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Biomedical subjects

Mark Siegler

Publications and source records attributed to Mark Siegler.

At least 19 recordsLinked to original sources
PubMed2005

Ethical issues in innovative colorectal surgery.

When physicians and surgeons investigate new drugs or devices, they must adhere to stringent regulatory standards governing human experimentation. Although these standards and regulations are not perfect, they serve to protect the interests of patients and research subjects. By contrast, few standards or regulations exist for innovative procedures, including new surgical techniques. Surgeons apply the term "innovative surgery" to describe practices ranging from minor technical modifications in standard procedures to non-validated investigational approaches indistinguishable from human research. By focusing on recent innovations in surgery, including colorectal surgery, this article proposes an ethical model of surgical innovation that protects patients while maintaining professional self-regulation of surgical advances.

Cholecystectomy, Laparoscopic↗
PubMed2004

Recipient death during a live donor liver transplantation: who gets the "orphan" graft?

The limited availability of deceased organ donors, prolongation of waiting time, and increasing number of patients dying awaiting transplantation have contributed to the increased use of adult-to-adult living-donor liver transplant. In the event that the intended recipient dies after the donor graft has been procured but before it has been transplanted, what should be done with the graft? A structured, nine-item oral survey of 26 experts in liver transplantation was conducted in June and July 2003. Respondents were selected primarily because of their extensive experience with liver transplantation, especially adult-to-adult living-donor transplant. All respondents said the surgical team should try to use the available graft for another recipient. Twenty-one respondents believed consent from the donor or the donor's family was required for allocation, whereas 19% believed consent desirable but not required. Nine respondents recommended an allocation organization place the graft, whereas 17 respondents recommended placement within the donor hospital. Two of the respondents had previously encountered this situation, whereas four had experienced an intraoperative recipient death before procurement of a live donor graft. On the basis of the responses, we offer the following recommendations for handling orphan liver grafts: (1) obtain predonation informed consent from all donors that indicates what the donor would want to have done with the "orphan graft" in all cases of living-donor liver transplantation; (2) avoid the premature removal of the donor graft until the recipient hepatectomy and survival are likely; (3) if a live donor graft has been procured and cannot be transplanted into the intended recipient, and if informed consent has been obtained before the donor operation, the organ should be reallocated without delay to minimize cold ischemia time and maximize the utility of the graft.

Female↗
PubMed2004

Inside information: Financial conflicts of interest for research subjects in early phase clinical trials.

In recent years, several research subjects have told us that they had bought or intended to buy stock in the companies sponsoring the clinical trials in which they were enrolled. This situation has led us to ask what, if any, are physician-investigators' scientific, ethical, and legal responsibilities concerning research subjects who choose to buy stock in the companies sponsoring the clinical trials in which they are participating. Although the scope of this problem is unknown and is likely to be small, this commentary examines the scientific, ethical, and legal concerns raised by such activities on the part of research subjects enrolled in early phase clinical trials. In addition, this commentary also outlines the basis for our opinion that research subjects involved in an early phase clinical trial should avoid the financial conflicts of interest created by trading stock in the company sponsoring the clinical trial.

Clinical Trials, Phase I as Topic↗
PubMed2004

Long-term quality of life issues among adult-to-pediatric living liver donors: a qualitative exploration.

Use of live donors as a source of transplantable livers has expanded to include adult recipients. Follow-up reports concerning living donor experiences are short-term and primarily focus on medical outcomes. We present our quality of life findings from a purposive sampling of a cohort of adult-to-pediatric live liver donors, 3-10 years after donation. In-depth interviews conducted among 15 live donors revealed the spectrum of complexity and impact that donation had on the donors. Virtually all donors (14/15) reported that they never really made a decision to donate; rather, agreeing to donate was an automatic leap. Overall, 10 out of the 15 donors related a sense that they were considered nonpatients by the medical team and family members in two primary areas: post operative treatment of pain (6/15) and long-term follow-up care (9/15) with five donors reporting concerns in both areas. Overall, family relationships were believed to have been strengthened by the donation process. Most donors experienced some degree of financial strain with three donors maintaining unrewarding employment to continue healthcare insurance. The majority of donors reported that return to normalcy took a significant amount of time even though no serious medical consequences were experienced. These observations serve to highlight some of the long-term quality of life issues that persist beyond the medical consequences of live donation.

Adult↗
PubMed2003

Is medical research cost effective? Response to Murphy and Topel.

The paper explores the relationship between medical innovation and cost of treatment. The methodology used by Murphy and Topel to calculate the statistical value of a life is examined. The authors discuss possible confounding factors, such as the general trend of decreasing mortality, and consider the possibility that non-medical sources, especially the decrease in tobacco use, may explain much of the decrease in mortality rates. The authors suggest an alternative to Murphy and Topel's population-level model for assessing the benefits of medical technology, based on Lewis Thomas' categorization of three levels of technology: non-technology ("caring"), half-way technology (does not reverse or prevent the underlying problem), and high technology (preventative or curative). The categories are applied to the example of type 1 diabetes mellitus, in which quality of life and mortality improvements are clearly the result of technological changes and not behavioral modifications. The authors emphasize the cost-effectiveness of high technology, which is based on medical research advances.

Biomedical Research↗
PubMed2002

Living donor liver transplantation: summary of a conference at The National Institutes of Health.

Living donor liver transplantation for adults was developed only recently in an attempt to increase the pool of donor organs; to reduce morbidity and mortality; and to improve the long-term survival of patients in need of liver transplant. Within a few brief years, this procedure has gained widespread support by both the public and transplant community. The procedure will soon be performed by nearly 80% of all liver transplant programs in the United States. Unfortunately, the long-term risks of the procedure to the recipient and especially the donor remain undefined. In response to the rapid growth and enthusiasm for this procedure, the National Institutes of Health sponsored a workshop, the goals of which were to review the scientific, medical, and nonmedical issues associated with living donor liver transplantation, and to define questions for future basic and clinical investigations which could improve the success and applicability of this procedure.

Adult↗
PubMed2002

Ethical issues in rehabilitation: a qualitative analysis of dilemmas identified by occupational therapists.

Little available research exists to address the range of ethical issues encountered by occupational therapists (OTs) in their daily clinical work. The few articles in the literature have tended to be case-based or anecdotal or have focused on professional issues rather than clinical issues. To characterize the array of clinical ethical issues in occupational therapy, we asked OTs in a free-standing academic rehabilitation hospital to describe in some detail up to three scenarios or situations from their clinical practice that raised morally troubling questions. A coding system was developed to preserve the richness of the detail but to allow for some categorization of the topics. A second section of the survey asked the therapists to rate whether various traditional ethics topics were of high, medium, or low interest to them. A third section asked that they identify the formats that would be most appealing to them for future educational interventions. Of the 56 therapists surveyed, 38 (or 68%) responded. The three self-generated topics mentioned most frequently by the therapists were (in decreasing order of frequency): reimbursement pressures, conflicts around goal setting, and patient/family refusal of team recommendations. The respondents were particularly interested in knowing more about patient-centered ethics topics, such as conflict resolution between teams and patients and the patient's role in decision making. Furthermore, they indicated a strong preference for interdisciplinary and interactive educational formats.

Journal Article↗
PubMed2002

Training doctors for professionalism: some lessons from teaching clinical medical ethics.

Medical professionalism encourages physicians to place their patients interests above self-interest. In recent years, many medical organizations, including the American Board of Internal Medicine (ABIM), Association of American Medical Colleges (AAMC), and the American Medical Association (AMA), have developed initiatives to strengthen medical professionalism. By emphasizing professionalism, supporters of these initiatives hope that medicine and physicians may recapture professional autonomy, decrease public criticism of medicine and physicians, and help physicians regain the moral high ground in the unending struggle with payers, both public and private. One crucial question facing medical educators is whether the concepts of professionalism can be taught to medical students and residents. This paper draws upon the author s thirty years of experience in teaching clinical medical ethics to provide guidance on how to teach the concepts of professionalism to students and residents.

Ethics, Clinical↗
PubMed2001

Clinical ethics revisited.

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems.

Bioethics↗