Health outcomes and managed care: discussing the hidden issues.
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Too often the debate over health outcomes and managed care has glossed over a series of complex social, political, and ethical issues. Exciting advances in outcomes research have raised hopes for logical medical reform. However, science alone will not optimize our patients' health, since value judgements are necessary and integral parts of attempts to improve health outcomes within managed care organizations. Therefore, to form healthcare policy that is both fair and efficient, we must examine the fundamental values and ethical concerns that are imbedded in our efforts to shape care. We must openly discuss the hidden issues including: (1) trade-offs between standardization of care and provider-patient autonomy; (2) effects of financial incentives on physicians' professionalism; (3) opportunity costs inherent in the design of insurance plans; (4) responsibilities of managed care plans for the health of the public; (5) judicious and valid uses of data systems; and (6) the politics of uncertainty. (+info)
Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.
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PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation. (+info)
Towards a feasible model for shared decision making: focus group study with general practice registrars.
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OBJECTIVES: To explore the views of general practice registrars about involving patients in decisions and to assess the feasibility of using the shared decision making model by means of simulated general practice consultations. DESIGN: Qualitative study based on focus group interviews. SETTING: General practice vocational training schemes in south Wales. PARTICIPANTS: 39 general practice registrars and eight course organisers (acting as observers) attended four sessions; three simulated patients attended each time. METHOD: After an introduction to the principles and suggested stages of shared decision making the registrars conducted and observed a series of consultations about choices of treatment with simulated patients using verbal, numerical, and graphical data formats. Reactions were elicited by using focus group interviews after each consultation and content analysis undertaken. RESULTS: Registrars in general practice report not being trained in the skills required to involve patients in clinical decisions. They had a wide range of opinions about "involving patients in decisions," ranging from protective paternalism ("doctor knows best"), through enlightened self interest (lightening the load), to the potential rewards of a more egalitarian relationship with patients. The work points to three contextual precursors for the process: the availability of reliable information, appropriate timing of the decision making process, and the readiness of patients to accept an active role in their own management. CONCLUSIONS: Sharing decisions entails sharing the uncertainties about the outcomes of medical processes and involves exposing the fact that data are often unavailable or not known; this can cause anxiety to both patient and clinician. Movement towards further patient involvement will depend on both the skills and the attitudes of professionals, and this work shows the steps that need to be taken if further progress is to be made in this direction. (+info)
Ethnicity, bioethics, and prenatal diagnosis: the amniocentesis decisions of Mexican-origin women and their partners.
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Bioethical standards and counseling techniques that regulate prenatal diagnosis in the United States were developed at a time when the principal constituency for fetal testing was a self-selected group of White, well-informed, middle-class women. The routine use of alpha-fetoprotein (AFP) testing, which has become widespread since the mid-1980s, introduced new constituencies to prenatal diagnosis. These new constituencies include ethnic minority women, who, with the exception of women from certain Asian groups, refuse amniocentesis at significantly higher rates than others. This study examines the considerations taken into account by a group of Mexican-origin women who had screened positive for AFP and were deciding whether to undergo amniocentesis. We reviewed 379 charts and interviewed 147 women and 120 partners to test a number of factors that might explain why some women accept amniocentesis and some refuse. A woman's attitudes toward doctors, medicine, and prenatal care and her assessment of the risk and uncertainty associated with the procedure were found to be most significant. Case summaries demonstrate the indeterminacy of the decision-making process. We concluded that established bioethical principles and counseling techniques need to be more sensitive to the way ethnic minority clients make their amniocentesis choices. (+info)
Autonomy, rationality and the wish to die.
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Although suicide has traditionally carried a negative sanction in Western societies, this is now being challenged, and while there remains substantial public concern surrounding youth and elder suicide, there is a paradoxical push to relax the prohibition under certain circumstances. Central to the arguments behind this are the principles of respect for autonomy and the importance of rationality. It is argued here that the concepts of rationality and autonomy, while valuable, are not strong enough to substantiate a categorical "right to suicide" and that the concepts of "understandability" and "respect" are more useful and able to provide the foundation for responding to a person expressing a wish to die. Roman suicide, sometimes held as an example of "rational suicide", illustrates the effects of culture, tradition and values on the attitudes to, and the practice of, suicide. (+info)
Fraud, misconduct or normal science in medical research--an empirical study of demarcation.
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OBJECTIVES: To study and describe how a group of senior researchers and a group of postgraduate students perceived the so-called "grey zone" between normal scientific practice and obvious misconduct. DESIGN: A questionnaire concerning various practices including dishonesty and obvious misconduct. The answers were obtained by means of a visual analogue scale (VAS). The central (two quarters) of the VAS were designated as a grey zone. SETTING: A Swedish medical faculty. SURVEY SAMPLE: 30 senior researchers and 30 postgraduate students. RESULTS: Twenty of the senior researchers and 25 of the postgraduate students answered the questionnaire. In five cases out of 14 the senior researchers' median was found to be clearly within the interval of the grey zone, compared with three cases for the postgraduate students. Three examples of experienced misconduct were provided. Compared with postgraduate students, established researchers do not call for more research ethical guidelines and restrictions. CONCLUSION: Although the results indicate that consensus exists regarding certain obvious types of misconduct the response pattern also indicates that there is no general consensus on several procedures. (+info)
Live attenuated vaccine trials in medically informed volunteers: a special case?
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A group of activist clinicians have offered to volunteer for clinical trials of live attenuated HIV vaccines. This has provided an important conceptual challenge to medical ethics, and to work on the development of HIV vaccines. In exploring these issues, this article highlights how the HIV field has altered the content as well as the tone of ethical discourse. The balance of expertise and authority between research subjects and triallists is profoundly changed, raising questions about the limits of voluntarism and differing perspectives on risk-benefit analysis. Care is needed to ensure that the novelty of the situation does not confuse the central ethical and scientific issues. (+info)
The man who claimed to be a paedophile.
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A psychiatrist recounts a case of a man presenting with severe depression who claimed to have abused children and his pet dog. Clinical management of the case hinged on whether this claim was true, a lie or delusional. The uncertainty over this raised complex ethical dilemmas regarding confidentiality and protection of the public (and animals). (+info)