Systems validation: application to statistical programs

BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation. Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation. However, the concepts of validation are not often discussed in biostatistics curriculum. DISCUSSION: This paper summarizes a "Plan, Do, Say" approach to validation that can be incorporated into statistical training so that biostatisticians can understand and implement validation principles in their research. SUMMARY: Validation is a process that requires dedicated attention. The process of validation can be easily understood in the context of the scientific method

On the conduct of sociological warfare: a reply to special section on Economy of Force

It is an honour to receive commentaries on Economy of Force from these four distinguished scholars. I am grateful to Tarak Barkawi, Patchen Markell, Julian Go, and Vivienne Jabri for devoting precious scholarly time to this book. Economy of Force is not about the ‘economics of war’, or not in any straightforward sense. Rather it retrieves the older, but surprisingly neglected, history and theory of oikonomia, ancient Greek for household governance. The book is a study of oikonomia in the use of military force, but also as underlying distinctly social forms of governance more broadly. There is a very long tradition of thinking about households-as-government and a great deal of scholarship in literary and gender studies on practices and ideologies of domesticity. Oikonomia is the origin of the language of modern ‘economics’, but more importantly and revealingly almost all writing about government in the West. International and much political theory is out of touch with these literatures resulting in blindness to a crucial reality about modern governance forms. The large-scale household administration of life processes plays a remarkably central role in international and imperial relations. Economy of Force illustrates this through a history of so-called ‘armed social work’ in counterinsurgency, beginning with late-nineteenth-century French and American colonial pacification and then detailed case studies of two late-colonial British emergencies in Malaya and Kenya, US counterinsurgency in Vietnam, and US-led multinational campaigns in Afghanistan and Iraq. In each case, to varying degrees and in different ways, the civilian base of armed resistance was weakened through the forcible removal and mass concentration of civilians; the selective delivery and withholding of humanitarian supplies; the empowering of local collaborators to rule ‘their population’; detention without trial and exemplary massacres; and the opening of markets and new schools. If insurgents and counterinsurgents are in a competition in government, then what is the nature of government under counterinsurgency rule? Through violence and control over life, through the management of gendered and racialised bodies in their extreme and irreducible vulnerability, counterinsurgents were seeking to create units of rule in which populations could be domesticated. That is, they drew on and innovated different forms of household management

Targeted interventions for patellofemoral pain syndrome (TIPPS): classification of clinical subgroups

Introduction Patellofemoral pain (PFP) can cause significant pain leading to limitations in societal participation and physical activity. An international expert group has highlighted the need for a classification system to allow targeted intervention for patients with PFP; we have developed a work programme systematically investigating this. We have proposed six potential subgroups: hip abductor weakness, quadriceps weakness, patellar hypermobility, patellar hypomobility, pronated foot posture and lower limb biarticular muscle tightness. We could not uncover any evidence of the relative frequency with which patients with PFP fell into these subgroups or whether these subgroups were mutually exclusive. The aim of this study is to provide information on the clinical utility of our classification system. Methods and analysis 150 participants will be recruited over 18 months in four National Health Services (NHS) physiotherapy departments in England. Inclusion criteria: adults 18–40 years with PFP for longer than 3 months, PFP in at least two predesignated functional activities and PFP elicited by clinical examination. Exclusion criteria: prior or forthcoming lower limb surgery; comorbid illness or health condition; and lower limb training or pregnancy. We will record medical history, demographic details, pain, quality of life, psychomotor movement awareness and knee temperature. We will assess hip abductor and quadriceps weakness, patellar hypermobility and hypomobility, foot posture and lower limb biarticular muscle tightness. The primary analytic approach will be descriptive. We shall present numbers and percentages of participants who meet the criteria for membership of (1) each of the subgroups, (2) none of the subgroups and (3) multiple subgroups. Exact (binomial) 95% CIs for these percentages will also be presented. Ethics and dissemination This study has been approved by National Research Ethics Service (NRES) Committee North West—Greater Manchester North (11/NW/0814) and University of Central Lancashire (UCLan) Built, Sport, Health (BuSH) Ethics Committee (BuSH 025). An abstract has been accepted for the third International Patellofemoral Pain Research Retreat, Vancouver, September 2013

Giant viscosity enhancement in a spin-polarized Fermi liquid

The viscosity is measured for a Fermi liquid, a dilute $^3$He-$^4$He mixture, under extremely high magnetic field/temperature conditions ($B \leq 14.8$ T, $T \geq 1.5$ mK). The spin splitting energy $\mu B$ is substantially greater than the Fermi energy $k_B T_F$; as a consequence the polarization tends to unity and s-wave quasiparticle scattering is suppressed for $T \ll T_F$. Using a novel composite vibrating-wire viscometer an enhancement of the viscosity is observed by a factor of more than 500 over its low-field value. Good agreement is found between the measured viscosity and theoretical predictions based upon a $t$-matrix formalism.Comment: 4 pages, 4 figure

Consequences of asteroid fragmentation during impact hazard mitigation

The consequences of the fragmentation of an Earth-threatening asteroid due to an attempted deflection are examined in this paper. The minimum required energy for a successful impulsive deflection of a threatening object is computed and compared to the energy required to break up a small size asteroid. The results show that the fragmentation of an asteroid that underwent an impulsive deflection, such as a kinetic impact or a nuclear explosion, is a very plausible event.Astatistical model is used to approximate the number and size of the fragments as well as the distribution of velocities at the instant after the deflection attempt takes place. This distribution of velocities is a function of the energy provided by the deflection attempt, whereas the number and size of the asteroidal fragments is a function of the size of the largest fragment. The model also takes into account the gravity forces that could lead to a reaggregation of the asteroid after fragmentation. The probability distribution of the pieces after the deflection is then propagated forward in time until the encounter with Earth. A probability damage factor (i.e., expected damage caused by a given size fragment multiplied by its impact probability) is then computed and analyzed for different plausible scenarios, characterized by different levels of deflection energies and lead times

The Neuromuscular Origins of Kinematic Variability during Perturbed Walking

We investigated the neuromuscular contributions to kinematic variability and thus step to step adjustments in posture and foot placement across a range of walking speeds in response to optical flow perturbations of different amplitudes using a custom virtual environment. We found that perturbations significantly increased step width, decreased step length, and elicited larger trunk sway compared to normal walking. However, perturbation-induced effects on the corresponding variabilities of these measurements were much more profound. Consistent with our hypotheses, we found that: (1) perturbations increased EMG activity of the gluteus medius and postural control muscles during leg swing, and increased antagonist leg muscle coactivation during limb loading in early stance, and (2) changes in the magnitude of step to step adjustments in postural sway and lateral foot placement positively correlated with those of postural control and gluteus medius muscle activities, respectively, in response to perturbations. However, (3) interactions between walking speed and susceptibility to perturbations, when present, were more complex than anticipated. Our study provides important mechanistic neuromuscular insight into walking balance control and important reference values for the emergence of balance impairment

Thin-film flow in helically wound shallow channels of arbitrary cross-sectional shape

We consider the steady, gravity-driven flow of a thin film of viscous fluid down a helically wound shallow channel of arbitrary cross-sectional shape with arbitrary torsion and curvature. This extends our previous work [D. J. Arnold et al., “Thin-film flow in helically-wound rectangular channels of arbitrary torsion and curvature,” J. Fluid Mech. 764, 76–94 (2015)] on channels of rectangular cross section. The Navier-Stokes equations are expressed in a novel, non-orthogonal coordinate system fitted to the channel bottom. By assuming that the channel depth is small compared to its width and that the fluid depth in the vertical direction is also small compared to its typical horizontal extent, we are able to solve for the velocity components and pressure analytically. Using these results, a differential equation for the free surface shape is obtained, which must in general be solved numerically. Motivated by the aim of understanding flows in static spiral particle separators used in mineral processing, we investigate the effect of cross-sectional shape on the secondary flow in the channel cross section. We show that the competition between gravity and inertia in non-rectangular channels is qualitatively similar to that in rectangular channels, but that the cross-sectional shape has a strong influence on the breakup of the secondary flow into multiple clockwise-rotating cells. This may be triggered by small changes to the channel geometry, such as one or more bumps in the channel bottom that are small relative to the fluid depth. In contrast to the secondary flow which is quite sensitive to small bumps in the channel bottom, the free-surface profile is relatively insensitive to these. The sensitivity of the flow to the channel geometry may have important implications for the design of efficient spiral particle separators.D. J. Arnold, Y. M. Stokes, and J. E. F. Gree

Noncovariant gauge fixing in the quantum Dirac field theory of atoms and molecules

Starting from the Weyl gauge formulation of quantum electrodynamics (QED), the formalism of quantum-mechanical gauge fixing is extended using techniques from nonrelativistic QED. This involves expressing the redundant gauge degrees of freedom through an arbitrary functional of the gauge-invariant transverse degrees of freedom. Particular choices of functional can be made to yield the Coulomb gauge and Poincar\'{e} gauge representations. The Hamiltonian we derive therefore serves as a good starting point for the description of atoms and molecules by means of a relativistic Dirac field. We discuss important implications for the ontology of noncovariant canonical QED due to the gauge freedom that remains present in our formulation.Comment: 8 pages, 0 figure