bluuebunny/crossref_metadata_2025_split huggingface dataset:
Estimating treatment effect in the presence of non‐compliance measured with error: precision and robustness of data analysis methods
Authors: Kenna Leslie A. , Sheiner Lewis B. 
Published: November 2004

AbstractNon‐compliance with the nominal prescribed dosage causes unintended variability in actual drug exposure during clinical trials. In the ideal case that compliance is not a confounder, and it is known—hence actual dosage is known—true dose–response can be validly estimated. Measuring compliance presents a challenge, however. A simulation study of the case that dosage history questionnaires (CQ—usually over‐optimistic estimates of actual compliance) are available in all subjects enrolled in a clinical trial, but accurate compliance measurements (C—e.g. from electronic medication event monitors), are only available in a (random) fraction of subjects is reported. It reveals that a ‘Maximum Penalized Marginal Likelihood’ (MPML) method which uses all compliance data, effectively calibrating CQ to C, is superior to other methods which use only one compliance measure, or both, or neither (neither = ITT, intention to treat, which assumes actual dosage equals nominal dosage), but do not calibrate. MPML yields the most precise estimates of dose–response over widely varying clinical trial designs, extremes in quality and quantity of compliance information, and a range of drug effect sizes. It is most beneficial when compliance data are sparse and maintains good performance even when its key assumptions are somewhat violated. Copyright © 2004 John Wiley & Sons, Ltd.
The use of bootstrap methods for estimating sample size and analysing health‐related quality of life outcomes
Authors: Walters Stephen J. , Campbell Michael J. 
Published: November 2004

AbstractHealth‐related quality of life (HRQoL) measures are increasingly used in trials as primary outcome measures. Investigators are now asking statisticians for advice on how to plan and analyse studies using such outcomes. HRQoL outcomes, like the SF‐36, are usual measured on an ordinal scale, although most investigators assume that there exists an underlying continuous latent variable and that the actual measured outcomes (the ordered categories) reflect contiguous intervals along this continuum. The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis that assume Normality and constant variance may not be appropriate. For this reason, conventional statistical advice would suggest non‐parametric methods be used to analyse HRQoL data. The bootstrap is one such computer intensive non‐parametric method for estimating sample sizes and analysing data.We describe three methods of estimating sample sizes for two‐group cross‐sectional comparisons of HRQoL outcomes. We then compared the power of the three methods for a two‐group cross‐sectional study design using bootstrap simulation. The results showed that under the location shift alternative hypothesis, conventional methods of sample size estimation performed well, particularly Whitehead's method. Whitehead's method is recommended if the HRQoL outcome has a limited number of discrete values (<7) and/or the expected proportion of cases at either of the bounds is high. If a pilot data set is readily available then bootstrap simulation will provide a more accurate and reliable estimate, than conventional methods.Finally, we used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in an example data set. We then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes. In the data set studied, with the SF‐36 outcome, the use of the bootstrap for estimating sample sizes and analysing HRQoL data produces results similar to conventional statistical methods. These results suggest that bootstrap methods are not more appropriate for analysing HRQoL outcome data than standard methods. Copyright © 2004 John Wiley & Sons, Ltd.
Verification and validation of operational software: a process and methodology critique
Authors: Arthur James D. , Gröner Markus K. 
Published: November 2004

AbstractVerification and Validation (V&V) play a crucial role in producing a quality product on time, within budget and within scope. In this article, we examine the effectiveness of the Software Engineering Evaluation System (SEES), a V&V methodology developed by the U.S. Army Software Engineering Directorate. The critique draws on experiences and insights stemming from an application of that methodology to a controlled software development effort. In addition to citing the beneficial activities mandated by the V&V methodology, we also provide a discussion of prescribed (or lacking) activities having an adverse impact on the V&V effort. Recommendations to improve V&V effectiveness are also presented. Although our discussion focuses on V&V activities defined by the Army's methodology, the insights, lessons learned, and suggested improvements are widely applicable to the more generalized approaches to V&V. Copyright © 2004 John Wiley & Sons, Ltd.
Innovative design approaches for large wind turbine blades
Authors: Jackson K. J. , Zuteck M. D. , van Dam C. P. , Standish K. J. , Berry D. 
Published: November 2004

AbstractA preliminary design study of an advanced 50 m blade for utility wind turbines is presented and discussed. The effort was part of the Department of Energy WindPACT Blade System Design Study with the goal to investigate and evaluate design and manufacturing issues for wind turbine blades in the 1–10 MW size range. Two different blade designs are considered and compared in this article. The first is a fibreglass design, while the second design selectively incorporates carbon fibre in the main structural elements. The addition of carbon results in modest cost increases and provides significant benefits, particularly with respect to blade deflection. The structural efficiency of both designs was maximized by tailoring the thickness of the blade cross‐sections to simplify the construction of the internal members. Inboard the blades incorporate thick blunt trailing edge aerofoils (flatback aerofoils), while outboard more conventional sharp trailing edge high‐lift aerofoils are used. The outboard section chord lengths were adjusted to yield the least complex and costly internal blade structure. A significant portion of blade weight is related to the root buildup and metal hardware for typical root attachment designs. The results show that increasing the number of studs has a positive effect on total weight, because it reduces the required root laminate thickness. The aerodynamic performance of the blade aerofoils was predicted using computational techniques that properly simulate blunt trailing edge flows. The performance of the rotor was predicted assuming both clean and soiled blade surface conditions. The rotor is shown to provide excellent performance at a weight significantly lower than that of current rotors of this size. Copyright © 2004 John Wiley & Sons, Ltd.
RUSSIA IN THE AGE OF WAR AND REVOLUTION, 1880–1940
Authors: BEER DANIEL 
Published: November 2004

The alcoholic empire: vodka and politics in late Imperial Russia. By Patricia Herlihy. Oxford: Oxford University Press, 2002. Pp. vi+244. ISBN 0-19-513431-1. £25.00.Nikolai Sukhanov: chronicler of the Russian Revolution. By Israel Getzler. Basingstoke: Palgrave, 2002. Pp. xix+226. ISBN 0-333-97035-7. £45.00.Making war, forging revolution: Russia's continuum of crisis, 1914–1921. By Peter Holquist. Cambridge, MA, and London: Harvard University Press, 2002. Pp. xi+359. ISBN 0-674-00907-X. £29.95.The Russian Civil War: primary sources. Edited by A. B. Murphy. Basingstoke: Macmillan Press, 2000. Pp. xviii+274. ISBN 0-333-77013-7. £45.00.Homosexual desire in revolutionary Russia: the regulation of sexual and gender dissent. By Dan Healey. Chicago: University of Chicago Press, 2001. Pp. xvi+392. ISBN 0-226-32233-5. £25.00.These five volumes under review each address different aspects of Russia's experience of modernization and revolution from the 1880s to the 1930s. Our understanding of the scale and complex nature of the changes wrought during these years has been immeasurably enriched by two important factors: first, the recent opening of the former Soviet archives and the detailed case studies that their contents have facilitated; secondly, a mounting reluctance to see 1917 as a radical break with the past and hence an increasing tendency to reinsert the Revolution into a broader series of dynamic and momentous changes that rocked Russia during the period. The rapid expansion of cultural history in the discipline has prompted many scholars to rethink central features of the revolutionary period and to open up new fields of study. Over the last decade, attention has turned to the dynamism and diversity of late tsarist and early Soviet culture embracing topics as wide-ranging as crime, popular religion, the natural and social sciences, and representations of sex.1 Another recent focus has been the experience of conflict across the years of the Revolution and Civil War and its impact on prospects for democracy in Russia.2 The rise to prominence in the historiography of the term ‘modernity’ is an obvious feature of a more comparative analytical framework that has sought to re-insert Russia's revolutionary experience into a pan-European perspective.
Semiologic and Electrophysiologic Correlations in Temporal Lobe Seizure Subtypes
Authors: Maillard Louis , Vignal Jean‐Pierre , Gavaret Martine , Guye Maxime , Biraben Arnaud , McGonigal Aileen , Chauvel Patrick , Bartolomei Fabrice 
Published: November 2004

Summary: Purpose:The International League Against Epilepsy (ILAE) classification distinguishes medial and neocortical temporal lobe epilepsies. Among other criteria, this classification relies on the identification of two different electroclinical patterns, those of medial (limbic) and lateral (neocortical) temporal lobe seizures, depending on the structure initially involved in the seizure activity. Recent electrophysiologic studies have now identified seizures in which medial and neocortical structures are both involved at seizure onset. The purpose of the study was therefore to study the correlations of ictal semiology with the spatiotemporal pattern of discharge in temporal lobe seizures.Methods: The 187 stereoelectroencephalography‐recorded seizures from 55 patients were analyzed. Patients were classified into three groups according to electrophysiologic findings: medial (M; seizure onset limited to medial structures, n = 24), lateral (L; seizure onset limited to lateral structures, n = 13), and medial‐lateral (ML; seizure onset involving both medial and lateral structures, n = 18). Clinical findings were compared between groups.Results: Initial epigastric sensation, initial fear, delayed oroalimentary and elementary upper limb automatisms, delayed loss of contact, long seizure duration, and absent or rare secondary generalizations were associated with M seizures. Initial auditory illusion or hallucination, initial loss of contact, shorter duration of seizures, and more frequent generalizations were associated with L seizures. Initial epigastric sensation, initial loss of contact, early oroalimentary and verbal automatisms, and long duration of seizures were associated with ML seizures.Conclusions: Although the syndrome of mesial temporal epilepsy is now relatively well defined, our findings support the idea that the organization of temporal lobe seizures may be complex and that different patterns exist. We demonstrate three distinct patterns, characterized by both semiologic and electrophysiologic features. This distinction may help to define better the epileptogenic zone and the subsequent surgical procedure.
Altered Expression of Neurotransmitter‐receptor Subunit and Uptake Site mRNAs in Hemimegalencephaly
Authors: Baybis Marianna , Lynch David , Lee Allana , Patel Anita , McKhann Guy , Chugani Diane , J.Kupsky William , Aronica Eleonora , Crino Peter B. 
Published: November 2004

Summary:  Purpose: Hemimegalencephaly (HMEG) is characterized by unilateral hemispheric enlargement and severe cytoarchitectural abnormalities that are highly associated with intractable epilepsy. No studies have defined alterations in neurotransmitter‐receptor subunit gene expression in HMEG. We hypothesize that a differential expression of excitatory amino acid and γ‐aminobutyric acid (GABA)A‐receptor subunit messenger RNAs (mRNAs) exists in HMEG. Methods: The expression of mRNAs encoding 20 neurotransmitter‐receptor subunits, synthetic enzymes, and uptake sites as well as select additional candidate genes was defined in HMEG samples (n = 8) compared with homotopic control cortex specimens by using targeted complementary DNA (cDNA) arrays. Expression of GLT‐1 (a glial glutamate transporter), EAAC‐1 (neuronal glutamate transporter), and NMDA2B was corroborated by immunohistochemical, Western, and ligand‐binding assays. Results: Differential expression of 11 neurotransmitter‐related mRNAs was demonstrated in HMEG compared with control cortex. For example, expression of GLT‐1 and GluR6 mRNAs was enhanced, whereas diminished expression of the neuronal glutamate transporter EAAC‐1, GABAAα2, GABAAγ2, GABAAγ3, NMDA2B, GluR1, GluR2, GluR4, and GluR5 subunits occurred. Reduced NMDA2B subunit mRNA expression in HMEG was confirmed by receptor ligand‐binding assays by using the NMDA2B‐receptor antagonist ifenprodil, which revealed barely detectable levels of NMDA2B binding compared with that in control cortex. Conclusions: Selective alterations occur in distinct neurotransmitter‐receptor and ‐uptake sites in HMEG. Differential expression of neurotransmitter‐receptor and ‐uptake sites in HMEG may contribute to epileptogenesis in HMEG.
Effect of an External Responsive Neurostimulator on Seizures and Electrographic Discharges during Subdural Electrode Monitoring
Authors: Kossoff Eric H. , Ritzl Eva K. , Politsky Jeffrey M. , Murro Anthony M. , Smith Joseph R. , Duckrow Robert B. , Spencer Dennis D. , Bergey Gregory K. 
Published: November 2004

Summary:  Purpose: Approved neural‐stimulation therapies for epilepsy use prolonged intermittent stimulation paradigms with no ability to respond automatically to seizures. Methods: A responsive neurostimulator that can automatically analyze electrocortical potentials, detect electrographic seizures, and rapidly deliver targeted electrical stimuli to suppress them was evaluated in an open multicenter trial in 50 patients, 40 of whom received responsive cortical stimulation via subdural electrodes implanted for epilepsy surgery evaluations. Results: Four patients, ages 15 to 28 years, monitored at three institutions, with clinical and electrographic response to neurostimulation, are described. Electrographic seizures were altered and suppressed in these patients during trials of neurostimulation lasting ≤68 h, with no major side effects. In one patient, stimulation appeared also to improve the baseline EEG. Conclusions: Responsive cortical neurostimulation may be a safe and effective treatment for partial epilepsy. This information was derived from a small group of patients in an observation study. A double‐blind, controlled Food and Drug Administration (FDA)‐approved study of a permanently implanted responsive neurostimulation system to treat medically refractory partial seizures is under way.
Epilepsy and Driving in Japan
Authors: Inoue Yushi , Ito Masotoshi , Kurihara Mana , Morimoto Kiyoshi ,   Commission on Legal Affairs, Japan Epilepsy Society (Japan chapter of ILAE)
Published: November 2004

Summary:  Purpose: The driving regulations in Japan were amended in 2002, which lifted the absolute ban on driving by persons with epilepsy (PWE) and granted licenses to PWE after a 2‐year seizure‐free period. Methods: To survey the effect of the new driving regulations, we sent questionnaires both to the driving authorities (DAs) and to doctors of the Japan Epilepsy Society (JES). Results: Around 1,400 PWE legally obtained a driving license within 1 year after the amendment, licenses were rejected in 157, and 61 had the license withheld for <6 months. In most cases, the attending doctor assessed fitness for driving; 171 doctors responded to the questionnaire. One third of them commented on a positive change in attitude of PWE with respect to driving. Their main remarks included the need to shorten the seizure‐free period to qualify for fitness to drive and the need for special guidelines for conditions such as rare seizure occurrence, recently diagnosed epilepsy, or reflex epilepsy. Problems of assessment identified included difficulty in deciding the time for reassessment, distress of PWE over cancellation of license, cost of the assessment, responsibility of the assessing doctors in case of seizure recurrence, and protection of privacy. They requested the DAs to promote publicity about the information and asked the JES to establish a guideline for assessing fitness to drive. Conclusions: The results highlighted the need for cooperation between the DAs and the JES for further amendment of the regulations as well as the importance of education for the public, patients, and professionals.
Multiple imaging techniques demonstrate the manipulation of surfaces to reduce bacterial contamination and corrosion
Authors: ARNOLD J. W. , BOOTHE D. H. , SUZUKI O. , BAILEY G. W. 
Published: November 2004

SummarySurface imaging techniques were combined to determine appropriate manipulation of technologically important surfaces for commercial applications. The complementarity of the microscopy methods, scanning electron microscopy, electron probe microanalysis and atomic force microscopy assessed and correlated form and function of the surface modifications. Stainless steel disks (1 cm in diameter) were laser‐cut from the same sheets of stainless steel and treated by electropolishing or left untreated for controls. Each treatment was analysed separately using each technique. First, the disks were examined by visual inspection and electron probe microanalysis for surface characteristics and elemental composition, respectively. Aliquots of bacterial suspensions (saline rinses of poultry carcasses from a commercial broiler processing plant) were then diluted in broth and monitored for growth by spectrophotometry. Stainless steel disks (1 cm in diameter) were added and the cultures were grown to sufficient density to allow attachment of bacterial cells to test surfaces. Relative differences in the surface morphology shown by atomic force microscopy, including Z ranges, roughness and other measurements, corresponded by treatment with the differences in reduction of bacterial counts shown by scanning electron microscopy. A model of wet‐processing conditions tested the effects of corrosive treatment of surfaces. Less bacterial attachment occurred after corrosive treatment on controls and electropolished samples. Electropolishing significantly reduced bacterial numbers and the effects of corrosive action compared to the controls. Thus, the multiple imaging techniques showed that engineered changes on stainless steel surfaces improved the resistance of the surface finish to bacterial attachment, biofilm formation, and corrosive action.
A method for determining void arrangements in inverse opals
Authors: BLANFORD C. F. , CARTER C. B. , STEIN A. 
Published: November 2004

SummaryThe periodic arrangement of voids in ceramic materials templated by colloidal crystal arrays (inverse opals) has been analysed by transmission electron microscopy. Individual particles consisting of an approximately spherical array of at least 100 voids were tilted through 90° along a single axis within the transmission electron microscope. The bright‐field images of these particles at high‐symmetry points, their diffractograms calculated by fast Fourier transforms, and the transmission electron microscope goniometer angles were compared with model face‐centred cubic, body‐centred cubic, hexagonal close‐packed, and simple cubic lattices in real and reciprocal space. The spatial periodicities were calculated for two‐dimensional projections. The systematic absences in these diffractograms differed from those found in diffraction patterns from three‐dimensional objects. The experimental data matched only the model face‐centred cubic lattice, so it was concluded that the packing of the voids (and, thus, the polymer spheres that composed the original colloidal crystals) was face‐centred cubic. In face‐centred cubic structures, the stacking‐fault displacementvector is . No stacking faults were observed when viewingthe inverse opal structure along the orthogonal <110>‐type directions, eliminating the possibility of a random hexagonally close‐packed structure for the particles observed. This technique complements synchrotron X‐ray scattering work on colloidal crystals by allowing both real‐space and reciprocal‐space analysis to be carried out on a smaller cross‐sectional area.
Shear force near‐field optical microscope based on Q‐controlled bimorph sensor for biological imaging in liquid
Authors: LEI F. H. , ANGIBOUST J.‐F. , QIAO W. , SOCKALINGUM G. D. , DUKIC S. , CHRIT L. , TROYON M. , MANFAIT M. 
Published: November 2004

SummaryShear force near‐field microscopy on biological samples in their physiological environment loses considerable sensitivity and resolution as a result of liquid viscous damping. Using a bimorph‐based cantilever sensor incorporating force feedback, as recently developed by us, gives an alternative force detection scheme for biological imaging in liquid. The dynamics and sensitivity of this sensor were theoretically and experimentally discussed. Driving the bimorph cantilever close to its resonance frequency with appropriate force feedback allows us to obtain a quality factor (Q‐factor) of up to 103 in water, without changing its intrinsic resonance frequency and spring constant. Thus, the force detection sensitivity is improved. Shear force imaging on mouse brain sections and human skin tissues in liquid with an enhanced Q‐factor of 410 have shown a high sensitivity and stability. A resolution of about 50 nm has been obtained. The experimental results suggest that the system is reliable and particularly suitable for biological cell imaging in a liquid environment.