informed consent process in which patient-subjects can choose to become directly involved in decisions of dose escalation. PATIENTS AND METHODS: Subjects were advanced cancer patients in the Hematology/Oncology Clinics at the University of Chicago who were eligible to participate in a phase I trial in which they underwent a three-step informed consent process that used cohort-specific consent and allowed them the option to choose their own doses of the chemotherapeutic agents under study, vinorelbine (NVB) and paclitaxel (TAX), within predetermined limits. NVB and TAX were administered in conventional 21- to 28-day cycles for two cycles while on study. Dose escalation occurred when a patient-subject chose a higher untested dose after they received information on all previously assessable patient-subjects. In addition to the phase I trial itself, a survey that consisted of structured interviews, which sought to evaluate patients' experiences with the interactive subject-choice phase I trial design and consent process, was conducted with participating subjects. The phase I trial itself sought to determine the associated toxicities of the agents under study. The survey results were compared with a similar survey of a matched control population of subjects who participated in other concurrently active conventional phase I trials at our institution. RESULTS: Twenty-nine patient-subjects participated in the phase I trial, with 24 who agreed to and completed the survey interviews. Seventy-six percent of patient-subjects opted to choose their dose of the agents under study, and 28% chose the highest available doses. More than half of the patient-subjects (56%) felt some degree of comfort in being asked to choose their dose of chemotherapy, with 53% stating that being asked to choose their dose made them feel in control, fully informed, or content. However, there were no statistically significant improvements in objective measures of the informed consent process, which included surveyed subjects' stated understanding of either provided information about phase I trials and alternatives to trial participation or of the research purpose of phase I trials. By making choices, the group of patients in the interactive subject choice trial changed the size of the dose cohorts and modified the process of dose escalation in this phase I study. CONCLUSION: Although complex, our innovative phase I trial design is feasible. In addition to the use of cohort-specific consent, the trial design may reduce the magnitude of many of the commonly recognized ethical dilemmas associated with this form of clinical research, which include difficulties with information provision and the understanding of possible risks and benefits of phase I trial participation, through direct subject involvement in research decision making by otherwise potentially vulnerable cancer patients.

Adult↗
PubMed1998

The future of the doctor-patient relationship in a world of managed care.

Today, the doctor-patient relationship is strictly linked with the larger context of the medical profession and the managed care revolution. This article focuses on three important questions: 1. In the U.S., how did we arrive at the current situation where the DPR is under sustained assault and is now being used increasingly as a mechanism of cost control? 2. What approaches will be used in the managed care setting to limit and control the decision-making freedom of patients and doctors within the doctor-patient relationship? 3. Will the doctor-patient relationship, as we know it, survive the managed care revolution?

Economics, Medical↗
PubMed1997

Learning from our patients: one participant's impact on clinical trial research and informed consent.

This Perspective includes an essay on modifying phase I clinical trials, written by George Zimmer, who was a professor of English and a commentary on that essay. Professor Zimmer was a cancer patient who participated in the phase I clinical trial program at the University of Chicago. His ideas are eloquently expressed and have had a profound effect on our investigational research for anticancer agents. Although at times his suggestions may seem radical, Professor Zimmer urges us to reconsider the 50-year-old Nuremberg paradigm that participants in human research are ignorant and vulnerable and must be protected. Although we must protect patients who have life-threatening diseases from coercive inducements and misplaced hopes, we must also listen carefully and thoughtfully to our patients. This is particularly true when, as research participants in the face of sacrifice and the threat of a life-ending diagnosis, they have made the effort to express their concerns. With the effect of the acquired immunodeficiency syndrome movement on clinical studies and on drug research and development, a precedent has been set that allows patients to reshape their role as participants in research trials. On a personal level, the essay by Professor Zimmer has had a significant effect on our research methods and, indeed, the focus of our research efforts. Thus, it is with a sense of respect and honor that we share George Zimmer's thoughts and our comments about the influence he has had on our research practices.

Acquired Immunodeficiency Syndrome↗
PubMed1997

An alternative strategy for studying adverse events in medical care.

BACKGROUND: Data about the frequency of adverse events related to inappropriate care in hospitals come from studies of medical records as if they represented a true record of adverse events. In a prospective, observational design we analysed discussion of adverse events during the care of all patients admitted to three units of a large, urban teaching hospital affiliated to a university medical school. Discussion took place during routine clinical meetings. We undertook the study to enhance understanding of the incidence and scope of adverse events as a basis for preventing them. METHODS: Ethnographers trained in qualitative observational research attended day-shift, weekday, regularly scheduled attending rounds, residents' work rounds, nursing shift changes, case conferences, and other scheduled meetings in three study units as well as various departmental and section meetings. They recorded all adverse events during patient care discussed at these meetings and developed a classification scheme to code the data. Data were collected about health-care providers' own assessments about the appropriateness of the care that patients received to assess the nature and impact of adverse events and how health-care providers and patients responded to the adverse events. FINDINGS: Of the 1047 patients in the study, 185 (17.7%) were said to have had at least one serious adverse event; having an initial event was linked to the seriousness of the patient's underlying illness. Patients with long stays in hospital had more adverse events than those with short stays. The likelihood of experiencing an adverse event increased about 6% for each day of hospital stay, 37.8% of adverse events were caused by an individual, 15.6% had interactive causes, and 9.8% were due to administrative decisions. Although 17.7% of patients experienced serious events that led to longer hospital stays and increased costs to the patients, only 1.2% (13) of the 1047 patients made claims for compensation. INTERPRETATION: This study shows that there is a wide range of potential causes of adverse events that should be considered, and that careful attention must be paid to errors with interactive or administrative causes. Healthcare providers' own discussions of adverse events can be a good source of data for proactive error prevention.

Female↗
PubMed1997

End of life decisions in amyotrophic lateral sclerosis: a cross-cultural perspective.

In an era where life-sustaining technology offers physicians unprecedented powers to prolong survival in terminal illness, the question of how end of life decisions are made has become a major subject of study and debate. Amyotrophic lateral sclerosis (ALS) is a disease in which physical ability declines while mental capacity most often remains intact. Since most patients with ALS die of respiratory failure, a distinguishing feature of this disease is whether a patient is offered and accepts a chance to go on long-term mechanical ventilation. This unusual feature makes ALS a compelling model for studying end of life decisions in different countries. This paper reviews the literature and presents preliminary data on how end of life decisions in ALS are made in the US, Great Britain, and Japan. We address this issue by examining how cultural differences in truth-telling and informed consent, societal differences in attitudes toward the use of artificial life support, and legal differences in the role and status of advance directives in each country influenced decisions in the following three groups of patients: (1) the mentally competent; (2) mentally incompetent patients who previously completed advance directives when competent; and (3) mentally incompetent patients who have not provided advance guidance about their wishes.

Amyotrophic Lateral Sclerosis↗
PubMed1996

Do actions reported by physicians in training conflict with consensus guidelines on ethics?

OBJECTIVE: To assess the extent to which actions reported by internal medicine trainees conflict with published guidelines on ethics. METHODS: A confidential survey was sent to a random sample (N = 1000) of associate members of the American College of Physicians (ACP). Questions were asked about ethical decision making in areas addressed by the guidelines in the ACP Ethics Manual. Quoted manual guidelines were provided, followed by 55 yes or no questions, such that a yes answer represented an action that conflicted with a guideline. There were two follow-up mailings to nonresponders. RESULTS: Forty percent (n = 397) completed the questionnaire; 17% indicated they were aware of the guidelines on ethics. On average, associates responded yes to 16% of questions where a yes response indicated they have acted outside guidelines on ethics one or more times. The mean number of responses (n = 55) that conflicted with a guideline was 7.6 per person (SD, 4.7 responses; range, 0 to 33 responses). Ninety-eight percent of respondents reported actions falling outside a guideline one or more times and 80% did so four or more times. The most frequently reported reason (965/3219 [30%]) from a list of four choices for acting outside a guideline was "I was aware of the guideline, but this did not represent an ethical dilemma to me." CONCLUSIONS: Few responding ACP associates indicated awareness of the ACP guidelines on ethics. Physicians in training nevertheless reported acting according to the presented guidelines most of the time, although nearly all respondents acted outside a guideline at least once, and some did so many times. Reported behaviors were sometimes inconsistent with consensus ethical standards that apply to internists. Physicians in training need to know more about ethical standards that apply to their own practice and should be aware when their actions deviate from ethical norms. Before acting outside guidelines on ethics, trainees should discuss their conflicts with others, such as attending physicians, clinical ethicists, or hospital ethics committees.

Codes of Ethics↗
PubMed1996

Medical students as patients: a pilot study of their health care needs, practices, and concerns.

BACKGROUND: The personal health experiences of medical students may contribute in important but previously unacknowledged ways to their well-being and education. This pilot study surveyed medical students about their health care needs, practices, insurance status, and concerns about seeking care. METHOD: A questionnaire was developed and distributed to 151 students at the University of New Mexico School of Medicine in 1993-94. Participant privacy was protected. Responses were compiled and analyzed using logistic regression models and odds ratios. RESULTS: A total of 112 students responded. Most reported health care needs and half routinely received care at their training institution. One-third had informally requested prescriptions or diagnostic tests from medical school faculty and housestaff; one-fourth used such informal consultation as their "usual" method of obtaining care. Eighteen students were uninsured. The students reported that they had not sought care for several reasons, and many had experienced difficulty in obtaining care. The students indicated concern about confidentiality and about the dual role as both student and patient at the training institution. They believed that their academic standing would be jeopardized if they developed certain health problems. When asked about hypothetical scenarios, a majority preferred to avoid the dual role of medical-student-patient. When asked about scenarios in which medical student peers exhibited suicidal depression or severe drug abuse, the students overwhelmingly preferred not to notify the medical school administration. Significant differences in responses were found with respect to gender and training level. CONCLUSION: This pilot study examined the health care needs, practices (including the use of informal consultation), insurance status, and concerns of students at one medical school. The findings highlight the students' perceptions of illness and vulnerability during medical school training. Constructive implications for academic medicine are discussed regarding initiatives in the areas of policy, research, and the resources and structure of student health care services.

Adult↗
PubMed1996

Patients with amyotrophic lateral sclerosis receiving long-term mechanical ventilation. Advance care planning and outcomes.

OBJECTIVE: To examine advance care planning and outcomes of patients with amyotrophic lateral sclerosis (ALS) receiving long-term mechanical ventilation (LTMV). DESIGN: Case series. SETTING: Population-based study in homes and chronic care facilities in four states, and Home Ventilator Program of California Kaiser Permanente. PATIENTS: Seventy-five ALS patients receiving LTMV were identified; 11 died prior to interview, and 6 were totally locked in; 50 of 58 (86%) who were able to communicate consented to structured interviews, of whom 36 lived at home and 14 in an institution. RESULTS: Thirty-eight patients (76%) had completed advance directives, and 96% wanted them. Thirty-eight patients wished to stop LTMV in certain circumstances, of whom 30 had completed advance directives. Those who had completed advance directives were more likely to have communicated their preference, to stop LTMV to family and physician than those who had not (76 vs 29%; p = 0.05). Patients living at home rated their quality of life on a 10-point scale better than those in an institution (7.2 vs 5.6; p = 0.0052), and their yearly expenses were less ($136,560 vs $366,852; p = 0.0018). CONCLUSIONS: Most ALS patients receiving LTMV would want to stop it under certain circumstances, and the process of advance care planning enhances communication of patient preferences to family and physicians. Home-based LTMV is less costly and associated with greater patient satisfaction.

Adult↗
PubMed1995

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↗