Semantic security: specification and enforcement of semantic policies for security-driven collaborations

Collaborative research can often have demands on finer-grained security that go beyond the authentication-only paradigm as typified by many e-Infrastructure/Grid based solutions. Supporting finer-grained access control is often essential for domains where the specification and subsequent enforcement of authorization policies is needed. The clinical domain is one area in particular where this is so. However it is the case that existing security authorization solutions are fragile, inflexible and difficult to establish and maintain. As a result they often do not meet the needs of real world collaborations where robustness and flexibility of policy specification and enforcement, and ease of maintenance are essential. In this paper we present results of the JISC funded Advanced Grid Authorisation through Semantic Technologies (AGAST) project (www.nesc.ac.uk/hub/projects/agast) and show how semantic-based approaches to security policy specification and enforcement can address many of the limitations with existing security solutions. These are demonstrated into the clinical trials domain through the MRC funded Virtual Organisations for Trials and Epidemiological Studies (VOTES) project (www.nesc.ac.uk/hub/projects/votes) and the epidemiological domain through the JISC funded SeeGEO project (www.nesc.ac.uk/hub/projects/seegeo)

Bayesian regression discontinuity designs: Incorporating clinical knowledge in the causal analysis of primary care data

The regression discontinuity (RD) design is a quasi-experimental design that estimates the causal effects of a treatment by exploiting naturally occurring treatment rules. It can be applied in any context where a particular treatment or intervention is administered according to a pre-specified rule linked to a continuous variable. Such thresholds are common in primary care drug prescription where the RD design can be used to estimate the causal effect of medication in the general population. Such results can then be contrasted to those obtained from randomised controlled trials (RCTs) and inform prescription policy and guidelines based on a more realistic and less expensive context. In this paper we focus on statins, a class of cholesterol-lowering drugs, however, the methodology can be applied to many other drugs provided these are prescribed in accordance to pre-determined guidelines. NHS guidelines state that statins should be prescribed to patients with 10 year cardiovascular disease risk scores in excess of 20%. If we consider patients whose scores are close to this threshold we find that there is an element of random variation in both the risk score itself and its measurement. We can thus consider the threshold a randomising device assigning the prescription to units just above the threshold and withholds it from those just below. Thus we are effectively replicating the conditions of an RCT in the area around the threshold, removing or at least mitigating confounding. We frame the RD design in the language of conditional independence which clarifies the assumptions necessary to apply it to data, and which makes the links with instrumental variables clear. We also have context specific knowledge about the expected sizes of the effects of statin prescription and are thus able to incorporate this into Bayesian models by formulating informative priors on our causal parameters.Comment: 21 pages, 5 figures, 2 table

Looking inside the black box : a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM) to improve referral and prescribing practices in primary care in Ontario, Canada

Background: Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths). This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs. Methods/design: We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the relationships between predictor and dependent variable (intention to advise diabetic patients to have annual retinopathy screening and to prescribe thiazide diuretics for first line treatment of uncomplicated hypertension). We will then compare groups using methods appropriate for comparing independent samples to determine whether there have been changes in the predicted constructs (attitudes, subjective norms, or intentions) across the study groups as hypothesised, and will assess the convergence between the process evaluation results and the main trial results.The OPEM trial and OPEM process evaluation are funded by the Canadian Institute of Health Research (CIHR). The OPEM process evaluation study was developed as part of the CIHR funded interdisciplinary capacity enhancement team KT-ICEBeRG. Gaston Godin, Jeremy Grimshaw and France Légaré hold Canada Research Chairs. Louise Lemyre holds an R.S. McLaughlin Research Chair

The impact of public basic research on industrial innovation: Evidence from the pharmaceutical industry

While most economists believe that public scientific research fuels industry innovation and economic growth, systematic evidence supporting this relationship is surprisingly limited. In a recent study, Acemoglu and Linn (2004) identified market size as a significant driver of drug innovation in the pharmaceutical industry, but they did not find any evidence supporting science-driven innovation from publicly funded research. This paper uses new data on biomedical research investments by the U.S. National Institutes of Health (NIH) to examine the contribution of public research to pharmaceutical innovation. The empirical analysis finds that both market size and NIH funded basic research have economically and statistically significant effects on the entry of new drugs with the contribution of public basic research coming in the earliest stage of pharmaceutical drug discovery. The analysis also finds a positive return to public investment in basic biomedical research. --R&D,NIH,social return,biomedical,research lags,public science,new molecular entities

Designing theoretically-informed implementation interventions.

Canadian Institutes of Health Research; Ontario Ministry of Healt

Designing theoretically-informed implementation interventions

Clinical and health services research is continually producing new findings that may contribute to effective and efficient patient care. However, the transfer of research findings into practice is unpredictable and can be a slow and haphazard process. Ideally, the choice of implementation strategies would be based upon evidence from randomised controlled trials or systematic reviews of a given implementation strategy. Unfortunately, reviews of implementation strategies consistently report effectiveness some, but not all of the time; possible causes of this variation are seldom reported or measured by the investigators in the original studies. Thus, any attempts to extrapolate from study settings to the real world are hampered by a lack of understanding of the effects of key elements of individuals, interventions, and the settings in which they were trialled. The explicit use of theory offers a way of addressing these issues and has a number of advantages, such as providing: a generalisable framework within which to represent the dimensions that implementation studies address, a process by which to inform the development and delivery of interventions, a guide when evaluating, and a way to allow for an exploration of potential causal mechanisms. However, the use of theory in designing implementation interventions is methodologically challenging for a number of reasons, including choosing between theories and faithfully translating theoretical constructs into interventions. The explicit use of theory offers potential advantages in terms of facilitating a better understanding of the generalisability and replicability of implementation interventions. However, this is a relatively unexplored methodological area

On the design of knowledge tranfer mechanism: applying the incomplete contracts model to developments in biotechnology.

This paper proposes a framework on how different mechanisms for knowledge transfer can be linked to the underlying technological life-cycle. Drawing on recent insights from the organizational economics literature, we analyze the design of knowledge transfer mechanisms and structures from an incentive point of view. The basic version of the incomplete contracts model (or property rights model) was adapted to include knowledge as an asset. Several empirical hypotheses can be derived from this model. They are contrasted with other theoretical approaches to model organizational growth and development, as we are specifically interested in the use of new ventures creation as a technology transfer mechanism. Using this framework as a starting point, a limited empirical test is two sub-fields of modern biotechnology : monoclonal antibodies and protein engineering. The results are interesting: the property rights model may add to current insights on spin-offs as a mechanism for knowledge transfer as well as to a better understanding of the incentive structures that influence an organization's decision to enter a technological collaboration with a university or another biotech firm.Model; Knowledge; Biotechnology;