Health-related quality of life in venous leg ulcer patients successfully treated with Apligraf: a pilot study.

Apligraf (Graftskin) is a bilayered, living human skin construct that is indicated for use with standard therapeutic compression for the treatment of noninfected partial- and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration that have not adequately responded to conventional ulcer therapy. A pilot study was conducted to assess the health-related quality of life impact of patients with venous leg ulcers treated with Apligraf. A 2-part questionnaire was administered over the telephone to patients treated with Apligraf whose ulcers had healed within the past 12 weeks. The patients were asked to respond to questions when thinking about the past week and when thinking about the time immediately prior to treatment. A total of 14 participants completed the questionnaire. All patients reported improvement in health-related quality of life after successful treatment of Apligraf. Compared with the time before treatment, 79% of respondents said their health was "much better" now. The greatest improvement was reported in pain and in other physical health dimensions. Despite the small sample size and cross-sectional design of the study, statistically significant differences were observed on a number of scales.

Prescription medication use in older Americans: a national report card on prescribing.

BACKGROUND AND OBJECTIVES: Due to their high prevalence of disease, older Americans receive more prescription medication than any other age group. We evaluated prescription medication use in patients age 50 or older; categorized and reported medication use by age group, drug class, and therapeutic class; and examined differences in prescribing patterns for older patients. METHODS: All prescription medications reported in the 1995 National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory care visits in the United States for patients age 50 and older (n = 16,289), were evaluated in a cross-sectional analysis. We evaluated the number of prescription medications reported for each patient visit and ranked use of drug and therapeutic classes. RESULTS: Most patients seeing physicians (61%) had a prescription for at least one medication, ranging from a mean of 1.27 medications in patients ages 50-64 to 1.58 in patients over 85. Calcium channel blockers and angiotensin-converting enzyme inhibitors were prescribed more than beta blockers in all patients. Data also indicated a significant decrease in estrogen/progestin and antidepressant medication use in older patients. CONCLUSIONS: Our findings indicate prescribing patterns inconsistent with national guidelines and decreased medication use, suggesting underprescription. Active intervention may be needed to improve the pharmacological treatment of older patients.

Evaluating cancer costs in NCI trials.

Economic evaluation is playing an increasingly important role in the assessment of clinical treatment strategies for cancer patients. Physicians and patients can use the comprehensive data on the cost and effectiveness of cancer therapies emerging from economic studies to help make treatment decisions. The data from economic analyses will afford clinical investigators an increasingly important tool to help determine the optimal treatment strategies for cancer patients and to help inform health policy decision-makers about the importance of specific cancer therapeutic strategies. In this chapter, we have outlined a set of procedures that can be used to assess the costs of care within NCI clinical trials. We review the economic framework for assessment of clinical trials, then review a proposed strategy for economic assessment. The design was successfully implemented, and the results have been recently published.

Pharmacist influence on economic and morbidity outcomes in a tertiary care teaching hospital.

The influence of pharmacist participation on economic and morbidity outcomes at a tertiary care teaching hospital was studied. Patients admitted to internal medicine wards during a nine-month period were assigned to either a treatment team or a control team. Each team consisted of an attending physician, senior and junior medical residents, and medical students; the treatment team included a pharmacist who reviewed all patient charts, made rounds with the team, and recommended modifications of drug therapy. Pharmacy interaction with the control team was limited to contacting physicians about potentially dangerous orders, answering questions from the medical team, and handling orders for items not on the formulary or otherwise unavailable. After discharge, data from patient records were analyzed for pharmacy costs and total hospital costs and length of stay (as markers of the pharmacist's effect on economics and morbidity, respectively). Analysis of baseline characteristics showed that the two groups of patients were statistically comparable. Treatment team patients who were included in the data analysis (414) had significantly shorter stays (by a mean of 1.3 days) and lower pharmacy and total hospital costs (by a mean of $301 and $1654, respectively) than those included in the control team analysis (453). The direct participation of a pharmacist on a patient care team significantly decreased pharmacy and hospital costs, as well as length of stay, compared with minimal participation of a pharmacist.

Genetic control of levels of murine kidney glucuronidase mRNA in response to androgen.

A cis-acting genetic element, designated Gus-r, regulates the androgen-induced rates of murine glucuronidase (EC 3.2.1.31) synthesis in kidney tubule cells and is tightly linked to the glucuronidase structural gene, Gus-s. To investigate the molecular mechanism underlying this regulation, we have cloned a glucuronidase-specific cDNA sequence in plasmid pBR322. This cloned DNA has been utilized as a probe in blot hybridization analyses to determine whether the control of androgen responsiveness of kidney glucuronidase synthesis by Gus-r is exerted over the level or the translatability of glucuronidase mRNA. Three important observations emerged from these studies: (i) glucuronidase mRNA exists as a single size class of approximately 2,800 nucleotides; (ii) androgen stimulation of glucuronidase synthesis is directly related to the level of glucuronidase mRNA; and (iii) strain differences in levels of kidney glucuronidase mRNA accumulated in response to androgen are controlled by alleles of Gus-r. Thus, Gus-r regulates the androgen responsiveness of glucuronidase synthesis by controlling the amount of glucuronidase mRNA available for translation and is a cis-acting genetic element that regulates the hormonal responsiveness of a specific mRNA.

Detection and quantitation of the beta-subunit of human chorionic gonadotropin in serum by radioimmunoassay.

Qualitative and quantitative radioimmunoassays (RIA) specific for the beta-subunit of human chorionic gonadotropin (HCG) produced by Wampole Laboratories and Monitor Science Corporation were compared in a study involving the sera from 213 individuals. Qualitative assays from both manufacturers were found to be equivalent in clinical specificity (99.2%). However, the clinical sensitivity of the Wampole beta-Tec qualitative RIA (95.6%) was greater than that of the Monitor Science beta-CG qualitative RIA (89%) in detecting hCG in serum. In quantitative assays, the Wampole beta-Tec RIA gave serum values 1- to 10-fold higher than those obtained using the Monitor Science beta-hCG system when the same patient or control serum was assayed. Preliminary studies comparing two additional quantitative RIA kits (Serno hCG-beta and Bio-RIA hCG-beta rapid RIA) indicate that the results obtained with the quantitative Wampole and Monitor Science reagents are not peculiar to these two assay systems. Possible explanations of the cause of such aberrant results are presented. It is concluded that variable results can be expected when assaying the same serum sample with different RIA reagents for beta-hCG owing to the lack of an acceptable reference preparation for hCG that can be utilized by all commercial or private producers of such reagents.

Evaluation and clinical application of the quantitative radioreceptor assay for serum hCG.

An evaluation of a radioreceptor assay (RRA) for the quantitation of human chorionic gonadotropin (hCG) in serum resulted in intra- and interassay variations of 2.6 and 5.5% (average), respectively. Recovery of hCG in a preparation of second IRP-hCG gave an accuracy of 93.2%. Standard curve data demonstrated that variation in reagent addition and incubation time allowed for flexibility in the use of the assay depending on the level of sensitivity desired. The most sensitive assay, which used an incubation of 2 hours, gave a usable range of 40--250 mIU/ml hCG on the standard curve. The applicability of the quantitative RRA in clinical cases is shown with 9 patients (total of 31 serum samples) in a comparison study with a radioimmunoassay (RIA) for the beta-subunit of hCG.

Determination of serum hCG levels by radioreceptor assay in the clinical laboratory.

The radioreceptorassay (RRA) has been used for measuring human chorionic gonadotropin (hCG) in sera from 751 individuals. The RRA is shown to be sensitive (98 percent) and specific (99.8 percent) in detecting hCG in a wide variety of conditions, including normal pregnancy and threatened or missed abortions. As a rapid qualitative or semiquantitative assay for hCG, the RRA is a valuable adjunct in the laboratory to less sensitive tests for hCG. Variation among different quantitative assays for hCG is examined, and it is concluded that the same assay system should be used for monitoring hCG LEvels in a single individual over a period of time in order to avoid inconsistent results. Application of the quantitative RRA for hCG in detecting the midcycle luteinizing hormone surge in infertility is also presented.

Application of the radioreceptor assay for human chorionic gonadotropin in pregnancy testing and management of trophoblastic disease.

A commercially prepared radioreceptor assay (RRA) for human chorionic gonadotropin (hCG) has been evaluated as a pregnancy test and in a quantitative assay to follow patients with hydatidiform mole. The RRA demonstrated almost 100% agreement in comparison with radioimmunoassay (RIA) and urinary hCG tests. In the quantitative assay, a limiting reliable concentration of 70 mIU/ml of hCG in serum could be obtained. Extremely good correlation was achieved between the RRA and RIA test for hCG in 2 patients with hydatidiform mole over a span of 3 months of followup after evacuation of the mole. The usefulness of the RRA as a replacement of RIA tests for hCG is discussed.

PIP: The use of a commercially prepared radioreceptor assay (RRA) for human chorionic gonadotropin (HCG) as a pregnancy test and in the follow-up of patients with hydatidiform mole is reported. In comparison with radioimmunoassay (RIA) and urinary HCG tests, the RRA gave results that were almost in 100% agreement. In 2 patients who were followed for 3 months after evacuation of a hydatidiform mole, the RRA and RIA showed an extremely good correlation. The limiting reliable concentration in the quantitative RRA assay was 70 mIU/ml of HCG in serum. The advantages and disadvantages of the RRA and RIA in a general hospital laboratory are discussed.