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Biomedical subjects

G A Sachs

Publications and source records attributed to G A Sachs.

At least 19 recordsLinked to original sources
PubMed2000

Treating nondementia illnesses in patients with dementia.

Physicians increasingly are called on to provide primary care for the growing population of people with Alzheimer-type dementia. However, little attention has been paid to the care of nondementia illnesses in this group of patients. To illustrate how presence of dementia can alter the risk-benefit ratio of treatment of a common medical problem, we present a case study in which a patient with dementia developed disastrous adverse effects to a drug commonly used to treat osteoporosis. This case and 2 composite vignettes illuminate how presence of dementia should influence the decision-making process for treatment of nondementia illnesses. We address issues such as decreased decision-making capacity, problems with reporting adverse effects, decreased cognition leading to problems with treatment adherence, and the role of screening and basic questions about acceptable burdens of treatments in patients with limited prognosis. We suggest ways to improve communication with patients with dementia in an effort to minimize complications and improve care, as well as policy changes to include patients with dementia in clinical trials. JAMA. 2000;283:3230-3235

Communication↗
PubMed1999

What is the quality of the reporting of research ethics in publications of nursing home research?

OBJECTIVE: To assess the quality of reporting of research ethics in published clinical research that involves a particularly vulnerable population: nursing home residents. DESIGN: A structured review of publications researched from 1992 to 1996 that involve nursing home residents. The review instrument assessed each publication's compliance with four common standards for research that involves nursing home residents or the cognitively impaired: justification of the use of nursing home residents, Institutional Review Board (IRB) review, nursing home committee review, and informed consent. For each publication, these results were summed into a quality score. The research ethics requirements contained in the journals' instructions for authors that corresponded with each publication were categorized in order to compare whether an association exists between the average quality score for each category and the detail of its research ethics instructions. RESULTS: Forty-five publications were identified. The four quality measures of research ethics showed that (1) all 45 publications reported justification of use of nursing home residents, (2) 36 publications reported that informed consent was obtained or waived, (3) 18 publications reported IRB review, and (4) six publications reported nursing home committee review. Of the 35 publications reporting informed consent was obtained, 16 reported assessing subjects' decisional capacity, and 24 reported whether cognitively impaired subjects were included (19) or excluded (5). The research ethics requirements of each publication's instructions for authors ranked it in one of four categories: (A) None (9); (B) Less than "Uniform Requirements (UR) for Manuscripts Submitted to Biomedical Journals" (7); (C) UR (24); (D) UR plus Additional Instructions (5). A positive association exists between the detail of a research ethics instructions category and the average research ethics quality score for each category (Kruskal-Wallis chi2 = 11.2, P = .01). That is, the more detailed the instructions, the greater the quality score. CONCLUSION: In publications of research that involves nursing home residents, basic standards of research ethics are not typically reported. However, the positive association between research ethics instructions category and research ethics quality score suggests that a journal's instructions for authors or other features of peer review and editing can affect the quality of reporting research ethics.

Clinical Trials as Topic↗
PubMed1998

Differences among geriatricians, general internists, and cardiologists in the care of patients with heart failure: a cautionary tale of quality assessment.

OBJECTIVES: To describe differences in the characteristics, processes of care, and resource utilization of patients with heart failure cared for by geriatricians, general internists, cardiologists, and combinations of physicians. DESIGN: A retrospective cohort study. SETTING: An urban academic medical center. PARTICIPANTS: A total of 439 outpatients with a billing diagnosis of heart failure or cardiomyopathy who were treated by geriatricians, general internists, cardiologists, and combinations of physicians. MEASUREMENTS: Demographic and clinical characteristics, medication use, diagnostic testing, hospitalizations, and inpatient and outpatient costs were measured. RESULTS: Compared with patients of cardiologists, patients cared for by geriatricians were older, more likely to have hypertension, diastolic dysfunction, and high comorbidity, and less likely to undergo echocardiography, cardiac catheterization, and electrocardiography. Use of angiotensin-converting enzyme inhibitors was similar among patients with reduced systolic function. Patients cared for by geriatricians had the same costs, rates of hospitalization, and likelihood of being symptomatic as patients of cardiologists. CONCLUSIONS: The processes of care for patients with heart failure seen solely by geriatricians differ from those for patients seen by other physicians, but the case-mix also varies. Assessment of left ventricular function by geriatricians probably needs to be increased. However, although they were older and had more comorbidity, patients of geriatricians had total costs and symptomatology similar to those of patients of cardiologists. Future work is needed to identify those patients most likely to benefit from treatment by geriatricians and to determine how care can be optimally coordinated among different types of physicians and health providers.

Academic Medical Centers↗
PubMed1997

The clinical introduction of genetic testing for Alzheimer disease. An ethical perspective.

OBJECTIVE: Primary caregivers should be aware of recent progress in the genetics of Alzheimer disease (AD) and of the clinical and ethical considerations raised regarding the introduction of genetic testing for purposes of disease prediction and susceptibility (risk) analysis in asymptomatic individuals and diagnosis in patients who present clinically with dementia. This statement addresses arguments for and against clinical genetic testing. PARTICIPANTS: The 20 participants were selected by the investigators (S.G.P., T.H.M., A.B.Z., and P.J.W.) to achieve balance in the areas of genetics, counseling, ethics, and public policy, and to include leadership from related consensus projects. The consensus group met twice in closed meetings and carried on extensive correspondence over 2 years (1995-1997). The project was supported by the National Human Genome Research Institute of the National Institutes of Health. EVIDENCE: All 4 involved chromosomes were discussed in group meetings against a background of information from several focus group sessions with AD-affected families. The focus groups comprised volunteers identified by the Cleveland Area Chapter of the Alzheimer's Disease and Related Disorders Association and represented a variety of ethnic populations. CONSENSUS PROCESS: The first draft was written in April 1996 by the principal investigator (S.G.P.) after the consensus group had met twice. The draft was mailed to all consensus group members 3 times over 6 months for extensive response and redrafting by the principal investigator until all members were satisfied. CONCLUSIONS: Except for autosomal dominant early-onset families, genetic testing in asymptomatic individuals is unwarranted. Use of APOE genetic testing as a diagnostic adjunct in patients already presenting with dementia may prove useful but it remains under investigation. The premature introduction of genetic testing and possible adverse consequences are to be avoided.

Advisory Committees↗
PubMed1997

Research on the cognitively impaired: lessons and warnings from the emergency research debate.

OBJECTIVES: To demonstrate that the recent events in emergency research have broad implications for the conduct of human subjects research with the cognitively impaired. This essay illustrates the similarities between the two kinds of research and suggests how understanding these similarities might help to resolve issues in human subjects research on the cognitively impaired. METHODS: A review of pertinent journal articles, books, regulations, and court cases. RESULTS: The emergency research controversy resulted in large part because of conflicting interpretations of arguably inadequate research regulations. The proposed Food and Drug Administration (FDA) regulations include advance informed consent, a broad role for family in approving a subject's participation, replacement of a threshold of permissible risk, called minimal risk, with a more sensible balancing of risks and benefits, and a role for the community in research approval. The current state of research on the cognitively impaired suggests that many of the same problems exist now that existed in emergency research before the FDA issued its proposed regulations. The ongoing case of T.D. et al. vs N.Y. State Office of Mental Health suggest that unless steps are taken similar to those taken in emergency research, much of clinical research on the cognitively impaired could cease. CONCLUSION: Representatives of the government, medicine, and the public must recognize the unresolved issues and inadequate regulations relating to research on the cognitively impaired. The proposed FDA regulations for emergency research may provide guidance for a settlement of these issues.

Cognition Disorders↗
PubMed1996

Physicians' attitudes about the care of patients in the persistent vegetative state: a national survey.

OBJECTIVE: To study the attitudes and beliefs of physicians who have experience caring for patients in the persistent vegetative state (PVS). DESIGN: Mailed questionnaire survey. PARTICIPANTS: 500 physicians, 250 from the American Academy of Neurology and 250 from the American Medical Directors Association. MEASUREMENTS: Physicians' beliefs about diagnosis of the PVS, patient awareness and suffering, treatment withdrawal, appropriate use of health maintenance and life-prolonging therapies, organ donation, lethal injection, and the treatment they would want if they were in the PVS. RESULTS: 68% of surveyed neurologists and 60% of medical directors responded. Thirteen percent of responders believe that patients in the PVS have awareness and experience hunger and thirst; 30% believe they experience pain. Fewer than 9% believe that respiratory failure, cardiogenic shock, acute renal failure, or cancer should be aggressively treated. Eighty-nine percent believe that it is ethical to withdraw artificial hydration and nutrition. Almost two thirds of responders believe that it would be ethical to use the vital organs of patients in the PVS for transplantation, and 20% believe that it would be ethical to hasten the patient's death by lethal injection. CONCLUSIONS: When evaluating the appropriateness of treatments for patients in the PVS, neurologists and medical directors largely concur. Most physicians in both groups believe that patients in the PVS would be better off dead; that it is not necessary to provide aggressive therapeutic interventions; and that all therapeutic interventions, including artificial nutrition and hydration, can be withheld in certain circumstances. The areas of consensus are remarkable and suggest that an ethical standard that physicians believe should be followed when caring for these patients may be emerging.

Acute Disease↗
PubMed1996

The application of health care surrogate laws to older populations: how good a match?

OBJECTIVE: The Health Care Surrogate Act (HCSA) in Illinois has been proposed as a model for state laws naming surrogate medical decision-makers for those without advance directives (ADs). Our objective was to determine if the HCSA identifies the same surrogate as older persons would choose for themselves. If not, is the discrepancy between legally identified surrogate and preferred surrogate troublesome to respondents? Because it is documented that black Americans have a variety of family structures, some of which may not be reflected in the HCSA list, we also wished to determine if discrepancies between surrogates named by the law and those desired by patients are associated with black or white race. DESIGN, SETTING AND PARTICIPANTS: A convenience sample of 144 patients aged 65 and older, without cognitive impairment, was interviewed at the geriatrics clinic of an academic medical center. MAIN OUTCOME MEASURES: Respondents without ADs who had a different stated choice for surrogate medical decision-maker than the surrogate defined by the Illinois HCSA, based on their existing family. RESULTS: Twenty-six percent of respondents without ADs chose a surrogate that differed from the surrogate defined by the HCSA. However, 67% of those with a different choice for surrogate than defined by law were not troubled by the discrepancy. The proportion of black subjects (25%) and white subjects (31%) who had surrogate discrepancies was not significantly different (P = .6). CONCLUSION: Because the Illinois HCSA named surrogates who would be agreeable to the majority of our respondents, it appears that it may be a useful model for state surrogacy laws.

Advance Directives↗
PubMed1994

Advance directives and the patient self-determination act.

Advance directives cover a wide variety of situations concerning the advance planning for medical care. Advance directives have existed for approximately 20 years; however, their forms and uses are presently expanding and evolving. This article presents advance directives, their various forms and uses, and reviews the current data on how well they achieve their desired goal. The Patient Self Determination Act, which was designed to promote the acknowledgment and completion of advance directives, is also discussed, as well as practical suggestions for the current and future uses for advance directives.

Advance Directives↗