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Biomedical subjects

A Meisel

Publications and source records attributed to A Meisel.

At least 55 records · Page 3Linked to original sources
PubMed1988

Two models of implementing informed consent.

The doctrine of informed consent has been controversial since its inception. In spite of the professed ideal of improving physician-patient communication, many commentators have argued that it interferes with the relationship. However, the problem may not be the doctrine itself but rather the manner in which it is usually implemented. This article describes two different ways in which informed consent can be implemented. The event model treats informed consent as a procedure to be performed once in each treatment course, which must cover all legal elements at that time. The process model, in contrast, tries to integrate informing the patient into the continuing dialogue between physician and patient that is a routine part of diagnosis and treatment. We suggest that the process model has many benefits.

Disclosure↗
PubMed1987

Conversion from low-dose insulin therapy to glipizide in patients with non-insulin-dependent diabetes mellitus.

This study examines the effect of glipizide therapy in patients with non-insulin-dependent diabetes mellitus (NIDDM) previously treated with a low-dose insulin regimen. To determine the comparative safety and efficacy of these two treatment regimens, 135 patients with NIDDM who received low-dose insulin (40 units per day or less) were enrolled in a prospective, multicenter trial. After a four-week period of continued insulin therapy, therapy was converted to the second-generation oral sulfonylurea, glipizide. This report includes efficacy data on 79 patients with NIDDM who completed an eight- to 10-week course of glipizide therapy. A majority of these patients were obese (more than 120 percent of ideal body weight), with a mean age of 61.4 years, and a mean duration of diabetes of 10.0 years. Conversion from low-dose insulin resulted in no deterioration in overall glycemic control as reflected by an unchanged glycosylated hemoglobin at 16 weeks. Seventy patients (89 percent) attained fair glucose control and continued an additional 12 weeks of glipizide maintenance therapy. Subgroup analysis by fasting plasma glucose criteria demonstrated that 44 percent of these patients had statistically significant improvements in glucose control with glipizide as compared with insulin therapy. As this study showed, many patients with NIDDM currently receiving treatment with low-dose insulin can have maintained and some even improved glucose and lipid parameters when therapy is converted to glipizide. The rate of hypoglycemic adverse reactions corrected for duration of treatment in all 135 patients was 0.32 event per patient-month of therapy with insulin as compared with 0.12 event per patient-month of therapy with glipizide. When issues of efficacy, safety, and convenience are considered, it might be more appropriate to administer an oral sulfonylurea to patients with NIDDM rather than proceeding to therapy with insulin.

Adult↗
PubMed1986

Deferred consent. A new approach for resuscitation research on comatose patients.

Methodological constraints inherent in the rapidly growing field of resuscitation research have created an apparent conflict with newly promulgated federal regulations, especially those concerning informed consent requirements. We propose that two new concepts be applied to resuscitation research to satisfy the current federal regulations governing biomedical research. The first of these concepts is "minimal differential risk," ie, in resuscitation medicine, the difference between the risk of an undesirable outcome when standard, commonly accepted therapy may be used and the risk of an undesirable outcome with experimental therapy is minimal. The second concept is "deferred consent," ie, obtaining consent to continue with an experimental therapy after administration of that therapy has already begun. We believe that the emergency exception to informed consent applies to resuscitation research. Recognition of the applicability of these concepts to resuscitation research should allow compliance with federal and state regulations that otherwise might inhibit or preclude such research endeavors.

Brain Diseases↗
PubMed1986

Unusual occurrence of EcoP1 and EcoP15 recognition sites and counterselection of type II methylation and restriction sequences in bacteriophage T7 DNA.

Selected and counterselected oligodeoxynucleotide sequences were identified in the total sequence of bacteriophage T7 DNA using a statistical criterion derived for a probability model of the Markov chain type. All extremely rare tetra- and pentadeoxynucleotides are (or contain) recognition sequences for the Escherichia coli DNA methylases dam or dcm. Most of the 37 hexadeoxynucleotides absent from T7 DNA are recognition sequences for type II modification/restriction enzymes of E. coli or related species. In contrast to most restriction sites counterselected during evolution, the EcoP1 site GGTCT occurs 126 times in the T7 genome, and phage T7 replication is severely repressed in P1-lysogenic host cells. We demonstrate that the frequency of the EcoP1 site is determined by that of the overlapping recognition sites for T7 primase, an essential phage enzyme. The recognition site of a type III enzyme, EcoP15, is also not counterselected. In T7 DNA all 36 EcoP15 sites are arranged in such a manner that the sequence CAGCAG is confined to the H strand, the complementary sequence CTGCTG to the L strand. This "strand bias" is highly significant and, therefore, very probably selected. A functional relation between this strand bias and the refractive behaviour of phage T7 to EcoP15 restriction is suspected.

Base Sequence↗
PubMed1986

Hospital guidelines for deciding about life-sustaining treatment: dealing with health "limbo".

The decision to withhold life-sustaining treatment from hopelessly ill patients is fraught with ethical dilemmas and legal uncertainties. Although there are extensive published commentaries on the subject and the law is gradually becoming clearer, care-givers often need concrete guidance when confronted with actual cases. Hospital ethics committees can assist care-givers, patients, and families in resolving these dilemmas, but the committees also need some specific guidance to be relatively consistent. Therefore, the Ethics and Human Rights Committee of Presbyterian-University Hospital, one of the University Health Center Hospitals in Pittsburgh, has developed guidelines for deciding about life-sustaining treatment.

Decision Theory↗
PubMed1986

Therapists' obligations to report their patients' criminal acts.

The law governing the obligation of therapists to report their patients' previous criminal acts was reviewed. Most often, discussions of this subject fall under the general category of "misprison of a felony," that is, the presumed general obligation of all citizens to report felonies that come to their attention. Review of federal law revealed that the courts have consistently interpreted the federal misprision statute as requiring active concealment of a crime, not a mere failure to report, in order to convict for the offense. State law is more diverse. Only one state has a general misprison statute labeled as such, and several states have recently repealed such statutes. The strong trend in states without statutes is to reject misprison as a common law crime, because of its incompatibility with modern notions of justice. Most states, however, have limited reporting statutes, such as for child abuse or gunshot wounds, that impose similar obligations. Therapists' reporting of past crimes may be affected by clinical and ethical concerns, as well as by obligations to protect future victims. In almost all jurisdictions, however, the fear of prosecution for failure to report a past crime should not be a factor in deciding on a course of action.

Confidentiality↗
PubMed1985

Responsibility and compensation for tardive dyskinesia.

Lawsuits seeking compensation for the suffering caused by tardive dyskinesia are becoming more common. Although most mental health professionals view the problem in the context of malpractice litigation, tardive dyskinesia is an example of a "mass accident," for which there are a number of judicially created remedies. These remedies include placing liability on manufacturers, asking society as a whole to bear the burden, and allowing patients with tardive dyskinesia to continue to carry the costs of their injuries. In attempting to influence policy in this area, psychiatrists should be sensitive to the implications of any policy for patient care.

Antipsychotic Agents↗
PubMed1985

Ethical and legal issues related to the use of computer programs in clinical medicine.

As computer programs are used with increasing frequency in the clinical setting, ethicists, lawyers, computer scientists, clinicians, and patients must confront a group of problems: In what situations is it appropriate to use a medical computer program? Who should use these programs and how should they be used? What is the legal status of a computer program that provides medical advice? Can a proper balance be achieved between confidentiality of patient information and shared access to records by health care personnel? How can regulatory agencies, physicians, and patients determine if a program is safe for human use? Will programs be able to communicate with users well enough to prevent clinically harmful misunderstandings? Because few if any definitive answers are yet available, these questions remain the subject of much discussion.

Computers↗
PubMed1985

Informed consent and incompetent medical patients.

The mentally incapacitated patient is frequently encountered in the general medical hospital. Incapacity is the clinical state in which a patient is unable to participate in a meaningful way in medical decisions. Mentally incapacitated patients relinquish the authority, that is the competent patient's right, to choose among professionally acceptable alternative treatments. Such patients, therefore, require a surrogate decision-maker. There are certain clinical situations in which questions of incapacity are especially important to consider. In a study for the President's Commission for the Study of Ethical Problems in Medical Biomedical and Behavioral Research, the most common problem in recognizing incapacity was found with previously capable patients who became transiently incapacitated during the course of hospitalization. Questions of incapacity or the authority of surrogate decision-makers also arose with comatose, mentally retarded, mentally ill, and physically handicapped patients. While standards to determine capacity remain unclear, a practical approach is to demonstrate that a patient is able to describe the physician's view of the situation and to understand the physician's opinion as to the best intervention. When a patient is deemed to be incapacitated, the physician should turn to family members, whenever possible, to make decisions.

Aged↗
PubMed1983

Barriers to informed consent.

The law of informed consent seeks to actively involve patients in decision making. Most authorities agree that this involvement has not occurred but disagree about why. Some suggest that patients are incapable of understanding medical issues and others that physicians have not explained issues clearly or extensively enough. We observed decision making in several hospital settings and found other significant barriers to patient participation. These barriers include the fact that treatment decisions take place over a long period; there are often many decisions to be made; although patients want information about treatment, they typically believe that decision making is the physician's task; physicians do not understand the rationale for the patient's role in decisions; and the medical decision-making process often involves so many people that the patient does not know who is responsible.

Aged↗