Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures

BACKGROUND: Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM) interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database. METHODS: The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM) and the CAM Education and Research Network of Alberta (CAMera). The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used. RESULTS: One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing. CONCLUSION: We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of outcome measures, such as individualized and holistic measures, with attention to issues of process and context

Insights into spatial sensitivities of ice mass response to environmental change from the SeaRISE ice sheet modeling project I: Antarctica

Atmospheric, oceanic, and subglacial forcing scenarios from the Sea-level Response to Ice Sheet Evolution (SeaRISE) project are applied to six three-dimensional thermomechanical ice-sheet models to assess Antarctic ice sheet sensitivity over a 500 year timescale and to inform future modeling and field studies. Results indicate (i) growth with warming, except within low-latitude basins (where inland thickening is outpaced by marginal thinning); (ii) mass loss with enhanced sliding (with basins dominated by high driving stresses affected more than basins with low-surface-slope streaming ice); and (iii) mass loss with enhanced ice shelf melting (with changes in West Antarctica dominating the signal due to its marine setting and extensive ice shelves; cf. minimal impact in the Terre Adelie, George V, Oates, and Victoria Land region of East Antarctica). Ice loss due to dynamic changes associated with enhanced sliding and/or sub-shelf melting exceeds the gain due to increased precipitation. Furthermore, differences in results between and within basins as well as the controlling impact of sub-shelf melting on ice dynamics highlight the need for improved understanding of basal conditions, grounding-zone processes, ocean-ice interactions, and the numerical representation of all three. Key Points Sensitivity study of Antarctica to atmospheric, oceanic and subglacial forcings Different sectors of Antarctica are vulnerable to the forcings Atmospheric forcing lead to a growth, but dynamic forcing lead to a mass loss ©2013. American Geophysical Union. All Rights Reserved

Insights into spatial sensitivities of ice mass response to environmental change from the SeaRISE ice sheet modeling project II: Greenland

The Sea-level Response to Ice Sheet Evolution (SeaRISE) effort explores the sensitivity of the current generation of ice sheet models to external forcing to gain insight into the potential future contribution to sea level from the Greenland and Antarctic ice sheets. All participating models simulated the ice sheet response to three types of external forcings: a change in oceanic condition, a warmer atmospheric environment, and enhanced basal lubrication. Here an analysis of the spatial response of the Greenland ice sheet is presented, and the impact of model physics and spin-up on the projections is explored. Although the modeled responses are not always homogeneous, consistent spatial trends emerge from the ensemble analysis, indicating distinct vulnerabilities of the Greenland ice sheet. There are clear response patterns associated with each forcing, and a similar mass loss at the full ice sheet scale will result in different mass losses at the regional scale, as well as distinct thickness changes over the ice sheet. All forcings lead to an increased mass loss for the coming centuries, with increased basal lubrication and warmer ocean conditions affecting mainly outlet glaciers, while the impacts of atmospheric forcings affect the whole ice sheet. Key Points Sensitivity study of Greenland to atmospheric, oceanic and subglacial forcings Each forcing result in a different regional thickness response All forcings lead to an increased mass loss for the coming centuries ©2013. American Geophysical Union. All Rights Reserved

Kneading Technique for Preparation of Binary Solid Dispersion of Meloxicam with Poloxamer 188

The aim of the present study was to enhance the dissolution rate of meloxicam (MLX), a practically water-insoluble drug by preparation of solid dispersion using a hydrophilic polymer, poloxamer 188 (PXM). The kneading technique was used to prepare solid dispersions. A 32 full factorial design approach was used for optimization wherein the drug, polymer ratio (X1), and the kneading time (X2) were selected as independent variables and the dissolution efficiency at 60 min (%DE60) and yield percent were selected as the dependent variable. Multiple linear regression analysis revealed that for obtaining higher dissolution of MLX from PXM solid dispersions, a high level of X1 and a high level of X2 were suitable. The use of a factorial design approach helped in optimization of the preparation and formulation of solid dispersion. The optimized formula was characterized by solubility studies, angle of repose, and contact angle; Fourier transform infrared spectroscopy, differential scanning calorimetry, x-ray diffraction studies, and scanning electron microscopy demonstrated that enhanced dissolution of MLX from solid dispersion might be due to a decrease in the crystallinity of MLX and PXM. Analysis of dissolution data of optimized formula indicated the best fitting with Korsemeyer–Peppas model and the drug release kinetics as Fickian diffusion. In conclusion, dissolution enhancement of MLX was obtained by preparing its solid dispersion with PXM using kneading technique