The role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers: A double-blind randomised-controlled trial

AbstractObjective: ischaemic lower-extremity ulcers in the diabetic population are a source of major concern because of the associated high risk of limb-threatening complications. The aim of this study was to evaluate the role of hyperbaric oxygen in the management of these ulcers. Method: eighteen diabetic patients with ischaemic, non-healing lower-extremity ulcers were recruited in a double-blind study. Patients were randomly assigned either to receive 100% oxygen (treatment group) or air (control group), at 2.4 atmospheres of absolute pressure for 90 min daily (total of 30 treatments). Results: healing with complete epithelialisation was achieved in five out of eight ulcers in the treatment group compared to one out of eight ulcers in the control group. The median decrease of the wound areas in the treatment group was 100% and in the control group was 52% (p = 0.027). Cost-effectiveness analysis has shown that despite the extra cost involved in using hyperbaric oxygen, there was a potential saving in the total cost of treatment for each patient during the study. Conclusion: hyperbaric oxygen enhanced the healing of ischaemic, non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible.Eur J Vasc Endovasc Surg 25, 513-518 (2003

POSSUM and P-POSSUM overpredict mortality for carotid endarterectomy

Objectives: the aim was to test the predictive accuracy of POSSUM and P-POSSUM on patients undergoing CEA. Design: retrospective and prospective study. Materials: 499 CEAs performed by four vascular surgeons from a single unit from 1992-99. The median age was 68 (range 38-86) and 60% were men. Methods: physiological parameters, operative parameters and the 30-day mortality were collected. Predicted mortality for each patient was calculated using POSSUM and P-POSSUM equations. Patients were stratified into risk groups and observed and predicted deaths were compared. Accuracy of the prediction was assessed using chi-squared analysis. Results: the observed 30-day mortality was 1.8% (9/499). The predicted deaths using POSSUM and P-POSSUM analysis were 49 and 25 respectively compared to nine observed deaths. There was significant evidence of lack of fit of both models in predicting mortality (chi-squared analysis, p<0.05). Conclusions: POSSUM and P-POSSUM overpredict mortality and are unsuitable for comparative audit of CEA. Models developed specific for CEA might accurately predict mortality

Application of the Margin of Exposure (MOE) approach to substances in food that are genotoxic and carcinogenic.

This paper presents the work of an expert group established by the International Life Sciences Institute - European branch (ILSI Europe) to follow up the recommendations of an international conference on "Risk Assessment of Compounds that are both Genotoxic and Carcinogenic: New Approaches". Twelve genotoxic and carcinogenic chemicals that can be present in food were selected for calculation of a Margin of Exposure (MOE) between a point of departure on the dose-response for oral carcinogenicity in animal studies and estimates of human dietary exposure. The MOE can be used to support prioritisation of risk management action and, if the MOE is very large, on communication of a low level of human health concern. Depending on the approaches taken in determining the point of departure and the estimation of exposure, it is possible to derive very different values for the MOE. It is therefore essential that the selection of the cancer endpoint and mathematical treatment of the data are clearly described and justified if the results of the MOE approach are to be trusted and of value to risk managers. An outline framework for calculating an MOE is proposed in order to help to ensure transparency in the results