Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: Towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies

This paper describes the background and current status of an OMERACT facilitated effort to improve the consistency of adverse event reporting in rheumatology clinical trials, The overall goal is the development of an adverse event assessment tool that would provide a basis for use of common terminology and improve the consistency of reporting severity of side effects within rheumatology clinical trials and during postmarketing surveillance. The resulting Rheumatology Common Toxicity Criteria Index encompassed the following organ systems: allergic/immunologic, cardiac, ENT, gastrointestinal, musculoskeletal, neuropsychiatric, ophthalmologic, pulmonary and skin/integument. Before this tool is widely accepted, its validity, consistency, and feasibility need to be assessed in clinical trials.

The role of Doppler left ventricular filling indexes and Doppler tissue echocardiography in the assessment of cardiac involvement in hereditary hemochromatosis

Although cardiac dysfunction in hereditary hemochromatosis (HHC) can be evaluated by conventional echocardiography, findings are often not specific. To test the hypothesis that the assessment of (1) conventional Doppler left ventricular filling indexes and (2) intrinsic elastic properties of the myocardium by Doppler tissue echocardiography can both enhance the accuracy of echocardiographic diagnosis of cardiac involvement in HHC, a group of 18 patients with HHC (mean age 50+/-7 years) and 22 age-matched healthy subjects were studied. The following indexes were characteristic for HHC: (1) the duration of atrial reversal measured from pulmonary venous flow (ms) was longer(118+/-20 vs 90+/-16; P

Linguistic evaluation method for the environmental assessment of infrastructure projects

A soft linguistic evaluation method is proposed for the environmental assessment of physical infrastructure projects based on fuzzy relations. Infrastructure projects are characterized in terms of linguistic expressions of 'performance' with respect to factors or impacts and the 'importance' of those factors/impacts. A simple example is developed to illustrate the method in the context of three road infrastructure projects assessed against five factors/impacts. In addition, a means to include hard or crisp factors is presented and illustrated with respect to a sixth factor.

An overview of APSIM, a model designed for farming systems simulation

The Agricultural Production Systems Simulator (APSIM) is a modular modelling framework that has been developed by the Agricultural Production Systems Research Unit in Australia. APSIM was developed to simulate biophysical process in farming systems, in particular where there is interest in the economic and ecological outcomes of management practice in the face of climatic risk. The paper outlines APSIM's structure and provides details of the concepts behind the different plant, soil and management modules. These modules include a diverse range of crops, pastures and trees, soil processes including water balance, N and P transformations, soil pH, erosion and a full range of management controls. Reports of APSIM testing in a diverse range of systems and environments are summarised. An example of model performance in a long-term cropping systems trial is provided. APSIM has been used in a broad range of applications, including support for on-farm decision making, farming systems design for production or resource management objectives, assessment of the value of seasonal climate forecasting, analysis of supply chain issues in agribusiness activities, development of waste management guidelines, risk assessment for government policy making and as a guide to research and education activity. An extensive citation list for these model testing and application studies is provided. Crown Copyright (C) 2002 Published by Elsevier Science B.V. All rights reserved.

Field hydraulic properties of an Alfisol under various fallow systems in southwestern Nigeria

The effects of various fallow management systems and cropping intensities on water infiltration were measured on an Alfisol at Ibadan in southwestern Nigeria. The objective was to determine the influence of the land use systems (a combination of crop-fallow sequences and intercropping types) on soil hydraulic properties obtained by disc permeameter and double-ring infiltration measurements. The experiment was established in 1989 as a split-plot design with four replications. The main plots were natural fallow, planted Pueraria phaseoloides and planted Leucaena leucocephala. The subplots were 1 year of maize/cassava intercrop followed by 3-year fallow (25% cropping intensity), or 2-year fallow (33% cropping intensity), or 1-year fallow (50% cropping intensity), or no fallow period (100% cropping intensity). Water infiltration rates and sorptivities were measured under saturated and unsaturated flow. Irrespective of land use, infiltration rates at the soil surface (121-324 cm h(-1)) were greater than those measured at 30 cm depth (55-144 cm h(-1)). This indicated that fewer large pores were present below 30 cm depth compared with 0-30 cm, depth. Despite some temporal variation, sorptivities with the highest mean value of 93.5 cm h(-1/2) increased as the cropping intensity decreased, suggesting a more continuous macropore system under less intensive land use systems. This was most likely due to continuous biopores created by perennial vegetation under long fallow systems. Intercropped maize and cassava yields also increased as cropping intensity decreased. The weak relationship between crop yields and hydraulic conductivity/infiltration rates suggests that the rates were not limiting.

Systems for assessing the effectiveness of management in protected areas

Since the mid-1990s, numerous methodologies have been developed to assess the management effectiveness of protected areas, many tailored to particular regions or habitats. Recognizing the need for a generic approach, the World Commission on Protected Areas (WCPA) developed an evaluation framework allowing specific evaluation methodologies to be designed within a consistent overall approach. Twenty-seven assessment methodologies were analyzed in relation to this framework. Two types of data were identified: quantitative data derived from monitoring and qualitative data derived from scoring by managers and stakeholders. The distinction between methodologies based on data types reflects different approaches to assessing management. Few methodologies assess all the WCPA framework elements. More useful information for adaptive management will come from addressing all six elements. The framework can be used to adapt existing methodologies or to design new, more comprehensive methodologies for evaluation, using quantitative monitoring data, qualitative scoring data, or a combination of both.

Illusions in advanced cancer: The effect of belief systems and attitudes on quality of life

Patients with advanced cancer frequently express positive attitudes and can be unduly optimistic about the potential benefits of treatment. In order to evaluate an illusory domain in the context of advanced cancer, we developed a scale of will to live and characterized the beliefs that patients held about the curability of their cancer, and how committed they were to using alternative treatments. A measure of quality of life was used as the dependent variable in order to assess the association between these attributes. After a preliminary exploration confirmed the presence of an illusory domain, these concepts were prospectively tested in 149 ambulant patients with advanced cancer who attended for palliative systemic treatment, radiation treatment or supportive care. The scale of global quality of life was reliable (Cronbach's alpha coefficient 0.72). The distribution of the scores of will to live was skewed, with no respondent scoring poorly, and the scale was reliable (Cronbach's alpha coefficient 0.82). The scale of belief in curability showed diverse beliefs. In some cases, there was a discrepancy between respondents' beliefs in curability and what they believed to be the report by their doctors. There was also an association between a committed use of alternative treatments and a belief in the curability of the cancer (p

Impact of scar thickness on the assessment of viability using dobutamine echocardiography and thallium single-photon emission computed tomography - A comparison with contrast-enhanced magnetic resonance imaging

OBJECTIVES We sought to determine whether the transmural extent of scar (TES) explains discordances between dobutamine echocardiography (DbE) and thallium single-photon emission computed tomography (Tl-SPECT) in the detection of viable myocardium (VM). BACKGROUND Discrepancies between DbE and Tl-SPECT are often attributed to differences between contractile reserve and membrane integrity, but may also reflect a disproportionate influence of nontransmural scar on thickening at DbE. METHODS Sixty patients (age 62 +/- 12 years; 10 women and 50 men) with postinfarction left ventricular dysfunction underwent standard rest-late redistribution Tl-SPECT and DbE. Viable myocardium was identified when dysfunctional segments showed Tl activity >60% on the late-redistribution image or by low-dose augmentation at DbE. Contrast-enhanced magnetic resonance imaging (ceMRI) was used to divide TES into five groups: 0%, 75% of the wall thickness replaced by scar. RESULTS As TES increased, both the mean Tl uptake and change in wall motion score decreased significantly (both p < 0.001). However, the presence of subendocardial scar was insufficient to prevent thickening; >50% of segments still showed contractile function with TES of 25% to 75%, although residual function was uncommon with TES >75%. The relationship of both tests to increasing TES was similar, but Tl-SPECT identified VM more frequently than DbE in all groups. Among segments without scar or with small amounts of scar (50% were viable by SPECT. CONCLUSIONS Both contractile reserve and perfusion are sensitive to the extent of scar. However, contractile reserve may be impaired in the face of no or minor scar, and thickening may still occur with extensive scar. (C) 2004 by the American College of Cardiology Foundation.

Incremental benefit of myocardial contrast to combined dipyridamole-exercise stress echocardiography for the assessment of coronary artery disease

Background-Although assessment of myocardial perfusion by myocardial contrast echocardiography (MCE) is feasible, its incremental benefit to stress echocardiography is not well defined. We examined whether the addition of MCE to combined dipyridamole-exercise echocardiography (DExE) provides incremental benefit for evaluation of coronary artery disease (CAD). Methods and Results-MCE was combined with DExE in 85 patients, 70 of whom were undergoing quantitative coronary angiography and 15 patients with a low probability of CAD. MCE was acquired by low-mechanical-index imaging in 3 apical views after acquisition of standard resting and poststress images. Wall motion, left ventricular opacification, and MCE components of the study were interpreted sequentially, blinded to other data. Significant (>50%) stenoses were present in 43 patients and involved 69 coronary territories. The addition of qualitative MCE improved sensitivity for the detection of CAD (91% versus 74%, P=0.02) and accurate recognition of disease extent (87% versus 65% of territories, P=0.003), with a nonsignificant reduction in specificity. Conclusions-The addition of low-mechanical-index MCE to standard imaging during DExE improves detection of CAD and enables a more accurate determination of disease extent.

Quantitative assessment of aortic sclerosis using ultrasonic backscatter

Background. The development of therapeutic interventions to prevent progressive valve damage is more likely to limit the progression of structural damage to the aortic valve with normal function (aortic sclerosis [ASC]) than clinically apparent aortic stenosis. Currently, the ability to appreciate the progression of ASC is compromised by the subjective and qualitative evaluation of sclerosis severity. Methods: We sought to reveal whether the intensity of ultrasonic backscatter could be used to quantify sclerosis severity in 26 patients with ASC and 23 healthy young adults. images of the aortic valve were obtained in the parasternal long-axis view and saved in raw data format. Six square-shaped 11 X 11 pixel regions of interest were placed on the anterior and posterior leaflets, and calibrated backscatter values were obtained by subtracting the regions of interest in the blood pool from the averaged backscatter values obtained from the leaflets. Results. Mean ultrasonic backscatter values for sclerotic valves exceeded the results in normal valve tissue (16.3 +/- 4.4 dB vs 9.8 +/- 3.3 dB, P < .0001). Backscatter values were greater (22.0 +/- 3.5 dB) in a group of 6 patients with aortic stenosis. Within the sclerosis group, the magnitude of backscatter was directly correlated (P < .05) with a subjective sclerosis score, and with transvalvular pressure gradient. mean reproducibility was 2.4 +/- 1.8 dB (SD) between observers, and 2.3 +/- 1.7 dB (SD) between examinations. Conclusion: Measurement of backscatter from the valve leaflets of patients with ASC may be a feasible means of following the progression and treatment response of aortic sclerosis.

Geometric distortion in clinical MRI systems - Part I: evaluation using a 3D phantom

Recently, a 3D phantom that can provide a comprehensive and accurate measurement of the geometric distortion in MRI has been developed. Using this phantom, a full assessment of the geometric distortion in a number of clinical MRI systems (GE and Siemens) has been carried out and detailed results are presented in this paper. As expected, the main source of geometric distortion in modern superconducting MRI systems arises from the gradient field nonlinearity. Significantly large distortions with maximum absolute geometric errors ranged between 10 and 25 mm within a volume of 240 x 240 x 240 mm(3) were observed when imaging with the new generation of gradient systems that employs shorter coils. By comparison, the geometric distortion was much less in the older-generation gradient systems. With the vendor's correction method, the geometric distortion measured was significantly reduced but only within the plane in which these 2D correction methods were applied. Distortion along the axis normal to the plane was, as expected, virtually unchanged. Two-dimensional correction methods are a convenient approach and in principle they are the only methods that can be applied to correct geometric distortion in a single slice or in multiple noncontiguous slices. However, these methods only provide an incomplete solution to the problem and their value can be significantly reduced if the distortion along the normal of the correction plane is not small. (C) 2004 Elsevier Inc. All rights reserved.

Assessment of diastolic function: What the general cardiologist needs to know

Diastolic dysfunction has a major impact on symptom status, functional capacity, medical treatment, and prognosis in both systolic and diastolic heart failure (HF), irrespective of the cause.w1 w2 When systolic dysfunction is clearly present, the central clinical question concerns the presence or absence of elevated filling pressure; a restrictive filling pattern is highly specific for elevated pulmonary wedge pressure in this setting.1w3 The transmitral flow pattern is also predictive of outcome; non-reversibility of restrictive filling with treatment portends a very poor prognosis.2 Thus, diastolic evaluation is an important component of the evaluation of the patient with systolic left ventricular (LV) impairment.

Power system sensitivity analysis for probabilistic small signal stability assessment in a deregulated environment

Deregulations and market practices in power industry have brought great challenges to the system planning area. In particular, they introduce a variety of uncertainties to system planning. New techniques are required to cope with such uncertainties. As a promising approach, probabilistic methods are attracting more and more attentions by system planners. In small signal stability analysis, generation control parameters play an important role in determining the stability margin. The objective of this paper is to investigate power system state matrix sensitivity characteristics with respect to system parameter uncertainties with analytical and numerical approaches and to identify those parameters have great impact on system eigenvalues, therefore, the system stability properties. Those identified parameter variations need to be investigated with priority. The results can be used to help Regional Transmission Organizations (RTOs) and Independent System Operators (ISOs) perform planning studies under the open access environment.