Should data monitoring committees assess efficacy when considering safety in trails in acute stroke?

The primary role of a trials Data Monitoring Committee (DMC) is to ensure the safety of enrolled patients. In stroke trials, safety is monitored typically by comparing death and stroke specific events between treatment groups. DMCs may also have the remit for monitoring efficacy depending on the aims of the trial. We hypothesised that functional outcome at end of follow-up, a measure of efficacy, is also a powerful measure of safety and tested this in a systematic review

A Novel Run-Time Monitoring Architecture for Safe and Efficient Inline Monitoring

20th International Conference on Reliable Software Technologies - Ada-Europe 2015 (Ada-Europe 2015), Madrid, Spain.

Run-time Monitoring Architecture for RealTime Systems

Presented at INForum - Simpósio de Informática (INFORUM 2015). 7 to 8, Sep, 2015. Portugal.

Genetic algorithm for shipping route estimation with long-range tracking data : automatic reconstruction of shipping routes based on the historical ship positions for maritime safety applications

Ship tracking systems allow Maritime Organizations that are concerned with the Safety at Sea to obtain information on the current location and route of merchant vessels. Thanks to Space technology in recent years the geographical coverage of the ship tracking platforms has increased significantly, from radar based near-shore traffic monitoring towards a worldwide picture of the maritime traffic situation. The long-range tracking systems currently in operations allow the storage of ship position data over many years: a valuable source of knowledge about the shipping routes between different ocean regions. The outcome of this Master project is a software prototype for the estimation of the most operated shipping route between any two geographical locations. The analysis is based on the historical ship positions acquired with long-range tracking systems. The proposed approach makes use of a Genetic Algorithm applied on a training set of relevant ship positions extracted from the long-term storage tracking database of the European Maritime Safety Agency (EMSA). The analysis of some representative shipping routes is presented and the quality of the results and their operational applications are assessed by a Maritime Safety expert.

Implementation of a probabilistic based framework for safety assessment of existing timber elements

The assessment of existing timber structures is often limited to information obtained from non or semi destructive testing, as mechanical testing is in many cases not possible due to its destructive nature. Therefore, the available data provides only an indirect measurement of the reference mechanical properties of timber elements, often obtained through empirical based correlations. Moreover, the data must result from the combination of different tests, as to provide a reliable source of information for a structural analysis. Even if general guidelines are available for each typology of testing, there is still a need for a global methodology allowing to combine information from different sources and infer upon that information in a decision process. In this scope, the present work presents the implementation of a probabilistic based framework for safety assessment of existing timber elements. This methodology combines information gathered in different scales and follows a probabilistic framework allowing for the structural assessment of existing timber elements with possibility of inference and updating of its mechanical properties, through Bayesian methods. The probabilistic based framework is based in four main steps: (i) scale of information; (ii) measurement data; (iii) probability assignment; and (iv) structural analysis. In this work, the proposed methodology is implemented in a case study. Data was obtained through a multi-scale experimental campaign made to old chestnut timber beams accounting correlations of non and semi-destructive tests with mechanical properties. Finally, different inference scenarios are discussed aiming at the characterization of the safety level of the elements.

Médicaments et grossesse : modifications pharmacocinétiques et place du suivi thérapeutique pharmacologique [Pharmacokinetic Alterations in Pregnancy and Use of Therapeutic Drug Monitoring].

Following the thalidomide tragedy, pharmacological research in pregnant women focused primarily on drug safety for the unborn child and remains only limited regarding the efficacy and safety of treatment for the mother. Significant physiological changes during pregnancy may yet affect the pharmacokinetics of drugs and thus compromise its efficacy and/or safety. Therapeutic drug monitoring (TDM) would maximize the potential effectiveness of treatments, while minimizing the potential risk of toxicity for the mother and the fetus. At present, because of the lack of concentration-response relationship studies in pregnant women, TDM can rely only on individual assessment (based on an effective concentration before pregnancy) and remains reserved only to unexpected situations such as signs of toxicity or unexplained inefficiency.

Inequalities Monitoring Update Second Bulletin 2007 (PDF 1952 KB)

Despite some relative improvements, there is a continuing health gap between the most deprived areas and NI overall. This is most evident in the potential years of life lost, infant mortality rates, teenage births, standardised admission rates to hospitals and cancer incidence rates indicators. The suicide rate within deprived areas, although still considerably higher (almost 50% higher), is now closer to the overall NI rate. Despite the reduction in the inequality gap, there was a recent increase in the number of deaths attributed to suicide across all areas. The extent to which this increase in suicides actually indicates an increase in the problem or it is due to recording/reporting practices changing over time has not been established. Life expectancy has been increasing in recent years for both males and females in both deprived areas and NI overall and there is no evidence of a narrowing of the inequality gap. The gap between deprived areas and Northern Ireland was maintained for circulatory and respiratory standardised death rates. The gap between the proportion of the deprived population suffering from a mood or anxiety disorder and that in NI overall has also remained fairly steady. Deprived areas actually fared better than NI generally for relative hospital waiting times and ambulance response times (although this may be an urban issue). åÊ

Health And Social Care Inequalities Monitoring System: First Update Bulletin 2004 (PDF 273 KB)

The Inequalities Monitoring System comprises a basket of indicators which are monitored over time to assess area differences in morbidity, utilisation of and access to health and social care services in Northern Ireland. Inequalities between the 20% most deprived electoral wards and Northern Ireland as a whole are measured with deprived areas identified from an update of the Noble Income domain for current ward boundaries. Results for 20% most rural areas were also compared against Northern Ireland overall using population density from the 2001 Census of Population as a measure of rurality. This report is the first annual update of the baseline results presented in Chapter 8 of Equality and Inequalities in Health and Social care in Northern Ireland – A Statistical Overview (DHSSPS 2004) which focused on 2001/2002. The morbidity and utilisation data in this report are the latest available while the locations of services for the accessibility analysis will be updated in subsequent years åÊ

Health and Social Care Inequalities Monitoring System (PDF 273 KB)

The Inequalities Monitoring System comprises a basket of indicators which are monitored over time to assess area differences in morbidity, utilisation of and access to health and social care services in Northern Ireland. Inequalities between the 20% most deprived electoral wards and Northern Ireland as a whole are measured with deprived areas identified from an update of the Noble Income domain for current ward boundaries. Results for 20% most rural areas were also compared against Northern Ireland overall using population density from the 2001 Census of Population as a measure of rurality. This report is the firståÊ annual update of the baseline results presented in Chapter 8 of Equality and Inequalities in Health and Social care in Northern Ireland – A Statistical Overview (DHSSPS 2004) which focused on 2001/2002. The morbidity and utilisation data in this report are the latest available while the locations of services for the accessibility analysis will be updated in subsequent years. åÊ åÊ