1,901 research outputs found

    Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

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    AbstractEfficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard

    Digital clinical guidelines modelling

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    Oliveira T., Costa A., Neves J., Novais P., Digital Clinical Guidelines Modelling, Modelling and Simulation 2011, Novais P., Machado J., Analide C., Abelha A., (Eds.) (ESM’2011 – The 2011 European Simulation and Modelling Conference, Guimarães, Portugal) EUROSIS Publisher, ISBN: 978-9077381-66-3, pp 392-398, 2011.Healthcare environments are very demanding, because practitioners are required to consult many patients in a short period of time, increasing the levels of stress which usually harms the outcome of healthcare processes. The short time practitioners have with their patients does not facilitate informed decision making and checking all possibilities. A possible solution is the use of guideline-based applications, because they have the potential of being an effective means of both changing the process of healthcare and improving its outcomes. However, current Clinical Guidelines are available in text format as long documents, which render them difficult to consult and to integrate in clinical Decision Support Systems. With this paper we present a new model for guideline interpretation, in order to facilitate de development of guideline-based Decision Support Systems and to increase the availability of Clinical Guidelines at the moment of the clinical process. This model will also provide mechanisms to comply with cases where incomplete and uncertain information is present. The development and implementation of this model will be presented in the following pages

    Development and implementation of clinical guidelines : an artificial intelligence perspective

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    Clinical practice guidelines in paper format are still the preferred form of delivery of medical knowledge and recommendations to healthcare professionals. Their current support and development process have well identified limitations to which the healthcare community has been continuously searching solutions. Artificial intelligence may create the conditions and provide the tools to address many, if not all, of these limitations.. This paper presents a comprehensive and up to date review of computer-interpretable guideline approaches, namely Arden Syntax, GLIF, PROforma, Asbru, GLARE and SAGE. It also provides an assessment of how well these approaches respond to the challenges posed by paper-based guidelines and addresses topics of Artificial intelligence that could provide a solution to the shortcomings of clinical guidelines. Among the topics addressed by this paper are expert systems, case-based reasoning, medical ontologies and reasoning under uncertainty, with a special focus on methodologies for assessing quality of information when managing incomplete information. Finally, an analysis is made of the fundamental requirements of a guideline model and the importance that standard terminologies and models for clinical data have in the semantic and syntactic interoperability between a guideline execution engine and the software tools used in clinical settings. It is also proposed a line of research that includes the development of an ontology for clinical practice guidelines and a decision model for a guideline-based expert system that manages non-compliance with clinical guidelines and uncertainty.This work is funded by national funds through the FCT – Fundação para a Ciência e a Tecnologia (Portuguese Foundation for Science and Technology) within project PEst-OE/EEI/UI0752/2011"

    Computer-interpretable guidelines using GLIF with Windows workflow foundation

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    Modern medicine is increasingly using evidence based medicine (EBM). EBM has become an integral part of medical training and ultimately on practice. Davis et al. [6] describe the “clinical care gap” where actual day-to-day clinical practice differs from EBC, leading to poor outcomes. This thesis researches the GLIF specification and implements the foundation for a GLIF based guideline system using Windows Workflow Foundation 4.0. There exists no public domain computer implementable guideline system. The guideline system developed allows a guideline implementer to create a guideline visually using certain medical related tasks, and to test and debug them before implementation. Chapter 5 of this thesis shows how to implement a guideline called Group A Streptococcal Disease Surveillance Protocol for Ontario Hospitals which is of fundamental importance for Ontario hospitals. The workflow approach allows developers to create custom tasks should the need arise. The Workflow Foundation provides a powerful set of base classes to implement clinical guidelines.Master's These

    Interoperable intelligent environmental decision support systems: a framework proposal

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    In this paper, an approach for the development of Interoperable Intelligent Environmental Decision Support Systems (IEDSS) is proposed. The framework is based upon the cognitive-oriented approach for the development of IEDSS proposed in (Sànchez-Marrè et al., 2008), where three kind of tasks must be built: analysis tasks, synthesis tasks and prognosis tasks. Now, a fourth level will be proposed: the model construction layer, which is normally an off-line task. At each level, interoperability should be possible and inter-level interoperability must be als o achieved. This interoperability is proposed to be obtained using data interchange protocols like Predictive Model Markup Language (PMML), which is a model interc hange protocol based on XML language, using an ontology of data and AI models to characterize data types and AI models and to set-up a common terminology, and using workflows of the whole interoperation scheme. In the future, a Multi-Agent System will be used to implement the software components. An example of use of the pro posed methodology applied to the supervision of a Wastewater Treatment Plant is provided. This Interoperable IEDSS framework will be the first step to an actual interoperability of AI models which will make IEDSS more reliable and accurate to solve complex environmental problems.Peer ReviewedPostprint (published version

    DCCSS:a meta-model for dynamic clinical checklist support systems

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    Clinical safety checklists receive much research attention since they can reduce medical errors and improve patient safety. Computerized checklist support systems are also being developed actively. Such systems should individualize checklists based on information from the patient’s medical record while also considering the context of the clinical workflows. Unfortunately, the form definitions, database queries and workflow definitions related to dynamic checklists are too often hard-coded in the source code of the support systems. This increases the cognitive effort for the clinical stakeholders in the design process, it complicates the sharing of dynamic checklist definitions as well as the interoperability with other information systems. In this paper, we address these issues by contributing the DCCSS meta-model which enables the model-based development of dynamic checklist support systems. DCCSS was designed as an incremental extension of standard meta-models, which enables the reuse of generic model editors in a novel setting. In particular, DCCSS integrates the Business Process Model and Notation (BPMN) and the Guideline Interchange Format (GLIF), which represent best of breed languages for clinical workflow modeling and clinical rule modeling respectively. We also demonstrate one of the use cases where DCCSS has already been applied in a clinical setting

    Towards a Learning Health System: a SOA based platform for data re-use in chronic infectious diseases

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    Abstract Information and Communication Technology (ICT) tools can efficiently support clinical research by providing means to collect automatically huge amount of data useful for the management of clinical trials conduction. Clinical trials are indispensable tools for Evidence-Based Medicine and represent the most prevalent clinical research activity. Clinical trials cover only a restricted part of the population that respond to particular and strictly controlled requirements, offering a partial view of the overall patients\u2019 status. For instance, it is not feasible to consider patients with comorbidities employing only one kind of clinical trial. Instead, a system that have a comprehensive access to all the clinical data of a patient would have a global view of all the variables involved, reflecting real-world patients\u2019 experience. The Learning Health System is a system with a broader vision, in which data from various sources are assembled, analyzed by various means and then interpreted. The Institute of Medicine (IOM) provides this definition: \u201cIn a Learning Health System, progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care\u201d. The final goal of my project is the realization of a platform inspired by the idea of Learning Health System, which will be able to re-use data of different nature coming from widespread health facilities, providing systematic means to learn from clinicians\u2019 experience to improve both the efficiency and the quality of healthcare delivery. The first approach is the development of a SOA-based architecture to enable data collection from sparse facilities into a single repository, to allow medical institutions to share information without an increase in costs and without the direct involvement of users. Through this architecture, every single institution would potentially be able to participate and contribute to the realization of a Learning Health System, that can be seen as a closed cycle constituted by a sequential process of transforming patient-care data into knowledge and then applying this knowledge to clinical practice. Knowledge, that can be inferred by re-using the collected data to perform multi-site, practice-based clinical trials, could be concretely applied to clinical practice through Clinical Decision Support Systems (CDSS), which are instruments that aim to help physicians in making more informed decisions. With 4 this objective, the platform developed not only supports clinical trials execution, but also enables data sharing with external research databases to participate in wider clinical trials also at a national level without effort. The results of these studies, integrated with existing guidelines, can be seen as the knowledge base of a decision support system. Once designed and developed, the adoption of this system for chronical infective diseases management at a regional level helped in unifying data all over the Ligurian territory and actively monitor the situation of specific diseases (like HIV, HCV and HBV) for which the concept of retention in care assumes great importance. The use of dedicated standards is essential to grant the necessary level of interoperability among the structures involved and to allow future extensions to other fields. A sample scenario was created to support antiretroviral drugs prescription in the Ligurian HIV Network setting. It was thoroughly tested by physicians and its positive impact on clinical care was measured in terms of improvements in patients\u2019 quality of life, prescription appropriateness and therapy adherence. The benefits expected from the employment of the system developed were verified. Student\u2019s T test was used to establish if significant differences were registered between data collected before and after the introduction of the system developed. The results were really acceptable with the minimum p value in the order of 10 125 and the maximum in the order of 10 123. It is reasonable to assess that the improvements registered in the three analysis considered are ascribable to this system introduction and not to other factors, because no significant differences were found in the period before its release. Speed is a focal point in a system that provides decision support and it is highly recognized the importance of velocity optimization. Therefore, timings were monitored to evaluate the responsiveness of the system developed. Extremely acceptable results were obtained, with the waiting times of the order of 10 121 seconds. The importance of the network developed has been widely recognized by the medical staff involved, as it is also assessed by a questionnaire they compiled to evaluate their level of satisfaction

    Towards computerizing intensive care sedation guidelines: design of a rule-based architecture for automated execution of clinical guidelines

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    <p>Abstract</p> <p>Background</p> <p>Computerized ICUs rely on software services to convey the medical condition of their patients as well as assisting the staff in taking treatment decisions. Such services are useful for following clinical guidelines quickly and accurately. However, the development of services is often time-consuming and error-prone. Consequently, many care-related activities are still conducted based on manually constructed guidelines. These are often ambiguous, which leads to unnecessary variations in treatments and costs.</p> <p>The goal of this paper is to present a semi-automatic verification and translation framework capable of turning manually constructed diagrams into ready-to-use programs. This framework combines the strengths of the manual and service-oriented approaches while decreasing their disadvantages. The aim is to close the gap in communication between the IT and the medical domain. This leads to a less time-consuming and error-prone development phase and a shorter clinical evaluation phase.</p> <p>Methods</p> <p>A framework is proposed that semi-automatically translates a clinical guideline, expressed as an XML-based flow chart, into a Drools Rule Flow by employing semantic technologies such as ontologies and SWRL. An overview of the architecture is given and all the technology choices are thoroughly motivated. Finally, it is shown how this framework can be integrated into a service-oriented architecture (SOA).</p> <p>Results</p> <p>The applicability of the Drools Rule language to express clinical guidelines is evaluated by translating an example guideline, namely the sedation protocol used for the anaesthetization of patients, to a Drools Rule Flow and executing and deploying this Rule-based application as a part of a SOA. The results show that the performance of Drools is comparable to other technologies such as Web Services and increases with the number of decision nodes present in the Rule Flow. Most delays are introduced by loading the Rule Flows.</p> <p>Conclusions</p> <p>The framework is an effective solution for computerizing clinical guidelines as it allows for quick development, evaluation and human-readable visualization of the Rules and has a good performance. By monitoring the parameters of the patient to automatically detect exceptional situations and problems and by notifying the medical staff of tasks that need to be performed, the computerized sedation guideline improves the execution of the guideline.</p
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