Computer touch-screen QOL questionnaires were well accepted by cancer patients, with good data quality and reliability.

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In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmaco-vigilance. In 2003, a group of statisticians, pharmaco-epidemiologists and pharmaco-vigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmaco-vigilance methods. Perspectives from both the FDA and the industry are provided. Data mining is a potentially useful adjunct to traditional pharmaco-vigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.

The results suggest that cholesterol lowering itself is beneficial but that specific adverse effects of fibrates and hormones increase the risk of CHD (hormones only), non-CHD, and total mortality.

The Hospital Anxiety and Depression Scale (HADS) is widely used as a tool for assessing psychological distress in patients and non-clinical groups. Previous studies have demonstrated conflicting results regarding the factor structure of the questionnaire for different groups of patients, and the general population. This study investigated the factor structure of the HADS in a large heterogeneous cancer population of 1474 patients. It also sought to investigate emerging evidence that the HADS conforms to the tripartite model of anxiety and depression (Clark & Watson, 1993), and to test the proposal that detection rates for clinical cases of anxiety and depression could be enhanced by partialling out the effects of higher order factors from the HADS (Dunbar et al., 2000). The results demonstrated a two-factor structure corresponding to the Anxiety and Depression subscales of the questionnaire. The factor structure remained stable for different subgroups of the sample, for males and females, as well as for different age groups, and a subgroup of metastatic cancer patients. The two factors were highly correlated (r =.52) and subsequent secondary factor analyses demonstrated a single higher order factor corresponding to psychological distress or negative affectivity. We concluded that the HADS comprises two factors corresponding to anhedonia and autonomic anxiety, which share a common variance with a primary factor namely psychological distress, and that the subscales of the HADS, rather than the residual scores (e.g. Dunbar et al., 2000) were more effective at detecting clinical cases of anxiety and depression.

Background-We determined the effect of incorporating the results of eight recently published trials of Hmg CoA reductase inhibitors ("statins") on the conclusions from our previously published meta-analysis regarding the clinical benefit of cholesterol lowering. Methods and Results-We used the same analytic approach as in our previous investigation, separating the specific effects of cholesterol lowering from the effects attributable to the different types of intervention studied. The reductions in coronary heart disease (CHD) and total mortality risk observed for the statins fell near the predictions from our earlier meta-analysis. Including the statin trial findings into the calculations led to a prediction that for every 10 percentage points of cholesterol lowering, CHD mortality risk would be reduced by 15% (PϽ.001), and total mortality risk would be reduced by 11% (PϽ.001), as opposed to the values of 13% and 10%, respectively, reported previously. Cholesterol lowering in general and by the statins in particular does not increase non-CHD mortality risk. Conclusions-Adding the results from the statin trials confirmed our original conclusion that lowering cholesterol is clinically beneficial. The relationships (slope) between cholesterol lowering and reduction in CHD and total mortality risk became stronger, and the standard error of the estimated slopes decreased by about half. Use of statins does not increase non-CHD mortality risk. The effect of the statins on CHD and total mortality risk can be explained by their lipid-lowering ability and appears to be directly proportional to the degree to which they lower lipids. (Circulation. 1998;97:946-952.)

Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.