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PubMed2001

Living wills and substituted judgments: a critical analysis.

In the literature three mechanisms are commonly distinguished to make decisions about the care of incompetent patients: A living will, a substituted judgment by a surrogate (who may or may not hold the "power of attorney"), and a best interest judgment. Almost universally, the third mechanism is deemed the worst possible of the three, to be invoked only when the former two are unavailable. In this article, I argue in favor of best interest judgments. The ever more common aversion of best interest judgments entails a risk that health care providers withdraw from the decision-making process, abandoning patients (or their family members) to these most difficult of decisions about life and death. My approach in this article is primarily negative, that is, I criticize the alleged superiority of the living will and substituted judgment. The latter two mechanisms gain their alleged superiority because they are supposedly morally neutral, whereas the best interest judgment entails a value judgment on behalf of the patient. I argue that on closer inspection living wills and substituted judgments are not morally neutral; indeed, they generally rely on best interest judgments, even if those are not made explicit.

Decision Making↗
PubMedDate not supplied

Does involuntary outpatient commitment lead to more intensive treatment?

Studies of involuntary outpatient commitment (OPC) among persons with severe mental illness have concluded that OPC is only effective in improving treatment outcomes when it is sustained for 6 months or longer and is combined with frequent outpatient services. This article explores factors that influence the delivery of outpatient services to subjects in a randomized trial of OPC and finds 2 general patterns. Outpatient visits were more frequent among all subjects with apparent clinical need, regardless of study assignment, and among subjects whose OPC was sustained beyond an initial court order. These results suggest that, in practice, sustained OPC represents a consensual agreement between clinicians and the court to more intensively address the complex needs of persons with severe and persistent mental illness.

Commitment of Persons with Psychiatric Disorders↗
PubMedDate not supplied

Outpatient civil commitment: a dangerous charade or a component of a comprehensive institution of civil commitment?

This article examines three criticisms frequently directed toward preventive commitment as one form of outpatient commitment. These criticisms contend that preventive commitment (a) abandons the dangerousness criteria for civil commitmnet, (b) promotes unwarranted inpatient commitment of those who do not meet civil commitment criteria, and (c) undermines important individual liberties by diluting the right to refuse treatment. Understanding and evaluating these criticisms requires analysis of the intersection among empirical, conceptual, and justificatory claims. According to the analysis presented here, advocates of preventive commitment can defend a legitimate role for preventive commitment. This analysis applies to preventive commitment as a dispositional alternative within a comprehensive institution of civil commitment involving distinct parens patriae and police power components.

Civil Rights↗
PubMed1997

Emergency commitment and legislative reform in New Jersey.

The effects of a state commitment law that combines use of the dangerousness criterion, screening for less restrictive alternatives, and a new mental health structure were investigated. A time-series analysis of the number of commitments in a 12-year period at one screening center revealed that the expected outcome of the legislation--a decrease in state-hospital commitments--was not realized.

Age Factors↗
PubMed2001

The Data Protection Act (1998): implications for health researchers.

AIMS: This paper reports on the methods used in two studies to obtain access to subjects to comply with the common law duty of confidence laid out in the Data Protection Act (1998) and discusses the researchers' problems in interpreting the procedures. RATIONALE: The amendments to the United Kingdom (UK) Data Protection Act (1998) are causing confusion within the health service and academic institutions. There is a need to balance patient confidentiality with the requirement to conduct vital, unbiased research in which health service professionals are not subject to ethical dilemmas. This paper examines the recruitment methods used in two studies in which the researchers' attempts to adhere to the requirements lengthened the study costs and may have produced less reliable results. METHODS: The methodological difficulties in two studies are presented. In Study 1, the difficulties encountered when the Multicentre Research Ethics Committee refused permission for researchers to recruit patients directly to a multicentre randomized controlled trial are discussed. In Study 2, the method used to compile a sampling frame for a national questionnaire survey following the eight principles of the Act are described. FINDINGS: Our experience has shown that health care professionals are increasingly required to recruit patients to intervention trials, and that researchers are not allowed access to the names of patients or other subjects to ask them for consent to participate in a study. The requirement for researchers to use "intermediaries" to obtain consent from and recruit subjects to studies increases the risk of selection bias, may expose the practitioner to ethical difficulties and may compromise the external validity of trial results. There is also a danger that research costs will soar when the Data Protection Act (1998) is fully realized. CONCLUSION: The Data Protection Act (1998) is currently being interpreted in a number of different ways. We conclude there is an urgent need for consensus within the health service and academic communities.

Clinical Trials as Topic↗
PubMed1999

Issues in balancing teenage clients' confidentiality and reporting statutory rape among Kansas Title X clinic staff.

Through Federal welfare reform, Congress directed states to aggressively enforce statutory rape laws. Family planning professionals deal with many adolescent clients, and their support for such enforcement or willingness to report is unclear. The authors of this study examined current attitudes and practices of family planning program managers (FPPMs) about statutory rape law enforcement, including current reporting practices. In 1997, all 77 local Kansas Title X FPPMs were surveyed. Structured telephone interviews were conducted with 10 FPPMs to add detail to quantitative responses. Sixty-eight FPPMs responded to the written survey (88%). Of these, 79% supported aggressive enforcement, and 43% thought enforcement would reduce adolescent pregnancy rates. With increased enforcement, 38% believed teenagers would be discouraged from seeking reproductive health care, compared to 41% who believed they would not. Among key informants, all of whom were FPPMs, willingness to report cases was mixed, with those who would report wanting the flexibility to judge on a case-by-case basis. For those not reporting cases, confidentiality concerns overrode beliefs in any positive outcome of enforcement. Kansas Title X FPPMs strongly supported aggressive enforcement, but had mixed beliefs about negative consequences. Among those interviewed, there were also mixed beliefs and practices about reporting. Reporting from FPPMs will be sporadic and arbitrary unless protocols are developed and laws are clarified.

Adolescent↗
PubMed2003

Changes in the use of do-not-resuscitate orders after implementation of the Patient Self-Determination Act.

OBJECTIVE: To determine changes in the use of do-not-resuscitate (DNR) orders and mortality rates following a DNR order after the Patient Self-determination Act (PSDA) was implemented in December 1991. DESIGN: Time-series. SETTING: Twenty-nine hospitals in Northeast Ohio. PATIENTS/PARTICIPANTS: Medicare patients (N = 91,539) hospitalized with myocardial infarction, heart failure, gastrointestinal hemorrhage, chronic obstructive pulmonary disease, pneumonia, or stroke. MEASUREMENTS AND MAIN RESULTS: The use of "early" (first 2 hospital days) and "late" DNR orders was determined from chart abstractions. Deaths within 30 days after a DNR order were identified from Medicare Provider Analysis and Review files. Risk-adjusted rates of early DNR orders increased by 34% to 66% between 1991 and 1992 for 4 of the 6 conditions and then remained flat or declined slightly between 1992 and 1997. Use of late DNR orders declined by 29% to 53% for 4 of the 6 conditions between 1991 and 1997. Risk-adjusted mortality during the 30 days after a DNR order was written did not change between 1991 and 1997 for 5 conditions, but risk-adjusted mortality increased by 21% and 25% for stroke patients with early DNR and late DNR orders, respectively. CONCLUSIONS: Overall use of DNR orders changed relatively little after passage of the PSDA, because the increase in the use of early DNR orders between 1991 and 1992 was counteracted by decreasing use of late DNR orders. Risk-adjusted mortality rates after a DNR order generally remained stable, suggesting that there were no dramatic changes in quality of care or aggressiveness of care for patients with DNR orders. However, the increasing mortality for stroke patients warrants further examination.

Aged↗
PubMed2002

Refusing artificial nutrition and hydration: does statutory law send the wrong message?

Ethical consensus and appellate court decisions view artificial nutrition and hydration (ANH) as medical treatment that can be refused like other treatments. However, advance directive statutes may produce obstacles for refusal of ANH, as distinct from other life-sustaining treatments, in patients who lack capacity. This paper reviews state statutes and appellate case law regarding medical decision making for patients who lack decisional capacity. Twenty states (39%) have one or more explicit statutory provisions delineating a separate and more stringent standard for ANH refusal. These standards include higher evidentiary standard; requirement for specific preauthorization, qualifying medical conditions, second medical opinion, or judicial review; refusal not permitted; refusal not permitted if death would result from "starvation" or "dehydration"; and previous law with higher standard applies to old documents. In 11 of these states and in eight others, statutory law contains language that could be misinterpreted, implying, but not rising to, an explicitly higher standard. Four appellate decisions departed from the judicial consensus that ANH can be refused like other treatments, but subsequent court decisions or legislative enactments reduced or eliminated their impact. Legislators and the courts should ask whether higher standards for ANH refusal are appropriate in light of case law authority that ANH should not be treated differently and in light of statutory language that preserves those common law rights. These higher standards may make it more difficult in certain states to refuse ANH for patients who lack capacity or place a burden on good practice by making providers fearful of the law.

Aged↗
PubMed1978

Physician responsibility for the cost of unnecessary medical services.

Most diagnostic and therapeutic services are ordered by physicians, but physicians practicing under fee-for-service conditions have few incentives to contain the costs of medical care. Without such incentives, effective cost control through mechanisms such as Professional Standards Review Organizations have been disappointing. Several legal approaches might be used to increase physicians' responsibility for the cost of unnecessary services--expansion of tort law, implied contact, redesign of insurance mechanisms, equitable estoppel and informed consent. However, increasing physician responsibility will require uniform but flexible definitions of medical necessity, reliable means for predeterming the need for services and effective penalties or incentives. We propose a peer-review system that would incorporate the sharing of financial risk among physician, hospital, insurer and patient in the fee-for-service sector.

Costs and Cost Analysis↗
PubMed1996

Evaluation of the notification procedure for physician-assisted death in the Netherlands.

BACKGROUND: In the Netherlands, a notification procedure for physician-assisted death has been in use since 1991. It requires doctors to report each case to the coroner, who in turn notifies the public prosecutor. Ultimately, the Assembly of Prosecutors General decides whether to prosecute. Although physician-assisted death remains technically illegal, doctors are extremely unlikely to be prosecuted if they comply with the requirements for accepted practice. In 1995, the ministers of health and justice commissioned an evaluation to determine the adequacy of the notification procedure. METHODS: A random sample of 405 physicians were interviewed. We also interviewed 147 physicians who had reported cases of physician-assisted death and 116 coroners, and we reviewed 353 judicial files of reported cases. In addition, we interviewed 48 public prosecutors and reviewed the minutes of the Assembly of Prosecutors General for 1991 to 1995 and all published court decisions from 1981 through 1995. RESULTS: In 1995, about 41 percent of all cases of euthanasia and physician-assisted suicide were reported. There were no major differences between reported and unreported cases in terms of the patients' characteristics, clinical conditions, or reasons for the action. Most patients had cancer and were described as suffering "unbearably" and 'hopelessly." Of the 6324 cases reported during the period from 1991 through 1995, only 13 involved prosecution of the physician. The majority of respondents in the groups interviewed thought that all cases of physician-assisted death should be reviewed, although most doctors thought the review should be performed by other doctors, and there was substantial concern about the burden associated with the reporting procedure. CONCLUSIONS: Substantial progress in the oversight of physician-assisted death has been achieved in the Netherlands. The reporting procedure could be more streamlined and less threatening.

Attitude of Health Personnel↗
PubMed2001

Adverse events reporting--the tip of an iceberg.

NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends $26 billion on research (compared to $16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for the years 1990 to August 2000 regarding all Institutional Incident Reports (IRPTs) and a list of Compliance Oversight Branch Investigations (COBIs) involving Multiple Project Assurances (MPAs). In the ten years of reporting for nearly seventy million human subjects, there were only 878 IRPTs and 41 investigations. From the incident reports to OHRP, 44% involved adverse events. Those projects investigated for Multiple Project Assurances violations (41 such investigations) showed that 51% were suspended or terminated. The number of deaths reported to OHRP in ten years for the seventy million human subjects is merely eight. The anticipated number of deaths among the general population in seventy million (assuming subject's duration in trials is one month) is 51,000. The number of suicides and attempted suicides alone among the seventy million expected research subjects can be anticipated to be about 5,000. Therefore, the number of expected deaths should have been between 5,000 and 51,000. These numbers and percentages represent minimal numbers since they are not a result of random audits or investigations, but a result of self-reporting or an exogenous complaint. Despite the fact that these are conservative estimates, they represent a significant problem. The purpose of this paper is to present the potential boundaries and magnitude of the problem in the current use of human subjects in research. This is a call for responsible institutions to undertake a thorough evaluation of the problem in order to obtain accurate information. For the immediate future, strong actions need to be taken to increase the protection of human subjects enrolled in research. This precautionary policy is prudent in light of recent revelations and data from this investigation.

Clinical Trials as Topic↗
PubMed2006

Catalytic oxidation of mixed wastes containing high organic content--emission reduction and the effect of steam.

To resolve mixed organic and radioactive waste disposal problems, Lawrence Berkeley National Laboratory (LBNL) initiated a treatability study using the catalytic chemical oxidation (CCO) system to oxidize a mixed-waste stream and to confine tritium as part of LBNL's pollution prevention program. LBNL has also adopted a legal approach by seeking an equivalent waste-treatment determination for the CCO process, and by petitioning the United States Environmental Protection Agency (EPA) to delist F-coded treatment residues. The results of this study demonstrate that (1) the CCO process can treat aqueous wastes containing a broad range of organic chemicals and achieve more than 99.999% destruction efficiency; (2) greater than 99.9% trapping efficiency for tritiated water can be achieved using an emission-reduction system that also confines the vapor of hydrochloric acid or nitric acid to the liquid residue; and (3) neutralized treatment residues can be disposed of as low-level radioactive waste at a permitted facility after EPA has approved LBNL's petitions, or the tritium in the residues can be recycled. The high oxidation efficiency of the CCO process is mainly due to the optimized operating conditions of the CCO process and the combined effect of steam reforming in the oxidation cell and the catalytic oxidation of organic mixtures and CO in the Pt/Al2O3 catalyst bed.

Catalysis↗