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Biomedical subjects

E Brown

Publications and source records attributed to E Brown.

At least 343 records · Page 19Linked to original sources
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Safety and metabolic effects of L-glutamine administration in humans.

A series of dose-response studies was conducted to evaluate the clinical safety, pharmacokinetics, and metabolic effects of L-glutamine administered to humans. Initial studies in normal individuals evaluated the short-term response to oral loads of glutamine at doses of 0, 0.1, and 0.3 g/kg. A dose-related increase in blood glutamine occurred after oral loading and elevation of amino acids known to be end products of glutamine metabolism occurred (including alanine, citrulline, and arginine). No evidence of clinical toxicity or generation of toxic metabolites (ammonia and glutamate) was observed. Glutamine was infused intravenously in normal subjects over 4 hr at doses of 0.0125 and 0.025 g/kg/hr. In addition, glutamine was evaluated as a component of parenteral nutrition solutions (0.285 and 0.570 g/kg/day) administered for 5 days to normal subjects. Intravenous administration of glutamine was well tolerated without untoward clinical or biochemical effects. Subsequent studies in patients receiving glutamine-enriched parenteral nutrition for several weeks confirmed the clinical safety of this approach in a catabolic patient population. In addition, nitrogen retention appeared to be enhanced when glutamine was administered at a dose of 0.570 g/kg/day in a balanced nutritional solution providing adequate calories (145% of basal) and protein (1.5 g/kg/day). Nitrogen balance in patients receiving lower doses of glutamine (0.285 g/kg/day) was similar to that in patients receiving standard formulations. Further controlled clinical trials of the metabolic efficacy, tolerance, and dose response of glutamine in other patient groups are necessary to determine the appropriate use of glutamine enrichment of nutrient solutions.

Administration, Oral↗
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Analgesia in children with sickle cell crisis: comparison of intermittent opioids vs. continuous intravenous infusion of morphine and placebo-controlled study of oxygen inhalation.

The objectives of the study were to compare the efficacy and safety of a continuous infusion (CIV) of morphine and intermittent parenteral opioids (IPO) in children with sickle cell vaso-occlusive crises (VOCs); to determine whether 50% oxygen administration through a face mask can reduce the duration of severe pain in patients receiving CIV morphine; and to measure morphine concentration at steady state for pharmacokinetic and pharmacodynamic analysis in patients receiving CIV morphine. The study was designed as a prospective, controlled, "before-and-after" evaluation of two different analgesic regimens. For patients receiving CIV morphine, there was a randomized, double-blind, placebo-controlled study of O2 vs. air. The patients were 66 children with sickle cell disease, 3-18 years old, requiring opioid therapy for severe VOC (32 patients in phase A, 34 in phase B). The analgesic regimens were as follows: phase A: meperidine, morphine, or codeine IM or IV bolus every 3 or 4 hours; phase B: morphine sulfate, loading dose 0.15 mg followed by CIV 0.04 mg/kg/hr. The infusion rate was adjusted every 8 hours according to pain and/or symptoms of opioid toxicity. Pain assessment was by behavioral observation (BPS). In terms of results, the mean opioid dose (morphine equivalent) was similar in both groups (0.032 +/- 0.020 mg/kg/hr in phase A and 0.035 +/- 0.011 in phase B). However, the duration of severe pain was significantly shorter in phase B (0.9 +/- 1.0 days) than in phase A (2.0 +/- 1.8 days). No severe opioid toxicity was observed in either group. Oxygen did not shorten the duration of severe pain compared to the placebo group (0.94 +/- 1.08 and 0.95 +/- 1.19 days, respectively) nor did it prevent the appearance of new pain sites. Pharmacokinetic analysis was performed in 24 patients of phase B. Total body clearance (TBC) of morphine was greater in children before puberty than after (40.4 +/- 10 vs. 28 +/- 11 mL/kg/min; p < 0.05). In conclusion, in children with severe VOCs, continuous infusion of morphine provides better analgesia than intermittent opioid therapy. Fifty percent oxygen inhalation had no effect on the duration of pain.

Adolescent↗
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Health care technology. Evolution toward revolution.

The assessment process has a significant effect on the development and diffusion of any new technology. An assessment during the infancy of a new technology may have to be updated as more experience and data accumulate and change the analysis of the technology's safety and effectiveness. An outdated assessment can result in inappropriate utilization either by hindering diffusion of a valuable technology or by promoting utilization of an inappropriate technology. Those who conduct technology assessments must recognize that technologies have life cycles of their own.

Methods↗
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Expert opinion's role in assessment.

How many articles start off by extolling the randomized clinical trial as the pinnacle of scientific evidence? The next sentence typically confronts the practical reality that randomized trials are simply not feasible in most cases. In the absence of definitive trials, technology assessment methodologies have been forced to rely on various types of observational studies--prospective cohort, case control, retrospective studies, cross-sectional and case studies--and a certain component of expert opinion/group judgement, as expressed either in the published medical literature or by the assessors themselves.

Randomized Controlled Trials as Topic↗
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Minimally invasive surgery: a payer's point of view.

For insurers, the decision to provide coverage for a new technology sets in motion a series of events that can cause real dilemmas. Ordinarily, a new technology, once covered as a benefit, expands in utilization, sometimes dramatically. The trick for the insurer is too determine how much of this new utilization is appropriate and how much is not. Failure to gain control of the technology can contribute to further cost increases.

Diffusion of Innovation↗
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Complementary and alternative medicine. The daunting challenge.

There is no question that the past few years have seen a tremendous surge in interest in what has come to be known as complementary and alternative medicine (CAM). Health plans contemplating adding CAM benefits face a daunting challenge. How should a plan define CAM benefits? How should a plan define appropriate CAM providers? How can these benefits be managed? Will the addition of CAM benefits undermine coverage policies for conventional biomedicine? The answer to these questions lies largely in uncharted waters, as even CAM advocates will agree that many alternative therapies (even those like Oriental medicine which has been in practice for some 5,000 years) have not yet undergone the type of rigorous, evidence-based analysis that is required to validate conventional biomedicine. This article explores options for CAM benefit design by considering two basic approaches-creating an uninsured benefit or insured benefit.

Ambulatory Care Facilities↗
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Medically necessary?

Coverage decisions can ultimately be traced back to three words in the original health policy contract: medically necessary and investigational. Investigational as a coverage exclusion applies to the minority of cases, in which there is inadequate data to validate the effectiveness of the intervention. In contrast, the majority of coverage decisions are based on medical necessity. Over the years the concept of medical necessity has evolved to encompass a multitude of medical management strategies. This discussion highlights the variable uses of the concept of medical necessity in terms of: (1) Determining the most appropriate intensity of service and place of service; (2) determining whether the proposed therapy is medically appropriate for the patient's condition; (3) distinguishing between medically necessary services and those that are performance enhancing or discretionary in nature; (4) making a distinction between medically necessary, cosmetic, and reconstructive services; and (5) defining medical necessity in accordance with generally accepted principles of good medical practice.

Decision Making↗
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Cox-2 inhibitors.

Increasing pharmacy costs are among the fastest growing segments of the health care budget. Health plans are focusing on appropriately managing pharmaceutical costs, both from a long-term global perspective and a short-term approach emphasizing newly marketed products. Over the next six months, cox-2 inhibitors are expected to be approved by the FDA. This new class of drugs, investigated as a safer alternative to non-steroidal anti-inflammatory drugs (NSAIDs), is among the most highly anticipated medications to hit the marketplace. How health plans react to the launch of cox-2 inhibitors may serve as an example for future pharmacy management efforts. A proactive policy regarding the use of cox-2 inhibitors may be challenging, but should include: Reviewing clinical information; evaluating the cost of the new drug; and identifying appropriate patient selection criteria. The available management strategies include precertification, a tiered co-payment system, restricting prescriptions to a provider specialty, retrospective physician profiling, and physician education.

Cyclooxygenase 2↗
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Cost-effectiveness and coverage policy.

Cost-effectiveness analyses have become a pervasive element of health care. But they have not had a major impact on medical coverage policy. The challenge of implementing cost-effectiveness as a medical coverage criterion is related to the following issues: (1) Contract language does not include cost-effectiveness as a coverage criterion; (2) cost-effectiveness analyses often take the societal, population-based perspective, while health care is delivered on an individual basis; (3) there is no standard methodology for cost-effective analysis; (4) there is no explicit cut-off between cost-effective and cost-ineffective; and (5) cost-effectiveness analyses are not time sensitive.

Community Health Planning↗
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ABMT and breast cancer: what have we learned?

The debate regarding the efficacy of and insurance coverage for ABMT for breast cancer has been raging since the widespread dissemination of ABMT in the early 1990s. Underlying the debate was the expectation that the results of randomized clinical trials would finally provide scientific data to resolve the frequently emotional controversy. Unfortunately, the results of these eagerly awaited trials failed to show a significant impact in patients with either metastatic breast cancer or those at high risk for metastatic disease. ABMT, as it is now offered, will not provide the breakthrough that was anticipated or a substantial benefit to the majority of patients. Research on ABMT may have evolved from the initial expectation that the trials would confirm a positive to more modest expectations that trials will disprove a negative. The promising results of early trials still require confirmation through randomized controlled trials, and participation in such clinical trials is vitally important.

Bone Marrow Transplantation↗
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An ounce of prevention?

While preventive health care is intuitively attractive, both from a disease morbidity and cost of care aspect, it is most effective when the natural history of a disease can be precisely predicted and when there is effective therapy to modify the risk factor. In contrast, if the natural history is uncertain, perhaps due to its multifactorial nature and treatment not entirely effective, there will inevitably be inefficiency in preventive treatment. In this complicated balancing act, the inefficiencies of preventive therapy may be buried beneath the surface, due in part to the method of reporting and perhaps to the enthusiasm for preventive medicine in general. Until we are able to identify more predictive risk factors, there will always be inefficiencies in preventive medicine, and many must be treated for one to benefit. However, the absolute risk reduction and the number needed to treat are useful measures to highlight what can actually be achieved with preventive therapy.

Community Health Planning↗
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The age of accountability.

The advent of accountability and evidence-based medicine set a new standard, suggesting that new medical technologies should require validation of their safety and effectiveness through controlled studies prior to their broad dissemination. Certainly, the concept of evidence-based medicine appears to be rational, objective, and consistent. However, the process can become extremely messy in its application to coverage decisions. After all, the coverage decision is really one of the most basic elements of health care. The following discussion represents a week in the life of a mythical medical director who is attempting to implement his or her company's evidence-based coverage policies.

Delivery of Health Care↗
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Followup study of possible HIV seropositivity among abusers of parenteral drugs in 1971-72.

Serum specimens obtained from a nationwide sample of parenteral drug abusers (PDAs) during the period 1971-72 had previously been screened for human immunodeficiency virus (HIV) antibodies. Some specimens were considered to be positive to both ELISA and Western blot (WB) analysis. These findings have been a topic of controversy, since HIV was not thought to have penetrated at-risk populations at such an early date. This study was a followup of those PDAs with apparent seropositivity to WB analysis. Of 10 persons followed, only one death (in 1985) was documented, and postmortem findings were inconsistent with HIV infection. Eight of the remaining PDAs were traced and found to be alive and well in 1989. Fresh specimens were obtained from the two persons with the strongest 1971-72 WB staining and were found to be both ELISA and WB negative on retesting. Their T-cell parameters were within normal limits. We concluded that the earlier WB results were most likely false positives and that definitive evidence of HIV infection in the U.S. addict population as early as 1971-72 is still lacking.

Blotting, Western↗
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Dialysis-related amyloidosis during peritoneal dialysis.

Patients treated with long-term hemodialysis may develop carpal tunnel syndrome, cystic bone lesions, and/or an arthropathy. This syndrome has been called hemodialysis-related amyloidosis (HRA) and appears to be the result of the accumulation of polymerized Beta-2 microglobulin (B2M). The risk to patients treated with peritoneal dialysis is unknown. Diphosphonate scans have been advocated as a useful noninvasive test for HRA. The authors report a well-documented case of HRA established during hemodialysis and progressing during peritoneal dialysis. In addition, this patient's HRA was not identified by a diphosphonate scan. This is the second well-documented case of HRA associated with peritoneal dialysis.

Aged↗