Thèse : Médecine : Paris : 1821. / N° d'ordre : n°92.

The purpose of this study is to develop a method to qualitatively and quantitatively measure and assess the field testing of a diagnostic tool by identifying the parameters that are relevant to assess a field test. The study is conducted at Scania CV AB, Södertälje, Sweden, a world leading manufacturer of trucks, buses and industrial and marine engines, where a method to assess the field test of their diagnostic currently does not exist. The study follows a deductive approach while taking a positivistic and hermeneutic perspective. The relevant theories and literature such as quality development and software testing are described to give a better understanding of the study. The study is conducted in four main steps- description of present situation, situation analysis, development of the assessment approach or framework and evaluation of the framework. The empirical information gathered from numerous interviews and meetings is presented in the description of present situation along with the various data sources available. The collected data from different databases is analysed where hypotheses are formulated based on the different influencing parameters for field testing. The correlations between the parameters are then calculated and analysed to verify the hypothesis as True or False. The ECU updates are also analysed to show that the ECU updates performed during field testing is a good representation of the actual usage after release. The framework to assess the field test is then developed using the available data and analysis made. A holistic view is taken to include the processes before and after the field test in the framework. The framework is in the form of an Excel workbook where data is either copied from databases or manually entered and relevant graphs describing the field test are generated automatically. The time period to be displayed on the graphs can be selected manually. This gives a good base to take decisions about how a field test has gone and whether or not the software is ready for release. Based on the correlation of the different parameters, a table with different key values of how much field test usage that should be conducted based on the number of implemented change requests are presented. Thus the result is that the most important attributes to consider for a field test are the amount of implemented changes where each field test usage occasion increases the chance of finding potential faults in the software of the diagnostic tool. An unrestricted framework is also described using data that may be available, but currently difficult to utilise effectively. Thus the recommended future work is represented by this framework which describes what information that can be obtained from different data sources and how they can be used to get a detailed understanding of what exactly has been used during field testing as well as after the software has been released. The framework is assessed in the last step and its uses along with limitations are described.  The difficulty in describing the success of software testing is also discussed to give a good context to the framework and understand its utility.

There are two Gadolinium-based liver-specific contrast media for Magnetic Resonance Imaging on the market, Gd-BOPTA (MultiHance®, Bracco Imaging, Milan, Italy) and Gd-EOB-DTPA (Primovist®, Bayer Schering Pharma, Berlin, Germany). The aim of this study in two parts was to evaluate the dynamics of biliary, parenchymal and vascular enhancement using these contrast media in healthy subjects. Ten healthy volunteers were examined in a 1.5 T magnetic resonance system using three-dimensional Volumetric Interpolated Breath-Hold (VIBE) sequences for dynamic imaging with both contrast media – at two different occasions – until five hours after injection. The doses given were 0.025 mmol/kg for Gd-EOB-DTPA and 0.1 mmol/kg for Gd-BOPTA. The enhancement over time of the common biliary duct in contrast to the liver parenchyma was analyzed in the first study. This was followed by a study of the image contrasts of the hepatic artery, portal vein and middle hepatic vein versus the liver parenchyma.While Gd-EOB-DTPA gave an earlier and more prolonged enhancement of the biliary duct, Gd-BOPTA achieved higher image contrast for all vessels studied, during the arterial and portal venous phases. There was no significant difference in the maximal enhancement obtained in the liver parenchyma.At the obtained time-points and at the dosage used, the high contrast between the common biliary duct and liver parenchyma had an earlier onset and longer duration for Gd-EOB-DTPA, while Gd-BOPTA achieved higher maximal enhancement of the hepatic artery, portal vein and middle hepatic vein than Gd-EOB-DTPA. Diseases of the liver and biliary system may affect the vasculature, parenchyma, biliary excretion or a combination of these. The clinical context regarding the relative importance of vascular, hepatic parenchymal and biliary processes should determine the choice of contrast media for each patient and examination.

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Kidney transplants from both living-related (LRD) and living unrelated (LURD) donors have superior function and survival than transplants from cadaver donors. This may be unsurprising as kidneys from living donors are procured under optimal conditions, from healthy donors with minimal ischaemia times. In contrast, cadaver kidneys are obtained from traumatised donors and may experience extended periods of cold ischaemic storage before transplantation. An immunohistochemical analysis has been performed on biopsies obtained before, and immediately after transplantation, to investigate the potential causes of early inflammatory events associated with cadaver renal transplantation that may influence subsequent graft outcome. An immunohistochemical analysis of biopsies obtained before transplantation demonstrated upregulated expression of endothelial E-selectin and proximal tubular expression of ICAM-1, VCAM-1 and HLA Class II antigens in cadaver donor kidneys. Analysis of donor parameters demonstrated that traumatic physiological events experienced in intensive care around the time of brain death were significantly associated with the induction of proinflammatory antigens. Antigen induction in cadaver donor kidneys before transplantation was significantly associated with early acute rejection. Furthermore, in cadaveric kidneys with long cold ischaemia times, glomerular neutrophil infiltration and deposition of activated platelets expressing P-selectin on intertubular capillaries were detected following reperfusion, in association with impaired short and long term graft function. Expression of inflammatory mediators were absent in all LRD renal allografts before and after reperfusion. A clinical trial was performed to determine whether ischaemia/reperfusion injury may be ameliorated by reflushing cadaver kidneys after cold storage to remove harmful products that may have accumulated in the vessel lumen. Reflushing did not prevent the inflammatory events observed after reperfusion or improve graft function. Therefore, a novel, oxygen free radical scavenger (lec-SOD) was obtained to assess its potential efficacy in preventing ischaemia/reperfusion injury. Lec-SOD bound with high affinity to macro- and microvascular endothelial cells under cold hypoxic conditions following incorporation into Marshall's preservation solution, significantly inhibiting cold hypoxia induced cell death, adhesion molecule induction and neutrophil adhesion. Furthermore, preservation of kidneys with lec- SOD for 18 hr in an experimental model of chronic renal allograft rejection, significantly attenuated neutrophil infiltration and MHC Class I induction day 1 post-transplant, with improved long term renal function. The results presented in this Thesis demonstrate that donor factors and cold ischaemia/ reperfusion injury elicit an early inflammatory response that may influence graft outcome of cadaver kidneys. Refinements in donor management and organ preservation may limit the deleterious effects of ischaemia/reperfusion injury in cadaver renal allografts, increasing graft survival to that observed in living donor transplantation.

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