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PubMed1994

Construction of a surrogate variable for impotence in the Massachusetts Male Aging Study.

Uncollected data must be filled in after the fact in many epidemiological studies. We compared several methods for constructing a surrogate variable for erectile potency, based on responses to related questions, in the Massachusetts Male Aging Study (MMAS). Quadratic discriminant analysis performed best among the procedures tested, achieving high rates of correct classification in cross-validation of training data and (according to posterior estimates) in classification of MMAS subjects. Two versions of the surrogate variable were constructed, one involving a discrete classification and the other involving a set of continuous probabilities. The two versions were used to investigate medical correlates of impotence in MMAS and produced similar results, although the continuous version appeared to provide higher statistical power. We conclude that construction of a surrogate variable is a viable and potentially beneficial option in epidemiological investigations.

Adult↗
PubMed2004

A method for testing low-value spatial clustering for rare diseases.

This paper proposes a method that tests for the existence of low-value spatial clustering while accounting for the influence of high-value clustering. Although the method was developed in reference to the Tango test, it can be extended to other testing methods. The simulation results showed that the proposed method is able to effectively detect low-value clustering with substantially lower rates of type I errors than those of the Tango test, while maintaining comparable statistical power. Applying the method in a case study of leukemia in Minnesota demonstrated an overall tendency toward low-value clustering of leukemia mortality for males but provided inconclusive results for females.

Confounding Factors, Epidemiologic↗
PubMed2004

Mapping QTLs for traits measured as percentages.

Many quantitative traits are measured as percentages. As a result, the assumption of a normal distribution for the residual errors of such percentage data is often violated. However, most quantitative trait locus (QTL) mapping procedures assume normality of the residuals. Therefore, proper data transformation is often recommended before statistical analysis is conducted. We propose the probit transformation to convert percentage data into variables with a normal distribution. The advantage of the probit transformation is that it can handle measurement errors with heterogeneous variance and correlation structure in a statistically sound manner. We compared the results of this data transformation with other transformations and found that this method can substantially increase the statistical power of QTL detection. We develop the QTL mapping procedure based on the maximum likelihood methodology implemented via the expectation-maximization algorithm. The efficacy of the new method is demonstrated using Monte Carlo simulation.

Chromosome Mapping↗
PubMed1995

Percutaneous transluminal coronary angioplasty versus thrombolysis in acute myocardial infarction: a meta-analysis.

While percutaneous transluminal coronary angioplasty (PTCA) as a primary modality for treating acute myocardial infarction (MI) has been shown to have important advantages over thrombolysis, a survival benefit has not been demonstrated because of the small size of the individual trials. To increase the statistical power to detect a survival benefit, we performed a meta-analysis of trials of PTCA and thrombolysis. We pooled the data for all randomized, controlled trials; randomized, controlled trials stratified according to thrombolytic agent [streptokinase vs. tissue plasminogen activator (TPA)]; and all trials. Pooling was performed by calculating the Mantel-Haenszel odds ratio with the Robins, Greenland, and Breslow estimate of variance. Calculation of the Q statistic was performed to assess heterogeneity. For all four analyses, the odds ratio indicated a significant survival advantage of PTCA over thrombolysis: all randomized controlled trials [0.57, 95% confidence index (CI): 0.48, 0.68)]; streptokinase trials (0.61, 95% CI: 0.43, 0.87); TPA trials (0.52, 95% CI: 0.36, 0.76); all trials (0.51, 95% CI: 0.43, 0.61). The Q statistic was not significant for any of the analyses. The results of our meta-analysis support the hypothesis that PTCA is associated with a significant reduction in mortality compared with thrombolysis.

Angioplasty, Balloon, Coronary↗
PubMed2006

Retention of survivors of acute lymphoblastic leukemia in a longitudinal study of bone mineral density.

Attrition in longitudinal studies of survivors of childhood cancer reduces these studies' statistical power, introduces bias and threatens internal and external validity. This study investigated the variables associated with dropout of survivors of acute lymphoblastic leukemia in a trial investigating the effect of vitamin D and calcium supplementation and nutritional counseling on bone mineral density (BMD). Twenty-five participants withdrew from the study. Common reasons given for withdrawing were intolerance of the study drug, family hardship and schedule conflicts. Few statistically and clinically significant differences identified participants who completed the study. Nurses need to be aware of the reasons that participants withdraw from clinical trials, as they are in a strategic position to encourage patients to participate in health promotion studies.

Adaptation, Psychological↗
PubMed1999

A test of transmission/disequilibrium for quantitative traits in pedigree data, by multiple regression.

The transmission/disequilibrium (TD) test (TDT), proposed, by Spielman et al., for binary traits is a powerful method for detection of linkage between a marker locus and a disease locus, in the presence of allelic association. As a test for linkage disequilibrium, the TDT makes the assumption that any allelic association present is due to linkage. Allison proposed a series of TD-type tests for quantitative traits and calculated their power, assuming that the marker locus is the disease locus. All these tests assume that the observations are independent, and therefore they are applicable, as a test for linkage, only for nuclear-family data. In this report, we propose a regression-based TD-type test for linkage between a marker locus and a quantitative trait locus, using information on the parent-to-offspring transmission status of the associated allele at the marker locus. This method does not require independence of observations, thus allowing for analysis of pedigree data as well, and allows adjustment for covariates. We investigate the statistical power and validity of the test by simulating markers at various recombination fractions from the disease locus.

Computer Simulation↗
PubMedDate not supplied

Cytokine genes and disease susceptibility.

Complex networks of cytokines interact in a dynamic way to homeostatically regulate immune responses and other biological pathways. It is, therefore, not surprising that variation in cytokine level has been correlated with disease susceptibility and process. A fundamental issue is whether such variation is a primary cause for disease or reflects secondary inflammatory change. This can be unravelled by investigating cytokine gene polymorphism to determine whether a genetic basis for cytokine dysregulation is associated with disease. Thousands of disease association studies investigating cytokine gene polymorphisms have been reported although many have not been replicated. This is largely due to lack of statistical power, poor definition of clinical phenotype and lack of matching between cases and controls. An appropriate study design should include: Any genetic analysis of cytokine genes in disease studies should also take into account the fact that cytokines rarely manifest their effects in isolation but rather work in complex regulatory networks. Thus, gene-gene and gene-environment interactions may be at the centre of any disease association. Statistical methods are now being introduced to determine such relationships and this should ultimately allow a more accurate estimate of disease risk for individuals with particular cytokine gene profiles.

Cytokines↗
PubMed2006

Is antisocial personality disorder continuous or categorical? A taxometric analysis.

BACKGROUND: Although the DSM-IV-TR is organized into discrete disorders, the question of whether a given disorder possesses a dimensional or a categorical latent structure is an empirical one that can be examined using taxometric methods. The objective of this study was to ascertain the latent structure of antisocial personality disorder (ASPD). METHOD: Participants were 1146 male offenders incarcerated in state prisons (n=569), or court-ordered to residential drug treatment (n=577). Participants were interviewed using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) to assess ASPD symptoms; they also completed the Personality Diagnostic Questionnaire-4 (PDQ-4) ASPD scale. Taxometric analyses were performed to examine whether ASPD is underpinned by a discrete category or a dimensional construct. RESULTS: Multiple taxometric procedures using two different sets of indicators provided no evidence that ASPD has a taxonic latent structure. Instead, the results were far more consistent with the proposition that ASPD exists on a continuum, regardless of whether it is assessed using a structured interview or a self-report measure. CONCLUSIONS: Evidence that ASPD is dimensional suggests that it is best studied using continuous measures and that dichotomizing individuals into ASPD versus non-ASPD groups will typically result in decreased statistical power. The findings are also consistent with a multifactorial etiology for ASPD and with recent attempts to conceptualize ASPD within the framework of extant dimensional models of personality.

Adult↗
PubMed2005

Analyzing patterns of staining in immunohistochemical studies: application to a study of prostate cancer recurrence.

BACKGROUND: Immunohistochemical studies use antibodies to stain tissues with the goal of quantifying protein expression. However, protein expression is often heterogeneous resulting in variable degrees and patterns of staining. This problem is particularly acute in prostate cancer, where tumors are infiltrative and heterogeneous in nature. In this article, we introduce analytic approaches that explicitly consider both the frequency and intensity of tissue staining. METHODS: Compositional data analysis is a technique used to analyze vectors of unit-sum proportions, such as those obtained from soil sample studies or species abundance surveys. We summarized specimen staining patterns by the proportion of cells staining at mild, moderate, and intense levels and used compositional data analysis to summarize and compare the resulting staining profiles. RESULTS: In a study of Syndecan-1 staining patterns among 44 localized prostate cancer cases with Gleason score 7 disease, compositional data analysis did not detect a statistically significant difference between the staining patterns in recurrent (n = 22) versus nonrecurrent (n = 22) patients. Results indicated only modest increases in the proportion of cells staining at a moderate intensity in the recurrent group. In contrast, an analysis that compared quantitative scores across groups indicated a (borderline) significant increase in staining in the recurrent group (P = 0.05, t test). CONCLUSIONS: Compositional data analysis offers a novel analytic approach for immunohistochemical studies, providing greater insight into differences in staining patterns between groups, but possibly lower statistical power than existing, score-based methods. When appropriate, we recommend conducting a compositional data analysis in addition to a standard score-based analysis.

Biomarkers, Tumor↗
PubMed2025

A spectral framework to map QTLs affecting joint differential networks of gene co-expression.

Studying the mechanisms underlying the genotype-phenotype association is crucial in genetics. Gene expression studies have deepened our understanding of the genotype  →  expression  →  phenotype mechanisms. However, traditional expression quantitative trait loci (eQTL) methods often overlook the critical role of gene co-expression networks in translating genotype into phenotype. This gap highlights the need for more powerful statistical methods to analyze genotype  →  network  →  phenotype mechanism. Here, we develop a network-based method, called spectral network quantitative trait loci analysis (snQTL), to map quantitative trait loci affecting gene co-expression networks. Our approach tests the association between genotypes and joint differential networks of gene co-expression via a tensor-based spectral statistics, thereby overcoming the ubiquitous multiple testing challenges in existing methods. We demonstrate the effectiveness of snQTL in the analysis of three-spined stickleback (Gasterosteus aculeatus) data. Compared to conventional methods, our method snQTL uncovers chromosomal regions affecting gene co-expression networks, including one strong candidate gene that would have been missed by traditional eQTL analyses. Our framework suggests the limitation of current approaches and offers a powerful network-based tool for functional loci discoveries.

Quantitative Trait Loci↗
PubMed1983

Final inline filtration for intravenous infusions: a prospective hospital study.

Phlebitis is the most common complication of intravenous therapy affecting more than 50 per cent of infusions. Particles in or added to infusions have been implicated, hence a filter with pore size of 0.2 micron containing both hydrophobic and hydrophilic elements (Pall Biomedical) has been evaluated. All infusions of likely duration greater than 48 h, set up in a 2-month period at this hospital, were randomized to filter or identical dummy. The endpoints and statistical power of the study were determined at the outset. Of the 226 infusions randomized, 32 failed within 24 h and were excluded leaving 194 of whom 93 had dummy and 101 filter. Only 38 infusions with dummy survived until no longer required compared to 63 infusions with filter (chi 2 = 7.68, P less than 0.01). Analysed by life table, the trend for filtered infusions to survive longer failed to achieve statistical significance, but inline filtration prolonged the phlebitis-free survival of infusions (P less than 0.01). These benefits were most marked in the 49 infusions where antibiotics were administered via the drip site. Inline filtration delays the onset of phlebitis, thus more infusions survive until they are no longer required. This effect is not sufficiently strong to institute an overall hospital policy but filters may be indicated in patients requiring intravenous antibiotics.

Anti-Bacterial Agents↗
PubMed1995

Adjuvant tamoxifen therapy for early stage breast cancer and second primary malignancies. Stockholm Breast Cancer Study Group.

BACKGROUND: Tamoxifen is being increasingly used for the treatment of breast cancer and is undergoing study for the primary prevention of breast cancer. However, concerns have been raised that the drug may increase the incidence of new primary malignancies, such as endometrial, liver, and colorectal cancers. PURPOSE: Our goal was to assess the carcinogenic risks associated with long-term use of tamoxifen in women with early stage breast cancer. METHODS: The incidence of new primary cancers among 2729 women participants of the Stockholm Trial was determined at a median follow-up of 9 years. In this trial, after primary surgery, postmenopausal patients aged less than 71 years with unilateral invasive breast cancer were randomly allocated to receive either 2 years of adjuvant tamoxifen (40 mg daily) or no adjuvant endocrine therapy. Information on second cancers was obtained by retrospective linkage to the Swedish Cancer Registry. To increase statistical power, a joint analysis of the incidence of endometrial and gastrointestinal cancers was performed in the following three major studies in Scandinavia evaluating adjuvant tamoxifen therapy: the Stockholm Trial, the Danish Breast Cancer Group Trial, and the South-Swedish Trial. These studies included a total of 4914 patients with a median follow-up of 8-9 years. All P values were calculated from two-tailed tests of statistical significance. RESULTS: In the Stockholm Trial, there was a statistically significant (P = .008) reduction in the incidence of second primary cancers in the contralateral breast among the tamoxifen-treated patients. However, there was a nearly sixfold increase in endometrial cancers (P < .001) and a threefold increase in gastrointestinal cancers in the tamoxifen-treated patients. The results of the joint studies showed a statistically significant increase in endometrial cancers among the tamoxifen-treated patients (relative risk [RR] = 4.1; 95% confidence interval [CI] = 1.9-8.9). There was also an excess of gastrointestinal cancers associated with tamoxifen. Most of this excess involved colorectal cancers (RR = 1.9; 95% CI = 1.1-3.3) and stomach cancer (RR = 3.2; 95% CI = 0.9-11.7). There was no substantial increase in any other type of gastrointestinal cancer (e.g., liver cancer) among the tamoxifen-treated patients. CONCLUSION: The endometrium and gastrointestinal organs may be target sites for tamoxifen-induced carcinogenesis in humans. IMPLICATIONS: The increased incidence of colorectal and stomach cancers reported here should be regarded as tentative until supported by long-term data from a larger number of tamoxifen trials. Also, appropriate surveillance of cancer incidence is warranted for the protection of participants enrolled in current tamoxifen chemoprevention trials.

Aged↗
PubMedDate not supplied

Genome-wide scanning in inflammatory bowel diseases.

Inflammatory bowel diseases (IBD) are multifactorial traits involving both environmental and genetic factors. In order to identify the IBD susceptibility genes, two groups of strategies have been developed. In the candidate gene approach, a specific hypothesis is tested by usually investigating the prevalence of specific alleles in groups of affected and control individuals with no familial relationship. Such association studies are powerful and straightforward. However, they are limited by possible recruitment biases and a multitesting problem due to the large number of possible candidate genes. Furthermore, they rely on the existence of a founder effect. In the genome scanning searches, no prior assumption is made on the susceptibility genes. The studies are based on cosegregation (or linkage) analyses performed on families with several affected members. Their drawbacks are the lack of statistical power and the low resolution of the localization. Nonetheless, using genome-wide screens, two IBD loci have been localized by several independent groups on chromosomes 12 and 16. Additional IBD loci have been proposed by individual groups on chromosomes 1, 3, 4, 7, 11, 15 and X. In order to gain wide acceptance, the latter localizations are to be confirmed by additional independent studies. Identification of IBD susceptibility genes would represent a key step in the understanding of the pathogenic mechanism of these diseases. However, in complex disorders, genes are only a part of the risk factors. Epidemiological studies looking for environmental factors are thus complementary of the genetic approach.

Chromosomes, Human, Pair 12↗
PubMed2005

Exploring whole genome amplification as a DNA recovery tool for molecular genetic studies.

The whole genome amplification (WGA) protocol evaluated during this study, GenomiPhi DNA amplification kit, is a novel method that is not based on polymerase chain reaction but rather relies on the highly processive and high fidelity Phi29 DNA polymerase to replicate linear genomic DNA by multiple strand displacement amplification. As little as 1 ng of genomic DNA template is sufficient to produce microgram quantities of high molecular weight DNA. The question explored during this study is whether such a WGA method is appropriate to reliably replenish and even recover depleted DNA samples that can be used for downstream genetic analysis. A series of human DNA samples was tested in our laboratory and validated using such analytical methods as gene-specific polymerase chain reaction, direct sequencing, microsatellite marker analysis, and single nucleotide polymorphism allelic discrimination using TaqMan and Pyrosequencing chemistries. Although degraded genomic DNA is not a good template for Phi29 WGA, this method is a powerful tool to replenish depleted DNA stocks and to increase the amount of sample for which biological tissue availability is scarce. The testing performed during the validation phase of the study indicates no discernable difference between WGA samples and the original DNA templates. Thus, GenomiPhi WGA can be used to increase precious or depleted DNA stocks, thereby extending the life of a family-based linkage analysis project and increasing statistical power.

Adult↗
PubMedDate not supplied

The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes.

PROMIS (Patient-Reported-Outcomes Measurement Information System) is an NIH Roadmap network project intended to improve the reliability, validity, and precision of PROs and to provide definitive new instruments that will exceed the capabilities of classic instruments and enable improved outcome measurement for clinical research across all NIH institutes. Item response theory (IRT) measurement models now permit us to transition conventional health status assessment into an era of item banking and computerized adaptive testing (CAT). Item banking uses IRT measurement models and methods to develop item banks from large pools of items from many available questionnaires. IRT allows the reduction and improvement of items and assembles domains of items which are unidimensional and not excessively redundant. CAT provides a model-driven algorithm and software to iteratively select the most informative remaining item in a domain until a desired degree of precision is obtained. Through these approaches the number of patients required for a clinical trial may be reduced while holding statistical power constant. PROMIS tools, expected to improve precision and enable assessment at the individual patient level which should broaden the appeal of PROs, will begin to be available to the general medical community in 2008.

Diagnosis, Computer-Assisted↗
PubMed2006

Evaluation of Ki67, p53 and angiogenesis in patients enrolled in a randomized study of neoadjuvant chemotherapy with or without cystectomy: a Southwest Oncology Group Study.

In this prospective biomarker study, we evaluated the prognostic significance of Ki67, p53 and angiogenesis in patients with locally advanced bladder cancer. The patients were volunteers from a Southwest Oncology Group trial of locally advanced bladder cancer who were randomized to treatment with neoadjuvant chemotherapy plus cystectomy or cystectomy alone. Tissue specimens were obtained prior to neoadjuvant chemotherapy from 42 patients randomized to receive the combination-treatment arm and 52 randomized to cystectomy alone. The statistical power of the study was quite limited by the small sample size. The biomarkers were assayed by immunohistochemistry. Angiogenesis was determined using anti-CD34 immunostaining. Patients whose tumors had increased Ki67 expression had better progression-free survival that was marginally significant, p=0.063. The median survival in those with higher Ki67 expression was 73 months, and in those with lower expression was 38 months. However, this did not achieve statistical significance, p=0.25. There was a suggestion of worse survival among patients whose tumors exhibited altered p53 staining [hazard ratio (HR) = 1.48; p=0.15], but there was no difference in progression-free survival (HR=1.02; p=0.93). The enumeration of tumor microvessels did not provide prognostic information.

Adult↗
PubMed1991

Residential radon exposure and lung cancer: an overview of published studies.

A possible link between presumed or measured household radon exposure and lung cancer is reviewed on the basis of published epidemiologic studies. Evidence of a link is reported as a result of studies in Sweden; findings are inconsistent elsewhere. A number of methodological problems were found. Many of the studies are ecological in design and are, therefore, primarily hypothesis generating. A number of studies lack any data on the number of lung cancers and are, therefore, difficult to evaluate. Some other studies provide results that are internally inconsistent. Of the case/control studies, there are many with minimal or no information on active and passive smoking, occupation, family history of cancer, and diet. The case/control studies are generally small in size and of low statistical power. Exposure classifications are nonstandardized, inconsistent in their findings, and often gross in their characterization of radon concentrations. Relatively few of the studies actually measured radon exposure. Some of the studies showed significant positive associations either with geological characteristics, water supply contamination, or house type. No significant associations were found with residence near uranium or radium processing waste. Where radon levels were measured, a relatively small percentage of studies found a statistically significant positive association with lung cancer. Overall, the evidence for an association between residential radon exposure and lung cancer is weak. There is a need for a more decisive case/control epidemiologic study of this problem.

Adult↗
PubMed1995

The effect of desmopressin on reducing blood loss in cardiac surgery--a meta-analysis of double-blind, placebo-controlled trials.

The effect of desmopressin (DDAVP) on reducing postoperative blood loss after cardiac surgery has been studied in several randomized clinical trials with conflicting outcomes. Since most trials had insufficient statistical power to detect true differences in blood loss, we performed a meta-analysis of data from relevant studies. Seventeen randomized, double-blind, placebo-controlled trials were analyzed, which included 1171 patients undergoing cardiac surgery for various indications; 579 of them were treated with desmopressin and 592 with placebo. Efficacy parameters were blood loss volumes and transfusion requirements. Desmopressin significantly reduced postoperative blood loss by 9%, but had no statistically significant effect on transfusion requirements. A subanalysis revealed that desmopressin had no protective effects in trials in which the mean blood loss in placebo-treated patients fell in the lower and middle thirds of distribution of blood losses (687-1108 ml/24 h). In contrast, in trials in which the mean blood loss in placebo-treated patients fell in the upper third of distribution (> 1109 ml/24 h), desmopressin significantly decreased postoperative blood loss by 34%. Insufficient data were available to perform a sub-analysis on transfusion requirements. Therefore, desmopressin significantly reduces blood loss only in cardiac operations which induce excessive blood loss. Further studies are called to validate the results of this meta-analysis and to identify predictors of excessive blood loss after cardiac surgery.

Adult↗