Search PubMed⌕ Search

Biomedical subjects

Paul S Appelbaum

Publications and source records attributed to Paul S Appelbaum.

At least 19 recordsLinked to original sources
PubMed2003

Decisional capacity of severely depressed patients requiring electroconvulsive therapy.

OBJECTIVE: The decisional capacity of severely depressed people frequently comes into question. The ability to improve this decisional capacity through educational efforts alone is not known. Our study aimed to determine the decisional capacity of severely depressed people requiring electroconvulsive therapy (ECT), and whether educational interventions improve their ability to provide informed consent for ECT. MATERIALS AND METHODS: Forty subjects with severe depression were recruited. Using the MacArthur Competence Assessment Tool for Treatment instrument, decisional capacity was assessed at baseline and reassessed after education. All of the subjects received standard education. Additionally, half were blindly randomized to receive an experimental educational intervention. RESULT: SAt baseline, there was no statistical difference in the decisional capacity between the standard and experimental intervention groups. After educational interventions, all four areas of decisional capacity improved for both groups (understanding p < 0.001, reasoning p < 0.001, appreciation p = 0.031, choice p = 0.006). However, there was no measurable additional improvement in scores for those randomized to receive additional education. CONCLUSION: Our findings indicate that this group of severely depressed people had good decisional capacities to give informed consent. Education improved their decisional capacity. There is an endpoint beyond which additional educational intervention does not result in measurable improvement in decisional capacity.

Adult↗
PubMed2003

The Declaration of Helsinki and clinical trials: a focus on placebo-controlled trials in schizophrenia.

OBJECTIVE: The authors' goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.

Controlled Clinical Trials as Topic↗
PubMed2003

Competence to consent to research among long-stay inpatients with chronic schizophrenia.

OBJECTIVE: Questions have been posed about the competence of persons with serious mental illness to consent to participate in clinical research. This study compared competence-related abilities of hospitalized persons with schizophrenia with those of a comparison sample of persons from the community who had never had a psychiatric hospitalization. METHODS: The study participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured instrument designed to aid in the assessment of competence to consent to clinical research. The scores of 27 persons who met DSM-IV criteria for schizophrenia who were long-stay patients on a state hospital research ward were compared with those of 24 individuals from the community who were of similar age, gender, race, and socioeconomic status. RESULTS: Significant differences were found between the patients and the community sample on three measures of competence-related abilities: understanding, reasoning, and appreciation. Degree of psychopathology and cognitive functioning were significantly negatively correlated with understanding and appreciation among the patients with schizophrenia. Length of hospitalization was significantly negatively correlated with all measures of decision-making capacities. CONCLUSIONS: The generally poor performance of the long-stay patients with chronic schizophrenia highlights the difficulties this group is likely to encounter in providing consent to research. However, variation across the sample points to the need for individualized assessment and for validated techniques for facilitating decision making in the face of decisional impairments.

Adult↗
PubMed2002

The therapeutic misconception: problems and solutions.

BACKGROUND: The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research. OBJECTIVES: This paper analyzes the nature and origins of the therapeutic misconception and suggests some ways in which researchers can overcome this problem when obtaining a subject's consent to participation in research. RESEARCH DESIGN: A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken. RESULTS: Research and clinical care involve different standards for how the patient/subject is to be treated. The confusion of the two often leads to profound misunderstandings on the part of the patient/subject. DISCUSSION: A method for describing to patients/subjects the differences between research and treatment is proposed as a potential solution to the therapeutic misconception. Research is needed to determine whether this or any other change in the nature of the disclosure is effective in reducing the therapeutic misconception.

Beneficence↗
PubMed2002

Privacy in psychiatric treatment: threats and responses.

OBJECTIVE: The author provides an overview of the current status of privacy in psychiatric treatment, with particular attention to the effects of new federal regulations authorized by the Health Insurance Portability and Accountability Act (HIPAA). METHOD: The author reviews the ethical and legal underpinnings for medical privacy, including the empirical data supporting its importance; discusses those portions of the new federal regulations most relevant to psychiatric practice; and suggests steps that psychiatrists can take to maintain their patients' privacy in the new environment. RESULTS: Medical ethics and law, in keeping with patients' preferences, traditionally have provided strong protection for the information that patients communicate while receiving medical care. In general, release of information has required patients' explicit consent. However, limitations of the consent model and technological innovations that permit the aggregation of computerized medical information have led to pressure for greater access to these data. Although the new federal regulations offer patients some additional protections (including security for psychotherapy notes), they also mark a retreat from reliance on patient consent and open up records to previously unauthorized uses, among them law enforcement investigations and marketing and fundraising by health care organizations. However, states retain the power to provide higher levels of protection. CONCLUSIONS: The new regulatory environment is less friendly to medical privacy but still leaves a great deal of discretion in physicians' hands. A commitment to protecting privacy as an ethical norm can be advanced by psychiatrists' requesting patients' consent even when it is not required, by ensuring that patients are aware of the limits on confidentiality, and by avoiding unnecessary breaches of privacy in the course of providing psychiatric care.

Confidentiality↗
PubMed2002

Capacity to provide informed consent for participation in schizophrenia and HIV research.

OBJECTIVE: The degree to which people with psychiatric symptoms and cognitive dysfunction can provide informed consent to participate in research is a controversial issue. This study was designed to examine the capacity of subjects with schizophrenia and subjects with HIV to provide informed consent for research participation and to determine the relationships among cognitive dysfunction, psychiatric symptoms, and decisional capacity. METHOD: Twenty-five men and women with a DSM-IV diagnosis of schizophrenia and 25 men and women with HIV were recruited. The groups were compared in terms of neuropsychological functioning, psychiatric symptoms, and ability to provide informed consent to a hypothetical drug trial. RESULTS: Eighty percent of the subjects with schizophrenia and 96% of the HIV-positive subjects demonstrated adequate capacity to consent to the hypothetical drug trial, but subjects in the schizophrenia group had significantly lower scores on two of the four aspects of decisional capacity. For the subjects with schizophrenia, neuropsychological functioning and psychiatric symptoms (e.g., apathy and avolition), but not psychotic symptoms (e.g., hallucinations and delusions), were significantly associated with decisional capacity. CONCLUSIONS: The majority of subjects who are recruited and willing to participate in schizophrenia or HIV research will have adequate capacity to provide consent. Cognitive dysfunction and the symptoms shown to be associated with impaired decisional capacity are not unique to schizophrenia and may occur with many other forms of illness. These findings underscore the importance of considering how decisional capacity will be assessed in all types of research, regardless of the specific condition being studied.

Adolescent↗
PubMed2002

The origins of commitment for substance abuse in the United States.

Policymakers in the United States have long been perplexed by how to deal with substance abuse. As attitudes shifted in the 19th century toward viewing substance abuse as a medical problem akin to insanity rather than as a moral failing, greater emphasis was given to the potential for treatment. Thus, by the middle of the 19th century, states began developing substance abuse commitment codes and institutions to which substance abusers could be committed. Public ambivalence over whether substance abusers should be seen as having an illness or a weakness of will, however, was reflected in the lack of sustained support for these efforts, in contrast to support accorded systems for commitment of the mentally ill. Contemporary policymakers are faced with the same ambivalence, as they struggle with the extent to which substance abusers ought to be subjected to involuntary treatment. The legacy of the early years of substance abuse commitment lives on.

Attitude to Health↗
PubMed1998

Ought we to require emotional capacity as part of decisional competence?

The preceding commentary by Louis Charland suggests that traditional cognitive views of decision-making competence err in not taking into account patients' emotional capacities. Examined closely, however, Charland's argument fails to escape the cognitive bias that he condemns. However, there may be stronger arguments for broadening the focus of competence assessment to include emotional capacities, centering on the ways in which emotions aid humans in processing information. Before emotional capacities are added to the list of functions essential for decisional competence, though, the feasibility and utility of such a reorientation must be demonstrated.

Brain Diseases↗
PubMed1997

Case vignette: unanticipated propinquity.

CASE VIGNETTE: UNANTICIPATED PROPINQUITY. Dr. Marge N. O'Vera has a reputation in the community as a thoughtful, caring, and highly ethical psychotherapist. For more than a year she has been treating Greta Grievance, helping her to cope with emotional and financial insecurities in the aftermath of a highly contentious divorce. During a therapy session, Ms. Grievance tells Dr. O'Vera that she has decided to sue the attorney who represented her during the divorce. Ms. Grievance believes that he did not represent her interests effectively and that she foolishly took his advice in accepting a very inferior settlement. She has retained another attorney who, she tells O'Vera, will soon be calling to request information on the stress of the divorce and Ms. Grievance's continuing need for therapy. Dr. O'Vera will be asked to testify as to the harm caused to her client and resulting treatment expenses. As Ms. Grievance gets up to leave, she tells Dr. O'Vera, "I'm so glad you'll help me teach that awful Tom Tort a lesson." As she hears the name of Attorney Tort for the first time, Dr. O'Vera begins to sweat. Thomas Tort, attorney at law, is also a client of hers. She had no idea that he had been Ms. Grievance's divorce lawyer. She has treated him for recurring major depression over several years and knows that he probably was sufficiently depressed so as to compromise his professional work at the time he represented Ms. Grievance. When she is named as an expert witness for the plaintiff, Attorney Tort will learn that his therapist was also treating Ms. Grievance. At the same time, her duty of confidentiality precludes her informing others that Tort is also her client. What is Dr. O'Vera to do?

Altruism↗