Coverage with evidence development: applications and issues

Copyright © Cambridge University Press, 2010OBJECTIVES: The aim of this study was to describe the current issues surrounding Coverage with Evidence Development (CED). CED is characterized by restricted coverage for a new technology in parallel with targeted research when the stated goal of the research or data collection is to provide definitive evidence for the clinical or cost-effectiveness impact of the new technology. METHODS: Presented here is information summarized and interpreted from presentations and discussions at the 2008 Health Technology Assessment International (HTAi) meeting and additional information from the medical literature. This study describes the differences between CED and other conditional coverage agreements, provides a brief history of CED, describes real-world examples of CED, describes the areas of consensus between the stakeholders, discusses the areas for future negotiation between stakeholders, and proposes criteria to assist stakeholders in determining when CED could be appropriate. RESULTS: Payers could interpret the evidence obtained from a CED program either positively or negatively, and a range of possible changes to the reimbursement status of the new technology may result. Striking an appropriate balance between the demands for prompt access to new technology and acknowledging that some degree of uncertainty will always exist is a critical challenge to the uptake of this innovative form of conditional coverage. CONCLUSIONS: When used selectively for innovative procedures, pharmaceuticals, or devices in the appropriate disease areas, CED may provide patients access to promising medicines or technologies while data to minimize uncertainty are collected.The development of the manuscript was funded by Medicines Australi

Odderon and spin dependence of high energy proton-proton scattering

The sensitivity of the spin dependence of high energy pp scattering, particularly the asymmetry A_{NN}, to the odderon is demonstrated. Several possible ways of determining the spin dependence of the odderon coupling from small-t data are presented.Comment: Figure corrected, some references modified and some minor changes to tex

How to identify when a performance indicator has run its course

The official published version can be found at the link below.Increasing numbers of countries are using indicators to evaluate the quality of clinical care, with some linking payment to achievement. For performance frameworks to remain effective the indicators need to be regularly reviewed. The frameworks cannot cover all clinical areas, and achievement on chosen indicators will eventually reach a ceiling beyond which further improvement is not feasible. However, there has been little work on how to select indictors for replacement. The Department of Health decided in 2008 that it would regularly replace indicators in the national primary care pay for performance scheme, the Quality and Outcomes Framework, making a rigorous approach to removal a priority. We draw on our previous work on pay for performance and our current work advising the National Institute for Health and Clinical Excellence (NICE) on the Quality and Outcomes Framework to suggest what should be considered when planning to remove indicators from a clinical performance framework

Helicity amplitudes and crossing relations for antiproton proton reactions

Antiproton proton annihilation reactions allow unique access to the moduli and phases of nucleon electromagnetic form factors in the time like region. We present the helicity amplitudes for the unequal mass single photon reaction $p \bar{p}\to l^+ l^-$ in the s channel including the lepton mass. The relative signs of these amplitudes are determined using simple invariance properties. Helicity amplitudes for the annihilation reaction $p \bar{p} \to N \bar{N}$ are also given, where $N$ is any spinor particle with structure. Crossing relations between the $e p \to e p$ scattering and the $p \bar{p}\to l^+ l^-$ annihilation channels are discussed and the crossing matrix for the helicity amplitudes is given. This matrix may be used to verify known expressions for the space like helicity amplitudes due to one photon exchange.Comment: 15 pages, 5 figures, submitted to EPJ

Robust MR-based approaches to quantifying white matter structure and structure/function alterations in Huntington's disease

Background: Huge advances have been made in understanding and addressing confounds in diffusion MRI data to quantify white matter microstructure. However, there has been a lag in applying these advances in clinical research. Some confounds are more pronounced in HD which impedes data quality and interpretability of patient-control differences. This study presents an optimised analysis pipeline and addresses specific confounds in a HD patient cohort. Method: 15 HD gene-positive and 13 matched control participants were scanned on a 3T MRI system with two diffusion MRI sequences. An optimised post processing pipeline included motion, eddy current and EPI correction, rotation of the B matrix, free water elimination ( FWE ) and tractography analysis using an algorithm capable of reconstructing crossing fibres. The corpus callosum was examined using both a region-of-interest and a deterministic tractography approach, using both conventional diffusion tensor imaging ( DTI )-based and spherical deconvolution analyses. Results: Correcting for CSF contamination significantly altered microstructural metrics and the detection of group differences. Reconstructing the corpus callosum using spherical deconvolution produced a more complete reconstruction with greater sensitivity to group differences, compared to DTI-based tractography. Tissue volume fraction ( TVF ) was reduced in HD participants and was more sensitive to disease burden compared to DTI metrics. Conclusion: Addressing confounds in diffusion MR data results in more valid, anatomically faithful white matter tract reconstructions with reduced within-group variance. TVF is recommended as a complementary metric, providing insight into the relationship with clinical symptoms in HD not fully captured by conventional DTI metrics

Two--Loop Anomalous Dimension Matrix for ΔS=1\Delta S=1 Weak Non-Leptonic Decays II: O(αeαs){\cal O}(\alpha_e \alpha_s)

We calculate the $10\times 10$ two--loop anomalous dimension matrix to order \ord(\alpha_e \alpha_s) in the dimensional regularization scheme with anticommuting $\gamma_5$ (NDR) which is necessary for the extension of the $\Delta S=1$ weak Hamiltonian involving electroweak penguins beyond the leading logarithmic approximation. We demonstrate, how a direct calculation of penguin diagrams involving $\gamma_5$ in closed fermion loops can be avoided thus allowing a consistent calculation of two--loop anomalous dimensions in the simplest renormalization scheme with anticommuting $\gamma_5$ in $D$ dimensions. We give the necessary one--loop finite terms which allow to obtain the corresponding two--loop anomalous dimension matrix in the HV scheme with non--anticommuting $\gamma_5$.Comment: 25 page

The flora and vegetation of an old solvay process tip in Jaworzno (Upper Silesia, Poland)

This paper demonstrates the flora, plant communities and substrates of an old soivay process spoil tip in Upper Silesia, Poland. In an area of 15 000 m2 there are growing 136 vascular plant species. The flora is characterised by the preponderance of Asteraceae - species and long-lived perennial herbs, many of them coming from meadows and grasslands. Ninety-five percent of species are apophytes despite the anthropogenic origin of the site. A majority of species are associated with moderately dry, base-rich soils with low or moderate levels of nitrogen. The site is shown to be an important refuge for some protected species, montane species and other elements uncommon in the local flora. An analysis of a series of samples used a methodology based on the assessment of percentage cover of particular species and multivariate analysis based on TWINSPAN. Both suggested a relatively high overall similarity between the samples with minor variations associated with moister substrates. Elemental analysis and pH determinations of soil samples associated with the releves revealed a narrow range of pH and an absence of any strong concentrations of heavy metals. A redundancy analysis of the soil-plant relationships suggested that the strongest trend of differentiation was most closely associated with a phosphate gradient, and the next strongest was pH and possibly waterlogging. The most species-rich vegetation was associated with low phosphate and high pH levels. The results could be interpreted to suggest that processes of soil development and plant succession are slow but nevertheless perceptible, with implications for future loss of diversity. The vegetation constitutes an assemblage essentially of one type showing only weak relationships with described vegetation types such as Molinio-Arrhenatheretea meadow, Festuco- Brometea grassland and Caricetalia davallianae mire. The results also suggest that the vegetation of the site is of considerable value for nature conservation. The site should be protected and be the subject of further research

An absolute polarimeter for high energy protons

A study of the spin asymmetries for polarized elastic proton proton collisions in the electromagnetic hadronic interference (CNI) region of momentum transfer provides a method of self calibration of proton polarization. The method can be extended to non-identical spin half scattering so that, in principle, the polarization of a proton may be obtained through an analysis of its elastic collision with a different polarized particle, helium 3 for instance. Sufficiently large CNI spin asymmetries provide enough information to facilitate the evaluation of nearly all the helicity amplitudes at small t as well as the polarization of both initial spin half fermions. Thus it can serve equally well as a polarimeter for helium 3