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Biomedical subjects

F G Miller

Publications and source records attributed to F G Miller.

At least 19 recordsLinked to original sources
PubMed2000

Placebo-controlled trials in psychiatric research: an ethical perspective.

The placebo-controlled trial is widely regarded as the gold standard for testing the efficacy of new treatments; however, this research design is subject to ethical controversy, especially when standard treatments of proven efficacy exist. After examining regulatory standards and ethical codes relevant to placebo-controlled trials, I offer a critique of arguments against the use of placebo control groups in psychiatric research. An absolute ethical prohibition of placebo-controlled trials in psychiatric disorders for which standard, effective treatments exist is rejected because it is based on a flawed conception of research ethics, ignores important contextual factors characteristic of psychiatric research, and could lead to the approval and use of new medications that appear equivalent in efficacy to standard treatments but may be no more effective than placebos. Four standards governing the ethical use of placebos in psychiatric clinical trials are explicated: 1) placebo-controlled trials should have scientific and clinical merit; 2) risks should be minimized and justified by the anticipated benefits of generating clinically relevant scientific knowledge and the expected benefits, if any, to individual patient volunteers; 3) patient volunteers should give informed consent; and 4) investigators should offer short-term treatment optimization to patient volunteers after completion of research participation.

Antipsychotic Agents↗
PubMed2000

Assisted suicide compared with refusal of treatment: a valid distinction? University of Pennsylvania Center for Bioethics Assisted Suicide Consensus Panel.

The continuing debate over the deeply controversial issue of physician-assisted suicide has been complicated by confusion about how this practice resembles or differs from refusal of life-sustaining treatment. Perspectives on ethics and policy hinge on the contested issue of whether a valid distinction can be made between assisted suicide and withdrawal of treatment. This paper uses three illustrative cases to examine leading arguments for and against the recognition of a fundamental distinction between these practices. The first case involves assisted suicide by ingestion of prescribed barbiturates, the second involves withdrawal of artificial nutrition and hydration, and the third involves a decision to stop eating and drinking. On theoretical and practical grounds, this paper defends the position that there is a valid distinction between assisted suicide and refusal of treatment.

Adult↗
PubMed2000

Clinical pragmatism, ethics consultation, and the elderly patient.

This article describes a process of moral problem solving for medicine termed clinical pragmatism. A structured and disciplined method of addressing ethical problems in medical practice that clinicians will find useful in their daily routines is provided. After outlining the method of clinical pragmatism, the authors illustrate its use in a case involving an older patient refusing medical treatment and conclude with comments on the importance of the process in ethics case consultation.

Aged↗
PubMed1999

End-of-life decision-making in the hospital: current practice and future prospects.

Chart review of patients who died in the hospital was used to describe the pattern of end-of-life decision-making and care for hospitalized dying patients and to propose a structured process of assessing the suitability of patients for palliative care. The setting was a large urban academic medical center, and the sample comprised 200 of 205 consecutive adult deaths during the first 4 months of 1996. The main outcome measures were identification of the patient as dying, do-not-resuscitate (DNR) orders, and comfort care plans. Charts of 72% of the patients had evidence that they were considered dying. DNR orders were in place for 77% of all the patients, and 46% had comfort care plans. Presence of a health care proxy was significantly associated with DNR orders and comfort care plans (P < 0.001). On average, comfort care plans were put in place 15 days after admission, as compared with an overall mean length of stay of 17 days. Substantial proportions of patients with comfort care plans continued to receive antibiotics (41%) and blood draws (30%). Only 13% of the patients on mechanical ventilation and 19% of those on artificial nutrition and hydration underwent withdrawal of these interventions prior to death. These findings suggest opportunities and challenges for improving practice patterns for hospitalized dying patients. We recommend several measurable objectives for evaluating end-of-life decision-making and care and propose the development of a goals of care assessment tool to guide appropriate transitions from life-sustaining treatment to comfort care and plan palliative services.

Adult↗
PubMed1998

Professional integrity in clinical research.

In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.

Beneficence↗
PubMed1998

The internal morality of medicine: explication and application to managed care.

Some ethical issues facing contemporary medicine cannot be fully understood without addressing medicine's internal morality. Medicine as a profession is characterized by certain moral goals and morally acceptable means for achieving those goals. The list of appropriate goals and means allows some medical actions to be classified as clear violations of the internal morality, and others as borderline or controversial cases. Replies are available for common objections, including the superfluity of internal morality for ethical analysis, the argument that internal morality is merely an apology for medicine's traditional power and authority, and the claim that there is no single, "core" internal morality. The value of addressing the internal morality of medicine may be illustrated by a detailed investigation of ethical issues posed by managed care. Managed care poses some fundamental challenges for medicine's internal morality, but also calls for thoughtful reflection and reconsideration of some traditionally held moral views on patient fidelity in particular.

Contracts↗
PubMed1998

Efficacy of the Substance Abuse Subtle Screening Inventory-3 (SASSI-3) in identifying substance dependence disorders in clinical settings.

This article presents analyses on psychometric properties of a recent revision of the Substance Abuse Subtle Screening Inventory (SASSI-3). Participants were 772 individuals from a range of clinical settings who were independently diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (3rd ed., rev. [DSM-III-R]; American Psychiatric Association [APA], 1987) or DSM-IV (APA, 1994) criteria regarding the presence or absence of a substance-dependence disorder. A development sample (n = 391) was used to formulate SASSI-3 decision rules that yielded 95% agreement with clinical diagnoses of substance dependence. Correspondence with the criterion variable was shown to be 97% in a cross-validation sample (n = 381) from the same clinical settings. Convergent relations were demonstrated with a variety of other indexes of substance misuse, including clinical assessments of substance abuse history, alcohol and drug-related arrests, self-reported use of illicit drugs, and other instruments designed to screen for substance misuse. Further, logistic regression analyses indicated no significant differences in the overall accuracy of the SASSI-3 as a function of respondents' demographic characteristics or clinical ratings of respondents' level of adjustment and functioning (Global Assessment of Functioning ratings; APA, 1987, 1994).

Adult↗