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PubMed2006

Meta-analysis on the effect of the N363S polymorphism of the glucocorticoid receptor gene (GRL) on human obesity.

BACKGROUND: Since both excess glucocorticoid secretion and central obesity are clinical features of some obese patients, it is worthwhile to study a possible association of glucocorticoid receptor gene (GRL) variants with obesity. Previous studies have linked the N363S variant of the GRL gene to increased glucocorticoid effects such as higher body fat, a lower lean-body mass and a larger insulin response to dexamethasone. However, contradictory findings have been also reported about the association between this variant and obesity phenotypes. Individual studies may lack statistical power which may result in disparate results. This limitation can be overcome using meta-analytic techniques. METHODS: We conducted a meta-analysis to assess the association between the N363S polymorphism of the GRL gene and obesity risk. In addition to published research, we included also our own unpublished data -three novel case-control studies- in the meta-analysis The new case-control studies were conducted in German and Spanish children, adolescents and adults (total number of subjects: 1,117). Genotype was assessed by PCR-RFLP (Tsp509I). The final formal meta-analysis included a total number of 5,909 individuals. RESULTS: The meta-analysis revealed a higher body mass index (BMI) with an overall estimation of +0.18 kg/m2 (95% CI: +0.004 to +0.35) for homo-/heterozygous carriers of the 363S allele of the GRL gene in comparison to non-carriers. Moreover, differences in pooled BMI were statistically significant and positive when considering one-group studies from the literature in which participants had a BMI below 27 kg/m2 (+ 0.41 kg/m2 [95% CI +0.17 to +0.66]), but the differences in BMI were negative when only our novel data from younger (aged under 45) and normal weight subjects were pooled together (-0.50 kg/m2 [95% CI -0.84 to -0.17]). The overall risk for obesity for homo-/heterozygous carriers of the 363S allele was not statistically significant in the meta-analysis (pooled OR = 1.02; 95% CI: 0.56-1.87). CONCLUSION: Although certain genotypic effects could be population-specific, we conclude that there is no compelling evidence that the N363S polymorphism of the GRL gene is associated with either average BMI or obesity risk.

Adolescent↗
PubMedDate not supplied

Decision analysis assessment of a national medical study.

To decide whether or not to undertake an expensive national survey to determine the effectiveness of infection control, we devised a quantitative decision model to analyze the costs and probabilities of successful study outcomes. The result allowed us to determine whether the proposed study method and design would provide sufficient statistical power to ensure meaningful conclusions from the research. The model was robust in assessing the adequacy of method accuracy and, within the range of assumptions specified, it suggested that the project should be undertaken. The results helped to secure official approval and funding for this large-scale research project. A novel approach to evaluating sensitivity analysis is included. As constructed, the model is applicable to other projects in applied research and, with some modification, to projects in basic research as well.

Costs and Cost Analysis↗
PubMed2005

A simulation study on detecting purging of inbreeding depression in captive populations.

Inbreeding depression threatens the survival of small populations of both captive and wild outbreeding species. In order to fully understand this threat, it is necessary to investigate what role purging plays in reducing inbreeding depression. Ballou (1997) undertook such an investigation on 25 mammalian populations, using an ancestral inbreeding regression model to detect purging. He concluded that there was a small but highly significant trend of purging on neonatal survival across the populations. We tested the performance of the regression model that Ballou used to detect purging on independently simulated data. We found that the model has low statistical power when inbreeding depression is caused by the build-up of mildly deleterious alleles. It is therefore possible that Ballou's study may have underestimated the effects of ancestral inbreeding on the purging of inbreeding depression in captive populations if their inbreeding depression was caused mainly by mildly deleterious mutations. We also developed an alternative regression model to Ballou's, which showed an improvement in the detection of purging of mildly deleterious alleles but performed less well if deleterious alleles were of a large effect.

Alleles↗
PubMed1997

Statistical assessment of crosscorrelation and variance methods and the importance of electrocardiogram gating in functional magnetic resonance imaging.

Processing of functional magnetic resonance imaging (fMRI) data is a critical step in evaluating experimental results. We address the question of choosing between a Student t-test method, crosscorrelation method, or a weighted z-score method in analyzing functional MR images. We present an analytic analysis that makes it possible to make a statistical decision in setting the threshold for the crosscorrelation coefficient. Specifically, the theory for an receiver operating characteristic (ROC) analysis (description of type I and type II error) has been applied to the crosscorrelation method. Both theoretical predictions as well as model simulations are presented to prove that the crosscorrelation and weighted z-score method have the same statistical power. We introduce the concept of a variance image and use it to not only choose between the correlation image and a simple t-test image but also to obtain a final image that combines the efficient aspects of both the correlation and the simple t-test images. The variance image itself is shown to be an indicator of both patient motion and/or internal physiological motion in the brain. Furthermore, we delineate the importance of electrocardiogram (ECG) gating in reducing the variance in fMRI of human motor cortex.

Electrocardiography↗
PubMed1982

Problems of sampling and inference in the study of fluctuating dental asymmetry.

Randomly distributed or "fluctuating" dental asymmetry has been accorded evolutionary meaning and interpreted as a result of environmental stress. However, except for congenital malformation syndromes, the determinants of human crown size asymmetry are still equivocal. Both a computer simulated sampling experiment using a combined sample size of N = 3000, and the requirements of adequate statistical power show that sample sizes of several hundred are needed to detect population differences in dental asymmetry. Using the largest available sample of children with defined prenatal stresses, we are unable to find systematic increases in crown size asymmetry. Given sampling limitations and the current inability to link increased human dental asymmetry to defined prenatal stresses, we suggest that fluctuating dental asymmetry is not yet established as a useful and reliable measure of general stress in human populations.

Body Height↗
PubMed1988

Multiple regression analysis of twin data: etiology of deviant scores versus individual differences.

The multiple regression analysis of twin data in which a cotwin's score is predicted from a proband's score and the coefficient of relationship (the basic model) provides a statistically powerful test of genetic etiology. When an augmented model that also contains an interaction term is fitted to the same data set, direct estimates of heritability (h2) and the proportion of variance due to shared environmental influences (c2) are obtained. A simple transformation of selected twin data prior to regression analysis facilitates direct estimates of h2g (an index of the extent to which the difference between the mean of probands and that of the unselected population is heritable) and a test of the hypothesis that the etiology of deviant scores differs from that of variation within the normal range.

Data Interpretation, Statistical↗
PubMed2005

Performance of flow cytometric analysis for the micronucleus assay--a reconstruction model using serial dilutions of malaria-infected cells with normal mouse peripheral blood.

To confirm the performance and statistical power of a flow cytometric method for scoring micronucleated erythrocytes, reconstruction experiments were performed. For these investigations, peripheral blood erythrocytes from untreated mice, with a micronucleated erythrocyte frequency of approximately 0.1% were combined with known quantities of Plasmodium berghei (malaria) infected mouse erythrocytes. These cells had an infected erythrocyte frequency of approximately 0.7%, and mimic the DNA content of micronuclei (MN). For an initial experiment, samples with a range of MN/malaria (Mal) content were constructed and analysed in triplicate by flow cytometry until 2000, 20,000 and 200,000 total erythrocytes were acquired. In a second experiment, each specimen was analysed in triplicate until 2000, 20,000, 200,000 and 1,000,000 erythrocytes were acquired. As expected, the sensitivity of the assay to detect small changes in rare erythrocyte sub-population frequencies was directly related to the number of cells analysed. For example, when 2000 cells were scored, increases in MN/Mal frequencies of 3.9- or 2.7-fold were detected as statistically significant. When 200,000 cells were analysed, a 1.2-fold increase was detected. These data have implications for the experimental design and interpretation of micronucleus assays that are based on automated scoring procedures, since previously unattainable numbers of cells can now be readily scored.

Animals↗
PubMed1986

Repeated measurement: sensitive tests for experiments with few animals.

Animal scientists who conduct experiments involving repeated measurements of animals often are frustrated by low statistical power of tests for comparisons of treatment means. In many cases, low power of the traditional tests simply is the consequence of low replication (few animals per treatment) that was forced by cost or complexity of experimental technique. A method is given for comparing treatments in a way that permits sensitive tests (via partition of the treatment X period interaction), often when the number of animals per treatment is not more than five or six. Modifications for the procedure are given for the case of heterogeneous variances and covariances. An example from mammary physiology is used to illustrate the procedure and to compare it with standard methods of analysis.

Analysis of Variance↗
PubMed2006

Testing for additivity at select mixture groups of interest based on statistical equivalence testing methods.

Several assumptions, defined and undefined, are used in the toxicity assessment of chemical mixtures. In scientific practice mixture components in the low-dose region, particularly subthreshold doses, are often assumed to behave additively (i.e., zero interaction) based on heuristic arguments. This assumption has important implications in the practice of risk assessment, but has not been experimentally tested. We have developed methodology to test for additivity in the sense of Berenbaum (Advances in Cancer Research, 1981), based on the statistical equivalence testing literature where the null hypothesis of interaction is rejected for the alternative hypothesis of additivity when data support the claim. The implication of this approach is that conclusions of additivity are made with a false positive rate controlled by the experimenter. The claim of additivity is based on prespecified additivity margins, which are chosen using expert biological judgment such that small deviations from additivity, which are not considered to be biologically important, are not statistically significant. This approach is in contrast to the usual hypothesis-testing framework that assumes additivity in the null hypothesis and rejects when there is significant evidence of interaction. In this scenario, failure to reject may be due to lack of statistical power making the claim of additivity problematic. The proposed method is illustrated in a mixture of five organophosphorus pesticides that were experimentally evaluated alone and at relevant mixing ratios. Motor activity was assessed in adult male rats following acute exposure. Four low-dose mixture groups were evaluated. Evidence of additivity is found in three of the four low-dose mixture groups. The proposed method tests for additivity of the whole mixture and does not take into account subset interactions (e.g., synergistic, antagonistic) that may have occurred and cancelled each other out.

Animals↗
PubMed1998

EMG variability during maximum voluntary isometric and anisometric contractions is reduced using spatial averaging.

Electromyography (EMG) is a commonly used tool that can be plagued with poor signal-to-noise ratios. One result of poor signal-to-noise ratios is increased within- and between-subject variability of quantified EMG variables, for example, the integrated EMG. Methods that reduce within- and between-subject variability of quantified EMG variables can increase the statistical power of an experimental design and aid in the functional interpretation of experimental results. The purpose of this investigation was to determine the effectiveness of spatially averaging the surface EMG signal to reduce the variability of the quantified EMG obtained during maximum voluntary contractions (MVC). The present study extends the work of earlier investigators describing the enhanced signal characteristics obtained by spatially averaging the surface EMG measured during submaximum voluntary isometric contractions and stretch reflexes. Ten subjects performed maximum voluntary isometric and anisometric (concentric and eccentric) contractions of the elbow flexors. Four electrodes, forming two pairs of bipolar electrodes were placed over both the biceps brachii and brachioradialis muscles. Four rectified and integrated EMG signals from the electrode array were compared. Data from each subject's contraction condition and from each muscle were used to compute a coefficient of variation that was considered representative of the within-subject variability. These data were analysed with a multifactorial repeated measures analysis of variance (ANOVA). The results revealed a muscle-specific, statistically significant superiority of one of the methods in reducing the variability of the rectified and integrated EMG signal. Summing the rectified and integrate signals from each bipolar pair of electrodes in the array was shown to reduce significantly the within-subject variability.

Adult↗
PubMed2000

The HLA class II locus DPB1 can influence susceptibility to type 1 diabetes.

HLA-DPB1 genotypes were determined for samples from 269 multiplex Caucasian families from the Human Biological Data Interchange. DRB1 and DQB1 loci were also characterized, allowing assignment of DPB1 alleles to haplotypes and calculation of linkage disequilibrium values. Frequencies for several DPB1 alleles differed significantly between patients and affected family-based control subjects. Some differences were attributable to linkage disequilibrium with DR and DQ alleles, whereas others were not. DPB1*0301 and DPB1*0202 alleles are predisposing for type 1 diabetes in these data, not only in analyses of individual alleles, but also in genotype analyses. DPB1*0402 appears protective; however, stratification analysis indicates that its protective effect is specific for DR3 haplotypes. A protective role for DPB1*0401 is suggested by genotype analysis. For increased statistical power, DPB1 alleles were pooled into three categories: susceptible, neutral, and protective after removal of effects due to linkage disequilibrium with DR-DQ. Analysis of these pools suggests that DPB1 primarily affects susceptibility to, rather than protection from, type 1 diabetes in a dominant fashion. This effect is more apparent in patients with genotypes other than the highest risk DR3/DR4-DQB1*0302 genotype. These data support a role for the DPB1 locus in conferring susceptibility to type 1 diabetes.

Alleles↗
PubMed2005

Experimentally increased social competition compromises humoral immune responses in house finches.

Although social behavior can substantially influence an individual's physiology, few studies have examined whether intraspecific competition compromises individual immunocompetence. We experimentally manipulated the intensity of social competition in captive non-breeding house finches (Carpodacus mexicanus) by supplying few (high competition) or many (low competition) feeding sites. We tested whether elevated levels of social competition caused individual changes in aggression rates, humoral immunity, body mass, and baseline and stress-induced corticosterone concentrations. We also examined whether physiological responses to social competition were related to an individual's social status. We found that house finches under high social competition had significantly higher aggression rates, lower antibody responses, and lost more body mass. Within flocks, dominant individuals mounted stronger immune responses in both competition treatments. Our statistical power to detect differences in circulating corticosterone concentrations was low, but we did not find any support for the hypothesis that corticosterone concentrations mediate immunosuppression among or within flocks: baseline and stress-induced corticosterone concentrations did not differ under high and low social competition, were unrelated to individual social status, and did not predict the extent of immunosuppression among individuals. Overall, we documented that two universal components of social behavior, intraspecific competition and social status, modulated the strength of a humoral immune response in house finches.

Adaptation, Physiological↗
PubMed2006

Meta-analysis shows significant association between dopamine system genes and attention deficit hyperactivity disorder (ADHD).

Molecular genetic investigations of attention deficit hyperactivity disorder (ADHD) have found associations with a variable number of tandem repeat (VNTR) situated in the 3'-untranslated region of dopamine transporter gene (DAT1), a VNTR in exon 3 of dopamine receptor 4 gene (DRD4) and a microsatellite polymorphism located at 18.5 kb from the 5' end of dopamine receptor 5 gene (DRD5). A number of independent studies have attempted to replicate these findings but the results have been mixed, possibly reflecting inadequate statistical power and the use of different populations and methodologies. In an attempt to clarify this inconsistency, we have combined all the published studies of European and Asian populations up to October 2005 in a meta-analysis to give a comprehensive picture of the role of the three dopamine-related genes using multiple research methods and models. The DRD4 7-repeat (OR=1.34, 95% CI 1.23-1.45, P= 2 x 10(-12)) and 5-repeat (OR=1.68, 95% CI 1.17-2.41, P=0.005) alleles as well as the DRD5 148-bp allele (OR=1.34, 95% CI 1.21-1.49, P= 8 x 10(-8)) confer increased risk of ADHD, whereas the DRD4 4-repeat (OR=0.90, 95% CI 0.84-0.97, P=0.004) and DRD5 136-bp (OR=0.57, 95% CI 0.34-0.96, P=0.022) alleles have protective effects. In contrast, we found no compelling evidence for association with the 480-bp allele of DAT (OR=1.04, 95% CI 0.98-1.11, P=0.20). No significant publication bias was detected in current studies. In conclusion, there is a statistically significant association between ADHD and dopamine system genes, especially DRD4 and DRD5. These findings strongly implicate the involvement of brain dopamine systems in the pathogenesis of ADHD.

3' Untranslated Regions↗
PubMed1999

99mTc-HMPAO regional cerebral blood flow and quantitative electroencephalography in Alzheimer's disease: a correlative study.

UNLABELLED: In this study the neuropsychological status of patients with Alzheimer's disease (AD) was correlated with quantitative electroencephalography (qEEG) and regional cerebral blood flow (rCBF) both in the cortex and in deep gray matter structures. METHODS: Forty-three outpatients (mean age 72.4 +/- 7.5 y) with probable AD underwent 99mTc-hexamethyl propyleneamine oxime SPECT with a brain-dedicated gamma camera and qEEG (relative values) within 1 mo. Preliminary factorial analysis with promax rotation identified four qEEG bands (2-5.5, 6-7.5, 8-11.5 and 12-22.5 Hz, with no distinction as to topography) and six SPECT regions (the two thalami together, the two parietal cortices together, the right temporal cortex, the right hippocampus, the left hippocampus and the remaining cortical areas together) as the variables with highest statistical power. All these variables and the Mini-Mental Status Examination score (MMSE, a sensitive marker of neuropsychological deficit) were processed by a final factorial analysis and multivariate analysis of variance. RESULTS: Both the 2-5.5 Hz and the 8-11.5 Hz powers were correlated with the perfusion level in the parietal regions of interest (ROls) (P = 0.0009), whereas the 2-5.5 Hz power was correlated with the right hippocampal perfusion level (P = 0.007). The MMSE score was significantly correlated with the perfusion level, both in the right (P = 0.006) and in the left (P = 0.004) hippocampal ROls and in the parietal ROls (P = 0.01); moreover, it was correlated with both the 2-5.5 Hz (P = 0.0005) and the 8-11.5 Hz (P = 0.004) power. CONCLUSION: rCBF (bilateral parietal perfusion) and qEEG (especially the slowest frequencies, i.e., 2-5.5 Hz) are confirmed to be good descriptors of AD severity. It is especially noteworthy that bilateral hippocampal CBF was the perfusional index best correlated with the MMSE as well as being significantly correlated to qEEG. Hippocampal SPECT imaging appears to be a promising index to improve characterization of AD in respect to other forms of primary degenerative dementia and may be proposed as a marker for evaluating the effects of pharmacotherapy of AD at the neuronal level.

Aged↗
PubMed1991

Ambulatory blood pressure monitoring in clinical trials.

Monitoring ambulatory blood pressure, instead of taking pressure readings in hospital, avoids the so-called white-coat effect and allows more readings to be obtained over a longer period of time. It improves the accuracy of the blood pressure estimate and increases the statistical power of therapeutic trials for hypertension. Subjects with white-coat or office hypertension can be detected by ambulatory blood pressure monitoring and excluded from clinical trials. In 23 studies, including a total of 3304 normotensive subjects, the 24-h ambulatory blood pressure averaged 118/72 mmHg; the daytime and night-time pressures were 123/76 mmHg and 106/64 mmHg, respectively. If the mean plus two standard deviation (s.d.) interval is considered the upper limit of normal, the meta-analysis suggested that hypertension may be suspected if the 24-h pressure exceeds 129/87 mmHg, or if the daytime or night-time pressures are higher than 146/91 mmHg or 127/79 mmHg, respectively. On balance, most studies suggest that placebo effects on blood pressure are not observed when blood pressure is measured with ambulatory recorders. If confirmed, this observation indicates that it is possible to simplify the design of trials in the field of hypertension. Ambulatory blood pressure readings should be obtained with properly validated monitors. If the recordings are of sufficient quality, editing does not increase the precision of the subsequent statistical analyses. The statistical analyses should account for diurnal rhythms, and subject and treatment effects.

Antihypertensive Agents↗
PubMedDate not supplied

Sensitivity to changes in disability after stroke: a comparison of four scales useful in clinical trials.

Although most current stroke intervention trials use disability scales to determine outcome, little is known about the sensitivity to change of these scales. The use of a more sensitive measure would increase the statistical power of rehabilitation treatment trials. We applied four well-known disability scales to a group of stroke rehabilitation inpatients to compare sensitivity to change. Ninety-five consecutive admissions to a stroke rehabilitation service were assessed for disability on admission and discharge. Two global scales, the Modified Rankin Scale (MRS) and the International Stroke Trial Measure (ISTM), were compared with two activities of daily living (ADL) scales, the Barthel Index (BI) and the Functional Independence Measure (FIM). We determined the number of patients that each scale detected a clinically significant change in disability. Standardized response means (SRM) and receiver operating characteristic (ROC) analyses were performed. The MRS detected change in 55 subjects, including all who changed on the ISTM; the ISTM detected change in only 23 subjects. The BI detected change in 71 subjects but demonstrated ceiling effects with 26% of subjects scoring >95. The FIM was most sensitive, detecting change in 91 subjects; no patient achieved a maximum score. The SRM of the FIM was superior to that of the BI (2.18 versus 1.72), and ROC analysis revealed C-statistics of 0.82 for the BI, 0.59 for the MRS, and 0.51 for the ISTM. Global scales were much less sensitive to changes in disability than were ADL scales. Though ADL scales may take longer to administer, their increased sensitivity may make them more useful in treatment trials by allowing fewer subjects to be enrolled.

Activities of Daily Living↗
PubMed2006

Using endophenotypes for pathway clusters to map complex disease genes.

Nature determines the complexity of disease etiology and the likelihood of revealing disease genes. While culprit genes for many monogenic diseases have been successfully unraveled, efforts to map major complex disease genes have not been as productive as hoped. The conceptual framework currently adopted to deal with the heterogeneous nature of complex diseases focuses on using homogeneous internal features of the disease phenotype for mapping. However, phenotypic homogeneity does not equal genotypic homogeneity. In this report, we advocate working with well-measured phenotypes portrayed by amounts of transcripts and activities of gene products or their metabolites, which are pertinent to relatively small pathway clusters. Reliable and controlled measures for oligogenic traits resulting from proper dissection efforts may enhance statistical power. The large amounts of information obtained on gene and protein expression from technological advances can add to the power of gene finding, particularly for diseases with unclear etiology. Data-mining tools for dimension reduction can assist biologists to reveal novel molecular endophenotypes. However, there are still hurdles to overcome, including high cost, relatively poor reproducibility and comparability among platforms, the cross-sectional nature of the information, and the accessibility of human tissues. Concerted efforts are required to carry out large-scale prospective studies that are integrated at the levels of phenotype characterization, high throughput experimental techniques, data analyses, and beyond.

Chromosome Mapping↗
PubMed2004

Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.

Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.

Health Care Costs↗