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PubMed1996

Menstrual phase and breast cancer surgery: influence on clinical outcome or pitfall of statistical analysis?

The influence of menstrual status at the time of surgery on the prognosis of women suffering from breast cancer is still discussed controversially. In our patient collective, including 149 patients, we obtained statistically significant results for six different time intervals, indicating that patients who underwent surgery between 11 and 22 days after the last menstrual period (LMP) have a poorer outcome. Focusing on the effect of statistical data evaluation strategy we designed a simulation study to evaluate the amount of type I error (error of a false positive test result) in a multiple testing situation involving a cyclical covariate. Accordingly, we corrected the minimum P-values for the occurring type I error rates. After that correction all six previously significant P-values failed to achieve statistical significance. The impact of different statistical data evaluation strategies in a multiple testing situation is discussed.

Adult↗
PubMed2003

Improving the prediction of complex diseases by testing for multiple disease-susceptibility genes.

Studies have argued that genetic testing will provide limited information for predicting the probability of common diseases, because of the incomplete penetrance of genotypes and the low magnitude of associated risks for the general population. Such studies, however, have usually examined the effect of one gene at time. We argue that disease prediction for common multifactorial diseases is greatly improved by considering multiple predisposing genetic and environmental factors concurrently, provided that the model correctly reflects the underlying disease etiology. We show how likelihood ratios can be used to combine information from several genetic tests to compute the probability of developing a multifactorial disease. To show how concurrent use of multiple genetic tests improves the prediction of a multifactorial disease, we compute likelihood ratios by logistic regression with simulated case-control data for a hypothetical disease influenced by multiple genetic and environmental risk factors. As a practical example, we also apply this approach to venous thrombosis, a multifactorial disease influenced by multiple genetic and nongenetic risk factors. Under reasonable conditions, the concurrent use of multiple genetic tests markedly improves prediction of disease. For example, the concurrent use of a panel of three genetic tests (factor V Leiden, prothrombin variant G20210A, and protein C deficiency) increases the positive predictive value of testing for venous thrombosis at least eightfold. Multiplex genetic testing has the potential to improve the clinical validity of predictive testing for common multifactorial diseases.

Genetic Diseases, Inborn↗
PubMed1999

Testing for multiple species in fossil samples: an evaluation and comparison of tests for equal relative variation.

Tests for equal relative variation are valuable and frequently used tools for evaluating hypotheses about taxonomic heterogeneity in fossil hominids. In this study, Monte Carlo methods and simulated data are used to evaluate and compare 11 tests for equal relative variation. The tests evaluated include CV-based parametric bootstrap tests, modifications of Levene's test, and modified weighted scores tests. The results of these simulations show that a modified version of the weighted scores test developed by Fligner and Killeen ([1976] J. Am. Stat. Assoc. 71:210-213) is the only test that maintains an acceptable balance of type I and type II errors, even under conditions where all other tests have extraordinarily high type I error rates or little power.

Animals↗
PubMed2006

Gene expression profiling of androgen receptor antagonists in the rat fetal testis reveals few common gene targets.

The androgen receptor (AR) is expressed in the fetal testis; however, the role of AR in fetal testicular development is poorly understood. Disrupted AR activity and subsequent gene expression alterations may disturb developmental programming of the fetal testis and result in testicular abnormalities later in life. The present study was performed to examine global gene expression patterns in rat fetal testis following in utero exposure to various AR antagonists. Pregnant Sprague-Dawley rats were treated with flutamide (50 mg/kg/day), linuron (50 mg/kg/day), vinclozolin (200 mg/kg/day), p,p'-DDE (100 mg/kg/day) or corn oil vehicle by gavage daily from gestation day (GD) 12-19. Testes were isolated on GD 19, and AR immunostaining, histology, and global changes in gene expression were determined. There were no alterations in the pattern or expression level of AR and no apparent histological changes in the fetal testes in any treatment group. Microarray analysis using Dunnett's test with multiple testing correction revealed no significant gene expression alterations following exposure to flutamide, linuron, vinclozolin, and p,p'-DDE. A less stringent analysis yielded some chemical specific effects on gene expression, and these effects were further evaluated by real-time RT-PCR. Vinclozolin treatment reduced the expression of several genes involved in cholesterol biosynthesis, though the testosterone levels were unchanged in the fetal testes in any treatment group. In flutamide, linuron, and p,p'-DDE treatment groups, the expression of hemoglobin Y, beta-like embryonic chain (Hbb-y) was reduced. Myomesin 2 (Myom2) expression was increased following linuron treatment. Given the lack of a common set of genes and the absence of overt histopathology, we conclude that the fetal testis is not a major target for AR activity at this stage of development although some cell-type specific gene expression changes cannot be ruled out.

Androgen Antagonists↗
PubMed2006

Using and interpreting diagnostic tests.

Diagnostic tests are invaluable to the practice of veterinary medicine. Using them correctly and interpreting the results appropriately depend on having a good understanding of the basic principles outlined in this article. Topics covered include sensitivity and specificity, agreement among tests, using multiple tests, and other issues related to the use and interpretation of diagnostic tests. The most important principle is recognition that the interpretation of test results varies across populations and requires an estimate of the prevalence of the infection (or disease) in the population being studied.

Animal Diseases↗
PubMed2005

A marginal model approach for analysis of multi-reader multi-test receiver operating characteristic (ROC) data.

The receiver operating characteristic curve is a popular tool to characterize the capabilities of diagnostic tests with continuous or ordinal responses. One common design for assessing the accuracy of diagnostic tests involves multiple readers and multiple tests, in which all readers read all test results from the same patients. This design is most commonly used in a radiology setting, where the results of diagnostic tests depend on a radiologist's subjective interpretation. The most widely used approach for analyzing data from such a study is the Dorfman-Berbaum-Metz (DBM) method (Dorfman et al., 1992) which utilizes a standard analysis of variance (ANOVA) model for the jackknife pseudovalues of the area under the ROC curves (AUCs). Although the DBM method has performed well in published simulation studies, there is no clear theoretical basis for this approach. In this paper, focusing on continuous outcomes, we investigate its theoretical basis. Our result indicates that the DBM method does not satisfy the regular assumptions for standard ANOVA models, and thus might lead to erroneous inference. We then propose a marginal model approach based on the AUCs which can adjust for covariates as well. Consistent and asymptotically normal estimators are derived for regression coefficients. We compare our approach with the DBM method via simulation and by an application to data from a breast cancer study. The simulation results show that both our method and the DBM method perform well when the accuracy of tests under the study is the same and that our method outperforms the DBM method for inference on individual AUCs when the accuracy of tests is not the same. The marginal model approach can be easily extended to ordinal outcomes.

Breast Neoplasms↗
PubMed1999

Diagnosis of perinatal TORCH infections.

Collectively, TORCH infections create more neonatal morbidity than early-onset group B streptococcal sepsis. Fortunately, the incidence of maternal infection by CMV or toxoplasmosis is low (2-10 per 1,000 births). There have been tremendous advances in direct antigen testing and in the sensitivity and specificity of IgG and IgM testing. Consistently, research laboratories show more accurate results than in the past. Unfortunately, commercial laboratories are using older, single-kit testing. The relatively poor degree of reliability can lead to unnecessary obstetric intervention or elective termination. Any positive pathogen-specific IgM on maternal serum should have additional confirmatory testing in a reputable research laboratory before any intervention. Direct antigen testing or multiple testing would seem to be appropriate for confirmation. This may include amniocentesis of fetal blood sampling. The research on the newer tests is based of the evaluation of blood from seriously immunocompromised subjects. Extrapolations of test accuracy to similar tests on healthy, pregnant women and their fetuses are likely to be in error. The application of these accurate tests to the obstetric population is a critical research need.

Cytomegalovirus Infections↗
PubMedDate not supplied

Short-term reliability of oxygen uptake on-kinetics in apparently healthy subjects.

PURPOSE: The analysis of oxygen (O2) uptake on-kinetics at the onset of aerobic exercise has been shown to be reflective of cardiovascular and skeletal muscle health in a number of previous investigations. The purpose of the present investigation is to assess the short-term reliability of O2 uptake on-kinetics in a group of apparently healthy individuals. METHODS: Forty apparently healthy subjects participated in 3 consecutive treadmill exercise sessions on 3 consecutive days. During each session, O2 uptake was collected at rest for 2 minutes and during ambulation at 2.2 miles per hour and a 6% grade for 6 minutes. The time constant (TC) for the O2 uptake response was calculated for each of the 3 sessions using the equation: O2(t) = O2(resting) + O2(steady-rate)[1 - e]. RESULTS: Two subjects did not adhere to the physical activity guidelines and were excluded from data analysis. The following data are representative of the remaining 38 subjects. The mean O2 uptake TC value for the 3 sessions was 33.67 +/- 7.87, 34.59 +/- 7.57, and 32.59 +/- 6.64 seconds, respectively. The intraclass correlation coefficient for the O2 uptake TC was 0.84 (P < .001). CONCLUSIONS: The results of the present study indicate O2 uptake on-kinetics may be reliably measured using a single testing session. Multiple testing sessions, which would limit the potential clinical application of O2 uptake on-kinetics, may therefore not be necessary. Future research should be directed toward determining if O2 uptake on-kinetics is equally reliable in patient populations.

Adult↗
PubMed2006

Rat brain DNA transcript profile of halothane and isoflurane exposure.

Inhaled anesthetics produce many effects and bind to a large number of brain proteins, but it is not yet clear if this is accompanied by widespread changes in gene expression of the biological targets. Such changes in expression might implicate functionally important targets from the large pool of binding targets. Both rats and isolated primary cortical neurons were exposed to anesthetics and DNA oligonucleotide microarrays were used to detect and quantify transcriptional changes in neural tissue. Using analysis of variance with multiple testing correction, multiple exposures of rats to 0.8 MAC (minimum alveolar concentration) halothane only produced significant changes in a few metabolic genes. No significant in-vivo gene transcriptional response to 0.8 MAC isoflurane was detected. The use of primary cortical neurons allowed exposure to 3 MAC anesthetics without evidence of toxicity. Isoflurane altered several genes involved with neurotransmitter transport, signaling and cellular structure, whereas halothane produced few detectable changes in these cultured cells. Selected genes were confirmed by quantitative reverse transcription-polymerase chain reaction. Although indicating only a small degree of transcriptional regulation, these data implicate several plausible targets, including synaptic vesicle handling, that might contribute to drug action. In addition, the data show different gene expression profiles for the two inhaled anesthetics, suggesting unique pharmacological targets and mechanisms in each case.

Anesthetics, Inhalation↗
PubMed2004

The utility of drug testing in epidemiological research: results from a general population survey.

AIMS: To assess the utility of biological testing in a general population survey for estimating prevalence and evaluating self-report data quality. DESIGN: An audio computer-assisted interview was administered to subjects from June 2001 to January 2002. Immediately following the interview, subjects were requested to participate in hair, oral fluid and urine testing. SETTING: Subjects were from randomly selected households in the City of Chicago using multi-stage sampling methods. Interviews were conducted in subjects' homes. PARTICIPANTS: The data represent 627 randomly selected adult participants, ages 18-40 years. MEASUREMENTS: Prevalance, kappa, conditioned kappa, sensitivity, specificity, under-reporting, 'mixed model' and logistic regression. FINDINGS: Higher rates of marijuana use were generated from survey reports than from drug testing. Drug testing generated higher prevalence rates than survey reports for recent use of cocaine and heroin. Under-reporting of recent drug use was apparent for all three substances. Sensitivity was particularly low for cocaine and heroin. Race was related to under-reporting, with African Americans less likely to report marijuana use despite a positive test result. CONCLUSIONS: The utility of drug testing for surveys depends on the type of substance examined as well as on the type of test employed. Multiple tests have more utility than a single test. Drug testing is useful for identifying the levels and sources of under-reporting in a survey and provides a basis for adjusting prevalence estimates based on self-reports.

Adolescent↗
PubMed1983

Response of pulmonary rapidly adapting receptors during lung inflation.

Studies were conducted to establish the factors that determine the response of canine pulmonary rapidly adapting receptors (RAR) during lung inflation. Inflations of the lung were performed at several constant rates during which the activity of individual RAR was counted. At each rate of inflation tested multiple identical tests were performed. The volume of each test inflation was controlled. Data obtained in all tests at each flow rate were averaged to give the mean response of the receptor at that rate of inflation. These studies indicate the major response characteristics of RAR during lung inflation in conditions of relatively constant lung mechanics. First, at a constant rate of inflation, the activity of RAR augments increasingly as the lung is expanded. Second, their activity is influenced markedly by the rate of inflation. However, this sensitivity is nonlinear. Specifically, at low rates of inflation increases in flow rate produce more marked augmentation of RAR firing than do identical increases in flow at higher rates of inflation. The major difference between receptors is in their threshold; however, this too is a function of flow rate. With increasing flow rate the threshold, whether measured as the inflation volume or transpulmonary pressure at which receptors begin to fire, declines. The response of receptors, however, with thresholds over the entire range show the major features discussed above. The present results provide quantitative information which are necessary to begin to eludicate the transduction properties of this receptor type.

Animals↗
PubMed2006

In vitro evaluation of metallic coronary artery stents with sub-millimeter multi-slice computed tomography using an ECG-gated cardiac phantom: relationship between in-stent visualization and stent type.

The aim of this experimental study was to investigate visualization of various coronary artery stents with sub-millimeter multi-slice spiral computed tomography (MSCT) using a cardiac physical phantom. Four 3-mm stents of various designs were implanted in tubes with an inner diameter of 3 mm to simulate coronary artery. Stents were placed on a cardiac phantom and scanned at different heart rates. Retrospective ECG-gated adaptive segmental reconstruction technique was employed. Profile curves across longitudinal curved planar reconstruction images of the stents were generated. From the profile curve, the full width at half maximum was defined as the stent lumen index. The effect of heart rate and stent type on the stent lumen index was evaluated. Visual evaluation for each stent at various heart rates was also performed. The heart rate had no significant effect on in-stent visualization. However, in-stent visualization differed significantly for the various stent types for both profile curve analysis and visual evaluation (the Tukey-Kramer multiple comparisons test). Multiple regression analysis indicated that strut thickness, especially minimal strut thickness, was the significant influencing factor for the in-stent visualization. On the basis of four stent models examined it would appear that visualization of the coronary stent lumen varies depending on the stent type, but not on the heart rate. Stents with slim struts are preferable for in-stent evaluation with multi-slice spiral computed tomography.

Biocompatible Materials↗
PubMed1999

Laboratory diagnosis of heparin-induced thrombocytopenia.

The characteristics of the currently available platelet function assays (platelet aggregation, serotonin release, and flow cytometry) and enzyme-linked immunosorbent assays that quantitate antiheparin-platelet factor 4 antibody titers were studied using sera collected from clinically diagnosed heparin-induced thrombocytopenia patients, patients without heparin-induced thrombocytopenia, patients with platelet immune disorders other than heparin-induced thrombocytopenia, and normal individuals. The platelet aggregation assay was less sensitive than the serotonin release assay, which was less sensitive than the enzyme-linked immunosorbent assay (p < 0.001). Yet heparin-induced thrombocytopenia was identified by platelet aggregation assay in cases where the serotonin release assay and/or the enzyme-linked immunosorbent assay were negative. Patients with heparin-induced thrombocytopenia and thrombosis were more often positive than heparin-induced thrombocytopenia patients without thrombosis (p < 0.05). Positive platelet aggregation assay and serotonin release assay results were generally associated with a higher antibody titer; however, a minimum critical titer could not be identified. Over a 30-day period the percentage of positive responses did not change significantly even though clinical symptoms corrected in most heparin-induced thrombocytopenia patients. Multiple testing over several days enhanced the chance of detecting a positive, and combined results of the three assays further enhanced the positive response (p < 0.005). In patients without heparin-induced thrombocytopenia, false-positive results were obtained with the enzyme-linked immunosorbent assay. These data demonstrate that there is no direct correlation between the positive responses of these assays, that clinically positive patients can be missed by all assays, and the presence of antibody alone does not determine clinical heparin-induced thrombocytopenia. With these limitations, the combination of aggregation, serotonin release, and enzyme-linked immunosorbent assay testing with multiple samples offers the best chance of identifying a positive heparin-induced thrombocytopenia patient. Caution is advised for all assays as none is optimal.

Anticoagulants↗
PubMed2003

Individual differences in the expression of a "general" learning ability in mice.

Human performance on diverse tests of intellect are impacted by a "general" regulatory factor that accounts for up to 50% of the variance between individuals on intelligence tests. Neurobiological determinants of general cognitive abilities are essentially unknown, owing in part to the paucity of animal research wherein neurobiological analyses are possible. We report a methodology with which we have assessed individual differences in the general learning abilities of laboratory mice. Abilities of mice on tests of associative fear conditioning, operant avoidance, path integration, discrimination, and spatial navigation were assessed. Tasks were designed so that each made unique sensory, motor, motivational, and information processing demands on the animals. A sample of 56 genetically diverse outbred mice (CD-1) was used to assess individuals' acquisition on each task. Indicative of a common source of variance, positive correlations were found between individuals' performance on all tasks. When tested on multiple test batteries, the overall performance ranks of individuals were found to be highly reliable and were "normally" distributed. Factor analysis of learning performance variables determined that a single factor accounted for 38% of the total variance across animals. Animals' levels of native activity and body weights accounted for little of the variability in learning, although animals' propensity for exploration loaded strongly (and was positively correlated) with learning abilities. These results indicate that diverse learning abilities of laboratory mice are influenced by a common source of variance and, moreover, that the general learning abilities of individual mice can be specified relative to a sample of peers.

Animals↗
PubMed1994

Automation and quality control in the coagulation laboratory.

Hemostasis is a balance between complex interactions of directly opposing systems (coagulation and fibrinolysis) with seemingly unrelated systems at both the enzymatic and cellular levels (platelets, endothelium, leukocytes). It should not be surprising that coagulation disorders often accompany many different disease states. Because the function of each protein involved in coagulation is now better defined, newer methodologies have been developed to assay them. In this regard, the hemostasis laboratory can take a two-step approach to diagnosis: global screening and targeted analysis. Several new global test systems provide more detailed, quantitative, and more physiologically relevant evaluations than earlier assays allowed. In addition, individual enzymes, inhibitors, cellular release products, and low molecular weight products of activation reactions (molecular markers) can now be measured in sensitive, specific assays. With this new perspective, genetic predisposition to pathologic hemostatic conditions can be identified through molecular biology and can be identified during the early stages of disease (i.e., at subclinical stages before major pathologic complications are established), and more specifically targeted prophylactic, as well as therapeutic drug interventions, can be administered. The molecular markers of hemostatic activation that can be assessed by various immunochemical methods provide very early evidence of thrombotic, fibrinolytic, or platelet-involved aberrations. Technological advances in methodology and instrumentation have changed the scope of all clinical laboratories but, in particular, that of the coagulation laboratory. The dramatic growth and development have resulted from the influences of clinical chemistry, clinical immunology, pharmacology, biochemistry, and biotechnology. Analytical instruments for use in hemostatic testing go beyond plasma or whole blood clot-based readers, platelet aggregometers, and microscopes to a range of automated, discrete, chemistrylike analyzers, spectrophotometers, microliter ELISA systems, RIA systems, and multiprobe instruments designed to measure simultaneously the different assay end-points of colorimetric and clotting assays and flow cytometers. Instruments are designed for batch processing of single tests on multiple samples or multiple test panels on a single sample. Versatility ranges from instruments that measure only the final reaction solution, by end-point or kinetic analysis, to instruments that automatically pipet reagents and sample, incubate, and analyze the reaction for truly walk-away assay performance. Typically, a wider range of assays are available in automated laboratories as opposed to laboratories performing manual assays.(ABSTRACT TRUNCATED AT 400 WORDS)

Amino Acid Sequence↗
PubMedDate not supplied

Albuterol delivery by metered-dose inhaler with a pediatric mechanical ventilatory circuit model.

STUDY OBJECTIVE: To determine albuterol delivery by metered-dose inhaler (MDI) in an in vitro pediatric mechanical ventilatory circuit model. The influence of a spacing device, endotracheal tube (ETT) diameter and length, and air humidity was also investigated. DESIGN: An albuterol MDI canister was connected to an AeroVent spacer or Airlife MDI adapter and ETT 4.0, 5.0, or 6.0 mm at commercially available and equal lengths. The ETT tip was attached to an in-line filter holder with a 1-microns type A/E glass fiber filter. Ventilator settings were fractional concentration of inspired oxygen 50%, tidal volume 250 ml, inspiratory:expiratory (I:E) ratio 1:3, rate 25 breaths/minute, temperature 35 degrees C, and a decelerating flow pattern. Ten albuterol canisters were activated two times each (total 2000 micrograms) into dry (4.0-, 5.0-, and 6.0-mm ETT) and humidified air (4.0- and 6.0-mm ETT) and repeated in triplicate. Percentage MDI output was determined by weighing the filter before and after drug administration (balance sensitivity 10 micrograms). Significant differences (p < or = 0.05) among the groups with and without a spacer and in dry and humidified air were determined by ANOVA with Scheffe's multiple comparison test. Multiple regression was used to determine significant associations between ETT diameter and length and delivery. MAIN RESULTS: With the AeroVent spacer in humidified air, delivery with the 4.0- and 6.0-mm ETT was approximately 2.3% and 5%, respectively. The spacer and dry air significantly improved delivery. CONCLUSIONS: In humidified air, the dose of albuterol by MDI with an AeroVent spacer should be doubled for children intubated with 6.0-mm ETT, and four puffs administered for every one puff desired for 4.0-mm ETT. The results of this investigation should prove useful in initial clinical trials of albuterol MDI in ventilator-dependent infants and children.

Administration, Inhalation↗
PubMed2001

Reliability of a 5-m multiple shuttle test.

The aim of the present study was to determine the reliability of a modified 5-m multiple shuttle test. The 'match-related fitness' of 23 female hockey players was assessed on four occasions within 4 weeks. The results of each test session and each shuttle were analysed using analysis of variance with repeated measures to determine the reliability of the test. The mean distance for each of the six shuttles decreased (121.2 +/- 7.5, 114.5 +/- 7.5, 112.2 +/- 7.5, 109.9 +/- 7.9, 108.4 +/- 8.1 and 108.7 +/- 8.3 m for shuttles 1-6, respectively; P < 0.001) similarly for each of the four sessions (P = 0.99). The total and peak distances covered during the tests were not significantly different (P = 0.99 and P = 0.12, respectively). The intra-class correlation coefficient (R) for these variables was 0.98 and 0.86, respectively. The delta distance and the fatigue index calculated post-test were significantly different (P = 0.001 and P = 0.006, respectively) between the four sessions. The intra-class correlation coefficient for both these variables was 0.74. Heart rate and rating of perceived exertion (RPE) were not significantly different between sessions (P = 0.42 and P = 0.095, respectively). The intra-class correlation coefficient for heart rate ranged from 0.65 to 0.97 and that for RPE from 0.85 to 0.91. We conclude that the 5-m multiple shuttle run test is a reliable measure of total and peak distances, heart rate and RPE response and is sufficiently reliabile to track changes in fitness over a season. The delta distance and fatigue index are not as reliable and should be interpreted with caution.

Adult↗